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.

 

(c)  The licensee shall maintain records in accordance with He-P 4021.09.

 

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;

 

(c)  Minimize, to the extent practicable, the generation of radioactive waste; and

 

(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.

 

(c)  The licensee shall notify the DHHS/RHS in writing within 60 days of the occurrence of any of the following:

 

(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.

 

(c)  The proposed decommissioning plan for the facility or site, or separate building or outdoor area, shall include:

 

(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.

 

(c)  In seeking the advice described in (b) above, the licensee shall provide for:

 

(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 DHHS/RHS, or as otherwise provided in this chapter.

 

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

 

(1)  All licensees are 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 through He-P 4096;

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

(9)  Licensees engaged in irradiator operations are 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 are subject to the requirements of He-P 4030.

 

(c)  All applications, supplements and supporting documents submitted to DHHS/RHS shall:

 

(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.  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;”

 

(3)  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

 

(4)  Be mailed to DHHS/RHS at NH DHHS Radiological Health Section, Health and Welfare Building, 29 Hazen Drive, Concord, NH  03301-6503.

 

(d)  Documentation including attached sheets of information, supplements, sketches and drawings can 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

 

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 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, 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, but not including glass enamel 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.  The counterweights are manufactured in accordance with a specific license issued by the U.S. Nuclear Regulatory Commission, authorizing distribution by the licensee pursuant to 10 CFR Part 40;

 

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

 

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

 

d.  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

 

e.  For counterweights manufactured prior to December 31, 1969, the requirements specified in He‑P 4030.02(c)(5)b. and c. shall be met if such counterweights are impressed with the legend: “CAUTION - RADIOACTIVE MATERIAL – URANIUM”;

 

(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 contained in finished optical lenses and mirrors, provided that each lens or mirror does not contain more than 10 percent by weight of thorium, and does not include:

 

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.

 

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 4030.03  Exemptions, Byproduct Materials Other Than Source Materials.

 

(a)  Except as provided in He‑P 4030.03(b), or an equivalent regulation of an agreement state, or the Nuclear Regulatory Commission, any person shall be exempt from He‑P 4030 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 He-P 4032.04, or a general license granted under He-P 4030.18, or the equivalent regulation of an agreement state, or the Nuclear Regulatory Commission 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; and

 

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, spark gap tubes, power tubes, gas tubes including glow lamps, receiving tubes, microwave tubes, indicator tubes, pick-up tubes, radiation detection tubes, and any other completely sealed tube that is designed to conduct or control electrical currents 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 4096 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;

 

(2)  This exemption also applies to any person who receives, possesses, uses, transfers, owns, or acquires 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; and

 

(3)  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, or produce 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, imported, or 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 (j), 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 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 and He-P 4036 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 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, is exempt from the requirements for a license set forth in He-P 4031 through He-P 4036 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 is 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 at 10 CFR Part 81, 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

 

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

 

(a)  Prime contractors performing work for the Nuclear Regulatory Commission or DOE at U.S. Government-owned or controlled sites;

 

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

 

(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 when DHHS/RHS and the Nuclear Regulatory Commission jointly determine that:

 

(1)  Under the terms of the contract or subcontract, there is 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 4039, and U.S. Nuclear Regulatory Commission 10 CFR 37 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

 

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)  Any person who desires to manufacture, prepare, process, produce, package, repackage, or transfer for commercial distribution such capsules shall apply for and receive a specific license pursuant to He-P 4032.03.

 

(d)  Nothing in this section shall relieve persons from complying with applicable 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

 

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 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” (December 2015) and DHHS/RHS-1 Supplement A “Training and Experience” (December 2015),

 

b.  DHHS/RHS–1M “Application for Radioactive Material License – Medical” (December 2015), and the following supplements as applicable, DHHS/RHS-1M Supplement A “Radiation Safety Officer Training and Experience and Preceptor Attestation,” or Supplement B-Diagnostic “Authorized User Training and Experience and Preceptor Statement” (December 2015), or Supplement B-Sources “Authorized User Training and Experience and Preceptor Attestation” (December 2015), or Supplement B-Therapy Authorized User Training and Experience and Preceptor Attestation” (December 2015), or Supplement C “Authorized Medical Physicist Training and Experience and Preceptor Attestation” (December 2015), or Supplement D “Authorized Nuclear Pharmacist Training and Experience and Preceptor Attestation” (December 2015); or 

 

c.  DHHS/RHS–1R “Application for Radioactive Material License–Use of Sealed Sources in Industrial Radiography” (December 2015), and DHHS/RHS–1R Supplement A “Training and Experience” (December 2015), or

 

d.  DHHS/RHS–3 “Application for Radioactive Material License–Source Material” (December 2015), as applicable and DHHS/RHS-3 Supplement A “Training and Experience.”

 

(2)  If submitted on DHHS/RHS-1M “Application for Radioactive Material License–Medical” (December 2015), then the following apply:

 

a.  Answers to questions 7 through 23 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, or

 

b. If answers to questions 7 through 23 are made following an appendix to the medical licensing guide, then the date of the referenced guide and the appendix letter should 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” (December 2015), 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.  And 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 1 million electron volts) and brachytherapy services; and

 

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.

 

h.  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 may at any time after the filing of the original application, and before the expiration of the license, require further statements or information in order for DHHS/RHS to determine whether the application should be granted or denied, or whether a license should be modified or revoked.

 

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

 

(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 not required in the public interest and would adversely affect the interest of a person concerned.

 

(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), (h)(3), and (h)(4), 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:

 

(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‑P4032.11(b); or

 

(3)  For sources of 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.

 

(4)  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, in the following cases calibration and reference sources containing no more than:

 

a.  37 megabecquerels (1 millicurie), for beta and/or gamma emitting radionuclides; or

 

b.  370 kilobecquerels (10 microcuries), for alpha emitting radionuclides.

 

(i)  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.

 

(j)  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 either:

 

a.  An evaluation showing that the maximum dose to a person offsite due to a release of radioactive materials would not exceed 1 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 to be approved, the evaluation in He-P 4030.07(j)(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(j)(1)b. shall include the following information:

 

a.  A description of the licensee’s facility and 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 will 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 accident 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(j)(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.

 

(k)  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 Nuclear Regulatory Commission 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 Nuclear Regulatory Commission 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

 

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 1012 is 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 1012 times 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.

 

(c)  Specific licenses shall be issued to named persons upon applications filed pursuant to He‑P 4030.

 

(d)  Each license issued pursuant to this part and parts He-P 4031 through 4036, and He-P 4039, shall be subject to all the provisions of RSA 125-F, to all rules of  DHHS/RHS He-P 4000, and orders of the commissioner of the department of health and human services.

 

(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 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 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) and (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 radioactive 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 radioactive material, as follows:

 

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

 

b.  The licensee who transferred the radioactive material shall retain each record of transfer for 3 years after each transfer unless otherwise specified in this chapter; and

 

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

 

(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.  The licensee shall record the results of each test and retain each record for 3 years after the record is made.

 

(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 does 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 two 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.

 

(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; and 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.

 

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 4030.11  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).

 

(c)  No less than 30 days before the expiration date specified in the license, the licensee shall either:

 

(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;