PART He-P 4030 LICENSING OF RADIOACTIVE MATERIAL

PART He-P 4023 WASTE DISPOSAL

Statutory Authority RSA 125-F:5,V

He-P 4023.01 Disposal Requirements.

(a) A licensee shall dispose of radioactive material only:

(1) By transfer to an authorized recipient as provided in He-P 4023.06 or in He-P 4030 or to the U.S. Department of Energy;

(2) By decay in storage;

(3) By release in effluents within the limits in He-P 4020.14; or

(4) As authorized pursuant to He-P 4023.02, He-P 4023.03, He-P 4023.04, He-P 4023.05, or He-P 4023.08.

(b) A person shall have a specific license to receive waste containing licensed material from other persons for:

(1) Treatment prior to disposal;

(2) Treatment or disposal by incineration;

(3) Decay in storage;

(4) Disposal at a land disposal facility licensed pursuant to He-P 4062; or

(5) Storage until transferred to a storage or disposal facility authorized to receive the waste.

Source. #5903, eff 2-1-95; ss by #6827, eff 8-6-98; ss by #8481, eff 11-5-05; ss by #10604, eff 5-23-14

He-P 4023.02 Method for Obtaining Approval of Proposed Disposal Procedures.

(a) A licensee or applicant for a license may apply to the DHHS/RHS in accordance with He-P 4030 for approval of proposed procedures to dispose of licensed material generated in the licensee's operations.

(b) Each application shall include:

(1) A description of the waste containing licensed material to be disposed of, including the physical and chemical properties that have an impact on risk evaluation, and the proposed manner and conditions of waste disposal;

(2) An analysis and evaluation of pertinent information on the nature of the environment;

(3) The nature and location of other potentially affected licensed and unlicensed facilities; and

(4) Analyses and procedures to ensure that doses are maintained ALARA and within the dose limits in He-P 4020.

Source. #5903, eff 2-1-95; ss by #6827, eff 8-6-98; ss by #8481, eff 11-5-05; ss by #10604, eff 5-23-14

He-P 4023.03 Disposal by Release into Sanitary Sewerage.

(a) A licensee may discharge licensed material into sanitary sewerage if each of the following conditions is satisfied:

(1) The material is readily soluble, or is readily dispersible biological material, in water;

(2) The quantity of licensed or other radioactive material that the licensee releases into the sewer in one month divided by the average monthly volume of water released into the sewer by the licensee does not exceed the concentration listed in Table 4090.1, Table III of He-P 4090;

(3) If more than one radionuclide is released:

a. The licensee shall determine the fraction of the limit in Table 4090.1, Table III of He-P 4090 represented by discharges into sanitary sewerage by dividing the actual monthly average concentration of each radionuclide released by the licensee into the sewer by the concentration of that radionuclide listed in Table 4090.1, Table III of He-P 4090; and

b. The sum of the fractions for each radionuclide required by He-P 4023.03(a)(3)a. shall not exceed unity; and

(4) The total quantity of licensed and other radioactive material that the licensee releases into the sanitary sewerage in a year does not exceed 185 GBq (5 Ci) of hydrogen-3, 37 GBq (1 Ci) of carbon-14, and 37 GBq (1 Ci) of all other radioactive materials combined.

(b) Excreta from individuals undergoing medical diagnosis or therapy with radioactive material shall not be subject to the limitations contained in He-P 4023.03(a).

Source. #5903, eff 2-1-95; ss by #6827, eff 8-6-98; ss by #8481, eff 11-5-05; ss by #10604, eff 5-23-14

He-P 4023.04 Treatment or Disposal by Incineration. A licensee may treat or dispose of licensed material by incineration only in the form and concentration specified in He-P 4023.05 or as specifically approved by the DHHS/RHS pursuant to He-P 4023.02.

Source. #5903, eff 2-1-95; ss by #6827, eff 8-6-98; ss by #8481, eff 11-5-05; ss by #10604, eff 5-23-14

He-P 4023.05 Disposal of Specific Wastes.

(a) A licensee shall dispose of the following licensed material as if it were not radioactive:

(1) 1.85 kBq (0.05 mCi), or less, of hydrogen-3 or carbon-14 per gram of medium used for liquid scintillation counting; and

(2) 1.85 kBq (0.05 mCi), or less, of hydrogen-3 or carbon-14 per gram of animal tissue, averaged over the weight of the entire animal.

(b) A licensee shall not dispose of tissue having been treated with radioactive material pursuant to He-P 4023.05(a)(2) in a manner that would permit its use either as food for humans or as animal feed.

Source. #5903, eff 2-1-95; ss by #6827, eff 8-6-98; ss by #8481, eff 11-5-05; ss by #10604, eff 5-23-14

He-P 4023.06 Transfer for Disposal and Manifests.

(a) This section shall:

(1) Control transfers of low-level radioactive waste by any waste generator, waste collector, or waste processor licensee who ships low-level waste either directly, or indirectly through a waste collector or waste processor, to a licensed low-level waste land disposal facility as defined in He-P 4003;

(2) Establish a manifest tracking system; and

(3) Supplement existing requirements concerning transfers and recordkeeping for those wastes.

(b) Any licensee shipping radioactive waste intended for ultimate disposal at a licensed land disposal facility shall document the information required on NRC’s Uniform Low-Level Radioactive Waste Manifest and transfer this recorded manifest information to the intended consignee in accordance with Appendix G to 10 CFR 20.

(c) Each shipment manifest shall include a certification by the waste generator as specified in Appendix G to 10 CFR 20, as appropriate.

(d) Each person involved in the transfer of waste for disposal or in the disposal of waste, including the waste generator, waste collector, waste processor, and disposal facility operator, shall comply with the requirements specified in Appendix G to 10 CFR 20, as appropriate.

(e) Any licensee shipping byproduct material, as defined in He-P 4003.01(v)(3), (4), and (5), intended for ultimate disposal at a land disposal facility under 10 CFR 61 shall document the information required on the NRC’s Uniform Low-Level Radioactive Waste Manifest and transfer this recorded manifest information to the intended consignee in accordance with He-P 4023.06.

Source. #5903, eff 2-1-95; ss by #6827, eff 8-6-98; ss by #8481, eff 11-5-05; ss by #10604, eff 5-23-14

He-P 4023.07 Compliance with Environmental and Health Protection Regulations. Nothing in He-P 4023.01, He-P 4023.02, He-P 4023.03, He-P 4023.04, He-P 4023.05, He-P 4023.06 or He-P 4023.08 shall relieve the licensee from complying with other applicable federal, state and local regulations or rules governing any other toxic or hazardous properties of materials that may be disposed of under He-P 4023.01, He-P 4023.02, He-P 4023.03, He-P 4023.04, He-P 4023.05, He-P 4023.06 or He-P 4023.08.

Source. #5903, eff 2-1-95; ss by #6827, eff 8-6-98; ss by #8481, eff 11-5-05; ss by #10604, eff 5-23-14

He-P 4023.08 Disposal of Certain Byproduct Material.

(a) Licensed material, as defined in He-P 4003.01(v)(3), (4), and (5), may be disposed of in accordance with 10 CFR 61, even though it is not defined as low-level radioactive waste. Therefore, any licensed byproduct material being disposed of at a facility, or transferred for ultimate disposal at a facility licensed under 10 CFR 61, shall meet the requirements of He-P 4023.06.

(b) A licensee may dispose of byproduct material, as defined in He-P 4003.01(v)(3), (4) and (5), at a disposal facility authorized to dispose of such material in accordance with any applicable federal, state or local rules and regulations or hazardous waste law, including the Solid Waste Disposal Act, as authorized under the Energy Policy Act of 2005.

Source. #10604, eff 5-23-14

Part He-P 4024 DECOMMISSIONING

Statutory Authority RSA 125-F:5,V

He-P 4024.01 Purpose.

(a) This part provides for removing safely from service a facility or site having radioactive material, a radiation-producing or radioactivity-inducing machine pursuant to He-P 4030 through 4036, 4039, 4040, 4044, and 4047.

(b) The purpose of this part is to conform with 10 CFR 20.1401 – 20.1406, 30.35, 30.36, 40.36, 40.42, 70.25, and 70.38.

Source. #8393, eff 7-23-05; ss by #10492, eff 12-24-13

He-P 4024.02 Scope. This part shall apply to any person licensed to receive, possess, own, acquire, use, process, transfer or dispose of radioactive material, and to any person responsible for decommissioning a facility or site.

Source. #8393, eff 7-23-05; ss by #10492, eff 12-24-13

He-P 4024.03 Exemptions. The following licensees shall be exempt from this part:

(a) Low-level waste disposal facility licensees under this chapter including ancillary facilities that support radioactive waste management and disposal activities; and

(b) Uranium and thorium recovery facility licensees under this chapter, or uranium solution extraction facilities.

Source. #8393, eff 7-23-05; ss by #10492, eff 12-24-13

He-P 4024.04 Minimization of Contamination. Applicants for licenses, other than renewals, shall describe in the application how facility design and procedures for operation shall:

(a) Minimize, to the extent practicable, contamination of the facility and the environment;

(b) Facilitate eventual decommissioning;

(d) Conduct, to the extent practical, operations to minimize the introduction of residual radioactivity into the site, including the subsurface, in accordance with the existing radiation protection requirements in He-P 4020.04 and radiological criteria for license termination in He-P 4024.04, He-P 4024.09, He-P 4024.10, He-P 4024.11, and He-P 4024.13.

Source. #8393, eff 7-23-05; ss by #10492, eff 12-24-13

He-P 4024.05 Continuation of Licenses Beyond Expiration Date.

(a) In accord with He‑P 4030, each existing license shall not expire until final action is taken by the DHHS/RHS.

(b) With respect to possession of radioactive material and residual radioactive contamination, each specific license continues in effect beyond the expiration date until the DHHS/RHS notifies the licensee in writing that the license is terminated, even if:

(1) The licensee decides not to renew the license;

(2) No application for license renewal is submitted;

(3) An application for renewal is denied; or

(4) The DHHS/RHS modifies or suspends the license.

(c) After the expiration date specified in the license, each licensee to which He-P 4024.05(b) applies and who possesses radioactive material, including residual radioactive material, shall:

(1) Limit actions involving radioactive material to those related to decommissioning; and

(2) Continue to control entry to restricted areas until they are suitable for release in accordance with DHHS/RHS requirements.

Source. #8393, eff 7-23-05 ss by #10492, eff 12-24-13

He-P 4024.06 Decommissioning Timeliness.

(a) Each licensee or person in possession of a non-exempt source of radiation who decides to terminate all activities involving that source of radiation shall notify the DHHS/RHS immediately, in writing.

(b) Each licensee or person responsible for a facility or site which includes a non‑exempt source of radiation or which may be contaminated by residual radioactivity shall, no less than 30 days before vacating or relinquishing possession or control of the facility or site, notify the DHHS/RHS, in writing, of the intent to vacate.

(1) The licensee has decided to permanently cease principal activities at the entire site or in any separate building or outdoor area that contains residual radioactivity such that the building or outdoor area is unsuitable for release in accordance with these regulations;

(2) No principal activities under the license have been conducted for a period of 24 months; or

(3) No principal activities have been conducted for a period of 24 months in any separate building or outdoor area that contains residual radioactivity such that the building or outdoor area is unsuitable for release in accordance with these regulations.

(d) From the date of notification of the DHHS/RHS required in (a) or (b) above, the licensee shall either:

(1) Begin decommissioning activities; or

(2) Within 12 months of notification, submit a decommissioning plan, if required by He-P 4024.07, and begin decommissioning upon DHHS/RHS approval of that plan.

(e) Coincident with the notification of the DHHS/RHS required in (a) and (b) above, the licensee shall maintain in effect all decommissioning financial assurances established by the licensee pursuant to He-P 4030.09 in conjunction with a license issuance or renewal or as required by this part.

(f) The amount of the financial assurance required by paragraph (e) of He-P 4024.06 shall be increased, or may be decreased, as appropriate, to cover the detailed cost estimate for decommissioning established pursuant to He-P 4024.07(c)5.

(g) The DHHS/RHS shall approve an alternate schedule for the submission of plans and for the completion of decommissioning as required pursuant to (a) and (b) above only if the DHHS/RHS determines that the alternate schedule:

(1) Is necessary to effectively conduct decommissioning;

(2) Presents no undue risks to public health and safety; and

(3) Is otherwise in the public interest.

(h) Any such request as described in He-P 4024.06(g) shall be submitted no later than 30 days before notification pursuant to He-P 4030.11(b).

(i) The schedule for decommissioning shall not commence until the DHHS/RHS has made a determination on the request.

Source. #8393, eff 7-23-05; ss by #10492, eff 12-24-13

He-P 4024.07 Decommissioning Plan.

(a) A licensee shall submit a decommissioning plan if:

(1) The licensee intends to terminate the license using radiological criteria specified in He-P 4024.10 and He-P 4024.11;

(2) Otherwise required by these rules;

(3) Required by license condition; or

(4) The procedures and activities necessary to carry out decommissioning of the site or separate building or outdoor area have not been previously approved by the DHHS/RHS and the procedures could increase potential health and safety impacts to workers or to the public, including but not limited to the following cases:

a. Procedures involving techniques not applied routinely during cleanup or maintenance operations;

b. Workers entering areas not normally occupied where surface contamination and radiation levels are significantly higher than routinely encountered during the operation for which the license was issued;

c. Procedures that could result in significantly greater airborne concentrations of radioactive materials than are present during operation; or

d. Procedures that could result in significantly greater releases of radioactive material to the environment than those associated with the operation for which the license was issued.

(b) Procedures with potential health and safety impacts shall not be carried out prior to approval of the decommissioning plan.

(1) A description of the conditions of the facility or site sufficient to evaluate the acceptability of the plan;

(2) A description of planned decommissioning activities;

(3) A description of methods used to ensure protection of workers and the environment against radiation hazards during decommissioning;

(4) A description of the radiation survey planned to demonstrate compliance with He-P 4024.08(d) and He‑P 4024.09(a), or if applicable, He-P 4024.09 or He-P 4024.11; and

(5) An updated, detailed cost estimate for decommissioning, comparison of that estimate with present funds set aside for decommissioning, and a plan for assuring the availability of adequate funds for completion of decommissioning.

(d) For decommissioning plans calling for completion of decommissioning later than 24 months after plan approval, the plan shall include a justification for the delay.

(e) The proposed decommissioning plan shall be approved by the DHHS/RHS only if the information therein demonstrates that the decommissioning will be completed as soon as practicable and that the health and safety of workers and the public will be adequately protected.

Source. #8393, eff 7-23-05; ss by #10492, eff 12-24-13

He-P 4024.08 Completion of Decommissioning.

(a) The licensee shall complete decommissioning of the facility or site as soon as practicable but no later than 24 months following the initiation of decommissioning, unless an alternate schedule addressing the factors in He-P 4024.08(c) is requested with written justification and approved by the DHHS/RHS.

(b) When decommissioning involves the entire site, the licensee shall request license termination upon completion of decommissioning activities.

(c) For decommissioning plans calling for completion of decommissioning later than 24 months after plan approval, the plan shall include a justification for the decommissioning schedule warranted by consideration of the following:

(1) Whether it is technically feasible to complete decommissioning within the allotted 24‑month period;

(2) Whether sufficient waste disposal capacity is available to allow completion of decommissioning within the allotted 24‑month period;

(3) Whether a significant volume reduction in wastes requiring disposal will be achieved by allowing short-lived radionuclides to decay;

(4) Whether a significant reduction in radiation exposure to workers can be achieved by allowing short-lived radionuclides to decay; and

(5) Other site-specific factors which the DHHS/RHS considers appropriate on a case-by-case basis, including but not limited to:

a. The regulatory requirements of other government agencies, lawsuits, groundwater treatment activities, monitored natural ground-water restoration, actions that could result in more environmental harm than deferred cleanup; and

b. Other factors beyond the control of the licensee.

(d) As the final step in decommissioning, the licensee shall:

(1) Conduct a radiation survey of the premises where the licensed activities were carried out, and:

a. Submit a report of the results of this survey in (1) above, unless the licensee demonstrates that the premises are suitable for release in some other manner;

b. As appropriate:

1. Report levels of gamma radiation in units of millisieverts, or microroentgens, per hour at one meter from surfaces; and

2. Report levels of radioactivity, including alpha and beta:

(i) In units of megabecquerels, or disintegrations per minute or microcuries, per 100 square centimeters, removable and fixed, for surfaces;

(ii) In units of megabecquerels, or microcuries, per milliliter for water; and

(iii) In units of becquerels, or picocuries, per gram for solids such as soils or concrete; and

c. Specify the survey instrument(s) used and certify that each instrument is properly calibrated and tested;

(2) Certify the disposition of all licensed material including accumulated wastes, by submitting a completed Form RHP-10 containing the following:

a. Name of licensee;

b. Address of licensee;

c. Department(s) of licensee, as applicable;

d. License number of licensee;

e. Individual isotope user(s);

f. The name of the certifying official duly authorized by the licensee to certify that licensable quantities of radioactive material under the jurisdiction of the DHHS/RHS are not possessed by the licensee, and to request that the license be terminated; and

g. The dated signature of the certifying official of the licensee;

(3) Clearly indicate on the form required by (d)(2) above whether:

a. All use of radioactive materials authorized by the license has been terminated;

b. Radioactive contamination has been removed to the level outlined in He‑P 4024.09 to the extent practicable;

c. No radioactive material has ever been procured or possessed by the licensee under the authorization granted by the licensee’s license;

d. All radioactive material previously procured or possessed under the authorization granted by the license has been disposed of by:

1. Transfer to another licensed entity authorized to possess the material and provide the recipient entity’s name, address, and the license number and radiation regulatory licensing authority;

2. Decay, survey, and disposal as non‑radioactive trash; or

3. A method in compliance with the provisions of He‑P 4023;

e. Radiation surveys or the equivalent as specified in He‑P 4024.08(d) are attached; and

f. Additional pages containing additional information are attached;

(4) Include, as additional attached pages to the Form RHP-10, a clear and detailed description of the method of disposal of radioactive material, if the licensee disposed of radioactive material using a method other than that indicated in He‑P 4024.08(d)(3)d.1. or 2. above; and

(5) Include, as additional attached pages to the form, report(s) of detailed radiation surveys required by He‑P 4024.08(d)(1).

Source. #8393, eff 7-23-05; ss by #10492, eff 12-24-13

He-P 4024.09 Termination of a License Without Restriction.

(a) A site shall be considered acceptable for unrestricted use only if:

(1) The residual radioactivity that is distinguishable from background radiation results in a TEDE to an average member of the critical group that does not exceed 0.10 millisievert (10 mrem) per year, including that from groundwater sources of drinking water; and

(2) The residual radioactivity has been reduced to levels that are as low as reasonably achievable (ALARA), taking into account consideration of any detriments, such as accidental deaths, expected to potentially result from decontamination and waste disposal.

(b) Specific licenses, including expired licenses, shall be terminated upon written notice to the licensee only when the DHHS/RHS determines that:

(1) Radioactive material has been properly disposed;

(2) Reasonable effort has been made to eliminate residual radioactive contamination, if present;

(3) Documentation is provided to the DHHS/RHS that:

a. A radiation survey has been performed which demonstrates that the premises are suitable for release in accordance with DHHS/RHS requirements; or

b. Other information submitted by the licensee is sufficient to demonstrate that the premises are suitable for release in accordance with DHHS/RHS requirements; and

(4) Records required by He-P 4030.10(n)(6) to be submitted to the DHHS/RHS prior to license termination have been received by the DHHS/RHS.

Source. #8393, eff 7-23-05; ss by #10492, eff 12-24-13

He-P 4024.10 License Termination Under Restricted Conditions. A site shall be considered acceptable for license termination under restricted conditions only if:

(a) The licensee can demonstrate that further reductions in residual radioactivity necessary to comply with the provisions of He‑P 4024.09 would result in net public or environmental harm or were not being made because the residual levels associated with restricted conditions are ALARA, taking into account consideration of any detriments, such as accidental deaths, expected to potentially result from decontamination and waste disposal;

(b) The licensee has made provisions for legally enforceable institutional controls that provide reasonable assurance that the TEDE from residual radioactivity distinguishable from background to the average member of the critical group will not exceed 0.10 millisievert (10 mrem) per year, including that from groundwater sources of drinking water;

(c) The licensee has provided sufficient financial assurance to enable an independent third party, including a governmental custodian of a site, to assume and carry out responsibilities for any necessary control and maintenance of the site. Acceptable financial assurance mechanisms shall include:

(1) Funds placed into a trust segregated from the licensee’s assets and outside the licensee’s administrative control, and in which the adequacy of the trust funds is to be assessed based on an assumed annual one percent real rate of return on investment;

(2) A statement of intent in the case of federal, state, or local government licensees, as described in He-P 4030.09(j)(5); or

(3) When a governmental entity is assuming custody and ownership of a site, an arrangement that is deemed acceptable by such governmental entity;

(d) The licensee has submitted a decommissioning plan to the DHHS/RHS indicating the licensee's intent to decommission in accordance with He-P 4024.06(c) and specifying that the licensee intends to decommission by restricting use of the site;

(e) The decommissioning plan required by (d) above sufficiently demonstrates:

(1) How the input of individuals and institutions in the community who may be affected by the decommissioning has been sought and incorporated, as appropriate, to include at a minimum the following:

a. Participation by representatives of a broad cross section of community interests who might be affected by the decommissioning;

b. An opportunity for a comprehensive, collective discussion on the issues by the participants represented; and

c. A publicly available summary of the results of all such discussions, including a description of the individual viewpoints of the participants on the issues and the extent of agreement and disagreement among the participants on the issues;

(2) Whether provisions for institutional controls proposed by the licensee provide reasonable assurance that the TEDE from residual radioactivity distinguishable from background to the average member of the critical group will not exceed the applicable limit in He-P 4020 through He-P 4023;

(3) Whether provisions for institutional controls will impose undue burden on the local community or other affected parties; and

(4) Whether the licensee has provided sufficient financial assurance to enable an independent third party, including a governmental custodian of a site, to assume and carry out responsibilities for any necessary control and maintenance of the site; and

(f) Residual radioactivity at the site has been reduced so that if the institutional controls were no longer in effect, there is reasonable assurance that the TEDE from residual radioactivity distinguishable from background to the average member of the critical group is as low as reasonably achievable and would not exceed either:

(1) One millisievert (100 mrem) per year; or

(2) Five millisievert (500 mrem) per year provided the licensee:

a. Demonstrates that further reductions in residual radioactivity necessary to comply with the one millisievert/year (100 mrem/y) value of He-P 4024.09(e)(3)a. are not technically achievable, would be prohibitively expensive, or would result in net public or environmental harm;

b. Makes provisions for durable institutional controls; and

c. Provides sufficient financial assurance, using an acceptable mechanism listed in He-P 4024.10(c), to enable a responsible government entity or independent third party, including a governmental custodian of a site, to:

1. Carry out periodic rechecks of the site no less frequently than every 5 years to assure that the institutional controls remain in place as necessary to meet the criteria of He-P 4024.10(b); and

2. Assume and carry out responsibilities for any necessary control and maintenance of those controls.

Source. #8393, eff 7-23-05; ss by #10492, eff 12-24-13

He-P 4024.11 Alternate Criteria for License Termination.

(a) The DHHS/RHS shall terminate a license using alternate criteria greater than the dose criteria of He-P 4024.09(a), He-P 4024.10(b), and He-P 4024.10(e)(1)a.1. only if the licensee:

(1) Provides assurance that public health and safety would continue to be protected, and that it is unlikely that the dose from all man-made sources combined, other than medical, would be more than the one millisievert/year (100 mrem/y) limit of He-P 4020.13 and He-P 4020.14, by submitting an analysis of possible sources of exposure;

(2) Has employed, to the extent practical, restrictions on site use according to the provisions of He-P 4024.10 in minimizing exposures at the site;

(3) Reduces doses to ALARA levels, taking into consideration any detriments such as traffic accidents expected to potentially result from decontamination and waste disposal;

(4) Has submitted a decommissioning plan to the DHHS/RHS indicating the licensee's intent to decommission in accordance with this part and specifying that the licensee proposes to decommission by use of alternate criteria; and

(5) Has provided sufficient financial assurance in the form of a trust fund to enable an independent third party, including a governmental custodian of a site, to assume and carry out responsibilities for any necessary control and maintenance of the site.

(b) The licensee shall document in the decommissioning plan required by (a)(4) above, how the advice of individuals and institutions in the community who may be affected by the decommissioning has been sought and addressed, as appropriate, following analysis of that advice.

(1) Participation by representatives of a broad cross section of community interests who may be affected by the decommissioning;

(2) An opportunity for a comprehensive, collective discussion on the issues by the participants represented; and

(3) A publicly available summary of the results of all such discussions, including a description of the individual viewpoints of the participants on the issues and the extent of agreement and disagreement among the participants on the issues.

(d) The use of alternate criteria to terminate a license shall require the approval of the DHHS/RHS after consideration of the staff’s recommendations addressing comments provided by federal, state, and local governments and any public comments submitted pursuant to He-P 4024.13.

Source. #8393, eff 7-23-05; ss by #10492, eff 12-24-13

He-P 4024.12 Requirement to Use Peak Annual TEDE. When calculating TEDE to the average member of the critical group, the licensee shall determine the peak annual TEDE dose expected within the first 1000 years after decommissioning.

Source. #8393, eff 7-23-05; ss by #10492, eff 12-24-13

He-P 4024.13 Public Notification and Public Participation. Upon the receipt of a decommissioning plan from the licensee, a proposal by the licensee for release of a site pursuant to He-P 4024.10 or He-P 4024.11, or whenever the DHHS/RHS deems such notice to be in the public interest, the DHHS/RHS shall:

(a) Notify and solicit comments from:

(1) Local and state governments in the vicinity of the site and any Indian Nation or other indigenous people that have treaty or statutory rights that could be affected by the decommissioning; and

(2) The U.S. Environmental Protection Agency for cases where the licensee proposes to release a site pursuant to He-P 4024.11; and

(b) Publish a notice in a forum, such as local newspapers, letters to state or local organizations, or other appropriate forum, that is readily accessible to individuals in the vicinity of the site, and solicit comments from affected parties.

Source. #8393, eff 7-23-05; ss by #10492, eff 12-24-13

He-P 4024.14 Applicability of Decommissioning Criteria Following License Termination. After a site has been decommissioned and the license terminated in accordance with the criteria in this part, additional cleanup shall be required if:

(a) Based on new information, the DHHS/RHS determines that the criteria of this part were not met; and

(b) Residual radioactivity remaining at the site could result in significant threat to public health and safety.

Source. #8393, eff 7-23-05; ss by #10492, eff 12-24-13

PARTS He-P 4025- 4029 - RESERVED

PART He-P 4030 LICENSING OF RADIOACTIVE MATERIAL

Statutory Authority RSA 125-F:5,V

Revision Note:

Doc. #6942, effective 2-1-99, repealed Parts He-P 2030, 2031, 2032, 2033, 2034, 2035, 2042 and 2093 relative to Radiation and Radioactive Material and adopted new rules to replace them and renumbered them as He-P 4030, 4031, 4032, 4033, 4034, 4035, 4093 and 4096.

He-P 4030.01 Requirements.

(a) No person shall manufacture, produce, receive, possess, use, transfer, own, or acquire byproduct materials, except as authorized pursuant to a license issued by the department of health and human services radiological health section (DHHS/RHS), or as otherwise provided in this chapter.

(b) In addition to the requirements of He‑P 4030:

(1) All licensees shall be subject to the requirements of He‑P 4001, He‑P 4003, He‑P 4019 through He-P 4024, He-P 4037, and He-P 4090 or its equivalent 10 CFR 20 Appendix B, through He-P 4096;

(2) Licensees engaged in industrial radiographic operations shall be subject to the requirements of He‑P 4034;

(3) Licensees using byproduct materials in the healing arts shall be subject to the requirements of He‑P 4035;

(4) Licensees engaged in land disposal of byproduct material shall be subject to the requirements of He‑P 4062;

(5) Licensees engaged in wireline and subsurface tracer studies shall be subject to the requirements of He‑P 4039;

(6) Licensees engaged in the manufacture or transfer of certain items containing byproduct material shall be subject to He‑P 4032;

(7) Licensees of broad scope for other than human use shall be subject to He‑P 4033;

(8) General licenses shall be subject to He‑P 4031;

(9) Licensees engaged in irradiator operations shall be subject to the requirements of He-P 4036; and

(10) Licensees that possess and use accelerator-produced byproduct material or discrete sources of radium 226 shall be subject to the requirements of He-P 4030.

(1) Be the original document and one copy;

(2) Be dated and include an original signature of the applicant, licensee, the applicant or licensee’s management that performs decision making functions for the applicant or licensee, or a person duly authorized in writing by the applicant, licensee or the applicant or licensee’s management to make binding commitments and to sign documents on the licensee or applicant’s behalf.

(3) The signed application shall include a certificate of the applicant’s or the licensee’s information, as follows:

“I certify under penalty of law that this document and all attachments were prepared in conformity with the New Hampshire Rules for the Control of Radiation under my direction or supervision. The information submitted is, to the best of my knowledge and belief, true, accurate, and complete. I am aware that there are significant penalties for submitting false information, including the possibility of fine and imprisonment for knowing violations.”;

(4) Include the certificate in He-P 4030.01(c)(2) above as part of any document submitted to DHHS/RHS with the application, or filed thereafter; and

(5) Be mailed to DHHS/RHS as specified in He-P 4001.08.

(d) Documentation including attached sheets of information, supplements, sketches, and drawings may be submitted on paper sized 8 ½ x 11 inches, any larger drawings shall be folded to size 8 ½ x 11 inches.

Source. (See Revision Note at part heading for He-P 4030) #6942, eff 2-1-99; ss by #8800, INTERIM, eff 2-1-07, EXPIRED: 7-31-07

New. #8959, eff 8-7-07; ss by #10896, INTERIM, eff 7-22-15, EXPIRES: 1-18-16; ss by #11006, eff 1-15-16; ss by #13421, eff 7-29-22

He-P 4030.02 Exemptions, Source Material.

(a) Any person shall be exempt from He‑P 4030 to the extent that such person receives, possesses, uses, owns, transfers, or delivers source material in any chemical mixture, compound, solution, or alloy in which the source material is by weight less than 1/20 of 1 percent (0.05 percent) of the mixture, compound, solution, or alloy.

(b) Any person shall be exempt from He‑P 4030 to the extent that such person receives, possesses, uses, or transfers unrefined and unprocessed ore containing source material.

(c) Any person shall be exempt from He-P 4019 through He-P 4023 and He‑P 4030 to the extent that such person receives, possesses, uses, or transfers:

(1) Any quantities of thorium contained in:

a. Incandescent gas mantles;

b. Vacuum tubes;

c. Welding rods;

d. Electric lamps for illuminating purposes provided that each lamp shall not contain more than 50 milligrams of thorium;

e. Germicidal lamps, sunlamps, and lamps for outdoor or industrial lighting provided that each lamp shall not contain more than 2 grams of thorium;

f. Rare earth metals and compounds, mixtures, and products containing not more than 0.25 percent by weight thorium, uranium, or any combination of these; or

g. Personnel neutron dosimeters, provided that each dosimeter shall not contain more than 50 milligrams of thorium;

(2) Source material contained in the following products:

a. Glazed ceramic tableware, manufactured before August 27, 2013, provided that the glaze shall not contain more than 20 percent by weight source material;

b. Glassware, containing not more than 2 percent by weight source material or, for glassware manufactured before August 27, 2013, 10 percent by weight source material; but not including commercially manufactured glass brick, pane glass, ceramic tile, or other glass or ceramic used in construction; or

c. Piezoelectric ceramic containing not more than 2 percent by weight source material.

(3) Photographic film, negatives, and prints containing uranium or thorium;

(4) Any finished product or part fabricated of, or containing, tungsten-thorium or magnesium-thorium alloys, provided that the thorium content of the alloy shall not exceed 4 percent by weight and that this exemption shall not be deemed to authorize the chemical, physical, or metallurgical treatment or processing of any such product or part;

(5) Uranium contained in counterweights installed in aircraft, rockets, projectiles, and missiles, or stored or handled in connection with installation or removal of such counterweights, provided that:

a. Each counterweight has been impressed with the following legend clearly legible through any plating or other covering: “DEPLETED URANIUM”;

b. Each counterweight is durably and legibly labeled or marked with the identification of the manufacturer and the statement: “UNAUTHORIZED ALTERATIONS PROHIBITED”;

c. This exemption shall not authorize the chemical, physical, or metallurgical treatment or processing of any such counterweights other than repair or restoration of any plating or other covering; and

d. The requirements specified in He-P 4030.02(c)(5)a. and b. need not be met by counterweights manufactured prior to December 31, 1969, provide that such counterweights were manufactured under a specific license issued by the Atomic Energy Commission and were impressed with the legend required by He-P 4030.02(c)(5)b. in effect on June 30, 1969;

(6) Natural or depleted uranium metal used as shielding constituting part of any shipping container, provided that:

a. The shipping container is conspicuously and legibly impressed with the legend: “CAUTION - RADIOACTIVE SHIELDING – URANIUM”; and

b. The uranium metal is encased in mild steel or equally fire resistant metal of minimum wall thickness of 1/8 inch (3.2 mm);

(7) Thorium or uranium contained in or on finished optical lenses and mirrors, provided that each lens or mirror does not contain more than 10 percent by weight of thorium or uranium, for lenses manufactured before August 27, 2013, 30 percent by weight of thorium and that the exemption contained in He-P 4030.02(c) does not authorize either:

a. The shaping, grinding, or polishing of such lens, mirror, or manufacturing processes other than the assembly of such lens or mirror into optical systems and devices without any alteration of the lens or mirror; or

b. The receipt, possession, use, or transfer of uranium or thorium contained in contact lenses, in spectacles, or in eyepieces in binoculars or other optical instruments; or

(8) Thorium contained in any finished aircraft engine part containing nickel-thoria alloy, provided that:

a. The thorium shall be dispersed in the nickel-thoria alloy in the form of finely divided thoria such as thorium dioxide; and

b. The thorium content in the nickel-thoria alloy shall not exceed 4 percent by weight.

(d) The exemptions in He-P 4030.02(c) shall not authorize the manufacture of any of the products described.

(e) No person shall initially transfer for sale or distribution a product containing source material to persons exempt under He-P 4030.02(c), or the equivalent regulations of an agreement state, or the Nuclear Regulatory Commission, unless authorized by a license issued under Nuclear Regulatory Commission regulation at 10 CFR 40.52 to initially transfer such products for sale or distribution.

(f) Persons authorized to manufacture, process, or produce these materials or products containing source material by DHHS/RHS, or an agreement state, and persons who import finished products or parts, for sale or distribution shall be authorized by a license issued under the Nuclear Regulatory Commission regulation 10 CFR 40.52 for distribution only and are exempt from the requirements of He-P 4019 through He-P 4023, and He-P 4030.09(a)(1) and (a)(2).

(g) Persons initially distributing source material in products covered by the exemptions in He-P 4030.02(c) before August 27, 2013, without specific authorization may continue such distribution for one year beyond this date.

Source. (See Revision Note at part heading for He-P 4030) #6942, eff 2-1-99; ss by #8800, INTERIM, eff 2-1-07, EXPIRED: 7-31-07

New. #8959, eff 8-7-07; ss by #10896, INTERIM, eff 7-22-15, EXPIRES: 1-18-16; ss by #11006, eff 1-15-16; amd by #13047, eff 6-20-20

He-P 4030.03 Exemptions, Byproduct Materials Other Than Source Materials.

(a) Except as provided in He‑P 4030.03(i)-(k), or an equivalent regulation of an agreement state, or the Nuclear Regulatory Commission, any person shall be exempt from He‑P 4030, He-P 4031 through He-P 4034, He-P 4036, and He-P 4039 to the extent that such person receives, possesses, uses, transfers, owns, or acquires products or materials containing byproduct material in concentrations not in excess of those listed in He‑P 4093. This exemption shall not be deemed to authorize the import of byproduct material or products containing byproduct material.

(b) No person shall introduce byproduct material into a product or material knowing or having reason to believe that it will be transferred to persons exempt under He‑P 4030.03(a) or equivalent regulations of an agreement state, or the Nuclear Regulatory Commission, except in accordance with a license issued pursuant to 10 CFR 32.11.

(c) Except for persons who apply byproduct material, or incorporate byproduct material into the following products, or persons who initially transfer for sale or distribution the following products containing byproduct material, any person shall be exempt from this chapter to the extent that such person receives, possesses, uses, transfers, owns, or acquires the following products:

(1) Timepieces or hands or dials of timepieces which shall contain not more than the following specified quantities of byproduct material and which shall not exceed the following specified levels of radiation:

a. 25 millicuries of tritium per timepiece;

b. 5 millicuries of tritium per hand;

c. 15 millicuries of tritium per dial to include bezels when used;

d. 100 microcuries of promethium 147 per watch or 200 microcuries of promethium 147 per any other timepiece;

e. 20 microcuries of promethium 147 per watch hand or 40 microcuries of promethium 147 per other timepiece hand;

f. 60 microcuries of promethium 147 per watch dial or 120 microcuries of promethium 147 per other timepiece dial to include bezels when used;

g. The levels of radiation from hands and dials containing promethium 147 shall not exceed, when measured through 50 milligrams per square centimeter of absorber:

1. For wrist watches, 0.1 millirad per hour at 10 centimeters from any surface;

2. For pocket watches, 0.1 millirad per hour at 1 centimeter from any surface; and

3. For any other timepiece, 0.2 millirad per hour at 10 centimeters from any surface; and

h. 0.037 megabecquerel (1 microcurie) of radium 226 per timepiece in intact timepieces manufactured prior to November 30, 2007;

(2) Precision balances containing not more than 1 millicurie of tritium per balance or not more than 0.5 millicurie of tritium per balance part manufactured before December 17, 2007;

(3) Marine compasses containing not more than 750 millicuries of tritium gas and other marine navigational instruments containing not more than 250 millicuries of tritium gas manufactured before December 17, 2007;

(4) Electron tubes, provided that:

a. Each tube shall not contain more than one of the following specified quantities of byproduct material:

1. 150 millicuries of tritium per microwave receiver protector tube or 10 millicuries of tritium per any other electron tube;

2. 1 microcurie of cobalt 60;

3. 5 microcuries of nickel 63;

4. 30 microcuries of krypton 85;

5. 5 microcuries of cesium 137; and

6. 30 microcuries of promethium 147; and

b. The level of radiation due to byproduct material contained in each electron tube containing byproduct material shall not exceed 1 millirad per hour at 1 centimeter from any surface when measured through 7 milligrams per square centimeter of absorber;

(5) Ionizing radiation measuring instruments containing, for purposes of internal calibration or standardization, one or more sources of byproduct material provided that:

a. Each source shall contain no more than one exempt quantity set forth in He‑P 4096;

b. Each instrument shall contain no more than 10 exempt quantities;

c. For purposes of He-P 4030.03(c)(5), an instrument’s source(s) may contain either one type or different types of radionuclides, and an individual exempt quantity may be composed of fractional parts of one or more of the exempt quantities in He‑P 4096, provided that the sum of such fractions shall not exceed unity; and

d. For purposes of He-P 4030.03(c)(5), 0.05 microcurie of americium 241 shall be considered an exempt quantity under He‑P 4096;

(6) Other radiation producing devices which contain not more than the following specified quantities of radioactive material:

a. Static elimination devices which contain, as a sealed source or sources, byproduct material consisting of a total of not more than 18.5 megabecquerels (500 microcuries) of polonium 210 per device;

b. Ion generating tubes designed for ionization of air that contain, as a sealed source or sources, byproduct material consisting of a total of not more than 18.5 megabecquerels (500 microcuries) of polonium 210 per device or of a total of not more than 1.85 gigabecquerels (50 millicuries) of hydrogen 3 (tritium) per device; and

c. Devices authorized before October 23, 2012 for use under the general license then provided in He-P 4031.04, or the equivalent regulations of agreement states, or Nuclear Regulatory Commission regulations pursuant to 10 CFR 31.3, and which were manufactured, tested, and labeled by the manufacturer in accordance with the specifications in a specific license issued by DHHS/RHS, or an agreement state or the Nuclear Regulatory Commission; or

(7) Ionization chamber smoke detectors containing not more than 1 microcurie of americium 241 per detector in the form of a foil and designed to protect life and property from fires.

(d) Except for persons who manufacture, process, produce, or initially transfer for sale or distribution, gas and aerosol detectors containing byproduct material, any person shall be exempt from the requirements in He-P 4019, He-P 4020, He-P 4021, He-P 4030 through He-P 4036, and He-P 4039 to the extent that such person receives, possesses, uses, transfers, owns, or acquires:

(1) Byproduct material in gas and aerosol detectors designed to protect health, safety, or property, and manufactured, processed, produced, or initially transferred in accordance with a specific license issued under Nuclear Regulatory Commission pursuant to 10 CFR Part 32.26, which license authorizes the initial transfer of the product for use under 10 CFR 32.26, and a certificate of registration in accordance with 10 CFR 32.210; and

(2) Gas and aerosol detectors manufactured or distributed before November 30, 2007, in accordance with a specific license issued by He-P 4032.10 authorizing distribution to persons exempt from regulatory requirements. This exemption shall not apply to any person who desires to manufacture, process, or produce gas and aerosol detectors containing byproduct material, or to initially transfer such products for use under He-P 4030.03(d) after November 30, 2007.

(e) Except for persons who manufacture, process, produce, or initially transfer for sale or distribution self-luminous products, any person shall be exempt from these rules to the extent that such person receives, possesses, uses, transfers, owns, or acquires tritium, krypton 85, or promethium 147 in self-luminous products manufactured, processed, produced, or initially transferred in accordance with a specific license issued by the Nuclear Regulatory Commission pursuant to 10 CFR Part 32.22. This exemption does not apply to tritium, krypton 85, or promethium 147 used in products primarily for frivolous purposes, or in toys, or adornments.

(f) Any person who desires to manufacture, process or produce, or initially transfer for sale or distribution, self-luminous products containing tritium, krypton 85, or promethium 147 for use under He-P 4030.03(e), shall apply for a license issued by the Nuclear Regulatory Commission pursuant to 10 CFR Part 32.22, and for a certificate of registration pursuant to 10 CFR Part 32.210.

(g) Except as provided in He‑P 4030.03(i) and (k), any person shall be exempt from these rules to the extent that such person receives, possesses, uses, transfers, owns, or acquires byproduct material in individual quantities, each of which does not exceed the applicable quantity set forth in He‑P 4096.

(h) Any person who possesses byproduct material received or acquired before September 25, 1971, under the general license formerly provided in He-P 4031, shall be exempt from the requirements for a license set forth in He‑P 4030 through He-P 4034, He-P 4036 and He-P 4039 to the extent that such person possesses, uses, transfers or owns such byproduct material.

(i) The provisions of He-P 4030.03(g) and (h) shall not authorize the production, packaging, or repackaging, or transfer of byproduct material for purposes of commercial distribution, or the incorporation of byproduct material into products intended for commercial distribution.

(j) No person shall, for purposes of commercial distribution, transfer byproduct material in the individual quantities set forth in He‑P 4096, knowing or having reason to believe that such quantities of byproduct material will be transferred to persons exempt under He‑P 4030.03(h) or (i) or equivalent regulations of the Nuclear Regulatory Commission, or an agreement state, except in accordance with a specific license issued by the Nuclear Regulatory Commission pursuant to 10 CFR 32.18, or equivalent regulations of an agreement state.

(k) For the purpose of producing an increased radiation level, no person shall combine quantities of byproduct material covered by this exemption so that the aggregate quantity exceeds the limits set forth in He-P 4096, except for byproduct material combined within a device placed in use before May 3, 1999, or otherwise permitted by the regulations in He-P 4030.

(l) A manufacturer, processor, or producer of a product or material, shall be exempt from the requirements for a license set forth in He-P 4031 through He-P 4036 and He-P 4039 to the extent that the person transfers byproduct material contained in a product or material in concentrations not in excess of those specified in He-P 4093 and introduced in the product or material by a licensee holding a specific license issued by DHHS/RHS expressly authorizing such introduction. This exemption shall not apply to the transfer of byproduct material contained in any food, beverage, cosmetic, drug, or other commodity or product designed for ingestion or inhalation by, or for application to, a human being.

(m) Except for persons who manufacture, process, produce, or initially transfer for sale or distribution industrial devices containing byproduct material designed and manufactured for the purpose of detecting, measuring, gauging or controlling thickness, density level, interface location, radiation, leakage or qualitative or quantitative chemical composition, or for producing an ionized atmosphere, any person shall be exempt from the requirements for a license set forth in He-P 4019 through He-P 4024, He-P 4030 through He-P 4036, and He-P 4039, or the requirements of an agreement state and the Nuclear Regulatory Commission in section 81 of the Atomic Energy Act, to the extent that:

(1) Such persons receive, possess, use, transfer, own, or acquire byproduct material, in these certain detecting measuring, gauging, or controlling devices, and certain devices for producing an ionized atmosphere, and manufactured, processed, produced or initially transferred in accordance with a specific license issued under He-P 4030.03 or an agreement state, or the Nuclear Regulatory Commission 10 CFR Part 32.30;

(2) Persons who desire to manufacture, process, produce, or initially transfer for sale or distribution industrial devices containing byproduct material for use under He-P 4030.03(m), shall apply for a license in accordance with the Nuclear Regulatory Commission pursuant to 10 CFR Part 32.30, and for a certificate of registration in accordance with 10 CFR 32.210; and

(3) This exemption shall not apply to sources not incorporated into a device, such as calibration and reference sources.

Source. (See Revision Note at part heading for He-P 4030) #6942, eff 2-1-99; ss by #8800, INTERIM, eff 2-1-07, EXPIRED: 7-31-07

New. #8959, eff 8-7-07; ss by #10896, INTERIM, eff 7-22-15, EXPIRES: 1-18-16; ss by #11006, eff 1-15-16; ; amd by #13047, eff 6-2-20; ss by #13421, eff 7-29-22

He-P 4030.04 Exemptions, U.S. Government Contractors and Carriers. Any Nuclear Regulatory Commission (NRC) and U.S. Department of Energy (DOE) prime contractor of the following categories operating in New Hampshire shall be exempt from He-P 4030 to the extent that such prime contractor under his prime contract manufactures, produces, receives, possesses, uses, transfers, owns, or acquires byproduct material:

(a) Prime contractors performing work for the Nuclear Regulatory Commission or DOE at U.S. Government-owned or controlled sites, including the transportation of byproduct material to or from such site and the performance of contract services during temporary interruptions of such transportation;

(b) Prime contractors performing research in, or development, manufacture, storage, testing or transportation of, atomic weapons or components thereof; or

(c) Prime contractors using or operating nuclear reactors or other nuclear devices in a U.S. Government-owned vehicle or vessel; and

(d) Any other prime contractor or subcontractor manufactures, produces, transfers, receives, acquires, owns, possesses, or uses byproduct material under his prime contract or subcontract when DHHS/RHS and the Nuclear Regulatory Commission jointly determine that:

(1) Under the terms of the contract or subcontract, there is adequate assurance that the work thereunder can be accomplished without undue risk to the public health and safety; and

(2) The exemption of such contractor or subcontractor is otherwise authorized by law as stated in 10 CFR 30.12.

(e) Common and contract carriers, freight forwarders, warehouse workers and the U.S. Postal Service are exempt from the regulations in He-P 4030 through He-P 4036, He-P 4038, and He-P 4039 to the extent that they transport or store byproduct material in the regular course of carriage for another or storage incident thereto.

Source. (See Revision Note at part heading for He-P 4030) #6942, eff 2-1-99; ss by #8800, INTERIM, eff 2-1-07, EXPIRED: 7-31-07

New. #8959, eff 8-7-07; ss by #10896, INTERIM, eff 7-22-15, EXPIRES: 1-18-16; ss by #11006, eff 1-15-16; amd by #13047, eff 6-2-20

He-P 4030.05 Radioactive Drug: Capsules Containing Carbon-14 Urea for “In Vivo” Diagnostic Use for Humans.

(a) Except as provided in He-P 4030.05(b) and (c), any person is exempt from the requirements for a license set forth in He-P 4030 and He-P 4035, provided that such person receives, possesses, uses, transfers, owns, or acquires capsules containing 37 kilobecquerels (1microcurie) of carbon-14 urea each, allowing for nominal variation that may occur during the manufacturing process, for “in vivo” diagnostic use for humans.

(b) Any person who desires to use the capsules for research involving human subjects shall apply for and receive a specific license pursuant to He-P 4035.

(c) Nothing in this section shall relieve persons from complying with applicable FDA, federal, and other state requirements governing receipt, administration, and use of drugs.

Source. (See Revision Note at part heading for He-P 4030) #6942, eff 2-1-99; ss by #8800, INTERIM, eff 2-1-07, EXPIRED: 7-31-07

New. #8959, eff 8-7-07; ss by #10896, INTERIM, eff 7-22-15, EXPIRES: 1-18-16; ss by #11006, eff 1-15-16; amd by #13047, eff 6-20-20

He-P 4030.06 Types of Licenses. Licenses for byproduct materials shall be one of the following:

(a) General licenses, as provided in He-P 4031, which grant authority to persons for certain activities involving byproduct material, are effective without the filing of an application with DHHS/RHS or the issuance of licensing documents to the particular persons. However, registration with DHHS/RHS may be required by the particular general license, as described in He-P 4031;

(b) Specific licenses which require the submission of an application to DHHS/RHS and the issuance of a licensing document by DHHS/RHS, under the provisions of this part and He-P 4032 through He-P 4036, and He-P 4039; and

(c) Specific licenses by rule, which are issued by DHHS/RHS without the necessity of filing an application for a specific license, in either of the following two circumstances:

(1) When a site must be timely remediated for contamination from byproduct materials that are subject to licensing under these rules but are unlicensed; or

(2) When radioactive materials existing as a result of improper handling, spillage, accidental contamination, or unregulated or illegal possession, transfer, or receipt, must be stored and those materials have not been licensed under these rules.

Source. (See Revision Note at part heading for He-P 4030) #6942, eff 2-1-99; ss by #8488, eff 11-18-05; ss by #8959, eff 8-7-07; ss by #10896, INTERIM, eff 7-22-15, EXPIRES: 1-18-16; ss by #11006, eff 1-15-16

He-P 4030.07 Specific Licenses, Filing of Application. Application for specific licenses shall be filed and processed in compliance with the following provisions:

(a) A completed application form for a specific license shall:

(1) Be filed on one of the following forms:

a. DHHS/RHS-1 “Application for Radioactive Material License” (July 2022) and DHHS/RHS-1 Supplement A “Training and Experience” (July 2022);

b. DHHS/RHS–1M “Application for Radioactive Material License – Medical” (July 2022), and the following supplements as applicable:

1. DHHS/RHS-1M Supplement A “Radiation Safety Officer Training or Associate Radiation Safety Officer Training, Experience and Preceptor Attestation,” (July 2022), in accordance with He-P 4035.61;

2. DHHS/RHS-1M Supplement B-Diagnostic “Authorized User Training, Experience and Preceptor Attestation” (July 2022), in accordance with He-P 4035.63, He-P 4035.64, He-P 4035.68, or He-P 4035.71;

3. DHHS/RHS-1M Supplement B-Sources “Authorized User Training, Experience and Preceptor Attestation” (July 2022), in accordance with He-P 4035.59, He-P 4035.67. He-P 4035.69, or He-P 4035.71;

4. DHHS/RHS-1M Supplement B-Therapy “Authorized User Training, Experience and Preceptor Attestation” (July 2022), in accordance with He-P 4035.65, He-P 4035.66, or He-P 4035.71;

5. DHHS/RHS-1M Supplement C “Authorized Medical Physicist or Ophthalmic Physicist Training, Experience and Preceptor Attestation” (July 2022), in accordance with He-P 4035.32 or He-P 4035.70; or

6. DHHS/RHS-1M Supplement D “Authorized Nuclear Pharmacist Training, Experience and Preceptor Attestation” (July 2022), in accordance with He-P 4035.74; or

c. DHHS/RHS–3 “Application for Radioactive Material License–Source Material”. (July 2022);

(2) If submitted on DHHS/RHS-1M “Application for Radioactive Material License–Medical” (July 2022), then the following shall apply:

a. Answers to questions 7 through 23 on the application shall be made on separately attached sheets which identify the item number by a heading located in the lower right corner of each page, and which includes the date of the application and the question number with which it is associated;

b. If answers to questions 7 through 23 on the application are made following an appendix to the medical licensing guide, then the date of the referenced guide and the appendix letter shall be specified;

c. All documentation including, attached sheets of information, supplements, sketches, and drawings, shall be identified indicating the correlating item number on the DHHS/RHS-1M “Application for Radioactive Material License–Medical” (July 2022), by a heading which includes the item number and the purpose of the document submitted;

d. All applicable sections of He-P 4035 shall be listed to describe the radioisotopes and quantities of licensed material used, including those used in remote afterloader units, teletherapy units, gamma stereotactic radiosurgery units, and in a list to be provided that specifies any emerging technologies devices;

e. If a supplement for a radiation safety officer is submitted, it shall identify the name, license, or permit number of a supervising individual’s training if the individual is a radiation safety officer, an authorized user, an authorized medical physicist, or an authorized nuclear pharmacist, or if more than one supervising individual is required by He-P 4035, separate sheets shall be used to document each individual’s training;

f. If a supplement requires a preceptor attestation, the attestation shall be:

1. Completed and signed by the individual’s preceptor;

2. If more than one preceptor is necessary to document experience, then a separate preceptor attestation shall be obtained from each preceptor; and

3. Each preceptor shall provide, direct, or verify the individual’s training and experience, but such preceptor does not need to be the individual’s supervisor;

g. If a supplement for a medical physicist is submitted, training and work experience shall be listed and shall have been conducted in clinical radiation facilities that provide high-energy external beam therapy photons and electrons with energies greater than or equal to one million electron volts and brachytherapy services.

h. The following training and work experience shall be documented as follows:

1. The required one year full-time medical physicist training and one year of full time work experience as required by He-P 4035 shall be not concurrent years; and

2. The supervising medical physicist shall meet the training and experience requirements in He-P 4035.70 and He-P 4035.73 for the use for which the individual is seeking authorization; and

i. Any supervising authorized user shall have the experience in administering dosages in the same dosage category or categories as the individual requesting authorized user status as required in He-P 4035.

(b) DHHS/RHS shall at any time after the filing of the original application, and before the expiration of the license, require further statements or information when necessary for DHHS/RHS to determine whether the application shall be granted or denied, or whether a license shall be modified or revoked.

(d) An application for a license may include a supplement for a license authorizing one or more activities.

(e) Applications, supplements, and documents submitted to DHHS/RHS may be made available for public inspection except that DHHS/RHS shall withhold any document or part thereof from public inspection if disclosure of its content is related to safety and security of radioactive materials or to confidential information about the license application or statements on the license.

(f) An application for a license to receive and possess byproduct material for commercial waste disposal by land burial or for the conduct of any other activity which might negatively affect the quality of the environment according to the criteria set forth in 10 CFR 30.32(f) and 10 CFR 51, shall be filed at least 9 months prior to commencement of construction of the plant or facility in which the activity will be conducted and shall be accompanied by an environmental report.

(g) Each application for a byproduct material license, other than a license exempted from He‑P 4070, or a request for an amendment of a license filed in accordance with He-P 4030.13, shall be accompanied by the fee prescribed in He‑P 4070.

(h) Except as provided in He-P 4030.07(h)(2), an application for a specific license to use, manufacture, process, or produce byproduct material in the form of a sealed source, in a device that contains the sealed source, or gas or aerosol detectors containing byproduct material manufactured after November 30, 2007, shall meet the following requirements in (1) and (2) below:

(1) For sealed sources and devices allowed to be distributed without registration of safety information in accordance with He-P 4030.07(h)(3) below, the applicant shall supply only the manufacturer, model number, radionuclide, and quantity; and

(2) If it is not feasible to identify each sealed source and device individually, the applicant shall propose constraints on the number and type of sealed source and devices to be used and the conditions under which they will be used, in lieu of identifying each sealed source and device; and one of the following:

a. Identify the sealed source or device that contains a sealed source by manufacturer and model number registered with DHHS/RHS, an agreement state, or in the Nuclear Regulatory Commission “Registry of Radioactive Sealed Sources and Devices” pursuant to 10 CFR 32.210, or for a source or a device containing radium 226 or accelerator-produced radioactive material with DHHS/RHS under provisions of He-P 4032.11; or

b. Include in the application the information identified in He‑P 4032.11(b); or

(i) Except as provided in He-P 4030.07(i)(1) and (i)(2), an application for a specific license to use, manufacture, process, or produce byproduct material in the form of a sealed source, in a device that contains the sealed source, or gas or aerosol detectors containing byproduct material manufactured after November 30, 2007, shall meet the following requirements in (1) or in (2) below:

(1) For sources or devices manufactured before October 23, 2012 that are not registered with DHHS/RHS, with an agreement state, or with the U.S. Nuclear Regulatory Commission under 10 CFR 32.210, and for which the applicant is unable to provide all categories of information specified in He-P 4032.11(b) or 10 CFR 32.210(c), the applicant shall provide both:

a. All available information identified in He-P 4032.11(b) or in 10 CFR 32.210(c) concerning the source, and, if applicable, the device; and

b. Sufficient additional information to demonstrate that there is a reasonable assurance that the radiation safety properties of the source or device are adequate to protect health and minimize danger to life and property. Such information shall include a description of the source or device, a description of radiation safety features, the intended use and associated operating experience, and the results of a recent leak test; or

(2) For sealed sources and devices allowed to be distributed without registration of safety information, the applicant shall supply only the manufacturer, model number, radionuclide, and quantity, and in the following cases calibration and reference sources containing no more than:

a. Thirty seven megabecquerels (1 millicurie), for beta and/or gamma emitting radionuclides; or

b. Three hundred and seventy kilobecquerels (10 microcuries), for alpha emitting radionuclides.

(j) As provided by He-P 4030.09(b), certain applications for specific licenses filed under He‑P 4030 and He-P 4032 through He-P 4035 shall contain a proposed decommissioning funding plan pursuant to He-P 4030(e) or a certification of financial assurance for decommissioning.

(k) Applications to possess byproduct materials in unsealed form, on foils or plated sources, or sealed in glass in excess of the quantities in He-P 4030.08, Table 4030.1, shall meet all of the requirements below:

(1) Each application shall contain one of the following:

a. An evaluation showing that the maximum dose to a person offsite due to a release of radioactive materials would not exceed one rem effective dose equivalent or 5 rems to the thyroid; or

b. An emergency plan for responding to a release of radioactive material;

(2) In order for the application to be approved, the evaluation in He-P 4030.07(i)(1)a. above shall include one of the following precautions or safety measures:

a. The radioactive material is physically separated so that only a portion could be involved in an accident;

b. All or part of the radioactive material is not subject to release during an accident because of the way it is stored or packaged;

c. The release fraction in the respirable size range would be lower than the release fraction shown in Table 4030.1 due to the chemical or physical form of the material;

d. The solubility of the radioactive material would reduce the dose received;

e. Facility design or engineered safety features in the facility would cause the release fraction to be lower than shown in Table 4030.1;

f. Operating restrictions or procedures would prevent a release fraction as large as that shown in Table 4030.1; or

g. Other factors appropriate for the specific facility;

(3) An emergency plan for responding to a release of radioactive material submitted under He‑P 4030.07(i)(1)b. shall include the following information:

a. A description of the licensee’s facility and the uncontrolled area near the site;

b. An identification of each type of radioactive material accident for which protective actions may be needed;

c. A classification system for classifying accidents as alerts or site area emergencies;

d. Identification of the means of detecting each type of accident in a timely manner;

e. A description of the means and equipment for mitigating the consequences of each type of accident, including those provided to protect workers onsite, and a description of the program for maintaining the equipment;

f. A description of the methods and equipment to assess releases of radioactive materials;

g. A description of the responsibilities of licensee personnel should an accident occur, including identification of personnel responsible for promptly notifying offsite response organizations and DHHS/RHS, and also responsibilities for developing, maintaining, and updating the plan;

h. A commitment to and description of the means to promptly notify offsite response organizations and request offsite assistance, including medical assistance for the treatment of contaminated injured onsite workers;

i. A commitment to establish a control point;

j. A commitment to establish a notification and coordination plan such that the unavailability of some personnel, parts of the facility, and some equipment will not prevent the notification and coordination;

k. Acknowledgment that the licensee shall also commit to notify DHHS/RHS immediately after notification of the appropriate offsite response organizations and not later than one hour after the licensee declares an emergency;

l. A description of the types of information on facility status, radioactive releases, and recommended protective actions, if necessary, to be given to offsite response organizations and to DHHS/RHS;

m. A description of the frequency, performance objectives, and plans for the training that the licensee shall provide workers on how to respond to an emergency including any special instructions and orientation tours the licensee would offer to fire, police, medical, and other emergency personnel, and documentation that the training shall:

1. Familiarize personnel with site-specific emergency procedures; and

2. Thoroughly prepare site personnel for their responsibilities in the event of accidental scenarios postulated as most probable for the specific site, including the use of team training for such scenarios;

n. A description of the means of restoring the facility to a safe condition after an accident;

o. Provisions for conducting quarterly communications checks with offsite response organizations and biennial onsite exercises to test response to simulated emergencies; and

p. A certification that the applicant has met its responsibilities under the Emergency Planning and Community Right-to-Know Act of 1986, Title III, Pub. L. 99-499, if applicable to the applicant’s activities at the proposed place of use of the byproduct material;

(4) The exercises required by He‑P 4030.07(i)(3)o. above shall provide for:

a. Quarterly communications checks with offsite response organizations which shall include the check and update of all necessary telephone numbers;

b. The invitation to offsite response organizations to participate in the biennial exercises;

c. Accident scenarios postulated as most probable for the specific site and which scenarios shall not be known to most exercise participants; and

d. Critiques of each exercise using individuals not having direct implementation responsibility for the plan and which shall evaluate the appropriateness of the plan, emergency procedures, facilities, equipment, training of personnel, and overall effectiveness of the response and deficiencies found by the critiques which shall be corrected by the licensee;

(5) The licensee shall allow the offsite response organizations expected to respond in case of an accident 60 days to comment on the licensee’s emergency plan before submitting it to DHHS/RHS; and

(6) The licensee shall provide any comments received within the 60 days to DHHS/RHS with the emergency plan.

(l) An application from a medical facility or an educational institution to produce Positron Emission Tomography (PET) radioactive drugs for noncommercial transfer to licensees in its consortium authorized for medical use under He-P 4035, or equivalent agreement state, or NRC requirements shall include:

(1) A request for authorization for production of PET radionuclides or evidence of an existing license issued under He-P 4030, or equivalent requirements of an agreement state, or the NRC for a PET radionuclide production facility within its consortium from which it receives PET radionuclides;

(2) Evidence that the applicant is qualified to produce radioactive drugs for medical use by meeting one of the criteria in He-P 4032.05(a)(2);

(3) If the applicant is a pharmacy, identification of individual(s) authorized to prepare the PET radioactive drugs, and documentation that the individual(s) meet(s) the requirements of an authorized nuclear pharmacist as specified in He-P 4032.05(b)(2); and

(4) Information identified in He-P 4032.05(a)(3) on the PET drugs to be commercially transferred to members of its consortium.

Source. (See Revision Note at part heading for He-P 4030) #6942, eff 2-1-99; ss by #8800, INTERIM, eff 2-1-07, EXPIRED: 7-31-07

New. #8959, eff 8-7-07; ss by #10896, INTERIM, eff 7-22-15, EXPIRES: 1-18-16; ss by #11006, eff 1-15-16; amd by #13047, eff 6-2-20; ss by #13421, eff 7-29-22; ss by #13619, eff 4-26-23

He-P 4030.08 Quantities of Radioactive Materials Requiring Consideration of the Need for an Emergency Plan for Responding to a Release. These quantities shall be as set forth in Table 4030.1 below:

Table 4030.1 Quantities of Radioactive Materials Requiring Consideration

of the Need for an Emergency Plan for Responding to a Release

Radioactive Material	Release Fraction	Quantity (curies)
Actinium-228	0.001	4,000
Americium-241	0.001	2
Americium-242	0.001	2
Americium-243	0.001	2
Antimony-124	0.01	4,000
Antimony-126	0.01	6,000
Barium-133	0.01	10,000
Barium-140	0.01	30,000
Bismuth-207	0.01	5,000
Bismuth-210	0.01	600
Cadmium-109	0.01	1,000
Cadmium-113	0.01	80
Calcium-45	0.01	20,000
Californium-252	0.001	9 (20 mg)
Carbon-14 (carbon dioxide)	0.01	50,000
(non-carbon dioxide)	0.01	50,000
Cerium-141	0.01	10,000
Cerium- 144	0.01	300
Cesium-134	0.01	2,000
Cesium-137	0.01	3,000
Chlorine-36	0.5	100
Chromium-51	0.01	300,000
Cobalt-60	0.001	5,000
Copper-64	0.01	200,000
Curium-242	0.001	60
Curium-243	0.001	3
Curium-244	0.001	4
Curium-245	0.001	2
Europium-152	0.01	500
Europium-154	0.01	400
Europium-155	0.01	3,000
Germanium-68	0.01	2,000
Gadolinium-153	0.01	5,000
Gold-198	0.01	30,000
Hafnium-172	0.01	400
Hafnium-181	0.01	7,000
Holmium-166m	0.01	100
Hydrogen-3	0.5	20,000
Iodine-125	0.5	10
Iodine-131	0.5	10
Indium-114m	0.01	1,000
Indium-192	0.001	40,000
Iron-55	0.01	40,000
Iron-59	0.01	7,000
Krypton-85	1.0	6,000,000
Lead-210	0.01	8
Manganese-56	0.01	60,000
Mercury-203	0.01	10,000
Molybdenum-99	0.01	30,000
Neptunium-237	0.001	2
Nickel-63	0.01	20,000
Niobium-94	0.01	300
Phosphorus-32	0.5	100
Phosphorous-33	0.5	1,000
Polonium-210	0.01	10
Potassium-42	0.01	9,000
Promethium-145	0.01	4,000
Promethium-147	0.01	4,000
Radium-226	0.001	100
Ruthenium-106	0.01	200
Samarium-151	0.01	4,000
Scandium-46	0.01	3,000
Selenium-75	0.01	10,000
Silver-110m	0.01	1,000
Sodium-22	0.01	9,000
Sodium-24	0.01	10,000
Strontium-89	0.01	3,000
Strontium-90	0.01	90
Sulfur-35	0.5	900
Technetium-99	0.01	10,000
Technetium-99m	0.01	400,000
Tellurium-127m	0.01	5,000
Tellurium-129m	0.01	5,000
Terbium-160	0.01	4,000
Thulium-170	0.01	4,000
Tin-113	0.01	10,000
Tin-123	0.01	3,000
Tin-126	0.01	1,000
Titanium-44	0.01	100
Vanadium-48	0.01	7,000
Xenon-133	1.0	900,000
Yttrium-91	0.01	2,000
Zinc-65	0.01	5,000
Zirconium-93	0.01	400
Zirconium-95	0.01	5,000
Any other beta-gamma emitter	0.01	10,000
Mixed fission products	0.01	1,000
Mixed corrosion products	0.01	10,000
Contaminated equipment beta-gamma	0.001	10,000
Irradiated material, any form other than solid noncombustible	0.01	1,000
Irradiated material, solid non- Combustible	0.001	10,000
Mixed radioactive waste, beta- gamma	0.01	1,000
Packaged mixed waste, beta-gamma¹	0.001	10,000
Any other alpha emitter	0.001	2
Contaminated equipment alpha	0.0001	20
Packaged waste, alpha¹	0.0001	20
Combinations of radioactive materials listed above²	-	-

¹Waste packaged in Type B containers does not require an emergency plan.

²For combinations of radioactive materials, consideration of the need for an emergency plan is required if the sum of the ratios of the quantity of each radioactive material authorized to the quantity listed for that material in Table 4030.1 exceeds one.

Source. (See Revision Note at part heading for He-P 4030) #6942, eff 2-1-99; ss by #8800, INTERIM, eff 2-1-07, EXPIRED: 7-31-07

New. #8959, eff 8-7-07; ss by #10896, INTERIM, eff 7-22-15, EXPIRES: 1-18-16; ss by #11006, eff 1-15-16

He-P 4030.09 Specific Licenses, Requirements for Issuance.

(a) A specific license application shall be approved if DHHS/RHS determines that:

(1) The applicant is qualified by reason of training and experience to use the material in question for the purpose requested in accordance with these rules in such a manner as to protect the public health and minimize danger to life or property;

(2) The applicant’s proposed equipment, facilities, calibration and all other procedures are adequate to minimize danger to protect the public health and minimize danger to life or property;

(3) The applicant satisfies any applicable special requirements in He-P 4031 through He-P 4036 and He-P 4039, and Nuclear Regulatory Commission 10 CFR 37; and

(4) In the case of an application for a license to receive and possess byproduct material for commercial waste disposal by land burial, the applicant shall satisfy any applicable special requirements in He-P 4023 and He-P 4062.

(b) In the case of an application for a license to receive and possess byproduct material to conduct any activity which DHHS/RHS determines might negatively affect the quality of the environment, the license application for the facility in which the activity will be conducted shall be reviewed and approved by DHHS/RHS before commencement of construction of the plant or the plant or facility in which the activity will be conducted.

Commencement of construction shall include:

(1) Non-construction activities if the activity has a reasonable nexus to radiological safety and security, any clearing of land, excavation, or other substantial action that would adversely affect the environment;

(2) The installation of a foundation, or in-place assembly, erection, fabrication, or testing for any structure, system, or component of a facility or activity subject to He-P 4030.09(b) that have a reasonable nexus to radiological safety or security; and

(3) Building necessary roads for site exploration, making borings to determine foundation conditions, or performing other preconstruction monitoring or testing to establish background information related to the suitability of the site or the protection of environmental values.

(c) Issuance of a specific license authorizing the activities of He-P 4030.09(b) shall be based upon a consideration by DHHS/RHS of the environmental, economic, technical, and other benefits in comparison with the environmental costs available alternatives and a determination that the action called for is the issuance of the proposed license, with any appropriate conditions to protect environmental values.

(d) Commencement of construction in violation of He‑P 4030.09(b) prior to review and approval by DHHS/RHS, shall be grounds for denial of a license to receive and possess byproduct material in such plant or facility.

(e) Each applicant for a specific license authorizing the possession and use of special nuclear material, source material, or unsealed byproduct material in quantities and amounts in excess of those indicated in Table 4030.2 below shall submit a decommissioning funding plan.

Table 4030.2 Quantities and Amounts Requiring Decommissioning Funding Plan

Type of Material	Exceeding
Special Nuclear Material	10⁵ times He‑P 4091
Source Material	100 millicuries in readily dispersible form
Byproduct Material (Unsealed)	Half-life greater than 120 days and in quantities exceeding 10⁵ times the applicable quantities set forth in He‑P 4091

(f) The decommissioning funding plan shall be submitted when a combination of isotopes is involved, if R divided by 10⁵ is greater than 1, where R is the sum of the ratios of quantity of each isotope to the applicable value in He‑P 4091.

(g) Each applicant for or holder of a specific license authorizing possession and use of special nuclear material, sealed sources, or plated foils of half-life greater than 120 days and 10¹² times the applicable quantities (or when a combination of isotopes is involved if R, as defined in He-P 4030.09(f), divided by 10¹²is greater than 1) indicated in Table 4030.3 shall:

(1) Submit to DHHS/RHS a decommissioning funding plan as described in He-P 4030.09(i); or

(2) Submit to DHHS/RHS a certification that financial assurance for decommissioning shall be provided in the amount prescribed by Table 4030.3 below using one of the methods described in He-P 4030.09(j); and

(3) Submit to DHHS/RHS as a part of the certification, a copy of the financial instrument obtained to satisfy the requirement of He‑P 4030.09(j).

(4) If, in surveys made under He-P 4022.01(a), residual radioactivity in the facility and environment, including the subsurface, is detected at levels that would, if left uncorrected, prevent the site from meeting the He-P 4024.09(a) criteria for unrestricted use, the licensee shall submit a decommissioning funding plan within one year of when the survey is completed.

Table 4030.3 Financial Assurance Amounts for Decommissioning

Type of Radioactive Material	Exceeding	Assurance Amount
Special Nuclear Material	Greater than 10⁴ but less than or equal to 10⁵ times the applicable quantities as indicated in He-P 4091. For a combination of isotopes, if R, as defined in He-P 4030.09(f) divided by 10⁴ is greater than 1 but R divided by 10⁵ is less than or equal to 1.	$1,125,000
	Greater than 10³ but less than or equal to 10⁴ times the applicable quantities as indicated in He-P 4091. For a combination of isotopes, if R, as defined in He-P 4030.09(f) divided by 10³ is greater than 1 but R divided by 10⁴ is less than or equal to 1.	$225,000
Source Material	Greater than 10 millicuries but less than or equal to 100 millicuries in a readily dispersible form. For a combination of isotopes, if R, as defined in He‑P 4030.09(f) divided by 10³ is greater than 1 but R divided by 10⁴ is less than or equal to 1.	$113,000
Byproduct Material	Half-life greater than 120 days and in quantities:
	Greater than 10⁴ but less than or equal to 10⁵ times applicable quantities in unsealed form as indicated in He-P 4091. For a combination of isotopes, if R, as defined in He-P 4030.09(f) divided by 10⁴ is greater than 1 but R divided by 10⁵ is less than or equal to 1.	$1,125,000
	Greater than 10³ but less than or equal to 10⁴ times the applicable quantities in unsealed form as indicated in He-P 4091. For a combination of isotopes, or if R, as defined in He-P 4030.09(f) divided by 10³ is greater than 1 but R divided by 10⁴ is less than or equal to 1.	$225,000
	Greater than 10¹⁰ but less than or equal to 10¹²times the applicable quantities in sealed sources or plated sources. For a combination of isotopes, if R, as defined in He‑P 4030.09(f) divided by 10¹⁰ is greater than 1, but R divided by 10¹² is less than or equal to 1.	$113,000

(h) Certification shall state that the appropriate assurance shall be obtained after the application has been approved and the license issued but prior to the receipt of licensed material.

(i) Each decommissioning funding plan shall be submitted for review and approval by DHHS/RHS, and shall contain a detailed cost estimate for decommissioning, and a description of the method of assuring funds for decommissioning including a means of adjusting cost estimates and associated funding levels over the life of the facility as set forth below:

(1) A detailed cost estimate for decommissioning shall be in an amount reflecting:

a. The cost of an independent contractor to perform all decommissioning activities;

b. The cost of meeting the He-P 4024.09 criteria for unrestricted use, provided that if the applicant or licensee can demonstrate its ability to meet the provisions of He-P 4024.10, the cost estimate may be based on meeting the He-P 4024.10 criteria;

c. The volume of onsite subsurface material containing residual radioactivity that will require remediation to meet the criteria for license termination; and

d. An adequate contingency factor pursuant to 10 CFR 30.35(e)(1)(i)(D);

(2) Identification of and justification for using the key assumptions contained in the decommissioning cost estimate;

(3) A description of the method of assuring funds for decommissioning from He-P 4030.09(j), including means for adjusting cost estimates and associated funding levels periodically over the life of the facility;

(4) A certification by the licensee that financial assurance for decommissioning has been provided in the amount of the cost estimate for decommissioning;

(5) A signed original financial instrument obtained to satisfy the requirements of He-P 4030.09(j), unless a previously submitted and accepted financial instrument continues to cover the cost estimate for decommissioning; and

(6) At intervals not to exceed 3 years, the decommissioning funding plan shall be resubmitted with adjustments as necessary to account for changes in costs and the extent of contamination;

a. The amount of financial assurance shall not be adjusted downward, until the updated decommissioning funding plan is approved; and

b. The decommissioning funding plan shall update the information submitted with the original, or prior approved plan, and shall specifically consider the effect of the following events on decommissioning costs:

1. Spills of radioactive material producing additional residual radioactivity in onsite subsurface material;

2. Waste inventory increasing above the amount previously estimated;

3. Waste disposal costs increasing above the amount previously estimated;

4. Facility modifications;

5. Changes in authorized possession limits;

6. Actual remediation costs that exceed the previous cost estimate;

7. Onsite disposal; and

8. Use of a settling pond; and

(7) Waste collectors and waste processors, also known as waste handling licensees as defined in He-P 4003.01, shall provide financial assurance in an amount based on a decommissioning funding plan as described in He-P 4030.09(i)(1). The decommissioning funding plan shall include:

a. The cost of disposal of the maximum quantity, by volume, of radioactive material which could be present at the licensee’s facility at any time; and

b. The cost to remediate the licensee’s site to meet the license termination criteria of He-P 4030.17.

(j) The financial instrument shall include the licensee’s name, license number, and the name, address, and other contact information of the issuer, and, if a trust is used, the name, address and other contact information of the trustee. When any of the foregoing information changes the licensee shall, within 30 days, submit the financial instruments reflecting such changes. The financial instrument shall be a signed original or signed original duplicate, except where a copy of the signed original is specifically permitted. Financial assurance for decommissioning shall be provided by any one or more of the following methods:

(1) Prepayment;

(2) A surety method or insurance;

(3) An external sinking fund;

(4) Any other funding methods which shall be demonstrated by the applicant or licensee to provide comparable assurance to methods listed in He-P 4030.09(g)(1) through (3); and

(5) In the case of state, or local government licensees, a statement of intent containing a cost estimate for decommissioning or an amount based on Table 4030.3, and indicating that funds for decommissioning shall be obtained when necessary.

(k) The prepayment method in He-P 4030.09(j)(1) above shall be:

(1) In the form of a trust, escrow account, government fund, certificate of deposit, or deposit of government securities;

(2) Deposited prior to the start of operation into an account segregated from licensee assets and outside the licensee’s administrative control of cash or liquid assets that will retain their value over the projected operating life of the facility; and

(3) In an amount such that the principal plus accumulated earnings shall be sufficient to pay the necessary costs.

(l) The surety method or insurance in He-P 4030.09(j)(2) above shall be in the form of a surety bond, letter of credit, line of credit, secured interest or other guarantee method such that the costs shall be paid should the licensee default.

(m) Any surety or insurance under He-P 4030.09(l) shall contain the following conditions:

(1) The surety or insurance shall be open-ended or, if written for a specified term, such as 5 years, shall be renewed automatically unless 90 days or more prior to the renewal date, the issuer notifies DHHS/RHS, the trust account, and the licensee of its intention not to renew;

(2) The surety or insurance shall provide that the beneficiary may automatically collect prior to the expiration without proof of forfeiture if the licensee fails to provide a replacement acceptable to DHHS/RHS within 30 days after receipt of notification of cancellation;

(3) The beneficiary of the surety or insurance shall be a trust account and trustee such as a state or federal government agency or entity which has the authority to act as a trustee and whose trust operations are regulated and examined by a federal or state agency; and

(4) The surety or insurance shall remain in effect until DHHS/RHS has terminated the license.

(n) An external sinking fund in He-P 4030.09(j)(3) shall be:

(1) In the form of a trust, escrow account, government fund, certificate of deposit or deposit of government securities;

(2) Established and maintained by the periodic deposit of a prescribed amount into an account segregated from licensee assets and outside the licensee’s administrative control;

(3) In a total amount for which the periodic deposits plus accumulated earnings shall be sufficient to pay the necessary costs at the time termination of operation is expected;

(4) Deposited to at least annually; and

(5) Coupled with a surety method or insurance, the value of which may decrease by the amount being accumulated in the sinking fund.

(o) Each person licensed under He-P 4030 shall keep records of information important to the safe and effective decommissioning of the facility in a specific location reserved for this purpose until the site is released for unrestricted use and the license terminated by DHHS/RHS.

(p) If records of relevant information are kept for other purposes, reference to these records and their locations shall be allowed to be kept with the records for decommissioning.

(q) Records important to decommissioning shall consist of:

(1) Records of spills or other unusual occurrences involving the spread of contamination in and around the facility, equipment, or site, which may be limited to instances:

a. When contamination remains after any cleanup procedures; or

b. When there is reasonable likelihood that contaminants may have spread to inaccessible areas such as seepage into porous materials such as concrete;

(2) Information on identification of involved radionuclides, quantities, chemical and physical forms, and concentrations, if known;

(3) As-built drawings and modifications of structures and equipment in restricted areas where byproduct materials are used or stored, and of locations of possible inaccessible contamination such as buried pipes, but if drawings are not available, the licensee shall substitute appropriate records of available information concerning these areas and locations;

(4) Except for areas containing only sealed sources, provided the sealed sources have not leaked or no contamination remains after any leak, or radioactive material having only half lives of less than 65 days, a list contained in a single document and updated every 2 years, of the following:

a. All areas designated and formerly designated restricted areas as defined in He-P 4003;

b. All areas outside of restricted areas that require documentation under He-P 4030.09(q);

c. All areas outside of restricted areas where current and previous wastes have been buried as documented under He-P 4021.09; and

d. All areas outside of restricted areas that contain material such that, if the license expired, the licensee would be required to either decontaminate the area to meet the criteria for decommissioning in He-P 4024, or apply for approval for disposal under He-P 4023.02; and

(5) Records of the cost estimate performed for the decommissioning funding plan or of the amount certified for decommissioning, and records of the funding method used for assuring funds if either a funding plan or certification is used.

(r) Before licensed activities are transferred or assigned in accordance with He-P 4030.15, licensees shall transfer all records required by He-P 4030.09(o) to the new licensee, and the new licensee shall be responsible for maintaining these records until the license is terminated.

(s) Each license issued or granted pursuant to He-P 4030.09, He-P 4031 through He-P 4036, and He-P 4039 shall be subject to all the provisions of the RSA 125-F, as amended, now or hereafter in effect, and to all valid rules, regulations and orders of DHHS/RHS.

(t) No license issued or granted pursuant to He-P 4030.09, He-P 4031 through He-P 4036, and He-P 4039 of this regulation nor any right under a license shall be transferred, assigned or in any manner disposed of, either voluntarily or involuntarily, directly or indirectly, through transfer of control of any license to any person, unless DHHS/RHS shall after securing full information find that the transfer is in accordance with RSA 125-F, and shall give its consent in writing.

(u) In providing financial assurance under He-P 4030.09, each licensee shall use the financial assurance funds only for decommissioning activities and each licensee shall monitor the balance of funds held to account for market variations. The licensee shall replenish the funds, and report such actions to DHHS/RHS, as follows:

(1) If, at the end of a calendar quarter, the fund balance is below the amount necessary to cover the cost of decommissioning, the licensee shall increase the balance to cover the cost, and shall do so within 30 days after the end of the calendar quarter;

(2) If at any time, the fund balance falls below 75 percent of the amount necessary to cover the cost of decommissioning, the licensee shall increase the balance to cover the cost, and shall do so within 30 days of the occurrence; and

(3) Within 30 days of taking the actions required by He-P 4030.09(u)(1) or (u)(2) above the licensee shall provide a written report of such actions to DHHS/RHS, and state the new balance of the fund.

Source. (See Revision Note at part heading for He-P 4030) #6942, eff 2-1-99; amd by #8488, eff 11-18-05; amd by #8800, INTERIM, eff 2-1-07, EXPIRED: 7-31-07

New. #8959, eff 8-7-07; ss by #10896, INTERIM, eff 7-22-15, EXPIRES: 1-18-16; ss by #11006, eff 1-15-16

He-P 4030.10 Specific Licenses, Issuance.

(a) Upon a determination that an application meets the requirements of the applicable sections of He-P 4000, He-P 4030, and RSA 125-F, DHHS/RHS shall issue a specific license authorizing the proposed activity.

(b) DHHS/RHS shall incorporate into any license issued pursuant to this part and He-P 4031 through 4036, and He-P 4039, at the time of issuance or thereafter, by appropriate rule or order, such additional requirements and conditions with respect to the licensee’s receipt, possession, use, and transfer of byproduct material as it deems appropriate or necessary in order to:

(1) Protect the public health and minimize danger to life or property;

(2) Require such reports and the keeping of such records, and to provide for such inspections of activities under the license as may be appropriate or necessary; and

(3) Prevent loss or theft of material subject to this part.

(d) Each license issued pursuant to this part and parts He-P 4031 through 4036, and He-P 4039, shall be subject to all of the provisions of RSA 125-F and to the administrative rules in chapter He-P 4000. Said licenses shall also be subject to any temporary orders issued pursuant to the governor’s state of emergency by the commissioner when necessary to protect the health and safety of employees, the general public, or the security of certain types of radioactive materials during the declared state of emergency.

(e) Neither the license nor any right under the license issued or granted pursuant this part and parts He-P 4031 through 4036, and He-P 4039, shall be assigned or otherwise transferred in violation of the provision of RSA 125-F.

(f) Each person licensed by DHHS/RHS pursuant to this part shall confine his or her use and possession of the material licensed to conditions specified on the license, such as:

(1) Standard licensing conditions as set forth in these rules, or

(2) Conditions formulated specifically for an individual license.

(g) Each licensee shall notify DHHS/RHS in writing when the licensee decides to permanently discontinue all activities involving materials authorized under the license.

(h) Each general licensee that is required to register by He-P 4031, and each specific licensee, shall notify DHHS/RHS in writing immediately following the filing of a voluntary or involuntary petition for bankruptcy under any Chapter of Title 11 of the United States Code by or against:

(1) The licensee;

(2) An entity, as that term is defined in 11 U.S.C. 101(15), controlling the licensee or listing the license or licensee as property of the estate; or

(3) An affiliate, as that term is defined in 11 U.S.C. 101(2), of the licensee.

(i) The notification specified in He-P 4030.10(h) shall indicate the bankruptcy court in which the petition for bankruptcy was filed and the date of the filing of the petition.

(j) Each licensee shall notify DHHS/RHS of radiological incidents and events, as follows:

(1) As soon as possible but not later than 4 hours after the discovery of an event that prevents immediate protective actions necessary to avoid exposures to radiation or radioactive materials that could exceed the limits specified in He-P 4020, or releases of licensed material that could exceed the limits specified in He-P 4020; and

(2) Within 24 hours after the discovery of any of the following events involving licensed material:

a. An unplanned contamination event that:

1. Requires access to the contaminated area, by workers or the public, to be restricted for more than 24 hours by imposing additional radiological controls or by prohibiting entry into the area;

2. Involves a quantity of radioactive material greater than 5 times the lowest annual limit of intake specified in He-P 4090 or the equivalent 10 CFR 20 Appendix B for the material; and

3. Requires access to the area to be restricted for a reason other than to allow isotopes with a half-life of less than 24 hours to decay prior to decontamination;

b. An event in which equipment is disabled or fails to function as designed when:

1. The equipment is required by the rules or license condition to prevent releases exceeding regulatory limits, to prevent exposures to radiation and radioactive materials exceeding the limits specified by He-P 4020, or to mitigate the consequences of an accident;

2. The equipment is required to be available and operable when it is disabled or fails to function; and

3. No redundant equipment is available and operable to perform the required safety function;

c. An event that requires unplanned medical treatment at a medical facility of an individual with spreadable radioactive contamination on the individual’s clothing or body; and

d. An unplanned fire or explosion damaging any licensed material or any device, container, or equipment containing licensed material when:

1. The quantity of radioactive material involved is greater than 5 times the lowest annual limit on intake specified in He-P 4090 for the material; and

2. The damage affects the integrity of the licensed material or its container.

(k) Licensees shall make reports to DHHS/RHS required by He-P 4030.10(j)(1) and (2) above, by telephone via the New Hampshire state police communications center at (603) 271-3636.

(l) To the extent that the information is available at the time of notification, the information provided in the telephonic report pursuant to (k) above shall include:

(1) The caller’s name and call back telephone number;

(2) A description of the event, including date and time;

(3) The exact location of the event;

(4) The isotopes, quantities, and chemical and physical form of the licensed material involved; and

(5) Any personnel radiation exposure data available.

(m) Each licensee who makes a report required by He-P 4030.10(j)(1) or (2) shall submit to DHHS/RHS a written follow-up report within 30 days of the initial report, which includes the following information:

(1) A description of the event, including the probable cause and the manufacturer and model number (if applicable) of any equipment that failed or malfunctioned;

(2) The exact location of the event;

(3) The isotopes, quantities, and chemical and physical form of the licensed material involved;

(4) Date and time of the event;

(5) Corrective actions taken or planned and the results of any evaluations or assessments; and

(6) The extent of exposure of individuals to radiation or to radioactive materials without identification of individuals by name.

(n) Relative to records, each person who receives byproduct material pursuant to a license issued pursuant He-P 4030 through He-P 4039 shall:

(1) Keep records showing the receipt, transfer, and disposal of the source or byproduct material, as follows:

a. The licensee shall retain each record of receipt of source or byproduct material as long as the material is possessed and for 3 years following transfer or disposal of the source or byproduct material;

b. The licensee who transferred the radioactive material shall retain each record of transfer of source or byproduct material until DHHS/RHS terminates each license that authorizes the activity that is subject to recordkeeping requirement;

c. The licensee who disposed of the source or byproduct material shall retain each record of disposal of radioactive material until the license that authorizes disposal of the material is terminated; and

d. If source or byproduct material is combined or mixed with other licensed material and subsequently treated in a manner that makes direct correlation of a receipt record with transfer, export, or disposition record impossible, the licensee shall use evaluative techniques, such as, first-in-first-out, to make the records that are required by He-P 4030 account for 100 percent of the material received;

(2) Retain each record that is required by this chapter or by license condition for the period specified by the applicable rule or license condition, except that if a retention period is not otherwise specified by rule or license condition, the record shall be retained until the license authorizing the activity that is subject to the recordkeeping requirement is terminated;

(3) Retain records required to be maintained pursuant to this chapter in the following format:

a. The original;

b. A reproduced copy, if such reproduced copy is duly authenticated by authorized personnel;

c. Microform, if such microform is duly authenticated by authorized personnel and is capable of producing a clear and legible copy after storage for the period specified by the rules; or

d. Stored in electronic media with the capability for producing legible, accurate, and complete records during the required retention period;

(4) Ensure that all pertinent information, including stamps, initials, and signatures, are included on all required records, including letters, drawings, specifications;

(5) Maintain adequate safeguards against tampering with and loss of records;

(6) Prior to termination of a license authorizing possession of radioactive material with a half-life greater than 120 days, in an unsealed form, forward the following records to DHHS/RHS:

a. Records of disposal of licensed material made under He-P 4023; and

b. Records required by He-P 4021.03(c)(4);

(7) At the time of transfer of a radioactive material license authorizing possession of radioactive material with a half-life of greater than 120 days, in an unsealed form, transferred or assigned in accordance with He-P 4030.15 to a new licensee, transfer the following records to the new licensee and the new licensee will be responsible for maintaining these records until the license is terminated, the following:

a. Records of disposal of licensed material made under He-P 4023; and

b. Records required by He-P 4021.03(c)(4); and

(8) Prior to license termination, forward the records to DHHS/RHS as required by He-P 4030.09(o) – (r).

(o) Relative to licensees preparing technetium-99m radiopharmaceuticals from molybdenum- 99/technetium-99m generators or rubidium-82 from strontium-82/rubidium-82 generators, each licensee shall test the generator eluates for molybdenum-99 breakthrough or strontium-82 and strontium- 85 contamination, respectively, in accordance with He-P 4035.32(a) through (d). The licensee shall record the results of each test and retain each record for 3 years after the record is made. The licensee shall report the results of any test that exceeds the permissible concentration listed in He-P 4035.32(a) at the time of the generator elution, in accordance with He-P 4035.32(e).

(p) Relative to licensees authorized under He-P 4030.07(k) to produce:

(1) PET radioactive drugs for noncommercial transfer to medical use licensees in its consortium shall not relieve the licensee from complying with applicable DHHS/RHS, or agreement state, or federal requirements governing radioactive drugs; and

(2) PET radioactive drugs for noncommercial transfer to medical use licensees in its consortium, the licensees shall satisfy:

a. The labeling requirements in He-P 4032.05(a)(4) for each PET radioactive drug transport radiation shield and each syringe, vial, or other container used to hold a PET radioactive drug intended for noncommercial distribution to members of the licensees consortium; and

b. The requirement for using instrumentation to measure the radioactivity of the PET radioactive drugs intended for noncommercial distribution to members of the licensees’ consortium and meet the procedural, radioactivity measurement, instrument test, instrument check, and instrument adjustment requirements of He-P 4032.05(d).

(q) Relative to pharmacies authorized under He-P 4030.07(k) to produce PET radioactive drugs for noncommercial transfer to medical use licensees in its consortium, each pharmacy shall require that any individual who prepares PET radioactive drugs shall be:

(1) An authorized nuclear pharmacist that meets the requirements in He-P 4032.05(b)(2);

(2) An individual under the supervision of an authorized nuclear pharmacist as specified in He-P 4035.11; or

(3) An individual working as an authorized nuclear pharmacist who meets the requirements of He-P 4032.05(b)(2).

(r) Relative to portable gauge licensees, each licensee shall:

(1) Secure the portable gauges such that each portable gauge license shall use a minimum of 2 independent physical controls that form tangible barriers to secure portable gauges from unauthorized removal, whenever portable gauges are not under the control and constant surveillance of the licensee; and

(2) Maintain utilization logs for 3 years for each source of radiation which contains the following information:

a. A description, including the make, model, and serial number of each sealed source and each device in which the sealed source is located;

b. The location and dates of use, including the dates removed and returned to storage; and

c. The identity and signature of the user of the device.

(s) Relative to licensee’s survey instruments, each licensee shall:

(1) Keep sufficient calibrated and operable radiation survey instruments at each location where sources of radiation are present to make the radiation surveys required by He-P 4022;

(2) Have each radiation survey instrument calibrated:

a. At energies appropriate for use and at intervals not to exceed 12 months or after instrument servicing, except for battery changes;

b. For linear scale instruments, at 2 points located approximately one-third and two-thirds of full scale on each scale. For logarithmic scale instruments, at mid-range of each decade, and at 2 points of at least one decade. For digital instruments, at 3 points between 0.02 and 10 millisieverts (2 and 1,000 mrem) per hour; and

c. So that an accuracy within plus or minus 20 percent at the calibration source can be demonstrated at each point checked; and

(3) Maintain records of the annual calibrations of its radiation survey instruments and retain each record for 3 years after it is made.

He-P 4030.11 Specific Licenses, Expiration.

(a) Except as provided in He-P 4030.12 for license renewal, each specific license shall expire annually at the end of one year.

(b) Each licensee shall notify DHHS/RHS, in writing, and request termination of the license when the licensee decides to terminate all activities involving byproduct material authorized under the license. This notification and request for termination of the license shall include the reports and information specified in He-P 4030.11(d)(4) and (5).

(1) Submit an application for license renewal under He-P 4030.12; or

(2) Notify DHHS/RHS, in writing, if the licensee decides not to renew the license.

(d) If a licensee does not submit an application for license renewal under He‑P 4030.12, the licensee shall, on or before the expiration date specified in the license:

(1) Terminate use of radioactive material;

(2) Remove radioactive contamination in accordance with He-P 4023;

(3) Dispose of radioactive material in accordance with He-P 4023;

(4) Submit a completed DHHS/RHS-10 “Certificate-Disposition of Radioactive Material” (July 2022) in accordance with He-P 4030.01(c); and

(5) Submit a radiation survey report of the licensed permanent location(s) of use and storage to confirm that the removable and fixed contamination levels are in accordance with levels specified in He-P 4021.21, as follows:

a. Report levels of radiation in units of microrad per hour of beta and gamma radiation at 1 centimeter and gamma radiation at 1 meter from surfaces;

b. Report levels of radioactivity, including alpha, in:

1. Units of transformations per minute per 100 square centimeters or microcuries per 100 square centimeters removable and fixed on surfaces;

2. Microcuries per milliliter in water; and

3. Picocuries per gram in contaminated solids such as soils or concrete; and

c. Specify the survey or measurement instrument(s) used for conducting the survey and certify that each instrument was properly calibrated and tested.

(e) If no residual radioactive contamination attributable to activities conducted under the license is detected, the licensee shall submit a certification that no detectable radioactive contamination of the location(s) was found.

(f) If detectable levels of residual radioactive contamination attributable to activities conducted under the license are found, the license shall continue to be in effect beyond the expiration date, with respect to possession of residual radioactive material present as contamination until such time as DHHS/RHS notifies the licensee in writing that the license is terminated. During this time the licensee shall be subject to the provisions of He-P 4030.11(h).

(g) If detectable levels of residual radioactive contamination attributable to activities conducted under the license are found, the licensee shall submit a plan for decontamination of the residual radioactive contamination which shall include in addition to the information submitted under He‑P 4030.11(d)(4) and (5), any expected levels of residual radioactive contamination which will remain at the time the license is terminated.

(h) Each licensee who possesses residual radioactive material under He‑P 4030.11(d)(3), following the expiration date specified in the license, shall:

(1) Limit actions involving radioactive material to those related to decontamination and other activities related to preparation for release for unrestricted use; and

(2) Continue to control entry to restricted areas until the licensee has met the provisions of He‑P 4020 for release for unrestricted use and DHHS/RHS has notified the licensee in writing that the license is terminated.

Source. (See Revision Note at part heading for He-P 4030) #6942, eff 2-1-99; ss by #8800, INTERIM, eff 2-1-07, EXPIRED: 7-31-07

New. #8959, eff 8-7-07; ss by #10896, INTERIM, eff 7-22-15, EXPIRES: 1-18-16; ss by #11006, eff 1-15-16; ss by #13421, eff 7-29-22

He-P 4030.12 Specific Licenses, Renewal.

(a) Except as provided in (b) below, in order to renew a license, a licensee shall file a completed application for renewal of specific licenses annually using DHHS/RHS-1.1 “Application for Annual Renewal of Radioactive Material License” (July 2022); and submit the applicable fee as required by He-P 4070.

(b) Not more often than once every 7 years after filing an application according to He-P 4030.07, the licensee shall renew the license by submitting a completed application as listed in He-P 4030.07(a) and applicable supplements, as requested by DHHS/RHS in order to fully review the license. The completed application shall comply with He-P 4030.07.

(c) In any case in which a licensee, not less than 30 days prior to expiration of his existing license, has filed an application in proper form as stated in (a) or (b) above, for renewal, or for a new license authorizing the same activities, such existing license shall not expire until the application has been finally determined by DHHS/RHS.

(d) If a licensee does not submit an application for license renewal, the licensee shall comply with the provisions of He-P 4030.10(n) and He-P 4030.17(d).

(e) Each application submitted shall meet the requirements of He-P 4030.01(c).

Source. (See Revision Note at part heading for He-P 4030) #6942, eff 2-1-99; ss by #8800, INTERIM, eff 2-1-07, EXPIRED: 7-31-07

New. #8959, eff 8-7-07; ss by #10896, INTERIM, eff 7-22-15, EXPIRES: 1-18-16; ss by #11006, eff 1-15-16; ss by #13421, eff 7-29-22

He-P 4030.13 Specific Licenses, Amendment at Request of Licensee. Requests for amendment of a license shall:

(a) Be filed in accordance with He‑P 4030.07;

(b) Specify the respects in which the licensee desires its license to be amended and the grounds for such amendment;

(c) Be submitted for review and authorization by DHHS/RHS prior to implementing the activity as stated in the initial request for the license to be amended; and

(d) Be submitted in a business letter format.

Source. (See Revision Note at part heading for He-P 4030) #6942, eff 2-1-99; ss by #8800, INTERIM, eff 2-1-07, EXPIRED: 7-31-07

New. #8959, eff 8-7-07; ss by #10896, INTERIM, eff 7-22-15, EXPIRES: 1-18-16; ss by #11006, eff 1-15-16

He-P 4030.14 Specific Licenses, DHHS/RHS Action of Applications to Renew or Amend. In considering an application by a licensee to renew or amend its license, DHHS/RHS shall apply the criteria set forth in this chapter for granting of an initial license.

Source. (See Revision Note at part heading for He-P 4030) #6942, eff 2-1-99; ss by #8800, INTERIM, eff 2-1-07, EXPIRED: 7-31-07

New. #8959, eff 8-7-07; ss by #10896, INTERIM, eff 7-22-15, EXPIRES: 1-18-16; ss by #11006, eff 1-15-16

He-P 4030.15 Specific Licenses, Inalienability. No license issued or granted under He-P 4000, and no right to possess or utilize byproduct material granted by any license issued pursuant to this part shall be transferred, assigned, or in any manner disposed of, either voluntarily or involuntarily, directly or indirectly, through transfer of control of any license to any person unless DHHS/RHS, after securing full information, find that the transfer is in accordance with the provisions of the act, and gives its consent in writing.

Source. (See Revision Note at part heading for He-P 4030) #6942, eff 2-1-99; ss by #8800, INTERIM, eff 2-1-07, EXPIRED: 7-31-07

New. #8959, eff 8-7-07; ss by #10896, INTERIM, eff 7-22-15, EXPIRES: 1-18-16; ss by #11006, eff 1-15-16

He-P 4030.16 Specific Licenses, Transfer of Source or Byproduct Material.

(a) No licensee shall transfer source or byproduct material except as authorized pursuant to Part He-P 4030.

(b) Except as otherwise provided in its license and subject to the provisions of He-P 4030.16(c) and (d), any licensee may transfer source or byproduct material:

(1) To DHHS/RHS only after receiving prior approval from DHHS/RHS;

(2) To the U.S. Department of Energy;

(3) To any person exempt from He‑P 4000 to the extent permitted under such exemption;

(4) To any person authorized to receive such source or byproduct material under terms of a general license or its equivalent or a specific license or equivalent licensing document, issued by DHHS/RHS, the Nuclear Regulatory Commission, an agreement state, or to any person otherwise authorized to receive such source or byproduct material by the Federal government of any agency thereof, DHHS/RHS, an agreement state; or

(5) As otherwise authorized by DHHS/RHS in writing.

(c) Before transferring source or byproduct material to a specific licensee of DHHS/RHS, the Nuclear Regulatory Commission, an agreement state, or a licensing state prior to receipt of the byproduct material, the transferor licensee shall verify that the transferee’s license authorizes the receipt of the type, form, and quantity of source or byproduct material to be transferred.

(d) The following methods for the verification required by He-P 4030.16(c) shall be acceptable:

(1) The transferor may have in its possession, and have read, a current copy of the transferee’s specific license or registration certificate;

(2) The transferor may have in its possession a written certification by the transferee that it is authorized by license or registration certificate to receive the type, form, and quantity of source or byproduct material to be transferred, specifying the license or registration certificate number, issuing agency, and expiration date;

(3) For emergency shipments the transferor may accept oral certification by the transferee that it is authorized by license or registration certificate to receive the type, form, and quantity of source or byproduct material to be transferred, the oral certification shall specify the license or registration certificate number, issuing agency, and expiration date, and shall be confirmed in writing within 10 days;

(4) The transferor may obtain other sources of information compiled by a reporting service from official records of DHHS/RHS, the Nuclear Regulatory Commission, or the licensing agency of an agreement state as to the identity of licensees and the scope and expiration dates of licenses and registration; or

(5) When none of the methods of verification described in He‑P 4030.16(d)(1) through (4) are readily available or when a transferor desires to verify that information received by one of such methods is correct or up-to-date, the transferor may obtain and record confirmation from DHHS/RHS, the Nuclear Regulatory Commission, or the licensing agency of an agreement state that the transferee is licensed to receive the source or byproduct material.

(e) Preparation for shipment and transport of source or byproduct material shall be in accordance with the provisions of He‑P 4037.

Source. (See Revision Note at part heading for He-P 4030) #6942, eff 2-1-99; ss by #8800, INTERIM, eff 2-1-07, EXPIRED: 7-31-07

New. #8959, eff 8-7-07; ss by #10896, INTERIM, eff 7-22-15, EXPIRES: 1-18-16; ss by #11006, eff 1-15-16; ss by #13047, eff 6-2-20

He-P 4030.17 Specific Licenses, Modification, Revocation, and Termination.

(a) The terms and conditions of all licenses shall be subject to amendment, revision, or modification or the license may be suspended or revoked by reason of amendments to the act, or by reason of rules, and orders issued by DHHS/RHS.

(b) Any license may be revoked, suspended, or modified, in whole or in part, for any material false statement in the application or any statement of fact required under provisions of the act, or because of conditions revealed by such application or statement of fact or any report, record or inspection or other means which would warrant DHHS/RHS to refuse to grant a license on an original application, or for violation of, the terms and conditions of the act, or the license, or of any rule, regulation, or order of DHHS/RHS.

(c) Except in cases of willfulness or those in which the public health, interest, or safety requires otherwise, no license shall be modified, suspended, or revoked unless, prior to the institution of proceedings therefor, facts or conduct which may warrant such action shall have been called to the attention of the licensee in writing and the licensee shall have been accorded an opportunity to demonstrate or achieve compliance with all lawful requirements.

(d) DHHS/RHS shall terminate a specific license upon request submitted by the licensee to DHHS/RHS in writing, provided that the licensee shall meet the requirements of He‑P 4030.11.

Source. (See Revision Note at part heading for He-P 4030) #6942, eff 2-1-99; ss by #8800, INTERIM, eff 2-1-07, EXPIRED: 7-31-07

New. #8959, eff 8-7-07; ss by #10896, INTERIM, eff 7-22-15, EXPIRES: 1-18-16; ss by #11006, eff 1-15-16

He-P 4030.18 Reciprocal Recognition of Specific Licenses.

(a) Subject to He‑P 4000, any person who holds a specific license from the Nuclear Regulatory Commission, an agreement state, as defined in He-P 4003.01 and issued by the agency having jurisdiction where the licensee maintains an office for directing the licensed activity and at which radiation safety records are normally maintained, shall hereby be granted a general license to conduct the activities authorized in such licensing document within this state, except in areas of exclusive federal jurisdiction, for a period not in excess of 180 days in any calendar year, provided that:

(1) The licensing document shall not limit the activity authorized by such document to specified installations or locations; and

(2) The out-of-state licensee shall notify DHHS/RHS as described in (d) below at least 3 working days prior to engaging in such activity and receive DHHS/RHS approval, except as provided in (e) below.

(b) DHHS/RHS shall grant the approval required by He-P 4030.18(a)(2) above when a general licensee meets all of the requirements under He-P 4030.18.

(c) The notification required by He-P 4030.18(a)(2) above shall indicate the location, period, and type of proposed possession and use within this state.

(d) The notification to DHHS/RHS, as specified in He-P 4001.08, shall be accompanied by a copy of the pertinent out of state licensing document, a copy of the licensee’s operating and emergency procedures, an annual fee as specified in He-P 4070, and a completed DHHS/RHS-15 “Radioactive Material Reciprocity Application” (July 2022) with the following certification:

“I hereby certify that all information provided in this application is true and complete, I have read and understand the provisions under He-P 4030.18, and I understand that activities, including storage, conducted in New Hampshire under this general license are limited to 180 days during any calendar year.”

(e) If, for a specific case, the 3-day period required by He-P 4030.18(a)(2) above would endanger the public health and safety, the licensee shall request a waiver from DHHS/RHS to proceed sooner.

(f) The out-of-state licensee shall submit in its initial request for reciprocity the applicable New Hampshire annual license fee in accordance with He-P 4070.

(g) The reciprocity fee required by (f) above shall cover a period of one year.

(h) The requirement in (f) above shall not waive the requirement for filing additional written notifications during the remainder of the calendar year following the receipt of the initial notification from a person engaging in activities under the general license provided in He-P 4030.18(a).

(i) The out-of-state licensee shall comply with all:

(1) Applicable rules of DHHS/RHS; and

(2) Terms and conditions of the licensee’s licensing document, except any such terms and conditions which are contrary to applicable rules of DHHS/RHS.

(j) The out-of-state licensee shall supply additional information, either telephonically or in writing, as requested by DHHS/RHS for the purposes of protecting public and worker health and safety and ensuring the safe use of byproduct sources within the state.

(k) The out-of-state licensee shall not transfer or dispose of byproduct material possessed or used under the general license provided in this section except by transfer to a person:

(1) Specifically licensed by DHHS/RHS, an agreement state, or by the Nuclear Regulatory Commission to receive such material; or

(2) Exempt from the requirements for a license for such material under He-P 4030.03.

(l) Before byproduct materials are used at a temporary job site within the state at any federal facility, the jurisdictional status of the job site shall be determined by the licensee.

(m) If the jurisdictional status of a temporary job site within the state at a federal facility is unknown, the licensee shall contact the federal agency to determine if the job site is under exclusive federal jurisdiction.

(n) In areas of exclusive federal jurisdiction, the general licensee shall be subject to all applicable rules, regulations, orders and fees of the Nuclear Regulatory Commission.

(o) Authorization for possession and use of byproduct materials at temporary job sites under exclusive federal jurisdiction shall be obtained from the Nuclear Regulatory Commission by either:

(1) Filing a Nuclear Regulatory Commission Form-241 in accordance with 10 CFR 150.20(b); or

(2) Applying for a specific Nuclear Regulatory Commission license.

(p) Before byproduct material is used by a specific licensee at a temporary job site in another state, authorization shall be obtained from that state if it is an agreement state, or from the Nuclear Regulatory Commission for any non-agreement state, either by filing for reciprocity or applying for and obtaining a specific license.

(q) Notwithstanding the provisions of He-P 4030.18(a), any person who holds a specific license issued by an agreement state, or the Nuclear Regulatory Commission, authorizing the holder to manufacture, install, or service a device described in He-P 4031.04(c) within an area subject to the jurisdiction of the licensing body shall be considered by DHHS/RHS to have a general license to install and service such device in this state provided that:

(1) Such person shall file a report with DHHS/RHS within 30 days after the end of each calendar quarter in which any device is transferred to or serviced in this state;

(2) The report required by He-P 4030.18(q)(1) above shall identify each general licensee by:

a. Name and address;

b. The type of device transferred; and

c. The quantity and type of byproduct material contained in the device;

(3) The device shall have been manufactured, labeled, installed, and serviced in accordance with applicable provisions of the specific license, or equivalent licensing document, issued to such person by the Nuclear Regulatory Commission or an agreement state;

(4) Such person shall assure that any labels required to be affixed to the device under regulations of the authority which licensed manufacture of the device bear a statement that “Removal of this label is prohibited”;

(5) In the event that a label, as specified in He-P 4030.18(q)(4) above, is missing or damaged, such person shall affix a label in accordance with the regulations of the authority which licensed manufacture of the device; and

(6) The holder of the specific license shall furnish to each general licensee to whom the licensee transfers such device or on whose premises he or she installs such device a copy of the general license contained in He-P 4031.02.

(r) In accordance with RSA 125-F:10, DHHS/RHS shall withdraw, limit, or qualify its acceptance of any specific license or equivalent licensing document issued by another agency, or any product distributed pursuant to such licensing document, upon determining that such action is necessary in order to protect the public health and minimize the danger to life or property.

(s) A licensee to whom action has been taken as described in He-P 4030.18(r) shall be afforded a hearing within 15 days on application, in the form of a written request, to DHHS/RHS requesting such hearing.

(t) A hearing held relative to action taken under He-P 4030.18(r) shall be conducted in accordance with He-C 200.

Source. (See Revision Note at part heading for He-P 4030) #6942, eff 2-1-99; ss by #7919, eff 7-18-03; ss by #8488, eff 11-18-05; ss by #8959, eff 8-7-07; ss by #10896, INTERIM, eff 7-22-15, EXPIRES: 1-18-16; ss by #11006, eff 1-15-16; ss by #13421, eff 7-29-22

He-P 4030.19 Requirements for License to Initially Transfer Source Material for Use Under the ‘Small Quantities of Source Material' General License. An application for a specific license to initially transfer source material for use under He-P 4031.03, equivalent regulations of an agreement state, or Nuclear Regulatory Commission under 10 CFR 40.22, shall be approved if:

(a) The applicant satisfies the general requirements specified in He-P 4030.09; and

(b) The applicant submits adequate information on, and DHHS/RHS approves the methods to be used for quality control, labeling, and providing safety instructions to recipients.

Source. #13047, eff 6-2-20

He-P 4030.20 Conditions of Licenses to Initially Transfer Source Material for Use Under the ‘Small Quantities of Source Material’ General License: Quality Control, Labeling, Safety Instructions, and Records and Reports.

(a) Each person licensed under He-P 4030.19 shall label the immediate container of each quantity material with the type of source material and quantity of material and the words, “radioactive material.”

(b) Each person licensed under He-P 4030.19 shall ensure that the quantities and concentrations of source material are as labeled and indicated in any transfer records.

(c) Each person licensed under He-P 4030.19 shall provide the information specified in this paragraph to each person to whom source material is transferred for use under He-P 4031.03, equivalent provisions in agreement state regulations, or Nuclear Regulatory Commission under 10 CFR 40.54. This information shall be transferred before the source material is transferred for the first time in each calendar year to the particular recipient. The required information includes:

(1) A copy of He-P 4030.03 and He-P 4030.16, equivalent regulations of an agreement state, or Nuclear Regulatory Commission 10 CFR 40.22 and 40.51; and

(2) Appropriate radiation safety precautions and instructions relating to handling, use, storage, and disposal of the material.

(d) Each person licensed under He-P 4030.19 shall report transfers as follows:

(1) File a report with DHHS/RHS. The report shall include the following information:

a. The name, address, and license number of the person who transferred the source material;

b. For each general licensee under He-P 4031.03, equivalent agreement state provisions to who greater than 50 grams (0.11 lb) of source material has been transferred in a single calendar quarter, or Nuclear Regulatory Commission 10 CFR 40.22, the name and address of the general licensee to whom source material is distributed; a responsible agent, by name and/or position and phone number, of the general licensee to whom the material was sent; and the type, physical form, and quantity of source material transferred; and

c. The total quantity of each type and physical form of source material transferred in the reporting period to all such generally licensed recipients;

(2) File a report with DHHS/RHS that identifies all persons, operating under provisions of He-P 4031.03, to whom greater than greater than 50 grams (0.11 lb) of source material has been transferred within a single calendar quarter. The report shall include the following information specific to those transfers made to DHHS/RHS being reported to:

a. The name, address, and license number of the person who transferred the source material;

b. The name and address of the general licensee to whom source material was distributed; a responsible agent, by name and/or position and phone number, of the general licensee to who the material was sent; and the type, physical form, and quantity of source material transferred; and

c. The total quantity of each type and physical form of source material transferred in the reporting period to such generally licensed recipients within New Hampshire;

(3) Submit each report by January 31 of each year covering all transfers for the previous calendar year. If no transfers were made to persons generally licensed under He-P 4031.03, equivalent agreement state provisions during the current period, or Nuclear Regulatory Commission 10 CFR 40.22, a report shall be submitted to DHHS/RHS indicating so. If no transfers have been made to general licensees in New Hampshire during the reporting period, this information shall be reported to DHHS/RHS upon request.

(e) Each person licensed under He-P 4030.19 shall maintain all information that supports the reports required by He-P 4030.20 concerning each transfer to a general licensee for a period of one year after the event is included in a report to DHHS/RHS.

Source. #13047, eff 6-2-20

PART He-P 4031 GENERAL LICENSES

Revision Note:

PART He-P 4031 GENERAL LICENSES

Statutory Authority: RSA 125‑F:5,V

He-P 4031.01 Purpose and Scope.

(a) This part establishes general licenses for the possession and use of byproduct material and a general license for ownership of byproduct material.

(b) Specific provisions of He-P 4030 shall be applicable to general licenses established by this part.

Source. (See Revision Note at part heading for He-P 4031) #6942, eff 2-1-99; ss by #8481, eff 11-5-05; ss by #10604, eff 5-23-14

He-P 4031.02 Terms and Conditions. The general license provided in this part shall be subject to the general provisions of He-P 4030.01, 4030.03(b), 4030.10(a), (c), (d), (i) and (j), He-P 4030.15, He-P 4030.16, He-P 4030.17, He-P 4001, He-P 4003, He-P 4019, He-P 4020, He-P 4021, He-P 4022, He-P 4023, and He-P 4037, unless indicated otherwise in the specific provision of the general license.

Source. (See Revision Note at part heading for He-P 4031) #6942, eff 2-1-99; ss by #8481, eff 11-5-05; ss by #10604, eff 5-23-14

He-P 4031.03 General Licenses - Source Material.

(a) A general license shall be issued authorizing commercial and industrial firms, research, educational, and medical institutions, and state and local government agencies to receive, possess, use, and transfer uranium and thorium, in their natural isotopic concentrations and in the form of depleted uranium, for research, development, educational, commercial, or operational purposes, in the following forms and quantities:

(1) No more than 1.5 kg (3.3 lb) of uranium and thorium in dispersible forms, which shall include gaseous, liquid, and powder forms, at any one time, and under the following conditions:

a. Any material processed by the general licensee that alters the chemical or physical form of the material containing source material shall be accounted for as a dispersible form;

b. A person authorized to possess, use, and transfer source material under He-P 4032.03(a) shall not receive more than a total of 7 kg (15.4 lb) of uranium and thorium in any one calendar year;

c. Persons possessing source material in excess of these limits in b. above may:

(i) Continue to possess up to 7 kg (15.4 lb) of uranium and thorium at any one time for one year until the DHHS/RHS takes final action on a pending application submitted on or before August 27, 2014, for a specific license for such material; and

(ii) Continue to receive up to 70 kg (154 lb) of uranium or thorium in any one calendar year until December 31, 2014, or until the DHHS/RHS takes final action on a pending application submitted on or before August 27, 2014, for a specific license for such material;

(2) No more than a total of 7 kg (15.4 lb) of uranium and thorium at any one time, and under the following conditions:

a. A person authorized to possess, use, and transfer source material under this paragraph shall not receive more than a total of 70 kg (154 lb) of uranium and thorium in any one calendar year; and

b. A person shall not alter the chemical or physical form of the source material possessed under He-P 4032.03(a) unless it is accounted for under the limits of He-P 4032.03(a)(1);

(3) No more than 7 kg (15.4 lb) of uranium, removed during the treatment of drinking water, at any one time. In addition, a person shall not remove more than 70 kg (154 lb) of uranium from drinking water during a calendar year under He-P 4032.03(a); or

(4) No more than 7 kg (15.4 lb) of uranium and thorium at laboratories for the purpose of determining the concentration of uranium and thorium contained within the material being analyzed at any one time. In addition, a person authorized to possess, use, and transfer source material under He-P 4032.03(a) shall not receive more than a total of 70 kg (154 lb) of source material in any one calendar year.

(b) Persons who receive, possess, use, or transfer source material pursuant to the general license issued in He-P 4031.03(a):

(1) Shall be prohibited from administering source material, or the radiation therefrom, either externally or internally, to human beings except as may be authorized by the DHHS/RHS in a specific license;

(2) Shall not abandon such source material;

(3) Shall dispose of such source material as follows:

a. A cumulative total of 0.5 kg (1.1 lb) of source material in a solid, non-dispersible form may be transferred each calendar year, by a person authorized to receive, possess, use, and transfer source material under this general license to persons receiving the material for permanent disposal. The recipient of source material transferred under the provisions of this paragraph shall be exempt from the requirements to obtain a license under this part to the extent the source material is permanently disposed. This provision shall not apply to any person who is in possession of source material under a specific license issued under He-P 4032 or He-P 4033; or

b. In accordance with He-P 4023.01;

(4) Shall be subjected to the provisions in He-P 4001.03, He-P 4001.05, He-P 4001.07, He-P 4001.08, He-P 4003.01, He-P 4024, He-P 4030.15 through He-P 4030.17, and He-P 4031.03;

(5) Shall respond to written requests from the DHHS/RHS to provide information relating to the general license within 30 calendar days of the date of the request, or other time specified in the request. If the person cannot provide the requested information within the allotted time, the person shall, within that same time period, request a longer period to supply the information by providing the DHHS/RHS, a written justification for the request; and

(6) Shall not export such source material except in accordance with 10 CFR Part 110.

(c) Any person who receives, possesses, uses, or transfers source material in accordance with He-P 4031.03(a) shall conduct activities so as to minimize contamination of the facility and the environment. When activities involving such source material are permanently ceased at any site, if evidence of significant contamination is identified, the general licensee shall notify the DHHS/RHS about such contamination and may consult with the DHHS/RHS as to the appropriateness of sampling and restoration activities to ensure that any contamination or residual source material remaining at the site where source material was used under this general license is not likely to result in exposures that exceed the limits in He-P 4024.09.

(d) Any person who receives, possesses, uses, or transfers source material in accordance with the general license granted in He-P4031.03(a) shall be exempt from the provisions of He-P 4019, He-P 4020, and He-P 4021 to the extent that such receipt, possession, use, and transfer are within the terms of this general license, except that such person shall comply with the provisions of He-P 4023.01 and He-P 4024.09 to the extent necessary to meet the provisions of He-P 4031.03(b)(2) and (c). However, this exemption shall not apply to any person who also holds a specific license issued under He-P 4032 or He-P 4033.

(e) A general license shall be issued to receive, acquire, possess, use, or transfer depleted uranium provided that:

(1) The depleted uranium is contained in industrial products or devices for the purpose of providing a concentrated mass in a small volume of the product or device in accordance with the provisions of He-P 4031.03(e)(2), (3), and (4);

(2) The depleted uranium authorized in He-P 4031.03(e)(1) is contained only in industrial products or devices which have been manufactured in accordance with a specific license issued to the manufacturer by the U.S. Nuclear Regulatory Commission or an Agreement State which authorizes manufacture of the products or devices for distribution to persons generally licensed by the U.S. Nuclear Regulatory Commission or an Agreement State;

(3) A person who receives, acquires, possesses, or uses depleted uranium pursuant to the general license established by He-P 4031.03(e)(1):

a. Shall not introduce such depleted uranium, in any form, into a chemical, physical, or metallurgical treatment or process, except when a treatment or process is for repair or restoration of the plating or covering of the depleted uranium;

b. Shall not abandon such depleted uranium;

c. Shall transfer or dispose of depleted uranium only by transfer in accordance with the provisions of He-P 4030.15;

d. Shall furnish the transferee a copy of this rule when depleted uranium is transferred in accordance with He-P 4031.03(e)(3)c;

e. Shall furnish the transferee a copy of He-P 4031 accompanied by a note explaining that use of the product or device is regulated by the U.S. Nuclear Regulatory Commission or an Agreement State in the case where the transferee receives the depleted uranium pursuant to a general license contained in the U.S. Nuclear Regulatory Commission's or an Agreement State's regulation equivalent to He-P 4031.03(e)(1);

f. Shall report within 30 days of any transfer, a report in writing to the DHHS/RHS the name and address of the person receiving the depleted uranium pursuant to such transfer; and

g. Shall not export depleted uranium except in accordance with a license issued by the U.S. Nuclear Regulatory Commission pursuant to 10 CFR 110; and

(4) Any person receiving, acquiring, possessing, using, or transferring depleted uranium pursuant to the general license established by He-P 4031.03(e) shall be exempt from the requirements of He P 4019 through He-P 4023 with respect to the provisions of He-P 4031.

(f) No person shall initially transfer or distribute source material to persons generally licensed under He-P 4031.03(a)(1) or (a)(2), equivalent regulations of an Agreement State, or Nuclear Regulatory Commission, unless authorized by a specific license issued in accordance with He-P 4032.03(a)(1) and (a)(2), equivalent provisions of an Agreement Statement, or Nuclear Regulatory Commission 10 CFR 40.54. This prohibition shall not apply to analytical laboratories returning processed samples to the client who initially provided the sample. Initial distribution of source material to persons generally licensed by He-P 4031.03(a) before August 27, 2013 without specific authorization, shall continue for 1 year beyond August 27, 2013. Distribution shall also be continued until DHHS/RHS or the Nuclear Regulatory Commission takes final action on pending application for license or license amendments to specifically authorized distribution submitted on or before August 27, 2014.

Source. (See Revision Note at part heading for He-P 4031) #6942, eff 2-1-99; ss by #8481, eff 11-5-05 (from He-P 4031.01); ss by #10604, eff 5-23-14; amd by #11198, eff 10-12-16; amd by #11198, eff 10-12-16

He-P 4031.04 General Licenses - Byproduct Material Other Than Source Material.

(a) Reserved.

(b) A general license shall be issued to commercial and industrial firms and to research, educational and medical institutions, individuals in the conduct of their business, and state or local government agencies to own, receive, acquire, possess, use or transfer in accordance with the provisions of He-P 4031.04(c), (d), and (e), byproduct material, excluding special nuclear material, contained in any fixed device designed and manufactured for the purpose of detecting, measuring, gauging or controlling thickness, density, level, interface location, radiation, leakage, or qualitative or quantitative chemical composition, or for producing light or an ionized atmosphere.

(c) The general license in He-P 4031.04(b) shall apply only to byproduct material contained in devices which have been manufactured or initially transferred and labeled in accordance with the specifications contained in a specific license issued by the DHHS/RHS pursuant to He-P 4032 or in accordance with the specifications contained in a specific license issued by the U.S. Nuclear Regulatory Commission or an Agreement State which authorizes distribution of devices to persons generally licensed by the NRC or an Agreement State.

(d) Devices containing byproduct material as described in He-P 4031.04(c) above shall have been received only from one of the specific licensees specified in He-P 4031.04(c) or through a transfer made in accordance with He-P 4031.04(e)(9).

(e) Any person who owns, receives, acquires, possesses, uses, or transfers byproduct material in a device pursuant to the general license in He-P 4031.04(b) shall:

(1) Assure that all labels affixed to the device at the time of receipt, and bearing a statement that removal of the label is prohibited, shall be maintained thereon and shall comply with all instructions and precautions provided by such labels;

(2) Assure that the device is tested for leakage of radioactive material and proper operation of the on-off mechanism and indicator, if any, at no longer than 6-month intervals or at such other intervals as are specified on the label; however:

a. Devices containing only krypton shall not be required to be tested for leakage of radioactive material; and

b. Devices containing only tritium or not more than 3.7 MBq (100 microcuries) of other beta and/or gamma emitting material or 370 kBq (10 microcuries) of alpha emitting material and devices held in storage in the original shipping container prior to initial installation shall not be required to be tested for any purpose;

(3) Assure that the tests required by He-P 4031.04(e)(2) and other testing, installation, servicing, and removal from installation involving the radioactive materials, its shielding or containment, are performed:

a. In accordance with the instructions provided by the labels; or

b. By a person holding a specific license from the DHHS/RHS, the NRC, or an Agreement State, to perform such activities;

(4) Maintain records showing compliance with the requirements He-P 4031.04(e)(2) and (3) which:

a. Show the results of tests; and

b. Show the dates of performance of, and the names of persons performing, testing, installing, servicing, and removal from installation concerning the radioactive material, its shielding or containment;

(5) Retain records as follows:

a. Each record of a test for leakage or radioactive material required by He-P 4031.04(e)(2) shall be retained for 3 years after the next required leak test is performed or until the sealed source is transferred or disposed of;

b. Each record of a test on the “on-off” mechanism and indicator required by He-P 4031.04(e)(2) shall be retained for 3 years after the next required test of the on-off mechanism and indicator is performed or until the sealed source is transferred or disposed of; and

c. Each record that is required by He-P 4031.04(e)(3) shall be retained for 3 years from the date of the recorded event or until the device is transferred or disposed of;

(6) Upon the occurrence of a failure of or damage to, or any indication of a possible failure of or damage to, the shielding of the radioactive material or the on-off mechanism or indicator, or upon the detection of 185 becquerel (0.005 microcurie) or more removable radioactive material, shall immediately suspend operation of the device until it has been repaired by the manufacturer or other person holding a specific license from the DHHS/RHS, the NRC, or an Agreement State to repair such devices, or disposed of by transfer to a person authorized by a specific license to receive the radioactive material contained in the device and, within 30 days, furnish to the DHHS/RHS a report containing a brief description of the event and the remedial action taken, and in the case of detection of 185 becquerel (0.005 microcurie) or more removable radioactive contamination or failure of or damage to a source likely to result in contamination of the premises or the environs, a plan for ensuring that the premises and environs are acceptable for unrestricted use, must be furnished to the DHHS/RHS, in accordance with the criteria set out in He-P 4021.20, and He-P 4024;

(7) Not abandon the device containing byproduct material;

(8) Not export the device containing byproduct material except in accordance with 10 CFR 110;

(9) Except as provided in He-P 4031.04(e)(10), transfer or dispose of the device containing byproduct material only by:

a. Export as provided by He-P 4031.04(e)(8);

b. By transfer to a general licensee as authorized by He-P 4031.04(e)(10); or

c. By transfer to a specific licensee of the DHHS/RHS, the NRC, or an Agreement State whose specific license authorizes him to receive the device and within 30 days after transfer or export of a device to a specific licensee shall furnish to the DHHS/RHS a report containing identification of the device by manufacturer's or initial transferor’s name, model number, and serial number, and the name, address, and license number of the person receiving the device, and the date of the transfer;

(10) Transfer byproduct material in a device pursuant to the general license in He-P 4031.04(b) if the general license holder obtains pre-approval from DHHS/RHS and:

a. Verifies that the specific license authorizes the possession and use, or applies for and obtains an amendment to the license authorizing the possession and use;

b. Removes, alters, covers, or clearly and unambiguously augments the existing label required by He-P 4031.04(e)(1) so that the device is labeled in compliance with He-P 4022.14, except that the manufacturer, model number, and serial number shall be retained;

c. Obtains the manufacturer’s or initial transferor’s information concerning maintenance that would be applicable under the specific license, such as leak testing procedures; and

d. Reports the transfer under He-P 4031.04(e)(9);

(11) Transfer the device to another general licensee only:

a. Where the device remains in use at a particular location, in which case the transferor shall give the transferee a copy of this rule and any safety documents identified in the label on the device and, within 30 days of the transfer, report to the DHHS/RHS the manufacturer's or initial transferor’s name, model number, and serial number of the device transferred, the name and address of the transferee, and the name, position, and telephone number of a responsible individual identified by the transferee in accordance with He-P 4031.04(e)(14) to have knowledge of and authority to take actions to ensure compliance with these rules, and who may constitute a point of contact between the DHHS/RHS and the transferee; or

b. Where the device is held in storage by an intermediate person in the original shipping container at its intended location of use prior to initial use by a general licensee;

(12) Comply with the provisions of He-P 4021.12 and 4021.13 for reporting radiation incidents, theft, or loss of licensed material, but shall be exempt from the other requirements of He-P 4019 through He-P 4023;

(13) Respond to written requests from the DHHS/RHS to provide information relating to the general license within 30 calendar days of the date of the request, or other time specified in the request, except that if the general licensee is unable to provide the requested information within the allotted time, it shall, within that same time period, request a longer period to supply the information by providing the DHHS/RHS a written justification for the request;

(14) Appoint an individual responsible for having knowledge of the appropriate rules and requirements, and for ensuring day-to-day compliance with the appropriate rules and requirements, and vested with the authority for taking required actions to comply with appropriate rules and requirements, although not relieving the general licensee of its responsibility in this regard;

(15) Register each device containing at least 370 MBq (10 mCi) of cesium-137, 3.7 MBq (0.1 mCi) of strontium-90, 37 MBq (1 mCi) of cobalt-60, 37 MBq (1 mCi) of americium-241, or 3.7 MBq (0.1 mCi) of radium-226, or any other transuranic, based on the activity indicated on the device label. Each address for a location of use, as described under He-P 4031.04(e)(16) of this section, represents a separate general licensee and requires a separate registration and fee;

(16) Register any and all devices meeting the criteria set out in He-P 4031.04(e)(15) annually with the DHHS/RHS and submit the fee required by He-P 4070. Registration shall be done by verifying, correcting, and/or adding to the information provided in a request for registration received from the DHHS/RHS. The registration information shall be submitted to the DHHS/RHS within 30 days of the date of the request for registration or as otherwise indicated in the request. In addition, a general licensee holding devices meeting the criteria of He-P 4031.04(e)(15) of this section is subject to the bankruptcy notification requirement in He-P 4030.10(h)-(i);

(17) In registering devices, furnish the following information and any other information specifically requested by the DHHS/RHS:

a. Name and mailing address of the general licensee;

b. Information about each device: the manufacturer (or initial transferor), model number, serial number, the radioisotope and activity (as indicated on the label);

c. Name, title, and telephone number of the responsible person designated as a representative of the general licensee under He-P 4031.04(e);

d. Address or location at which the device(s) are used and/or stored. For portable devices, the address of the primary place of storage;

e. Certification by the responsible representative of the general licensee that the information concerning the device(s) has been verified through a physical inventory and checking of label information; and

f. Certification by the responsible representative of the general licensee that they are aware of the requirements of the general license;

(18) Report changes to the mailing address for the location of use or a change in name of general licensee to the DHHS/RHS within 30 days of the effective date of the change. For a portable device, a report of address change is only required for a change in the device’s primary place of storage; and

(19) Not hold devices that are not in use for longer than 2 years. If devices with shutters are not being used, the shutter shall be locked in the closed position. The testing required by He-P 4031.04(e) need not be performed during the period of storage only; however, when devices are put back into service or transferred to another person, and have not been tested within the required test interval, they shall be tested for leakage before use or transfer and the shutter tested before use. Devices kept in standby for future use shall be excluded from the 2-year time limit if the general licensee performs quarterly physical inventories of these devices while they are in standby.

(f) The general license in He-P 4031.04(b) shall not authorize the manufacture or import of devices containing byproduct material.

(g) The general license provided in He-P 4031.04(b) shall be subject to the provisions of He-P 4001 through He-P 4003, He-P 4030.10, He-P 4030.16, He-P 4030.17, and He-P 4037.

(h) A general license is hereby issued to own, receive, acquire, possess, and use tritium or promethium 147 contained in luminous safety devices for use in aircraft, provided:

(1) Each device contains not more than 370 GBq (10 curies) of tritium or 11.1 GBq (300 millicuries) of promethium 147; and

(2) Each device has been manufactured, assembled or initially transferred in accordance with a license issued by the U.S. Nuclear Regulatory Commission or each device has been manufactured or assembled in accordance with the specifications contained in a specific license issued by the DHHS/RHS or an Agreement State to the manufacturer or assembler of such device for distribution to persons generally licensed by an Agreement State pursuant to licensing requirements equivalent to the previsions of 10 CFR Part 32.53 of the regulations of the U.S. Nuclear Regulatory Commission.

(i) Persons who own, receive, acquire, possess, or use luminous safety devices pursuant to the general license in He-P 4031.04(h) shall be exempt from the requirements of He-P 4019 through 4023, except that they shall comply with the provisions of sections He-P 4021.12 and He-P 4021.13.

(j) The general license in He-P 4031.04(h) shall not authorize the manufacture, assembly, repair, import or export of luminous safety devices containing tritium or promethium 147.

(k) The general license in He-P 4031.04(h) shall not authorize the ownership, receipt, acquisition, possession or use of promethium 147 contained in instrument dials.

(l) The general license in He-P 4031.04(h) shall be subject to the provisions of He-P 4001 through He-P 4003, He-P 4030.10, He-P 4030.16, He-P 4030.17 and He-P 4037.

(m) A general license shall be issued to those persons listed below to own, receive, acquire, possess, use, and transfer in accordance with the provisions of He-P 4031.04(p), (q) and (s) americium 241 or radium 226 in the form of calibration or reference sources:

(1) Any person who holds a specific license issued by the Agency which authorizes him to receive, possess, use, and transfer byproduct materials, source material; and

(2) Any person who holds a specific license issued by the U.S. Nuclear Regulatory Commission which authorizes him to receive, possess, use, and transfer special nuclear material.

(n) [Reserved].

(o) A general license shall be issued to any person to own, receive, possess, use, and transfer radium in the form of calibration or reference sources in accordance with equivalent provisions of He-P 4031.04(p), (q), and (s) who holds a specific license issued by the Agency which authorizes him to receive, possess, use, and transfer radioactive material.

(p) The general licenses in He-P 4031.04(m) and (o) shall apply only to calibration or reference sources which have been manufactured in accordance with the specifications contained in a specific license issued to the manufacturer or importer of the sources by the U.S. Nuclear Regulatory Commission, pursuant to section 32.57 of 10 CFR Part 32 or Section 70.39 of 10 CFR Part 70 or which have been manufactured in accordance with the specifications contained in a specific license or equivalent licensing document issued to the manufacturer by the DHHS/RHS, or an Agreement State pursuant to licensing requirements equivalent to those contained in Section 32.57 of 10 CFR Part 32 or Section 70.39 of 10 CFR Part 70 of the regulations of the U.S. Nuclear Regulatory Commission.

(q) The general licenses provided in He-P 4031.04(m) and (o) shall be subject to the provisions of He-P 4001 through He-P 4003, He-P 4019 through He-P 4023, He-P 4030.10, He-P 4030.16, He-P 4030.17 and He-P 4037.

(r) Persons who own, receive, acquire, possess, use, and transfer one or more calibration or reference sources pursuant to He-P 4031.04(m) or (o):

(1) Shall not possess at any one time, at any one location of storage or use, more than 0.185 MBq (5 microcuries) of americium 241 and 0.185 MBq (5 microcuries) of radium 226 in such sources;

(2) Shall not receive, possess, use, or transfer such source unless the source, or the storage container, bears a label which includes one of the following statements or a substantially similar statement which contains the information called for in the following statement:

"The receipt, possession, use and transfer of this source, Model___________, Serial No.______________, are subject to a general license and the regulations of the Nuclear Regulatory Commission or of a state with which the Commission has entered into an agreement for the exercise of regulatory authority. Do not remove this label. CAUTION-RADIOACTIVE MATERIAL

THIS SOURCE CONTAINS (AMERICIUM 241) or (RADIUM-226, as appropriate)

DO NOT TOUCH RADIOACTIVE PORTION OF THIS SOURCE

(Name of Manufacturer or Initial Transferor)”

(3) Shall not transfer, abandon, or dispose of such source except by transfer to a person authorized by a license from the DHHS/RHS, the U.S. Nuclear Regulatory Commission, or an Agreement State to receive the source;

(4) Shall store such source, except when the source is being used, in a closed container designed and constructed to contain americium 241or radium-226 which might otherwise escape during storage; and

(5) Shall not use such source for any purpose other than the calibration of radiation detectors or the standardization of other sources.

(s) The general licenses in He-P 4031.04 He-P 4031.04(m) and (o) shall not authorize the manufacture, import or export of calibration or reference sources containing americium-241or radium-226.

(t) A general license shall be issued to own radioactive material without regard to quantity. Notwithstanding any other provisions of this part, this general license does not authorize the manufacture, production, transfer, receipt, possession, use, import or export of byproduct material, except as authorized in a specific license.

(u) A general license shall be issued to own, receive, acquire, possess, use, and transfer strontium 90 contained in ice detection devices, provided each device contains not more than 1.85 MBq (50 microcuries) of strontium 90 and each device has been manufactured or initially transferred in accordance with a specific license issued by the U.S. Nuclear Regulatory Commission or each device has been manufactured in accordance with the specifications contained in a specific license or equivalent licensing document issued by the DHHS/RHS, or an Agreement State to the manufacturer of such device pursuant to licensing requirements equivalent to those of 10 CFR Part 32.61 of the regulations of the U.S. Nuclear Regulatory Commission.

(v) Persons who own, receive, acquire, possess, use, or transfer strontium 90 contained in ice detection devices pursuant to the general license in He-P 4031.04(u) shall:

(1) Upon occurrence of visually observable damage, such as a bend or crack or discoloration from overheating, to the device, discontinue use of the device until it has been inspected, tested for leakage and repaired by a person holding a specific license or equivalent licensing document from the Nuclear Regulatory Commission or an Agreement State to manufacture or service such devices; or shall dispose of the device pursuant to the provisions of those rules;

(2) Assure that all labels affixed to the device at the time of receipt, and which bear a statement which prohibits removal of the labels, are maintained thereon; and

(3) Be exempt from the requirements of He-P 4019 through He-P 4023, except that such person shall comply with the provisions of He-P 4023, He-P 4021.12 and He-P 4021.13.

(w) The general license in He-P 4031.04(u) shall not authorize the manufacture, assembly, disassembly, repair, or import of strontium 90 in ice detection devices.

(x) The general license in He-P 4031.04(u) shall be subject to the provisions of He-P 4001 through He-P 4003, He-P 4030.10, He-P 4030.16, He-P 4030.17, and He-P 4037.

Source. #8481, eff 11-5-05 (from He-P 4031.02); ss by #10604, eff 5-23-14; amd by #11198, eff 10-12-16; amd by #12625, eff 9-26-18

He-P 4031.05 General License to Install Devices Generally Licensed in He-P 4031.04(b). Any person who holds a specific license issued by an Agreement State or the U.S. Nuclear Regulatory Commission, authorizing the holder to manufacture, install, or service a device described in He-P 4031.04(b) within such Agreement State or non-Agreement State, is hereby granted a general license to install and service such device in this state and a general license to install and service such device in offshore waters, as defined in 10 CFR 150.3 provided:

(a) The device has been manufactured, labeled, installed, and serviced in accordance with applicable provisions of the specific license issued to such person by the Agreement State or, the Nuclear Regulatory Commission; and

(b) Such person assures that any labels required to be affixed to the device under regulations of the Agreement State or the Nuclear Regulatory Commission, which licensed manufacture of the device bear a statement that removal of the label is prohibited.

Source. #8481, eff 11-5-05 (from He-P 4031.03); ss by #10604, eff 5-23-14; amd by #12625, eff 9-26-18

He-P 4031.06 General License for Certain Items and Self-luminous Products Containing Radium-226.

(a) A general license is hereby issued to any person to acquire, receive, possess, use, or transfer, in accordance with provisions of He-P 4031.06(b), (c), and (d), radium-226 contained in the following products manufactured prior to November 30, 2007.

(1) Antiquities originally intended for use by the general public. For the purposes of He-P 4031.06(a)(1), antiquities mean products originally intended for use by the general public and distributed in the late 19^th and early 20^th centuries, such as radium emanator jars, revigators, radium water jars, radon generators, refrigerator cards, radium bath salts, and healing pads;

(2) Intact timepieces containing greater than 37 kBq (1 microcurie), nonintact timepieces, and timepiece hands and dials no longer installed in timepieces;

(3) Luminous items installed in air, marine, or land vehicles;

(4) All other luminous products, provided that no more than 100 items are used or stored at the same location at any one time;

(5) Small radium sources containing no more than 37 kBq (1 microcurie) of radium-226. For the purposes of He-P 4031.06(a)(5), “small radium sources” means discrete survey instrument check sources, sources contained in radiation measuring instruments, sources used in educational demonstrations (such as cloud chambers and spinthariscopes), electron tubes, lightning rods, ionization sources, static eliminators, or as designated by the DHHS/RHS.

(b) Persons who acquire, receive, possess, use, or transfer byproduct material under the general license issued in He-P 4031.06(a) are exempt from the provisions of He-P 4001.03, He-P 4019 through He-P 4023, and He-P 4030.10(j), to the extent that the receipt, possession, use, or transfer of byproduct material is within the terms of the general license; provided, however, that this exemption shall not be deemed to apply to any such person specifically licensed under He-P 4031.

(c) Any person who acquires, receives, possesses, uses, or transfers byproduct material in accordance with the general license in He-P 4031.06(a):

(1) Shall notify the DHHS/RHS should there be any indication of possible damage to the product so that it appears it could result in a loss of the radioactive material. A report containing a brief description of the event, and the remedial action taken, shall be furnished to the DHHS/RHS within 30 days;

(2) Shall not abandon products containing radium-226. The product, and any radioactive

material from the product, shall be disposed of according to He-P 4023 or by transfer to a person authorized by a specific license to receive the radium-226 in the product or as otherwise approved by the DHHS/RHS;

(3) Shall not export products containing radium-226 except in accordance with U.S. Nuclear Regulatory Commission 10 CFR 110;

(4) Shall dispose of products containing radium-226 at a disposal facility authorized to dispose of radioactive material in accordance with any federal or state solid or hazardous waste law, including the Solid Waste Disposal Act, as authorized under the Energy Policy of 2005, by transfer to a person authorized to receive radium-226 by a specific license issued under He-P 4030, or equivalent regulations of an agreement state, or as otherwise approved by the U.S. Nuclear Regulatory Commission;

(5) Shall respond to written requests from the DHHS/RHS to provide information relating to the general license within 30 calendar days of the date of the request, or other time specified in the request. If the general licensee cannot provide the requested information within the allotted time, the general licensee shall, within the same time period, request a longer period to supply the information by providing the DHHS/RHS, a written justification for the request.

(d) The general license in He-P 4031.06(a) does not authorize the manufacture, assembly, disassembly, repair, or import of products containing radium-226, except that timepieces may be disassembled and repaired.

Source. #11198, eff 10-12-16

PART He-P 4032 SPECIFIC LICENSES FOR MANUFACTURE OR TRANSFER OF CERTAIN ITEMS CONTAINING BYPRODUCT MATERIAL

Statutory Authority RSA 125-F:5,V

Revision Note:

He-P 4032.01 Purpose.

(a) This part prescribes requirements for the issuance of specific licenses to persons who manufacture or initially transfer items containing byproduct material for sale or distribution to:

(1) Persons exempted from the licensing requirements of He-P 4030; or

(2) Persons generally licensed under He-P 4031 or He-P 4035.

(b) This part shall prescribe requirements for manufacturers or initial transferors of sealed source or devices containing sealed sources which are to be used by persons specifically licensed under He-P 4030 and U.S. Nuclear Regulatory Commission (NRC) in 10 CFR Part 37 or equivalent regulations of the NRC, an agreement state or a licensing state.

Source. (See Revision Note at part heading for He-P 4032) #6942, eff 2-1-99; ss by #8488, eff 11-18-05; ss by #8959, eff 8-7-07; ss by #10983, eff 11-24-15

He‑P 4032.02 Scope. The provisions and requirements of this part shall be in addition to, and not in substitution for, other requirements of He-P 4000. In particular, the provisions of He-P 4030 apply to applications, licenses and certificates of registration subject to He-P 4032, and the provisions of the Nuclear Regulatory Commission in 10 CFR Part 37 apply to applications and licenses subject to He-P 4032.

Source. (See Revision Note at part heading for He-P 4032) #6942, eff 2-1-99; ss by #8800, INTERIM, eff 2-1-07, EXPIRED: 7-31-07

New. # 8959, eff 8-7-07; ss by #10983, eff 11-24-15

He-P 4032.03 Licensing the Manufacture and Distribution of Devices to Persons Generally Licensed.

(a) An application for a specific license to manufacture or initially transfer devices containing byproduct material, excluding special nuclear material, to persons generally licensed under He-P 4031.04, or equivalent regulations of the NRC, or an agreement state as established by the Atomic Energy Act of 1954, or a licensing state shall be approved if:

(1) The applicant satisfies the general requirements of He-P 4030.09;

(2) The applicant submits complete information relating to the design, manufacture, prototype testing, quality control, labels, proposed uses, installation, servicing, leak testing, operating and safety instructions, and potential hazards of the device which shall ensure that:

a. The device can be safely operated by persons not having training in radiological protection;

b. Under ordinary conditions of handling, storage, and the use of the device, the byproduct material contained in the device cannot be released or inadvertently removed from the device;

c. Under ordinary conditions of handling, storage, and the use of the device, it is unlikely that any person will receive in one year a dose in excess of 10% of the annual limits specified in He-P 4020.05; and

d. Under accident conditions (such as fire and explosion) associated with handling, storage, and use of the device, it is unlikely that any person would receive an external radiation dose or dose commitment in excess of the organ doses in Table 4032.1 below:

Table 4032.1 Organ Doses Under Accident Conditions

Body Part	Organ Dose
Whole body; head and trunk; active blood-forming organs; gonads, or lens of eye	15 rems (150 mSv)
Hands and forearms; feet and localized areas of skin averaged over areas no longer than 1 square centimeter	200 rems (2 Sv)
Other organs	50 rems (500 mSv);

(3) Each device bears a durable, legible, clearly visible label or labels, which contain in a clearly identified and separate statement:

a. Instructions and precautions necessary to ensure safe installation, operation, and servicing of the device or identification of operating and service manuals used to provide this information;

b. The requirement, or exemption of a requirement, for leak testing, or for testing any on-off mechanism and indicator, to include the maximum time interval for such testing, the identification of radioactive material by isotope, the quantity of radioactivity, and the date of determination of the quantity; and

c. The information called for in the following statement in the same form:

1. “The receipt, possession, use and transfer of this device Model_____ Serial No._____ are subject to a general license or the equivalent and the regulations of the NRC, the Agreement State or the Licensing State which has regulatory authority.”;

2. “This label shall be maintained on the device in a legible condition.”;

3. “Removal of this label is prohibited.”;

4. The words, “CAUTION - RADIOACTIVE MATERIAL”; and

5. The name of the manufacturer or distributor;

(4) Each device having a separable source housing that provides the primary shielding for the source also bears on the source housing, a durable label containing:

a. The device model number and serial number;

b. The isotope and quantity;

c. The words, “CAUTION - RADIOACTIVE MATERIAL”;

d. The radiation symbol described in He‑P 4022.11; and

e. The name of the manufacturer or initial distributor;

(5) Each device meeting the criteria of He-P 4031.04(e)(15), bears a permanent, such as embossed, etched, stamped, or engraved, label affixed to the source housing if separable, or the device if the source housing is not separable, that includes the words, “CAUTION-RADIOACTIVE MATERIAL”, and, if practicable, the radiation symbol described in He-P 4022.11; and

(6) The device has been registered in the NRC Sealed Source and Device Registry.

(b) Should an applicant under He-P 4032.03(a)(3)b. desire that a device be required to be leak tested or tested for proper operation of the on-off mechanism and indicator, at intervals greater than 6 months, DHHS/RHS shall consider at least the following information in determining the acceptable interval:

(1) Primary containment (source capsule);

(2) Protection of primary containment;

(3) Method of sealing containment;

(4) Containment construction materials;

(5) Form of contained radioactive material;

(6) Maximum temperature withstood during prototype test;

(7) Maximum pressure withstood during prototype tests;

(8) Maximum quantity of contained radioactive material;

(9) Radiotoxicity of contained radioactive material; and

(10) Operating experience with identical devices or similarly designed and constructed devices.

(c) In the event the applicant under He-P 4032.03(a) desires that the general licensee under He-P 4031, or under equivalent regulations of the NRC, an agreement state, or a licensing state, be authorized to install the device, collect the sample to be analyzed by a specific licensee for leakage of byproduct material, service the device, test the on-off mechanism and indicator, or remove the device from installation, the applicant shall:

(1) Include written instructions to be followed by the general licensee;

(2) Include the estimated calendar-quarter doses associated with such activity or activities, and bases for such estimates; and

(3) Demonstrate that performance of such activity or activities by an individual untrained in radiological protection is unlikely to cause that individual to receive a calendar-quarter dose in excess of 10% of the limits specified in He-P 4020.05(a).

(d) If a device containing byproduct material is to be transferred for use under the general license contained in He-P 4031.04(b), each person that is licensed under He-P 4032.03 shall provide to each person to whom a device is to be transferred, prior to transferring the device, the following:

(1) A copy of the general license contained in He-P 4031.04(b), except if paragraphs He-P 4031.04(e)(2) through (e)(4) or He-P 4031.04(e)(15) do not apply to the particular device, those paragraphs may be omitted;

(2) A copy of He-P 4031.02, He-P 4030.10(n), He-P 4021.12, He-P 4021.13, and He-P 4021.19;

(3) A list of the services that can only be performed by a specific licensee;

(4) Information on acceptable disposal options including estimated costs of disposal; and

(5) An indication that DHHS/RHS shall take enforcement action for improper disposal.

(e) If the transfer specified in He-P 4032.03(d) is through an intermediate person, the information to be provided as described in He-P 4032.03(d) shall also be provided to the intended user prior to initial transfer to the intermediate person.

(f) If byproduct material is to be transferred in a device for use under the equivalent general license of an agreement state or equivalent regulations of the NRC, or a licensing state each person that is licensed under He-P 4032.03 shall provide to each person to whom a device is to be transferred, prior to transferring the device, the following:

(1) A copy of the agreement state’s regulations equivalent to He-P 4031.04, He-P 4031.02, He-P 4030.10(n), He-P 4021.12, and He-P 4021.13, a copy of 10 CFR §§31.5, 31.2, 30.51, 20.2201, and 20.2202, or

(2) A copy of He-P 4031.04, He-P 4030.02, He-P 4030.10(n), He-P 4021.12, and He-P 4021.13, except if certain paragraphs of these rules do not apply to the particular device, those paragraphs may be disregarded;

a. If a copy of the agreement state’s regulations equivalent to New Hampshire rules as listed in this paragraph, is provided to a prospective general licensee in lieu of the applicable agreement state’s, licensing state’s or NRC regulations, the copy of the agreement state’s, licensing state’s or equivalent regulations of the NRC shall be accompanied by a note explaining that use of the device is regulated by the agreement state, licensing state or NRC, as applicable; and

b. If certain paragraphs of the regulations do not apply to the particular device, those paragraphs may be omitted;

(3) A list of the services that can only be performed by a specific licensee;

(4) Information on acceptable disposal options including estimated costs of disposal; and

(5) The name or title, address, and phone number of the contact at the agreement state or licensing state regulatory agency or NRC from which additional information may be obtained.

(g) If the transfer specified in He-P 4032.03(f) is through an intermediate person, the information to be provided as described in He-P 4032.03(f) shall also be provided to the intended user prior to initial transfer to the intermediate person.

(h) In lieu of the requirements of He-P 4032.03(d) through (g) above, the applicant may propose an alternative approach to informing customers, subject to approval by DHHS/RHS. In its review of such a request, DHHS/RHS shall ensure that the proposed alternative approach to informing customers:

(1) Meets the essential objectives of He-P 4032.03(d) through (g);

(2) Provides the same information as required by He-P 4032.03(d) through (g); and

(3) Is not harmful to public health and safety.

(i) Each device that is transferred after November 17, 2005, shall meet the labeling requirements in He-P 4032.03(a)(3) through (a)(5).

(j) If a notification of bankruptcy has been made under He-P 4030.10(h) or the license is to be terminated, each person licensed under He-P 4032.03 shall provide, upon request, to DHHS/RHS, the NRC, any appropriate agreement state, or licensing state records of final disposition required under He-P 4032.03(m) and (n).

(k) Each person licensed under He-P 4032.03 to initially transfer devices to generally licensed persons shall:

(1) Report, in a clear and legible report, to DHHS/RHS all transfers of such devices to persons for use under the general license in He-P 4031.03 and all receipts of devices from persons licensed under He-P 4031.03 including:

a. The identity of each general licensee by name and mailing address, and address location of use. If there is no mailing address for the location of use, an alternative address for the general licensee shall be submitted along with information on the actual location of use;

b. The name, title, and telephone number of the individual identified by the general licensee as having knowledge of and authority to take required actions to ensure compliance with the applicable rules, and who may constitute a point of contact between DHHS/RHS and the general licensee;

c. The date of transfer;

d. The type, model number, and serial number of device transferred;

e. The quantity and type of byproduct material contained in the device;

f. If one or more intermediate persons will temporarily possess the device at the intended place of use prior to its possession by the user, the general licensee shall provide the same information for both the intended user and each intermediate person, which shall clearly designate and identify the intermediate person(s); and

g. The identity of the specific licensee submitting the report, including the license number of the specific licensee;

(2) Report, in a clear and legible report, to DHHS/RHS all receipts of devices from persons licensed under He-P 4031.03, including, for devices received from persons generally licensed under He-P 4031.03:

a. The identity of the general licensee by name and address;

b. The type, model number, and serial number of the device received;

c. The date of receipt, and, in the case of devices not initially transferred by the reporting licensee, the name of the manufacturer or initial transferor; and

(3) Report to DHHS/RHS the identity of the general licensee, the device, and the changes to information on the device label, if the licensee authorized under He-P 4032.03 makes changes to a device possessed by a general licensee authorized under He-P 4031.04(b), such that the label must be changed to update required information;

(4) Report to DHHS/RHS if no transfers have been made to or from persons generally licensed under He-P 4031.04(b) during the reporting period;

(5) Report to the NRC, on NRC Form 653 “Transfers of Industrial Devices Report” or in a clear and legible report containing all data required by the form, all transfers of such devices to persons for use under the NRC general license in section 31.5 of 10 CFR 31;

(6) Report to the responsible agreement state, licensing state agency or the NRC all transfers of such devices to persons for use under a general license in the agreement state’s licensing state’s or NRC regulations equivalent to He-P 4031;

(7) Identify in the report required by He-P 4032.03(k)(5) or (6), the following:

a. The identity of each general licensee by name and mailing address, and address location of use; if there is no mailing address for the location of use, an alternative address for the general licensee shall be submitted along with information on the actual location of use;

c. The date of transfer;

d. The type, model, and serial number of the device transferred;

e. The quantity and type of byproduct material contained in the device; and

f. The identity of the specific licensee submitting the report, including the license number of the specific licensee;

(8) Report to the NRC, on NRC Form 653 “Transfers of Industrial Devices Report” or in a clear and legible report containing all data required by the form, all receipts of such devices from persons authorized under the NRC general license in section 31.5 of 10 CFR 31;

(9) Report to the responsible agreement state, or licensing state agency or the NRC all receipts of such devices from persons authorized under a general license in the agreement state’s, licensing state’s or NRC regulations equivalent to He-P 4031.04;

(10) Include in the report for devices received from persons generally licensed under agreement state, licensing state, or NRC regulations equivalent to He-P 4031.04:

a. The identity of the general licensee by name and address;

b. The type, model number, and serial number of the device received;

c. The date of receipt, and, in the case of devices not initially transferred by the reporting licensee, the name of the manufacturer or initial transferor; and

d. The identity of the specific licensee submitting the report, including the license number of the specific licensee;

(11) Report to the responsible agreement state or licensing state agency or the NRC, the identity of the general licensee, the device, and the changes to information on the device label, if the licensee authorized under He-P 4032.03 makes changes to a device possessed by a general licensee authorized under regulations equivalent to He-P 4031.04(b), such that the label must be changed to update required information;

(12) Report to the NRC, if no transfers have been made to or from NRC general licensees during the reporting period;

(13) Report to the agreement state or licensing state agency or the NRC regulated state if no transfers have been made to or from that agreement state or licensing state or the NRC regulated state during the reporting period;

(14) Keep records showing:

a. The name of each general licensee or intermediate person to whom transfers of byproduct material in devices for use pursuant to the general license provided in He‑P 4031.04, or equivalent regulations of the NRC, an agreement state or licensing state have been made;

b. Address of each general licensee or intermediate person to whom transfers of byproduct material in devices for use pursuant to the general license provided in He‑P 4031.04, or equivalent regulations of the NRC, an agreement state or licensing state have been made;

c. The point of contact for each general licensee or intermediate person to whom transfers of byproduct material in devices for use pursuant to the general license provided in He-P 4031.04, or equivalent regulations of the NRC, an agreement state or licensing state have been made;

d. The date of each transfer of byproduct material;

e. Identification of the radioisotope contained in each device transferred;

f. The quantity of radioactivity in each device transferred;

g. The identity of any intermediate person; and

h. The requirements of He-P 4031 specifics for this transfer;

(15) Cover each calendar quarter in its reports submitted under He-P 4032;

(16) Submit reports required in He-P 4032.03 within 30 days of the end of the calendar quarter; and

(17) Indicate in reports required in He-P 4032.03, the period covered by the report.

(l) In the event that one or more intermediate persons will temporarily possess the device at the intended place of use prior to its possession by the user, the licensee shall provide the same information for both the intended user and each intermediate person, and shall clearly designate the identity of the intermediate person(s); and

(m) Each person licensed under He-P 4032.03 shall maintain all information concerning transfers and receipts of devices that supports the reports required by this section.

(n) Records required by (l) shall be maintained for a period of 3 years following the date of the recorded event.

Source. (See Revision Note at part heading for He-P 4032) #6942, eff 2-1-99; ss by #8488, eff 11-18-05; ss by #8959,
eff 8-7-07; ss by #10983, eff 11-24-15

He-P 4032.04 Licensing the Introduction of Byproduct Material Into Products in Exempt Concentrations.

(a) In addition to the requirements in He-P 4030.09, a specific license authorizing the introduction of byproduct material into a product or material owned by or in the possession of the licensee or another to be transferred to persons exempt under paragraph He-P 4030.03 shall be issued if:

(1) The applicant submits:

a. A description of the product or material into which the byproduct material will be introduced;

b. The intended use of the byproduct material and the product into which it is introduced;

c. The method of introduction;

d. The initial concentration of the byproduct material in the product or material;

e. The control methods to ensure that no more than the specified concentration is introduced into the product or material;

f. The estimated time interval between introduction and transfer of the product or material; and

g. The estimated concentration of the byproduct material in the product or material at the time of transfer by the licensee; and

(2) The applicant provides written statements in the application that:

a. The concentrations of byproduct material at the time of transfer will not exceed the concentration in He‑P 4093;

b. That reconcentration of the byproduct material in concentrations exceeding those in He-P 4093 is not likely;

c. That use of lower concentrations is not feasible; and material shall not be incorporated in any food, beverage, cosmetic, drug, or other commodity or product designed for ingestion or inhalation by, or application to, a human being.

(b) Each person licensed under He-P 4032.04 shall file an annual report with DHHS/RHS.

(1) Identify:

a. The type and quantity of each product or material into which radioactive material has been introduced during the reporting period;

b. Name and address of the person who owned or possessed the product or material into which byproduct material has been introduced at the time of introduction;

c. The type and quantity of radionuclide introduced into each such product or material; and

d. The initial concentrations of the radionuclide in the product or material at the time of transfer of the byproduct material by the licensee;

(2) Indicate if no transfers of byproduct material have been made pursuant to He-P 4032.04 during the reporting period;

(3) Cover the year ending June 30; and

(4) Be filed within 30 days thereafter.

Source. (See Revision Note at part heading for He-P 4032) #6942, eff 2-1-99; ss by #8800, INTERIM, eff 2-1-07, EXPIRED: 7-31-07

New. #8959, eff 8-7-07; ss by #10983, eff 11-24-15

He-P 4032.05 Manufacture, Preparation, or Distribution of Radiopharmaceuticals Containing Byproduct Material for Medical Use.

(a) An application for a specific license to manufacture, prepare, or distribute radiopharmaceuticals containing byproduct material for use by persons licensed pursuant to He-P 4035 shall be approved if:

(1) The applicant satisfies the requirements specified in He-P 4030.09;

(2) The applicant submits evidence that the applicant is at least one of the following:

a. Registered with the U.S. Food and Drug Administration (FDA) as the owner or operator of a drug establishment that engages in the manufacture, preparation, propagation, compounding, or processing of a drug under 21 CFR 207.20(a);

b. Registered or licensed with a state or federal agency as a drug manufacturer;

c. Licensed as a pharmacy by a state board of pharmacy;

d. Operating as a pharmacy within a federal medical institution; or

e. A Positron Emission Tomography (PET) drug production facility licensed by a state or federal agency;

(3) The applicant submits the following information:

a. The radionuclide;

b. The chemical and physical form;

c. The packaging including maximum activity per vial, syringe, generator, or other container of the radioactive drug; and

d. The shielding provided by the packaging of the byproduct material shall be appropriate for safe handling and storage of radiopharmaceuticals by group licensees in accordance with He-P 4037.04; and

(4) The applicant satisfies the following labeling requirements:

a. A label shall be affixed to each transport radiation shield of a radioactive drug to be transferred for commercial distribution;

b. The label shall include:

1. The radiation symbol and the words “CAUTION, RADIOACTIVE MATERIAL” or “DANGER, RADIOACTIVE MATERIAL”;

2. The name of the radioactive drug or its abbreviation; and

3. The quantity of radioactivity at a specified date and time, except in the case of radioactive drugs with a half-life greater than 100 days, for which the time may be omitted;

c. A label shall be affixed to each syringe, vial, or other container used to hold a radioactive drug to be transferred for commercial distribution;

d. The label required in He‑P4032.05(a)(4)c. shall include:

1. The radiation symbol and the words “CAUTION, RADIOACTIVE MATERIAL” or “DANGER, RADIOACTIVE MATERIAL”; and

2. An identifier that ensures that the syringe, vial, or other container can be correlated with the information on the transport radiation shield label; and

e. The labels, leaflets, or brochures required by He‑P 4032.03(a)(4) shall be in addition to the labeling required by the Food and Drug Administration (FDA), and shall be separate from or, if approved by the FDA may be combined with, the labeling required by FDA.

(b) A licensee described by He-P 4032.05(a)(2)c. or (a)(2)d.:

(1) Shall prepare radioactive drugs for medical use, and shall ensure that the radioactive drug is prepared by an authorized nuclear pharmacist, as specified in He-P 4032.05(b)(2) and (b)(3), or an individual under the supervision of an authorized nuclear pharmacist, as specified in He‑P 4035;

(2) Shall allow a pharmacist to work as an authorized pharmacist only if:

a. This individual qualifies as an authorized nuclear pharmacist as defined in He‑P 4035;

b. This individual meets the requirements specified in He‑P 4035 and the licensee has received an approved license amendment identifying this individual as an authorized nuclear pharmacist; or

c. This individual is designated as an authorized nuclear pharmacist in accordance with He-P 4032.05(b)(3);

(3) Shall name a pharmacist as defined in He-P 4003.01(df) as an authorized nuclear pharmacist as defined in He-P 4035.03(c), only if:

a. The individual was a nuclear pharmacist preparing only radioactive drugs containing accelerator-produced radioactive material; and

b. The individual practiced at a pharmacy at a government agency or federally recognized Indian Tribe before November 30, 2007 or at all other pharmacies before August 8, 2009, or an earlier date as noticed by the NRC;

(4) Shall provide to DHHS/RHS:

a. A copy of each individual’s certification by a specialty board whose certification process has been recognized by the Nuclear Regulatory Commission or an agreement state as specified in He-P 4035.74(a) with the written attestation signed by a preceptor as required by He-P 4035.74(b)(2); or

b. The Nuclear Regulatory Commission or agreement state license or licensing state license; or

c. A Nuclear Regulatory Commission master materials licensee permit; or

d. The permit issued by a licensee of broad scope, or the authorization from a commercial nuclear pharmacy authorized to list its own authorized nuclear pharmacist; or

e. Documentation that only accelerator-produced radioactive materials were used in the practice of nuclear pharmacy at a government agency or federally recognized Indian Tribe before November 30, 2007 or at all other locations of use before August 8, 2009, or an earlier date as noticed by the Nuclear Regulatory Commission; or

f. A copy of the state pharmacy licensure or registration, no later than 30 days after the date that the licensee allows pursuant to He-P 4032.05(b)(2)a. and (b)(2)c., the individual to work as an authorized nuclear pharmacist;

(c) The actions authorized in He-P 4032.05(b)(1) and (b)(2) are permitted in spite of more restrictive language in license conditions.

(d) A licensee authorized under He-P 4032.05 shall:

(1) Possess and use instrumentation to measure the radioactivity of radioactive drugs;

(2) Have procedures for use of the instrumentation;

(3) Measure, by direct measurement or by combination of measurements and calculations, the amount of radioactivity in dosages of alpha-, beta-, or photon-, emitting radioactive drugs prior to transfer for commercial distribution; and

(4) Perform tests before initial use, periodically, and following repair, on each measurement instrument for accuracy, linearity, and geometry dependence, as appropriate for the use of the instrument, and make adjustments when necessary; and

(5) Check each measurement instrument for constancy and proper operation at the beginning of each day of use.

(e) Nothing in this section relieves the licensee from complying with applicable FDA, other federal, and state requirements governing radioactive drugs.

Source. (See Revision Note at part heading for He-P 4032) #6942, eff 2-1-99; ss by #8800, INTERIM, eff 2-1-07, EXPIRED: 7-31-07

New. #8959, eff 8-7-07; ss by #10983, eff 11-24-15

He-P 4032.06 Manufacture and Distribution of Generators or Reagent Kits for Preparation of Radiopharmaceuticals Containing Byproduct Material.

(a) An application for a specific license to manufacture and distribute generators or reagent kits containing byproduct material or reagent kits not containing byproduct material used for preparation of radiopharmaceuticals by persons licensed pursuant to He-P 4035 shall be approved if:

(1) The applicant satisfies the general requirements specified in He‑P 4030.09;

(2) The applicant submits evidence that:

a. The generator or reagent kit is to be manufactured, labeled, and packaged in accordance with the Federal Food, Drug, and Cosmetic Act or the Public Health Service Act, such as a new drug application (NDA) approved by the Food and Drug Administration (FDA), a biological product license issued by FDA, or a “Notice of Claimed Investigational Exemption for a New Drug” (IND) that has been accepted by the FDA; or

b. The manufacture and distribution of the generator or reagent kit are not subject to the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act;

(3) The applicant submits the following information:

a. The radionuclide;

b. The chemical and physical form;

c. The packaging including maximum activity per package; and

d. The shielding provided by the packaging of the byproduct material contained in the generator or reagent kit;

(4) The label affixed to the generator or reagent kit contains information on the radionuclide, quantity, and date of assay; and

(5) The label affixed to the generator or reagent kit, or the leaflet or brochure which accompanies the generator or reagent kit, contains:

a. Radiation safety information on the procedures to be followed and the equipment and shielding to be used in eluding the generator or processing byproduct material with the reagent kit; and

b. A statement that this generator or reagent kit is approved for use by persons licensed by the DHHS/RHS pursuant to He‑P 4035 or under equivalent licenses of the Nuclear Regulatory Commission, an agreement state or licensing state.

(b) The labels, leaflets, or brochures required by He‑P 4032.06(a)(4) and (a)(5) are in addition to the labeling required by FDA and they may be separate from, or if approved by the FDA may be combined with, the labeling required by FDA.

Source. (See Revision Note at part heading for He-P 4032) #6942, eff 2-1-99; ss by #8800, INTERIM, eff 2-1-07, EXPIRED: 7-31-07

New. #8959, eff 8-7-07; ss by #10983, eff 11-24-15

He-P 4032.07 Manufacture and Distribution of Sources or Devices Containing Byproduct Material for Medical Use.

(a) An application for a specific license to manufacture and distribute sources and devices containing byproduct material to persons licensed pursuant to He-P 4035 for use as a calibration, transmission, or reference source, or sources for the uses in manual brachytherapy, or sealed sources for diagnosis, or sealed source for the use in a remote afterloader unit, teletherapy unit, or gamma stereotactic radiosurgery unit in accordance with He-P 4035 shall be approved if:

(1) The applicant satisfies the general requirements in He-P 4030.09;

(2) The applicant submits the following radiation safety information for each type of source or device:

a. The byproduct material contained, its chemical and physical form, and amount;

b. Details of design and construction of the source or device;

c. Procedures for, and results of, prototype tests to demonstrate that the source or device maintains its integrity under stresses likely to be encountered in normal use and accidents;

d. For devices containing byproduct material, the radiation profile of a prototype device;

e. Details of quality control procedures to ensure that production sources and devices meet the standards of the design and prototype tests;

f. Procedures and standards for calibrating sources and devices;

g. Legend and methods for labeling sources and devices for their radioactive content; and

h. Instruction for handling and storing the source or device from the radiation safety standpoint, as follows:

1. These instructions shall be included on a durable label attached to the source or device or attached to a permanent storage container for the source or device; or

2. If the instructions are too lengthy for such label, they may be summarized on the label and printed in detail on a brochure which is referenced on the label;

(3) The label affixed to the source or device, or to the permanent storage container for the source or device, contains the following information:

a. The radionuclide;

b. Quantity;

c. Date of assay; and

d. A statement that includes the name of source or device which is licensed by DHHS/RHS for distribution to persons licensed pursuant to He‑P 4035 or under equivalent licenses of the Nuclear Regulatory Commission, an agreement state, or licensing state; and

(4) The source or device has been registered in the Sealed Source and Device Registry.

(b) In the event the applicant desires that the source or device be required to be tested for leakage of radioactive material at intervals longer than 6 months:

(1) The application shall include sufficient information to demonstrate that such longer interval is justified by performance characteristics of the source or device or similar sources or devices and by design features that have a significant bearing on the probability or consequences of leakage of radioactive material from the source; and

(2) In determining the acceptable interval for test of leakage of radioactive material, DHHS/RHS will consider information that includes, but is not limited to:

a. Primary containment (source capsule);

b. Protection of primary containment;

c. Method of sealing containment;

d. Containment construction materials;

e. Form of contained radioactive material;

f. Maximum temperature withstood during prototype tests;

g. Maximum pressure withstood during prototype tests;

h. Maximum quantity of contained radioactive material;

i. Radiotoxicity of contained radioactive material; and

j. Operating experience with identical sources or devices or similarly designed and constructed sources or devices.

Source. (See Revision Note at part heading for He-P 4032) #6942, eff 2-1-99; ss by #8800, INTERIM, eff 2-1-07, EXPIRED: 7-31-07

New. #8959, eff 8-7-07; ss by #10983, eff 11-24-15

He-P 4032.08 Special Requirements for the Manufacture, Assembly, Repair, or initially transfer of Luminous Safety Devices for Use in Aircraft. An application for a specific license to manufacture, assemble, or repair luminous safety devices containing tritium or promethium-147 for use in aircraft, for distribution to persons generally licensed under He-P 4031.04(h) shall be approved if:

(a) The applicant satisfies the general requirements specified in He-P 4030.09; and

(b) The applicant satisfies the requirements of 10 CFR 32.53, 32.54, 32.55 and 32.56.

Source. (See Revision Note at part heading for He-P 4032) #6942, eff 2-1-99; ss by #8800, INITERIM, eff 2-1-07, EXPIRED: 7-31-07

New. #8959, eff 8-7-07; ss by #10983, eff 11-24-15

He-P 4032.09 Licensing the Distribution of Byproduct Material in Exempt Quantities.

(a) An application for specific license to distribute byproduct material other than source or byproduct material to persons exempted from licensing pursuant to He‑P 4030.08 may be approved if:

(1) The byproduct material is not contained in any food, beverage, cosmetic, drug, or other commodity designed for ingestion or inhalation by, or application to, a human being;

(2) The byproduct material is in the form of processed chemical elements, compounds, or mixtures, tissue samples, bioassay samples, counting standards, plated or encapsulated sources, or similar substances, identified as radioactive and to be used for its radioactive properties, but is not incorporated into any manufactured or assembled commodity, product, or device intended for commercial distribution; and

(3) The applicant submits copies of prototype labels and brochures and DHHS/RHS approves such labels and brochures.

(b) The license for exempt quantities issued under He‑P 4032.09 shall be subject to the following conditions:

(1) No more than 10 exempt quantities as listed in He-P 4092.01, which may be composed of fractional parts, shall be sold or transferred in a single transaction, provided that the sum of the fractional parts shall not exceed one;

(2) Each exempt quantity shall be separately and individually packaged;

(3) No more than 10 packaged exempt quantities shall be contained in any outer package for transfer to persons exempt pursuant to He-P 4030.03;

(4) The outer package shall be such that the dose rate at the external surface of the package does not exceed 0.5 millirem per hour;

(5) The immediate container of each quantity or separately packaged fractional quantity of radioactive material shall bear a durable, legible label which:

a. Identifies the radionuclide and the quantity of radioactivity; and

b. Bears the words “Radioactive Material”; and

(6) In addition to the labeling information required by He‑P 4032.09, the label affixed to the immediate container, or an accompanying brochure, shall:

a. State that the contents are exempt from licensing state requirements;

b. Bear the words “Radioactive Material – Not for Human Use – Introduction into Foods, Beverages, Cosmetics, Drugs, or Medicinal, or into Products Manufactured for Commercial Distribution is Prohibited – Exempt Quantities Should Not be Combined”; and

c. Set forth additional radiation safety precautions and instructions relating to the handling, use, storage, and disposal of the byproduct material.

(c) Each person licensed under He‑P 4032.09 shall maintain records identifying, by name and address, each person to whom byproduct material is transferred for use under He‑P 4030.03 or the equivalent regulations of the Nuclear Regulatory Commission or an agreement state or licensing state, and the kinds and quantities of byproduct material transferred.

(d) An annual summary report shall be filed with DHHS/RHS, as follows:

(1) Each report shall state the total quantity of each radionuclide transferred under the specific license;

(2) Each report shall cover the year ending June 30;

(3) Each report shall be filed within 30 days after the end of the quarter; and

(4) If no transfers of byproduct material have been made pursuant to this section during the reporting period, the report shall so indicate.

Source. (See Revision Note at part heading for He-P 4032) #6942, eff 2-1-99; ss by #8800, INTERIM, eff 2-1-07, EXPIRED: 7-31-07

New. #8959, eff 8-7-07; ss by #10983, eff 11-24-15

He-P 4032.10 Licensing the Incorporation of Byproduct Material Other than Source or Byproduct Material into Gas and Aerosol Detectors.

(a) In addition to the requirements set forth in He‑P 4030.09, an application for a specific license authorizing the incorporation of byproduct material other than source or byproduct material into gas and aerosol detectors to be distributed to persons exempt under He‑P 4030.03 shall only be approved if the application satisfies requirements equivalent to those contained in 10 CFR 32.26.

(b) The maximum quantity of radium-226 in each device shall not exceed 0.1 microcurie.

Source. (See Revision Note at part heading for He-P 4032) #6942, eff 2-1-99; ss by #8800, INTERIM, eff 2-1-07, EXPIRED: 7-31-07

New. #8959, eff 8-7-07; ss by #10983, eff 11-24-15

He-P 4032.11 Special Requirements for License to Manufacture, Import or Initially Distribute Sealed Sources or Devices Containing Sealed Sources to Persons Having a Specific License.

(a) An application for a license to manufacture or initially distribute sealed sources or devices containing sealed sources for initial transfer to persons having a specific license to receive such sealed sources or devices shall be approved subject to the following conditions:

(1) The applicant satisfies the general requirements specified in He‑P 4030.09; and

(2) The licensee subject to He‑P 4032.11 shall not transfer a sealed source or device containing a sealed source to any person except in accordance with the requirements of He‑P 4030.16.

(b) Any manufacturer or initial distributor of a sealed source or device containing a sealed source whose product is intended for use under a specific license may submit a request to DHHS/RHS for evaluation of radiation safety information about its product and for its registration, as follows:

(1) A request for evaluation of a sealed source or device containing a sealed source shall be submitted in duplicate and shall include information required by He‑P 4032.11(b)(2) or (b)(3), as applicable, demonstrating that the radiation safety properties of such source or device will not endanger public health and safety or property;

(2) A request for evaluation of a sealed source shall include the following radiation safety information:

a. Proposed uses for the sealed source;

b. Chemical and physical form and maximum quantity of byproduct material in the sealed source;

c. Details of design of the sealed source, radiation and its shielding including blueprints, engineering drawings, or annotated drawings;

d. Details of construction of the sealed source including a description of materials used in construction;

e. Radiation profile of a prototype sealed source;

f. Procedures for and results of prototype testing;

g. Details of quality control procedures to be followed in manufacture;

h. A description or facsimile of labeling to be affixed to the sealed source;

i. Leak testing procedures; and

j. Any additional information, including experimental studies and tests, required by DHHS/RHS to facilitate a determination of the safety of the sealed source, as required by He‑P 4030.09;

(3) A request for evaluation of a device containing a sealed source shall include the following radiation safety information:

a. Proposed uses for the device;

b. Manufacturer, model number, chemical and physical form, and maximum quantity of radioactivity in the sealed source or sources to be used in the device;

c. Details of design of the sealed source, including blueprints, engineering drawings, or annotated drawings;

d. Details of construction of the sealed source, including a description of materials used in construction;

e. Radiation profile of a prototype device;

f. Procedures for and results of prototype testing;

g. Details of quality control procedures to be followed in manufacture;

h. A description or facsimile of labeling to be affixed to the device;

i. Leak testing procedures;

j. A description of potential hazards in installation, service, manufacture, handling, use, and operation of the device;

k. Information about installation, service, and maintenance procedures;

l. Handling, operating, and safety instructions; and

m. Any additional information, including experimental studies and tests, required by DHHS/RHS to facilitate a determination of the safety of the device as required by He‑P 4030.09;

(4) The person submitting a request for evaluation of a product shall manufacture and distribute the product in accordance with:

a. The statements and representations, including the quality control program, described in the request; and

b. The provisions of the evaluation sheet prepared by DHHS/RHS and submitted to the U.S. Department of Health and Human Services, for filing in the “Radioactive Material Reference Manual” or in the U.S. Nuclear Regulatory Commission, for filing in the “Registry of Radioactive Sealed Sources and Devices.” and

(5) The request for review shall be mailed to DHHS/RHS office, “ATTN: SSDR”.

(d) After completion of the evaluation, DHHS/RHS shall issue a certificate of registration to the applicant described in 10 CFR 32.210(e).

(e) Authority to manufacture or initially distribute a sealed source or device to specific licensees shall be provided in the license without the issuance of a certificate of registration described in 10 CFR 32.210(g).

(f) After the certificate is issued, DHHS/RHS shall conduct an additional review described in 10 CFR.32.210(h).

(g) When inactivating certificates of registration of sealed sources and devices, DHHS/RHS shall apply the inactivation criteria described in 10 CFR 32.211.

Source. (See Revision Note at part heading for He-P 4032) #6942, eff 2-1-99; ss by #8800, INTERIM, eff 2-1-07, EXPIRED: 7-31-07

New. #8959, eff 8-7-07; ss by #10983, eff 11-24-15

He-P 4032.12 Prohibition. No person shall introduce byproduct material into a product or material knowing or having reason to believe that it will be transferred to persons exempt under He‑P4030.03 or equivalent regulations of an Agreement State, the Nuclear Regulatory Commission or Licensing State, except in accordance with a license issued pursuant to He‑P 4032.04 or the general license provided in He‑P 4030.18.

Source. (See Revision Note at part heading for He-P 4032) #6942, eff 2-1-99; ss by #8800, INTERIM, eff 2-1-07, EXPIRED: 7-31-07

New. #8959, eff 8-7-07; ss by #10983, eff 11-24-15

He-P 4032.13 Serialization of Nationally Tracked Sources.

(a) Each licensee who manufactures a nationally tracked source after February 6, 2007 shall assign a unique serial number to each nationally tracked Source. Serial numbers shall be composed only of alpha-numeric characters.

Source. #10983, eff 11-24-15

He-P 4032.14 Special Requirements for License to Manufacture or Initially Transfer Calibration Sources Containing Americium-241 or Radium-226 for Distribution to Persons Generally Licensed Under He-P 4031.04(r).

(a) An application for a specific license to manufacture or initially transfer calibration or reference sources containing americium-241 or radium-226 for distribution to persons generally licensed under He-P 4031.04(r), shall be approved if:

(1) The applicant satisfies the general requirements of He-P 4030.09;

(2) The applicant submits sufficient information regarding each type of calibration or reference source pertinent to evaluation of the potential radiation exposure, including:

a. Chemical and physical form and maximum quantity of americium-241 or radium-226 in the source;

b. Details of construction and design;

c. Details of the method of incorporation and binding of the americium-241 or radium-226 in the source;

d. Procedures for and results of prototype testing of sources, which are designed to contain more than 185 becquerel (0.005 microcurie) of americium-241 or radium-226, to demonstrate that the americium-241 or radium-226 contained in each source will not be released or be removed from the source under normal conditions of use;

e. Details of quality control procedures to be followed in manufacture of the source;

f. Description of labeling to be affixed to the source or the storage container for the source; and

g. Any additional information, including experimental studies and tests, required by DHHS/RHS to facilitate a determination of the safety of the source;

(3) Each source will contain no more than 185 kilobecquerel (5 microcurie) of americium-241 or radium-226; and

(4) DHHS/RHS determines, with respect to any type of source containing more than 185 becquerel (0.005 microcurie) of americium-241 or radium-226, that:

a. The method of incorporation and binding of the americium-241 or radium-226 in the source is such that the americium-241 or radium-226 will not be released or be removed from the source under normal conditions of use and handling of the source; and

b. The source has been subjected to and has satisfactorily passed the appropriate tests prescribed by He-P 4032.14(d).

(b) Each person licensed under He-P 4032.14 shall affix to each source, or storage container for the source, a label which shall contain sufficient information relative to safe use and storage of the source and shall include the following statement or information:

“The receipt, possession, use and transfer of this source, Model __, Serial No. __, are subject to a general license and the regulations of the DHHS/RHS, the NRC, an Agreement State, or a Licensing State. Do not remove this label. CAUTION--RADIOACTIVE MATERIAL-- THIS SOURCE CONTAINS (AMERICIUM-241) OR (RADIUM-226). DO NOT TOUCH RADIOACTIVE PORTION OF THIS SOURCE (Name of Manufacturer or Transferor).”

(c) Each person licensed under He-P 4032.14 shall perform a dry wipe test upon each source containing more than 3.7 kilobecquerel (0.1 microcurie) of americium-241 or radium-226 before transferring the source to a general licensee under He-P 4031.04(r). This test shall be performed by wiping the entire radioactive surface of the source with a filter paper with the application of moderate finger pressure. The radioactivity on the paper shall be measured using methods capable of detecting 185 becquerel (0.005 microcurie) of americium-241 or radium-226. If a source has been shown to be leaking or losing more than 185 becquerel (0.005 microcurie) of americium-241 or radium-226 by the methods described in He-P 4032(c), the source shall be rejected and shall not be transferred to a general license under He-P 4031.04(r), or equivalent regulations of the NRC, an agreement state or a licensing state.

(d) The applicant shall subject at least five prototypes of each source that is designed to contain more than 0.185 kilobecquerel (0.005 microcurie) of americium-241 or radium-226 to tests as follows:

(1) The initial quantity of radioactive material deposited on each source is measured by direct counting of the source;

(2) The sources are subjected to tests that adequately take into account the individual, aggregate, and cumulative effects of environmental conditions expected in service that could adversely affect the effective containment or binding of americium-241 or radium-226, such as physical handling, moisture, and water immersion;

(3) The sources are inspected for evidence of physical damage and for loss of americium-241 or radium-226, after each stage of testing, using methods of inspection adequate for determining compliance with the criteria in He-P 4032.14(d)(4); and

(4) Source designs are rejected for which the following has been detected for any unit: Removal of more than 0.185 kilobecquerel (0.005 microcurie) of americium-241 or radium-226 from the source or any other evidence of physical damage.

Source. #10983, eff 11-24-15

He-P 4032.15 Manufacture and Distribution of Byproduct Material for Certain In Vitro Clinical or Laboratory Testing Under General License. An application for a specific license to manufacture or distribute byproduct material for use under the general license of He-P 4031.06 shall be approved if:

(a) The applicant satisfies the general requirements specified in He-P 4030.09;

(b) The radioactive material is to be prepared for distribution in prepackaged units of:

(1) Carbon-14 in units not exceeding 370 kilobecquerel (10 microcurie) each;

(2) Cobalt-57 in units not exceeding 370 kilobecquerel (10 microcurie) each;

(3) Hydrogen-3 (tritium) in units not exceeding 1.85 megabecquerel (50 microcurie) each;

(4) Iodine-125 in units not exceeding 370 kilobecquerel (10 microcurie) each;

(5) Mock Iodine-125 in units not exceeding 1.85 kilobecquerel (0.05 microcurie) of iodine-129 and 185 becquerel (0.005 microcurie) of americium-241 each;

(6) Iodine-131 in units not exceeding 370 kilobecquerel (10 microcurie) each;

(7) Iron-59 in units not exceeding 740 kilobecquerel (20 microcurie) each; and

(8) Selenium-75 in units not exceeding 370 kilobecquerel (10 microcurie) each.

(1) Identifying the radioactive contents as to chemical form and radionuclide, and indicating that the amount of radioactivity does not exceed 370 kilobecquerel (10 microcurie) of iodine-125, iodine-131, carbon-14, cobalt-57, or selenium-75; 1.85 megabecquerel (50 microcurie) of hydrogen-3 (tritium); 740 kilobecquerel (20 microcurie) of iron-59; or Mock Iodine-125 in units not exceeding 1.85 kilobecquerel (0.05 microcurie) of iodine-129 and 185 becquerel (0.005 microcurie) of americium-241 each; and

(2) Displaying the radiation caution symbol described in He-P 4022.11(c). and the words, "CAUTION, RADIOACTIVE MATERIAL", and "Not for Internal or External Use in Humans or Animals".

(d) The following statement or information shall appear on a label affixed to each prepackaged unit or appears in a leaflet or brochure which accompanies the package:

“This radioactive material may be received, acquired, possessed, and used only by physicians, veterinarians, clinical laboratories, or hospitals and only for in vitro clinical or laboratory tests not involving internal or external administration of the material, or the radiation therefrom, to human beings or animals. Its receipt, acquisition, possession, use, and transfer are subject to the regulations and a general license of the DHHS/RHS or the NRC or of a state with which the NRC has entered into an agreement for the exercise of regulatory authority. (Name of Manufacturer).”

(e) The label affixed to the unit, or the leaflet or brochure which accompanies the package, contains adequate information as to the precautions to be observed in handling and storing such byproduct material. In the case of the Mock Iodine-125 reference or calibration source, the information accompanying the source shall also contain directions to the licensee regarding the waste disposal requirements set out in He-P 4023.01 of these rules.

Source. #10983, eff 11-24-15

He-P 4032.16 Ice Detection Devices Containing Strontium-90; Requirements for License to Manufacture or Initially Transfer. An application for a specific license to manufacture or initially transfer ice detection devices containing strontium-90 for distribution to persons generally licensed under the Nuclear Regulatory Commission 10 CFR 31.10 shall be approved if:

(a) The applicant satisfies the general requirements specified in He-P 4030.09; and

(b) The applicant satisfies the requirements of 10 CFR 32.61 and 32.62.

Source. #10983, eff 11-24-15

PART He-P 4033 SPECIFIC LICENSES OF BROAD SCOPE FOR OTHER THAN HUMAN USE

Revision Note:

He-P 4033.01 Purpose. This part shall prescribe requirements for the issuance of specific licenses of broad scope for byproduct material and certain regulations governing holders of such licenses.

Source. (See Revision Note at part heading for He-P 4033) #6942, eff 2-1-99; ss by #8800, INTERIM, eff 2-1-07, EXPIRED: 7-31-07

New. #8959, eff 8-7-07; ss by #10983, eff 11-24-15

He-P 4033.02 Scope. The provisions and requirements of this part shall be in addition to, and not in substitution for, other requirements of this chapter. In particular, the provisions of He-P 4030 and He-P 4038 apply to applications and licenses subject to this part.

Source. (See Revision Note at part heading for He-P 4033) #6942, eff 2-1-99; ss by #8800, INTERIM, eff 2-1-07, EXPIRED: 7-31-07

New. #8959, eff 8-7-07; ss by #10983, eff 11-24-15

He-P 4033.03 Types of Specific Licenses of Broad Scope.

(a) Type A specific license of broad scope shall be a specific license authorizing receipt, acquisition, ownership, possession, use, and transfer of any chemical or physical form of a quantity of byproduct material usually in the multi-curie range specified in the license, but not exceeding quantities specified in the license, for any authorized purpose.

(b) A Type B specific license of broad scope shall be:

(1) A specific license which allows any chemical or physical form of byproduct material specified in He‑P 4033.07, Table 4033.1, for any authorized purpose;

(2) A specific license whereby the possession limit, if only one radionuclide is possessed thereunder, shall be the quantity specified for that radionuclide in He‑P 4033.07, Table 4033.1, Column 1; or

(3) A specific license whereby if 2 or more radionuclides are possessed thereunder, the possession limit for each shall be determined as follows:

a. For each radionuclide, determine the ratio of the quantity possessed to the applicable quantity specified in He‑P 4033.07, Table 4033.1, Column 1, for that radionuclide; and

b. The sum of the ratios for all radionuclides possessed under the license shall not exceed unity.

(1) A specific license authorizing receipt, acquisition, ownership, possession, use, and transfer of any chemical or physical form of byproduct material specified in He P 4033.07, Table 4033.1, for any authorized purpose;

(2) A specific license whereby the possession limit, if only one radionuclide, is possessed thereunder, shall be the quantity specified for that radionuclide in He‑P 4033.07, Table 4033.1, Column 2; or

(3) A specific license whereby if two or more radionuclides are possessed thereunder, the possession limit shall be determined for each as follows:

a. For each radionuclide, determine the ratio of the quantity possessed to the applicable quantity specified in He‑P 4033.07, Table 4033.1, Column 2, for that radionuclide; and

b. The sum of the ratios for all radionuclides possessed under the license shall not exceed unity.

Source. (See Revision Note at part heading for He-P 4033) #6942, eff 2-1-99; ss by #8800, INTERIM, eff 2-1-07, EXPIRED: 7-31-07

New. #8959, eff 8-7-07; ss by #10983, eff 11-24-15

He-P 4033.04 Application for Specific Licenses of Broad Scope. An application for specific license of broad scope shall be made according to the requirements set forth in He-P 4033.05.

Source. (See Revision Note at part heading for He-P 4033) #6942, eff 2-1-99; ss by #8800, INTERIM, eff 2-1-07, EXPIRED: 7-31-07

New. #8959, eff 8-7-07; ss by #10983, eff 11-24-15

He-P 4033.05 Requirements for the Issuance of Specific Licenses of Broad Scope.

(a) An application for a Type A specific license of broad scope shall be approved if:

(1) The applicant satisfies the requirements specified in He-P 4030.09;

(2) The applicant has engaged in a reasonable number of activities involving the use of byproduct material; and

(3) The applicant has established administrative controls and provisions relating to organization and management, procedures, record keeping, material control and accounting, and management review that are necessary to ensure safe operations, including:

a. The establishment of a radiation safety committee composed of a radiological safety officer, a representative of management, and persons trained and experienced in the safe use of radioactive material;

b. The appointment of a radiological safety officer who is qualified by training and experience in radiation protection, and who is available for advice and assistance on radiological safety matters; and

c. The establishment of appropriate administrative procedures to ensure:

1. Control of procurement and use of byproduct material;

2. Completion of safety evaluations of proposed uses of radioactive material which take into consideration such matters as the adequacy of facilities and equipment, training and experience of the user, and the operating or handling procedures; and

3. Review, approval, and recording by the radiation safety committee of safety evaluations of proposed uses prepared in accordance with He-P 4033.05(a)(3)c.2. prior to use of the byproduct material.

(b) An application for a Type B specific license of broad scope shall be approved if:

(1) The applicant satisfies the general requirements specified in He‑P 4030.09; and

(2) The applicant has established administrative controls and provisions relating to organization and management, procedures, record keeping, material control and accounting, and management review that are necessary to ensure safe operations, including:

a. The appointment of a radiological safety officer who is qualified by training and experience in radiation protection, who is available for advice and assistance on radiological safety matters; and

b. The establishment of appropriate administrative procedures to ensure:

1. Control of procurement and use of byproduct material;

2. Completion of safety evaluations of proposed uses of byproduct material which take into consideration such matters as the adequacy of facilities and equipment, training and experience of the user and the operating or handling procedures; and

3. Review, approval, and recording by the radiological safety officer of safety evaluations of proposed uses prepared in accordance with He‑P 4033.05(b)(2)b.2., prior to use of the byproduct material.

(1) The applicant satisfies the requirements specified in He‑P 4030.09;

(2) The applicant submits a statement that byproduct material shall be used only by, or under the direct supervision of, individuals who have received:

a. A college degree at the bachelor level, or equivalent training and experience, in the physical or biological sciences or in engineering; and

b. At least 40 hours of training and experience in the safe handling of radioactive materials, and in the characteristics of ionizing radiation, units of radiation doses and quantities, radiation detection instrumentation, and biological hazards of exposure to radiation appropriate to the type and forms of radioactive material to be used; and

(3) The applicant has established administrative controls and provisions relating to procurement of byproduct material, procedures, record keeping, material control, and accounting and management review necessary to ensure safety operations.

Source. (See Revision Note at part heading for He-P 4033) #6942, eff 2-1-99; ss by #8800, INTERIM, eff 2-1-07, EXPIRED: 7-31-07

New. #8959, eff 8-7-07; ss by #10983, eff 11-24-15

He-P 4033.06 Conditions of Specific Licenses of Broad Scope.

(a) Unless specifically authorized pursuant to other sections of He‑P 4033, persons licensed under this section shall not:

(1) Conduct tracer studies outside of the licensee’s controlled area of byproduct material;

(2) Receive, acquire, own, possess, use, transfer, or import devices containing 100,000 curies or more of byproduct material in sealed sources to be used for irradiation of materials;

(3) Conduct activities for which a specific license issued by the DHHS/RHS is required; or

(4) Add or cause the addition of byproduct material to any food, beverage, cosmetic, drug, or other product designed for ingestion or inhalation by, or application to, a human being.

(b) Each Type A specific license of broad scope issued by the DHHS/RHS shall be subject to the condition that byproduct material possessed under the license shall be used only by, or under the direct supervision of, individuals approved by the licensee’s radiation safety committee.

(c) Each Type B specific license of broad scope issued by the DHHS/RHS shall be subject to the condition that byproduct material possessed under the license shall be used only by, or under the direct supervision of, individuals approved by the licensee’s radiological safety officer.

(d) Each Type C specific license of broad scope issued by the DHHS/RHS shall be subject to the condition that byproduct material possessed under the license shall be used only by, or under the direct supervision of, individuals who satisfy the requirements of He‑P 4033.05(c).

Source. (See Revision Note at part heading for He-P 4033) #6942, eff 2-1-99; ss by #8800, INTERIM, eff 2-1-07, EXPIRED: 7-31-07

New. #8959, eff 8-7-07; ss by #10983, eff 11-24-15

He-P 4033.07 License Quantities for License of Broad Scope. License quantities for licenses of broad scope shall be as described in Table 4033.1.

Table 4033.1 Quantities of Byproduct Material for Licenses of Broad Scope

Byproduct Material	Column 1 (curies)	Column 2 (curies)
Antimony-122	1.0	0.01
Antimony-124	1.0	0.01
Antimony-125	1.0	0.01
Arsenic-73	10.0	0.1
Arsenic-74	1.0	0.01
Arsenic-76	1.0	0.01
Arsenic-77	10.0	0.1
Barium-131	10.0	0.1
Barium-140	1.0	0.01
Beryllium-7	10.0	0.1
Bismuth-210	0.1	0.001
Bromine-82	10.0	0.1
Cadmium-109	1.0	0.01
Cadmium-115m	1.0	0.01
Cadmium-115	10.0	0.1
Calcium-45	1.0	0.01
Calcium-47	10.0	0.1
Carbon-14	100.0	1.0
Cerium-141	10.0	0.1
Cerium-143	10.0	0.1
Cerium-144	0.1	0.001
Cesium-131	100.0	1.0
Cesium-134m	100.0	1.0
Cesium 134	0.1	0.001
Cesium-135	1.0	0.01
Cesium-136	10.0	0.1
Cesium-137	0.1	0.001
Chlorine-36	1.0	0.01
Chlorine-38	100.0	1.0
Chromium-51	100.0	1.0
Cobalt-57	10.0	0.1
Cobalt-58m	100.0	1.0
Cobalt-58	1.0	0.01
Cobalt-60	0.1	0.001
Copper-64	10.0	0.1
Dysprosium-165	100.0	1.0
Dysprosium-166	10.0	0.1
Erbium-169	10.0	0.1
Erbium-171	10.0	0.1
Europium-152 (9.2 h)	10.0	0.1
Europium-152 (13 y)	0.1	0.001
Europium-154	0.1	0.001
Europium-155	1.0	0.01
Fluorine-18	100.0	1.0
Gadolinium-153	1.0	0.01
Gadolinium-159	10.0	0.1
Gallium-72	10.0	0.1
Germanium-71	100.0	1.0
Gold-198	10.0	0.1
Gold-199	10.0	0.1
Hafnium-181	1.0	0.01
Holmium-166	10.0	0.1
Hydrogen-3	100.0	1.0
Indium-113m	100.0	1.0
Indium-114m	1.0	0.01
Indium-115m	100.0	1.0
Indium-115	1.0	0.01
Iodine-125	0.1	0.001
Iodine-126	0.1	0.001
Iodine-129	0.1	0.01
Iodine-131	0.1	0.001
Iodine-132	10.0	0.1
Iodine-133	1.0	0.01
Iodine-134	10.0	0.1
Iodine-135	1.0	0.01
Iridium-192	1.0	0.01
Iridium-194	10.0	0.1
Iron-55	10.0	0.1
Iron-59	1.0	0.01
Krypton-85	100.0	1.0
Krypton-87	10.0	0.1
Lanthanum-140	1.0	0.01
Lutetium-177	10.0	0.1
Manganese-52	1.0	0.01
Manganese-54	1.0	0.01
Manganese-56	10.0	0.1
Mercury-197m	10.0	0.1
Mercury-197	10.0	0.1
Mercury-203	1.0	0.01
Molybdenum-99	10.0	0.1
Neodymium-147	10.0	0.1
Neodymium-149	10.0	0.1
Nickel-59	10.0	0.1
Nickel-63	1.0	0.01
Nickel-65	10.0	0.1
Niobium-93m	1.0	0.01
Niobium-95	1.0	0.01
Niobium-97	100.0	1.0
Osmium-185	1.0	0.01
Osmium-191m	100.0	1.0
Osmium-191	10.0	0.1
Osmium-193	10.0	0.1
Palladium-103	10.0	0.1
Palladium-109	10.0	0.1
Phosphorus-32	1.0	0.01
Phosphorus-33	10.0	0.1
Platinum-191	10.0	0.1
Platinum-193m	100.0	1.0
Platinum-193	10.0	0.1
Platinum-197m	100.0	1.0
Platinum-197	10.0	0.1
Polonium-210	0.01	0.0001
Potassium-42	1.0	0.01
Praseodymium-142	10.0	0.1
Praseodymium-143	10.0	0.1
Promethium-147	1.0	0.01
Promethium-149	10.0	0.1
Radium-226	0.01	0.0001
Rhenium-186	10.0	0.1
Rhenium-188	10.0	0.1
Rhodium-103m	1,000.0	10.0
Rhodium-105	10.0	0.1
Rubidium-86	1.0	0.01
Rubidium-87	1.0	0.01
Ruthenium-97	100.0	1.0
Ruthenium-103	1.0	0.01
Ruthenium-105	10.0	0.1
Ruthenium-106	0.1	0.001
Samarium-151	1.0	0.01
Samarium-153	10.0	0.1
Scandium-46	1.0	0.01
Scandium-47	10.0	0.1
Scandium-48	1.0	0.01
Selenium-75	1.0	0.01
Silicon-31	10.0	0.1
Silver-105	1.0	0.01
Silver-110m	0.1	0.001
Silver-111	10.0	0.1
Sodium-22	0.1	0.001
Sodium-24	1.0	0.01
Strontium-85m	1,000.0	10.0
Strontium-85	1.0	0.01
Strontium-89	1.0	0.01
Strontium-90	0.01	0.0001
Strontium-91	10.0	0.1
Strontium-92	10.0	0.1
Sulphur-35	10.0	0.1
Tantalum-182	1.0	0.01
Technetium-96	10.0	0.1
Technetium-97m	10.0	0.1
Technetium-97	10.0	0.1
Technetium-99m	100.0	1.0
Technetium-99	1.0	0.01
Tellurium-125m	1.0	0.01
Tellurium-127m	1.0	0.01
Tellurium-127	10.0	0.1
Tellurium-129m	1.0	0.01
Tellurium-129	100.0	1.0
Tellurium-131m	10.0	0.1
Tellurium-132	1.0	0.01
Terbium-160	1.0	0.01
Thallium-200	10.0	0.1
Thallium-201	10.0	0.1
Thallium-202	10.0	0.1
Thallium-204	1.0	0.01
Thulium-170	1.0	0.01
Thulium-171	1.0	0.01
Tin-113	1.0	0.01
Tin-125	1.0	0.01
Tungsten-181	1.0	0.01
Tungsten-185	1.0	0.01
Tungsten-187	10.0	0.1
Vanadium-48	1.0	0.01
Xenon-131m	1,000.0	10.0
Xenon-133	100.0	1.0
Xenon-135	100.0	1.0
Ytterbium-175	10.0	0.1
Yttrium-90	1.0	0.01
Yttrium-91	1.0	0.01
Yttrium-92	10.0	0.1
Yttrium-93	1.0	0.01
Zinc-65	1.0	0.01
Zinc-69m	10.0	0.1
Zinc-69	100.0	1.0
Zirconium-93	1.0	0.01
Zirconium-95	1.0	0.01
Zirconium-97	1.0	0.01
Any Byproduct material other than alpha emitting material not listed above.	0.1	0.001

Source. (See Revision Note at part heading for He-P 4033) #6942, eff 2-1-99; ss by #8800, INTERIM eff 2-1-07, EXPIRED: 7-31-07

New. #8959, eff 8-7-07; ss by #10983, eff 11-24-15

PART He-P 4034 RADIATION SAFETY REQUIREMENTS FOR INDUSTRIAL RADIOGRAPHIC OPERATIONS

Revision Note:

He-P 4034.01 Purpose. This part prescribes requirements for the issuance of licenses or registration for the industrial use of sources of radiation and radiation safety requirements for persons using these sources of radiation in industrial radiography.

Source. (See Revision Note at part heading for He-P 4034) #6942, eff 2-1-99; ss by #8800, INTERIM, eff 2-1-07, EXPIRED: 7-31-07

New. # 8959, eff 8-7-07; ss by #10983, eff 11-24-15

He-P 4034.02 Scope. The provision and requirements of this part are in addition to, and not in substitution for, other requirements of these regulations and cover both radiation machines and sealed sources containing byproduct material but do not apply to medical uses of byproduct material. In particular, the requirements and provisions of He-P 4038 apply to applications and license subject to this part.

Source. (See Revision Note at part heading for He-P 4034) #6942, eff 2-1-99; ss by #8800, INTERIM, eff 2-1-07, EXPIRED: 7-31-07

New. # 8959, eff 8-7-07; ss by #10983, eff 11-24-15; ss by #12930, eff 11-26-19

He-P 4034.03 Definitions. The following definitions shall apply to this part:

(a) “ALARA” (acronym for "as low as is reasonably achievable") means making every reasonable effort to maintain exposures to radiation as far below the dose limits specified in He-P 4020 as is practical consistent with the purpose for which the licensed activity is undertaken, taking into account the state of technology, the economics of improvements in relation to state of technology, the economics of improvements in relation to benefits to the public health and safety, and other societal and socioeconomic considerations, and in relation to utilization of nuclear energy and licensed materials in the public interest;

(b) “Annual refresher safety training” means a review conducted or provided by the licensee or registrant for its employees on radiation safety aspects of industrial radiography. The review may include, as appropriate, the results of internal inspections, new procedures or equipment, new or revised regulations, accidents or errors that have been observed, and should also provide opportunities for employees to ask safety questions;

(c) “Associated equipment” means equipment that is used in conjunction with a radiographic exposure device to make radiographic exposures that drives, guides, or otherwise comes in contact with the source, (e.g., guide tube, control tube, control (drive) cable, removable source stop, “J” tube and collimator when it is used as an exposure head);

(d) “Cabinet radiography” means industrial radiography conducted in an enclosure or cabinet so shielded that every location on the exterior meets the dose limits for the individual member of the public as specified in He‑P 4020;

(e) “Cabinet x-ray system” means an x-ray system with the x-ray tube installed in an enclosure independent of existing architectural structures except the floor and is intended to contain at least that portion of a material being irradiated, provide radiation attenuation, and exclude personnel from its interior during generation of radiation. The term includes “cabinet” and x-ray systems designed primarily for the inspection of carry-on baggage at airline, railroad, and bus terminals and in similar facilities. An x-ray tube used within a shielded part of a building, or x-ray equipment that might temporarily or occasionally incorporate portable shielding, is not a cabinet x-ray system;

(f) “Certifiable cabinet x-ray system” means an existing uncertified x-ray system that has been modified to meet the certification requirements specified in 21 CFR 1010.2;

(g) “Certified cabinet x-ray system” means an x-ray system that has been certified in accordance with 21 CFR 1010.2 as being manufactured and assembled pursuant to the provisions of 21 CFR 1020.40;

(h) “Certifying entity” means an independent certifying organization meeting the requirements in He‑P 4034 Appendix A, Parts II and III, or the equivalent requirements of an Agreement State or in Nuclear Regulatory Commission 10 CFR 34 appendix A;

(i) “Collimator” means a radiation shield that is placed on the end of the guide tube or directly onto a radiographic exposure device to restrict the size of the radiation beam when the sealed source is cranked into position to make a radiographic exposure;

(j) “Control cable” means the cable that is connected to the source assembly and used to drive the source to and from the exposure location. The term includes “drive cable”;

(k) “Control drive mechanism” means a device that enables the source assembly to be moved into and out of the exposure device;

(l) “Control tube” means a protective sheath which connects the control drive mechanism to the radiographic exposure device for guiding the control cable;

(m) “Exposure head” means a device that locates the gamma radiography sealed source in the selected working position. The term includes “source stop”;

(n) “Field station” means a facility from which sources of radiation may be stored or used and from which equipment is dispatched;

(o) “Guide tube” means a flexible or rigid, “J” tube, for guiding the source assembly and the attached control cable from the exposure device to the exposure head which may also include the connections necessary for attachment to the exposure device and to the exposure head. The term includes “projection sheath”;

(p) “Hands-on experience” means experience in all of those areas considered to be directly involved in the radiography process, and includes taking radiographs, calibration of survey instruments, operational and performance testing of survey instruments and devices, film development, posting of radiation areas, transportation of radiography equipment, posting of records, and radiation area surveillance;

(q) “Independent certifying organization” means an independent organization that meets all of the criteria of He-P 4034 Appendix A;

(r) “Industrial radiography” means an examination of the structure of materials by nondestructive methods, utilizing ionizing radiation to make radiographic images;

(s) “Lay-barge radiography” means industrial radiography performed on any water vessel used for laying pipe;

(t) “Offshore platform radiography” means industrial radiography conducted from a platform over a body of water;

(u) “Permanent radiographic installation” means an enclosed shielded room, cell, or vault, not located at a temporary job site, in which radiography is performed;

(v) “Practical examination” means a demonstration through application of the safety rules and principles in industrial radiography including use of all appropriate procedures and equipment to be used by radiographic personnel;

(w) “Radiation safety officer for industrial radiography” means an individual with the responsibility for the overall radiation safety program on behalf of the licensee or registrant and who meets the requirements of He-P 4034.16;

(x) “Radiographer” means any individual who performs or who, in attendance at the site where the sealed sources or sources of radiation are being used, personally supervises industrial radiographic operations and who is responsible to the licensee or registrant for assuring compliance with the requirements of DHHS/RHS rules and the conditions of the license or the registration;

(y) “Radiographer certification” means written approval received from a certifying entity stating that an individual has satisfactorily met certain established radiation safety, testing, and experience criteria;

(z) “Radiographer’s assistant” means any individual who under the direct supervision of a radiographer, uses radiographic exposure devices, sealed sources or related handling tools, or radiation survey instruments in industrial radiography;

(aa) “Radiographic exposure device” means any instrument containing a sealed source fastened or contained therein, in which the sealed source or shielding thereof may be moved, or otherwise changed, from a shielded to unshielded position for purposes of making a radiographic exposure. The term includes “camera” or “projector”;

(ab) “Radiographic operations” means all activities associated with the presence of radioactive source in a radiographic exposure device or with a radiation machine to include use, transport (except when being transported by a common or contract transport) performing surveys to confirm the adequacy of boundaries, setting up equipment, and any activity inside restricted area boundaries;

(ac) “S-tube” means a tube through which the radioactive source travels when inside a radiographic exposure device;

(ad) “Shielded position” means the location within the radiographic exposure device or source changer where the sealed source is secured and restricted from movement;

(ae) “Source assembly” means an assembly that consists of the sealed source and a connector that attaches the source to the control cable and may include a stop ball used to secure the source in the shielded position;

(af) “Source changer” means a device designed and used for replacement of sealed sources in radiographic exposure devices which may also be used for transporting and storing sealed sources;

(ag) “Storage area” means any location, facility, or vehicle which is used to store or to secure a radiographic exposure device, a storage container, a sealed source, or a radiation machine when it is not in use and which is locked or has a physical barrier to prevent accidental exposure, tampering with, or unauthorized removal of the device, container, source, or radiation machine;

(ah) “Storage container” means a container in which sealed sources are secured and stored;

(ai) “Temporary jobsite” means a location where radiographic operations are conducted and where licensed material may be stored other than those location(s) of use authorized on the license; and

(aj) “Underwater radiography” means industrial radiography performed when the radiographic exposure device and/or related equipment are beneath the surface of the water.

Source. (See Revision Note at part heading for He-P 4034) #6942, eff 2-1-99; ss by #8800, INTERIM, eff 2-1-07, EXPIRED: 7-31-07

New. #8959, eff 8-7-07; ss by #10983, eff 11-24-15; ss by #12626, eff 9-26-18; amd by #12930, eff 11-26-19

He-P 4034.04 Exemptions.

(a) Certified and certifiable cabinet x-ray systems, including those designed to allow admittance of individuals, shall be exempt from the requirements of this part except that:

(1) No registrant shall permit any individual to operate a cabinet x-ray system until the individual has received a copy of, and instruction in the operating procedures for the unit;

(2) Tests for proper operation of interlocks shall be conducted and recorded at intervals not to exceed 6 months;

(3) The registrant shall perform an evaluation to determine compliance with He‑P 4020.13(a) through (f), and 21 CFR 1020.40, at intervals not to exceed one year; and

(4) Records of the evaluation required in (a)(1) – (a)(3) above shall be maintained for DHHS/RHS inspection until disposal is authorized by DHHS/RHS.

(b) Certified and certifiable cabinet x-ray systems shall be maintained in compliance with 21 CFR 1020.40, and no modification shall be made to the system unless prior DHHS/RHS approval has been granted.

(c) Industrial uses of hand-held light intensified imaging devices are exempt from the regulations in this part if the exposure level 18 inches from the source of radiation to any individual does not exceed 2 millirem per hour.

(d) Industrial uses of hand-held light intensified imaging devices with exposure levels that exceed the 2 millirem per hour level shall meet the applicable requirements of this part and He-P 4040 or He-P 4030, as applicable.

Source. (See Revision Note at part heading for He-P 4034) #6942, eff 2-1-99; ss by #8800, INTERIM, eff 2-1-07, EXPIRED: 7-31-07

New. #8959, eff 8-7-07; ss by #10983, eff 11-24-15

He-P 4034.05 Licensing and Registration Requirements for Industrial Radiography Operations. DHHS/RHS shall approve an application for a specific license for the use of sealed sources in industrial radiography or a registration for use of radiation machines if:

(a) The applicant or registrant satisfies the general requirements specified in He-P 4040 for radiation machine facilities or He-P 4030 for use of sealed sources in industrial radiography, and any special requirements contained in this part;

(b) The applicant submits an adequate program for training radiographers and radiographers’ assistants that meets the requirements of He‑P 4034.17;

(c) The applicant or registrant submits procedures for verifying and documenting the certification status of radiographers and for ensuring that the certification of individuals acting as radiographers remains valid;

(d) The applicant or registrant submits written operating and emergency procedures as described in He‑P 4034.18;

(e) The applicant or registrant submits a description of a program for inspections of the job performance of each radiographer and radiographer’s assistant at intervals not to exceed 6 months as described in He‑P 4034.17(e);

(f) The applicant or registrant submits a description of the applicant’s overall organizational structure as it applies to the radiation safety responsibilities in industrial radiography, including specified delegation of authority and responsibility;

(g) The applicant or registrant submits the qualifications of the individual(s) designated as the Radiation Safety Officer as described in He‑P 4034.16 and potential designees responsible for ensuring that the licensee’s or registrant’s radiation safety program is implemented in accordance with approved procedures;

(h) An applicant intends to perform leak testing of sealed sources or exposure devices containing depleted uranium (DU) shielding, or intends to analyze their own wipe samples, the applicant describes the procedures for performing these tests to include:

(1) Methods of collecting the samples;

(2) Qualifications of the individual who analyzes the samples;

(3) Instruments to be used; and

(4) Methods of analyzing the samples;

(i) The applicant or registrant intends to perform calibrations of survey instruments and alarming ratemeters, the applicant describes methods to be used and the experience of the person(s) who will perform the calibrations;

(j) All calibrations of survey instruments and alarming ratemeters are performed according to the procedures described and at the intervals prescribed in He‑P 4034.09 and He‑P 4034.20(p);

(k) The applicant or registrant identifies and describes the location(s) of all field stations and permanent radiographic installations;

(l) The applicant or registrant identifies the locations where all records required by this and other parts of these regulations will be maintained;

(m) A license application or radiation machine use includes underwater radiography, a description of the following is included:

(1) Radiation safety procedures and radiographer responsibilities unique to the performance of underwater radiography;

(2) Radiographic equipment and radiation safety equipment unique to underwater radiography; and

(3) Methods for gas-tight encapsulation of equipment;

(n) An application or radiation machine use includes offshore platform or lay-barge radiography, a description of the following is included:

(1) Transport procedures for sealed source to be used in industrial radiographic operations;

(2) Storage facilities for sealed source; and

(3) Methods for restricting access to radiation areas; and

(o) Each registrant complies with the requirements, as appropriate, of He‑P 4034.04 for use of radiation machines in industrial radiographic operations.

Source. (See Revision Note at part heading for He-P 4034) #6942, eff 2-1-99; ss by #8800, INTERIM, eff 2-1-07, EXPIRED: 7-31-07

New. #8959, eff 8-7-07; ss by #10983, eff 11-24-15; amd by #12626, eff 9-26-18; amd by #12930, eff 11-26-19

He-P 4034.06 Performance Requirements for Industrial Radiography Equipment. Equipment used in industrial radiographic operations shall meet the following minimum criteria:

(a) Each radiographic exposure device, source assembly or sealed source, and all associated equipment shall meet the requirements specified in American National Standard Institute, N432-1980 “Radiological Safety for the Design and Construction of Apparatus for Gamma Radiography,” (published as NBS Handbook 136, issued January 1981). This publication has been approved for incorporation by reference by the Director of the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR Part 51. This publication may be purchased from the American National Standards Institute, Inc., 25 West 43rd Street, New York, New York 10036; Telephone: (212) 642–4900. Copies of the document are available for inspection at the Nuclear Regulatory Commission Library, 11545 Rockville Pike, Rockville, Maryland 20852. A copy of the document is also on file at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

(b) In addition to the requirements specified in He‑P 4034.06(a), the following requirements apply to radiographic exposure devices, source changers, source assemblies and sealed sources:

(1) The licensee shall ensure that each radiographic exposure device has attached to it a durable, legible, clearly visible label bearing the:

a. Chemical symbol and mass number of the radionuclide in the device;

b. Activity and the date on which this activity was last measured;

c. Model or product code and serial number of the sealed source;

d. Manufacturer’s identity of the sealed source; and

e. Licensee’s name, address, and telephone number;

(2) Radiographic exposure devices intended for use as Type B transport containers shall meet the applicable requirements of He‑P 4037; and

(3) Modification of radiographic exposure devices, source changers, and source assemblies and associated equipment is prohibited, unless the design of any replacement component, including source holder, source assembly, controls, or guide tubes would not compromise the design safety features of the system;

(c) In addition to the requirements specified in He‑P 4034.06(a) and (b) of this section, the following requirements shall apply to radiographic exposure devices, source assemblies, source changers, and associated equipment that allow the source to be moved out of the device for radiographic operations:

(1) The coupling between the source assembly and the control cable shall be designed in such a manner that the source assembly will not become disconnected if cranked outside the guide tube. The coupling must be such that it cannot be unintentionally disconnected under normal and reasonably foreseeable abnormal conditions;

(2) The device shall automatically secure the source assembly when it is cranked back into the fully shielded position within the device;

(3) This securing system required in He‑P 4034.06(c)(2) shall only be released by means of a deliberate operation on the exposure device;

(4) The outlet fittings, lock box, and drive cable fittings on each radiographic exposure device shall be equipped with safety plugs or covers which must be installed during storage and transportation to protect the source assembly from water, mud, sand or other foreign matter;

(5) Each sealed source or source assembly shall have attached to it or engraved on it, a durable, legible, visible label with the words: “DANGER -- RADIOACTIVE”;

(6) The label required in He‑P 4034.05(c)(5) shall not interfere with the safe operation of the exposure device or associated equipment;

(7) The guide tube shall:

a. Be able to withstand a crushing test that closely approximates the crushing forces that are likely to be encountered during use; and

b. Be able to withstand a kinking resistance test that closely approximates the kinking forces that are likely to be encountered during use;

(8) Guide tubes shall be used when moving the source out of the device;

(9) An exposure head or similar device designed to prevent the source assembly from passing out of the end of the guide tube shall be attached to the outermost end of the guide tube during industrial radiography operations;

(10) The guide tube exposure head connection shall be able to withstand the tensile test for control units specified in ANSI N432-1980; and

(11) Source changers shall provide a system for ensuring that the source will not be accidentally withdrawn from the changer when connecting or disconnecting the drive cable to or from a source assembly.

(d) All radiographic exposure devices and associated equipment in use after January 10, 1996, shall comply with the requirements of He-P 4034.06; and

(e) Notwithstanding He-P 4034.06(a), equipment used in industrial radiographic operations shall not be required to comply with “§ 8.9.2(c) of the Endurance Test in American National Standards Institute N432-1980,” if the prototype equipment has been tested using a torque value representative of the torque that an individual using the radiography equipment can realistically exert on the lever or crankshaft of the drive mechanism.

Source. (See Revision Note at part heading for He-P 4034) #6942, eff 2-1-99; ss by #8800, INTERIM, eff 2-1-07, EXPIRED: 7-31-07

New. #8959, eff 8-7-07; ss by #10983, eff 11-24-15; amd by #12626, eff 9-26-18; amd by #12930, eff 11-26-19

He-P 4034.07 Limits on External Radiation Levels from Storage Containers and Source Changers. The maximum exposure rate limits for storage containers and source changers are 2 millisieverts (200 mrem) per hour at any exterior surface, and 0.1 millisieverts (10 mrem) per hour at 1 meter from any exterior surface with the sealed source in the shielded position.

Source. (See Revision Note at part heading for He-P 4034) #6942, eff 2-1-99; ss by #8800, INTERIM, eff 2-1-07, EXPIRED: 7-31-07

New. #8959, eff 8-7-07; ss by #10983, eff 11-24-15

He-P 4034.08 Locking of Radiographic Exposure Devices, Storage Containers and Source Changers.

(a) Each radiographic exposure device shall have a lock or outer locked container designed to prevent unauthorized or accidental removal of the sealed source from its shielded position.

(b) The exposure device, or its container, or both shall be kept locked (and if a keyed-lock, with the key removed at all times) when not under the direct surveillance of a radiographer or a radiographer’s assistant except at permanent radiographic installations as stated in He‑P 4034.22.

(c) During radiographic operations the sealed source assembly shall be secured in the shielded position each time the source is returned to that position.

(d) Each sealed source storage container and source changer shall have a lock or outer locked container designed to prevent unauthorized or accidental removal of the sealed source from its shielded position.

(e) Storage containers and source changers shall be kept locked, and if a keyed-lock, with key removed at all times, when containing sealed sources except when under the direct surveillance of a radiographer or a radiographer’s assistant.

(f) The control panel of each radiation machine shall be equipped with a lock that will prevent the unauthorized use of an x-ray system or the accidental production of radiation.

(g) The radiation machine shall be kept locked and the key removed at all times except when under the direct visual surveillance of a radiographer or a radiographer’s assistant.

Source. (See Revision Note at part heading for He-P 4034) #6942, eff 2-1-99; ss by #8800, INTERIM, eff 2-1-07, EXPIRED: 7-31-07

New. #8959, eff 8-7-07; ss by #10983, eff 11-24-15; amd by #12626, eff 9-26-18; amd by #12930, eff 11-26-19

He-P 4034.09 Radiation Survey Instruments.

(a) The licensee or registrant shall keep sufficient calibrated and operable radiation survey instruments at each location where sources of radiation are present to make the radiation surveys required by this part and by He-P 4022.

(b) Instrumentation required by He‑P 4034.09(a) shall be capable of measuring a range from 0.02 millisieverts (2 mrem) per hour through 0.01 sievert (1 rem) per hour.

(1) At intervals not to exceed 6 months and after instrument servicing, except for battery changes;

(2) For linear scale instruments, at 2 points located approximately one-third and two-thirds of full-scale on each scale; for logarithmic scale instruments, at mid-range of each decade, and at 2 points of at least one decade; and for digital instruments, at 3 points between 0.02 and 10 millisieverts (2 and 1,000 mrem) per hour; and

(3) So that an accuracy within plus or minus 20 percent of the calibration source can be demonstrated at each point checked.

(d) The licensee shall maintain records of the results of the instrument calibrations in accordance with He-P 4034.26.

Source. (See Revision Note at part heading for He-P 4034) #6942, eff 2-1-99; ss by #8800, INTERIM, eff 2-1-07, EXPIRED: 7-31-07

New. #8959, eff 8-7-07; ss by #10983, eff 11-24-15; amd by #12930, eff 11-26-19

He-P 4034.10 Leak Testing and Replacement of Sealed Sources.

(a) The replacement of any sealed source fastened to or contained in a radiographic exposure device and leak testing of any sealed source shall be performed by persons authorized to do so by DHHS/RHS, another agreement state, or the Nuclear Regulatory Commission.

(b) The opening, repair, or modification of any sealed source shall be performed by persons specifically authorized to do so by DHHS/RHS, another agreement state, or the Nuclear Regulatory Commission.

(d) The leak testing of a sealed source shall include:

(1) A method approved by DHHS/RHS, another agreement state, or the Nuclear Regulatory Commission;

(2) A wipe sample taken from the nearest accessible point to the sealed source where contamination might accumulate;

(3) An analysis of the wipe sample for radioactive contamination which is capable of detecting the presence of 185 becquerel (0.005 mCi) of radioactive material on the test sample; and

(4) Performance of the wipe sample by a person specifically authorized by DHHS/RHS, another agreement state, or the Nuclear Regulatory Commission.

(e) The licensee shall maintain records of the leak tests in accordance with He‑P 4034.27.

(f) Unless a sealed source is accompanied by a certificate from the transferor that shows that it has been leak tested within 6 months before the transfer, it shall not be used by the licensee until tested for leakage.

(g) Sealed sources that are in storage and not in use shall not require leak testing.

(h) Sealed sources that are in storage and not in use shall be tested before use or transfer to another person if the interval of storage exceeds 6 months.

(i) Any test conducted pursuant to He‑P 4034.10 that reveals the presence of 185 becquerel (0.005 mCi) or more of removable radioactive material shall be considered evidence that the sealed source is leaking.

(j) If a sealed source is found to be leaking, the licensee shall immediately withdraw the equipment involved from use and shall have it decontaminated and repaired or disposed of in accordance with He-P 4000.

(k) If a sealed source is found to be leaking, a report must be filed with DHHS/RHS within 5 days of the test, describing the equipment involved, the test results, and the corrective action taken. A copy of the report shall be sent to DHHS/RHS in accordance with He-P 4001.08.

(l) Each exposure device using depleted uranium (DU) shielding and an S-tube configuration shall:

(1) Be tested for DU contamination at intervals not to exceed 12 months;

(2) Be analyzed by a method capable of detecting the presence of 185 becquerel (0.005 mCi) of radioactive material on the test sample; and

(3) Have the test performed by a person specifically authorized by DHHS/RHS, another agreement state, or the Nuclear Regulatory Commission to perform the analysis.

(m) Should the testing required in He‑P 4034.10(l) reveal the presence of 185 becquerel (0.005 mCi) or more of removable DU contamination, the exposure device shall be removed from use until an evaluation of the wear of the S-tube has been made.

(n) Should the evaluation in He‑P 4034.10(m) reveal that the S-tube is worn through, the device shall not be used again.

(o) DU shielded devices shall not have to be tested for DU contamination while in storage and not in use.

(p) Before using or transferring a DU device, the device shall be tested for DU contamination if the interval of storage exceeds 12 months.

(q) A record of the DU leak-test shall be made in accordance with He‑P 4034.27.

Source. (See Revision Note at part heading for He-P 4034) #6942, eff 2-1-99; ss by #8800, INTERIM, eff 2-1-07, EXPIRED: 7-31-07

New. #8959, eff 8-7-07; ss by #10983, eff 11-24-15; ss by #12930, eff 11-26-19

He-P 4034.11 Quarterly Inventory.

(a) Each licensee or registrant shall conduct a quarterly physical inventory to account for all sources of radiation and for all devices containing depleted uranium which have been received and possessed under the license.

(b) The licensee or registrant shall maintain records of the quarterly inventory in accordance with He-P 4034.28.

Source. (See Revision Note at part heading for He-P 4034) #6942, eff 2-1-99; ss by #8800, INTERIM, eff 2-1-07, EXPIRED: 7-31-07

New. #8959, eff 8-7-07; ss by #10983, eff 11-24-15; amd by #12930, eff 11-26-19

He-P 4034.12 Inspection and Maintenance of Radiation Machines, Radiographic Exposure Devices, Transport and Storage Containers, Associated Equipment, Source Changers, and Survey Instruments.

(a) The licensee or registrant shall perform visual and operability checks on survey meters, radiation machines, radiographic exposure devices, transport and storage containers, associated equipment and source changers at the start of each days use, or work shift, to ensure that:

(1) The equipment is in good working condition;

(2) The sources are adequately shielded; and

(3) Required labeling is present.

(b) Survey instrument operability shall be performed using check sources or other appropriate means.

(c) Each licensee or registrant shall conduct a program for inspection and maintenance of radiation machines, radiographic exposure devices, source changers, associated equipment, transport and storage containers, and survey instruments at intervals not to exceed 3 months or before the first use thereafter to ensure the proper functioning of components important to safety is in accordance with manufacturer’s specifications.

(d) Each licensee or registrant shall ensure that all replacement components for radiation machines, radiographic exposure devices, source changers, associated equipment, transport and storage containers and survey instruments meet design specifications.

(e) If any equipment problems are found, the equipment shall be removed from service and labeled as defective until repaired.

(f) The licensee’s inspection and maintenance program shall include procedures to ensure that Type B packages used to transport radioactive materials are shipped and maintained in accordance with the certificate of registration or other approval.

(g) Records of equipment problems and of any maintenance performed under He‑P 4034.12 shall be made in accordance with He‑P 4034.30.

Source. (See Revision Note at part heading for He-P 4034) #6942, eff 2-1-99; ss by #8800, INTERIM, eff 2-1-07, EXPIRED: 7-31-07

New. #8959, eff 8-7-07; ss by #10983, eff 11-24-15; amd by #12930, eff 11-26-19

He-P 4034.13 Permanent Radiographic Installations.

(a) Each entrance that is used for personnel access to the high radiation area in a permanent radiographic installation shall be equipped with:

(1) An entrance control of the type described in He‑P 4022.04(a)(1) that causes the radiation level upon entry into the area to be reduced; or

(2) Conspicuous visible and audible warning signals to warn of the presence of radiation as follows:

a. The visible signal must be actuated by radiation whenever the source is exposed or the machine is energized; and

b. The audible signal must be actuated when an attempt is made to enter the installation while the source is exposed or the machine is energized.

(b) The alarm system described in He‑P 4034.13(a)(2) shall be tested for proper operation of both the visible and audible signals, with a radiation source, each day before the installation is used for radiographic operations.

(c) Entrance control devices that reduce the radiation level upon entry as designated in He‑P 4034.13(a)(1) shall be tested monthly.

(d) If an entrance control device or an alarm system is not operating properly, it shall be immediately labeled as defective and repaired within 7 calendar days.

(e) An installation with a defective entrance control device or alarm system may continue to be used for a 7-day period, provided the licensee or registrant implements the continuous surveillance requirements of He‑P 4034.22 and an alarming ratemeter is used.

Source. (See Revision Note at part heading for He-P 4034) #6942, eff 2-1-99; ss by #8800, INTERIM, eff 2-1-07, EXPIRED: 7-31-07

New. #8959, eff 8-7-07; ss by #10983, eff 11-24-15; amd by #12930, eff 11-26-19

He-P 4034.14 Labeling, Storage, and Transportation.

(a) The licensee shall not use a source changer or a container to store licensed material unless the source changer or the storage container has securely attached to it a durable, legible, and clearly visible label bearing the standard trefoil radiation caution symbol in conventional colors, i.e., magenta, purple or black on yellow background, having a minimum diameter of 25mm and the wording:

“CAUTION [or “DANGER”]

RADIOACTIVE MATERIAL

NOTIFY CIVIL AUTHORITIES [or “NAME OF COMPANY”]”

(b) The licensee shall not transport licensed material unless the material is packaged, and the package is labeled, marked, and accompanied with appropriate shipping papers in accordance with He‑P 4037.

(c) Locked radiographic exposure devices, storage containers, and radiation machines, shall be physically secured to prevent tampering or removal by unauthorized personnel.

(d) The licensee shall store licensed material in a manner that will minimize danger from explosion or fire.

(e) The licensee shall lock and physically secure the transport package containing licensed material in the transporting vehicle to prevent accidental loss, tampering, or unauthorized removal of the licensed material from the vehicle.

Source. (See Revision Note at part heading for He-P 4034) #6942, eff 2-1-99; ss by #8800, INTERIM, eff 2-1-07, EXPIRED: 7-31-07

New. #8959, eff 8-7-07; ss by #10983, eff 11-24-15; ss by #12626, eff 9-26-18; amd by #12930, eff 11-26-19

He-P 4034.15 Conducting Industrial Radiographic Operations.

(a) Whenever radiography is performed at a location other than a permanent radiographic installation, the following shall be required:

(1) The radiographer shall be accompanied by at least one other qualified radiographer or an individual who has at a minimum met the requirements of He-P 4034.17(c);

(2) The second qualified individual on site shall observe the operations and be capable of providing immediate assistance to prevent unauthorized entry into the restricted area; and

(3) Radiography shall not be performed if only one qualified individual is present.

(b) All radiographic operations conducted at locations of use authorized on the license shall be conducted in a permanent radiographic installation unless otherwise specifically authorized by DHHS/RHS.

(c) A licensee or registrant shall conduct lay-barge, offshore platform, or underwater radiography only if procedures have been approved by DHHS/RHS, an agreement state, or the U.S. Nuclear Regulatory Commission.

Source. (See Revision Note at part heading for He-P 4034) #6942, eff 2-1-99; ss by #8800, INTERIM, eff 2-1-07, EXPIRED: 7-31-07

New. #8959, eff 8-7-07; ss by #10983, eff 11-24-15; ss by #12626, eff 9-26-18; amd by #12930, eff 11-26-19

He-P 4034.16 Radiation Safety Officer.

(a) The Radiation Safety Officer (RSO) shall ensure that radiation safety activities are being performed in accordance with approved procedures and regulatory requirements in the daily operation of the licensee’s or registrant’s program.

(b) The minimum qualifications, training, and experience for RSOs for industrial radiography shall be as follows:

(1) Completion of the training and testing requirements of He‑P 4034.17(a);

(2) 2,000 hours of hands-on experience as a qualified radiographer in industrial radiographic operations; and

(3) Formal training in the establishment and maintenance of a radiation protection program.

(c) In lieu of (b), a licensee may apply to DHHS/RHS for approval of an individual to serve as RSO when such individual has appropriate training or experience in the field of ionizing radiation, and in addition, has adequate formal training with respect to the establishment and maintenance of a radiation safety protection program.

(d) The specific duties and authorities of the RSO shall include, but shall not be limited to:

(1) Establishing and overseeing all operating, emergency, and ALARA procedures as required by He‑P 4020 through He‑P 4023 and reviewing these procedures regularly to ensure that the procedures in use conform to DHHS/RHS rules and the license or registration conditions;

(2) Overseeing and approving the training program for radiographic personnel to ensure that appropriate and effective radiation protection practices are taught;

(3) Ensuring that required radiation surveys and leak tests are performed and documented in accordance with He‑P 4034, including any corrective measures when levels of radiation exceed established limits;

(4) Ensuring that personnel monitoring devices are calibrated, if applicable, and used properly by occupationally exposed personnel;

(5) Ensuring that records are kept of the personnel monitoring results;

(6) Ensuring that timely notifications are made as required by He‑P 4021.14; and

(7) Ensuring that working operations are conducted safely, that corrective actions are implemented, and that unsafe operations are terminated.

Source. (See Revision Note at part heading for He-P 4034) #6942, eff 2-1-99; ss by #8800, INTERIM, eff 2-1-07, EXPIRED: 7-31-07

New. #8959, eff 8-7-07; ss by #10983, eff 11-24-15; amd by #12626, eff 9-26-18; amd by #12930, eff 11-26-19

He-P 4034.17 Training.

(a) The licensee or registrant shall not permit any individual to act as a radiographer until the individual:

(1) Has received training in the subjects in He-P 4034.17(h) in addition to a minimum of 2 months of on-the-job training;

(2) Is certified through a radiographer certification program by a certifying entity in accordance with the criteria specified in He-P 4034 Appendix A. (An independent organization that would like to be recognized as a certifying entity shall submit its request to DHHS/RHS).

(3) Has received training in the subjects outlined in He-P 4034.17(h) and demonstrated an understanding of these subjects by successful completion of a written examination.

(b) In addition to (a) above, the licensee or registrant shall not permit any individual to act as a radiographer until the individual:

(1) Has received copies of, and instruction in the requirements described in, the rules contained in this part, applicable sections of He-P 4001.07, He-P 4019 through He-P 4023, and He-P 4037, the license or registration under which the radiographer will perform industrial radiography, and the licensee’s or registrant’s operating and emergency procedures;

(2) Has demonstrated an understanding of the licensee’s license and operating and emergency procedures by successful completion of a written or oral examination covering this material;

(3) Has received training in the use of the registrant’s radiation machines, or the licensee’s radiographic exposure devices, sealed sources, in the daily inspection of devices and associated equipment, and in the use of radiation survey instruments; and

(4) Has demonstrated understanding of the use of radiographic exposure devices, sources, survey instruments, and associated equipment described in He-P 4034.17(b)(1) and (b)(3) by successful completion of a practical examination covering this material.

(1) Has received copies of, and instruction in the requirements described in, the rules contained in this part, applicable sections of He-P 4001.07, He-P 4019 through He-P 4023, and He-P 4037, the license or registration under which the radiographer’s assistant will perform industrial radiography, and the licensee’s or registrant’s operating and emergency procedures;

(2) Has demonstrated an understanding of items in He-P 4034.17(c)(1) by successful completion of a written examination on the subjects covered;

(3) Under the personal supervision of a radiographer, has developed competence in the use of the registrant’s radiation machines, or the licensee’s radiographic exposure devices, sealed sources, in the daily inspection of devices and associated equipment, and in the use of radiation survey instruments; and

(4) Has demonstrated understanding of the use of the equipment described in He-P 4034.17(c)(3) by successful completion of a practical examination on the use of such equipment.

(d) The licensee or registrant shall provide annual refresher safety training for each radiographer and radiographer’s assistant at intervals not to exceed 12 months.

(e) Except as provided in He-P 4034.17(f)(3), the RSO or designee shall conduct an inspection program of the job performance of each radiographer and radiographer’s assistant to ensure that DHHS/RHS rules, license or registration requirements, and the applicant’s operating and emergency procedures are followed.

(f) The inspection program required in He-P 4034.17(e) shall:

(1) Include observation of the performance of each radiographer and radiographer’s assistant during an actual industrial radiographic operation, at intervals not to exceed 6 months;

(2) Provide that, if a radiographer or a radiographer’s assistant has not participated in an industrial radiographic operation for more than 6 months since the last inspection, the radiographer shall demonstrate knowledge of the training requirements of He‑P 4034.17(b)(3) and the radiographer’s assistant shall demonstrate knowledge of the training requirements of He-P 4034.17(c)(3) by a practical examination before these individuals can next participate in a radiographic operation; and

(3) Provide written document to ensure that DHHS/RHS rules, license or registration requirements, and operating and emergency procedures are followed in those situations where:

a. The individual serves as both radiographer and RSO; and

b. Performs all radiography operations, such that an inspection program is not required.

(g) The licensee or registrant shall maintain records of all required training, including certification documents, written and practical examinations, refresher safety training, and inspections of job performance in accordance with He-P 4034.32.

(h) The licensee or registrant shall include the following subjects in the training program required in He-P 4034.17(a):

(1) Fundamentals of radiation safety including:

a. Characteristics of gamma radiation;

b. Units of radiation dose and quantity of radioactivity;

c. Hazards of exposure to radiation;

d. Levels of radiation from licensed materials or sources of radiation; and

e. Methods of controlling radiation dose (time, distance, and shielding);

(2) Radiation detection instruments including:

a. Use, operation, calibration, and limitations of radiation survey instruments;

b. Survey techniques; and

c. Use of personnel monitoring equipment;

(3) Equipment to be used including:

a. Operation and control of radiographic exposure equipment, remote handling equipment, and storage containers, including pictures or models of source assemblies pigtails;

b. Operation and control of radiation machines;

c. Storage, control, and disposal of licensed material or sources of radiation; and

d. Inspection and maintenance of equipment;

(4) The requirements of this chapter and pertinent regulations in the Code of Federal Regulations; and

(5) Case histories of accidents in radiography.

(i) Records of radiographer certification maintained in accordance with He-P 4034.32(a) shall provide appropriate affirmation of certification requirements specified in He-P 4034.17(a)(1) and (a)(2).

Source. (See Revision Note at part heading for He-P 4034) #6942, eff 2-1-99; ss by #8800, INTERIM, eff 2-1-07, EXPIRED: 7-31-07

New. #8959, eff 8-7-07; ss by #10983, eff 11-24-15; ss by #12626, eff 9-26-18; amd by #12930, eff 11-26-19

He-P 4034.18 Operating and Emergency Procedures.

(a) Operating and emergency procedures shall include, as a minimum, instructions in the following:

(1) Appropriate handling and use of licensed sealed sources, radiographic exposure devices, and sources of radiation so that no person is likely to be exposed to radiation doses in excess of the limits established in He‑P 4020;

(2) Methods and occasions for conducting radiation surveys;

(3) Methods for posting and controlling access to radiographic areas;

(4) Methods and occasions for locking and securing radiographic exposure devices, transport and storage containers, sealed sources, and sources of radiation;

(5) Personnel monitoring and the use of personnel monitoring equipment;

(6) Transporting sealed sources and equipment to field locations, including packing of radiographic exposure devices and storage containers in the vehicles, placarding of vehicles when required, and control of the sealed sources and equipment during transportation as required in He‑P 4037 and U.S. Department of Transportation 49 CFR Parts 171-173;

(7) The inspection, maintenance, and operability checks of radiographic exposure devices, radiation machines, survey instruments, alarming ratemeters, transport containers, and storage containers;

(8) Steps that shall be taken immediately by radiography personnel in the event a pocket dosimeter is found to be off-scale or an alarming ratemeter alarms unexpectedly;

(9) The procedure(s) for identifying and reporting defects and noncompliance, as required by He‑P 4034.38;

(10) The procedure for notifying proper persons in the event of an accident or incident;

(11) Minimizing exposure of persons in the event of an accident or incident, including a source disconnect, a transport accident, or loss of a source of radiation;

(12) Source recovery procedure if licensee will perform source recovery; and

(13) Maintenance of records.

(b) The licensee or registrant shall maintain copies of current operating and emergency procedures in accordance with He-P 4034.33 and He-P 4034.37.

Source. (See Revision Note at part heading for He-P 4034) #6942, eff 2-1-99; ss by #8800, eff 2-1-07, EXPIRED: 7-31-07

New. #8959, eff 8-7-07; ss by #10983, eff 11-24-15; amd by #12626, eff 9-26-18; ss by #12930, eff 11-26-19

He-P 4034.19 Supervision of Radiographers’ Assistants.

(a) The radiographer’s assistant shall be under the personal supervision of a radiographer when using sources of radiation, radiographic exposure devices, associated equipment, sealed sources, or conducting radiation surveys required by He‑P 4034.21(b) to determine that the sealed source has returned to the shielded position or the radiation machine is off after an exposure.

(b) The personal supervision required in He‑P 4034.19(a) shall include:

(1) The radiographer’s physical presence at the site where the sealed sources or sources of radiation are being used;

(2) The availability of the radiographer to give immediate assistance if required; and

(3) The radiographer’s direct observation of the assistant’s performance of the operations referred to in this section.

Source. (See Revision Note at part heading for He-P 4034) #6942, eff 2-1-99; ss by #8800, INTERIM, eff 2-1-07, EXPIRED: 7-31-07

New. #8959, eff 8-7-07; ss by #10983, eff 11-24-15; ss by #12626, eff 9-26-18

He-P 4034.20 Personnel Monitoring.

(a) The licensee or registrant shall not permit any individual to act as a radiographer or a radiographer’s assistant unless, at all times during radiographic operations, each individual wears, on the trunk of the body, a combination of direct reading dosimeter, an alarming ratemeter, and a personnel dosimeter that is processed and evaluated by an accredited National Voluntary Laboratory Accreditation Program (NVLAP) processor.

(b) At permanent radiography installations where alarming or warning devices are in routine use, or during radiographic operations using radiation machines, the wearing of an alarming ratemeter is not required.

(1) Have a range from zero to 2 millisieverts (200 mrem); and

(2) Be recharged at the start of each shift.

(d) Electronic personal dosimeters shall only be used in place of ion-chamber pocket dosimeters.

(e) Each personnel dosimeter shall be assigned to and worn by only one individual.

(f) Film badges shall be exchanged at periods not to exceed one month and other personnel dosimeters processed and evaluated by an accredited NVLAP processor shall be replaced at periods not to exceed three months.

(g) After replacement, each personnel dosimeter shall be processed as soon as practicable.

(h) Direct reading dosimeters, such as pocket dosimeters or electronic personal dosimeters, shall:

(1) Be read at the beginning and end of each shift;

(2) Have the exposures recorded at the beginning and end of each shift; and

(3) Be recorded in records maintained in accordance with He‑P 4034.34.

(i) Pocket dosimeters, or electronic personal dosimeters, shall be checked at periods not to exceed 12 months in order to verify that readings are within plus or minus 20 percent of the true radiation exposure.

(j) Records resulting from the check of pocket dosimeters or electronic personal dosimeters shall be maintained in accordance with He‑P 4034.34.

(k) If an individual’s pocket dosimeter is found to be off-scale, or the electronic personal dosimeter reads greater than 2 millisieverts (200 mrem) and the possibility of radiation exposure cannot be ruled out as the cause:

(1) The individual’s personnel dosimeter shall be sent for processing within 24 hours;

(2) The individual shall not resume work associated with the use of licensed material or sources of radiation until a determination of the individual’s radiation exposure has been made by the RSO or the RSO’s designee; and

(3) The results of this determination shall be included in the records maintained in accordance with He-P 4034.34.

(l) If the personnel dosimeter that is required by He-P 4034.20(a) is lost or damaged, the worker shall cease work immediately until a replacement personnel dosimeter is provided and the exposure is calculated for the time period from issuance to loss or damage of the personnel dosimeter.

(m) The results of the calculated exposure required in He‑P 4034.20(l) and the time period for which the personnel dosimeter was lost or damaged shall be included in the records maintained in accordance with He‑P 4034.34.

(n) Reports received from the accredited NVLAP personnel dosimeter processor shall be retained in accordance with He‑P 4034.34.

(o) Each alarming ratemeter shall:

(1) Be checked to ensure that the alarm functions properly before using at the start of each shift;

(2) Be set to give an alarm signal at a preset dose rate of 5 millisieverts per hour (500 mrem/hr), with an accuracy of plus or minus 20 percent of the true radiation dose rate;

(3) Require special means to change the preset alarm function;

(4) Be calibrated at periods not to exceed 12 months for correct response to radiation; and

(5) Have the records of alarm ratemeter calibrations maintained by the licensee in accordance with He‑P 4034.34.

Source. (See Revision Note at part heading for He-P 4034) #6942, eff 2-1-99; ss by #8800, INTERIM, eff 2-1-07, EXPIRED: 7-31-07

New. #8959, eff 8-7-07; ss by #10983, eff 11-24-15; ss by #12626, eff 9-26-18

He-P 4034.21 Radiation Surveys. The licensee or registrant shall:

(a) Conduct surveys with a calibrated and operable radiation survey instrument that meets the requirements of He-P 4034.09;

(b) Using a survey instrument meeting the requirements of He-P 4034.21(a), conduct a survey of the radiographic exposure device and the guide tube after each exposure when approaching the device or the guide tube. The survey shall determine that the sealed source has returned to its shielded position before exchanging films, repositioning the exposure head, or dismantling equipment;

(d) Conduct a survey of the radiographic exposure device with a calibrated radiation survey instrument whenever the source is exchanged and whenever a radiographic exposure device is placed in a storage area as defined in He-P 4034.03(ag), to ensure that the sealed source is in its shielded position; and

(e) Maintain records in accordance with He‑P 4034.35.

Source. (See Revision Note at part heading for He-P 4034) #6942, eff 2-1-99; ss by #8800, INTERIM, eff 2-1-07, EXPIRED: 7-31-07

New. #8959, eff 8-7-07; ss by #10983, eff 11-24-15; amd by #12626, eff 9-26-18

He-P 4034.22 Surveillance. During each radiographic operation the radiographer, or the other individual present, as required by He-P 4034.15, shall maintain continuous direct visual surveillance of the operation to protect against unauthorized entry into a radiation area or a high radiation area, as defined in He-P 4003.01, except at permanent radiographic installations where all entryways are locked and the requirements of He-P 4034.13 are met.

Source. (See Revision Note at part heading for He-P 4034) #6942, eff 2-1-99; ss by #8800, INTERIM, eff 2-1-07, EXPIRED: 7-31-07

New. #8959, eff 8-7-07; ss by #10983, eff 11-24-15; ss by #12626, eff 9-26-18; ss by #12930, eff 11-26-19

He-P 4034.23 Posting.

(a) All areas in which industrial radiography is being performed shall be conspicuously posted as required by He-P 4022.12.

(b) The exceptions listed in He-P 4022.13 of this chapter do not apply to industrial radiographic operations.

Source. (See Revision Note at part heading for He-P 4034) #6942, eff 2-1-99; ss by #8800, INTERIM, eff 2-1-07, EXPIRED: 7-31-07

New. #8959, eff 8-7-07; ss by #10983, eff 11-24-15; ss by #12626, eff 9-26-18

He-P 4034.24 Records for Industrial Radiography. Each licensee or registrant shall maintain a copy of its license or registration, licensed conditions, documents incorporated by reference, and amendments to each of these items, until superseded by new documents approved by DHHS/RHS, or until DHHS/RHS terminates the license or registration.

Source. (See Revision Note at part heading for He-P 4034) #6942, eff 2-1-99; ss by #8800, INTERIM, eff 2-1-07, EXPIRED: 7-31-07

New. #8959, eff 8-7-07; ss by #10983, eff 11-24-15; ss by #12626, eff 9-26-18

He-P 4034.25 Records of Receipt and Transfer of Sources of Radiation.

(a) Each licensee or registrant shall maintain records showing the receipts and transfers of sealed sources, devices using DU for shielding, and radiation machines, and retain each record for 3 years after it is made.

(b) These records shall include the date, the name of the individual making the record, radionuclide, number of becquerels (curies) or mass (for DU), and manufacturer, model, and serial number of each sealed source, source of radiation, or device, as appropriate.

Source. (See Revision Note at part heading for He-P 4034) #6942, eff 2-1-99; ss by #8800, INTERIM, eff 2-1-07, EXPIRED: 7-31-07

New. #8959, eff 8-7-07; ss by #10983, eff 11-24-15; amd by #12626, eff 9-26-18

He-P 4034.26 Records of Radiation Survey Instruments. Each licensee or registrant shall maintain records of the calibrations of its radiation survey instruments that are required under He-P 4034.09 and retain each record for 3 years after it is made.

Source. (See Revision Note at part heading for He-P 4034) #6942, eff 2-1-99; ss by #8800, INTERIM, eff 2-1-07, EXPIRED: 7-31-07

New. #8959, eff 8-7-07; ss by #10983, eff 11-24-15

He-P 4034.27 Records of Leak Testing of Sealed Sources and Devices Containing DU.

(a) Each licensee shall maintain records of leak test results for sealed sources and for devices containing DU in units of becquerels (mCi).

(b) The licensee shall retain each record for 3 years after it is made or until the source in storage is removed.

Source. (See Revision Note at part heading for He-P 4034) #6942, eff 2-1-99; ss by #8800, INTERIM, eff 2-1-07, EXPIRED: 7-31-07

New. #8959, eff 8-7-07; ss by #10983, eff 11-24-15

He-P 4034.28 Records of Quarterly Inventory.

(a) Each licensee or registrant shall maintain records of the quarterly inventory of sealed sources of radiation, including devices containing depleted uranium as required by He‑P 4034.11, and retain each record for 3 years.

(b) The record shall include the date of the inventory, name of the individual conducting the inventory, radionuclide, number of becquerels (curies) or mass (for DU) in each device, location of sources of radiation or devices, and manufacturer, model, and serial number of each sealed source of radiation and/or device, as appropriate.

Source. (See Revision Note at part heading for He-P 4034) #6942, eff 2-1-99; ss by #8800, INTERIM, eff 2-1-07, EXPIRED: 7-31-07

New. #8959, eff 8-7-07; ss by #10983, eff 11-24-15; ss by #12930, eff 11-26-19

He-P 4034.29 Utilization Logs.

(a) Each licensee or registrant shall maintain utilization logs showing for each source of radiation the following information:

(1) A description, including the make, model, and serial number of the radiation machine or the radiographic exposure device, transport, or storage container in which the sealed source is located;

(2) The identity and signature of the radiographer assigned to keep the log of the equipment or devices described in (1) above;

(3) The plant or site where used and dates of use, including the dates removed and returned to storage; and

(4) For permanent radiographic installations, the dates each radiation machine is energized.

(b) The licensee or registrant shall retain the logs required by He‑P 4034.29(a) for 3 years after the log is made.

Source. (See Revision Note at part heading for He-P 4034) #6942, eff 2-1-99; ss by #8800, INTERIM, eff 2-1-07, EXPIRED: 7-31-07

New. #8959, eff 8-7-07; ss by #10983, eff 11-24-15; ss by #12930, eff 11-26-19

He-P 4034.30 Records of Inspection and Maintenance of Radiation Machines, Radiographic Exposure Devices, Transport and Storage Containers, Associated Equipment, Source Changers, and Survey Instruments.

(a) Each licensee or registrant shall maintain records specified in He-P 4034.12 of equipment problems found in daily checks and quarterly inspections of radiation machines, radiographic exposure devices, transport and storage containers, associated equipment, source changers, and survey instruments; and retain each record for 3 years after it is made.

(b) The record shall include the date of check or inspection, name of inspector, equipment involved, any problems found, and what repair or maintenance, if any, was performed.

Source. (See Revision Note at part heading for He-P 4034) #6942, eff 2-1-99; ss by #8800, INTERIM, eff 2-1-07, EXPIRED: 7-31-07

New. #8959, eff 8-7-07; ss by #10983, eff 11-24-15

He‑P 4034.31 Records of Alarm System and Entrance Control Checks at Permanent Radiographic Installations. Each licensee or registrant shall maintain records of alarm system and entrance control device tests required by He-P 4034.13 and retain each record for 3 years after it is made.

Source. (See Revision Note at part heading for He-P 4034) #6942, eff 2-1-99; ss by #8800, INTERIM, eff 2-1-07, EXPIRED: 7-31-07

New. #8959, eff 8-7-07; ss by #10983, eff 11-24-15

He‑P 4034.32 Records of Training and Certification. Each licensee or registrant shall maintain the following records for each radiographer and each radiographer’s assistant for 3 years after the record is made:

(a) Records of training to include radiographer certification documents and verification of certification status, copies of written tests, dates of oral and practical examinations, and names of individuals conducting and receiving the oral and practical examinations;

(b) Records of annual refresher safety training to include a list the topics discussed during the refresher safety training, the dates the annual refresher safety training was conducted, and the names of the instructors and attendees; and

(c) Records of semi-annual inspections of job performance to include a list showing the items checked and any non-compliance observed by the RSO.

Source. (See Revision Note at part heading for He-P 4034) #6942, eff 2-1-99; ss by #8800, INTERIM, eff 2-1-07, EXPIRED: 7-31-07

New. #8959, eff 8-7-07; ss by #10983, eff 11-24-15; amd by #12930, eff 11-26-19

He-P 4034.33 Copies of Operating and Emergency Procedures.

(a) Each licensee or registrant shall maintain a copy of current operating and emergency procedures until DHHS/RHS terminates the license or registration.

(b) Superseded material in the operating and emergency procedures shall be retained for 3 years after the change is made.

Source. (See Revision Note at part heading for He-P 4034) #6942, eff 2-1-99; ss by #8800, INTERIM, eff 2-1-07, EXPIRED: 7-31-07

New. #8959, eff 8-7-07; ss by #10983, eff 11-24-15

He-P 4034.34 Records of Personnel Monitoring. Each licensee or registrant shall maintain the following exposure records specified in He-P 4034.20:

(a) Direct reading dosimeter readings and yearly operability checks required by He‑P 4034.20(i) and (j) for 3 years after the record is made;

(b) Records of alarming ratemeter calibrations for 3 years after the record is made;

(c) Reports received from the film badge, TLD, or OSL processor until DHHS/RHS terminates the license or registration; and

(d) Records of estimates of exposures as a result of off-scale personal direct reading dosimeters, or lost or damaged film badges, TLDs, or OSLs, until DHHS/RHS terminates the license or registration.

Source. (See Revision Note at part heading for He-P 4034) #6942, eff 2-1-99; ss by #8800, INTERIM, eff 2-1-07, EXPIRED: 7-31-07

New. #8959, eff 8-7-07; ss by #10983, eff 11-24-15

He-P 4034.35 Records of Radiation Surveys.

(a) Each licensee shall maintain a record of each exposure device survey conducted before the device is placed in storage as specified in He-P 4034.21(d).

(b) Each record shall be maintained for 3 years after it is made.

Source. (See Revision Note at part heading for He-P 4034) #6942, eff 2-1-99; ss by #8800, INTERIM, eff 2-1-07, EXPIRED: 7-31-07

New. #8959, eff 8-7-07; ss by #10983, eff 11-24-15; amd by #12930, eff 11-26-19

He-P 4034.36 Form of Records.

(a) Each record required by He-P 4034 shall be legible throughout the specified retention period.

(b) The record shall be the original or a reproduced copy or a microform provided that the copy or microform is authenticated by an individual authorized by the registrant or licensee and that the microform is capable of reproducing a clear copy throughout the required retention period.

(c) The record shall also be stored in electronic media with the capability for producing legible, accurate, and complete records during the required retention period, if electronic media is available.

(d) Records, such as letters, drawings, and specifications, shall include information, such as stamps, initials, and signatures.

(e) The licensee or registrant shall maintain safeguards against tampering with and loss of records.

Source. (See Revision Note at part heading for He-P 4034) #6942, eff 2-1-99; ss by #8800, INTERIM, eff 2-1-07, EXPIRED: 7-31-07

New. #8959, eff 8-7-07; ss by #10983, eff 11-24-15

He-P 4034.37 Location of Documents and Records.

(a) Each licensee or registrant shall maintain copies of records required by He‑P 4034 and other applicable parts of these rules at the location specified in He‑P 4034.05(l).

(b) Each licensee or registrant shall also maintain copies of the following documents and records sufficient to demonstrate compliance at each applicable field station and each temporary job site:

(1) The license or registration authorizing the use of sources of radiation;

(2) A copy of He-P 4003, He-P 4019 through He-P 4023, and He-P 4034;

(3) Utilization records for each radiographic exposure device dispatched from that location as required by He-P 4034.29;

(4) Records of equipment problems identified in daily checks of equipment as required by He‑P 4034.30(a);

(5) Records of alarm system and entrance control checks required by He‑P 4034.31, if applicable;

(6) Records of direct reading dosimeter and/or electronic personal dosimeters readings as required by He-P 4034.34;

(7) Operating and emergency procedures required by He-P 4034.33;

(8) Evidence of the latest calibration of the radiation survey instruments in use at the site, as required by He-P 4034.26;

(9) Evidence of the latest calibrations of alarming ratemeters and operability checks of pocket dosimeters and/or electronic personal dosimeters as required by He-P 4034.34;

(10) Survey records as required by He-P 4034.35 and He-P 4021.03 as applicable, for the period of operation at the site;

(11) The shipping papers for the transportation of radioactive materials required by He‑P 4037; and

(12) When operating under reciprocity pursuant to He-P 4030.18, a copy of the Agreement State license or registration, or NRC license authorizing the use of licensed materials or sources of radiation.

Source. (See Revision Note at part heading for He-P 4034) #6942, eff 2-1-99; ss by #8800, INTERIM, eff 2-1-07, EXPIRED: 7-31-07

New. #8959, eff 8-7-07; ss by #10983, eff 11-24-15; ss by #12930, eff 11-26-19

He-P 4034.38 Notifications.

(a) In addition to the reporting requirements specified in He-P 4021 and He-P 4030.10(j) through (m), each licensee or registrant shall provide a written report to DHHS/RHS within 30 days of the occurrence of any of the following incidents involving radiographic equipment:

(1) Unintentional disconnection of the source assembly from the control cable;

(2) Inability to retract the source assembly to its fully shielded position and secure it in this position;

(3) Failure of any component, which is critical to safe operation of the device, to properly perform its intended function;

(4) Failure of an indicator on a radiation machine to show that radiation is being produced;

(5) Failure of an exposure switch to terminate production of radiation when switched to the off position; or

(6) Failure of a safety interlock to terminate x-ray production.

(b) The licensee or registrant shall include the following information in each report submitted under He-P 4034.38(a), and in each report of overexposure submitted under He-P 4021.14 which involves failure of safety components of radiography equipment:

(1) Description of the equipment problem;

(2) Cause of each incident, if known;

(3) Name of the manufacturer and model number of equipment involved in the incident;

(4) Place, date, and time of the incident;

(5) Actions taken to establish normal operations;

(6) Corrective actions taken or planned to prevent recurrence; and

(7) Names and qualifications of personnel involved in the incident.

(c) Any licensee or registrant conducting radiographic operations or storing sources of radiation at any location not listed on the license or registration for a period in excess of 180 days in a calendar year, shall notify DHHS/RHS prior to exceeding the 180 days.

Source. (See Revision Note at part heading for He-P 4034) #6942, eff 2-1-99; ss by #8800, INTERIM, eff 2-1-07, EXPIRED: 7-31-07

New. #8959, eff 8-7-07; ss by #10983, eff 11-24-15; amd by #12930, eff 11-26-19

He-P 4034.39 Specific Requirements for Radiographic Personnel Performing Industrial Radiography.

(a) At a job site, the following shall be supplied by the licensee or registrant:

(1) At least one operable, calibrated survey instrument for each exposure device or radiation machine in use;

(2) A current whole body individual monitoring device such as: film badge, TLD, or OSL for each worker;

(3) An operable, calibrated pocket dosimeter with a range of zero to 200 milliroentgens for each worker;

(4) An operable, calibrated, alarming ratemeter for each worker; and

(5) The appropriate barrier ropes and caution signs.

(b) Each radiographer at a job site shall have on their person a valid certification ID card issued by a certifying entity.

(c) Industrial radiographic operations shall not be performed if any of the items in He‑P 4034.39(a) are not available at the job site or are inoperable.

(d) During an inspection, DHHS/RHS shall terminate an operation if any of the items in He‑P 4034.39(a) are not available or operable, or if the required number of radiographic personnel is not present.

(e) Operations terminated under the conditions of He‑P 4034.39(d) shall not be resumed until all required conditions are met.

Source. (See Revision Note at part heading for He-P 4034) #6942, eff 2-1-99; ss by #8800, INTERIM, eff 2-1-07, EXPIRED: 7-31-07

New. #8959, eff 8-7-07; ss by #10983, eff 11-24-15

PART He-P 4035 USE OF RADIONUCLIDES IN THE HEALING ARTS

Revision Note:

He-P 4035.01 Purpose. This part shall establish requirements and provisions for the medical production, preparation, compounding, and use of byproduct material in the healing arts and for issuance of licenses authorizing the medical use of this material which provide for the radiation safety of workers, the general public, patients, and human research subjects.

Source. (See Revision Note at part heading for He-P 4035) #6942, eff 2-1-99; ss by #8800, INTERIM, eff 2-1-07, EXPIRED: 7-31-07

New. #8959, eff 8-7-07; ss by #10897, INTERIM, eff
7-22-15, EXPIRES: 1-18-16; ss by #11011, eff 1-15-16; ss by #13473, eff 10-25-22

He-P 4035.02 Scope.

(a) The requirements and provisions of this part shall be in addition to, and not in substitution for, other parts in this chapter.

(b) The requirements and provisions of He‑P 4019 through He‑P 4023, He‑P 4030, He‑P 4037, He-P 4038, He‑P 4070, and He-P 4071 apply to applicants and licensees subject to He‑P 4035 unless specifically exempted.

Source. (See Revision Note at part heading for He-P 4035) #6942, eff 2-1-99; ss by #8800, INTERIM, eff 2-1-07, EXPIRED: 7-31-07

New. #8959, eff 8-7-07; ss by #10897, INTERIM, eff
7-22-15, EXPIRES: 1-18-16; ss by #11011, eff 1-15-16; ss by #13048, eff 6-2-20; ss by #13473, eff 10-25-22

He-P 4035.03 Definitions.

(a) “Address of use” means the building or buildings that are identified on the license and where byproduct material may be prepared, received, used, or stored.

(b) “Area of use” means a portion of an address of use that has been set aside for the purpose of preparing, receiving, using, or storing byproduct material.

(1) Meets the requirements in He-P 4035.61 and He-P 4035.73; and

(2) Is currently identified as an associate radiation safety officer for the types of use of byproduct material for which the individual has been assigned duties and tasks by the radiation safety officer on:

a. A specific medical use license issued by DHHS/RHS, an agreement state, or the Nuclear Regulatory Commission; or

b. A medical use permit issued by a Nuclear Regulatory Commission master material licensee.

(d) “Authorized medical physicist” means an individual who:

(1) Meets the requirements in He-P 4035.70 and He-P 4035.73; or

(2) Is identified as an authorized medical physicist or teletherapy physicist on:

a. A specific medical use license issued by DHHS/RHS, or an agreement state, or the Nuclear Regulatory Commission;

b. A medical use permit issued by a Nuclear Regulatory Commission master material licensee;

c. A permit issued by DHHS/RHS, or an agreement state, or the Nuclear Regulatory Commission broad scope medical use licensee; or

d. A permit issued by a Nuclear Regulatory Commission master license broad scope medical use permittee.

(e) “Authorized nuclear pharmacist” means a person who is a “licensed pharmacist” as defined in RSA 318:1, VII, and who:

(1) Meets the requirements in He-P 4035.73, He-P 4035.74(a), and NH pharmacy board administrative rule Ph 405.03;

(2) Is identified as an authorized nuclear pharmacist on:

a. A specific license issued by DHHS/RHS, or an agreement state, or the Nuclear Regulatory Commission that authorizes medical use, or the practice of nuclear pharmacy;

b. A permit issued by a Nuclear Regulatory Commission master material licensee that authorizes medical use or the practice of nuclear pharmacy;

c. A permit issued by DHHS/RHS, or an agreement state, or the Nuclear Regulatory Commission broad scope medical use licensee that authorizes medical use or the practice of nuclear pharmacy; or

d. A permit issued by a Nuclear Regulatory Commission master material license broad scope medical use permittee that authorizes medical use or the practice of nuclear pharmacy; or

(3) Is identified as an authorized nuclear pharmacist by a commercial nuclear pharmacy that has been authorized to identify authorized nuclear pharmacists; or

(4) Is designated as an authorized nuclear pharmacist in accordance with He-P 4032.05(b)(2), or by an equivalent agreement state regulation, or by the Nuclear Regulatory Commission pursuant to 10 CFR 32.72(b)(4).

(f) “Authorized user” means a physician, dentist, or podiatrist who:

(1) Meets the applicable requirements for an authorized user as listed in in He-P 4035.59, He-P 4035.63, He-P 4035.64, He-P 4035.65, He-P 4035.66, He-P 4035.68, or He-P 4035.69, and He-P 4035.73, or

(2) Is identified as an authorized user on:

a. A DHHS/RHS, or an agreement state, or Nuclear Regulatory Commission license that authorizes the medical use of byproduct material;

b. A permit issued by a Nuclear Regulatory Commission master material licensee that is authorized to permit the medical use of byproduct material;

c. A permit issued by DHHS/RHS, or an agreement state, or a Nuclear Regulatory Commission specific licensee of broad scope that is authorized to permit the medical use of byproduct material; or

d. A permit issued by a Nuclear Regulatory Commission master material license broad scope permittee that is authorized to permit the medical use of byproduct material.

(g) “Brachytherapy” means a method of radiation therapy in which sources are utilized to deliver a radiation dose at a distance of up to a few centimeters by surface, intracavitary, intraluminal, or interstitial application.

(h) “Brachytherapy source” means a radioactive source, or a manufacturer-assembled source train, or a combination of these sources that is designed to deliver a therapeutic dose within a distance of a few centimeters.

(i) “Client’s address” means the area of use or a temporary job site for the purpose of providing mobile medical service in accordance with He-P 4035.26.

(j) “Dedicated check source” means a radioactive source that is used to assure the constant operation of a radiation detection or measurement device over several months or years.

(k) “Dentist” means an individual licensed to practice dentistry in New Hampshire, another state or territory of the United States, the District of Columbia, or the Commonwealth of Puerto Rico.

(l) “High dose-rate remote afterloader” (HDR) means a brachytherapy device that remotely delivers a dose rate in excess of 12 gray (1200 rads) per hour at the point or surface where the dose is prescribed.

(m) “Low dose-rate remote afterloader” (LDR) means a brachytherapy device that remotely delivers a dose rate of less than or equal to 2 gray (200 rads) per hour at the point or surface where the dose is prescribed.

(n) “Management” means the chief executive officer, or other individual having the authority to manage, direct, or administer the licensee’s activities, or those persons’ delegate or delegates.

(o) “Manual brachytherapy” means a type of brachytherapy in which the brachytherapy sources (e.g., seeds, ribbons) are manually placed topically on or inserted either into the body cavities that are in close proximity to a treatment site or implanted directly into the tissue volume.

(p) “Medical event” means an event that meets the criteria in He-P 4035.14(a) or (b).

(q) “Medical institution” means an organization in which more than one medical discipline is practiced.

(r) “Medical use” means the intentional internal or external administration of byproduct material or the radiation from byproduct material to patients or human research subjects under the supervision of an authorized user.

(s) “Medium dose-rate remote afterloader” (MDR) means a brachytherapy device that remotely delivers a dose rate of greater than 2 gray (200 rads) per hour, but less than or equal to 12 gray (1200 rads) per hour at the point or surface where the dose is prescribed.

(t) “Mobile medical service” means the transportation of byproduct material to, and its medical use at, the client’s address.

(u) “Ophthalmic physicist” means an individual who:

(1) Meets the requirements in He-P 4035.32(f)(2) and He-P 4035.73; and

(2) Is identified as an ophthalmic physicist on a:

a. Specific medical use license issued by DHHS/RHS, an agreement state, or the Nuclear Regulatory Commission;

b. Permit issued by DHHS/RHS, an agreement state, or a Nuclear Regulatory Commission broad scope medical use licensee;

c. Medical use permit issued by a Nuclear Regulatory Commission master material licensee; or

d. Permit issued by a Nuclear Regulatory Commission master material licensee broad scope medical use permittee.

(v) “Output” means the exposure rate, dose rate, or a quantity related in a known manner to these rates from a brachytherapy source, teletherapy unit, remote afterloader, or gamma stereotactic radiosurgery unit for a specified set of exposure conditions.

(w) “Patient intervention” means actions by the patient or human research subject, whether intentional or unintentional, such as dislodging or removing treatment devices or prematurely terminating the administration.

(x) “Podiatrist” means an individual licensed to practice podiatry in New Hampshire, another state or territory of the United States, the District of Columbia, or the Commonwealth of Puerto Rico.

(y) “Positron emission tomography (PET) radionuclide production facility” means a facility operating a cyclotron or accelerator for the purpose of producing PET radionuclides.

(z) “Preceptor” means an individual who provides, directs, or verifies training and experience required for an individual to become an authorized user, an authorized medical physicist, an authorized nuclear pharmacist, a radiation safety officer, or an associate radiation safety officer.

(aa) “Prescribed dosage” means the specific activity or range of activity of unsealed byproduct material as documented:

(1) In a written directive; or

(2) In accordance with the directions of the authorized user for procedures pursuant to He-P 4035.27 and He-P 4035.31.

(ab) “Prescribed dose” means:

(1) For gamma stereotactic radiosurgery, the total dose as documented in the written directive;

(2) For teletherapy, the total dose and dose per fraction as documented in the written directive;

(3) For manual brachytherapy, either the total source strength and exposure time or the total dose, as documented in the written directive; or

(4) For remote brachytherapy afterloaders, the total dose and dose per fraction as documented in the written directive.

(ac) “Pulsed dose-rate remote afterloader” means a special type of remote afterloading brachytherapy device that uses a single source capable of delivering dose rates in the “high dose-rate” range, but:

(1) Is approximately one-tenth of the activity of typical high dose-rate remote afterloader sources; and

(2) Is used to simulate the radiobiology of a low dose-rate treatment by inserting the source for a given fraction of each hour.

(ad) “Radiation Safety Officer” means an individual who:

(1) Meets the requirements in He-P 4035.61(a) or (c) and He-P 4035.73; or

(2) Is identified as a radiation safety officer on a specific medical use license issued by DHHS/RHS, or an agreement state, or the Nuclear Regulatory Commission, or a medical use permit issued by a Nuclear Regulatory Commission master material licensee.

(ae) “Stereotactic radiosurgery” means the use of external radiation in conjunction with a stereotactic guidance device to very precisely deliver a therapeutic dose to a tissue volume.

(af) “Structured educational program” means an educational program designed to impart particular knowledge and practical education through interrelated studies and supervised training.

(ag) “Teletherapy” means a method of radiation therapy in which collimated gamma rays are delivered at a distance from the patient or human research subject.

(ah) “Temporary job site” means a location where mobile medical services are conducted other than those location(s) of use authorized on the license.

(ai) “Therapeutic dosage” means a dosage of unsealed byproduct material that is intended to deliver a radiation dose to a patient or human research subject for palliative or curative treatment.

(aj) “Therapeutic dose” means a radiation dose delivered from a source containing byproduct material to a patient or human research subject for palliative or curative treatment.

(ak) “Treatment site” means the anatomical description of the tissue intended to receive a radiation dose, as described in a written directive.

(al) “Unit dosage” means a dosage prepared for medical use for administration as a single dosage to a patient or human research subject without any further manipulation of the dosage after it is initially prepared.

(am) “Written directive” means an authorized user’s written order for the administration of byproduct material or radiation from byproduct material to a specific patient or human research subject, as specified in He-P 4035.13.

Source. (See Revision Note at part heading for He-P 4035) #6942, eff 2-1-99; ss by #8800, INTERIM, eff 2-1-07, EXPIRED: 7-31-07

New. #8959, eff 8-7-07; ss by #10897, INTERIM, eff 7-22-15, EXPIRES: 1-18-16; ss by #11011, eff 1-15-16; ss by #13048, eff 6-2-20; ss by #13473, eff 10-25-22

He-P 4035.04 License Required.

(a) No person shall manufacture, produce, prepare, compound, acquire, receive, possess, use, or transfer byproduct material for medical use except in accordance with a specific license issued by DHHS/RHS, or an agreement state, or the Nuclear Regulatory Commission, or as allowed in He-P 4035.04(b) or (c).

(b) A person shall receive, possess, use, or transfer byproduct material in accordance with He-P 4035 under the supervision of an authorized user as provided in He‑P 4035.11 unless prohibited by license condition.

(c) A person shall prepare unsealed byproduct material for medical use in accordance with He‑P 4035 under the supervision of an authorized nuclear pharmacist, or authorized user as provided in He‑P 4035.11, unless prohibited by license condition.

(d) A person shall conduct research involving human subjects using byproduct materials specified on a license for the uses authorized on the license provided that:

(1) The research is conducted, funded, supported, or regulated by a federal agency which has implemented the Federal Policy for the Protection of Human Subjects and in accordance with He-P 4035.04(d)(2)b.; or

(2) The licensee has:

a. Applied for and received approval of a specific amendment to its license prior to conducting such research; and

b. Obtained informed consent from the human subjects and has obtained prior review and approval of the research activities by an “Institutional Review Board” in accordance with the meaning of these terms as defined and described in the Federal Policy for the Protection of Human Subjects.

(e) Nothing in He-P 4035.04(d) relieves licensees from complying with other requirements in He-P 4035.

Source. (See Revision Note at part heading for He-P 4035) #6942, eff 2-1-99; ss by #8800, INTERIM, eff 2-1-07, EXPIRED: 7-31-07

New. #8959, eff 8-7-07; ss by #10897, INTERIM, eff 7-22-15, EXPIRES: 1-18-16; ss by #11011, eff 1-15-16; ss by #13048, eff 6-2-20; ss by #13473, eff 10-25-22

He-P 4035.05 License Amendments. A licensee possessing a license in accordance with He-P 4030 shall receive a license amendment before:

(a) Receiving, preparing, or using byproduct material for a method or type of medical use not permitted by the license issued under He-P 4035;

(b) Permitting anyone to work as an authorized user, an authorized nuclear pharmacist, or an authorized medical physicist, under the license;

(d) Permitting an authorized user or an individual qualified to be a radiation safety officer under He-P 4035.61 and He-P 4035.73 to:

(1) Function as a temporary radiation safety officer; and

(2) Perform the functions of a radiation safety officer in accordance with He-P 4035.10(d);

(e) Permitting an authorized user or an individual qualified to be an associate radiation safety officer, or before the radiation safety officer assigns duties and tasks to an associate radiation safety officer that differ from those for which this individual is authorized on the license;

(f) Receiving byproduct material that is in excess of the licensed amount of radionuclide, or a different form, or a different radionuclide than is authorized on the license;

(g) Receiving a sealed source from a different manufacturer or of a different model number than authorized by its license unless the sealed source is used for manual brachytherapy, is listed in the sealed source and device registry, and is in a quantity and for an isotope authorized by the license;

(h) Adding to or changing the areas of use or address or addresses of use identified in the application or on the license;

(i) Changing statements, representations, and procedures which are incorporated into the license;

(j) Revising procedures required by He-P 4035.50 and He-P 4035.55, if those revisions reduce radiation safety.

Source. (See Revision Note at part heading for He-P 4035) #6942, eff 2-1-99; ss by #8800, INTERIM, eff 2-1-07, EXPIRED: 7-31-07

New. #8959, eff 8-7-07; ss by #10897, INTERIM, eff 7-22-15, EXPIRES: 1-18-16; ss by #11011, eff 1-15-16; ss by #11011, eff 1-15-16; ss by #13048, eff 6-2-20; ss by #13473, eff 10-25-22

He-P 4035.06. Notifications. A licensee shall notify the DHHS/RHS in writing within 30 days when an authorized user, an authorized nuclear pharmacist, a radiation safety officer, an associate radiation safety officer, an authorized medical physicist, or ophthalmic physicist permanently discontinues performance of duties under the license, or has a name change, has appointed a temporary radiation safety officer as provided in He-P 4035.10(d), or has appointed an associate radiation safety officer as provided in He-P 4035.10(c).

Source. (See Revision Note at part heading for He-P 4035) #6942, eff 2-1-99; ss by #8800, INTERIM, eff 2-1-07, EXPIRED: 7-31-07

New. #8959, eff 8-7-07; ss by #10897, INTERIM, eff
7-22-15, EXPIRES: 1-18-16; ss by #11011, eff 1-15-16; ss by #13048, eff 6-2-20; ss by #13473, eff 10-25-22

He-P 4035.07 Radiation Protection Program Changes.

Radiation protection program requirements shall be as follows:

(a) A licensee shall revise its radiation protection program without DHHS/RHS approval if:

(1) The revision does not require a license amendment;

(2) The revision is in compliance with the rules and the license;

(3) The revision has been reviewed and approved by the radiation safety officer and licensee management;

(4) The affected individuals are instructed on the revised program before the changes are implemented; and

(b) A licensee shall retain a record of each radiation protection program change for 5 years. The record shall include:

(1) A copy of the old and new procedures;

(2) The effective date of the change; and

(3) The signature of the licensee management that reviewed and approved the change.

Source. (See Revision Note at part heading for He-P 4035) #6942, eff 2-1-99; ss by #8800, INTERIM, eff 2-1-07, EXPIRED: 7-31-07

New. #8959, eff 8-7-07; ss by #10897, INTERIM, eff
7-22-15, EXPIRES: 1-18-16; ss by #11011, eff 1-15-16; ss by #13048, eff 6-2-20; ss by #13473, eff 10-25-22

He-P 4035.08 Radiation Safety Officer.

(a) A licensee shall appoint a radiation safety officer who agrees in writing, and with the approval of DHHS/RHS, to be responsible for implementing the radiation protection program.

(b) The licensee, through the radiation safety officer, shall ensure that radiation safety activities are being performed in accordance with approved procedures and regulatory requirements in the daily operation of the licensee’s byproduct material program. A licensee’s management may appoint, in writing, one or more associate radiation safety officers to support the radiation safety officer.

(c) With written agreement of the licensee’s management, the radiation safety officer shall assign the specific duties and tasks to each associate radiation safety officer in accordance with He-P 4035.10(c). These duties and tasks are restricted to the types of use for which the associated radiation safety officer is listed on a license. The radiation safety officer shall not delegate the authority or responsibilities for implementing the radiation protection program.

Source. (See Revision Note at part heading for He-P 4035) #6942, eff 2-1-99; ss by #8800, INTERIM, eff 2-1-07, EXPIRED: 7-31-07

New. #8959, eff 8-7-07; ss by #10897, INTERIM, eff
7-22-15, EXPIRES: 1-18-16; ss by #11011, eff 1-15-16; ss by #11011, eff 1-15-16; ss by #13048, eff 6-2-20; ss by #13473, eff 10-25-22

He-P 4035.09 Radiation Safety Committee.

(a) Licensees that are authorized for two or more different types of uses of byproduct material or two or more types of units of photon emitting remote afterloader, teletherapy, and gamma stereotactic radiosurgery shall establish a radiation safety committee to oversee the uses of byproduct material permitted by the license.

(b) The radiation safety committee required in He-P 4035.09(a) above shall meet the following administrative requirements:

(1) Membership shall consist of at least four individuals, as follows:

a. An authorized user of each type of use permitted by the license;

b. The radiation safety officer;

c. A representative of the nursing service;

d. A representative of management who is neither an authorized user nor a radiation safety officer; and

e. Other members may be included on the radiation safety committee as the licensee deems appropriate;

Source. (See Revision Note at part heading for He-P 4035) #6942, eff 2-1-99; ss by #8800, INTERIM, eff 2-1-07, EXPIRED: 7-31-07

New. #8959, eff 8-7-07; ss by #10897, INTERIM, eff
7-22-15, EXPIRES: 1-18-16; ss by #11011, eff 1-15-16; ss by #13048, eff 6-2-20; ss by #13473, eff 10-25-22

He-P 4035.10 Statement of Authorities and Responsibilities.

(a) In addition to the radiation protection program requirements of He-P 4020.04, a licensee's management shall approve in writing as set forth in He-P 4030.01(c) the following:

(1) Requests for a license application, renewal, or amendment before submittal to DHHS/RHS;

(2) Any individual before allowing that individual to work as an authorized user, authorized nuclear pharmacist, or authorized medical physicist; and

(3) Radiation protection program changes that do not require a license amendment and are permitted under He-P 4035.07.

(b) A licensee's management shall appoint a radiation safety officer, who agrees, in writing, to be responsible for implementing the radiation protection program. The licensee, through the radiation safety officer, shall ensure that radiation safety activities are being performed in accordance with licensee-approved procedures and regulatory requirements.

(c) A licensee’s management may appoint, in writing, one or more associate radiation safety officers to support the radiation safety officer. The radiation safety officer, with written agreement of the licensee’s management, shall assign the specific duties and tasks to each associate radiation safety officer. These duties and tasks are restricted to the types of use for which the associate radiation safety officer is listed on a license. The radiation safety officer may delegate duties and tasks to the associate radiation safety officer but shall not delegate the authority or responsibilities for implementing the radiation protection program.

(d) For up to 60 days each year, a licensee may permit an authorized user, who may be temporarily appointed as a radiation safety officer, or an individual qualified to be a radiation safety officer under He-P 4035.61 and He-P 4035.71, to function as a temporary radiation safety officer and to perform the functions of a radiation safety officer, as provided in He-P 4035.10(g), if the licensee takes the actions required in He-P 4035.10(b), (c), (f), (g) and (h) and notifies DHHS/RHS in accordance with He-P 4035.05(d).

(e) A licensee may simultaneously appoint more than one temporary radiation safety officer in accordance with He-P 4035.10(d), if needed, to ensure that the licensee has a temporary radiation safety officer who satisfies the requirements to be a radiation safety officer for each of the different types of uses of byproduct material permitted by the license.

(f) A licensee shall establish the authority, duties, and responsibilities of the radiation safety officer in writing.

(g) A licensee shall provide the radiation safety officer sufficient authority, organizational freedom, time, resources, and management prerogative; to:

(1) Identify radiation safety problems;

(2) Initiate, recommend, or provide corrective actions;

(3) Stop unsafe operations; and

(4) Verify implementation of corrective actions.

(h) A licensee shall retain a record of actions taken under He-P 4035.10(a), He-P 4035.10(b), He-P 4035.10(c), and He-P 4035.10(e). A license shall retain a record of actions for 5 years. The record, signed by the licensee management shall include:

(1) A summary of the actions taken and a signature of licensee management. The licensee shall retain a copy of authority, duties, and responsibilities of the radiation safety officer as required by He-P 4035.10(e);

(2) A signed copy of each radiation safety officer’s agreement to be responsible for implementing the radiation safety program, as required by He-P 4035.10(b) and (c), for the duration of the license; and

(3) For each associate radiation safety officer appointed under He-P 4035.10(b) and (c), the licensee shall retain, for 5 years after the associate radiation safety officer is removed from the license, a copy of the written document appointing the associate radiation safety officer signed by the licensee’s management.

Source. (See Revision Note at part heading for He-P 4035) #6942, eff 2-1-99; ss by #8800, INTERIM, eff 2-1-07, EXPIRED: 7-31-07

New. #8959, eff 8-7-07; ss by #10897, INTERIM, eff
7-22-15, EXPIRES: 1-18-16; ss by #11011, eff 1-15-16; ss by #13048, eff 6-2-20; ss by #13473, eff 10-25-22

He-P 4035.11 Supervision.

(a) A licensee who permits the receipt, possession, use, or transfer of byproduct material by an individual under the supervision of an authorized user as allowed by He-P 4035.04(b) shall:

(1) In addition to the requirements in He-P 4019.04, instruct the supervised individual in licensee’s written radiation protection procedures, written directive procedures, He-P 4035, and the license conditions with respect to the use of byproduct material; and

(2) Require the supervised individual to follow the instructions of the supervising authorized user for medical uses of byproduct material, written radiation protection procedures established by the licensee, written directive procedures, He-P 4035, and the license conditions with respect to the medical use of byproduct material.

(b) A licensee that permits the preparation of byproduct material for medical use by an individual under the supervision of an authorized nuclear pharmacist, or physician who is an authorized user, as allowed by He-P 4035.04(c), shall:

(1) In addition to the requirements in He-P 4019.04, instruct the supervised individual in the preparation of byproduct material for medical use, as appropriate to that individual’s involvement with byproduct material; and

(2) Require the supervised individual to follow the instructions of the supervising authorized user or authorized nuclear pharmacist regarding the preparation of byproduct material for medical use, the written radiation protection procedures established by the licensee, the written directive procedures, the applicable sections of He-P 4035, and the license conditions.

(c) A licensee that permits supervised activities under He-P 4035.04(a) and (b) shall be responsible for the acts and omissions of the supervised individual.

Source. (See Revision Note at part heading for He-P 4035) #6942, eff 2-1-99; ss by #8800, INTERIM, eff 2-1-07, EXPIRED: 7-31-07

New. #8959, eff 8-7-07; ss by #10897, INTERIM, eff
7-22-15, EXPIRES: 1-18-16; ss by #11011, eff 1-15-16; ss by #13048, eff 6-2-20; ss by #13473, eff 10-25-22

He-P 4035.12 Mobile Medical Service Administrative Requirements.

(a) DHHS/RHS shall license mobile medical services and/or clients of such services, limited to the following services:

(1) Uptake, dilution and excretion;

(2) Imaging and localization;

(3) Sealed sources in diagnosis; and

(4) Certain in-vitro clinical or laboratory testing.

(b) The client of the mobile medical service shall be licensed by DHHS/RHS if the client receives or possesses byproduct material to be used by a mobile medical service.

(c) Mobile medical service licensees shall obtain a letter signed by the management of each client for which services are rendered that permits the use of byproduct material at the client’s address and clearly delineates the authority and responsibility of the licensee and the client. Each letter shall be retained 3 years after the last provision of service.

(d) If the client is licensed, the letter shall document procedures for notification, receipt, storage and documentation of transfer of byproduct material delivered to the client’s location for use by the mobile medical service.

(e) A mobile medical service shall not have byproduct material delivered directly from the manufacturer or the distributor to the client’s address of use, unless the client has a license to receive and possess that byproduct material.

(f) Byproduct material delivered to the client’s address of use shall be received and handled in conformance with the client’s license. The mobile medical service shall:

(1) Check instruments used to measure the activity of unsealed byproduct material for proper function before medical use at each client's address or on each day of use, whichever is more frequent. At a minimum, the check for proper function shall include a constancy check;

(2) Check survey instruments for proper operation with a dedicated check source before use at each client's address; and

(3) Before leaving a client's address, survey all areas of use to ensure compliance with the requirements in He-P 4022.

(g) A mobile medical service shall inform a responsible individual, such as a representative of management, a registered nurse in charge of the patient, or the registered nurse in charge of the nursing unit, who is on site at each client’s address of use at the time that radiopharmaceuticals are being administered.

Source. (See Revision Note at part heading for He-P 4035) #6942, eff 2-1-99; ss by #8800, INTERIM, eff 2-1-07, EXPIRED: 7-31-07

New. #8959, eff 8-7-07; ss by #10897, INTERIM, eff
7-22-15, EXPIRES: 1-18-16; ss by #11011, eff 1-15-16; ss by #11011, eff 1-15-16; ss by #13048, eff 6-2-20; ss by #13473, eff 10-25-22

He-P 4035.13 Written Directives and Procedures for Administrations Requiring a Written Directive.

(a) A written directive shall be dated and signed by an authorized user before the administration of I-131 sodium iodide greater than 1.11 megabecquerels (MBq) (30 microcuries (µCi)), any therapeutic dosage of unsealed byproduct material, or any therapeutic dose of radiation from byproduct material.

(b) If, because of the emergent nature of the patient’s condition, a delay in order to provide a written directive would jeopardize the patient’s health, an oral directive is acceptable. The information contained in the oral directive shall be documented as soon as possible, in writing, in the patient’s record. A written directive shall be prepared within 48 hours of the oral directive.

(1) For any administration of quantities greater than 1.11 megabecquerel (30 microcuries) of sodium iodide I-131: the dosage;

(2) For an administration of a therapeutic dosage of unsealed byproduct material other than sodium iodide I-131: the radioactive drug, dosage, and route of administration;

(3) For gamma stereotactic radiosurgery: the total dose, treatment site, and values for the target coordinate settings per treatment for each anatomically distinct treatment site;

(4) For teletherapy: the total dose, dose per fraction, number of fractions, and treatment site;

(5) For high dose-rate remote afterloading brachytherapy: the radionuclide, treatment site, dose per fraction, number of fractions, and total dose;

(6) For permanent implant brachytherapy:

a. Before implantation: treatment site, the radionuclide, and the total source strength; and

b. After implantation but before the patient leaves the post-treatment recovery area: the treatment site, the number of sources implanted, the total source strength, and the date; or

(7) For all other brachytherapy, including low, medium, and pulsed dose rate remote afterloaders:

a. Before implantation: the treatment site, the radionuclide, and dose; and

b. After implantation but before completion of the procedure: the radionuclide, treatment site, number of sources, and total source strength and exposure time (or the total dose).

(d) A written revision to an existing written directive may be made if the revision is dated and signed by an authorized user before the administration of the dosage of unsealed byproduct material, the brachytherapy dose, the gamma stereotactic radiosurgery dose, the teletherapy dose, or the next fractional dose.

(e) If, because of the patient’s condition, a delay in order to provide a written revision to an existing written directive would jeopardize the patient’s health, an oral revision to an existing directive shall be acceptable.

(f) The oral directive shall be documented as soon as possible in the patient’s record. A revised written directive shall be signed by the authorized user within 48 hours of the oral revision.

(g) The licensee shall retain a copy of each written directive in accordance with He-P 4035.13 for 3 years.

(h) For any administration requiring a written directive, the licensee shall develop, implement, and maintain written procedures to provide high confidence that:

(1) The patient or human subject’s identity is verified before each administration; and

(2) Each administration is in accordance with the written directive.

(i) At a minimum, the procedures required by He-P 4035.13(h) shall address the following items that are applicable to the licensee's use of byproduct material:

(1) Verifying the identity of the patient or human research subject;

(2) Verifying that the administration is in accordance with the treatment plan, if applicable, and the written directive;

(3) Checking both manual and computer-generated dose calculations;

(4) Verifying that any computer-generated dose calculations are correctly transferred into the consoles of therapeutic medical units authorized by He-P 4035.29 or He-P 4035.47;

(5) Determining if a medical event, as defined in He-P 4035.14, has occurred; and

(6) Determining, for permanent implant brachytherapy, within 60 calendar days from the date the implant was performed, the total source strength administered outside of the treatment site compared to the total source strength documented in the post-implantation portion of the written directive, unless a written justification of patient unavailability is documented.

(j) A licensee shall retain a copy of the procedures under He-P 4035.13(h) for the duration of the license.

Source. (See Revision Note at part heading for He-P 4035) #6942, eff 2-1-99; ss by #8800, INTERIM, eff 2-1-07, EXPIRED: 7-31-07

New. #8959, eff 8-7-07; ss by #10897, INTERIM, eff 7-22-15, EXPIRES: 1-18-16; ss by #11011, eff 1-15-16; amd by #11108, eff 5-25-16; amd by #12054, eff 11-19-16; ss by #13048, eff 6-2-20; ss by #13473, eff 10-25-22

He-P 4035.14 Notifications and Reports of Medical Events.

(a) Each licensee shall report any medical event to DHHS/RHS, except for an event that results from patient intervention, in which the administration of byproduct material or radiation from byproduct material, except permanent implant brachytherapy, results in:

(1) A dose that differs from the prescribed dose or dose that would have resulted from the prescribed dosage by more than 0.05 Sievert (5 rem) effective dose equivalent, 0.5 Sievert (50 rem) to an organ or tissue, or 0.5 Sievert (50 rem) shallow dose equivalent to the skin; and

a. The total dose delivered differs from the prescribed dose by 20 percent or more;

b. The total dosage delivered differs from the prescribed dosage by 20 percent or more or falls outside the prescribed dosage range; or

c. The fractionated dose delivered differs from the prescribed dose, for a single fraction, by 50 percent or more.

(2) A dose that exceeds 0.05 Sievert (5 rem) effective dose equivalent, 0.5 Sievert (50 rem) to an organ or tissue, or 0.5 Sievert (50 rem) shallow dose equivalent to the skin from any of the following:

a. An administration of a wrong radioactive drug containing byproduct material or the wrong radionuclide for a brachytherapy procedure;

b. An administration of a radioactive drug containing byproduct material by the wrong route of administration;

c. An administration of a dose or dosage to the wrong individual or human research subject;

d. An administration of a dose or dosage delivered by the wrong mode of treatment; or

e. A leaking sealed source;

(3) A dose to the skin or an organ or tissue other than the treatment site that exceeds by:

a. 0.5 Sievert (50 rem) or more of the expected dose to that site from the procedure if the administration had been given in accordance with the written directive prepared or revised before administration; and

b. Fifty percent or more of the expected dose to that site from the procedure if the administration had been given in accordance with the written directive prepared or revised before administration.

(4) For permanent implant brachytherapy, the administration of byproduct material or radiation from byproduct material (excluding sources that were implanted in the correct site but migrated outside the treatment site) that results in:

a. The total source strength administered differing by 20 percent or more from the total source strength documented in the post-implantation portion of the written directive;

b. The total source strength administered outside of the treatment site exceeding 20 percent of the total source strength documented in the post-implantation portion of the written directive; or

c. An administration that includes the wrong radionuclide; the wrong individual or human research subject; sealed source(s) implanted directly into a location discontinuous from the treatment site, as documented in the post-implantation portion of the written directive; or a leaking sealed source resulting in a dose that exceeds 0.5 Sievert (50 rem) to an organ or tissue.

(b) A licensee shall report any event resulting from intervention of a patient or human subject in which the administration of byproduct material or radiation from byproduct material results or will result in unintended permanent functional damage to an organ or a physiological system, as determined by a physician.

(c) The licensee shall notify by telephone the DHHS/RHS no later than the next calendar day after the discovery of the medical event.

(d) By an appropriate method listed in He-P 4001.08, the licensee shall submit a written report to the DHHS/RHS within 15 days after discovery of the medical event.

(e) The written report required in He-P 4035.14(b) shall contain:

(1) The licensee’s name;

(2) The name of the prescribing physician;

(3) A brief description of the medical event, why it occurred, the effect, if any, on the individual(s) who received administration;

(4) What actions, if any, have been taken or are planned to prevent recurrence;

(5) Certification that the licensee notified the individual (or the individual’s responsible relative or guardian) and if not, why not; and

(6) The report shall not contain the individual’s name or any other information that could lead to identification of the individual.

(f) The licensee shall provide notification of the event to the referring physician and also notify the individual who is the subject of the medical event no later than 24 hours after its discovery, unless the referring physician personally informs the licensee either that he or she will inform the individual or that, based on medical judgment, telling the individual would be harmful. The licensee is not required to notify the individual without first consulting the referring physician. If the referring physician or the affected individual cannot be reached within 24 hours, the licensee shall notify the individual as soon as possible thereafter. The licensee may not delay any appropriate medical care for the individual, including any necessary remedial care as a result of the medical event, because of any delay in notification. To meet the requirements of He-P 4035.14(f), the notification of the individual who is the subject of the medical event may be made instead to that individual's responsible relative or guardian. If a verbal notification is made, the licensee shall inform the individual, or appropriate responsible relative or guardian that a written description of the event can be obtained from the licensee upon request. The licensee shall provide such a written description if requested.

(g) Aside from the notification requirement, nothing in He-P 4035.14 affects any rights or duties of licensees and physicians in relation to each other, to individuals affected by the medical event, or the individual’s responsible relatives or guardians.

(h) A licensee shall annotate a copy of the report provided to the DHHS/RHS with the name of the individual who is the subject of the event and identification number or if no other identification number is available, the social security number of the individual who is the subject of the event. Provide a copy of the annotated report to the referring physician, if other than the licensee, no later than 15 days after the discovery of the event.

Source. (See Revision Note at part heading for He-P 4035) #6942, eff 2-1-99; ss by #8800, INTERIM, eff 2-1-07, EXPIRED: 7-31-07

New. #8959, eff 8-7-07; ss by #10897, INTERIM, eff
7-22-15, EXPIRES: 1-18-16; ss by #11011, eff 1-15-16; ss by #13048, eff 6-2-20; ss by #13473, eff 10-25-23

He-P 4035.15 Suppliers for Sealed Sources or Devices for Medical Use. A licensee shall use for medical use only:

(a) Sealed sources, or devices manufactured, produced, labeled, prepared, compounded, packaged, and distributed in accordance with a license issued pursuant to He-P 4030 and He‑P 4032.07 or the equivalent regulations of an agreement state or the Nuclear Regulatory Commission;

(b) Sealed sources, or devices non-commercially transferred from a DHHS/RHS licensee, or an agreement state medical use licensee or a Nuclear Regulatory Commission Part 35 licensee; and

(c) Teletherapy sources manufactured and distributed in accordance with a license issued pursuant to He‑P 4030, He-P 4032.05, and He-P 4032.06 or the equivalent regulations of an agreement state or the Nuclear Regulatory Commission.

Source. (See Revision Note at part heading for He-P 4035) #6942, eff 2-1-99; ss by #8800, INTERIM, eff 2-1-07, EXPIRED: 7-31-07

New. #8959, eff 8-7-07; ss by #10897, INTERIM, eff
7-22-15, EXPIRES: 1-18-16; ss by #11011, eff 1-15-16; ss by #13048, eff 6-2-20; ss by #13473, eff 10-25-23

He-P 4035.16 RESERVED

rpld by #13473, eff 10-25-22

He-P 4035.17 Possession, Use, Calibration, and Check of Dose Calibrators.

(a) For direct measurements performed in accordance with He-P 4035.19, a licensee shall possess and use instrumentation to measure the activity of unsealed byproduct materials before it is administered to each patient or human research subject.

(b) A licensee shall calibrate the instrumentation required in He-P 4035.17(a) in accordance with nationally recognized standards or the manufacturer’s instructions.

(1) The model and serial number of the instrument;

(2) The date of the calibration;

(3) The results of the calibration; and

(4) The name of the individual who performed the calibration.

Source. (See Revision Note at part heading for He-P 4035) #6942, eff 2-1-99; ss by #8800, INTERIM, eff 2-1-07, EXPIRED: 7-31-07

New. #8959, eff 8-7-07; ss by #10897, INTERIM, eff
7-22-15, EXPIRES: 1-18-16; ss by #11011, eff 1-15-16; ss by #13048, eff 6-2-20; ss by #13473, eff 10-25-22

He-P 4035.18 Calibration of Survey Instruments.

(a) A licensee shall calibrate the survey instruments used to show compliance with He-P 4020 through He-P 4023 before first use, at intervals not to exceed 12 months, and following repair that affects the calibration.

(b) To satisfy the requirements of He-P 4035.18(a), the licensee shall:

(1) Calibrate all required scale readings up to 10 millisieverts (1000 mrem) per hour with a radiation source;

(2) Calibrate 2 separated readings on each scale or decade that will be used to show compliance; and

(3) Clearly mark the date of calibration on the instrument.

(c) To satisfy the requirements of He-P 4035.18(b), the licensee shall use survey instruments if the difference between the indicated exposure rate and the calculated exposure rate is less than 20 percent.

Source. (See Revision Note at part heading for He-P 4035) #6942, eff 2-1-99; ss by #8800, INTERIM, eff 2-1-07, EXPIRED: 7-31-07

New. #8959, eff 8-7-07; ss by #10897, INTERIM, eff
7-22-15, EXPIRES: 1-18-16; ss by #11011, eff 1-15-16; ss by #13048, eff 6-2-20; ss by #13473, eff 10-25-22

He-P 4035.19 Assay of Dosages of Unsealed Byproduct Material for Medical Use. A licensee shall meet the following requirements for determination of dosages of unsealed byproduct material:

(a) A licensee shall determine and record the activity of each dosage prior to medical use;

(b) For a unit dosage, this determination shall be made by:

(1) Direct measurement of radioactivity; or

(2) A decay correction, based on the activity or activity concentration determined by:

a. A manufacturer or preparer licensed under He-P 4032.05, or the equivalent requirements of an agreement state, or the Nuclear Regulatory Commission;

b. A DHHS/RHS, or an agreement state or a Nuclear Regulatory Commission licensee for use in research in accordance with a Radioactive Drug Research Committee-approved protocol or an Investigational New Drug (IND) protocol accepted by FDA; or

c. A PET radioactive drug producer licensed under He-P 4032.05, the equivalent requirements of an agreement state, or the Nuclear Regulatory Commission;

(1) Direct measurement of radioactivity; and either

(2) Combination of measurement of radioactivity and mathematical calculations; or

(3) Combination of volumetric measurements and mathematical calculations, based on the measurement made by:

a. A manufacturer or preparer licensed under He-P 4032.05, or the equivalent requirements of an agreement state, or the Nuclear Regulatory Commission; or

b. A PET radioactive drug producer licensed under He-P 4032.05, the equivalent requirements of an agreement state, or Nuclear Regulatory Commission;

(d) Unless otherwise directed by the authorized user, a licensee shall not use a dosage if the dosage does not fall within the prescribed dosage range or if the dosage differs from the prescribed dosage by more than 20 percent; and

(e) A licensee shall retain a record of the dosage determination required by He-P 4035.19 for 3 years. The record shall include:

(1) The radiopharmaceutical;

(2) The patient’s or human research subject’s name, or identification number if one has been assigned;

(3) The prescribed dosage, the determined dosage, or a notation that the total activity is less than 1.1 megabecquerels (30 microcuries);

(4) The date and time of the dosage determination; and

(5) The name of the individual who determined the dosage.

Source. (See Revision Note at part heading for He-P 4035) #6942, eff 2-1-99; ss by #8800, INTERIM, eff 2-1-07, EXPIRED: 7-31-07

New. #8959, eff 8-7-07; ss by #10897, INTERIM, eff
7-22-15, EXPIRES: 1-18-16; ss by #11011, eff 1-15-16; ss by #13048, eff 6-2-20; ss by #13473, eff 10-25-22

He-P 4035.20 Authorization for Calibration, Transmission, and Reference Sources. Any person authorized by He‑P 4035.04 for medical use of byproduct material may receive, possess, and use the following byproduct material for check, calibration, transmission, and reference use:

(a) Sealed sources that do not exceed 1.11 gigabecquerels (30 millicuries) each that are:

(1) Manufactured and distributed by persons specifically licensed pursuant to He‑P 4032, or the equivalent provisions of an agreement state, or the Nuclear Regulatory Commission; or

(2) Redistributed by persons specifically licensed to redistribute the sealed sources manufactured and distributed by a person licensed pursuant to He-P 4032, or the equivalent provisions of an agreement state, or the Nuclear Regulatory Commission, providing the redistributed sealed sources are in the original packaging and shielding and are accompanied by the manufacturer’s approved instructions;

(b) Any byproduct material with a half-life of 120 days or less in individual amounts not to exceed 555 megabecquerels (15 millicuries);

(c) Any byproduct material with a half-life greater than 120 days in individual amounts not to exceed 7.4 megabecquerels (200 microcuries) each or 1000 times the quantities listed in He-P 4096.01; and

(d) Technetium-99m in individual amounts as needed.

(e) Byproduct material in sealed sources authorized by this provision shall not be:

(1) Used for medical use as defined in He-P 4035.03 except in accordance with the requirements in He-P 4035.39; or

(2) Combined (i.e. bundled or aggregated) to create an activity greater than the maximum activity of any single sealed source authorized under He-P 4035.20.

(f) A licensee using calibration, transmission, and reference sources in accordance with the requirements in He-P 4035.20(a) through (d) or He-P 4035.20(e) need not list these sources on a specific medical use license.

Source. (See Revision Note at part heading for He-P 4035) #6942, eff 2-1-99; ss by #8800, INTERIM, eff 2-1-07, EXPIRED: 7-31-07

New. #8959, eff 8-7-07; ss by #10897, INTERIM, eff
7-22-15, EXPIRES: 1-18-16; ss by #11011, eff 1-15-16; ss by #13048, eff 6-2-20; ss by #13473, eff 10-25-22

He-P 4035.21 Requirements for Possession of Sealed Sources and Brachytherapy Sources.

(a) A licensee in possession of any sealed source or brachytherapy source shall follow the radiation safety and handling instructions supplied by the manufacturer or equivalent instructions.

(b) A licensee in possession of a sealed source shall ensure that:

(1) The source is tested for leakage before its first use unless the licensee has a certificate from the supplier indicating that the source was tested within 6 months before transfer to the licensee; and

(2) The source is tested for leakage at intervals not to exceed 6 months or at intervals approved by DHHS/RHS, or another agreement state or the Nuclear Regulatory Commission in the Sealed Source and Device Registry.

(c) To satisfy the leak test requirements of He‑P 4035.21(b), the licensee shall ensure that leak tests are capable of detecting the presence of 185 becquerels (0.005 microcurie) of radioactive material on the test sample.

(d) A licensee shall retain leak test records for 3 years.

(e) The leak test records shall contain:

(1) The model number;

(2) Serial number, if assigned, of each source tested;

(3) The identity of each source radionuclide;

(4) The estimated activity of each source radionuclide;

(5) The measured activity of each test sample expressed in becquerels (microcuries);

(6) The date of the test; and

(7) The name of the individual who performed the test.

(f) If the leak test reveals the presence of 185 becquerels (0.005 microcurie) or more of removable contamination, the licensee shall:

(1) Immediately withdraw the sealed source from use and store, repair or dispose of it in accordance with the requirements of He‑P 4023; and

(2) File a report as described in He-P 4035.21(e) with DHHS/RHS within 5 days of receiving the leak test results describing the equipment involved, the test results, and the action taken.

(g) A licensee:

(1) Shall not be required to perform a leak test on the following sources:

a. Sources containing only byproduct material with a half-life of less than 30 days;

b. Sources containing only byproduct material as a gas;

c. Sources containing 3.7 megabecquerels (100 microcuries) or less of beta or gamma-emitting material or 370 kilobecquerels (10 microcuries) or less of alpha-emitting material;

d. Seeds of iridium-192 encased in nylon ribbon; and

e. Sources stored and not being used; but

(2) Shall test each such source in (g)(1) above for leakage before any use or transfer unless it has been tested for leakage within 6 months before the date of use or transfer.

(h) A licensee in possession of a sealed source or brachytherapy source, except for gamma stereotactic radiosurgery sources, shall conduct a physical inventory of all such sources in its possession at intervals not to exceed 6 months.

(i) The licensee shall retain each sealed source inventory record for 3 years.

(j) The sealed source inventory records shall contain:

(1) The model number of each source;

(2) The serial number, if one has been assigned;

(3) The identity of each source radionuclide;

(4) The estimated activity of each source radionuclide;

(5) The location of each source;

(6) The date of the inventory; and

(7) The name of the individual who performed the inventory.

Source. (See Revision Note at part heading for He-P 4035) #6942, eff 2-1-99; ss by #8800, INTERIM, eff 2-1-07, EXPIRED: 7-31-07

New. #8959, eff 8-7-07; ss by #10897, INTERIM, eff
7-22-15, EXPIRES: 1-18-16; ss by #11011, eff 1-15-16; ss by #13048, eff 6-2-20; ss by #13473, eff 10-25-22

He-P 4035.22 Reserved

Source. (See Revision Note at part heading for He-P 4035) #6942, eff 2-1-99; ss by #8800, INTERIM, eff 2-1-07, EXPIRED: 7-31-07

New. #8959, eff 8-7-07; ss by #10897, INTERIM, eff
7-22-15, EXPIRES: 1-18-16; rpld by #11011, eff 1-15-16

He-P 4035.23 Syringe and Vial Shields and Labels.

(a) Each syringe and vial that contains unsealed byproduct material shall be labeled to identify the radioactive drug.

(b) Each syringe shield and vial shield shall also be labeled unless the label on the syringe or vial is visible when shielded.

Source. (See Revision Note at part heading for He-P 4035) #6942, eff 2-1-99; ss by #8800, INTERIM, eff 2-1-07, EXPIRED: 7-31-07

New. #8959, eff 8-7-07; ss by #10897, INTERIM, eff
7-22-15, EXPIRES: 1-18-16; ss by #11011, eff 1-15-16; ss by #13473, eff 10-25-22

He-P 4035.24 Surveys for Ambient Radiation Exposure Rate.

(a) In addition to the surveys required by He-P 4022, a licensee shall survey with a radiation detection survey instrument at the end of each day of use all areas where unsealed byproduct material requiring a written directive is prepared for use or administered.

(b) A licensee shall not need to perform the surveys required by He-P 4035.24(a) above in the area(s) where patients or human research subjects are confined when they cannot be released under He-P 4035.25.

(d) The survey record required in He-P 4035.24(a) shall include:

(1) The date of the survey;

(2) A sketch of each area surveyed and the results of the survey;

(3) The serial number and the model number of the instrument used to make the survey or analyze the samples; and

(4) The name of the individual who performed the survey.

Source. (See Revision Note at part heading for He-P 4035) #6942, eff 2-1-99; ss by #8800, INTERIM, eff 2-1-07, EXPIRED: 7-31-07

New. #8959, eff 8-7-07; ss by #10897, INTERIM, eff
7-22-15, EXPIRES: 1-18-16; ss by #11011, eff 1-15-16; ss by #13048, eff 6-2-20; ss by #13473, eff 10-25-22

He-P 4035.25 Release of Individuals Containing Unsealed Byproduct Material or Implants Containing Byproduct Material.

(a) A licensee shall authorize the release from its control any individual who has been administered unsealed byproduct material or implants containing byproduct material if:

(1) The total effective dose equivalent to any other individual from exposure to the released individual is not likely to exceed 5 millisieverts (0.5 rem); or

(2) The calculated doses, based on methods and tables of activities described in NUREG-1556 (Vol. 9), “Consolidated Guidance about Materials Licenses: Program-Specific Guidance About Medical Use Licenses” show that the total effective dose equivalent to any other individual from exposure to the released individual is not likely to exceed 5 millisieverts (0.5 rem).

(b) A licensee shall provide the released individual, or the individual's parent or guardian, with instructions, including written instructions, on actions recommended to maintain doses to other individuals as low as is reasonably achievable if the total effective dose equivalent to any other individual is likely to exceed 1 millisievert (0.1 rem).

(c) If the total effective dose equivalent to a nursing infant or child could exceed 1 millisievert (0.1 rem), assuming there are no interruption of breast-feeding, the instructions shall also include:

(1) Guidance on the interruption or discontinuation of breast-feeding; and

(2) Information on the potential consequences, if any, of failure to follow the guidance.

(d) A licensee shall maintain a record of the basis for authorizing the release of an individual in accordance with He-P 4035.25(f)(1).

(e) The licensee shall maintain a record of instructions provided to a breast-feeding female in accordance with He-P 4035.25(f)(2).

(f) Records of the released individuals containing unsealed byproduct material or implants containing byproduct material:

(1) A licensee shall retain a record of the basis for authorizing the release of an individual in accordance with He-P 4035.25, if the total effective dose equivalent is calculated by:

a. Using the retained activity rather than the activity administered;

b. Using an occupancy factor less than 0.25 at 1 meter;

c. Using the biological or effective half-life; or

d. Considering the shielding by tissue;

(2) A licensee shall retain a record that the instructions required by He-P 4035.25(b) and (c) were provided to a breast-feeding female if the radiation dose to the infant or child from continued breast-feeding could result in a total effective dose equivalent exceeding 5 millisieverts (0.5 rem); and

(3) The records required by He-P 4035.25(f)(1) and (f)(2) above shall be retained for 3 years after the date of release of the individual.

Source. (See Revision Note at part heading for He-P 4035) #6942, eff 2-1-99; ss by #8800, INTERIM, eff 2-1-07, EXPIRED: 7-31-07

New. #8959, eff 8-7-07; ss by #10897, INTERIM, eff
7-22-15, EXPIRES: 1-18-16; ss by #11011, eff 1-15-16; ss by #13048, eff 6-2-20; ss by #13473, eff 10-25-22

He-P 4035.26 Provision of Mobile Medical Service.

(a) A licensee providing mobile medical service shall:

(1) Obtain a letter signed by the management of each client for which services are rendered that permits the use of byproduct material at the client’s address and clearly delineates the authority and responsibility of the licensee and the client;

(2) Check the instruments used to measure the activity of unsealed byproduct material for proper function before medical use at each client’s address, or on each day of use, whichever is more frequent. At a minimum, the check for proper function required by He-P 4035.26 shall include a constancy check;

(3) Check the survey instruments for proper operation with a dedicated check source before use at each client’s address; and

(4) Before leaving a client’s address, complete a survey all areas of use to ensure compliance with the requirements of He-P 4020 through He-P 4023.

(b) A mobile medical service shall not have byproduct material delivered from the manufacturer or the distributor to the client’s address unless the client has a license allowing possession of the byproduct material. Byproduct material delivered to the client shall be received and handled in conformance with the client’s license.

(c) A licensee providing mobile medical services shall retain a copy of the letter required in He-P 4035.26(a)(1) and the record of each survey required in He-P 4035.26(a)(4) for 3 years. The records shall include:

(1) The copy of the letter that clearly delineates the authority and responsibility of the licensee and the client; and

(2) For each survey done, the following:

a. The date of the survey;

b. The results of the survey;

c. The instrument used to make the survey; and

d. The name of the individual who performed the survey.

Source. (See Revision Note at part heading for He-P 4035) #6942, eff 2-1-99; ss by #8800, INTERIM, eff 2-1-07, EXPIRED: 7-31-07

New. #8959, eff 8-7-07; ss by #10897, INTERIM, eff
7-22-15, EXPIRES: 1-18-16; ss by #11011, eff 1-15-16; ss by #13048, eff 6-2-20; ss by #13473, eff 10-25-22

He-P 4035.27 Use of Unsealed Byproduct Material for Uptake, Dilution, and Excretion Studies for Which a Written Directive is Not Required.

(a) Except for quantities that require a written directive under He-P 4035.13(c), a licensee may use any unsealed byproduct material prepared for medical use for uptake, dilution, or excretion studies that is:

(1) Obtained from:

a. A manufacturer or preparer licensed under He-P 4032.05, or the equivalent requirements of an agreement state, or the Nuclear Regulatory Commission;

b. A PET radioactive drug producer licensed under He-P 4030.07(k), or the equivalent requirements of an agreement state, or the Nuclear Regulatory Commission.

(2) Prepared by, excluding production of PET radionuclides:

a. An authorized nuclear pharmacist;

b. A physician who is an authorized user and who meets the requirements specified in He-P 4035.64, or He-P 4035.65 and He-P 4035.64(c)(1)b.7;

c. An individual under the supervision, as specified in He-P 4035.11, of the authorized nuclear pharmacist in He-P 4035.27(a)(2)a. or the physician who is an authorized user in He-P 4035.27(a)(2)b.; or

(3) Obtained from and prepared by a DHHS/RHS, or an agreement state, or the Nuclear Regulatory Commission licensee for use in research in accordance with a Radioactive Drug Research Committee-approved protocol or an Investigational New Drug (IND) protocol accepted by FDA; or

(4) Prepared by the licensee for use in research in accordance with a Radioactive Drug Research Committee-approved application or an Investigational New Drug (IND) protocol accepted by FDA.

Source. (See Revision Note at part heading for He-P 4035) #6942, eff 2-1-99; ss by #8800, INTERIM, eff 2-1-07, EXPIRED: 7-31-07

New. #8959, eff 8-7-07; ss by #10897, INTERIM, eff
7-22-15, EXPIRES: 1-18-16; ss by #11011, eff 1-15-16; ss by #13048, eff 6-2-20; ss by #13473, eff 10-25-22

He-P 4035.28 Decay-In-Storage.

(a) A licensee may hold byproduct material for decay-in-storage if the material has a physical half-life of less than or equal to 120 days.

(b) Before disposal without regard to its activity, a licensee shall hold byproduct material for decay-in-storage and shall be exempt from the waste disposal requirements of He‑P 4023 if the licensee:

(1) Monitors byproduct material at the surface before disposal and determines that its radioactivity cannot be distinguished from the background radiation level with an appropriate radiation detection survey instrument set on its most sensitive scale and with no interposed shielding;

(2) Removes or obliterates all radiation labels, except for radiation labels on materials that are within containers; and

(3) Manages as biomedical waste after they have been released from the licensee.

(c) For licensed material disposed in accordance with He‑P 4035.28(b), the licensee shall retain a record of each disposal for 3 years.

(d) The disposal record shall include:

(1) The date of the disposal;

(2) The model and serial number of the survey instrument used;

(3) The background radiation level;

(4) The radiation level measured at the surface of each waste container; and

(5) The name of the individual who performed the survey.

Source. (See Revision Note at part heading for He-P 4035) #6942, eff 2-1-99; ss by #8800, INTERIM, eff 2-1-07, EXPIRED: 7-31-07

New. #8959, eff 8-7-07; ss by #10897, INTERIM, eff
7-22-15, EXPIRES: 1-18-16; ss by #11011, eff 1-15-16; ss by #13473, eff 10-25-22

He-P 4035.29 Other Medical Uses of Byproduct Material or Radiation From Byproduct Material. A licensee may use byproduct material or a radiation source approved for medical use which is not specifically addressed in He-P 4035 if:

(a) The applicant or licensee has submitted the information required by He-P 4030; and

(b) The applicant or licensee has received written approval from DHHS/RHS in a license or license amendment and uses the material in accordance with the regulations and specific conditions DHHS/RHS considers necessary for the medical use of the material.

Source. (See Revision Note at part heading for He-P 4035) #6942, eff 2-1-99; ss by #8800, INTERIM, eff 2-1-07, EXPIRED: 7-31-07

New. #8959, eff 8-7-07; ss by #10897, INTERIM, eff 7-22-15, EXPIRES: 1-18-16; ss by #11011, eff 1-15-16; ss by #13473, eff 10-25-22

He-P 4035.30 RESERVED

Source. (See Revision Note at part heading for He-P 4035) #6942, eff 2-1-99; ss by #8800, INTERIM, eff 2-1-07, EXPIRED: 7-31-07

New. #8959, eff 8-7-07; ss by #10897, INTERIM, eff
7-22-15, EXPIRES: 1-18-16; rpld by #11011, eff 1-15-16

He‑P 4035.31 Use of Unsealed Byproduct Material for Imaging and Localization Studies for Which a Written Directive Is Not Required. Except for quantities that require a written directive under He-P 4035.13(c), a licensee may use any unsealed byproduct material prepared for medical use for imaging and localization studies that is:

(a) Obtained from:

(1) A manufacturer or preparer licensed under He-P 4032.05, the equivalent requirements of an agreement state, or Nuclear Regulatory Commission; or

(2) A PET radioactive drug producer licensed under He-P 4030.07(k), the equivalent requirements of an agreement state, or Nuclear Regulatory Commission; or

(b) Prepared by, excluding production of PET radionuclides:

(1) An authorized nuclear pharmacist;

(2) An authorized user physician who meets the requirements of He-P 4035.64 or He-P 4035.64(c)(1)b.7 and He-P 4035.65; or

(3) An individual under the supervision, as specified in He-P 4035.11, of the authorized nuclear pharmacist in He-P 4035.31(b)(1) or the physician who is an authorized user in He-P 4035.31(b)(2);

(c) Obtained from and prepared by DHHS/RHS, another agreement state, or a Nuclear Regulatory Commission licensee for use in research in accordance with a Radioactive Drug Research Committee-approved protocol or an Investigational New Drug (IND) protocol accepted by FDA; or

(d) Prepared by the licensee for use in research in accordance with a Radioactive Drug Research Committee-approved application or an Investigational New Drug (IND) protocol accepted by FDA.

Source. (See Revision Note at part heading for He-P 4035) #6942, eff 2-1-99; ss by #8800, INTERIM, eff 2-1-07, EXPIRED: 7-31-07

New. #8959, eff 8-7-07; ss by #10897, INTERIM, eff
7-22-15, EXPIRES: 1-18-16; ss by #11011, eff 1-15-16; ss by #13048, eff 6-2-20; ss by #13473, eff 10-25-22

He-P 4035.32 Permissible Molybdenum-99, Strontium-82, Strontium-85 Concentrations, and Strontium-90 Sources for Ophthalmic Treatments.

(a) A licensee shall not administer to humans a radiopharmaceutical that contains:

(1) More than 0.15 kilobecquerel of molybdenum-99 per megabecquerel of technetium-99m (0.15 microcurie of molybdenum-99 per millicurie of technetium-99m); or

(2) More than 0.02 kilobecquerel of strontium-82 per megabecquerel of rubidium-82 chloride injection (0.02 microcurie of strontium-82 per millicurie of rubidium-82 chloride); or more than 0.2 kilobecquerel of strontium-85 per megabequerel of rubidium-82 chloride injection (0.2 microcurie of strontium-85 per millicurie of rubidium-82).

(b) A licensee that uses molybdenum-99/technetium-99m generators for preparing a technetium-99m radiopharmaceutical shall measure the molybdenum-99 concentration in each eluate from a generator to demonstrate compliance with He-P 4035.32(a).

(c) A licensee that uses a strontium-82/rubidium-82 generator for preparing a rubidium-82 radiopharmaceutical shall, before the first patient use of the day, measure the concentration of radionuclides strontium-82 and strontium-85 to demonstrate compliance with He-P 4035.32(a).

(d) If a licensee is required to measure the molybdenum-99 concentration or strontium-82 and strontium-85 concentrations, the licensee shall retain a record of each measurement. A licensee shall maintain the record for 3 years. The record shall include:

(1) For each measured elution of technetium-99m, the ratio of the measures expressed as kilobecquerel of molybdenum-99 per megabecquerel of technetium-99m (or microcuries of molybdenum per millicurie of technetium), the time and date of the measurement, and the name of the individual who made the measurement; or

(2) For each measured elution of rubidium-82, the ratio of the measures expressed as kilobecquerel of strontium-82 per megabecquerel of rubidium-82 (or microcuries of strontium-82 per millicurie of rubidium) and kilobecquerel of strontium-85 per megabecquerel of rubidium-82 (or microcuries of strontium-85 per millicurie of rubidium), the time and date of the measurement, and the name of the individual who made the measurement.

(e) The licensee shall report any measurement that exceeds the limits in He-P 4035.32(a) at the time of generator elution, in accordance with the following:

(1) The licensee shall notify by telephone DHHS/RHS and the distributor of the generator within 7 calendar days after discovery that an eluate exceeded the permissible concentration listed in He-P 4035.32(a) at the time of generator elution. The telephone report to DHHS/RHS shall include the manufacturer, model number, and serial number (or lot number) of the generator; the results of the measurement; the date of the measurement; whether dosages were administered to patients or human research subjects, when the distributor was notified, and the action taken.

(2) By an appropriate method listed in He-P 4001.08, the licensee shall submit a written report to DHHS/RHS within 30 calendar days after discovery of an eluate exceeding the permissible concentration at the time of generator elution. The written report shall include the action taken by the licensee; the patient dose assessment; the methodology used to make this dose assessment if the eluate was administered to patients or human research subjects; and the probable cause and an assessment of failure in the licensee's equipment, procedures or training that contributed to the excessive readings if an error occurred in the licensee's breakthrough determination; and the information in the telephone report as required by He-P 4035.32(e)(1).

(f) Licensees who use strontium-90 for ophthalmic treatments shall ensure that certain activities as specified in He-P 4035.32(g) and (h) are performed by either:

(1) An authorized medical physicist; or

(2) An individual who is identified as an ophthalmic physicist on a specific medical use license issued by DHHS\RHS, an agreement state, or the Nuclear Regulatory Commission; permit issued by DHHS/RHS, an agreement state, or a Nuclear Regulatory Commission broad scope medical use licensee; medical use permit issued by a Nuclear Regulatory Commission master material license; or permit issued by a Nuclear Regulatory Commission master material licensee broad scope medical use permittee; and

a. Holds a master’s or doctor’s degree in physics, medical physics, other physical sciences, engineering, or applied mathematics from an accredited college or university; and

b. Has successfully completed 1 year of full-time training in medical physics and an additional year of full-time work experience under the supervision of a medical physicist; and has documented training in:

1. The creation, modification, and completion of written directives;

2. Procedures for administrations requiring a written directive; and

3. Performing the calibration measurements of brachytherapy sources as detailed in He-P 4035.46.

(g) The individuals who are identified in He-P 4035.32(f) shall calculate the activity of each strontium-90 source that is used to determine the treatment times for ophthalmic treatments. The decay calculation shall be based on the activity determined under He-P 4035.46.

(h) The individuals who are identified in He-P 4035.32(f) shall assist the licensee in developing, implementing, and maintaining written procedures to provide high confidence that the administration is in accordance with the written directives. These procedures shall include the frequencies that the individual meeting the requirements in He-P 4035.32(f) will:

(1) Observe treatments;

(2) Review the treatment methodology;

(3) Calculate treatment time for the prescribed dose; and

(4) Review records to verify that the administrations were in accordance with the written directives.

(i) A licensee shall retain a record of the activity of each strontium-90 source required by He-P 4035.32(f) and (g) for the life of the source. The record shall include:

(1) The date and initial activity of the source as determined under He-P 4035.46; and

(2) For each decay calculation, the date and the source activity as determined under He-P 4035.32(g).

Source. (See Revision Note at part heading for He-P 4035) #6942, eff 2-1-99; ss by #8800, INTERIM, eff 2-1-07, EXPIRED: 7-31-07

New. #8959, eff 8-7-07; ss by #10897, INTERIM, eff
7-22-15, EXPIRES: 1-18-16; ss by #11011, eff 1-15-16; ss by #11011, eff 1-15-16; ss by #13048, eff 6-2-20; ss by #13473, eff 10-25-22

He-P 4035.33 RESERVED

Source. (See Revision Note at part heading for He-P 4035) #6942, eff 2-1-99; ss by #8800, INTERIM, eff 2-1-07, EXPIRED: 7-31-07

New. #8959, eff 8-7-07; ss by #10897, INTERIM, eff
7-22-15, EXPIRES: 1-18-16; ss by #11011, eff 1-15-16; rpld by #13473, eff 10-25-22

He-P 4035.34 RESERVED

Source. (See Revision Note at part heading for He-P 4035) #6942, eff 2-1-99; ss by #8800, INTERIM, eff 2-1-07, EXPIRED: 7-31-07

New. #8959, eff 8-7-07; ss by #10897, INTERIM, eff
7-22-15, EXPIRES: 1-18-16; rpld by #11011, eff 1-15-16

He-P 4035.35 Use of Unsealed Byproduct Material—Written Directive Required. A licensee shall use any unsealed byproduct material identified in He-P 4035.65(b)(2)b., prepared for medical use and for which a written directive is required that is:

(a) Obtained from one of the following:

(1) A manufacturer or preparer licensed under He-P 4032.05, or the equivalent requirements of an agreement state, or the Nuclear Regulatory Commission; or

(2) A PET radioactive drug producer licensed under He-P 4030.07(k), or the equivalent requirements of an agreement state, or the Nuclear Regulatory Commission; or

(b) Excluding production of PET radionuclides, prepared by:

(1) An authorized nuclear pharmacist;

(2) A physician who is an authorized user and who meets the requirements specified under He-P 4035.64 or He-P 4035.65; or

(3) An individual under the supervision, as specified in He-P 4035.11, of the authorized nuclear pharmacist in He-P 4035.35(b)(1) or the physician who is an authorized user in He-P 4035.35(b)(2); or

(c) Obtained from and prepared by a DHHS/RHS licensee, or an equivalent agreement state, or a Nuclear Regulatory Commission licensee for use in research in accordance with an Investigational New Drug (IND) protocol accepted by FDA; or

(d) Is prepared by the licensee for use in research in accordance with an Investigational New Drug (IND) protocol accepted by FDA.

Source. (See Revision Note at part heading for He-P 4035) #6942, eff 2-1-99; ss by #8800, INTERIM, eff 2-1-07, EXPIRED: 7-31-07

New. #8959, eff 8-7-07; ss by #10897, INTERIM, eff
7-22-15, EXPIRES: 1-18-16; ss by #11011, eff 1-15-16; amd by #12054, eff 11-19-16; ss by #13048, eff 6-2-20; ss by #13473, eff 10-25-22

He-P 4035.36 Safety Instruction for Use of Unsealed Byproduct Material—Written Directive Required.

(a) A licensee shall provide oral and written radiation safety instruction for all personnel caring for patients or human research subjects who cannot be released under He-P 4035.25.

(b) Refresher training shall be provided at intervals not to exceed 1 year.

(1) Patient or human research subject control;

(2) Visitor control, including:

a. Routine visitation to hospitalized individuals in accordance with He-P 4020.13(a)(1); and

b. Visitation authorized in accordance with He-P 4020.13(c);

(3) Contamination control;

(4) Waste control;

(5) Notification of the radiation safety officer, or his or her designee, and an authorized user in case of the patient’s or human research subject’s death or medical emergency; and

(6) Training, which shall be commensurate with the duties of the personnel, as required by He‑P 4019.

(d) A licensee shall keep a record of:

(1) Individuals receiving operational and safety instructions required by He‑P 4035.36(a);

(2) A description of the instruction;

(3) The date of instruction; and

(4) The name(s) of the individual(s) who gave the instruction.

(e) The record required in He‑P 4035.36(d) shall be maintained for inspection by DHHS/RHS for 3 years.

Source. (See Revision Note at part heading for He-P 4035) #6942, eff 2-1-99; ss by #8800, INTERIM, eff 2-1-07, EXPIRED: 7-31-07

New. #8959, eff 8-7-07; ss by #10897, INTERIM, eff
7-22-15, EXPIRES: 1-18-16; ss by #11011, eff 1-15-16; ss by #13048, eff 6-2-20; ss by #13473, eff 10-25-22

He-P 4035.37 Safety Precautions for Use of Unsealed Byproduct Material—Written Directive Required.

(a) For each patient or human research subject who cannot be released under He‑P 4035.25, a licensee shall:

(1) Provide a private room, or share with another individual who also cannot be released under He-P 4035.25, with a private sanitary facility;

(2) Post the patient’s or human research subject’s door with a “Caution: Radioactive Material” sign and note on the door or on the patient’s or human research subject’s chart where and how long visitors may stay in the patient’s or human research subject’s room; and

(3) Either monitor material and items removed from the patient’s room or the human research subject’s room to determine that their radioactivity cannot be distinguished from the natural background radiation level with a radiation detection survey instrument set on its most sensitive scale with no interposed shielding, or handle these materials and items as radioactive waste.

(b) The radiation safety officer, or his or her designee, and an authorized user shall be notified immediately if the patient or human research subject dies or has a medical emergency.

Source. (See Revision Note at part heading for He-P 4035) #6942, eff 2-1-99; ss by #8800, INTERIM, eff 2-1-07, EXPIRED: 7-31-07

New. #8959, eff 8-7-07; ss by #10897, INTERIM, eff
7-22-15, EXPIRES: 1-18-16; ss by #11011, eff 1-15-16; ss by #13048, eff 6-2-20; ss by #13473, eff 10-25-22

He-P 4035.38 Report and Notification of a Dose to an Embryo/Fetus or a Nursing Child.

(a) A licensee shall report any dose to an embryo/fetus, that is greater than 50 millisieverts (5 rem) dose equivalent that is a result of an administration of byproduct material or radiation from byproduct material to a pregnant individual unless the dose to the embryo/fetus was specifically approved, in advance, by the authorized user.

(b) A license shall report any dose to a nursing child that is a result of an administration of byproduct material to a breast-feeding individual that:

(1) Is greater than 50 millisieverts (5 rem) total effective dose equivalent; or

(2) Has resulted in unintended permanent functional damage to an organ or a physiological system of the child, as determined by a physician.

(c) The licensee shall notify by telephone DHHS/RHS no later than the next calendar day after discovery of a dose to the embryo/fetus or nursing child that requires a report in He-P 4035.38(a) or He-P 4035.38(b).

(d) The licensee shall submit a written report to DHHS/RHS within 15 days after discovery of a dose to the embryo/fetus or nursing child that requires a report in He-P 4035.38(a) or He-P 4035.38(b). The written report shall include:

(1) The licensee’s name;

(2) The name of the prescribing physician;

(3) A brief description of the event;

(4) Why the event occurred;

(5) The effect, if any, on the embryo/fetus or the nursing child;

(6) What actions, if any, have been taken or are planned to prevent recurrence;

(7) Certification that the licensee notified the pregnant individual or mother (or the mother’s child’s responsible relative or guardian), and if not, why not; and

(8) The report shall not contain the individual’s or child’s name or any other information that could lead to identification of the individual or child.

(e) The licensee shall provide notification of the event to the referring physician and also notify the pregnant individual or mother, both hereafter referred to as the mother, no later than 24 hours after discovery of an event that would require reporting under He-P 4035.38(a) or He-P 4035.38(b), unless the referring physician personally informs the licensee either that he or she will inform the mother or that, based on medical judgment, telling the mother would be harmful. The licensee shall:

(1) Not be required to notify the mother without first consulting with the referring physician. If the referring physician or mother cannot be reached within 24 hours, the licensee shall make the appropriate notifications as soon as possible thereafter;

(2) Not delay any appropriate medical care for the embryo/fetus or for the nursing child, including any necessary remedial care as a result of the event, because of any delay in notification;

(3) Notify the mother’s or child’s responsible relative or guardian instead of the mother;

(4) Inform the mother, or the mother’s or child’s responsible relative or guardian, if a verbal notification is made, that a written description of the event can be obtained from the licensee upon request; and

(5) Provide such a written description if requested.

(f) In the report, a licensee shall:

(1) Annotate a copy of the report provided to DHHS/RHS with the following:

a. Name of the pregnant individual or the nursing child who is the subject of the event; and

b. Identification number or if no other identification number is available, the social security number of the individual who is the subject of the event; and

(2) Provide a copy of the annotated report to the referring physician, if other than the licensee, no later than 15 days after the discovery of the event.

Source. (See Revision Note at part heading for He-P 4035) #6942, eff 2-1-99; ss by #8800, INTERIM, eff 2-1-07, EXPIRED: 7-31-07

New. #8959, eff 8-7-07; ss by #10897, INTERIM, eff
7-22-15, EXPIRES: 1-18-16; ss by #11011, eff 1-15-16; amd by #12054, eff 11-19-16; ss by #13473, eff 10-25-22

He-P 4035.39 Use of Sealed Sources and Medical Devices for Diagnosis. A licensee shall use only:

(a) Sealed sources that are not in medical devices for diagnostic medical uses if the sealed sources are approved in the Sealed Source and Device Registry for diagnostic medicine. The sealed sources may be used for diagnostic medical uses that are not explicitly listed in the Sealed Source and Device Registry but shall be used in accordance with the radiation safety conditions and limitations described in the Sealed Source and Device Registry;

(b) Medical devices containing sealed sources for diagnostic medical uses if both the sealed sources and medical devices are approved in the Sealed Source and Device Registry for diagnostic medical uses. The diagnostic medical devices may be used for diagnostic medical uses that are explicitly listed in the Sealed Source and Device Registry but shall be used in accordance with the radiation safety conditions and limitations described in the Sealed Source and Device Registry; and

(c) Sealed sources and devices for diagnostic medical uses in research in accordance with an active Investigational Device Exemption (IDE) application accepted by the U.S. Food and Drug Administration provided the requirements of He-P 4035.15(a) are met.

Source. (See Revision Note at part heading for He-P 4035) #6942, eff 2-1-99; ss by #8800, INTERIM, eff 2-1-07, EXPIRED: 7-31-07

New. #8959, eff 8-7-07; ss by #10897, INTERIM, eff
7-22-15, EXPIRES: 1-18-16; ss by #11011, eff 1-15-16; ss by #13048, eff 6-2-20; ss by #13473, eff 10-25-22

He-P 4035.40 RESERVED

Source. (See Revision Note at part heading for He-P 4035) #6942, eff 2-1-99; ss by #8800, INTERIM, eff 2-1-07, EXPIRED: 7-31-07

New. #8959, eff 8-7-07; ss by #10897, INTERIM, eff
7-22-15, EXPIRES: 1-18-16; ss by #11011, eff 1-15-16; rpld by #13058, eff 6-2-20

He-P 4035.41 Use of Sources for Manual Brachytherapy. A licensee shall use only brachytherapy sources for therapeutic medical use:

(a) As approved in the Sealed Source and Device Registry. The manual brachytherapy sources may be used for manual brachytherapy uses that are not explicitly listed in the Sealed Source and Device Registry, but shall be used in accordance with the radiation safety conditions and limitations described in the Sealed Source and Device Registry; or

(b) In research to deliver therapeutic doses for medical use, in accordance with an active Investigational Device Exemption (IDE) application accepted by the FDA provided the requirements of He-P 4035.15(a) are met.

Source. (See Revision Note at part heading for He-P 4035) #6942, eff 2-1-99; ss by #8800, INTERIM, eff 2-1-07, EXPIRED: 7-31-07

New. #8959, eff 8-7-07; ss by #10897, INTERIM, eff
7-22-15, EXPIRES: 1-18-16; ss by #11011, eff 1-15-16; ss by #13048, eff 6-2-20; ss by #13473, eff 10-25-22

He-P 4035.42 Safety Instruction for Use of Brachytherapy Sources. In addition to the requirements of He-P 4019.04:

(a) The licensee shall provide radiation safety instruction (commensurate with the duties of the personnel) initially to personnel caring for patients or human research subjects who are receiving brachytherapy and cannot be released under He-P 4035.25;

(b) Refresher training shall be provided at intervals not to exceed one year;

(1) The size and appearance of the brachytherapy sources;

(2) The safe handling and shielding instructions;

(3) The procedures for patient or human research subject control;

(4) The procedures for visitor control; including:

a. Routine visitation of hospitalized individuals in accordance with He-P 4020.13(a)(1); and

b. Visitation authorized in accordance with He-P 4020.13(c); and

(5) The procedures for notification of the radiation safety officer, or his or her designee, and an authorized user if the patient or human research subject dies or has a medical emergency.

(d) A licensee shall maintain a record of individuals receiving instruction required by He‑P 4035.42(a), a description of the instruction, the date of instruction, the name(s) of the attendee(s), and the name(s) of the individual(s) who gave the instruction for 3 years.

Source. (See Revision Note at part heading for He-P 4035) #6942, eff 2-1-99; ss by #8800, INTERIM, eff 2-1-07, EXPIRED: 7-31-07

New. #8959, eff 8-7-07; ss by #10897, INTERIM, eff
7-22-15, EXPIRES: 1-18-16; ss by #11011, eff 1-15-16; amd by #12054, eff 11-19-16; ss by #13048, eff 6-2-20; ss by #13473, eff 10-25-22

He-P 4035.43 Safety Precautions for Use of Brachytherapy Sources.

(a) For each patient or human research subject receiving brachytherapy and cannot be released under He-P 4035.25, a licensee shall:

(1) Not place the patient or human research subject in the same room with a patient who is not receiving brachytherapy; and

(2) Post the patient’s or human research subject’s door with a “Caution: Radioactive Materials” sign and note on the door or the patient’s or human research subject’s chart where and how long visitors may stay in the patient’s or human research subject’s room.

(b) A licensee shall have applicable emergency response equipment available near each treatment room to respond to a source:

(1) Dislodged from the patient; and

(2) Lodged within the patient following removal of the source applicators.

(c) The radiation safety officer, or his or her designee, and an authorized user shall be notified immediately if the hospitalized patient or human research subject dies or has a medical emergency.

Source. (See Revision Note at part heading for He-P 4035) #6942, eff 2-1-99; ss by #8800, INTERIM, eff 2-1-07, EXPIRED: 7-31-07

New. #8959, eff 8-7-07; ss by #10897, INTERIM, eff
7-22-15, EXPIRES: 1-18-16; ss by #11011, eff 1-15-16; ss by #13048, eff 6-2-20; ss by #13473, eff 10-25-22

He-P 4035.44 Brachytherapy Sources Accountability.

(a) A licensee shall:

(1) Maintain accountability at all times for all brachytherapy sources in storage or use; and

(2) As soon as possible after removing sources from a patient or a human research subject, return brachytherapy sources to a secure storage area.

(b) A licensee shall maintain a record of brachytherapy source accountability for 3 years.

(1) For temporary implants, the record shall include:

a. The number and activity of sources removed from storage, the time and date they were removed from storage, the name of the individual who removed the source(s) from storage, and the location of use; and

b. The number and activity of sources returned to storage, the time and date they were returned to storage, and the name of the individual who returned the source(s) to storage.

(2) For permanent implants the record shall include:

a. The number and activity of sources removed from storage, the date they were removed from storage, and the name of the individual who removed the source(s) from storage;

b. The number and activity of sources not implanted, the date the source(s) were returned to storage, and the name of the individual who returned the source(s) to storage; and

c. The number and activity of sources permanently implanted in the patient or human research subject.

Source. (See Revision Note at part heading for He-P 4035) #6942, eff 2-1-99; ss by #8800, INTERIM, eff 2-1-07, EXPIRED: 7-31-07

New. #8959, eff 8-7-07; ss by #10897, INTERIM, eff 7-22-15, EXPIRES: 1-18-16; ss by #11011, eff 1-15-16; amd by 12054, eff 11-19-16; ss by #13048, eff 6-2-20; ss by #13473, eff 10-25-22

He-P 4035.45 Surveys After Source Implant/Removal and Surveys of Individuals Treated With a Remote Afterloader Unit.

(a) Immediately after implanting sources in a patient or a human research subject, the licensee shall make a survey to locate and account for all sources that have not been implanted.

(b) Immediately after removing the last temporary implant source from a patient or a human research subject, the licensee shall make a survey of the patient or the human research subject with a radiation detection survey instrument to confirm that all sources have been removed.

(c) Before releasing a patient or a human research subject from license control, a licensee shall survey the patient or the human research subject and the remote afterloader unit with a portable radiation detection survey instrument to confirm that the source(s) has been removed from the patient or human research subject and returned to the safe shielded position.

(d) A licensee shall maintain a record of patient or human research subject surveys which demonstrate compliance with He‑P 4035.45(a) through (c) for 3 years, including the date and the results of the survey, the survey instrument used, and the name of the individual who made the survey.

Source. (See Revision Note at part heading for He-P 4035) #6942, eff 2-1-99; ss by #8800, INTERIM, eff 2-1-07, EXPIRED: 7-31-07

New. #8959, eff 8-7-07; ss by #10897, INTERIM, eff
7-22-15, EXPIRES: 1-18-16; ss by #11011, eff 1-15-16; ss by #13473, eff 10-25-22

He-P 4035.46 Calibration Measurements of Brachytherapy Sources.

(a) Before the first medical use of a brachytherapy source, a licensee shall have:

(1) Determined the source output or activity using a dosimetry system that meets the requirements of He-P 4035.53(a) and (b);

(2) Determined source positioning accuracy within applicators; and

(3) Used published protocols currently accepted by nationally recognized bodies to meet the requirements of He-P 4035.46(a)(1) and (a)(2); or

(4) Used measurements provided by the source manufacturer or by a calibration laboratory accredited by the American Association of Physicists in Medicine that are made in accordance with He-P 4035.46(a).

(b) A licensee shall mathematically correct the outputs or activities determined by He-P 4035.46(a) for physical decay at intervals consistent with 1 percent physical decay.

(c) A licensee shall retain a record of each calibration of brachytherapy source for 3 years after the last use of the source. The record shall include:

(1) The date of the calibration;

(2) The manufacturer’s name, model number, and serial number for the source and the instruments used to calibrate the source;

(3) The source output or activity;

(4) The source positioning accuracy within the applicators; and

(5) The name of the individual, the source manufacturer, or the calibration laboratory that performed the calibration.

Source. (See Revision Note at part heading for He-P 4035) #6942, eff 2-1-99; ss by #8800, INTERIM, eff 2-1-07, EXPIRED: 7-31-07

New. #8959, eff 8-7-0707; ss by #10897, INTERIM, eff
7-22-15, EXPIRES: 1-18-16; ss by #11011, eff 1-15-16; ss by #13048, eff 6-2-20; ss by #13473, eff 10-25-22

He-P 4035.47 Use of a Sealed Source in a Remote Afterloader Unit, Teletherapy Unit, or Gamma Stereotactic Radiosurgery Unit. A licensee shall use sealed sources in photon emitting remote afterloader units, teletherapy units, or gamma stereotactic radiosurgery units:

(a) As approved in the Sealed Source and Device Registry to deliver therapeutic doses for medical uses, or in research in accordance with an active Investigational Device Exemption (IDE) application accepted by the FDA provided the requirements of He-P 4035.15(a) are met; or

(b) Approved in the Sealed Source Device Registry to deliver a therapeutic dose for medical use. These devices may be used for:

(1) Therapeutic medical treatments that are not explicitly provided for in the Sealed Source and Device Registry, but shall be used in accordance with radiation safety conditions and limitations described in the Sealed Source and Device Registry; or

(2) In research in accordance with an active Investigational Device Exemption (IDE) application accepted by the FDA provided the requirements of He-P 4035.15(a) are met.

Source. (See Revision Note at part heading for He-P 4035) #6942, eff 2-1-99; ss by #8800, INTERIM, eff 2-1-07, EXPIRED: 7-31-07

New. #8959, eff 8-7-07; ss by #10897, INTERIM, eff
7-22-15, EXPIRES: 1-18-16; ss by #11011, eff 1-15-16; ss by #11011, eff 1-15-16; ss by #13048, eff 6-2-20; ss by #13473, eff 10-25-22

He-P 4035.48 Installation, Maintenance, Adjustment, and Repair of Remote Afterloader Units, Teletherapy Units, or Gamma Stereotactic Radiosurgery Units.

(a) Only a person specifically licensed by DHHS/RHS, or an agreement state, or the Nuclear Regulatory Commission shall install, maintain, adjust, or repair a remote afterloader unit, teletherapy unit, or gamma stereotactic radiosurgery unit that involves work on the source(s) shielding, the source(s) driving unit, or other electronic or mechanical component that could expose the source(s), reduce the shielding around the source(s), or compromise the radiation safety of the unit or the source(s).

(b) Except for low dose-rate remote afterloader units, only a person specifically licensed by DHHS/RHS, or an agreement state, or the Nuclear Regulatory Commission shall install, replace, relocate, or remove a sealed source or source contained in other remote afterloader units, teletherapy units, or gamma stereotactic radiosurgery units.

(c) For a low dose-rate remote afterloader unit, only a person specifically licensed by DHHS/RHS, an agreement state, or the Nuclear Regulatory Commission, or an authorized medical physicist shall install, replace, relocate, or remove a sealed source(s) contained in the unit.

(d) A licensee shall retain a record of the installation, maintenance, adjustment, and repair of remote afterloader units, teletherapy units, and gamma stereotactic radiosurgery units for 3 years. Each record shall include:

(1) The date;

(2) The description of the service; and

(3) The name(s) of the individual(s) who performed the work.

Source. (See Revision Note at part heading for He-P 4035) #6942, eff 2-1-99; ss by #8800, INTERIM, eff 2-1-07, EXPIRED: 7-31-07

New. #8959, eff 8-7-07; ss by #10897, INTERIM, eff
7-22-15, EXPIRES: 1-18-16; ss by #11011, 1-15-16; amd by #12054, eff 11-19-16; ss by #13473, eff 10-25-22

He‑P 4035.49 RESERVED

Source. (See Revision Note at part heading for He-P 4035) #6942, eff 2-1-99; ss by #8800, INTERIM, eff 2-1-07, EXPIRED: 7-31-07

New. #8959, eff 8-7-07; ss by #10897, INTERIM, eff
7-22-15, EXPIRES: 1-18-16; ss by #11011, 1-15-16; ss by #11011, 1-15-16; rpld by #13473, eff 10-25-22

He-P 4035.50 Safety Procedures and Instructions for Remote Afterloader Units, Teletherapy Units, and Gamma Stereotactic Radiosurgery Units.

(a) A licensee shall:

(1) Secure the unit, the console, the console keys, and the treatment room when not in use or unattended;

(2) Permit only individuals approved by the authorized user, radiation safety officer, or authorized medical physicist to be present in the treatment room during treatment with the source(s);

(3) Prevent dual operation of more than one radiation producing device in a treatment room if applicable; and

(4) Develop, implement, and maintain written procedures for responding to an abnormal situation when the operator is unable to place the source(s) in the shielded position, or remove the patient or human research subject from the radiation field with controls from outside the treatment room. The procedures shall include:

a. Instructions for responding to equipment failures and the names of the individuals responsible for implementing corrective actions;

b. The process for restricting access to and posting of the treatment area to minimize the risk of inadvertent exposure; and

c. The names and telephone numbers of the authorized users, the authorized medical physicist, and the radiation safety officer to be contacted if the unit or console operates abnormally.

(b) A copy of the procedures required by He-P 4035.50(a)(4) shall be physically located at the unit console.

(1) The location of the procedures required by He-P 4035.50(a)(4); and

(2) The names and telephone numbers of the authorized users, the authorized medical physicist, and the radiation safety officer to be contacted if the unit or console operates abnormally.

(d) Prior to the first use for patient treatment of a new unit or an existing unit with a manufacturer upgrade that affects the operation and safety of the unit, a license shall ensure that vendor operational and safety training is provided to all individuals who will operate the unit. The vendor operational and safety training shall be provided by the device manufacturer or by an individual certified by the device manufacturer to provide the operational and safety training.

(e) A licensee shall provide operational and safety instruction, initially and annually, to all individuals who operate the unit, as appropriate to the individual’s assigned duties. The instructions shall include:

(1) The procedures identified in He-P 4035.50(a)(4); and

(2) The operating procedures for the unit.

(f) A licensee shall ensure that operators, authorized medical physicists, and authorized users participate in drills of the emergency procedures, initially and at least annually.

(g) A licensee shall retain a record of individuals receiving instruction required by He-P 4035.50(d) and (e) for 3 years. The record shall include:

(1) A list of the topics covered;

(2) The date of the instruction;

(3) The name(s) of the attendee(s); and

(4) The name(s) of the individual(s) who provided the instruction.

(h) A licensee shall retain a copy of the procedures required by He-P 4035.50(a)(4) and (e)(2) until the licensee no longer possesses the remote afterloader unit, teletherapy unit, or gamma stereotactic radiosurgery unit.

Source. (See Revision Note at part heading for He-P 4035) #6942, eff 2-1-99; ss by #8800, INTERIM, eff 2-1-07, EXPIRED: 7-31-07

New. #8959, eff 8-7-07; ss by #10897, INTERIM, eff
7-22-15, EXPIRES: 1-18-16; ss by #11011, 1-15-16; ss by #13048, eff 6-2-20; ss by #13473, eff 10-25-22

*He-P 4035.51 Safety Precautions for Remote Afterloader Units, Teletherapy Units and Gamma Stereotactic Radiosurgery Units.

(a) A licensee shall control access to the treatment room by a door at each entrance.

(b) A licensee shall equip each entrance to the treatment room with an electrical interlock system that shall:

(1) Prevent the operator from initiating the treatment cycle unless each treatment room entrance door is closed;

(2) Cause the source(s) to be shielded when an entrance door is opened; and

(3) Prevent the source(s) from being exposed following an interlock interruption until all treatment room entrance doors are closed and the beam “on-off” control is reset at the console.

(c) A licensee shall require any individual entering the treatment room to assure, through the use of appropriate radiation monitors, that radiation levels have returned to ambient levels.

(d) Except for low-dose remote afterloader units, a licensee shall construct or equip each treatment room with viewing and intercom systems to permit continuous observation of the patient or the human research subject from the treatment console during irradiation.

(e) For licensed activities where sources are placed within the patient’s or human research subject’s body, a licensee shall only conduct treatments which allow for expeditious removal of a decoupled or jammed Source.

(f) In addition to the requirements specified in He-P 4035.51(a) through(e), a licensee shall:

(1) For medium dose-rate and pulsed dose-rate remote afterloader units, shall require:

a. An authorized medical physicist and either an authorized user or a physician, under the supervision of an authorized user, who has been trained in the operation and emergency response for the unit to be physically present during the initiation of all patient treatment involving the unit; and

b. An authorized medical physicist and either an authorized user or an individual, under the supervision of an authorized user, who has been trained to remove the source applicator(s) in the event of an emergency involving the unit, to be immediately available during continuation of all patient treatments;

(2) For high dose-rate remote afterloader units, shall require:

a. An authorized user and an authorized medical physicist to be physically present during the initiation of all patient treatments involving the unit; and

b. An authorized medical physicist and either an authorized user or a physician, under the supervision of an authorized user, who has been trained in the operation and emergency response for the unit, to be physically present during continuation of all patient treatments involving the unit;

(3) For gamma stereotactic radiosurgery units, require an authorized user and an authorized medical physicist to be physically present throughout all patient treatments involving the unit; and

(4) Notify the radiation safety officer, or his/her designee, and an authorized user immediately if the patient or human research subject has a medical emergency or dies.

(g) A licensee shall have applicable emergency response equipment available near each treatment room to respond to a source:

(1) Remaining in the unshielded position; or

(2) Lodged within the patient following completion of the treatment.

Source. (See Revision Note at part heading for He-P 4035) #6942, eff 2-1-99; ss by #8800, INTERIM, eff 2-1-07, EXPIRED: 7-31-07

New. #8959, eff 8-7-07; ss by #10897, INTERIM, eff
7-22-15, EXPIRES: 1-18-16; ss by #11011, eff 1-15-16; ss by #13048, eff 6-2-20

He-P 4035.52 Technical Requirements for Mobile Remote Afterloader.

(a) A licensee providing mobile remote afterloader service shall:

(1) Check survey instruments before medical use at each address of use or on each day of use, whichever is more frequent; and

(2) Account for all sources before departure from a client’s address of use.

(b) In addition to the periodic spot-checks required by He-P 4035.55(i) through (o), a licensee authorized to use mobile afterloaders for medical use shall perform checks on each remote afterloader unit before use at each address of use. At a minimum, checks shall be made to verify the operation of:

(1) Electrical interlocks on treatment area access points;

(2) Source exposure indicator lights on the remote afterloader unit, on the control console, and in the facility;

(3) Viewing and intercom systems;

(4) Applicators, source transfer tubes, and transfer tube-applicator interfaces;

(5) Radiation monitors used to indicate room exposures;

(6) Source positioning (accuracy); and

(7) Radiation monitors used to indicate whether the source has returned to a safe shielded position.

(c) In addition to the requirements for checks in He-P 4035.52(b), a licensee shall ensure overall proper operation of the remote afterloader unit by conducting a simulated cycle of treatment before use at each address of use.

(d) If the results of the checks required in He-P 4035.52(b) indicate the malfunction of any system, a licensee shall lock the control console in the “off” position and not use the unit except as may be necessary to repair, replace, or check the malfunctioning system.

(e) A licensee shall retain a record of each check required by He-P 4035.52(b) for 3 years. The record shall include:

(1) The date of the check;

(2) The manufacturer’s name, model number, and serial number of the remote afterloader unit;

(3) Notations accounting for all sources before the licensee departs from a facility;

(4) Notations indicating the operability of each entrance door electrical interlock, radiation monitors source exposure indicator lights, viewing and intercom system, applicators source transfer tubes, and transfer tube applicator interfaces, and source positioning accuracy; and

(5) The name and the signature of the individual who performed the check.

Source. (See Revision Note at part heading for He-P 4035) #6942, eff 2-1-99; ss by #8800, INTERIM, eff 2-1-07, EXPIRED: 7-31-07

New. #8959, eff 8-7-07; ss by #10897, INTERIM, eff
7-22-15, EXPIRES: 1-18-16; ss by #11011, eff 1-15-16; ss by #13048, eff 6-2-20

He-P 4035.53 Dosimetry Equipment.

(a) Except for low dose-rate remote afterloader sources where the source output or activity is determined by the manufacturer, a licensee shall have a calibrated dosimetry system available for use.

(b) To satisfy the requirement in He‑P 4035.53(a), one of the following two conditions shall be met:

(1) The system shall have been calibrated using a system or source traceable to the National Institute of Standards and Technology and published protocols accepted by nationally recognized bodies; or by a calibration laboratory accredited by the American Association of Physicists in Medicine. The calibration shall have been performed within the previous 2 years and after any servicing that may have affected system calibration; or

(2) The system shall have been calibrated within the previous 4 years and 18 to 30 months after the calibration, intercompared with another dosimetry system that was calibrated within the past 24 months by the National Institute of Standards and Technology or by a calibration laboratory accredited by the American Association of Physicists in Medicine.

(c) The results of a calibration intercomparison shall have indicated that the calibration factor of the licensee’s system had not changed by more than 2 percent.

(d) The licensee shall not use an intercomparison result to change the calibration factor.

(e) When intercomparing dosimetry systems to be used for calibrating sealed sources for teletherapy units, the licensee shall use a comparable unit with beam attenuators or collimators, as applicable, and sources of the same radionuclide as the source used at the licensee’s facility.

(f) The licensee shall have a dosimetry system available for use for spot-check output measurements, if applicable. To satisfy this requirement:

(1) The system shall be compared with a system that has been calibrated in accordance with He-P 4035.53(a) through (e);

(2) The comparison shall have been performed within the previous year and after each servicing that may have affected system calibration; and

(3) The spot-check system shall be the same system used to meet the requirements in He-P 4035.53(a) through (e).

(g) The licensee shall retain a record of each calibration, intercomparison, and comparison of its dosimetry equipment for the duration of the license. For each calibration, intercomparison, or comparison, the record shall include:

(1) The date;

(2) The manufacturer’s name, model numbers, and serial numbers of the instruments that were calibrated, intercompared, or compared as required by He-P 4035.53(a) through (f);

(3) The correction factor that was determined from the calibration or comparison or the apparent correction factor that was determined from an intercomparison; and

(4) The names of the individuals who performed the calibration, intercomparison, or comparison.

Source. (See Revision Note at part heading for He-P 4035) #6942, eff 2-1-99; ss by #8800, INTERIM, eff 2-1-07, EXPIRED: 7-31-07

New. #8959, eff 8-7-07; ss by #10897, INTERIM, eff
7-22-15, EXPIRES: 1-18-16; ss by #11011, eff 1-15-16; ss by #13048, eff 6-2-20

He-P 4035.54 Full Calibration Measurements on Teletherapy Units, Remote Afterloader Units, and Gamma Stereotactic Radiosurgery Units.

(a) A licensee authorized to use a teletherapy unit for medical use shall perform full calibration measurements on each teletherapy unit as follows:

(1) Before the first medical use of the unit;

(2) Before medical use under the following conditions:

a. Whenever spot check measurements indicate that the output differs by more than 5 percent from the output obtained at the last full calibration corrected mathematically for radioactive decay;

b. Following replacement of the source or following reinstallation of the teletherapy unit in a new location; and

c. Following any repair of the teletherapy unit that includes removal of the source or major repair of the components associated with the source exposure assembly; and

(3) At intervals not exceeding one year.

(b) To satisfy the requirement of He‑P 4035.54(a), full calibration measurements shall include determination of:

(1) The output within +/- 3 percent for the range of field sizes and for the distance or range of distances used for medical use;

(2) The coincidence of the radiation field and the field indicated by the light beam-localizing device;

(3) The uniformity of the radiation field and its dependence on the orientation of the useful beam;

(4) Timer accuracy and linearity over the range use;

(5) “On-off” error; and

(6) The accuracy of all distance measuring and localization devices in medical use.

(c) A licensee shall use the dosimetry system described in He-P 4035.53(a) through (f) to measure the output for one set of exposure conditions, and the remaining radiation measurements required in He-P 4035.54(b)(1) shall then be made using a dosimetry system that indicates relative dose rates.

(d) A licensee shall make full calibration measurements required by He‑P 4035.54(a) in accordance with published protocols accepted by nationally recognized bodies.

(e) A licensee shall correct mathematically the outputs determined in He‑P 4035.54(b)(1) for physical decay for intervals not exceeding one month for cobalt-60, intervals not exceeding 6 months for cesium-137, or at intervals consistent with one percent decay for all other nuclides.

(f) Full calibration measurements required by He-P 4035.54(a) and physical decay corrections required by He‑P 4035.54(e) shall be performed by an authorized medical physicist. A licensee shall retain a record of each calibration in accordance with He-P 4035.54(u) and (v).

(g) A licensee authorized to use a remote afterloader unit for medical use shall perform full calibration measurements on each unit:

(1) Before the first medical use of the unit;

(2) Before medical use under the following conditions:

a. Following replacement of the source or following reinstallation of the unit in a new location outside the facility; and

b. Following any repair of the unit that includes removal of the source or major repair of the components associated with the source exposure assembly; and

(3) At intervals not exceeding 3 months for high dose-rate, medium dose-rate, and pulsed dose-rate remote afterloader units with sources whose half-life exceeds 75 days; and

(4) At intervals not exceeding 1 year for low dose-rate remote afterloader units.

(h) To satisfy the requirement of He-P 4035.54(g), full calibration measurements shall include, as applicable, determination of:

(1) The output within +/- 5 percent;

(2) Source positioning accuracy to within +/- 1 millimeter;

(3) Source retraction with backup battery upon power failure;

(4) Length of the source transfer tubes;

(5) Timer accuracy and linearity over the typical range of use;

(6) Length of the applicators; and

(7) Function of the source transfer tubes, applicators, and transfer tube-applicator interfaces.

(i) A licensee shall use the dosimetry system described in He-P 4035.53(a) through (f) to measure the output.

(j) A licensee shall make full calibration measurements required in He-P 4035.54(g) in accordance with published protocols accepted by nationally recognized bodies.

(k) In addition to the requirements for full calibration for low dose-rate remote afterloaders in He-P 4035.54(h), a licensee shall perform an autoradiograph of the source(s) to verify inventory and source(s) arrangement at intervals not exceeding 3 months.

(l) For low dose-rate remote afterloader units, a licensee shall use measurements provided by the source manufacturer that are made in accordance with He-P 4035.54(g) through (k).

(m) A licensee shall mathematically correct the outputs determined in He-P 4035.54(h)(1) for physical decay at intervals consistent with 1 percent physical decay.

(n) Full calibration measurements required by He-P 4035.54(g) and physical decay corrections required by He-P 4035.54(m) shall be performed by the authorized medical physicist. A licensee shall retain a record of each calibration in accordance with He-P 4035.54(u) and (v).

(o) A licensee authorized to use a gamma stereotactic radiosurgery unit for medical use shall perform full calibration measurements on each unit:

(1) Before the first medical use of the unit;

(2) Before medical use under the following conditions:

a. Whenever spot check measurements indicate that the output differs by more than 5 percent from the output obtained at the last full calibration corrected mathematically for radioactive decay;

b. Following replacement of the sources or following reinstallation of the gamma stereotactic radiosurgery unit in a new location; and

c. Following any repair of the gamma stereotactic radiosurgery unit that includes removal of the sources or major repair of the components associated with the source assembly; and

(3) At intervals not exceeding 1 year, with the exception that relative helmet factors need only be determined before the first medical use of a helmet and following any damage to a helmet.

(p) To satisfy the requirement of He-P 4035.54(o), full calibration measurements shall include determination of:

(1) The output within +/- 3 percent;

(2) Relative helmet factors;

(3) Isocenter coincidence;

(4) Timer accuracy and linearity over the range of use;

(5) “On-off” error;

(6) Trunnion centricity;

(7) Treatment table retraction mechanism, using backup battery power or hydraulic backups with the unit off;

(8) Helmet microswitches;

(9) Emergency timing circuits; and

(10) Stereotactic frames and localizing devices (trunnions).

(q) A licensee shall use the dosimetry system described in He-P 4035.53(a) through (f) to measure the output for one set of exposure conditions. The remaining radiation measurements required in He-P 4035.54(p)(1) shall be made using a dosimetry system that indicates relative dose rates.

(r) A licensee shall make full calibration measurements required by He-P 4035.54(o) in accordance with published protocols accepted by nationally recognized bodies.

(s) A licensee shall mathematically correct the outputs determined in He-P 4035.54(p)(1) at interval not exceeding 1 month for cobalt-60 and at intervals consistent with 1 percent physical decay for all other radionuclides.

(t) Full calibration measurements required by He-P 4035.54(o) and physical decay corrections by He-P 4035.54(s) shall be performed by the authorized medical physicist. A licensee shall retain a record of each calibration in accordance with He-P 4035.54(u) and (v).

(u) A licensee shall maintain a record of each calibration of teletherapy unit, remote afterloader unit, and gamma stereotactic radiosurgery unit for 3 years.

(v) The record in (u) above shall include the date of the calibration, the manufacturer’s name, model number, and serial number of the teletherapy, remote afterloader, and gamma stereotactic radiosurgery unit(s), the source(s), and the instruments used to calibrated the unit(s); the results and an assessment of the full calibrations; the results of the autograph required for low dose-rate remote afterloader units; and the signature of the authorized medical physicist who performed the full calibration.

Source. (See Revision Note at part heading for He-P 4035) #6942, eff 2-1-99; ss by #8800, INTERIM, eff 2-1-07, EXPIRED: 7-31-07

New. #8959, eff 8-7-07; ss by #10897, INTERIM, eff
7-22-15, EXPIRES: 1-18-16; ss by #11011, eff 1-15-16; ss by #13048, eff 6-2-20

He-P 4035.55 Periodic Spot-Checks for Teletherapy Units, Remote Afterloader Units, and Gamma Stereotactic Radiosurgery Units.

(a) A licensee authorized to use teletherapy units for medical use shall perform output spot-checks on each teletherapy unit once in each calendar month that include determination of:

(1) Timer accuracy and timer linearity over the range of use;

(2) “On-off” error;

(3) The coincidence of the radiation field and the field indicated by the light beam-localizing device;

(4) The accuracy of all distance measuring and localization devices used for medical use;

(5) The output for 1 typical set of operating conditions measured with the dosimetry system described in He-P 4035.53(g); and

(6) The difference between the measurement made in He‑P 4035.55(a)(5) and the anticipated output, expressed as a percentage of the anticipated output (i.e., the value obtained at last full calibration corrected mathematically for physical decay).

(b) A licensee shall perform spot-checks required by He‑P 4035.55(a) in accordance with written procedures established by the authorized medical physicist. That individual need not actually perform the spot check measurements.

(c) A licensee shall have the authorized medical physicist review the results of each output spot-check within 15 days. The authorized medical physicist shall promptly notify the licensee in writing of the results of each output spot-check.

(d) A licensee authorized to use a teletherapy unit for medical use shall perform safety spot-checks of each teletherapy facility once in each calendar month and after each source installation, to assure proper operation of:

(1) Electrical interlocks at each teletherapy room entrance;

(2) Electrical or mechanical stops installed for the purpose of limiting use of the primary beam of radiation restriction of source housing angulation or elevation, carriage or stand travel, and operation of the beam “on-off” mechanism;

(3) Source exposure indicator lights on the teletherapy unit, on the control console, and in the facility;

(4) Viewing and intercom systems;

(5) Treatment room doors from inside and outside the treatment room; and

(6) Electrically assisted treatment room doors with the teletherapy unit electrical power turned “off”.

(e) A licensee shall lock the control console in the “off” position if the results of the checks required in He-P 4035.55(d) indicates the malfunction of any system, and not use the unit except as may be necessary to repair, replace, or check the malfunctioning system.

(f) A licensee shall maintain a record of each spot-check required by He‑P 4035.55(a) and (d) for 3 years.

(g) The record shall include:

(1) The date of the spot-check;

(2) The manufacturer’s name, model number, and serial number of the teletherapy unit, source, and instrument used to measure the output of the teletherapy unit;

(3) An assessment of timer linearity and constancy;

(4) The calculated “on-off” error;

(5) A determination of the coincidence of the radiation field and the field indicated by the light beam-localizing device;

(6) The determined accuracy of each distance measuring or localization device;

(7) The difference between the anticipated output and the measured output;

(8) Notations indicating the operability of each entrance door electrical interlock, each electrical or mechanical stop, each source exposure indicator light, the viewing and intercom system and doors; and

(9) The name of the individual who performed the periodic spot-check and the signature of the authorized medical physicist who reviewed the record of the spot-check.

(h) A licensee shall retain a copy of the procedures required by He-P 4035.55(b) until the licensee no longer possesses the teletherapy unit.

(i) A licensee authorized to use a remote afterloader unit for medical use shall perform spot-checks of each remote afterloader facility and on each unit:

(1) Before the first use of a high dose-rate, medium dose-rate, or pulsed dose-rate afterloader

unit on a given day;

(2) Before each patient treatment with a low dose-rate remote afterloader unit; and

(3) After each source installation.

(j) A licensee shall perform the measurements required by He-P 4035.55(i) in accordance with written procedures established by the authorized medical physicist. That individual need not actually perform the spot check measurements.

(k) A licensee shall have the authorized medical physicist review the results of each spot-check within 15 days. The authorized medical physicist shall promptly notify the licensee in writing of the results of each spot-check.

(l) To satisfy the requirements of He-P 4035.55(i), spot-checks shall, at a minimum, assure proper operation of:

(1) Electrical interlocks at each remote afterloader unit room entrance;

(2) Source exposure indicator lights on the remote afterloader unit, on the control console, and in the facility;

(3) Viewing and intercom systems in each high dose-rate, medium dose-rate, and pulsed dose-rate remote afterloader facility;

(4) Emergency response equipment;

(5) Radiation monitors used to indicate the source position;

(6) Timer accuracy;

(7) Clock (date and time) in the unit’s computer; and

(8) Decay source(s) activity in the unit’s computer.

(m) If the results of the checks required in He-P 4035.55(l) indicate the malfunction of any system, a licensee shall lock the control console in the “off” position and not use the unit except as may be necessary to repair, replace, or check the malfunctioning system.

(n) A licensee shall retain a record of each check required by He-P 4035.55(l) for 3 years. The record shall include, as applicable:

(1) The date of the spot-check;

(2) The manufacturer’s name, model number, and serial number for the remote afterloader unit and source;

(3) An assessment of timer accuracy;

(4) Notations indicating the operability of each entrance door electrical interlock, radiation monitors, source exposure indicator lights, viewing and intercom systems, and clock and decayed source activity in the unit’s computer; and

(5) The name of the individual who performed the periodic spot-check and the signature of the authorized medical physicist who reviewed the record of the spot-check.

(o) A licensee shall retain a copy of the procedures required by He-P 4035.55(j) until the licensee no longer possesses the remote afterloader unit.

(p) A licensee authorized to use a gamma stereotactic radiosurgery unit for medical use shall perform spot-checks of each gamma stereotactic radiosurgery facility and on each unit:

(1) Monthly;

(2) Before the first use of the unit on a given day; and

(3) After each source installation.

(q) A licensee shall:

(1) Perform the measurements required by He-P 4035.55(p) in accordance with written procedures established by the authorized medical physicist. That individual need not actually perform the spot check measurements.

(2) Have the authorized medical physicist review the results of each spot-check within 15 days. The authorized medical physicist shall promptly notify the licensee in writing of the results of each spot-check.

(r) To satisfy the requirements of He-P 4035.55(p)(1), spot-checks shall, at a minimum:

(1) Assure proper operation of:

a. Treatment table retraction mechanism, using backup battery power or hydraulic backups with the unit off:

b. Helmet microswitches;

c. Emergency timing circuits; and

d. Stereotactic frames and localizing devices (trunnions).

(2) Determine:

a. The output for one typical set of operating conditions measured with the dosimetry system described in He-P 4035.53(g);

b. The difference between the measurement made in He-P 4035.55(r)(2)a. and the anticipated output, expressed as a percentage of the anticipated output (i.e., the value obtained at last full calibration corrected mathematically for physical decay);

c. Source output against computer calculation;

d. Timer accuracy and linearity over the range of use;

e. “On-off” error; and

f. Trunnion centricity.

(s) To satisfy the requirements of He-P 4035.55(p)(2) and (p)(3), spot-checks shall assure proper operation of:

(1) Electrical interlocks at each gamma stereotactic radiosurgery room entrance;

(2) Source exposure indicator lights on the gamma stereotactic radiosurgery unit, on the control console, and in the facility;

(3) Viewing and intercom systems;

(4) Timer termination;

(5) Emergency “off” buttons; and

(6) Radiation monitors used to indicate room exposures.

(t) A licensee shall arrange for repair of any system identified in He-P 4035.55(r) that is not operating as soon as possible.

(u) If the results of the checks required in He-P 4035.55(s) indicate the malfunction of any system, a licensee shall lock the control console in the “off” position and not use the unit except as may be necessary to repair, replace, or check the malfunctioning system.

(v) A licensee shall retain a record of each check required by He-P 4035.55(r) and (s) for 3 years. The record shall include:

(1) The date of the spot-check;

(2) The manufacturer’s name, model number, and serial number for the gamma stereotactic radiosurgery unit and the instrument used to measure the output of the unit;

(3) An assessment of timer linearity and accuracy;

(4) The calculated “on-off” error;

(5) A determination of trunnion centricity;

(6) The difference between the anticipated output and the measured output;

(7) An assessment of source output against computer calculations;

(8) Notations indicating the operability of radiation monitors, helmet microswitches, emergency timing circuits, emergency “off” buttons, electrical interlocks, source exposure indicator lights, viewing and intercom systems, timer termination, treatment table retraction mechanism, and stereotactic frames and localizing devices (trunnions); and

(9) The name of the individual who performed the periodic spot-check and the signature of the authorized medical physicist who reviewed the record of the spot-check.

(w) A licensee shall retain a copy of the procedures required by He-P 4035.55(r) and (s) until the licensee no longer possesses the gamma stereotactic radiosurgery unit.

Source. (See Revision Note at part heading for He-P 4035) #6942, eff 2-1-99; ss by #8800, INTERIM, eff 2-1-07, EXPIRED: 7-31-07

New. #8959, eff 8-7-07; ss by #10897, INTERIM, eff
7-22-15, EXPIRES: 1-18-16; ss by #11011, eff 1-15-16; amd by #12054, eff 11-19-16; ss by #13048, eff 6-2-20

He-P 4035.56 Radiation Surveys for Therapy Facilities.

(a) In addition to the survey requirements in He-P 4022.01, a licensee shall make surveys to ensure that the maximum radiation levels and average radiation levels from the surface of the main source safe with the source(s) in the shielded position do not exceed the levels stated in the Sealed Source and Device Registry.

(b) The licensee shall make the survey required by He-P 4035.56(a) at installation of a new source and following repairs to the source(s) shielding, the source(s) driving unit, or other electronic or mechanical component that could expose the source, reduce the shielding around the source(s), or compromise the radiation safety of the unit or the source(s).

(c) A licensee shall retain a record of the radiation surveys of treatment units made in accordance with He-P 4035.56(a) for the duration of use of the unit. The record shall include:

(1) The date of the measurements;

(2) The manufacturer’s name, model number and serial number of the treatment unit, source, and instrument used to measure radiation levels;

(3) Each dose rate measured around the source while the unit is in the off position and the average of all measurements; and

(4) The name and the signature of the individual who performed the test.

Source. (See Revision Note at part heading for He-P 4035) #6942, eff 2-1-99; ss by #8800, INTERIM, eff 2-1-07, EXPIRED: 7-31-07

New. #8959, eff 8-7-07; ss by #10897, INTERIM, eff
7-22-15, EXPIRES: 1-18-16; ss by #11011, eff 1-15-16; amd by #12054, eff 11-19-16

He-P 4035.57 Therapy-related Computer Systems. The licensee shall perform acceptance testing on the treatment planning system of therapy-related computer systems in accordance with published protocols accepted by nationally recognized bodies. At a minimum, the acceptance testing shall include, as applicable, verification of:

(a) The source-specific input parameters required by the dose calculation algorithm;

(b) The accuracy of dose, dwell time, and treatment time calculations at representative points;

(d) The accuracy of the software used to determine sealed source positions from radiographic images; and

(e) The accuracy of electronic transfer of the treatment delivery parameters to the treatment delivery unit from the treatment planning system.

Source. (See Revision Note at part heading for He-P 4035) #6942, eff 2-1-99; ss by #8800, INTERIM, eff 2-1-07, EXPIRED: 7-31-07

New. #8959, eff 8-7-07; ss by #10897, INTERIM, eff
7-22-15, EXPIRES: 1-18-16; ss by #11011, eff 1-15-16

He-P 4035.58 RESERVED

Source. (See Revision Note at part heading for He-P 4035) #6942, eff 2-1-99; ss by #8800, INTERIM, eff 2-1-07, EXPIRED: 7-31-07

New. #8959, eff 8-7-07; ss by #10897, INTERIM, eff
7-22-15, EXPIRES: 1-18-16; rpld by #11011, eff 1-15-16

He-P 4035.59 Training for Use of Remote Afterloader Units, Teletherapy Units, and Gamma Stereotactic Radiosurgery Units. Except as provided in He-P 4035.71, the licensee shall require an authorized user of a sealed source for use authorized under He-P 4035.47 to be a physician who:

(a) Is certified by a medical specialty board whose certification process has been recognized by the DHHS/RHS, an agreement state, or the Nuclear Regulatory Commission and who meets the requirements in He-P 4035.59(c). The names of board certifications that have been recognized by DHHS/RHS, and agreement state, or the Nuclear Regulatory Commission are posted on the NRC’s Medical Uses Licensee Toolkit webpage. To have its certification process recognized, a specialty board shall require all candidates for certification to:

(1) Successfully complete a minimum of 3 years of residency training in a radiation therapy program approved by the Residency Review Committee of the Accreditation Council for Graduate Medical Education or the Royal College of Physicians and Surgeons of Canada or the Committee on Post-Graduate Training of the American Osteopathic Association; and

(2) Pass an examination, administered by diplomats of the specialty board, which tests knowledge and competence in radiation safety, radionuclide handling, treatment planning, quality assurance, and clinical use of stereotactic radiosurgery, remote afterloaders and external beam therapy; or

(b) Has completed a structured educational program in basic radionuclide techniques applicable to the use of a sealed source in a therapeutic medical unit that includes:

(1) 200 hours of classroom and laboratory training in the following areas:

a. Radiation physics and instrumentation;

b. Radiation protection;

c. Mathematics pertaining to the use and measurement of radioactivity; and

d. Radiation biology; and

(2) 500 hours of work experience, under the supervision of an authorized user who meets the requirements in He-P 4035.59, He-P 4035.71, the equivalent requirements of an agreement state, or the Nuclear Regulatory Commission at a medical facility that is authorized to use byproduct materials in He-P 4035.47, involving:

a. Reviewing full calibration measurements and periodic spot-checks;

b. Preparing treatment plans and calculating treatment doses and times;

c. Using administrative controls to prevent a medical event involving the use of byproduct material;

d. Implementing emergency procedures to be followed in the event of the abnormal operation of the medical unit or console;

e. Checking and using survey meters; and

f. Selecting the proper dose and how it is to be administered; and

(3) Has completed 3 years of supervised clinical experience in radiation therapy, under an authorized user who meets the requirements in He-P 4035.59, He-P 4035.71, the equivalent requirements of an agreement state, or the Nuclear Regulatory Commission, as part of a formal training program approved by the Residency Review Committee for Radiation Oncology of the Accreditation Council for Graduate Medical Education or the Royal College of Physicians and Surgeons of Canada or the Committee on Postdoctoral Training of the American Osteopathic Association. This experience may be obtained concurrently with the supervised work experience required by He-P 4035.59(b)(2); and

(4) Has obtained written attestation that the individual has satisfactorily completed the requirements in He-P 4035.59(b)(1), (b)(2), and (b)(3), and He-P 4035.59(c), and is able to independently fulfill the radiation safety-related duties as an authorized user of each type of therapeutic medical unit for which the individual is requesting authorized user status. The written attestation shall obtained from either:

a. A preceptor authorized user who meets the requirements in He-P 4035.59, He-P 4035.71, the equivalent requirements of an agreement state, or the Nuclear Regulatory Commission for type(s) of therapeutic medical unit for which the individual is requesting authorized user status; or

b. A residency program director who affirms in writing that the attestation represents the consensus of the residency program faculty where at least one faculty member is an authorized user who meets the requirements in He-P 4035.59, He-P 4035.71, or the equivalent requirements of an agreement state, or the Nuclear Regulatory Commission, for the type(s) of therapeutic medical unit for which the individual is requesting authorized user status, and concurs with the attestation provided by the residency program director. The residency training program shall be approved by the Residency Review Committee of the Accreditation Council for Graduate Medical Education or the Royal College of Physicians and Surgeons of Canada, or the Council on Postdoctoral Training of the American Osteopathic Association and shall include training and experience specified in He-P 4035.59(b), (b)(1), (b)(2), and (b)(3).

(c) Has received training in device operation, safety procedures, and clinical use for the type(s) of use for which authorization is sought. This training requirement may be satisfied by satisfactory completion of a training program provided by the vendor for new users or by receiving training supervised by an authorized user or authorized medical physicist, as appropriate, who is authorized for the type(s) of use for which the individual is seeking authorization.

Source. (See Revision Note at part heading for He-P 4035) #6942, eff 2-1-99; ss by #8800, INTERIM, eff 2-1-07, EXPIRED: 7-31-07

New. #8959, eff 8-7-07; ss by #10897, INTERIM, eff
7-22-15, EXPIRES: 1-18-16; ss by #11011, eff 1-15-16; ss by #13048, eff 6-2-20

He-P 4035.60 Full Inspection Servicing for Teletherapy and Gamma Stereotactic Radiosurgery Units.

(a) A licensee shall have each teletherapy unit and gamma stereotactic radiosurgery unit fully inspected and serviced during each source replacement to assure proper functioning of the source exposure mechanism and other safety components. The interval between each full-inspection servicing shall not exceed 5 years for each teletherapy unit and shall not exceed 7 years for each gamma stereotactic radiosurgery unit.

(b) This inspection and servicing shall only be performed by persons specifically licensed to do so by DHHS/RHS, an agreement state, or the Nuclear Regulatory Commission.

(c) A licensee shall maintain a record of the full inspection servicing for teletherapy and gamma stereotactic radiosurgery units for the duration of use of the unit.

(d) The record required in He-P 4035.60(c) shall contain:

(1) The inspector’s name;

(2) The inspector’s radioactive materials license number;

(3) The date of inspection;

(4) The manufacturer’s name and model number and serial number for both the treatment unit and source;

(5) A list of components inspected;

(6) A list of components serviced and the type of service;

(7) A list of components replaced; and

(8) The signature of the inspector.

Source. (See Revision Note at part heading for He-P 4035) #6942, eff 2-1-99; ss by #8800, INTERIM, eff 2-1-07, EXPIRED: 7-31-07

New. #8959, eff 8-7-07; ss by #10897, INTERIM, eff
7-22-15, EXPIRES: 1-18-16; ss by #11011, eff 1-15-16; ss by #13048, eff 6-2-20

He-P 4035.61 Training for Radiation Safety Officer and Associate Radiation Safety Officer. Except as provided in He-P 4035.71, the licensee shall require an individual fulfilling the responsibilities of the radiation safety officer or an individual assigned duties and tasks as an associate radiation safety officer as provided in He-P 4035.10 to be an individual who:

(a) Is certified by a specialty board whose certification process has been recognized by DHHS/RHS, or an agreement state, or the Nuclear Regulatory Commission, and which meets the requirements in He-P 4035.61(e). The names of board certifications that have been recognized by DHHS/RHS, an agreement state, or the Nuclear Regulatory Commission are posted on the NRC’s Medical Uses Licensee Toolkit web page. To have its certification process recognized, a specialty board shall require all candidates for certification to:

(1) Hold a bachelor’s or graduate degree from an accredited college or university in physical science or engineering or biological science with a minimum of 20 college credits in physical science;

(2) Have 5 or more years of professional experience in health physics (graduate training may be substituted for no more than 2 years of the required experience) including at least 3 years in applied health physics; and

(3) Pass an examination administered by diplomats of the specialty board, which evaluates knowledge and competence in radiation physics and instrumentation, radiation protection, mathematics pertaining to the use and measurement of radioactivity, radiation biology, and radiation dosimetry; or

(4) Hold a master’s or doctorate level degree in physics, medical physics, other physical science, engineering, or applied mathematics from an accredited college or university; and

(5) Have 2 years full-time practical training; and supervised experience in medical physics; under either:

a. The supervision of a medical physicist who is certified in medical physics by a specialty board recognized by DHHS/RHS, or an agreement state or the Nuclear Regulatory Commission; or

b. In clinical nuclear medicine facilities providing diagnostic and/or therapeutic services under the direction of physicians who meet the requirements for authorized users in He-P 4035.64, He-P 4035.65 or He-P 4035.71; and

(6) Pass an examination, administered by diplomats of the specialty board, that assesses knowledge and competence in clinical diagnostic radiological or nuclear medicine physics and in radiation safety.

(b) Has completed a structured educational program consisting of:

(1) 200 hours of classroom and laboratory training in the following areas:

a. Radiation physics and instrumentation;

b. Radiation protection;

c. Mathematics pertaining to the use and measurements of radioactivity;

d. Radiation biology;

e. Radiation dosimetry; and

(2) One year of full-time radiation safety experience under the supervision of the individual identified as the radiation safety officer on a DHHS/RHS, or agreement state, or Nuclear Regulatory Commission license, or permit issued by a Nuclear Regulatory Commission master material license that authorized similar type(s) of use(s) of byproduct material. An associate radiation safety officer shall provide supervision for those areas for which the associate radiation safety officer is authorized on a DHHS/RHS or an agreement state license or permit issued by a Nuclear Regulatory Committee master material license. The full radiation safety experience shall involve the following:

a. Shipping, receiving, and performing related radiation surveys;

b. Using and performing checks for proper operation of instruments used to determine the activity of dosages, survey meters, and instruments used to measure radionuclides;

c. Securing and controlling byproduct material;

d. Using administrative controls to avoid mistakes in the administration of byproduct material;

e. Using procedures to prevent or minimize radioactive contamination and using proper decontamination procedures;

f. Using emergency procedures to control byproduct material; and

g. Disposing of byproduct material; and

(3) Obtaining a written attestation, signed by a preceptor radiation safety officer or associate radiation Safety officer who has experience with the radiation safety aspects of similar types of use of byproduct material for which the individual is seeking approval as a radiation safety officer or an associate radiation safety officer. The written attestation shall state that the individual has satisfactorily completed the requirements in He-P 4035.61 (b)(1), and (b)(2), and is able to independently fulfill the radiation safety-related duties as a radiation safety officer or as an associate radiation safety officer for a medical use license; or

(c) Is a medical physicist who has been certified by a specialty board whose certification process has been recognized by DHHS/RHS under 4035.70(a), or an agreement state, or the Nuclear Regulatory Commission, and has experience in radiation safety for similar types of use of byproduct material for which the licensee is seeking the approval of the individual as radiation safety officer or as associate radiation safety officer, and who meets the requirements in He-P 4035.61€; or

(d) an authorized user, authorized medical physicist, or authorized nuclear pharmacist identified on the DHHS/RHS or agreement state or Nuclear Regulatory Commission license, a permit issued by a Nuclear Regulatory Commission master material licensee, a permit issued by DHHS/RHS or agreement state or Nuclear Regulatory Commission licensee of broad scope, or a permit issued by a Nuclear Regulatory Commission master material license broad scope permittee, and has experience with:

(1) The radiation safety aspects of similar types of use of byproduct material for the licensee seeks the individual as the radiation safety officer or associate radiation safety officer, and meets the requirements in He-P 4035.61(e); or

(2) The radiation safety aspects of the types of use of byproduct material for which the individual is seeking simultaneous approval both as the radiation safety officer and the authorized user on the same new medical use license or new medical use permit issued by a Nuclear Regulatory Commission master material license. The individual shall also meet the requirements in He-P 4035.61(e).

(e) Has training in the radiation safety, regulatory issues, and emergency procedures for the types of use for which a licensee seeks approval. This training requirement may be satisfied by completing training that is supervised by a radiation safety officer, associate radiation safety officer, authorized medical physicist, authorize nuclear pharmacist, or authorized user, as appropriate, who is authorized for the type(s) of use for which the licensee is seeking approval.

Source. (See Revision Note at part heading for He-P 4035) #6942, eff 2-1-99; ss by #8800, INTERIM, eff 2-1-07, EXPIRED: 7-31-07

New. #8959, eff 8-7-07; ss by #10897, INTERIM, eff
7-22-15, EXPIRES: 1-18-16; ss by #11011, eff 1-15-16; ss by #13048, eff 6-2-20

He-P 4035.62 RESERVED

Source. (See Revision Note at part heading for He-P 4035) #6942, eff 2-1-99; ss by #8800, INTERIM, eff 2-1-07, EXPIRED: 7-31-07

New. #8959, eff 8-7-07; ss by #10897, INTERIM, eff
7-22-15, EXPIRES: 1-18-16; rpld by #11011, eff 1-15-16

He-P 4035.63 Training for Uptake, Dilution, or Excretion Studies.

(a) Except as provided in He‑P 4035.71, the licensee shall require the authorized user of unsealed byproduct material listed in He‑P 4035.27 to be a physician, whois certified by a medical specialty board whose certification process has been recognized by DHHS/RHS, or an agreement state, or the Nuclear Regulatory Commission. The names of board certifications that have been recognized by DHHS/RHS, agreement state, or Nuclear Regulatory Commission on the NRC’s Medical Uses Licensee Toolkit web page. To have its certification process recognized, a specialty board shall require all candidates for certification to:

(1) Complete 60 hours of training and experience in basic radionuclide handling techniques and radiation safety applicable to the use of unsealed byproduct material for uptake, dilution, and excretion studies as described in He-P 4035.63(b)(1); and

(2) Pass an examination, administered by diplomats of the specialty board, which assesses knowledge and competence in radiation safety, radionuclide handling, and quality control; or

(b) Except as provided in He-P 4035.71, an authorized user of unsealed byproduct material for the uses authorized under He-P 4035.64, He-P 4035.65, or the equivalent requirements of an agreement state of the Nuclear Regulatory Commission to be a physician, who:

(1) Completed 60 hours of training and experience, including a minimum of 8 hours of classroom and laboratory training, in basic radionuclide handling techniques applicable to the medical use of unsealed byproduct material for uptake, dilution, and excretion studies.

a. The training and experience shall include classroom and laboratory training in the following areas:

1. Radiation physics and instrumentation;

2. Radiation protection;

3. Mathematics pertaining to the use and measurement of radioactivity;

4. Chemistry of byproduct material for medical use;

5. Radiation biology; and

b. Work experience, under the supervision of an authorized user who meets the requirements in He-P 4035.63, He-P 4035.64, He-P 4035.65, He-P 4035.71, the equivalent requirements of an agreement state, or the Nuclear Regulatory Commission involving:

1. Ordering, receiving, and unpacking radioactive materials safely and performing the related radiation surveys;

2. Performing quality control procedures on instruments used to determine the activity of dosages and performing checks for proper operation of survey meters;

3. Calculating, measuring, and safely preparing patient or human research subject dosages;

4. Using administrative controls to prevent a medical event involving the use of unsealed byproduct material;

5. Using procedures to contain spilled byproduct material safely and using proper decontamination procedures;

6. Administering dosages of radioactive drugs to patients or human research subjects; and

(2) Obtained written attestation that the individual has satisfactorily completed the requirements of He-P 4035.63(b)(1) and is able to independently fulfill the radiation safety-related duties as an authorized user for the medical uses authorized under He-P 4035.27. The attestation shall be obtained from either:

a. A preceptor authorized user who meets the requirements in He-P 4035.63, He-P 4035.64, He-P 4035.65, or He-P 4035.71, the equivalent requirements of an agreement state, or the Nuclear Regulatory Commission; or

c. The residency training program shall be approved by the Residency Review Committee of the Accreditation Council for Graduate Medical Education or the Royal College of Physicians and Surgeons of Canada or the Council on Postdoctoral Training of the American Osteopathic Association and shall include training and experience specified in He-P 4035.63(b)(1).

Source. (See Revision Note at part heading for He-P 4035) #6942, eff 2-1-99; ss by #8800, INTERIM, eff 2-1-07, EXPIRED: 7-31-07

New. #8959, eff 8-7-07; ss by #10897, INTERIM, eff
7-22-15, EXPIRES: 1-18-16; ss by #11011, eff 1-15-16; ss by #13048, eff 6-2-20

He-P 4035.64 Training for Imaging and Localization Studies.

(a) Except as provided in He-P 4035.71, the licensee shall require the authorized user of unsealed byproduct material listed in He‑P 4035.31 to be a physician who:

(1) Is certified by a medical specialty board whose certification process has been recognized by DHHS/RHS, or an agreement state, or the Nuclear Regulatory Commission. The names of board certification have been recognized by DHHS/RHS, an agreement state, or the Nuclear Regulatory Commission are posted on the NRC’s Medical Uses Licensee Toolkit web page; or

(2) Is an authorized user under He-P 4035.62 and meets the requirements in He-P 4035.64(c)(1)b.7, or the equivalent requirements of an agreement state, or the Nuclear Regulatory Commission requirements.

(b) To have its certification process recognized, a specialty board shall require all candidates for certification to:

(1) Complete 700 hours of training and experience in basic radionuclide handling techniques and radiation safety applicable to the medical use of unsealed byproduct material for imaging and localization studies as described in He-P 4035.64(c)(1)a. through (c)(1)b.7.; and,

(2) Pass an examination, administered by diplomats of the specialty board, which assesses knowledge and competence in radiation safety, radionuclide handling, and quality control.

(c) Except as provided in He-P 4035.65 and meets the requirements in He-P 4035.64(c)(1)b.7., or the equivalent requirements of an agreement state, or the Nuclear Regulatory Commission, an authorized user who:

(1) Has completed 700 hours of training and experience, including a minimum of 80 hours of classroom and laboratory training, in basic radionuclide handling techniques applicable to the medical use of unsealed byproduct material for imaging and localization studies. The training and experience shall include, at a minimum:

a. Classroom and laboratory training in the following areas:

1. Radiation physics and instrumentation;

2. Radiation protection;

3. Mathematics pertaining to the use and measurement of radioactivity;

4. Chemistry of byproduct material for medical use;

5. Radiation biology and

b. Work experience, under the supervision of an authorized user who meets the requirements in He-P 4035.64, He-P 4035.71, or He-P 4035.65 and He-P 4035.64(c)(1)b.7, or the equivalent requirements of an agreement state, or the Nuclear Regulatory Commission requirements. An authorized nuclear pharmacist who meets the requirements in He-P 4035.71 or He-P 4035.74, the equivalent requirements of an agreement state, or the Nuclear Regulatory Commission may provide the supervised work experience for He-P 4035.64(c)(1)b.7. Work experience shall involve:

1. Ordering, receiving and unpacking radioactive materials safely and performing the related radiation surveys;

2. Performing quality control procedures on instruments used to determine the activity of dosages and performing checks for proper operation of survey meters;

3. Calculating, measuring and safely preparing patient or human research subject dosages;

4. Using administrative controls to prevent a medical event involving the use of unsealed byproduct material;

5. Using procedures to contain spilled byproduct material safely and using proper decontamination procedures;

6. Administering dosages of radioactive drugs to patients or human research subjects; and

7. Eluting generator systems appropriate for preparation of radioactive drugs for imaging and localization studies, measuring and testing the eluate for radionuclide purity, and processing the eluate with reagent kits to prepare labeled radioactive drugs; and

(2) Obtained a written attestation that the individual has satisfactorily completed the requirements in He-P 4035.64(c)(1) and is able to independently fulfill the radiation safety-related duties as an authorized user for the medical uses authorized under He-P 4035.27 and He-P 4035.31. The attestation shall be obtained from either:

a. A preceptor authorized user who meets the requirements in He-P 4035.64, He-P 4035.71, or He-P 4035.65 and He-P 4035.64(c)(1)b.7., or the equivalent requirements of an agreement state, or the Nuclear Regulatory Commission; or

b. A residency program director who affirms in writing that the attestation represents the consensus of the residency program faculty where at least one faculty member is an authorized user who meets the requirements in He-P 4035.64, He-P 4035.71, or He-P 4035.65 and He-P 4035.64(c)(1)b.7., or the equivalent requirements of an agreement state, or the Nuclear Regulatory Commission, and concurs with the attestation provided by the residency program director. The residency training program shall be approved by the Residency Review Committee of the Accreditation Council for Graduate Medical Education or the Royal College of Physicians and Surgeons of Canada or the Council on Postdoctoral Training of the American Osteopathic Association and shall include training and experience specified in He-P 4035.64(c)(1).

Source. (See Revision Note at part heading for He-P 4035) #6942, eff 2-1-99; ss by #8800, INTERIM, eff 2-1-07, EXPIRED: 7-31-07

New. #8959, eff 8-7-07; ss by #10897, INTERIM, eff
7-22-15, EXPIRES: 1-18-16; ss by #11011, eff 1-15-16; ss by #13048, eff 6-2-20

He-P 4035.65 Training for Use of Unsealed Byproduct Material for Which a Written Directive Is Required.

(a) Except as provided in He-P 4035.71, the licensee shall require the authorized user of unsealed byproduct material listed in He‑P 4035.35 to be a physician who:

(1) Is certified by a medical specialty board whose certification process has been recognized by DHHS/RHS, or an agreement state, or the Nuclear Regulatory Commission. The names of board certifications that have been recognized by DHHS\RHS, an agreement state, or the Nuclear Regulatory Commission are posted on the NRC’s Medical Uses Licensee Toolkit web page; and

(2) Meets the requirements in He-P 4035.65(c)(2)b. and He-P 4035.65(d) through (e).

(b) To have its certification process recognized, a specialty board shall require all candidates for certification to:

(1) Successfully complete residency training in a radiation therapy or nuclear medicine training program or a related medical specialty. These residency training programs shall include 700 hours of training and experience as described in He-P 4035.65(c)(1) through He-P 4035.65(c)(2)a.5. Eligible training programs shall be approved by the Residency Review Committee of the Accreditation Council for Graduate Medical Education, the Royal College of Physicians and Surgeons of Canada, or the Committee on Post-Graduate Training of the American Osteopathic Association; and,

(2) Pass an examination, administered by diplomats of the specialty board, which assesses knowledge and competence in radiation safety, radionuclide handling, and quality assurance and clinical use of unsealed byproduct material for which a written directive is required; or

(c) Except as provided in He-P 4035.71, an authorized user of unsealed byproduct material for the uses authorized under He-P 4035.35 shall be a physician who has:

(1) Completed 700 hours of training and experience, including a minimum of 200 hours of classroom and laboratory training, in basic radionuclide handling techniques applicable to the medical use of unsealed byproduct material requiring a written directive. The classroom and laboratory training shall include:

a. Radiation physics and instrumentation;

b. Radiation protection;

c. Mathematics pertaining to the use and measurement of radioactivity;

d. Chemistry of byproduct material for medical use;

e. Radiation biology; and

(2) Work experience, under the supervision of an authorized user who meets the requirements in He-P 4035.65 or He-P 4035.71, or the equivalent requirements of an agreement state, or the Nuclear Regulatory Commission. A supervising authorized user, who meets the requirements in He-P 4035.65(c) through (e), shall also have experience in administering dosages in the same dosage category or categories (i.e., He-P 4035.65(c)(2)b.) as the individual requesting authorized user status.

a. The work experience shall involve:

1. Ordering, receiving, and unpacking radioactive materials safely and performing the related radiation surveys;

2. Performing quality control procedures on instruments used to determine the activity of dosages and performing checks for proper operation of survey meters;

3. Calculating, measuring, and safely preparing patient or human research subject dosages;

4. Using administrative controls to prevent a medical event involving the use of unsealed byproduct material;

5. Using procedures to contain spilled byproduct material safely and using proper decontamination procedures;

b. Administering dosages of radioactive drugs to patients or human research subjects from the 3 categories in this paragraph. Radioactive drugs containing radionuclides in categories not included in this paragraph are regulated under He-P 4035.29. This work experience shall involve a minimum of 3 cases in each of the following categories for which the individual is requesting authorized user status:

1. Oral administration of less than or equal to 1.22 gigabecquerels (33 millicuries) of sodium iodine I-131, for which a written directive is required;

2. Oral administration of greater than 1.22 gigabecquerels (33 millicuries) of sodium iodine I-131[Experience with at least 3 cases in Category (c)(2)b.2. also satisfies the requirement in Category(c)(2)b.1.]; or

3. Parenteral administration of any radioactive drug that contains a radionuclide that is primarily used for its electron emission, beta radiation characteristics, alpha radiation characteristics, or a a photon energy less than 150 keV, for which a written directive is required; and

(d) In addition to meeting the requirements of (a) or (b) or (c) above, a licensee shall require an authorized user to obtain a written attestation that the individual has satisfactorily completed the requirements in He-P 4035.65(c) and is able to independently fulfill the radiation safety-related duties as an authorized user for the medical uses authorized under He-P 4035.35 for which the individual is requesting authorized user status.

(e) The written attestation shall be obtained from either:

(1) A preceptor authorized user who meets the requirements in He-P 4035.65 or He-P 4035.71, or the equivalent requirements of an agreement state, or the Nuclear Regulatory Commission and has experience in administering dosages in the same dosage category or categories as the individual requesting authorized user status; or

(2) A residency program director who affirms in writing that the attestation represents the consensus of the residency program faculty where at least one faculty member is an authorized user who meets the requirements in He-P 4035.65 or He-P 4035.71, or the equivalent requirements of an agreement state, or the Nuclear Regulatory Commission, has experience in administering dosages in the same dosage category or categories as the individual authorized user status, and concurs with the attestation provided by the residency program director. The residency training program shall be approved by the Residency Review Committee of the Accreditation Council for Graduate Medical Education or the Royal College of Physicians and Surgeons of Canada, or the Council on Postdoctoral Training of the American Osteopathic Association and shall include and experience specified in He-P 4035.65(c).

Source. (See Revision Note at part heading for He-P 4035) #6942, eff 2-1-99; ss by #8800, INTERIM, eff 2-1-07, EXPIRED: 7-31-07

New. #8959, eff 8-7-07; ss by #10897, INTERIM, eff
7-22-15, EXPIRES: 1-18-16; ss by #11011, eff 1-15-16; ss by #13048, eff 6-2-20

He-P 4035.66 Training for the Oral Administration of Sodium Iodide I-131 and for the Parenteral Administration Requiring a Written Directive.

(a) Except as provided in He‑P 4035.71, the licensee shall require the authorized user for the oral administration of sodium iodide I-131 requiring a written directive in quantities less than or equal to 1.22 gigabecquerels (33 millicuries), to be a physician who:

(1) Is certified by a medical specialty board whose certification process includes all the requirements in He-P 4035.66(b)(1), (b)(2), and whose certification process has been recognized by DHHS/RHS, an agreement state, or the Nuclear Regulatory Commission. The names of board certifications that have been recognized by DHHS/RHS, an agreement state, or Nuclear Regulatory Commission on the NRC’s Medical Uses Licensee Toolkit web page; or

(2) Is an authorized user under He-P 4035.65 for uses listed in He-P 4035.65(c)(2)b.1. or He-P 4035.65(c)(2)b.2., or He-P 4035.66(d) and (e), or equivalent requirements of an agreement state, or the Nuclear Regulatory Commission; or

(b) Except as provided in He-P 4035.71, a physician who does not meet the requirement of He-P 4035.66(a) above shall: successfully complete 80 hours of classroom and laboratory training, applicable to the medical use of sodium iodide I-131 for procedures requiring a written directive.

(1) The training shall include:

a. Radiation physics and instrumentation;

b. Radiation protection;

c. Mathematics pertaining to the use and measurement of radioactivity;

d. Chemistry of byproduct material for medical use; and

e. Radiation biology; and

(2) Has work experience, under the supervision of an authorized user who meets the requirements in He-P 4035.65, He-P 4035.66(a) through (e), He-P 4035.71, or the equivalent requirements of an agreement state, or the Nuclear Regulatory Commission. A supervising authorized user who meets the requirements in He-P 4035.65(c) through (e) shall also have experience in administering dosages as specified in He-P 4035.65(c)(2)b.1. or (c)(2)b.2. The work experience shall include:

a. Ordering, receiving, and unpacking radioactive materials safely and performing the related radiation surveys;

b. Performing quality control procedures on instruments used to determine the activity of dosages and performing checks for proper operation of survey meters;

c. Calculating, measuring, and safely preparing patients or human research subject dosages;

d. Using administrative controls to prevent a medical event involving the use of byproduct material;

e. Using procedures to contain spilled byproduct material safely and using proper decontamination procedures; and

f. Administering dosages to patients or human research subjects, that includes at least 3 cases involving the oral administration of less than or equal to 1.22 gigabecquerels (33 millicuries) of sodium iodide I-131; and

(3) Have obtained a written attestation that the physician has satisfactorily completed the requirements in He-P 4035.66(b)(1) and (b)(2), and is able to independently fulfill the radiation safety-related duties as an authorized user for oral administration of less than or equal to 1.22 gigabecquerel (33 millicuries) of sodium iodide I-133 for medical uses authorized under He-P 4035.35.

(1) A preceptor authorized user who meets the requirements in He-P 4035.65, He-P 4035.66(a)through (e), He-P 4035.71, or the equivalent requirements of an agreement state, or the Nuclear Regulatory Commission; and

(2) Has experience in administering dosages as specified in He-P 4035.65(c)(2)b.1. or 2.; or

(3) A residency program director who affirms in writing that the attestation represents the consensus of the residency program faculty where at least one faculty member is an authorized user who meets the requirements in He-P 4035.65, He-P 4035.66(a) through (e), He-P 4035.71, or the equivalent requirements of an agreement state, or the Nuclear Regulatory Commission, has experience in administering dosages as specified in He-P 4035.65(c)(2)b.1., or b.2., and concurs with the attestation provided by the residency program director. The residency training program shall be approved by the Residency Review Committee of the Accreditation Council for Graduate Medical Education or the Royal College of Physicians and Surgeons of Canada, or the Council on Postdoctoral Training of the American Osteopathic Association and shall include and experience specified in He-P 4035.66(b)(1) and (2).

(d) Except as provided in He‑P 4035.71, the licensee shall require the authorized user for the oral administration of sodium iodide I-131 requiring a written directive in quantities greater than 1.22 gigabecquerels (33 millicuries), to be a physician who:

(1) Is certified by a medical specialty board whose certification process includes all of the requirements in He-P 4035.66(e)(1) and (2), and whose certification has been recognized by the DHHS/RHS, or an agreement state, or the Nuclear Regulatory Commission. The names of board certifications that have been recognized by DHHS/RHS, an agreement state, or the Nuclear Regulatory Commission are posted on the NRC’s Medical Uses Licensee Toolkit web page; or

(2) Is an authorized user under He-P 4035.65 for uses listed in He-P 4035.65(c)(2)b.2., or the equivalent requirements of an agreement state, or the Nuclear Regulatory Commission; or

(e) Except as provided in He‑P 4035.71, the licensee shall require the authorized user for the oral administration of sodium iodide I-131 requiring a written directive in quantities greater than 1.22 gigabecquerels (33 millicuries), to be a physician who:

(1) Has successfully completed 80 hours of classroom and laboratory training, applicable to the medical use of sodium iodide I-131 for procedures requiring a written directive. The training shall include:

a. Radiation physics and instrumentation;

b. Radiation protection;

c. Mathematics pertaining to the use and measurement of radioactivity;

d. Chemistry of byproduct material for medical use; and

e. Radiation biology; and

(2) Has work experience, under the supervision of an authorized user who meets the requirements in He-P 4035.65, He-P 4035.66(d) and (e), He-P 4035.71, or the equivalent requirements of an agreement state, or the Nuclear Regulatory Commission. A supervising authorized user, who meets the requirements in He-P 4035.65(c) through (e), shall also have experience in administering dosages as specified in He-P 4035.65(c)(2)b.2. The work experience shall involve:

a. Ordering, receiving, and unpacking radioactive materials safely and performing the related radiation surveys;

b. Performing quality control procedures on instruments used to determine the activity of dosages and performing checks for proper operation of survey meters;

c. Calculating, measuring, and safely preparing patient or human research subject dosages;

d. Using administrative controls to prevent a medical event involving the use of byproduct material;

e. Using procedures to contain spilled byproduct material safely and using proper decontamination procedures; and

f. Administering dosages to patients or human research subjects, that include at least 3 cases involving the oral administration of greater than 1.22 gigabecquerels (33 millicuries) of sodium iodide I-131; and

(3) Has obtained written attestation that the individual has satisfactorily completed the requirements in He-P 4035.66(e)(1) and (e)(2), and has achieved a level of competency sufficient to function independently as an authorized user for medical uses authorized under He-P 4035.35. The attestation shall be obtained from either:

a. A preceptor authorized user who meets the requirements in He-P 4035.65, He-P 4035.66(d), and (e), He-P 4035.71, the equivalent requirements of an agreement state, or the Nuclear Regulatory Commission, and has experience in administering dosages as specified in He-P 4035.65(c)(2)b.2.; or

b. A residency program director who affirms in writing that the attestation represents the consensus of the residency program faculty where at least one faculty member is an authorized user who meets the requirements in He-P 4035.65, He-P 4035.66(d) and (e), He-P 4035.71, or the equivalent requirements of an agreement state, or the Nuclear Regulatory Commission, has experience in administering dosages as specified in He-P 4035.65(c)(2)b.2., and concurs with the attestation provided by the residency program director. The residency training program shall be approved by the Residency Review Committee of the Accreditation Council for Graduate Medical Education or the Royal College of Physicians and Surgeons of Canada, or the Council on Postdoctoral Training of the American Osteopathic Association and shall include and experience specified in He-P 4035.66(e)(1) and (2).

(f) Except as provided in He-P 4035.71, the licensee shall require an authorized user for the parenteral administration requiring a written directive, to be a physician who:

(1) Is an authorized user under He-P 4035.65 for uses listed in He-P 4035.65(c)(2)b.3.the equivalent requirements of an agreement state, or the Nuclear Regulatory Commission; or

(2) Is an authorized user under He-P 4035.59 or He-P 4035.69, or the equivalent requirements of an agreement state, or Nuclear Regulatory Commission and meets the requirements in He-P 4035.66(f)(4) – (f)(6); or

(3) Is certified by a medical specialty board whose certification process has been recognized by DHHS/RHS, under He-P 4035.59 or He-P 4035.69 or the equivalent requirements of an agreement state or the Nuclear Regulatory Commission, and who meets the requirements in He-P 4035.66(f)(4) through (f)(6); and

(4) Shall have successfully completed 80 hours of classroom and laboratory training, applicable to parenteral administrations listed in He-P 4035.65(c)(2)b.3. The training shall include:

a. Radiation physics and instrumentation;

b. Radiation protection;

c. Mathematics pertaining to the use and measurement of radioactivity;

d. Chemistry of byproduct material for medical use; and

e. Radiation biology; and

(5) Has work experience, under the supervision of an authorized user who meets the requirements in He-P 4035.65, He-P 4035.66(f) and He-P 4035.71, or the equivalent requirements of an agreement state, or the Nuclear Regulatory Commission, in the parenteral administration listed in He-P 4035.65(c)(2)b.3. A supervising authorized user who meets the requirements in He-P 4035.65, He-P 4035.66(f), or equivalent requirements of an agreement state, or the Nuclear Regulatory Commission, shall have experience in administering dosages in the same category or categories as the individual requesting authorized user status. The work experience shall involve:

a. Ordering, receiving, and unpacking radioactive materials safely and performing the related radiation surveys;

b. Performing quality control procedures on instruments used to determine the activity of dosages, and performing checks for proper operation of survey meters;

c. Calculating, measuring, and safely preparing patient or human research subject dosages;

d. Using administrative controls to prevent a medical event involving the use of unsealed byproduct material;

e. Using procedures to contain spilled byproduct material safely and using proper decontamination procedures;

f. Administering dosages to patients or human research subjects that include a minimum of 3 cases involving the parenteral administration as specified in He-P 4035.65(c)(2)b.3.; and

(6) Has obtained written attestation that the individual has satisfactorily completed the requirements in He-P 4035.66(f)(4) and (f)(5) is able to independently fulfill the radiation safety-related duties as an authorized user for the parenteral administration of unsealed byproduct material requiring a written directive. The written attestation shall be obtained from either:

a. A preceptor authorized user who meets the requirements in He-P 4035.65, He-P 4035.66(f), He-P 4035.71, the equivalent requirements of an agreement state, or the Nuclear Regulatory Commission A preceptor authorized user who meets the requirements in He-P 4035.65, He-P 4035.66(f), the equivalent requirements of an agreement state, or the Nuclear Regulatory Commission shall have experience in administering dosages in the same category or categories as the individual requesting authorized user status; or

b. A residency program director who affirms in writing that the attestation represents the consensus of the residency program faculty where at least one faculty member is an authorized user who meets the requirements in He-P 4035.65, He-P 4035.66(f), He-P 4035.71, or the equivalent requirements of an agreement state, or the Nuclear Regulatory Commission, has experience in administering dosages in the same dosage category or categories as the individual requesting authorized user status, and concurs with the attestation provided by the residency program director. The residency training program shall be approved by the Residency Review Committee of the Accreditation Council for Graduate Medical Education or the Royal College of Physicians and Surgeons of Canada, or the Council on Postdoctoral Training of the American Osteopathic Association and shall include and experience specified in He-P 4035.66(f)(4) and (5).

Source. (See Revision Note at part heading for He-P 4035) #6942, eff 2-1-99; ss by #8800, INTERIM, eff 2-1-07, EXPIRED: 7-31-07

New. #8959, eff 8-7-07; ss by #10897, INTERIM, eff
7-22-15, EXPIRES: 1-18-16; ss by #11011, eff 1-15-16; amd by #12054, eff 11-19-16; ss by #13048, eff 6-2-20

He-P 4035.67 Training for Ophthalmic Use of Strontium-90.

(a) Except as provided in He‑P 4035.71, the licensee shall require the authorized user of strontium-90 for ophthalmic radiotherapy to be a physician who:

(1) Is an authorized user under He-P 4035.69, or the equivalent requirements of an agreement state or the Nuclear Regulatory Commission; or

(2) Has completed 24 hours of instruction applicable to the medical use of strontium-90 for ophthalmic radiotherapy, and a period of supervised clinical training in ophthalmic radiotherapy, as follows:

a. To satisfy the requirement for instruction, the classroom and laboratory training shall include:

1. Radiation physics and instrumentation;

2. Radiation protection;

3. Mathematics pertaining to the use and measurement of radioactivity; and

4. Radiation biology; and

b. To satisfy the requirement for a period of supervised clinical training in ophthalmic radiotherapy, training shall be under the supervision of an authorized user at a medical institution, clinic, or private practice and shall include the use of strontium-90 for the ophthalmic treatment of 5 individuals that includes:

1. Examination of each individual to be treated;

2. Calculation of the dose to be administered;

3. Administration of the dose; and

4. Follow-up and review of each individual’s case history.

(b) In accordance with He-P 4035.67(a) above, an authorized user who is a physician shall:

(1) Obtain a written attestation, signed by a preceptor authorized user who meets the requirements in He-P 4035.67, He-P 4035.69, He-P 4035.71, or the equivalent requirements of an agreement state, or the Nuclear Regulatory Commission , that the individual has satisfactorily completed the requirements in He-P 4035.67(a)(2); and

(2) Is able to independently fulfill the radiation safety-related duties as an authorized user of strontium-90 for ophthalmic use.

Source. (See Revision Note at part heading for He-P 4035) #6942, eff 2-1-99; ss by #8800, INTERIM, eff 2-1-07, EXPIRED: 7-31-07

New. #8959, eff 8-7-07; ss by #10897, INTERIM, eff
7-22-15, EXPIRES: 1-18-16; ss by #11011, eff 1-15-16; ss by #13048, eff 6-2-20

He-P 4035.68 Training for Use of Sealed Sources and Medical Devices for Diagnosis. Except as provided in He‑P 4035.71 the licensee shall require the authorized user of a diagnostic sealed source in a device specified in He‑P 4035.39 to be a physician, dentist, or podiatrist who:

(a) Is certified by a specialty board whose certification process includes all the requirements in He-P 4035.68(c) and (d) and whose certification has been recognized by DHHS/RHS, an agreement state, or the Nuclear Regulatory Commission. The names of board certifications that have been recognized by the DHHS/RHS, an agreement state, or the Nuclear Regulatory Commission are posted on the NRC’s Medical Uses Licensee Toolkit web page;

(b) Is an authorized user for uses listed in He-P 4035.31, or the equivalent requirements of an agreement state or the Nuclear Regulatory Commission; or

(c) Has completed 8 hours of classroom and laboratory training in basic radionuclide handling techniques specifically applicable to the use of the device, including training in:

(1) Radiation physics, mathematics pertaining to the use and measurement of radioactivity, and instrumentation;

(2) Radiation biology; and

(3) Radiation protection.

(d) Has completed training in the use of the device for the uses requested.

Source. (See Revision Note at part heading for He-P 4035) #6942, eff 2-1-99; ss by #8800, INTERIM, eff 2-1-07, EXPIRED: 7-31-07

New. #8959, eff 8-7-07; ss by #10897, INTERIM, eff
7-22-15, EXPIRES: 1-18-16; ss by #11011, eff 1-15-16; amd by #12054, eff 11-19-16; ss by #13048, eff 6-2-20

He-P 4035.69 Training for Use of Manual Brachytherapy Sources.

(a) Except as provided in He‑P 4035.71, the licensee shall require the authorized user of a manual brachytherapy source for the uses authorized under He-P 4035.41 to be a physician who:

(1) Is certified by a medical specialty board whose certification process has been recognized by the DHHS/RHS, or an agreement state, or the Nuclear Regulatory Commission. The names of board certifications that have been recognized by DHHS/RHS, an agreement state, or the Nuclear Regulatory Commission are posted on the NRC’s Medical Uses Licensee Toolkit web page. To have its certification process recognized, a specialty board shall require all candidates for certification to:

a. Successfully complete a minimum of 3 years of residency training in a radiation oncology program approved by the Residency Review Committee of the Accreditation Council for Graduate Medical Education or the Royal College of Physicians and Surgeons of Canada or the Committee on Post-Graduate Training of the American Osteopathic Association; and

b. Pass an examination, administering by diplomats of the specialty board, that tests knowledge and competence in radiation safety, radionuclide handling, treatment planning, quality assurance, and clinical use of manual brachytherapy; or

(2) Meets the requirements in He-P 4035.69(b); or

(b) Has completed a structured educational program in basic radionuclide handling techniques applicable to the use of manual brachytherapy sources that includes:

(1) 200 hours of classroom and laboratory training in the following:

a. Radiation physics and instrumentation;

b. Radiation protection;

c. Mathematics pertaining to the use and measurement of radioactivity;

d. Radiation biology; and

(2) 500 hours of work experience, under the supervision of an authorized user who meets the requirements in He-P 4035.69, He-P 4035.71, or the equivalent agreement state, or the Nuclear Regulatory Commission requirements at a medical facility authorized to use byproduct materials under He-P 4035.41, involving:

a. Ordering, receiving, and unpacking radioactive materials safely and performing the related radiation surveys;

b. Checking survey meters for proper operation;

c. Preparing, implanting, and removing brachytherapy sources;

d. Maintaining running inventories of material on hand;

e. Using administrative controls to prevent a medical event involving the use of byproduct material;

f. Using emergency procedures to control byproduct material; and

(3) Has completed 3 years of supervised clinical experience in radiation oncology, under an authorized user who meets the requirements in He-P 4035.69, He-P 4035.71, or the equivalent requirements of an agreement state, or the Nuclear Regulatory Commission, as part of a formal training program approved by the Residency Review Committee for Radiation Oncology of the Accreditation Council for Graduate Medical Education or the Royal College of Physicians and Surgeons of Canada or the Committee on Postdoctoral Training of the American Osteopathic Association. This experience may be obtained concurrently with the supervised work experience required by He-P 4035.69(b)(2); and

(4) Has obtained a written attestation that the individual has satisfactorily completed the requirements in He-P 4035.69 (b)(1), (b)(2), and (b)(3) and is able to independently fulfill the radiation safety-related duties as an authorized user of manual brachytherapy sources for the medical uses authorized under He-P 4035.41. The attestation shall be obtained from either:

a. A preceptor authorized user who meets the requirements in He-P 4035.69, He-P 4035.71, or the equivalent requirements of an agreement state, or the Nuclear Regulatory Commission; or

b. A residency program director who affirms in writing that the attestation represents the consensus of the residency program faculty where at least one faculty member is an authorized user who meets the requirements in He-P 4035.69, He-P 4035.71, or the equivalent requirements of an agreement state, or the Nuclear Regulatory Commission, and concurs with the attestation provided by the residency program director. The residency training program shall be approved by the Residency Review Committee of the Accreditation Council for Graduate Medical Education or the Royal College of Physicians and Surgeons of Canada or
the Council on Postdoctoral Training of the American Osteopathic Association and shall include training and experience specified in He-P 4035.69(b)(1) through (b)(3).

Source. (See Revision Note at part heading for He-P 4035) #6942, eff 2-1-99; ss by #8800, INTERIM, eff 2-1-07, EXPIRED: 7-31-07

New. #8959, eff 8-7-07; ss by #10897, INTERIM, eff
7-22-15, EXPIRES: 1-18-16; ss by #11011, eff 1-15-16; ss by #13048, eff 6-2-20

He-P 4035.70 Training for Authorized Medical Physicist. Excepted as provided in He-P 4035.71, the licensee shall require the authorized medical physicist to be an individual who:

(a) Is certified by a specialty board whose certification process has been recognized by DHHS/RHS, or an agreement state, or the Nuclear Regulatory Commission, and who meets the requirements in He-P 4035.70;

(b) The name of board certifications that have been recognized by DHHS/RHS, an agreement state, or the Nuclear Regulatory Commission are posted on the NRC’s Medical Uses Licensee Toolkit web page. To have its certification process recognized, a specialty board shall require all candidates for certification to:

(1) Hold a master’s or doctor’s degree in physics, medical physics, other physical science, engineering, or applied mathematics from an accredited college or university; and

(2) Have 2 years of full-time practical training and/or supervised experience in medical physics:

a. Under the supervision of a medical physicist who is certified in medical physics by a specialty board recognized by the DHHS/RHS, or an agreement state, or the Nuclear Regulatory Commission; or

b. In clinical radiation facilities providing high-energy, external beam therapy (photons and electrons with energies greater than or equal to 1 million electron volts) and brachytherapy services under the direction of physicians who meet the requirements in He-P 4035.59, He-P 4035.69, or He-P 4035.71; and

(3) Pass an examination, administered by diplomats of the specialty board, that assesses knowledge and competence in clinical radiation therapy, radiation safety, calibration, quality assurance, and treatment planning for external beam therapy, brachytherapy, and stereotactic radiosurgery; or

(4) Hold a master’s or doctor’s degree in physics, medical physics, other physical science, engineering, or applied mathematics from an accredited college or university has completed 1 year of full-time training in medical physics; and

a. An additional year of full-time work experience under the supervision of an individual who meets the requirements for an authorized medical physicist for the type(s) of use for which the individual is seeking authorization; and

b. This training and work experience shall be conducted in clinical radiation facilities that provide high-energy, external beam therapy (photons and electrons with energies greater than or equal to 1 million electron volts) and brachytherapy services and shall include:

1. Performing sealed source leak tests and inventories;

2. Performing decay corrections;

3. Performing full calibration and periodic spot checks of external beam treatment units, stereotactic radiosurgery units, and remote afterloading units as applicable; and

4. Conducting radiation surveys around external beam treatment units, stereotactic radiosurgery units, and remote afteloading units as applicable; and

(5) Have obtained written attestation that the individual has satisfactorily completed the requirements in He-P 4035.70(b)(1) and (c), and is able to independently fulfill the radiation safety-related duties as an authorized medical physicist for each type of therapeutic medical unit for which the individual is requesting authorized medical physicist status. The written attestation shall be signed by a preceptor authorized medical physicist who meets the requirements in He-P 4035.70, He-P 4035.71, or the equivalent requirements of an agreement state, or the Nuclear Regulatory Commission for an authorized medical physicist for each type of therapeutic medical unit for which the individual is requesting authorized medical physicist status.

(c) Has training for the type(s) of use for which authorization is sought that includes hands-on device operation, safety procedures, clinical use, and the operation of a treatment planning system. This training requirement may be satisfied by satisfactorily completing either a training program provided by the vendor or by training supervised by an authorized medical physicist authorized for the type(s) of use for which the individual is seeking authorization.

Source. (See Revision Note at part heading for He-P 4035) #6942, eff 2-1-99; ss by #8800, INTERIM, eff 2-1-07, EXPIRED: 7-31-07

New. #8959, eff 8-7-07; ss by #10897, INTERIM, eff
7-22-15, EXPIRES: 1-18-16; ss by #11011, eff 1-15-16; amd by #12054, eff 11-19-16; ss by #13048, eff 6-2-20

He-P 4035.71 Training for Experienced Radiation Safety Officer, Teletherapy or Medical Physicist, Authorized Medical Physicist, Authorized User, Nuclear Pharmacist, and Authorized Nuclear Pharmacist.

(a) An individual identified as:

(1) A radiation safety officer, a teletherapy or medical physicist, an authorized medical physicist, a nuclear pharmacist, or an authorized nuclear pharmacist on a DHHS/RHS, or an agreement state, or a Nuclear Regulatory Commission license or a permit issued by DHHS/RHS, or a Nuclear Regulatory Commission broad scope licensee or master material license permit, or by a master material license permittee of broad scope before January 14, 2019, need not comply with the training requirements of He-P 4035.61, He-P 4035.70, or He-P 4035.74, respectively except the radiation safety officers and authorized medical physicists identified in He-P 4035.71(a)(1) shall meet the training requirements in He-P 4035.61(e) or He-P 4035.70(c), as appropriate, for any material or uses for which they were not authorized prior to this date;

(2) An individual certified by the American Board of Health Physics in comprehensive health physics; American Board of Radiology; American Board of Nuclear Medicine; American Board of Science in Nuclear Medicine; Board of Pharmaceutical Specialties in Nuclear Pharmacy; American Board of Medical Physics in radiation oncology physics; Royal College of Physicians and Surgeons of Canada in nuclear medicine; American Osteopathic Board of Radiology; or American Osteopathic Board of Nuclear Medicine on or before October 24, 2005, need not comply with the training requirements of He-P 4035.61 to be identified as a radiation safety officer or as an associate radiation safety officer on a DHHS/RHS, an agreement state, or Nuclear Regulatory Commission license or Nuclear Regulatory Commission master material license permit for those materials and uses that these individuals performed on or before October 24, 2005; or

(3) An individual certified by the American Board of Radiology in therapeutic radiological physics, Roentgen ray and gamma ray physics, x-ray and radium physics, or radiological physics, or certified by the American Board of Medical Physics in radiation oncology physics, on or before October 24, 2005, need not comply with the training requirements for an authorized medical physicist described in He-P 4035.70, for those materials and uses that these individuals performed on or before October 24, 2005.

(b) Physicians, dentists, or podiatrists identified as authorized users for the medical use of byproduct material on a license issued by the DHHS/RHS, an agreement state, or the Nuclear Regulatory Commission, or a permit issued by a Nuclear Regulatory Commission master material licensee, a permit issued by the DHHS/RHS, or an agreement state, or the Nuclear Regulatory Commission broad scope licensee, or a permit issued by a Nuclear Regulatory Commission master material license broad scope permittee before January 14, 2019, who perform only those medical uses for which they were authorized on that date need not comply with the training requirements of He-P 4035 subparts equivalent to 10 CFR 35 Subparts D through H.

(c) Physicians, dentists, or podiatrists not identified as authorized users for the medical use of byproduct material on a license issued by DHHS/RHS, an agreement state, or the Nuclear Regulatory Commission, or a permit issued by a Nuclear Regulatory Commission master material licensee, a permit issued by DHHS/RHS, an agreement state, or Nuclear Regulatory Commission broad scope licensee, or a permit issued by a Nuclear Regulatory Commission master material license of broad scope on or before October 24, 2005, need not comply with the training requirements of He-P 4035 subparts equivalent to 10 CFR 35 Subparts D through H for those materials and uses that these individuals performed on or before October 24, 2005, as follows:

(1) For uses authorized under He-P 4035.27 or He-P 4035.31, or oral administration of sodium iodide I-131 requiring a written directive for imaging and localization purposes, a physician who was certified on or before October 24, 2005, in nuclear medicine by the American Board of Nuclear Medicine; diagnostic radiology by the American Board of Radiology; diagnostic radiology or radiology by the American Osteopathic Board of Radiology; nuclear medicine by the Royal College of Physicians and Surgeons of Canada; or American Osteopathic Board of Nuclear Medicine in nuclear medicine;

(2) For uses authorized under He-P 4035.35, a physician who was certified on or before October 24, 2005, by the American Board of Nuclear Medicine; the American Board of Radiology in radiology, therapeutic radiology, or radiation oncology; nuclear medicine by the Royal College of Physicians and Surgeons of Canada; or the American Osteopathic Board of Radiology after 1984;

(3) For uses authorized under He-P 4035.41 or He-P 4035.47, a physician who was certified on or before October 24, 2005, in radiology, therapeutic radiology or radiation oncology by the American Board of Radiology; radiation oncology by the American Osteopathic Board of Radiology; radiology, with specialization in radiotherapy, as a British “Fellow of the Faculty of Radiology” or “Fellow of the Royal College of Radiology”; or therapeutic radiology by the Canadian Royal College of Physicians and Surgeons; and

(4) For uses authorized under He-P 4035.39, a physician who was certified on or before October 24, 2005, in radiology, diagnostic radiology, therapeutic radiology, or radiation oncology by the American Board of Radiology; nuclear medicine by the American Board of Nuclear Medicine; diagnostic radiology or radiology by the American Osteopathic Board of Radiology; or nuclear medicine by the Royal College of Physicians and Surgeons of Canada.

(d) Physicians, dentists, or podiatrists who used only accelerator-produced radioactive materials, discrete sources of radium-226, or both, for medical uses performed at locations of use before August 8, 2009, or an earlier date as noticed by DHHS/RHS, need not comply with the training requirements of He-P 4035 subparts equivalent to 10 CFR 35 Subparts D through H when performing the same medical uses. A physician, dentist, or podiatrist, who used only accelerator-produced radioactive materials, discrete sources of radium-226, or both, for medical uses at the locations and time period identified in this paragraph, qualifies as an authorized user for those materials and uses performed before these dates, for the purposes of He-P 4035.

(e) Individuals who need not comply with training requirements as described in He-P 4035.71(a) through (d) above may serve as preceptors for, and supervisors of, applicants seeking authorization on DHHS/RHS licenses for the same uses for which these individuals are authorized.

Source. (See Revision Note at part heading for He-P 4035) #6942, eff 2-1-99; ss by #8800, INTERIM, eff 2-1-07, EXPIRED: 7-31-07

New. #8959, eff 8-7-07; ss by #10897, INTERIM, eff
7-22-15, EXPIRES: 1-18-16; ss by #11011, eff 1-15-16; ss by #13048, eff 6-2-20

He-P 4035.72 Reserved

Source. (See Revision Note at part heading for He-P 4035) #6942, eff 2-1-99; ss by #8800, INTERIM, eff 2-1-07, EXPIRED: 7-31-07

New. #8959, eff 8-7-07; ss by #10897, INTERIM, eff
7-22-15, EXPIRES: 1-18-16; rpld by #11011, eff 1-15-16

He-P 4035.73 Recentness of Training. The training and experience specified in the requirements of He-P 4035, subparts equivalent to 10 CFR 35 Subparts B and D through H shall have been obtained within the 7 years preceding the date of application, or the individual shall have had related continuing education and experience since the required training and experience was completed.

Source. (See Revision Note at part heading for He-P 4035) #6942, eff 2-1-99; ss by #8800, INTERIM, eff 2-1-07, EXPIRED: 7-31-07

New. #8959, eff 8-7-07; ss by #10897, INTERIM, eff
7-22-15, EXPIRES: 1-18-16; rpld by #11011, eff 1-15-16; ss by #11108, eff 5-25-16; ss by #13048, eff 6-2-20

He-P 4035.74 Training for an Authorized Nuclear Pharmacist. Except as provided He-P 4035.71, the licensee shall require the authorized nuclear pharmacist to be a licensed pharmacist, as defined in RSA 318:1, VII, who:

(a) Is certified by a specialty board whose certification process has been recognized by DHHS/RHS, or an agreement state, or the Nuclear Regulatory Commission. The names of board certifications that have been recognized by DHHS/RHS, an agreement state, or the Nuclear Regulatory Commission are posted on the NRC’s medical use licensee toolkit web page. To have its certification process recognized, a specialty board shall require all candidates for certification to:

(1) Have graduated from a pharmacy program accredited by the American Council on Pharmaceutical Education (ACPE) or have passed the Foreign Pharmacy Graduate Examination Committee (FPGEC) examination;

(2) Hold a current, active license to practice pharmacy;

(3) Provide evidence of having acquired at least 4000 hours of training/experience in nuclear pharmacy practice. Academic training may be substituted for no more than 2000 hours of the required training and experience; and

(4) Pass an examination in nuclear pharmacy administered by diplomats of the specialty board, that assesses knowledge and competency in procurement, compounding, quality assurance, dispensing, distribution, health and safety, radiation safety, provision of information and consultation, monitoring patient outcomes, research and development; or

(b) Has met the following requirements:

(1) Have completed 700 hours in a structured educational program consisting of both:

a. 200 hours of classroom and laboratory training in the following areas:

1. Radiation physics and instrumentation;

2. Radiation protection;

3. Mathematics pertaining to the use and measurement of radioactivity;

4. Chemistry of byproduct material for medical use; and

5. Radiation biology; and

b. Supervised practical experience in a nuclear pharmacy involving the following:

1. Shipping, receiving, and performing related radiation surveys;

2. Using and performing checks for proper operation of instruments used to determine the activity of dosages, survey meters, and, if appropriate, instruments used to measure alpha- or beta-emitting radionuclides;

3 Calculating, assaying, and safely preparing dosages for patients or human research subjects;

4 Using administrative controls to avoid medical events in the administration of byproduct material;

5. Using procedures to prevent or minimize radioactive contamination and using proper .decontamination procedures; and

(2) Has obtained a written attestation, signed by a preceptor authorized nuclear pharmacist, that the individual has satisfactorily completed the requirements in He-P 4035.74(b)(1) and is able to independently operate as an authorized nuclear pharmacist.

Source. (See Revision Note at part heading for He-P 4035) #6942, eff 2-1-99; ss by #8800, INTERIM, eff 2-1-07, EXPIRED: 7-31-07

New. #8959, eff 8-7-07; ss by #10897, INTERIM, eff
7-22-15, EXPIRES: 1-18-16; ss by #11011, eff 1-15-16; ss by #13048, eff 6-2-20

He-P 4035.75 RESERVED

Source. (See Revision Note at part heading for He-P 4035) #6942, eff 2-1-99; ss by #8800, INTERIM, eff 2-1-07, EXPIRED: 7-31-07

New. #8959, eff 8-7-07; ss by #10897, INTERIM, eff
7-22-15, EXPIRES: 1-18-16; ss by #11011, eff eff 1-15-16

PART He-P 4036 Licensing and Radiation Safety Requirements for Irradiators

He P 4036.01 Purpose. The purpose of this rule is to set forth the requirements for issuance of a license authorizing the use of sealed sources containing radioactive materials in irradiators used to irradiate objects or materials using gamma radiation, and the radiation safety requirements for operating irradiators. The requirements of this section are in addition to, and not in substitution for, the requirements of Parts He-P 4003, 4019, 4020, 4021, 4022, 4023, 4024, 4030, and 4038 of this chapter.

Source. #8211, eff 11-23-04; ss by #10188, eff 9-26-12; ss by #13542, eff 1-28-23

He-P 4036.02 Scope. This part shall apply to persons using sealed sources containing radioactive material in irradiators as specified in Title 10, Code of Federal Regulations (CFR), Part 36, “Licenses and Radiation Safety Requirements for Irradiators”.

Source. #8211, eff 11-23-04; ss by #10188, eff 9-26-12; ss by #13542, eff 1-28-23

He P 4036.03 Definitions. To reconcile differences between this part and the incorporated sections of 10 CFR Part 36 relating to using sealed sources containing radioactive sources in irradiators, the following words and phrases shall be substituted for the language in 10 CFR Part 36 as follows:

(a) All references to “NRC” or “Commission” shall mean the New Hampshire department of health and human services;

(b) The definition of “licensed material” shall be as defined in He-P 4003 of this chapter; and

Source. #8211, eff 11-23-04; ss by #10188, eff 9-26-12; ss by #13542, eff 1-28-23

He-P 4036.04 Incorporation of 10 CFR Part 36.

(a) Except for the sections noted in (b) below and He-P 4036.03 above, persons using sealed sources containing radioactive material in irradiators shall comply with Title 10, Code of Federal Regulations (CFR), Part 36, “Licenses and Radiation Safety Requirements for Irradiators”.

(b) The following sections of the Title 10 CRF Part 36 shall not apply to those persons using sealed sources containing radioactive material in irradiators:

(1) Title 10 CFR Part 36.5 relating to interpretations;

(2) Title 10 CFR Part 36.8 relating to information collection;

(3) Title 10 CFR Part 36.91 relating to violations; and

(4) Title 10 CFR Part 36.93 relating to criminal penalties.

Source. #8211, eff 11-23-04; ss by #10188, eff 9-26-12; ss by #13542, eff 1-28-23

PART He-P 4037 TRANSPORTATION OF RADIOACTIVE MATERIAL

He-P 4037.01 Purpose. The purpose of this rule is to set forth the requirements for packaging, preparation for shipment, and transportation of licensed material. The requirements of this section are in addition to, and not in substitution for, the requirements of He-P 4003, 4019, 4020, 4021, 4022, 4023, 4024, and 4030 of this chapter.

Source. #7980, eff 10-22-03; ss by #9621, eff 12-24-09; ss by #12447, eff 1-5-18

He-P 4037.02 Scope. This part shall apply to any person who transports radioactive material or delivers radioactive material to a carrier for transport, including common and contract carriers not subject to the requirements of the U.S. Department of Transportation or U.S. Postal Service, as specified in Title 10, Code of Federal Regulations (CFR), Part 71, “Packaging and Transportation of Radioactive Material.”

(a) The rules in He-P 4037 shall apply to any licensee authorized by specific or general license issued by DHHS/RHS to receive, possess, use or transfer licensed material if the licensee:

(1) Delivers that material to a carrier for transport;

(2) Transports the material outside the site of usage as specified in the license; or

(3) Transports that material on public highways.

(b) No provision of He-P 4037 authorizes possession of licensed material.

Source. #7980, eff 10-22-03; ss by #9621, eff 12-24-09; ss by #12447, eff 1-5-18

He-P 4037.03 Definitions. To reconcile differences between this part and the incorporated sections of 10 CFR Part 71 relating to packaging, preparation for shipment, and transportation of radioactive material, the following words and phrases shall be substituted for the language in 10 CFR Part 71 as follows:

(a) “Communications” means all communications, reports, and applications described in He-P 4001.08.

(b) “Licensed material” means “licensed material” as defined in He-P 4003 of this chapter.

(c) “NRC”, “Commission”, or “Authority” mean the department of health and human services, radiological health section as defined in He-P 4003 of this chapter (DHHS/RHS).

(d) “Sealed source” means “sealed source” as defined in He-P 4003.01 of this chapter.

Source. #7980, eff 10-22-03; ss by #9621, eff 12-24-09; ss by #12447, eff 1-5-18

He-P 4037.04 Incorporation of 10 CFR Part 71.

(a) Except for the sections noted in (b) below and He-P 4037.03 above, all persons or any licensee authorized by specific or general license issued by DHHS/RHS who transports radioactive material or delivers radioactive material to a carrier for transport, including common and contract carriers not subject to the requirements of the U.S. Department of Transportation or U.S. Postal Service, shall comply with Title 10, Code of Federal Regulations (CFR), Part 71, “Relating to Packaging and Transportation of Radioactive Material.”

(b) The following sections of the Title 10 CFR Part 71 shall not apply to persons or any licensee authorized by specific or general license issued by DHHS/RHS who transports radioactive material or delivers radioactive material to a carrier for transport, including common and contract carriers not subject to the requirements of the U.S. Department of Transportation or U.S. Postal Service:

(1) Title 10 CFR Part 71.2, relating to interpretations;

(2) Title 10 CFR Part 71.6, relating to information collection;

(3) Title 10 CFR Part 71.11, relating to protection of safeguards information;

(4) Title 10 CFR Part 71.14(b), relating to low level material exemption;

(5) Title 10 CFR Part 71.19, relating to previously approved packages;

(6) Title 10 CFR Part 71 Subpart D, relating to application for package approval;

(7) Title 10 CFR Parts 71.41, 71.43, 71.45, 71.51, 71.55, 71.59, 71.61, 71.63, 71.64, and 71.65, relating to package approval standards;

(8) Title 10 CFR Part 71 Subpart F, relating to package, special form, and LSA-III tests;

(9) Title 10 CFR Part 71.85(a)-(c) relating to preliminary determinations;

(10) Title 10 CFR 71.91(b), relating to records;

(11) Title 10 CFR Part 71.99, relating to violations;

(12) Title 10 CFR Part 71.100, relating to criminal penalties;

(13) Title 10 CFR Part 71.101(c)(2), (d), and (e), relating to quality assurance requirements; and

(14) Title 10 CFR Parts 71.107, 71.109, 71.111, 71.113, 71.115, 71.117, 71.119, 71.121, 71.123, and 71.125, relating to quality assurance.

Source. #7980, eff 10-22-03; ss by #9621, eff 12-24-09; ss by #12447, eff 1-5-18

PART He-P 4038 THE PHYSICAL PROTECTION OF CATEGORY 1 AND CATEGORY 2 QUANTITIES OF RADIOACTIVE MATERIAL

He-P 4038.01 Purpose. The purpose of this rule is to set forth the requirements for the physical protection program for any licensee that possesses an aggregated category 1 or category 2 quantity of radioactive material listed in Table 4038.1 in this section. These requirements provide reasonable assurance of the security of category 1 or category 2 quantities of radioactive material by protecting these materials from theft or diversion. Specific requirements for access to material, use of material, transfer of material, and transport of material are included. No provision of this part authorizes possession of licensed material.

Source. #11105, eff 5-25-16

He-P 4038.02 Scope.

(a) He-P 4038.07 through He-P 4038.22 apply to any person who, under the regulations in He-P 4038, possesses or uses at any site, an aggregated category 1 or category 2 quantity of radioactive material.

(b) He-P 4038.23 through He-P 4038.28 applies to any person who, under the regulations of He-P 4038:

(1) Transports or delivers to a carrier for transport in a single shipment, a category 1 or category 2 quantity of radioactive material; or

(2) Imports or exports a category 1 or category 2 quantity of radioactive material; the provisions only apply to the domestic portion of the transport.

Source. #11105, eff 5-25-16

He-P 4038.03 Definitions. As used in He-P 4038:

(a) “Access control” means a system for allowing only approved individuals to have unescorted access to the security zone and for ensuring that all other individuals are subject to escorted access.

(b) “Aggregated” means accessible by the breach of a single physical barrier that would allow access to radioactive material in any form, including any devices that contain the radioactive material, when the total activity equals or exceeds a category 2 quantity of radioactive material.

(c) “Approved individual” means an individual whom the licensee has determined to be trustworthy and reliable for unescorted access in accordance with He-P 4038.07 through 4038.13 and who has completed the training required by He-P 4038.15(c).

(d) “Background investigation” means the investigation conducted by a licensee or applicant to support the determination of trustworthiness and reliability as defined in (z) below.

(e) “Carrier” means a person engaged in the transportation of passengers or property by land or water as a common, contract, or private carrier, or by civil aircraft.

(f) “Category 1 quantity of radioactive material” means a quantity of radioactive material meeting or exceeding the category 1 threshold in Table 4038.1 in He-P 4038.31. This is determined by calculating the ratio of the total activity of each radionuclide to the category 1 threshold for that radionuclide and adding the ratios together. If the sum is equal to or exceeds one, the quantity would be considered a category 1 quantity. Category 1 quantities of radioactive material do not include the radioactive material contained in any fuel assembly, subassembly, fuel rod, or fuel pellet.

(g) “Category 2 quantity of radioactive material” means a quantity of radioactive material meeting or exceeding the category 2 threshold but less than the category 1 threshold in Table 4038.1 in He-P 4038.31. This is determined by calculating the ratio of the total activity of each radionuclide to the category 2 threshold for that radionuclide and adding the ratios together. If the sum is equal to or exceeds one, the quantity would be considered a category 2 quantity. Category 2 quantities of radioactive material do not include the radioactive material contained in any fuel assembly, subassembly, fuel rod, or fuel pellet.

(h) “Diversion” means the unauthorized movement of radioactive material subject to this part to a location different from the material's authorized destination inside or outside of the site at which the material is used or stored.

(i) “DHHS/RHS” means the state of New Hampshire department of health and human services/radiological health section.

(j) “Escorted access” means accompaniment while in a security zone by an approved individual who maintains continuous direct visual surveillance at all times over an individual who is not approved for unescorted access.

(k) “Fingerprint orders” means the legally binding requirements issued by DHHS/RHS, an agreement state, or the Nuclear Regulatory Commission (NRC) that require fingerprints and criminal history records checks for individuals with unescorted access to category 1 and category 2 quantities of radioactive material or safeguards information-modified handling.

(l) “License”, except where otherwise specified, means a license for byproduct material issued pursuant to the rules in He-P 4030 through He-P 4036 and He-P 4039;

(m) “License issuing authority” means the licensing agency that issued the license, i.e. DHHS/RHS, the appropriate agency of an agreement state, or the NRC;

(n) “Local law enforcement agency” (LLEA)” means a public or private organization that has been approved by a federal, state, or local government to carry firearms and make arrests, and is authorized and has the capability to provide an armed response in the jurisdiction where the licensed category 1 or category 2 quantity of radioactive material is used, stored, or transported.

(o) “Mobile device” means a piece of equipment containing licensed radioactive material that is either mounted on wheels or casters, or otherwise equipped for moving without a need for disassembly or dismounting, or is designed to be hand carried. Mobile devices do not include stationary equipment installed in a fixed location.

(p) “Movement control center” means an operations center that is remote from transport activity and that maintains position information on the movement of radioactive material, receives reports of attempted attacks or thefts, provides a means for reporting these and other problems to appropriate agencies and can request and coordinate appropriate aid.

(q) “No-later-than arrival time” means the date and time that the shipping licensee and receiving licensee have established as the time at which an investigation shall be initiated if the shipment has not arrived at the receiving facility. The no-later-than arrival time may not be more than 6 hours after the estimated arrival time for shipments of category 2 quantities of radioactive material.

(r) “Non-agreement state” means any state that has not entered into an effective agreement under subsection 274b. of the Atomic Energy Act of 1954, as Amended (73 Stat. 689).

(s) “Person” means:

(1) Person as defined in RSA 125-F:3, XII; and

(2) Any individual, corporation, partnership, firm, association, trust, estate, public or private institution, group, government agency other than the NRC or the Department of Energy (DOE), except that the DOE shall be considered a person within the meaning of the regulations in 10 CFR chapter I to the extent that its facilities and activities are subject to the licensing and related regulatory authority of the NRC under section 202 of the Energy Reorganization Act of 1974 (88 Stat. 1244), the Uranium Mill Tailings Radiation Control Act of 1978 (92 Stat. 3021), the Nuclear Waste Policy Act of 1982 (96 Stat. 2201), and section 3(b)(2) of the Low-Level Radioactive Waste Policy Amendments Act of 1985 (99 Stat. 1842), any state or any political subdivision of or any political entity within a state, any foreign government or nation or any political subdivision of any such government or nation, or other entity; and

(3) Any legal successor, representative, agent, or agency of the foregoing.

(t) “Reviewing official” means the individual authorized by the licensee who shall make the trustworthiness and reliability determination, as defined in (z) below, of an individual to determine whether the individual may have, or continue to have, unescorted access to the category 1 or category 2 quantities of radioactive materials that are possessed by the licensee.

(u) “Sabotage” means deliberate damage, with malevolent intent, to a category 1 or category 2 quantity of radioactive material, a device that contains a category 1 or category 2 quantity of radioactive material, or the components of the security system.

(v) “Safe haven” means a readily recognizable and readily accessible site at which security is present or from which, in the event of an emergency, the transport crew can notify and wait for the local law enforcement authorities.

(w) “Security zone” means any temporary or permanent area determined and established by the licensee for the physical protection of category 1 or category 2 quantities of radioactive material.

(x) “State” means a state of the United States, the District of Columbia, the Commonwealth of Puerto Rico, the Virgin Islands, Guam, American Samoa, and the Commonwealth of the Northern Mariana Islands.

(y) “Telemetric position monitoring system” means a data transfer system that captures information by instrumentation or measuring devices about the location and status of a transport vehicle or package between the departure and destination locations.

(z) “Trustworthiness and reliability” are characteristics of an individual considered dependable in judgment, character, and performance, such that unescorted access to category 1 or category 2 quantities of radioactive material by that individual does not constitute an unreasonable risk to the public health and safety or security. A determination of trustworthiness and reliability for this purpose is based upon the results from a background investigation.

(aa) “Unescorted access” means solitary access to an aggregated category 1 or category 2 quantities of radioactive material or the devices that contain the material.

Source. #11105, eff 5-25-16; amd by #12055, eff 11-19-16; ss by #13598, eff 3-24-23

He-P 4038.04 Communications. All communications and reports concerning the rules in He-P 4038 shall be sent as follows:

(a) By mail addressed to: ATTN: Radioactive Materials Manager, DHHS/Radiological Health Section, 29 Hazen Drive, Concord, NH 03301-6504; or

(b) By hand delivery to the above address.

Source. #11105, eff 5-25-16; amd by #12744, eff 3-20-19

He-P 4038.05 Interpretations. Except as specifically authorized by DHHS/RHS in writing, no interpretation of the meaning of He-P 4038 by any officer or employee of DHHS/RHS other than a written interpretation by the Attorney General’s Office shall be recognized as binding upon DHHS/RHS.

Source. #11105, eff 5-25-16

He-P 4038.06 Specific Exemptions.

(a) The DHHS/RHS may, upon application of any interested person or upon its own initiative, grant such exemptions from the requirements of the rules in He-P 4038 as it determines are authorized by law and will not endanger life or property and are otherwise in the public interest.

(b) Any licensee's, DHHS/RHS, or NRC-licensed activities are exempt from the requirements of He-P 4038.07 through He-P 4038.22 to the extent that the activities are included in a security plan required by He-P 4038 or the Nuclear Regulatory Commission in accordance with 10 CFR 73.

(c) A licensee that possesses radioactive waste that contains category 1 or category 2 quantities of radioactive material is exempt from the requirements of He-P 4038.07 through He-P 4038.28 of this part. Except that any radioactive waste that contains discrete sources, ion-exchange resins, or activated material that weighs less than 2,000 kg (4,409 lbs.) is not exempt from the requirements of this part. The licensee shall implement the following requirements to secure the radioactive waste:

(1) Use continuous physical barriers that allow access to the radioactive waste only through established access control points;

(2) Use a locked door or gate with monitored alarm at the access control point;

(3) Assess and respond to each actual or attempted unauthorized access to determine whether an actual or attempted theft, sabotage, or diversion occurred; and

(4) Immediately notify the LLEA and request an armed response from the LLEA upon determination that there was an actual or attempted theft, sabotage, or diversion of the radioactive waste that contains category 1 or category 2 quantities of radioactive material.

Source. #11105, eff 5-25-16; amd by #12744, eff 3-20-19

He-P 4038.07 Personnel Access Authorization Requirements for Category 1 or Category 2 Quantities of Radioactive Material.

(a) Any licensee or applicant:

(1) That possesses an aggregated quantity of radioactive material at or above the category 2 threshold shall establish, implement, and maintain an access authorization program in accordance with the requirements of He-P 4038.07 through He-P 4038.13;

(2) That becomes newly subject to the requirements of He-P 4038.07 through He-P 4038.13 upon application for modification of its license shall implement the requirements of He-P 4038, as appropriate, before taking possession of an aggregated category 1 or category 2 quantity of radioactive material; or

(3) That has not previously implemented the security orders or been subject to the requirements in He-P 4038.07 through He-P 4038.13 shall implement the provisions of He-P 4038.07 through He-P 4038.13 before aggregating radioactive material to a quantity that equals or exceeds the category 2 threshold.

(b) The licensee's access authorization program shall ensure that the individuals specified in He-P 4038.07(c)(1) and (c)(2) are trustworthy and reliable.

(1) Any individual whose assigned duties require unescorted access to category 1 or category 2 quantities of radioactive material or to any device that contains the radioactive material; and

(2) All reviewing officials.

(d) Licensees are not required to subject the categories of individuals listed in He-P 4038.11(a)(1) through (a)(13) to the investigation elements of the access authorization program.

(e) Licensees shall approve for unescorted access to category 1 or category 2 quantities of radioactive material only those individuals with job duties that require unescorted access to category 1 or category 2 quantities of radioactive material.

(f) Licensees shall include individuals needing access to safeguards information-modified handling under He-P 4038 in the access authorization program under He-P 4038.07 through He-P 4038.13.

Source. #11105, eff 5-25-16

He-P 4038.08 Access Authorization Program Requirements.

(a) Licensees shall implement the requirements of He-P 4038.07 through He-P 4038.13 for granting initial or reinstated unescorted access authorization.

(b) Individuals who have been determined to be trustworthy and reliable shall also complete the security training required by He-P 4038.15(c) before being allowed unescorted access to category 1 or category 2 quantities of radioactive material.

(c) Reviewing officials are the only individuals who may make trustworthiness and reliability determinations that allow individuals to have unescorted access to category 1 or category 2 quantities of radioactive materials possessed by the licensee.

(d) Each licensee shall name one or more individuals to be reviewing officials. After completing the background investigation on the reviewing official, the licensee shall provide under oath or affirmation, a certification that the reviewing official is deemed trustworthy and reliable by the licensee. Provide oath or affirmation certifications to DHHS/RHS. The fingerprints of the named reviewing official must be taken by a law enforcement agency, Federal or state agencies that provide fingerprinting services to the public, or commercial fingerprinting services authorized by New Hampshire to take fingerprints. The licensee shall recertify that the reviewing official is deemed trustworthy and reliable every 10 years in accordance with He-P 4038.09(d).

(e) Reviewing official shall:

(1) Be permitted to have unescorted access to category 1 or category 2 quantities of radioactive materials or access to safeguards information or safeguards information-modified handling, if the licensee possesses safeguards information or safeguards information-modified handling;

(2) Not approve other individuals to act as reviewing officials;

(3) Not need to undergo a new background investigation before being named by the licensee as the reviewing official if:

a. The individual has undergone a background investigation that include fingerprinting and an FBI criminal history records check and has been previously determined to be trustworthy and reliable by the licensee; or

b. The individual is subject to a category listed in He-P 4038.11(a).

(f) Licensees shall not initiate a background investigation without the informed and signed consent of the subject individual. This consent shall include authorization to share personal information with other individuals or organizations as necessary to complete the background investigation. Before a final adverse determination, the licensee shall provide the individual with an opportunity to correct any inaccurate or incomplete information that is developed during the background investigation. Licensees shall not need to obtain signed consent from those individuals that meet the requirements of He-P 4038.09(b) and (c). A signed consent must be obtained prior to any reinvestigation.

(g) The subject individual may withdraw his or her consent at any time. Licensees shall inform the individual that:

(1) If an individual withdraws his or her consent, the licensee may not initiate any elements of the background investigation that were not in progress at the time the individual withdrew his or her consent; and

(2) The withdrawal of consent for the background investigation is sufficient cause for denial or termination of unescorted access authorization.

(h) Any individual who is applying for unescorted access authorization shall disclose the personal history information that is required by the licensee's access authorization program for the reviewing official to make a determination of the individual's trustworthiness and reliability. Refusal to provide, or the falsification of, any personal history information required by this He-P 4038.07 through He-P 4038.13 is sufficient cause for denial or termination of unescorted access.

(i) The licensee shall:

(1) Determine whether to permit, deny, unfavorably terminate, maintain, or administratively withdraw an individual's unescorted access authorization based on an evaluation of all of the information collected to meet the requirements of He-P 4038.07 through He-P 4038.13;

(2) Not permit any individual to have unescorted access until the licensee has evaluated all of the information collected to meet the requirements of He-P 4038.07 through He-P 4038.13 and determined that the individual is trustworthy and reliable. The reviewing official may deny unescorted access to any individual based on information obtained at any time during the background investigation;

(3) Document the basis for concluding whether or not there is reasonable assurance that an individual is trustworthy and reliable;

(4) May terminate or administratively withdraw an individual's unescorted access authorization based on information obtained after the background investigation has been completed and the individual granted unescorted access authorization; and

(5) Maintain a list of persons currently approved for unescorted access authorization. When a licensee determines that a person no longer requires unescorted access or meets the access authorization requirement, the licensee shall remove the person from the approved list as soon as possible, but no later than 7 working days, and take prompt measures to ensure that the individual is unable to have unescorted access to the material.

(j) Licensees shall develop, implement, and maintain written procedures for implementing the access authorization program. The procedures shall include:

(1) Provisions for the notification of individuals who are denied unescorted access. The procedures shall include provisions for the review, at the request of the affected individual, of a denial or termination of unescorted access authorization; and

(2) Provision to ensure that the individual is informed of the grounds for the denial or termination of unescorted access authorization and allow the individual an opportunity to provide additional relevant information.

(k) Prior to any final adverse determination, licensees shall provide:

(1) Each individual subject to He-P 4038.07 through He-P 4038.13 with the right to complete, correct, and explain information obtained as a result of the licensee's background investigation;

(2) A confirmation of receipt by the individual of this notification to be maintained by the licensee for a period of 1 year from the date of the notification;

(3) Each individual with an opportunity to make revisions, corrections, updates to, or explanations of information in his or her criminal history record, if the individual believes it is incorrect or incomplete in any respect. The individual may initiate challenge procedures to change, correct, update, or explain anything in the record. The individual may initiate a challenge which shall include:

a. A direct application by the individual challenging the record to the law enforcement agency that contributed the questioned information or a direct challenge as to the accuracy or completeness of any entry on the criminal history record to the Federal Bureau of Investigation, Criminal Justice Information Services (CJIS) Division, ATTN: SCU, Mod. D–2, 1000 Custer Hollow Road, Clarksburg, WV 26306 as set forth in 28 CFR 16.30 through 16.34. In the latter case, the Federal Bureau of Investigation (FBI) will forward the challenge to the agency that submitted the data, and will request that the agency verify or correct the challenged entry; and

b. Upon receipt of an official communication directly from the law enforcement agency that contributed the original information, the FBI Identification Division shall make any changes necessary in accordance with the information supplied by that law enforcement agency;

(4) Provide at least 10 days for an individual to initiate action to challenge the results of an FBI criminal history records check after the record being made available for his or her review; and

(5) Make a final adverse determination based upon the criminal history records shall be made only after receipt of the FBI's confirmation or correction of the record; and

(l) The licensee shall retain:

(1) Documentation regarding the trustworthiness and reliability of individual employees for 3 years from the date the individual no longer requires unescorted access to category 1 or category 2 quantities of radioactive material;

(2) A copy of the current access authorization program procedures as a record for 3 years after the procedure is no longer needed. If any portion of the procedure is superseded, the licensee shall retain the superseded material for 3 years after the record is superseded; and

(3) The list of persons approved for unescorted access authorization for 3 years after the list is superseded or replaced.

Source. #11105, eff 5-25-16; amd by #12055, eff 11-19-16; amd by #12744, eff 3-20-19

He-P 4038.09 Background Investigations.

(a) Before allowing an individual unescorted access to category 1 or category 2 quantities of radioactive material or to the devices that contain the material, licensees shall complete a background investigation of the individual seeking unescorted access authorization. The scope of the investigation shall encompass at least the 7 years preceding the date of the background investigation or since the individual's eighteenth birthday, whichever is shorter. The background investigation shall include at a minimum:

(1) Fingerprinting and an FBI identification and criminal history records check in accordance with He-P 4038.10;

(2) Verification of the true identity of the individual who is applying for unescorted access authorization to ensure that the applicant is who he or she claims to be. A licensee shall:

a. Review official identification documents such as a driver's license, passport, government identification, or a certificate of birth issued by the state, province, or country of birth, and compare the documents to personal information data provided by the individual to identify any discrepancy in the information;

b. Document the type, expiration, and identification number of the identification document, or maintain a photocopy of identifying documents on file in accordance with He-P 4038.12;

c. Certify in writing that the identification was properly reviewed, and maintain the certification and all related documents for review upon inspection;

d. Complete an employment history verification, including military history and verify the individual's employment with each previous employer for the most recent 7 years before the date of application;

e. Verify that the individual participated in the education process during the claimed period;

f. Complete reference checks as required:

(i) To determine the character and reputation of the individual who has applied for unescorted access authorization;

(ii) To conduct reference checks with any person who is not a close member of the individual’s family when other references are not available, including but not limited to the individual's spouse, parents, siblings, or children, or any individual who resides in the individual's permanent household; and

(iii) Performing reference checks shall be limited to whether the individual has been and continues to be trustworthy and reliable;

g. To the extent possible, obtain independent information by seeking references not supplied by the individual to corroborate that information which has been provided by the individual; and

h. Obtain from an alternative source:

(i) If a previous employer, educational institution, or any other entity with which the individual claims to have been engaged fails to provide information or indicates an inability or unwillingness to provide information within a time frame deemed appropriate by the licensee but at least after 10 business days of the request; or

(ii) If the licensee is unable to reach the entity, document the refusal, unwillingness, or inability in the record of investigation.

(b) The individuals who have been determined to be trustworthy and reliable for unescorted access to category 1 or category 2 quantities of radioactive material under the fingerprint orders shall continue to have unescorted access to category 1 and category 2 quantities of radioactive material without further investigation. These individuals shall be:

(1) Subjected to the reinvestigation requirement in (d) below; and

(2) Trustworthy and reliable under the provisions of He-P 4038, the regulations of an equivalent agreement state, the NRC 10 CFR 73, or security orders for access to safeguards information, safeguards information-modified handling, or risk-significant material may have unescorted access to category 1 and category 2 quantities of radioactive material without further investigation.

(c) The licensee shall document that the individual was determined to be trustworthy and reliable under the provisions of He-P 4038, the regulations of an equivalent agreement state, the NRC 10 CFR 73, or a security order. Security order, in this context, means any order that was issued by the NRC that required fingerprints and an FBI criminal history records check for access to safeguards information, safeguards information-modified handling, or risk significant material such as special nuclear material or large quantities of uranium hexafluoride. These individuals shall be subject to the reinvestigation requirement.

(d) Licensees shall conduct a reinvestigation every 10 years for any individual with unescorted access to category 1 or category 2 quantities of radioactive material. The reinvestigation shall:

(1) Consist of fingerprinting and an FBI identification and criminal history records check in accordance with He-P 4038.10; and

(2) Be completed within 10 years of the date on which these elements were last completed.

Source. #11105, eff 5-25-16; amd by #12055, eff 11-19-16; amd by #12744, eff 3-20-19; amd by #12931, eff 11-26-19; ss by #13598, eff 3-24-23

He-P 4038.10 Requirements for Criminal History Records Checks of Individuals Granted Unescorted Access to Category 1 or Category 2 Quantities of Radioactive Material.

(a) General performance objective and requirements shall include the following:

(1) Except for those individuals listed in He-P 4038.11 and those individuals grandfathered under He-P 4038.09(b), each licensee subject to the provisions of He-P 4038.07 through He-P 4038.13, shall fingerprint each individual who is to be permitted unescorted access to category 1 or category 2 quantities of radioactive material. Licensees shall transmit all collected fingerprints to the NRC for transmission to the FBI. The licensee shall use the information received from the FBI as part of the required background investigation to determine whether to grant or deny further unescorted access to category 1 or category 2 quantities of radioactive materials for that individual;

(2) The licensee shall notify each affected individual that the individual’s fingerprints shall be used to secure a review of the individual’s criminal history record, and shall inform the individual of the procedures for revising the record or adding explanations to the record;

(3) Fingerprinting is not required if a licensee is reinstating an individual's unescorted access authorization to category 1 or category 2 quantities of radioactive materials if:

a. The individual returns to the same facility that granted unescorted access authorization within 365 days of the termination of the individual’s unescorted access authorization; and

b. The previous access was terminated under favorable conditions;

(4) Fingerprints do not need to be taken if an individual who is an employee of a licensee, contractor, manufacturer, or supplier has been granted unescorted access to category 1 or category 2 quantities of radioactive material, access to safeguards information, or safeguards information-modified handling by another licensee, based upon a background investigation and fingerprinting orders, conducted under He-P 4038.07 through He-P 4038.13, the regulations of an equivalent agreement state, or the NRC 10 CFR 73. An existing criminal history records check file may be transferred to the licensee asked to grant unescorted access in accordance with the provisions of He-P 4038.12(c); and

(5) Licensees shall use the information obtained as part of a criminal history records check solely for the purpose of determining an individual's suitability for unescorted access authorization to category 1 or category 2 quantities of radioactive materials, access to safeguards information, or safeguards information-modified handling.

(b) A licensee shall not:

(1) Base a final determination to deny an individual unescorted access authorization to category 1 or category 2 quantities of radioactive material solely on the basis of information received from the FBI involving:

a. An arrest more than 1 year old for which there is no information of the disposition of the case; or

b. An arrest that resulted in dismissal of the charge or an acquittal; or

(2) Use information received from a criminal history records check obtained under He-P 4038 in a manner that would infringe upon the rights of any individual under the First Amendment to the Constitution of the United States, nor shall licensees use the information in any way that would discriminate among individuals on the basis of race, religion, national origin, gender, or age.

(1) Use an appropriate method listed in the NRC 10 CFR 37.7 to submit to the NRC, Director, Division of Physical and Cyber Security Policy, 11545 Rockville Pike, ATTN: Criminal History Program/Mail Stop T-07D04M, Rockville, Maryland 20852, one completed, legible standard fingerprint card, Form FD–258, ORIMDNRCOOOZ provided by the NRC, electronic fingerprint scan or, where practicable, other fingerprint record for each individual requiring unescorted access to category 1 or category 2 quantities of radioactive material. Copies of these forms may be obtained by NRCemailing a request to MAILSVS.Resource@nrc.gov. Guidance on submitting electronic fingerprints can be found at https://www.nrc.gov/security/chp.html;

(2) Submit payment with the application for the processing of fingerprints through corporate check, certified check, cashier's check, money order, or electronic payment, made payable to "U.S. NRC." For guidance on making electronic payments, contact the Division of Physical and Cyber Security Policy by emailing Crimhist.Resource@nrc.gov. Combined payment for multiple applications is acceptable. The Commission publishes the amount of the fingerprint check application fee on the NRC's public website. To find the current fee amount, go to the licensee criminal history records checks and firearms background check information page at https://www.nrc.gov/security/chp.html and see the link for “How do I determine how much to pay for the request?”; and

(3) The NRC will forward to the submitting licensee all data received from the FBI as a result of the licensee's application(s) for criminal history records checks.

Source. #11105, eff 5-25-16; amd by #12055, eff 11-19-16; amd by #12744, eff 3-20-19; ss by #13598, eff 3-24-23

He-P 4038.11 Relief from Fingerprinting, Identification, and Criminal History Records Checks and Other Elements of Background Investigations for Designated Categories of Individuals Permitted Unescorted Access to Certain Radioactive Materials.

(a) Fingerprinting, and the identification and criminal history records checks required by Section 149 of the Atomic Energy Act of 1954, as amended, and other elements of the background investigation are not required for the following individuals prior to granting unescorted access to category 1 or category 2 quantities of radioactive materials:

(1) An employee of the Nuclear Regulatory Commission or of the Executive Branch of the U.S. Government who has undergone fingerprinting for a prior U.S. Government criminal history records check;

(2) A member of Congress;

(3) An employee of a member of Congress or Congressional committee who has undergone fingerprinting for a prior U.S. Government criminal history records check;

(4) The Governor of New Hampshire or his or her designated state employee representative;

(5) Federal, state, or local law enforcement personnel;

(6) State Radiation Control Program Directors and State Homeland Security Advisors or their designated State employee representatives;

(7) Employees of the state of New Hampshire or an agreement state conducting security inspections on behalf of the NRC under an agreement executed under section 274.i. of the Atomic Energy Act;

(8) Representatives of the International Atomic Energy Agency (IAEA) engaged in activities associated with the U.S. IAEA Safeguards Agreement who have been certified by the NRC;

(9) Emergency response personnel who are responding to an emergency;

(10) Commercial vehicle drivers for road shipments of category 1 and category 2 quantities of radioactive material;

(11) Package handlers at transportation facilities such as freight terminals and railroad yards;

(12) Any individual who has an active Federal security clearance, provided that he or she makes available the appropriate documentation. Written confirmation from the agency/employer that granted the Federal security clearance or reviewed the criminal history records check shall be provided to the licensee. The licensee shall retain this documentation for a period of 3 years from the date the individual no longer requires unescorted access to category 1 or category 2 quantities of radioactive material; and

(13) Any individual employed by a service provider licensee for which the service provider licensee has conducted the background investigation for the individual and approved the individual for unescorted access to category 1 or category 2 quantities of radioactive material. Written verification from the service provider shall be provided to the licensee. The licensee shall retain the documentation for a period of 3 years from the date the individual no longer requires unescorted access to category 1 or category 2 quantities of radioactive material.

(b) Fingerprinting, and the identification and criminal history records checks required by section 149 of the Atomic Energy Act of 1954, as amended, are not required for an individual who has had a favorably adjudicated U.S. Government criminal history records check within the last 5 years, under a comparable U.S. Government program involving fingerprinting and an FBI identification and criminal history records check provided that he or she makes available the appropriate documentation. Written confirmation from the agency/employer that reviewed the criminal history records check shall be provided to the licensee. The licensee shall retain this documentation for a period of 3 years from the date the individual no longer requires unescorted access to category 1 or category 2 quantities of radioactive material. These programs include, but are not limited to:

(1) National Agency Check;

(2) Transportation Worker Identification Credentials (TWIC) under 49 CFR part 1572;

(3) Bureau of Alcohol, Tobacco, Firearms, and Explosives background check and clearances under 27 CFR part 555;

(4) Health and Human Services security risk assessments for possession and use of select agents and toxins under 42 CFR part 73;

(5) Hazardous Material security threat assessment for hazardous material endorsement to commercial driver’s license under 49 CFR part 1572; and

(6) Customs and Border Protection's Free and Secure Trade (FAST) Program.

Source. #11105, eff 5-25-16; amd by #12744, eff 3-20-19

He-P 4038.12 Protection of Information.

(a) Each licensee who obtains background information on an individual under He-P 4038.07 through He-P 4038.13 shall establish and maintain a system of files and written procedures for protection of the record and the personal information from unauthorized disclosure.

(b) The licensee shall not disclose the record or personal information collected and maintained to persons other than the subject individual, his or her representative, or to those who have a need to have access to the information in performing assigned duties in the process of granting or denying unescorted access to category 1 or category 2 quantities of radioactive material, safeguards information, or safeguards information-modified handling. No individual authorized to have access to the information shall disseminate the information to any other individual who does not have a need to know.

(c) The personal information obtained on an individual from a background investigation may be provided to another licensee:

(1) Upon the individual's written request to the licensee holding the data to disseminate the information contained in his or her file; and

(2) The recipient licensee verifies information such as name, date of birth, social security number, gender, and other applicable physical characteristics.

(d) The licensee shall make background investigation records obtained under He-P 4038.07 through He-P 4038.13 available for examination by DHHS/RHS to determine compliance with the regulations and laws.

(e) The licensee shall retain all fingerprint and criminal history records (including data indicating no record) received from the FBI, or a copy of these records if the individual's file has been transferred, on an individual for 3 years from the date the individual no longer requires unescorted access to category 1 or category 2 quantities of radioactive material.

Source. #11105, eff 5-25-16; amd by #12055, eff 11-19-16

He-P 4038.13 Access Authorization Program Review.

(a) Each licensee shall be responsible for:

(1) Continuing effectiveness of the access authorization program;

(2) Ensuring that access authorization programs are reviewed to confirm compliance with the requirements of He-P 4038.07 through He-P 4038.13 and that comprehensive actions are taken to correct any noncompliance that is identified;

(3) Evaluating all program performance objectives and requirements; and

(4) Reviewing annually the access program content and implementation.

(b) The results of the reviews, along with any recommendations, shall:

(1) Be documented;

(2) Identify conditions that are adverse to the proper performance of the access authorization program, the cause of the condition(s), and, when appropriate, recommend corrective actions, and corrective actions taken; and

(3) Review the finding and take any additional corrective actions necessary to preclude repetition of the condition, including reassessment of the deficient areas where indicated.

Source. #11105, eff 5-25-16; amd by #12744, eff 3-20-19

He-P 4038.14 Security Program.

(a) Each licensee that possesses an aggregated category 1 or category 2 quantity of radioactive material shall establish, implement, and maintain a security program in accordance with the requirements of He-P 4038.14 through He-P 4038.22. In addition to those requirements, the licensee shall be subjected to the following:

(1) An applicant for a new license and each licensee that would become newly subject to the requirements of He-P 4038.14 through He-P 4038.22 upon application for modification of its license shall implement the requirements of He-P 4038.14 through He-P 4038.22, as appropriate, before taking possession of an aggregated category 1 or category 2 quantity of radioactive material; and

(2) Any licensee that has not previously implemented the security orders or been subject to the provisions of He-P 4038.14 through He-P 4038.22 shall provide written notification to DHHS/RHS as specified in He-P 4038.04 at least 90 days before aggregating radioactive material to a quantity that equals or exceeds the category 2 threshold.

(b) Each licensee shall establish, implement, and maintain a security program that is designed to monitor and, without delay, detect, assess, and respond to an actual or attempted unauthorized access to category 1 or category 2 quantities of radioactive material.

(c) Each licensee's security program shall include the program features, as appropriate, described in He-P 4038.15 through He-P 4038.21.

Source. #11105, eff 5-25-16; amd by #12744, eff 3-20-19; ss by #13598, eff 3-24-23

He-P 4038.15 General Security Program Requirements.

(a) The security plan shall require:

(1) Each licensee identified in He-P 4038.14(a) to develop a written security plan specific to its facilities and operations. The purpose of the security plan shall be to establish the licensee's overall security strategy to ensure the integrated and effective functioning of the security program required by He-P 4038.14 through He-P 4038.22. The security plan shall, at a minimum:

a. Describe the measures and strategies used to implement the requirements of this He-P 4038.14 through He-P 4038.22; and

b. Identify the security resources, equipment, and technology used to satisfy the requirements of He-P 4038.14 through He-P 4038.22.

(2) A review and approval by the individual with overall responsibility for the security program;

(3) The security plan shall be revised by the licensee as necessary to ensure the effective implementation of DHHS/RHS requirements. The licensee shall ensure that:

a. The revision has been reviewed and approved by the individual with overall responsibility for the security program; and

b. The affected individuals are instructed on the revised plan before the changes are implemented.

(4) The current security plan as a record shall be retained by the licensee for 3 years after the security plan is no longer required. If any portion of the plan is superseded, the licensee shall retain the superseded material for 3 years after the record is superseded.

(b) The security plan shall be implemented by the following procedures:

(1) The licensee shall develop and maintain written procedures that document how the requirements of He-P 4038.14 through He-P 4038.22 and the security plan will be met;

(2) The implementing procedures and revisions to these procedures shall be approved in writing by the individual with overall responsibility for the security program; and

(3) The licensee shall retain a copy of the current procedure as a record for 3 years after the procedure is no longer needed. Superseded portions of the procedure shall be retained for 3 years after the record is superseded.

(1) Each licensee shall conduct training to ensure that those individuals implementing the security program possess and maintain the knowledge, skills, and abilities to carry out their assigned duties and responsibilities effectively. The training shall include instruction in:

a. The licensee's security program and procedures to secure category 1 or category 2 quantities of radioactive material, and in the purposes and functions of the security measures employed;

b. The responsibility to report promptly to the licensee any condition that causes or may cause a violation of DHHS/RHS requirements;

c. The responsibility of the licensee to report promptly to the local law enforcement agency and licensee any actual or attempted theft, sabotage, or diversion of category 1 or category 2 quantities of radioactive material; and

d. The appropriate response to security alarms.

(2) In determining those individuals who shall be trained on the security program, the licensee shall consider each individual's assigned activities during authorized use and response to potential situations involving actual or attempted theft, diversion, or sabotage of category 1 or category 2 quantities of radioactive material. The extent of the training shall be commensurate with the individual's potential involvement in the security of category 1 or category 2 quantities of radioactive material; and

(3) Refresher training shall be provided at a frequency not to exceed 12 months and when significant changes have been made to the security program. This training shall include:

a. Review of the training requirements of paragraph (c) of this section and any changes made to the security program since the last training;

b. Reports on any relevant security issues, problems, and lessons learned;

c. Relevant results of DHHS/RHS inspections; and

d. Relevant results of the licensee's program review and testing and maintenance.

(4) The licensee shall maintain records of the initial and refresher training for 3 years from the date of the training. The training records shall include dates of the training, topics covered, a list of licensee personnel in attendance, and related information.

(d) All information and implementing procedures included as part of a security plan shall be protected as follows:

(1) Licensees authorized to possess category 1 or category 2 quantities of radioactive material shall limit access to and unauthorized disclosure of their security plan, implementing procedures, and the list of individuals that have been approved for unescorted access;

(2) Efforts to limit access shall include the development, implementation, and maintenance of written policies and procedures for controlling access to, and for proper handling and protection against unauthorized disclosure of, the security plan, implementing procedures, and the list of individuals that have been approved for unescorted access;

(3) Before granting an individual access to the security plan, implementing procedures, or the list of individuals that have been approved for unescorted access, licensees shall:

a. Evaluate an individual's need to know the security plan, implementing procedures, or the list of individuals that have been approved of unescorted access; and

b. If the individual has not been authorized for unescorted access to category 1 or category 2 quantities of radioactive material, safeguards information, or safeguards information-modified handling, the licensee shall complete a background investigation to determine the individual's trustworthiness and reliability. A trustworthiness and reliability determination shall be conducted by the reviewing official and shall include the background investigation elements contained in He-P 4038.09(a)(2).

(4) Licensees need not subject the following individuals to the background investigation elements for protection of information:

a. The categories of individuals listed in He-P 4038.11(a)(1) through (a)(13); or

b. Security service provider employees, provided written verification that the employee has been determined to be trustworthy and reliable, by the required background investigation in He-P 4038.09(a)(2), has been provided by the security service provider.

(5) The licensee shall document the basis for concluding that an individual is trustworthy and reliable and should be granted access to the security plan, implementing procedures, or the list of individuals that have been approved for unescorted access;

(6) Licensees shall maintain a list of persons currently approved for access to the security plan, implementing procedures, or the list of individuals that have been approved for unescorted access. When a licensee determines that a person no longer needs access to the security plan or implementing procedures, or the list of individuals that have been approved for unescorted access, or no longer meets the access authorization requirements for access to the information, the licensee shall remove the person from the approved list as soon as possible, but no later than 7 working days, and take prompt measures to ensure that the individual is unable to obtain the security plan, implementing procedures, or the list of individuals that have been approved for unescorted access;

(7) When not in use, the licensee shall store its security plan, implementing procedures, and the list of individuals that have been approved for unescorted access in a manner to prevent unauthorized access. Information stored in non-removable electronic form shall be password protected; and

(8) The licensee shall retain as a record for 3 years after the document is no longer needed:

a. A copy of the information protection procedures; and

b. The list of individuals approved for access to the security plan, implementing procedures, or the list of individuals that have been approved for unescorted access.

Source. #11105, eff 5-25-16; amd by #12744, eff 3-20-19; amd by #12931, eff 11-26-19

He-P 4038.16 Local Law Enforcement Agency (LLEA) Coordination.

(a) A licensee subject to He-P 4038.14 through He-P 4038.22 shall coordinate, to the extent practicable, with a licensed law enforcement agency (LLEA) for responding to threats to the licensee's facility, including any necessary armed response. The information provided to the LLEA shall include:

(1) A description of the facilities and the category 1 and category 2 quantities of radioactive materials along with a description of the licensee's security measures that have been implemented to comply with He-P 4038.14 through He-P 4038.22; and

(2) A notification that the licensee will request a timely armed response by the LLEA to any actual or attempted theft, sabotage, or diversion of category 1 or category 2 quantities of material.

(b) The licensee shall notify the DHHS/RHS as specified in He-P 4038.04, within 3 business days if:

(1) The LLEA has not responded to the request for coordination within 60 days of the coordination request; or

(2) The LLEA notifies the licensee that the LLEA does not plan to participate in coordination activities.

(d) The licensee shall coordinate with the LLEA at least every 12 months, or when changes to the facility design or operation adversely affect the potential vulnerability of the licensee's material to theft, sabotage, or diversion.

Source. #11105, eff 5-25-16; amd by #12744, eff 3-20-19

He-P 4038.17 Security Zones.

(a) Licensees shall ensure that all aggregated category 1 and category 2 quantities of radioactive material are used or stored within licensee established security zones. Security zones shall be permanent or temporary.

(b) Temporary security zones shall be established as necessary to meet the licensee's transitory or intermittent business activities, such as periods of maintenance, source delivery, and source replacement.

(1) Isolation of category 1 and category 2 quantities of radioactive materials by the use of continuous physical barriers that allow access to the security zone only through established access control points. A physical barrier is a natural or man-made structure or formation sufficient for the isolation of the category 1 or category 2 quantities of radioactive material within a security zone; or

(2) Direct control of the security zone by approved individuals at all times; or

(3) A combination of continuous physical barriers and direct control.

(d) For category 1 quantities of radioactive material during periods of maintenance, source receipt, preparation for shipment, installation, or source removal or exchange, the licensee shall, at a minimum, provide sufficient individuals approved for unescorted access to maintain continuous surveillance of sources in temporary security zones and in any security zone in which physical barriers or intrusion detection systems have been disabled to allow such activities.

(e) Individuals not approved for unescorted access to category 1 or category 2 quantities of radioactive material shall be escorted by an approved individual when in a security zone.

Source. #11105, eff 5-25-16

He-P 4038.18 Monitoring, Detection, and Assessment.

(a) Security zones shall be assessed as follows:

(1) Licensees shall establish and maintain the capability to continuously monitor and detect without delay all unauthorized entries into its security zones. Licensees shall provide the means to maintain continuous monitoring and detection capability in the event of a loss of the primary power source, or provide for an alarm and response in the event of a loss of this capability to continuously monitor and detect unauthorized entries.

(2) Monitoring and detection shall be performed by:

a. A monitored intrusion detection system that is linked to an onsite or offsite central monitoring facility;

b. Electronic devices for intrusion detection alarms that alert nearby facility personnel;

c. A monitored video surveillance system;

d. Direct visual surveillance by approved individuals located within the security zone; or

e. Direct visual surveillance by a licensee designated individual located outside the security zone.

(3) A licensee subject to He-P 4038.14 through He-P 4038.22 shall also have a means to detect unauthorized removal of the radioactive material from the security zone. This detection capability shall provide:

a. For category 1 quantities of radioactive material, immediate detection of any attempted unauthorized removal of the radioactive material from the security zone. Such immediate detection capability shall be provided by:

1. Electronic sensors linked to an alarm;

2. Continuous monitored video surveillance; or

3. Direct visual surveillance.

b. For category 2 quantities of radioactive material, weekly verification through physical checks, tamper indicating devices, use, or other means to ensure that the radioactive material is present.

(b) Licensees shall immediately assess each actual or attempted unauthorized entry into the security zone to determine whether the unauthorized access was an actual or attempted theft, sabotage, or diversion.

(c) For personnel and automated or electronic systems supporting the licensee's monitoring, detection, and assessment systems, licensees shall:

(1) Maintain continuous capability for personnel communication and electronic data transmission and processing among site security systems; and

(2) Provide an alternative communication capability for personnel, and an alternative data transmission and processing capability, in the event of a loss of the primary means of communication or data transmission and processing. Alternative communications and data transmission systems shall not be subject to the same failure modes as the primary systems.

(d) Licensees shall immediately respond to any actual or attempted unauthorized access to the security zones, or actual or attempted theft, sabotage, or diversion of category 1 or category 2 quantities of radioactive material at licensee facilities or temporary job sites. For any unauthorized access involving an actual or attempted theft, sabotage, or diversion of category 1 or category 2 quantities of radioactive material, the licensee's response shall include requesting, without delay, an armed response from the LLEA.

Source. #11105, eff 5-25-16; ss by #13598, eff 3-24-23

He-P 4038.19 Maintenance and Testing.

(a) Each licensee subject to He-P 4038.14 through He-P 4038.22 shall implement a maintenance and testing program to ensure that intrusion alarms, associated communication systems, and other physical components of the systems used to secure or detect unauthorized access to radioactive material are maintained in operable condition and are capable of performing their intended function when needed. The equipment relied on to meet the security requirements of He-P 4038 shall be inspected and tested:

(1) For operability and performance at the manufacturer's suggested frequency; or

(2) If there is no suggested manufacturer's suggested frequency, at least annually, not to exceed 12 months.

(b) The licensee shall maintain records on the maintenance and testing activities for 3 years.

Source. #11105, eff 5-25-16

He-P 4038.20 Requirements for Mobile Devices. Each licensee that possesses mobile devices containing category 1 or category 2 quantities of radioactive material shall:

(a) Have two independent physical controls that form tangible barriers to secure the material from unauthorized removal when the device is not under direct control and constant surveillance by the licensee; and

(b) For devices in or on a vehicle or trailer, unless the health and safety requirements for a site prohibit the disabling of the vehicle, the licensee shall utilize a method to disable the vehicle or trailer when not under direct control and constant surveillance by the licensee. Licensees shall not rely on the removal of an ignition key to meet this requirement.

Source. #11105, eff 5-25-16

He-P 4038.21 Security Program Review.

(a) Each licensee shall:

(1) Be responsible for the continuing effectiveness of the security program;

(2) Ensure that the security program is reviewed to confirm compliance with the requirements of He-P 4038.14 through He-P 4038.22 and that comprehensive actions are taken to correct any noncompliance that is identified;

(3) Review the radioactive material security program content and implementation; and

(4) Periodically, meaning at least annually, review the security program content and implementation.

(b) The results of the review, along with any recommendations, shall be documented. Each review report shall:

(1) Identify conditions that are adverse to the proper performance of the security program, the cause of the condition(s), and, when appropriate, recommend corrective actions, and corrective actions taken; and

(2) Review the findings and take any additional corrective actions necessary to preclude repetition of the condition, including reassessment of the deficient areas where indicated.

Source. #11105, eff 5-25-16; amd by #12744, eff 3-20-19

He-P 4038.22 Reporting of Events.

(a) The licensee shall immediately notify the LLEA after determining that an unauthorized entry resulted in an actual or attempted theft, sabotage, or diversion of a category 1 or category 2 quantity of radioactive material. As soon as possible after initiating a response, but not at the expense of causing delay or interfering with the LLEA response to the event, the licensee shall notify DHHS/RHS by calling (603-271-4588) Monday through Friday during regular working hours, 8:00 a.m. - 4:30 p.m., or at any other time shall notify the NH State Police by calling (603-271-3636). In no case shall the notification to DHHS/RHS be later than 4 hours after the discovery of any attempted or actual theft, sabotage, or diversion.

(b) The licensee shall assess any suspicious activity related to possible theft, sabotage, or diversion of category 1 or category 2 quantities of radioactive material and notify the LLEA as appropriate. As soon as possible but not later than 4 hours after notifying the LLEA, the licensee shall notify DHHS/RHS by calling (603-271-4588) Monday through Friday during regular business hours, 8:00 a.m. – 4:00 p.m., or at any other time shall notify the NH State Police by calling (603-271-3636).

(c) The initial telephonic notification required by He-P 4038.22(a) shall be followed within a period of 30 days by a written report submitted to DHHS/RHS by an appropriate method listed in He-P 4038.04. The report shall include sufficient information for DHHS/RHS analysis and evaluation, including identification of any necessary corrective actions to prevent future instances.

Source. #11105, eff 5-25-16; ss by #12744, eff 3-20-19

He-P 4038.23 Additional Requirements for Transfer of Category 1 and Category 2 Quantities of Radioactive Material. A licensee transferring a category 1 or category 2 quantity of radioactive material to a licensee of DHHS/RHS, an agreement state, or the U.S. NRC shall meet the license verification provisions listed below instead of those listed in He-P 4030.16(d) or 10 CFR 30.41(d):

(a) Any licensee transferring category 1 quantities of radioactive material to a licensee of the DHHS/RHS, an agreement state, or the NRC, prior to conducting such transfer, shall verify with the DHHS/RHS’, an agreement state’s, or NRC's license verification system or the license issuing authority that the transferee's license authorizes the receipt of the type, form, and quantity of radioactive material to be transferred and that the licensee is authorized to receive radioactive material at the location requested for delivery. If the verification is conducted by contacting the license issuing authority, the transferor shall document the verification. For transfers within the same organization, the licensee does not need to verify the transfer.

(b) Any licensee transferring category 2 quantities of radioactive material to a licensee of the DHHS/RHS, an agreement state, or the NRC, prior to conducting such transfer, shall verify with the DHHS/RHS’s, an agreement state’s, or NRC's license verification system or the license issuing authority that the transferee's license authorizes the receipt of the type, form, and quantity of radioactive material to be transferred. If the verification is conducted by contacting the license issuing authority, the transferor shall document the verification. For transfers within the same organization, the licensee does not need to verify the transfer.

(c) In an emergency where the licensee cannot reach the license issuing authority and the license verification system is nonfunctional, the licensee may accept a written certification by the transferee that it is authorized by license to receive the type, form, and quantity of radioactive material to be transferred. The certification shall:

(1) Include the license number, current revision number, issuing agency, expiration date, and for a category 1 shipment the authorized address;

(2) Be retained by the licensee; and

(3) Be confirmed by use of the DHHS/RHS’s, an agreement state’s, or NRC's license verification system or by contacting the license issuing authority by the end of the next business day.

(d) The transferor shall keep a copy of the verification documentation on record for 3 years.

Source. #11105, eff 5-25-16; ss by #13598, eff 3-24-23

He-P 4038.24 Applicability of Physical Protection of Category 1 and Category 2 Quantities of Radioactive Material During Transfer.

(a) For shipments of category 1 quantities of radioactive material, each shipping licensee shall comply with the requirements for physical protection contained in He-P 4038.25(a) and (e); He-P 4038.26; He-P 4038.27(a)(1), (b)(1), and (c); and He-P 4038.28(a), (c), (e), (g), and (h).

(b) For shipments of category 2 quantities of radioactive material, each shipping licensee shall comply with the requirements for physical protection contained in He-P 4038.25(b) through (e); He-P 4038.27(a)(2), (a)(3), (b)(2), and (c); and He-P 4038.28(b), (d), (f), (g), and (h). For those shipments of category 2 quantities of radioactive material that meet the criteria of the Nuclear Regulatory Commission 10 CFR 71.97(b).

(c) The shipping licensee shall comply with He-P 4038.23 through He-P 4038.28 unless the receiving licensee has agreed in writing to arrange for the in-transit physical protection required under He-P 4038.23 through He-P 4038.28.

(d) Each licensee that imports or exports category 1 quantities of radioactive material shall comply with the requirements for physical protection during transit contained in He-P 4038.25(a)(2) and (e); He-P 4038.26; He-P 4038.27(a)(1), (b)(1), and (c); and He-P 4038.28(a), (c), (e), (g), and (h) for the domestic portion of the shipment.

(e) Each licensee that imports or exports category 2 quantities of radioactive material shall comply with the requirements for physical protection during transit contained in He-P 4038.27(a)(2), (a)(3), and (b)(2); and He-P 4038.28(b), (d), (f), (g), and (h) for the domestic portion of the shipment.

Source. #11105, eff 5-25-16; ss by #12744, eff 3-20-19

He-P 4038.25 Preplanning and Coordination of Shipment of Category 1 or Category 2 Quantities of Radioactive Material.

(a) Each licensee that plans to transport, or deliver to a carrier for transport, licensed material that is a category 1 quantity of radioactive material outside the confines of the licensee's facility or other place of use or storage shall:

(1) Preplan and coordinate shipment arrival and departure times with the receiving licensee;

(2) Preplan and coordinate shipment information with the governor of New Hampshire or the governor's designee of New Hampshire or any state through which the shipment will pass to:

a. Discuss the state's intention to provide law enforcement escorts; and

b. Identify safe havens; and

(3) Document the preplanning and coordination activities.

(b) Each licensee that plans to transport, or deliver to a carrier for transport, licensed material that is a category 2 quantity of radioactive material outside the confines of the licensee's facility or other place of use or storage shall coordinate the shipment no-later-than arrival time and the expected shipment arrival with the receiving licensee. The licensee shall document the coordination activities.

(c) Each licensee who receives a shipment of a category 2 quantity of radioactive material shall confirm receipt of the shipment with the originator. If the shipment has not arrived by the no-later-than arrival time, the receiving licensee shall notify the originator.

(d) Each licensee, who transports or plans to transport a shipment of a category 2 quantity of radioactive material, and determines that the shipment will arrive after the no-later-than arrival time provided pursuant to He-P 4038.25(b), shall promptly notify the receiving licensee of the new no-later-than arrival time.

(e) The licensee shall retain a copy of the documentation for preplanning and coordination and any revision thereof, as a record for 3 years.

Source. #11105, eff 5-25-16

He-P 4038.26 Advance Notification of Shipment of Category 1 Quantities of Radioactive Material. As specified in He-P 4038.26(a) and (b), each licensee shall provide advance notification to the governor of a state, or the governor's designee and DHHS/RHS of the shipment of licensed material in a category 1 quantity, through or across the boundary of New Hampshire, before the transport, or delivery to a carrier for transport of the licensed material outside the confines of the licensee's facility or other place of use or storage.

(a) Procedures for submitting advance notification shall be:

(1) Made to DHHS/RHS, and the office of each appropriate governor or governor's designee. Notification to DHHS/RHS shall be as specified in He-P 4038.04. The contact information, including telephone and mailing addresses, of governors and governors’ designees, is available on the NRC’s website at https://scp.nrc.gov/special/designee.pdf. A list of the contact information is also available upon request by sending the request to the Director, Division of Material Safety, Security, State, and Tribal Programs, Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001. The notification to the NRC may also be made by email to RAMQC_SHIPMENTS@nrc.gov or by fax to 301-816-5151;

(2) Delivered by mail and shall be postmarked at least 7 days before transport of the shipment commences at the shipping facility; and

(3) Delivered by any means other than mail and shall reach DHHS/RHS at least 4 days before the transport of the shipment commences and shall reach the office of the governor or the governor's designee at least 4 days before transport of a shipment within or through the state.

(b) Each advance notification of shipment of category 1 quantities of radioactive material shall contain the following information, if available at the time of notification:

(1) The name, address, and telephone number of the shipper, carrier, and receiver of the category 1 radioactive material;

(2) The license numbers of the shipper and receiver;

(3) A description of the radioactive material contained in the shipment, including the radionuclides and quantity;

(4) The point of origin of the shipment and the estimated time and date that shipment shall commence;

(5) The estimated time and date that the shipment is expected to enter each state along the route;

(6) The estimated time and date of arrival of the shipment at the destination; and

(7) A point of contact, with a telephone number, for current shipment information.

(1) The licensee shall provide any information not previously available at the time of the initial notification, as soon as the information becomes available but not later than commencement of the shipment, to the governor of the state or the governor's designee, and to DHHS/RHS.

(2) A licensee shall promptly notify the governor of the state or the governor's designee of any changes to the information provided in accordance with He-P 4038.26(b) and (c)(1) of this section. The licensee shall also immediately notify DHHS/RHS of any such changes.

(d) Each licensee who cancels a shipment for which advance notification has been sent shall send a cancellation notice to the governor of each state or to the governor's designee previously notified, and to DHHS/RHS. The licensee shall send the cancellation notice before the shipment would have commenced or as soon as possible thereafter. The licensee shall state in the notice that there is a cancellation of shipment and as a result the advance notification of shipment is no longer applicable and the shipment is being withdrawn.

(e) The licensee shall retain, and make available for review, a copy of the advance notification and any revision and cancellation notices as a record for 3 years.

(f) State officials, state employees, and other individuals, whether or not licensees of the DHHS/RHS, an agreement state, or the NRC, who receive schedule information of the kind specified in He-P 4038.26(b) shall protect that information against unauthorized disclosure as specified in He-P 4038.15(d)

Source. #11105, eff 5-25-16; amd by #12055, eff 11-19-16; amd by #12744, eff 3-20-19; amd by #12931, eff 11-26-19; ss by #13598, eff 3-24-23

He-P 4038.27 Requirements for Physical Protection of Category 1 and Category 2 Quantities of Radioactive Material During Shipment.

(a) For any shipment made by road:

(1) Each licensee who transports, or delivers to a carrier for transport, in a single shipment, a category 1 quantity of radioactive material shall:

a. Ensure that movement control centers are established that maintain position information from a remote location. These control centers shall monitor shipments 24 hours a day, 7 days a week, and have the ability to communicate immediately, in an emergency, with the appropriate law enforcement agencies;

b. Ensure that redundant communications are established that allow the transport to contact the escort vehicle (when used) and movement control center at all times. Redundant communications shall not be subject to the same interference factors as the primary communication;

c. Ensure that shipments are continuously and actively monitored by a telemetric position monitoring system or an alternative tracking system reporting to a movement control center. A movement control center shall provide positive confirmation of the location, status, and control over the shipment. The movement control center shall be prepared to promptly implement preplanned procedures in response to deviations from the authorized route or a notification of actual, attempted, or suspicious activities related to the theft, loss, or diversion of a shipment. These procedures will include, but not be limited to, the identification of and contact information for the appropriate LLEA along the shipment route;

d. Provide an individual to accompany the driver for those highway shipments with a driving time period greater than the maximum number of allowable hours of service in a 24-hour duty day as established by the Department of Transportation Federal Motor Carrier Safety Administration. The accompanying individual may be another driver;

e. Develop written normal and contingency procedures to address:

1. Notifications to the communication center and law enforcement agencies;

2. Communication protocols. Communication protocols shall include a strategy for the use of authentication codes and duress codes and provisions for refueling or other stops, detours, and locations where communication is expected to be temporarily lost;

3. Loss of communications; and

4. Responses to an actual or attempted theft or diversion of a shipment.

f. Each licensee who makes arrangements for the shipment of category 1 quantities of radioactive material shall ensure that drivers, accompanying personnel, and movement control center personnel have access to the normal and contingency procedures.

(2) Each licensee that transports category 2 quantities of radioactive material shall maintain constant control and/or surveillance during transit and have the capability for immediate communication to summon appropriate response or assistance.

(3) Each licensee who delivers to a carrier for transport, in a single shipment, a category 2 quantity of radioactive material shall:

a. Use carriers that have established package tracking systems. An established package tracking system is a documented, proven, and reliable system routinely used to transport objects of value. In order for a package tracking system to maintain constant control and/or surveillance, the package tracking system shall allow the shipper or transporter to identify when and where the package was last and when it should arrive at the next point of control.

b. Use carriers that maintain constant control and/or surveillance during transit and have the capability for immediate communication to summon appropriate response or assistance; and

c. Use carriers that have established tracking systems that require an authorized signature prior to releasing the package for delivery or return.

(b) For any shipment made by rail:

(1) Each licensee who transports, or delivers to a carrier for transport, in a single shipment, a category 1 quantity of radioactive material shall:

a. Ensure that rail shipments are monitored by a telemetric position monitoring system or an alternative tracking system reporting to the licensee, third-party, or railroad communications center. The communications center shall provide positive confirmation of the location of the shipment and its status. The communications center shall implement preplanned procedures in response to deviations from the authorized route or to a notification of actual, attempted, or suspicious activities related to the theft or diversion of a shipment. These procedures shall include, but not be limited to, the identification of and contact information for the appropriate LLEA along the shipment route.

b. Ensure that periodic reports to the communications center are made at preset intervals.

(2) Each licensee who transports, or delivers to a carrier for transport, in a single shipment, a category 2 quantity of radioactive material shall:

b. Use carriers that maintain constant control and/or surveillance during transit and have the capability for immediate communication to summon appropriate response or assistance; and

c. Use carriers that have established tracking systems that require an authorized signature prior to releasing the package for delivery or return.

(c) Each licensee who makes arrangements for the shipment of category 1 quantities of radioactive material shall immediately conduct an investigation upon the discovery that a category 1 shipment is lost or missing. Each licensee who makes arrangements for the shipment of category 2 quantities of radioactive material shall immediately conduct an investigation, in coordination with the receiving licensee, of any shipment that has not arrived by the designated no-later-than arrival time.

Source. #11105, eff 5-25-16

He-P 4038.28 Reporting of Shipping Events.

(a) The shipping licensee shall notify the appropriate LLEA and DHHS/RHS within 1 hour of its determination that a shipment of category 1 quantities of radioactive material is lost or missing. The appropriate LLEA shallbe the law enforcement agency in the area of the shipment's last confirmed location. During the investigation required by He-P 4038.27(c), the shipping licensee shall provide agreed upon updates to DHHS/RHS on the status of the investigation.

(b) The shipping licensee shall notify DHHS/RHS by calling 603-271-4588 Monday through Friday during regular business hours, 8:00 a.m.- 4:00 p.m., or at any other time outside of the aforementioned hours, shall notify the NH state police by calling 603-271-3636 within 4 hours of its determination that a shipment of category 2 quantities of radioactive material is lost or missing. If, after 24 hours of its determination that the shipment is lost or missing, the radioactive material has not been located and secured, the licensee shall immediately notify DHHS/RHS that the missing radioactive material cannot be found.

(c) The shipping licensee shall notify the designated LLEA along the shipment route as soon as possible upon discovery of any actual or attempted theft or diversion of a shipment or suspicious activities related to the theft or diversion of a shipment of a category 1 quantity of radioactive material. As soon as possible after notifying the LLEA, the licensee shall notify DHHS/RHS by calling 603-271-4588 Monday through Friday during regular business hours, 8:00 a.m. – 4:00 p.m., or at any other time outside of the aforementioned hours, shall notify the NH state police by calling 603-271-3636 upon discovery of any actual or attempted theft or diversion of a shipment, or any suspicious activity related to the shipment of category 1 radioactive material.

(d) The shipping licensee shall notify DHHS/RHS by calling 603-271-4588 Monday through Friday during regular business hours, 8:00 a.m. – 4:00 p.m., or at any other time outside of the aforementioned hours, shall notify the NH state police by calling 603-271-3636 as soon as possible upon discovery of any actual or attempted theft or diversion of a shipment, or any suspicious activity related to the shipment, of a category 2 quantity of radioactive material.

(e) The shipping licensee shall notify DHHS/RHS by calling 603-271-4588 Monday through Friday during regular business hours, 8:00 a.m. – 4:00 p.m., and at any other time shall notify the NH state police by calling 603-271-3636, and the LLEA as soon as possible upon recovery of any lost or missing category 1 quantities of radioactive material.

(f) The shipping licensee shall notify DHHS/RHS by calling 603-271-4588 Monday through Friday during regular business hours, 8:00 a.m. – 4:00 p.m., and at any other time shall notify the NH state police by calling 603-271-3636 as soon as possible upon recovery of any lost or missing category 2 quantities of radioactive material.

(g) The initial telephonic notification required by He-P 4038.28(a) through (d) shall be followed within a period of 30 days by a written report submitted to DHHS/RHS by an appropriate method listed in He-P 4038.04. A written report is not required for notifications on suspicious activities required by He-P 4038.38(c) and (d). In addition, the written report provided to DHHS/RHS shall set forth the following information:

(1) A description of the licensed material involved, including kind, quantity, and chemical and physical form;

(2) A description of the circumstances under which the loss or theft occurred;

(3) A statement of disposition, or probable disposition, of the licensed material involved;

(4) Actions that have been taken, or shall be taken, to recover the material; and

(5) Procedures or measures that have been, or shall be, adopted to ensure against a recurrence of the loss or theft of licensed material.

(h) Subsequent to filing the written report, the licensee shall also report any additional substantive information on the loss or theft within 30 days after the licensee learns of such information.

Source. #11105, eff 5-25-16; amd by #12744, eff 3-20-19; ss by #13598, eff 3-24-23

He-P 4038.29 Forms of Records.

(a) Any record or document required by He-P 4038 shall be legible throughout the retention period specified by He-P 4038.

(b) The record may be the original or a reproduced copy or a microform, provided that the copy or microform is authenticated by authorized personnel and that the microform is capable of producing a clear copy throughout the required retention period.

(c) The record may also be stored in electronic media with the capability for producing legible, accurate, and complete records during the required retention period.

(d) Records such as letters, drawings, and specifications, shall include all pertinent information such as stamps, initials, and signatures.

(e) The licensee shall maintain adequate safeguards against tampering with and loss of records.

Source. #11105, eff 5-25-16

He-P 4038.30 Record Retention.

(a) Licensees shall maintain the records or documents that are required by He-P 4038 for the period specified by the appropriate section.

(b) If a retention period is not otherwise specified, these records shall be retained until the DHHS/RHS terminates the facility's license.

Source. #11105, eff 5-25-16

He-P 4038.31 Inspections. Each licensee shall make available to DHHS/RHS for inspection, upon reasonable notice, records kept by the licensee pertaining to its receipt, possession, use, acquisition, import, export, or transfer of category 1 or category 2 quantities of radioactive material.

Table 4038.1—Category 1 and Category 2 Threshold

The terabecquerel (TBq) values are the regulatory standard. The curie (Ci) values specified are obtained by converting from the TBq value. The curie values are provided for practical usefulness only.

Radioactive material	Category 1(TBq)	Category 1(Ci)	Category 2(TBq)	Category 2(Ci)
Americium-241	60	1,620	0.6	16.2
Americium-241/Be	60	1,620	0.6	16.2
Californium-252	20	540	0.2	5.40
Cobalt-60	30	810	0.3	8.10
Curium-244	50	1,350	0.5	13.5
Cesium-137	100	2,700	1	27.0
Gadolinium-153	1,000	27,000	10	270
Iridium-192	80	2,160	0.8	21.6
Plutonium-238	60	1,620	0.6	16.2
Plutonium-239/Be	60	1,620	0.6	16.2
Promethium-147	40,000	1,080,000	400	10,800
Radium-226	40	1,080	0.4	10.8
Selenium-75	200	5,400	2	54.0
Strontium-90	1,000	27,000	10	270
Thulium-170	20,000	540,000	200	5,400
Ytterbium-169	300	8,100	3	81.0

Note: Calculations Concerning Multiple Sources or Multiple Radionuclides

The "sum of fractions" methodology for evaluating combinations of multiple sources or multiple radionuclides is to be used in determining whether a location meets or exceeds the threshold and is thus subject to the requirements of this part.

I. If multiple sources of the same radionuclide and/or multiple radionuclides are aggregated at a location, the sum of the ratios of the total activity of each of the radionuclides must be determined to verify whether the activity at the location is less than the category 1 or category 2 thresholds of Table 4038.1, as appropriate. If the calculated sum of the ratios, using the equation below, is greater than or equal to 1.0, then the applicable requirements of this part apply.

II. First determine the total activity for each radionuclide from Table 4038.1. This is done by adding the activity of each individual source, material in any device, and any loose or bulk material that contains the radionuclide. Then use the equation below to calculate the sum of the ratios by inserting the total activity of the applicable radionuclides from Table 4038.1 in the numerator of the equation and the corresponding threshold activity from Table 4038.1 in the denominator of the equation.

Calculations must be performed in metric values, i.e., TBq, and the numerator and denominator values must be in the same units.

R₁ = total activity for radionuclide 1

R₂ = total activity for radionuclide 2

R_N = total activity for radionuclide n

AR₁ = activity threshold for radionuclide 1

AR₂ = activity threshold for radionuclide 2

AR_N = activity threshold for radionuclide n

Source. #11105, eff 5-25-16; ss by #13598, eff 3-24-23

PART He-P 4039 Radiation Safety Requirements for Wireline Services Operations and Subsurface Tracer Studies

He-P 4039.01 Purpose. The purpose of this rule is to set forth the requirements for wireline services operations and subsurface tracer studies. The requirements of this section are in addition to, and not in substitution for, the requirements of He-P 4003, 4019, 4020, 4021, 4022, 4023, 4024, 4030, 4031, and 4038 of this chapter.

Source. #5903, eff 12-1-94, EXPIRED: 12-1-00

New. #8212, eff 11-23-04; ss by #10188, eff 9-26-12; ss by #13541, eff 1-28-31

He-P 4039.02 Scope. This part shall apply to persons using sources of radiation for wireline service operations including mineral logging, radioactive markers, and subsurface tracer studies as specified in Title 10, Code of Federal Regulations (CFR), Part 39, “Licenses and Radiation Safety Requirements for Well Logging”.

Source. #5903, eff 12-1-94, EXPIRED: 12-1-00

New. #8212, eff 11-23-04; ss by #10188, eff 9-26-12; ss by #13541, eff 1-28-31; ss by #13541, eff 1-28-31

He-P 4039.03. Definitions. To reconcile differences between this part and the incorporated sections of 10 CFR Part 39 relating to using sources of radiation for wireline service operations including mineral logging, radioactive markers, and subsurface tracer studies, the following words and phrases shall be substituted for the language in 10 CFR Part 39 as follows:

(a) All references to “NRC” or “Commission” shall mean the New Hampshire department of health and human services;

(b) The definition of “licensed material” shall be as defined in He-P 4003 of this chapter; and

Source. #5903, eff 12-1-94, EXPIRED: 12-1-00

New. #8212, eff 11-23-04; ss by #10188, eff 9-26-12; ss by #13541, eff 1-28-31

He-P 4039.04 Incorporation of 10 CFR Part 39.

(a) Except for the sections noted in (b) below and He-P 4039.03 above, persons using sources of radiation for wireline service operations including mineral logging, radioactive markers, and subsurface tracer studies shall comply with Title 10, Code of Federal Regulations (CFR), Part 39, “Licenses and Radiation Safety Requirements for Well Logging”.

(b) The following sections of the Title 10 CRF Part 39 shall not apply to those persons using sources of radiation for wireline service operations:

(1) Title 10 CFR Part 39.5 relating to interpretations;

(2) Title 10 CFR Part 39.8 relating to information collection;

(3) Title 10 CFR Part 39.101 relating to violations; and

(4) Title 10 CFR Part 39.103 relating to criminal penalties.

Source. #5903, eff 12-1-94, EXPIRED: 12-1-00

New. #8212, eff 11-23-04; ss by #10188, eff 9-26-12; ss by #13541, eff 1-28-31