ML19295A109
| ML19295A109 | |
| Person / Time | |
|---|---|
| Issue date: | 09/09/1980 |
| From: | Dircks W, Monogue R NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS), NRC OFFICE OF STANDARDS DEVELOPMENT |
| To: | |
| References | |
| FRN-45FR67018, RULE-PR-20, TASK-CC, TASK-SE SECY-80-415, NUDOCS 8009290471 | |
| Download: ML19295A109 (40) | |
Text
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UNITED S TATES NUCLEAR REGULATORY COMMISSION Seotember 9, 1980 WASHINGTON,0. C. 20555 SECY-80-415 CONSENT CALENDAR ITEM For:
The Comissioners From:
William J. Dircks, Director Office of Nuclear Material Safety and Safeguards Robert B. Minogue, Director
- p. y Office of Standards Development 4,,y Thru:
Acting Executive Director for Operations
Subject:
PROPOSED AMENDMENTS OF 10 CFR PART 20 ON DISPOSAL OF CERTAIN H-3 AND C-14 WASTES
Purpose:
To obtain Comission approval of a notice of proposed rule-making that would (a) permit NRC licensees to dispose of liquid scintillation media and animal carcasses containing tracer levels of hydrogen-3 and carbon-14 without regard to their radioactivity and (b) raise the limit for disposal of these radioisotopes to the sanitary sewerage system.
Category:
This paper covers a minor policy question.
Issue:
(1)
Should liquid scintillation media and animal carcasses containing tracer levels of hydrogen-3 and carbon-14 be disposed of as radioactive waste?
(2)
Should the limit be raised for disposal of hydrogen-3 and carbon-14 by release to the sanitary sewerage system?
Discussion:
The following facts bear on the resolution of Issue 1:
1.
Liquid scintillation media and animal carcasses contaminated with tracer levels of hydrogen-3 and carbon-14 (typically less than.05 microcuries per gram) are end products of biomedical research.
2.
Although some other limited options are available,10 CFR 30.41 and 10 CFR 20.301 and similar Agreement State regulations generally result in liquid scintillation media and animal carcasses with any added hydrogen-3 and carbon-14 being handled as radioactive waste and consigned to a radioactive waste burial ground.
Contact:
J. Cook, NMSS 427-4240 E. Podolak, SD 443-5860 8009290471
The Comissioners 3.
Transportation of these materials to radioactive waste burial grounds presents problems because liquid scintilla-tion media are flammable and the decaying carcasses are unsanitary and generate methane gas which can explode or otherwise rupture waste containers.
These materials pose similar problems at burial grounds. Additionally, the voids formed in the burial trenches by the decaying animal carcasses are believed to contribute to migration of chemicals by increasing rain water percolation in the trenches.
4.
Of the three active radioactive waste burial grounds in the United States, only two accept both liquid scintillation media and animal carcasses; the other accepts only animal carcasses.
State regulatory bodies are attempting to reduce the volume of incoming waste to prolong use of the sites.
5.
The proposed rulemaking in Enclosure 1 would allow NRC licensees to dispose of liquid scintillation media and animal carcasses containing less than 0.05 microcuries of hydrogen-3 or carbon-14 per gram without regard to their radioactivity. This action would result in the annual release of approximately 28 curies of hydrogen-3 and 6 curies of carbon-14 into the environment (see Preliminary Value/ Impact Statement, Enclosure 2). The steady state environmental inventory produced mainly by natural cosmic production is 28 million curies of hydrogen-3 and 280 million curies of carbon-14.
6.
The staff explored how animal carcasses are disposed of by biomedical research institutions. The bulk of the animal carcasses, mice, rats, and dogs, are incinerated or put in the trash for removal to sanitary landfills. The staff investigated specific disposal scenarios which would maximize radiation exposure to man.
The incineration procedure makes the radioactivity most readily available to man's environment.
Sanitary landfill was also considered, and the staff concluded that the resulting radiation exposures would be an order of magnitude less than for the incineration scenario. Also, the staff considered the possibility that very small quantities of decaying animal matter could be incorporated into fertilizer or otherwise find its way into the food chain.
The amount of radioactivity entering the food chain from decaying animal matter would be small, the dilution factor would be very large, and the resulting radiation exposure to man would be miniscule in the unlikely event that this were to occur.
4 The Comissioners 7.
For incineration of liquid scintillation media and animal carcasses from a large facility, calculations employing conservative assumptions indicate that if radiation exposure occurs as a result of the rule change the dose to exposed individuals is likely to be much less than 1 mrem per year (see Enclosure 2). This is a fraction of a percent of natural background doses.
8.
Consigr. ment of liquid scintillation media and animal carcasses to radioactive waste burial grounds costs approximately $16 million annually for packaging materials, transportation and disposal.
This consumes approximately 50 percent of the burial space used for waste not related to nuclear power generation and its supporting fuel cycle.
Taking into account the cost of disposing of these materials as non-radioactive hazardous waste, the rule change is likely to result in an annual cost savings in excess of
$13 million to hospitals and research institutions if the Agreement States adopt similar amendments.
9.
This Commission action will not, in itself, solve the problem of disposal of liquid scintillation media and animal carcasses.
The proposed rulemaking in Enclosure 1 will not relieve licensees from complying with other applicable regulations of federal, state, and local government agencies regarding the disposal of hazardous chemical and biological wastes.
10.
This Commission action may affect the growing interest by some states in establishing low-level waste burial grounds.
A portion of this state interest is stimulated by the medical community to solve the very problem that this Comission action would alleviate.
However, the staff believes that the proposed rulemaking in Enclosure 1 is the straightforward approach to addressing the problem of biomedical radioactive waste.
Further, the need for additional low-level radioactive waste burial capacity, including capacity for medical related wastes, remains a problem requiring a long-term solution.
The following facts bear on the resolution of Issue 2:
1.
There are other hydrogen-3 and carbon-14 wastes in the research laboratory that do not result in liquid scintillation vials or animal carcasses; for example, the solutions and attendant material used to prepare the research samples.
The Comissioners 2.
Under present regulations in Section 20.303 these wastes, if they are readily soluble or dispersable in water, may be released into the sanitary sewerage system (within the limitations of Sections 20.303(b) and (c)) provided the gross quantity of licensed material does not exceed 1 curie per year.
The one curie limit is an arbitrary value placed in 10 CFR 20 in the 1950's when little was known about how the nuclear industry would grow.
3.
Several associations of academic institutions have together asked the Radiation Policy Council to suggest that NRC raise the above limit of I curie per year for all NRC licensed radioisotopes to a limit of 5 curies for hydrogen-3,1 curie for carbon-14, and 1 curie for all other NRC licensed radioisotopes.
4.
The proposed rulemaking in Enclosure 1 would leave all the conditions in Section 20.303 intact, except that the annual limits for disposal of hydrcgen-3 and carbon-14 would be raised to 5 curies and 1 curie respectively as requested by the above groups.
5.
Calculations employing conservative assumptions (see ) indicate that when radiation exposure occurs as a result of the rule change, the dose to individuals is likely to be much less than 1 mrem per year.
6.
The staff estimates that raising the limits for disposal of hydrogen-3 and carbon-14 to the sanitary sewage system would benefit 20-30 NRC ifcensees.
Although the dollar savings and the savings in radioactive waste burial capacity are not known, they are probably small compared to the benefits of the action in Issue 1 of this paper. However, even small savings in the cost of medical research and small savings in radioactive waste burial capacity are of direct benefit to the public.
Advisory Committee:
The proposed rule was reviewed with the Advisory Comittee on the Medical Uses of Isotopes at its meeting on August 18, 1980.
Based on the premise that the staff estimates of quantities of hydrogen-3 and carbon-14 involved and dose calculations are substantially correct, the Committee agreed with a statement submitted by Dr. Rosalyn Yalow (Enclosure 3) that:
"1.
Based on the calculations in the report and ny own analysis, the risk to the public would be undetectable since the'se wastes add a negligible amount of radia-tion to natural background.
The Comissioners "2.
The professional time lost in accounting for and packaging wastes represents an enormous drain in the scientific community. This drain of talent is serious, particularly in view of the decreasing participation of the medical community in bio-medical research.
"3.
At this time when it is essential to preserve research resources, tens of millions of dollars could be saved for useful investigative studies rather than be dissipated because of regulations not needed for protection of the public."
Accordingly, the Comittee supports the proposed rule change.
RPC Task Force:
The Radiation Policy Council Task Force on Low-Level Radioactive Waste recommends that the Radiation Policy Council adopt as policy that, for specific waste streams, there are concentration limits below which these streams need not be con-trolled for uie purposes of radiation protection. The RPC's Task Force also recomends that the RPC endorse the efforts of the NRC in pursuing such approaches as prepared in this paper with respect to specific waste streams from medical and research institutions and encourage the NRC on this effort for other waste streams.
Agreement States:
The Agreement States were provided copies of the proposed rule for coment.
Five of the six states that responded to the request for comment concurred in the proposed rule change. The sixth state, New York, has four radiation control programs.
Three of these have concurred. The New York City control program stated that it does not intend to change its regulations for sewage disposal and will continue to impose restrictions on incineration.
The Office of State Programs does not intend to make this proposed rule an item of compatibility; however, it does expect most of the Agreement States to adopt similar changes to their regulations.
Recomendation:
The Commission:
1.
Approve a notice of proposed rulemaking (Enclosure 1) that would (a) permit licensees to dispose of liquid scintillation media and animal carcasses containing less than 0.05 microcuries per gram of hydrogen-3 or carbon-14 without regard to their radioactivity and (b) raise the limit for disposal of these radioisotopes into the sanitary sewerage system.
The Commissioners 2.
Note:
a.
The amendment would be published in the Federal Register for a 45 day
- public comment period; b.
A public announcement such as Enclosure 4 will be issued when the proposed rule is filed with the Office of the Federal Register; c.
All affected licensees and the appropriate Congressional committees will be informed (Enclosure 5); and d.
Neither an environmental impact statement nor a negative declaration need be made in connection with this rulemaking because it is non-substantive and insignificant from the standpoint of environmental impact (Enclosure 2).
Coordination:
The Offices of Inspection and Enforcement and State Programs and the Division of Rules and Records concur in the recommendation of this paper.
The Office of Policy Evaluation concurs in the recomendation of this paper and their comments have been accommodated (Enclosure 6). The Office of the Executive Legal Director has no legal objection.
The preliminary Value/ Impact Statennnt was reviewed by the Office of Management and Program Analysis.
The draft public announcement was prepared by the Office of Public Affairs.
The Office of the General Counsel concurs in the recomenda-tion of this paper.
Giiring a temporary state-imposed embargo in mid-1979, some hospitals and research institutions apparent 13 came within days of curtailing operations involving liquid scintillation counting and animal research before the radio active burial grounds resumed accepting biomedical wastes. The staff recommends a 45 day public comment period because of the serious disruption of medical services that could result from another closing of the radioactive waste burial grounds to these wastes.
The Commissioners m j.
William J. Dircks, Director Office of Nuclear Material Safety and Safeguards h.
Ltut}M f
l Robert B. Minogue, Director Office of Standards Development
Enclosures:
1.
Federal Register Notice of Proposed Rulemaking 2.
Preliminary Value/ Impact Analysis 3.
Statement by Dr. R. Yalow 4.
Draft Public Announcement 5.
Draft Congressional letter 6.
09E Coments Commissioners' comments or consent should be provided directly to the Office of the Secretary by c.o.b. Wednesday, September 24, 1980.
Commission Staff Office comments, if any, should be submitted to the Commissioners NLT September 17, 1980, with an information copy to the Office of the Secretary.
If the paper is of sach a na'.. ore that it requires additional time for analytical review and comment, the Commissioners and the Secretariat should be apprised of when comments may be expected.
This paper is tentatively scheduled for affirmation at an Open Meeting during the Week of September 29, 1980.
Please refer to the appropriate Weekly Commission Schedule, when published, for a specific date and time.
DISTRIBUTION Commissioners Commission Staff Offices Exec Dir for Operations ACRS Secretariat
7590-01 NUCLEAR REGULATORY COMMISSION 10 CFR PART 20 STANDARDS FOR PROTECTION AGAINST RADIATION AGENC):
Nuclear Regulatory Commission ACTION:
Proposed Rule.
SUMMARY
The NRC is considering amending its regulations to permit licensees greater leeway in disposing of liquid scintillation media and animal carcasses containf tg tracer levels of hydrogen-3 (tritium) or carbon-14. Most licensees presently dispose of these items by sending them to a radioactive waste burial ground or by obtaining special authorization from NRC for incineration or onsite burial. Under the proposed regulations, the licensee may dispose of specified concentrations of these materials without regard to their radioactivity.
The NRC is also considering amending its regulations to raig9 the annual limits for disposal of hydrogen-3 and carbon-14 by release to the sanitary sewerage system.
The proposed rule changes would conserve waste burial capacity that is already in short supply.
EFFECTIVE DATE:
Comment period expires
- Note:
Comments received after the expiration date will be considered if it is practical to do so, but assurance of consideration cannot be given except as to comments filed on or before that date.
- Insert date 45 days from publication.
ENCLOSURE 1
2 ADDRESSES:
Interested persons are invited to submit written comments and suggestions for consideration on the proposed amendments to the Secretary of the Commission, U.S. Nuclear Regulatory Commission, Washington, D.C. 20555, Attention: Docketing and Service Branch.
Copies of the preliminary value/
impact analysis and of comments received may be examined at the C>mmission's Public Document Room at 1717 H Street, N.W., Washington, D.C.
Single copies of the preliminary value/ impact analysis are available from John R. Cook at the phone number and address listed below.
FOR FURTHER INFORMATION CONTACT: John R. Cook, Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Connission, Wash'ington, D.C. 20555 (Telephone:
301-427-4240).
SUPPLEMENTARY INFORMATION:
Radionuclide tracers are used extensively in biomedical research and for the diagnosis of diseases in humans.
One of the end products of these research and medical activities is radioactive wastes.
These wastes are usually shipped to radioactive waste burial grounds although certain water soluble or dispersible wastes are released into sanitary sewerage systems.
Two of the most commonly used radioisotopes in biomedical research (and to a lesser extent in medical procedures) are hydrogen-3 and carbon-14.
The concentrations of these radionuclides in biomedical waste are minute, generally less than 0.05 microcuries per gram.
4 3
Liquid scintillation media and animal carcasses, both containing tracer quantities of hydrogen-3 or carbon-14, constitute the largest volume of radioactive biomedical waste.
Liquid scintillation counting has become a widespread technique for detecting radioactivity in biological samples such as blood cr urine. Typically, a fraction of a milliliter of the biological sample containing tracer levels of hydrogen-3 or carbon-14 is combined with 20 milliliters or less of an organic solvent, primarily toluene, in a small vial to make a liquid scintillation medium. The vial is placed in a liquid scintillation counter, and the biological sample is assayed. The vials are used once and then collected and shipped to a radioactive waste burial ground.
Research laboratories and hospitals throughout the country presently use between 84 and 159 million v1s per year, which represents between 200,000 and 400,000 gallons of liquid scintillation media.
Disposal of this waste in radioactive waste burial grounds requires approximately 400,000 cubic feet of space at a cost of over $13 million per year for packing materials, transport, and disposal,.his does not include the cost of licensee labor or overhead).
Liquid scintillation media are approximately 43% of the total volume of radioactive waste shipped to burial grounds that is not related to nuclear power generation and its supporting fuel cycle.
4 Animals are used in research mainly for the development and testing of new drugs.
Virtually every chemical compound that is considered for use as a human or veterinary drug is first tagged with a hydrogen-3 or carbon-14 tracer and injected into research animals to study how th chemical compound behaves.
These research animals include mice, rats, dogs, monkeys, swine, and sheep.
The animal carcasses containing trace quantities of hydrogen-3 and carbon-14 are usually shipped to radioactive waste burial grounds. Animal carcasses annually require about 80 thousand cubic feet of burial space at a cost of almost $3 million per year. Animal carcasses are approximately 9% of the total volume of radioactive waste shipped to burial grounds that is not related to nuclear power generatic, and its supporting fuel cycle.
There are other hydrogen-3 and carbon-14 waste streams in the research laboratory that do not result in liquid scintillation vials and animal carcasses;
,for example, the solutions and attendant material used to prepare the research samples.
These materials also contain tracer levels of hydrogen-3 and carbon-14.
Under present NRC regulation:, hydrogen-3 and carbon-14 wastes that are readily soluble or dispersible in water can be disposed of by release to the sanitary sewerage system.
The annual limit for release to the sanitary sewerage system is found in 10 CFR 20.303 and is limited to a total of 1 curie of all radionuclides per year for each licensee.
This proposed rule would
5 raise the limit for hydrogen-3 to 5 curies per year and the limit for carbon-14 to 1 curie per year.
This change would result in a negligible addition to the level of these radioisotopes already present in the natural environment.
There are alternatives for disposal of liquid scintillation media and animal carcasses containing hydrogen-3 and carbon-14 other than consignment to a radioactive waste burial ground.
Liquid scintillation media can be evaporated, distilled, burned, or buried on a licensee's site if an appropriate location is available. Animal carcasses can be incinerated in a pathogen incinerator.
Currently, none of these alternatives to radioactive waste burial are recdily available. Generally, liquid scintillation media and animal carcasses with any added hydrogen-3 or carbon-14 are being handled as radioactive waste and consigned to a radioactive waste burial ground under NRC's regulations (5130.41 and 20.301) and similar Agreement State regulations.
The state agencies that control the existing radioactive waste burial grounds do not want to accept liquid scintillation media or animal carcasses.
Liquid scintillation media are flammable and are suspected of leaching radioactive chemicals out of the burial trenches.
Also, some of the shipping containers arrive at the burial grounds leaking. Liquid scintillation media are chemically toxic and are suspected of being carcinogenic and thus pose a waste hazard unrelated to their radioactive character. Animal carcasses decompose and can be a pathogen hazard.
Sometimes the animal carcasses will
6 cause their containers to burst during shipment.
The soids formed in the burial trenches by the decaying animal carcasses are also believed to contribute to migration of chemicals by increasing rain water percolation in the trenches.
The three radioactive waste burial grounds in the U.S. are located in Barnwell, South Carolina; Beatty, Nevada; and Richland, Washington.
The Richland, Washington and Beatty, Nevada sites accept both liquid scintillation media and animai carcasses. The Barnwell, South Carolina site does not accept liquid scintillation media but does accept animal carcasses. At all three sites, the state regulatory bodies are attempting to reduce the volume of incoming waste to prolong site use.
During a temporary state-imposed embargo in mid-1979, some hospitals and research institutions across the country apparently came within days of curtailing operations involving liquid scintillation counting and animal research before the radioactive waste burial grounds in Richland, Washington and Beatty, Nevada resumed accepting liquid scintillation vials and animal carcasses.
The Rule This rulemaking would allow NRC licensees to dispose af liquid scintillation media and animal carcasses containing less than 0.05 microcuries of hydrogen-3 or carbon-14 per gram without regard to their radioactivity.
7 This regulation would not relieve licensees from complying with other applicable regulations of Federal, state, and local government agencies regarding the disposal of non-radioactive materials.
Scintillation media are toxic and flammable, and animal carcasses are sometimes pathogenic.
These characteristics, which are a more important public health problem than their radioactivity, may require them to be disposed of under applicable Federal, state, and local laws governing chemical and biological hazards. This rulemaking would also allow the disposal by release to a sanitary sewerage system of up to 5 curies of hydrogen-3 and 1 curie of carbon-14 per year, in addition to the presently allowed 1 curie per year for all radionuclides.
Neither the rulemaking allowing d'.;posal of liquid scintillation media and animal carcasses without regard to their radioactivity nor that raising the limit for disposal of hydrogen-3 and carbon-14 to sanitary sewerage, authorizes disposal of liquid scintillation media (e.g., toluene) into the sanitary sewage system.
Because the amount of hydrogen-3 and carbon-14 that could be released to the environment as a result of this rulemaking is very small, and be ause calculations employing conservative assumptions indicate the dose to any exposed indivHual is likely to be much less than 1 millirem per year, the Conmission believes that the rulemaking would have little adverse impact from a radiological health standpoint.
8 The rule would essentially remove any NRC restrictions on the disposal of liquid scintillation media and animal carcasses.
It would no longer be necessary for NRC licensees to ship these materials, which could pose a chemical and biological hazard, up to thousands of miles across the country for disposal in a radioactive waste burial ground.
NRC Agreement States could make similar amendments to their regulations in order to extend the benefit of this action to their licensees.
The preliminary value/ impact analysis prepared by the NRC staff to support the proposed rule concludes that this rule change is the best solution to the problem of disposal of liquid scintillation media and animal carcasses containing tracer amounts of hydrogen-3 and carbon-14. The preliminary value/ impact analysis indicates that the action is non-substantial and insignificant from the standpoint of environmental impact.
If al,so adopted by the Agreement States, this action would save hospitals and research institutions in excess of
$13 million annually ($16 million for the cost of packaging materials, transpor-tation, and disposal, minus the $3 million estimated for non-radioactive waste disposal).
Also, it would save almost one-half million cubic feet of radioactive waste burial capacity annually, or half of that used "or radioactive waste not related to nuclear power generation and its supporting fuel cycle.
9 In summary, the proposed amendments concerning the disposal of tracer levels of hydrogen-3 and carbon-14 in liquid scintillation media and animal carcasses would be appropriate because:
(a) the proposed amendments would not pose an unreasonable risk to the common defense and security and to the health and safety of the public; (b) disposal of these wastes in radioactive waste burial grounds is expensive and without benefit commensurate with the expense; (c) the flammability of liquid scintillation media (organic solvents) and the decomposition of animal carcasses cause a significant problem in transporting these wastes to burial grounds; and (d) these wastes consume a significant portion of radioactive waste burial capacity which is in short supply.
Similarly, the amendment raising the limit for sanitary sewerage disposal of hydrogen-3 and carbon-14 is appropriate because it would not pose an unreasonable risk to the public.
In addition, the shipment of this waste to radioactive waste burial grounds is costly and consumes valuable burial space that could be made available for more hazardous radioactive waste.
The Commission has decided that a 45 day comment period for this rulemaking is appropriate because the potential radiological impacts are small and there is a shortage of available burial ground capacity.
Under the Atomic Energy Act of 1954, as amended, the Energy Reorganization Act of 1974, as amended, and Section 553 of Title 5 of the United States Code, notice is hereby given that adoption of the following amendments to 10 Part 20 is contemplated.
10 1.
In 520.301, paragraph (c) is revised to read as follows:*
520.301 General requirement.
(c)
As provided in 520.303 or 520.304,** applicable respectively to the disposal of licensed material by release into sanitary sewerage systems or burial in soil, or in 520.306 for disposal of specific wastes, or in 520.106 (Radioactivity in effluents to unrestricted areas).
2.
In 520.303, paragraph (d) is revised to read as follows:
520.303 Disposal by release into sanitary sewerage systems.
(d) The gross quantity of licensed and other radioactive inaterial, excluding hydrogen-3 and carbon-14, released into the sewerage system by the licensee does not exceed one curie per year.
The quantities of hydrogen-3 and carbon-14 released into the sanitary sewerage system may not exceed 5 curies per year for hydrogen-3 and 1 curie per year for carbon-14.
Excreta from individuals undergoing medical diagnosis or therapy with radioactive material shall be exempt from any limitations contained in this section.
Additions to the present rule are underlined.
- A Commission Paper, SECY 80-392, transmits a staff recommendation that the Commission delete 520.304 in a final rulemaking.
11 3.
520.305 is revised to read as follows:
120.305 Treatment or disposal by incineration.
No licensee shall treat or dispose of licensed material by incineration except for materials listed under 120.306 or as specifically approved by the Commission pursuant to 5920.106 (b) and 20.302.
4.
A new 920.306 is aeded to read as follows:
520.306 Disposal of specific wastes Any licensee may dispose of the following licensed material without regard to its radioactivity:
(a) 0.05 microcuries or less of hydrogen-3 or carbon-14, per gram of medium, used for liquid scintillation counting; and (b) 0.05 microcuries or less of hydrogen-3 or carbon-14, per gram of animal tissue averaged over the weight of the entire enimal; provided however, tissue may not be disposed of under this section in a manner that would permit its use either as food for humans or as animal feed.
(c)
Nothing in this section, however, relieves the licensee of maintaining records showing the receipt, transfer and disposal of such byproduct material as specified in 630.51 of Part 30 of this chapter.
[Sec. 81,161b, Pub. L.83-703, 68 Stat. 935, 948, as amended (42 U.S.C. 2111, 2201), Sec. 201, Pub. L,93-438, 88 Stat.1242 (42 U.S.C. 5841)]
12 Dated at Washington, D.C., this day of FOR THE N'JCLEAR REGULATORY COMMISSION Samuel J. Chilk Secretary of the Comission
t PRELIMINARY YALUE/ IMPACT STATEMENT OF AMENDMENTS TO 10 CFR 20 FOR DISPOSAL OF BIOMEDICAL AND AQUE0US WASTES I.
The Proposed Action A.
Description - The principal current method for disposal of biomedical and aqueous waste containing tracer quantities of hydrogen-3 and carbon-14 under NRC regulations is to ship them to commercial radio-active waste disposal grounds.
The amendments to 10 CFR 20 will allow licensees to dispose of these wastes without regard to their radio-activi ty. However, they will be subject to other federal, state and local regulations governing any other toxic properties of the materials.
Thus the proposed amendments would allow licensees to dispose of certain biomedical and aqueous wastes using commercial or municipal refuse collection services, incineration, landfill, or other means, to the extent permitted by applicable, non-radioactive waste disposal regulations.
B.
Need for the Proposed Action - Byproduct material licensees are required under 10 CFR 30.41 to transfer licensed material only to persons licensed to receive byproduct material.
About 51% of this waste is comprised of liquid scintillation vials, animal carcasses and aqueous fluids containing tracer quantities of hydrogen-3 or carbon-14. Present disposal in commercial radioactive waste disposal grounds necessitates the transportation of these wastes, generally over great distances, and at great expense to the licensees.
The transportation of these materials poses a difficult materials ENCLOSURE 2
2 handling problem because the scintillation medium is both flammable and carcinogenic, and the decaying carcasses, in addition to being unsanitary, generate methane gas which can explode or othe'rwise rupture waste containers.
Moreover, these wastes consume scarce waste disposal grounds capacity, which would otherwise be used for radioactive wastes truly requiring burial. Finally, should the waste sites be closed for any reason, there could be a prompt and serious interruption of biomedical research activities throughout the nation.
10 CFR 20 should be amended to eliminate the problems involved in the transport or storage of these wastes and the unnecessary consumption of scarce waste disposal grounds capacity.
C.
Value/ Impact of the Proposed Action 1.
NRC Operations - The proposed amendments to 10 CFR 20 would reduct the impact on NRC resource requirements.
The licensing staff would not need to consider licensing amendments, such as incineration, for alternatives to commercial disposal of these materials.
It would also reduce the number of waste packages that need to be inspected.
The amendments would require no new reporting, new funding, nor time or personnel resources once the rule is published.
3 2.
Other Government Agencies - NRC Agreement States could make similar amendments to their regulations in order to extend tha benefits to licensees in those states. The value to the Agreement States would be similar to that of the NRC.
3.
Licensees - The primary value of the amendments would be to biomedical research institutions, and to a lesser extent, nuclear medicine laboratories.
Other types of laboratories might also receive some benefits. The value results from a reduction of cost for disposal of scintillation vials, animal carcasses, and certain aqueous fluids. Current costs for packing materials, transportation and disposal of these wastes as now required are estimated below (does not include cost of licensee labor or overhead):
a.
For Liquid Scintillation Counting Waste (LSCW) (see Attachment 1 for documentation of biomedical waste statistics):
6 3
Total low-level waste (LLW) shipped to a burial site = 3 x 10 ft / year Approximately 30% of LLW is so-called institutional waste:
6 3
5 3
3 x 10 ft / year x 0.3 = 9 x 10 ft / year About 43% of institutional waste is due to disposal of liquid scintillation vials or fluids:
5 3
5 3
9 x 10 ft /yr x.43 = 3.9 x 10 ft / year 3
A 55 gallon drum will hold about 7.35 ft ; thus:
5 3
3 3.9 x 10 ft / year
- 7.35 f t / drum i 53,000 drums / year
4 Ne estimate the average cost of packaging materials, trans-portation, and burial of a drum of liquid scintillation waste to be at least $250.
Therefore, the estimated total cost for annual shipments of liquid scintillation waste to disposal grounds is:
53,000 drums / year x $250/ drum = $13,250,000.
b.
For Animal Carcasses - About 9% of institutional waste is comprised of animal carcasses, tissues, and other biological matter associated with biomedical research.
From the above:
5 3
9 x 10 ft / year x 0.09 = 81,000 ft / year or 4
3 3
8.1 x 10 ft / year + 7.35 ft / drum = 11,020 drums of biological waste.
We estimate the average cost of packaging materials, transportation and burial of a drum of biological waste to be at least $300.
Thus, the estimated total cost for annual shipments of biological waste to disposal grounds is:
11,020 drums / year x S300/ drum = $3,306,000.
5 c.
For aqueous waste - No data are available to estimate the number of drums of adsorbed or solidified aqueous waste shipped to disposal grounds.
It is believed, however, that in revising the 1 curie limit contained in 10 CFR 20.303 to 5 curies and 1 curie for hydrogen-3 and carbon-14, respectively, some benefit would accrue to institutions engaged in biomedical research.
Industrial facilities would be little affected by the proposed amendments to increase the sanitary sewerage limits for hydrogen-3 and carbon-14. The scale of research using hydrogen-3 and carbon-14 tracers in industrial facilities is generally small and is unlikely to lead to many industrial licensees' research activities taking advantage of the rule change.
There are, however, some industrial licensees (e.g., manufacturers of labeled compounds, luminous source manufacturers, etc.) who might benefit from the rule change. However, they are relatively small in number and, therefore, would not contribute significantly to the total environmental release nor realize substantial cost savings.
To summarize, the proposed amendments would save approximately
$16,000,000 in waste disposal costs; most of these savings would be realized in biomedical research.
New costs would be incurred, however, in the disposal of these wastes through conventional means.
Since conventional disposal is much cheaper than transport and burial at radioactive waste disposal grounds, it is estimated that the net savings would be about
$13,000,000.
6 d.
Disposal Grounds - The amendments would result in a loss of revenue due to the elimination of most shipments from biomedical facilities.
These shipments currently account for 15% of annually buried waste and therefore are not an economic necessity. The amendment would prolong site use at a time when disposal capacity is in short supply.
4.
Public/Environniental - The decrease in costs to biomedical facilities for waste disposal would allow these resources to be used in productive areas of biomedical investigation for the public benefit.
There should be no increased costs to the public resulting from these amendments.
The public would also benefit through the continued operation of biomedical facilities in the event of an embargo at disposal grounds and from the ability of the grounds to accept additional volume of other types of radioactive waste.
The effects of the cmendments on the environment were analyzed.
Estimated exposures are as follows:
With respect to alternative disposal methods for the liquid scintilla-tion medium and animal carcasses, we have concluded that incineration would provide the greatest radiation impact on the environment.
7 To calculate the dose to the maximum exposed individual, an individual living near a very large biomedical research facility was considered (see Attachment 2).
It was assumed the facility generated about 275 mci of tritium and 75 mci of carbon-14 in liquid scintillation and carcass wastes combined each year, and that all these wastes were incinerated.
For the dose due to inhalation, it was assumed the individual remained at a distance of 40 meters from the incinerator stack for the entire year.
Using inhalation rates, dose conversion factors and other data contained in Regulatory Guide 1.109, " Calculation of Annual Doses to Man From Routine Releases of Reactor Effluents for the Purpose of Evaluating Compliance with 10 CFR Part 50, Appendix I," the doses to the total body (for hydrogen-3) and bone (for carbon-14) were calculated. The results estimate the dose from the hydrogen-3 to be 0.01 mrem / year and 0.04 mrem / year from carbon-14.
For the dose from ingestion, it was assumed the individual subsisted completely on food grown or water located at a distance of 40 meters from the incinerator stack. Using ingestion parameters from a model developed by Oak Ridge National Laboratory, the doses to the whole body (critical organ for hydrogen-3) and bone marrow (critical organ for carbon-14) were calculated, yielding a dose of about 0.03 mrem / year from hydrogen-3 and 5.3 mrem / year from carbon-14.
8 Thus, the maximum individual exposure calculated to result from this disposal scenario is on the order of 5 mrem per year, or about 1/20 of the dose considered to be natural background radiation.
Furthermore, the assumptions used greatly exaggerate any actual dose to a member of the public, which would likely be much less than 1 mrem / year, considerably less than EPA's 4 mrem drinking water standard for hydrogen-3.
Disposal of these wastes via municipal solid waste was also considered. Appendix D of an NRC sponsored Study of Consumer Products Containing Radioactive Material developed a calculational technique for examining the impacts of disposal of consumer products into municipal refuse. Consideration of this analysis with respect to municipal refuse disposal of liquid scintillation media or animal carcasses leads to the conclusion that the dose from this disposal alternative would be minor relative to that from incineration.
With respect to increasing the annual sewerage release limit for hydrogen-3 and carbon-14 to 5 and 1 curies respectively, the maximum ingestion dose was calculated for an individual sub-sistin.; on the nearest potable water supply downstream from the sewerage treatment plant.
It was assumed a very large user of hydrogen-3 and carbon-14 was located immediately upstream from the treatment plant, and that the five curies of hydrogen-3 and curie of carbon-14 were discharged at a constant rate over a one year period.
Using the dose conversion factor and other data
9 from Regulatory Guide 1.109, the doses to the whole body (critical organ for hydrogen-3) and bone (critical organ for carbon-14) were calculated. Assuming the facility was located in a metropolitan area, the dose from hydrogen-3 contributed by the rule change
- would be about 0.005 mrem / year and 0.03 mrem / year for carbon-14. The actual dose to a member of the public would be much less than 1 mrem, again less than EPA's 4 mrem standard for drinking water for hydrogen-3.
Since the amount of hydrogen-3 and carbon-14 released to the environment due to the proposed amendments is orders of magnitude less than natural levels, and since the probable dose to exposed members of the public is less than 1 mrem per year, it is concluded that th proposed ~ amendments have no significant impact on the environment.
This rule will not result in a change in the total quantity of hydrogen-3 and carbon-14 as waste.
It is estimated that under the new rule the resulting health effects will be much less than one per year and will not be substantially different tha-the health effects resulting from disposal of these materials under present rules.
D.
Decision on the Proposed Action - The proposed amendments should be published in the Federal Register for public comment.
II. Technical Approach A.
Technical Alternatives Alternative 1:
Rely on conventional waste disposal methods for scintillation vials and animal carcasses less than
- Assuming a background level of 287 pCi/ liter of hydrogen-3 in water, the total volume of water used in this calculation would contain approximately 240 Ci of hydrogen-3 from natural causes and weapons fallout.
s 10 0.05 uCi/gm in hydrogen-3 or carbon-14 concentration, subject to regulations regarding disposal of non-radioactive waste.
Provides immediate elimination of long-distance transportation hazards with no significant increase in risks to the public or licensees.
Al ternative waste management systems (e.g., collection services or sewerage system) are already established. Greatly reduced cost to licensees and to a lesser extent to NRC would result from this alternative.
Alternative 2:
Establish new disposal sites that would accept biomedical waste.
There is some difficulty in keeping the three existing disposal grounds open due to a variety of problems, including public concern.
It is unlikely that any new sites will be operational soon.
Even if new sites are established, the same problems would exist except there would be some increase in disposal capacity.
Alternative 3:
As an interim solution, require licensees to store biomedical waste on site.
11 This alternative would require a change in the license of a gr'at many affected licensees, resulting in considerable expenditure of time and personnel resources for both licensees and the NRC. Would expose licensees to the hazards similar to those involved in the transport of the wastes, i.e., fire and carcinogenic hazard of scintillation vials, and sanitation and explosion hazard from decaying carcasses.
This alternative does not solve the problem because the long half-lives of hydrogen-3 (12 years) and carbon-14 (5,730 years) require the wastes to be disposed of eventually.
Alternative 4:
Cease biomedical research and other activities involving uses of hydrogen-3 and carbon-14.
This alternative would be unacceptable to the public, who derive great benefit from biomedical research and other activities involving hydrogen-3 and carbon-14.
Alternative 5: Wait for exemptions as part of the general rule for low-level waste (10 CFR Part 61).
Relief is needed now. The rule will not be an effective regulation until 1982 at the earliest.
12 B.
Decision on Technical Approach - The proposed amendments should be published in the Federal Register for public comment, relying on the technical approach described in Alternative 1.
III.
Procedural Approach A.
Procedural Alternatives Alternative 1:
Amend 10 CFR 20 through (1) addition of a new Part 20.306 to allow disposal of scintillation vial medium and animal carcasses containing less than 0.05 pCi/gm of hydrogen-3 or carbon-14 subject to other applicable disposal regulations; and (2) the modification of 10 CFR 20.303 to allow disposal of aqueous waste containing hydrogen-3 or carbon-14 to a maximum of 5 curies per year for hydrogen-3 and 1 curie per year for carbon-14.
This alternative provides immediate relief from the current storage and transportation problems associated with biomedical waste.
It assures continued operation of facilities using hydrogen-3 and carbon-14 in the event of an embargo at disposal grounds.
This alternative can also be implemented at little or no cost to either NRC, its licensees, or the public.
Environmental impacts from a radiation standpoint will be negligible.
13 Alternative 2: Allow licensees to apply for license modifications (e.g., incineration) permitting the disposal of biomedical and aqueous wastes.
This alternative would require months, even years, before all the license modifications could be reviewed and approved.
Therefore, it does not eliminate the storage and transport hazard of biomedical waste, nor does it assure all facilities will remain operational in the event of disposal ground embargoes.
This alternative would require expenditure of licensee resources to prepare the license modifications and NRC resources to review the modifications.
For many licensees there is little if any option under the present regulation other than sending the waste to burial grounds. For example, many licensees located in metropolitan areas have state or 1ccal laws prohibiting incineration, and they are not located upon sites in which they can bury their own wastes.
B.
Decision on Procedural Approach - The procedural approach described in Alternative 1 should be proposed for public comment.
IV.
Statutory Considerations A.
NRC Authority - The amendments fall under the authority and safety requirements of the Atomic Energy Act of 1954, as amended.
14 B.
Need for NEPA Statement - The proposed action is non-substantive and insignificant from a standpoint of environmental impact and therefore does not require either an environmental impact state-ment or a negative declaration.
V.
Relationship to Other Existing or Proposed Regulations on Policies - No conflicts or overlaps with requirements promulgated by other agencies are foreseen.
The amendments are consistent and in accord with the Commission's regulations and policies.
VI.
Summary and Conclusions - The proposed amendments to 10 CFR 20 on biomedical and aqueous waste disposal should be published in the Federal Register for public comment.
Value/ Impact Statement BIOMEDICAL WASTE STATISTICS The total activities and volumes of biomedical waste here were derived from average concentrations reported in various laboratories, from biomedical supply houses, NUREd/CR-ll37, and data files of NRC's Division of Waste Management. An early NUS Corporation report entitled " Preliminary State-By-State Assessment of Low-Level Radioactive Wastes Shipped to Commercial Burial Grounds" reported much higher total activities than those estimated here.
The data in this report are now believed, however, to overestimate the quantities of biomedical wastes, and the report is being revised by the authors to reflect a reassessment of biomedical waste shipments.
The following sections document or show the derivation of biomedical waste statistics used in this paper.
The sections included are:
I.
Summary of Annual U. S. Low Level Radioactive Waste Volume II.
Estimated Total Volume of Liquid Scintillation Counting (LSC)
Media Waste III.
Reported Radioactivity Concentrations and Estimated Total Activities for Liquid Scintillation Counting Media IV.
Estimated Annual Activity of Hydrogen-3 and Carbon-14 Contained in Biological Waste V.
Estimated Total Radioactivity of Hydrogen-3 and Carbon-14 in The Liquid Scintillation Counting (LSC) and Biological Wastes Generated Annually in the United States
I.
SUMMARY
OF ANNUAL U.S. LOW LEVEL RADI0 ACTIVE WASTE VOLUME Annual Volume Per Cent of 55 gal. drums
- cubic feet Total Low Level Uaste Refe rence Total Low Level Waste 408,200 3,000,000 100.0 1
Institutional Waste ** 122,400 900,000 30.0 l
Liquid Scintillation Counting Waste 53,060 390,000 12.9 2
Biological Waste ***
11,020 81,000 2.7 2
3
- Volume of a 55-gallon drum = 7.35 ft
- Institutional waste as used here includes low level radioactive waste not generated by nuclear power plants or the supporting nuclear fuel cycle facilities
- Biological waste as used here includes animal carcasses and tissues from biomedical research facilities Refe rences :
1.
NRC Division of Waste Management:
" General Description of Low Level Waste Generated for Commercial Disposal in the United States," October 1979.
2.
NUREG/CR-ll37, Institutional Radioactive Wastes, published October 1979, Table 3.13, p. 44, discussion p. 67.
2
II.
ESTIMATED TOTAL VOLUME OF LIQUID SCINTILLATION COUNTING (LSC) MEDIA WASTE The exact volume of LSC media waste is unknown, but the range of the volume can be estimated.
The lower range value is based on the annual production of liquid scintillation vials and an estimate of the number of liquid scintillation counters in the U.S.
Mr. C. Killian of New England Nuclear Corporation, the largest producer of scintillation vials in this country, has estimated that in total 7,000 vials are produced for each of 12,000 counters each year.
Hence:
6 vials /yr 7,000 vials / counter /yr x 12,000 counterr = 84 x 10 Assuming each vial contains 10ml:
84 x 106 vials /yr x 10ml/ vial = 840,000 liters /yr or 221,800 gallons of liquid scintillation media per year For the upper range value, the total number of LSC vials disposed of annually in the U.S. is calculated from the estimated number of LSC waste drums and the maximum number of vials disposed of per drum.
Using the previous estimate of 53,060 drums of LSC waste and assuming 3,000 vials per drum (NUREG-ll37,
- p. 67 suggests 2200-3000 vials / drum), we have:
53,060 drums / year x 3,000 vials / drum = 159 x 106 vials / year Again, at 10ml/ vial:
159 x 106 vials /yr x 10ml/ vial = 1,590,000 liters /yr or 419,800 gallons of liquid scintillation media per year The volume of liquid scintillation media is thus estimated to be between 221,800 and 419,800 gallons per year.
3
III. REPORTED RADI0 ACTIVITY CONCENTRATIONS AND ESTIMATED TOTAL ACTIVITIES FOR LIQUID SCINTILLATION COUNTING MEDIA Total Activity in Curies per Year Assuming:
Concentration 6
6 pCi/ vial Reference 84 x 10 vials /yr 159 x 10 vials /yr Hydrogen-3 0.004 1
0.3 Ci/yr 0.6 Ci/yr 0.070 2
5.9 11.1 0.019 3
1.6 3.0 0.100 4
8.4 15.9 0.280 5
23.5 44.5 0.001 6
0.8 1.6 Carbon-14 0.00015 1
0.13 Ci/yr 0.2 Ci/yr 0.00021 2
0.18 0.3 0.00019 3
0.16 0.3 0.00080 5
0.67 1.3 0.00010 6
0.08 0.159 0.00017 7
0.14 0.3
References:
1.
Personal communication with Dr. Robert Hamilton, Chief of Radiation, Physics Dept. of V. A. Medical Center, Bronx, New York, and Professor of Nuclear Medicine of Albert Einstein College of Medicine.
Also includes data from Columbia Presbyterian Medical Center, New York.
August 1980.
2.
NUREG/CR-1137, Institutional Radioactive Wastes, published October 1979, pp. 58 and 60.
3.
Personal conmunication with Roger Broseus, National Institutes of Health, August 1980.
Reported concentrations are an average.
4.
Captain W. H. Briner, NRC consultant.
Concentration given is an upper limit.
5.
Personal communication with Leland Cooley, Radiation Safety Office, University of Maryland, August 1980.
This is a high concentration estimated average from reviewing data from 100 LSC drums.
6.
Personal communication with C. Killian, Environmental Control Director, New England Nuclear, August 1980.
7.
NUREG/CR-0028, Institutional Radioactive Wastes, published March 1978, p. 49.
4
IV.
ESTIMATED ANNUAL ACTIVITY OF HYDROGEN-3 AND CARBON-14 CONTAINED IN BIOLOGICAL WASTE NRC's Waste Management Division recently sponsored a study of waste categories which the prime contractor, Dames & Moore, subcontracted to Leland Cooley at the University of Maryland.* Based on a survey of large waste generating institutions believed to account for approximately 21% of the biological waste in the United States, the study estimated the annual activity contained in animal carcasses, tissues, excreta, and bedding, combined, to be 3.23 curies of hydrogen-3 and 1.26 curies of carbon-14.
The 21% share of total U. S. biological waste estimated for these large institutions may underestimate their actual contribution by 10% or more.
If the 21% figure is assumed, however, the annual V. S. biological waste would be calculated to contain 15.4 Ci of hydrogen-3 and 6.0 Ci of carbon-14.
- Unpublished data 5
V.
ESTIMATED TOTAL RADI0 ACTIVITY OF HYDR 0 GEN-3 AND CARBON-14 IN THE LIQUID SCINTILLATION COUNTING (LSC) AND BIOLOGICAL WASTES GENERATED ANNUALLY IN THE UNITED STATES Total Activity in Ci/ year Assuming Waste Avarage or Maximum Concentrations Hydrogen-3 Range or Average Maximum LSC 11.0 - 16.0 44.5 Biological 15.4 15.4 15.4 24.6 - 31.4 59.9 28.0 60.0 Carbon-14 LSC 0.3 1.3 Biological 6.0 6.0 6.3 7.3 6
Value/ Impact Statement Disposal of Liquid Scintillation Media and Animal Carcasses Containing Tracer Levels of H-3 or C-14 Without Regard to Their Radioactivity:
Estimates of Maximum Potential Radiation Dose to an Individual
The radiation dose commitment to an individual due to disposal of liquid scintillation counting wastes and animal carcasses containing H-3 and C-14 is calculated in this report.
Both inhalation and ingestion pathways are considered in the calculations.
Since H-3 and C-14 are low energy beta emitters, the external exposure from these two sources will not be considered.
The dose commitment is calculated according to the following basic equation.
D = C x U x DCF Where D is the dose commitment to a given organ of an individual, in mrem /yr; C is the concentration of a nuclide in the media, in pCi/ liter; U is the usage factor unit in liter /yr; and DCF is the dose conversion factor in units of mrem or mrem per C_i 3
pCi yr m
(I)
Inhalation Mode Dose commitment to an individual is calculated based on the assumption that the individual inhaled contaminated effluents produced by com-bustion of animal carcasses and liqrid scintillation counting wastes containing H-3 and C-14.
The calculation is also based on the following assumptions:
(1) H-3 and C-14 enter the human body by inhalation in the form of HT0 and C0 respectively.
2 (2)
Source terms:
total activity
- Represents the annual activities in the liquid scintillation wastes and animal carcasses generated in large research and medical institutions in this country as determined in an NRC in-house survey.
2 (3)
The nearest resident is located about 10-40 meters from the incinerator.
The air concentration once exiting the incinerator will be reduced by an atmospheric dilution factor of 10-3 sec/m when it reaches'the nearest resident.
(4) The incinerator is operated 2000 hours0.0231 days <br />0.556 hours <br />0.00331 weeks <br />7.61e-4 months <br /> per year.
Dose From Inhalation D = C x U x DCF Where D = Dose commitment due to inhalation by an individual remaining at a distance of 40 meters downwind from the incinerator for the entire year; C = Concentration of radioactive effluents at 10-40 meters from the incinerator, and is calculated as follows:
C = Activity (Ci) x X/Q sec x hrs incinerator operation time (hrs) 3600 sec 3
m For H-3:
10-3
= 0.275 Ci x
sec x
hrs 2000 hrs 3600 sec 3
m I
= 3.8 x 10-II C_i_
3.8 x 10 pCi
=
3 3
m m
3 For C-14:
10-3 sec x
hrs 0.075 Ci x
=
2000 hrs 3600 sec 3
m 3
I 3
1.0 x 10-II Ci/m 1.04 x 10 pCi/m
=
=
Breathing rate, U:
3 3 3 U = 8000 m /yr x yr x
2000 hr
= 1.83 x 10 m /yr 8760 hr yr DCF: Dose conversion factors for inhalation dose were obtained from Regulatory Guide 1.109.
DCF for H-3 (total body as critical organ) is 1.58 x 10-7 mraq pC1 DCF for C-14 (bone as critical organ) is 2.3 x 10-6 mrem pCi.
Dose due to inhalation of H-3 1
3 3
1.58 x 10-7 3.8 x 10 pCi x 1.83 x 10 m
x mrem D
=
e-3 yr pC1 3
m 0.01 mrem /yr (total body)
=
Dese due to inhalation of C-14:
3 3 x 2.3 x 10-6 DC-14 = 10.4 pCi x 1.83 x 10 m
mrem E'
3 m
0.04 mrem /yr (bone)
=
(II)
Ingestion Mode The estimated dose due to dietary and drinking water intake of H-3 and C-14 from incineration of biomedical wastes is also calculated under assumptions 2 and 3 listed for the inhalation mode.
In addition, it is assumed the food and drinking water are in equilibrium with the
4 specific activity of H-3 in the atmosphere, and the specific activity of C-14 in human tissue is equal to the average steady-state value in the atmosphere. The methodology of the calculation is presente,d fully in ORNL-4992, "A Methodology for Calculating Radiation Dose from Radioactivity Release to the Environment."
A.
Dose from ingestion:
D = C x DCF Where D = Dose in mrem /yr due to dietary and drinking water intake; C = Annual average concentration of radioactivity at 10-40 meters from the incinerator resulting from the incineration of 0.275 Ci H-3 and 0.075 Ci of C-14 annually.
For H-3:
10-3 C=
0.275 Ci x
sec x
hrs 3600 sec yr 3
m 10-3 0.275 Ci x
sec x
hrs
=
8760 hr/yr 3600 sec 3
m 8.7 x 10-12 Ci/m 3
=
For C-14:
C=
0.075 Ci x 10-3 sec x
hrs 8760 hr/yr 3600 sec 3
m 2.2 x 10-12 Ci/m3
=
5 3
DCF = Dose conversion factor in mrem yr/Ci/m, annual dose rate per unit air concentration of H-3 or C-14 radioactivity at the point of interest (data taken from ORNL-4992):
For H-3, with total body as critical organ:
9 3
DCF = 3.68 x 10 mrem / Ci/m yr For C-14, with bone marrow as critical organ:
12 3
DCF = 2.22 x 10 mrem / Ci/m yr Dose due to ingestion of H-3:
D = 3.68 x 10 mrem /yr/C1/m x 8.7 x 10-II Ci/m 9
3 3
= 0.03 mrem /yr to total body Dose due to ingestion of C-14:
D = 2.22 x 10 mrem / C1/m x 2.4 x 10-12 Ci/m 12 3
3 yr
= 5.33 mrem /yr to bone marrow
4 6
B.
Dose due to drinking the contaminated water The dose is calculated to an individual who subsists on the potable water supply from the sewerage treatment plant.
It is further assumed that a very large user of hydrogen-3 and carbon-14, located in a metropolitan area and upstream from the treatment plant, discharged 5 curies of H-3 and 1 curie of C-14 into the sewer over a period of one year.
The doses to the critical organ of an individual were cal-culated by using dose conversion factors given in NRC Regulatory Guide 1.109.
Dose from Ingestion D = C x U x DCF D = Dose in mrem /yr due to ingestion of contaminated water C = Potable water concentration of H-3 and C-14.
It is assumed that the discharged 5 Ci of H-3 and 1 Ci of C-14 was diluted by a 6
volume of 600 x 10 gallons water at releasing point of the 6
water treatment plant. 600 x 10 gallons of water represents the total water that is being handled each day by a large cit.) 's water treatment facility.
7 For H-3:
3 2.2 x 10 pCi C=
5 Ci
=
6 600 x 10 gal For C-14:
2 4.4 x 10 pCi C=
1 Ci
=
6 600 x 10 gal U = Water consumption rate per year = 730 liter /yr DCF = Dose conversion factors for ingestion
-7 For H-3:
1.05 x 10 mrem (Total body as critical organ).
W For C-14:
2.8 x 10-6 mrem (Bone as critical organ) pCi Dose due to ingestion of H-3:
D = 2.2 x 10 pCi x 730 liter /yr x 1.05 x 10-7 3
mrem liter pCi
= 1.68 x 10-I mrem /yr
= 0.17 mrem /yr (Tota _1 body)
4 8
Dose due to ingestion of C-14:
D = 4.4 x 10 pCi x
730 liter x 2.8 x 10-6 2
mrem liter yr iiCT-
= 0.9 mrem /yr (Bone)
August 16, 1980 I have reviewed the proposed amendments dealing with the disposal of radioactive wastes.
Trained in nuclear physics and with 33 years' experience in the medical uses of radioisotopes, I am thoroughly familiar with the problem and am equipped to evaluate scientifically independently the solutions proposed in these amendments.
As immediate past President of the Endocrine Society, I am quite familiar with the impact of these proposed regulations in this field of biomedical investigation as well.
I fully endorse and support the proposed rule changes for the following reasons:
1.
Based on the calculations in the report and my own analysis, the risk to the public would be undetectable since these wastes add a negligible amount of radiation to natural background.
2.
The professional time lost in accounting for and packaging wastes represents an enormous drain in the scientific community.
This drain of talent is serious, particularly in view of the decreasing pa.-ticipation of the medical community in biomedical research.
3.
At this time when it is essential to preserve research resources, tens of millions of dollars could be saved for useful investigative studies rather than be dissipated because of regulations not needed for protection of the public.
l' NW RosalynS.Y? low,Ph.g.
<3 Nobel Laureate ii. Physiology and Medicine 1977 ENCLOSURE 3
NRC CONSIDERS CHANGES TO REGULATIONS ON DISPOSAL OF RADI0 ACTIVE WASTES RESULTING FROM BIOMEDICAL RESEARCH The Nuclear Regulatory Commission is considering changing its regulations to eliminate the requirement that licensed biomedical research laboratories and hospitals send animal carcasses and vials containing tr6cer amounts of certain radioactive materials to radioactive waste burial grounds.
Under the U.:e. ded regulations, licensees would be able to dispose of these materials without regard to their radioactivity.
The itcensed materials covered by the changes would be:
1.
0.05 microcuries or less of hydrogen-3 or carbon-14, per gram of liquid scintillation media, and 2.
0.05 microcuries or less of hydrogen-3 or carbon-14, per gram of animal tissue averaged over the weight of the entire animal.
Tracer amounts of hydrogen-3 and carbon-14 are added to chemical compounds or experimental drugs to study the drugs' behavior in research animals.
Af ter the drug containing radioactive material is administered to an animal, a sample from the animal's urine, blood or tissue is combined with an organic. solvent, such as toluene, in a small vial to make a " liquid scintillation medium." The vial is placed in a " liquid scintillation counter,"
which measures the amount of radioactivity in the sample. The radioactivity amount can be used to derive the needed information on the behavior of tha drug. The vials are used once and then are ready for disposal.
2 Rs tearch laboratories and hospitals throughout the country are using between 84 and 159 million vials per year, which represents 200 to 400 thousand gallons of liquid scintillation media.
Disposal of this waste in radioactive waste burial grounds requires approximately 390 thousand cubic feet of storage space at a cost of over $13 million per year.
Animals are also used for the development and testing of new drugs.
Virtually every chemical compound that is considered for use as a human or veterinary drug is first tagged with a hydrogen-3 or carbon-14 tracer and injected into research animals to study how the compound behaves.
The animal carcasses containing tracer quantities of hydrogen-3 and carbon-14 require about 80 thousand cubic feet of space in radioactive waste burial ground! at a cost of about $3 million per year.
Liquid scintillation media and animal carcasses containing tracer quantities of hydrogen-3 and carbon-14 together constitute the largest volume of radioactive medical waste.
Liquid scintillation media make up approximately 43 percent of the total volume of radioactive waste in burial grounds that is not related to nuclear power generation and its supporting fuel cycle. Animal carcasses constitute about 9 percent of the non-nuclear-power-related radioactive waste in burial grounds.
Because the amount of hydrogen-3 and carbon-14 that could be released to the environment as a result of this rulemaking would be much less than natural background levels, and because the probable dose to any individual
3 would be less than 1 millirem per year, the Commission believes that the changes to the regulations would have no adverse impact on the environment.
The proposed rule changes would conserve waste burial capacity that is already in short supply. Further, the savings realized by research institutions from the rule change could be used for medical research for the public benefit.
The amendments would also raise the limit for the amount of hydrogen-3 and carbon-14 that may be released to sanitary sewerage systems.
Under present NRC regulations, a licensee may release a total of 1 curie of all radioactive materials in this manner.
Raising the limit for hydrogen-3 to 5 curies per year and for carbon-14 to 1 curie per year, as would be permitted by the proposed revisions to the regulations, would be a negligible addition to the amount of radioactivity already present in the natural environment.
Interested persons are invited to submit written comments on the proposed amendments, which are to Part 20 of the Commission's regulations, 60 the Secretary, U.S. Nuclear F.egulatory Commission, Washington, D.C. 20555, Attention:
Docketing and Service Branch, by
___ (45 days after publication in the Federal Register on
).
DRAFT CONGRESSIONAL LETTER
Dear Mr. Chairman:
Enclosed for the information of the Subcommittee are copies of Nuclear Regulatory Commission proposed amendments to its regulations in 10 CFR Part 20 regarding the disposal of certain radioactive waste, mainly biomedical.
Under the proposed amendments, licensees woted be permitted greater leeway in disposing of liquid scintillation media and animal carcasses containing tracer levels of hydrogen-3 (tritium) or carbon-14. Licensees are now required to dispose of these items by sending them to a radioactive waste burial ground or by obtaining special authorization from NRC for incineration or onsite burial.
The purpose of the proposed amendments is to permit the licensee to dispose of these materials without regard to their radioactivity.
These proposed amendments will also raise the limit for disposal of hydrogen-3 and carbon-14 by release to the sanitary sewer;;e systesa.
The proposed rule will be published in the Federal Register for a 45 day public comment period.
Enclosed also are copies of a public announcement to be released by the Commission in this matter in the next few days.
Sincerely, William J. Dircks, Director Office of Nuclear Material Safety and Safeguards
Enclosures:
- 1. Proposed Rule
- 2. Public Announcement ENCLOSURE 5
4 0FFICE OF POLICY EVALUATION COMMENTS The Office of Policy Evaluation stated that the proposed action is reasonable and well supported by the staff paper.
OPE offered a few minor comments:
1.
Coment:
The text does not refer to E 20.401(c) " Records of Surveys, Radiation Monitoring, and Disposal." Is it intended that no records of disposal be kept?
Response
The rule requires the licensee to maintain records of receipt, transfer and disposal of byproduct material as specified in 530.51.
2.
Coment:
On page 9 of Enclosure 1, shouldn't you delete "520.304" or make some reference to the final rulemaking regarding deletion of 10 CFR Part 20.304?
Response: now references SECY 80-392 which transmits a staff recomendation that the Comission delete 520.304 in a final rulemaking.
3.
Coment:
On paia 10 of Enclosure 1, the footnote should be underlined, because the footnote is new text.
Response: The footnote which appeared on page 10 of Enclosure 1 has been deleted from the text of the rule.