ML20149L640
| ML20149L640 | |
| Person / Time | |
|---|---|
| Issue date: | 06/27/1996 |
| From: | Lieberman J NRC OFFICE OF ENFORCEMENT (OE) |
| To: | Morrison D NRC OFFICE OF NUCLEAR REGULATORY RESEARCH (RES) |
| Shared Package | |
| ML20148P089 | List: |
| References | |
| FRN-61FR65120, RULE-PR-20 AF31-2, AF31-2-048, AF31-2-48, NUDOCS 9607250130 | |
| Download: ML20149L640 (56) | |
Text
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/ UNITED STATES 3
j NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 2006H001 V
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June 27, 1996 MEMORANDUM T0: avid L. Morrison, Director Office of Nuclear Regulatory Research FRON: . James Lieberman, Director Office of Enforcement b . "
SUBJECT:
FINAL RULE: RESOLUTION OF DUAL REGULATION OF AIRBORNE EMISSIONS, CLEAN AIR ACT - 10 CFR PART 20
' The Office of Enforcement (OE) has re' viewed the subject rule change and has
- the following. comments:
Commission Paper:
The Commission Paper should~ include as an enclosure a proposed Notice for the federal Register, to be issued on the same day as the final rule, to modify the " General Statement of Policy and Procedures for NRC Enforcement Actions" (Enforcement Policy) to add an example at Severity Level IV of a violation where the licensee had information to indicate that it had exceeded the ALARA
> dose constraint in 10 CFR 20.1101(d)(1), but failed to report the exceedance or. failed to take the required corrective actions. OE will provide a draft of the Notice to change the Enforcement Policy. Conforming changes will need to
!. be made to the " Subject", " Purpose", " Discussion", and " Recommendation" i
sections of the Commission Paper to indicate that the Commission also is being asked to approve the draft Notice to modify the Enforcement Policy.
Commission Paper, Discussion, page 2: "
. . .if a licensee exceeds the constraint, reports to NRC, and takes corrective actions as aereed upon,
.. . . exceedance. in subsequent years would not be violations."
It is not clear how the corrective actions would be agreed upon. Per Cheryl Trottier, a license amendment process is not envisioned. Therefore, it would be better..to substitute: " . . . and takes corrective actions as required by the regulation."
Since the 10 mrem /yr TEDE is a constraint and not a limit', exceedance is never a violation; thus, there is no need to provide an "if"' clause that states-certain conditions under which exceedance would not be a violation.
Statements of Consideration, Modification of Enforcement Policy.
At an appropriate point in .the statements of consideration, the text should indicate that, by' separate' Notice in the Federal Register on the same day, the CommissionLis modifying its " General Statement of Policy and. Procedures for NRC Enforcement Actions" (Enforcement Policy),. to address the new ~ regulation, and that this change also will be reflected when the Enforcement. Policy-is reprinted in;its entirety in the next revision of NUREG-1600.
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-( David L. Morrison Statements of Consideration, Supplementary Information, Background, page 7:
. . . a[n] NOV will be issued only upon failure to report that . . . doses -
~, have exceeded the constraint value and/or failure to institute appropriate measures to correct and prevent further emissions. . ."
Does NRC plan to review or inspect the corrective action? If licensees-provide.the corrective action to NRC and NRC receives it, but does not raise any question about it, it may be difficult, .in the future, for NRC to say.that .. .
the corrective action was not appropriate. It seems that NRC will need to review the corrective action and respond to the licensee with a statement that the corrective action will- be subject to future inspection. You need to obtain the views of NMSS on this issue as it raises a resource question. . If we don't intend to review or follow up on the corrective action, why require licensees _to submit it?- Under that scenario, it should be enough to have the L11censees retain a record of their corrective action for future inspection.
Additionally, we need to recognize that the term " appropriate" is not defined in the regulation; therefore, a rule of reason must be applied. The fact there-is a repeat exceedance does not necessarily mean that the licensee's corrective action was inappropriate, given the information available-to the licensee at the time that the corrective action for the exceedance was taken.
Statements of Consideration, Response to Comments, Issue 2,.page 16: "This kind of ALARA rule imposes a limit in the sense that exceedance will lead to
. enforcement action to achieve compliance, but it is not a limit in the sense that conformance is needed for adequate protection."
OE recommends that this passage be modified to read: "This kind of ALARA rule imposes a limit in the sense that exceedance will lead to corrective action, but it is not a limit in the sense that exceedance per se would constitute a violation of any regulatory requirement. A violation occurs only when a licensee fails to report an exceedance or fails to take appropriate corrective
. Action."
Statements of Consideration, Response to Comments, Issue 2, page 16: "Thus, to say that the constraint rule cannot be based on ALARA because it is in effect a '11mit' impermissibly interchanges a narrow concept of
- ALARA' with a '
broad concept of ' limit.'"
OE recommends that the word, "impermissibly" be deleted. It is not clear who I does not permit this or why.
- . Statements of Consideration, Response to Comments, Issue 2, page 16
- "The ;
_ constraint rule is not a-limit needed for adequate protection, and is something more than a narrow translation of_the particular ALARA concept in
-10 CFR 20.1003.. . ."
OE recommends that this sentence be modified as follows: "The constraint is not a= limit needed for adequate protection, and the constraint rule is something more'than a narrow translation of the particular ALARA concept in 10 CFR 20.1003."
N.
' David L. Morrison Statements of Consideration, Response to Comments, Issue 2, page 17: "[If]
the dose limit is, or is projected to be, exceeded, licensee actions to come
[into] compliance are expected and, if needed, will be enforced."
Since the constraint is not a limit, " compliance" with the constraint is not required. What the rule does require is that the licensee: (1) make a report to NRC; and (2) take adequate corrective action to assure that the constraint is not exceeded again in the future. Enforcement action can only be takta if ---
~t he report is.not made or adequate corrective action is not taken.
i Statements of Consideration, Response to Comments, Issue 3, page 18: "The constraint is a dose at which the licensee must notify NRC, but it is not a dose above which enforcement action would necessarily be taken."
OE recommends that this statement be modified to read: "The constraint is a dose at which the licensee must notify NRC, but it is not a dose limit above which enforcement action will be taken." The reasoning behind this recommendedchangeisthat,since"exceedanceisnotaviolation"(Id.,atIJ-18), enforcement action will not ever be taken for exceeding the constraint.
l Enforcement' action can only be taken if the report is not made or adequate l
corrective action is not taken.
Statements of Consideration, Respcnse to Comments, Issue 3, page 18: "[If]
lO the constraint has again been exceeded, where agraed upon corrective actions had been appropriately implemented, ~ enforcement action would not necessarily be considered."
As noted above, it is not clear how corrective actions would be " agreed upon."
, Since "exceedance is not a violation" (Id., at 17-18), enforcement action will not ever be taken for exceeding the constraint.
Statements of Consideration, Response to Comments, Issue 8, page 23: "If a
-licensee exceeds the constraint, the rule requires that corrective actions be taken in a timely fashion. If a' licensee is uncooperative or fails to take appropriate actions, a notice of violation and civil penalties are possible."
l To parallel the rule OE recommends that this statement be modified to read:
". . . the rule requires that corrective actions be promptly taken. If a licensee does not comply,' enforcement action will mult."
Rule, 10 CFR 20.1101(d)(1): "To implement the ALARA requirement of 20.1101(b), and notwithstanding the requirements in 20.1301 of this part, licensees. . . shall constrain environment air emissions so that the
. individual member of the public likely to receive the highest dose will not be expected to receive a dose in excess of. . ."
To parallel the definition of " constraint" in 20.1003, and to clarify that the constraint-is not a regulatory limit, OE recommends that the rule be modified 10f course, enforcement action would be taken if other radiation limits were exceeded as well.
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David L. Morrison. _ 4_ .,
to read: "To implement the ALARA requirement of 20.1101(b), and notwithstanding the' requirements in 20.1301 of this part, a constraint on e^ t 2nmental air emissions. of radioactive materials is hereby established
- ct that the individual member of the public likely to receive the highest ou.u will not be expected to receive a dose in excess of . . ."
cc: ' C. Paperiello, NMSS M. Weber,-NMSS - ' ' ~ ~
F. Cameron, OGC l
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MEMORANDUM TO: David L Morrison ,
Director _.
Office of Nuclear nyulatory Research . ,
FROM:. Msrtin G.Malsch Deputy General Counsel Office of the General Counsel i SU8 JECT: OGC REVIEW OF THE DRAFT FINAL RULE ON A CONSTRAINT FOR AIR EMISSIONS FOR OTHER THAN POWER REACTORS We have completed our review of the latest version (July 1,1996) of the rulemaking package on establishing a constraint on ;
air _ emissions for other then power reactors. I provided our comments on the previous version (May 10,1996) of this draf t ;
final rule in a memorendum to you of June 27,1996. Although most of the issues identified in the June 27th memo have been addressed in the latest version of the package, two issues are still outstanding. We also have several additional I
concerns that arise from some changes that luve beer made to the previous package. Provided the issues identified below L are addressed satisfactorily, we will be prepared to provide a "no legal objection" to the rulemaking package.
Issues Noi addrest;.ed From the June 27,1996 Memo 1.' We should notify the Commission the't the final EPA rescission rule will not be issued until the NRC informs tbs ;
EPA that the Commission's procedures for suspending or terminating deficient Agreement State programs are j finalized. We should also notify the Commission that tha Office of State Programs ' plans to apply the procedures for suspeasion and termination of Agreement Stato programs that were submitted to the Commission on Apd X, 1996. As such these procedures will be treated as f!nal despite the f act that the Policy Statement on Principles M8 and Policy for the Agreement State Program has not been approved by the Commission for finalimplementation. agg.
Furthermore, the FRN for the final rule willindicate that the Commission does have these procedures in place. Thir ;
should satisfy EPA's concemf (Point 4 in our June 27th memo)
- 2. Add the following to the discussion of issue 5 on pages 20 through 22 of the FRN (and also to page 13 of the Regulatory Analysis):"Under %ction 274 of the Atomic Energy Act the Commission reviews Agreement State w , //
programs to ensure that adequacy and compatibility of the State Program is maintained. The Commission has also 4 approved procedures to suspend or terminate programs that are not adequate or compatible. (Point lo in our June 27th memo).
- New issues and comments i _
- 1. On page 2 of the commission Paper, add the following efter the first sentence of the second full paragraph in the Discussion section
- "However, the proposed rule did receive substantial support from the Nuclear Faergy institute
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' - (NEI)in the sense that the rule was preferred to dual regulation."
- in the same paragraph, the' discussion notes that "two states did not see a benefit to " transferring responsibility vAI/
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to NRC." We should also discuss any support for the rule from the States, a 4d- ,
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- 2. _ The Cammission Paper now includes a discussion of the opinions of " staff" on various aspects of the rule, e.g.,
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that some NRC staff believe that the constremt rule " violates the basic philosophy of ALARA"; or that some nombers of the staff " feel that NRC does not have the legal authority to impose a constraint whose only purpose !
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is to provide a legal basis for EPA to rescind an unnecessary regulation promulgeted under the Clean Air Act."
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- We believe there are two major problems presented by this discussion. The first is whether statements as to what some staff believe or don't believe is appropriate at alin the Commission Paper given the reality of the office concurrence process and the availability of a formal Differing Professional 0 pinion process for individual staff members. If the staff in a particular office disagree with a proposed approach, the decisionmaking process in the l office is the vehicle for developing a final office position on that approach. If the office ultimately does not agree
- with the approach, then that can be presented by the office as a nonconcurrence (or as some other type of ,
reservation about the approach). If individual staff members disagree with the office position, they are free to use the Differing Professional 0 pinion process to register their concerns.
Our second concern is that no discussion is provided on the merits of these staff beliefs. For example, the FRN
- contains an in depth discussion of the "ALARA philosophy" issue. However, the statement of staff disagreement does not address the arguments put forth in the FRN. Likewise, the FRN does not state that the "only purpose" of ,
the rule is to rescirid an unnecessary regulation. However, the statement of staff disagreement as to legal i' authority does not discuss this f act.
We would recommend deletion of this entire discussion.
- 3. As noted in "1" above under " outstanding issues", the Commission Paper should address the issue of the suspension and termination procedures for Agreement State programs. On a related point, the Commission Paper raises the issue that " EPA has expressed concern over the time period permitted for the Agreement States to
. adopt compatible regulations." in regard to this statement, we would note that the EPA Office of General Counsel
- has informed us that it has advised the EPA technical staff that the time period need not f arm the basis for an EPA decision to not rescind Subpart 1. However, even if EPA is formally raising this as an issue for the NRC to address, the Commission Paper does not contain any discussion of what the issue is, e.g., why it is a concem, what the d.i 2^-
NRC staff positionis,etc
- 4. OGC had provided RES staff with a discussion of the ALARA issue as the basis for responding to the various public comments on this issue. The May 10,1996 version of the rule included this discussion on pages 14 through 18.
However, the latest version of the package has revised this discussion in several ways that need to be i
reconsidered.
The May 10 version included the statement on page 16 of the FRN that "This kind of ALARA rule imposes a limit w. ll in the sense that exceedance willlead to erforcement action to achieve compliance, but is not a limit in the sense *f b that conformance is needed for adequate protection." This statement has been revised in the latest version to read "This kind of ALARA rule imposes a limit in the sense that exceedence willlead to corrective action, but it is not a limit in the sense that exceedence per se would constitute a violation of any regulatory requirement." We believe that the original statement is more accurate and sd ephe the revised version. 'l I
On a related point, there are several statements in the response to Issue 3 "Whether the Constraint is Actually a -
Limit", that should be revised. The first sentence of the response states that a constraint is "not a dose limit d'M '
above which enforcement action wil be taken". Further on, the resp:;nse states that "If the constraint is again g h., ,
. exceeded, af ter corrective actions had been appropriately implemented, enforcement action would not be taken."
- j
- We believe that these two statements are misleading and wiH only create unnecessary anxiety at EPA and in the public mind on the enforceability issue.' The previous version is preferre d, with the exception that any statements M of the type that indicate that "a constraint is not the same as a limit" or that "a constraint is not needed to pw&h protect public health and safety" should be clarified to indicate that a constraint is not a limit in the sense of
. something necessary to provide adequate protection of public health and safety. We should also refer the reader l
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back to the discussion on " limits" included in response to issue 2.
We believe that EPA will face substantiallitigative risk in defending rescission (the EPA's and NRC's mutual V objective)if we make statements like "the constraint is not enforceable per se" or "the constraint is not a s regulatory requirement". However, we have no objection to the Statement of Considerations including a statement to the effect that:" While a failure to report would warrant enforcement aciion, a reported firsttime Q 1og exceedence of the 10 mrem constraint would not be used to suspend or revoke licenses or to impose civil or 4tg I[j (\ criminal pensities. However any exceedance will require the licensee to take corrective :ction to come into compliance and additional enf orcement action could be taken if licensees f ail to implement their corrective action."
h The material beginning at the end of page 16 and continuing on to page 17 of the May 10 version has been revised j,b in a small but, we believe, significant way. This traterial now appears as a response to a comment that begins y "The constraint cannot be ALARA..."(the pages are unnumbered in our copy of the latest version). The discussion now includes the conclusion that the rule offers a "small but positive, net health and safety benefit", but it does '
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[\ not include the rationale from the May 10 version,i.e., the rule will have the effect of preventing possible future b< d i
backsliding by licensees. This should be added to the latest version. l 4
Likewise,;5e discussion of reference levels deletes the final sentence of the discussion that appeared in the previous version. This sentence,"It is not the purpose of the constraint rule to provide such added assurance",
M d-should be added to the latest version. !
Y The discussion in the latest version, originally included as the first full paragraph of page 17 of the May 10
$f version, deletes what we believe is an important point,i.e., licensee actions to come into compliance with the 4
g constraint are expected, and if needed, will be enforced. This concept should be added back in to the latest f N version. In addition, the use of the terms " recommend corrective actions", and "take those actions as agreed upo I3 with NRC"in the latest version of this paragraph sends the incorrect message that the licensee doesn't have to M*d e take any corrective action to lower the dose until the completion of the NRC review.
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Finally, the following should be added at the end of the first paragraph of the response to the ALARA comments:~
"The ALARA concept in the current regulations is site specific in that some of the f actors to be considered may vary from case to case, as the court so found in York Committee for a Safe Environment v. NRC 527 F. 2d 812 (D.C. Cir.1975). The Commission has presumed, without deciding, that the ALARA concept in 20.1003 can be enforced in a particular case so as to require a specific radiation protection practice, but it is clear that the !
existing regulation does not translate readily into a generic dose number, which,if exceeded, willlead to gL l enforcement action.
- 5. The response to issue 7 " Effective Date" should be revised to read that "The NRC and EPA will arrange to publish 4
both final rules concurrently with the same eflective date."
- 6. The section summarizing the changes in the final rule indicates that Section 20.2203(b)(2) has been changed to require the name, social security number, and date of birth only for occupationally exposed individuals. This is essentially the same as existing 20.2203(b){2) and it is unclear what,if anything, we are revising. d d Distribution: Centrel Files OGC slf OGC tlf a
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1
- MEMORANDUM T0: David L. Morrison 1
Director. !
!- Office of Nuclear Regulatory Research FRON: Hartin G. Malsch i Deputy General Counsel Office of the General Counsel l
SUBJECT:
OGC REVIEW OF THE DRAFT FINAL RULE ON A CONSTRAINT FOR AIR EMISSIONS FOR OTHER THAN POWER REACTORS We have completed our review of the latest version (July 1, 1996) of the i rulemaking package on establishing a constraint on air emissions for other ;
than power reactors. I provided our comments on the previous version (May 10, 1996) of this draft final rule in a memorandum to you of June 27, 1996.
Although most of the issues identified in the June 27th memo have been >
addressed in the latest version of the package, two issues are still outstanding. We also have several additional concerns that arise from some changes that have been made to the previous package. Provided the issues identified below are addressed satisfactorily, we will be prepared to provide a "nn legal objection" to the rulemaking package. ,
' Issues Not Addressed From the June 27, 1996 Memo
- 1. We should notify the Commission that the final EPA rescission rule will ge not be issued until the NRC informs the EPA that the Commission's
/ procedures for suspending or terminating deficient Agreement State ,
_ nraaram are finalized.lWe should also notify the Commission that the -
Office of State Programs plans to apply the procedures for suspension ,
- and termination of Agreement State programs that were submitted to the 1h
/ Cossnission on April 25, 1996. As such these procedures will be treated as final despite the fact that the Policy Statement on Principles and Policy for the Agreement State Program has not been ap) roved >y the i Commission for final implementation.[Furthermore, the :RN for the final rule w1:1 tr.aicate tnat tne commission does have these procedures in IC-
/ place. This should satisfy EPA's concern. (Point 4 in our June 27th memo)
- 2. Add the following to the discussion of Issue 5 on pages 20" through 22 of the FRN (and also to page 13 of the Regulatory Analysis): Under Section 274 of the Atomic Energy Act the Commission reviews Agreement State
[ programs to ensure that adequacy and compatibility of the State Program is maintained. The Comm9sion has also approved procedures to suspend or terminate programs that are not adequate or compatible. (Point 10 in our June 27th memo). _ g gg M W g Fg AJ eJ; New issues and comments
- 1' On page 2 of the Commission Paper, add the following after the first j sentence of the second full paragraph'in the Discussion section: p\* (
v "However, the proposed rule did receive substantial support from the Nuclear-Energy' Institute ~(NEI) in the~ sense that the rule was preferred to dual regulation "
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l In the same paragraph, the discussion notes that "two states did not see F\ ,
p a benefit to " transferring responsibility to NRC." We should also discuss any support.for the rule from the States.
1
'2. The Commission Paper now includes a discussion of the opinions of
" staff" on various aspects of the rule, e.g., that some NRC staff believe that the constraint rule " violates the basic philosophy of ALARA"; or.that some members of the staff " feel that NRC does not have the legal authority to impose a constraint whose only purpose is to provide a legal basis for EPA to rescind an unnecessary regulation promulgated under the Clean Air Act." l We believe there are two major problems presented by this discussion.
'The first is whether statements as to what some staff believe or don't ;
believe is appropriate at all in the Commission Paper given the reality of the office concurrence process and the availability of a formal Differing Professional Opinion process for individual staff members. If
'the staff in a particular office disagree with a proposed approach, the decisionmaking process in the office is the vehicle for developing a k ~ final office position on that approach. If the office ultimately does j d not agree with the approach, then that can be presented by the office as 1 O a nonconcurrence (or as some other type of reservation about the M approach). If individual staff members disagree with the office k position, they are free to use the Differing Professional Opinion process to register their concerns.
Our second concern is that no discussion is provided on the merits of these staff beliefs. For example, the FRN contains an in-depth discussion of the "ALARA philosophy" issue. However, the statement of staff disagreement does not address the arguments put forth in the FRN.
Likewise, the FRN does not state that the "only purpose" of the rule is to rescind an unnecessary regulation. However, the statement of staff
- disagreement as to legal authority does not discuss this fact. j We would recommend deletion of this entire discussion. ,
l 3. As noted in "1" above under " outstanding issues", the Commission Paper should address the issue of the suspension and termination procedures :
for Agreement State programs. On a related point, the Commission Paper l
/ raises the issue that " EPA has expressed concern over the time period
- permitted for the Agreement States to adost compatible regulations." In fp
' regard to this statement, we would note t1at the EPA Office of General
! Counsel has informed us that it has advised the EPA technical staff that the time period need not form the basis for an EPA decision to not rescind Sub) art I. However, even if EPA is formally raising this as an issue for.tte NRC to-address, the Commission Paper does not contain any discussion of.what the issue is, e.g., why it is a concern, what the NRC
!. : staff position is, etc..
! 4. 0GC had provided RES staff with a discussion of the ALARA issue as the i
! . basis.for responding to the various public comments on this issue. The May.10, 1996 version of the rule included this discussion'on pages 14 l
~
1
_3_
1 through 18. However, the latest version of the package has revised this I discussion in several ways that need to be reconsidered. l The May 10 version included the statement on page 16 of the FRN that "This kind of ALARA rule imposes a limit in the sense that exceedance will lead to enforcement action to achieve compliance, but is not a limit in the sense that conformance is needed for adequate protection."- ps 1 This statement has been revised in the latest version to read "This kind p I 3
6- @gh.of corrective ALARA rule imposes a limit in the sense that exceedance will lead to 4 action, but it is not a limit in the sense that exceedance Y per se would constitute a violation of any regulatory requirement." We believe that the original statement is more accurate and should replace the revised version.
~
On a related point, there are several statements in the response to Issue 3 "Whether the Constraint is Actually a Limit", that should be I revised. The first sentence of the respone states that a constraint is l "not a dose limit above which enforcement action will be taken".
Further on, the response states that "If the constraint is again exceeded, after corrective actions had been appropriately implemented, enforcement action would not be taken." We believe that these two UIO i
statements are misleading and will only create unnecessary anxiety at EPA and in the public mind on the enforceability issue. The previous 1 version is preferred, with the exception that any statements of the type y y that indicate that "a constraint is not the same as a limit" or that "a constraint is not needed to protect public health and safety" should be l
J p fg clarified to indicate that a constraint is not a limit in the sense of g something necessary to provide adequate protection of public health and safety. We should also refer the reader back to the discussion on
" limits" included in response to Issue 2.
We believe that EPA will face substantial litigative risk in defending rescission (the' EPA's and NRC's mutual objective) if we make statements like "the constraint is not enforceable per se" or "the constraint is not a regulatory requircment". However, we have no objection to the p Statement of Considerations including a statement to the effect that: " %C
/f .While a failure to report would warrant enforcement action, a reported e first-time exceedance of the 10 arem constraint would not be used to M suspend or revoke licenses or to impose civil or criminal penalties.
However any exceedance will require the licensee to take corrective action to come into compliance and additional enforcement action could be taken if licensees fail to implement their corrective action."
^
The material;beginning at the end of page=16 and continuing on to page 17 of the May 10 version has been revised in a small but, we believe, f significant way. This material now appears as a response to a comment g that begins "The constraint cannot be ALARA..." (the pages are unnumbered in our copy of the latest version). The discussion now 9 49 includes the conclusion that the rule offers a "small but positive, net 4 health and safety benefit", but it does not include the rationale from p cthe May 10 version, i e., the rule will have the effect of preventing
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possible future backsliding by licensees. This should be added to the latest version.
Likewise, the discussion of reference levels deletes the final sentence p
/. of the discussion that appeared in the previous version. This. sentence, 9 ,
"It is not the purpose of the constraint rule to provide such added +
assurance", should be added to the latest version.
% discussion in the latest version, originally included as the first full paragraph of page 17 of the May 10 version, deletes what we believe is an important point, i.e., licensee actions to come into compliance with the constraint are expected, and if needed, will be enforced. This y p
-concept should be added back in to the latest version. In addition, the use of the terms " recommend corrective actions", and "take those actions as agreed upon with NRC" in the latest version of this paragraph sends the incorrect message that the licensee doesn't have to take any corrective action to lower the dose until the completion of the NRC review. _
~
Finally, the following should be added at the end of the first paragraph of the response to the ALARA comments: "The ALARA concept in the current regulations is site specific in that some of the factors to be considered may vary from case to case, as the court so found in 1qth 8
) Committee for a Safe Environment v. NRC, 527 F. 2d 812 (D.C. Cir. 1975).
The Commission has presumed, without deciding, that the ALARA concept in 20.1003 can be enforced in a particular case so as to require a specific radiation protection practice, but it is clear that the existing regulation does not translate readily into a generic dose number, which, '
e if exceeded, will lead D - S m ,4 :st.ian.
- 5. The response to Issue 7 " Effective Date"-should be revised to read that f
/ "The NRC and EPA will arrange to publish both final rules concurrently d6 with the same effective date."
- m. -
4
- 6. The section summarizing the changes in the final rule indicates that -
Section 20.2203(b)(2) has been changed to require the name, social security number, and date of birth only for occupationally exposed individuals. This is essentially the same as existing 20.2203(b)(2) and lf 'k it is unclear what, if anything, we are revising.
Distribution: Central Files '
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f_QB: The Commissioners ERQti: - James M. Taylor, Executive Director for Operations ENEGI: FINAL RULEMAKING - REVISION TO 10 CFR PART 20 RELATED TO CONSTRAINT FOR AIRBORNE RADI0 ACTIVE EFFLUENTS TO THE ENVIRONMENT FROM NRC AND AGREEMENT STATE LICENSEES; AND REVISION OF THE GENERAL STATEMENT OF POLICY AND PROCEDURES FOR NRC ENFORCEMENT ACTIONS PURPOSE:
To request Commission approval to (1) publis h .a not i ce of final rulemaking ,
amending the regulations in 10 CFR Part 20 -and (2) publish a revision to the
-General- Statement of Policy and Procedures for NRC Enforcement Actions (Enforcement Policy).
BACKGROUND:
The EPA promulgated National Emission Standards for Hazardous Air Pollutants .
i (NESHAPs) for'radionuclidos on October 31,'1989. Under 40 CFR Part 61, Subpart I,' emissions'of radionuclides must be limited so that' no member of the public would receive an effective dose equivalent greater than 10 mrem (0.1 mSv) per year. In 1990, Congress enacted amendments to the Clean Air Act (CAA) informing EPA that NRC and-Agreement State licensed facilities need not be subject to specific radionuclide limits under the CAA if the' EPA Administrator determines that the NRC regulatory program provides an ample margin of safety to protect public health. EPA's proposed rescission of-40 CFR Part.61, Subpart I, was published on December 1, 1992 (57 FR'56877).
Based on the results of surveys. undertaken by EPA, EPA made an initial determination' that the NRC prograr. 99 provide an ample margin of safety (57 FR 56880). ' However,' EPA express?ci concern regarding the adequacy of CONTACT:
Charleen T. Raddatz, RES 415;6215 I
.___________.____E____ _ _ _ _ _
The Commissioners 2 current measures to assure that future emissions will not exceed levels that provide an ample margin of safety,-and did not rescind 40 CFR Part 61, Subpart I. . Consequently, NRC and Agreement State licensees are currently subject to dual regulation of air emissions of radionuclides. On September 28, 1995, EPA published a notice reopening the comment period on the rescission of Subpart I (60 FR 50161).
On November 15, 1995, the Commission directed the staff to publish a proposed rule amending 10 CFR Part 20, that would establish a constraint of 10 mres (0.1 mSv) per year total tifective dose equivalent (TEDE) for dose to members of the public-from airborne radioactive effluents from NRC licensed facilities other than power raactors. A proposed rule was published in the Federal Reaister on December 13, 1995 (60 FR 63984), amending 10 CFR Part 20 to include a constraint on air emissions.
The proposed rule specified that to implement the as low as is reasonably achievable (ALARA) requirements of Part 20, licensees other than power reactors would be required to report to NRC, air emissions that by calculation or measurement, could result in a dose to a member of the public in excess of 10 mres (0.1 mSv) in'any year. In addition, the licensee would be required to implement corrective actions that NRC agrees are adequate to ensure against future air emissions leading to doses in excess of the constraint.
DISCUSSION:
Fifty-seven comment letters were received addressing the proposed rule and/or draft Regulatory Guide DG-8016. Among the 57 letters, 24 were from licensees, 7 from professional organizations, 5 from States,16 from members of the public, and 5 from environmental organizations.
In general, those commenters who believed that the proposed constraint was too l restrictive, too burdensome, and unnecessary were licensees, members of the Ng public, and professional societies. However, the proposed rule did receive %
substantial support from the Nuclear Energy Institute (NEI) in the sense that the rule was preferred to dual regulation. The commenters who believed that the proposed constraint was too lax, inadequate to protect the health of the ;
public, and not adequately enforceable were representatives of environmental
. groups. Two of the three States commenting on the proposed rule did not see a .
benefit in transferring responsibility to NRC. One state was concerned that i the cost to states for implementing compatible rules would not be justified by ,
any benefit. The other felt that the proposed constraint was less protective "
than Subpart I. Anotherstatedidnotobjecttoftherule,butexpressed concern that naturally occurring materials were not covered by the rule. Many commenters believed that EPA should be able to rescind on the basis of existing evidence.
The final. rule is basically unchanged from the proposed rule and requires licensees, other than nuclear power reactors, to constrain doses to members of the public to less than _10 mrea. (0.1 mSv) per year. This requirement will be codified as a means for implementing the ALARA requirements in 20.1101(b) l for air emissions. Any exceedance of the constraint would require prompt i
i
1 The Commissioners 3 y g_g corrective actions and a report to the NRC. Some-member 4-of_the_ staff believe s
- lo S y that the existing NRC programs are adequate s and a &rule constraint m &for air emissions is not needed. However, the staff recommendation is to go forward with the constraint rule.
In resolving public comments, a few minor changes were made to the final rule.
The proposed rule included a requirement to report demographic information on I exposed members of the public. The final rule was revised to specify that i demographic information is only required for occupationally exposed individuals, because the information is not needed by NRC except for occupationally exposed workers. Some commenters expressed concerns that the NRC rule applied to onsite airborne emissions. To more closely parallel the existing requirements of Subpart I, the final rule has been revised to clarify that the constraint is intended to apply only to airborne radioactive effluents to the environment.
In addition, the staff is recommending that the Enforcement Policy be amended I to add an example at Severity Level IV of a violation where the licensee had information to indicate that it had exceeded ALARA dose constraint in 10 CFR 20.1101(d), but failed to report the exceedance or failed to take the required corrective actions. l l
EPA has informed the staff that the EPA rescission rule will not be issued g, i until the NRC informs the EPA that the Comission s procedures for the N5 !
suspending or terminating deficient Agreement State programs are finalized. )
It is intended that both the NRC final rule and the EPA rescission will be published concurrently to avoid any unnecessary burden on licensees as a result of dual regulation.AThe EDO provided the procedures for suspension and termination of Agreement Stafe' programs to the Comission on April 25, 1996. gg In the absense of comments from the Commission to the contrary, these procedures will be treated as final in theTvent-that-theyJe_needed_ The ,
staff is aware that the Policy Statement on Principles and Policy for the Agreement State program has not been approved by the Comission for final
/hd i
implementation. Amm uk / gm4d py :4.d h IM 4 b~Md d 4 d.
ww M A j A draft regulatory guide was issued for public coment concurrent with the proposed rule. The regulatory guide has been revised to address coments received, as well as comments on the rule itself where appropriate. The final regulatory guide will be available to licensees on the effective date of the l
> rule.
BUDURCES:
l The Office of Nuclear Materials Safety and Safeguards anticipates an expenditure of 3.5 FTE for the first year, and 2.1 FTE per year thereafter, for the development of licensing guidance, inspector training, revisions to the inspection module, review of any licensee reports, routine and reactive inspections. Although the current NHSS Budget does not contain resources to implement this rulemaking, the 3.5 FTE are expected to be available for reprogramming from those allocated for the medical Quality Management i
1
.The Commissioners: 4 Temporary Inspection Module, and possibly from modifications to the medical-program.
COORDINATION: ,
The Office.of the General Counsel has no legal objection to this paper.
RECOMMENDATION: .
That the Commission: ,
.l. Approve publication of the final rule.. t 2.. Certify that the final rule will not have a negative economic impact on a substantial number of small ertities, in order to satisfy requirements of the Regulatory Flexibility Act, 5 U.S.C. 605(b).
I Nn11:
a.. The final rule (Attachment 1) will be published in the Federal Reaister;
- b. .The revision to the Enforcement Policy (Attachment 2) will be published in the Federal Reaister;
- c. A Regulatory Analysis has been prepared and will be made available in the Public Document Room (Attachment 3);
- d. 'The staff has determined that, under the Small Business Regulatory Enforcement Fairness Act of 1996, this is not a major rule because licensees affected by this rule are currently subject to the more
~
- burdensome requirements of 40 CFR 61, Subpart I, that it replaces.
' Appropriate notification will' be made (Attachment 4);
- e. An environmental assessment and finding of no significant impact 4
has been prepared and will be made available in the Public
- Document Room (Attachment 5);
I
- f. In accordance with the Regulatory Flexibility Act, a regulatory l
-flexibility analysis has been prepared. The analysis is not a l
- separate document but is part of the' Federal Register notice. The analysis indicates that the economic impact on licensees and small
. entities will not be significant. .The analysis will be made available in the Public Document Room. A copy will be sent to the Chief Counsel for Advocacy of.the Saall Business Administration.
4 .
1 i g.' The final rule contains new information collection requirements '
'and, therefore, is subject to the requirements of the Paperwork Reduction Act of 1995 (44 U.S.C'. 3501 et seq.). The staff.is.
preparing a Federal Register notice for submittal to OMB before l publication of the-final: rule; i e
a V
i
, _~ - . . , . . . . - . . . . , , - - . . . ~ . _ _ _ _ _ _ _ _ _ . _____I
'The Commissioners 5
- h. A public announcement will be issued (Attachment 6);
- i. The appropriate Congressional committees will be informed (Attachment 7); and
- j. Copies of the Federal Register notice of final rulemaking will be distributed to all licensees. The notice will be sent to other interested parties upon request.
James M. Taylor Executive Director for Operations Attachments: As stated (7) l l
l I
i 4
2 4
a I
1 1
i The Commissioners 5
- e. An environmental assessment and finding of no
~
'significant impact has been prepared and will be made available in the Public Document Room (Attachment 5);
- f. In accordance with the Regulatory Flexibility Act, a regulatory flexibility analysis has been prepared. The analysis is not a separate document but is part of the Federal Register notice. The analysis indicates that the economic impact on licensees and small entities will not be significant. The analysis will be made l available in the Public Document Room. A copy will be sent to the Chief Counsel for Advocacy of the Small Business Administration.
- g. The final rule contains new information collection requirements and, therefsre, is subject to the requirements of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.).
The staff is preparing a l Federal Register notice for submittal to 0MB before l publication of the final rule: l
- h. A public announcement will be issued (Attachment 6):
4
- 1. The appropriate Congressional committees will be informed (Attachment 7); and i k
- j. Copies of the Federal Register notice of final rulemaking will be distributed to all licensees. The q I
notice will be sent to other interested parties upon request.
James M. Taylor Executive Director ,
for-Operations I Attachments: As stated (7) o
~
- The Commissioners 6 RECORD NOTE: A COPY OF THE FINAL RULE WAS SENT TO OIG FOR INFORMATION ON mal 10,.1996.
l Distribution:
RPHEB r/f EDO r/f TSpets NCostanzi CGallagher LRiani DOCUMENT NAME: A:\FINCOM.FAP T. w. . y ov w. m ,=, >* w v 6.t c - c m ww.ut m m .,==, e - c.,y mi.n - .n.6>.u r-wmy
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0FFC DRA/RPHEBl ADM l NMSS l NRR IRM l DRA/RPHEB l NAME- CRaddatz JGlenn DMeyer CPaperiello BGrimes BJShelton DATE 07/ /96 07/ /96 06/10/96 *M 06/21/96 *M 07/ /96 05/28/96 *M 0FFC OE I OGC l DRA:D I RES:D I EDO [
NAME JLieberman Malsch BMorris DLMorrison JMTaylor ,
^
DATE 06/27/96 *M 06/27/96'*M 07/ /96 07/ /96 07/ /96
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[7590-01-P]
NUCLEAR REGULATORY COMMISSION
~10 CFR Part 20.
RIN 3150 AF31 Resolution of Dual Regulation of Airborne Effluents of Radioactive Haterials: Clean: Air Act AGENCY: Nuclear Regulatory Commission.
ACTION: Final - rule.
SUMMARY
- The Nuclear Regulatory Commission is amending its regulations to~
establish a constraint of 10 mrem (0.1 mSv) per year total effective dose equivalent (TE0E) for dose to members of the public from air emissions of radionuclides from NRC licensed facilities other than power reactors.
This action is necessary-to: (1) provide assurance to the Environmental
'- Protection Agency-(EPA)'that future emissions from NRC licensees will not'
. exceed dose levels 1that will provide an ample margin _of safety: and (2) to provide EPA a basis upon'which-to. rescind-its Clean Air Act (CAA)
' regulations-as defined.in'40 CFR Part 61 for NRC licensed facilities
, J(other_ thanipower reactors) and. Agreement. State licensees. thereby
+
r 1
.f relieving these _ licensees from unnecessary. dual regulations.
By separate notice in the Federal' Register the Commission is mo'difying its General Statement of Policy and Procedures for NRC Enforcement Actions (fnforcement Policy), to address the new regulation, and to provide'an example Severity Level IV violation of the constraint.
This change.will also be reflected when the Enforcement Policy is reprinted in its entirety in the next revision of NUREG-1600.
EFFECTIVE.DATE: This rule will become effective 30 days after publication in.the Federal Register.
FOR FURTHER INFORMATION CONTACT: Charleen T. Raddatz, Office of Nuclear l
i Regulatory Research, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, telephone (301) 415 6215.
e SUPPLEMENTARY INFORMATION:
Background
l i- The EPA promulgated National Emission Standards for Hazardous Air l Pollutants (NESHAPs) for radionuclides on October 31, 1989. Under 40 CFR 2
a
-- w- --
Part 61. Subpart I, emissions of radionuclides must be limited'so.that no
-member offthe.public would receive an effective dose equivalent greater than 10 mremT (0.1 mSv) per. yearn Subpart I of 40_CFR Part-61.was promulgated to_ implement the CAA and limit doses to members of the public I
from air emissions of radionuclides (other than Radon-222) from all NRC licensees other than licensees possessing only sealed sources high-level waste repositories, and uranium mill tailings piles that have been disposed of in accordance with 40 CFR Part 192. Radon-222. emissions from tailings were covered by 40 CFR Part 61, Subparts T (addressing non-operational uranium mill tailings piles) and W (addressing operating mill j teilings piles). EPA rescinded Subpart T for NRC licensees after Appendix l
A to 10 CFR Part 40 was amended by the Commission to conform to changes EPA issued to 40 CFR Part 192. Subpart W still applies to NRC licensees.
Because Radon-222 is adequately addressed in 10 CFR Part 40, Appendix A.
and other provisions of 10 CFR Part 20. it is not covered in this final rulemaking.
In 1990. Congress enacted amendments to the CAA. Section 112(d)(9) of these amendments to the CAA (the Simpson amendment) states:
No standard for radionuclide emissions from any category or 4
- 1 Subpart I expresses dose lin effective dose equivalent (EDE). NRC expresses dose in total effective dose equivalent (TEDE). These terms are
. essentially. equivalent.
3
subcategory of facilities licensed by the Nuclear Regulatory Commission (or an Agreement State) is required to be promulgated under this section if the Administrator determines, by rule, and after consultation with the Nuclear Regulatory Commission. that the regulatory program established by the Nuclear Regulatory Commission pursuant to the Atomic Energy Act for such category or subcategory provides an ample margin of safety to protect the public health.
Upon issuance, the effectiveness of Subpart I for all NRC licensees was immediately stayed by EPA pending further evaluation. During the stay 1
I period, EPA conducted two studies of the air emissions fram NRC and 1
Agreement State materials licensees. The first was a survey of 367 l randomly selected nuclear materials licensees. EPA determined that the highest estimated dose to a member of the public from air emissions from these facilities was 8 mrem (0.08 mSv) per year, based on very conservative modeling. In addition, 98 percent of the facilities surveyed were found to have doses to members of the public resulting from air emissions less than 1 mrem (0.01 mSv) per year. The second study evaluated doses from air emissions at 45 additional facilities that were selected because of their potential for air emissions resulting in significant public exposures. EPA found that 75 percent of these licensees had air emissions resulting in an estimated maximum public dose 4
y
.less than limrem (0.01JmSv) per year. For the licensees evaluated. none exceeded 10 mrem (0.1 mSv) per year.
In its' initial proposal to rescind Subpart I for NRC licensees other Et han power reactors. EPA stated that:
1 I
Based on'the results of the survey undertaken by EPA and the l l
commitments made by NRC in the MOU EPA has made an initial l
determination that the NRC program under the Atomic Energy Act provides an ample margin of safety to protect public health (57 FR 56880: December 1. 1992).
However. EPA continued to express concern regarding the adequacy of
~
the measures to assure that future emissions from NRC licensees will not exceed. levels.that will provide an ample margin of safety. The stay on Subpart I expired on November 15, 1992, and Subpart I became effective on November 16, 1992. Subsequently, in July of 1993, the EPA Administrator determined that there was insufficient basis at that time to rescind Subpart 1. Consequently. NRC and Agreement State licensed facilities were
' subject to dual regulation of airborne effluents of radionuclides under both the AEA and the'CAA. including regulatory oversight by EPA (or authorized State) and NRC (or Agreement State).
'NRCilicensees subjectito EPA's Subpart I are also subject to NRC
'S s
- e
{ . ig g
.. ~
i
- dose-limits foe: members of the.public contained.in 10 CFR Part 20. Subpart LD, entitled Radiation' Dose Limits for Individual Members of the Publich' (Subpart D).- Under Subpart D, licensees shall' ensure that doses to
-members of the public are less than 100 mrem (1.0 mSv) per year from all
~
-pathways (including airborne effluents).and all sources associated with the licensee's' operation. In addition, under Subpart B, entitled
'hRadiation Protection Programs, licensees must ensure that doses to members of the public be kept as low as is reasonably achievable (ALARA).
Based-on the studies conducted by EPA and licensee reporting of doses to members of the public from airborne effluents to EPA, it is evident that less'than 10 mrem ( 0.1 mSv) per year to the maximally exposed member of
'the public from airborne radioactive effluents' to.the environment is reasonably achievable.
NRC power reactor licensees subject to 10 CFR 50.34a must keep doses to members of.the public from airborne effluents consistent with the numerical guidelines in Appendix 1 to 10 CFR Part 50. These licensees have reported estimated doses to members of the public from air emissions well below the Subpart I'value for many years. Based on the combination
-of a continuing regulatory basis for reduced air emissions and documented proof:of the effectiveness of the NRC program for these licensees. EPA rescinded.Subpart:1 forfpower reactors licensed by NRC (60 FR 37196:
.F September 5, 1995).
6
.w:
C
Amendments ,
~The amendments proposed on December 13, 1995 (60 FR 63984), and
' finalized in this rule establish a constraint of 10 mrem (0.1 mSv) per year-TEDELto members of the public from-airborne radioactive effluents to e environment from NRC-licensed facilities other than power reactors as a part-of its program to maintain doses ALARA. These amendments codify i
i numerical values for NRC's application of ALARA guidelines for radioactive j l
For power
~
air emissions'from'its licensees, other than power reactors.
reactors. ALARA guidelines have already been established within 10 CFR j l'
Part 50 and existing facility licensing conditions. These final amendments en=ure that air emissions are maintained at very low-levels and, taking into consideration the elimination of dual regulation, at some reduced cost. This action brings consistency between the EPA's dose standard and the NRC's ALARA application, and is expected to be the final step in providing EPA with the basis to rescind Subpart I as it applies to NRC-licensed facilities other than power reactors. NRC has been working cooperatively with EPA to achieve rescission of EPA's standards in 40 CFR Part 61 Subpart I, under Section 112(d)(9) of the CAA. EPA published a proposed rescission of 40 CFR Part 61 Subpart I, on December 1, 1992 (57 FR 56877). 'On September 28, 1995. EPA published a notice in
'the Federal Register reopening the comment period on rescission of Subpart:I (60 FR 50161). The objective of this effort is to eliminate l
7
____l
q
., m
.duplicative regula't ions that. provide no incremental benefit in terms of public and environmental protection.
-The regulatory l framework that NRC is providing as a basis for rescission of EPA's Subpart I consists of the requirements in 10 CFR Part 20 to' limit doses to members of the public to 100 mrem (1.0 mSv) per year.
L to maintain these doses as far below this limit as is reasonably
~
achievable (ALARA), and to constrain doses to members of the public from airborne effluents of radioactive materials to the environment from a single licensed operation to 10 mrem (0.1 mSv) per year.
Currently, under S 20.1501 licensees are required to make or cause to be made surveys that may be necessary to comply with the regulations in
- 10 CFR Part 20. This data would be made available to inspectors upon request. If the licensee estimates or measures a dose to the nearest resident from air emissions greater than 10 mrem (0.1 mSv) per year, the 1 licensee would be required to report the dose to NRC in writing within 30 days, which would' include the circumstances that led to the greater than
-10. mrem (0.1 mSv) per year dose, a description of the corrective steps the licensee had taken or proposed to take to ensure that the constraint is not again exceeded, a timetable for implementing the corrective steps, and lthe expected results. Records of the results of measurements and calculations needed to evaluate the release of radioactive effluents to
'the environment will still be required pursuant to-10 CFR 20.2103(b)(4).
8
{
[
i 5
Exceeding this constraint will not result in a Notice.of Violation-
. ~
(NOV) as would be the case in-a limit. An NOV will be issued only if and ;
when-(1) a_ licensee fails to report an actual or estimated dose from airborne; effluent releases from a facility that has' exceeded the .
constraint value: or (2) if a licensee fails to institute agreed upon icorrective' measures intended to prevent further airborne effluents in excess of those which.would result in doses exceeding the constraint
' level.
The rule. applies to airborne effluents of radioactive materials to the environment, other than Radon-222 and daughters, from all NRC licensees except power reactors. Power reactors are exempt from this rule because.they are already required under 10 CFR 50.34a to identify design objectives and the means to be employed for keeping doses to members of the public from air effluents ALARA in their license application, ;
Appendix I to 10.CFR Part 50 contains the numerical guidelines to meet l this requirement.
4 Resoonse to Comments fifty-seven individuals and organizations provided written comments
- on' the proposed rule and Draf t Regulatory Guide DG-8016. Among the 57 ,
l commenters, 24 were licensees, seven were professional organizations, five were States, 16 were members of the public, and five were environmental 9 !
e p -f e -.
t 7:
! organizations. Because'manycletters commenting on the Draft Regulatory.-
. Guide DG-8016 also included comments on the rule, these comments were also ,
. considered in: developing'the final rule. !
f m
Issue 1--Proposed Rule Approach i
Comments: A total of' thirty one individuals and organizations -
commented on the basis for.the rule. Five commenters agreed with the approach and need for'the constraint. Four commented that the rule should not be finalized and that EPA's Subpart I, should remain in effect.
Twenty-two'commenters stated that existing NRC programs.provided an ample ;
^
margin of safety and that the constraint was not needed. However, of j i
these, seven agreed that the constraint was preferable to dual regulation j or Subpart I alone, i-Those commenting'that existing NRC programs are adequate to protect f l the public cited the two EPA studies on doses from air emissions. Two-thirds of these commenters were opposed to going forward with the constraint because..they believed it was not needed and that licensee and regulator costs could not be justified given the expectation that risk to j i
~
public health and-safety would not be reduced. These commenters encouraged NRC to' continue working with EPA to provide sufficient basis i
for. rescission of Subpart I without the imposition of an equally !
u !
- 1 10-
unnecessary regulation. A few commenters stated that the risk'was
~
l considerably _less'than estimated'because' excessively conservative t calculational methods were used by EPA. A few commenters compared the
^10 mrem _(0.1 mSv) per year constraint to variability in background or doses.from commercial' air _ traffic as evidence that the dose and tiie risk is trivial. Seven commenters cited burden reduction and single-agency
' oversight as the reasons for agreeing that the constraint was preferable ;
i
'to: dual regulation or EPA's Subpart I alone. !
l Commenters opposed to the constraint as'a less protective standard.
-stated that the constraint was based upon a voluntary program (ALARA) ard, as such, was not adequate to protect the public. One commenter stated l that NRC does not perform confirmatory measurements and therefore. NRC jurisdiction was not adequate.
Resoonse: NRC and EPA have been working to develop a basis upon d which dual regulation could be eliminated._ EPA has stated that there are two necessary components to any finding that NRC's program is sufficient to protect the health and safety of the public. The first is evidence
- that doses from air emissions are below 10 mrem (0.1 mSv) per year to a member of the public. This has been demonstrated through the two studies by EPA and by licensee reporting of actual air emissions. The second component is a program to ensure that doses remain at this level. In the~
absence of rulemaking requiring' licensees to maintain doses to levels of 11 6
no more than 10 mrem (0.1 mSv) per year, EPA would not rescind Subpart I and dual regulation would continue. ,
The Federal Radiation Council (FRC) was formed in 1959. to provide recommendations to the President for Federal policy regarding radiation matters that affect health. In May 1960, FRC set forth basic principles for protection of both workers and the public. The council was abolished in 1970 when its functions were transferred to the EPA Administrator. In 1981. EPA published proposed recommendations for new Federal guidance for occupational exposure. In 1987, President Reagan approved recommendations by the EPA Administrator for new hRadiation Protection Guidance to Federal ,
agencies for Occupational Exposure. EPA has not yet issued recommendations on limits for the public. A working group comprised of representatives from affected Federal agencies and experts on radiological health matters has been developing these recommendations for several years and expects to provide them during the next year.
In 1977, the International Council on Radiological Protection (ICRP) issued its Report No. 26 Recommendations of the International Council on Radiological Protection in 1977. These recommendations concluded that the average doses to members of the public should not exceed 100 w em (1.0 mSv) per year with a limit of 500 mrem (5.0 mSv) per year to any individual.
The National Council on Radiation Protection and Measurements (NCRP) 12
i u
. is required by_ Congress to recommend limits for exposure to ionizing !
radiation.. In June 1987,LNCRP issued'its Report No. 91..hRecommendations r on-Limits for' Exposure to Ionizing Radiation. This report contains i I ' recommendations-on exposure limits for both occupationally exposed I
individuals and individual members of the public. The report recommended
^
- that doses-to individual members of the public be limited to 100 mrem (1.0
~
mSv) per year averaged over a lifetime, not to exceed 500 mrem (5.0 mSv) in 1 year.
J In_1991, NRC revised 10 CFR Part 20 RStendards for Protection l Against-Radiation. This revision included new limits for individual members of the public. Though both the ICRP and the NCRP recommended limits of 500 mrem (5.0 mSv) in any one year, the NRC established a limit
^
of 100' mrem (1.0 mSv) per year because it was impractical to control dose ,
in terms of lifetime average without keeping track of individual i exposures. In addition, 10 CFR Part 20 requires that licensees use procedures'and engineering controls to maintain doses ALARA.
Both the NRC and EPA regulatory programs are designed to achieve protection of the public with an ample margin of safety. The approaches of the two agencies differ. NRC limits TEDE, requires that doses are maintained ALARA, and maintains an active inspection program. EPA limits
' dose from individual pathways of exposure and individual radionuclides to ensure that the total dose does not exceed recommended levels. Both 13
i
.8 programs. achieve similar levels of protection. ;
l 1
NRC' agrees that adoption of the constraint in S 20.1101(d) is l preferable to dual regulation due to the reduction in burden on licensees as well as State and Federal agencies. Under the provisions of 40 CFR Part 61 licensees with doses to members of the public greater than 1 mrem '
(0.1 mSv) per year but less than 10 mrem (0.1 mSv) per year must submit reports. However, under 10 CFR 20.1101(d), these licensees will not have I to file reports for doses below the constraint level because doses can be
- evaluated during routine inspections. Under the final rule, the burden of calculating doses should be reduced for most licensees because the proposed guidance for demonstrating compliance with 10 CFR 20.1101(d) allows significantly more flexibility and simpler methods for calculat' 4 doses than the model curr.cotly used to demonstrate compliance with 40 CFR Part 61. These new methods for calculating doses should result in fewer !
reporting.and corrective actions, as under EPA's Subpart I.
Licensees are required under S 20.2103 to maintain records of surveys required to demonstrate compliance with the public dose limit.
i.
Review of licensee records used to demonstrate compliance with the public dose limit is part of the NRC inspection program. Confirmatory ;
measurements would generally not be-useful since most licensees in this category do not have routine ongoing effluent releases.
Finally, concerning those commenters that believe NRC's requirements-F i 14
..+w - , r - - y- e- ~
g -
n.
l are less safe.than Subpart I, Congress enacted legislation. comprehensively.
amending the-Clean Air Act:(CAA) which included a section addressing the issue of regulatory duplication between EPA and NRC in 1990. The 1990 CAA- ;
s amendments pr' cit the EPA Administrator:to rescind the CAA standards as they apply to ' radionuclides, at' sites ~ licensed by NRC, and the Agreement -
+
States', if he or she finds that the NRC regulatory program provides'an! +
4 :
. ample margin of. safety to protect the'public health.
EPA's analysis of the NRC regulatory program focused'on two general issuest (1) whether the implementation of the NRC regulatory program E
i results in~sufficiently low doses to protect the health and safety of the 1
public with an ample margin of safety; and (2) whether the NRC program is sufficiently comprehensive and thorough, and administered in a manner that 4
will' continue to protect public health in the future. EPA undertook studies to determine the level of protection provided by the existing
. regulatory program and found that doses were sufficiently low to protect
-the health and safety of the public with an ample margin of safety. The implementation of this rule will ensure that doses to members of the public from air effluents will continue to remain below 10 mrem (0.1 mSv) per year and provide evidence to EPA that the current level of protection j will continue. i The purpose of this rulemak'ing is not to reduce doses, because it hasialready been demonstrated that doses are sufficiently low. The 1
15-
)
purpose is to ensure that doses are maintained at the low-level currently achieved by NRC licensees. eliminate unnecessary dual regulation. and reduce costs associated with the current level of protection, by providing a basis upon which EPA can find that doses will not increase as a result of rescission of Subpart !.
Issue 2 --Promulgation of the Constraint as ALARA Comments: There vere a number of commenters who objected to the ALARA basis for the proposed constraint rule. Some commenters objected on the ground that ALARA is a matter of operating philosophy. good radiation i
protection practice and licensee judgment, and cannot be translated into (
7 an enforceable dose number. Other commenters objected on the basis that ALARA is inherently site specific and cannot be defined generically or that the proposed dose constraint cannot be ALARA but must be a limit because the constraint contemplates some enforcement actions for exceedance even if the licensee has followed all good radiation protection practices. Some commenters argued that the rule cannot be ALARA because it adds costs with no safety benefit. Other commenters stated that the constraint is inconsistent with a prior NRC decision in 10 CFR Part 20 (56 FR 23360) on the use of " reference levels.
Resoonse: The Commission has retained an ALARA basis for the rule 16
7
,z .but recognizes-that its use of'the term in this rule may.have led to some confusion. The Commission' acknowledges that the ALARA concept in 20 CFR 20.1003 is an operating philosophy which requires good radiation protection practice and-the exercise of expert licensee judgement. The ALARA concept-is' site specific in'that some.of the factors to be considered may vary from case to case, as the court so found in lori Committee for a Safe Environment v.'NRC, 527 F. 2d 812 (D.C. Cir. 1975). f
- The. Commission has presumed, without 10ciding, that the ALARA concept in i
Section 20.1003 can be enforced in a particular case so as to required a specific rad'ation protection practice, but it is clear that the existing regulati3n does not translate readily into a generic dose number, which, if exceeded, will lead to enforcement action.
)
1 The NRC intended the constraint rule to be a somewhat broader concept found in the governing statute, the Atomic Energy Act of 1954, as amended (Act). The Act, as construed by both the Commission (e.g., 10 CFR 50.109) and the courts (Union of Concerned Scientists v. NRC, 824 F.2d 108 (D.C. Cir. 1987)), contemplates two distinct approaches to radiological regulation. First, a level of " adequate protection" must be defined and l enforced without regard to economic cost. Second, risk may be reduced to a level below that associated with " adequate protection" to " minimize l i
danger ~to life or property"'with economic cost and other factors as permissible balancing considerations. See " Revision of'Backfitting.
17 I
Process for Power Reactors," (53 FR 20603: June 6. 1988). It is important
, to note that Section 161b of the Act requires the Commission to adopt and enforce generic requirements using either approach. Many recent NRC regulations (e.g., 10 CFR 50.63) have been directed at incremental risk reduction under the second approach based on a generic regulatory or backfit analysis which considered and balanced economic and other ccsts and safety backfits. These " minimize danger" regulations provide " limits" because they establish generic requirements directly enforceable against licensees. However, in a broad sense they are also ALARA regulations because cost, feasibility, and other relevant factors identified in 10 CFR 20.1003 are evaluated.
Viewed in its larger statutory context, ALARA in 10 CFR 20.1003 is ,
one means to implement the second approach to radiological regulation.
However, other similar requirements can also be part of this second l approach. While the ALARA concept in 10 CFR 20.1003 may not be consistent with a generic enforceable dose requirement, other concepts of ALARA premised on generic considerations are also appropriate. This broader concept of ALARA as a broadly applicable dose requirement based on a generic weighing and balancing of health and safety, feasibility, and other factors is the basis for the longstanding limits on nuclear power reactor emissions in 10 CFR Part 50, Appendix I, and is the basis for the constraint rule. The ALARA rule imposes a limit in the sense that 18
M
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- exceedance'will-lead to corrective. action. but it is not a limit in the sense!that exceedance per se'would constitute a violation of'any 2
regulatory requirement. A' violation occurs only when a licensee fails to
. ' report an exceedance or fails to take appropriate corrective: actions. A limit.would bo~ appropriate if compliance were needed to ensure. adequate
- protection of health and safety. In this case, the constraint is needed ,
only to ensure thati currently afforded levels of protection are not reduced. This will' provide the basis for rescission of 40 CFR Part 61, '!
LSubpartIbyEPA.
Thus, to say that the constraint rule cannot be. based on ALARA .;
because it is in effect a " limit," interchanges a narrow concept of "ALARA" with a broad concept of " limit." If a broad definition is used, the constraint rule withstands scrutiny as both ALARA and a limit. In the l statutory context of the Atomic Energy Act and general principles of administrative law, the constraint rule is a limit based on generic ALARA I
considerations. The constraint rule is not a limit needed for adequate
. protection and the constraint rule is something more than a narrow translation of the particular ALARA concept contained-in 10 CFR 20.1003.
The term." constraint" was used for the rule to' avoid confusion with the narrow concepts of ALARA and the limit employed in radiation protection discussion.
.Three matters must be addressed:
19
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.(1)_ The comment that the rule cannot te based on ALARA because it will result in' increased cost with no. safety benefit:
(2) _ The problem of the licensee who cannot meet the dose constraint despite using all good radiation protection practices; and
'(3) The allegedly inconsistent Commission discussion of reference levels in a recent revision to 10 CFR Part 20.
The Commission disagrees with the premise of the first comment.
There was no disagreement with the Commission's conclusion that all of the
-licensees affected by the rule are achieving a level of control such that doses are'below the 10 mrem (0.1 mSv) per year level and 50 there is no ;
1f actual dispute _over whether this level of radiation protection is readily achievable. The final rule and EPA's rescission of its Clean Air Act emission limits and related requirements will result in a significant net cost savings ~to licensees. The NRC acknowledges that the positive direct health effects are likely to be small and possibly nonexistent in the near future, given the. current level of controls. However, the rule can be '
said to offer a small, but positive, net health and safety benefit in that it will' prevent a decrease in the level of protection afforded the public if.Subpart I were rescinded in the absence of a rule like the constraint. .
bnder the ALARA concept, it is appropriate to base a requirement on a small positive health and safety benefit when cost savings are also likely.
20
1 i
4.
-i
..The NRC'does not expect that any licensee subject to the rule will
.be~ unable to. demonstrate that' doses ~to members of.'the public from releases df airborne radioactive materials to the environment are less than 10 mrem
( .1 mSv) per year, in the unl'ikely case that this dose ~1s. exceeded or is j projected to be exceeded, due to some temporary circumstances or lapse in :
. cont ro l s, the NRC expects the licensee to take any immediate corrective actions that might be necessary, to report the dose. to reconmend further !
= corrective actions if necessary, and take those corrective actions agreed .
upon with NRC- .
In the unlikely case that a licensee is unable to take adequate corrective actions, because of limits in technology or cost constraints, these issues can be addressed in the future on a case-by-case basis.
The application of the ALARA principle used in this rule is not the r same as the concept of reference level which was rejected by the ,
6 Commission when 10 CFR Part 20 was recently revised. Commenters on the 1991 revision to 10 CFR Part 20 objected to the use of reference levels because they were implemented exactly the same as limits. For that reason, the Commission did not adopt reference levels in the 1991 revision. Implementation of the constraint is different than a limit because-exceeding the constraint is not a violation, and only requires the licensee to take_ actions to.come into compliance. It is not the purpose of the constraint rule to provide such added assurance.
21 f
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- . ~ . _ ,
- ;u >
x s ,
i l
Issue 3 --Whether the Constraint ~ is' Actually' al Limit
., l Comments: Nine comments were received.on whether the constraint is ,
t
-or sh'ould-be a-limit.- Two commenters believed that'the constraint was no different than a limit 10ne'commenter agreed with the_ term constraint.
B Three commenters expressed concern that the constraint was an
- inappropriate relaxation of requirements. ,
Those commenting that the constraint was a de facto limit s
. interpreted th'e requirements to indicate that a second exceedance of the constraint would result in enforcement action and therefore the constraint' is'a limit. .Three commenters indicated that the rule should be a strict ,
n i limit. -They expressed concern that the constrai nt was less protective
- than EPA requirements.
Resoonse: If a licensee exceeds a limit that is needed'to protect ~
health'and safety, the NRC may take immediate enforcement action.
If.a licensee exceeds a constraint, the licensee will be required to notify NRC _;
'and implement corrective actions that are adequate to prevent further F
l doses:in excess of the constraint. This is because, unlike a. limit, the
_ mm m hj,uvi b a d' ua k j a SW *h fMc-constraint'is not necd J ie__pictcc, health and safe y. However, if the
' licensee fail'ed to report it to NRC or failed.to implement appropriate-22 L
, v ,~
-. ~ . - . . ., . .. _ _ . - . . . . . .- = - - . . . . . _ .. . _ -_-
b,
.' 1
-correr.tive actions'as-agreed upon, enforcement action would be. expected.
.The NRC does not agree that the constraint is less protective.than.
. current EPA requirements. Both EPA's Subpart I and the NRC constraint require licensees to take actions to ensure that doses to members of the J
public do not exceed 10 mrem (0.1 mSv) per year from ambient air
' emissions. NRC routinely inspects licensed facilities-to ensure that air effluents do not result in doses to members of the public that exceed the requirements in 10 CFR Part 20. The inspection and enforcement program l will be amended as a result of this fincl rule, to review licensee records used to demonstrate compliance with the constraint.
l Issue 4 --Citizen Suits.
Comments: Three commenters opposed finalization of the constraint on the basis that it forfeits citizen rights to sue a licensee who exceeds the constraint.
Resoonse: The Commission's regulations in 10 CFR 2.206 provide the public with the right to petition the NRC to take enforcement action against a licensee for a violation of the Commission's regulations. This would include the final constraint rule.
' Issue 5 --Agreement State Compatibility.
23
s O
Carnments: Four commenters addressed the proposal that the ,
constraint be a Division 2 matter of compatibility. Under Division 2.
States could adopt similar or more stringent requirements. Three commenters agreed that this rule should not be codified as a Division 2 requirement..but rather as a Division 1 matter of compatibility. Under Division 1, the States would be required to adopt regulations that were essentially identical. These commenters believed that if stricter standards were permitted, reactor and non reactor licensees would be under different requirements and certain practices, such as nuclear medicine, could be jeopardized. One commenter noted that because this is really a limit. it should be under 10 CFR 20.1301 and would be a Division 1 matter of compatibility. Another commenter stated that NRC should have provided a greater opportunity for State involvement in this rulemaking, and that as a division 2 rule. Agreement States would have to spend scarce resources to develop a compatible rule.
Resoonse: Section 116 of the Clean Air Act specifies that, nothing precludes States from imposing air emission requirements that are more stringent than those developed by EPA. Section 116(d)(9), which contains the provisions related to EPA's margin of safety determination for NRC or Agreement State licenses, specifies that: "Nothing in this subsection shall preclude or deny the right of any State or political subdivision thereof to adopt or enforce any standard or limitation respecting 24 u
y,
. emissions of-' radionuclides which'is more stringent than the standard'or
~
limitation in effectiunder- Section 7411' of this title or thislsection."-
The' Commission' believes that this provision clarifies.that EPA's :
' determination regarding,NRC and Agreement State licensees has no effect on !
the existing authority' of-States to impose air. emission standards that are 1 more. stringent than those of EPA.
With regard to the comment:concerning involvement of the Agreement States in'the developinent of this rule. NRC has routinely reported its i progress'on providing an adequate basis.upon which EPA could rescind Subpart I to.both the Organization of Agreement States (0AS) and the Conference of Radiation Cor. trol Program Directors (CRCPD) at each of their-annual meetings. The Agreement States were consulted extensively on this issue over the last several years. Althoughthey-dtd nei for=lly rcceive -
dnscrIspi vi i1fFsrrft=eule_. there were extensive discussions of the concept with the individual States and with the Executive Board of the OAS. 9
' Issue'6 --Demographic Information Contained in Required Reports. ,
Comments: Seven commenters addressed the application of the ,
requirement contained in 10 CFR 20.2203(b)(2) to the constraint. This section requires reports to contain demographic information on the exposed 25'
. - ~ _
4 I
individual. -These commenters expressed concern that a member of the 1 l
public would be under no obligation to provide demographic information to ]
l licensees and that licensees would not always be able to comply with the l
requirement. :
Resoonse: NRC agrees that members of the public may choose to withhold the demographic information from licensee. Such information is only needed for occupationally exposed individuals to ensure that lifetime i
exposure records are accurate. Section 20.2203 has been changed to only ]
require such information on occupationally exposed individuals. l l
Issue 7 --Effective Date.
Comment: One commenter requested that an effective date be added to l the final rule to coincide with EPA's rescission of Subpart I.
Resoonse: The NRC and EPA will, to the extent possible, publish both final rules so that they become effective concurrently. I Issue 8 -Enforcement.
Comments: Five commenters stated that NRC should establish a limit rather than a constraint. They believed that often the limit has been exceeded, a r.otice of violation and civil penalties should always result.
26 i
. 1
. _ - _, . . . . - _ . - _ _ ~ _ . . . _ _ . . . ~ .
J 1
. . z: .;
l 10ne commenter expressed concern that self-reporting and confession is ]
not adequate. :Another stated that because ALARA is'only guidance, it is not enforceable. -j ResDonse: ALARA is not guidance. -As stated previously, the_1991, 1 revision to 10 CFR Part 20 codified ALARA=as a required part of the:
licensee's radiation protection program. A limit implies that doses must ;
l be controlled'below that le'el v in order to provide adequate protection of i
- health'and safety of the public and workers. To meet ALARA requirements l l
licensees are currently controlling effluents to levels below that which f
.'would be required under the constraint. If a licensee exceeds the constraint, the rule requires that corrective actions be promptly taken.
If a licensee does not comply, enforcement action will result.
Issue 9 --Exemptions Comments: Five commr.atert stated that the rule should only apply to members of the public off site. They cited the EPA's Subpart I requirement to calculate dose to the nearest resident or offsite individual likely to receive the highest dose. Under Subpart I, licensees would not calculate doses from air emissions to visito,s in hospitals, workers'that-are not radiation workers within the facility, or other
>- members of the public within the facility.
27
4'n 4la4. g,, M,wwa,a _.4%
l M_, a j ___4,4,+..-A . p4 J - N w--.>
.--w_a_ - 3%.W.m4 ,,
- Resnonse: The language in the rule has been changed to reflect that it is intended to apply to radioactive airborne effluents to the ;
environment. The Draft Regulatory Guide DG-8016 will be revised to l
- - ~
indicate that the dose limit is to be calculated or measured at the nearest resident or individual offsite likely to receive the highest dose. q s
The final regulatory guide will be 6vailable when the rule is in force, j Comments: Two commenters stated that air emissions from adjacent ;
nearby exempt uranium mills should not be included in the calculation of l
' dose.- One commenter stated that materials from unlicensed portions of the facility such as ore stockpiles should not be considered in the 4
L calculation of dose.
J Response: Subpart I does not apply to disposal at facilities I regulated under 40 CFR Part 191. Subpart B. or to any uranium mill tailings pile after it has been disposed of under 40 CFR Part 192. The l l
i constraint applies to airborne effluents of only licensed materials to the l environment. Draft Regulatory Guide DG-8016 will be changed to clarify that windblown particulates from other licensed facilities or unlicensed ;
materials do not need to be considered in the calculation of doses used to'
- l demonstrate compliance with the constraint. !
Comments: Four commenters stated that air emissions from patients should be' exempted from this rule.
Resoonse: The regulatory impact analysis (NUREG-1492) for a recent 4
28 i
l
..NRC rulemaking analyzed potential doses from exposure.to patients who were
- released'after administration ~of radiopharmaceuticals. This analysis .
concluded'that internal doses from inhalation of radioactive materials in the: exhaled air of a released patient are trivial. For licensees using an-inventory approach to demonstrating compliance with the rule, such as the COMPLY computer code, there is no need to account specifically for the, materials that might be released to the air through respiration or transpiration by patients. The Draft Regulatory Guide DG-8016 will make it' clear that dose from air emissions from patients do not need to be
~
-specifically_ addressed in the calculation of dose used to demonstrate compliance with the constraint.
Comments:. Four commenters stated that in addition to Rn-222, all daughters produced after release should also be excluded.
Resoonse: EPA's Subpart I exempts both Rn-222 and any daughters produced after release of Rn 222 because these types of releases are normally not attributable to licensed activities. The proposed rule was s
not intended to be more stringent than Subpart I. The rule language has been changed to reflect this exemption. i Comments: Two commenters recommended that in addition to Rn-222 Rn 220 and its' daughters should also be exempted. One commenter stated Lthat'it was an EPA oversight that led to this erroneous omission from the ,
final'Subpart I.
29- l l
g-ik Resoonse: Rn-220 is normally attributable!to licensed activities.
EPA does not exempt Rn-220 Lor its daughters from' consideration in the dose calculations in' support of demonstrating compliance with Subpart I. The. ,
.commen t er s suggestion that an oversight led to the erroneous omission of ,
.i this exemption-from Subpart I is incorrect, and Rn-220 should not be j
- excluded! from the ' calculations that are used to demonstrate-compliance .
with-the constraint. ;
Comments: Six commenters requested that in addition to sealed i' isources, sealed containers should also be excluded from the rule.
Resoonse: Paragraph 2(a) of Appendix D to 40 CFR Part 61 states:
Radioactive materials in sealed packages that remain unopened, and have
! not leaked during the assessment period should not be included in the calculations. Subpart I exempts sealed packages, because any package that has remained sealed cannot contribute to airborne effluents. When a total inventory of licensed materials possessed during-the year is used to model potential doses, it is unnecessary to include materials that could not have contributed to airborne effluents. The Draft Regulatory Guide DG 8016 will provide further guidance on this issue.
i Issue 10l--Measurabilityof10' mrem (0.1mSv)peryear.
i
' 30 l 1
4
Comments: Three commenters stated that 10 mrem (0.1 mSv) per year was not measurable. One commenter stated that although 10 mrem (0.1 mSv) per year might be easily achievable, it is not easily measurable. Another stated that the exposure rate corresponds to 1 microR (0.01 micro-Sv) per hour and cannot be measured accurately.
Efingnig: Draft Regulatory Guide DG-8016 provides several methods for demonstrating compliance with the constraint, and only one of the methods described would require direct measurement at the receptor location. If this method is not practical due to'the emission characteristics of the radionuclide releases, there are other options cited in Draft Regulato y Guide DG-8016 that do not require a direct measurement to demonstrate compliance with the constraint.
Issue 11 --Scope of the Rule Comments: One commenter stated that if there must be a constraint, it should apply to all licensees, including power reactor licensees.
Resoonse: Although this rule only applies to licensees other than power reactor licensees, the Commission's existing regulations in 10 CFR Part 50, Appendix 1. already establish a similar regulatory framework for power reactors. Appendix ! includes separate requirements to develop design objectives and operational levels sufficient to demonstrate 31
compliance with EPA's Subpart I. In addition, reactor licensees must annually report quantitics of radioactive materials released into the environment, as well as the resulting doses.
Issue 12 --Location of Constraint in NRC Regulations.
The Commission requested specific comment on the question of whether the 10 mrem (0.1 mSv) per year constraint should be established in 10 CFR Part 20 as proposed or whether it should be established separately in each appropriate part of Title 10 instead.
1 Comments: Two comments were received in response to this issue.
I The !
One commenter stated that the constraint should be in 10 CFR Part 20. I other commenter stated that the constraint should be in each a, ropriate I part. Two other commenters stateo that the constraint should be in S 20.1301 with the dose limits.
Resoonse: While the constraint could just as easily be included under other parts of the regulations, including it in 10 CFR Part 20 provides uniformity, Because 10 CFR Part 20 is the designated area for radiation protection standards, it is the appropriate location for the constraint. The rule will be codified under S 20.1101 to make it clear that although the constraint is not the same as a limit, licensees are 32 i
y
' expected.toidevelop radiation programs to ensure that doses from air
- emissionsarefbelowl10 mrem (0.1mSv)peryear.
l l
Aareement State Comoatibility-g a
The'Comm'ission believes that the Division 2 compatibility
- ' designation for the rule is consistent with state authority in this area as. described'in'the Clean Air Act. The Division 2 desigr,3 tion means that
Agreement States must address these rules in their regulations but may
-adopt requirements more restrictive than those of NRC. Accordingly, the authority.of the Agreement States to impose air emissions standards under i t
their Atomic Energy Act authority after the effective date of this rule will be consistent with their existing authority. Under Section 274 of .
the Atomic Energy Act the Commission reviews Agreement State. programs to .;
ensure that adequacy and compatibility.of the State Program is maintained. Ib-The Commission has,also approved procedures to suspend or terminate programs that are not adequate or compatible.
Summary of Chanaes in the Final Rule ,
Based on the.responsesito comments, a few changes were made in the final rule. Otherwise.'the-provisions of the final rule are the same as 33
-i if
,e s ,
-those;presentedin.the,proposedamendments. Specific changes to the final rule are: summarized as follows: ,
~
(1)-Section 20.2203(b)(2) has been changed'to require the.name, social' security number, and date of birth only for occupationally exposed
-individuals and not for doses. in excess of the public limits, including -i i
. the constraint.
t (2) The language of the rule has been changed to indicate that Rn- T
. 222 and a'll. daughters produced after the release of the radon are
> categorically excluded from this rule.
(3) The language of-the rule has been changed to indicate that the ,
constraint applies'only to release of airborne radioactive effluents to the. environment and, thus, dose to the nearest resident, offsite business ;
or school is to be constrained. ;
In addition,.the following changes will be made to Draft Regulatory i
Guide DG-8016: ;
t (1) An inventory of radioactive materials used to model a potential Jdose to.a member of the public need not include radioactive materials in
-sealed' containers that have remained sealed throughout the compliance period.
(2) Airborne emissions of radioactive materials from patients does
, not need to be considered if the materials have already been included in 34 [
t r
h
-, m ,. .n -
, y , -m. . -
- l. .
L :
i the site inventory.
(3) The example calculation has been deleted.
l- The Regulatory Guide was issued in draft for public comment concurrent with the proposed rule. The final regulatory guide will be available by the effective date of this rule.
Finding of No Significant Environmental Impact The Commission has determined under the National Environmental Policy Act of 1969, as amended, and the NRC's regulations in Subpart A of 10 CFR Part 51, that this rule, if adopted. would not be a major Federal action significantly affecting the quality of the human environment and therefore, an environmental impact statement is not required. This action is not expected to have any significant environmental impact because the programs will provide eqaivalent protection. Also, airborne effluents of radioactive materials to the environment are not expected to increase.
The changes-to the final rule are to the procedural methods for demonstrating compliance, as well as, licensing and inspection procedures.
The environmental assessment and finding of no significant impact on which this determination.is based are available for inspection and photocopying for a fee at the NRC Public Document Room,'2120 L Street NW. (Lower
. Level) Washington, DC.
35
Paperwork Reduction Act Statement This final rule amends information collection requirements that are subject to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et. Seq.).
These requirements were approved by the Office of Management and Budget, approval number 3150-0014.
The public reporting burden for this collection of information is estimated to average 80 hours9.259259e-4 days <br />0.0222 hours <br />1.322751e-4 weeks <br />3.044e-5 months <br /> per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. Send comments on any aspect of this collection of information, including suggestions for further reducing this burden, to the Information and Records Management Branch (T-6 F33), U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, or by Internet electronic mail to bsjl@nrc. gov; and to the Desk Officer, Office of Information and Regulatory Affairs. NE0B 10202. (3150-0014), Office of Management and Budget, Washington, DC 20503.
Small Business Regulatory Enforcement Fairness Act In accordance with the Small Business Regulatory Enforcement Fairness Act of 1996, the NRC has determined that this action is not a 36 J