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UNITED STATES
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NUCLEAR REGULATORY COMMISSION n
WASHINGTON. D. C. 20656 49*....
DEC :.
a MEMORANDUM FOR: Harold R. Denton, Director, Office of Governmental and Public Affairs FROM:
odnes M. Taylor, Executive Director for Operations
SUBJECT:
QUESTIONS ON COMMISSION POLICY ON EXEMPTIONS FROM REGULATORY CONTROL On October 26, 1989, Mr. Joseph J. Fouchard, Director of Public Affairs trans41ttad 24 questions on the Below Regulatory Concern Polig. An additional 21 questions were transmitted by Mr. Carlton Kammerer, Director, State, Local and Indian Tribe r ) grams on November 8,1989.
The draft answers to these questions are n
enclosed for your use.
The Commission paper transmitting the final policy statement reconnanded that a new paragraph be added to the definition of a practice which states that scos practices, such as the use of radioactive material in iter:s intended for children (e.g., toys), are not likely cand14tes for exemption.
If the Ccamission accepts this recommendation, the answers to several of the questions would need to be sodified.
Please note that we have changed the reference from "8RC" policy to
" exemption" policy in the questions end responses in order to be consistent with the final policy statement that has been prepared in response to the Commission's Staff Requirements Memorandum of October 13, 1989.
Or'poa.sgnedBy Jartes M. Taylor Jame! M. T2ylor Exech+1ve Director for Operations
Enclosures:
BRC Questions N
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d QUESTIONS ON EXEMPTION POLICY 1.
Will waste found to be "below regulatory concern" go to the town dump?
Will the public know it's there?
Under the exemption policy statement, low-level radicar:tive waste could be deposited in a sanitary landfill or a rown dump if a regulation authorizing such a disposal was promulgated. However, because of the characteristics of " dumps" as opposed to sanitary landfills, it is doubtful that most town dumps would qualify as appropriate disposal sites.
Since exempted waste may be disposed of without regard to its radioactive q
content, the public would not normally be aware of its presence.
2.
Will radioactive toys be allowed under the exemption policy? Will any allowance be made for the greater susceptibility to radiation of young children?
j Under exemption policy statement, articles such as radioactive toys could be allowed if the resulting doses were under the individual and collective dose criteria and other conditions were satisfied.
In determining the dose corresponding to the risk levels on which the policy is based, the staff has used a conversion factor relating risk to dose which presumes exposure of an individual at a constant dose rate over his entire lifetime.
In the development of this factor, the greater risk from exposures during an individual's early lifetime has been included.
3.
Will radioactive fishing lures be allowed? Wouldn't that pollute rivers and increase radiation dose to fish and humans?
As was noted in answer to Question Number 2, articles could be allowed which contained radioactive material, so long as the policy's individual and collective dose criteria are met and other policy conditions are satisfied. Any increases in dose would be taken into account and limited by the individual and collective dose criteria. Most exemption decis.1ons will be accomphnited by an environmental assessment of the impacts of the action.
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4.
Will radioactive cosmetics be allowed?
d Ye's, as long as the individual end collective dose criteria and other policy conditions are met, materials such as radioactive cosmetics could g
be allowed.
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5.
Wher. will this exemption policy go into effect?
The policy statement is to be published in final form and, tSerefore, is l
immedia tely ef fective.
Huwever, it shoald be noted that the pralicy statement j
does not, in itself, exempt any redioactive rtateritl from regulatory contro'.
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In orde-for rnateria ls te be exempted, the appropriate rulema king and l
licer. sing actions will have to be initiated and cortpleted.
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-1 6.
The exen.ption policy says that, for a thing to be released from regulatory control, the collective radiation dose resulting from exposure to it must be ALARA and not more than 2000 person-rems per year. What does
" collective dose" mean?
Collective dose is a term which refers to the su' of all of the individual m
doses in the population.
Thus,-if 100,000 people were exposed as a result of a particular practice involving radioactive material, and each one of those people received 10 millirem of radiation in that year, the collective dose would be 1,000,000 person-millfrems or 1000 person-rems.
7.
What allowance is made for multiple exposures to radiation--i.e., the person who is an X-ray technician, wears a radioactive topar ring every.
day of the year, flies cross-country frequently, vacations on high-radiation-level beaches-in Brazil, lives on a site that was formerly
'a nuclear power plant, etc.?
(Maybe exposure to one of these thin wouldn't hurt you, but taken altogether, what will the effect be?)gs
.The policy statement contains several provisions to assure that the total dose to an individual from multiple exposures does not exceed a significant fraction of the total dose currently allowed individual members of the public.
In particular, for practices which involve the widespread distribution of radioactive material, such as consumer l
products, the individual dose criterion is set at an interim value of 1 mrem / year. Thus, it would take hundreds of practices, each exposing the same individual to the maximum' dose allowed under this policy criteria, in order for that individual to equal the currently defined dose limit. The Commission also intends to examine carefully the'different types of practices which will be allowed under the policy statement and to evaluate and take into account the potential for multiple exposures when regulatiuns are promulgated or licensing decisions are made. Thus, if a potential exists for an' individual to approach dose limits, further con.straints will be: applied to assure that the dose Ifmits are not p.
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What opportunities will there be for public connent on allowing release of l
radioactive things ths', are BRC?
As was noted in the response to Question 5, this policy statement does not provide for exemption of any radioactive materials.
In order for the policy to be implemented, an appropriate rulemaking or licensing action must take place. As is the case with all rulemakings, public consent is specifically invited during both the public comment period on the proposed rule and, if the rule were proposed by an outside organization in a L
petition for rulemaking, in the notice of receipt of the petition for rulera king..
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If'someone petitions for an exemption, will there be a hearing?- If so, when -- before or af ter action on the petition?
A petition for rulemaking received by the Commission will first be noticed in the Federal Register as having been received by the Commission. The staff will then analyze the petition and determine if a rulemaking is j
justified.
If so, the proposed rule will be prepared and noticed for public comment.
Licensing actions may be subject to a hearing process.
- 10. Who will decide on petitions for exemption -~ the Commission or the staff?.
l In the case of rulemakings, the staff will prepare the analysis and staff 1
h recomendations which will be forwarded to the Commission for l
consideration and action. The staff presently grants exemptions in L
licensing actions, and this practice may be continued, as appropriate.
- 11. Why did the Comission choose 10 mR/ year for most things and 1 mR for.
things used by the general public (e.g., consumer products) as the maximum individual dose that should be expected in order for something to be considered for exemption? How were those values chosen? How does the public know they are safe?
The Comission has selected individual dose criteria of 10 mR/ year and 1 mR/ year on the basis of both the risk associated with radiation dose at these levels and a policy decision with regard to how much effort should be expended in achieving lower doses. A.value of 1 mR/ year was chosen as an interim value for materials which could be subject to widespread distribution and thus potentially cause exposures to large segments of the general public. Thus, the 1 millirem per year value would specifically apply to consumer products. This action was taken in order to better assure that exposures to multiple practices, such as different types of consumer products, would be controlled such that the total dose to any
. individual from a number of practices would not exceed a significant L
fraction of the applicable public dose limit. The individual dose l;~
criteria were chosen using information that has been developed on the-l radiation risks to humans, including the revised epidemiology and dosimetry of the Japanese atomic bomb survivors. These ris( estimates have been derived by expert scientific bodies and have been documented in l
- a United Nations Scientific Comittee on Atomic Radiation (UNSCEAR) report l'
which was published in 1988 and a Comittee on Radiological Effects of Ionizing Radiation (BEIR V) report. This latter report is expected to be published in December 1989. Both doses represent radiation risks which are very low in comparison to natural background,~and although they may represent a concern to some individuals, the Comission believes that these levels define a point at which regulatory resources may be optimally redirected to address more significant radiation protection issues, i
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- 12. Does the publication of this policy statement mean some low-level radioactive waste can go to the town dump now? Does it mean any jewelry, toys, frying pans, etc., below I mR/ year cat he sold 3 7 No. The policy statement does not exempt radioactive material from regulatory
. control. Before materials could be released to the environment, or be" ore-
' jewelry, toys, frying pans, etc., can be distributed to the public, an appropriate licensing action or rulemaking procedure must be pursued and completed. The question of whether such material-could go to the town dump was addressed in response to Question 1.
- 13. Once the policy statement is published, what happens next? Will things with low levels of radiation start creeping into the public domain?
After the publication of the final policy statement, the staff will implement the policy statement, through various rulemaking actions and licensing decisions.
In each of these cases involving an initial exemption rulemaking, a notice and opportunity for public comment will be provided. Thus, each time an exemption decision is made, the public will be informed of the decision to exempt a particular practice from further regulatory control.- It is anticipated that exemptions will result in some L
additional amounts of radioactive material in the public domain.
14 Once the' policy statement takes effect, how will the public know there are some more things around them_with below-regulatory-concern radiation levels? How will we know if our town dump is radioactive, or our frying pan?
In each initial rulemaking decision to exempt material from regylatory control, opportunity for public comment will be provided. However, in most situations, once the decision has been made to exempt the material from regulatory control, the requirements for notification and labelling of the materials would no longer be present. Thus, in most cases, it will l
L not be possible to determine if a particular item, such as a frying pan, l
does or does not contain material which has been exempted from regulatory control.
- 15. Will radioactive consumer products be labelled?
-If the material is exempted from regulatory control, then in most situations, L
labelling _and notification of the presence of the radioactivity would not be required.
- 16. Are there some radioactive things out there in the public domain already that I may not know about that are not labelled? What are they? (Please attach list.)
Most materials in the environment, including our own body, are radioactive to some extent. A number of exemptions are already provided for in the Comission's regulations.
Thus, there are some types of consumer products such as gas mantles and luminous watches and welding rods which contain radioactivity and are not labelled.
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- 6 17.
Why is the Commission issuing an exemptien policy at this particular time?
What prompted it?
The Comission is issuing an overall exemption policy at this time because it believes that it must optimize the use of radiation protection resources. To accomplish this goal, the Comission believes that it should define the framework under which all exemption decisions are made.
The decision, however, was prompted by several different events, including passage of the Low-Level Radioactive Waste Policy Amendments Act of 1985 and the Comission's considerations in regard to ifcensing the
. distribution of neutron irradiated topaz. Since the Commission's regulations already contain a number of exemptions which have been made at various times, this Comission action will assure that all-its exemption
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18.
If a thing meets the requirements of the policy statement (i.e., radiation levels under (1). individual dose Ifmit of 10 mR for most things or 1 mR' for things used by the general public and (2) collective dose ALARA and 1000 person rems per year), will it automatically be permitted for t.
unrestricted release? Or is there some other requirement for approval?
The individual and collective criteria constitute the basic criteria under which decisions can be made. However, a licensee must also demonstrate that potential impacts from misuse or accidents involving the exempted material are not significant. An exemption will also need to include the restrictions necessary to assure that those dose criteria continue to be met after the exemption is granted.
i 19.
How will.the NRC ensure that things released from regulatory control because they are BRC actually meet the maximum dose levels allowed? For example, will someone from the.NRC check to make sure that each smoke detector gives an individual exposure of no more than 1 mR/ year?
The NRC will continue to exercise control in the areas of release of radioactive materials.
Thus there are or may be constraints associated o
with the transfer of material from a controlled to an uncontrolled status.
These constraints could include limits on the total quantity of radioactive material released or on the concentration of radioactive material in a particular product or waste stream the processes by which these quantities are measured or determined and control may also be imposed on the quality control measures to be implemented by licensees.
NRC will retain its authority with regard to inspection and enforcement of this transfer process to ensure all those constraints are being implemented so that the individual and collective dose criteria remain valid.
However, individuals from NRC will not check each action.
20.
Why add to the environmental burden by deregulating nuclear material?
The Commission believes the release material under the principles of the exemption policy will not add significantly to the environmental burden.
The Comission has reached this conclusion based on the small hypothetical 5
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risks which would be potentially associated with its exemption decisions and the perspective that a large quantity of radioactive material is L
H already present in the environment due to naturally occurring radioactive materials.
- 21. Has the NRC done an Environmental Impact Statement on releasing things.
from regulatory control? Will this se done in the future?
An Environmental Impact Statement has not been prepared for the policy statement itself.
However, the policy statement does not involve the release of any radioactive material under an exemption. An environmental assessment, or environmental impact statement, as appropriate, will be L
issued for specific exemption decisions as required by NRC regulations contained in 10 CFR Part 51.
22.
If the NRC approves a petition to exempt some (sty 30 percent by volume) 2 low-level radioactive waste from regulation because it is below re concern, what effect will this have on the development of new low pulatory J
evel waste disposal sites? Will it mean that not as marty sites are needed?
l That the disposal facilities will be smaller?
a NRC approval of a petition to exempt radioactive materials from disposal in a regulated waste disposal site could result in the reduction of the total amount of material going to licensed low-level radioactive waste disposal sites.
If this option were used, it could reduce the number of sites that would otherwise be needed, or those sites which are built might be smaller consistent with economic considerations.
- 23. How can the NRC establish a BRC limit of 10 mR/ year individual dose when-EPA is considering 4 mR7 How do the NRC's BRC limits compare with other EPA-proposed limits under the Clean Air Act?
The NRC actions to establish individual dose criteria of 10 and I arem per year constitute a policy decision on radiation risks applicable to a wide range of activities or practices licensed by the Commission and are
.dfrected at determining the appropriateness of the continued application of the as low as reasonably achievable principle as a basic element of radiation protection. EPA, in their przposed low-level waste standard, is considering.a BRC dose value of 4 mrom per year, as applied to low-level waste disposal. The NRC value of 10 and 1 mrom per year apply to a broad range of practices by which an individual may be exposed as a result of a spectfic exemption decision. Both EPA and NRC are aware of these differences and are actively pursuing efforts to ensure a consistent Federal position.
The NRC value of 10 mrem per year could appear to be numerically equivalent to the EPA Clean Air Act value of 10 mrem per year applied to airborne emissions from specific sources.
However, there are distinct differences in regulatory approaches between EPA and NRC. Again, both Agencies are pursuing attempts to ensure consistent radiation protection policies.
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. 24.
What is the health risk from the BRC levels that the NRC is establishing */
6 The health risks associated with exemptions from regulatory control are L
believed by the Commission to be appropriate for the protection of the public' health ~ and safety. Using a dose to risk conversion factor of 5 chances in 10,000 per rem of exposure, a dose of 10 area in a-year would hypothetically result-in an incremental increase in an individual fatal cancer risk of approximately 5 chances in 1 million.
The collective dose L
of 1000 person-rem would hypothetically result in a risk of 0.5 deaths per year in the exposed population.
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-4 l-POSSIBLE QUESTIONS ON COMMISSION POLICY L
ON EXEMPTIONS FROM REGULATORY CONTROL
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Can States be more restrictive or lenient in thW definition of what is "below regulatory concern *?
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The Commission considers exemption regulations to be an integral element-of the basic framework of radiation protection for which the Commission has statutory authority. As a result, the Comission intends that any regulations developed under this policy will be made matters of strict t
compatibility for Agreement States. These regulations will' include the characterization of and conditions imposed on radioactive material as it is transferred from a controlled to an uncontrolled status. Agreement States granting exemptions under existing regulatory provisions (10 CFR Part 20.302) will be strongly encouraged to use the principles of the l
Comission's exemption policy.
2.
Maine has approved legislation which says that even if the NRC designates certain waste streams as BRC, all Maine Yankee LLW (regardless of NRC-designation) will still have to be disposed in a licensed LLW disposal facility. Can a State do this?
As discussed in answer to question 1, if the Comission characterizes its exemption decisions (e.g., BRC waste disposals) as regulations within the basic framework of radiation protection Federal regulations would preempt any conflicting State laws to the extent that those laws dealt with the radiological properties of,the material. However, State regulations based upon other properties or characteristics of the waste would not be preempted.
3.
Will States know if BRC waste is being disposed in sanitary landfills?
Will there be some recordkeeping requirement of where this waste is sent for disposal?-
If an exempted waste is disposed of in a sanitary landfill, a State's knowledge of the disposal at a particular site would be dependent on recordkeeping requirements imposed on a licensee by the applicable NRC or State implementing regulations and a State's review of these records. BRC waste disposal regulations are expected to specify acceptable disposal facilities or methods and may require licensees to keep records of specific disposal sites.
4 What type of regulatory program will the NRC have to ensure compliance with the BRC policy? How will NRC know that the waste is being properly characterized and disposed?
The Commission intends to use its normal inspection and enforcement programs to ensure that its licensees comply with any applicable BRC regulatory requirements.
From time to time, however, the Comission may i
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initiate activities to assess 'and verify the environmental impact of some or all of its exemption decisions.
5.
CanaState.banthesaleofradioactive(BRC)consumerproducts?.
No, consistent with current practice, the authority to issue licenses to a
distribute new consumer products containing radioactive material will remain with the NRC. The State would not ban sale on the basis of radioactivity or radioactive material, but could ban a product for other (nonradiological) reasons.
6.
What are the implications on the NRC exemption policy if EPA issues a l-different BRC standard?
If the EPA, under its Atomic Energy Act authority, issues a generally i
applicable environmental standard different from any NRC regulations based l
on the Cosmission's exemption policy, EPA standards would prevail and, if required, appropriate changes to NRC regulations would be initiated to ensure compatibility.
7.
Will BRC consumer products and waste streams have to be labelled during transportation? Will this require some action by the Department of
-Transportation (DOT)?
-DOT has defined a threshold limit of 2.nanocuries per gram for classifying materials as radioactive.
If consumer products containing radioactive material or BRC waste streams should exceed this limit, taen the labelling, placarding, and manifesting requirements contained in 49 CFR Part 173 would apply.
l 8.
Will Agreement States have flexibility in designating other waste streams 1
as BRC which the NRC has not yet ruled on? How much coordination will be required of the NRC and Agreement States?
Yes, if in its regulations, NRC has not defined a particular waste stream to be BRC, Agreement States may do so. The NRC will encourage close coordination with the States on these deteminations, and BRC rulemaking activities initiated by NRC will be undertaken in close coordination with Agreement States.
9.
Some local governments have passed (or are considering) resolutions or ordinances which prohibit the disposal of BRC waste in municipal landfills. What are the effects of such actions? If such actions are valid, where can generators dispose of.BRC waste?
As stated in response to Questions 1 and 2, the Consnission intends that its regulations defining exemptions will preempt conflicting State regulations or local ordinances to the extent that these regulations are based upon the radiological properties of the material. Licensees, in any event, always have the option of sending waste that was designated as BRC
-to licensed low-level radioactive waste disposal sites.
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- 10. Will the existing exem)tions in part 20 and Part 30 be reevaluated to assure consistency wit) the new policy?
.Yes,-it is-the Commission's stated intention to review existing exemptions in 10 CFR Part 20 and 30 against the provisions of the exemption policy.
Any inconsistencies will be identified and corrective actions, if needed,
..will be undertaken.
11.
If a State or citizens group environmental monitoring detects a not increase of greater than 1 mrem / year after waste is disposed onsite, what will the NRC s response to this situation be?
If a State or citizens grbup should detect a measurable quantity of radioactivity indicating the potential for individual exposures through
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Commission-defined scenarios, in excess of the dose criteria values in the c
exemption policy, NRC would investigate to ensure that individual licensees were not violating exemption conditions applicable to each-specific licensee.
If violations are documented ' enforcement actions couldbetakenwhichcouldincluderequirementsforappropriatesite cleanup.
- 12. Could a State use'this policy to apply for exemptions for NARM disposal?
Since'NRC does not regulate NARM disposal, petitions applying for BRC exemptions for these materials would not be accepted by the NRC. The U.S.
6 Environmental Protection Agency and the. States have jurisdiction for NARM and could consider such petitions under their authority.
- 13. Could generally-licensed devices (e.g., exit signs) be disposed in groups if the 10 mrem / year is not exceeded?
If, as a class, national or region wide disposal of generally-licensed devices can be demonstrated to meet the dose criteria and other conditions
.of the exemption policy, a petition for rulemaking, declaring these 3
disposals to be BRC for purposes of disposal, could be considered by the Commission.
- 14. BRC policy is now being differentiated from the exemption policy. Will the two concepts be technically reconciled?
The BRC exemptions which could be granted for certain low-level waste disposals at other than licensed sites are considered as one subset of l
practices to which the. exemption policy may be applied. Thus, the concepts are-technically reconciled.
- 15. What exactly is BRC?
BRC is an acronym meaning "below regulatory concern." This tenninology is taken from Section 10 of the Low-Level Radioactive Waste Policy Amendments Act of 1985 (Pub. L.99-240) which refers to waste streams containing sufficiently low concentrations or quantities of radionuclides 3
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that the waste stream may be exempted from regulation by the Nuclear Regulatory Comission.
~ 16.
I am building a child care center, can I use'BRC material for land fill?
If sligntly contaminated soil is released for unrestricted public use in accordance with an NRC regulation based on the exemption policy's framework, this material could be used for landfill. Such use, however,'
l must comply with other applicable Federal, State and local regulations -
governing any other toxic or hazardous property of this material.
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- 17. What prevents the BRC material from leaching out of the soil and collecting into hot radioactive pockets?
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Leaching and other reconcentration processes wil'1 be considered in determining whether the management and disposal of a specific waste stream is.BRC. NRC's: IMPACTS-BRC Computer Code, for example, includes D
consideration of these processes in its methodologies for estimating h
radiological impacts.
- 18. What agency will monitor the burial sites to be assured that only BRC mat 6 rial is being dumped into landfill areas?
It is anticipated that no regulatory agency will be required to monitor the burial sites receiving BRC waste-streams. The monitoring of these waste streams will take place when the material leaves a licensee's L
control and is transferred to an uncontrolled or exempt status.
- 19. Who will know where BRC has been buried if the regulatory limits change?
Records of where BRC waste material is buried may, in certain cases, be i
kept by the individual licensees disposing of the BRC waste. No records.
l are currently required for' disposal of consumer products containing small amounts of radioactive material. The continued appropriateness of this-provision will be addressed in rulemakings to implement the exemption-policy.
- 20. Are all Federal and State agencies in agreement with the BRC limits? If-not, who will have final regulatory authority?
All Federal and State agencies who have commented on the Commission's proposals for an exemption policy have supported the "below regulatory concern" concept. ' There have been, however, differing opinions on the numerical value which should be selected for the policy's individual dose criterion.
The EPA has proposed a value of 4 millirem per year for a-specific group of exemptions involving BRC waste disposals. The Conference of Radiation Control Program Directors, Inc., comprised of State and local radiation control program officials, has reconnended that the exemption policy include an individual dose criterion in the 1-5 millirem per year range.
Final regulatory authcrity would reside with EPA t.
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Will the exemption policy apply to mixed waste? What types of analyses 21.
will'the NRC need to show that exempted mixed wastes placed in a hazardous
-waste site meet the Commission's criteria?
The exemption policy could apply to the radiological properties of mixed The types of analyses that would be needed are the same for mixed waste.
Disposal of waste that can be. exempted waste as for. other types of waste.
on the basis of its radiological properties would depend upon the chemical l
and toxic properties of the waste.
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EDO Principa1' Correspondence Control-f FRON:-
DUE: 01/19/90 EDO CONTROL: 0005037
~ DOC.DT: 01/04/90 k
m FINAL REPLY:
Samuel J. Chilk SECY-TO::
i James,M. Taylor FOR' SIGNATURE OF:
i Executive' Director
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EXEMPTION FRON REGULATORY CONTROL"'
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