ML20149L622
| ML20149L622 | |
| Person / Time | |
|---|---|
| Issue date: | 06/21/1996 |
| From: | Paperiello C NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | Morrison D NRC OFFICE OF NUCLEAR REGULATORY RESEARCH (RES) |
| Shared Package | |
| ML20148P089 | List: |
| References | |
| FRN-61FR65120, RULE-PR-20 AF31-2, AF31-2-046, AF31-2-46, NUDOCS 9607030105 | |
| Download: ML20149L622 (180) | |
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j UNITED STATES NUCLEAR REGULATORY COMMISSION cc: Glenn Raddatz
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l June 21, 1996 MEMORANDUM T0: David L. Morrison, Director 1 Office of Nuclear Regulatory Research FROM: Carl J. Paperiello, Director Office of Nuclear Ha.terial Safety h
and Safeguards SUBACT: CONCURRENCE ON FINAL RULE: RESOLUTION OF DUAL REGULATION OF AIRBORNE EMISSIONS, CLEAN AIR ACT - 10 CFR PART 20 We have reviewed the draft Commission paper entitled " Final Rulemaking -
Revision to 10 CFR Part 20 Related to Constraint for Air Emissions from NRC and Agreement State Licensees Other than Power Reactors." This review includes comments from the Divisions of Waste Management, Industrial and Medical Nuclear Safety, and Fuel Cycle Safety and Safeguards. Editorial and minor technical comments were transmitted to Cheryl Trottier, RES separately.
We concur, pending incorporation of the following major changes:
- 1. Clarify when the Regulatory Guide associated with this rule is to be 4 finalized (or developed as a draft for public comment). Although much of this Commission paper and associated attachments reference the Regulatory Guide, it is not clear when the document will be complete, or whether or not it will be issued as a draft for comment. If the intent is to make it available at the time of the effective date of the final y rule, then this should be clarified in the Commission paper as well as the supplemental attachment text. In addition, much of what will be in this Regulatory Guide will need to be incorporated into the development of licensing guidance, as well as changes to the inspection procedures.
- 2. Throughout the text, replace "...from a single source to 0.1 mSv (10 mrem) per year" with "...from a single licensed operation to 0.1 mSv (10
/ mrem) per year"... from a single licensed facility to 0.1 mSv (10 mrem) per year." The term " single source" ts not defined in our regulations, and it is not clear what this would means in practice.
- 3. The statements of consideration in both the proposed rule as well as the final Federal Reaister notice state that NRC and Agreement State licensees will be " required" to record the estimated or measured dose
/ and the assumption used to calculate these doses from air effluents less than 10 mrem per year to members of the public (see page 6-7, 8).
There is no requirement in the proposed 520.2103, nor a logical health physics reason for requiring licensees to maintain written records for CONTACT: Phyllis Sobel, NMSS/DWM 415-6714 7-2-97
2 doses greater than zero, yet less than 10 mrem. The current I regulations under 520.2103(b)(4) are adequate for these
- recordkeeping purposes. We believe that this requirement should be eliminated from the proposed rule. Language changes to the 8 to clarify this were provided earlier to RES. l
- 4. The Federal Reaister states in many different places that there will be little or no additional burden to NRC as a result of the promulgation of i
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the rule (see p. 2 Commission paper, p. 12 8 , etc.), and in supporting this assertion, states that "no additional resources will be required to implement the rule" (page 2, Commission paper). SECY-93-229, page 11, states, " Inspections against commitments made in accordance with the
/' Regulatory which areGuide (andnot currently proposed rule) budgeted." will require NMSS believesabout 5 FTE that the per year resources will be approximately 3.5 FTE (basis provided to Cheryl Trottier, RES on
- June 13), as there are NRC resources needed for completion of the Regulatory Guide, development of materials (as well as non-power reactor) inspection and licensing guidance, as well as initial training of materials licensing and inspection staff. Except for IP 87102, which )
would need revision if the rule is made final, there has been no !
guidance developed, nor any FTE budgeted for changes to implement this
-rule in either the materials or non-power reactor licensing program.
The 3.5 FTE estimate does not include resource estimates for either NRR's inspection and licensing program, nor RES's resource needs.
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- 5. Throughout the text, the word " environmental" should be removed from the phrase " environmental air emissions" to be consistent with 10 CFR Part
. , 20. The key concept is dose to individual members of the public
/ resulting from air emissions. We have substituted the words " release of radioactive effluents to the environment" per 520.2103(b)(4).
- 6. The Regulatory Analysis and the Environmental Assessment need to be updated with current (up through 1995) data. As an example, thus far, three States have been granted Clean Air Act authority by the EPA; however on page 12 of the Regulatory Analysis, it states, "The EPA Administrator has not at this time approved any State for Subpart I implementation." In addition, the Regulatory Analysis provided outdated
/, (early 1990s) data regarding the cost of Subpart I implementation to licensees. The costs since that date for maintenance of the Clean Air Act for both EPA and HRC was drastically reduced from these_ini.tial estimated numbers. The EPA labor rates discussion beginning on page 20 of this section, was the EPA estimate from their original OMB clearance.
We now have'had several years of operating experience under dual regulations, and these cost estimates, as well as actual licensee reporting data (through 1995) to EPA need to be included in this discussion. Several changes to this section were proposed in the comments, provided earlier to RES.
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- 7. There are NRC staff who believe that the existing NRC programs are
' adequate and a constraint rule for air emissions is not needed. These differing views should be discussed in the pros and cons of the 4 altern I
!' paper.atives of the we Although regulatory analysis support the section or in the staff recommendation Commission to the Commission, ,
we believe that it's important for the Commission tc know that there are !
differing views.
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MEMORANDUM T0: David L. Morrison, Director l Office of Nuclear Regulatory Research FROM: James Lieberman, Director Office of Enforcement
SUBJECT:
FINAL RULE: RESOLUTION OF DUAL REGULATION OF 1 AIRBORNE EMISSIONS, CLEAN AIR ACT - 10 CFR PART 20 l l
The Office of Enforcement (OE) has reviewed 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 Reg / Ster, 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 i 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" sections of the Commission Paper to indicate that the Commission ,
also is being asked to approve the draft Notice to modify the i
Commission Paper, Discussion, page 2: "
. . .if a licensee 4
exceeds the constraint, reports to NRC, and takes corrective actions as aareed unon, . . . exceedance in subsequent years would not be violations."
jft is not clear how the corrective actions would be agreed upon.
v 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."
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David L. Morrison 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 Reg / Ster on the same day, the Commission is modifying its
" General Statement of Policy and Procedures for NRC Enforcement
,[ Actions"(EnforcementPolicy), to address the new regulation, and v that this change also will be reflected when the Enforcement Policy is reprinted in its entirety in the next revision of NUREG-1600.
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 i) licensees 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.
6 David L. Morrison Statements of Consideration, Response to Comments, Issue 2, page l
. 16: "This kind of ALARA rule imposes a limit in the sense that j 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." ]
i OE recommends that this passage be modified to read: "
This kind of ALARA rule imposes a limit in the sense that exceedance will ,
i lead to corrective action, but it is not a limit in the sense i 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' imoermissibly
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interchanges a narrow concept of 'ALARA' with a broad concept of 1 l limit.'" ;
OE recommends that the word, "impermissibly" be deleted. It is not clear who does not permit this or why.
. Statements of Consideration, Response to Comments, Issue 2, page i 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.. . ." ,
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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 j the particular ALARA concept in 10 CFR 20.1003."
i 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." l l
Since theLconstraint 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
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I David L. Morrison .
4 again in the future. Enforcement action can only be taken if the report is not made or adequate corrective action is not taken.
i Statements of Consideration, Response to Comments, Issue 3, page 4
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."
DE recommends that this statement be modified to read: ."The
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/ constraint 'is a limit it is not a dose doseabove at which which the licensee must enforcement actionnotify NRC, but will be l/ taken." The reasoning behind this recommended change is that, v since "exceedance is not a violation" (Id. , at 17-18),
enforcement action will not ever be taken for exceeding the constraint.2 Enforcement action can only be taken if the report is not made or adequate corrective action is not taken. )
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- Statements of Consideration, Response to Comments, Issue 3, page i 18
- "[If] the constraint has again been exceeded, where agreed
- upon corrective actions had been appropriately implemented, j enforcement action would not necessarily be considered."
s noted above, it is not clear how corrective actions would be
- " agreed upon." Since "exceedance is not a violation" (Id. , at l
17-18), enforcement action will not ever be taken for exceeding the constraint.
l 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."
, j To parallel the rule, OE recommends that this statement be I v modified to read: " . . the rule requires that corrective
. l actions be promptly taken. If a licensee does not comply, enforcement action will result."
2 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 4
- Of course, enforcement action would be taken if other radiation limits were exceeded as well.
David L. Morrison 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 to read: "To implement the ALARA requirement of 20.1101(b), and notwithstanding the 7
requirements in 20.1301 of this part, a constraint on environmental air emissions of radioactive materials is hereby established such that the individual member of the public likely to receive the highest dose will not be expected to receive a dose in excess of . . ."
cc: C. Paperiello, NMSS M. Weber, NMSS F. Cameron, OGC
David L. Morrison to read: "To implement the ALARA requirement of 20.1101(b), and notwithstanding the requirements in 20.1301 of this part, a constraint on environmental air emissions of radioactive materials is hereby established such that the individual member of the public likely to receive the highest dose will not be expected to receive a dose in excess of . . ."
cc: C. Paperiello, NMSS M. Weber, NHSS F. Cameron, 0GC DISTRIBUTION:
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06/04/96- 06/ /96 06/ /96~
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ATTACHMENT 1 FEDERAL REGISTER NOTICE i
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[7590-012P] ,
NUCLEAR REGULATORY COMMISSION 10 CFR Part 20 ,
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RIN 3150-AF31 Resolution of Dual Regulation of Airborne Emissions, Clean Air Act ,
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- AGENCY
- Nuclear Regulatory Commission. b k
i ACTION: Final rule.
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SUMMARY
- The Nuclear Regulatory Commission is amending its regulations 'to establish a constraint of 10 mrem /yr total effective dose equivalent (TEDE) 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 provide assurance to the Environmental Protection Agency (EPA) that future emissions from NRC licensees will not exceed dose levels that will provide an ample margin of safety. This action is expected to be the' final step in ;
providing EPA with a basis upon which to rescind its Clean Air Act (CAA) .
regulations'for NRC licensed facilities (other than power reactors) and '
Agreement St' ate _ licensees, thereby relieving these licensees'from unnecessary dual regulations.
TFinal Constraint Rule 1 May 10, 1996 4
& _-._m____________m______
EFFECTIVE DATE: This rule will become effective on the date of publication in ,
the ' Federal Register of the rescission of 40 CFR 61, Subpart I by EPA.
FOR FURTHER INFORMATION CONTACT: Charleen T. Raddatz, Office of Nuclear Regulatory Research, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001,_ telephone (301) 415-6215.
SUPPLEMENTARY INFORMATION:
9
Background
The EPA promulgated National Emission Standards for Hazardous Air Pollutants (NESHAPs) for radionuclides on October 31, 1989. Subpart I of ,
40 CFR 61 was promulgated to implement the CAA and limit doses to members of the public 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,and-are strbject to the requirementruh h ith!'u - R
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% & adon-222
-(c emis ons)from tailings were covered by Y r
[40CFR61,$u;bpaftsTfandW.yjg p Sub rt T.was rescinded for NRC licensees after oca"
$ Appendix A to Part 40 was amended by the Commission to conform to changes EPA / )
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/ issued to 40 CFR 192 that adoptea the provisions of Subpart ( ubpart W still /
applies to NRC licensee . Because Radon-222 is adequately addressed in
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Appendix A to,Part 40 and other provisions of Part 20 3 it is not covered in /
this , x - ,rulemaking.
F o /
(inl Final ~ Constraint Rule 2 May 10, 1996 l
e Under Subpart I, emissions of radionuclides must be limited so that no member of the public would receive an effective dose equivalent of greater ,
than 10 mrem /yr'.
In 1990, Congress enacted amendments to the CAA. Section ll2(d)(9) of these amendments to the CAA (the Simpson amendment) states: -
No standard for radionuclide' emissions from any category or 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 l for such category or subcategory provides an ample margin of safety to I protect the public health.
l Upon issuance, the effectivene'ss of Subpart I for all NRC licensees was innediately stayed by EPA pending further. evaluation. During the stay period, EPA conducted two studies of the air emissions from NRC and Agreement State materials licensees. The first was a survey of 367 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 /yr, based onLvery conservative modeling. In addition, 98 percent of the.
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/ Subpart I.exp~r esses dose in effective dose equivalent.(EDE). NRC ex esses dose in total effective dose equivalent (TEDE). These terms are H essentially equivalent. For the sake of consistency, this paper will refer to all. doses in terms of TEDE.
l; Final Constraint. Rule
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facilities surveyed reported doses to members of the public resulting from air emissions less than 1 mrem /yr. The second study evaluated do rom air emissions from 43 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 less than 1 mrem /yr. For the licensees evaluated, none exceeded 10 mrem /yr.
In its initial proposal to rescind Subpart I for NRC licensees other-
.than power reactors, EPA stated that: -
i BasedontheresuhfthesurveyundertakenbyEPAandthecommitments made by NRC in the MOU, EPA has made an initial determination that the NRC program under the Atomic Energy Act provides an ample margin of safety to protect the public health (57 FR 56880; December 1,1992).
However, EPA continued to express concern regarding the adequacy of the measures to " assure EPA 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 I. Consequently, NRC and Agreement State licensed facilities were i subject to dual regulation of air emissions of radionuclides under both the AEA and the CAA, including regulatory oversight by EPA (or authorized State) ,
and NRC (or Agreement State). ,
Final Constraint Rule 4 May 10, 1996 6
NRC licensees subject to Subpart I are also subject to NRC dose limits for members of the public contained in 10 CFR Part 20, Subpart D entitled
' Radiation Dose Limits for Individual Members of the Public" (Subpart D).
Under Subpart D, licensees shall ensure that doses to members of the public are less than 100 mrem /yr from all pathways (including air emissions) and all sources associated with the licensee's operation. In addition, doses to members of the public must be kept as low as is reasonably achievable (ALARA).
Based on the aforementioned studies conducted by EPA and licensee reporting of doses to members of the public from air emissions to EPA, it is evident that less than 10 mrem /yr to the maximally exposed member of the public from air emissions is reasonably achievable.
NRC power reactor licensees subject to 10 CFR 50.34a must keep doses to members of the public from air emissions consistent with the numerical guidelines in Appendix I to 10 CFR Part 50. In addition, these licensees have 1
for many years reported estimated doses to members of the public from air J l
emissions well below the Subpart I value. 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 has already rescinded Subpart I for power reactors licensed by NRC (60 FR 37196; September 5, 1995).
I Amendments The amendments proposed on December 13, 1995 (60 FR 63984), and finalized herein, establish a constraint of 10 mrem /yr TEDE for do o members of the public from air emissions of radionuclides from NRC licensed Final Constraint Rule 5 May 10, 1996
facilities other than power reactors as a part of its program to maintain doses ALARA. The amendments codify numerical values for NRC's application of ALARA guidelines on radioactive air emissions from its licensees, other than power reactors. For power reactors, ALARA guidelines have already been
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established within 10 CFR Part 50 and facility licensing conditions. The amendments ensure that air emissions are maintained at a very low evel and, #
taking into consideration the elimination of dual regulation, at little or no cost. This action brings consistency between EPA's dose standard and the NRC's ALARA application, thereby providing EPA with a basis upon which to rescind Subpart I as it applies to NRC licensed facilities other than power reactors.
This action is expected to be the final step in providing EPA with a basis upon which to rescind Subpart I for NRC licensees other than power reactors.
NRC has been working cooperatively with EPA over the last several years to support rescission of EPA's standards in Subpart I of 40 CFR Part 61 in accordance with Section ll2(d)(9) of the CAA. The fundamental objective of this effort is to eliminate unnecessary duplicative regulations that provide no incremental benefit in terms of public and environmental protection.
The regulatory framework within which NRC is providing a basis for rescission of Subpart I consists of the requirements in 10 CFR Part 20 to limit doses to members of the public to 100 mrem /yr, to maintain these doses as far below this limit as is reasonably achievable (ALARA), and to constrain [
dosho member.s of the public from air emissions of radioactive materials from # !
a single source to 10 mrem /yr.
The rule will require that if the licensee estimates or measures a dose to a member of the public expected to receive the highest dose from air Final Constraint Rule 6 May 10, 1996
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l l-effluents to be less than 10 mrem /yr, the licensee would be required to record l
' the dose and the assumption used to calculate it, consistent with the l requirements of 5 20.2103. This data would be made available to inspectors upon' request. If the licensee estimates or measures a dose to the member of.
the public expected to receive the highest dose from air effluents to be greater than.10 mrem /yr, the licensee would be required to report the dose to NRC in writing within 30 days. In addition, the licensee would be required to l include in that report the circumstances that led to the greater than 10 mrem / 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 the expected results.
The constraint on dose-from air emissions is different than a limit.
Exceeding this constraint will not result in a Notice of Violation (N0V).
Rather, a NOV will be issued only upon failure to report that actual or estimated dose from air effluent releases from a facility, have exceeded the I constraint value and/or failure to institute appropriate measures to correct andpreventfurtheremissionsinexcessofthosewhichwouldresultindos@
exceeding the constraint level. 7i a.
The rule will apply to airborne releases, other than Radon-222 and .. jyt
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daughters, from all NRC licensees except power reacto d wer reactors are exempt from this proposed rule because they are already required under 10 CFR 50.34a to identify, in their application, design objectives and the means to be employed for keeping doses to members of the public from air effluents ALARA. ' Appendix I to Part 50 contains the numerical guidelines to meet this -t requirement.
Final Constra' int Rule 7 May 10, 1996 e
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b Response to Comments ,
Fifty-seven individuals and organizations provided written comments on the proposed rule and the regulatory _ guide. Among the 57 comments, 24 were
- licensees, 7 professional organizations, 5 States,16 members of the public, ,,-
and 5 environmental organizations. Since mar,v letters ef'commentl%n the
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subject oNregulatory guide ' cluded comments _ on the rule, they were'also -
considered in developing the final rule.
Issue 1 - PROPOSED RULE APPROACH 1
Connents: 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
- Subpart I should remain in effect. Twenty-two commenters stated that existing a
NRC programs provided an ample margin of safety and that the constraint was 3
not needed. However, of these, seven agreed that the constraint was preferable to dual regulation or Subpart I alone.
,- l i Those commenting that existing NRC programs are adequate to protect the public cited the-EPA studies on doses from air emissions. Two-thirds of these commenters were opposed to going forward with the constraint as it was not needed and costs could not be justified given the expectation that risk would I not be reduced. These commenters encouraged NRC to continue working with EPA to provide . sufficient basis for rescission of Subpart I without the imposition j
- of an equally unnecessary regulation. A few stated that the risk was considerably less than estimated as excessively, conservative calculational i Final Constraint Rule 8 May 10, 1996 4
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methods were used by EPA. A few compared the 10 mrem /y constraint to variability in background or doses from commercial air traffic as evidence that the dose, and the risk, is trivial. Of the seven agreeing that the constraint was preferable to dual regulation or EPA's Subpart I alone, burden reduction and single-agency oversight were the reasons cited.
Commenters opposed to the constraint as a less protective standard, stated that the constraint was based upon a voluntary program (ALARA) and as such was not adequate to protect the public. One commenter stated that NRC does not do confirmat:ry measurements and therefore NRC jurisdiction was not adequate.
Response: NRC and EPA have been working cooperatively to develop a basis upon 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 /y to a member of the public. This has been demonstrated through the two studies undertaken by EPA and by licensee reporting of actual air emissions. The second component is a program to ensure that doses remain at this low level. In the absence of rulemaking requiring licensees to maintain doses to levels of no more than 10 mrem /y, EPA would not rescind Subpart I, and dual regulation would continue.
The Federal Radiation Council (FRC) was formed in 1959 to provide reconnendations to the President for Federal policy on radiation matters affecting health. In May of 1960, FRC set forth basic principles for protection of both workers and members of the public. The council was i
Final Constraint Rule 9 May 10, 1996
abolished in 1970 and its functions transferred to the Administrator of the newly formed Environmental Protection Agency. In 1981, EPA published proposed recommendations for new Federal guidance for occupational exposure. In 1987, President Reagan approved recommendations by the Administrator of EPA for new
" Radiation Protection Guidance to Federal Agencies for Occupational Exposure."
EPA has not yet issued recommendations on limits for members of the public. A working group comprised of representatives of affected Federal Agencies and experts has been developing these recommendations for several years. It is' expected that they will do so within the next year.
The International Council on Radiological Protection (ICRP) issued its Report No. 26 " Recommendations of the International Council on Radiological Protection" in 1977. These recommendations included that the average doses to members of the public should not exceed 100 mrem /yr with a limit of 500 mrem /yr to any individual.
The National Council on Radiation Protection and Measurements (NCRP) has the responsibility under its charter from the Congress of the United States to recommend limits for exposure to ionizing radiation. In June of 1987, NCRP issued its Report No. 91 " Recommendations on Limits for Exposure to Ionizing Radiation." This report makes recommendations on limits for both occupationally exposed individuals, and individual members of the public. The report recommended that doses to individual members of the public be limited to 100 mrera/y averaged over a lifetime, not to exceed 500 mrem in any one year.
Final Constraint Rule 10 May 10, 1996
in 1991 NRC revised its 10 CFR Part 20 " Standards for Protection 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 in any one year, the NRC established a limit of 100 mrem /yr as it was deemed to be impractical to control dose in terms of lifetime average without keeping track of individual exposures. In addition, Part 20 requires that licensees use procedures and engineering controls to maintain doses as low as is reasonably achievable (ALARA).
Both the NRC and EPA regulatory programs are designed to achieve the goals presented in the Federal guidance, ICRP recommendations, and NCRP recommendations. The approaches of the two agencies differ. NRC limits TEDE and requires that doses are maintained ALARA. EPA limits dose from individual pathways of exposure and individual radionuclides to ensure that the total l
dose does not exceed the recommended levels. Both programs achieve similar J
levels of protection.
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NRC agrees that adoption of the constraint in 5 20.1101(d) is preferable to dual regulation or regulation under 40 CFR 61, Subpart I alone due to the reduction in burden on licensees as well as State and Federal Government ;
agencies. Under the provisions of 40 CFR 61, licensees with doses to members of the public greater than 1 mrem /y but less than 10 mrem /y have to submit reports, recommend and implement corrective actions pursuant to Subpart I.
These reporting requirements, even for licensees who have not exceeded any limit, are necessary under Subpart I as EPA does not perform routine inspections to ensure compliance with their regulations. However, under Final Constraint Rule 11 May 10, 1996
5 20.1101(d), these licensees will not have to file reports r doses below the constraint levd. -The reason this is not necessary, is that doses can be' evaluated at the time of routine inspections performed by trained inspectors. Under the new regime, .the burden of calculating doses should be reduced for most licensees because the proposed guidance for demonstrating compliance with 6 20.1101(d) allows significantly more flexibility and simpler methods.for calculating doses than does the COMPLY model currently used to implement 40 CFR 61. These new methods for calculating doses should result in fewer reporting and corrective actions.
duced as "
The Federal and State Government burden should be the number of annual reports requiring review and follow up actions should decline from several hundred per year to at most a few. Because NRC inspectors are already inspecting records of air emissions, there is little additional burden to NRC as a result of the promulgation of this rule. There is the one time burden for promulgation of the rule, rescission of Subpart I and development of regulatory guidance and inspection procedures. There is also a one time burden for implementation of compatible regulations by .
wJll #
Agreement States. Overall, the burden to State and Federal agencies sh=1dgbe reduced.
The NRC inspection program does not routinely include confirmatory measurements, but air effluent records are routinely inspected by NRC and confirmatory measurements are performed if it is deemed necessary by the inspector. Further, as previously stated, confirmatory measurements are not currently performed to ensure compliance with Subpart I.
Final Constraint Rule 12 May 10,.1996 1
Finally, concerning those commenters that believe NRC's requirements JAv --
b less safe than Subpart I, in 1990, Congress enacted legislation comprehensively amending the Clean Air Act (CAA), which included a section addressing the issue of regulatory duplication between EPA and iM. The 1990 CAA amendments permit the Administrator of EPA to rescind the CAA standards as they apply to radionuclides, at sites licensed by NRC and the Agreement States, if she finds that the NRC regulatory program provides an ample margin of safety to protect the public health.
EPA's analysis of the NRC regulatory program focused on two general issues: (1) whether the implementation of the NRC regulatory program results in sufficiently low doses to protect the health and safety of the public with an ample margin of safety, and (2) whether the NRC program is sufficiently comprehensive and thorough, and administered in a manner that 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 /y and thereby provide evidence to EPA that the currently I existing level of protection will continue to be afforded into the future.
The purpose of this rulemaking is therefore not to reduce doses, as it has already been demonstrated that doses are sufficiently low. Rather, the primary purpose is to reduce costs associated with the level of protection currently afforded, by providing a basis upon which EPA can find that doses will not increase as a result of rescission of Subpart I. Secondarily, the Final Constraint Rule 13 May 10, 1996
[ l
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4 rule will ensure that doses.are maintained at the' low level currently achieved by NRC' licensees.
Issue 2 - _ PROMULGATION OF THE CONSTRAINT AS ALARA .
T Comments: Ther'e were a number of commenters who objected to the ALARA basis for the proposed constraint rule. Some objected on the ground that ALARA is.a matter of operating philosophy, good- radiation protection practice and licensee Judgment,, and cannot be translated into an enforceable dose
~
objected'that ALARA is inherently site specific and #'
- number. Others cannot be. defined generically,.or that the proposed dose constraint cannot be .
4 ALARA but' must instead be a limit because the constraint contemplates some -
enforcement actions for exceedance even if the licensee has followed all good ;
. a radiation protection practices. Finally, some argued that the rule cannot be ALARA because it adds costs with no safety benefit y and others stated that the .
- constraintisinconsistentwithapriorNRCdecisionon"referencelevels.g Response: The Commission has retained an ALARA basis for the rule 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 licensee expert judgement.
What the NRC'had in mind in the proposed constraint rule is 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 i
l FinaliConstraint' Rule. 14 May 10, 1996 1
\
(D.C. Cir. 1987), contemplates two distinct approaches to radiological regulation. First a level of " adequate protection" must be defined and enforced without regard to economic cost, and second risk may be reduced to a level below that associated with " adequate protection" to " minimize danger to life or property" with economic cost and other factors as permissible balancing considerations. See " Revision ~ of Backfitting Process for Power Reactors," 53 Fed. Reg. 20603 (June 6, 1988). Of critical importance here, the Act provides the Commission with power to adopt and enforce generic requirements using either approach (Act 5 161b) 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 costs and safety backfits. These
" minimize danger" regulations provide " limits" in the sense that they establish generic requirements directly enforceable against licensees, but in a broad sense they are also ALARA regulations in that cost, feasibility and other relevant factors identified in 10 CFR 20.1003 are weighed and balanced.
Viewed in its larger statutory context, ALARA in 10 CFR 20.1003 is one means to implement the second approach to radiological regulation but other similar requirements can also be part of this second approach. In particular, 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 h M cons
.iderations are also leoally
[
nn emu s i bl e. This broader concept of ALARA -
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 i i
Final Constraint Rule 15 May 10, 1996 j
Part 50, Appendix I, and is the basis for the constraint rule. 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.
Thus, to say that the constraint rule cannot be based on ALARA because j it is in effect a " limit" ';-. . d /_ interchanges _a narrow concept of
/
"ALARA" with a broad concept of " limit." If a broad definition is usedjthe t/
constraint rule withstands scrutiny as both ALARA and a limit. In particular, in the statutory context of the Atomic Energy Act and general principles of administrative law, the constraint rule is a limit based on generic ALARA considerations. The constraint rule is not a limit needed for adequate protection, and is something more than a narrow translation of the particular ALARA concept !a 10 CFR 20.1003. Solely to avoid confusion with the narrow concepts of ALARA and limit often employed in radiation protection discussion, /
the term " constraint" was used for the rule p '_. n ._._.m .u..
This leaves three matters to be addressed - the comment that the rule cannot be based on ALARA because it will result in increased cost with no safety benefit, the problem of the licensee who cannot meet the dose constraint despite using all good radiation protection practices, and 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 licenses affected by the rule are achieving a level of control suchthatdose'hrebelowthe10mre evel and so there is no factual dispute over whether this level of radiation protection is readily achievable. The Final Constraint Rule 16 May 10, 1996
rule itself, considered with EPA's rescission of its Clean Air Act emission limits and related requirements, will resul /rr a significant net cost savings , _ . '
to licensees. We acknowledge that, given the current level of controls, the positive direct health effects are likely to be small and possibly zero in the near future, but the rule will have the effect of preventing possible future backsliding by licensees, and so can be said to offer some small but positive net health and safety benefit. Under the broad ALARA concept described above, it is entirely appropriate to base a rule on a small positive health and safety benefit when cost savings are also likely.
We do not expect that any licensee subject to the rule will be unable to comply. In the unlikely event that, due to some temporary circumstances or lapse in controls, the dose level is or is projected to be exceeded, licensee actions to come wit ompliance are expected and, if needed, will be enforced.
{ e unforeseen h iven current information on the practicality of stringent controls, niikely circumstance of a licensee being unable to comply, because /
of limits in the technology or exorbitant cost, can b ddressed in the
~
future on a case by case basis, slees ne+ 4 ly .y Finally, this rule is not inconsistent with the enneen f reference level which was rejected by the Commission when Part 20 was recently revised.
Commenters on the 199? revision to Part 20 objected to the use of reference levels as they were implemented exactly the same as limits. For that reason the Commission eliminated reference levels from the final 1991 revision.
F "
Implementationoftheconstraintisdifferentthanalimitinthatexceedfnce A
Final Constraint Rule 17 May 10, 1996
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' ' /
/ l is not a violation, and it only requires licensee actior It is not th -
purpose of the constraint rule to provide such added assuranc rt$sive4 by a referna level7 l1 Issue 3 - WHETHER THE CONSTRAINT IS ACTUALLY A LIMIT Comments: Nine comments were received on whether the constraint is or should be a limit. . Two. commented that the constraint was no different than a limit. One commenter agreed with the term constraint. Three commenters expressed concern that the constraint was an inappropriate relaxation of requirements.
Those commenting that the constraint was a de facto limit, interpreted V
/ -
therequirementstoindicatethatasecondexceedynceoftheconstraintwould result in enforcement action and therefore is a limit. Three commenters indicated that the rule should be a strict limit. They expressed concern that the constraint was less protective than Subpart I.
l Response: A constraint is not the same as a limit. The constraint is a dose at which the licensee must notify NRC, but it is not a dose above which I 1
enforcement action would necessarily be taken. If a licensee exceeds a limit, the NRC may take immediate enforcement action. If a licensee exceeds a constraint, licensees will be required to notify NRC and implement corrective I actions that are adequate to prevent further doses in excess of the constraint. In the unlikely event that calculations in the following year indicate that the constraint has again been exceeded, where agreed upon corrective _ actions had been appropriately implemented, enforcement action final Constraint Rule 18 May 10, 1996 i
i
would not necessarily be considered. I owever, the licensee had failed to ._
report it to NRC or had failed to implement the corrective actions as agreed upon, enforcement action would be expected.
1 The adoption of a constraint is not needed to provide adequate protection of the public and the environment. The existing regulatory program of established limits in Part 20 and the application of ALARA is adequate for
'that purpose. _Therefore, it is not necessary to promulgate the constraint as a limit.
The NRC does not agree that the constraint is less protective than Subpart I. Both Subpart I and the constraint require licensees to take actions to ensure that' doses' to members of the public do not exceed 10 mrem /y from environmental air emissions. Enforcement would be similar under either [
requirement routinely inspects licensed facilities to ensure that air l effluents do not result in doses to members of the public in excess of the requirements in Part 20. Confirmatory measurements are performed when they A F*"t" - / I are deemed approprigte ?c ri-ihr pregrea m inspectionandenforcementgiH >
. knvVL be t p1;;;c,ted as a result of this rulemaking.
Issue 4 - CITIZEN SUITS l
Comments: Three commenters opposed finalization of the constraint on J j
- the basis that it forfeits citizen rights to sue a licensee exceeding the constraint.
Response: The hck hf : citizca w it prevision in the Atve-;c Encr m Aet-fT iii5Fe oppr;prictcly a matter for the
[
l'A Lu cuns;&r i reachin it' --
Final Constraint Rule 19 May 10, 1996 I
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l l reeci e r ien-dec4sion. lanwayet, it shotilILhe-eted-thd7he Commission's regulations in 10 CFR 2.206 provide the public with the right to petition the Commission to take enforcement action against a licensee for such things as a violation of the Commission's regulations. This would include the constraint rule when finalized.
Issue 5 - AGREEMENT STATE COMPATIBILITY Comments: 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 division 1. Under division 1, the States would be required to adopt regulations that were essentially identical. These commenters said that if stricter standards were permitted, that reactors and non reactor licensees would be under different requirements, and that certain practices such as nuclear medicine could be jeopardized. One commenter noted that because this is really a limit, it should be under 6 20.1301 and would therefore be $
A division 1 matter of compatibility. Another commenter sated 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.
Response: Section 116 of the Clean Air Act indicates that, with certain exceptions not applicable here, nothing in the Act precludes States from imposing air emission requirements that are more stringent than those Final Constraint Rule 20 May 10, 1996
de oped by EPA. Se )(9), which contains the provisions related to
~PA's " ample margin of safety determination for NRC or Agreement State 4h 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 staridard or limitation respecting emissions of radionuclides which is more a stringent than the standard or limitation in effect under Section 7411 of this itle or this section." The Commission believes that this provision so- ,
116~ clarifies that EPA's determination regarding NRC an /
Agreement State licensees has no effect on the existing authority o .
tes to impose air emission standards that are more stringent than those of EPA.
Accordingly, the Commission believes that the division 2 compatibility /
designation for the rule is consistent wit b te authority in this area as described in the Clean Air Act. The division 2 designation means that i
Agreement States must address these rules in their regulations but may adopt ;
requirements more restrictive than those of NRC. Accordingly, the power of the Agreement States to impose air emission standards under their Atomic l
Energy Act authority after the effective date of this rule will be consistent with their existing authority.
With regard to the comment concerning involvement of the Agreement States in the development 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 Control Program Directors (CRCPD) at each of their annual meetings.
The Agreement States were consulted extensively on this issue over the last several years. While they were not formally sent an advance copy of the draf t Final Constraint Rule 21 May 10, 1996
m rule, there were extensive discussions of the concept, not only with the ohs- 06 individual States, but also with the Executive Board of the e,3mnizahen -- ~'
.htreemenL=St w Issue 6 - DEMOGRAPHIC INFORMATION CONTAINED IN REQUIRED REPORTS Comments: Seven commenters addressed the application of the requirement contained in 5 20.2203 (b)(2) to the constraint. This section requires that reports contain demographic information on the exposed individual. These commenters expressed concern that a member of the public would be under no obligation to provide demographic information to licensees. Licensees would therefore not always be able to comply with the requirement.
Response: NRC agrees that members of the public may choose to withhold l the demographic information from licensees. Section 20.2203 has been changed j 1
to delete that requirement. ,
l Issue 7 - EFFECTIVE DATE i
Comment: One commenter requested that an effective date be added to the final rule to coincide with EPA's rescission of Subpart I.
Response: NRC agrees and this provision has been added. This provision is needed to ensure that there is not a time when both Subpart I and the constraint are in effect. Because it is very difficult to coordinate these rulemakings such that they are issued simultaneously, a delay in the effective date is appropriate.
Final Constraint Rule 22 May 10, 1996
Issue 8 - ENF'ORCEMENT-Comments: Five commenters c; =;ct S that NRC should establish a limit rather than a constraint'. They stated that once.the limit has~been exceeded, a notice of. violation and civil penalties should always result. One commenter expressed concern that "self-reporting and confession" is not adequate.
Another stated that because ALARA is es=only guidance, it is not enforceable.
Response: A limit implies that doses must be controlled below that / !
level in order to provide adequate protection.of the health and safety of the public and worker A r$o~t ce ofifo'lat'IoIan[ civil penalties are not n s (16nsurethatlicenseeswillnotexceedaconstraint.{Licenseesare currently controlling effluents to levels belew that which would be required undertheconstrainttomeetcurrentALARArequirements,gifalicensee exceeds the constraint, the rule requires that corrective actions be taken in ,
.a timely fashion. 'If a licensee is uncooperative or fails to take appropriate actions, a notice of violation and civil penalties are possible.
ALARA is not a guidance. As' stated previously, the 1991 revision to 10 CFR Part 20 codified ALARA as a required part of the licensee's radiation protection program. f Issue 9 - EXEMPTIONS Comments: Five commenters stated that the rule should only apply to members of the.public off site. They cited the Subpart I requirement to
' calculate dose to the nearest resident. Under Subpart I, licensees would not ,
Final Constraint Rule 23 May 10, 1996
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)
i calculate doses from~ air emissions to visitors in hospitals, workers that are j
'not radiation workers within the facility, or. Other members of the public )
within the facility.
Response: 'NRC agrees that Subpart 1 only applies to the nearest l resident. The language in the. rule has t'een changed to reflect that it is intended to apply to environmental air emissions. The guidance will be revised to indicate that the dose limit is to be calculated t he nearest
- f WA$Wid '
resident. ;
l Comments: Two commenters stated that air emissions from adjacent nearby -
exempt uranium mills should not be included in the calculation of dose. One j
commenter stated that materials from unlicensed portions of the facility such as ore stockpiles should not need to be considered in the calculation of dose.
Response: Subpart I does not apply to disposal at facilities 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 constraint applies to environmental emissions of licensed materials only. Therulelanguagehas] h been changed to make it clear that windblown particulates from other nearby #
F licensed facilities or unlicensed materials need not be considered in the g -
calculation of deses used to demonstrate compliance with the constraint. _J -
Comments: Four commenters stated that air emissions from patients '
should be exempted from this rule.
Response: NRC agrees that air emissions from patients are excluded from this rule. The Regulatory Impact Analysis for NRC's recent Patient Release
- Final Constraint Rule 24 May 10, 1996 l
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Rulemaking._(NUREG-1492), analyzed potential doses from exposure to patients having.been released following administration of radiopharmaceuticals. This analysis concluded that internal doses from intakes of radioactive materials l
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 final regulatory guide will make it clear that ,
dose from air emissions from patients need not be specifically addressed in-the calculation _of dose used to demonstrate compliance with the constraint.
l Comments: Four commenters stated that in addition to Rn-222, all ]
daughters produced after release _should also be excluded.
Response: Subpart I exempts both Rn-222 and any daughters produced after release of Rn-222 as it is normally not attributable to licensed activities. The proposed rule was not intended to be more stringent than ]
Subpart I. The rule language has been changed to reflect this exemption. I 1
Comments: Two commenters recommended that in addition to Rn-222, Rn-220 and its daughters should also be exempted. One commenter stated that it was an EPA oversight that led to this erroneous omission from the final Subpart I.
Response: Rn-220 is normally attributable to licensed activities. EPA does not exempt Rn-220 or its daughters from consideration in the dose calculations-in support of demonstrating compliance with Subpart I. The commenter$ suggestion that an oversight led to the erroneous omission of this A
y 1
Final Constraint' Rule 25 May 10, 1996 I
1 exemption.from Subpart I is incorrect. Therefore, Rn-220 will not be excluded 1
from the calculations demonstrating compliance with the constraint.
Comments: Six commenters requested that in addition to sealed sources, sealed containers should also be excluded from the rule.
p l Response: Paragraph 2(a) of Appendix 0 to 40 CFR 61 states 4 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, as any package that has remained sealed cannot contribute to airborne emissions. 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 emissions. The final regulatory guide will provide further guidance on this issue.
Issue 10 - MEASURABILITY OF 10 MREM / YEAR Comments: Three commenters stated that 10 mrem /y was not measurable.
One commenter stated that while 10 mrem /y might be easily achievable, it is n , gnot easily measurable. Another stated that the exposure rate corresponds to 1 microR/hr and cannot be measured accurately.
Response: The regulatory guide provides several methods for
/- demonstrating compliance with the constraint. Only one of the methods acceptable to staff is direct measurement at the receptor location. If this k'
method is not practical due to the emission characteristics of the s
Final Constraint Rule 26 May 10, 1996
T a
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radionuclide releases, there are several valid options cited in the regulatory- ,
guide. . .,
Jssue 11 -2 SCOPE OF THE RULE' i
- Comments: ~ One comenter stated' that if we must'have a constraint, it
~
should apply'to'all: licensees, not'just non-reactors. ,
Response: Although this rule only_ applies to licensees other than power i reactor licensees, the Commission's existing regulations in Part 50, 7 Appendix I, already_ establish' a'similar regulatory frameworg Appendix I kM " '
includes separate requirements to develop design objectives and operational !
levels sufficient to demonstrate' compliance with Subpart I. In addition, !
reactor licensees must report quantities of radioactive materials' released in
]
air'and water annually,.as well as the doses that result.
' Issue 12 LOCATION OF' CONSTRAINT IN NRC REGULATIONS !
The Commission requested specific comment on the-question of whether the-constraint should be established in 10 CFR Part 20,: as proposed, or j 10 mref .
whether it should be established separately in each appropriate Part of Title ;
10 instead. ,
-Comments: Two comments were. received in response to this issue. One '
stated that the' constraint should be in Part-20. The other stated that the. 1
- constraint should be in each appropriate part. Two other commenters stated ,
i FinalLConstraint Rule. 2 7 .- May--10, 1996, w- =
that the constraint should be in 1 20.1301 with dose limits.
Response: In order to make clear that the constraint is intended to
. control do o members of the blic, but that it is not the same as a limit, it will be codified in a Suboa o Part 20, " Dose constraints for members of the publi k MdY DNm M' N' $
Summary of Changes in the Final Rule Based on the responsho comments, a few changes were made in the final '
rule. Otherwise, the final rule provisions are the same as those presented in of '.
the " background" section under the section titled proposed amendments. -
f Specific changes made to the proposed rule in the final rule are summarized as follows.
(1) The requirement in 5 20.2203(b)(2) has been changed to eliminate k the requirement to report the name, social security number, and date of birth for each individual member of the public exposed to doses n excess of /
limits or constraints, f (2) Paragraph 20.1101(d)(2) has been added to indicate that the effective date of the rule imposing the constraint is to coincide with EPA's rescission of 40 CFR 61, Subpart I.
(3) The language of the rule has been changed to indicate that Rn-222 and all daughters produced after the release of the radon are categorically excluded from this rule. ,, /
QQu} his At ih ' W Fh
+ ms , A Final Constraint Rule 28 May 10, 1996
i I
(4) The language of the rule has been changed to indicate that the constraint applies only to environmental air emissions and thus dose to the-nearest' resident is to be constrained.
In addition, the following changes will be made to the regulatory guide:
y (1) An inventory of radioactive materials used to model a potential ;
dose 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 need not be considered if the materials have already been included in the site inventory.
(3) The example has been changed to demonstrate compliance with an environmental release constraint by caltalating a dose to the nearest resident from a routine release point.
Finding of No Significant Environmental Imyact 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 would provide equivalent protection. Actual air emissions are not expected to change. The changes would be procedural methods for demonstrating compliance i
Final Constraint Rule 29 May 10, 1996
.- . . . ~ . . . . . . - . . . - -.. . - . . = . . _ - . - _ - . . . . . _ _ _ .
I 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. ,
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. l 1he 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 bsjl0nrc. gov; and to the Desk Officer, Office of Information and Regulatory Affairs, NE08-10202, (3150 -
0014), Office of Management and Budget, Washington, DC 20503. ,
t G
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. Final Constraint Rule 30 May 10, 1996
Public Protection Notification The NRC may not conduct or sponsor, and a person is not required to
~
respond.to, a_ collection of information unless it displays a currently valid ,
OMB control number.
Regulatory Analysis The NRC has prepared a regulatory analysis for this final rule. The
, analysis cgalitd=ly examines the costs and benefits of the alternatives _____-
considered by the NRC. In the response to comments, the NRC concluded that only some minor changes to the draft regulatory analysis were n'ecessary, corresponding to some minor procedural changes in the final rule. The regulatory analysis is available for inspection in the NRC Public Document Room, 2120 L Street, N'J. (Lower level), Washington, DC 20555-0001. Single copies of the analysis may be.obtained from Charleen T. Raddatz, Office of Nuclear Regulatory Research, U.S. Nuclear Regulatory Commission, Washington,- )
DC 20555-0001, telephone (301) 415-6215.
I Regulatory flexibility Certification In accordance with the Regulatory Flexibility Act of 1980, (5 U.S.C.
605(b)); the Commission certifies that this rule, if adopted, will not-have a l significant economic impact on a substantial number of small- entities. This final rule only impacts NRC . licensees with emissions of _significant quantities ;
FinaliConstraint Rule 31 May 10,.1996 4
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3- b s..
of radioactive material. .This category of. licensee includes only a few small- ' '
' businesses.
a
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Small Business Regulatory Enforcement Fairness Act: ,
. In ,accordance with the Small Business Regulatory EnforcementL Fairness Act of 1996,.the NRC has determined that this action is not a' major rule and' has ~ verified this determination with the Office of Information and. Regulatory
- Affairs of OMB.
Backfit Analysis The NRC has determined that the backfit rule, 10 CFR 50.109, does not apply'to this final rule because it does not apply to' power reactor licensees, and therefore, that a backfit analysis is not required for this final rule because these amendments do not involve any provisions which would impose !
backfits as defined in'10 CFR 50.109(a)(1).
List of Subjects In 10 CFR Part 20
' Byproduct material, Criminal penalties, Licensed material, Nuclear materials, Nuclear. power plants and reactors, Occupational safety and health, Packaging and containers, Radiation protection, Reporting and recordkeeping
. requirements,. Source material, Special nuclear material, Waste treatment and dispos'a1.-
5 Final Constra' int Rule. 32 'May 10, 1996 4
i For the reasons set out in the preamble and under the authority of the Atomic Energy Act of 1954, as amended, the Energy Reorganization Act of 1974, as amended, and 5 U.S.C. 553, the NRC is adopting the following amendments to 10 CFR Part 20.
PART 20 - STANDARDS FOR PROTECTION AGAINST RADIATION l
- 1. The authority citation for Part 20 continues to read as follows:
AUTHORITY: Secs. 53, 63, 65, 81, 103, 104, 161, 182, 186, 68 stat, 930, 933, 935, 936, 937, 948, 953, 955, as amended, sec. 1701, 106 Stat. 2951, 2952, 2953 (42 U.S.C. 2073, 2093, 2095, 2111, 2133, 2134, 2201, 2232, 2236, 2297f); secs. 201, as amended, 202, 206, 88 stat. 1242, as amended, 1244, 1246 (42 U.S.C. 5841, 5842, 5846).
- 2. In i 20.1003, the definition of Constraint is added to read as I
follows:
5 20.1003 Definitions.
Constraint (dose constraint) means a va1ue above which specified licensee actions are required.
- * + *
- I
- 3. In i 20.1101 paragraph (d) is added to read as follows:
Final Constraint Rule 33 May 10, 1996
bee h>hyhaldio AJ4/ir Rinduid rdt ? N/
- 4'kA *bana b flt v 1 % f lose s n h % l fo P 3 f k & 0 O'Ab *A N " % bY/*rflM'/'/ity shd wM led 4 to ss;t tW hJ;y Adhs m pafheLd./i, lh mg.g
- (c]) To implement the ALARA requirements of_ 5 20.1101 (b), and
, N/d. wt notwithstanding the requirements in 5 20.1301 of this g icensees o k those subject to 55 50.34a w ;G.%fbshall constrain environmental air emissions of ;. radioactive materials so that the individual member of the public [
likely to. receive the highest dose will not be expected to receive a dose in If excess 'of 10 mrem /yr TEDE from these emissions. I'r.M.
($) If a licensee subject to this requirement exceeds this dose N
- constraint, the licensee shall report the exceedgnce as provided in 5 20.2203 v and promptly take appropriate corrective action to ensure against recurrence.
(1) This requirement sha'l be effective on the effective date of the rescission by EPA of 40 CFR 61, Subpart I for NRC licensed facilities other than power reactors.
i
- 4. In 5 20.2203 a new paragraph (a)(2)(vi) is added and paragraph (b)(1)(iv) is revised to read as follows: !
5 20.2203 Reports of exposures, radiation levels, and concentrations of radioactive material exceedina the constraints or limits.
(a)
(2)
(vi) The ALARA constraints for air emissions established under 5 20.1101( @ d I (b)
(1)
(ivif orrective steps tatan or planned to ensure against a recurrence, including the schedule for achieving conformance with applicable limits, ALARA 1
/
Final Constraint Rule 34 May 10, 1996
constraints, generally applicable environmental standards,. and associated -
' license-conditions. '
(2) Each report filed pursuant to. paragraph (a) of_this section, for
. ~,
- doses to occupationally exposed individuals in excess of limits, must includ ,
,. . . _, v for each individual - 9 j ,
- ~7 * * -*
4
' Dated _at Rockville, Maryland, this day of , 1996.
- For the Nuclear Regulatory Commission.
6 4 I ' Tgp j,, . p[ ' /48 i
) 3 v.w Lt)(1)(iV) s p,'pe3 (f2.) A/
John C. Hoyle, !'
. Secretary of the Commission.
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i Final Constraint Rule- 35 -May 10, 1996
IJ KL CM ATTACHMENT 2 REGULATORY ANALYSIS i
-I
,... j l
I Regulatory Analysis for the NRC. Constraint Rule on j
- <Radionuclide Air Emissions.from NRC and Agreement State !
Licensees Other.than Nucleae Power Reactors ~
l
- 1. Statement of Problem-e
- .Radionuclide air emissions from Nuclear Regulatory Commission-(NRC) licensees'other than. power reactors,' and NRC Agreement State licensees are j currently regulated by both the NRC.(or Agreement' State) and the Environmental
. Protection Agency'(EPA). .The NRC and Agreement State regulations have been-issued under the authority of the Atomic Energy Act (AEA).
~
The EPA ,
(
1
~
regulations have been issued under the authority of the Clean Air Act (CAA). l The purpose of this Regulatory Analysis is to evaluate a final NRC rulemaking l i
that provides assurance to the EPA that future emissions from NRC licensees- )
will not excee'd levels that would provide-an ample margin of safety. This :
action is expected to be.the final step in providing EPA with a basis upon j which to' rescind'40 CFR Part 61 " National Emission Standards for Hazardous Air j
- Pollutants" (NESHAPS),' Subpart 'I, as it applies to NRC licensed facilities j l other. than power reactors,'_ hereby relieving these NRC licensees from +
- i i
e
' unnecessary dual regulatio1n . _
i The EPA's regulations, 40 CFR Part 61, Subpart I, are currently in 4
effect for.all'NRC and Agreement State licensees, except power reactors. The j
.C l- dose' standard contained within.this regulation is not consistent with those of {
NRC in 10'CFRLPart 20.~ The EPA dose standard in Subpart I is'10 mrem per t 1 EPA has rescinded Subpart I for power reactors based on. requirements ~ j
. contained in 10 CFR Part 50, Appendix I, and a history of over 20' years of :
1 reported air emissions from power reactors resulting in= doses well below
- 10 mrem /yr,to the maximally exposed member of the'public. !
year, total effective dose equivalent (TEDE)- for air emissions from any single j facility (buildings, structures, and operations on one contiguous site). This j
. standard'is different in both numerical value and approach to that of the NRC.
The EPA approach to ensuring that dose limits adequately protect the l
public with an~ ample margin of safety is to limit individual ~ pathways and sources to a fraction of the 100 mrem /yr TEDE limit for members of. the public.
The NRC approach to_ ensuring that doses to members of the public are-adequately protective is to require compliance with an upper limit of 100 mrem per year TEDE from all path s, and.to the extent practical, maintain doses
. -as far below this li .as is reasonably achievable (ALARA , taking into A A ,
account social and economic considerations and sound radiation protection principles.
~
L ~There are three mechanisms for demonstrating compliance with the NRC 100 f a l
~
i demonstrated if the design objectives in Appendix I to 10 CFR Part 50 are achieved. For other NRC and Agreement State licensees, compliance with the dose limit and the ALARA requirement is demonstrated in one of two ways. The l
first,_is to demonstrate that the average concentrations in air and liquids ,
-released from the facility do not exceed ues in Appendix 8 to 10 CFR Part 20,.and are.ALARA, and direct exposures do not exceed 50 mrem /yr, and are ALARA; or second, to demonstrate that the dose to the member of the public likely_to receive the highest dose from all pathways is less than 100 mrem /yr TEDE and is ALARA.
The NRC believes ~ that for its licensees the application of ALARA goals l and guidelines has been-successful in maintaining actual air emissions to levels that are well below the EPA standard. Past experience and effluent information reported to the NRC staff have indicated that ALARA dose. goals.in
/
j h
the . range of 10 mrem per year or less should be achievable for all materials licensees, including fuel cycle facility licensees. Studies conducted by EPA (Ref. 1) concluded that NRC and Agreement State licensees are, in general, maintaining air emissions and resulting doses to members of the public well /
below the 10 mre tandard. This conclusion has been confirmed by a review of the annual reports submitted by licensees to EPA as required by Subpart I.
For 1993, only one licensee reported air emissions above the 10 mrem per year standard; corrective measures were initiated by the licensee and no enforcement actions were taken by EPA.
This rulemaking establishes a 10 mrem per year TEDE dose constraint on radionuclide air emissions. While not considered a health and safety issue such that adequate protection of the public health and safety would not be assured otherwise, this re ulatory action ensures that air emissions are maintained at a very lo evel, at little or no incremental cost (and -
considering the elimination of dual regulation, a net savings), and bring consistency between EPA's dose standard and the NRC's ALARA application, thereby providing EPA with a basis upon which to rescind Subpart I as it applies to NRC licensed facilities other than power reactors.
1.1 Background on EPA's Implementation of Radionuclide NESHAPs for NRC Licensed Facilities The 1977 amendments to the CAA required EPA to consider whether radionuclides should be identified as a hazardous air pollutant and, if so, to adopt standards to limit their emissions. Section 122(c)(2) of this 1977 amendment also required EPA and NRC to enter into a cooperative agreement to / j
/ !
minimize duplication of effort and conserve resources in establishing, V h
.~ . -
b P
i implementing, and enforcing standards for airborne radionuclide emissions from sources and facilities licensed by NRC. In 1979 EPA subsequently identified ,
radionuclides as a hazardous air pollutant (44 FR 76738; December 27, 1979).
i
.In April'1983, EPA proposed standards regulating radionuclide air i emissions from four (4) source categories, with one being NRC licensed {
i facilities. .-In October 1984, EPA withdrew the proposed emission standards for- ,
'certain sources, including NRC licensed facilities, based on a finding that ,
controls already. in-place-protected the public with an " ample margin of ;
. safety" (48 FR 15076; April 6, 1983). In July 1987, the U. S. Court of i
. i
. Appeals for the District of Columbia Circuit, remanded to EPA the air emission
~
L standard for . vinyl chloride because the Court found that EPA had improperly j t
considered cost and technological feasibility in setting the standard without ,
first determining a sufficient level of protection a: required by_the CAA.
Later that year, EPA petitioned the Court for a voluntary remand of its
' existing air emission standard for radionuclides. In March 1989, EPA proposed a revised emission standard of 10 mrem /yr TEDE for NRC and Agreement State licensed facilities. .This standard was established based on the concept of an
" ample margin of safety" as directed by the Court in its remand of the vinyl l t
chloride NESHAP.
~
On December 15, 1989'(54 FR 51654), the. EPA issued its final rule on the NESHAPs under Section 112 of the CAA for emissions of radionuclides from
- numerous source categories, with one category including NRC and Agreement State licensees. The rule was issued-as 40 CFR Part 61. Subpart I of this ,
rule. pertained to NRC and Agreement State licensees. The standard states that Lair emissions of radionuclides shall not cause any member of the public to - ,
receive more than 10. mrem TEDE in any year, or more than 3 mrem TEDE from radio' iodines. Radon-222 and its decay products-formed after release from the-4
. . e
\$
\7\ -O 1 facilityareexcluded.gEffectivewith.theissuance,however,wasastayon Subpart I, which delayed the effective date of that part of the rule covering NRC and Agreement State licensees. Subpart I was stayed until March 15, 1990, to allow EPA time to consider concerns raised, in particular, by the NRC and theNationalInstituteofHealth(NIH)(YanNRClicensee)aboutunnecessary _.__. .
duplicative, and perhaps conflicting, standards e&{RC licensees.
n l= '
At the time of issuance of the rule, the EPA reaffirmed a previously stated position that it "... continues to believe existing emissions from these sources [NRC licensees] are already so low that the public health and safety is already protected with an ample margin of safety" (50 FR 5190; February 6, 1985). The NRC had raised concerns about whether regulation of its licensees under the CAA provided any additional public health and safety benefit. The NIH, as an NRC licensee, voiced concerns about the potential negative effects .
of the dual standards on the use of nuclear medicine. Even recognizing these concerns, the EPA decided it was legally bound to include Subpart I in its final rule promulgation due to court-ordered deadlines. A 60-day comment period was established for the purpose of receiving further information and ,
l comments related to these concerns: a 3 month stay of Subpart I was effected to allow further consideration.
The 1990 amendments to the CAA included provisions in Section ll2(d)(9) that allow EPA to decline regulating airborne radionuclide emissions from NRC licensed facilities if it determines, through a rulemaking, that NRC's program provides protection of the public health with an " ample margin of safety."
This legislative initiative, referred to'as the Simpson Amendment, created the i
framework for cooperative activities between the agencies, which supported the /
rescission 40tof Ftt.
Subp? VO art i A 9
'a ~ ~
nd Subpart I for power reactors jf CTR Part 51 c - - -
. A l 5
,4
Subpart T covers radon emissions from disposed uranium mill tailings at sites where operations have ceased (59 FR 36280; July 15, 1994). ,
On April 24, 1991,- the EPA issued a final stay until November 15, 1992, for all NRC and Agreement State licensees, except power reactors, which under separate ruling had been stayed indefinitely pending the rulemaking on Subpart I rescission-(56 FR 18735; April 24, 1991). During this period of ;
stay,' EPA conducted two studies of the air emissions from NRC and Agreement State material licensees for the purpose of evaluating the state of compliance. The first was a survey of 367 randomly selected nuclear material licensees. The highest estimated dose to a member of the public from air emissions was 8 mrem per year TEDE, based on very conservative modeling. In addition, 98 percent of the facilities surveyed had doses of less than 1 mrem per year from air emissions. :
The second EPA study evaluated doses from air emissions from 43 additional facilities that were selected because of their potential for air i
emissions with calculated annual doses to members of the public at a sizable fraction of the 10 mre dysestandard. Of these, 75 percent had estimated f
maximumdoshoamemberofthepublicdessthan1mremperyear.
b None 'y exceeded the 10 mre tandard. The results of these studies were published by '
EPA (57 FR 56877; Dec 1, 1992) and, in summary, showed that radionuclide air
. emissions from the NRC and Agreement State licensees were typically, with the ,
potential' for few exceptions, well within the EPA's CAA standard of 10 mrem per year.
. i EPA's conclusion, based in part on these studies, was that the current ,
NRC program, which' limits public dose to 100 mrem per year, in concert with' j the requirement to keep' doses ALARA, has been successful in maintaining air I i
. emissions well below the.10 mrem per year Subpart I standard. However,
)
6 l
4 f because of EPA's concern regarding the litigative risk of extending stays of 9
previoulypromulgatedNESHAPsdurin{pendenc}farescissionrulemaking,and e actp the DC Circuit hahlready reversed the previous stay for licensees other than. power reactors, the stay on Subpart I was allowed to expire by its own terms on November 15, 1992 (57 FR 56877).
In July 1993, the EPA Administrator determined that there was insufficient basis at that time to rescind Subpart I. Concerns remained about the NRC's Agreement State program and the fact that there was no mechanism to ensure doses from air emissions would remain below 10 mrem per year in the absence of Subpart I. Consequently, licensed facilities other than power i
reactors are currently subject to dual regulation of air emissions of radionuclides under both the AEA and the CAA, with dual regulatory oversight by EPA (and/or authorized States) and NRC (or Agreement States).
i l
1.2 Past NRC and EPA Efforts to Rescind Subpart I Under the Simpson Amendment l l
Over the past 15 years, the NRC and EPA have worked together on the objective of eliminating the duplicate regulatory oversight. The NRC and EPA entered into a Memorandum of Understanding (MOU) in November 1980 to work together in developing mutually acceptable procedures for implementing and.
1 enforcing EPA's standards in accordance.with Section 122(c)(2) of the CAA (45 FR 72980; November 3, 1980). The 1980 M0V stated, "Under this agreement EPA shall promulgate standards for airborne radionuclide emissions under its Clean Air Act authority and NRC shall have the primary role in implementing and enforcing these standards where applicable for sources and facilities licensed by NRC."
7
b l
In 1990, Congress amended the CAA specifically addressing the issue of ,
duplicate regulationi This amendment enacted Section 112(d)(9) of the Act. '
It< included provisions whereby standards for radionuclide emissions from NRC ]
l (or NRC Agreement State)-licensees would not need to be promulgated, if the l EPA. Administrator determined, by rule and after consultation with the NRC,
.that the regulatory programs established by the NRC provide an " ample margin of safety" to protect the public health. Under these conditions, radionuclide NESHAPs for NRC and Agreement State licensees would not be required. This provision was enacted to enable EPA to elimina+e duplicate regulation and
- eliminate redundant efforts between EPA's and NRC's regulatory programs.
In 1992,. EPA proposed rescission of Subpart I, and subsequently allowed it to become effective, and NRC and EPA issued an MOU (57 FR 60778; i December 22, 1992). Its-intent was to determine NRC actions that could form the basis for EPA to rescind Subpart I. NRC was to put in place additional regulatory guidance to ensure air emissions would be maintained at a level i consistent with the level of protection afforded under EPA's Subpart I, i.e., ,
" ample margin of safety." NRC was to develop and issue regulatory guidance
~
for. its licensees, other than power. reactors, on designing and implementing a radiation protection program to ensure that doses resulting from effluents would remain ALARA. NRC also agreed to develop inspection guidance on ALARA i
considerations for effluents and incorporate ALARA in its Standard Review -
Plans. NRC was to. work with Agreement States to adopt and implement a compatible program. EPA was to develop and publish in the Federal Register a Notice:of Proposed Rulemaking, pursuant to its authority under the CAA, :
Section ll2(d)(9),- to rescind its existing regulations of 40 CFR Part 61, lSubpart I, as applied to licensed facilities other than power reactors.
~
8 - I a-
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As an implementation of its ALARA guidelines, th e NRC developed W
\ redsk Regulatory Guide 8.37, which included a specific ALARA' goal of 10 mrem per year TEDE to the maximally exposed individual from rad onuclide air emissions (Ref 2). Additionally,InspectionProcedureMIP)87102j ed to include a review of emissions from those facilities with the potential of exceeding 20 percent of the 10 CFR 20, Appendix B, Table 2 values (Ref. 3).
Generally, this 20 percent level corresponds to a calculated dose from air exposure of 10 mrem per year, which is comparable with the EPA's Subpart I vnd%{V10 standard. An Inspection Referral Form was included within IP 87102, which is A -
to be completed by the NRC inspector and forwarded by NRC Region' Management to the cognizant egional Radiation Program Manager,ef the UA.-
b 6
- Under the Simpson Amendment and the 1992 MOV, EPA agreed to propose a rulemaking rescinding its existing regulations in 40 CFR Part 61, Subpart I, as applied to licensed facilities other than nuclear power reactors (56 FR i 18735; April 24, 1991). EPA announced its intent to propose rescission of Subpart I (57 FR 43173; September 18, 1992); and later in 1992, EPA issued the Federal Register notice proposing the rescission (57 FR 56877; December 14, 1992). However, on November 15, 1992, EPA allowed the stay on Subpart I to expire for facilities other than power reactors. This action was taken because of substantial doubts that EPA had concerning the legality of any further stay. A September 22, 1992, DC Court ruling in response to a Natural Resources Defense Council (NRDC) petition found that EPA had exceeded its authority by staying Subpart I for facilities other than power reactors, while it was collecting information to make a finding under Section ll2(d)(9)
-(Simpson Amendment). Following this determination, in July 1993, the EPA Administrator deci.ded there was insufficient regulatory basis to rescind Subpart-I.
9
- t. ,
in its' January 28, 1994 Federal Register notice.(59 FR 4228), EPA stated:
At this time, EPA has not taken final administrative- action concerning !
'the rule to rescind Subpart I for NRC and Agreement State licensees ,
- other than commercial nuclear power reactors which it proposed on
-December.1,.1992. EPA is recommending that NRC make certain changes in its regulatory program in order to fully support the substantive finding ,
I which is required by CAA Section ll2(d)(9) before EPA may rescind Subpart I for NRC licensees other than commercial nuclear power-
. reactors.
EPA has historically identified two components to this finding: ) that "U the facilities licensed by NRC and Agreement States are currently in compliance with the quantitative emission limits in Subpart I (10 mrem per {
year,TEDE),and(2)thattheNRCprogrammustbesufficienttoensurethat / I A
emissions would remain below this level in the future, thereby protecting the ;
public with an ample margin of safety. t 1.3 issue of Unnecessar_y and Conflicting Dose Standards The issues surrounding the necessity for duplicate regulation relate to EPA's!need to demonstrate an " ample margin of safety" as called for in the CAA.
Past ' studies conducted by the EPA have in'dicated that, except'for unusual cases, all _NRC and Agreement State licensees currently subjected to Subpart I 1 meet the Subpart_I dose standard. NRC's' reviews of licensees' air emissions
- further support the position that the ALARA goals of Regulatory Guide 8.37 are
- consistently being met. For the calendar. year 1993, the first year under ,
10; [
i
l
! i
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which Subpart I reporting was required, EPA received approximately 670 reports from NRC and Agreement-State licensed facilities. Of these, approximately 30 ,
reported doses greater than 10 mrem /yr from air emissions. EPA staff told NRC ,
staff that after clarification with several facilities in their use of the COMPLY code, only one licensee had_ radioactive air emissions. in excess. of the i Subpart'I dose standard. This licensee took' corrective measures; no enforcement actions were taken by EPA. The 1995 annual reports are currently ,
,being submitted to EPA, and the reports reviewed to date have not identified ;
any licensee with air emissions above the Subpart I standard.
The dual, regulations by EPA and NRC are considered unnecessary for the following reasons. 'First, the level of air emissions from NRC licensed facilities has historically been well below the NRC's dose limit. The !
application of the ALARA principle has resulted in facility programs and emissions that, except for a few unusual cases, readily meet the EPA standard. i These unusual situations are best addressed on a case-by-case basis. Second, i with this level of compliance, subjecting facilities to dual reviews, i
reporting, evaluations, and inspections is unnecessary for protecting the public safety. Compliance can most efficiently be covered by a single regulatory process. The NRC constraint rule provides an ample margin of safety.
EPA's compliance program relies primarily on evaluations and reports prepared by the facility. Licensees emitting radionuclides in amounts that ,
would cause doses'less than 10 percent of the Subpart I limits _(e.g., < 1 mrem /yr_ TEDE) are ' exempt from the' reporting requirement but must still monitor effluents and maintain records of dose calculations. Licensees subject to Subpart I annual reporting requirements (e.g.,' doses > 1 mrem /yr TEDE) are required to submit an annual report by March 31 of each year to EPA n air - - --
_l 11
. - - . . .. - . . .- - -- - ..~ - - - - .. .
I
- 1
[ emissions for the previous calendar year. Licensees with air emissions in excess of'the annual limit (e.g., > 10 mrem /yr TEDE) must include in the report' proposed corrective leasures to ensure' future doses will be below the ,
limitEand report on a monthly' basis until EPA determines that adequate i
corrective measures have been taken and reporting is no longer necessary. ,
There,are currently about 7,000 NRC. licensed facilities and about 15,000 .
Agreement State : licensees. About half of these facilities use radioactive
. materials _in the- form of sealed sources (i.e., contained within a metal or
.other material casing). These licensees are not subject to Subpart I because
'of the negligible potential for any significant air emissions (see
- 40 CFR 61.100 applicability). The facilities (other than power reactors) with I f
4 potential air emissions for which compliance evaluations are required are those that use materials in unsealed form, predominantly hospitals, clinics, radiopharmacies, research and academic facilities, fuel cycle facilities, and
( ,
research reactors. .
i The CAA, as amended, establishes in Section 112(1)(1) the basis upon i which States may submit to the EPA Administrator a program for implementing
@ and enforcing emission standards for hazardous air pollutants for stationary l sources located in such State. The States are.*et-authorized to set standards ,
M t gent-thakhosepromulgatedbytheEPA. he A distratorhas -
x N . t ot tH r Umg ap roved 4dy A
tes for Subpart I implementation.
B Presently, -
[(--
seven States are engaged in a demonstration program with the EPA focusing on f 3
- the' development of! State compliance programs needed for implementation of j radionuclide NESHAPs, covering NRC licensed facilities, DOE facilities, and- l 1 f other miscellaneous sources covered by 40.CFR Part 61.
l i
~12 j
1
f 1
.1. 4 Agreement-States Under the provisions of Section 274(b) .of the Atomic Energy Act (AEA) of f l
1954, as amended, certain States have assumed the responsibility and authority.
for regulating radioactive material (byproduct material, source material, and special nuclear material in. limited quantities) users within such State. l These NRC' Agreement States' rules and regulations replace those of NRC. l However, adequacy and compatibility are assured because.the AEA includes a :
. provision-that the Commission must find that the State program is compatible with the Commission's. program for regulation of such materials, and that the
}'
- State program is adequate to protect the public health and ' safety with respect to.the materials covered by the proposed agreement.
Conforming regulations enacted by Agreement States are essentially
, identical, in level of protection afforded, to those of the Commission.
Associated guidance and inspection efforts are normally similar. , i
- 2. P Objectives of Rulemaking b i 1
1 The objective of the rulemaking is to provide assurance that future emissions from NRC licensees will not exceed levels that will provide an ample margin of safety. This action is expected to be the final step in providing i EPA with a basis upon which to rescind 40 CFR Part-61 " National Emission.
Standards for ardous Air Pollutants," Subpart I, as it applies to NRC
. 1 ities other than power reactors, thereby relieving these -
- licensees from unnecessary . dual regulations. To support the determination by.
EPA-that NRC's programs. provide an equivalent level of protection, this 13 )
4
-e
. .. ~ ._ _
rulemaking codifies a 10 mrem per year dose constraint applicable to NRC licensed facilities, excluding power reactors.
This rulemaking, followed by an EPA rescission of Subpart I, will eliminate duplicate regulatory oversight of NRC and Agreement State licensees by EPA under the CAA and lessen the burden of regulatory compliance on
' licensees. It will eliminate redundancy in the regulatory processes between NRC and EPA, thereby' reducing government's oversight effort. The resulting Y
cost savings will be achieved while maintaining r^"' 'i.#, ethsame margin of "
public and environmental safety as that currently afforded under Subpart I.
.With the elimination of dual regulation [, the burden of implementation and _,/
continued demonstration of compliance with duplicate regulations by the users will be reduced. Efforts will be reduced for maintaining compliance and-
- 4 enforcement programs by two separate government agencies for the same emission source. EPA will be able to eliminate its continuing efforts required for ;
i ,
maintaining a compliance evaluation program for NRC and Agreement State licensees, including developing and maintaining guidance programs, training of i EPA regional staff, transition of authority to States, training of State )
I agencies, reviewing emission reports, reviewing construction and mooification j applications, and, as required, conducting enforcement actions. NRC's l programs will require essentially no additional efforts beyond its current /;
/
inspection and enforcement programs.
wUl sLV Agreement States have similar compliance -
V f
evaluation programs, if they have not already done so.
- 3. Alternatives
~
1). . Alternative 1 - Dual Regulation - NRC and EPA would each retain h -
existing regulations and compliance programs.
14
t i
2)' Alternative 2 - EPA Regulations Only - Revise NRC requirements to eliminate air effluents.
- 3) Alternative 3 - NRC Constraint Rulemaking and EPA Rescission of Subpart I. Codify constraint dose levels for air emissions from NRC licensed facilities (other than power reactors). ;
Each alternative is discussed below.
3.1 Alternative 1 - Dual Regulation There ic general agreement between NRC and EPA that with few exceptions, all NRC and Agreement State licensed facilities are maintaining air emissions well below the'40 CFR Part 61, Subpart I, dose standard of 10 mrem per year.' However, EPA determined that NRC's regulatory framework did not fully support the substantive finding which is required by CAA Section 112(d)(9) before EPA may' rescind Subpart I for NRC licensees other than power reactors (59.FR 4228,-January 28, 1994).
Under this approach, NRC and EPA would each continue its existing regulatory requfrements and compliance programs without substantive changes to reduce any burden of dual regulatory oversight. The NRC's inspection program / '
,s r would continue to provide on7 site inspections and reviews of ALARA goals, __ -
which, in effect, would afford a basis _for evaluating compliance with the dose standards of:Subpart I. NRC-would continue to provide letter summaries to' EPA aon licensee compliance. However, NRC would not be involved from a legal 2l Refer to the Federal Register Not' ice-(54 FR 51654). promulgating Subpart I and EPA's subsequent study of radionuclide air ' emissions for NRC' licensed facilities (Ref.'l).
15
L-I
.l compliance standpoint.if a facility exceeded the standard, unless NRC standards were.also exceeded. EPA would retain its regulatory authority for enforcementacthons.
-EPA _would continue its compliance programs, including developing and maintaining guidance programs, training of EPA regional staff, transition of authority to States, training of State agencies, reviewing emission reports, reviewing construction and modification applications, and as require,1,. ,
. conducting enforcement actions. Many States can be expected to develop corresponding regulatory requirements with licensing (fee) and inspection programs under the' authority of Section 112(1)(1) .of the CAA. /
The availability of citizen suits under the CAA would remain if Subpart1.isnotrescinded(hwever,ifEPAdoesultimatelyrescind,the#
public petition process for NRr enforcement action against a licensee under J 10 CFR 2.206 would offset t'ne unavailability of the CAA citizen suit provision; however, judicial _ review of 2.206 petition denials is not readily EP^. hn stated that J",0% curr ent regulatcry 6==r' did at >
p, available.
ym , f prav_ide-a-sttffW ent legal and technie & basis Tur resc.iridir.g Subpart I /Ro ,
--4228;,lanU37 tut 94) While not supporting a timely rescission of Subpart 1, maintaining dual regulation would allow time for EPA to gain additional experience with the implementation of the Subpart I standard on NRC l
and Agreement State licensees. Over a period of' time, this experience could provide _the necessary information to support a decision by EPA to rescind
'Subpart I.
e 16 j
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~3.2- Alternative 2 - EPA Regulation Only g,
)
Under this alternative,'NRC would make a finding that the EPA regulatory framework adequately protects members of th public from air effluents of NRC
/
licensees. Inspection ProceduretIP-87102, Regulatory Guide 8.37 and the MOV-D with EPA ~on inspection' referrals would be Section . withdrawn,,r 20.1302 would4 b be n
revised to indicate that compliance with Subpart I is sufficient to demonstrate that dose .from air effluents does not exceed 10 mrem /yr.
Appendix B, -Table 2, Column 1 to Part 20 would be deleted.
- As in Alternative 1, EPA would continue its compliance programs and citizen suits under the CAA would remain.
3.3 Alternative 3 - Constraint Rulemakinq This alternative addresses NRC's development of a regulatory constraint within 10 CFR Part 20 on allowable air emissions from NRC licensed facilities, :
excluding power reactors. The regulation would constrain air emissions to a l level corresponding to a calculated dose of 10 mrem per year to the maximally exposed member of the public. This approach would add numerical criteria for material and fuel cycle facilities and test and research reactors, similar to ,
l that already in place for nuclear power reactors (i.e.,il 50.34a, 50.36a, and
. Appendix 'I to Part 50). It would not'be a regulatory limi A4 Tcensee 7 -
)
ceeding a limit would be :in violation of NRC regulations and subject to w&/ \
l h4Tk ;
+n ("h=it = __= i enforcemen p cane ^e exceeding a ccnstraint wa"1d bd rc; & ^d
-rpport, and m e crdia + implement appropr M*a ra cect h action.. Failure-
-.JJW to~ report excee ce of the constraint or failure to implement agreed upon fets N corrective actions would be a violation of NRC regulations subject to jg 17 pyp iY
enforcement act Licensees exceeding the constraint level would be kequMo submit a report to the NRC identifying the situation and pppropriate measures for reducino emissions to below the constraint. EPA staff has indicated in meetings with NRC staff that this approach would provide a sufficient legal and regulatory framework upon which EPA could rescind its regulation of Subpart I.
In accordance with Section 112(d)(9) of the CAA, for EPA to rescind Subpart I, a finding must be made that there is no decrease in the level of protection afforded the public. Therefore, the NRC rulemaking evaluated under this approach would be to impose a dose constraint that would provide compatibility with EPA's dose standard of Subpart I. An ALARA dose constraint of 10 mrem per year TEDE to members of the public from air emissions of radionuclides would provide consistency. These requirements, codified within NRC's regulations, would provide a sufficient regulatory framework, thereoy supporting a finding by EPA that NRC's regulations provide "an ample margin of safety."
- 4. Consequences This Regulatory Analysis does not address a serious health and safety ,
issue. Instead, the basis for evaluating consequences is eliminating
'vt regulationsthatareconsideredduplicat,gandunnecessary. The consequences /
are evaluated against a baseline comparison.
18
\
1 1
4.1 -Dual Regulation Dual regulation would not support a timely elimination of duplicate EPA l and NRC regulation. It would not reduce the. current level of effort for the EPA in its compliance programs. NRC's inspection and referral efforts would also be expected to be maintained to meet its regulatory responsibilities under the AEA and to fulfill the 1992 M00 with EPA. NRC and Agreement State licensees would continue to be subjected to dual regulation.
NRC and Agreement State licensees would have different regulatory ;
requirements addressing air emissions within two 'different titles of the Code of Federal Regulation (i.e., Title 10 for the NRC and Title 40 for EPA). In !
addition, as individual States establish their EPA 40 CFR Part 61 compatible programs, licensees would be subjected to another, and potentially different,.
compliance program. Each-licensee would have two regulatory groups within a j State with whom to interact relative to compliance, including on-site
~
inspections, methods for demonstrating compliance, licensing reviews (for NRC i programs), facility modification reviews (EPA), and recordkeeping and !
reporting. Some Agreement State representatives have stated that qualified radiation protection personnel may move from the radiation protection program ;
to the environmental program to administer Subpart I. This might result in personnel shortages in some States. Maintaining enough qualified radiation ;
protection personnel has consistently been a problem for many State programs. ,
Increased efforts are associated with duplicate requirements, duplicate implementa' tion programs and duplicate regulatory inspections.
Maintaining dual regulation would not' require a rulemaking. NRC's ,
current regulatory programs would continue to support the established '
radiation protection framework in 10 CFR Part 20,-including the dose limit of i
19
100 mrem per year and the principle of ALARA. EPA's compliance programs would continue, including the selected inspections, evaluations of licensee submitted annual reports, and continued support to individual State program development. EPA staff has indicated that they expect individual State involvement would increase as individual compliance programs are put in place.
Based on the 1992 NRC/ EPA MOU, NRC has provided assistance through its inspection program to EPA for its Subpart I implementation. As an implementation of its ALARA guidelines and based in part on this MOU, the NRC revised its Inspection Procedure 87102 to include a review of emissions from those facilities with the potential of exceeding 20 percent of the 10 CFR Part 20,' Appendix B, Table 2 values (Ref. 3). The procedure requires that an Inspection Referral Form be completed by the NRC inspector and forwarded by NRC regional management to the cognizant EPA Regional Radiation Program Manager.
Based on EPA labor rates, the cost of Subpart I to licensees is $517 per licensee or over $3 million per year for all licensees. EPA estimated the burden to NRC and Agreement State licensees assuming that 6000 licensees would %e be affected and using 3 separate hourly rates for professional ($27/hr), ((-
managerial ($38/hr) and clerical ($10/hr) personnel.
The burden estimated in EPA's OMB clearance assumes that 200 licensees [
T will file reports annually and that it will require 11 staff hours to review each report. The EPA estimated government burden for Subpart I is 2200 ho or,$44,600. For calendar year 1993, 670 licensees filed reports. -
Since 1989, NRC has devoted about 15 FTE to the Subpart I issue. This effort has consisted of interface with EPA in support of rescission, development of Regulatory Guide 8.37 ("ALARA For Effluents For Materials Facilities"), development of inspection guidance, inspection efforts, referral 20 l
of inspection results to EPA, and development of the Constraint Rule. Under
'this alternative, it is expected that EPA's burden would remain at' about 3 FTE annually, with periods of incr$ased effort when . facilities experience
-increased air emissions at or above the standard. NRC and Agreement State
-licensees' efforts can be expected to remain at about 138,000 hours0 days <br />0 hours <br />0 weeks <br />0 months <br /> annually l (23 hours2.662037e-4 days <br />0.00639 hours <br />3.80291e-5 weeks <br />8.7515e-6 months <br /> / licensee), provided facility design and/or operations do not U
significantly change. Licensees would continue to have to demonstrate ,
~
compliance with dual regulatory requirements. p/
The burden of Alternative - 1 is summarized in the following table:
0.M6 4Mwellig- g o ,
f Cost _ \
NRC a id Agreement State Licensees G 3.100,000 )-
EPA (n (3p7"6p M7 44,600 ,
NRC(k5FTEjforinspectionandreferralsIoEPA) 50,000 V TOTAL $3,194,600 )
l1 4.2 Eliminate NRC Regulation of Air Emissions Elimination of NRC regulation of air emissions would eliminate dual regulation. NRC's burden would be reduced as inspection of licensee records i would no longer be performed. Agreement States radiation program concerns '
relative to'the loss of qualified radiation protection personnel to State environmental programs would not be resolved. However, States would not have. ,
to enforce duplicative. regulations in each of ~ these ' programs.
Elimination of NRC regulations of air emissions would require rulemaking
.to revise i 20.1302. This revision would be necessary to make clear that NRC
. inspection and enforcement of compliance with public dose limits would not 21 l l
include' air emissions unless the dose from direct exposure and liquid effluents exceeded 90 mrem /yr TEDE. It is expected that this rulemaking would
~
take approximately 1 FTE over a 2-year period. :Similar revisions to Agreement
-State regulations would be needed. Because of the simplicity of this rulemaking, it is estimated that each of 29 Agreement States would expend-
.about 0.1 FTE revis_ing'their rules.
The burden on licensees and on EPA _would be the same as under the dual regulation alternative. The annual burden to NRC would be slightly reduced as routine inspection of doses to members of the public would include only direct exposures and liquid effluents. As air effluents are a very small portion of doses to members of the public for most facilities, this burden reduction is t
expected to be' very small.
The burden associated with Alternative - 2 is summarized in the tables below:
Annual Burdens: Cost NRC and Agreement State Licensees $3,100,000 EPA. 44,600 NRC (reduced inspection burden 0.25 FTE) -25,000
-TOTAL $3,119,600 One-Time Expenditures- FTE Costs NRC_Rulemaking 1.0 $100k NRC Inspection Procedures and-Inspector-Training 0.5 50k Agreement . State Regulations Revision 2.9 290k TOTALS 4.4 $440k 22 i , ,
Alternative'3 - Constraint Rule i A constraint level would be enforced by NRC through its current licensing and insp on and enforcement grams. The current IP 87102 -.
T P Vo %f $ M;G0/p ?M /
(Ref 3)j would require minor modification in wording for consistency with the rule; the Referral form and letter to EPA would no longer be needed. NRC regulatory guidance would be revised to specifically address the cons't raint rule. Acceptable methods for demonstrating compliance and reporting
_ guidelines would need to be added. For licensees, an overall simplification t
-in compliance assessment methods would be expected due to the streamlining of methods needed for both Subpart I compliance and 10 CFR Part 20 compliance.
The main savings would be for facilities that maintain effluents at a ]
1 small. fraction of the standard, i.e., those facilities for whom additional .l evaluations, reports and overall dual regulatory oversight are not required for ensuring public safety with an ample margin of safety. Annual reporting would not be required provided air emissions were maintained below the NRC's constraint level. NRC's routine inspection program would provide the necessary regulatory oversight.
Licensees who exceeded the constraint level would be required to submit a report to NRC and to develop and implement corrective measures in keeping with ALARA, to reduce air emissions to within the constraint level.
. Enforcement actions would only be taken for those facilities that fail to perform the required evaluations and/or those facilities that fail to take appropriate measures 6 keepin;;'ettF ^!^DN for. reducing air emissions. C Because doses from air effluents are currently being calculated using Appendix 8 to 10 CFR Part 20 to demonstrate compliance with the public dose limits, no additional effort would be expended to demonstrate compliance with 23
d a\0 ,
/ 1 the constraint rule if the dose did not exceed Very few licensees (if - --
any) would'have doses to members of the public in excess of the 10 mrem /y constraint, and therefore be required to make a report to NRC or an Agreement State. It is assumed that an avera e of three reports per year will be ynbrd5 received. The total licensee.burde is dstimated to be $12,000 annually - -
(3 reports /yr x 80 licensee-hours / report x $50/hr - $12k/yr).
The burden of reviewing the air effluent control programs of licensees reporting doses to members of the public in excess of the constraint is estimated to be $24,000 annually (3 reports /yr x 160 NRC staff-hours / report' x $50/NRC staff-hr = $24k/yr)
The constraint rule is not considered a necessary public health and safety measure because adequate protection has been maintained. Therefore, efforts associated with the rulemaking would be limited to mainly administrative efforts for the preparation of appropriate legal notices and ,
issuance. The basis for the rulemaking would be the elimination of
% -~~~
unnecessary duplicat regulatory oversight. Public hearings, additional technical reviews, etc. would not be anticipated.
Under Alternative 3, NRC and the Agreement States would incur one time costs for completion of the rulemaking, development of regulatory guidance, /
modification of the 9tmF inspection procedures and training of 8NRC inspection -
/
personnel. EPA will also incur one time costs for the rescission of Subpart I.
The constraint rule would be categorized as one of Division II compatibility under the current NRC Policy Statement governing the Agreement 3 This estimate is based on NMSS assumption that 160 hours0.00185 days <br />0.0444 hours <br />2.645503e-4 weeks <br />6.088e-5 months <br /> would be expended per report. This cost includes a reactive special inspection, recalculation of dose, and gLodification of the facility license to incorporate approved corrective actions as license condttion wit) headquarters concurrence.
24 N 88'y
- State Program (January 23, 1981; 46 FR_7540, July 16, 1981; 46 FR 36969, July 21, 1983; 48 FR 33376).' As such, Agreement States may choose to adopt a rule that is more restrictive but no less restrictive than the one approved i by the Commission. Agreement States would have three years to adopt the compatible or more stringent regulations. The Agreement States are expected to adopt similar compliance programs guidance (i.e., regulatory guidance and inspection procedures). Therefore, the potentially significant impact would be that associated with a rulemaking. For cost comparisons, it is assumed that the 29 NRC Agreement States would each adopt a rule and compliance ,
program similar to that of the NRC's.
Currently, Agreement States have programs in place that implement and enforce the 10 CFR Part 20 dose limits and ALARA guidelines. Therefore, based on NRC's precedence in establishing the regulatory framework for a constraint rule, it can be assumed that additional efforts on the part of Agreement i States for development of compliance programs would be no more than 0.25 FTE per State or approximately $725,000 (29 States x 0.25 FTE/ State x 2000 i
hours /FTE x $50/hr = $725,000). NRC would continue its evaluation of Agreement State programs for adequacy and compatibility.
1 4
4 The NRC is in the process of revising its compatibility pol. icy and has l issued a proposed policy for public comment (59 FR 37269; July 21, 1994). l Although, the compatibility policy has not yet been finalized, the NRC ;
anticipates that a similar ' level.of Agreement State compatibility will be required for air emissions under the new Policy as is required under~a ,
Division-Level 2 designation. l 25
4 b
Costs for Alternative 3 are summarized below:
Annual Expenditures FTE Costs NRC and Agreement State Licensees 0.12 $12k I a
i NRC and Agreement State Governments 0.24 24k TOTALS 0.36 $36k :
+ l One Time Expenditures FTE Costs l
NRC Rulemaking $50k V 0.5 50k NRC Inspection Procedures and Inspector Training 4 NRC Regulatory Guidance Development 0.5 50k Agreement State Regulations Development 7.25 725k l EPA Subpart I Rescission Rulemaking 0.5 50k 1
TOTALS 9.25 $925k 4
. 5. Decision Rationale For.the alternatives analyzed, the level of protection afforded the public health and safety is essentially the same. For each alternative',
acceptable levels for radionuclide air emissions are based on a dose of 10 mrem per year TEDE to the maximally exposed member of the public. Under Alternatives 1 (dual regulation). and 2 (eliminate NRC regulation of air
)
1 emissions), the EPA Subpart I dose standard would remain in effect. Under 26 1 i
v
, , e a uo, , - , , , , - , - %. m-v
7 t j
'l Alternative.3 (constraint rule), NRC would enact a rule imposing a constraint !
dose of 10 mrem per year and EPA would rescind Subpart I.
]
The NRC believes that, in amending the CAA in 1990 to specifically' address the issue of duplicate regulation, Congress intended that dual regulatory oversight by EPA and NRC be eliminated if it could be done effectively. Alternative 1.(dual regulation) makes no significant effort to support a finding required by the CAA, Section 112(d)(9), for the dual regulation to be rescinded. Alternatives 2 and 3 are-intended to be responsive to the Congressional mandate to reduce duplicative regulations. ;
1 Alternative 2 achieves this goal by discontinuing NRC' inspection and enforcement of dose to members of the public from air emissions. Alternative 3 achieves this goal by providing assurance that the NRC regulatory framework will provide an. ample margin of safety. This Alternative will support an EPA finding to that effect, and thereby, support a subsequent' rescission of Subpart 1. This decision can only be made by the EPA Administrator. Based on discussions with the EPA staff, the framework of Alternative 3 represents the [:
EPA preferred approach. M M M
, EPA has historically identified two components of the finding of sufficiency. First, NRC and Agreement State licensees must be in compliance with the quantitative emission limits of Subpart I (i.e., 10 mrem per year,.
4 TEDE). - Overall,'this condition has been demonstrated by studies conducted by p
EPA (Ref. 1) an'd by the recent reports submitted for Subpart I compliance to EPA,by licensees. The second component af a fiOMfTsl that' the NRC's and - ,
Agreement States'. compliance programs provide sufficient continued assurance :
that. emissions would remain below the'Subpart I standard, thereby protecting ,
e the public and environment with an " ample margin of safety." Of the.
alternatives,1only Alternative 3 would be effective in achieving this second 4
r v 1"'
component. Alternative.1 has been determined by the EPA not to provide the regulatory framework necessary to make this finding.
For Alternative 3, that of imposing controls by regulation, the relatively straightforward rule contemplated has been estimated to require
- p. [ person-year of Federal Government effort (including development of the rule, regulatory guidance, inspection guidance, inspector training and EPA b rescission of Subpart I). Assuming all twenty-nine Agreement States would process parallel rules, this effort has been estimated to require an additional 7.25 staff-years (0.25 staff-year per State). This lower level of effort for rulemaking by an Agreement State has been assumed considering the s
precedent established by NRC's rulemaking.
The total cost of each option is summarized in the table below:
Option One Time Annual Costs Costs 1 - No Action / Dual Regulation 2 - Eliminate NRC Regulation of Air Emissions o
$44/,000
$3,194,600
$3,119,600
[
3 - Constraint Rule.and Rescission of Subpart I $925,000 $36,000 I
I Based on the above discussion, it is determined that Alternative 3 j represents the preferred approach. Although Alternative 1 would be acceptable from-a public health and safety perspective, it would not eliminate dual l l
regulation. Alternative 2 would also be acceptable from a public health and safety perspective but would be far more burdensome to lic'ensees as it would -
)
not support a rescission by EPA of Subpart I. y$ l
\
28
- 6. Implementation No impediments to implementation of the recommended alternative have been identified. The documents necessary to support a proposed rulemaking have been developed. The level of effort required for completing the ipf
}
rulemaking has been estimated at 0.5 staff-years, over a_ /
The staff prepark atory guidanc further clarif the applicability of the rule and WP}t provide 5 guidance on acceptable me,thods for A
f demonstrating compliance and for evaluating and reporting elevated effluents should the constraint level be exceeded. For Agreement States, a 3-year period is allowed from time of issuance of the final rule for the States to develop and implement compatible regulations.
l l
I I
i l
i 29
References.
~
- 1. EPA 430-R-92-Oll, "NESHAPS Rulemaking on Nuclear Regulatory Commission and~ Agreement State Licensees Other than Nuclear Power Reactors, Background Information Document," U. S. Environmental Protection Agency, November 1992.(available from Government Printing Office).
- 2. Regulatory Guide 8.37, "ALARA Levels for Effluents from Materials facilities," U. S. Nuclear Regulatory Commission, July 1993 (available-
'from Government Printing Office).
- 3. Inspection Procedure 87102, " Maintaining Effluents from Materials Facilities as low as is Reasonably Achievable (ALARA)," NRC Inspection Manual, issued November-10,1994 (available from the NRC Public Document Room).
-4. ICRP Publication 60, "1990 Recommendations of the International Commission on Radiological Protection," Annals'of the ICRP, Volume 21, e No.1-3, published for the International Commission on Radiological Protection by Pergamon Press, 1991.
- 5. ICRP Publication 64, " Protection from Potential Exposure: A Conceptual Framework," Annals of the ICRP, Volume 23, No.1, published for the International Commission on Radiological Protection by Pergamon Press, 1993.
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ATTACHMENT 3 NOTIFICATION FOR CONGRESSIONAL REVIEW I
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I
3a rg 4 *- ' i . UNITED STATES
- g. g, NUCLEAR REGULATORY COMMISSION e # WASHINGTON, D.C. 20565-0001 ,
. d Mr Robert P. Murphy General Counsel General-Accounting Office ,
Room 7175 441 G. St...NW, g- :
Washington, DC 20548
Dear Mr. Murphy:
i Pursuant to Subtitle E of the Small Business Regulatory Enforceme Fairness Act of 1996, S U.S.C. 801, the Nuclear Regulatory Commission (NR is p ',
submitting a final rule that will constrain air emissions from F C licerad licensees such that no member of the public will receive a dosepof 10 mrem in a year from such emissions. This action is expected to be the inal step in providing a basis under which the Environmental Protection Agency (EPA) can rescind 40 CFR 61, Subpart I " National Emission Standards for Radionuclide Emissions from Facilities Licensed by the Nuclear Regulatory Commission and Federal Facilities Not Covered by Subpart H." Rescission of Subpart I will result in a significant reduction in burden to the Federal Government and to NRC licensees without any negative health and safety impact.
We have determined that this rule is not a " major rule" as defined in 5 U.S.C.
804(2). We have confirmed this determination with the Office of Management and Budget.
Enclosed is a copy of the final rule which is being transmitted to the Office of the Federal Register for publication. The Regulatory Flexibility Certification is included in the final rule. Also enclosed is a copy of the Regulatory Analysis for this final rule that contains the NRC's cost-benefit i determinations. This final rule is scheduled to become effective concurrent I with the effective date of EPA's rescission of 40 CFR 61, Subpart I. A notice of its effectiveness will be published in the Federal Register.
Sincerely, John C. Hoyle Secretary of the Commission
Enclosures:
Final Rule Regulatory Analysis
Mr. Robert P. Murphy-General Counsel General Accounting Office
' Room 7175 441 G. St., NW, Washington, DC 20548
Dear Mr. Murphy:
Pursuant to-Subtitle E of the~ Small Business negulatory Enforcement Fairness Act of 1996, 5 U.S.C. 801, the Nuclear Regulatory Commission (NRC) is submitting a final rule that will constrain air emissions from NRC 1 e licensees such that no member of the public will receive a dose of 10 mrem in :
a year from such emissions. This action is expected to be the final step in providing a basis under which the Environmental . Protection Agency (EPA) can rescind 40 CFR 61, Subpart 'I " National Emission Standards for Radionuclide
-Emissions from Facilities Licensed by the Nuclear Regulatory Commission and Federal Facilities Not Covered by Subpart H." Rescission of Subpart I will result in c significant. reduction in burden to the Federal Government and to NRC licensees without' any negative health and safety impact.
We have determined that this rule is not a " major rule" as defined in 5 U.S.C. ^
804(2). We have confirmed this determination with the Office of Management and Budget.
Enclosed'is a copy of the final rule which is being transmitted to the Office )
of the Federal Register for publication. The Regulatory Flexibility l Certification is included in the final rule. Also enclosed is a copy of the <
Regulatory Analysis for this final rule that contains the NRC's cost-benefit l determinations. This final rule is scheduled to become effective concurrent 4
with the effective date of EPA's rescission of 40 CFR 61, Subpart 'I. A notice ,
of its effectiveness will be published in the Federal Reaister.
Sincerely, John C. Hoyle Secretary of the Commission ,
Enclosures:
Final Rule Regulatory Analysis s DISTRIBUTION: !
RPHEB R/F EDO R/F-OGC R/F
'TSpeis _
l FCostanzi CGallagher-LRiani To receive'a copy of this document, indicate in the box: "C" = copy without attach- '
m nt/ enclosure "E" = Copy with attachment / enclosure "N" = No copy .
FFICE RPHEB:DRA _-l RPHEB:DRA, g OGC l D: DRAG /ag D:RES fg l NAME- CTRaddatz--/ % JEGlenn C(L WJ0lmstead BMMords i DLMorri son' ;
DATE- .5/q /96 f/1/96 / -/ /96 f//#/96 y/g/96 i
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OFFICIAL RECORD COPY l (RES File Code) RES-
gR KfG(,
,[ -1 UNITED STATES . ,
E [ NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20515 0001
'\.....}* i t
LThe Honorable Al Gore
'The President of the Senate
- S-212,-The Capitol -
-Washington, DC 20510
Dear Mr. President:
Pursuant to Subtitle E of the Small Business Regulatory Enforcement Fairness
--Act of 1996, 5 U.S.C; 801, the Nuclear Regulatory Commission (NRC) is #
/
submitting a final rule that will' constrain air emissions from NRC fic r a licensees. such that no member of the public will receive a dose of 10 mrem in
'a year from such emissions. This action is expected to be the final. step' in providing a basis under which._the Environmental Protection Agency (EPA) can rescind 40 CFR 61, Subpart I " National Emission Standards for Radionuclide Emissions from Facilities Licensed by the Nuclear Regulatory Commission and Federal Facilities Not Covered by Subpart H." Rescission of Subpart I will .
result in a significant reduction in burden to the Federal Government and to r NRC licensees without'any negative health and safety impact.
We have determined that this rule is not a " major rule' as defined in 5 U.S.C.
804(2). We have confirmed this determination with the Office of Management >
~
and Budget.
Enclosed _is a copy of the final rule which is_ being transmitted to the Office of the Federal Register for publication. The Regulatory Flexibility Certification is included in the final rule. Also enclosed is a copy of the Regulatory Analysis for this final rule that contains the NRC's cost-benefit determinations. This final rule is scheduled to become effective concurrent with the effective date of EPA's rescission of 40 CFR 61, Subpart I. A notice of its effectiveness will be published in the Federal Register.
Sincerely, John C. Hoyle Secretary of the Commission
Enclosures:
. Final Rule -
Regulatory Analysis
- . . _ .. __ _ _ _. _ _ . . - ~ ~- .. - . . . _ . . . _ __ ___ _
+ - y ,
<;,: ' ,h e _ ,
4 .. ,
2 60 s:The. Honorable'Al Gore ~ i
- The-President of;the Senatei 1 i . S-212,;The. Capitol'
~ Washington,'DC 20510 V
~
Dear Mr. President:
l LPursuant to Sub' title E of-the Small Business Regulatory Enforcement Fairness-Act ofil996, 5 U.S.C. 801, the Nuclear Regulatory Commission.(NRC) is submitting i final. rule that will constrain. air emissions from NRC H=--F
/ .i
!i
. llcensees such that no member of.the public will receive a dose of 10 mrem in' ,j
. a year:from such emissions. This. action-is' expected to be the final step in. ;
providing 'a' basis under which the Environmental- Protection Agency -(EPA) .can rescind .40 CFR 61,: Subpart I " National Emission Standards for'Radionuclide. ;;
i Emissions:from Facilities Licensed by the Nuclear Regulatory Commission and f ' FederalLFacilities.Not Covered by Subpart H."' Rescission of Subpart I will
- result in a significant reduction.in burden.to the Federal Government ~and to .,
. .NRC licensees without any negative health and safety' impact. !
i We have determined that this rule is not a " major rule" as-defined in 5'U.S.C.
804(2). 'We have confirmed ~this determination with the Office of Management ,
- and Budget. i Enclosed 'is a copy of the. final rule which -is being transmitted to the Office k of. the: Federal Register for publication. ' The Regulatory Flexibility; g Certification is included in the final rule. ~ Also enclosed is~ a copy of the-
Regulatory Analysis' for this final rule that contains the NRC's cost-benefit ,
determinations. This final rule is. scheduled to become effective concurrent !
with the effective:date of EPA's rescission of 40 CFR 61, Subpart I. A notice ,
of its effectiveness will be published in the Federal Register. >
Sincerely, I
John C. Hoyle 4
' Secretary of the Commission
Enclosures:
Final' Rule ,
' Regulatory Analysis '
)
I
. DISTRIBUTION:
RPHE8 R/F.
gTSpeis' '
')
FCostanzi
..CGallagher '
LRiani ]
- fTo receive a': copy.of this. document, indicate in the box: "C" = copy without attach- -J
.mont/enclosureL '"E" =' Copy with attachment / enclosure ' "N" 4 No copy m
FICE. RPHEB:DRA RPHEB:DRA g OGC l- D:DRA- 6l D:RES /A l j S A E. CTRaddatz (12 - JEGlenn (Vf# WJ0lmstead BMMorr W
- DLMorrif6n'- {
'klDATE- '
3/q /96- f/ *n /96 ' - '/ ./96' (/g /96 (/m/96 I s
OFFICIAL RECORD COPY- l 1
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J - -
$M O& V
.O * .- -
- t. UNITED STATES j-
'g
-[
NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20565-0001
/
The Honorable Newt'Gingrich
'The Speaker H-209, The Capitol -
Washington, DC 20515
Dear _.Mr. Speaker:
Pursuant to Subtitle E of the Small Business Regulatory Enforcement Fairness Act of 1996, 5 U.S.C. 801, the Nuclear Regulatory Commission (NRC) is submitting a final rule that.will constrain air emissions from NRC
. licensees such that no member of the public will receive a dose of 10 mrem in a year from such emissions. This action is expected to be the final step in providing a basis under which the Environmental Protection Agency (EPA) can -
rescind 40 CFR 61, Subpart I " National Emission Standards for Radionuclide >
Emissions from Facilities Licensed by the Nuclear Regulatory Commission and Federal Facilities Not Covered by Subpart H.* Rescission of Subpart I will result in a significant reduction in burden to the Federal Government and to NRC licensees without'any negative health and safety impact.
We have determined that this rule is-not a " major rule" as defined in 5 U.S.C.
804(2). We have confirmed this determination with the Office of Management-and Budget.
Enclosed is a. copy of the final rule which is. being transmitted to the Office of the. Federal Register for publication. The Regulatory Flexibility Certification is included in .the final rule. Also enclosed is a copy of the Regulatory Analysis for this final rule that contains the NRC's cost-benefit i determinations. This final rule is scheduled to become effective concurrent
. with the effective date of 'cPA's rescission of 40 CFR 61, Subpart I. A notice of-its effectiveness will be published in the Federal Register.
Sincerely, John C. Hoyle Secretary of the Commission
Enclosures:
Final Rule
- Regulatory Analysis - .
i l
The Honorable Newt:Gingrich 1 The Speaker i 11-209, 1 The . Capitol l Washington, DC. -20515 i
Dear,
Mr. Speaker:
Pursuant to Subtitle E of the Small Business Regulatory Enforcement Fairness I is Act.of 1996, submitting 5 U.S.C.
a final: 801, rule that will the Nuclear constrain Regulatory air emissions from Commission NRC (NRC) M y licensees such that no member of the public will receive a dose of 10 mrem in a year from such emissions. This action is expected to be the final step in providino a basis under which the Environmental Protection Agency (EPA) can -
- rescind 40 CFR 51, Subpart I." National Emission Standards for Radionuclide Emissions from Fat.flities Licensed by the Nuclear Regulatory Commission and Federal Facilities Not Covered by Subpart H." Rescission of Subpart I will result in a significant reduction in burden to the Federal Government and to
- NRC licensees without any negative health and safety impact.
We have determined that this rule is not a " major rule" as defined in 5 U.S.C.
804(2). We have confirmed this determination with the Office of Management ,
and Budget.
Enclosed is a copy of the final rule which is being transmitted to the Office of the Federal Register .for publication. The Regulatory Flexibility '
Certification is included in the final rule. Also enclosed is a copy of the .
Regulatory Analysis for this final rule that contains the NRC's cost-benefit determinations. This final rule is scheduled to become effective concurrent with the effective date of EPA's re' scission of 40 CFR 61, Subpart I. A' notice of its effectiveness will be published in the Federal Register._
Sincerely, John C. Hoyle Secretary of the Commission
Enclosures:
' Final Rule Regulatory Analysis DISTRIBUTION:
RPHEB R/F ED0'R/F:
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TSpeis FCostanzi CGallagher LRiani To receive a copy'of this document, indicate in the box: "C" = Copy without attach- ,
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. OFFICIAL RECORD COPY
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ATTACHMENT 4 ENVIRONMENTAL ASSESSMENT
Environmental Assessment and Finding of No Significant Impact on Proposed Rule on " Constraint For Dose to Individual Members of the Publi Vg$$$" .
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- 1. THE ACTION The action is a final rule to amend 10 CFR Part 20 to include a constraint for dose to members of the public from air emissions of radioactive materials from NRC licensed facilities other than power reactors. Most of the T
provisions of this rule were previously inspected against nd reported to the Environmental Protection Agency (EPA), under an agreement with EPA. This action will provide assurance to the EPA that future emissions from NRC licensees will not exceed levels that will provide an ample margin of safety.
This action is expected to be the final step in providing EPA with a basis upon which to rescind 40 CFR Part 61 " National Emission Standards for Hazardous Air Pollutants," Subpart I as it applies to NRC licensed facilities other than power reactors,' thereby relieving these NRC licensees from unnecessary dual regulations.
1 l
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' EPA previously proposed rescission of Subpart I for power reactors based on requirements contained in 10 CFR 50, Appendix I and a history of over f 20 years of reported air emissions from power reactors resulting in doses well /
below 10 mrem to the maximally exposed member of the public. W
.J "at he rescission of Subpart I for power reactors "' finalized L ' ;ia ma5 ndependent of this rulemaking. h y M i
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.II. THE NEED FOR THE RULEMAKING ACTION 1
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. Subpart I currently limits dosho members of the public from air emissions of radionuclides from all NRC licensees except licensees possessing .
only sealed sources and uranium mill tailings piles disposed of in accordance !
with 40 CFR Part 192 Subpart I was promulgated to implement the Clean Air
'Act (CAA). The standard in Subpart I is that emissions of radionuclides to the ambient air from a facility regulated under this subpart shall not exceed those amounts that would cause any member of the public to receive in any year ;
an effective dose equivalent of 10 mrem /yr. l l
NRC licensees subject to Subpart I are also subject to NRC dose limits j i
for members of the public contained in 10 CFR Part'20, Subpart D, entitled
" Radiation Dose Limits for Individual Members of the Public"(dishpeMMppe Under Subpart D, licensees shall ensure that doses to members of the public ]
are less than 100 mrem /yr from all pathways (including air emissions) and all l sources associated with the licensee's operation. In addition, doses to members of the public must be as low as is reasonably achievable (ALARA).
Based on studies conducted by EPA and licensee reporting of doses to members of the public from air emissions, it is evident that mrem /yr to the p[h maximally exposed member of the public from air emissions is reasonably achievable. Therefore, EPA's Subpart I represents duplicate dose regulation for affected licensees.
The NRC is establishing a constraint fo_r dose to members of the public from air emissions of radionuclides of 10 mrem /yr total effective dose equivalent (TEDE). This action is necessary to provide a sufficient basis 2
... ,7 upon'which EPA can rescind Subpart I for.NRC licensees other than power reactors.
_To ensure that Federal regulations are-not excessively burdensome on the regul'ated community and most efficiently use government and licensee
. resources, NRC and EPA are coordinating rulemakings. The effect of these
.rul'emakings is to vest NRC with the principal responsibility for ensuring that the health and safety of the public are protected from the potentially harmful effects of airborne emissions of radionuclides from NRC licensed facilities.
.III. ALTERNATIVES T0 THE RULEMAKING ACTION As required by 5102(2)(E) of NEPA (42 USC 4322(2)(E)), alternatives' to the action have been considered. Three alternatives were considered.
Alternative 1 - No Action Alternative 1 maintains the status quo which involves licensees demonstratingcompliancewiththelimits'inPart20fordoshomembersofthe public, including the ALARA requirement, and with the limits in 40 CFR Part 61
/2 i for dos (3&o members of the public from air emissions of radionuclides. EPA ,
has determined that it will not rescind Subpart I for NRC licensees other than
~ power reactors without a codified or otherwise enforceable dose value not to exceed 10. mrem /yr. The impact of this action would be the continued inefficient use of licensee, NRC, EPA, and State resources, less confidence in
- the NRC program to protect the health and_ safety of the public, and disregard of congressional _ requirements to avoid duplicative regulation through i interagency cooperation.
3
3
- f. - 3 A* h Ah 4 Alternative Rulemaking Under' alternative 2, the NRC would amend the current regulations in
[ s 10 CFR'Part 20 to include a section on constraints for dos o members of the - - - i
'public. A codified or otherwise enforceable dose value is an EPA condition for rescission of Subpart I. The impact of this alternative is that licensees /
would'be subject to only one regulatory program for the control of 'dosho '
members of the public and effluent release. Licensees would therefore need only calculate dosho members of the public against a single set of criteria
[ -
which are risk based and use a common dosimetry. Failure to report a dose.in excess of the constraint level or failure to take prompt corrective actions would result in a notice of violation. Licensees and the public will have a better understanding of how the Federal Government expects %eethe health and -
h safety of the public and the environment will be protected from activities that could lead to radiation exposure, a YAAh Alternative 3 - License Amendments 4 .r3 k.
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Under alternative 3, the C would examine each lic issued under 10 CFR Parts 30, 40, 50 excluding po e reactors,60,72,gthoselicensedfor possession of sealed sources only, to determ ne if a probability existed that the licensee would have air emissions greater th n ecified value (e.g.,
10 percent of the constraint value, or a dose of 1 mrenf/y and impos[mer --
~~~
individual conditions on each such licensee to constrain doshqembers of .
the public from air emissions to less than 10 mrem /yr. The impact on N
licensees from this alternative would 7 sep be similar wq (;tmsu to that Ju)Da0 of alternative 2.d t b k nev'au The impact on NRC would be signifi, cant as e r. f several thousand licenses #
9;& f b t m' sAahpM '
would have to be reviewed each year in conjunction with renewal or amendments as well as new applications to ensure that any licensee who might exceed the 4
constraint would be required to report as a condition of the individual license.
IV. ENVIRONMENTAL IMPACTS OF THE ACTION The Commission has examined the current regulatory framework for controlling doho members of the public to ascertain the appropriate s regulatory path to take that would continue to assure the level of protection currently afforded under the duplicative regulations while minimizing the burden on licensees and the government. There are no adverse impacts associated with this rule as air emissions would continue to be constrained at the same level as exists today.
V. FINDING 0F NO SIGNIFICANT IMPACT The Commission has determined under the National Environmental Policy Act of 1969, as amended, and the Commission's regulations in 10 CFR Part 51, that the amendment to 10 CFR Part 20 will not have a significant impact on the quality of the human environment and that an environmental impact statement is not required.. This determination is based on the foregoing environmental assessment performed in accordance with the procedures and criteria in Part 51 Environmental Protection Regulations for Domestic Licensing and Related Regulatory Function."
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TVI. PERSONS CONTACTED:
TTim 'Bac'kst. rom,'- EPA, 0GC j; . . +.
- .Gail B A f g i
The~dr'fta rule language has been discussed with the Agreement States. A- -
draft of-the package was provided to them on April 18, 1995.
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ATTACHMENT 6 CONGRESSIONAL LETTERS k
se 47 p 4 UNITED STATES R 3~
j di NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20556-0001 I
The Honorable Lauch Faircloth, Chairman Subcommittee on Clean Air, Wetlands, Private Property and Nuclear safaty.
Committee on Environment and Public Works United States Senate Washington, DC 20510
Dear Mr. Chairman:
Enclosed for the information of the Subcommittee is a copy of a notice of final rulemaking to be published in the Federal Reaister. This final rulemaking amends NRC regulations to constrain dose to members of the public from air emissions of radioactive materials from NRC licensed facilities other than pcwer reactors.
This action is expected to be the final step in providing EPA with a basis upon which to rescind 40 CFR 61 " National Emission Standards for Hazardous Air Pollutants," Subpart I as it applies to NRC licensed facilities other than ,
power reactors, thereby relieving these NRC licensees from unnecessary dual regulations. EPA has already rescinded Subpart I for power reactors based on requirements contained in 10 CFR Part 50, Appendix I, and a history of over 20 years of reported air emissions from power reactors resulting in doses well below 10 mrem /yr to the maximally exposed member of the public. This action will provide assurance to the EPA that-future emissions from NRC licensees, l will not exceed levels that provide an ample margin of safety.
Sincerely, ggy
.powe !
J Dennis K. Rathbun, Director Office of Congressional Affairs f ;
Enclosure:
Federal Register Notice I cc: Senator Bob Graham i
The Honorable Lauch Faircloth, Chairman Subcommittee on Clean Air, Wetlands, Private Property and Nuclear Safety Committee on Environment and Public Works United States Senate Washington, DC 20510
Dear Mr. Chairman:
Enclosed for the information of the Subcommittee is a copy of a notice of final rulemaking to be published in the Federal Register. This final rulemaking amends NRC regulations to constrain dose to members of the public from air emissions of radioactive materials from NRC licensed facilities other than power reactors.
This action is expected to be the final step in providing EPA with a basis upon which to rescind 40 CFR 61 ' National Emission Standards for Hazardous Air Pollutants," Subpart I as it applies to NRC licensed facilities other than power reactors, thereby relieving these NRC licensees from unnecessary dual regulations. EPA has already rescinded Subpart I for power reactors based on requirements contained in 10 CFR Part 50, Appendix I, and a history of over 20 years of reported air emissions from power reactors resulting in doses well below 10 mrem /yr to the maximally exposed member of the public. This action will provide assurance to the EPA that future emissions from NRC licensees will not exceed levels that provide an ample margin of safety.
Sincerely, Dennis K. Rathbun, Director Office of Congressional Affairs
Enclosure:
Federal Register Notice cc: Senator Bob Graham Distribution:
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Document Name: [a:\ congress.ltr) hfI l
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.( [ NUCLEAR REGULATORY COMMISSION .
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I The Honorable Dan Schaefer," Chairman Subcommittee on Energy and-Power Committee on Commerce- .
United States House of Representatives Washington,.DC 20515
Dear Mr. Chairman:
Enclosed for the information of the Subcommittee is a copy of a notice of final rulemaking to be. published in the Federal Reatster. This final.
rulemaking. amends NRC regulations to constrain dose to members of'the public
.from air emissions of radioactive materials from NRC licensed facilities other than power reactors:. .
This-action is expected to be the final step in providing EPA with a basis upon which to rescind 40 CFR 61 " National Emission Standards for Hazardous Air ,
Pollutants," Subpart I as it applies _to NRC licensed facilities other than power reactors, thereby relieving ~these NRC licensees from unnecessary dual regulations. EPA has already rescinded Subpart I for power reactors based on requirements contained in.10 CFR Part 50, Appendix I, an'd a history of over 20 years of reported air emissions from power reactors resulting in doses well below 10 mrem /yr to the maximally exposed member of the public. This action will provide assurance to the. EPA that future emissions from NRC licensees will not exceed levels that provide an ample margin of safety.
Sincerely, Dennis K. Rathbun, Director Office of Congressional Affairs
Enclosure:
Federal Register' Notice cc: Representative Frank Pallone
- _ h
- io s
The-jHonorableDanSchaefer, Chairman Subcommittee on Energy and Power .
Committee on Commerce-United States House of Representatives Washington,.DC 20515
Dear Mr._ Chairman:
Enclosed for the-information of the-Subcommittee is a copy of a notice of final rulemaking to be published in the Federal Register. - This final .
rulemaking amends NRC regulations to' constrain dose to members of the public from air emissions of radioactive materials from NRC licensed facilities other '
than power reactors.
.This action is expected to be the final step in providing EPA with a basis upon which to rescind 40 CFR 61 " National Emission Standards for Hazardous Air
- Pollutants," Subpart I as it applies to NRC licensed facilities other than
. power reactors, t here by relieving these NRC licensees from unnecessary dual.
regulations. EPA has already rescinded Subpart I for power reactors based on requirements contained in 10 CFR Part 50, Appendix I, and a history of over 20
- years of reported air emissions from power' reactors resulting in doses well below 10 mrem /yr to the maximally exposed member of the public. .This action will provide assurance to the EPA that future emissions from NRC licensees will,not exceed levels that provide an ample margin of safety.
Sincerely, Dennis K. Rathbun, Director Office of Congressional- Affairs
Enclosure:
Federal Register Notice cc: Representative Frank Pallone Distribution:
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OFFICE RPHEB:DRA RPHEB:DRA- D:DRA:REA D:RES dh D:OCA NAME CTRaddatz JEGlenn hO BMMorris ) DMorrbr[ DKRathbun DATE 5/I/98 5/ I/96 - 5// F/98 5 //498- / /96 OFFICIAL RECORD. COP'r
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FOR: The Commissioners FROM: James M. Taylor, Executive Director for Operations
SUBJECT:
FINAL RULEMAKING - REVISION T0 10 CFR PART 20 RELATED TO CONSTRAINT FOR AIR EMISSIONS FROM NRC AND AGREEMENT STATE LICENSEES OTHER THAN POWER REACTORS PURPOSE:
To request Commission approval to publish a notice of final rulemaking #
amending the regulations in 10 CFR Par 20.
BACKGROUND:
W *pM /
On .lovember 15, 1995, the Comhission directed the staff to publish a proposed /
rule amending 10 CFR Part 20,, establishkg a constraint of 10 mrem /yr total effe#ctive dose equivalent (TEDE) for dose to members of the public from air emissions of radionuclides from NRC licensed facilities other than oower reactors. AproposedrulewaspublishedintheFederalRegister((60FR63984h
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on December 13, 1999? amending 10 CtX Fart 7.0 to TnEIude a constraint on air ~
emissions.
The proposed rule specified that to implement the as low as is reasonably achievable (ALARA) requirements..of Par licensees other than power reactors would be required.to reporf or measurement, resulted in a,dosCto NR air emissions that by calculation bir of the public in excess of
[
10 mrem in any yearq p ddition, the licensee would be required to propose corrective actions adequate to ensure against future air emissions leading to doses in excess of the constraint. The proposed rule exempted emissions of radon-222 from consideration.
CONTACT:
Charleen T. Raddatz, RES 415-6215
y ,-
'The Commissioners 3
- 1. Approve publication of the final rule. s
- 2. Certify that the final rule will not have a negative economic impact on a . substantial number of small entities, in order to satisfy requirements of the Regulatory Flexibility Act, 5 U.S.C. 605(b).
Note:
- a. The final rule (Attachment 1) will be published in the Federal Reaister;
- b. A Regulatory Analysis has been prepared and will be made available in the Public Document Room (Attachment 2);
- c. The staff has determined that, under the Small Business Regulatory Enforcement Fairness Act of 1996, this is not a major rule because 1 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 3);
- d. An environmental assessment and finding of no significant impact has been prepared and will be made available in the Public Document Room (Attachment 4);
[
/
- e. Thaidn accordance with the Regulatory Flexibility Act, a regulatory flexibility analysis has been prepared. The analysis .
/
is not a separate document butApart of the Federal Register !i notice. The analysis indicates that tne economic impact on licensees and small entities will not be significant. The analysis will be made available in the Public Document RoomM copy will be sent to the Chief Counsel for Advocacy of the Small(
Business Administration.
- f. 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 0MB submittal before publication of the final rule;
- g. A public announcement will be issued (Attachment 5);
" IIALcommittees Wfti-t7eMnformed Attac ment bnd
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The Commissioners 4 ,
4
- 1. 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.
i 1
James M. Taylor -
Executive Director i for Operations Attachments: As stated (6) d' i
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'The Commissioners 2 DISCUSSION:
Fifty-seven comment letters were received on the proposed rule. Among the 57 letters, 24 were licensees, 7 professional organizations, 5 States,16 members of the public, and 5 environmental o(ganizgiorts.
C#mMf a in general, those.per;sfis%;jp/S rceringed U cVMRd' 1 ;,4 t hat the proposed constraint wad too restrictive, too burdensome, and unnecessary were licensees, members-of the publicgnd professional societies. In ;;ncrol, thes ;:rt- erre:: agyTh . N 48 th: Jice tIat the proposed constraint was too lax, inadequate to protect the w o gg health of the public, and not adequately enforceable were representatives of environmental groups.
The final rule is basically unchanged from the proposed rule. However, in resolving public comments, a few minor changes were made Athe__ final rule.
The. staff removed the requirement to report demographic information on exposed {E w
- g Qjnhers_of_the oublic/as. the information may not be available to licensees and is not needed by NRC for any purpose. A provision defining the effective date of the rule has been added to ensure that there is not a time when both /
NRC's and EPA's rule would be in effe The rule has been revised to clarify I./ <
that the constraint is intended to on1
- hg Thi:- i; exigto more closely parallel tie existing requirements ofdi to environmenta I Subpart I'. In addition, the regulatory guide will be revised to address '
additional public comments.
The statement f considerations for final rule addresses other comments i by clarifying the purpose of the rule states that if a licensee exceeds l the constraint, reports to NRC, and takes corrective actions as agreed upon, i
,, g-eet exceedence in subsequent years would not be violations. Rather, the Ntht!((
would again be required to report and take appropriate corrective actions RESOURCES:
i The current budget contains' resources to conduct the inspection and enforcement of licensee programs to control air emissions in accordance with the existing rules. No additional resources will be required to implement the provisions of the final rule.
COORDINATION:
The. Office of' the. General Counsel has no legal objection to this paper.
RECOMMENDATION: '
That'the Commission: !
L '
A DM i tJ M x ..
0AT/ .
, [7590-01-P] l NUCLEAR REGULATORY COMMISS10ii 10 CFR Part 20 RIN 3150-AF31 ,
' Resolution of Dual- Regulation of Airborne Emissions @
Clean Air Act i
AGENCY:- Nuclear Regulatory Commission.
l ACTION: Final rule.
1
SUMMARY
- The Nuclear Regulatory Commission is.amenc'ing its regulations to j
4 establish a constraint of 10 mrem /yr total effective dose equivalent (TEDE) I for dose to members of the public from air emissions of radionuclides from NRC l l
licensed facilities other than power reactors. This action is necessary to provide assurance to the Environmental Protection Agency (EPA) that future ,
emissions from NRC licensees will not exceed dose levels that will provide an l
. 1
. ' ample margin of safety. This action is expected to be the final step in providing EPA with a basis upon which to rescind its Clean Air Act (CAA)
J regulations for NRC licensed facilities (other than power reactors) and Agreement State licensees, thereby relieving these licensees from unnecessary dual regulations,
- f. -
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. 1 Fin, Con'straint Rule I- ~N May 10, 1996
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EFFECTIVE DATE: This rule will become effective on the date of T1ublicatimru- ,
-the fsderal Reolstee-ef the rescission of 40 CFR 61, Subpart (by EPA /
J deroan n e ^ ee /n. e.
h N K sd/ pubEd FOR FURTHER INFORMATION CONTACT: Charleen T. Raddatz, Office of Nuclear a Sv/#h e h'/
ck%t a,Sm Regulatory Research, U.S. Nuclear Regulatory Commission, Washington, DC 20555 g, g .,g 0001, telephone (301) 415-6215. /#N-SUPPLEMENTARY INFORMATION:
Background
The EPA promulgated National Emission Standards for Hazardous Air Pollutants (NESHAPs) for radionuclides on October 31, 1989. Subpart I of 40 CFR 61 was promulgated to implement the CAA and limit doses to members of the public 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 ,
1 in accordance with 40 CFR Part 192 and are subject to the requirements of Subpart I. Initially, Radon-222 emissions from tailings were covered by 40CFR61,SubpagtsTandW. Subpart T was rescinded for NRC licensees after AppendixAtoAPart40wasamendedbytheCommissiontoconformtochangesEPA issued to 40 CFR 192 that adopted the provisions of Subpart T (Subpart W stil [
applies to NRC licensees). Because Radon-222 is adequately addressed in
\0 (.f b GLfA AppendixAtoAPart40andotherprovisionsoffPart2 it is not covered in this prepared rulemaking. l l
Final Con pa Rule 2 May/ 1996
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90 Cfd (l; Under Subpart I, emissions of radionuclides must be limited so that no member of the public would receive an effective dose equivalent of greater than 10 mrem /yr .
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 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 period, EPA conducted two studies of the air emissions from NRC and Agreement State materials licensees. The first was a survey of 367 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 /yr, based on very conservative modeling. In addition, 98 percent of the
& ubpart S I expresses dose in effective dose equivalent (EDE). NRC /
y expresses dose in total effective dose equivalent (TEDE). These terms are Q essentially equivalent. For the sake of consistency, this paper will refer to all doses in terms of TEDE.
/
Final Constrai Rule 3 May 1996
1 1
facilities surveyed reported doses to members of the public resulting from air emissions less than 1 mrem /yr. The second study evaluated dose from air emissions from 43 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 less than 1 mrem /yr. For the licensees evaluated, none exceeded 10 mrem /yr.
In its initial proposal to rescind Subpart I for NRC licensees other than power reactors, EPA stated that:
Based on the result of the survey undertaken by EPA and the commitments made by NRC in the MOV, EPA has made an initial determination that the NRC program under the Atomic Energy Act provides an ample margin of safety to protect the public health (57 FR 56880; December 1,1992).
1 However, EPA continued to express concern regarding the adequacy of the measures to " assure EPA that future emissions from NRC licensees will not exceed levels that will provide an ample margin of safety." The stay on 1 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 I. Consequently, NRC and Agreement State licensed facilities were subject to dual regulation of air emissions of radionuclides under both the AEA and the CAA, including regulatory oversight by EPA (or authorized State) and NRC (or Agreement State). l i )
Final Constrai Rule 4 ay 10, 1996 l
@f /
NRClicenseessubjectto)SubpartIarealsosubjecttoNRCdoselimits for members of the public contained in 10 CFR Part 20, Subpart D entitled 9 p> [
- " Radiation Dose Limits for Individual Members of the Public" (Subpart D).
Under Subpart D, licensees shall ensure that doses to members of the public are less than 100 mrem /yr from all pathways (including air emissions) and all sources associated with the licensee's operation. In addition, doses to members of the public must be kept as low as is reasonably achievable (ALARA).
I Basedontheafe,emenuc,c{studiesconductedbyEPAandlicenseereportingof doses to members of the public from air emissions to EPA, it is evident that less than 10 mrem /yr to the maximally exposed member of the public from air emissions is reasonably achievable.
NRC power reactor licensees subject to 10 CFR 50.34a must keep doses to I members of the public from air emissions consistent with the numerical guidelines in Appendix I to 10 CFR Part 50. In addition, these licensees havej hmanyy estimated doses _ to members of the public from air emissionswellbelowtheSubpartIvaluehBasedonthecombinationofa continuing regulatory basis for reduced air emissions and documented proof of the effectiveness of the NRC program for these licensees, EPA has already rescinded Subpart I for power reactors licensed by NRC (60 FR 37196; September 5, 1995).
l Amendments The amendments proposed on December 13, 1995 (60 FR 63984), and
%\ TAG y 1
finalized %iggstablish a constraint of 10 mrem /yr TEDE for dcp to membersofthepublicfromairemissionsofradionuclidesfromNRCYlicensed
[
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5 M 10, 1996 Final Con 7iaint Rule -
.. . . . -, ,. - .-- - ~-. .- - . . . . - - . . . .- - ..
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. facilities other than power reactors as a part of its program to maintain j w- . :
Thefamen.dments codify numerical values for'NRC's application of doses (ALARA.
ALARA guidelines on radioactive air emissions from its. licensees, other than-
- power reactors. For power reactors, ALARA guidelines have already been established within 10 CFR Part 50 and facility licensing conditions. The
).
- amendments ensure that air emissions ahe maintained at a very low-level and,
!taking Linto consideration the elimination of dual regulation, at little or no cost. This act' ion brin s consistency between PA's dose standard and the NRC's
.- An i n ALARA application,.J48Pehx.providfag, EPA with kS g; x h ici(to rescind
- basis I
This action is expected to.be the final step in providing EP ; .
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- pr.AicyorescindSubpartIfor[NRClicenseeg
- th:-thiEx;rreacturg.,
NRC has been working cooperatively with EPA c cr the h:t mm el ,eers d to support rescission of. EPA's standards in Subpart I of 40 CFR Part 61. W Wth
_accor d =e= Ht Section 112(d)(9) of the CAA. The objective of
, this effort is to eliminate errersgduplicative regulations that provide
- no incremental benefit in terms of publ environmental rotection.
The regulatory framework w4Mr+1r1i
, RCisprovidingfabasisfor 4
rescission offs bpart I consists of the requirements.in 10 CFR Part 20 to !
limit doses to members of the public to 100 mrem /yr, to maintain these doses j as far below this limit as.is reasonably achievable (ALARA), and to constrain
. dose'.to members of the public from air emissions of radioactive materials ~ from' c a single: source'.to 10 mrem /yr.. l The rule WiQ requirefs that'if the licensee estimates or measures a dose y M .) .i
". to.a member of the public4expectKte re::Qthehighestdose'fromair j
) ,
ina Cons int Rule. 6 May 1 , 1996.
- .k ..
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effluents to be less than 10 mrem /yr, the licensee would be required to record the dose and the assumption used to calculate i f consistent with the requirements of 5 20.2103. This data would be made available to inspectors upon request. If the licensee estimates or measures a dose to the member of the public expected to receive the highest dose from air effluents to be greater than 10 mrem /yr, the licensee would be required to report the dose to ,
NRC in writing within 30 days. In addition, the licensee would be required to include in that report the circumstances that led to the greater than 10 mrem / 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 the expected results.
The constraint on dose from air emissions is different than a limit. ;
Exceeding this constraint will not result in a Notice of Violation (NOV) .
Ratheg )4 NOV will be issued only upon failure to report that actual or e estimated doses from air effluent relgases from a facility have exceeded the.
M Q M
constraint valuegad/or(felM446 all to institut who a propriate measures to correct -
f those wouldresultindosej and prevent further emissions 4ta_exr.es exceeding the constraint level / W I N hPM N// 5 vs The rule will applf to airborne releases j other than Radon-222 and daughters, from all NRC licensees except power reactors. Power reactors are
/*
exempt from this proposed rule because they are already required under 10 CFR theirapNcat design objectives and the means to 50.34atoidentifp n be. employed for keeping doses to members of the public from air effluents ALARAbAppendixItoPart50containsthenumericalguidelinestomeetthis requirement, j
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Final Constraint Rule 7 May'10, 1996 !
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Response to Comments Fifty-seven individuals and organizations provided written comments on i
- er l the proposed rule and the regulatory guide. Amongthe57commenp,24were-htMan ut Wlw licensees,4professionalorganizations{,ytM A4 states, IQgmembers of the public, an environmental organizations. [e.manylettersofcommentonthe i
adj :t af theg regulatory guide included comments on the rule, they were also considered in developing the final rule. i issue ! !
9
-P h A/ g 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 I for the constraint. Four commented that the rule should not be finalized andN -
EPf3ubpartIshouldremainineffect. Twenty-two commenters stated that existing NRC programs provided an ample margin of safety and that the constraint was
- not needed. However, of these, seven agreed that the constraint was preferable to dual regulation or Subpart I alone.
Those commenting that existing NRC programs are adequate to protect the public cited the EPA studies on doses from air emissions. Two-thirds of these.
bilNR hky Vl}lMd commenters were opposed to going forward with the constraint A .it was not needed and ts could not be justified given the expectation that risk would not be reduced. These commenters encouraged NRC to continue working with EPA to provide sufficient basis for rescission of Subpart I without the imposition (cm dr W I of an equally unnecessary regulation. A fewAstated that the risk was
\Uhd!
considerably less than estimatedAekcessively conservative calculational
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Final Constraint Rule 8 May 0, 1996
P
- p l%durlthly methods were used by EPA. Afe{comparedthe10 mrem /yconstraintto variability in background or doses from commercial air traffic; as evidence !
t9st,ablil/lckb . l
~that the dos and the risp is trivial. -Of%6evengagreeing that the !
ORY constraint was preferable to dual regulation orAEPA's Subpart 4:l=c,. urden hductionandsingle-agencyoversight the reason ,
f 1 Commenters opposed to the constraint as a less protective standard, stated that the constraint was based upon a voluntary program (ALARA),an as such was not adequate to protect the public. One commenter stated that NRC i
> t htt does not confirmatory measurements and therefor NRC jurisdiction was not adequate. ,
Response: NRCandEPAhavebeenworkingwuyeiotivelgtodevelopa basis upon 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 /y to a member of the public. This has been demonstrated through the two studies _under4agby EPA and by licensee reporting of actual air emissions. The second component is a program to ensure that doses remain at this K evel. In the absence of rulemaking requiring licensees to maintain doses to levels of no more than 10 mrem /y, EPA would not rescind Subpart and dual regulation would continue.
The Federal Radiation Council (FRC) was formed in 1959 to provide recommendations to the President for Federal policy ra aionmattersh affect 4 g health. In May 4 1960, FRC set forth basic principles for protection of both workers and :::bers s{the public. The council was
/
Final Constra t Rule 9 May 10, 1996
4 WbM abolished in 197p,Att(its functions transferred to the%dministrato4+f th
~nfwly f;r..cd$,;l,u2,ciiid F usodica a;= gin 1981, EPA published proposed recommendations for new Federal guidance for occupational 9xposure. In 1987, PresidentRer.ganapprovedrecommendationsbytheAdministratorQhfornew
" Radiation Protection Guidance to Federal Agencies for Occupational Exposure."
EPA has not yet issued recommendations on limits for r-Scr: Of q the public. A
-f#m working group 90mprised of representatives #f, affected Federal [encies and n rAdfolopc4l ,ngen ,,g expertskhas been developing these recommendations for several years N
,m expecth4c W V4v&
et-they4ht9V d#ig g yi. h inythe next year.
-l11-da
/he International Council on Radiological Protection (ICRP) issued 4tn-Report No. 2g" Recommendations of the International C uncil on Radiological These recommendations that the average doses to Protectiog members-agthe public should not exceed 100 mrem /yr with a limit of 500 mrem /yr to any individual.
IS US/,y/
The National Council on Radiation Protection and Measurements (NCRP) has Um respons-ibility ur.dcr ituharter--4rc; th^fongress ef the Vaited St:tc to recommend limits for exposure to ionizing radiation. In June ( 1987, NCRP issued its eport No. 91 " Recommendations on Limits for Exposure to Ionizing C&W Radiation." Thisreportaakes{4W
@8DE recommendationsonJ11mitsforboth occupationally exposed individual and individual members of the public. The report recommended that doses to individual members of the public be limited to100 mrem /yaveragedoveralifetime,nottoexceed500mremin.aagone year.
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10 Ma 10, 1996
-FinalConst/rahtRule
In199(NRCrevised 10 CFR Part 20 4 " Standards for Protection 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 in bym M any one year, the NRC established a limit of 100 mrem /yr Mt was dee~ed-%
% impractical to control dose in terms of lifetime average without keeping l p CF A. l track of individual exposures. In addition,APart 20 requires that licensees !
1 use procedures and engineering controls to maintain doses as low as is reasonably achievable (ALARA).
Both the NRC and EPA regulatory programs are designed to achieve the goalspresentedinthgFederalguidance,ICRPrecommendations,andNCRP recommendations. The approaches of the two agencies differ. NRC limits TEDE i and requires that doses are maintained ALARA. EPA limits dose from individual pathways of exposure and individual radionuclides to ensure that the total dose does not exceed -tgrecommended levels. Both programs achieve similar levels of protection.
NRC agrees that adoption of the constraint in 5 20.1101(d) is preferable p/
to dual regulation or regulation under 40 CFRI61, Subpart I ahngdue to the reduction in burden on licensees as well as State and Federal 4cverised v -
font agencies. Undertheprovisionsof40CFRI61,licenseeswithdosestomembers of the public greater than 1 mrem /y but less than 10 mrem /y submit bl l reports, ecommend and implement corrective actions pursuant to Subpart I.
These reporting requirements, even for licensees who have not exceeded any l bubdC limit, are necessary under Subpart I A EPA does not perform routine 1
inspections to ensure compliance with their regulations. However, under l
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Final Constraipt Rule 11 May 0, 1996
O f
g (fA 20.1101(d), these licensees will not have to file reports und for doses CM\l below the constraint level reason tnis is nct necesory; h that doses can be evaluated a 4 routine inspections parfer-ad by trained; p
hDA inspecteep Under thedagtmo, the burden of calculating doses should be ;
reduced for most licensees because the proposed guidance for demonstrating~
ad r le CAR 'i l a d#
compliance with 120.1101(d) allows significantly more flexibility and simplerj methods for calcula ng doses than g he m M urrently used to implement 40CFRb61. These new methods for calculating doses should result in fewer reporting and corrective actions.
The Federal and State -Goverr,mca(burden should be somewhat reduced 7%
buul(
the number of annual reports requiring review and follow up actions should decline from several hundred per year to at most a few. Because NRC inspectors are already inspecting records of air emissions, there is little additional burden to NRC as a result of the promulgation of this rule. There M\y ,-
isAthe onedime burden for promulgation of the rule, rescission of Subpart 1) and development of regulatory guidance and inspection procedures. There is also a onktime burden for implementation of compatible regulations by Agreement States. veral [he burden to State and Federal agencies should be reduced.
The NRC inspection program does not routinely include confirmatory HNMf measurements .bA air effluent records are routinely inspected by NRC and confirmatory measurements are performed & " is decmsQecessary by--tfp
-inspec4o% Further, aMeeviottsly-stet nfirmatory measurements are not currently performed to ensure compliance with Subpart I.
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Final Constraint ule 12 May 1996
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Finally, concerning those commenters that believe NRC's requirements [
less safe than Subpart I, i 199 Congress enacted legislation 9
comprehensively amending the Clean Air Act (CAA), which included a section addressing the issue of regulatory duplication between EPA and NRg. The 1990 CAAamendmentspermitthehdministr to rescind the CAA standards as they apply to radionuclides, at sites licensed by NRQnd the Agreement kl V .)
States, iffshe finds that the NRC regulatory program provides an ample margin of safety to protect the public health.
EPA's analysis of the NRC regulatory program focused on two general issues: (1) whether the implementation of the NRC regulatory program results in sufficiently low doses to protect the health and safety of the public with ;
anamplemarginofsafetdand(2)whethertheNRCprogramissufficiently )
comprehensive and thorough, and administered in a manner that 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 pubig from air efflue will continue to remain below 10 mrem /y and 44eet(provide evidence to EPA that the current %
edst4ng evel of protection will continue tc be dferded 4tc the fut %
4 e purpose of this rulemaking i has Jottoreducedoses already been demonstrated that doses are sufficiently low. 4athe ,he primary purpose is to reduce costs associated with thejl evel of protection hrrenM{aHerded by providing a basis upon which EPA can find that doses will not increase as a result of rescission of Subpart I. _Secondae r
he
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Final Constr, nt Rule 13 May 10 1996
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0,b rulewill[ensurethatdosesaremaintainedatthelowlevelcurrentlyachieved by NRC licensees.
th MlOWY A issue 2 L P/t0HUMATf0Tpf T))t C,0RITRAINTf/ I ALARg Comments: There were a number of commenters who objected to the ALARA basis for the proposed constraint rule.
t swM )!
Somejobjecte(d on the ground that ALARA is a matter of operating philosophy, good radiation protection practicen and licensee judgment, and cannot be translated into an enforceable dose (s v*t,+(f<.Tm number. Othergs4mRady ected that ALARA is inherently site specific and cannot be defined generically or that the proposed dose constraint cannot be ALARA but must Megbe a limit because the constraint contemplates some enforcement actions for exceedance even if the licensee has followed all good (0annbikj radiation protection practices. -HttaHg[Momejarguedthattherulecannotbe (9 pta GTMf n
ALARA because it adds costs with no safety benefig btherf stated that the constraint is inconsistent with a prior NRC decision on " reference levels."
Response: The Commission has retained an ALARA basis for the rule 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 D
practice and the exercise of licensee xpert judgement.
t dtb ' Ni bl.
itgieNRC zn e h % the p, ,- nstraint rule A a somewhat broader concept found in the governing statute, the Atomic Energy Act of 1954, t The Act, as construed by both the Commission (e.g. 10 CFR as amended (Jv 50.109) and the courts (Union of Concerned Scientists v. NRC, 824 F.2d 108
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Final Constr 'nt Rule 14 May 1996
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(D.C. Cir.1987f, contemplates two distinct approaches to radiological regulation. Firskalevelof"adequateprotection"mustbedefinedand
.)
enforced without regard ;o economic cost agSecondriskmaybereducedtoa level below that associated with " adequate protection" to " minimize danger to life or property" with economic cost and other factors as permissible balancing considerations. See " Revision of Backfitting Process for Power y FA & 97 M N 4o dif Reactors," 53 F% Reg. 20603',(June 6,1988). N importar@e. W (' {Qf d th the Commission e th pt::M adopt and enforce generic LeAct
-requirements using either approach fact Many recent NRC regulations g
i (e.g.,10 CFR 50.63) have been directed at incremental risk reduction under l l
the second approach based on a generic regulatory or backfit analysis which !
considered and balanced economic and other costs and safety backfits. These uQ
" minimize danger" regulations provide " limits".6 t k = they ;
HOWfW$u establish generic requirements directly enforceable against licensees bot in >
g a broad sense they are also ALARA regulations cost, feasibilit nd ep\vittd other relevant facers identified in 10 CFR 20.1003 are M ond h hn cd.
Viewedinitslargerstatutorycontext,ALARAin10CFR20.1003isope
' 04($
means to implement the second approach to radiological regulation bat _other similar requirements can also be part of this second approach. Ie part4etttary-e 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 legally permissible. This broader concept of ALARA 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 Final Co s int Rule 15 May 1996
l' l
l' I
Part50,AppendixI,andistheMsgfortheconstraintrule. J hlARA rule imposes a limit i+4he sunwthatJzedOgill ead to ,
ot/ - th;stmits '
enforcement action to achieve complianc> but y
M conformance is acc h for adequate protection.
Thu[ to say that the constraint rule cannot be based on ALARA because it is in effect a " limit" impermissibly interchanges a narrow concept of "ALARA" with a broad concept of " limit." If a broad definition is usedgthe J
constraint rule withstands scrutiny as both ALARA and a limit. W h the statutory context of the Atomic Energy Act and general principles of administrative law, the constraint rule is a limit based on generic ALARA considerations. The constraint rule is not a limit needed for adequate i protectioy and s ething more than arrow translation of the particular ALARA concept A in 10 CFR 20.1003. c^'-Ig_to avoid confusion with the narrow concepts of ALARA and mitj N r oyed in radiation protection discussiong term EP was used for the rule under considerati L4is- leev ree matters be addressed comment that the rule / j cannot be based on ALARA because it will result in increased cost with no lD safety benefptQthe problem of the licensee who cannot meet the dose constr int despite using all good radiation protection practices; an he A
alleget iy inconsistent Commission discussion of reference levels in a recent q revision to 10 CFR Part 20. }heCommissiondisagreeswiththepremiseofthe vI first comment. There was no disagreement with the Commission's conclusion that all of the licenses affected by the rule are achieving a level of control suchthatdoskarebelowthe10mremlevelandsothereisnofactualdispute over whether this level of radiation protection is readily achievable. TheM4, Final Constraint Rule 16 May 10, 1996
(4 ad rule it1 rem, cens!derad-wi-th EPA's rescission of its Clean Air Act emission 4
t-limits and related rec irements s will result an a significant met-: s(savings
~ .
to licensees. % t WA/'.acknowledgf that,/ hen
~
6bi 6d
_thecurrentle positive direct health effects are likely to be small and possibly.zfra.fut in the ;
nearfutur/.ht e rule will hava t ffects(prevent ossible future backsliding by licenseep and se e offer some small but positive net health and safety benefit. Under the,-broad RA conceptj xribed absvtg it is appropriate to base a fC UWMth J on a small positive health and safety benefit when cost savings are also likely.
% hML JW ot expect that any licensee subject to the rule will be unable to comply. -!A the c.l'_t:13 x =t,th:tg to q temporary circumstances or i 1
hapse in controlf t' he dose'TeTel is%yis projected to be excee ed,. lice- m
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t l
acH ant tn en=a w t' crpli=g(Hg (481 fly ce :r expeck ap'i. if arch,g y Ity 4 8W liuditt h t/ m p
i Jhn unforeseen and, aivan enrrant infnrmatinn nn tha practiality cf d ringent +ei&Oru,y4 W,,
.cnntenle, unlikely circumstanea alicenseej unabletocompgbecause N can gIblff of limits in tgtechnology or :=rbitan(cop, Mll. ,ddressed in the i future on a cast 9bf/ case basis. bSf4/h ;
finall [fis rule is not inconsistent with the concept of reference l M 10 Cid i level.whic was rejected by the Commjssion when g Part 20 was recently revised.
IO LfR Commenters on the 1991 revision to Part 20 objected to the use of reference 4
QdRk .
levels A they were implemented exactly the same as limits. For that reasony '
2 the Commission eliminated reference levels from the final 1991 revision. ,
Implementation of the constraint is different than a limit CoiM H( k hz~ i;)
a.t exceederide ,
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Final Constr t Rule 17 !10,1996 M/
i
o is not a violation j and it only requires licensee actions,. Jt h nat th; furpose+f--the censtraint-rule Lv pruviue sus added a ssweencs.~)4 Issue 3 W)iETHEkk}8CfNSTRAINfMAfTUALLi[LJh Comments: Nine comments were received on whether the constraint is or biliMN should be a limit. These commenters were divided. Two comment that the constraint was no different than a limit. One commenter agreed with the term constraint. Three commenters expressed concern that the constraint was an inappropriate relaxation of requirements.
Those commenting that the constraint was a de facto limit interpreted the requirements to indicate that a second exceedence of the constraint would ge um te.*
result in enforcement action and therefor s a limit. Three commenters indicated that the rule should be a strict limit. They expressed concern that EM N1N the constraint was less protective than Sub6a&1.(a]("p%
Response: A constraint is not the same as a limit. The constraint is a dose at which the licensee must notify NRC bg 7t is not a dose above which enforcement action would necessarily be taken. If a licensee exceeds a limit, ;
the NRC may take immediate enforcement action. If a licensee exceeds a 1 constraint, licensees will be required to notify NRC and implement corrective actions that are adequate to prevent further doses in excess of the constraint. 4" the "n14'aly eunnt that calculatinn q relic,wir,; ycere indicate tha the constraint he :;;ii ' exceeded co-egreed up w l R
A corrective actions had been appropriately implemented, enforcement action 4
/~\ 7- l Final Constrait Rule
/ 18 May 10 1996 :
9
would not necessarily be considered. f owever, the licensee Aad led to N andl report it to NRC or had--faile(to implement,p%fcorrective t actionp@
J 15genforcement action would be expected.
-The adoption of a constraint is not needed to provide adequate protection of the public and the environment. The existing regulatory program 1 6FR of established limits i Part 20 and the application of ALARA is adequate for that purpose. Therefore, it is not necessary to promulgate the constraint as a' limit. g The NRC does not agree that the constraint is less protective tha[d /gg g g*
fVtG utL 4ubpart $ Bot Subpart I and the4 constraint require licensees to take actions to ensure that doses to members of the public do not exceed 10 mrem /y l from environmental air emissions. Enforcement would be similar under either requirement RC routinely inspects licensed facilities to ensure that air effluents do not result in doses to members of the public .the 10 Cfll g i requirementsigPart20. Confirmatory measurements are performedg . , = t hey >- ,.
aredec..dappropriate. A similar program of inspection and enforcement will l be implemented as a result of this rul hul 4 2%;y c I
Issue 4-C[TihNSf Comments: Three commenters opposed finalization of the constraint on 5
Wb0 the basis that it forfeits citizen rights to sue a licensee exceedifig the constraint.
l Response: The lack of a citizen suit provision in the Atomic Energy Act is more appropriately a matter for the EPA to consider in reaching it's
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Final Const int Rule 19 May 1996
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rescission decision. However, it rhnuld he notad t the Commission's regulation in 10 CFR 2.206 ovide the public'with the right to petition the Uhs to take en orcement action against a licensee for m.h iningo ga. violation of .the-t6Siitttm4 regulations. This would include the I/"/
constraint rul g p final boa-Issue 5-A(REEMENTSkECpPATIBILIT Comments: Four commenters addressed the proposal that the constraint be l
a division 2 matter of compatibility. Under division 2, States could adopt similar or more stringent requirements. Three commenters agreed that this ruleshouldnopbecod,1fiedasadivision2 requirement,butratherasp rydy rt UP 4t 6h$t division . Under ivision , the States would be required to ado,pt of 4
regulations that were essentially identical. These commenters at if stricter standards were permitted, t j ctory and non reactor licensees would be under different requirement and.tha(certainpracticessuchas f
nuclear medicine,could be jeopardized. One commenter noted that because this j is really a 'imit, it should be under 5 20.1301 and would tharder "
division . matter of compatibility. Another commenter stated that NRC should have provided a greater opportunity for State involvement in this rulemakingF Yd40 gM andfthatA a division 2 rule, Agreement States would have to spend scarce i resources to develop a compatible rule. _,
Response: Section 116 of the Clean Air Act imh that Wth c
-excerHanc-st =palicable_heregnothing i- th A(precludes States from imposing air emission requirements that are more stringent than those n /
Final Constral Rule 20 10 996 May /
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developed by EPA. Section ll2(d)(9), which contains the provisions related to EPA's %mpt(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 emissions of radionuclides which is more stringent than the standard or limitation in effect under Section 7411 of this title or this section." The Commission believes that this provision W L~
- .-. .. g (^ Q larifies that EPA's determination regarding NRC and AgreementStatelicenseeshasnoeffectontheexistingauthorityofhatesto kl Limpose air emission standards that are more stringent than those of EPA.
Accordingly, the Commission believes that the division 2 compatibility designation for the rule is consistent with State authority in this area as d in the Clean Air Act. The division 2 designation means that Agreement States must address these rules in their regulations but may adopt requirements more restrictive than those of NRC. Accordingly, the power of the Agreement States to impose air emission standards under their Atomic Energy Act authority after the effective date of this rule will be consistent with their existing authority.
With regard to the comment concerning involvement of the Agreement
-States in the development of this rule, NRC has routinely reported its 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 Control Program Directors (CRCPD) at each of their annual meetings.
The Agreement States ere consulted extensively on this issue over the last Muf heywe[d,notforma11yJeht.anadvancecopyofthedraft several years. JdkMe ffUlic
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Final Constra Rule 21 May , 1996
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1 rule, there were extensive discussions of the concept with #
ud individual Stateshwith the Executive Board of-the Organization of l Agreement States.
l
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Issue 6Y DlM0GRAPHI'I/[C FORMATIO 5CkTAINEDfpR[QWEhROdRTk.
? Comments: Seven commenters addressed the application of the requirement n
contained in i 20.2203 *
(b)(2) to the constraint. This section requires %
ip reportsfcontaindemographicinformationontheexposedindividual. These commenters expressed concern that a member of the public would be under no Sd $1VT obligationtoprovidedemographicinformationtolicenseespicenseeswould J.hasegnot. always be able to comply with the requirement.
Response: NRC agrees that members of the public may choose to withhold l the demographic information from licensees. 20.2203 has been changed )
to delete that requirement.
Issue 7 E/FECTIVsh i
Comment: One commenter requested that an effective date be added to the final rule to coincide with EPA's rescission of Subpart I.
Response: NRC agrees and this provision has been added. This provision is needed to ensure that there is not a time when both Subpart I and the constraint are in effect. Because it is very difficult to coordinate these C0 rulemakings nuFtirat. they are issued simultaneously, a delay in the effective
-date is appropriate.
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/ 22 May 1,0;/
1996 FinalConst7aintRule '
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IssuehEfFORCEMEN Coments:
Nd .
NRC should establish a limit Five commenters comnfeRed th rather than'a constraint. They' that the limit has been exceeded, l
a notice of violation an 1 e lties should always result. One commenter ed WM( ! ;
expressed concern that elf-repoM ng and confession" is not adequate.
- Another stated that because ALARA is the only guidance, it is not enforceable.
Response: A limit implies that doses must be controlled below that
. level in order to provide adequate protection of the health and . safety of the public and workers. A notice of violation and civil penalties are not needed to ensure that licensees will not exceed a constraint. Licensees are currently controlling effluents to levels below that which would be required under the constraint to meet current ALARA requirements. 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.
ALARA is not a' guidance. As siaieu Ye1991revisionto 10 CFR Part 20 codified ALARA as a required part of.the licensee's radiation protection program.
Issuek-E[EMPTIONh j Comments: Five commenters stated that thq rule should only apply to
[ twt members of the public off site. TheycitedtheASubpartIrequirementto calculate dose to the nearest resident. Under Subpart-I, licensees would not
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~ Final Constra Rule- 23 May 0 1996
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7 g *ovyw,f y +- -y e e- -- - - - - y , rw-. - , - - - _ _ _ _ - _ _ - - - . _ _ - - _ _ _ - - - - - - - - - -
4
.i ,
calculate doses from air emissions to visitors in hospitals, workers that are not radiation workers within the facility, or other members of the public f within'the facility.
- Response: NRC agrees that h Subpart I only applies to the nearest
~
4 resident. The language in the rule has been changed to reflect that it is- l intended to apply to environmental air emissions. The guidance will be j
. revised to' indicate that the dose limit is to be calculated to the nearest resident. _
Clk '
Comments: Two commenters stated that air emissions from adjacent nearby exempt uranium mills should not be included in the calculation of dose. One l 1
commenter stated that materials from unlicensed portions of the facility such !
-as ore stockpiles should not ac;d-t4 be considered in the calculation of dose.
Response: Subpart I does not apply to disposal at facilities 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 constraint applies to P
environmental emissions of licensed material The rule language has
^* d4% .. . I been changed.to. it that windblown particulates from other-acedy e i licensed facilities or unlicensed materialsfn be considered in the calculation.of doses used to demonstrate compliance with the constraint. !
Comments: Four commenters stated that air emissions from patients l
~should be-exempted from this rule ~. I
~ Response: .NRC' agrees that airLemissions from patients are excluded from thisrule.-The/egulatoryfpact alysis for NRC's-recent /atient[elease
/
LFinal Constraip[ Rule 24c 996 Mayl10 l
r
, . , , _ .,a._ , _ -
_- - _ . . . _ - - _ _ = . ... . _ _ _ _ . . _ _ _ _ . _ .
i
-t t .I
... l 4
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1 aking (NUREG-1492) anglyzed potential doses from exposure to patients
' released M d 59 administration of radiopharmaceuticals. This -
" i ana lysis' concluded that internal doses from intakes of radioactive materials J
in- the exhaled air of a released patient are trivial ~. Forlicenseesuskan
' inventory approach to demonstrating compliance with the rule, such as the ;
' COMPLY computer code, there is no need to account sp ::Tkail gfor the. ,
materials.that'might'be released.to the air through respiration or
- transpiration by patients. _ The final regulatory guide will make it clear that
! l dose from air: emissions from patient n be g::ifin114addressedin 1the calculation of dose used to demonstrate compliance with the constraint.
Gli' W ;
Coments: Four comenters stated that in addition to Rn-222, all l i
I daughters produced after release should also be excluded.
Response:ff6 ,
g Subpart I exempts both Rn-222 an any daughters produced i
M hllt I 64 film J Art :
after release of Rn-222 no 11y not attributable to licensed activities. The. proposed rule was not intended to be more stringent than ,
Subpart~I. The rule language has been changed to reflect this exemption.
Y Comments: Two comenters recomended that in addition to Rn-222, Rn-220 II and its daughters should also be exempted. One comenter stated that it was I an EPA osersight that-led to this erroneous omission from Subpart N4b ,
i ~ Response: Rn-220 is normally attributable to licensed activities. EPA' 1
Jdoes not exempt Rn-220:or its-daughters from consideration in the dose. <
t
- calculations in ~ support of demonstrating compliance with Subpart I.
The- i icomenters suggestion that an; oversight led to the erroneous omission of this i
a, ,
J-
- Final: Constrain Rule. 25 M 1996 p/
/ay1 ;
k-.' -,-.,....--r
. u. 4 42,.
4 4, # .m% 2 - a .o. _ ..o._.,..#..#+= a - m a..a ~~sa442-.. e,u. . . . + a E
t-t
- i. - exemption from Subpart 3 is incorrect. Therefore, Rn-220 will not be excluded hW e from the calculations demonstratthg. compliance with the' constraint.
Comments: Six comenters requested that in. addition to sealed sources,
, sealed containers should also' be excluded from the rule. af g Response: Paragraph'2(a)~ of Appendix D to 40 CFR 61 states: , adioac ive materials in' sealed packages that remain _ unopened, and have not leaked during
- - the assessment period should not be included h the calculations." Subpart I bt(Akj&
- exempts sealed packageyt any package that has remained sealed cannot contbibute to airborne emissions. 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 emissions. The final regulatory guide will provide further guidance on this ,
issue.
Issue-lh PjfASURABILIfY/)I 10 Mh/Yf YR i
Comments: Three commenters stated that 10 mrem /y was not measurable.
Abgh i
One commenter stated that wMie.10 mrem /y might be easily achievable, it'is not easily measurable. Another stated that the' exposure rate corresponds to 1 microR/hr and cannot be measured accurately.
Response: -
The regulatory guide provides several methods for
' demonstrating compliance.with the constraint. Y/nly one of the methodsAd~ is acceptable safg t measu'rement at he receptor locatiorp If this method is not practical due' to. the emission characteristics of the -
i
- f. l Final Co fraintRule 26 May 10, 1996
- r. .
4- . . .
pUf/ _
- ;radionuclide releases, there are severalfvalid options cited in the regulatory ;
- guide.
Issue'11$SkE/[.hRh gdt .
Comments: One commenter stated ,that if a must a constraint,-it :
30,M $0WteM-\Qg=
i !
should apply to all licenseep greactorg.
Response: _Although this rule only applies to licensees other than power 10CM
. reactor licensees,- the' Commission's existing regulations infPart 50, Appendix I, already establish a similar regulatory framework. Appendix I includes separate requirements to develop design objectives and operational i EPA I levels' sufficient to demonstrate compliance with Subpart I. In addition, l A
react r licensees must report quantities of radioactive materials released inh y;g 4hY ' IIN~ nV Art .
-+ annually #ose4 d % 4 esulty Issue 12 Lp N[CdNSTRAINTfNRCR[GULATIO The Commission requested specific comment on the question of whether the 10mremconstraintshouldbeestablishedin10CFRPart2pasproposedgr whether it should be established separately'in each appropriate [ art of Title i 10 instead.
- Comments: Two comments were received in response to this issue. One '#* ^ N
. stated that the constraint'should be'in a 20.
Theothdhate$thatthe Lconstraint should be in each-appropriate part. Two other commenters stated i
I
4 OL that the constraint should be in i 20.1301 with dose limits.
Response: In order to make clear that the constraint is intended to control dose to members of the public butthatitisnot(he ame as a limit,
\Q(fA HTML it will be codified in a separate Subpart E to Part'2 " Dose nstraints for mbers of the iblic."
%w g .
Summary of Chanaes in the Final Rule Based on the response to comments, a few cha_ es were made in the final 6 0<
rule. Otherwise, the final rule rovisions e same as those presented in
. the "hrten, nund" welic,r, onder th: d rectie W tteg proposed amendments.
Specific changes made to tb prepered "Me -in the final rule are summarized as 1
followM gr '
(1) Tha-reqthement-in 0.2203(b)(2) has been changed to eliminate therequirementtoreportthename,socialsecuritynumber,anddateofbjrth i ( H ffd for each individual er+er a# the pt:tMgexposed to dosesgin-e ress-c
- limits or constraints.
(2) Paragraph 20.1101(d)(2) has been added to indicate that the effective date of the rule imposing the constraint is to coincide with EPA's rescission of 40 CFR 61, Subpart I.
(3) The language of the rule has been changed to indicate that Rn-222 and all daughters produced after the release of the radon are categorically
- excluded from this rule.
l /
Final Constr t Rule 28 May/10 996
(4) The language of the rule has been changed to indicate that the constraint applies only to environmental air emissions and thus dose to the nearest resident is to be constrained.
In addition, the following changes will be made to the regulatory guide:
(1)- An inventory of radioactive materials used to model a potential dose 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 patient (0 be considered if the materials have already been included in the site inventory.
1 (3) The example has been changed to demonstrate compliance with an environmental release constraint by calculating a dose to the nearest resident If '
from a routine release point. l h
Finding of No Significant Environmental Impact t j 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 ;
i i to have any significant environmental impact because the pro rams 4-. !
0 69 provide equivalent protection; 3 ntYtal A
W d pad;W W 9t @ d{
aifa emissionsAare not expected to l
% H6L NNDNL 4K ht %L
. <hage. The change %b(dehe, procedural methods for demonstrating compliance s wet '
j FinalConstrajn Rule 29 Ma 0, 1996
/
~
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.
Paperwork Reduction Act Statement d
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 bsjlenrc. gov; and to the Desk Officer, Office of Information and Regulatory Affairs, NE08-10202, (3150-1-
0014), Office of Management and Budget Washington, DC 20503.
_ f /
Final Constr 30 May 1996 lntRule
, \
&: I l
Public Protection Notification
'The NRC may not conduct or sponsor, and a' person is not required to' respond to, a collection of information unless it displays a currently valid OMB control number.
Regulatory Analysis The NRC has prepared a regulatory analysis for this final rule. The
' analysis qualitatively examines the costs and benefits of the alternatives considered by the NRC. In the response to comments, the NRC concluded that
- only some minor changes to the draft regulatory analysis were necessary, corresponding to some minor procedural changes in the final rule. The regulatory analysis is available for inspection in the NRC Public Document Room,_2120 L Street, NW. (Lower level), Washington, DC 20555-0001. Single copies of the analysis inay be obtained from Charleen T. Raddatz, Office of
-Nuclear Regulatory Research, U.S' Nuclear Regulatory Commission, Washington, DC 20555-0001, telephone (301) 415-6215.
Regulatory Flexibility Certification In accordance with the Regulatory Fluxibility Act of 1980, (5 U.S.C.
- 605(b)), the Commission certifies that this rule, if adopted, will not have a
- significant economic impact on a substantial number of small entities. This
-final rule only impacts NRC licensees with emissions of significant quantities
/' /
.j -
~ Final Constraint 1tule 31- May , 1996._ l 7
4
in"/.
pp/14/l g),
p/w A Nf '
l
. </ l of radioactive material. This category of licensee includes only a few small l auf n ,H xe/we /irearm 6om f)e N/w < r owV } vN'r 1 businessesf y y , , , , ,,, , g g( g,, ,1 4 4 &ys; , J.n Juks
~
Jeen e // J</u Small Business Regulatory Enforcement Fairness Act the #/c 4c- c l t, mil an./ 1 aud de In accordance with the Small Business Regulatory Enforcement Fairness j j Act of 1996, the NRC has determined that this action is not a major rule and C. f, ,
has verified this determination with the Office of Information and Regulatory f,1,"
Affair B.
I 1
Backfit Analysis '
j]Y The NRC has determined that the backfit rule. 10 CFR 50.109, does not apply to this final rule because it does not apply to power reactor licensees, and therefore, that a backfit analysis is not required for this final rule because these amendments do not involve any provisions which would impose backfits as defined in 10 CFR 50.109(a)(1).
List of Subjects In 10 CFR Part 20 Byproduct material, Criminal penalties, licensed material, Nuclear materials, Nuclear power plants and reactors, Occupational safety and health, .
1 Packaging and containers, Radiation protection, Reporting and recordkeeping l requirements, Source material, Special nuclear material, Waste treatment and disposal. l l
l /
Final Constraipt Rule 32 M 0, 1996 l
l ,
I For-the reasons set out in the preamble and under the authority of the l Atomic'. Energy Act of 1954, as ~ amendek the Energy Reorganization Act of 1974, asamendedand5U.S.C.558theNRCisadoptingthefollowingamendmentsto t
PART 20 - STANDARDS FOR PROTECTION AGAINST RADIATION
- 1. The' authority citation for Part 20 continues to read as follows: .
AUTHORITY: Secs. 53, 63, 65, 81, 103, 104, 161, 182,-186, 68 stat. 930,
- 933, 935, 936, 937, 948, 953, 955, as amended, sec. 1701, 106 Stat. 2951, ,
2952, 2953 (42 U.S.C. 2073, 2093, 2095, 2111, 2133, 2134, 2201, 2232, 2236, 2297f); secs. 201, as amended, 202, 206, 88 stat. 1242, as amended, 1244, 1246 (42 U.S.C. 5841, 5842, 5846).
1
- 2. In i 20.1003, the definition of Constraint is added to read as follows:
i 20.1003 Definitions.
Constraint (dose constraint) means a value above which specified licensee actions are required.
- * * *
- l
- 3. . In i 20.110 aragraph (d)-is added to read as follows:
i l
/ / !
l Final Constrgint Rule 33 May 10,y 96
./ ./
l
.. C,, 'AO, h Q { KAh MbM PWIlb86 't d O#U '
4 j 4 T 5 Y
_%) To implement the ALARA requirements of 5 20.1101 (b), and notwithstanding the requirements in 520.1301 ef-this par +, licensees other than those subject to 55 50.34a or 50.36b, shall constrain vironmental air emissions of. radioactive materials 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 10 mrem /yr TEDE from these emis (2[Ifalicenseesubjecttothisrequirementexceedsthisdose M constraint, the licensee shall report the exceedence as provided in 5 20.2203 g i and promptly_take_ appropriate. correct.iye action to ensure against recurrencey e [ This requirement effective on the effective date of the rescission by EPA of 40 CFR 61, Subpart I for NRC licensed facilities other ;
than power reactors. l
- 4. In$2p.2203anewparagraph(a)(2)(vi)isaddedandparagraph)
Adh (b)(1)(iv Arevised (O Mto Cd read 6 as follows:
5_20.2203 Reports of exposures, radiation levels, and concentrations of radioactive material exceedino the constraints or limits.
(a)
(2) i i
(vi) The ALARA constraints for air emissions established under 5 20.1101(c); or
- (b)
(1)
(iv) Corrective steps taken or planned to ensure against a recurrence, including the schedule for achieving conformance with applicable limits, ALARA
/ )
FinalConstrai! Rule /
34 May f l0, 1996
- 3 l *: .
L
.constra'ints, generally applicable environmental standards, and associated 4
license conditions.^;
.(2')Each report filed pursuant to paragraph (a) of th'is section, for doses to occupationally exposed individuals in excess of limits', must include 7
' for each ndivid I' ' I M** V ; 9vY 4 kk. I
' %\( M 7f ul, I}. Q*\l k 20 l$4$ bl ^"" ^^U'0"fh'
- I ,
54I I Ik4 M V"h'AAb h/hdi }A [fh/ ht
. Dated at. Rockville, Maryland, this day of , 1996.
- For the Nuclear Regulatory Commission. .
i John C. Hoyle, Secretary of the Commission. ,
- J P
4 i
f 1
' Final. Const'rai Rule _
35 'May , 1996 i
f&IM Il1 [n d
... /iyCL I Regulatory Analysis for the NRC Constraint Rule on Radionuclide Air Emissions from NRC and Agreement State !
Licensees Other than Nuclear Power Reactors P '
j 1. Statement of Problem ,
i Radionuclide air emissions from Nuclear Regulatory Commission (NRC) licenseesotherthanpowerreactorsQndNRCAgreementStatelicenseesare /
currently regulated by both the NRC (or[ Agreement State) and the Environmental
' Protection Agency (EPA). The NRC and Agreement State regulations have been issued under the authority of the Atomic Energy Act (AEA). The EPA regulations have been issued under the authority of the Clean Air Act (CAA).
The purpose of this Regulatory Analysis is to evaluate a final NRC rulemaking that provides assurance to the EPA that future emissions from NRC licensees will not exceed levels that would provide an ample margin of safety. This action is expected to be the final step in providing EPA with a basis upon which to rescind 40 CFR Part 61 " National Emission Standards for Hazardous Air Pollutants" (NESHAPS), Subpart I, as it applies to NRC licensed facilities other than power reactors,* thereby relieving these NRC licensees from unnecessary dual regulations.
The EPA's regulations, 40 CFR Part 61, Subpart I, are currently in effect for all NRC and Agreement State licensees, except power reactors. The dose standard contained within this regulation is not consistent with those of NRC in 10 CFR Part 20. The EPA dose standard in Subpart I is 10 mrem per l
1 ' EPA has rescinded Subpart I for power reactors based on requirements . !
contained in 10 CFR Part-50, Appendix I, and a history of over 20 years of
-reported air emissions from power reactors resulting in doses well below
'l0 mrem /yr to the maximally exposed member of the public.
- = -. --.- .. . - . . -
L{ \ [ h!. V k
year, total effective dose equivalent (TEDE) for air emissions from any single facility (buildings, structures, and operations on one contiguous site). This standard is different in both numerical value and approach to that of the NRC.
The EPA approach to ensuring that dose limits adequately protect the public with an ample margin of safety is to limit individual pathways and sources to a fraction of the 100 mrem /yr TEDE limit for members of the public.
.The NRC approach to ensuring that doses to members of the public are adequately protective is to require compliance with an upper limit of 100 mrem per year TEDE from all pathways, and to the extent practical, maintain doses y
as far below this limit as isjreasonably achievable (ALARA), taking into account social and economic considerations and sound radiation protection l
principles.
)
. There are three mechanisms for demonstrating compliance with the NRC 100 I mrem /yr TEDE limit and ALARA. For light water reactors, compliance is demonstratedifthedesignobjectivesinAppendix3 m
10 CFR Part 50, are achieved. For other NRC and Agreement State licensees, compliance with the [
dose limit and the ALARA requirement is demonstrated in one of two ways @ W dnt i emonstrate that the average concentrations in air and liquids released from the facility do not exceed values inhndi 10 CFR Part 20 andareALARA,and$directexposuresdonotexceed50 mrem /yr,andare ALARA; or 41hmonstratethatthedosetothememberofthepublic !
.s a likely to receive the highest dose from all pathways is less than 100 mrem /yr TEDE and is ALARA.
The NRC believes that for its licensees the application of ALARA goals :
and guidelines has been successful in maintaining actual air emissions to levels that are well below the EPA standard. Past experience and effluent information reported to the NRC staff have indicated that ALARA dose goals in
. -/p7g ,
J t
the range of 10 mrem per year or less should be achievable for all materials licensees, including fuel cycle facility licensees. Studies conducted by EPA (Ref.1) concluded that NRC and Agreement State licensees are, in general, maintaining air emissions and resulting doses to members of the public well below the 10 mrem standard. This conclusion has been confirmed by a review of the annual reports submitted by licensees to EPA as required by Subpart I. / -
4 Ib11993,onlyonelicenseereportedairemissionsabovethe10mremperyear
$WMC standard orrective measures were initiated by the licensee and no /
enforcement actions were taken by EPA.
This rulemaking establishes a 10 mrem per year TEDE dose constraint on AMiuk 4 it radionuclide air emissions. JMtAnot considered a health and safety issue
[
such that adequate protection {thq nnbl4<- M th. gj 3&fe Would not be assured otherwise, this regulatory action ensures that air emissions are maintained at a very low-level, at little or no incremental cost (and considering the elimination of dual regulation, a net savings), and bring {
%yconistency{lbetween W[h d EPA's dose standard and the NRC's ALARA g* application i
-tu providJng EPA with a basis upon which to rescind Subpart I as it applies to NRC licensed facilities other than power reactors.
1.1 Backaround on EPA's Implementation of Radionuclide NESHAPs for NRC Licensed Facilitie; The 1977 amendments to the CAA required EPA to consider whether radionuclides should be identified as a hazardous air pollutant and, if so, to adopt standard's to limit their emissions. Section 122(c)(2) of this 1977 amendment also required EPA and NRC to enter into a cooperative agreement to minimize duplication of effort and conserve resources in establishing,
implementing, and enforcing standards for airborne radionuclide emissions from sources and facilities licensed by NRC. In 197 EPA subsequently identified /
radionuclides as a hazardous air pollutant (44 FR 76738; December 27, 1979).
In April 1983, EPA proposed standards regulating radionuclide air emissions from four (4) source categories, with one being NRC licensed facilities. In October 1984, EPA withdrew the proposed emission standards for ;
certain sources, including NRC licensed facilities, based on a finding that controls already in-place protected the public with an " ample margin of i safety" (48 FR 15076; April 6, 1983). In July 1987, the U. S. Court of Appeals for the District of Columbia Circuit, remanded to EPA the air emission standard for vinyl chloride because the Court found that EPA had improperly considered cost and technological feasibility in setting the standard without first determining a sufficient level of protection as required by the CAA.
i Later that year, EPA petitioned the Court for a voluntary remand of its existing air emission standard for radionuclides. In March 1989, EPA proposed a revised emission standard of 10 mrem /yr TEDE for NRC and Agreement State licensed facilities. This standard was established based on the concept of an
" ample margin of safety" as directed by the Court in its remand of the vinyl chloride NESHAP.
On December 15,1989 (54 FR 51654), the EPA issued its final rule on the ,
NESHAPs under Section 112 of the CAA for emissions of radionuclides from numerous source categories, with one category including NRC and Agreement State licensees. The rule was issued as 40 CFR Part 61. Subpart I of this rule pertained to NRC and Agreement State licensees. The standard states that air emissions of radionuclides shall not cause any member of the public to receive more than 10 mrem TEDE in any year, or more than 3 mrem TEDE from radiciodines. Radon-222 and its decay products formed after release from the 4
h L ,
facility are excluded. Effective with the issuance, however, was a stay on Subpart I, which delayed the effective date of that part of the rule covering NRC and Agreement State licensees. Subpart I was stayed until March 15, 1990, to allow EPA time to consider concerns raised, in particular, by the NRC and the National Institute of Health (NIH) (as an NRC licensee) about unnecessary duplicative, and perhaps conflicting, standards on NRC licensees.
At the time of issuance of the rule, the EPA reaffirmed a previously stated position that it "... continues to believe existing emissions from these sources [NRC licensees) are already so low that the public health and safety is already protected with an ample margin of safety" (50 FR 5190; February 6, 1985). The NRC had raised concerns about whether regulation of its licensees under the CAA provided any additional public health and safety benefit. The NIH, as an NRC licensee, voiced concerns about the potential negative effects of the dual standards on the use of nuclear medicine. Even recognizing these I concerns, the EPA decided it was legally bound to include Subpart I in its final rule promulgation due to court-ordered deadlines. A 60-day comment period was established for the purpose of receiving further information and comments related to these concerns 3 month stay of Subpart I was effected M
to allow further consideration. /
n /
The 1990 amendments to the CAA included provisions in Section ll2(d)(9) that allow EPA to decline regulating airborne radionuclide emissions from NRC licensed facilities if it determines, through a rulemaking, that NRC's program provides protection of the public health with an " ample margin of safety."
This legislative initiative, referred to as the Simpson Amendment, created the framework for cooperative activities between the agencies, which supported the rescission of Subpart T (and Subpart I for power reactors) of 40 CFR Part 61.
5
a Subpart T covers radon emissions from disposed uranium mill tailings at sites where operations have ceased (59 FR 36280; July 15, 1994).
On April 24, 1991, the EPA issued a final stay until November 15, 1992, for all NRC and Agreement State licensees, except power reactors, which under separate ruling had been stayed indefinitely pending the rulemaking on Subpart I rescission (56 FR 18735; April 24, 1991). During this period of stay, EPA conducted two studies of the air emissions from NRC and Agreement State material licensees for the purpose of evaluating the state of compliance. The first was a survey of 367 randomly selected nuclear material licensees. The highest estimated dose to a member of the public from air emissions was 8 mrem per year TEDE, based on very conservative modeling. In
)
addition, 98 percent of the facilities surveyed had doses of less than 1 mrem per year from air emissions.
The second EPA study evaluated doses from air emissions from 43 additional facilities that were selected because of their potential for air emissions with calculated annual doses to members of the public at a sizable fraction of the 10 mrem dose standard. Of these, 75 percent had estimated maximum dose to a member of the public less than 1 mrem per year. None exceeded the 10 mrem standard. The results of these studies were published by EPA (57 FR 56877; Dec 1, 1992) and, in summary, showed that radionuclide air emissions from the NRC and Agreement State licensees were typically, with the potential for few exceptions, well within the EPA's CAA standard of 10 mrem per year.
EPA's conclusion, based in part on these studies, was that the current NRC program, which limits public dose to 100 mrem per year, in concert with the requirement to keep doses ALARA, has been sv :essful in maintaining air emissions well below the 10 mrem per year Subpart I standard. However,
~
6
a because of EPA's concern regarding the litigative risk of extending stays of p ev ausly promulgated NESHAPs during pendency of a rescission rulemaking nd the g' Circuit has already reversed the previous stay for licensees [/,
other than power reactors, the stay on Subpart I was allowed to expire by its "
own terms on November 15, 1992 (57 FR 56877).
In July 1993, the EPA Administrator determined that there was insufficient basis at that time to rescind Subpart I. Concerns remained about the NRC's Agreement State program and the fact that there was no mechanism to ensure doses from air emissions would remain below 10 mrem per year in the absence of Subpart I. Consequently, licensed facilities other than power reactors are currently subject to dual regulation of air emissions of radionuclides under both the AEA and the CAA, with dual regulatory oversight by EPA (and/or authorized States) and NRC (or Agreement States).
1.2 Past NRC and EPA Efforts to Rescind Subpart I Under the Simpson Amendment Over the past 15 years, the NRC and EPA have worked together on the objective of eliminating the duplicate regulatory oversight. The NRC and EPA entered into a Memorandum of Understanding (M0U) in November 1980 to work together in developing mutually acceptable procedures for implementing and enforcing EPA's standards in accordance with Section 122(c)(2) of the CAA (45 FR 72980; November 3, 1980). The 1980 MOU stated, "Under this agreement EPA shall promulgate standards for airborne radionuclide emissions under its clean Air Act authority and NRC shall have the primary role in implementing and enforcing these standcrds where applicable for sources and facilities licensed by NRC."
7
4
-In-1990, Congress amended the CAA specifically addressing the issue of duplicate 'regul ation. This amendment en' acted Section 112(d)(9) of the Act.
It included provisions whereby standards for radionuclide emissions from NRC
~
(or NRC Agreement State) licensees would not need to be promulgated the ;
EPA Administrator determined, by rule and af ter consultation with the NRC',
that the regulatory programs established by the NRC provide an " ample margin of safety".to protect public health. Under these conditions, radionuclide _
!NESHAPs for NRC and Agreement State licensees would not be required. This l
' provision was enacted'to enable EPA to eliminate duplicate regulation and eliminate redundant efforts between EPA's and NRC's regulatory programs.
4 ,
- In 1992, EPA proposed rescission of Subpart I, and subsequently allowed
! it to become effective, and NRC and EPA issued.an M00 (57 FR 60778;
- December 22,1992). Its intent was to determine NRC actions that could form the basis for EPA to rescind Subpart I. NRC was to put in place additional regulatory guidance to ensure air emissions would be maintained at a level consistent with-the level of protection afforded under EPA's Subpart I, i.e.,
- " ample margin of safety." NRC was to develop and issue regulatory guidance for its licensees, other than power reactors, on designing and implementing a radiation protection program to ensure that doses resulting from effluents would remain ALARA. NRC also agreed to develop inspection guidance on ALARA considerations for effluents and incorporate ALARA in its Standard Review
. Pl ans . NRC was to work with Agreement States to adopt and implement a compatible program. EPA was to develop and publish in the Federal _ Reaister a 4
- Notice'of-Proposed Rulemaking, pursuant to its authority under the CAA, \
Section 112(d)(9), to rescind its existing regulations of 40 CFR Part 61, Subpart I, as applied.to licensed facilities other than power reactors.
8 ,
, . . . . - - . . . . . _ .. _ - e,-- - _ . _
l l
As an implementation of its ALARA guidelines, the NRC developed
'Regul'atory Guide 8.37, which included a specific ALARA goal of 10 mrem per year TEDE to the maximally exposed individual from radionuclide air emissions (Ref 2). Additionally, inspection Procedure (IP) 87102 was developed to include a review of emissions from those facilities with the potential of exceeding 20 percent of the 10 CFR 20, Appendix B, Table 2 values (Ref. 3).
Generally, this 20 percent level corresponds to a calculated dose from air exposure of 10 mrem per year, which is comparable with the EPA's Subpart I standard. An Inspection Referral Form was included within IP 87102, which is to be completed by the NRC inspector and forwarded by NRC Region Management to the cognizant Regional Radiation Program Manager of the EPA.
Under the Simpson Amendment and the 1992 M0V, EPA agreed to propose a rulemaking rescinding its existing regulations in 40 CFR Part 61, Subpart I, l
as applied to licensed facilities other than nuclear power reactors (56 FR ;
18735; April 2 1991). EPA announced its intent to propose rescission of o
V Subpartif57FR4317 ptember 18, 199 .anfhterin1992,EPAissuedthe /
Federal Register notice proposing the rescission FR 5687 (December 14%
499 % However, on November 15, 1992, EPA allowed the stay on Subpart I to /
4 expire for facilities other than power reactors. This action was taken because of substantial doubts that EPA had concerning the legality of any ;
- further stay. A September 22, 1992, DC Court ruling in response to a Natural Resources Defense Council (NRDC) petition found that EPA had exceeded its authority by staying Subpart I for facilities other than power reactors, while it was collecting information to make a finding under Section ll2(d)(9) i (Simpson-Amendment). Following this determination, in July 1993, the EPA )
l Administrator decided there was insufficient regulatory basis to rescind '
Subpart I.
9
p-
'In its January 28,'1994 Feder Register c 5 EPA stated:
At this time, EPA has not taken final administrative action concerning the rule to rescind Subpart I for NRC and Agreement State licensees other than commercial nuclear power reactors which it proposed on December 1, 1992. EPA is recommending that NRC make certain changes in its regulatory program in order to fully support the substantive' finding -
which is required by CAA Section 112(d)(9) before EPA may rescind -
Subpart I for NRC licensees other than commercial nuclear power reactors.
EPA has historically identified two components to this finding: (1) that the facilities licensed by NRC and Agreement States are currently in compliance with the quantitative emission limits in Subpart I (10 mrem per ,
year,TEDE) hand (2)thattheNRCprogrammustbesufficienttoensurethat //
emissions would remain below this level in the future, thereby protecting the public with an ample margin cf safety.
1.3 Issue of Unnecessar_y and Conflictino Dose Standards The issues surrounding the necessity for duplicate regulation relate to EPA's need to demonstrate an " ample margin of safety" as called for in the CAA.
Past studies conducted by the EPA have indicated that, except for unusual cases, all NRC and Agreement State licensees currently subjected to Subpart I meet the Subpart I dose standard. NRC's reviews of licensees' air emissions further support the position that 'the ALARA goals of Regulatory Guide 8.37 are consistently being met. For the calendar year 1993, the first year under 10
which Subpart I reporting was required, EPA received approximately 670 reports from NRC and Agreement State licensed facilities. Of these, approximately 30 reported doses greater than 10 mrem /yr from air emissions. EPA staff told NRC staff that after clarification with several facilities in their use of the COMPLY code, only one licensee had radioactive air emissions in excess of the Subpart I dose standard. This licensee took corrective measures; no enforcement actions were taken by EPA. The 1995 annual reports are currently being submitted to EPA, and the reports reviewed to date have not identified any licensee with air emissions above the Subpart I standard.
The dual regulations by EPA and NRC are considered unnecessary for the following reasons. First, the level of air emissions from NRC licensed facilities has historically been well below the NRC's dose limit. The application of the ALARA principle has resulted in facility programs and emissions that, except for a few unusual cases, readily meet the EPA standard.
These unusual situations are best addressed on a case-by-case basis. Second, with this level of compliance, subjecting facilities to dual reviews.
1 reporting, evaluations, and inspections is unnecessary for protecting the public safety. Compliance can most efficiently be covered by a single regulatory process. The NRC constraint rule provides an ample margin of safety.
EPA's compliance program relies primarily on evaluations and reports prepared by the facility. Licensees emitting radionuclides in amounts that would cause doses less than 10 percent of the Subpart I limits (e.g., < 1 mrem /yr TEDE) are exempt from the reporting requirement but must still monitor effluents and maintain records of dose calculations. Licensees subject to Subpart I annual reporting requirements (e.g., doses > 1 mrem /yr TEDE) are required to submit an annual report by March 31 of each year to EPA on air 11
_ ~ __ _ _ _ . . _ . _ .. _ . _ _ -.
. f l
l i
- i emissions Lfor the previous- calendar year. Licensees with air emissions in A
, excess of the annual limit (e.g., > 10 mrem /yr TEDE) must include in the
~
report proposed corrective neasures to ensure future doses will be below the t
limit.and report on a monthly basis until EPA determines that adequate 4 corrective measures have been taken and reporting is no longer necessary. ;
There are currently about 7,000 NRC licensed facilities and about 15,000 Agreement State licensees. About half of these facilities use radioactive materials in the form of sealed sources (i.e., contained within a metal or other material casing). These licensees are not subject to Subpart I because !
of the negligible potential for any significant air emissions (see :
40 CFR 61.109 j7 applicability). The facilities (other than power reactors) with potential air' emissions for which compliance evaluations are required are ,
those that use materials in unsealed form, predominantly hospitals, clinics, radiopharmacies, research and academic facilities, fuel cycle facilities, and ,
research reactors.
The CAA, as amended, establishes in Section 112(1)(1) the basis upon which States may submit to the EPA Administrator a program for implementing and enforcing emission standards for hazardous air pollutants for stationary sources located in such State. The States are not authorized to set standards less stringent than those promulgated by the EPA. The EPA Administrator has ,
not at this time approved any State for Subpart I implementation. Presently, '
seven States are engaged in a demonstration program with the EPA focusing on the development of State compliance programs needed for implementation of radionuclide NESliAPs, covering NRC licensed facilities, DOE facilities, and other miscellaneous sources covered by 40 CFR Part 61.
I 1
12 am - o , - - w- r w -,, - a
1.4 Agreement States ;
Under'the provisions of Section 274(b) of the Atomic Energy Act (AEA) of ,
1954, as amended, certain States have assumed the responsibility and authority '
for regulating radioactive material (byproduct material, source material, and special' nuclear material in limited quantities) users within such State.
These NRC Agreement States' rules and regulations replace those of NRC.
However, adequacy an; compatibility are assured because the AEA includes a provision that the Commissi~. must find that the State program is compatible ,
.w'i th the Commission's program for regulation of such materials, and that the State program is adcquate to protect the public health and safety with respect to the materials covered by the proposed agreement.
Conf:,rming regulations enacted by Agreement States are essentially identical, in level of protection afforded, to those of the Commission.
Associated guidance and inspection efforts are normally similar. I
- 2. Objectives of Rulemaking The objective of the rulemaking is to provide assurance that future emissions from NRC licensees will not exceed levels that will provide an ample margin of safety. .This action is expected to be the final step in providing EPA with a basisiupon which to rescind 40 CFR Part 6p" National Emission Standards for Hr.zardous Air Pollutants,"[Subpart S , as it applies to NRC
' licensed facilities other than power reactors, thereby relieving these NRC licensees from unnecessary-dual-regulations. To support the determination by EPA that NRC's programs' provide an equivalent level of protection, this 13-
rulemaking codifies a 10 mrem per year dose constraint applicable to NRC licensed facilities, excluding power reactors.
This rulemaking, followed by an EPA rescissicn of Subpart I, will elimi.nate duplicate regulatory oversight of NRC and Agreement State licensees by EPA under the CAA and lessen the burden of regulatory compliance on
' licensees. It will eliminate redundancy in the regulatory processes between NRC and EPA, thereby reducing government's oversight effort. The resulting cost savings will be achieved while maintaining essentially the same margin of public.and environmental safety as that currently afforded under Subpart I.
With the elimination of dual regulations, the burden of implementation and continued demonstration of compliance with duplicate regulations by the users will be reduced. Efforts will be reduced for maintaining compliance and enforcement programs by two separate government agencies for the same emission s source.9 EPA will be able to eliminate its continuing efforts required for
/
maintaining a compliance evaluation program for NRC and Agreement State licensees, including developing and maintaining guidance programs, training of EPA regional staff, transition of authority to States, training of Sta' agencies, reviewing emission reports, reviewing construction and modio .ation applications, andj 3quir nducting enforcement act NRC's programs will require essentially no additional efforts beyond its current inspection and enforcement programs. Agreement States have similar compliance evaluation programs 4f- they-have not aTreaay aang
- 3. Alternativeg n , Alternative 1 - Dual Regulation - NRC and EPA would each retain f 1)
Txisting regulations and compliance programs.
14
- 2) Alternative 2 - EPA Regulations Only - Revise NRC requirements to /
{--- -' eliminate air effluents.
- 3) Alternative 3 - NRC Constraint Rulemaking and EPA Rescission of i part I. Codify constraint dose levels for air emissions from NRC licensed facilities (other than power reactors).
} ,
Each alternative is discussed below.
3.1 Alternative 1 - Dual Regulation 4
There is general agreement between NRC and EPA that with few exceptions, all NRC and Agreement State licensed facilities are maintaining air emissions well below the 40 CFR Part 61, Subpart I, dose standard.of 10 mrem per year.' However, EPA determined that NRC's regulatory framework did not fully support the substantive finding which is required by CAA Section 112(d)(9) before EPA may rescind Subpart I for NRC licensees other than power reactors (59FR4228Ibanuary 28,1994).
Under this approach, NRC and EPA would each continue its existing regulatory requirements and compliance programs without substantive changes to reduce any burden of dual regulatory oversight. The NRC's inspection program would continue to provide on site inspections and reviews of ALARA goals, which, in effect, would afford a basis for evaluating compliance with the dose standards of Subpart I. NRC would continue to provide letter summaries to EPA on licensee compliance. However, NRC would. not be involved from a legal 2 Refer to the Federal Register Notice (54 FR 51654) promulgating Subpart I and. EPA's subsequent study of radionuclide air emissions for NRC licensed
- facilities (Ref. 1).
15 !
1 i
.compliancestandpointfifafacilityexceededthe' standard less NRC
~s tandards were also exceeded. EPA would retain its regulatory authority for. !
I enforcement actions.
EPA would continue its compliance programs, including developing and l 1
maintaining guidance programs, training of EPA regional staff, transition of authority to States,-training of State agencies, reviewing emission reports, reviewing construction and modification applications, and as required, conducting enforcement actions. Many States can be expected to develop corresponding regulatory requirements with licensing (fee) and inspection programs under the authority of Section 112(1)(1) of the CAA.
The availability of citizen suits under the CAA would remain if [
Subpart I is not rescinded fEPAdoesultimatelyrescing,?*N$
Sb the
/
public petition process for hRC enforcement action against a licensee under 10 CFR 2.206 would offset the unavailability of the CAA citizen suit .
provision owever, judicial review of G.E 206 petition denials is not readily available. EPA has stated that NRC's current regulatory framework did not provide a sufficient legal and technical basis for rescinding Subpart I (59 FR 4228; January 28,1994). n t supporting a timely rescission of Subpart I, maintaining dual regulation would allow time for EPA to gain additional experience with the implementation of the Subpart I standard on NRC and Agreement State licensees. is experience could Ove" a perkd M + b[ut provide the necessary information to support a decision by EPA to rescind Subpart I..
16 i
3.2 Alternative 2 - EPA Regulation Only Under this alternative, NRC would make a finding that the EPA regulatory framework adequately protects members of the public from air effluents of NRC licensees. Inspection Procedure IP-87102, Regulatory Guide 8.3 and the M00 with EPA on inspection referrals would be withdrawn. Section 20.1302 would be revised to indicate that compliance with Subpart I is sufficient to demonstrate that dose from air efflu nts does not exceed 10 mrem /yr. :
on II Uf '.
' Appendix B, Table 2, Column 1 A Part 20 would be deleted.
kD MIMi . Q, As in Alternative 1, EPA would continue its compliance programs a K j l
-citizen suits under the CAA would remain.
3.3 Alternative 3 - Constraint Rulemakinq ;
l This alternative addresses NRC's development of a regulatory constraint ;
within 10 CFR Part 20 on allowable air emissions from NRC licensed facilities, ,
1 excluding power reactors. The regulation would constrain air emissions to a
~1evel corresponding to a calculated dose of 10 mrem per year to the maximally exposed member of the public. This approach would add numerical criteria for material and fuel cycle facilities and test and research reactors, similar to 4
that already in place for nuclear power reactors (i.e.,il 50.34a, 50.36a, and Appendix I to Part 50). It would not be a regulatory limit. A licensee exceeding a limit would be in violation of NRC regulations and sut, ject to enforcement. A licensee exceeding a constraint would be required to abmit a report and recommend and implement appropriate corrective actions. ilure to report exceedence of the constraint or failure to implement agreed >upon corrective actions would be a violation of NRC regulations subject to 17
6 enforcement actions. Licensees exceeding the constraint level would be required to submit a report to the NRC identifying the situation and 4ht t,/j appropriatemeasuresforreducingemissionstobelowtheconstraint.fEPA ,
staff has indicated in meetings wit RC staff that this approach would provide a sufficient legal and regulatory framework upon which EPA could rescind its regulation of Subpart I.
In accordance with Section ll2(d)(9) of the CAA, for EPA to rescind Subpart I, a finding must be made that there is no decrease in the level of protection afforded the public. Therefore, the NRC rulemaking evaluated under this approach would be to impose a dose constraint that would provide compatibility with EPA's dose standard of Subpart I. An ALARA dose constraint of 10 mrem per year TEDE to members of the public from air emissions of radionuclides would provide consistency. These requirements, codified within /
NRC's regulations, would provide a sufficient regulatory frameworkM support ( ngby that NRC's regulations provide "an ample margin of safety."
l
- 4. Consequencesp l This Regulatory Analysis does not address a serious health and safety ;
1 issue. Instead, the basis for evaluating consequences is eliminating regulations that are considered duplicate and unnecessary. The consequences ;
are evaluated against a baseline comparison. I 18
. . . . . . .-- - . - . . . _- . - . - - ~ .
o
.4.1 Dual Regulation i
Dual regulation would not support a timely elimination of duplicate EPA
, and NRC regulation. It would not reduce the current level of effort for the 1
EPA in its compliance programs. NRC's inspection and referral efforts would ~
l also be expected to be maintained to meet its regulatory responsibilities under the AEA and to fulfill the 1992 MOU with EPA. NRC and Agreement State licensees would continue to be subjected to dual regulation.
NRC_and Agreement State licensees would have different regulatory
' requirementsaddressingairemissionswithintwodifferenttitlesktheCode of Federal Regulation)(i.e., Title 10 for the NRC and e 40'for EPA). In U )
addition, as individual States establish tgEP 40 CFR Part 61 compatible !
programshicenseek would be subjected to anothe potentially different e complJanceprog ensee would havejt wo regulatory groups within a /
Stat ith g to inter elative to compliance,-including on-site inspections, methods for demonstrating compliance, licensing reviews (for NRC 4
programs), facility modification reviews (EPA), and recordkeeping and reporting. Some Agreement State representatives have stated that qualified radiation protection personnel may move from the radiation protection program
. to the environmental program to administer Subpart I. This might result in personnel shortages in some States. Maintairing enough qualified radiation protection personnel has consistently been a problem for many State programs.
' Increased efforts are associated with duplicate requirements, duplicate i implementationprogramsgndduplicateregulatoryinspections.
Maintaining dual regulation would not require a rulemaking. NRC's 4
current regulatory programs would continue to support the established radiation protection framework. in'10 CFR Part 20, including the dose limit of 19
100 mrem per year and the principle of ALARA. EPA's compliance programs would continue, including the selected inspections, evaluations of licensee .
submitted annual reports, and continued support to individual State program
/h6 OW[
development. hEPA staff hedndicated that igexpecf individual State e6cnd /
involvement would increase as individual compliance programs are p N p uce.
Basedonthe1992WRefEP(MOV,NRChasprovidedassistancethroughits inspection program to EPA for its Subpart I implementation. As an implementation of its ALARA guidelines and based in part on this MOU, the NRC revised its Inspection Procedure 87102 to include a review of emissions from those facilities with the potential of exceeding 20 percent of the 10 CFR Part 20, Appendix B, Table 2 values (Ref. 3). The procedure requires that an Inspection Referral form be completed by the NRC inspector and forwarded by NRC regional management to the cognizant EPA Regional Radiation Program Manager. !
,- - ~ ~ ~ '
Based on EPA labor-rat ~es, the cost of Subpart I to licensees is $517'per N i licenseeoroveI$ million per year for all licensees. EPA estimated the \ l
/ \
burden'to NRC and Agreement State licensees assumffig ha 6000 licensees would 7
D'/eaffectedanduslg3separatehour)yras or rofe sional ($27/hr),
managerial ($38/hr and<ctwical JO/hrtpersonnel.
Theburdenestm$tedin P / ffB clearance assumes that 200 licensees will file reports annu' ly-dd that-4t ywill require 11 staff hours to review
's
.ach report. The EP/gestimated vernment burden for Subpart I is 2200 hours0.0255 days <br />0.611 hours <br />0.00364 weeks <br />8.371e-4 months <br /> or' 44,600. For calendar year 1993, 670 licensees filed reports.
/
SincP t9Bb J Q evoted about 15 FT p bp3rt I issue. This efforthasconsistedofynterfacewithEPAinsupportofrescission,
/
ARA For Effluents For Materials development of Regulatory Guide 8 5 Facilities"), development of inspection guidance, inspection efforts, referral 20
of inspection results to EPA, and development of the[onstraint[ule. Under this alternative, it is expected that EPA's burden would remain at about 3 FTE annually, with periods of increased effort when facilities experience increased air emissions at or above the standard. NRC and Agreement State licensees' efforts can be expected to remain at about 138,000 hours0 days <br />0 hours <br />0 weeks <br />0 months <br /> annually _
(23 hours2.662037e-4 days <br />0.00639 hours <br />3.80291e-5 weeks <br />8.7515e-6 months <br /> / licensee), provided facility design and/or operations do not significantly change. Licensees would continue to have to demonstrate compliance with dual regulatory requirements.
The burden of Alternative - 1 is summarized in the following table:
1 Cost NRC and Agreement State Licensees $3,100,000 EPA 44,600 NRC (0.5 FTE for inspection and referrals to EPA) 50,000 TOTAL $3,194,600 4.2 Eliminate NRC Regulation of Air Emissions Elimination of NRC regulation of air emissions would eliminate dual regulation. NRC's burden would be reduced as inspection of licensee records would no longer be performed. Agreement States radiation program concerns relative to the loss of qualified radiation protection personnel to State environmental programs would not be resolved. However, States would not have to enforce duplicative regulations in each of these programs.
Elimination of NRC regulations of air emissions would require rulemaking to revise i 20.1302. This revision would be necessary to make clear that NRC inspection and enforcement of compliance with public dose limits would not 21
I h
a b
include air emissions unless the dose from direct exposure and liquid-
~
effluents- exceeded 90 mrem /yr TEDE. It is expected that this rulemaking would take approximately 1 FTE over a 2-year period. Similar revisions to Agreement
+
State regulations would be needed. Because of the simplicity of this i
~ hl / [
rulemaking, it is estimated that each o 29 Agreement States would expend about 0.1 FTE revising their rules.
The burden on licensees and on EPA would be the same as under the dual ,
regulation alternative. The annual burden to NRC would be slightly reduced as routine inspection of doses to members of the public would include only direct exposures and liquid effluents. a effluents are a very small portion of l doses to members of the public for most facilities, this burden reduction is f expected to be very small.
The burden associated with Alternative - 2 is summarized in the tables j below:
Annual Burdens . Cost
. NRC and Agreement State Licensees $3,100,000 EPA 44,600
- i. NRC (reduced inspection burden 0.25 FTE) -25,000 _
TOTAL $3,119,600 l l One T_ime. Expenditures FTE. Costs !
i ;
- NRC Rulemaking 1.0 $100k i
] NRC Inspection Procedures and Inspector Training 0.5 50k Agreement. State Regulations Revision 2.9 290k TOTALS 4.4 .$440k 22 9 e -- -, - - c. , , .
E . 1 p~ 4 .
-Alternative 3 - Constraint Rule d
- A constraint level would be enforced by NRC through its current
~
licensing and-in'pection s and enforcement programs. The current IP 87102-(Ref 3) would require minor modification in wording for consistency with the j; rule :he Referral Form and letter to EPA would no longer be needed._ -NRC; 4
~ regulatory guidance would be revised to-specifically address the constraint.
' rule. Acceptable methods for demonstrating compliance and reporting .
J guidelines would need to be added. For licensees, an overall simplification.
L in compliance assessment methods would be expected due to the streamlining of methods needed for both Subpart I compliance and 10 CFR Part 20 compliance. j l
The main savings would be for facilities that maintain effluents at a small fraction of the standard, i.e., those facilities for whom additional .
evaluations. reports and overall dual regulatory oversight are not required i: . for' ensuring public safety with an ample margin of safety. Annual reporting
.would not be required provided air emissions were maintained below the NRC's constraint level. NRC's routine inspection program would provide the necessary regulatory oversight.
Licenseeswhoexceedadeconstraintlevelwouldberequiredtosubmit a report to NRC and:to develop and implement corrective measures in keeping with"ALARA,- to reduce air emissions to within the constraint level.
Enforcement. actions would only be taken for.those facilities that fail to perform thel required evaluations and/or those facilities that fail to take -
Jappropriate'measuresinkeepingwithALARAQorreducingairemissions.
lBecause doses from air effluents are currently being ' calculated using-
- Appendix B to 10 CFR Part 20 to demonstrate compliance with the public dose R
[ limits,lnot additional _ effort would be expended to demonstrate compliance with 23 i
2 -w-- . _ . . _ + . . ' _ _--_ _ - _ _ _ _ -_ _ _ _l-
the constraint rule if the dose did not exceed it. Very few licensees (if any) would have doses to members of the public in excess of the 10 mrem /y constraint, and therefore be required to make a report to NRC or an Agreement State. It is assumed that an average of three reports per year will be received. The total licensee burden is estimated to be $12,000 annually (3 reports /yr x 80 licensee-hours / report x $50/hr - $12k/yr).
The burden of reviewing the air effluent control programs of licensees reporting doses to members of the public in excess of the constraint is estimated to be $24,000 annually (3 reports /yr x 160 NRC staff-hours / report' x$50/NRCstaff-hr-$24k/yrg The constraint rule is not considered a necessary public health and
/
safety measure because adequate protection has been maintained. Therefore, efforts associated with the rulemaking would be limited to mainly administrdive efforts for the preparation of appropriate legal notices and issuance. The basis for the rulemaking would be the elimination of unnecessary duplicate regulatory oversight. Public hearings, additional technical reviews, etc. would not be anticipated.
Under Alternative 3, NRC and the Agreement States would incur one time costs for completion of the rulemaking, development of regulatory guidance, modification of the NRC inspection procedure and training of NRC inspection
< personnel.
' A EPA will also incur one time costs for the rescission of f Subpart I.
The constraint rule would be categorized as one of Division 11 compatibility under the current NRC Policy Statement governing the Agreement 3 This estimate is based on NMSS assumption that 160 hours0.00185 days <br />0.0444 hours <br />2.645503e-4 weeks <br />6.088e-5 months <br /> would be expended per report. This cost includes a reactive special inspection, recalculation of dose, and modification of the facility license to incorporate approved corrective actions as 'scense conditions, with headquarters concurrence.
24
1 i
( l 1
State Program (January 23, 1981; 46 FR 7540, July 16, 1981; 46 FR 36969, July 21,.1983; 48 FR 33376).' As such, Agreement States may choose to adopt a rule that is more restrictive but no less restrictive than the one approved by the Commission. Agreement States would have three years to adopt the compatible or.more stringent regulations. The Agreement States are expected to adopt similar compliance programs guidance (i.e., regulatory guidance and inspection procedures). Therefore, the potentially significant impact would be that associated with a rulemaking. For cost comparisons, it is assumed that the 29 NRC Agreement States would each adopt a rule and compliance I
program similar to that of the NRC's.
Currently, Agreement States have programs in place that implement and enforce the 10 CFR Part 20 dose limits and ALARA guidelines. Therefore, based on NRC's precedence in establishing the regulai.ory framework for a constraint j rule, it can be assumed that additional efforts on the part of Agreement !
States for development of compliance programs would be no more than 0.25 FTE I per State or approximately $725,000 (29 States x 0.25 FTE/ State x 2000 j hours /FTE x $50/hr = $725,000). NRC would continue its evaluation of Agreement State programs for adequacy and compatibility.
i 4 The NRC is in the process of revising its compatibility policy and has i issued a proposed policy for public comment (59 FR 37269; July 21, 1994).
Although, the compatibility policy.has not yet been finalized, the NRC anticipates that -a similar level of Agreement State compatibility will be required-for air emissions under the new Policy as is required under a Division level 2 designation.
25 l
i Costs for Alternative 3 are summarized below:
4 Annual Expenditures FTE Costs NRC and Agreement State Licensees 0.12 $12k I -
NRC and Agreement State Governments 0.24 24k TOTALS 0.36 $36k One Time Expenditures. FTE costs NRC.Rulemaking 0.5 $50k NRC Inspection Procedures and Inspector Training 0.5 50k NRC Regulatory Guidance Development 0.5 50k Agreement State Regulations Development 7.25 725k EPA Subpart I Rescission Rulemaking 0.5 50k l
TOTALS 9.25 $925k i 1
'I
- 5. Decision Rationale 6
For the alternatives analyzed, the level _of protection afforded the public health and safety is essentially the same. For each alternative, i acceptable levels for radionuclide air emissions are based on a dose of 10 mrem per year TEDE to the maximally exposed member of the public. Under Alternatives 1 (dual regulation) and 2 (elic.inate NRC regulation of air emissions), the EPA Subpart I dose standard would remain in effect. Under 26
h i
Alternative 3 (constraint rule), NRC would enact a rule imposing a corstraint dose of 10 mrem per year and EPA would rescind Subpart I.
/heNRCbelieve h amending the CAA in 1990 to specifically 3
address the issue of duplicate regulation,), Congress intended that dual V
regulatory oversight by EPA and NRC be eliminated if it could be done effectively. Alternative 1 (dual regulation) makes no significant effort to support a finding required by the CAA, Section 112(d)(9) for the dual regulation to be rescinded. Alternatives 2 and 3 are intended to be j l responsive to the ongressional mandate to reduce duplicative regulations.
Alternative 2 achieves this goal by discontinuing NRC inspection and i
enforcement of dose to members of the public from air emissions. Alternative 3 achieves this goal by providing assurance that the NRC regulatory framework will provide an ample margin of safety. This/lternativewillsupportanEPA l finding to that effect, and thereby, support a subsequent rescission of Subpart I. This decision can only be made by the EPA Administrator. Based on discussions with the EPA staff, the framework of Alternative 3 represents the u
EPAfpreferredapproach.
/
EPA has historically identified two componenc of the finding of sufficiency. First, NRC and Agreement State licensees must be in compliance with the quantitative emission limits of Subpart I (i.e., 10 mrem per year, TEDE). Overall, this condition has been demonstrated by studies conducted by EPA (Ref. 1) and by the recent reports submitted for Subpart I compliance to EPA by licensees. The second component of a finding is that the NRC's and Agreement States' compliance programs provide sufficient continued assurance that emissions would remain below the Subpart I standard, thereby protecting the public and environment with an "ampic margin of safety." Of the alternatives, only Alternative 3 would be effective in achieving this second 27
Q l
r .
component. Alternative 1 has been determined by the EPA not to provide the regulatory framework necessary to make this finding.
For Alternative 3, that of imposing controls by regulation, the relatively straightforward rule contemplated has been estimated to require 2-person-year of Federal Government effort (including development of the rule, regulatory guidance, inspection guidance, inspector training and EPA rescission of Subpart I). Assuming all-twenty-nine Agreement States would process parallel rules, this effort has been estimated to require an additional 7.25 staff-years (0.25' staff-year per State). This lower level of effort for rulemaking by an Agreement State has been assumed considering the precedent established by NRC's rulemaking. j 1
l l
The total cost of each option is summarized in the table below:
Option One Time Annual-. Costs-Costs 1 - No Action / Dual Regulation $3,194,600 2 - Eliminate NRC Regulation of Air Emissions $445,000 $3,119,600 4 3 - Constraint Rule and Rescission of Subpart I $925,000 $36,000 Based on the above discussion, it is determined that Alternative 3 ;
represents the preferred approach. Although Alternative 1 would be acceptable from a public health and safety perspective, it would not eliminate dual regulation. Alternative 2 would also be acceptable from a public health and y b M kit safety perspective but would be far more burdensome to licensees A it would not support a rescission by EPA of Subpart I.
28
.O 6.- Implementation f
No impediments to implementation of the recommended alternative have been identified. The documents necessary to support a proposed.rulemaking ,
have been developed. The level of effort required for completing the rulemaking has' been estimated at 0.5 staff-years, over a 6-month time period.
Th s ff will prepare regulatory guidance that will further clarify the / '
applicability of the rule and vide guidance on acceptable methods for dem strating compliancyand for evaluating and reporting elevated effluents /
6 J d JM the constraint level Aexceeded. For Agreement States, a 3-year period is allowed from time of issuance of the final rule for the States to develop and implement compatible regulations.
l l
l 1
-29
References }
i
- 1. EPA 430-R-92-011, "NESHAPS Rulemaking on Nuclear Regulatory Commission ,
and Agreement State Licensees Other than Nuclear Power Reactors, Background Information Document," U. S. Environmental Protection Agency, November 1992 (available from Government Printing Office).
- 2. Regulatory Guide 8.37, "ALARA Levels for Effluents from Materials Facilitier," U. S. Nuclear Regulatory Commission, July 1993 (available from Government Printing Office).
- 3. Inspection Procedure 87102, " Maintaining Effluents from Materials Facilities as Low as is Reasonably Achievable (ALARA)," NRC Inspection Manual, issued November 10,1994 (available from the NRC Public Document Room).
- 4. ICRP Publication 60, "1990 Recommendations of the International Commission on Radiological Protection," Annals of the ICRP, Volume 21, No.1-3, published for.the International Commission on Radiological ,
Protection by Pergamon Press, 1991.
- 5. ICRP Publication 64, " Protection from Potential Exposure: A Conceptual Framework," Annals of the ICRP, Volume 23, No.1, published for the International Commission on Radiological Protection by Pergamon Press, 1993.
l I
.30
w
.): ,.
hDM-
,w, /%
/ k UNITED STATES o- h [J4 f,-
.; , NUCLEAR REGULATORY COMMISSION e WASHINGTON, D.C. 20086 0001
'g*****[!'
a .
Mr. Robert P. Murphy- L
' General Counsel. 3
. General Accounting.0ffice
' Room 7175
.441 G. St., NW, Washington, DC 20548'
Dear Mr. Murphy:
Pursuant to Subtitle E of the Small Business Regulatory Enforcement Fairness
- Act of 1996, 5 U.S.C. 801, the Nuclear Regulatory Commission (NRC) is submitting;a final rule that will constrain air emissions from NRC licensed p 111censees Athat no member of the public will receive a dose of 10 mrem in a year from jHnt. . emissions. This action is expected to be the final step in //
'gL- : providing a basis under which the Environmental Protection Agency (EPA) can /
/
. rescind.40 CFR 61, Subpart WNational Emission Standards for Radionuclide Emissions from Facilities Ld tensed by the Nuclear Regulatory Commission and /
//
Federal Facilities Not Covered by Subpart H." Rescission of Subpart I will result in a significant reduction in burden to the Federal government and to NRC licensees without any negative health and safety impact.
We have determined that this rule is not a " major rule" as defined in 5 U.S.C.
804(2). We have' confirmed this' determination with the Office of Management / ,
and Budget. / '
Enclosed is a copy of the final rule is being transmitted to the Office of the ' Federal Register for publication. The Regulatory Flexibility Certification is included in the final rule. Also enclosed is a copy of the Regulatory Analysis for this final rule that contains the NRC's cost-benefit determinatior.s. This final rule is scheduled to become effective concurrent with the effective dato of EPA's rescission of 40 CFR 61, Subpart I. A notice e; of its effectiveness will be published in the Federal Register.
Sincerely,
/h ah / /c./jjun1 IM"Ani w -
. W10e if (opw?u/ / b'd g:
Enc 1osuresi ~ Final Rule Regulatory Analysis i
_. . . . . . . - . . . .~-- . . . .-. .. - -- ..._.- . - - .
- p. :) , s.
/*%g p k UNITED STATES j.
g NUCLEAR REGULATORY COMMISSION c, .g WASHINGTON, D.C. 20066 4001
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TheHonorableAlGoref ,/
% President of the/ Senate /~
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Washington, DC 20510 V
Dear Mr. President:
Pursuant to Subtitle E of the Small Business Regulatory Enforcement Fairness Act of ~1996, 5 U.S.C. 801, the Nuclear Regulatory Commission (NRC) is
- submitting a final rule that will constrain air emissions from NRC licensed gg . licenseesAthat no member of the public will receive a dose of 10 mrem in
-a year from Jdth emissions. This action is expected to be the final step in-
$Qk providing a basis'under which the Environmental Protection Agency (EPA) can rescind 40 CFR 61, Subpart Mational Emission Standards for Radionuclide
/ Emissions from Facilities Li ensed by the Nuclear Regulatory Commission and Federal Facilities _Not Covered by Subpart H." Rescission of Subpart I will l resultinasignificantreductioninburdentotheFederalgovernmentandto 7 NRC licensees without any negative health and safety impact.
We have determined that this rule is not a " major rule" as defined in 5 U.S.C.
804(2). We have confirmed this determination with the Office of Management and Budget.
. Enclosed is a copy of the final rule is being transmitted to the Office of the Federal Register for publication. The Regulatory Flexibility
. Certification is included in the final rule. Also enclosed is a copy of the !
Regulatory Analysis for this final rule that contains the NRC's cost-benefit determinations. 'This final rule is scheduled to become effective concurrent with the effective date of EPA's rescission of 40 CFR 61, Subpart I. A notice of its effectiveness will be published in the Federal Reaister.
Sincerely, p /}en,,h A' /2o/Alkg N'E " kn nC oy1e pffk ,{ Com/wkw H I N'W retryoftiie'Cogissijn
Enclosures:
Final Rul'e Regulatory Analysis-i V
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UNITED STATES NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20565 4001
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The Honorable' Newt Gingrich lI" H Speaker,. . ob f/fe M09r-The-Gapitol Washington, DC 20S15^
Dear Mr. Speaker:
Pursuant to Subtitle E of the Small Business Regulatory Enforcement Fairness Act of 1996, 5 U.S.C. 801, the Nuclear Regulatory Commission (NRC) is submitting a final rule that will constrain air emissions frore NRC licensed
.g_ licensees that no member of the public will receive a dose of 10 mrem in a year from emissions. This action is expected to be the final step in providing a basis under which the Environmental Protection Agency (EPA) can g/ rescind 40 CFR 61, Subpart Ix* National Emission Standards for Radionuclide Emissions from Facilities LThensed by the Nuclear Regulatory Commission and l Federal Facilities Not Covered by Subpart H." Rescission of Subpart I will result in a significant reduction in burden to the Federal overnment and to / ;
NRC licensees without any negative health and safety impac .
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We have determined that this rule is not a " major rule" as defined in 5 U.S.C.
804(2). We have confirmed this determination with the Office of Management and Budget.
At Enclosed is a copy of the final rule wMdLis being transmitted to the Office '
of the Federal Register for publication. The Regulatory Flexibility Certification is included in the final rule. Also enclosed is a copy of the Regulatory Analysis for this final rule that contains the NRC's cost-benefit determinations. This final rule is scheduled to become effective concurrent with the effective date of EPA's rescission of 40 CFR 61 Subpart I. A notice of its effectiveness will be published in the Federal Register.
Sincerely, JohnG-Hoyl oQ
. Secretary of
Enclosures:
Final Rule " " # #"' '"'"
Regulatory Analysis OfVse /G,yanoJ AWm :
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Abm 6/27 /9& -
0 /< v Environmental Assessment and Finding of No Significant Impact on Proposed Rule on " Constraint For Dose to Individual Members of the Public" I. THE ACTION The action is a final rule to amend 10 CFR Part 20 to include a constraint for dose to members of the public from air emissions of radioactive materials from NRC licensed facilities other than power reactors. Most of the provisions of this rule were previously inspected against and reported to the Environmental Protection Agency (EPA), under an agreement with EPA. This action will provide assurance to the EPA that future emissions from NRC licensees will not exceed levels that will provide an ample margin of safety.
This action is expected to be the final step in providing EPA with a basis upon which to rescind 40 CFR Part 6p" National Emission Standards for Hazardous Air Pollutants," t s it applies to NRC licensed facilities other than power reactors,2 thereby relieving these NRC licensees from unnecessary dual regulations.
EPA previously proposed rescission of Subpart I for power reactors )
based on requirements contained in 10 CFR 50, Appendix I and a history of over i 20 years of reported air emissions from power reactors resulting in doses well below 10 mrem /yr to the maximally exposed member of the public. It is 1 expected that the rescission of Subprt I for power reactors will be finalized by mid 1995 independent of this rul e s ing.
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II. THE NEED FOR THE RULEMAKING ACTION Subpart I currently limits dose to members of the public from air emissions of radionuclides from all NRC licensees except licensees possessing only sealed sources and uranium mill tailings piles disposed of in accordance with 40 CFR Part 192. Subpart I was promulgated to implement the Clean Air Act (CAA). The standard in Subpart I is that emissions of radionuclides to the ambient air from a facility regulated under this subpart shall not exceed those amounts that would cause any member of the public to receive in any year an effective dose equivalent of 10 mrem /yr.
NRC licensees subject to Subpart I are also subject to NRC dose limits for members of the public contained in 10 CFR Part 20, Subpart D, entitled
" Radiation Dose Limits for Individual Members of the Publicpubpa+0[
Under Subpart 0, licensees shall ensure that doses to members of the public are less than 100 mrem /yr from all pathways (including air emissions) and all sources associated with the licensee's operation. In addition, doses to members of the public must be as low as is reasonably achievable (ALARA).
Based on studies conducted by EPA and licensee reporting of doses to members of the public from air emissions, it is evident that 10 mrem /yr to the maximally exposed member of the public from air emissions is reasonably achievable. Therefore, EPA's Subpart I represents duplicate dose regulation for affected licensees.
The NRC is establishing a constraint for dose to members of the public from air emissions of radionuclides of 10 mrem /yr total effective dose equivalent (TEDE). This action is necessary to provide a sufficient basis 2
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l upon wh',ch EPA can rescind Subpart--.I for NRC licensees other than power- l
, - reactors.-
To ensure that Federal regulations are not excessively burdensome on the regulated community-and most efficiently use government and licensee resources,-NRC and EPA are coordinating rulemakings. The effect of these -
- rulemakings
- is to vest'NRC'with the principal: responsibility for ensuring that
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the health and safety of the public are protected from the potentially harmful i , .
effects of airborne emissions of radionuclides from NRC licensed facilities.
1 p 5III. ALTERNATIVES TO THE RULEMAKING ACTION i
Sce' Asrequiredby,fl02(2)(E)ofNEPA(42USC4322(2)(E)),alternativesto
.- the action have been considered. Three alternatives were considered.
' Alternative 1 - No Action Alternative-1 maintains the status' quo which involves licensees demonstrating compliance with the limits in Part 20 for dose to members of the public, including the ALARA requirement, and with the limits in 40 CFR Part 61 for dose to members of the public from air emissions of radionuclides. EPA
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has determined that it will not rescind Subpart I for NRC licensees other than power reactors without a codified or otherwise enforceable dose value not to
- exceed 10 mrem /yr. The impact of this action would be the continued
- inefficient use of licensee, NRC, EPA, and State resources, less confidence in.
the' NRC program' to protect the health and safety of the public, and disregard ~ j oficongressional requirements to avoid duplicative i'egulation through Linteragencyl cooperation, l 3
Alternative 2 - Rulemaking Under alternative 2, the NRC would amend the current regulations in 10 CFR Part 20 to include a section on constraints for dose to members of the public. A codified or otherwise enforceable dose value is an EPA condition for rescission of Subpart I. The impact of this alternative is that licensees would be subject to only one regulatory program for the control of dose to members of the public and effluent release. Licensees would therefore need only calculate dose to members of the public against a single set of criteria which are risk based and use a common dosimetry. Failure to report a dose in excess of the constraint level or failure to take prompt corrective actions would result in a notice of violation. Licensees and the public will have a better understanding of how the Federal [overnment expects that the health and # V safety of the public and the environment will be protected from activities that could lead to radiation exposure. l Alternative 3 - License Amendments I I
Under alternative 3, the NRC would examine each licen e issued under f
10 CFR Parts 30, 40, 50 excluding power reactors, 60, 7 th se icensed for possession of sealed sources only, to determine if a probability existed that the licensee would have air emissions greater than a specified value (e.g.,
10 percent of the constraint value, or a dose of 1 mrem /yr) and imposing individual conditions on each such licensee to constrain dose to members of the public from air emissions to less than 10 mrem /yr. The impact on licensees from this alternative would be similar to that of alternative 2.
The impact or. NRC would be significant as each of several thousand licenses 4
t would have to be reviewed each year in conjunction with renewal or amendments as well as new applications to ensure that any licensee who might exceed the constraint would be required to report as a condition of the individual >
license.
IV. ENVIRONMENTAL IMPACTS OF THE ACTION The Commission has examined the current regulatory framework for controlling dose to members of the public to ascertain the appropriate regulatory path to take that would continue to assure the level of protection currently afforded under the duplicative regulations while minimizing the burden on licensees and the government. There are no adverse impacts associated with this rule as air emissions would continue to be constrained at ;
the same level as exists today.
i V. FINDING OF NO SIGNIFICANT IMPACT !
The Commission has determined under the National Environmental Policy i
Act of 1969, as amended, and the Commission's regulations in 10 CFR Part 51, j that the amendment to 10 CFR Part 20 will not have a significant impact on the l quality of the human environment and that an environmental impact statement is not required. This determination is based on the foregoing environmental
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assessment performed in accordance with the procedures and criteria in Part 51
" Environmental Protection Regulations for Domestic Licensing and Related Regulatory Function."
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.VI, . PERSONS CONTACTED:
Tim.Backstrom, EPA, OGC Gail Benano, EPA The. draft rule language has been' discussed with the Agreement States. A. ;
. draft of the package was provided. to them on April' 18, 1995.
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, , A Dm itJ h)6 Conum.wk27 4/s9fsc L NRC CONSIDERS REVISINCREVISES REGULATIONS ON RELEASE OF RADIOACTIVE MATERIALS FROM NUCLEAR FACILITIES The Nuclear Regulatory Commission is concidering-amending its regulations that govern release of radioactive materials from NRC-licensed facilities other than nuclear power plants. The changes are expected to eliminate unnecessary dual regulation by both the NRC and the Environmental Protection Agency by providing a basis for EPA to rescind its regulations for NRC non-reactor licensees.
The revisions wouldwill require affected NRC licensees to constrain air emissions of radioactive materials from their l
facilities so that the highest radiation dose an individual '
member of the public would be likely to receive as a result of those emissions is 10 millirems per year. This proposal is part of NRC's program to maintain radiation doses from licensed l
facilities to levels that are as low as is reasonably achievable.-
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gs - It is conciatent with rccc=cadationc of the International sommbecica on Radiological Prctcetion.
NRC euerently--requires its licensees to ensure that the dose to an individual member of the public does not exceed 100
- millirems per year from all pathways (including air emissions).)
The?commiss_i'on beli des %hatRth ss @u dshE5fegulationslppoVida adeqhste protecti~on[ofithejysbl' ins: health 7hn;dfs;afetpj The Gemmiccion belicvec that these current--regulatienc provide adequatwretection -of-t-hc public health and cafety, but- the 1
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l propcccd revisions wouldThi'ssrevisiohikill ensure that air i
emissions are maintained at a very low level for little or no extra cost (and, consideringtheeldminationofdualregulation, probably at a net savings).
Under the NRC's propcccd revised regulations, if the 10-millirem per year constraint level is exceeded, the licensee j wouldWill! have to report to the NRC, take prompt and appropriate
' corrective action to. avoid recurrence and provide a schedule for lowering'the dose below the 10-millirem constraint level.
Exceeding the 10-millirem " constraint level" wouldfs not be-a violation of.the regulations (but failing to report a dose in excess of the constraint level or failing to take appropriate l
steps to ensure against recurrence would Scis a violation). In j contrast, exceeding the 100-millirem "limita does constitute a violation of NRC regulations--under both current and proposed rules.
The 1977 amendments to the Clean Air Act required EPA to consider whether radioactive materials should be identified as a hazardous air pollutant and, if so, to adopt standards to limit their emissions. EPA decided that radioactive materials are a hazardous pollutant and issued standards for their emission in
. air on October 31, 1989. Later that year, Congress enacted l amendments'to the Clean Air Act that said (in the Simpson amendment) that EPA need not issue standards for emissions of radioactive material from' facilities licensed by the NRC if the j EPA Administrator determines that the regulatory program 2
- e established by the NRC provides "an ample margin of safety to protect the public health."
EPA stayed the effectiveness of its regulations for a while, but its regulations are now in effect for non-reactor licensees, 1
which means that NRC-licensed facilities are currently subject to i
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dual regulation of air emissions by both the NRC and EPA. (For l l
1 nuclear power plants, the effectivencoc of EPA'c regulationc is ebi-1-1-etayed and= EPA has prepoccd- to rcccindyd56isn}5d them, based on NRC regulations currentlyalyshdpl in place for power reactors and a history of more than 20 years of reported air emissions i
l well below 10 millirems per year for these plants.) The EPA i regulations state that emissione of radioactive materials to air from NRC-licensed facilities must not exceed amounts that would cause any member of the public to receive a radiation dose of 10 millirems per year.
EPA conducted two studies of air emissions from NRC non-reactor licensees. For the more than 500 licensees evaluated, none exceeded 10 millirems per year. On the basis of these studies, it is evident that constraining air emissions of radioactive material to 10 millirems for the maximally exposed member of the public is reasonably achievable.
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UNITED STATES 34: '- ) M E
,E NUCLEAR REGULATORY COMMISSION / /
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The Honorable Lauch Faircloth, Chairman Subcommittee on Clean Air, Wetlands, Private Property and Nuclear Safety .-
Committee on Environment and Public Works United States Senate Washington, DC 20510
Dear Mr. Chairman:
Enclosed for the information of the Subcommittee is a copy of a notice of final rulemaking to be published in the Federal Register. This final rulemaking amends NRC regulations to constrain dose to members of the public from air emissions of radioactive materials from NRC licensed facilities other than power reactors.
This action is expected to be the final step in providing EPA with a basis upon which t V cind 4 CTR 67 National Emission Standards for Hazardous Air Pollutants," ubpar s it applies to NRC licensed facilities other than power reactors, timre relieving these NRC licensees from unnecessary dual regulations. EPA has already rescinded Subpart I for power reactors based on requirements contained in 10 CFR Part 50, Appendix I, and a history of over 20 years of reported air emissions from power reactors resulting in doses well below 10 mrem /yr to the maximally exposed member of the public. This action will provide assurance to the EPA that future emissions from NRC licensees will not exceed levels that provide an ample margin of safety.
Sincerely, Dennis K. Rathbun, Director Office of Congressional Affairs
Enclosure:
Federal Register Notice cc: Senator Bob Graham k
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f j NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 2000&O001 n% /
The Honorable Dan Schaefer, Chairman Subcommittee on Energy and Power Committee on Commerce .
United States House of Representatives Washington, DC 20515
Dear Mr. Chairman:
. Enclosed for the information of the Subcommittee is a copy of a notice of final rulemaking to be published in the Federal Reaister. This final rulemaking amends NRC regulations to constrain dose to members of the public from air emissions of radioactive materials from NRC licensed facilities other
'than power reactors.
This action is expected to be the final step in providing EPA with a basis , /
upon which to rescind 4 R 61f" National Emission Standards for Hazardous Air V Pollutants,' Spartl s it applies to NRC licensed facilities other than power reactors, third relieving these NRC licensees from unnecessary dual regulations. EPA has already rescinded Subpart I for power reactors based on requirements contained in 10 CFR Part 50, Appendix I, and a history of over 20 years of reported air emissions from power reactors resulting in doses well below 10 mrem /yr to the maximally exposed member of the public. This action will provide assurance to the EPA that future emissions from NRC licensees will not exceed levels that provide an ample margin of safety.
Sincerely, Dennis K. Rathbun, Director Office of- Congressional Affairs
Enclosure:
Federal Register Notice cc: Representative Frank Pallone-
,