ML20044C663
| ML20044C663 | |
| Person / Time | |
|---|---|
| Issue date: | 04/23/1993 |
| From: | Parler W NRC OFFICE OF THE GENERAL COUNSEL (OGC) |
| To: | |
| References | |
| SECY-93-106, NUDOCS 9304280090 | |
| Download: ML20044C663 (44) | |
Text
_
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POLICY ISSUE-W 23, 1993 SECY-93-106 (Notation Vote)
FOR:
The Commissioners FROM:
William C.
Parler General Counsel James M. Taylor Executive Director for Operations
SUBJECT:
WITHDRAWAL OF BELOW REGULATORY CONCERN POLICY STATEMENTS IN ACCORDANCE WITH THE ENERGY POLICY ACT OF 1992 PURPOSE:
To present for Commission review and approval the actions necessary to implement Section 2901 of the Energy Policy Act of 1992 which formally revoked the Commission's Below Regulatory Concern (BRC)
Policy Statements.
SUMMARY
Section 2901 of the Energy Policy Act (Attachment A) revoked the Commission's BRC Policy Statements of August 29, 1986 and July, 3,
1990.
The staff proposes that the Commission formally take action to implement this statutory provision.
The proposed Commission action would consist of approving the issuance of a Federal Recister Notice (Attachment B) which provides the formal notice of the withdrawal for the two policy statements and for the Commission termination of a pending staff action that was initiated to implement the 1986 BRC Policy.
BACKGROUND:
l Section 10 of the Low-Level Radioactive Waste Policy Amendments Act (LLRWPAA) of 1985 directed the Commission to develop criteria and procedures to act upon petitions "to exempt specific radioactive waste streams from regulation due to the presence of radionuclides in sufficiently low concentrations or
)
quantities as to be below regulatory concern. "
The Commission
{
responded-to this statutory provision by issuing a
policy statement on August 29, 1986 (51 FR 30839) that contained criteria Contacts: Francis X.
Cameron, OGC NOTE:
TO BE MADE PUBLICLY i
t.
504-1642 AVAILABLE WHEN THE FINAL SRM IS MADE AVAILABLE.
p4 c.
Donald A. Cool RES._
-~~
I u
U 492-3785 y
~
e_-
2 for evalua tina such petitions. See Attachment C, " General Statement of Policy and Procedures Concerning Petitions Pursuant to Section 2.802 for Disposal of Radioactive Waste Streams Below Regulatory Concern."
These criteria and procedures are codified in 10 CFR Part 2, Appendix B, of the Commission's regulations.
In order to establish a consistent risk framework for making regulatory exemption decisions across the broad spectrum of activities regulated by the Commission, the Commission later issued a second policy statement addressing the below regulatory concern issue. See Attachment D,
" General Statement of Policy on Below Regulatory Concern," July 3, 1990, 55 FR 27522.
In reaction to the public concern about the implications of the 1990 Policy, the Commission initiated a consensus-building process in July 1991 to seek the advice of affected interests in a re-evaluation of the Policy.
In conjunction with tha 4.nitiation of I
the consensus-building. process, the O wai. scion placed a moratorium on the implementation of the Policy.
When the consensus-building process was terminated in December 1991 due to_the difficulty of
)
obtaining the participation of all affected interests in the process, the commission indefinitely extended the moratorium on the
{
implementation of the Policy.
i i
In October 1992, the Congress enacted the Energy Policy Act of 1992 (H.R.
776), and the bill was subsequently signed into law by President Bush.
Section 2901 revoked the Commission's 1986 and 1990 BRC Policy Statements.
)
DISCUSSION:
In order to implement the revocation provision of the Energy Policy Act of 1992, the staff proposes to publish a Federal Recister i
Notice that formally withdraws the 1986 and 1990 BRC Policy Statements.
The Notice provides a
brief and straightforward description of the background on the BRC policies and the Congressional action.
The Federal Recister Notice also includes instructions to the Office of the Federal Register to remove the 1986 BRC Policy from 10 CFR Part 2, Appendix B, of the Commission's regulations.
In addition to the BRC Policy Statements themselves, there is one 1
pending action that was initiated to implement the BRC Policies, 1
and consequently, should be terminated.
This action is--
o Rulemaking on Radioactive Waste Below Regulatory Concern (WITS 860197).
The Commission published an Advanced Notice of I
Proposed Rulemaking (ANPR) on this action on December 2, 1986 (51 FR 43367) and public comments were submitted in response to the ANPR.
Although the staff recommends termination of this action, the staff will evaluate the public comments submitted on the ANPR to ensure that any comments relevant to i
f 3
the enhanced participatory rulemaking are evaluated as part of that rulemaking process.
As noted in SECY-92-045, the staff will continue to work on those items originally consolidated in the BRC Action Plan that are necessary to establish the technical underpinnings for the rulemaking to establish the radiological criteria for site cleanup and decommissioning.
An updated list of other activities originally included as part of the BRC Action Plan is provided for the Commission's information in Attachment E.
In addition to the withdrawal of the Policy Statements, there are two_ other issues related to the Energy Policy Act of 1992 for Commission consideration.
Although Section 2901 of the Energy Policy Act effectively revoked the-1986 BRC Policy Statement by providing that it should have no further effect, it did not i
explicitly remove the Commission's obligation under Section 10 of-the Low-Level Radioactive Waste Policy Amendments Act of 1985 to develop criteria and procedures for evaluating exemption requests for specific radioactive waste streams.
Nor did the Act revoke the Commission's authority under the Atomic Energy Act to exempt classes of materials from licensing.
The staff does not believe i
that it is necessary at this time to initiate the development of new generic criteria and procedures to replace those established in 1986 Policy Statement that implemented Section 10 of the LLRWPAA.
There is only one pending petition for rulemaking that would have been addressed by the criteria and procedures in the 1986 BRC Policy.
This petition was submitted by the University of Utah
-?
related to an exemption for the disposal of biomedical wastes containing small quantities of radionuclides.
Two other similar petitions submitted by Rockefeller University were withdrawn by the petitioner (57 FR 11920, April 8, 1992).
Although the fact that only one petition is pending does not reflect the total potential interest in exemptions for specific waste streams, the staff believes that the current situation could allow these types of exemption requests to be effectively handled on a case-by-case basis'using the Commission's existing authority under the Atomic Energy Act and the existing general procedures for the expedited processing of petitions for rulemaking.
This would also be consistent with the Commission's intent to make case and activity-specific risk decisions as needed during the pendency of the enhanced participatory rulemaking.
In regard to the University of Utah petition, the staff believes that it would be prudent to return the petition for rulemaking to the University of Utah.
Returning the petition without prejudice would allow the petitioner to resubmit the petition at a later date, if they deem.it appropriate, updated to reflect changes in waste stream processing, solid waste management, and dosiretry. At some point in the future, it may be appropriate for the Commission I
to act upon an updated petition.
The staff believes that the Commission should defer action on the University of Utah petition,
4 or any similar petitions, until two future developments have been evaluated.
One of these is the evaluation of what is the most appropriate and effective process for public involvement in the waste stream exemption process.
An evaluation of the enhanced participatory rulemaking process may provide useful information on this issue.
A second development is the Environmental Protection Agency's (EPA) planned rulemaking on residual radioactivity standards.
It is anticipated that EPA will have made progress on the standard by the time that the enhanced participatory rulemaking is completed and the EPA's work on these standards should be considered before the Commission acts on any waste stream exemption petitions.
The staff recommends that any action on waste stream petitions be deferred until after the enhanced participatory rulemaking process is completed.
By that time, the Commission will have more information both on the type of process that might be appropriate for addressing waste stream exemption requests and on related standards that might be used to evaluate such requests.
In addition to revoking the 1986 and 1990 Policy Statements, Section 2901 of the Energy Policy Act grants State governments the authority to regulate, on the basis of radiological hazard, the disposal or off-site incineration of low-level radioactive waste if the Commission exempts such waste from regulation after the date of enactment of the Energy Policy Act. Although the provision appears straightforward, two of the statutory terms are subject to several possible interpretations, i.e., what constitutes " disposal" of low-level radioactive waste and what actions would constitute the Commission " exempting" such waste from regulation.
Although these terms are relatively clear in terms of Commission practice, unfortunately, the legislative history of the Energy Policy Act does not provide any definitive guidance on how these terms should be interpreted.
However, because the decision to implement this provision rests solely with state governments, we do not believe that it would be appropriate for the Commission to put forth an interpretation of the scope of state authority under this provision.
The Commission can reevaluate the need to take a legal position on this issue in light of any future state actions.
RECOMMENDATION:
That the Commission should approve:
1.
the draft Federal Recister Notice in Attachment B rescinding the Commission's BRC policies and terminating the rulemaking action noted therein; 2.
the return of the University of Utah petition without prejudice; and
5 3.
the deferral of the development of an interpretation of Section 2901 of the Energy Policy Act.
William C.
Parler General Counsel
./
N aes M.
ylor
.ecutive Director for Operations Attachments:
A.
Section 2901 of the Energy Policy Act of 1992 B.
Draft f_ederal Reaister Notice C.
BRC Policy Statement of August 29, 1986 D.
BRC Policy Statement of July 3, 1990 E.
Update of staff actions identified in SECY-92-045.
Commissioners' comments or consent should be provided directly to the Office of the Secretary by COB Monday, May 10, 1993.
Commission Staff Office comments, if any, should be submitted to the Commissioners NLT May 3, 1993, with an information copy to the Office of the Secretary.
If the paper is of such a nature that it requires additional review and comment, the Commissioners and the Secretariat should be apprised of when comments may be expected.
DISTRIBUTION:
Commissioners OGC OIG CAA-OPP DCD Central Files EDO SECY i
j
Attachment A P L.102-486 LAWS OF 102nd CONG.-2nd SESS.
Oct. 24 Sec.1807 TITLE XXIX-ADDITIONAL NUCLEAR ENERGY PROVISIONS 1
SEC. 2s01. STATE AtTTHORITY TO REGULATE RADIATION BEI4W LEVEL OF NRC REGULATORY CONCERN.
I (a) IN GENERAL.-The Atomic Energy Act of 1954 (42 U.S.C.
2011 et seq.)is amended by inserting abr section 275 the following new section:
- SEC. 278. STATE AUTHORITY TO REGULATE RADIATION BE14W LEVEL OF REGULATORY CONCERN OF NUCLEAR REGU.
LATORY COMMISSION.
I
"(a) IN CENERAL.-No provision of this Act, or of the Low.
Level Radioactive Waste Policy Act, may be construed to prohibit or otherwise restrict the authority of any State to regulate, on the basis of radiological harard, the disposal or off site incineration of low level radioactive waste, if the huelear Regulatory Commis-sion, abr the date of the enactment of the Energy Policy Act of1992 exempts such waste frem regulation.
- (b) RELATION TO OTHER STATE AUTHORITY.-This section may not be construed to imply preemption of existing State authority.
Except as expressly provided in subsection (a), this section may not be construed to confer on any State any additional authority to regulate activities licensed by the Nuclear Regulatory Ccmmis-anon.
"(c) DEFINmONS.-For purposes of this section:
"(1) The term ' low-level radioactive waste' means radio-active material classified by the Nuclear Regulatory Commis-sion as low level radioactive waste on the date of the enactment of the Energy Policy Act of1992.
"(2) The term off site incineration' means any incinerction of radioactive materials at a facility that la located off the site where such materials were generated.
"(3) The term ' State' means each of the several States, the District of Columbia and any commonwealth, territory, or possession of the United States."-
(b) REVOCATION OF REtATED NRC POuCY STATEMEN7s.-The policy statements of the Nuclear Regu! story Commission published in the Federal Register on July 3, 1990 (55 Fed. Reg. 27522) and August 29, 1956 (51 Fed. Reg. 30839), relating to radioactive waste below regulatory concern, shall have no effect abr the date of the enactment of this Act.
(c) CONFORMING AMENDMENT.-The table of contents of the Atomic Energy Act of 1954 (42 U.S.C. 2011 pree.) is amended by inserting abr the item relating to section 275 the following new item:
- Sec. 276. State authority to replete radiation below level or rep! story concern of Nucleat Esplatory Comminion.*.
106 STAT. 3122
i i
Attachment B
[7590-01]
NUCLEAR REGULATORY COMMISSION 10 CFR Part 2 RIN-3150-AE56 Withdrawal of Below Regulatory Concern
'I Policy Statements and Related Rulemaking Actions AGENCY:
Nuclear Regulatory Commission.
ACTION:
Withdrawal of policy statements and related rulemaking activities.
SUMMARY
The Nuclear Regulatory Commission is formally withdrawing its Below Regulatory Concern (BRC) policy statements.
This action is necessary to comply with provisions of the Energy Policy Act of 1992.
Specifically, this action removes the BRC j
j Policy Statement issued on. July 3, 1990 and the BRC Policy issued in 1986 concerning the submittal of petitions.for disposal-of radioactive waste streams below' regulatory concern that was codified in_the Commission's regulations.
The Commission is also terminating a rulemaking action initiated to implement the 1986 BRC policy, i
l i
i
2 I
1 EFFECTIVE DATE:
This action is effective (upon publication in the Federal Register).
FOR FURTHER INFORMATION CONTACT:
Francis X.
Cameron, Office of the General Counsel, U.S. Nuclear Regulatory Commission, t
Washington, DC 20555. Telephone (301) 504-164' l
SUPPLEMENTARY INFORMATION:
Section 10 of the Low-Level Radioactive Waste Policy 1
Amendments Act (LLRWPAA) of 1985 directed the Commission to develop criteria and procedures to act upon petitions "to exempt specific radioactive waste streams from regulation...due to the presence of radionuclides...in sufficiently low concentrations or
)
quantities as to be below regulatory concern."
The Commission responded to this statutory provision by issuing a policy
~
statement on August 29, 1986 (51 FR 30839) that contained criteria for evaluating such petitions.
These criteria and procedures are codified in 10 CFR Part 2, Appendix B, of the Commission's regulations.
In order to establish a consistent risk framework for making regulatory exemption decisions across the broad spectrum of activities regulated by the Commission, j
i the Commission later issued a second policy statement addressing i
the below regulatory concern issue, " General Statement of Policy I
on Below Regulatory Concern," July 3, 1990, (55 FR 27522).
1 i
r 3
In reaction to the public concern about the implications of the 1990 Policy, the Commission initiated a consensus-building i
i process in July 1991 to seek the advice of affected interests on a re-evaluation of the Policy.
In conjunction with the initiation of the consensus-building process, the Commissian placed a moratorium on the implementation of the 1990 Folicy.
t When the consensus-building process was terminated in December 1991 due to the difficulty of obtaining the participation of all j
affected interests in the process, the Commission indefinitely extended the moratorium on the implementation of the Policy. In October 1992, the Congress enacted the Energy Policy Act of 1992 (H.R. 776), and the bill was subsequently signed into law by President Bush.
Section 2901 revoked the Commission's 1986 and 1990 BRC Policy Statements.
The Commission formally withdraws the two BRC Policy Statements in response to the Congressional action.
The Commission is also terminating the following rulemaking action that was initiated to implement the 1986 BRC Policy.
On December 2,
1986 (51 FR 43367), the Commission published an advance notice.
of proposed rulemaking (ANPR) entitled " Radioactive Waste Below Regulatory Concern; Generic Rulemaking" (RIN 3150-AC35).
This ANPR is withdrawn.
However, the NRC staff will evaluate the public comments submitted on the ANPR to ensure that any comments that are relevant to the enhanced participatory rulemaking on the
4 radiological criteria for site cleanup and decommissioning are considered as part of that rulemaking process.
Although Section 2901 of the Energy Policy Act effectively revoked the 1986 BRC Policy Statement by providing that it should have no further effect, it did not explicitly remove the Commission's obligation under Section 10 of the Low-Level Radioactive Waste Policy Amendments Act of 1985 to develop criteria and procedures for evaluating exemption requests for specific radioactive waste streams.
Nor did the Act revoke the Commission's authority under the Atomic Energy Act to exempt classes of materials from licensing.
The Commission does not believe that it is necessary at this time to initiate the development of new generic criteria and procedures to replace l
those established in 1986 Policy Statement that implemented Section 10 of the LLRWPAA.
There is only one pending petition for rulemaking that would have been addressed by the criteria and procedures in the 1986 BRC Policy.
This petition was submitted by the University of Utah related to an exemption for the disposal of biomedical wastes containing small quantities of f
radionuclides.
Two other similar petitions submitted by Rockefeller University were withdrawn by the petitioner (57 FR 11920, April 8, 1992).
The Commission believes that the current situation could allow these types of exemption requests to be effectively handled on a case-by-case basis using the j
Commission's existing authority under the Atomic Energy Act and i
i li
5 the existing general procedures for the expedited processing of petitions for rulemaking.
However, in regard to the University of Utah petition, the Commission has decided to return the petition for rulemaking to j
t?.2 University of Utah without prejudice.
Returning the petition l
without prejudice would allow the petitioner to resubmit the petition at a later date, if they deem it appropriate, updated to reflect changes in waste stream processing, solid waste management, and dosimetry.
At some point in the future, it may be appropriate for the Commission to act upon an updated petition.
However, the Commission will defer action on the University of Utah petition, or any similar petitions that may be I
submitted, until two future developments have been evaluated.
One of these is the evaluation of what is the most appropriate and effective process for public involvement in the waste stream exemption process.
An evaluation of the enhanced participatory rulemaking process may provide useful information on this issue.
i A second development is the Environmental Protection Agency's (EPA) planned rulemaking on residual radioactivity standards.
It is anticipated that EPA will have made progress on the standard by the time that the enhanced participatory rulemaking is completed and the EPA progress on this standard should be considered before the Commission acts on any waste stream exemption petitions.
Therefore, the Commission will defer action on waste stream petitions until after the enhanced I-participatory rulemaking process is completed.
By that time, the
6 commission will have more information both on the type of process 1
that might be appropriate for addrescing waste stream exemption requests and on related standards that might be used to evaluate such requests.
e Paperwork Reduction Act Statement r
i Withdrawal of this policy statement removes information collection requirements that were subject to the Paperwork Reduction Act of 1980 (44 U.S.C.
3501 et seq.).
Office of j
Management and Budget approval of the requirements contained in Appendix B to 10 CFR Part 2 was allowed to expire on December 31, 1992.
The 10 CFR Part 2 information collection requirements that remain in effect were approved by the Office of Management and Budget approval number 3150-0136.
List of Subjects in 10 CFR Part 2 l
l Administrative practice and procedure, Antitrust, Byproduct material, Classified information Environmental protection, Nuclear materials, Nuclear power plants and reactors, Penalties, Sex discrimination, Source material, Special nuclear material, Waste. treatment and disposal.
For the reasons set out in the preamble and under the authority of the Atomic Energy Act of 1954, as amended, the i
Energy Reorganization Act of 1974, as amended, and 5 U.S.C.
552 J
c.
t 7
and 553, the NRC is adopting the following amendment to 10 CFR Part 2.
PART 2 - RULES OF PRACTICE FOR DOMESTIC LICENSING PROCEEDINGS AND ISSUANCE OF ORDERS (Note:
Authority cite must be revised to remove provisions applicable to App. B) 1.
The authority citation for Part 2 is revised to read as i
follows:
AUTHORITY:
Secs. 161, 181, 68 Stat. 948, 953, as amended (42 U.S.C.
2201, 2231); sec. 191, as amended, Pub.
L.87-615, 76 Stat. 409 (42 U.S.C.
2241); sec. 201, 88 Stat. 1242, as amended (42 U.S.C.
5841); 5 U.S.C.
552.
i Section 2.101 also issued under secs. 53, 62, 63, 81, 103, 104, 105, 68 Stat. 930, 932, 933, 935, 936, 937,-938, as amended (42 U.S.C.
2073, 2092, 2093, 2111, 2133, 2134, 2135); sec.
' j 114(f), Pub. L.97-425, 96 Stat. 2213, as amended (42 U.S.C.
10134 (f) ) ; sec. 102, Pub.
L.91-190, 83 Stat. 853, as amended (42 U.S.C.
4332); sec. 301, 88 Stat. 1248 (42 U.S.C. 5871).
Sections 2.102, 2.103, 2.104, 2.105, 2.721 also issued under secs. 102, 103, 104, 105, 183, 189, 68 Stat. 936, 937, 938, 954, i
955, as amended (42 U.S.C.
2132, 2133, 2134, 2135, 2233, 2239).
Section 2.105 also issued under Pub.
L.97-415, 96 Stat. 2073 (42 U.S.C. 2239).
Sections 2.200-2.206 also issued under secs.
161b, i, o, 182, 186, 234, 68 Stat. 948-951, 955, 83 Stat. 444, i
I
^
i l
8 as amended (42 U.S.C.
2236, 2282); sec. 206, 88 Stat. 1246 (42 U.S.C. 5846).
Sections 2.600-2.206 also issued under sec. 102, Pub.
L.91-190, 83 Stat. 853, as amended (42 U.S.C. 4332).
Sections 2.700a, 2.719 also issued under 5 U.S.C.
554.
Sections-2.754, 2.760, 2.770, 2.780.also issued under 5 U.S.C.
557.
Section 2.764 and Table 1A of Appendix C also issued under secs.
l 135, 141, Pub. L.97-425, 96 Stat. 2232, 2241 (42 U.S.C.
- 10155, 10161).
Section 2.790 also issued under sec. 103, 68 Stat. 936, as amended (42 U.S.C. 2133) and 5 U.S.C.
553.
Section 2.809 also issued under 5 U.S.C.
553 and sec. 29, Pub. L.85-256, 71 Stat.
i 579, as amended (42 U.S.C. 2039).
Subpart K also issued under sec. 189, 68 Stat. 955 (42 U.S.C. 2239); sec. 134, Pub. L.97-425, 96 Stat. 2230 (42 U.S.C. 10154).
Subpart L also issued j
under sec. 189, 68 Stat. 955 (42 U.S. C. 2239).
Appendix A also i
issued under sec.
6, Pub. L.91-560, 84 Stat. 1473 (42 U.S.C.
l 2135).
I Appendix B to Part 2 [ Reserved]
t f
i 1
--...n---w_,
7-.
9 2.
Appendix B to 10 CFR Part 2 is removed.
Dated at Rockville, Maryland, this day of 1993.
For the Nuclear Regulatory Commission.
Samuel J.
Chilk Secretary of the Commission 4
i l
~1 l
- 'Attachnent C-
~
Fed:ral Regist:r / V:1. 51, Ns 168 / Friday. August 20, 1986 / Rul:s and Regul:tions 30839
~
%e documents describe the kind of
- Pub. L 97-415, se Stat 2073 (42 UAC 224 information petitioners abould file to Secdons L200-2.206 also luned under aca, allow timely Commission review of the ' 186, AS4. es Stat e55,43 Stat 444. as amaedad (42 U.SC 2236,2282h pc.2m as Stat ma petition. They also describe decision (42 USC 6646). Sections Leoneos also criterie the Commission will use and the issued ander mer. t02, Pub. L 91-180,83 Stat administrative proceduns to be ass, as amended (42 USC 4332h Sections foUowed in order to permit the spoon.1519 alp heued undu 8 UAC 554.
Commission to act upon the petition in Sections 2.754,2.780,2770 also tuned mader 5 an expedited marmer.Hese documents USC &$7. Section 2.790 also lasund emder respond to a mandate in the icw44 sal uc. 203, se Stat. e36, as ameeded (42 UAC Radioactive Waste Policy Amendments 21131 and 5 USC 651 Sections 2Aco and Act of1985 and are being published as 2.908 aho iseued undu a USC &&3. Section i
Appendix B to 10 CFR Part L 2.800 aho tuned under 8 UAC 553 and sec.
- 29. Pub. L B5-256,71 Stat $79, as amended EFFECTIVE DAtt October 27,1986.
(42 USC 2039). Subpart K also tenued under ADDRESSEE: Send any written comments sec.189,68 Stat 955 (42 USC 2D9h sec.134, or suggestions to the Secretary of the Pub. L B7-425. 96 Stat 223o (42 USC 10154).
Commission, U.S. Nuclear Regulatory Appendix A also issued under sec.8.Pob.L Commission, Washington, DC 20555; et-660,64 Stat.1437 (42 USC 2135).
Attention: Docketing and Service Appendix B la aho luued under sec.10. Pub.
Branch. Comments received within S)
L 99-240, so Stat.1a42 (42 UAC. Sonb et days would be most helpful. Copies of "91 comments received by the Commisalon
- 2. Add the following policy ' tstament e
may be examined or copied for a fee at as Appendix B to Part 2:
the U.S. Nucle at Regulatory Commission Appendix B to Part fr-General Statement (NRC) Public Document Room.1717 H of Pobey and Procedures Conceming Street NW, % ashington. DC 20555.
Peutions Pursuant to 12.802 for Disposal of FOR FURTHER tNPORMATION CONTACM Radioactive Waste Streams Below Kitty S. Dragonette, DMsion of Waste Regulatory Con ern:
Management. Office of Nuclear Material L Introduction and Purpose Safety and Safeguards, U.S. Nuclear D. Standanh and Procedures Regulatory Commission, Washington.
E!. Agreement Statn DC 20555, telephone: (301) 427-4300.
IV. Future Action SUPPt.EMENTARY INFORii4AT 09C LIntroduction and Purpose List of Subjects in 10 CFR Part 2 The tow 4evel Ra6oactive Wate Policy Amendments Act of1985 (the Act)[42 UAC l
Administrative practice and zonb et wg I was enacted January 15.1986, procedure, Classified business Section 10 of the Act addnues disposal of informstion, Freedom of information, wastu tenced "below regulatory concern" NUCLE AR REGUI.ATORY Hazardous waste, Nuclear material, that would not need to be subject to N
Nuclear power plants and reactors, reguhtory control to assun adequate. "
10 CFR Part 2 Penalties. Sex discrimination.
Protection of the public health and safety For the reasons set forth below and oecause of their udioacuve content.m gos!
',^ t e j
- 6]I
'dI prjd 4
[
Radoactive Weste Below Regulatory under the authority of the Atomic Concern; Policy Statement Energy Act of1954 as amended, the decisions to determine when wastes need not Energy Reorganization Act of1974, as Wu decisions wm be expressed be, sal ette.
so to a licensed low. level waste dis AGENew Nuclear Regulatory amended, and 5 U.S.C. 553, the NRC la gh Commission.
adopting the following amendments to rulemaking. Alternative disposalwould ACTION: Final rule: policy statement.
to CFR Part 2.
conserve space in the existing sites while new sites an established and reduce the
SUMMARY
- his notice contains a policy PART 2-RULES OF PRACTICE FOR costs of disposal. Rulemaking petitions may statement and staffimplementation plan DOMESTIC UCENSING PROCEDURES play a role in the masonallow-level waste strategy outlined by the Act.The Act regarding expeditious handling of 1.ne authority citation for Part 2 la provides that the Comminion eetablish-petitions for rulemaking to exempt revised to read as follows:
procedures for acting expeditiously on specific radioactive wsste streams from disposal in a licensed low level waste Authority: Sees. tet.181. 68 Stat. 848. 953, petitions to exempt speciSc radioacdvs weste stname from the Commission's disposal facility. For the Nuclear
- ' emendeg42 US C 2201,2231):see.1st as 7s 8
(
Regulatory Commission (NRC) to grant k,f 3,at.1 42 e
on of this statement and these rulemaking petitions, the waste amended (42 US C 6641); 8 USC 551 accompanying implementation plan is to j
streams must be sufficiently low in Section 2101 also issued under seca. 53. St.
estabbah the standards and procedures that concentration or quantitles of
- 63. 31.103.104.105,88 Stat. 930. 832. 933. 935, will permit the Commission to act upon
+
radionuclides for the Commission to find 935. 937,838. as amended (42 IJAC aor3.
tulemaling peutions in an exposticus that they may be disposed of by 2092,2003,211L M33. nM,2135) we.102.
ananner u called for in the Act TW policy alternative means without posing an Pub. L 91-190. 83 Stat. 853, as amended (42 statement does root nguire petitioners to undue risk to public health and safety
- US C. 4332t ac. 301. sa Stat 1248 (42 UAC present all the information outlined or 6671). Sections 1102, f 103. L104.1105.1721 demonstrate that the decision criteria for ge po} icy statement and plan are in the aho inued under secs.102,103.104.105.183, expedited handling can be met. if euch astute of regulatory guidance for 189. 68 Stat. 236,937, S38. 954,955, ea expe6ted handling is not wanted. For i
implementing ex.isting requirements for amended (42 US C nat n33. 21H. 2135, example petitions requesting exemption of rulemaking pelitions in 10 CFR 2.802.
2233,2239) Seccon L105 aho issued under concentrations of resonuclides that might 4
l 30840 Federal Register / Vol 51, No.168 / Friday, August 29, 1986 / Rules and Regulations result in individual exposures higher than EL ne weste is compatible with the
. IV. Future Anos --
those recommended in the decision criteria proposed treatment and disposal optims.
He Commission will conduct a generic may be submitted, but expedited headling 7.ne exemption is useful on a national rulemaking on waste streams below cannot be assured.
scala,i.e it is likely to be used by a categwy regulatory concern based on a number of Finally, this policy statement and of licensees or at least a significant portion of factors.Re factors include pub!Ic commants accompanying implemen'tation plan are acategory, received on the statement, the number and '
intended to facilities handling of rulemaking 8.He radiologicalproperties of the waste types of petitons for rulemaHng remtved, and petitions for streams from multiple producers stream have been characterized on a national how effective the sistement is in enabling and do not apply to individue!licensina basis. the variability has been projected. and timely processing of petitions. A generic 8
l the range of variation will not invalidate rulemaking is warranted to provide a more lifen e's w' pprovb*for f
supporting analyses, afficient and effective means of h
I 9.
e aste characteriaatimis based on accomplishing the goals reflected in Section th spos Ipla der 10 a.
data on real wastes.
10 of the Act. An advance notice of proposed II. Standards and Procedures 10.ne disposed form of the waste has rulemaking will be published within 90 daya.
negligible potential for recycle.
Furthermore, the Commission may He standards and procedures needed to n
um can e sheM4 periodically review all rulemakings in order handle petitions exped tiously fallinto the licensable. and inspectable programs for the to assure that the relevant parameters have following three categories:(1)lnformation waste prior to transfer to demonstrate not changed significantly and may ask the petitioners should ide in support of the comphance.
petitioner to submit updated information to petitions. (2) standards for assessing the 11 e offsite tnetment or disposal assist in the review.ne Commission would adequacy of the proposals and providing medium (e.g sanftsry landfill) does not need also have to confirm that approved petitioners insight on the decision critena the to be controlled or monitored for radiatim exemptions are consistent with any general Commission intends to use so that all protection purposes, standards issued by EPA.
relevant informational issues will be 13.ne methods and procedurn need to Dated at Washington DC this g5th day of addressed in the petition, and (3) the internal manage the wastes and to assess the impacts g,p,g, gggg, NRC administrative procedures for handhng a
ated For the Nuclear Regulatory Commission.
e attacYed st f pe o the po a dres materials.
Samuel L M Implementation plan.The staff plan was 14.Here are no rep! story or legal Secretary to the Commission.
developed in response to Commission obstacles to use of the proposed treatment or Editorial Note: %e etaff implementation direction to prowde detailed guidance on implementmg the general approach outhned
&sposal methods, plan will not appear in the Cods of Federal in this policy statement. Although alaff may IIL Agreement State Regulstion.
I'
"$an He Low-level Radioactive Weste Policy Nuclear Regulatory Commlaslon StaH ga ed in r ce smg i io a p
^*endments Act of1985 establishes a implementation of Nuclear Regulatory outlmes e reasonable basis for accomplishing national system for dealing with low-level Commission Policy on Radioactiva the approach. Staff is to publish revisions as waste &.sposal.He system assigns to the Waste Below Regulatory Concern i
NUREG documents and notice the States responsiblity for disposal capacity for availability of the revisions in the Federal Iow-level wastes not exceeding Class C L Introduction Register.
wastes as defined in 10 CFR 81.55. Section 10 IL Information to Support Petitions As a practical matter, the primary of the Act encourages a reduction in volume A. General information for justifying and supporting of such wastes subject to State responsibbtly L to CFR Part 2 Requirements.,
petitions must be supphed by the petitioner if the Commission is to act in an expedited for disposal through the option of determining 1 EnvironmentalImpacts. ' ' -
that certain wastes need not go to existing J. Economic impact on Small Entities manner. If the petitioner wishes to assure expedited action, the supporting information licensed disposal facilities or new sites
- 4. Computer Program licensed under to CFR Part 61 or equivalent
- 5. Scope should be complete enough so that Commission action is primarily limited to State regulations. lf rediological safety can be B. Waste Characterization 4
independent evaluation and administrative assured. such disposal would conserve space L Radiological Properties in the existing sites while new sites are 1 Other Considerstrons processing Decision criteria for ledging whether to developed, and would serve as an important
- 3. Totals grant a petition involve the overallimpacts of adjunct to volume reduction efforts in
- 4. Basis the proposed action, waste properties, and meeting the weate volume allocation limits
- 5. As Iow as Reasonably Achievable l
implementation of the proposed exemption.
set forth in the Act.nus, these rulemakings (ALARA)
The following criteria address these areas.
should aid the States in fulfilling their C. Waste Management Options Petitions which demonstrate that these responsibilities under the Act. Equity also D. Analyses criteria are met should be suitable for
. suggests that all waste generators be able to L RadiologicalImpacts exped ted action, take advantage of below regulatory concern 1 Other impacts
- 1. Disposal and treatment of the wastes as options as part of their waste management
- 8. Regulatory Analysis specified in the petition will result in no strategies. Generators in both Agreeement E.Recordkeeping and Reporting j
s:gnificant irnpact on the quality of the and non. Agreement States will be competing
- 1. Surveys human environment.
for space in the existing sites and the concept L Reports 1 The maximum expected effective don should be applicable nationwide.
F. Proposed Rule equivalent to an individual member of the Agreement States will play an important III. Decision Criteria public does not exceed a few millirem per role in ensuring that the system works on a IV. Administrative Handling 1
year for normal operations and anticipated national basis and that it remains equitable.
Undchu States beve been encouraging findings that events.
I 3 The conective doses to the critical certain wastes are below regulatory concern Sectiontoof thelow-level population and general pulation are small.
and do not have to go to low-level waats Radioactive Waste Policy Amendments
- 4. The potentsal radio ogical consequences sites.The States have been voicing this view Act M M mh 6e helear I
of accidents or equipment malfunction for a number of years through forums such as Regulatory Commission (NRC) to involving the wastes and intrusion into the Conference of Radiation CentroI Program disposa sites after loss of normal Directors. Rulemakings granting petitons will develop standards and procedures for institutional controls are not significant.
be made a matter of compatibility for expeditious handling of petitions for 5 ne exemption will result in a significant Agreement States. Consequently, rulemaking rulemaking to exempt disposal of ceduction in societal costa.
will be coordmeted with the States.
radioactive waste determi.ned to be
Federal Register / Vol. 51. No.168 / Friday. August 29, 1988 / Rules and Regulations 30841 below regulatory concern. The Act also When a rulemaking action is likely to When alternate calculational requires NRC to identify information have a significant economic impact on a methodologies are used, the petitioner I
petitioners should file. The Commission substantial number of small entities, the should provide all the specific input l
Pohey Statement provides general Regulatory Flexibility Act requires that needed to analyze the waste stream in guidance on how to meet the the impacts on these small entities must the petition using IMPACTS-BRC and j
requirements of section to of the Act, be specifically addressed. (The provide a rationale for all parameter outhnes the overall approach to be Commission's size standard for selections.The Commission may clarify followed. and lista decision criteria to be identifying a small entity is $3.5 million or modify the computer code from time i
used. Implementation of the general or less in annual receipts except for to time. Petitioners choosing to use spproach and decision criteria of the private practice physicians and NRC's code should be sure to use the Commission Policy Statement involves educationalinstitutions where the current revision. The National Energy l
developing more detailed guidance and standard is $1 million or less in annual Softwan Center will provide changes to i
procedures. In accordance with receipts for private practice physicians persons obtaining the program frorn the Commission direction, the NRC staff has and 500 employees for educational Center. Users are encouraged to developed more detailed guidance and institutions. See 50 FR 50214, December comment on the code so that their procedures for implementation of the 9,1985.) For any rulemaking, the experience can be factored into future Commission policy Statement. This staff Commission must either certify that the revisions.
guidance and procedures cover:(1) rule will not economically impact or will
- 5. Scope.The petitioner should define l
Information petitioners should file in have no significant economic impacts on the geographic area to which the support of petitions to enable expedited small entitles, or present an analysis of processing. f2) discussion of the decision alternatives to minimize the impacts, proposed mle thould apply and the criteria, and (3) administrative Because rulemakings on below reasons suppo: ting any area less than procedures to be followed.
regulatory concern should provide relief nationalin scope.it might be ossible to from requirements for all affected justify limiting the scope to a ow-level fl. laformation to Support Petitions entities, satisfaction of this requirement waste ngionaI capact m a state but A Ceneral should be straightforward but it must be implementation issues such as import or y
export of wastes outside the compact or
- 1. # CFR Port 2 requirements. The Qedin an
, b6 epar$ti n of the state should be addressed in the codified information requirements for radmale.
petitions for rulemaking are outlined in proposed ru e respondmg to the petition, 1
the etitioner should submit an the Commission a regulations in 10 CFR
,y,fuation of the estimated economic
" d##'####"
2 802[c). These regulations require the petitioner to identify the problem and impacts a small entitles.The propose solutions. to state the evaluati n sh uld include estimates of 1.Rodiologicolproperties. The i cetitioner's grounds for and interest in the costs for small entitles in terms of minimum radiological properties that should be described are the I
l the action, and to provide supporting staff time and dollar costs. Any concentration or contamination levels d
Mu!d acceptish the and the half. lives, total quantity, and I
ae H
~
information and rationale. As a practical matter, the information demonstrating bjective of the petitioner's proposed identities of the radionuclides present.
[
that the radiological health and safety mle while minimizing the ecmmic impacts are so low as to be below impact on small entities should be The chemical and physical form of the' regulatory concern must be provided by punntedJhe nalueuen should radionuclides should be addressed. All radionuclides prnent hbresent or potentially the petitioner if the Commission is to act efeme arYcor5eep and reporting speM,includng
(
in an expedited manner. petitions for re m n i en e u trace rulemaking should therefore be costs that would be associated with the
[
constituents.The distribution of the submitted following the staff's petiti ned rule change.
radionuclides within the wastes should supplemental guidance and procedures
- 4. Computerpmgmm. The computer be noted (e.g. surface or volume to assure expedited action.
pmgram (IMPACT-BRC) the distribution). Mass and volume average mma n ten to un to
- 2. En vironmentalimpacts. Pe titions concentrations should also be j
must enable the Commission to make a E'"
presented. For incineration, the "ts ofimpacts is based on,'De radioactive content of the ash and L
l finding of no significant impact on the
" H**%,a s t Mmmis quality of the human environment. Such Methodology,,e Impacts Analysis noncombustible fraction should be
[
Co'nmission fmdings must be based on UNG/CR-35as) described.The variability as a function d
an Fnvironmental Assessment that published February 1984.8 Petitioners of process variation and varistion f
complies with to CFR 51.30 and must
" aged to na
.am na licenst es sh a d be addressed
[
in o d
,9 d
meet the requirements of 10 CFR 51.32.
These requirements include addressmg Commission's information needs. The the need for the proposed action, IMPACTS-BRC program will be 2MnesMemtions. An identifying alternatives, and assessing distributed by the National Energy understanding of nonradiological the potential environmentalimpacts of Software Center on floppy diskettes for properties of ths waste stream is needed h
the proposed action and alternatives.
use on IBM-PC and compatible to assure that they are consistent with p
Consistent with 10 CFR 51.41, the computers. The Center's address is 9700 the proposed disposal method and to g
South Cass Avenue Argonne National evaluate the adequacy of the analysis of
. Petitioner should sub: nit the information Laboratory. Argonn'e. Illinois 00439. The the radiologicalimpacts. (NRC's pr needed to meet these requirements and do so in a manner that permits users guide for IMPACTS-BRC will be deregulation of the radioactive content independent evaluation by the published as a draft Volume II of would not relieve licensees from the Camnsion of the data and NUREG/CR-3585. Petitioners may appucable mles of oser agMn wM I
the imp f th d
cover the nonradiological properties]
nethodology used and the conclusions
$['using NRC's code,1 d The petitioner should provide a detailed i d.
nached.
description of the waste materials,
- 3. Economic impact on small entities.
' tootnotes ei red at unck including their origin. chemical 1
.'i
30842 Federal Register / Vol. 51 No. 28 / Friday. Azrgust 21,19sa / Rntes and Regulatsoeis composition, physical state. vahzme and estimated for the petstamed =mpa A ConsidaeMe d.sta and expenessa mass.
concentretum distnbeton wouhihe a abould be a,rrilathe to a&laar -
The term " stream" only raeens wastes helpful toci is charactemmg the wasta charactersxmg the r.hteemi centent prodaced frnrn a cornmoo set af atream. For exampic, the pettact and comsmaitzen el the wsete sermaca circumsteces and possening cranmon could indicate that w% of the westes being addressed la the pe.ataan. h characteristics. It does not mean fall in the range of 1-10,- pee same pancsp!es acthued tra10 CFR
liquid" although the stream aray be lo a gram. 60% iaB to the 10-100 ernee, and 61.55(aM8) may be app!!ad.La walanes liquid form (e.g, waste oil). The wastes 30% in the 120-1.000 rarage. Sur.h band on direct measuressents, indnesci may be resin beads,laboratary distributian would permit amore realistac methods related to measurements, er glassware, or any other form. Waste asseasment ofimpads in adddaan to material accourtabihity.
form includes packages or ccsatainers conservative bouriding estumatue u.aist
- 5. As hw ca is sessencNyc '. %-
used to manage (i.e, etore, handle, ship, rnannum values. la any case. the (ALARA,A h C--* h's ALARA or dispose) the wastes. The vari =hifity typical quantities prodweed r requirement in to CFR 2fL11c) appises to and potential changes in the waste form generator and an estimate the efforts by Ecmasees to =amintaka as a function of process variation ahnuM ge06mphic distnbu* ion d de generatoes radiation exposma and relernes al be addressed W vadation among should be desenbed.
radioactive zurtenals in efDuents to licensees should be described and
& Basia h basis inr the wasta weed anas as law is semaa=My bounded.
strearn charactecnation shoald be achievable. to CFR Part 58. Appeedsx 1.
Compatibihty with requirements provided.The basis br chai-um'"
desenbc.a m b rdaoutm associated with the proposed of the wastes and the total quantitian rnatedala in hght water seactee eEhnents.
management options should be cerrfuIIy produced should be describad.
Licensee c.xmphance wuh to CFR 20.1(c) presented. For example. If the petitioner Monitoring, analytical data. and is a precondition to acceptacce by HRC proposes that the wastes be incinerated, rahtaticas shcsad be specified Azizal of any waste st:tana an exempt.
the waste fonn should be shown to be measurements or takes that can be Therefore, a description should be compatible with the temperms. !Vs rektad to measu:sments to en= firm
'pmvidd d reasonWe pmedes that rates. feed rates, and other operating calculations an important.h waste generators would be expected to parameters of typicalincineraters that desenption of the bases sha.dd ineht' use 6 w'M'a rMiahn umes may be used. The petitioner aboold quahty assurance aspects. For example.,
nsultkg from the disposal d na identify the minimum requirements an the petitioner should descdhe the exempt waste, e.g., removal of pntfans incinerator must meet to assure number of samples measured, the contamination. hse procedures are adequate combustion. N forra and representanveness of the aamples, and assumed to apply prior to charactedsing volume of the ash and other residue the appropriateness of theInstnunents from incineration should be described.
used. & statistical corhen In the the w aste to be uzmptai l
Similar consideration for dispesal at estimates thould be evaluated If the C Waste Mcnogesaent Opemme sanitary landfills or harardocs waste petitioner conducted any aurveys of ne t opties M 6e sites should be anddrersed. For example, beensees or relied on surveys b athen enmminsion can deal with expeditiously wastes that include components or to help quantify the amount am content properties that would quahfy the waste of vastes they should be describei an those described in NUREG,'CR-3555.
as a " hazardous waste"under EPA rules Market Information might be usefulin OnaBe opues bdude 6dnerahn and in 40 CFR Parts 200 thmugh 25 should characterizing weste generahn on a burla!. Offsite options are municipat not be proposed for disposal at a national bas!s. Designation as a trace wam Nsposal facMes (sannary municipal lardfitt concentration"should be related to land s1 municipal wasta McIntrators.
N potential for recycle abould be rpecified detectionlimita but detect!on hazardous disposal faef!Illes, and presented possible treatment. such as hmits themselves are not sufficient hazardous waste inctaeratoes.
shredding, the would redace the recycle reason to dismiss trace concentrations Pretreatment,e.g shredding of potential abould be described. Both the when methods exist to infar otherwl.se potentiaIIy recyclable resource value (e.g, salvageable - f da) concentrations.
materfats. Is a potential adjunct to efther and the functional usefulness (e.g, For estimates of the radionpefide onsite or offsite options. Combinations usable tools) should be addressed. Both content of the waste streem, the of these optims can also be erahrsted shon. and long-term potentials Ice petitimer may take edvar.tege of For example. wastes may be indnerated recycle are of sigruncant concern to the licensee experience in ciessifying on site and the ash thrpped to a raaitary Commisaion, wa stes for disposal at low. level w,,.,,
landfill. ne favored disporal options
- 3. Totals. A subsequent rulemaking sites. For exataple, the transurarde should be identified and fuffy descrfbed.
based upon an accepted petition is radionuchde content of the wastes The petitioner abould evaluate a fuD generic, and the exemption willlikely be would likety be below dete ctica Dmite, range of options.The practicahty of the used nationwide. brefore, to the but beenaces havs already estabbshed pmposed optin(s) should be presented extent possible. the petitioner should scaling factors for estimating the Wette compatthffrty d'rseessed andler is estimate the number of NRC and transureme content of wastes as part of one aspect. h natiocal av.:llabflity l
As erment State licensees that produce ccrnplying with to CFR Part 52 wasta and dirtdbut!cn of the option is another.
the waste the annual volumes and classification requirements. Waste U dates a natimal regulations erva P
mass, and the total annual quantities of generators use peceric scaling lactors laws pertaining to the propored option e3ch radionuchde that woutd be and facsars ertsblished far their speafic should be described and might have to disposed of.The estimates abould wastes through -A=+=ted maalyses.
be considered in refecting acceptable include the current situation and the The scahng factam are used to tafer the options.
likely variability over the reasonably presence and concmrations af many n g3g,,,
y foreseeable future. If the petition is for a radiomxdides based on measurement of proposed rele that wiR be Rmited to h es only a few nachdes. The classificaban To support and )wtify the submittal than natior.al seepe te g.. a state or scheme in 1D CFR Part El has been is cach petitioner thould inctnde analyses compact region), the totals should be effect since December 1983.
of the radiologicalimpacts assocfated
Federal Registrr / Vol. St. No.168 / Friday August 29, 1986 / Rules tnd R:gulati:ns 30843 with handling. transport, and disposal of indicate how likely the extreme case may be higher on an individual basis but the specific wastes. Any incremental may be). In addition, the petitioner's tl.a exposures and the number of nonradiologicalimpacts should be analysis should also address pe'ential exposed individuals are more assessed. Also the petitioner should use exposures from handling and transport predictable and the exposuns are short-the analyses to prepare and submit a accidents.The petitioner's analysis of term.ne critical group abould be the detailed regulatory analyiis with the accidents should include all segment of the population most highly petition.
assumptions, data. and results to exposed exclusive of radiation workers.
1.Radiologicolimpacts. The facilitate review.The potential for.
He other part is the general populat'an evaluation of radiologicalimpacts shipment of the entire waste stream to where the expected exposures and siwa should distinguish between expected one or a few facilities should be of the exposed population are less and potential exporures and events.
assessed. This scenario currently exists predictable,potentialindividual Impacts should be assessed for the for 10 CFR 20.306 exempted liquid exposyres are probably much smaller, expected concentrations and quantities scintillation wastes and might result and exposures may extend overlonger of radionuclides.The petitioner should from very limited numbers c ( treatment timetrames. Presentation of the quantitatively evaluate the impacts from facilities or decontamination setvices.
population exposures in these two parts the proposed waste for each option The analysis ofimpacts for transport.
should contribute to a more meanir.glul requested.The petiticner should clearly handling, and disposal should include cost / benefit analysis.
relate the analytical findings to specific evaluation of this potential circumstance
- 2. Otherlmpacts.The NRC action to provisions in the recommended rule unless it can be clearly ruled out.
exempt the radiological content of the changes For example, the basis for each As suggested in Paragraph 89 on page wastes would not relieve persons recommended radionuclide limit should 20 ofICRPIublication 46 ::
handling. processing, or disposing of the be clearly explained.
Exception from regulation and wastes from requirements applicable to The ra diological impacts included in requirements on these bases should not be the nonradiological properties. The NUREG/CR-3565 and in NRC's used to make it possible to dispose ofIrege petition should demonstrate that the computer program (thiPACTS-BRC) quantities of radioactive materialin diluted nonradiologicslproperties of the cover exposures to workers and fom, or in divided pcrtions, causinE radioactive waste are the same as the individual members of the public and widespread pollution which would eventually nonradioactive materials normally cumulative population exposures.ne
["any"sm handled and disposed of by the N P ses to d s should proposed methods.lf the program calculates both extemal direct they be used to exempt activttles that, by nonradiological properHes are similar gamma exposures and exposures from isolation or treatment, have been made irtested or inhaled radionuclides. NRC's temporarily harmless but that imply large and the volurces of exempted waste computer program can be used to potential for release and could give rise to would not impact the normal operations, calculate the expected radiological high individual doses or high collective doses. there should be no incrementalimpacts.
The analysis of er ected radiological If the petitioneris aware of other impacts from generator activities-transportation. treatment, disposal impacts should clearfy address:
impacts which should be considered for operahons. and post. disposal inputs-
-The maximum individual exposures. the epecific wastes in the petition, the l
The program can analyze a wide range
-The critical group exposures petitioner should also address the i
ni management options including
-The cumulative population additionalimpacts,
- 3. Regulatory analysis. In order to onsite treatment and disprsal by the exposures.
ernerator. shipment to municipal waste The maximum individual exposur'e expedite subsequent rulemaking if the management facihties, and shipment to evaluation should include exposures to petition is granted, the analysis should hazardous waste management facilities.
all members of the public who may be also address the topics NRC must The program covers impacts beginning exposed beginning with the initial address in a Regulatory Analysis (e.g.,
with initial handling and treatment by handling et the generator's facility see NUREC/BR-.0058, Revision 1..
the generator through fmal disposal of through post-closure. Both internal
Regulatory Analysis Guidelines of the all the radionuclides contained in the uptake and extemal exposures should IJ.S. Nuclear Regulatory Commission **).'
waste stream. Sequential treatment, be included.The individual may be a Following the Regulatory Analysis sorting. and incineration onsite and at member of the general population (e.g.,
format will structure the analytical municipal and hazardous facilities can consumer of contaminated ground fmdings, present the bases for decisions, be assessed. Disposal of resulting ash water) or a person receiving the and address the environmental and residue is included. post-disposal exposure from his or ber occupation.
assessment requirements.The toples impacts that can be calculated include Anyone who may be exposed and is not are:
releases due to intrusion, ground. water a radiation worker should be considered (t) A statement of theproblem. This migration, erosion and leachate a member of the public. For example, a topic le the need for determining which accumulation.The pregram thus worker at a sanitary landfill or a wastes may be safely disposed of by addresses both expected and potential commercial trash truck driver would not means other than shipment to licensed post-disposal impscts.
be a radiation worker.However.
Iow-level waste sites.
The petitioner's analysis of transport occupational exposures to radiation (2) Alternatives. Allreasonable impacts should be based on a workers should be eval' sted and alternatives to the proposed action u
reasonably expected special distribution considered in the cost / benefit analysis should be described.The no action or oflicensees and waste treatment and of the incrementalimpacts between status quo alternative should always be disposal facilities which will accept the disposal at a licensed facility and the included.
wastes.The petitioner should address reguested disposal options.
(3) Consequences.This topic calls for parameters such as everage and The total population exposures can be an analysis of the impacts of each extreme transport distances.The estimated and summed in two parta.
alternative described.ne factors the pe!'tioner's analysis should address the One part is the smaller critical group petitioner should address include costs basis for parameter selection and (usually the occupationally exposed and benefits and practical orlegal characte.-ize the expected patterns (e.g.,
population) where potential exposures constroints. Cost / benefit considerations
e-song Federal Register / Vol 52, No.168 / Friday August 28.-7966 / Rules and Reguletiens 1
and constraints em 6scussed amore M!y to implementation. For anost to dioactive address whether chenges in tedmiml after this kstmg of topias.
materials, the general DOT freebohl specinestrees er!5 ceases smry be (4) Decisist rudancie. his top!c is a limits of 0.002 microcunes per grama needed.
condusions statement that crpt^e why apply. Ilowever, the DCR' 6esoed a anal the prefernd ahernative(s) abanki he rule en June 6. tyss po FR 23811)that E. PnpsmedKads adopted.
~
amended 49 CFR part 173 to examp(lose p) lap 1 net.:xiori. This topic cpeers specific actMty wastes me dese, bed la The petition abould include the tes:t the teps and schedoles for actsal NRC's rdes in 30 CFR 2.386. (?kse that fw the pmposed rule (we W CR implerne.ctation of the preposed rule.
DOTemphasized that the westes remain 2.802(c)(1.The med taxinhoeid The petitiocer shodd address the tepic subject to the proviskms reisted to o6er cover at leest the lotbwing: from the weste generator's perspectree hazards; see 40 CFR 17332S(d).] (1)m gaantryand/ar ree ties s and indvde surveys thscussed under limit for each saches sc!ide present Top;c liLA.5. Recordkeepmg and E Re ."cv4 ondRepart:g. (trees rodianscfides cadd be lamped Reporting ' together with a total hell): A crst/benef2t discusalon la en
- 1. Surveys Enstmg regulations la i10 (2) A method to deel with essential part of both ecvironmental and CFR n1 establish geneml NRC radioW We regulatory impact considerations and is, requirements for pedwmmg serveys as therefore, assential to expedited necessary to emrJy with PartaiL pe mnradoyca!spedesuans handimg. N discntsion should focus Licensees wcmad have to conduct necessary to adequately def!ns the en expected exposures and reahstic suneys of the waste propaties prior ta waste; and concentrations or quantities of release for exempt disposal to verify (4) The specifsc method (s) of am.ampt radionuclides. N cost /basarit that the waste meets the prescribed disposal discussion shodd incJude the limits. Such survey programs mIght If tracticable, and if the supporting differential exposure and e-4 consist of (1) fairly cocapreh enstve information indicates the need the texf costs betw een disposal at a licensed initial sempEng and analysis to ran8-should also address other W-se auch -
low. level waste disposal alte and the that the licensee's wastes will fall below as annual kmits on eech gene atmein proposed option (s). It may also in+Aa the limits, (2) persoche ana as part of terms of vohane. masa, ce total qualitative benefits. Reduced hazards a procese or quality program to radioactmty, and =A-W=*ative se from not storing hazardous or cor: firm the initial finangs, and p) a procedral reqdrements '-M== combustible c.aterials might he a routine survey pmgram prior to release pmcess cautrols, stresys, etc., that base benefit. Diminatinn or reduction of the of wastas to monitor for gross been discussed.N text should not hazardous properties (e.g. by irregular!Hes.To show that hennees include the varians dose hmits coed to incineration) could be another. can be axpected to conduct complianca jusufy the W adionedide hadis. Detnmental coats might also be surveys prior to weste transfer the qualitative such as loss of space in petitioner shouh! describe a sample nL ped== Ckitada municipal or hazardous waste sites. The survey program. The three components economic impact on the licensed site just discussed should be inckded.5 N Commission policy statement operations (i.e., loss ofincome from appropriate for the waste sceam. establishes that the latiosing criteria diverted wastes) and its potential eHect Records of the surveys would be should be csed by ataff as geArbnen $ar on the availability of economic and safe maintained forinspection-acting on a petition. Eada criterion'is disposal shoc!d be addressed. Costs of surveys and verifying camp!!anca 2.Repwes.N pecGoner should npeated and ad h as, l imp ementation an L'- discussed under Topic gg a asume that annual nports on cBsposals = Recordkeeping and Reporting should will be reWnd and that snoociated 1.Drspoeal and LA.M of the also be covered. ne cost / benefit should recordkeeping to penerste the reports wastes as epecified in the petttmn will also reflect ALARA considestions. will be impowd. Minimum irdermation result in no signifrennt impset as the Radia!!cn worker enorure. pub 5c in the anmal reports hiturEyzeight qualf!y of the human wamt. exposure, and environmental releases include the type of waste,Its votame, Rs Discuss /on Unless this finding can be might be appmpriate in ALARA estitsaled curie content, and the place made during information submit:md by considerations. In we.rghmg the and manner of disposalIncreeaed the peudoner, the Cnmmf aston must ex osure costs and economrc costs for recordkeepkg and wpornng prepare an EnvironmentafImpact ligkt. water-coo!ed rmelear nactor requirements would ad*ess Stata=ent to mare fully examins the wastes, the petitioner could use, for uncertainties in projecting futur',d proposed acunn hees to the vobm " amounts of wastes ar perspective. the $2.030 per N-rca pmposed arte and associaiad Fuideline in 10 CDt Part 50. Appendix L NRC3 q WbRity to consider the potentialimpacts of alternatives. for efDnent releases frem these facf!Mies. cumulat2ve knpacts of mum 7;de m octitier.er should identify any erescptiorzs. When these requirements Preparation would Ekely invalve legal or regthtory constretrrts that ridght are proposed, OfEce of Menegement contractual suppmt and would Ekdy impaet implemenhtion of the petitioned and Badget (OMB) sp;rovai is requised. tM yurs w mon to WA N change.h compatibuity of the weste To facilitate NRC f.hng for OMB Commission could not act in the petition with the pmpeoed raethod of deposal approval, the petitioner should indede g, "" "P' g """**'" was discussed under Topic ILB.2. Other any dupuesting or ewerlepping reporting 2.h rna*-n expected dW constraints might stem from Department requirwments, the mas *ber sad type of done equivalent to an individent of Transpertatica (DOT)labaisag expected responderts, entgestions for mmber af the pubhc does set axceed a placardteg. and manifestmg minimizing the burden, estio stes of the few millirum per year h masmal req:nrernecos for raditureve meterials. staff %oues and coses to prepare the operations and antm;w d events. s Since the mo ms incihty wiR rust be reports and keep the records, and a brief IEcyseierr % effecove dose licensed to receira rarbosctrve - description of the besis fer the equivalent meens the K:Rp Pobhcathm naterials, this cxxdd be an impedmtsat estianstrs.& petitioner ther.ld ah>o 28 and 30 e eum of the dose fmm I
t {,' Federal Regkter / Vol. 51. No. %8 / Friday Augm i 29, 1986 / Rules and Regulatimts 30M5 p = extemal exposure and the done incurred besith.*ta thalevel of rink co rewsde obbctives inchde annual notal body J 't to an annaal dose of the order of L 2 msvlu doses of 3 m!Hirems for Equid efhnts froto that year's sntake of radiocuchrtaa allhrem]. and 5 mHlirems for gaseous efb* If i While a range of 1-10 millirem par year might be acceptable, a one milLiem dose g,,,",nr s N em! ""'h* EC'"*'*8E" "I '"88" E h U Pet *wd far as a specified disposal a would facuitate expeditad processing. assessment, to decide whether e some ce Higher doses may require more w ut,et,,,, h idt,,,,g, peri, m A option. the petiticaer abould addreas extensive justification. Based on a Camderation abou}d be snran to the a wd br how the r M s ctivity, er=nh==d unortshty risk coefficient for induced aszy optunisetmn of radzauun protectka and with all o*ber efhnts from the ahms. {' cancer and hereditary effects ol 2x10" to the posalibty that meey practs.ee e d would not exzzed the design objectkve sources of the maan kind cudd combuer aow skises in Appen&x ! to 30 CFR Part M3. f' per rem (ICRp Publication 26), tsdistian or in the Ltm so tt.at their utal eHact miay 3.De collectrve doses to the critical p exposure at a lecel ofinHlisen per year "hvalent population and general population are l. would result in an anmral mortahty risk ,,ytnd al r e of 2x10' (i.e. 2x" effects /re=x rem / below e,2 mSr (to milltr-m) to Indrviduals in smaH. the crttical group. Yhte mey irreolve Disarssiart An addittrmal advantage [ year). The EPA is developing criteria for anessroente of dow commitments and of b when ind!vidual doses are no more than identifyir.g low-level radioactive waste conect we done per unit practice or ocuras. In -1 mulirem per year is thirt the co!!ective r i that may be below regulatory concern order to emann that the andmdna! done ,gons are gen senaHons per my as part of that agency's developtnent of requirement will not be exceeded new er in maU upmurm coHachse
- g the fature. tt we almost certain he de general environmental standards for twal annual dose to a s@ mManHmm "aluaMs My for inbah low-level waste disposal.The epa cumpted sources will be 1er aan ten timme purposes, cost /benelli canalderations.
published an Advance Notice of the contribution from the e.empted source and to mnfirm the f*F af no Proposed Rulemaking on August 31,1983 m Mighest endnhJ dose.Tbh significant impact on the quality of the i i (48 FR 39503) and currently hopes to mapect could. therefore 'ca: eDowed for by human environment.This determination I l publish proposed standards in early reducing the enneelindividual doe' wiD be made bued on biormatirm 1987.Other epa standards that the exemptmn critwien from o.1 to am mSe (to Me & W d nach doses can be compared to are the Clean to t withrum). g g ggy g, Air Act radioactive release standard of The NRC staff recogntzes that at times, notes that the United Kie pahey on f 25 millitems per year in 40 CFR part el human reactions are not so strictly bdnidual dose B nits edes an i g verned by quartative considerations annociated conactive dose criterion. Y g[*[f2 hir G as the ICRP excerpt suggesta. (The coBective dose wiiezion maust be One millirem is very small wben Nevertheless, the 10' per year value met in additie to the individaallimita). compar to naturally occurring seems about as low as practicaW, in ICRp Pubbcation 44, a similar background doses from cosmic and seems too low to justify significant criterion is stated. terrestrial sources. Backg ound doses in d ble the United States are typically in the
- $,$nifedb
- sYati nal' pod raw i
' " * *"C** 10Mzo m!Uirems per year range Radiological Protection Board has "" * " I" "8 O' "" "" exclusive of the lung doses from redon. d"" d nimi " I"" I **I * ** *
- f One millirem is also small when o)dle%ric 7Jan 19 )
- that compared to the annua! 500 mI!!irem has status simuar to Federal Radiation cant.
j i dose hmit for individual members of the Guidance issued by the President in this Disever/ art: Potential doses fmm l general public in Federal Radiation country.The Board identified effective accidents c'intrusca should be well j Counci! guidance. dose equivalents of 5 muliretc per year within public exposure limits and take An important feature is that doses of as inalgniLeant when members of the ine accout the bab@y or i cp to1 minirem from the individual public make their dentslons.The 5 pus % dav mnts. In a Matemnt petition should minimize concerns over mHlfrem limit represents the total dose dated April 28.1985.* the hrternational exposure to multiple exempted waste contributloc from aD exempted Commission on Radiological Pmtection rtreams. ICRp Publication 46 addressed practices. For individual practices, the DCRP) stated that the ICRp's present + individual dose hmits and other Isrues Board divided by 10 (I.e~ 0.5 mHhrem vkw is that the prbe!pd dose hmM b related to exemptions and stated,in per year) to secount for exposures imm members of the public is 100 millirems.in peregraphs 23 and 84 as pege19-multipk practhaMese hmits are a year.ne W fwier c M &aW Mary r:6ation exposures routmely applied genericany. Isso causervatism 500 mulirem lim!t from ICRp Publication encountered in radietion protection-under the well defmed drcumstances 26 could be used as a subsidiary hm!t l partienlarly those received by mechers of the associa ted with specific waste streams provided the lifetime average doas not pubhc. are eery eme!! try comparison wnh and disposal options envisaged in this s'rceed the principal hm!t ,1$3"[M[*k NRC statement seems )ustified,in a P " P heal:b b has proposed pehey statement dated May 8. d Xp appearance of dele been demonstrated. In indivulualdsted 1985.* the Canadian Alonac Energy be more ea Dy justified !! they are well assesments.11is widely recognized that Contml Board specTscally addressed below100 milhrem per year principal there are ts&ation dames that are so em all disposal of specific wastes that are of no hmn that they involve risks that would be regulatory mnesm. An individual does 5.The exemption wClresuhin a, regarded as rieghgeble by the exposed limit of 5 millireme per year was indmduals. Studies of comrerstree risks proposd for this limitad application. nW"M reduction in societal costa.
- P'"'"C #
- P'P'I' * " " * "
A maximum individual exposure of1 Discuarion:When the eennomic and 7 milhren per year is alao consiste.nt with exposure costs associated.etth the h b h ath Appenetr I to 10 CFR Part n Appendix exemption are compared to disposal at a r af 2fr year or tese is not taken into eceount by I specifies dealga ob}ective doaas far licensed low-level waste site there Whviduals in then decisions as to achoss that could trauence their cak s. Llama operstional light-water-cooled nuchar ahnaki be a algnificant reduction in rounded dose response Isetors for inan-t power reactor eIDaents. These deafgn costa.
I l Fedml Regist:r / Vol. 51. No.168 / Friday. August 29, 1986 / Rul:s cnd Regulations 5 30846 6.The waste is compatible with the and projected waste characteristics, expeditious action on the petitions. In proposed treatment and disposal reporting on the wastes actually addition, the Handbook notes general options. transferred for below reFulatory concem scheduling advic? that proposed rules to Discussion:This criterion relates to disposal will be important and should grant petitions should be published in e - the nonradiological properties of the be practical. 12 months after acceptance and wastes. For example, disposal of
- 12. The offsite treatment cr disposal publication for comment. Proposed rules,
radioactive wastes that also qualify as a medium (e.g., sanitary landfill) does not will be forwarded to the Commission on nonradiological hazardous material need to be controlled or monitored for a 6-month schedule to the extent should be proposed for disposal radiation protection purposes. permitted by resource limits, the nature methods in accord with epa regulations Discussion:The evaluation of and extent of public comments. and (e.g incineration or disposal at a expected exposures should provide the intemal Control of Rulem s hazardous waste facility). Also, wastes basis for meeting this criterion. pmcedures. Rulemakings inv ving proposed for incineration should be However, this is an area where NRC. power reactors must be reviewed by the combustible ar.d wastes proposed for will have a continuing responsibility as Committee on Review of Generic landfills should be appropriate for multiple petitions are processed. Requirements prior to publication. disposal in typical landfills anywhere in Repo ' on actual disposals will help Proposed rules involving reacton will the ration. NRCad ess this responsibility and therefore be forwarded to the 7.The exemption is useful on a monitor the adequacy of the limits Commission on a 7-month schedule to national scale. i.e it is likely to be used included in the exempted disposals. the extent permttted by resources. by a category oflicensees or at least a 13.The methods and procedures used significant portion of a category. to manage the wastes and to assess the comments, and approval procedures. In Discussion: Rulemaking is usually not impacts are no different from those that both cases, every effort will be made to warranted for wastes involving a single would be applied to the correspondin8 publish roposed rules no later than 12 licensee, whether a contin
- disposal uncontaminated materials.
months fter noticing forpublic activity or a one. time d;sposa. Such Discussion:Since the receiving facility comment. proposals by individuallicensees are willnot be licensed for radioactive Ahhough the procedures in Part 11 of normally processed as licensing actions ma terials, special handling or measures NUREG/BR-0053 include fast track under 10 CFR 20.302(e). should not be re d at the processing processing, the natore of the anticipated B.The radiological properties of the or disposal sites ecause of the petitions do not full comply with the waste stree n have been characterized rad 2oactive content of the wastes. This decision criteria to llow this
- 3$,*,*e o*f the key features of the on a national basis, the variability has critedon also means that realistic been projected, and the range of assumptions about the disposal methods sanation will not invalidate supporting have been made in estimating handling procedures include the analyses.
exposures. following steps for complete and fully Discussion One of the merits of
- 14. There are no regulatory orlegal supported petitions.
dealing with ecific weste streams is obstacles to use of the proposed
- 1. Petitioners may confer on dat the actua properties of the waste treatment or disposal methods.
procedural matters with the staff before siz eam can be relied upon in estimating Discussien:To have practical use the filing a petition for rulemaking. Requests impacts rather than conservative disposal option must be available. For to confer on rocedural matters should counding parameters.The specific example.if all hazardous waste be addresse to: The Director. Division athways that must be considered can facilities that accept offsite wastes are of Rules and Records. Office of e linsted to manageable numbers.The closed or are not reasonably distributed, Administration. U.S. Nuclear Regulatory expecud fate can be credibly limited the practicality of an exemption to allow Commission. Washington. DC 20555, based on the pro erties. disposal at such sites is questionable. Attention: Chief. Rules and Procedures
- 9. The waste aracterization is based Since the receMng facility will not be
&anch. on data on real wastes. licensed for radioactive materials.
- 2. Petitions should be addressed to:
Discussion: Actual data on real waste shipments to landfi!!s or hazardous ne Secretary. U.S. Nuclear Regulatory provide reasonable assurance that the waste facilities should not requit, Commission. Washington. DC 20555 waste characterization is accurate. Identification as radioactive materials, Attention: Docketing and Service 10.The disposed form of the waste has negligible potential for recycle. .A stra6va HandHng Branch. In keeping with 10 CFR 2.802(f). petitioners will be promptly informed if Discussion: Eliminating the ~ Agency procedures for expeditious the petition meets the threshold uncertainties associated with recycle is handling of petitions for rulemaking requirements for a petition for necessary to expeditious handling. were initially published in 1982 in rulemaking in 10 CFR 2.802(c) and can Specifying specific wastes and specific NUREG/BR-0053, Regulations be processed in accordance with this methods of disposal narrows the Handbook.8 The procedures are implementation plan. Ordinarily this pathways and timeframes to contained in Part 11 of the Handbook determination will be made within 30 manageable numbers. and were most recently revised in days after receipt of the petition.
- 11. Licensees can establish effective.
September 1985.Because of resource
- 3. Following this determination. the licensable, and inspectable programs for limitations and other fac' tors, these petition will be noticed in the Federal the waste prior to transfer to procedures have not been fully Register for a public comment period of demonstrate compliance.
implemented. Petitions for rulemaking at least 60 days. piscussion: Survey programs and submitted in accordance with the 4.The petitioner will be provided quality control programs will be needed Commission's policy statement and this copies of all comments received. to provide reasonable assurance that staffimplementation plan will be schedu!!ng information, and periodic actual wastes disposed of under an processed in full compliance with these status reports. exemption rule meet the specified procedures.These procedures coupled ne procedures in NUREG/BR-0053 parameters. Since disposal woulql be with agency policy to complete all also include the process for denial and exempted based on both established rulemaking within 2 years will provide withdrawel of petitions.
rediral Register / Vd. '51, No.168 / Friday, August 29,1986/ Rules and Regulethms NBCP Footnotes: a Copies of NUREC/BR-sos 3 NUREC/BR- . stE8 and NL' REG /CR-3585 may be purchased through the U.S. Cceermnect Prmtmg Of6ce by calhng (2C2) 275-ao60 or by writing to the U.S Government Printing Office.P.O. Box 3'D&? Washington. DC 20013-7082. Copies may also be purchased from the National Technical information Semce. U.S. Department of Comrnerce, s186 Port Royal Road Spririgneld. VA 223tL Copies are avaikble for t::spection and/or copylg fw a I. fee in the NRC Pubbe Document Roorn. 2M7 l H Street. NW. Washington. DC 20555. l
- ICRP PubLcabon 4E "Radastion Protection Pnneiples for the Disposal of Sold Radioactive Weste." adopted July 1985.
s ICRP Pubhestion 26. " Recommends + roos of the Intemabonal Commission on Radiological Protection? adopted January 17 1sn.1CRP Pubbeston 30. "Ibnits for bitake of Rsdionuchdes by Wohrs? odeped July 19 8.
- Copies of the United Kicadam's document are available for inspection as enclosures to SECY-45-147A (rela ting to to CFR Part 20]
dated July 25.1985 in the Commhrsion's Pubbe Document Room.1"17 H Street NW. WashinFton. DC 205:5. The United Kingdora docu nects are available fr.t sale from: Her Wiesty's Stai; onery Office. P.O. Box 56a. London SE1 SNH United Kingdom as Advice document ASP-7 and a relsted technical j l seport.*The Signitesnce of Sma!! Domes of Radiation to Members of the Pobife."NPJB-R175. l 8 Copies of the Canadan docenent are g available for mspectrcm as an anciesme to SECY-45-scA trelatbg to to CFli Part 20) 1 dated July 25.1985 an the Commission's I Pubhc Document Room.1717 H Street MV. i Washir:gton, DC 20555.The Canadaan document was innued as Consultatrve Document C-85. yhe Easts for Exempting the Disposal of Certain Radiosciive Meterials Imm Ucensing" by the Atenic Energy Control Board. P.O Bos toes. Ottawa. Ontario. Canada. K1P ESS.
- 2CRP/85/G C3 *Tastement frnra the 1965 Faris Meeti::g of the Internabama!
) Commission on RadiologicalProtect.*1985-84 25. ]FR Doc. 85-19530 Filed 6-2Me,8 45 am) s w uocoot7seo4sw b 'I l
Attachment D. i 27522 Federal Register / Vol. 55. No.128 / Tuesday. July 3.1990 / Notices l For the Nuclear Regulatory Commission. udequate and consistent level of Statement of Policy Patricio G. Norry, protection of the public in their use of
- 1. Introduction f
Designated Semor Officrolfor tnformaroon radioactive materials. and focuses the Resources Management. Nation's resources on reducing the most lonizing radiation is a fact of hfe. p'R Doc. 90-15400 Filed 7-2-90. 8 45 amj significant radiological risks from From the day we are born until the day . aun.o caos ts es.u practices under NRC's jurisdiction. The we die, our bodies are exposed to low average U.S. citizen should benefit from levels of radiation emitted from a u plementation of the BRCpolicy variety of natural and man made l n Below Regulatory Concern; Po!!cy through (1) enhanced ability of NRC. sources, including the cosmos, earth. Statement Agreement States, and licensees to building materials. industrial facilities. AGENCY: Nuclear Regulatory I cus resources on more significant risks clothing, medicine, food, air. and our l Commission' posed by nuclear materials: (2) timely own bodies. All materials exhibit some and consistent decisions on the need for degree of radioactivity.The consensus ACTION:Poh.ey statement. cleanup of contaminated sites:(3) among scientists is that even low levels
SUMMARY
- This policy statement increased a.isurance that funds of radiation typical of the natural establishes the framework within which available to decommission operating environment pose some correspondingly -
the Commission will formulate rules or nuclear facilities will be adequate:(4) low risk of adverse health effects to make licensing decisions to exempt from reduced costs and overall risks to the humans. Recognition of the risk due to some or all regulatory controls certain public from managing certain types of radiation exposure from natural sources practices involving small quantities of slightly radioactive waste in a manner provides perspective on the risks radioactive material. Opportunity for commensurate with their low associated with human uses of public comment will be provided with radiological risk: and (5) increased radioactive materials. each rulemaking and each licensing assurance of a consistent level of safety Natural and man.made radionuclides action where generic exemption for consumer products containing are used in today's society in many provisions have not already been radioactive material under the forms for a variety of purposes. such as established.The exemptions may Commission's jurisdiction. medical therapy and diagnosis. involve the release of licensee. EFFECTIVE DATE: July 3.1990. materials analysis, and power controlled radioactive material either to ADDRESSES: Documents referenced in generation. In general, the existing the generally accessible environment or this policy statement are available for regulatory framework ensures that j to persons who would be exempt from mspection in the NRC Public Document radioactive materials are controlled.- Commission regulations. Practices for Room. 2120 L Street. NW. (Lower Level). consistent with the degree of risk posed which exemptions may be granted Washington. DC. to the public and the environment.Some I include. but are not limited to. (1) the release for unrestricted public use of FoR FURTHER INFORMATION CONTACT: products such as smoke detectors-lands and structures contaimns residual The appropriate NRC Regional Office: c ntain sman quantities of radioactive materials that pose such a low risk that radioactivity;(2) the distribution of Region 1-Dr. Malcom Knepp. King of they have been widely distributed consumer products containing small Prussia. Pennsylvania; telephone (215) without continuing regulatory controls. I 337-5000 amounts of radioactive muterial;(3) the disposal of very low-level radioactive Region Il-Mr. J. Philip Stohr. Atlanta. To require that all radioactive materials be controlled in the same strict manner waste at other than licensed disposal Re i n If 1. regardless of the risks they pose would I s E. or ius* j sites; and (4) the recycl ng of slightly i not be a sound use of limited National contaminated equipment and materials. EUyn. imnois: telephone (708) resoarces. Such strict control could also As described in this policy statement. eprive society of the benefits already. NRC intends to continue exemptmg Reg nI Mr. Arthur D. Beuch~ specific practices from regulatory Arbngton. Texas: telephone (817) 8so-derived from appropriate uses of radiouctive materials and radiation. In 8100 t controlif the application or continuation of regulatory controls is not necessary 1 Region V-Mr. Ross A. Scarano. Walnut addition. such control would not protect the public health and safety and Creek. Cahfornia: telephone (415) 943-
- I
"" Y
- 3700 with radiation exposure from controlled the environment. and is not cost sources compared with risks associated cffective in further reducing risk. The l'ederal and State Covernment Officials with natural background radiation.
i policy statement defines the dose may contact: Mr. Frederick Combs. U.S. Therefore, responsible decisions need to criteria and other considerations that Nuclear Regulatory Commission, be made on how radioactive materials I will be used by NRC in making Washington DC 20555. Office of are controlled based on a judgement exemption decisions. The policy Covernmental and Public Affairs. about the levels of risk they pose and i establishes individual dose enteria (1 telephone (301) 492-0325 - the effectiveness of regulatory control 1o and 10 mrem per year (0.01 and 0.1 Questi ns may also be directed to the reduce those risks. mithsievert per year}} and a collective f Ilowing individuals: Over the last several years. the dose criterion (1000 person. rem per year Dr. Donald A. Cool. Office of Nuclear Commission has pursued development (10 person-Sievert per year)). These Regulatory Research. U.S. Nuclear of a risk threshold to distinguish those criteria, coupled with other Regulatory Commission. Washingicn. radioactive materials that do not require consideratiens enumerated m the pohcy DC 20555: telephone 13011492-3785 the same stringent level of regulatory statement will be major factors in the Mr. john W. N. Hickey. Office of control as that imposed on potentially Commission's determinuuot, w whether Nuc! car Matenal Safety and more hazardous materials. The l exemptions from regulatory controls will Safeguards; telephone [301) 492-3332 Commission recognized throughout this be granted. Mr. L. J. Cunningham. Ofhce of Nuclear process that the threshoM would need to The policy statement establishes a Reactor Rerulation: telephone (301) be low enough to continue to ensure consistent risk framework for regulatory 492-108G adequate protection of the public.The exemption decisions, ensures an SUPPLEMF ATARY INFORM AT8ON: Commission also recognited that the S-041900 (xm02 xo2-J UL-90-14.27.50) F4703.FMT...[16.30] 7-08 88
.I Federal Register / Vol. 55. No.128 / Tuesday July 3,1990 / Notices 27523 [ t threshold shou!d be compatible with can be exempted from the full scope of for radioactive material.These i technological and measurement NRC's comprehensive regulatory exemptions allow a person or a licensee. capabilities so it could be readily used controls. Under the criteria and under certain circumstances, to receive. [ in NRC's regulatory program for nuclear principles of this policy statement. possess, use, transfer. own. or acquire materials. In addition. the Commission exemptions of radioactive materials radioactive material without a identified the need to balance from regulatory controls would involve requirement for a license (30 FR 8185: incremental reductions in risk below the the transfer of very small quantities of June 28.19G5 and 35 FR 6425: April 22 safety threshold with the attendant the materials from a regulated to an 1970).The Commission currently allows expenditure of private and public unregulated status. NRC will analyze distribution of consumer products or resources. each proposed exemption to ensure that devices to the general public and allows In today'r notice, the Commissieu doses resulting from the proposed releases of radioactive material to the establishes a policy to guide its transfer will be sufficiently low that the environment convstent with established decisions on which radioactive public health and safety and the - regulations. For example, regulations .i materials are "below regulatory environment will remain adequately currently specify the conditions under concern"(BRC) because the low levels protected. A licensed activity producing which licensees are allowed to dispose - of risk they pose do not warrant an exempt material would continue to of small quantities of radioactive regulation to the same degree as other be subject to the full range of regulatory materialinto sanitary sewer systems radioactive materials to ensure oversight. inspection. and enforcement (see 10 CFR 20.303).These existing adequate protection of the public and actions up to and including the point of regulations specify requirements. the environment.This policy translates transfer to an exempt ststus.The conditions, and constraints that a the Commission's judgement on Commission also intends to conduct licensee must meet if radioactive i acceptable risk into explicit and research periodically to evaluate the material is to be " transferred" from a l practical criteria on which to base effectiveness of this policy and to regulated to an exempt or unregubled t decisions to exempt practices from ihe confirm the safety bases that support status. full scope of NRC's regulatory program. the exemption decisions. More recently section 10 of the Low-The ERC criteria are necessary to Through appropriate rulemaking Level Radioactive Waste policy i ensure adequate and consistent actions or licensing decisions, the Amendments Act (LLRWpAA) of1985 - . decisions on acceptable risks posed by Commission will establish constraints. directed the Commission to develop - i decontaminated and decommissioned requirements, and conditions applicable standards and procedures and act upon nuclear facilities, consumer products to specific exemptions of radioactive petitions "to exempt specific radioactive f containing radioactive materials, and materials from NRC's regulations.The waste streams from regulation * *
- due l
Very low activity radioactive wastes. NRC will verify that licensees adhere to to the presence of radionuclides.* *
- in These decisicns will be implemented by these exemption constraints and sufficiently low concentrations or the Commission through rulemakings conditions through NRC's licensing, quantities as to be below regulatory.
and licensing decisions based on careful inspection, and enforcement programs. concern." The Commission responded to l and thorough analyses of the risks For example. the Commission may this legislation by issuing a pclicy i associated with specific practices to promulgate regulations that would statement on August 29.1980 (51 FR ensure that the public is adequately require some type oflabeling so that 30839). That policy statement contained i protected, consumers could make informed criteria that. Il satisfactorily addressed Under the regulatory approach used decisions about purchasing a product in a petition for rulemaking, would allow by the U.S.Nuc! car Regulatory containing exemi ted materials. Such the Commission to act expeditiously in i Commission (NRC). the use of labeling is presently required by the proposing appropriate reliefin its l radioactive materials is subject to limits Commission for smoke detectors regulations on a " practice. specific" and conditions that ensure the containing radioactive material (see 10 basis consistent with the merits of the i protection of the health and safety of CFR 32.26).The NRC ensures that petition. l both workers and members of the manufacturers label the detectors in Federal and State agencies have also i general public, and the environment. For compliance with the labeling developed and implemented similar example. radioactive material is requirement through licensing reviews exemptions based on evaluations of l controlled by NRC-and Agreement and inspections. Specific source controls their risks to the public and the State. licensees to ensure that dose and exemption conditions are not environment.The Food and Drug limits are not execeded. In addition. discussed further in this policy because Administration (FDA). for example, has j sources of radiation are designed, used they will be more appropriately applied sensitivity.of-method. risk-and disposed ofin a manner that addressed in developing the exemption based guidelines in connection with the j ensures that exposures to radiation or requirements for specif c exemption regulation of animal drugs. food j radioactive material are as low as is proposals. contaminants. and trace constituents in reasonably achievable ( ALARA). The concept of regulatory exemptions some food additives. Similarly. the economic and social factors being taken is not new.The Atomic Energy Act of Environmental Protection Agency (epa). Into account. NRC has endorsed the 1954, as amended, authorizes the esteblished exemption or threshold ALARA provision in regulatory practice Commission to exempt certain classes. levels based on Individual risks in the for a number of years (10 CFR part 20). quantities, or uses of radioactive regulation of pesticides and other toxic flowever. NRC has not yet provided material when it finds that such and carcinogenic chemicals. For criteria that would establish the basis exemptions will not constitute an example. EPA employs such a concept for defining the level of residual risk at unreasonable risk to common defense in defining hazardous waste through the which further regulatory control is no .md security and to the health and new Toxicity Characteristic rule in 40 longer warranted. safety of the public. In the 1900s and CFR part 201 (55 FR 11798: March 29. The policy statement in today's notice 1970s, the Atomic Energy Commission 1990). provides a unifying risk framework for used this authority to promulgate tables The Commission believes that the making decisions about which practices of exempt quantities and concentrations Below Regulatory Concern policy is 5-04t999 oG4 t(02 XO2-JUL-90-14.2M3) F4703.FMT.[16.30]. 7-08-88 -.t
27524 Federal Register / Vol. 55. No.128 / Tuesday. July 3.1990 / Notices needed to establish a consistent, risk. authority to regulate source, special public health and safety.The based framework for making exemption nuclear, and byproduct materials to Commission is concerned that decisions. Specifically, this framework ensure protection of the public health inconalstent regulation of BRC wastes is needed to (1) focus the resources of and safety. While Congress could result in differing levels of risks to NRC. Agreement States, and licensees subsequently provided for Federal-State the public and the environment through on addressing more significant risks agreements under Section 274b of the the application of different residual posed by nuclear materials: (2) ensure Atomic Energy Act through which States radioactive criteria in the cleanup of that beyond the adequate protection could assume regulatory responsibilities contaminated sites.The Commission is threshold potential benefits from in lieu of Federal regulation for certain also concerned that inconsistent additional regulation outweigh the classes of nuclear materials. it required regulation of BRC waste could in fact associated burdens:(3) establish that State radiation protection standards undermine State and Federal efforts to residual radioactivity criteria and be coordinated and compatible with the manage low level waste safely. A requirements for decommissioning and Federal standards for radiation uniform framework for exemption cleanup of radioactive contamination at protection. decisions is needed now to avoid licensed and formerly. licensed facilities: NRC regulations exempting BRC disrupting State and compact (4) ensure that licensee wastes will not affect the authority of development of new disposal facilities decommissioning funding plans provide State or local agencies to regulate BRC close to Congressional milestones in adequate funds to cover the costs of wastes for purposes other than radiation 1993 and 1996. Such a framework may cleanup of these facilities to protect protection in accordance with Section also facilitate the resolution of the people and the environment:(5) ensure 274b of the Atomic Energy Act.Under mixed waste issues for these BRC that the public is consistently protected the Atomic Energy Act. Congress wastes. against undue risk from consumer intended that there be uniformity The policy described in this document products that centain radioactive between the NRC and Agreement States materials under the Commission's on basic radiation protection standards. is intended to provide the public health and safety protection framework thut lurisdiction: (0) provide decision criteria Future DRC Rulemakings w,ll establish i for reviewing petitions to exempt very basic radiation protection standards would apply to a wide spectrum of low level radioactive wastes in below which regulatory oversight is not Coremission exemption decisions. As accordance with the Low-Level needed.The Commission will address such. it provides individual and Radioactive % aste Policy Amendments compatibility issues in future collective dose criteria, and discusses Act of 1985: and (7) ensure that existing rulemakings. In initialmg proceedings t otherimportant elements of the exemptions involving radioactive implement NRC's BRC policy, the exemption decision-making process, matenals are consistent and adequate to Commission ws!! continue to consult Section !! provides definitions of key protect the pubhc. vnth and seek the advice of the States. terms and concepts used in the policy Commission's DRC policy establishes Some States have expressed concerns statement. Section !!! presents the basic an explicit and uniform nsk framework that economic and institutional impacts elements of the policy. while Section IV for making regulatory exemption of actions resulting from the discusses how the policy will be implemented through rulemakings and decisions. Thgs policy will also be used Commis,sion's BRC policy may licensing actions and describes how the by the Commission as a basis for undermine their efforts to develop new reevaluating existing NRC exemptions disposal facilities for low level public will have an opportunity to to ensure that they are consistent with radioactive waste in accordance with comment on the Commission's the criteria defined herem. In lieu of the Low-Level Radioactive Weste Policy exemption decisions.This section n!so such a policy, the Commission could Amendments Act ofl985.These States notes NRC plans to review past continue the current practice of would prefer to establish their own exemption decisions to ensure evalualmg exemptions on a case-standards for determining which wastes consistency with the risk framework specific basis. Such an approach, should be exempted from regulatory described in the DRC policy. Section V however, does not ensure cor.sistent control rather than adopting standards describes. In general terms. the evaluation and control of risks that are compatible with uniform I^I '**11 n needed to support the associated with exempted practices. For Federal standards.The Commission has exempt.i n decisi n-making process. this reason und the reasons discussed developed the DRC policy to provide a //. Definitions. above, the Commission has established uniform and consistent health and the DRC Policy Statement.This policy safety framework for exemption MM (acronym for "as low as is supersedes the Atomic Energy decisions. In so doing. the Commission reasonably achievable") means making Commission's policy statement on this recognized the concerns expressed by every reasonable effort to maintain subject (30 FR 34ft2: March 16.1965). Congress when it enacted the Low-Level radiation exposures as far below The Commission recognizes that Radioactive Waste Policy Amendments applicable dose limits as is practical. Agreement States will play an important Act of1985 that health, safety, and consistent with the purpose for which rolein the implementation of the Delow environmental considerations should the licensed activity is undertaken Regulatory Concern policy, specifically take precedence over economic or taking into account the state of in the areas of developing and enforcing institutional concerns (see Senate technology, the economics of compatible State regulations, regulating Report 99-199 that accompanied S.1517 Improvements in relation to benefits to cleanup and decommissioning of certain Senate Committee on Energy and the public health and safety, and other types of contaminated nuclear facilities. Natural Resources. November 22.1985, societal and socioeconomic and exempting certain low. level 99th Congress.1st Session at page 9). considerations and in relation to radioactive wastes from requirements The Commission is confident that utilization of nuc! car energy and j for disposal in licensed low-level waste w aste exemption decisions made in licensed rnatenals in the public interest. j disposal facilities.The Atomic Energy accordance with requirements that " Agreement State" means may State Act of1D54. as amended, gives to the implement its BRC policy will be with which the Commission has entered Federal government the exclusive adequate to ensure protection of the into an effective agreement under i S-041999 0042(02x024ULAO-14.27.57) F4703Jhff D6.30) 7-08-88 1 [ he
Fsderal Register / Vol. 55. No.128 / Tuesday. July 3.1990 / Notices 27525 l subsection 274(b) of the Atomic Energy license issued by the Commission or an (1) Uranlum or thorium, or any Act of 1954, as amended. Agreement State. combination of uranium and thorium in Byproduct mater!almeans-Licensee means the holder of an NRC any physical or chemical form: or (1) Any radioactive material (except or Agreement State license. (2) Ores which contain, by weight. special nuclear material) yielded in, or Linear. no thresholdhypothesis refers one. twentieth of one percent (0.05 made radioactive by. exposure ta the to the theory that there is a proportional percent). or more, of uranium, thon,um. f radiation incident to the process of relationship between a given dose of or any combination of uranium and j producing or utilizing special nuclear material: and radiation and the statistical probability thorium. Source material does not of the occurrence of a health effect (such include special nuclear material. (2)The tailings or wastes produced by as latent cancers and genetic effects). Specio/ nucleor materiolmeans-the extraction or concentration of and that there is no dose level below (1) Plutonium, uranium.233. uranium uranium or thorium from ore processed which there is no risk from exposure to enriched in the isotope 233 or in the primarily for its source material content, radiation. isotope 235. and any other material including discrete surface wastes resulting from uranium solution Naturalbockgrounddose means the which the Commission. pursuant to the extraction processes. Underground ore dose received from naturally occurring provisions of section 51 of the Act, cosmic and terrestrial radiation and determines to be special nuclear bodies depleted by these solution radioactive material but not from material, but does not include source t extraction operations do not constitute materiah or byproduct material within this source, byproduct or special nuclear definition. material' (2) Any material artificially enriched i Collective doses is the sum of the Practice is a defined activity or a set by any of the foregoing but does not include source materlat. Individual doses (total effective dose r combination of a number of similar equivalents) received in a given period coordinated and continuing activities Totaleffective dose equivalent means i of time by a specified population from aimed at a given purpose that involves the sum of the deep dose equivalent (for exposure to a specifed source of the potential for radiatira exposure. external exposures) and the committed radiation (or practice involving the use Disposal of specified types of very low effective dose equivalent (for internal i of radioactive material). Note: The leve! radioactive waste: the release for exposures) expressed in rem or sievert. l calculated collective dose used to unrestricted public use, oflands and lit. Policy Elements determine compliance with the criterion structures with residuellevels of of this policy need not include radioactivity: the distribution. use and The purpose of this policy statement is to establish the risk framework within individual dose contributions received disposa1 of specific consumer products which the Commission willinitiate the contam, g small amounts of radioactive at a rate ofless than 0.1 mrem per year m (0.001 mSv/ year). material: and the recycle and reuse of development of appropriate regulations Commined effective dose equirolent specific types of residually or make licensing decisions to exempt -l certain practices from some or all i is the sum of the products of weighting c ntaminated materials and equipment regulatory controls.This policy is factors applicable to each of the body . examples of practices for which this directed principally toward rulemaking 'See Sect {l have potential applicability, activities but may be applied to license policy wi organs or tissues that are irradiated and ion !!! for further discussion of the committed dose equivalent to those amendments or license applications organs or tissues. practice), involving the release oflicensed Deep dose equivalent is the dose Rem is the special unit of dose radioactive material either to the equivalent at a tissue depth of1 cm. equivalent (t rem - D.01 sievert). environment or to persons who would Dose or rodlotion dose in this policy is Risk, for purposes of this policy. be exempt from Commission regulations, the total effective dose equivalent. means the annual or lifetime probability In either case, opportunity for public Exemption from regulatory control of the development of fatal cancer from-comment will be provided with each refers to a decision process that may exposure to ionizing radiation and is rulemaking and each licensing action allow radioactive material to be taken as the product of the dose where generic exemptions provisions transferred from a regulated status to an received by an exposed it.dividual and a have not already been established. unregulated status. In which the conversion factor based upon the linear. It is the Commission's intent to material wili no longer be subject to no. threshold hypothesis.The conversion broadly define specific practices so that NRC requirements. Decisions to grant factor for dose to risk is taken to be 5 x the effect of an exemption decision on exemptions will be based upon findings 10-* fatal cancers per tem of radiation any individual or population will be by reason of quantity or concentration dose.The fatal cancer risk is evaluated in its entirety and not in a that the radioactive material poses a considered. in general to be more likely piecemeal fashion. At the same time, the small risk to public health and safety than other radiation induced health practice must be identified and and the environment and that the small effects and to be the most severe described in terms that will facilitate magnitude of the risk does not warrant outcome to an individual. While the reasonable impact analyses and allow expenditure of additionalresources of Commission recognizes that the risks imposition of appropriate constraints, regulatory agencies and the regulated from exposure to radiation are greater requirements, and conditions as the community in attempting to further for children than adults and that there radioactive material passes from a reduce the risk. are increased risks from exposure to the regulated to an unregulated status (i.e.. Exposure means being exposed to embryo / fetus, the estimate of fatal the materialis no longer required to be ionizing radiation or to radioactive cancer risk for all ages and both sexes is under the control of a licensee). Under material. considered to be an appropriate this policy the definition of a " practice' Licensedmateriolmeans source measue of risk from practices being in any specific decision (rulemaking or material. special nuclear material, or considered for exemption in accordance licensing action)is a critical feature.The byproduct material that is received, with this policy statement (see NRC will ensure that formulation of possessed, used, transferred. or Appendix). exemptions from regulatory control will disposed of under a general or spec!fic Source materio/ means-not allow deliberate dilution of material S-041999 ODO(02XD2-J U L-90-14.28.00) F4703 FMT [16.30] 7-08-B8
i 27526 Federal Register / Vol. 55, No.128 / Tuesday, July 3.1990 / Notices or fractionation of the radiation or decide if exemption is appropriate, the The Commission notes that adoption radioactive material for the purpose of Commission must determine if adequate of the Individual and collective dose circumventing controls that would protection is provided and one of the criteria does not indicate a decision that otherwise be appilcable.The definition following conditions is met: doses above the criteria would of the practice in any specific exemption decision will also provide the 1 The application or continuation of necessarily preclude exemptions. The framework for taking into account the regulatory controls on the practice does criteria simply represent a range of risk i not result in any significant reduction in that the Commission believes is potentialeffects of aggregated exposure from that practice together with other dose received by individuals within a sufficiently small compared to other exempted practices, as well as the critical group (i.e., the group expected to individual and societal risks that further possible consequences of accidents or receive the highest exposure) and by the cost. risk reduction analyses are not j misuse or the potential for other exposed population: or required in order to make a decision nonstochastic radiological impacts 2.The costs of the controls that could regarding the acceptability of an associated with the exemption. be imposed for further dose reduction exemption. Praclices not meeting these criteria may nevertheless be granted aganced y t; e p tent exemptions from regulatory control on a The Commission may determine on a n the basis of risk estimates and associated uncertainties that certain At a sufficiently low level of risk, the case-by-case ba:Is in accordance with practices should not be considered Commission be!Ieves the decision-the principles embodied within this candidates for exemption such as the making process for granting specific policy,1f(1) the potential doses to introduction of radioactive materials exemptions from some or all regulatory individualmembers of the public are I into products to be consumed or used controls can be essentially reduced to sufficiently small or unlikely: (2) further primarily by children. Such practices an evaluation of whether the overall reductions in the doses are neither should be specifically evaluated to individual and collective risks from each readily achievable nor significant in determine if they could result in greater particular practice are sufficiently small. terms of protecting the public health and risk levels to exposed members of the The Commission believes that safety and the environment: and (3) the public than the levels found acceptable individual and co!!ective dose criteria collective dose from the exempted by the Commission in formulating this should be basic features ofits overall practice is ALARA. i policy.These decisions clearly fall policy to define the region where the D.The Individua! Dose Criterion within the Commission's purview to expenditure of Commission resources to protect the health and safety of the enforce requirements for further dose The Commission has noted that. public. reductions orlicensee resources to although there is significant uncertainty in calculations of risks from low. level In formulating this policy statement. comply with such requirements is no radiation. in general these risks are 6 the Commission deliberated at length on the need to consider whether practices longer warranted.These specific criteria better understood than the risks from include (1) values for the individual other hazards such as toxic chemicals. must be rigorously justified in terms of annual dose reasonably expected to be Moreover, radiation from natural societal benefit regardless of the level of + risk they pose. justification of practice is received se a result of the practice (e.8-background poses involuntary risks an average dose to individuals in a (primarily cancers). which must be recogmzed by health physics professionals and national and critical group) and (2) a measure of accepted as a fact of!ife and are radiologicalimpact to the exposed I ree fu da e a! t s of rji population. in combination. thesa identical to the kinds of risks posed by fthe ion radiation from nuclear materials under protection (justification. dose limits. and criteria are chosen to ensure that. for the NRC jurisdiction. These facts provide a j ALARA.).The Commission has prepared average dose to members of the critical context in which to compare th'a po1 cy latement in conformance p pulation group from a given exempted quantitatively the radiation nsks from practice. Individuals will not be exposed various practices and make radiation g r exe ption ebi 'P P to a significant radiological risk and that risk especia!!y amenable to the use of Co t M the position of the International Atomic the population as a whole does not the approach described below to define Energy Agency in its Safety Series suffer a significant radiologicalimpact. an acceptable BRC level. Report No. 89, the Commission believes It is important to emphasize that. In The Commission believes that if the that justification decisions usually this policy, the Commission does not risk from doses to individuals from a derive from considerations that are assert an absence or threshold of risk at practice under consideration for much broader than radiation protection low radiation dose levels but rather exemption is comparable to other alone.The Commission believes that establishes a baseline level of risk voluntary and involuntary risks which Justification decisions involving social beyond which further government are commonly accepted by those same and cultural value judgments should be regulation to reduce risks is individuals without significant efforts to made by affected elements of society unwarranted. As described in the reduce them. then the level of protection and not the regulatory agency. Appendix to this policy statement. the from that practice should be adequate. Consequently. the Commission will not technical rationale for the Commission's Furthermore. for risks at or below these consider whether a practice is justified BRC criteria is explicitly based on the levels there would be little merit in in terms of nel societal benefit. hypothesis that the risk from exposure expending resources to reduce this risk A. Principles of Exemption to radiation is linearly proportional to further.The Commission believes the the dose to an individual. However, the definition of a BRC dose level can be The principal consideration in presence of natural background developed from this perspective. exempting any practice from some or all radiation and variations in the levels of Variations in natural background regulatory controls hinges on the general this background have been used to radiation apparently play no role in i question of whether the application or provide a perspective from which to individuals' decisions on common continuation of regulatory controls is judge the relative significance of the matters such as places to live or work necessary to protect the public heahh radiological risks involved in the (e.3 the 60-70 mrem differences and safety and the environment.To exemption decision. making process. between average annual doses received S-081999 00:4(02X024UL-90-14.28:04) F4703. INT DB.30] J-08-88
Federal Register / Vol. 55, No.128 / Tuesday. July 3.1990 / Notices 27527 E in Denver. Colorado versus Washington, uncertainties associated with tow doses determines that doses to members of the D.C.).In addition, individuals generally and dose rates. public are ALARA and that additional do not seem to be concerned about the in view of the uncertainties involved regulatory controlls not warranted by difference in doses between living in a in risk assessment at low doses and further reductions in individual and brick versus a frame house the 5 mrem taking into account the aforementioned collective doses, dose received during a typical roundtrip risk and dose perspectives, the C.The Collective Dose Criterion coast to-coast flight, or incremental Commission finds that the average dose doses from other activities that fa!! well to individuals in the critical group The Commission believes that the within common variations in natural should be less than to mrem per year collective dose (i.e the sum of background radiation.These factors (0.1 mSv per year) for each exempted individual total efrective dose lead to the conclusion that differential practice. In addition, an interim dose equivalents) resulting from exposure to risks corresponding to doses on the criterion of 1 mrem per year (0.01 mSv an exempt practice should be ALARA. i order of 5-10 mrem (0.05-al mSv) are per year) average dose to individuals in However.if the collective dose resulting well within the range of doses that are the critical group will be applied to from an exempted practice is less than commonly accepted by members of the those practices involving widespread an expected value of1000 person-rem I public, and that this is an appropriate distribution of radioactive materialin per year (10 person.Sv per year). the order of magnitude for the Commission's such items as consumer products or resources of the Commission and its DRC individual dose criterion, recycled material and equipment. until licensees could be better spent by Although the uncertainties in risk the Commission gains more experience addressing more significant health and estimates at such low doses are large, with the potential for individual safety issues than by requiring further the risk to an individual as calculated exp sures from multiple licensed and analysts. reduction and confirmation of exempted practices.These criteria the magnitude of the collectwe dose. nsing the linear. no-threshold hypothesis is shown in Table 1 for various defined provide individual dose thresholds The Commission notes that, at this level levels of annualindividual dose.The below which continued regulatory of collective dose, the number of c ntrols are unnecessary and hypothetical health effects calculated values in the hypotheticallifetime risk unwarranted to require further for an exempted practice on an annual column are based on the further ucqons in individual doses.The basis would be less than one. i assumption that the annual dose is Commission considers these entena to The Nat,onal Council on Radiat,on i i l continuously received during each year be appropriate given the uncertainties Protection and hieasurements 1 of a 70-year lifetime.To provide further inv hed in estimatmg doses and risks. recommends in its Report No.91 8 that l perspective. a radiation dose of to mrem 8 cdectwe hse assessments for a i per year (0.1 mSv per year) received
- '.t 6ese c$ eda sbuM f" lementation of this poh.
- 8 P" ' E'UC' '
- C continuously over a lifetime corresponds imp ey in future consideration of those individuals to a risk of about 4 chances in 10.000 rulemakings or licensing decisions.
whose annual effective dose equivalent (3.5 x10"] or a hypothetical increase of The Commission believes that. Is less than or equal to t mrem per year i l about 025% in an individual's lifetime n twithstanding exemption of practices (0.01 mSv per year). In the sensitivity-of-risk of fatal cancer.The Commission fr m regulat ry c ntrol under these measure. risk. based guidelines,used by prefers to use factors of ten to describe criteria,it still has reasonable assurance epa and FDA. a to
- lifetime nsk of such low individaal doses because of that exposures to individual members of cancer has been used as a quantitat, e
{ w the large uncertainties associated with the public from alllicensed activities enterion of insignificance. Using an hd ^Fpend x to the and exempted practices will not exceed annual risk coefficient of 5x10" health J policy state nt p sa 100 mrem Per year (1 mSV per year) effects per tem (5x10 per sievert) as complete discussion of the risks and l given the Commission's intent (11 to discussed in the Appendix, the 10-define practices broadly:(2) to evaluate lifetime risk value would approximate TABd 1 potential exposures over the lifetime of the calculated risk that an individual the practice:[3] to evaluate the potential would incur from a continuous lifetime N N ns[ for aggregated exposures from multiple dose rate in the range of 0.01 to 0.1 mrem l Hypotneucai j enciementar, annual incrementai stom etempted practices:(4) to impose both (0.0001 to 0.001 mSv) per year.
- 0*'
cy individual and collective dose criteria: As a practical matter, consideration of 1 i oow" (5) to monitor and verify how dose rates in the microrem per year exemptions are implemented under this range and large numbers of hypothetical 500 mrom (1.o msv). 5004 3 s x te
- policy:(0) to verify dose calculations individuals potentially exposM to an to enrem io.i msvL.
sao. 35oc. through licensing reviews and exempted practice may undul, $r* Ei sE sI $ $yj rulemakings with full benefit of public complicate the dose calculations that n review and comment: and (7) to inspect will be used to support demonstrations The aprewon of oou seins s and enforce licensee adherentu to that proposed exemptions comport with Effect ve oow to-aient in,s icm o tne Total l ine sum o' specific constraints and conditions the cri!cria in this policy.The l f 'le n".i ton *t$rN*ine cNCs'a"e*,$," imposed by the Commission on Commission believes that inclusion of e 1.nois teo i cou eowiv. ni son.ources.nternal to exempted practices. Individual doses below 0.1 mrem per r l Ca$uiai.o us.no a consorvenn nsa coen.c.eni The Commission intends that only year (0.001 mSv per year) introduces of 5 ao-a p ..m as = io-s p, sa io,== i.nur under unusual circumstances would unnecessary complexity into collectw, e encoy transim aa$aion t.aseo on ine resst* exemptions be considered for practices dose assessments and could impute an '$N" un o' ta[N "d"'n that could cause continuing rmbation unrealistic sense of the significance and a ine Ettects of Atemsc R40saison (UNsCEAR). t9fis exposure lo individuals exceeding a Aepori to the Gwneral Assembey wem Annenes and small fraction of100 mrem per year (1 8 Fecommendehone on IJmits for E.mposure so
- Hearin Ettects of Esposures to Lt>= Leveis of mSV per year). In rare Cases, exemptions tomams Rad. teen. NCRP Report No. 91, Nat.unal Councd on Red. han Prosecuen and Me umments.
longing Ra$aton, BEIR V.* 1990. Committee on oy sucg ractices mayge granyg gg, ayter g,,,,,,,,7, g,,,g,g,3, g,, p,,4,,, g,,, ggg, p i Beoiogscal Ettects of loreng RaSat.on, tdai.anar Research Couned (see also NUREGICA-afia. As,. conductsng a thorough analysis of the PW.uhou.7sto Woudmoni An.SWie nots. l u proposed exemption. the Commission semsd.. uo zosia. 1 F4703.FMT 416.30). 7-08 58 . ?m ~..-
= -. j 27528 Federal Regist:r / Vol. 55. No.128 / Tuesday. July 3,1990 / Notices i ~ certainty of such done levels.For all of under these circumstances. constitute a individual and collective doses i these reasons the Commission finding that the practice is exempted in attributed to the practice under 1 concludes that 0.1 mrem (0.001 mSv per accordance with the provisions of the consideration should either meet the year)is an appropriate truncation value regulation and that ALARA policy's dose criteria or otherwise be to be applied in the assessment of considerations have been adequately demonstrated to be low enough to collective doses for the purposes of this addressed from a regulatory standpoint. ensure protection of the public health l policy. The Commission in no wsy wishes to and safety and ALARA. in addition to discourage the voluntary application of the impacts of routine exposures. IV. Implementorion addit!onal health physics practices reallstic !mpaets resulting from potential The Commission's BRC policy will be which may. in fact, reduce actual doses misuse or accident scenarios should also implemented principally through significantly below the BRC criteria or be evaluated and demonstrated to be rulemakings: however. exemption the development of new technologies to insignificant.The NRC may reject decisions could also be implemented enhance protection to public and the proposals for exemptions if they do not through specific licensing actions. environment.This is particularly provide a sufficient technical basis to in the first case a proposal for pertinent in the area of decontamination support analysis of the potential exemption, whether initiated by the and decommissioning, where the exemption. NRC or requested by outside parties in a Commission anticipates that emerging Practices should be defined with petition for rulemaking. must provide a technologies over the next several respect to the geographic and basis upon which the Commission can decades should enhance existing demographic areas to which the i determine if the basic policy criteria technical capabilities and further reduce exemption will apply. In some cases, an have been satisfied.The Commission doses to workers and the public and exemption will be limited to one intends to initiate a number of where other federal agencies are in the particular locality or area. However. l rulemakings on its own e.g to establish procest of developing standards which many practices will have national 1 r a dose criterion for decommissioning) may affect those receiving exemptions. applicability and should be and may initiate others as a result of The second means of policy characterized accordingly. Information NRC's review of existing codified implementation could involve on these issues will be necessary for exemptions le.g., consumer product exemptions that would be granted determinations regarding which i exemptions in 10 CFR parts 30 and 40). through licensing actions, such as individual dose criterion should be Rulemakings may also be initiated in determinations that a specific site has applied. response to petitions for rulemakmg been sufficiently decontaminated to be The Commission believes that the submitted by outside parties. such as a released for unrestricted public use.The implementation guidance provided with DRC waste petition submitted in NRC intends to develop guidance its " General Statement of Policy and accordance with Section to of the 1.ow* regarding the implementation of the DRC Procedures Concerning Petitions Level Radioactive Waste Policy criteria to ensure that such site-specific Pursuant to i 2.802 for Disposal of Amendment Act of 1985. In general, actions adhere to the criteria and Radioactive Waste Streams Below prin i les of this policy statement.New Regulatory Concern." published August P sse s e po ent al health a safe y I cens ng actions that transfer 29.1988. 51 FR 30839. generally defines impacts that could result if the radioactive material to an unregulated the types of information needed to exemption were to be granted. sta us w n Uce in the Federal support an exemption decision. I The proposal should consider the uses of the radioactive materlats, the Register if they differ from previous However. not all of the information may pathways of exposure, the levels of generic exemption decisions. be applicable to the broader range of radioactivity, and the methods and One of the principal benefits of the practices considered for exemption constraints for ensuring that the p licy is that it provides a framework to under this policy. Applicants should I assumptions used to define a practice evaluate and ensure the consistency of examine potentially relevant guidance remain appropriate as the radioactive past exemption decisions by the available at the time the exemption materials move from a regulated to an Commission. With the adoption of this proposalis being prepared and provide unregulated status. Any such rulemaking BRC policy, the NRC willinitiate a the information which is relevant to the action would follow the Administrative systemauc assessment of exempHons particular type of exemption decision Procedure Act,which requires currently existing in NRC's regulations being requested. BRMal Garac@ anon n c ns typ m o I cit public co m n o the rulemaking action under consideration. risks associated with exempted 1.Rodiologicolproperties. The The rulemaking action would include an practices. In addition, the NRC will on a radiological properties of the materials appropriate level of environmental periodic basis, review the exemptions to be exempted should be described, review in accordance with the granted under this policy to ensure that including as appropriate, the Commission's regulations in to CFR part the public health and safety continue to concentration or contamination levels j
- 51. which implement the National be protected adequately, and the half. lives, total quantitles, and Environmental Policy Act.
V. Information To Support Exemption identitles of the radionuclides If a proposal for exemption results in
- Decision, associated with the exempted practice.
a Commission regulation containing The chemical and physical form of the A. General specific renutrements for a particular radionuclides should be specified. All exemption. a licensee using the The information required to support radionuclides present or potentially exemption would no longer be required an exemption decision in a rulemaking present should be specified.The to apply the ALARA principle to reduce or licensing action should provide the distribution of the radionuclides should doses further for the exempted practice basis for the proposed exemption in be noted (e.g., surface or volume provided that it meets the condific.no accordance with Section III of this distribution). Mass and volume. specified in the regulation.The ' policy. In addressing the radiological averaged concentrations should also be promulgation of the regulation would, health and safety impacts, potential presented.The variability of 5-041999 0xt<02)h.J.JUL-90-14.28:12) F4703.Fhrl'...DB.30] 7-08-88
A Fed:ral Register / Vol. 55, No.128 / Tuesday, July 3,1990 / Notices 27529 radionuclide concentration distribution, provided in support of the -Average doses to the critical or type as a function of process characterization. Actual measurements population group: l variation or variations among licensees or values that can be related to -Collective doses to the critical l should be addressed and bounded, as measurements to confirm calculations population group and the total appropriate, are important and should be provided, exposed population (under conditions i
- 2. Nonradiologicolproperties. The The description should address the defined in Section !!!): and nonradiological properties of the quality assurance program used in data
-The potential for and magnitude of materials to be exempted should be collection and analysis and supporting doses associa'ed with accidents, described to ensure complete information.lf any surveys were misuses, and reconcentration of characterization of the properties of the conducted. they should be described. radionuclides. material and consideration of any Market information may be usefulin The collective doses should be adverse impacts associated with these characterizing a practice on a national estimated and summed in two parts: properties. An NRC exemption, based basis. total dose to the critical population on radiological impacts, would not 3 A, fow o, j, fee,ocabfy achievabf, group and total dose to the exposed relieve licensees from comphance w.th (ALARAJ. An analysis should be population. The critical group is the i applicable rules of other agencies which cover nonradiologleal properties. A provided that demonstrates that relatively homogeneous group of description of the materials. including radiation exposure and radionuclide individuals whose exposures are likely releases associated with the exempted to be the greatest and for whom the their origin. chemical composition, physical state. volume and mass should practice overall will be ALARA assessment of doses is likely to be the consistent with the criteria in this most accurate. Average doses to this t e contro I g fact 1 i ing oten h ges in ater als as a policy.The ALARA principle referred to ]{p at function of process variation should be in 10 CFR part 20 applies to efforts by licensees to maintain radiation ompared w th the individual dose addressed. The variation among g;g licensees should be described and exposures and releases of radioactive bounded, as applicable' materials to unrestricted areas as low as 8roup should be the se8 ment of the is reasonably achievable. Appendix 1 to population most highly exposed to radiation or radioactive matenals C. Practice Characterization 10 CFR part 50 describes ALARA for associated with the use of radioactive
- 1. Totolimpact. A regulatory action radioactive material releases from light material under unregulated conditions, taken under this policy is likely to be water reactors (nuclear power plants).
The second part of the population generic and may be nationwide in schte. Exemption proposals should describe exposure is the general population Therefore. to the extent possible, an how ALARA considerations have been estimate of the number of NRC and applied in the design, development, and exposure, exclusive of critical group exposure. For this group, the individual Agreement State licensees that possess implementation of controls for the exposures should be smaller, and the the radioactive material considered for proposed practice. Licensee compliance assessment will often be less precise. exemption. the annual volumes and with the ALARA principle must remain The impacts analysis should present an masses, and the total quantitles of each in effect up to and including the point at estimate of the distribution of doses radionuclide that would be a part of the which the materials are transferred to within the Eeneral population. In exempted practice should be given.The an unregulated status in accordance situati ns where truncation of the estimates should include the current w th an exemption granted under this collective dose calculation is done under situation and the likely variability over policy
- the provisions of this policy, the basis the reasonably foreseeable future. A geographical description would be a D. Impact Analyses for applying the truncation provision should be provided.
helpful tool in characterizing the To support and justify a request for The evaluation of radiological impacts j distribution of radioactive material exempti n. each petitioner or licensee should distinguish between expected involved in the exemption decision. should assess the radiological and and potential exposures and events.The J Such distribution, submitted as part of n nradiologicalimpacts of the proposed analysis of potentia'. exposures in the practice characterization. should be i exemption. The analyses should be accident or misuse scenarios should used to assess realistic impacts of the based on the characterizations include all of the assumptions, data, and practice, in addition to conservative described previously and should cover results used in the analysis in order to bounding estimates that tend to overestimate human exposures and all aspects of the proposed exempt facilitate review.The evaluation should doses. In any case, the typical quantities practice. including possession. use, provide sufficient information to allow a l produced per practice (e.g number of transfer. ownership, and disposal of the reviewer to independently confirm the material.NRC consideration of the results.The potential for reasonable units of a particular consumer product) and an estimate of the geographic exemption proposal and any interactions between the exempted environmental assessments and radioactive material and the public description of the practice should be described.The potential for short. and regulatory analyses required to should be assessed. long. term recycle or reuse of the product implement the exemption will be based
- 2. Otherimpacts. The analy.-is of containing the exempted radioactive on the impact analyses and supportin8 other radiologicalimpacts such as those material should also be addressed. Both characterizations-from transportation handling, the resource value (e.g salvageable
- 1. Radiologicolimpoets. The processing. and disposal of exempted metals) and the functional usefulness evaluation of radiologicalimpacts materials should be evaluated.
(e.g.. usable tools) should be examined. should clearly address the policy's Nonradiological impacts on humans and i 2.Bosisforossessment. A description individual and collective dose criteria or the environment should also be of bases for the materials and practice provide a sufficient Al. ARA evaluation evaluated in accordance with NRC characterizations should be provided. supporting the exemption.In either case, requirements in to CFR Part 51.The Monitoring and analytical data and the following impacts should be analsyls should also consider any calculations should be specified and sesessed: adverse impact of the measures taken to 5-041999 0047t03x02-JUL-90-te.29.9) l F4703.FMT...[16.30]-.7-08 88
1 27530 Fsdtral Rzgist;c / Vol. 55. No.128 / Tuesday. }uly 3,1990 / Notic: provide nonradiologleal protection on exemption proposal should provide proposals, the total efrective dose radiation ex; osure and releases of specific requirements for Quality equivalent must be taken into account. radioactive material. Any NRC action to Assurance / Quality Control and ll.Estm.oting //colth Effects hom exempt a practice from further Reporting that have been tailored to the regulatory control would not setieve licensee's program. Ro6ation hpose persons using, handling. processing.
- 1. Quality assurance / quality control.
A. Individual Risks owning. or disposing of the radioactive The program to ensure compliance with material from other requirements specific exemption constraints. In the establishment of its radiation app!! cable to the nonradiological requirements, or conditions should be protection policies, the Commission has properties of the material. defined.The records ofinventory tests, considered the three maior types of E. Cost Benefit Considerations (As surveys, and calculations used to stochastic (i.e random) health effects demonstrate compliance with the that can be caused by relatively low Required) exemption constraints should be doses of radiation: cancer. genetic A cost / benefit analysis is an essential maintained for inspection. Such effects, and developmental anomalies in i part of both environmental and programs are necessary to provide the fetuses.The NRC principally focuses on j regulatory impact considerations. %e NRC and the public reasonable the risk of fatal cancer development analysis should focus on expected assurance of conformance with the because (t) the mortality risk represents exposures and realistic concentrations cos.straints and of adequate protection a more severe outcome than the j or quantities of radionut!! des.The cost / of human health and the environment. nonfetal cancer risk, and (2) the benefit analysis should compare the
- 2. Reports. Reports may be required mortality risk is thought to be higher exposures and economic costs from licensees who, by rule or license, than the risk associated with genetic associated with the regulated practice are permitted to release materials effects and developmental effects on i
and alternatives not subject to exempted from regulatory control. fetuses.* llowever. even though regulation. Denefits and costs should be Associated ternrdkeeping to generate radiation has been shown to be 1 considered in both quantitative and the reports should be defined. Minimum carcinogenic, the development of a risk qualitative terms. Costs of surveys and information in the reports could include factor applicable to continuing radiation i compliance verification discussed under volume, isotope and curie content. More exposures at levels equal to natural item V.C. should also be covered. Any detailed recordkeeping and reporting background s requires a significant legal or regulatory constraints that might requirements may be imposed to extrapolation from the observed effects affect an exemption decision should be address uncertainties in projecting at much higher doses and dose rates.* Identified. E or example. one such future volumes or amounts of exempted This results in significant uncertainty in constraint might stem from Department materials and to consider the cumulative risk estimates as reflected by the views of Transportation (DOT) requirements impacts of multiole exemptions. of experts in the field. For example, the for Inbeling. placarding, and manifesting Committee on the Biological Effects of radioactive materials in 49 CFR part 173. Appendix-Dose and llaalth Effects lonizing Radiation (BEIRlillof the Estimation F. Constraints. Requirements. or National Academy of Science cautioned i Cnndlilons on Exemptions I. Dose Estimation that the risk values are "* *
- based on In most cases, the characterizations of In estimating the dose rates to incomplete data and involve a large the materInl and the assessment of rwmbers of the public that might arise
('8",,of u((,rta
- y. e ec n e j
impacts will be based on either explicit through various practices for which stated that it... does not know j or implicit constraints. such as exemptions are being conaldered, the limitat;ons on the amount of radioactive Commission has decided to apply the whether dose rates of gamma or x rays materlui In a consumer product. In order concept of the " total effective dose i for an exemption deelston to Iske credit equivalent." This concept. which is ' Wrib' d'ac=*a af 'h= *r** * ***d
- for these constraints. the exemption based on a comparison of the delayed QQ[",'(*j$,8",*8 " jag, proposal should specifically identify health effects of ionizing radiation g Ai
.e m dubon [tW5CEARI. toen Reporu the approprinte constraints, such as exposures, permits the calculation of the ceneret Anembly with Ann,ses quentity limits, concentration limits, a nd whole body dose equivalent of partial ' Nat ret t= clam.ad nowtwa can wy with physical form characteristics.The bases body and organ exposures through use '""' ad lac *'** la W*'h'N*s tsc. n.imt Id,$",".d ,'g""3'",'U",,",d", %"," dd on which these constraints are to be of weighting factors.The concept was i ensured should also be discussed. In proposed by the International ms.jpg hii,in tknwe.colar.d the.tw a l general, constraints should be verifiable Commission on Radiological Protection et= t tuo mmm pre me it s ms.rppn t oth in order to provide the be:Is for an (ICRP) in its Pubilcation 26 issued in
- "* '*'*HF aca'"m ad"="" **"al
- exemption decialon, 1977. Since that time, the concept has
'",, "",*j "",N,7' '[,' 8* p q een new naluatd. and adopad M.cw w adon oninw... ,. 4d,. .i C. Quality Assurance and Reporting by radiation protection organtsallons dm of 20 mrm rev p.e ta maiinlin m mbm d This portion of the exemption throughout the world and has pained 'h' U2 8*e*"a tW 8er=" N* **Mamm [*,7 "g'P""" d "* P"P"'*"*" *' 'h' U"'* proposal should be tailored to either a wide acceptance.The " total effective generic petition for rulemaking or dose equivalent" concept is . n, g g,n,,3,io,,,,,,ng gd,,, spectfic pruposal for a license incorporatod in
- Radiation Protection e.d.n n h.w.cnemd enac[i its.a==
rts am#indment. For generic petitions for Guldance to Federal Aaencies for ada'*a*w h ***= iw **m c s=mb rulemaking. the proposal should provide Occupational Exposure.-- "''****'""h"""**h**'"*" and justify generic requirements for Recommendations Approved by the k',',N,**'[,,7,,,,*j 1 Quality Assurance / Quality Control and President." that was slaned by the .nnut on. sh.i n.o .n .rdm.t n ,n, d. Reporting. Such proposals should President and published in the Federal *uhaa ik da rewd by hm.a r=r**aa. Include example requirements and show Register on January 27.1967 ($2 FR '***b"h"*"**"'""**""d their effectiveness and feastbility. For 2s:21.The Commission recognises that. [,',E",7,,*,*,D .$*"27*' site specific license amendments, the in considering specific exemption do n S-04t m atutto)xc2.W1..so-14.2e.Sen j nm.n.rr num raa
Federal Registst / Vol. 55. No.128 / Tuesday, July 3,1990 / Notices 27531 (low 1.ET: low linear energy transfer international radiation protection an individual's lifetime risk of cancer ~ radiation) of about 100 mrads/ year (1 authorities have established radiation death. Ten millirem per year (05 mSv mCy/ year) are detrimental to man." protection standards defining per year)is also a dose rate that is a More recently, the BEIR V Committee of recommended dose limits for radiation small fraction of naturally occurring the National Academy of Science / workers and individual members of the background radiation and comparable National Research Council stated that it public. As a matter of regulatory to the temporal variations in natural l " recognizes that its risk estimates prudence, all these bodies have derived background radiation due to fluctuations l become more uncertain when applied to the value presumed to apply at lower that occur at any specific location. l very low doses. Departures from a linear doses and dose rates associated with model at low doses, however, could the radiation protection standards by a T Ast.E 1 either increase or decrease the linear extrapolation from values derived [ estimation of] risk per unit dose." The at higher doses and dose rates.This HypoN*cei. Commission understands that the modells frequently referred to as the ggj
- T,*,'.n"o" l Committees
- statements reflect the linear, no-threshold hypothesis, in which oo.
.nnu.i conimu
- ",",,uT
'*k ' uncertainties involved in estimating the the risk factor at low doses reflects the risks of radiation exposure and do not straight-line (linear) dose.effect imply either the absence or presence of relationship at much higher doses and ioo mem os msvt _ s = to a 3 s xio-a detrimental effects at such low dose dose rates. In this respect, the BEIR V to wom eo.1 msvu s = to -' 3.s =to " levels. report notes that"in spite of evidence i mem to os msv3 s = to -' 3.s = to ** The United Nations Scientific that the molecular lesions which give o 1 mrom to ooi ms L sx to ** 3 s x to ** Committee on the Effects of Atomic rise to somatic and genetic damage can % gn,c, Radiation (UNSCEAR) stated in their be repaired to a considerable degree, the we oose tou'veient me term a the sum o8 the l 1988 Report to the General Assembly new data do not contradict the gtogodose ggg'or sourcy that "* *
- there was a need for a hypothesis, at least with respect to g c og oo,,qu,..ni,,,
u,c mism s i. reduction factor to modify the risks cancer induction and hereditary genetic ine emoy. (derived at high doses and dose rates)." effects. that the frequency of such ,,' AN E" *ii IM e'E'M$N,s, s ii
- forlow doses and dose efrects increases with low. level treen conse~swe'y t>aseo on e= reus reponed a l
rates * * * {A]n appropriate range (for radiation as a linear.,non-threshold gg'8,5,a, tnog 2) and BEIR V tese also this factor) to be applied to total risk for function of the dose. Iow dose and dose rate should be The Commission. in the development The Commission prefers to use factors between 2 and 10." This factor would of the BRC policy. is faced with the issue of ten to describe such low individual lead to a risk coefficient value between of how to characterize the individual doses because of thelarge uncertainties 7 x 10-* and 3.5 x 10"per rad (7 x and population risks associated with associated with the dose estimates. Use 1 10"3 and 3.5 x to-sper Gy) based on low doses and dose rates. Although the of values such as 0.7 or 12 imputes a l en UNSCEAR risk coefficient of 7.1 x uncertainties are large, useful significance and sense of certainty that 10" per red [7.1 x to "per gray) for 100 perspective on the bounding risk is not justified considering the levels of rad (1 gray) organ absorbed doses at associated with very low levels of uncertainty in the dose and risk high dose rates. The report also stated. radiation can be provided by the linear, estimates at these low levels.Thus.
- The product of the risk coefficient no. threshold hypothesis. Consequently, order of magnitude values such as 1 and appropriate for individual risk and the such risk estimates have been a primary to are preferable to avoid providing relevant collective done will give the factor in establishing individual and analysts and the public with a sense of I
expected number of cancer deaths in the collective dose criteria associated with certainty and significance that is not l exposed population, provided that the this policy.The estimations of the low commensurate with the actual precision collective dose is at least of the order of risk from potentially exempted practices and certainty of the estimates. 100 person Sv (10.000 person rem). lf the can be compared to the relatively higher B. Collective or Population Risk collective dose la only a few person-Sv potential risks associated with other (a few hundred person tem), the most activities or decisions over which the in the application of the fundamental likely outcome is zero deaths." In NRC has regulatory responsibility. principles of radiation protection. l December 1989. the BEIR V Committee Through such comparisons, the collective dose provides a useful way to l published a report entitled " Health Commission can ensure that its express the radiological impact (i.e Effects of Exposure to Low Levels of radiation protection resources and those potential detriment ) of a practice on the Ionizing Radiation." which contained of its licensees are expended in an health of the exposed population. risk estimates that are.in general, optimal manner to accomplish its public Because of the stochactic nature of risk. ~ similar to the findings of the 1988 health and safety mission, analysis of exposures oflarge groups of UNSCEAR report.The BEIR V report's in this context, the risk to an people to very small doses may result in estimate oflifetime excess risk of death individual as calculated using the linear. calculated health efrects in the from cancer following an acute dose of no. threshold hypothesis is shown in population at large. Collective dose is 10 rem (0.1 Sv) oflow LET radiation was Table I for various defined levels of the sum of the individual total efrective l 8 x 10".Taking into account a dose annuat individual done.The values in dose equivalents resulting from a rate efrectiveness factor for doses the hypotheticallifetime risk column are practice or source of radiation exposure. occurring over an extended period of based on the further assumption that the it is used in comparative cost. benefit time, the risk coeIficient is on the order annual done is continuously received and other quantitative analytical l of 5 x 10"per rem. consistent with the during each year of a 70 year llfetime. techniques and, therefore,is an upper level of risk estimated by To provide further perspective, a important factor to consider in i UNSCEAR. radiation dose of to mrem per year (0.1 balancing benefits and societal in view of this type ofinformetton, the mSv per year) received continuously detriments in applying the ALARA NRC. the Environmental Pretection over a lifetime corresponds to a principle.For purposes of this policy. Agency, and other national and 1 ypotheticalincrease of about 0.25% in individual total eflective dose l 5-04te99 0049tch02-JUL.-oo-14.M04 F4703.FMT.[16.30b.7 08-88
27532 Fcderal Register / Vol. 55. No.128 / Tuesday, July 3,1990 / Notices equivalents less than 0.1 mrem per year concern (BRC).The principal advantage we regulate and in view of the fact that (0.001 mSv per year) do not need to be of such a policy.in my view,is that it the purpose of this Policy Statement is considered in the estimation of will bring much-needed discipline and to establish a framework for identifying collective doses.The Commission technical coherence to the patchwork of those practices that the Commission believes consideration of individual BRC regulatory decisions that have been considers to be below regulatory doses below 0.1 mrem per year imputes rendered to date, providing a clearly-concern. a sense of significance and certainty of articulated, risk. based approach for Beyond this. if the collective dose their magnitude that is not justified reaching decisions on matters such as-criterion la to be defined as the floor to considering the inherent uncertainties in (1) the release for unrestricted public ALARA (as I would propose below), a dose and risk estimates associated with use oflands and structures containing more conservative approach to potentially exempted practices. The residual radioactivity;(2) the establishing a collective dose criterion is Commission also notes that doses in the distribution of consumer products warranted in view of the fact that doses 4 range of 0.01 to 0.1 mrem per year containing small amounts of radioactive may be truncated in the calculation of correspond approximately to lifetime materiah (3) the disposal of very low
- collective dose and the collective dose risks on the order of one in a mi!! ion.
level radioactive waste: and (4) the criterion may be applied to single The NRC has used collective dose, recycling of slightly contaminated licensing actions. including rationales for its truncation. In equipment and materials. A coherent. For these reasons. I do not support a I a number of rulemaking decisions and in risk. based policy is urgently needed to collective dose criterion of 1000 person-resolving a variety of generic safety provide the foundation for future rem. Instead.in view of what appears to regulatory actions in each of these be the prevailing technical view on this 1: sues. ngl 8 gl s pport matter.1 would endorse a collective Ill. Dose and Risk Estimation h7s'ini a i e d se criterion of 100 person-rem. The Commission recognizes that it is There are certain aspects of this frequently not possible to measure risk policy, however, with which I must ALARA to individuals or populations directly reluctantly disagree. My views on these I would define the individual and and. In most situations. it is impractical matters fo!!ow: collective dose criteria as floors to te measure annual doses to individuals Individual Dose Criteria ALARA.8 Unfortunately, the Policy I support the individual dose criteria Statement is equivocal on this issue, at the low levels associated with suggesting at one point that the potential exemption decisions. of 0 millirem per fear for practices individual and collective dose criteria Typically, radionuclide concentrations bvolving potentia exposures to limited numbers of the public and t millirem per should be construed as floors to measure before th ra os ve year for widespread practices that AIARA-material is released from regulatory involve p tential exposures to large [A] licensee * *
- would no longer be control. Estimates of doses to members numbers of the public. In view of the required to apply the ALARA principle of the public from the types of practices potential for multiple exposures from to reduce doses further for the exempted that the Commission would consider widespread practices, however, and in practice provided that it meets the exempting from regulatory control must the interest of administrative finality.1 conditions specified in the regulation.
be based on input of these believe that the Commission should but then going on to send what I measurements into exposure pathway establish the t millirem criterion as a consider to be a conflicting and models. using assumptions related to the b"al critenon, rather than an interim g gg ways in which people might become vague. exposed.These assumptions incorporate Commission expects-sufficient conservatism to account for Collective Dose Criterion The Commission in no way wishes to uncertainties so that any actual doses I do not support the establishment of a discourope the voluntary application of would be expected to be lower than the collective dose criterion at a level of additionel health physics practices which calculated doses.The Commission 1000 person. rem.This levelis an order rney. in fact reduce actual doses below the ERC criteria or the development of new believes that this is an appropriate of magnitude higher than the level technologies to enhance protection to public approach to be taken when determining recommended in IAEA Series No. 89 as
- "d'h""I'*"**"'I'*P ''*dd'dI h
if an exemption from some or all well as the level recommended by most reFulatory controls is warranted. other international groups. Furthermore, if the Commissic iintends to say. as I The additional views of Commissioner it is an order of magnitude higher than believe it does in this Policy Statement. Curtiss and Chairma.: Carr's response the 1986 collective dose to members of that those practices that fall within the are attached. the public due to effluents from all Individual and collective dose critera Dated at Rockville. Maryland, this W day opersting reactora, the most recent year can be designated below regulatory "II""' N for which figures are avallable. For the Nuclest Reguistory Commission. A collective done criterion of1000 . I would point out ihet the policy siniement Samuel I. Ch!!k. person-rem would mean, for example. .itows he,her cotlective do.es ir enetrees show the Secretary of the Commissicn. that if, pursuant to this Pulley Statement. ihe coti ctive do e is ALanA for a stver. practice. the Commission were to exempt on the Wmfon. edoption of the tower IAEA estue of 100 penon. rem b.wd on dotter esumetes of resources AdditionalViewe of Commissioner order of fifteen separate practices with to do deistied AtARA.n.1rses would not enminet Curtiss Collective doses al or neat the the option to pprove practices such as smoke I strongly endorse going forwatd with exemption level of 1000 person rem-not detectors th.unvolve i..se numbers of potennetir a comprehensive policy that will an unteaaonable expectation, given "P*"d membem of the pubhc. l establish a disciplined and consistent prevlous praettee-- we would project a my -noor to At. ARA. I me.n thet the petmane-Iramework within which the somewhere between 5 and to excess and the sisfr are reueved from the reeutatory
- %8'"'" P"f""n tunhn ALAMA nahus Commission can define those practices health effects annually.1 consider this thet from the etandpoint of radiological level to be unacceptably high, when NiE",$'o'$[,"dM*M*,c'l",,'"d,m 1
l risk we consider to be below regulatory viewed in the context of other risks that pee.on. rem. s.onm omonaut:1..nunon F4703.FMT...[16.301.. 7-08-88 i i
o Fed:ral Rsglster / Vol. 55. No.128 / Tuesday. July 3.1990 / Notices 27533 concern. it is unclear why the this approach poses the very real this important responsibility. Commission would then go on to say potential that the Commission could, on Accordingly the states were given a that it expects additional steps to be the one hand, reject a practice involving great deal oflatitude in deciding how taken to keep exposures ALARA. As a children (e.g.. baby food, pacifiers and best to proceed with the development. general matter.1 do not object to the the like) on the ground that the risk construction. and opuntion of new low-ALARA concept. Indeed. I support the posed by such a practice is too high yet level waste disposal facilities.To take notion that collective dose and ALARA authorize a practice directed at the one example. Congress recognized that analyses should be performed in a general public that could, coincidenta!!y. some states may decide to construct manner that is consistent with basic expose an even greater number of facil ties that, from a technical national and international radiation children, even though the practice itself standpoint, go beyond the requirements protection principles. But in the context is not specifically directed at children. established in to CFR Part 61 for of a Policy Statement on Below in my view, this ambigutiy should be shallow land burial facilities: for this Regulatory Concern for the Commission resolved in favor of a clear and reason. Congress directed the NRC to to say on the one hand that the unequivocal statement endorsing the develop guidance on alternatives to the individual and collective dose criteria principle of justification of practice. shallow land burial approach reflected reflect levels below which no regulatory While I acknowledge that the princ. le in Part 61 (see section 8 of P.L. 9M40). ip resources should be expended, while at of Justification of practice calls upon the Similarly should a State decide to the same time encouraging voluntary Commission to make decisions involving require radioactive wastes beyond those ALARA efforts to achieve lower doses so-called questions of societal value, defined by the NRC as Class A. B. and C sends a confusing regulatory message.s that is an insufficient reason. in my wastes to be disposed ofin a regional For the sake of regulatory clarity.1 view, to step back from this widely-disposal facility, the Act permits the would explicitly identify the individual accepted health. physics principle. states that option as well(see section Indeed. the Commission already takes bhh and collective dose criteria as floors to such considerations into account. either LLRWPAA grants states a great deal of ALARA. explicitly or implicitly,in many of the latitude in deciding what kind of facility /ustification o/Proctice decisions that it renders. On the issue of justification of Accordingly. in view of the central to build and what types of waste will be practice. the Policy Statement is unclear role that the justification of practice disposed of in that facility, so long as-as to when and under what principle has played in health physics (1) the facility comphes with the circumstances the justification of practice. as well as the complexity and requirements of 10 CFR Part 61: and (2) practice principle would be applied. At confusion that will invariably result the State provides disposal capacity for one point the Policy Stat: ment provides from the approach set forth in the Policy Class A. B. and C wastes. Statement. I would stete explicitly in if one interprets the LLRWPAA in this that: this Policy Statement that the manner, as I do, then in my judgment it The Commission believes that justification Commission retains the prerogative to is consistent with this general approach decisions involving social and cultural value determine that specific practices may be to conclude that this Policy Statement judgments should be made by affected unsuitable for exemption, regardless of (and the subsequent rulemaking elements of society and not the regulatory
- Eency. Consequently, the Commission will risk. documenting such determinations initiatives implementing the Policy not consider whether a practice is justified in on a case-by-case basis.
Statement) should not be considered Agreement State Compatibility matters of compatibility.The result of terms of net societal benefit. 1 such an approach would be that At another point. the Policy Statement With one exception. I concur in the individ.ial states would be allowed the indicates that: ption of deciding whether Ic+1evel The Commission may determine on the (ate en th s wastes designated BRC by 8ae basis of nsa estimates and associated Agreement State compatibility. The one Commission under this Pohey Statement i uncertainties that certain prac* ices should h h should nevertheless be disposed ofin a reatment of att r i v nglo level u h as he in uct o of red osc ive licensed low-level radioactive waste materials into products to be consumed or radioactive waste disposal. used primarily by children. As I understand the position of the di8Posal facility. I majority. the approach estab!!shed in Ths argument, as I understand it, that This bifurcated approach to this Policy Statement, and to be is advanced in support of the approach justification of practice. which appears implemented in the context of taken in the Policy Statement-that the to distinguish practices involving sesequent rukmaWg inWahes. wW Commission's position on BRC should children from all other practices, will be considered a matter of strict be a matter of compatibility-is that inevitably lead to confusion. Moreover. compatibility for Agreement State states should be foreclosed from programs. As a consequence, the departing in any way from the approach s tSNhShe INy sieteEn a[ peer,io appr ach taken byindividual established by the Commission.To take Agreement States on BRC issues must the most visible and controversial A be motivated. in part, ty e concern that the be identical to the approach taken by exarnple that has arisen to date. this Envirtmmental Protect 6cn Asency may at some f.turo pomi ei more strinsent er tene toe sac. of the Commission. I disagree with this would lead to the result that a State particular note is the statement thei-- approach for the folloeving reasons: could not require that low. level waste ntEhe s ecoft r$. When Congress enacted the Low streams designated BRC by the d Level Radioactive Waste Policy Commission nevertheless be disposed of pert decommission!ns * *
- where other federal asencies m in the process of developins standards which Amendments Act of 1985 (LLRWPAA). It in a licensed low-level radioactive m.y enect iho.. receivins enemrtion vested in the states the responsibility for waste disposal facility.
In niy view, the AtARA iss9e should be developing new low. level radioactive approached with the objective of formulettes a waste disposal Capacity. Indeed. ihe e,,,,,,,,,,c,,,,,,,,,,,,,,,,,,,,,,,,,,,, sound and defensible policy. eether thr 1 with en Congress recognized at the time that the Rocky Mountain compact proposed to dispose of eye towards trytns to anttelpate what pohey EPA might estabbsh in the future states were uniquely equipped to handle radium waste in the Rocky Moun'em compact site. 5-041999 OC31(03X024UL-90 14.3a10) F4703.FMT.DB.30] 7-08-88 i
27534 Federal Registsr / Vol. 55. No.128 / Tuesday, July 3,1990 / Notices ! am not aware of any public health For the foregoing reasons.1 would not establishing a comprehensive and safety rationale involving low-level treu. the federal policy on below framework for making decisions on waste disposal that has been advanced regulatory concern as set forth in this regulatory exemptions. However, he as a basis for the NRC to insist that the policy Statement and subsequent takes issue with five elements of the Commission's position on BRC should rulemakings, as a matter of policy:(1) The interim nature of the 1 be a matter of compatibility for compatibility for Agreement States millirem per year criterion for practices Agreement States. One hears the when it comes to issues involving with widespread distribution. (2) ar.eedotal information about reducing commerciallow-level radioactive waste seteetion of the 1000 person-rem per exposures to truck drivers by allowing
- disposal, year criterion for collective dese. (3) the BRC waste streams to be disposed of in manner in which the Commission views locallandfills, rather than requiring such Chairman Carr's Response to the BRC criteria as a " floor" to Al. ARA.
Commissioner Curtiss Views on the waste to be transported across the (4) omission of the principle of country to a licensed low-level waste BRC Policy Statement justification of practice, and (0) making disposal facility.lf examples such as I am proud of the Commission's BRC rules an item of compatibility for this constitute the basis for declaring accomplishment in completing a Agreernent State programs.These issues that a health and safety concern exists comprehensive Below Regulatory were fully considered by the such that the Commission should. in Concern policy statement. ! appreciate Commission and the NRC staffin the turn, prohibit a State from requiring such Commissioner Curtiss' enthusiasm and course of developing the BRC policy, waste to be disposed ofin a licensed strong support for the policy. Inde'ed. Commissioner Curtiss voted in low-level waste disposal facility, then a Commission deliberation of such views September 1989 to approve the BRC more disciplined and persuasive has helped to forge a comprehensive policy, the essence of which is presentation of the argument is needed. risk framework for ensuring that the preserved in the final BRC policy in To date. I have yet to see such a case ' public is protected at a consistent level today's notice. In the absence of a health and safety of safety from existing and future Interim /ndividuo/ Dose Criterion concern, it is incongruous, in my exemptions and releases of radioactive judgment, to say that the risk from a materials to the general environment. On the first issue. Commisaloner particuler waste stream can be so The framework should also be helpfulin Curtiss would prefer to establish the 1 insignificant as to be "below [NRC's] allowing NRC States, and the public to millirem per year criterion as a final regulatory concern". but at the same focus resources on reducing the more criterion. rather than an interim value. time insist that we nevertheless have a significant risks under NRC's As stated in the BRC policy, the sufficient interest to dictate how a State jurisdiction.1 offer the following Commission is establishing the 1 might otherwise wish to handle that response to Commissioner Curtiss' millitem per year criterion as an interim waste stream.' thoughtful views in the spirit of the value until after it develops more constructive process that has experience with the potential for
- This kind of into sn.iion may well be a part of culminated in the BRC policy.
Individual exposures from multiple [p ',; "*"',ly,"$"","$','jl,'j,"','j,','f sj As with many of the issues that the licensed and exempted praetices.The would hold open the option of revisliing this Commission deals wlth, there were very widespread practices to which this question il and when the petition is filed. But at this few right and wrong 3olutions to the criterion app!!es are primarily consumer pomt.1 have yet to see a hestih and safety issues associated with the BRC policy. products, which could involve very i iss$o"n s p*'EhssU.Nou((tIp"r e"[ piedThe Commission reached its decisions small doses to large numbers of people, I. from the ophon of requinne weste streams on the polky by selecting preferred The 1 millirem criterion was selected designated DRC under this Policy Statement to be solutions from among a spec!Tum of specifically to address the possibility disposed of in licensed low levet radioachve weste possible policy options.These decisions that members cf the public may be .Y,'*,'$he been made th.t permitune were made based on the Commission's exposed to several exempted practices. states the ophon of requirins DRC waste streens to technical analysis of the issues Simply put, exposure of an individual be disposed ofin licensed low level weste 6sposal associated with regulatory exemptions. to a handful of exempted praClices Could facilshes would use up scarce disposal capacity and ]ggg] interpretation of governirig result in annual doses close to 100 7,'p'"$,p",c',",[d','o" d. his epp[I to wwe legislation. and regulatory experience in millirem if each practice were allocated n been one of the principsi concerns advanced in the approving exemptions since the birth of individual doses up to 10 m!!!! rem per commission's isee polier si.i, ment on BRc. civilian uses of nuclear materials in the year.This is highly improbable given the Iow*Netw. Ee*s Itsto sEId " Yr's'for1950's. I believe Commissioner Curtiss' Commission's plans to closely monitor c et space in the esisima lu.w dispos.ti sites and the views on selected isnues constitute part any overlsp of rxposed populations loRci concept shovid be opphcabie noisonwide in of the continuous spectrum of policy from exempted practices as well as the l order to ensure ih iihe sy.iem worke on. options. However, for the reasons aggregate dose to the public from in$a'i r'oNs *m'.[I[ihSUhU"*m**n"IsloNei r l crticulated below. I affirm theexemptions. Nevertheless. NRC does not c in the 1986 Pohey Statement that futom Commission's deClsion to spprove the presently know how many exemption -lriviem. kings s.niina peiitions Ion crc l will be policy statement in its present form and requests will be submitted by the public, made a maHer of compe11b!hty Int Agreement reject the differing Views put forth by how many will be approved, und what iN*N."eIer m$riNt.N.ch Commisaloner Curtiss. types of doses will be associa4d with uau misht have had at the time. I disasme with it for two Commissioner Curtiss clearly the exemptions. If few exemptions are masono tit conneess h.s vested si.tes with the endorses the policy and the concept of requested and granted, the probability eespoesibility for developtr's and menesins disposal capscfty for low level weste end. In view of this, of multiple exposures from exempted decisions about how best to proceed. includins about husbandina limited disposal ca pacity no and licensed practlCes exceedlng a decisionis shout whether states prefer to requin lanser appears to be relevant. Indeed, the decision substantial fraction of 100 millitem per BRC waaie streams to be Aaposed cfin heensed to permit the Rocky Mountain compact to dispose of year is Considerably reduced.Therefore, low level weste snea rather than sanitary landfdle, radium waste in it resionel disposal facility seems am best leh to the enrhvidual sietea.121 Dere le an to susnest that the objective of preservins hmned the 1 milIlrem per year Criterion may be i abundance of 6sposal capacity ender development disposal capacity for the disposal of low.levet too restrictlve and the regulatory I et the present stme end. for this reason the concern ra60ecthe weste is not the drivina caristderation, resources associated with its S-041999 0052(03XO2-JUL.90-LOO.14) F4703.FMT.D 8,30].. 7-08-88
/. t s l Rd:ral Register / Vol. 55. No.128 / Tuzaday, July 3,1990 / Notices 27535 i Implementation may be better spent to broad definition of practice), should the 2000 person-rem / year dose. Specific control more significant risks. ensure a consistent and adequate level examples include 1200 person-rem / year Consequently, the 1 millirem per year of protection of members of the public from watches whose dials are adorned criterion was selected as an interim from all exempted and licensed with paint contalning tritium. 800 individual done criterion to ensure that practices. person. rem / year from smoke detectors the sum of all exposures to an individual
- 3. Although co!!ective dose has been containing radioactive materials, and from exempted practices does not considered in evaluating environmental 8000 person-rem / year from gas mantles i
exceed a substantial fraction of100 hnpacts and in assessing the forlanterns that contain thorium (NCRP millirem per year.This criterion w!!! effectiveness oflicensee ALARA Report No. 95). remain an interim value until after the programs. NRC's regulatory program has In addition, the Commission Commission gains experience with the not traditionally placed specific considered the magnitude of collective potential for multiple exposures to constraints on collective doses doses associated with licensed exempted and licensed activities. associated with regulated activities. activities. such as discharge of effluents The initial rulemakinds to implement
- 4. Based on comments submitted to from nuclear power plants.The the policy.particularly in the area of the Commission on its proposed BRC Commission established ALARA design consumer product exemptions should policy. including comments presented by object!ves for effluent treatment systems provide valuable insights into the the Health Physics Society, the for power plants in Appendix I to to validity and appropriateness of the 1 prevailing technical view opposed CFR Part 50.The Commission noted that millirem criterion in terms ofits need to adoption of a co!!ective dose criterion in the dose values established in the protect the public against multiple the BRC policy.
design objectives are generally exposures to nuclear materials. Despite these considerations. the consistent with a collective dose Although I agree with Commissioner Commission also recognized the benefit criterion with a magnitude of1000 Curtiss that a final criterion would be of a collective dose criterion in limiting person-rem / year. However, the l desirable from the standpoint of the total population dose associated Commission also recognized that - ** administrative finality."It would be with exempted practices and in licensees have performed better than premature to establish the 1 millirem evaluating environmentalimpacts and required in accordance with Appendix ! l criterion as a final criterion until after the effectiveness of ALARA programs. by reducing estimated collective doses l the Commission gains more experience-Consequen'ly, the Commission decided from reactor plant effluents to 110 with exemptions of practices with to establish a cdlective dose criterion person-rem per year in 1986. whch is the I widespread distribution. as a part of the BRC policy.provided most recent year for which the data that it was based on valid scientific Collective Dose Criterion have been completely assessed (see analysis and that it did not constrain NUREG/CR-2850. Vol. 8). Commissioner Curtiss would have decisim on exemptions without an preferred to adopt a collective dose adequate health and safety or Finally. the Commission and its staff I criterion of 100 person rem / year environmental basis. are only beginning to evaluate specific because of his view that this value is Based on these provisions, the details of how the BRC policy will be more consistent with the prevalent Commission selected the value of1000 implemented through subsequent technical view on this mat.er. person-rem / year as a level of collective rulemakings and licensing decisions. For the reasons discussed below. I does that ensures less than one health Even at this preliminary stage the believe that a collective dose criterion of efrect per practice. In selecting this Commission has identified substantive 1000 person rem / year is more consistent value, the Commission relied on implementation issues pertaining to the l with the prevalent technical view on contemporary recommendations of application of the collective dose this matter and provides a sounder expert national and international criterion. For example an issue has regulatory basis for making exemption bodies.These included the 1988 been identified regarding how the decisions.The Commission considered conclusions of the United Nations collective dose criterion would be two fundamental questions associated Scientific Committee on the Effects of applied in making decisions about with the collective dose criterion:(1)Is Atomic Radiation (UNSCEAR) that appropriate levels of cleanup for there a need for a collective dose co!!ective dose calculations only provide contaminated sites. Specifically. does criterion end. lf so. (2) what should the reasonable estimates of health risks if the collective dose criterion apply value of that criterion be? the collective dose is atleast of the generically to the practice of The Commission initially questioned order of 10.000 person-rem.This value is decommissioning or would it be applied the very need for a collective dose an order of magnitude greater than the on a site-specific bests? Similarly, how criterion for the types of practices that value of the collective dose criterion should the collective dose criterion by would be considered as potential selected by the Commission. UNSCEAR 8pplied in cases where nuclear candidates for exemption.This also stated that the most likely outcome operations have contaminated questioning was based on a number of of collective doses on the order of a few Eroundwater resources that could factors that indicated that the hundred person-rem is zero deaths. potentially supply municipal drinking Commission may not need to consider The Commission also considered the water systems? Resolution of these and i co!!ective dose in making exemption magnitudes of collective doses other issues could cause the decisions.These factors included: associated with practices. primarily Commission to revise its selection of the 1.There is considerable uncertainty consumer products, that have already magnitude of the collective dose associated with the validity of risk been exempted by the Commission " Itis criterion through future rulemakings and estimates based on projections of was done to provide a benchmark for development of generic guidance. collective doses composed of small to the value of the collective dose criterion However, based on the technical very small dosen to large numbers of based on historical decisions that the information and recommendations people. pub!!c found acceptable.The currently before the Commission.1000 2.The individual dose criteris of I and Commission found that the magnitudes person-tem / year appears to be an 10 millirem per year, coupled with the of the collective doses for these appropriate magnitude for the collective other provisions of the polley (e.g., exempted practices fellin the range of dose criterlon. S-041999 o03)(03)(02-JUL-90-100.17) l F4703.FMT..118.30) 7-08-88 u^ v - C "9w(
l e 3 27536 Fadtral Register / Vol. 55, No.128 / Tuesday July 3.1990 / Notices 4 for all of these reasons, the further, we do not want to discourage example, to the best of my knowledge, l Commission established a collective their efforts to do so either.This would the Environmental Protection Agency i dose criterion of 1000 person-rem / year be tantamount to telling a !!censee how does not question whether the for each practice. to operate his or her business regardless generation of hazardous wastes is of whether any health and safety issues justified in terms of net societal benefit. A are involved.Such a direction would be even though the agency promotes the Commissioner Curtiss would prefer to inappropriate because it clearly falls minimlration and elimination of such define the individual and collective dose outside of the health and safety focus of wastes to reduce risks, criteris as " floors" to ALARA. I.e., that the NRC. I believe that Commissioner Curtiss the regulated community and NRC are in formulating the BRC polley, the misinterprets the BRC policy when he relieved from the regulatory obligation Commission recognized that new claims that it embodies a bifurcated to perform further ALARA analyses technologies being developed today approach on the principle of justification below these levels if Individual doses promise to reduce doses, and therefore of practice. As clearly indicated in the are 1 millirem /10 millirem and the risks, at lower costs than present policy, the Commission may determine collective dose is 100 person-rem. technologies. Indeed, technological and that certain practices should not be l Specifically, Commissioner Curtiss cost conalderations are explicitly considered candidates for exemption on believes that the BRC policy sends a recognized in the definition and the basis of risk estimates or associated confusing message by encouraging application of the term "ALARA."Thus-uncertaintles. Rejection of such an l voluntary efforts to achieve doses below I believe it would be inappropriate to application should be based on the risks the BRC criteria. telllicensees that they cannot posed by the practice, rather than l j In responding to Commissioner implement new technologies and health whether the practice is justified in terms Curtiss veiw on this issue it is important physics practices to further reduce doses of net societal benefit.The types of to begm from the defintion of the term if they want to. concerns he rasises about risks to o ep i a all n expos and /nuficadon of&cdce n and the g era publicwould )Y effluents should be reduced as low as Commissioner Curtiss would prefer to
- I
y8 reasonably achievable taking into endorse the principle of lustification of g
- n e
a practices account the state of technology, and the practice (i.e., whether the potential should be exempted.Therefore 1 believe economics of improvements in relation impacts of a practice are justified in that h blish d to the benefits to public health and terms of net societal benefits) and retain ,ppropri te BR o Icy that does not safety and other societal and the prerogative to reject applications for consider whether a proposed practice is socioeconomic considerations, and in exemptions regardless of the risk they justified in terms of societal benefit, relation to the utilization of atomic
- pose, energy in the pub!!c interest (10 CFR 20.1 I disagree with Commissioner Curtiss* Agreement State Compatibility l
{c)).The ALARA concept is one of the view on this matter because it puts the o i stoner rtise al disagrees fundamental tenets of radiation Commission in a position of making protection and has been a keystone in decisions in areas outside the normal IO Y the need for uniformity between basic NRC's regulatory framework. Public arena ofits expertise, where the agency comments on the proposed BRC policy would be especially vulnerable, perhaps radiation protection standards - established by NRC and Agreement statement and on proposed revisions to justifiably so, to criticism. Consistent States. He indicates that he would not to CFR Part 20 urged the Commission to with the mission of the NRC, the define " floors" to ALARA or thresholds Commission should base its judgments treat the Commission's polley on below below which NRC would not require on an explicit, objective and rational regulatory concern as a matter of further reductions in doses or effluents. consideration of the health, safety, and compatibility for Agreement States with The Commission responded to these er vironmental risks associated with respect to disposal of commerciallow-level radioactive waste. He reaches this comments in the policy by stating that practices rather than on what many
- *
- a licensee using the exemption would perceive as personal preferences conclusion in part because he reads the would no longer be required to apply the of the Commissioners.Such an approach Low-Level Radioactive Waste Policy ALARA principle to reduce doses.
fosters long term stability in regulatory Amendments Act of1985 as giving further for the exempted practice decisionmaking on potential states a great deal oflatitude in deciding _ provided that it meets the conditions exemptions, how to proceed with the development, specified in the regulation" established Decisions on justification of practice construction and operation of new low-for a particular exemption. In other involve social and cultural level waste disposal facilities. Drawing words, the BRC criteria and considerations that fall outside of the upon this interpretation. he concludes implementing regulations will provide Commission's primary focus and that individual states should be allowed j
- floors" to ALARA for the exempted expertise for ensuring adequate the option of deciding whether low-level practice. In this regard. I agree with protection of the public health and waste designated BRC should be Commissioner Curtiss because the safety from the use of nuclear materlats. disposed ofin a licensed low-level truncation of further efforts to reduce Such decisions should be made by radioactlye waste disposal facility.
doses is one of the principal regulatory affected elements of society, such as This policy statement in and of itself motivations for establishing the BRC residents nest a contaminated site, does not make any compatibility policy. potential customers, suppliers, and other determinations: as indicated in the However.1 disagree with the rest of members of the general public, rather statement, compatibility issues will be Commissioner Curtiss' view on this than NRC.1 believe that this position is addressed in the context ofindividual issue. it would be inappropriate to tell constatent with regulatory practices of rulemakings as they occur. But I believe the regulated community that they other government agencies that it is important to respond to cannot reduce doses below the BRC generally do not regulate on the basis of Commissioner Curtise on this issue in criteria. In short, although we will not whether a particular practice is justified Iwo respects. First.1 do not read the require licensees to reduce doses in terms of net societal benefit.For Low-Level Radioactive Waste Policy S-041999 00$4(03X02-JUI WlOO.21) F4703JMT. DB.30) 7-08-8B
p y 4 Fedtral Reglsirr / Vol. 55, No.128 / Tuesday. July 3,1990 / Nolices 27537 Amendments Act as giving the States designating wasie streams which are waste fac!!!!y. lf a patchwork of particular latitude let alone specific below regulatory concern. disposal criteria were to develop.It authority in the area cf waste to The respective roles of the would be virtually impossible in establish radiation standards different Commisalon and the States with respect establish decommissioning funding than those of the Commisalon.Second. ! to the licensing and regulation of Atomic requirements that would be adequate to do not believe that the 13:ue of BRC for Energy Act materiala. including the assure that alllicensed fact!!!!es will set weste disposal can esilly be divorced disposal orlow-level radioactive waste s.alde sufficient funds over the life of a from BRC in other stess such as received from other persons, are facility to pay for decommissioning. The decommissioning. governed by the provisions of section resulting confusion from these The law. Level Radioactive Waste 274 of the Atomic Energy Act of1954.as conflicting standards could well result in i policy Amendments Act did not change amended. Absent the execution of a delays in adequate decommissioning of the regulatory framework applicable to section 274b Agreement with the NRC, a contaminated sites and certainly in Atomic Energy Act materlats. On the State is preempted by Federallow from unnecessary concern on the part of the j contrary, the Act specifically recognized exercising regulatory authority over the public. ! continue to believe that the importance of that framework by radiological hazards of these materials. reserving to the NRC the authority to Including provlsions such as the The Commission is authorized to enter establish basic radiation protection following: i Into an agreement with a State only standards,lacludhg designatir g which Sec. 4{bl * *
- 13) ETTECT OF COMPACTS upon a finding that the State program is waste streams are below regulatory ON FEDERAL LAW.--Noting contained in compatible with the Commission's concern. le fully justified to ensure an this Act or sny compset msy be construed to program for regulation of radioactive adequate, uniform and consistent level confer any new authority on shy campset materials and adequate to protect the of protection of the pub!!c health, safety 3
{A o gu te a cksging. genera tion. p ea and safey. Secdon and b en&nmeM. trea tment. storsge. disposat. or transporta tion 274d.(2).The legislative hlstory of { of low.leve! radioactive weste in a manner section 274 stresses throughout the [FR Doc. 90-15309 Filed 7-2-et. 8:45 smj incompatible with the regulations of the Importance of and the need for Nuclear Regulatory Commission * * *: continuing compatibility between (B) to regulate health, sefety, or Federal and state regulatory programs. environmental hazards from source material. byproduct material, or special nuclear In comments on the legislation, the joint
- '"I*h Committee on Atomic Energy (JCAE) stated that 14)FIDERAL AtJTHORTTY.-Except as SMe loint Commlun beheves it expressly provided in this Act nothing important to emphasize that the radiation contained in this Act or any compact mey be standards adopted by States under the construed to limit the applicability of any egreements of this bill should either be Tederellow or to diminish or otherwise identical or compatible with those of the j
impair the furisdiction of any Federal Federal Govemment. For this reason the j stency. * *
- committee removed the language *to the i
i Unlike the Uranium Ml!! Ta!!ings extent feasible
- In subsection g. of the original Radiation Control Act of1978, as AEC bill considered at hearings from May to amended, the Low. Level Radioactive to 22.1959.The committee recognfies the 1
importance of the testimony before it by Weste policy Act, as amended, does not numerous witnesses of the dangers of authorize States to establish more conflicting, overlapping and inconsistent atringent atandards.The Act also standards in different jurisdictions, to the specifically directed the Commission to hindrance ofindustry and jeopardy of public establish standards for exempting " IY" specific radioactive waste streams from Sen. Rept. No. 870. September 1.1959 regulation due to the presence of BBth Cong 1st. Sess. radionuclides in such waste streams in The potential problems from sufficiently low concentrations or conflicting standards identified by the quantilles as to below regulatory JCAEIn 1959 are fully apparent In the concern.lf,in response to a request to context of BRC and demonstrate why exempt a specific waste stream, the the scope of cornpatib!!)ty findings to be Commission determines that regulatlon made by the NRC cannot be drawn to of a radioactive waste stream le not exclude low. level radioactive waste necessary to protect the public health disposal For instance, the Commission and safety, the Commission is directed intends to use the risk criteria identified to take necessry steps to exerrpt the in the polley statement to establish j disposal of such radioactive material decommissioning criteria, i.e., the level from regulstion by the Commission. at which a formerly licensed site may be Thus, the Act d!d not, in my view. grant released for unrestricted use.lf the any particularlatitude to the States to states are permitted to requ!re that low. determine which waste streams were of level weste streams designated BRC by regulatory concern. Rather,it reaffirmed the Commission be disposed ofin a low-the existing roles of the NRC and tha level waste facility. It could result in a States in determining regulatory s!!e in one state being released for j standards for low. level waste and unrestricted use, while soll or materials specifically defined the Commission's in an adjacent state a,t that level would authority in this regard as including be required to be confined in a low. level 5-041999 005S(03XC2-JUL-90-1430.24) F4703.FMT DB.30) 7-08-B8 l
1 Attachment E UPDATED STAFF ACTION PLANS RELATED TO ISSUES OTHER THAN ) l RADIOLOGICAL CRITERIA FOR DECOMMISSIONING I. RADIOLOGICAL CRITERIA FOR RECYCLE OF MATERIALS AND EQUIPMENT Technical basis report - Contract awarded in September 1992 GEIS and rule - Rulemaking and development of a GEIS will not be undertaken until completion of technical basis report and completion of enhanced participatory rulemaking. II. REVIEW 0F WASTE DISPOSAL PRACTICES Waste Characterization Study - Draft contractor report received 5 August 1991; final report scheduled for summer 1993. NUREG/CR-5797, QA and revision of IMPACTS-BRC computer code, j published in April 1992. 1 Waste petitions and rulemaking - Two of the three petitions have previously been withdrawn; the third is to be returned to the petitioner for potential update. The generic waste exemption rulemaking, which was initiated with an advance notice of proposed rulemaking, would be terminated by Federal Register notice. j III. REVIEW 0F SEWAGE SLUDGE DISPOSAL PRACTICES NUREG/CR-5814, an evaluation of doses from sewage sludge (excluding the impact of human excreta), was published in i May 1992. Rulemaking to revise sewer disposal limits has been requested in a d user need request from NMSS to RES dated February 25,'1993. IV. REVIEW 0F EXISTING EXEMPTIONS 'l Contractor, ORNL, is evaluating doses from existing exemptions; a i draft report is scheduled for summer 1993. A cost-benefit analysis of those exemptions with the most significant ootential doses will follow and will provide a technical basis to' evaluate whether the exemption should be modified, continued or removed. Rulemaking on any revision to existing' exemptions will not be j undertaken prior to the completion of these analyses. =i Rulemaking to update Part 40 was initiated in part'to improve j control of material being distributed to exempt use but was-l expanded to consider any updating needs for.Part 40. An Advance Notice of Proposed Rulemaking was published October 28, 1992. Work is underway to analyze the comments received.and to plan the approach and scope of rulemaking. The staff will provide the Commission with the analysis of' l comments and recommendation on scope and priority for rulemaking. The staff is discussing differences in the perceived need for a lower priority rulemaking to revise the schedule of reports submitted on materials distributed under Part 30 exemptions and will provide the Commission with recommended actions at a later time. . ~..
j e.' !.i j V. REVISIONS TO REGULATORY GUIDES Guidance documents supporting any of the.rulemakings discussed j above will be scheduled as appropriate relative to the progress of 1 each rule to which it relates. 1 VI. UPDATING OF HEALTH EFFECTS RESEARCH This is an ongoing effort proceeding as planned. VII. WASTE OIL RULEMAKING Complete - Final rule published December 7,1992. - j VII.
SUMMARY
OF PUBLIC MEETINGS ON BRC POLICY Complete - The transcripts and related information from the meetings were placed in the Public Document Room. A meeting summary was not published as directed by the Commission. j A I l 1 i l i 2 '[ a k e J l l ,.. _.. _..}}