ML19247D499
| ML19247D499 | |
| Person / Time | |
|---|---|
| Issue date: | 01/28/1981 |
| From: | Dircks W NRC OFFICE OF THE EXECUTIVE DIRECTOR FOR OPERATIONS (EDO) |
| To: | |
| Shared Package | |
| ML19219A599 | List: |
| References | |
| REF-10CFR9.7, TASK-PIA, TASK-SE SECY-81-077, SECY-81-77, NUDOCS 8103050865 | |
| Download: ML19247D499 (71) | |
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SECY-8I-77 January 28, 1931 cs a: /,
POLICY ISSUt-
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( Affirmation)
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From:
William J. Dircks h
I Executive Director for Operations l
Subject:
FINAL AMENDMENTS TO 19 (FR PART 20 DN DISPOSAL 1
0F CERTAIN H-3 AND C-14 WASlES i
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Tc obtain Commistion appraval of a rotice of final
Purpose:
rulemakir.g that would (a; permit NRC licensees to dispose of liquid scintillation media and animal carcasses containing tracer levels of hydrogen-1 and carbon-14 without regard i.o their radioactivity, arc (b) raise the limit for disposal of thcse radioisotopes to the sanitary se n rage systems.
- inor poilcy quc;r4cr Cnegory:
Tnis paper :o.
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Discusenn.
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'n'.cmoer 1?, I F 0, the Core ;i.i T w d cc:
+3 amencmants co 10 CFr. Per : 7:0 (SECi-E0 wl J whien w re 4.,
publi sr.cd ~c a a5 day cublic went per od <,nich ended en November 24, 198C Enclosure : is a c.,pv of tha c prcposed rule and a transmittal letter w"f ch ubs sent to 3,000 NPC materials licensees th:: sN!.es erd 200 interest groups and organizations.
t ihe final rule (Encloc.re 1) is the same as the proposed rule except for a clarification statemer.t,;ni ch N S been 2
added.
The final rule will allow NRC. licens es to dispose of liquid scintillation r.edia and anin.al carcc3.;es
+
contain.nc less than 0.05 microcuries of nydrogen ; and l
l carbon-14 per gram without regard to their radioactivi':y l
and also will allow the disposal uf release into a sanitary rewerage.;ystem of up to C curies of bjdrc;an-3 and 1 curie of carbon-14 per year in addition to t.he im P ] O '3 0 5 UDD
Contact:
JoN R. Cook, NMSS J 2, '.24 0 Edward M.
Pudolck, SD I
44-3586:
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, presently allor;ed 1 cur 'e per year for all radiequclides.
The final rule contains a s*atenent requested by EPA which clarifies that disposal of scintillation media and er,imal carcasses without regu a to their racioactivity rom complying wit:. other c
will not relieve licensees applicable re;ulations of fede-el, state and local government agencies regarainL chemical and biological hazards.
The proptscd rule was reviewed and endorsed by the Radiation Policy Ccuncil Task Force on Low-Level Radioactive Waste anc by *he NRC Advisory Committee on the Medical Uses of P.otopes.
Public Cs...nents.
The NRC recei.Ad 321 conments or, the proposed rule Trso academic era medical facilities, government agencies, professional groups, private indiviauals and special interest groups.
Twu hundred and seventy-one commenters supported the rule, 44 opposed it, and 7 commented.vitnout indicating support or cpposition.
The comments supporting the p-oposea ruie conte largely from thosc whose work woulc benefi t from the rule and they cited the ber.afits of the rule to research and society.
Some commenters supportec the proco3ed rule witb such statements as:
"We ap.nlaud the Exe ; prooosai: wnich is consiscent <;ith the protcc+,ica of tne public health, safety and weifare, to ed:ce tne volume o' low-level r%1icartive waste *' be cur- ~1 and to thvety comerve cr;t:cally
- ar n ste burial capacity."
"he rule is a major step toward de' elop;ng environmc.att.lly safe procedures to reduce low level waste volume; in tne United States.
NRL is to be commended for its recogrition of the need fc-and its speed in developsng the sol' tion.
All organi zatict.s thot have studied low level waste, cblems recognize that much o' the waste roving into the three oisposal sitas is of such low radioactivity content that it should Le treated as nonradioactiva in /iew of the i,igh cost o# disposing of hydrogen-3 and car bon-14 waste: and tne large amcunt,f disposal space being taken by thi' iow nazard wa;te.'
~ Comments opposing the rule were split mainly between those who opposed any release of radioactive,natorial into the envirnnment and those who expressed concern that this rule could be a first step in othe rule changes leading to further release o,' radioactive material into the environment.
None of those opposing the ru; ' change provided new information wnich would cause the staff *o alter its assessment of potential public exposure anu environnental impacts or tb9 benefits to be derived from the rule change.
1.ie staff did, he;ever, make some ad)ue*aelts in che final value/ impact analysis,Enclus.re 5) based on the public comments in order to make imracts more clear.
For exam ie, the staff performea a more rigorous assessment r
of Lcliective dose as requasted by the Environmental Protection Agency and others.
thi d of those supporting the rule urged the About ont r
NRC to expand the scope to include other hydrogen-3 and to include other radionuclides carbon-14 waste streams v
in various waste streams.
Several commenters opposing the rule urged NRC to abandon it saying it might lead to other radionuclides to be considered aa candidates for disposal without regard to their radioactivity.
As indicated in the detailed analysis of the comments (tnclosur e 6), the staff will pursue a policy of
.caluaf ing specific waste streams on a case-by-case basis a ' recommended by tne federal Radietion Policy Council.
Crie comenter questioce6 the need for the i ule changa if there were nore space at weste disposal facilities.
Although this question is somewhat acaden.ic becau; 3 there is a severe shortage of disposae capacity available for these wastes, as indicated in the,alue/ impact assessme t and summarized later in this paper, the staff Delieves theru are compelling economic, adminis-trative 2nd safety benefits te be derived from the rule change regardless of + he radiaactive waste disposal capacity question.
Impact of Regulations.
The value/ impact analysis
[ Enclosure 5) prepared by the staff to support the rule conclJdes that the rule change is the best solution to the problem or disposal of liqJd scintillation media and animal carcasses containing tracer amounts of hydrogen-3 and carbon-14.
It also concludes that the action is norsubstantive and insignificant from the
-tandpoint of environmental impact.
The amount of
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N 4 hydrogen-3 and carbon-14 that might be released to the environment each year as a result of the rule change pertaining to scintillation media and animal carcasses is small (28 curies and 6 curies respectively) particularly l
when compared to the steady s*. ate environmental inventory I
of 28 million curies of hydrogen-3 and 2SJ million curies of carbon-14.
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 less than 1 millirem per year.
Total health effects are estimated to be less than one health effect, even including the world a
oopulation integrated over all time.
This is a fraction h<
cr a parcent of the annual dose and health effects attributaMe to natural background radiation.
i The benefits to be derived from the rule change are 1
substantial.
If it is also adopted by the Agreement States, this action would save hospitals and research institutions in excess of 13 million dollars annually.
It would also reduce problems associated with packaging, f
transport and disposal of the material in radioactive waste burial grounds and save almost one-half million cubic feet ot waste disposal capacity annually.
The rule change pertaining to increasing the quantity of hydrogen-3 and carbon-14 releasable into the sanitary sewerage systems should result in impacts and benefits simil.r in kind to those for the scint:llation media ano enimal carcasses rule change, although the magnitude of br th the environmer.tal impact and the benefit is 7
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expa 'ed to bc less.
Calculations employing conservative ass. ~.ptions indice?.a that if radi'tisn exposures occur as _ result of the rule change the dose to individuals is likely to be much less than 1 millirem pr year.
The staff believes that raising the limits would benefit p:
perhaps 20-30 NRC licensees.
Although the dallar
[
savings and savings in radioactive waste burial capacity are not known, even some savingt v. the cost of medical l
research and some savings in rN1oactive waste burial t
capacity are a direct benefit to the public.
Reccmmendations:
The Commission:
1.
Approve a notice of final rulemaking (Enclosure i) l that would (a) permit licensees to dispose of liquid sc 'ntillation media and animal carcasses containing d
less than 0.05 microcuries per gram 'f hydrogen 3 or carbon-14 without regard to their radioactisity and (b) raise the limit for disposal of these redioisotones into the sanitary sewerage system.
I
. 2.
Note:
a.
The amerJments,tould be published i., the Federal Registe_r to be effective on publication because
' hey relieve licensees from restrictions; b.
A public announcement such as Enclosure 3 will be issued when t.he rule is filed with the Office of tr;a Federal Register; c.
All affected licensees and the appropriate Congressional comnittees will be informed (Enclosure 4); 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 environ-mental impact (Erclosure 5).
s W liiam>J. Dircks Executive Director for Operations
Enclosures:
1.
Final Rule 2.
Proposed Rule 3.
Public Announcement 4.
Congressional Letters 5.
Value/ Impact Analysis 6.
Analysis of Commenta Commissioners' :omments or consent should be provided directly to the Office vi the Secretary by c.o.b. Thursdev, February 12, 1981.
Commission Staff Office comments, if any, should be submitted to the Commissioners NLT February 5,1981, with an information copy to the Office of the Secretary.
If the paper is of such s nature t at 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 scneduled for affirmation at an Open Meeting during the Week of February 23, 1981.
Please refer to the appropriate Weekly Commission Schedule, when 9ublished, for a specific date ano time.
DISTRIBUTION Commissioners Commission Staff Offices Exec Dir for Operations ACRS ASLBP Secretariat
Ef4 CLOSURE 1
7590-01 NUCLEAR REGULATORY COMMISSION 10 CFR Part 20 Biomedical Waste Disposal AGENCY:
Nuclear Regul atory Commission.
ACTION:
Final rule.
SUMMARY
The NRC is amending its regulations to permit licensees greater leeway in disposing of liquid scintillation media and animal carcasses containing tracer levels of hydrogen-3 (tritium) or carbon-14.
These rul e changes will primarily affect NRC licensed hospitals and medical research institutions.
Most licensees presently dispose of these items by sending them to a radioactive waste burial ground or by obtaining special authorization from NRC for incinera-tion or onsite burial.
Under the new regulations, the licensee may dispose of specified concentrations of these materials without regard to their radioact;vity.
The NRC is also amending its regulations to raise the annual limits for disposal of hydrogen-3 and carbon-14 by release to the sanitary sewerage systens.
The rule changes will conserve waste burial capacity that is already in short supply.
EFFECTIVE DATE:
ADDRESSES:
Copies of the value/ impact analysis and the analysis of connents received may be examined at the Commission's Dublic Docunent Room at 1717 H Street NW., Washington D.C.
Single copies of the value/ impact analysis are available from John R. Cook, Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regul atory Commission, Washington, D.C. 20555 (Telephone:
301-427-4240).
759u-O' 2
FCR FURTHER INFCRYATION CONTACT:
John R. Ccok, Of fice of Nuclear Paterial Safety and Safeguards, U.S. Nuclear Regul atcry Cennission, Washington, D.C.
20555 (Telephone.
301-427 4240).
SUPPLEMENTARY INFORM.ATIO1
Background
Radionuclice tracers are used extensively 'n biomedical research and for the diagr) sis of diseases in hunans.
One of the end procucts of these research and oedic al activities is radioactive wastes. These wastes are usually shipped to radioactive waste burial grounds alth0 ugh certain water 5;luole or dis;ersitle wastes are released into sanitary sewerage systems.
Two of the nost con ;nly used radioisotopes in biomedical research (and to a lesser exter' in medical procet :res) are hydrogen-3 and carbon-14 The concentrations of these radio-nuclides in biomedical waste are ninute, generally less than 0.05 nicrocuries per gran.
Liquid scintillation redia and animal carcasses, both ccotaining tracer quantities of hydrogen-3 or carbon-la. constitute the largest volure of radicact.ive bioredical waste.
Liquid scintillation counting has bernne a widespreac technique for detecting radioactivity in biological samples such as blood or urine. Typically a fraction of a milliliter of the biological sample containing tracer levels of hydrogen-3 or carbon-14 is combined with 20 illiliters or less of an organic
7590-01 3
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 for shipment to a radioactive warte burial ground.
Research laboratories and hospitals throughout the country presently use between 84 and 159 million vials per year, which represents between 200,000 and 400,000 gallons of liquid scintillation media. Disposal of this viste in radioactive waste burial grounds requires approximately 400,000 cuoic #9et of space at a cost of over $13 million per year for packing materials, transport, and disposal (this 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 industrial applications or nuclear power generation and its supporting fuel cycle.
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 tagge with a hydrogen-3 or carbon-14 tracer and injected into research animals to study how the chem' cal compound behav es. 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 csrcasses are approximately 9% of the total volume of radioactive waste shipped to burial grounds that is not related to industrial applications or "uclear power generation and its supporting fuel cycle.
7590-01 4
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 s ampl es. These materials also contain tracer levels of hydrogen-3 and carbon-14.
Unaer present NRC regulations, hydrogen-3 and carbon-14 wastes that are readily soluble or dispersible in water can be disposed of by release to the sanitary sewerage systems. The annual limit for release to the sanitary sewerage systems is found in 10 CFR 5 20.303 and is limited to a total of I curie for all radionuclides per year for each licensee. This proposed rule would 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'. L: quid 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 i nci nera tor. Currently, none of these alternatives to radioactive waste bu:ial are readily 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 weste burial ground under NRC's regulations (10 CFR 353".41 and 20.301i and s4milar Agreement State regulations.
7590-01 5
The state agencies that control the existing radioactive waste buri al grounds do not want to accept liquid scintillation media or animal carcasses.
Liquid scintillation media are flamnable 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
.ause their containers to burst during shipment. The voids fnrmed 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 operating commercial rad 4' active 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 animal carcasses. However, af ter December 1984, the Richland, Washington site will not accept liquid scintillation media. The Barnwell, South Carolina site does not accept liquid scintillation media but doer, 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 hospital s 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.
4
<590-01 6
The Rule This final rulemaking will allow NRC licensees to dispose of liquid scintillation media and animal c3rcasses containing less than 0.05 microcuries of hydrogen-3 or carbon-14 per gram without regard to their radioactivity.
This regulation will not relieve licensees from complying with other applicable regulations of federal, state, and local government agencies regarding tae di sposal of non-radioactive material s.
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 will also allow licensees to dispose by release to sanitary sewerage systems of up to 5 curies of hydrogen-3 and 1 curie of carbon-14 per year, in addition to the 3.
Neither the rulemaking presently allowed 1 curie per year for all radionucl' allowing disposal of liquid scintillation media and animal carcasses without regard to their radioactivity nor that raising the limit for disposal of hydrogen-a and carbon-14 tu
-..itary sewerage, authorizes disposal of liquid sci ntillation medi6 (e.g., toluene) into the sanitary sewerage systems.
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 because calculations employing conservative assumptions indicate the dose to any exposed individual is likely to be much less than 1 millirem per year, the Commission believes that the rulemaking will have little adverse impact from a radiological health standpoint.
7590-01 7
The rule will essentially remove any NRC restrictions on the disposal of liquid scintillation media and animal carcasses.
It will 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 analysis prepared by the NRC staf f to support the rule concludes that this rule change is the best solution to the problem of disposal cf liquid scintillation media and animal carcasses contai-ing tracer amounts of hydrogen-3 and carbon-14. The value/ impact analysis indi' a :es that the a-tion is non-substantive and insignificant from the standpoint of environmental impact.
If also adoptcd 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, transportdtion, and disposal, minus the $3 million estimated for non-radioactive waste disposal). Also, it will save almost one-half million cubic feet of radioactive waste burial capacity annually, or half of that used for radioactive waste not related to industrial applications or nuclear power generation and its supporting fuel cycle.
?n summary, the proposed amendments concerning the disposal of tracer levels of hydrogen-3 and carbon-14 in liquid scintillation media and animal carcasses are appropriate because:
(a) the amendments will not pose an un-reasonable 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
7590-01 8
is expensive and without benefit cam 1ensurate with tFe expense, (c) the flannability of liquid scintillation nedia (organic solvents) and the decomposition of animal carcasses cause a significant proble. 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 will not pose an un-reasonable risk to the public.
In addition, the shipnent of this waste to radioactive waste burial grounds is costly and consunes valuable burial space that could be nade available for nore hazardous radioactive waste.
The Comments This rule was published as a proposed rule in the Federal Register of October 8,1930 (45 FR 67018).
The final rule is essentially the same as the proposed rule except for minor editor.. changes and an additional statement regarding the non-radioactive hazardous and toxic properties cf the wastes.
This additional statement was included at the request of the Environmental Protection Agency and is discussed below under the heading Fate of Wastes.
The Feder_a,l_ Register notice on the proposed rule contained essentially the same background information provided above, and invited public connents for a 45 day period ending November 24, 1980.
7590-01 9
NRC received 321 connents on the proposed rule fron academic institutions, medical facilities. state governnents, professional groups, private individuals and special interest groups. Two hundred seventy one commenters supported the rule, 44 opposed it and 7 comcented without indicating support or opposition.
The comments supporting the rule came primarily from institutions, professional groups and individuals whose work vould benefit frm1 the rule and they cited those benefits both to their research and to society.
The conments opposing the rule were split between individuals who were opposed to any release of radioactive naterial into the environnent and individuals or special interest groups who were concerned about where this rule would lead i.e., to a policy of dispersal of radioactive material as opposed to containnent.
The comments addressed the following aspects of the proposed rule.
Need Most of the 271 connenters who supported the rule stated their reasons.
Their reasons are basically the same as those stated in the preanble to tnis rul e1a ki ng.
The estimates of annual savings offered by the conmenters if the proposed regulations went into effect ranged from $2,000-5250,000, depend',ng on the size of the inst tution's biomedical program.
Some of the organizations that supported the rule were the National Institutes of Health, the American Medical Association, the American College of Nuclear Physician; the American College of Radiology, the American Hospital Association, the Joint Commission on Accreditation of Hospitals, the Society of Nuclear Medicine, the Endocrine Society, the American Council on Education, Scientists for Public Safety and the In:ersociety Council for Biology and Medicine.
7590-01 10 A few of the opposing connents questioned the need for the rulenaking.
One of these conmenters asked, "If there were no space proolems, would the question of changing the regulations ever have arisen?"
The answer to this question is yes. the regulations need changing evaa withouu the problem of space in the burial grounds because present regulations impose an economic and administrative burden on licensees that is,'et j usti fleo.
As one commenter who favored the proposed rule observed.
"...My own experience is that the strict regul ations now in effect have resulted in the holding of hundreds of dead carcasses until money becomes available for procer packaging of these materials for disposal.
The result has oeen a significent reduction in research ano a reluctance to undertake orojects which involve low levels of radioactivity in animals.
Thus, my experience indicates that present restrictions have innibited research..."
There are additional reasons for the rule changes regarding safety at the burial grounds, transportation to the burial grounds and safety in the laboratory. The problems in shipping these wast'_s to the burial grounds and the problems that these wastes cause in the burial trenches are discussed above under Backq_round Regarding safety in tha laboratory, one conmenter favoring the regulation observed:
"I believe the effort expended in neeting previous regulations has been more damaging to the health of my laboratory personnel than the small amount of radiation, i.e., difficulties of lung and s'.in exposure to toluene-based fluids (despite the use of hoods, gloves, etc.).
I hope these hazards will decrea se with these rul es."
759C-01 11 Sccce While one-third of the commenters supporting the rule urged NRC to expand the scope of the rule to include other hydrogen-3 and caroon-10 waste streans or to include other radionuclides in various waste streams, several of the commenters opposine the rule urged NRC to abandon the rule because it might lead to other rulelakings identifying further waste streams or radionuclides as candidates for disposal without regard to their radioactivity.
These l atter connenters nost often cited the need for a conprehensive environmental analysis covering all possible radionuclides and all possible waste streams as their reason for opposing th;s present rulemaking.
The Conmission is aware of the merit of naving one comprehensive rule-making to include many or perhaps all of the possible radionuclides and waste streans.
This type of conprehensive rulemaking and its associated generic environmental analysis of all of the benefits and risks is theoretically an optimun approach, but as a practical matter it is an unworkable approach.
The practical approach is to exanine the specific waste strears which contribute a large volume to the burial grounds as candidctes fcr alternative regul atory approaches.
Tne U.S. Radiation Policy Council at their September 25, 1980 public meeting discussed both the generic approach and the specific waste streams approach.
At that meeting the Council -
" Adopted a Federal policy acknowl ejging that there are concentrations of specific radionuclides in specific waste streams which pose such small risks that control for radiation protection purposes is not necessary.
In accordarice with th!s policy requested that the NRC present to the (Council's) Working Group by November la an interim plan for identification and analysis of specific waste streams beginnir.g with the C-14 and H-3 (tritiun) medical waste streams for whicn early action is appropriate and develop a proposed regulatory framework for this activity.
7590-01 12 Single copies of that interim plan, called for by the Council, are available from John R. Cook at the above address.
Fate of Wastes Several commenters, both for and against the proposed rule, expressed concern about the fate of these biomedical wastes if the NRC allowed disposal without regard to their radioactivity. Most of these commenters were concerned that the liquid scintillation medium toluene, which is fiammable and toxic, would be poured down the drain and into the sanitary sewerage systems. The Environmental Protection Agency (EPA), while supporting NRC's amendment covering liquid scintillation media and animal carcasses, re;ontended that the regulation itself include a clarifying statement that disposal of scintillation media and animal carcasses without regard to their radioactivity will not relieve licensees from complying with other applicable regulations of federal, state and local government agencies regarding chemical and biological hazards. This recommenda-tion was echoed by two other commenters. Also, a group of sanitation workers expressed concern that they might face an increased occupational hazard from the radioactive wastes, which they believed might concentrate in certain sewerage system components.
7590-01 13 The prearbl es to bot'1 the proposed rule and this final rule include a statenent similar to that recommended by EPA ana others.
However, the Commission agrees with EPA and those comnenters who would like to see such a clarifying stater. lent in the regulation itself regarding the non-radioactive hazards of liquid scintillation media anc animal carcasses.
Therefore, a statement has been added to the final rul e at 10 CFR 5 20.306(d) as follows:
"(d)
Nothing in this section relieves the licensee from complying with other applicable federal, state, and local regulations governing any other toxic or nazardous property of these materials."
Finally, regarding the question of a radiation hazard to sanitation workers from deposition in sewerage system components, because the hydrogen-3 and carbon-14 behave chemically the same as non-radioactive hydrogen and carbon, there is no reason to expect significant deposition or accumulation in sewerage system components.
Further, hydrogen-3 and carbon-14 emit weak beta radiations, which are completely shielded by piping, condait, ground, water, etc.
Concentration Limit A few commenters questioned the concentration limit in the proposed rule which was set at 0.05 microcuries or less of hydrogen-3 or carbon-14, per gram of liquid scintillation medium or animal tissue.
Some commenters simply asked about the basis for the 0.05 microcuries per gram value.
Cne commenter said the concentration limit should be raised to 0.1-0.2 nicrocuries per gram.
Another commenter said that the concentration limit should be lowerec to 0.02 or 0.025 microcuries per gran.
7590-01 14 The connenter who suggested raising the concentration limit said that this could be done on the basis of the analysis of risks due to releases at these l evel s.
The commenter who suggested lowering the proposed concentration limit offered an analysis which shows that 0.05 microcuries per gran is too high an activity for liquid scintillation counting and that 0.02 micirmries per gam will cover most applications of liquid scintillation counting.
This latter :ommenter pointed out that the "as low as is reasonably achievable"
( ALARA) t oncept of radiation protection dictates going to the lower concentra-tion limit This same conmenter argued for an overall release linit for each licensee based on his analysis which assunes that all of the 200,000-400,C00 gallons of liquid scintillation media are released at the maximun 0.05 micro-
- uries per gram level.
The 0.05 microcuries per gran concentration limit was recommended to the Connission by its expert consultants as a level that would cover most bionedical research involving tracer use in animals.
The Commission adopted the same level for liquid scintillation media as an administrative sinplification, recognizing that the 0.05 microcuries per gram level will be higher than that normally encountered in liquid scintillation work.
If the limi, were set much closer to the concentrations actually used, licensees would be required to perform more exacting calculations and analytical steps to demonstrate compliance with the rule.
This adds to the cost of administration for both the licensees and NRC.
Setting the concentration limit at 0.05 nicrocuries per gren for both animal carcasses and liquid scintillation media does not violate the ALARA principle because the concentrations actually used are controlled by the sensitivity of the counting equipment and the cost of hydrogen-3 and carbon-14 labelled compounds which typically are quite expensive.
7590-01 15 The Cornission derived its estimates of the potential quantities of hydrogen-3 and carbon-14 released to the environnent as a result of this rule-making from actual production and use data.
It would be erroneous to assune that all of the liquid scintillation media would be released at the maximum 0.05 microcuries per gram concentration.
This assumption leads to release estimates that exceed the total produced for such uses.
Basically, the value/ impact analysis does not indicate the need for a maximun release limit for each licensee.
The Connissicn does not believe that setting the concentration limit higher than that actually used in practice will result in unnecessary (non-ALAP,A) releases to the environnent.
The Commission does beliavc that these higher limits will reduce the cost of administration of these regul ations.
Value/ Impact Analysis Several commenters both for and against the proposed rule commented on
~
the preliminary value/ impact analysis.
A few commenters suggested that the final value/ impact analysis consider the impact of multiple users on a common sewerage system disposing of hydrogen-3 and carbon-14 under the new limits.
Also, the Environmental Protection Agency recommended lower dilution factors for this part of the analysis.
The Commission agrees with these comments and the final value/ impact analysis addresses the impact of multiple users and employs adjusted dilution factors.
The conclusion of the analysis, however, has not changed, i.e., the amendment raising the limit for sanitary sewerage disposal of hydrogen-3 and carbon-14 is appropriate because it will not pose an unreasonable risk to the public.
7590-01 16 The Environmental Protection Agency and at least one other commenter observed that the information presented in the preliminary value/ impact analysis was not sufficient to support the need to raise the limits for hydrogen-3 and carbon-14 which can be discharged to sanitary sewers. The EPA also states that the increased health risk from the release c' hydrogen-3 and carbon-14 in the quanti ties now in use appears to be very low.
The Comission believes that raising the limits for release of hydrogen-3 and carbon-14 to the sanitary sewerage systems will benefit perhaps 20-30 NRC licensees. The dollar savings in radioactive waste burial capacity are not kr.,wn; however, even some savings in the cost of medical research and some savings in radioactive waste burial capacity are a direct benefit to the public and should not be foregone because they are dif ficult to quantify.
Finally, the Environmental Protection Agency noted that the preliminary value/ impact analysis gave estimates of the individual doses which might result from the proposed changes; however, they suggested that the final value/ impact analysis include an assessment of the collective dose comitment. The preliminary value/ impact analysis included a brief treatment of the collective dose commitment.
The final value/ impact analysis includes a more rigorous treatment of this question. However, the conclusion of the final value/ impact analysis has not changed. Basically, the value/ impact analysis concludes this rulemaking is non-substantive and insignificant from the standpoint of environmental impact.
7590-01 17 Clarifications Several commenters requested clarification on the boundaries of the rule change.
Does the term liquid scintillation media include the vials containing the media? Does the term animal tissue include organs or fluids which may have been removed from the carcasses for analysis?
The regulation in 10 CFR 520.306(a) applies to the disposal of liquid scintillation media of 0.05 microcuries or less of hydrogen-3 or carbon-14 per gram of medium.
Licensees may dispose of liquid scintillation nedia containing this concentration of hydrogen-3 or carbon-14 without regard to its radioactivity.
Scintillation vials themselves are not radioactive.
Rather, it is the scintilla-tion media remaining in the vials that contains the radioactivity.
The rule covers that macarial.
Therefore, it would be permissible to dispose of the used vials along with the nedia.
Similarly, the regulation in 10 CFR s20.306(b) applies to the disposal of animal tissue of 0.05 microcuries or less of hydrogen-3 or carbon-14 per gran of tissue averaged over the weight of the entire animal, whether the tissue (or organ) is ultimately reloved from the carcass or not.
However, the regul ation does not apply to either the radioactive chemicals before they are administered to the animals or to the animal feces or urine or contaminated bedding.
7590-01 18 Finally, some commenters asked if the rule change would permit incineration of the scintillation mecia and animal carcasses without obtaining permission from NRC via a license amendment.
The answer is, yes, liquid scintillation media and animal carcasses may be incinerated without a license amendment to the extent permitted by applicable non-radioactive waste disposal regulations.
Authority This rule is being made effective on the date of publication in the Federal Register because it relieves licensees from restrictions.
Under the Atomic Energy Act of 1954, as amended, the Energy Reorganizatica Act of 1974, as amended, and Sections 552 and 553 of Title 5 of the United States Code, the following amen'nents to Title 10, Chapter I, Code of Federal Regulations, Part 20, are published as a document subject to codification.
Part 20 -- STANDARDS FOR PROTECTION AGAINST RADIATICN 1.
In 5 20. 301, paragraph (c) is revised to read as follows:*
520.301 General requirenent.
(c) As provided in 520.303, applicable to the disposal of licensed material by release into sanitary sewerage systems, or in s20.306 for disposal of specific wastes, or in 520.106 (Radioactivity in effluents to unrestricted areas).
- Additions to the present rule are underlined.
7590-01 19 2.
In 520.303, paragraph (d) is revised to read as follows:
520.303 Disposal by release into sanitary sewerage systens.
(d)
The gross cuantity of licensed and other radioactive material, excluding hydrogen-3 and carbon-14, released into she 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 radioacti"e material shall be exempt from any limitations contained in thi s secticn.
3.
520.305 is revised to read as follows:
520.306 Treatment or disposal by incineration.
No licensee shall treat or dispose of licensed material by incineration except for materials listed under 520.306 or as specifically approved by the Commission pursuant to 5 520.106 (b) and 20.302.
4.
A new 520.306 is added to read as follows:
520.306 Disposal of specific wastes Any licensee may dispose of the following licensed material without regarc to its radioactivity:
7590-01 20 (a) 0.05 mir ocuries 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 animal; 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 a_s specified in 530.51 of Part 30 of this chapter; and (d)
Nothing in this section relieves the licensee from complying with other apolicable federal, state and local regulations governing any other toxic or hazardous property of these materials.
[Sec.161b, Pub. L.83-703, 68 Stat. 943 (42 U.S.C. 2201), Sec. 201,
. Pub. L.93-438, 88 Stat. 1242 (42 U.S.C. 5841)]
Dated at Washington, D.C.,
this day of 1981.
FOR THE NUCLEAR REGULATORY COMMISSION Samuel J. Chilk Secretary of the Commission
ENCLOSURE 2
aHe
,C, UNITED STATES i I, c 377 i NUCLEAR REGULATORY COMMISSION WASHINGTON. O, C. 20S55 i.,, M. /,sl q
Octeoer 10, 1920 TO ALL MATERIAL LICENSEES AIC ADDRESSEES The Nuclear Regulatory Comission is considering amending its regulations to permit licensees greater leeway in disposing of liquid scintillation media and animal carcasses containing tracer levels of hydrogen-3 (tritium)
Most licensees presently dispose of these items by sending o r carbon-14.
' hem to a radioactive waste burial ground or by obtaining special authori-zation fror NRC for incineration or onsi te burial.
A copy of the procoseo regul ations is enclosed.
Under the proposed regulations, tr.e licensee may diso:se of speci#ied concentrations of these materials without regard to their radioactivity.
The NRC is also considering amending its regulations to raise the annual limits for disposal of hydrogen-3 and carbon-14 by release to tne sanitary The proposed rule changes would conserve waste burial sewerage system.
capacity that is already in short supply.
Interested persons are invited to suomit written connents and suggestions for consideration on the proposed amendments to the Secretary of the
- 20555, Comission, U.S. Nuclear Regulatory Comission, Wasnington, D.C, Attention:
Docketing and Service Branch.
Please refer to Docket No. DR 20 Coments received af ter. November 24, 1950, will be considered (45 FR 67018).
if it is practical to do so, but assurance of consideration cannot be given except as to coments filed on or before that date.
/h (Richard E. Cunningna Division of Fuel Cycle and Material Safety En closu re:
Federal Register Notice l
L
, j/
6 U j,.,,, j' a
!q 40 in:m :
87010 Fedsral Register / V 45 No.197 / Wetinesdat 0:tcher B.1980 / Procosed hules_ --
NUCL1.AR REGULATORY radioactive wastes. These wastes are approu=ately 9% of tne tott.1 volume cf COMMISSION usually shipped to radioactive waste radioactive waste shipped to bunal bunal grounds although certam water peu vis that is not related to nuc!ent 10 CFR Part 20 soluble or dispersible wastes are power generatiot. cid its supperung fuel released into sanitary seweraga cycle.
Standards fer Protection AcAlnst systems.Two of the mest commonly There are oder hydrogena ane-Raelation used radioisotopes in bicmedcal carbon.14 wam streams in Se reneuch research (and to a lesser extent ii laberatcry that do not result in hau:d Actg r Nuciesr Regulatory medical precedures) are hyc'rege. 3 and scinttuauon vials and.. anal carcasses:
C '""
- carbon 14.The concentrathns of these for example, the solunena and at:e tdant acron: Prc;csed rule.
radionuclides m biomedcal was:e are matenal used to prepare the resea.ch mimite, gennauy less dan a05 samples. The:e matenals aiso mntam SUMMAn:The NRC is considenng microcunes per gram.
tracer leveis of hydregen 3 and c:. ton-am nding its rep!ations to permit I.iquid scinudation me6,s and animal 14.
licensees greater leeway in disposmg of carcasses both contaming tracer Under present NRC regulatiens.
liquid scinullation media and ammal quantit:es ef hydregen 3 or caroca 14 hydregen.3 and carcen 14 wastes mat carcasses contaimna tracer levels of consutute de largest volume M are rea6ly soluWe or 6spesde in hydrogen 3 (tntium) or carbon 14. Most rad!oactive biomed! cal waste.
v ater can be espesed of by release to licensees presently dispose of these scnuuah eng has de samtag sewerage sysum. De items by sending them to a radioactive tecome a widespread technique for annuallimit far release to de sanita y waste bunal pound or by obtaining detecting radioactivity in biological sewerage syste= is found m 10 CFR special authenrauen from NCR for samples such as blood or unne.
20.303 and is linuted to a total cf I cune inemerat.un or on site bunal. Under the Typictlly, a fraction of a m@hter of Ge of all raionuc! ides per year for each proposed regulatons, the licensee may biological sample containing tracer licensee. This proposed rule would raise discese of s;ac fled concentratwns of levels of hydrogen 3 cr carbon-14 is the limit for hydrocen-3 to 5 cunec per
$rse matenals without regard to their combined with :0 milliliters or less cf an year and the hmit for carbonq4 to i radicaeavuy The NRC,s also organic solvent, pnmanly toluene, in a cune per year. This change would resu!t t
ectmd.:nn; amening its reguladens to small vial to make a liquid scintillation, in a neabg21e aditen to me level cf ra:se me annual Letts for 6.aposal of medium. The vialis placed in a liquid these raiotsotepes alreacv present in hydropn.3 and carbon 14 by release to scmtination counter. and the biolegical the natural envircement. '
the sanitary sewerage system. The sample is assayed. The vials areNsed There are alternanves for esposal of proposed rule changes would conserve once and den ecllected and shipped to liquid scmul!ation meda and ammal waste cur al capacity that is already~in a radioactive waste burial ground.
carcasses conteining hydrogen 3 and short supp y-Research laboratones and hospitals carbon 14 other than censignment to a OATE: Comment penod expires throughout the country presently use radioactive waste bunal ground. Lquid November :4.1980.
between 64 and 159 million vials per scintillation media tan be evaporated.
year, which re7 resents between 20C.000. disulled, burned, or buned en a Note.--Comments received after the expiracen date wdl be censidered it it is and 400.000 gallons of liquid semnllatica licensee's site if an appropnate location pracutal to do so. but assurance of media. Disposal of this waete in is avadable. Ant =al en:asse., can be cenneetan:n ertnot be gwen except as to radioactive wa : bunal g-ounds in.;merated in a pathogen mcmerater.
- omments f. led on er before dat date.
requires approximately 400.000 cubic Cur ently, none of ese alternatives to feet of space at a cost of over $13 million radicscave waste b nal are readly scoRessts: Interested persons are invited to submit wntten comments and per year for packing materials, ave dable. Generally, liquid scmtilla tion transport. and disposal (tlus does not media and ammal carcasses with cny su:gestions for censideration on the include the cost oflicensee labor or sded hydrogen 3 cr carbon 14 are proposed amendments to the Secretary overhead). I.! quid scmtd!ation meda are
'emg hancled as radioacuve waste and of he Cocmussion. U.S. Naclear apprcximately 43% of the total volume consigned to a radioacuve waste bunal Rentlatory Commission, Washington, of radicactive waste shipped to bunal pound under NRC s r egulations D C. 20555. attention: Docketmg and pounds that is not related to nuclear (1120.41 and 20.301) and similar Servue Branch. Coptea of the p wer generation and its supporting fuel Agreement State regulaticns, prehmmary value/ impact analysis and cycle.
The state agencies tha: centrol de of comments received may be exammed Ammals are used in research mainly existmg radioactive waste bunal at 'he Cornsussion's Public Dccument f r de jevehpment and testmg of new pounds do ::ot war 'o accept liqu.d clocm at 1717 H Street NW..
dngs. Ytrtuah em chemical senttilation medb. or animai carcasses.
Washington. D. C. Single copies of de ccmpound eat is considered for use as I.iquid scmtillaun.:edia are flammabie relim:nas vah.e/ impact analysis are a human or vetennary dn:g is first and are srspected of!cach*ng available ficm John R. Cock at de tagged with a hydrogen-3 or carbon 14 radioactive enemicals out of the burial phone number and address listed below. tracer and infected into research trenches. Also, some of de ship;mg roR ruRTHER INFORM AT1ON CONTA@
arumals to study hoW he Chem 1Ca}
Containers Ernve at the bunal grounds ionn R. Cock. Cffice of Nuclear Matenal compound behaves. These research leakmg. I.iquid scetillation mec:a are Safety and Safeguards. U.S. Nuclear anacals melude mice, rats, dogs, chemica!!y toxic and are suspectec of hauiater-/ Commission. Washmgton, menkeys, swme, and sheep. The arumal bemg cart:ne3eruc anc tus pose a D C. 20535 n elephene: 301-4:7.-4:40).
carcasses contairung trace quanuties of waste hazard unrelated to mser SUPPt.KMENT AM INFORM ATIOW.
hydrogen 3 and Carbon-14 are usually radioaCuve Char 3Cter. Ammai 'arCasses Raianuclide tracers are used shipped to radioactive waste bunal decompost a "d can be a patnogen extensively :n biomedical research and grounds. Ammal carcasses annual!y hazard. Sot-nes ce animal carcasses for de diagnosis of d!seases in humans.
require about 30 thousand cubic feet of wdl cause tae.r.cntamers to burst One cf Se end products of these bunal space at a cost of almost 33 dunng shipment.The voids formed m researen and medical activities is mailion per year. Ammal carcasses are me bunal trenches by tne decaym;
Federal Regisur / Vol. 45. Ne 197 / Wednesday. October 8.1980 / Proposed Rules 67319 animal carcasses are also believed to rulemaking is very str.au. and because by '.rogen 3 and carbor: 14 is apr upnate cor nbute to rn!pation cf chemicals by calculat.ons employmg conservative becausc It would not pose an int easing ram water percolation in the assumptions indicate tne dose to any unreaunaUe nsk to the ;ubli In t' acnes.
e cposed individualis likely to be rnuch additior.. the shipme st of thi> vaste to The tree radicactive waste burial less than 1 mt!2 rem per year, the radioactive waste burial gwunds is rounds in ths U.S. are !ccated in Commission believes that Se castly and :ensames valuable bunal Bamwed. South Carehna: Beatty.
n.!emakeg wouk aava hule adverse spare Wat ceruid ':e made available for Nevada: cnd Richland. Washuqten. The impact from a rcatalog: cal health ta:.re harardnus rad:orctve waste.
R.chland. Washmaton and Beatty, s tar dpoL:t.
. n Comnutet h.a dec:ded that a 45 Nevada sites accept both liquid The rale wuald essentially remove day commcnt pened for bis mlemak=g scmtilladon me6a and animal any N7C restncJons on the dispcsal of is t.p9topnate because be pott.nMal carcarses. The Barnwell. South Carolina Uquid scintilbtion.a 6a and aru:al radlog:calimpacts are small and there site d. es not t < cep' lf.pid scint"lation carcasses. It would no len;;-r be
's a shortage of available bunal pourd media but does accept anunal c.reasses, neces:ary for NPC licenseo to ship ca pacity.
At all three sites, the state reguletrry these raaterials which couM peu a Under the Atomic Energy Act of1954 bodies are attempting to re uce the chemical and bic:ogn hazard. up t as umended. 6e Energy Reorganicat:en volume cf incocung waste to prolong thousands of miles across the count y Act of 1974. as amended. and seclicn site use.
for disposalin a radicactfve waste 553 of Title 5 of the Urtted States Code.
Durmg a temparary state-impesrd burial gronn ! NRC A;;.eement States.
notict 4 hereby given that adoption cf embargo in mid 1979. some hospitals could makt similar an:endments to tnetr the following amendments to 10 CFR and research institutions across the regulat!ons in erder to extend the Part 20 !s contemplated, cuntry apparently came within days of benefit o' this action to their licensees.
- 1. In } 20.301, paragsph (c)is revisec; curtailira operations involvtra li quid The preibtinary value/trrr.act to resa as follon semttilaton counting and antmal ana', sis pr2 pared by ths.NRC staff to research before the radioactive waste support the prei /td w concludes dat l :0.3c1 Generai requrement.
buna! pounds in Richland. Washingma this rule chqnge is the sest sol. con to and deatty Nevada resumad acceptmg the ; *oblem of disposal cf !!;uid M A8ETCVid'd m. j 20.003 rr } 20004.
'iquid scmtillation vials and animal scintillation mei!a and ammal carecsses app caMe respective:y to tne c;sposas
- arcasses.
contamu.g tracer u:: aunts of hydrogen.3 cf mensed matenal by release tnto,
and carbona 1. The preh=inar, vaiu,,
sotary sewerage systems or bunal m h: pact analysis indicated tnat the actica This ru!emaking world allow NRC is non substantial and insigmficant from soil, or in s 20.306 for c,isposal of licensees to dispose of Uguid the standpoint of envtrenmentalimpa;t.
specific waste.. or m 1 20.106 scmttilation media and animal carcasses if also adopted by the Apeet ent Sta;et (Radioactvity in efL:ents to containing less than 0.05 tr.icrocuries of thl: action would save hospitals and unrestr'rtd areas).
hydrogen-3 or carbon 14 per gram researeA institt.tions ia excess of $13
- 2. h. I 20.303. parapaph (d)is revised without regard to their radioactivity, million annually ($16Y1111on for de cost to read '.s fol'ows:
This regulatier. would not relieve of packaging materiab. transportatiero I21000 # ' " **' D * " ** * * ** ***U licer.:m from coccolying with other ad disposal. minus tna 33 miUlen applicable regulath.'s of Federal.., tate, esti.aated for non radioact've ware
" ",* G " ' {' ' "*'
and local governmert agencies disposal). Also, it would save almmt regarding the disposd of non-ene half milhon cubic fee
- of rsciow1v,
'd) The poss quanuty of !!censac and rauicactive materials. A.i tillation waste bunal capacity annuauy. or half other radioactive metenal. excluding n
of hat used for radioactive waste net hydrogen 3 and carbo..14. released mto medis are tox!c and flammable /and t
animal carcasses are som3 times related to nucl*ar power generation and te sewerage system by de licensee does ne t exceed one cur:e per yea. The pathogeme. These charac. istics, which its supportmg fuel cycle.
are a more important p. olit. health In suit =ary. the proposed quar,t.nes of hydrogen.3 and carbon.14 problec: than their radioac ivity, may amendments concernmg the disposai of reieased m!c ?ne f Pfutary s6.retage require them to be disposeo of und
encer levels of hydrogen 3 and carbom synem may not exceed 5 cunes per yet applicable Federal. state, anc Imallawo 14 in liquid scintt!!ation media and for hydrogen 3 and I curie per se r.Sr governmg chemical and biokgi al animal carcasses would be approcriate caroon.14 F.xcreta from individuals hacards. This rulemaking w ould also because: (a) the proposed mendments undergoing medMal darnests or merapy allow tne disposal by reier.se to a would not pose an unreasonable nsk to with.adioactve matenai snail be ny ' rem,ny hmitauons contaued samtary sewerage sy: ten s of up to 5 the coctman defense and secunty and to ei cunes of hydrogen 3 ane, i curie of de health and safety of the public:(b) n ;' :s secten.
d carbon 14 per year tn adriition to de disposal of Wese wastes in radioactive
- 3. I 20.005 !s tuvised to read as presendy allower? I cune per year for au waste bunal pounds is expensive and r4 * '.
radionuclides. Neitner the rulemakin3 widout benent enemensurate with de allowing disposal of liquid scmtillation expense:(c) the flai mability of 11guld I mac5 Treatment or otsoonan e /
mecia and ammal carcasses without scmtihat:en media forsame solvents) meinersuon.
regard to the:: radioacuvir/ nor dat and me decomposition of an' mal No !!censee shad treat or dispose of raismg the limit for disposal of carcas 's cause a significant problem m
'.! censed matenal by inctnerat:on except hydrogen 3 and carbon 14 to sanitsty transportmg these wastes to bunal for matena.s listed under i 20.006 cr as sewera;e authonzed disposal of liquida pounds; and (d) 6ese wastes consume soec:ficauy approved by me sc:m:llation media (e g., toluenej into de a sigmhcant pornon of radioacuve Camm!ssion pursuant in ij 20.106f b) samtary sewerage system, waste bunal capabity watch :s in shcrt and 2L002.
Because the amount of hydregen 3 suoply.
and carbon.14 that could be released to Similariy. the amendment raismg We
- 4. A new i 20.300 is added to raad a-the environment as a result of t!us-
!inut for samtary sewerage disposal of fouows:
6 tE0 Federal Registe -
'/ol. 45. No.197 / Wednesday. October 8,1980 / Proposed Rules rm I 2tL306 Dbposal of specroc wastes.
(a) Any ficensee may dispose of the following licensed material without r gard to its radicactve.e (1) 0.05 microcunes or less of hydrogen 3 or carbon 14. per gram of medium, us.d fcr liquid sctnt:112 tion countine; a:.d (2) 0.05 T.te occnes er less of hydrogend or carl in 14. per ram of ammal *:ss ae averaged over the weight of ee entire ammal: provided however.
'. issue may not be disposed of under t. Sus section in a manner that would pert:ut its use etthe* r.s food for humans or as a nimal feed.
(b) Nothing in this section. however, relieves the licensee of maintaining records showing the receipt. transfer.
and disposal of such byproduct matenal as specif.ed in i N151 of this chapter.
!Sec. P :61b. Pub. L O-ro3. 68 Stat. 25. 48, as 1.7 ended (4 U.S C. 2111. 2:J1J. Sec. M.
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ENCLOSURE 3 t
t t
4
NRC CHANGES REGULATIONS ON DISPOSAL OF RADIOACTIVE WASTES RESUL ING FROM MEDICAL RESEARCH The Nuclear Regulatory Commission is changing its regulations to eliminate che rnquirenent that licensed biomedical research laboratories and hospitals send animal carcasses and vicls containing tracer amounts of certcir radioactive materials to radioactive waste burial grounds.
Under the amended regulations, licensees will be able to dispose of these materials without regard to their radioactivity.
The licensed materials covered by the changes are:
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 nydrogen-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 body tissue is combined with an organic solvent--such as toluene--in a small vial to make a " liquid scintillation medium." The vial is ple,ed in a " liquid scintillation counter," which neasures the amount of radioactivity in the sample.
The radioactivity amount can be used to derive the needed information on the behavior of the drug.
The vials are used once and then are ready for disposal.
ENCLOSURE 3
4
_2 Most NRC licensees currently dispose of these vials and the animal carcasses containing radioactive materials by sending them to a radioactive waste burial ground.
The vials and carcasses together constitute the largest volume of radioactive meuical waste.
The amount of hydrogen-3 and carbon-14 that could be i 1:ased to the environ 1ent as a result of the amendments to permit burial of these items without regard to their radioactivity is very small.
Calculations indicate that the dose to any exposed person is likely to be much less thaa 1 millirem per year (as compared ta a dose of about 3 millirems to persons flying a single round trip coast-to-coast on airliners).
The Commission therefore believes that the changes to the regulations will have little adverse impact on the environnent from a radiological health standnoint.
On the benefit side, the rule changes will pennit the conservation of radioactive waste burial capacity that is already in short supply and will alleviate the significant problems involved in transporting to the waste burial grounds the liquid scintillation media (containing flammable toluene) and decomposing animal carcasses.
ENCLOSURE 3
, Other portions of the amendments will raise the limit for the amount of hydrogen-3 and carbon-14 that may be released to sewerage systems.
Under present NRC regulttions, a licensee may release a total of I curie per year of all radioactive materials in this manner.
The revised regulations raising the limit for hydrogen-3 to 5 curies per year and for carbor-14 to 1 curie per year will result in a negligible addition to the amount of radioactivity already present in the natural environment.
The amendments, which are to Part 20 of the Conmission's regulations, will be effective on the date of publication in the Federal Register
(
).
They were published in the Federal Register in proposed form on October E,1980, for public connent.
No significant changes h;<e been made as a result of the comments received.
f ENCLOSURE 3
8 i
\\
ENCLOSURE 4 e
4 DRAFT CONGRESSIONAL LETTER
Dear Mr. Chairman:
Enclosed for the information of the Subecmmittee are copies of Nuclear Regulatory Commission effective amendments to its regulations in 10 CFR Part 20 regarding the disposal of certain radioactive waste, mainly biomedical.
Under these amendments, licensees will be permitted greater leeway in disposing of liquid scintillation media and animal carcasses containing tracer levels of hydrogen-3 (tritium) ar 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 these 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 sewerage system.
The final rule will be published in the Federa' gister to be effective on pu bl ica tio n.
Enclosed also are copies of a pub : announcement to be released by the Commission in this matter in the next few days.
Sincerely, John G. Davis, Director Office of Nuclear Material Safety and Safeguards
Enclosures:
1.
Final Rule 2.
Public Announcement ENCLOSURE 4
ENCLOSURE 5
/
VALUE/ IMPACT STATEMENT OF AMENDMENTS TO 10 CFR 20 FOR DISPOSAL OF BIOMEDICAL WASTES 1.
The Final Rule A.
Description - The principal current method for disposal of biomedical and aqueous waste containing tracer quantities c' 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-act u i ty.
However, they will be subj ect to other federal, etate and local regulations g&verning any other toxic property of the materials.
Thus the amendments will 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 per..iitted by applicable, non-radioactive waste disposal regulations.
B.
Need for the Rule - 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 dif ficult materials ENCLOSURE 5
2 handling problem because the scintillation medium is both flamnable and toxic, and the decaying carcasses, in addition to being unsanitary, generate methane gas which can explode or otherwise rupture waste containers.
Moreover, these wastes consume scarce waste disposal grounds capacity, which could otherwise be used for radioactive westes that need to be buried.
Finally, should the waste sites be closed for dny 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 Action 1.
NRC Operations - The amendments to 10 CFR 20 will reduce the impact on NRC resource requirenents.
The licensing staff will not need to consider licensing anendments, such as incineration, for alternatives to commercial disposal of these materials.
It will also reduce the number of waste packages that need to be inspected, The amendments will require no new reporting, new funding, nor time or personnel resources once the final rule is published.
ENCLOSURE 5
3 2.
Other Government Agencies - NRC Agreement States could nake 31milar amendments to their regulations in order to extend the benefits to licensees in those states.
The value to the Agreement Statas would be similar to that of the NRC.
3.
Licensees - The primary value of the amendments will be to biomedical research institutions, and to a lesser extent, nuclear medicine laboratories.
Other types of laboratories night also receive some b!nefits.
The value results from a reduction of cost for disposal of scintillation vials, animal carcasses, and certain aqueous fluids.
Current costs for 'ICensees that generate waste 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 institut;.'nal 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:
9 x 10 ft /yr x.43 1.s.0 x, 5 ft / year 3
3 A 55 gallon drun will hold about 7.35 ft, thus:
5 3
3 3.9 x 10 ft / year ! 7.35 ft / drum I 53,000 drums / year ENCLOSURE 5
4 We estimate the average cost of packaging naterial s, trans-portation, and burial of a drum of liquid scintillation w'ste 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
3 9 x 10 ft / year x 0.09 = 81,000 ft / year or 4
3 8.1 x 10 ft / year i 7.35 f t /drun = 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 drans/ year x $300/drun = $3,306,000.
ENCLOSURE 5
5 c.
For aqueous waste - No data are available to estimate the number of drums of absorbed 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 uuries and 1 curie for hydrogen-3 and carbon-14, respectively, some benefit will accrue to institutions engaged in biomedical research.
Industrial facilities will 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. Howev er, 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 savings to licensees that generate waste, the proposed amendments will save approximately $16,000,000 in waste disposal costs; most of these savings will be realized in biomedical research. New costs will 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 will be about
$13,000,000.
ENCLOSURE 5
6 The anendments will resul t in a loss of revenue due to the elimination of most shipnents from bionedical f acilities to licensees that operate waste disposal facilities.
These shipments currently account for 15% of annually buried waste and therefore are not an economic necessity.
The amendment will prolong site use at a time when disposal capacity is in short supply.
4.
Publi'/ Environmental - The decrease in costs to biomedical facilities for waste disposal will allow these resources to De used in productive areas of bicaedical investigation for the public benefit.
There should be no increased costs to the public resulting from these amendments.
The public will also benefit through the continued operation of biomedical facilities in the event of an enbargo at disposal grounds and from the ability of the grounds to accept additional volume of other types of radioactive waste.
The effects of the amendments on the environnent were analyzed.
Estimated exposures are as follows:
a.
With respect to alternative disposal methods for the liquid scintillation medium and animal carcasses, we have concluded that incineration would provide the greatest radiation inpact on the environment.
ENCLOSURE 5
7 To calculate the dose to the maximun exposed individual, an individual living near a very large bionedical research facility was considered (sce AttacNaent 2).
It was assuned 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 maters from the incinerator stack for the entire year.
Using inhalation rates, dose conversion factors and other data contained in Regulatory Guide 1.109, "Calcul ation of Annual Doses to Man Fron Routine Releases of Reactor Ef fluents 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 fror' the hydrogen-3 to be 0.01 mrem / year and 0.04 mren/ 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 narrow (critical crgan for carbon-14) were calculated, yielding a dose of about 0.03 nren/ year fron hydrogen-3 and 5.3 mren/ year fron carbon-14.
ENCLOSURE 5
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 De 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 in:ineration, b.
With respect to increating the annual sewerage release limit for hydrogen-3 and caroua-14 to 5 and 1 curies respectively, the maximum ingestion dose was calculated for an individual subsisting on the nearest potaole 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 treatme 't plant, and that the five curies of hydrogen-3 ENCLOSURE 5
9 and one curie of carbon-14 were discharged at a constant rate over a one-year period. Using the dose conversion factor and other data from Regulatory Guide 1.109, the doses to the whole body (critical organ for hydrogen ~) crd 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 0.06 mrem / year and 0.3 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.
Even if multiple releases occurred in the same sewerage system, it can be seen by inspection that the resulting dose would be less than a couple of millirem.
Since the amount of hydrogen-3 and carbon-14 released to the environ-ment 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 the proposed amendments have no.'gnificant 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 inuch less than one per year even including the world population integrated over all ti me.
D.
Decision on the Rule Action - The proposed amendments should be published in the Federal Register as a final rule.
ENCLOSURE 5
10 II.
Technical Approach A.
Technical Alternatives Al ternative 1.
Rely on conventional waste disposal methods for scintillation vials and animal carcasses less than 0.05 pCi/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 terna t iv e 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 will 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 problans, including public concern.
It is unlikely that any new sites will be operational soon.
If new sites are established, transportation costs night be reduced; however, the same problems would exist except there would be sone increase in disposal capacity.
ENCLOSURE 5
11 Alternative 3:
As an interim solution, require licensees to store biomedical waste on site.
This alternative would require a change in the license of a great many affected licensees, resulting in considerable expenditure of time and personnel resources for both licensees anJ the NRC.
This alternative will also expose licensees to hazards similar to those involved in the transport of the wastes, i.e., fire and toxic 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 bionedical 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 exenptions as part of the general rule for low-level waste (10 CFR Part 61).
Relief is needed now.
The rule would no* be an effective regulation until 1982 at the earliest.
ENCLOSURE 5
12 B.
Decision on Technical Approach - The proposed amendments should b<>
published in the Federal Register as a final rule, 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 uCi/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 bionedical 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.
ENCLOSURE 5
13 Alternative 2:
Allc licensees to apply for license modifications (e.g., incineration) permitting the disposal of biomedical and aqueous wastes. This alternative would require months, e/en years, before all the license modifications could be reviewed and approved.
Therefore, it would 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 regulations other than sending the waste to burial grounds. For example, many licensees located in metropolitan areas have state or local 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 used in the final rule.
ENCLOSURE 5
14 IV.
Statutory Considerations A.
NRC Authority - Ti., amendments fall under the authority and safety requirements of the Atomic Energy Act of 1954, as amended.
B.
Need for NEPA Statement - The proposed action is non-substantive and insignificant from a standpoint of environmental 9npact 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 requirenents promulgates 1 by other agencies are foreseen.
The amendments are consistent and in accord with the Commission's regul ations 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 as a final rule.
ENCLOSURE 5
Vaiue/ Impact Statenent 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, NUREG/CR-ll37, and data files of NRC's Division of Waste Management.
Ari 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 bionedical 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 Volune 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 Waste Reference Total Low Level Waste 408,200 3,000,000 100.0 1
Institutional Waste **
122,400 900,000 30.0 1
Liquid Scintillation 53,060 390,000 12.9 2
Counting Waste 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 industrial facilities or nuclear power plants or the supporting nuclear fuel cycle facilities.
- Biological waste as used here includes animal carcasses and tissues from biomedical research facilities.
Re ferences :
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-1137, Institut.ional Radioactive Wastes, published C.cober 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 arnual production of liquid scintillation vials and an estimate of the number of liquid scintillation counters in the United States.
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 7,000 vials / counter /yr x 12,000 counters = 84 x 10 vials /yr Assuming each vial contains 10 al:
6 84 x 10 vials /yr x 10 ml/ 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-1137, p. 67 suggests 2200-3000 vials / drum), we have:
0 53,060 drums / year x 3,000 vial s/ drum = 159 x 10 vial s/ year Again, at 10 ml/ vial.-
6 159 x 10 vials /yr x 10 ml/ 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
0 III REPORTED RADI0 ACTIVITY CONCENTRATIONS AND ESTIMATED TOTAL ACTIVITIES FOR LIQUID SCINTILLATION COUNTING MEDIA Total Activity in Curies per Year Assumino; Ci/ vial Reference 84 x 10 vials /yr 159 x 10 vials /yr Hyd rogen-3 0.004 1
0.3 C1/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
?
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. Rebert 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 communication 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 Of fice, University of Maryl and, August 1980.
This is a high concentration estinated 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 dadioactive Wastes, published March 1973, p. 49.
4
IV ESTIMATED ANNUAL ACTIVITY OF HYDROGEN-3 AND CARBON-14 CONTAINED IN BIOLOGICAL WASTE NRC's Division of Waste Management recently sponsored a study of waste categories which the prime contractor, Dames a Moore, ;ubcontracted to Leland Cooley at the Universi ty of Maryl and.*
Based on a survey of large waste generating institutions believed to account for approximately Cl% of the biological waste in the United States, the study estimated the annual activity contained in
'~al carcasses, tissues, excreta, and bedding, combined, to be 3.23 curies of hydrogen-3 and 1.26 curk, of carbon-14.
The 21% share of total U.S. biological waste estimatwi for these large institutions may underestimate their actual contribution by 10% or more.
If the 21% figure is assumed, however, the annual U.S. biological waste would be calculated to contain 15.4 Ci of hydrogen-3 and 6.0 Ci of carbon-14.
9
- Unpuolished data 5
V ESTIMATED TOTAL RADI0 ACTIVITY OF HYDROGEN-3 AND CARBON-14 IN THE LIQUID SCINTILL.ATION COUNTING (LSC) AND BIOLOGICAL WASTES GENERATED ANNUALLY IN THE UNITED STATES Total Activity in Ci/ year Assuming Waste Average or Maximum Conceirations Hyd rogen-3 Range or Average Maximum LSC 11.0 - 16.0 44.5 Biol ogical 15.4 15.4 15.4 26.4 - 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 Potentiel Radiation Dose to an Individual and Total Collective Dose
The radiation dose connitment 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 calcul ations.
Since H-3 and C-14 are low energy beta tenitters, the external exposure from these two sourc9s will not De considered.
The dose commitment is calculated acco.-ding to tne following basic equation.
D = C x U x DCF Where D is the dose coanittent to a given organ of an individuLl, it.
nren/yr; C is the concentration of a nuclide in the media, in pCi/ liter, U is the usage factor unit in liter /yr, and OCF is the dose conversion factor in units of mrem or mren pe r g
pCi yr m
(I)
Inhalation Mode Dose connitment to an individual is calculated based on the assunption that the individual inhaled contaninated effluents produced by con-oustion of aninal carcasses and liquid scintillation counting wastes contairing H-3 and C-14.
The calculaticn is also based on the following assumptions:
(1)
H-3 and C-14 enter the human body by inhal ation in :ne forn of HTO and CO re specti vely.
2 (2)
Source terms:
total activity
- Represents the annual activities in the liquid scintillation wastes and aniral carcasses generated in large research and medical institutions in tnis country a 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.
3 (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 connitment 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
For H-3:
10-3
= 0.275 Ci x
sec x
_brs 2000 hrs e600 sec 3
m I
= 3.8 x 10-II CJ 3.8 x 10 pCi
=
3 3
m m
3 For C-14:
-3 0.075 Ci x 10 sec x
hrs
=
2000 hrs 3000 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 Regul atory Guide 1.109.
-7 DCF for H-3 (total body as critical organ) is 1.58 x 10 mrem pCi
-6 DCF for C-14 (bone as critical organ) is 2.3 x 10 mrem pC1.
Dose due to inhalation of H-3 I
3 3
-7 3.8 x 10 pCi x
1.83 x 10 m
x 1.58 x 10 mrem D
=
H-3 3
yr pC1 m
0.01 mren/yr (total body)
=
Dose due to inhalation of C-14:
3 3
-6 DC-14 = 1.04 x 10 pCi x 1.83 x 10 m
x 2.3 x 10 mrem 3
yr pC1 m
0.04 mren/yr (bone)
=
(I') ingestion Mode fhe estimated cose 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 presented fully in ORNL-4992, " A Methodology for Calcul ating Radiation Dose fron 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 fron the irlcineration of 0.275 Ci H-3 and 0.075 Ci of C-14 annually.
o For H-3:
10-3 C=
0.275 Ci x
sec x
hrs yr 3600 sec 3
m 10-3 0.275 Ci x
sec x
hrs
=
8760 hr/yr 3600 sec 3
m
-12 8.7 x 10 Ci/m
=
For C-14:
C=
0.075 Ci x 10-3 sec x
hrs 8760 hr/yr 3600 sec 3
m 3
2.4 x 10-12 Ci/m
=
5 3
DCF = Dose conversion factor 'n uren/yr/Ci/m, annual dose rate per unit air concentrat. ion 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 wem/p/Ci/m For C-14, with bone marrow as critical organ:
l 3
DCF = 2.22 x 10 mrem /yr/C;/m Dose due to ingestion of H-3:
9 3
-12 3
D = 3.68 x 10 mrem /yr/ Ci/m x 8.7 x 10 Ci/m
= 0.03 mrem /yr to total body Dose due to ingestion of C-14:
12 3
-12 3
D = 2.22 x 10 mrem /yr/ Ci/m x 2.4 x 10 Ci/m
= 5.33 mren/yr to bone marrow
5 B.
Dose due to drinking water contaninated fron sewer releases of H-3 and C-14.
The dose is calculated to an individual wno subsists on the potable water supply from the sewage treatment plant.
It is further assumed that a very large user of tritium and carbon-14, located in a netropolitan area and upstrean from the treatment plant, discharged 5 curies of H-3 and 1 curie of C-14 into the sewer in a single day.
The doses to the critical organ of an individual were calculated by using dose conversion factors given in NRr Regul atory Guide 1.109.
Dose from Ince.stion D = C x U x DCF D = Dose in aren/yr due to ingestion of contanirated water C = Potable water concentration of H-3 and C-14 It is assur:ed that the discharged 5 Ci of H-3 and 1 Ci of C-14 was diluted by a 6
vol une of 5 x 10 gallons water at releasing point of ne 6
water treatment pl ant.
5 x 60 gallons of water represents the total water that is being handled each day by a large city's water treatment facility.
7 For H-3:
12 2
C 5 Ci/yr x 10 Ci/Ci
= 7.2 x 10 g3 5 x 106 gal / day x 3.7851/ gal x 365 days /yr liter For C-14:
12 9
C=
1 Ci/yr x 10 pCi/Ci 1.4 x 10-pCi
=
5 x 106 gal / day x 3.7851/ gal x 365 days /yr liter U = Water consumption rate per year = 730 liter /yr max.
DCF = Dose conversion factors for ingestion For H-3:
1.05 x 10-7 mrem (Total body as criticdl organ) pCi
-6 For C-14:
2.8 x 10 mrem (Bone as critical organ) pCi Dose due to ingestion of H-3:
0 = 7.2 x 10 pCi x 730 liter /yr x 1.05 x 10~7 2
' mrem liter pCi
= 5.52 x 10-2 mrem /yr
= 0.06 mrem /yr (Total body)
8 Dose due to ingestion of C-14:
0 = 1.4 x 10 pCi x
730 liter x 2.8 x 10-6 2
mrem 1 iter yr pCi
= 0.3 mrem /yr (Bone)
Collective Dose Assessment For the scintillation media and animal carcass amendment:
The collective doses resulting from the rule change may be readily calculated by assuming that all the hydrogen-3 and carbon-14 used in scintillation media and animal carcasses in a year is released to the environment through incineration.
The population of the United States is employed in calculating the collective dose. Employing the calculational approach used in the Final Generic Environmental Statement on the Use of Recycle Plutonium in Mixed Oxide Fuel in Light Water Cooled Reactors (GESMO), it is estimated that 100 curies of hydrogen-3 delivers 1 person-rem to the U.S. population.
S1nce 28 curies of hydrogen-3 could be released per year as a result of the rt'le, this would yield 0.28 person-rem in total. The National Academy of Sciences BEIR-III report eximates 1 health effect per 10,000 person-rem.
Hence we estinc+a 0.00003 health effects per year from the release of hydrogen-3.
9 For carbon-14, the model described in the report entitled "A Diffusion-Type Model of the Global Carbon Cycle for the Estimation of Dose to the World Population from Releasto of Carbon-14 to the Atmosphere," ORNL-5267, was used.
This report indicates a collective dose commitment of 620 person-rem per curie of carbon-14, or 3,720 person-rem in total for the 6 curies released each year via the rule. Again, using the 1 health effect per 10,000 person-rem from the BEIR-III cport, we estimate a total of 0.37 health effects to the world pop ul ation. Hence, employing assumptions which overestimate the likely exposures, we conclude the rule change would result in less than oae health ef fect per year.
For the sewer release amendment:
To calculate the collective dose from this change, we assume drinking water is the primary pathway and that all the radioactivity released will be consumed by the U.S. popul ation.
Assuming water contains 'about 300 pCi/E of hydrogen-3 from natural s'ources, and that the maximum personal consumption of water is 730 t /yr, we have:
6 300 pCi/E x 730 t/ person /yr x 1 x 10-7 mrem /pCi x 225 x 10 persons in U.S.
= 5000 person-rem /yr to US population from naturally occurring hydrogen-3 in drinking water.
Multiplying the collective dose from naturally occurring hydrogen-3 in drinking water by the ratio of the quantity released by the rule and the quantity naturally in the environment yields an approximation of the collective dose due to the.ule change.
If we assume 25 f acilities all release 5 curies, we have 125 Ci total or
10 125 Ci (released) x 5000 person-ren = 0.02 person-ren 6
28x 10 Ci (e nv i ronme ntal i nv entory )
At 10,000 person-rem / heal th ef fect, this results in very much hss than 1 nealth effect per year.
Carbon-14 is known to contribute about it of the natural background dose to the U.S. popul ati on.
If the average background dose per person is 0.1 rem, 6
the natural background dose is about 22.5 x 10 erson-rem with 2.25 x 10 person-rem due to carbon-14 We again determine the fraction of this collective dose, received primarily through ingestion of naturally occurring carbon-14, that would result from tne rul e.
Thus, if 25 facilities all released 1 curie of carbon-14, a total of 25 5
curies would be released.
Since we estimate that 2.25 x 10 person-rem is received by the U.S. population from the 280 million curies in the environrent, we can approximate that an additional 25 curies would yield an additional 5
25 Ci (released) x 2.25 x 10 person-rem = 0.02 person-rem 6
230 x 10 Ci (erviron ental inventory)
Again, at 10,000 person-rem / health ef fect, this would yield very much less than i health effect per year.
Even if our results were in error by a couple orders of magnitude, the conclusion would remain the sane:
the collective doses and health effects resulting from tne rule are estimated to be 50 smil that they are regligible.
9 I
ENCLOSURE 6
ANALYSIS OF COMMENTS Tne NRC received 321 comments on the proposed rule.
Most connents criginated fran acade:nic institutions and medical facilities, with the renainder sent from industry, government agencies, professional groups, private citizens, and specia' inLarest groups.
Favoravie Comnents Of the 321 connents, 271 supported the proposed rule, with nany requesting that the rule be expanded to include other low-level wastes.
While the staff intends to explore regul atory options for other waste streams, this will be acconplished through separate actions.
Most of the supporting comments indicated that the rule change would: safeguard the health and safety of the public; reduce the potential for interruption of bionedical research due to closure of burial grounds; reduce the unnecessary and costly burden of current disposal practices; and conserve radicactive waste burial gruunds space.
Among the many organizations lending their support to the rule was the kaerican Medical Assoc!ation, which stated:
"We applaud the NRC's propcsal, which is consistent with the protection of the public health, safety and welfare, to reduce the volune of low-level radioactive waste to be buried and to thereby conserve critically necessary waste burial capacity."
ENCLOSURE 6
2 Other professional groups and associations supporting the rule included the American College of Nuclear Physicians; the Society of Nuclear Medicine; the Aaerican Board of Nuclear Medicine; the American College of Radiology; the Association of Physicists in Medicine; the American Hospital Association; and the A5sociation of knerican Medical Colleges and Universities, as well as many acclaimed medical research institutions across the country.
Many comments stressed the benefits of the amendment regarding scintillation media and animal carcass waste.
Typical statements include the following:
"The rule is a major step toward developing environmentally safe procedures to reduce low level waste volumes in the United States.
NRC is to be commended for its recognition of the need for and its speed in developing cae solution.
All organizations that have studied low level waste probleas recognize that much of the waste moving into the three disposal sites is of such low radioactivity content that it should be treated as nonradioactive in view of the high cost of disposing C-14 and H-3 and the large amount of disposal space being taken by this low hazard waste."
"The rule will conserve burial space for more appropriate use, and will allow the disposal of niedia and carcasses in conformity with their major hazards rather than a minor consideration.
As a teacher, public spirited citizen, environmentalist, cor servationist, and taxpayer, I hope to hear in due course tha: this eminently sensible and cautious change has been approved."
"I believe that a large amount of effort is expended in trying to meet previous regulations which actually is more damaging to the health of my laboratory personnel than would be the small amounts of radiation, i.e., the difficulties of lung and skin exposure to toluene-based fluids in the handling process (despite : sing hoods,
wearing gloves, etc.) are a greater hazard than the small amounts of radiation."
ENCLOSURE 6
s Cc rents Identifying Proclem Areas er Pe:uestir; Clarificati;r A nuncer of connents ex;ressed ccncern atout ;cssi le ir; cts of :ne rule cc otherwise requested clarification of the various as;ects of tre ;rc;:se:
amendments.
The Natural Resources Defense Council (hROC) was concerned tha
'e:'s c ase-by-case approach to raising de ninimis (sic) levels would prevent considerati:n of cunulative health effects and physical impa::s on sanitary Cis;osal systems.
NRDC also fel that similar rule changes taken collectively nigh; narrent preparation of an Envircrnental In;at: State en: (EIS) as re;uired Oy
- ne Nation?.1 Environmental Policy Act (NE A).
C*.h er c orre n t s s t a t e :na disposal cy release and dilution in the environnant sets a dangerous precedent.
In identifying and proposing these anendments for biomedical waste, NRC is conplying with the reques of the Federal Pediation Policy C;uncil to :recen "an interim plan for the identification and analysis of 5;ecific waste streans beginning with the C-la and H-3 'tritivn) medical waste strea s for which early action is appropriate."
Turtherncre, the total cuantities ita would be released are less tnan.001% of the natural in<en :ry cf :nese radionuclides in t'ie environ ent and would be released in any event under current regul ati;ns.
A number of cc ents puesticr,ed the derivation of :ne O.C5 -icrccuries ;er gra-level for scintillation necia anc aninal carcasses, and suggested charging :nis level to anynnere fron 0.2 microcuries ;er gra-to 0.02 micr: curies ;er gran, or estaolishing cifferent levels for each waste.
The 3.05 -icrc uries per gra-level was recocendec to ne Cconission ny its ex:ect censultants as a level
,. m n -. r e oo
~
- ww
4 which would encompass most biomedical research involving tracer use in animals.
While the level might be slightly higher than that normally encountered in liquid scintillation work, it simplifies the administrative burden of the rule by eliminating exacting calculations and surveys that would be required if the level were set very close to working levels.
Moreover, liquid scintillation counting equipment can be saturated if too much r adioactivity is used, hence even if the level is above that required for average situations, this is not expected to change the quantity of radioactivity from that used currently.
Several comments requested clarification on the scope of the amendment concerning scintillation media and animal carcasses, i.e., whether the anendment includes the scintillation vials containing the media, and whether it includes tissues, organs, or fluids removed from the carcasses.
With regard to the first matter, there appears to have been concern that if a licensee emptied the scintillation medium from a vial, the vial, containing a residue of the medium, could not be disposed of along with the medium it sel f.
Scintillation vials themselves are not radioactive.
Rather, it is the scintillation media remaining in the vials that contains the radioactivity.
The rule covers that material.
Therefore, it would be permissible to dispose of the used vials along with the media.
Researchers wanted to know whether the rule applied to an organ of a research animal in which the H-3 or C-14 might concentrate and exceed the 0.05 microcuries per gram limit specified in the rule and perhaps might be later renoved from the carcass.
Organs and tissues, whether renoved from the carcass or not, containing either more or less tnan 0.05 microcuries per gram, could be disposed of under the rule providing this material does not exceed 0.05 microcuries per gram of hydrogen-3 or carbon-14 per grsi of animal tissue averaged over the weight of the entire animal.
ENCLOSURE 6
5 Some connenters were concerned about the possibility of no one's accepting the waste covered by the rule change.
It was postul ated, for exanpl e, that some Agreement States might consider these wastes radioactive, but they would no longer be accepted by radioactive waste handlers; or that radicactive waste disposal facilities would refuse to accept then and chemical waste facilities would also refuse because the wastes are known to contain radioactivity.
However, the staff is not aware of any reason to expect the burial sites to refuse to accept these wastes as a consequence of the proposed rule.
Whil e there might be a possibility that some chemical waste sites would refuse to accept these wastes because of their radioactivity, it does not change the merit of the rul e.
Regarding incineration of the scintillation media and animal carcasses, the proposed amendments would permit licensees to incinerate these wastes without ob aining permission from NRC via a license amendment.
The dose assessment in the value/inpact statement shows that the doses would be small using assunptions that are conservative.
Two conments expressed concern that the proposed amendment for scintillation media and animal carcasses does not specify a limit for the tota' ancunt released.
This is correct; however, the total amount released will oe equal to or less than the total amount produce the latter quantity being used in the value/ impact assessment of possible b;alth e#fects.
This quantity is sufficiently small that even with 'easonable growth in the quantity produced for research purposes, the conclusions of the value/ impact assessment would not be expected to change.
ENCLOSURE 6
6 A few car:1ents expressed the opinion that NRC is simply backing itself out of a difficult situation and transferring the problem rather than resolving it.
The staff believes the proposed rule and its supporting analysis stands on its own merit.
One comment expressed concern that the amendments would delay resolution of the need for new low level waste sites.
Another comment stated that disposal site capacity should be made available for the safe disposal of health related radioactive materials first, thus assuring adequate burial capacity for these wastes.
Decisions about establishing new disposal facilities in "olve many complex public and technical issues.
While reduction of demand for burial capacity due Lo the rule change and the need for burial capacity to assure uninterrupted biumedical research might be factors in weighing such decisions, it is unlikely to change the balance of need for new capacity.
Again, the proposed rule stands on its own merit and is justified independent of the need for additional disposal capacity.
One comment proposed that by diluting with solvent, a licensee could dispose of an unlimited pool of hydrogen-3 or carbon-14.
This is possible but very unlikely.
At the current prices for these solvents, such an approe.ch is not cost effective and is virtually cost prohibitive.
Comments Concerning Disposition of Wastes Several comments were concerned about possible misinterpretation of the rule's provisions leading to improper disposal of scintillation nedia in the sanitary sewer system.
Scintillation media are flammable and should rot be poured down the drain.
ENCLOSURE 6
7 S <eral other conments inquired about who would have regulatory responsibility for these wastes, especially how these materials would be handled under EPA regul atient.
It is anticipated that local, state and federal agencies' regulations applicable to the disposal of nonradioactive wastes in the region in which the licensee is located will apply.
To clarify these points, the staff has accepted the suggestion by EPA to include a statement in the rule regarding the licensees' responsibility for proper disposal of the waste:
"Nothing in this section relieves the licensee from complying with other federal, state and local regulations governing any other toxic or hazardous property of these materials."
Another comment inquired about the buildup of these wastes in the environment (e.g., groundwater) over many years, and its final disposition.
While it is correct that perhaps an additional 28 curies of hydrogen-3 and 6 curies of carbon-14 could be released each year, it should be noted that 1.1 million curies of hydrogen-3 and 30 thousand curies of carbon-14 are generated in the environment each year as a result of natural processes.
The additional radioactivity released under the proposed rule would blend uniformly with that naturally produced and could not be detected once incorporated in the huge environmental inventory of these radionuclides (28 million curies of hydrogen-3 and 280 million curies of carbon-14).
ENCLOSURE 6
8 Several of the opposing connents came froa private citizens.
Their most frequent comment was that they did not like the idea of radicactive materials being spr ead into the environnent, and were concerned about the effect of these releases on their health.
These connents did not contain new information which would change the value/ impact assessment.
The final value/ impact assessment estimates possible doses and health effects.. These are very small and sufficient to justify the rule change.
One coment stated that "NRC radiological assessments are off by factors of 100 to 1,000."
No technical evidence is presented, however, that supports these claims with respect to the proposed rule.
The staff has not located errors which would increase assessment of impacts.
One comment stated that animal carcasses would pose problems as great at hazardous waste facilities as at nuclear waste facilities.
Under the proposed rule, there would be little need to send carcasses to a hazardcus waste facility.
It is more likely that they would be incinerated, buried on site or shipped to sanitory landfill, where they biodegrade naturally.
ENCLO5URE 6
9 Comments Requesting General Changes in the Rule Two comments suggested that liquid scintillation could be rer
+1 by other measurement techniques, or smaller scintillation vials t
'ducing the volume of these wastes.
No alternatives to liquid
.e re proposed, however, and while smaller vials may have sone mer., the design of these research tools has already been standardized.
To change over at this point would be extremely costly and the net reduction of environnental impacts would be very small.
One comment suggested that effluent concentrations (maximuii permissible concentration [MPC]) should be used instead of concentration in the itaste prior to incineration.
Staff calculations indicate that even i'
'0*', of the total quantity of these biomedical wastes were incinerated at a single facility, the maximum individual dose would be less than a millirem, which indicates the average effluent concentration would be 500 times less than the MPC.
Comments Addressing Increases in Sewer Release Limits EPA stated in its comments that they did not believe the information presented was sufficient to support the need to raise the limits of hydrogen-3 and carbon-14 which can be discharged to sanitary sewers.
However, EPA also stated that impacts would be small.
The staff believes that the analysis of sewerage releases contained in the value/ impact analysis is sufficient to justify the rule change.
The resources required to be spent by the government and licensees to gather more detailed ENCLOSURE 6
t 10 inforuation concerning needs are not justified in the light of the nature of the change.
(The need for this change has been eq cessed by ths American Association of Medical Colleges, eid since the resulting doses would be so saiall, we believe the levels should be increased.)
A couple of comments suggested that the sewer release limit should be based on the capacity of the sewer system and that the preliminary value/ impact statement did not address the case of multiple licensees using the same sewer system.
This would result in a vast array of release limits which would be very difficult and costly to administer.
The staff believes the benefits vould be very minimal if they existed at all.
Even in the unlikely event that more than one licensee discharged into the same system above the one curie limit, the final value/ impact statement shows that the impacts would be very small.
Two connents stated that no dilu: ion factors had been provided in the amendment to increase the limits for hydrogen-3 and carbon-14 disposal by discharge into the sanitary sewer system.
The proposed amen.Nent s specify only the limit on the quantity of annual releases.
The concentration limits are already specified in 10 CFR 20.
A group of sanitation workers expressed concern that they might face an increased occupational hazard from the radioactive wastes, which they believed might concentrate in certain system components.
Hydrogen-3 and carbon-14 are not believed to concentrate in 'he environment, hence there is no reason to expect any significant depositions in systen equipment.
Furthermore, these ENCLOSURE 6
11 nuclides emit beta radiations, which would nore than adequately be shielded by any piping, conduit, ground, etc.
Another caament warned that " excluding" hydrogen-3 and carbon-14 frca the current I curie limit on sewer disposal would increase the amounts of other isotopes discarded into the sewer. While it is possible to discharge 1 curie of radionuclides other than hydrogen-3 and carbon-14 under present regulations, it is ver; unlikely that the rule change would nake a substantive difference in the total caount of radionuclides released into the sanitary sewerage systen. txcept for bionedical licenstes, few use hydrogen-3 or carbon-14 and would not be affected by the rule change.
Bionedical researchers typically do not have large quantities of other radioisotopes to discard into the sewer.
ENCLOSURE 6