ML20133L406

Notice of Availability of Reg Guide 4.20, Constraint on Releases of Airborne Radioactive Matls to Environ for Licensees Other than Power Reactors, Which Provides Guidance on Methods Acceptable to NRC on Air Emissions

ML20133L406
Person / Time
Issue date:	12/04/1996
From:	Speis T NRC OFFICE OF NUCLEAR REGULATORY RESEARCH (RES)
To:
Shared Package
ML20133L396	List: ML20133L394 ML20133L406
References
RTR-REGGD-04.020, RTR-REGGD-4.020 CCS, NUDOCS 9701220015
Download: ML20133L406 (34)

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7590-01-P NUCLEAR REGULATORY COMMISSION, l

Regulatory Guide; Issuance, Availability l

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Ine"duelear Regulatory Commission has issued a new guide in its f

Regulatory Guide Series. This series has been developed to describe and make available to the public such information as methods acceptable to the NRC f

staff for implementing specific parts of the Commission's regulations, techniques used by the staff in evaluating specific problems or postulated accidents, and data needed by the staff in its review of applications for permits and licenses.

l l Regulatory Guide 4.20, " Constraint on Releases of Airborne Radioactive Materials to the Environment for Licensees Other than Power Reactors," provides guidance on methods acceptable to the NRC staff for This l compliance with the constraint on air emissions to the environment.

constraint is required by the NRC's regulations in 10 CFR Part 20, " Standards for Protection Against Radiation," in Section 20.1101(d). The draft of this Regulatory Guide 4.20 was issued in December 1995 as DG-8016.

Co:nments and suggestions in connection with items for inclusion in guides currently being developed or improvements in all published guides are encouraged at any time. Written comments may be submitted to the Publications Branch, Division of Freedom of Information and Publications Services, Office of Administration, U.S. Nuclear Regulatory Commission, Washington, DC 20555.

Regulatory guides are available for inspection or copying for a fee at the Commission's Public Document Room, 2120 L Street NW., Washington, DC.

Single copies of regulatory guides, both active and draft, may be.obtained free of charge by writing the Office of Administration, Attn: Distribution 9701220015 961211 PDR RE00D 04.020 C PDR A

t l i r-2 .

4 and Services Section, USNRC, Washington, DC 20555-0001, or by fax at (301)415-2260. Issued guides may also be purchased from the National Technical Information Service on a standing order basis. Details on this service may be'-

obtained by writing NTIS, 5285 Port Royal Road, Springfield, VA 22161. -.

j Regulatory guides are not copyrighted, and Commission approval is not required i

to reproduce them.

(5 U.S.C. 552(a))

Dated at Rockville, Maryland, this day of D f d E M W 1996.

For the Nuclear Regulatory Commission f

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M Themis P. Speis, Diputy Director Office of Nuclear Regulatory Research i

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December 1996 U.S. NUCLEAR REGULATORY COMMISSION

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DE Q (%***** OFFICE ) OF NUCLEAR REGU l REGULATORY GUIDE 4.20 (Draft issued as DG-8016) f

! CONSTRAINT ON RELEASES OF AIRBORNE RADIOACTIVE MATERIALS TO THE ENVIRONMENT FOR LICENSEES OTHER THAN POWER REACTORS 1

i A. INTRODUCTION than those subject to 10 CFR 50.34a, such that the individual member of the public likely to receive the la 10 CFR Part 20, " Standards for Protection highest dose will not be expected to receive a total Against Radiation," i 20.1302(b) requires that: effective dose equivalent in excess of 10 mrem (0.1 A licensec shall show compliance with the annual mSv) per year from these emissions. If a licensee dose limit in i 20.1301 by (1) Demonstrating by subject to this requirement exceeds this dose con-l measmement or calculation that the total effective straint, the licensee shall report the exceedance as

dose equivalent to the individual likely to receive provided in 10 CFR 20.2203 and promptly take ap-l the highest dose from the licensed operation does propriate corrective action to ensure against not exceed the annual dose Smit; or (2) Demonstrat- recurrence.

ing that (i) The annual average concentrations of ra-I dioactive material released in gaseous and liquid This regulatory guide provides guidance on meth-

) effluents at the boundary of the unrestricted area do ods acceptable to the NRC staff for compliance with the constraint on air emissions to the environment. If addi-d not execed the values specified in Table 2 of Appen-dix B to Part 20; and (ii) lf an individual were contin- tional significant comments are received in the first year l unusly present in an unrestricted area, the dose following its issuance, the staff will revise the guide as ap-

! from external sources would not exceed 0.002 rem propriate. Guidance on ALARA programs can be found (0.02 mSv) in an hour and 0.05 rem (0.5 mSv) in a in other regulatory guides. Although these guides deal year. primarily with occupational exposure and may be specif-ic to one type of licensee, they contain programmatic in-In addition,10 CFR 20.1101(d) requires that:

formation that may be useful to all licensees. These Ib implement the ALARA [as low as is reasonably guides are:

achievable] requirements of 6 20.1101(b), and not-withstanding the requirements in i 20.1301 of this

• Regulatory Guide 8.10, " Operating Philosophy for part, a constraint on air emissions of radioactive ma- Maintaining Occupational Radiation Exposures As terial to the environment, excluding radon-222 and Low As is Reasonably Achievable." This guide de-its daughters, shall be established by beensees other lineates the components of an ALARA program.

USNRC RI Gt'IATORY Gt'IDI s The Guides are neued m the followng tan broad devisons Regulatory Guw1ee are mound to describe and make avalable to the public such informa-tion as methods acceptabte to the NRC staff for Impiamenting specific parts of the Com- 1 Power Reactors 6 Products fneenson s regulatiore. techniques used by th6 staff m evaluating specific probkirre or pm 2 Research and Test Reactors .. Transportate 1Llated accidents, and omta necoed by the NRC staff m its rev,ew of apphcales for per. 3 Fuels and Matenais Facilmes 0 Occupational Heatth mrta and bconses Regulatory guides are not substitutes for regiAetions. and compliera 4 gny,ronmental and Siteg 9 Armtrust and Fmancsal Review with them e not requered Methrxis arti soluttore Orfterent from those set o Jt in the Dulces 5 Matenas and Plant proractm 10 General will be acceptable if they previos a bame for tNu findings requisite to the issuance or con-tmuance of a permit or heense by the Commiss on.

The gende was maued after consderation of comments received from the public Com- Admmetrwon Attente Detnbubon and Services Sectm. US Nucsear Regu6atory ments end suggestnors for improvements m these Guides are encouraged at alt 'imes and Comrmaseon, Wesrungton. DC 2055S-0001, or by tax er p04a15-2200 puedes we be revi6 ed. as appropriate. to accommodate comments and to refisct new in-lasued guides may amo be purchased from the National Technical fntormate Serwce on WMflen cosEments may be submfltted to the Rules Review and Directives Branch. eMPS, a standin0 order base Dotada on this service enay be obtened by wemr.g NTIS 5255 Port

\ Royal Roet s anngfield. VA 22161 s.DM. u s Nucinar Reguineory Commisman. Waerungton, DC 205SS-0001

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o Regulatory Guide 8.18, "Information Relevant to The NRC staff examines licensee prograrns to def er.

Ensuring that Occupational Radiation Exposures at mine whether they are in compliance with the require.

Medical institutions Will Be As Low As Reasonably ments of 10 CFR Part 20. This guide addresses only a ,

Achievable." part of a licensee's overall radiation protection program.

• Regulatory Guide 8.31, "Information Relevant to SPecifically, it addresses rnethods for demonstrating Ensuring that Occupational Radiation Exposures at c mpliance with the constramt on releases of airborne Uranium Mills Will Be As Low As Is Reasonably radioactive materials to the environment. In addition to Achievable.. contromng doses from the releases of airborne radioac-tive materials to the environment, licensees must imple-e Regulatory Guide 8.37,"ALARA Levels for Efflu- ment a radiation protection program that controls liquid ents from Materials Facilities " effluents and dose rates in unrestricted areas.

e Regulatory Guide 10.8," Guide for the Preparation Many NRC licensees possess source, byproduct, or of Applications for Medical Use Programs." Sec- special nuclear material in a form that would not cause tion 1.3 and Appendix G deal specifically with doses to members of the public from releases of airborne ALARA programs for medical facilities. radioactive material to the environment. These licens-In addition, further information can be found in Re. ecs include radiographers, well loggers, and other users vision I to NUREG-0267," Principles and Practices for of scaled sources. These licensees need not take any ac-Keeping Occupational Radiation Exposures As Low As tions to demonstrate compliance with the constraint on Reasonably Achievable"(October 1982).1 releases of airborne radioactive matenals to the environment.

The information collections contained in this regu-latory guide are covered by the requirements of 10 CFR CONSTRAINTS Part 20, which were approved by the Office of Manage-ment and Budget, approval number 3150-0014. The A dose limit derived from a basic radiation protec-NRC may not conduct or sponsor, and a person is not re- tion standard is the upper acceptable bound of radiation quired to respond to, a collection ofinformation unless it dose and is needed to protect the health and safety of in-displays a currently valid OMB control number. dividuals; a limit is a value not to be exceeded. Such lim-B. DISCUSSION its should be set with the assumption that effluent re-leases associated with licensed activities would result in The dose limits in 10 CFR Part 20 are based on limit- doses to the public that are substantially below that val-ing dose to an acceptably low level of risk to the exposed ue. Such limits are approached only under unusual cir-individual. liowever, any radiation exposure may carry cumstances, and only for a small fraction of the exposed some risk. Thus, the NRC requires licensees to take ac- population. A constraint is a dose value above which li-tions, to the extent practicable, utilizing procedures and censees are required to report to NRC and to take cor-engineering controls to further reduce risk below the lev- rective actions to lower the dose below the constraint val-cls implicit in the dose limits in keeping with the princi- ue. Enforcement action would only occur if a licensee ple that exposures should be as low as is reasonably fails to report an exceedance of the constraint or fails to achievable. This is the goal and purpose for radiation take appropriate and timely corrective actions.

protection programs. In order to achieve this goal, li-censees must control the way radioactive material is han. C. REGULATORY POSITION died from receipt through disposal.

1. CONSTRAINT ON ENVIRONMENTAL AlR (

ALARA EMISSIONS The following methods are acceptable to the NRC Components of an effective radiation protection staff for determining the dose to members of the public program, as required by 10 CFR 20.1101, melude radi" from exposure to airborne radioactive material that has ation exposure centrol, written procedures and policies' control of radioactive materials, radioactive contamina- been released to the environment by NRC licensees oth-er than power reactors. Licensees should choose a moni-tion control, radioactive waste management, trammg, program reviews, and audits.

toring period (e.g., a year, month, or quarter) to demon-strate compliance with the airborne emissions constraint in accordance with 10 CFR 20.1101(d). For most licens-ICopies are available for purchase from the U.S. Government Prmtmg ecs, the monitoring period will be one year.

Office, PO. Box 37082. W.ishmgton, DC 20013 - 7082 telephone (202) 512 -2249, or from the National TechnicalInformation Service 1.1 Licensees who (1) operate a nuclear power reac-c$r$"a'va lab for n onIr y n for)e fro te P tor subject to 10 CFR 50.34a or (2) possess and use radio-bc Document Room at 2120 L Street NW., Washington, DC; the PDR1 nuclides only in the form of sealed sources need not take

'naihngaddressisMailSt pLL-6.Washmgton.DC20555; telephone (202)634-3273, fax (202)634-3343. any actions to demonstrate compliance with the constram, t.

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, i 1.2 Radioactive miterials in scaled containers thit C " fg rediain uno'pened and have not leaked during the assess- y-ment period need not be included in the calculations. Ex-7G amples of sealed containers would include radiopharma- Where:

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' V) ceuticals in unopened manufacturers packages and C =

Average air concentration at the receptor materials in undamaged shipping containers. Indepen.

(Ci/m3 or pCi/ml) dent spent fuel storage canisters that do not have vents to the atmosphere may also be considered sealed f = Fraction of the time the wind blows toward containers. the receptor of interest (dimensionless)

(For a single " puff" release, the appropri-1.3 Effluents from patients need not be included if compliance with the constraint is demonstrated by using atualue n 1.)

en inventory approach. If compliance with the constraint Q = Effluent release rate (Ci/s) is demonstrated by using measured or calculated con- V = Volumetric flow rate at the point of release centrations of radioactive materials in the environment, 3 (m /s) the contribution from patients is considered insignifi- .

The " sum of the fractions" technique should be used c nt and need not be considered.

to assess compliance for effluents contammg multiple ra-1.4 Ifit can be determined that some detected mate- dionuclides. With this technique, if radionuclides "a,"

rials did not result from licensed activities of the licens- "b," and "c" are present in concentrations Ca, Cb, and Cc, ee, only radioactive materials from the licensed activity and if the applicable effluent concentrations in Column 1 need be considered. Materials that are windblown from of Table 2 in Appendix B to 10 CFR Part 20 are ECa, other facilities need not be considered. ECb, and ECc respectively, satisfying the following in-equality is sufficient to demonstrate compliance with the 1.5 in determining the member of the publiclikely constramt.

to receive the highest dose from airborne radioactive material released from licensed operations to the envi-ronment, licensees need not consider nonresidents with- C, C3 in the facility boundary. EC. EC, + EC _Q, < 0.2 Q j

2. CALCULATION OF DOSE TO Tile MEMBER OF Tile PUBLIC LIKELY TO RECEIVE TIIE 2.3 Additional methods acceptable to the NRC staff for demonstrating compliance with 10 CFR 20.1101(d) 4v IllGilEST DOSE FROM Alk EFFLUENTS can be found in the worksheets contained in either in demonstrating compliance with 10 CFR NCRP Commentary No. 3, " Screening Techniques for 20.1101(d), licenaces should determine whether there Determining Compliance with Environmental Stan-have been any facility or design modifications, increases dards,"2 or EPA 520/1-89-002, "A Guide for Deter-in radionuclide inventories, or operational changes; li- mining Compliance with the Clean Air Act Standards for censees should determine whether any of these factors Radionuclide Emissions from NRC-Licensed and Non-resulted in variations to airborne emissions since the last DOE Federal Facilities" (Revision 2).3 monitoring period. If licensee operations have not 2.4 Another method that is acceptable to the NRC changed, the review of licensed operations and demon- staff for demonstrating compliance with 10 CFR stration of compliance with the constraint will be rela- 20.1101(d)is the use of the computer code COMPLY.

tively straightforward. COMPLY was developed by the EPA to assess doses by Any of the following methods are acceptable for using site-specific information in the determination of dose. COMPLY has four screening levels. In Level 1, the demonstrating compliance with 10 CFR 20.1101(d).

simplest level, only the quantity of radioactive material j 2.1 The simplest screening technique is to assume possessed during the monitoring period is entered. The that the air concentration at the receptor is equal to the calculations are based on generic parameters. Level 4 air concentration measured at the point of release. This produces a more representative dose estimate by provid-is analogous to using Appendix B to 10 CFR Part 20 to ing for more complete treatment of air dispersion by re-demonstrate compliance with the dose limits in Part 20. quiring site pecific information. It is expected that all 2.2 To demonstrate compliance with the constraint 2NCRP Commentary No. 3 was pubhshed in January 1989 and the ad-on air emissions, the licensee should demonstrate, by dendum was published % netober 1989. Copics may be purchased measurement or calculation, that the annual average from the National coa. an Radiation Protection and Measure-

'" ' , NCRP Pubhca' 7910Woodmont Avenue,Bethesda,MD concentration of airborne radioactive material released 20814.

( ) to the environment does not exceed 20% of the values in 3 Copies rnay be obtainM irom the U.S. Environmental Protection U' Column 1 of Table 2 in Appendix B to 10 CFR Part 20. Agency, Office of Radiation and indoor Air,401 M Street SW, Wash-The following formula demonstrates this technique. ington, DC 20460.

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8 t NRC licensees will be able to demonstrate compliance at learning of the dose in encess of the constraint, and,10 one of the four levels. The basis for the compliance mea- CFR 20.2203(b)(1) requires licensees to describe the'ex- ,i sures in COMPLY are contained in " Background Infor- tent of exposure. The report should include the follow- /

mation Document: Procedures Approved for Demon- ing information.

strating Compliance with 40 CFR Part 61, Subpart I"

• An estimate of the dose 4 (EPA 520/1-89-001, October 1989).4 e e mncentrations of the radioactive material If a computer code other than those listed above is released used to demonstrate compliance with the constraint, the licensee should be prepared to demonstrate that the o The cause of the elevated concentrations in code has undergone verification and validation (V & V). effluents For more information on software quality assurance in-

• The corrective steps taken or planned to ensure cluding V & V, licensees may refer to NUREG/

aga nst a recumnce l 11R-0167, " Software Ouality Assurance Program and Guidelines." This document can be purchased from the e A schedule for completing the corrective steps. The U.S. Government Printing Office, P.O. Box 37082, Wash- report should contain enough information to allow ington, DC 20402 - 9328. the NRC staff to verify the calculations.

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3. REPORTS TO NRC IF CONSTRAINTllAS The report should be sent to the U.S. Nuclear Regu-IIEEN EXCEEDED latory Commission, Document Control Desk, Washing-ton, DC 20555-0001, with a copy to the appropriate If the constraint of 10 mrem (0.1 mSv) per year to ,

NRC Regional Office listed in Appendix D to 10 CFR the member of the public likely to receive the highest Part 20' dose has been exceeded as determined by measurement or calculation,10 CFR 20.2203(a)(2)(vi) requires licens- D. IMPLEMENTATION ces to send a report to the NRC within 30 days after The purpose of this section is to provide m. forma-4 tion to applicants and licensees regarding the NRC Copiesof thc EPA Dackground information Document and the COM. . .

PLY compute r code with its Use rs Guide may be obtained by writing io staff.s plans for using this guide.

the Ce nter for l'ederal Guidance and Air Standards (66023). Office of .

Radiation and Indoor Air, Environmental Protection Agency, Wash. Except m those cases in which an applicant proposes ington, DC 20460. It can also be downloaded from the Technology an acceptable alternative method for complying with

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Transfer Network (TTN) Electronic Bulletin Board under the Office sPceified P'irtions of the NRC's reEulations, the meth-of Radiation and Indoor Air technicalinformation area. The number for the TTN is (919)$41-5742. In addition, EPA has pages on the ods described in this guide will be used in the evaluation I World Wide Web as another rncchamsm to provide computer codes t of applications for new licenses, license renewais, or ii.

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t nwErtpnc epa gov cense amendments and for evaluating compliance with 10 CFR Part 20.

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• REGULATORY ANALYS!S p A separate regulatory analysis was not prepared for this regulatory guide. The regulatory analysis prepared for the amendments to 10 CFR Part 20," Standards for Protection Against

('v) Radiation," provides the regulatory basis for this guide. A copy of this regulatory analysis is available, as an enclosure to SECY-95-133, for inspection or copying for a fee at the NRC Public Document Room,2120 L Street NW., Washington, DC.

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• _ Regulatory Analysis for the NRC Constraint Rule on i Radionuclide Air Emissions from NRC and Agreement State  ;

4 Licensees Other than Nuclear Power Reactors

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Statement of Problem

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Radionuclide air emissions from Nuclear Regulatory Commission (NRC) j licensees other than power reactors, and NRC Agreement State licensees are

currently regulated by both the NRC (or the Agreement State) and the Environmental Protection Agency (EPA). The NRC and Agreement State .

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j; 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 l Air Act (CAA). The purpose of this Regulatory Analysis is to evaluate a final 4

NRC rulemaking that provides assurance to the EPA that future emissions from NRC licensees will not exceed levels that EPA has determined would provide an h

ample margin of safety. This action is expected to be the final step in j l j 1

l J- providing EPA with a basis upon which to rescind 40 CFR Part 61 " National t

Emission Standards for Hazardous Air Pollutants" (NESHAPS), Subpart I, as it l

applies to NRC licensed facilities other than power reactors,' thereby a

relieving these NRC licensees from unnecessary dual regulation. l l

l The EPA's regulations, 40 CFR Part 61, Subpart I, are currently in a

effect for all NRC and Agreement State licensees, except power reactors. The dose standard contained within this regulation is not consistent with those of j NRC in 10 CFR Part 20. The EPA dose standard in Subpart I is 10 mrem i

1 EPA has rescinded Subpart I for power reactors based on requirements contained in 10 CFR Part 50, Appendix 1, and a history of over 20 years of reparted. air emissions from power reactors resulting in doses well below 10 mrem /yr to the maximally exposed member of the public.

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(0.1 mSv) per year, total effective dose equ.ivalent (TEDE) for air emissions -

from any single facility (buildings, structures, and operations on one j contiguous site). This standard is different in both numerical value and l approach to that of the NRC. The EPA approach to ensuring that dose limits i adequately protect the public with an ample margin of safety is to limit individual pathways! and sources to a fraction of the 100 mrem (1 mSv) per year 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 arem per year TEDE from all pathways, and to the extent practical, maintain doses as far below this limit as is reasonably l achievable (ALARA), taking into account social and economic considerations and i

sound radiation protection principles.

There are three mechanisms for demonstrating compliance with the NRC limit and ALARA. For light water reactors, compliance is demonstrated if the design objectives in 10 CFR Part 50, Appendix I, are achieved. For other NRC j and Agreement State licensees, compliance with the dose limit and the ALARA requirement is demonstrated in one of two ways: (1) Demonstrate that the average concentrations in air and liquid effluents released from the facility do not exceed the values in 10 CFR Part 20, Appendix B, and are ALARA, and that direct exposures do not exceed 50 mrem (0.5 mSv) per year, and are ALARA; or (2) Demonstrate that the dose to the member of the public likely to receive i

the highest dose from all pathways is less than 100 mrem (1 mSv) per year TEDE .

and is ALARA.

I The NRC believes that for its licensees the application of ALARA goals and guidelines has been successful in maintaining actual air emissions to 1

' levels that are well below the EPA standard. Past experience and effluent l L f

information reported to the NRC staff have _ indicated that ALARA dose goals in the range of 10 mrem (0.1 mSv) per year or less should be achievable for all j materials licensees, including fuel cycle facility licensees. .ccudies 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 (0.1 mSv) per year standard. This

- conclusion has been confirmed by a review of the annual reports submitted by licensees to EPA as required by 40 CFR Part 61, Subpart I. In 1995, only one licensee reported air emissions above the 10 mrem (0.1 mSv) per year standard.

Corrective measures were initiated by the licensee and no enforcement actions were taken by EPA.

This rulemaking establishes a 10 mrem (0.1 mSv) per year TEDE dose constraint on radionuclide air emissions. Although it is not considered a health and safety limit such that adequate protection would no ae 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, at a net savings), and brings consistency between EPA's dose standard and the NRC's ALARA application. The f.nal rule ,

provides EPA with a basis upon which to rescind Subpart I as it applies to NRC-licensed facilities other than power reactors.

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i 1.1 Backqt and on EPA's implementation of Radionuclide NESHAPs for NRC Licensed Facilities l

The 1977 amendments to the CAA renuired FPA to consider whether i

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 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 1979, EPA subsequently identified l radionuclides as a hazardous air pollutant (44 FR 76738; December 27,1979).

In April 1983, EPA proposed standards regulating radionuclide air emissions from four 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 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. Later that year, EPA petitioned the Court for a voluntary remand of its existing air a

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.

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On December 15,1989 (54 FR 51654), the EPA issued its final rule on the 4 NESHAPs under Section-112 of the CAA for emissions of radionuclides from l 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 tii i. - -

air emissions of radionuclides shall not cause any member of the public to receive more than 10 mrem (0.1 mSv) TEDE in any year, or more than 3 mrem Radon-222 and its decay products formed  ;

(0.03 mSv) TEDE from radioiodines.

after release from the 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), an NRC l licensee, about unnecessary duplicative, and perhaps conflicting, standards for NRC licensees. -

At the time of issuance of the rule, the EPA reaffirmed a previously l stated position that it "... continues to believe existing emissions from these  ;

sources (NRC licensees] are already so low that public health and safety are 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 i under the CAA provided any additional public health and safety benefit. The  ;

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NIH, as an NRC licensee, voiced concerns about the potential negative effects j 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 I

final rule promulgation due to court-ordered deadlines. A 60-day comment period was established for the purpose of receiving further information and i

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comments related to these concerns. A 3-month stay of Subpart I was effected t'o allow further consideration.

The 1990 amendments to the CAA included provisions in~Section Il2(d)(9) that allow EPA to decline regulating airborne radionuclide emissions from NRC licensed facilities if it' determines, through a rulemaking,'Liidi 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 40 CFR Part 61 Subpart T (and Subpart I for power reactors).

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 (0.08 mSv) per year TEDE, based on very conservative.

modeling. In addition, 98 percent of the facilities surveyed had doses of less than 1 mrem (0.01 mSv) 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 (0.1 mSv) per year dose standard. Of these, 75 percent had estimated maximum doses to a member of. the public of less than 6

- _._ . _ _ . _ . _ . _ - _ . _ _ _ . _ _ _ _ _ - . _ . = - - - . _ . - _ . _ _. _

.. . y +

s 2

+C_*

4 I' mrem (0.01' mSv) per year. None exceeded the 10 mrem (0.1 mSv) per year standard. The results of these studies were published by EPA (57 FR 56877;

-Dec 'l~,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 to;l mSv) per year.

. EPA's conclusion, based in part on these studies, was that the current  ;

i NRC- program, which limits public dose to 100 mrem (1 mSv) per year, in concert  ;

with'the. requirement to keep doses ALARA, has been successful in maintaining  ;

i air emissions well below the 10 mrem (0.1 mSv) per year Subpart I standard. .

i However, because of EPA's concern regarding the litigative risk of extending  ;

stays of previously promulgated NESHAPs during pendency of a rescission rulemaking and that the D.C. Circuit had already reversed the previous stay for licensees other than power reactors, the stay on Subpart I was allowed to j 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 1. 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).

i h  !

7

1.2 Past NRC and EPA Efforts to Rescind Subpart I Under the Simpson .

Amendment l Over the nast.16. years, the NRC and EPA have worked together on the objective of eliminating the duplicate regulurory oversight. The NRC and EPA entered into a Memorandum of Understanding (M00) 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 an, NRC shall have the primary role in implementing and enforcing these standards where applicable for sources and facilities licensed by NRC."

In 1990, Congress amended the CAA specifically addressing the issue of duplicate regulation. This amendment enacted Section ll2(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 if the EPA Administrator determined, by rule and after consultation with the NRC, that the regulatory programs established by the NRC provide an " ample margin of l safety" to protect 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 eliminate 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 MOV (57 FR 60778; December 22, 1992). Its intent was to determine NRC actions that could form the basis for EPA to rescind Subpart 1. NRC was to put in place additional 8

., O 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"ehsure 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 Plans. 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 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. l As an implementation of its ALARA guidelines, the NRC developed Regulatory Guide 8.37, which included a specific ALARA goal of 10 mrem (0.1 ,

mSv) per year TEDE to the maximally exposed individual from radionuclide air

emissions (Ref 2). Additionally, NRC Inspection Procedures (IP) 87102 was developed, 40750 and 80745 were revised, to include a review of emissions from thoto facilities with the potential of exceeding 20 percent of the 10 CFR Part 20, Appendix B, Table 2 values (Ref. 3). Generally, this 20 percent level corresponds to a calculated dose from air exposure of 10 mrem (0.1 mSv) i per year, which is comparable with the EPA's Subpart I standard. An Inspection Referral Form was included within IP 87102, 40750, and 80745 which was completed by the NRC inspector and forwarded by the regional office to the' cognizant EPA Regional Radiation Program Manager. l Under the Simpson Amendment and the 1992 MOU, 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 9 l

(56,FR 18735; April 24, 1991). EPA announced its intent to propose rescission of Subpart I on September 18, 1992 (57 FR 43173). Later in 1992, EPA issued the Federal Register notice proposing the rescission on December 14, 1992 (57 FR 56877). However, on November 15, 1992, EPA allowed the stay on .

Subpart I to expire ibr 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 i 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 112(d)(9) l (Simpson Amendment). Following this determination, in July 1993, the EPA Administrator decided there was insufficient regulatory basis to rescind Subpart I.

In its January 28,1994 (59 FR 4228) Federal Register notice, 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 l l

reactors.

EPA has historically identified two components to this finding: (1) that the facilities licensed by NRC and Agreement States are in compliance with the i

quantitative emission limits in Subpart I (10 mrem (0.1 mSv) per year TEDE);

10

t -

l

.8 .

and (2) that the NRC program must be sufficient to ensure that emissions would remain below this level in the future, thereby protecting the public with an

• ample margin of safety.

i.3 - Issue of Unnecessary and Confldctina Dose Standards The issues surrounding the necessity for duplicate regulation relate to i

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 l further support the position that the ALARA goals of Regulatory Guide 8.37 are f consistently being met. For the calendar year 1993, the first year under 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 (0.1 mSv) per year from air emissions.

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 which also exceeded the 10 CFR Part 20 limits for members of the public. This licensee took corrective measures; no enforcement actions were  ;

taken by EPA as enforcement action was taken by NRC. The 1995 annual reports have been submitted to EPA. No licensee reported air emissions above the Subpart I standard.

The dual regulations by EPA and NRC are considered unnecessary for the 1

following reasons. First, the level of air emissions from NRC licensed facilities has historically been well below the EPA and NRC dose limits. The application of the ALARA principle has resulted in facility programs and ,

11

i -

i 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, dual reportina,.and evaluations, in addition to NRC inspections, is unnecessary for protecting public health'and safety. Compliance can most efficiently be -

covered by_ a single regulatory process.

EPA's compliance program relies primarily.on evaluations and-reports

~p repared 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 ,

l (0.01 mSv) per year 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 (0.01 mSv)/yr TEDE) are required to submit an annual report to EPA by March 31 of each ' year on air emissions for the previous calendar year. Licensees with air emissions in excess of the annual limit (e.g., > 10 mrem (0.1 mSv) per year I TEDE) must include in the report proposed corrective measures to ensure future i doses will be below the limit and report on a monthly basis until EPA determines that adequate corrective measures have been taken and reporting is 1

no longer necessary.

There are currently about 6,000 NRC licensed facilities and about 14,000 4 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 need only understand Subpart I and l

~

determine that their licensed activity has a negligible potential for any i significant air emissions (see 40 CFR 61.100 applicability). The facilities

.'(other than power reactors) with potential air emissions for which compliance j evaluations are required are those that c a materials in unsealed form, e

12

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. I I

predominantly bospitals,' clinics, radiopharmacies, research and academic facilities, fuel cycle facilit'ies, 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 authorized to set standards at least as stringent as those promulgated by the EPA. At this time, the EPA Administrator has approved three States 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 NESHAPs, covering NRC licensed facilities, DOE ,

i facilities, and other miscellaneous sources covered by 40 CFR Part 61.

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 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 public health and safety with respect to l 4  ;

the materials covered by the proposed agreement.

13 i

,, -I

, q 7

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.

2. Objectives of the Rulemaking ..

The objective of the rulemaking is to provide ar.,urance 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, Subpart I, " National l Emission Standards for Hazardous Air Pollutants," as it applies to NRC and -

Agreement State licensed facilities other than power reactors, thereby  ;

I relieving these licensees from unnecessary dual regulations. To support the j determination by EPA that NRC's programs provide an equivalent level of l protection, this rulemaking codifies a 10 mrem (0.1 mSv) 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 l l

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 the same margin of public and environmental safety as that currently afforded under Subpart 1. With the l elimination of dual regulation, the burden of implementation and continued demonstration of compliance with duplicate regulations by the users will be I

reduced. Efforts will be reduced for maintaining compliance and enforcement programs by two separate government agencies for the same emission source.  !

14

- - -. .. .~ - - . .- - . - - .. ._- ... - .. . -. . - -- .-

7 l EPA will be able to eliminate its continuing efforts required for l 4

maintaining a compliance evaluation program for NRC and Agreement State I

licensees, including developing and maintaining guidance programs, training of r

EPA regional staff, transition of authority to States, training of State j agencies, reviewing emission reports, reviewing construction and modification applications, and conducting enforcement actions as required. NRC's programs.

j will require some additional efforts beyond its current inspection and

enforcement programs to verify that licensees are in compliance with the '

constraint. Agreement States will adopt similar compliance evaluation ,

i l 1 programs. 1 i

J

! 3. Alternatives.

I  !

i

1) Alternative 1 - Dual Regulation - NRC and EPA would each retain their  ;

j existing regulations and compliance programs.

2) Alternative 2 - EPA Regulations Only - Revise NRC requirements to eliminate air effluents. l

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). 1 l

Each alternative is discussed below.

3.1 Alternative 1 - Dual Regulation There is general agreement between NRC and EPA that all NRC and Agreement State licensed facilities are maintaining air emissions well below 15

. s .

the 40 CFR Part 61, Subpart I, dose standard of 10 mrem (0.1 mSv) per year.'

i However, EPA determined that NRC's regulatory framework did not fully support ,

i their substantive finding which is required by CAA Section ll2(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 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 compliance with 10 CFR Part 20 which includes maintaining doses ALARA and 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 compliance standpoint if a facility exceeded EPA's 10 mrem (0.1 mSv) per year limit, unless NRC standards j were also exceeded. EPA would retain its regulatory authority for enforcement actions. i EPA would continue its compliance programs, including maintenance of  ;

guidance, 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 j licensing (fee) and inspection programs under the authority of Section l 112(1)(1) of the CAA.

2 Refer to the federal Register notice (54 FR 51654), promulgating Subpart I j and EPA's subsequent study of radionuclide air emissions for NRC licensed  !

facilities (Ref. 1), as well as recent reports to EPA by NRC and Agreement ,

State licensees (1994-1995). 1 16

The availability of citizen suits under the CAA would remain if .

Subpart I is not rescinded. If EPA does ultimately rescind Subpart I, the public petition process for NRC enforcement action against a licensee under 5.2.206 wpuld offset the unavailability of the CAA citizen suit provision.

However, judicial review of 5 2.206 petition denials is not readily available.

3.2 Alternative 2 - EPA Reaulation 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 Procedures IP-87102, 40750, and 80745; Regulatory Guide 8.37; and the MOU with EPA on inspection referrals would be withdrawn or revised. Section 20.1302 would be revised to indicate that compliance with Subpart I is sufficient to demonstrate that dose from air effluents does not exceed 10 mrem /yr. There would be some moderate savings (about 1 FTE) in inspection as the monitoring and recordkeeping reviews in the area of air emissions would no longer be performed. Appendix B, Table 2, Column 1 of 10 CFR Part 20 would be deleted.

As in Alternative 1, EPA would continue its compliance programs, also the option to file citizen suits under the CAA would remain.

3.3 Alternative 3 - Constraint Rulemaking This alternative addresses NRC's development of a regulatory constraint within 10 CFR Part 20 on allowable releases of radioactive effluents to the environment from NRC licensed facilities, ' excluding power reactors. The regulation would constrain air emissions released to the environment to a 17

. - - . . - . - -- . -- - . . . - . . ....~ - - - - - - . -

. g . ,

level corresponding to a calculated dose of 10 mrem (0.1 mSv).per year to the ,

. maximally exposed member of the public. This approach would add numerical ,

. criteria for material licensees, fuel cycle facilities, and test'and research reactors, similar to that already in place for nuclear power reactors (i.e., ,

~

55 50.34a, 50.36a, and Appendix I to Part 50). A licensee er Hir g this constraint would.be required to submit a report and implement v opriate l corrective actions. Failure to report exceedance of the constraint or failure  ;

-to implement agreed upon corrective actions would be a-violation of NRC regulations subject to enforcement actions. Licensees exceeding the constraint level would be required to submit a report to the NRC identifying  :

the situation and appropriate measures for reducing emissions to below the l constraint. EPA has indicated 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 1. An ALARA dose constraint of 10 mrem (0.1 mSv) per year TEDE to members of the public from air emissions of radionuclides would proviae consistency. These requirements, codified within NRC's regulations, would provide a sufficient regulatory framework to support an EPA finding that NRC's regulations provide "an ample margin of i safety."

1 i

18

. _ . - . _ . . _ __ ._ _. ._ . ~

'$' ),. '

7

4. Consequences t

'This' Regulatory A'nalysis does not address a serious health and safety

~

]

issue. Instead, the basis for evaluating consequences is eliminating ,,

regulations that are considered duplicative and unnecessary.. The consequences-- '

are . evaluated against a baseline comparison.

4.1 Dual Requiation 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 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 1,1censees would have different regulatory requirements addressing air emissions within two different titles in the Code of Federal Regulations (i.e., Title 10 for the NRC and Title 40 for EPA). ,

Each licensee would have to interact with two regulatory groups within a State relative to compliance, including possible on-site inspections by EPA methods for demonstrating compliance, licensing reviews (for NRC programs), facility modification reviews (EPA), and recordkeeping and reporting. Some Agreement

' State representatives have stated that qualified radiation protection personnel may move from the State's radiation protection program to the State's environmental program to administer Subpart 1. This might result in personnel shortages in some States, and maintaining enough qualified radiation .

1 2

protecti$n pers' nnel o has~ consistently been a problem for many State programs.

19

r- -,--._-. ~. - -._ - _ _ _ _ _ _ _ _

l Increased efforts are associated with duplicate requirements, duplicate implementation programs, and duplicate regulatory inspections.

Maintaining dual regulation would not require a rulemaking. NRC's c'u rrent regulatory programs would cont.inue to support the established

• radiation protection framework in 10 CFR Part 20, including'tne puol'ic a~ose limit of 100 mrem (1 mSv) per year and the principle of maintaining doses ALARA. EPA's compliance programs would continue, including the selected i

reactive inspections, evaluations of licensee submitted annual reports, and i continued financial as well as technical support to individual State program l l development. The EPA staff expects that individual State involvement would .

l l increase as individual compliance programs are implemented. l Based on the'1992 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 l

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 ft. :ded by NRC regional management to the cognizant EPA Regional Radiation Program Manager.

For calendar year 1995, EPA received 300 reports from NRC and Agreement State licensees to comply with Subpart I reporting requirements. EPA estimates their burden for reviewing each report to be approximately 12 hours1.388889e-4 days <br />0.00333 hours <br />1.984127e-5 weeks <br />4.566e-6 months <br /> (compliance verification (9 hours1.041667e-4 days <br />0.0025 hours <br />1.488095e-5 weeks <br />3.4245e-6 months <br />) and filing (3 hours3.472222e-5 days <br />8.333333e-4 hours <br />4.960317e-6 weeks <br />1.1415e-6 months <br />)). Thus, EPA estirated its' total burden and cost for Subpart I as 3,600 hours0.00694 days <br />0.167 hours <br />9.920635e-4 weeks <br />2.283e-4 months <br /> or $167,400 for 1995.

20 u_.m_____ _ _ - - . ____-.:______________. _ . _ _ _ . _ _ _ _ _ _ . _ _ _ - _ _ _ _ _ .

e .

[ .

In order to demonstrate compliance with Subpart I NRC and Agreement State l

licensees will have to take actions to show that doses are less than 1 mrem /yr L

or file reports with EPA. About half of the 25,000 licensees will only have to read and understand the rules and determine that there is no potential for  !

effluents from their facility. This will take approxim.iteiy I hour per i licensee. In addition to the above actions, some licensees with air effluents will be able to compare the average annual effluent concentrations, calculated l

s to show compliance with Part 20, with tables provided by EPA for that purpose.

Some licensees will have to calculate the difference between the total radioactive materials possessed during'the year and the amount of radioactive materials that remained in sealed containers throughout the year. This value can be compared to tables provided by EPA for this purpose. Some licensees will need to collect varying amounts of site specific data to use in the COMPLY computer code provided by EPA for this purpose. Licensees unable to demonstrate by any of the above methods that doses to members of the public are below 1 mrem /yr will be required to prepare and submit a report to EPA of the estimated doses. Licensees unable to demonstrate that the doses to members of the public are below 10 mrem /yr will be required to develop, negotiate, transmit to EPA, and implement corrective actions adequate to ensure that doses return to levels

, less than 10 mrem /yr on an agreed upon schedule. The following table summarizes L

these cost estimates.

21

i

• s'o c.

... l hrs /lic licensees ' hrs Cost: -t

.1 - Potential for effluents? *1 10,000 10,000 $500,000 2 Concentration Tables 2 2,425 4,850 $242,500 , ,

3 Quantity Possessed Tables 5 2,425 12,125 $606,250 i

i 4 COMPLY-1 10 2,425 24,250 $1,212,500 5 COMPLY-2 20 2,420 48,400 $2,422,000 6 Report Required 40 300 12,000 $600,000 1 7 Corrective Actions 80 5 400 $20,000 TOTAL 20000 112,025 $5,603,250 i

Thus,- the average cost to NRC and Agreement State licensees is $280 per 1

licensee ($ 5,603,250 / 20,000 - $ 280). l I

l Since 1989, NRC has devoted about 15 FTE to the Subpart I issue. This '

). effort has consisted of the interface with EPA in support of rescission, l development of Regulatory Guide 8.37, 'ALARA For Effluents For Materials i i Facilities", development of inspection guidance, inspection efforts, referral of i i inspection results to EPA, and development of the constraint rule. l i

The burden of Alternative - 1 (dual regulation) is summarized in the following table:

y 22

• e .

m,-a .

C6st NRC and Agreement State Liccnsees - $5,603,250 ,

EPA 167,400 NRC (0.5 FTE for inspection and referrals to EPA) 50,000

~~ '

TOTAL $5,820,650 4.2 EPA Regulation of Air Emissions Only i

Elimination of NRC regulation of air emissions would eliminate dual [

regulation. NRC's burden would be reduced as inspection of licensee records, review of calculations, and licensing reviews of the air emission program would no longer be performed. Agreement States radiation program concerns relative to the loss of qualified radiation protection personnel to State environmental I 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 1 20.1302. This revision would be necessary to make clear that NRC inspection and enforcement of compliance with public dose limits would not 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 (2,000 hours0 days <br />0 hours <br />0 weeks <br />0 months <br /> 0 $50/ hour) 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 the 29 Agreement States would expend about 0.1 FTE (200 hours0.00231 days <br />0.0556 hours <br />3.306878e-4 weeks <br />7.61e-5 months <br /> 0 $50/ hour) revising their rules, i-The burden on licensees would be the same as under the dual regulation alternative. The burden to EPA may increase due to the potential need for EPA l inspection of licensed activities as well as enforcement activities. The annual 23

. - . . - . . _ = ._= . .. .. . -

e

• s ,

g ,

9

.t.

• burden to NRC would be reduced as routine inspection of doses to members of the  ;

public would include only doses resulting from direct exposures and liquid effluents. Because air effluents are a small portion of doses to members of the I

a public for most facil,1 ties, this burden reduction is expected to be very small.

4 4

The burden associated with Alternative - 2 is summarized below:

Annual"B0 dens? *n

^

Z <

!^ "fCoif .

NRC and Agreement State Licensees $5,603,250 EPA' 217,400 NRC 0.00 TOTAL $5,820,650

, Ji FTE!j Costs; OneTimetExpendituresj ,

m g. , m j .

NRC Rulemaking 1.0 $100k 4 NRC Inspection Procedures and Inspector Training 1.5 150k Agreement State Regulations Revision 2.9 290k TOTALS 5.4 $540k Alternative 3 - NRC Constraint Rule and EPA Rescission of Subpart I A constraint level would be enforced by NRC through its current licensing and-inspection and enforcement programs. The current IP 87102 (Ref 3), IP.

80745 (Ref. 7), and IP 40750 (Ref. 8) would require modification in wording for -

consistency with the rule. The Referral Form and letter to EPA would be eliminated from the inspection procedures. NRC regulatory guidance would be 24

s .

?. ,

revised and issued before the constraint rule is in effect, to specifically ,

I address the constraint rule. Acceptable methods for demonstrating compliance -

and reporting guidelines would be added to the regulatory guide. For licensees, an overall simplification in compliance assessment methods would be expected due t

to tiie st.'s.auining of methods needed for both Subpart I compliance and 10 CFR . . . -

Part 20 compliance.

Significant savings may be realized for facilities that maintain effluents ,

. -at a small fraction of the standard, i.e., those facilities for whom submission ,

of annual evaluations, reports and overall dual regulatory oversight are not required for ensuring public safety with an ample margin of safety. 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 1 additional effort would be expended to demonstrate compliance with the l constraint rule if the dose did not exceed the 10 mrem /y. 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 submit a report to NRC or an Agreement State. It is assumed that an average of five reports per year will be submitted to NRC or an Agreement State. The burden is shown in the following table.

25 ,

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. Action Required hrs /lic licensees hrs Cost 1 Potential for effluents? 1 10,000 10,000 $500,000 2 Concentration Tables 2 9,000 18,000 $900,000 ,

3 Quantity Possessed Tables 5 332 1,660 $83,000- -

4 COMPLY-1 10 332 3,320 $166,000 5 COMPLY-2 20 331 6,620 $331,000 6 Report Required 40 0 0 $0 7 Corrective Actions Required 80 5 400 $20,000 TOTAL 20,000 40,000 $2,000,000 The total licensee burden is estimated to be $1,993,250 annually or about

$100 per licensee ($ 2,000,000 / 20,000 = $ 100). 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 licensees that fail to perform the required evaluations and/or those licensees that fail to take appropriate measures, for reducing air emissions.

The burden of reviewing reports of doses in excess of the constraint, is estimated to be 0.2 FTE or $20,000 annually (based on an estimate of no more than 5 reports /yr x 80 NRC staff-hours / report x $50/NRC staff-hr = $20k/yr).

The burden for inspection and enforcement is estimated at 1.8 FTE ($180,000).

An additional 0.3 FTE would be needed for headquarters support of licensing and enforcement actions, training, and other overhead. Assuming that the burden on 20

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' Agreement States would be proportional to the number of licensees, the total government burden would be approximately 6.9 FTE or $690,000 annually.

Under Alternative 3, the NRC would incur one time costs for completion of the rulemaking (0.5 FTE), completion of regulatory guidance (0.5 FTE),

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- - development of licensing procedures (0.3 FTE), modification of the inspection ,

procedures and training of inspection personnel (1.0 FTE). EPA will also incur a one-time cost 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 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 compatible or more stringent regulations. The Agreement States are expected to adopt similar compliance program 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 woulo 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 radiation protection programs including ALARA guidelines. Therefore, based on NRC's precedence in establishing the regulatory framework for a constraint rule, it can be assumed 4 The NRC is in the process of revising its compatibility policy and has issued a proposed policy for public comment (59 FR 3/269; 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.

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i that additional efforts on the part of Agreement States for the 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 hours0.0231 days <br />0.556 hours <br />0.00331 weeks <br />7.61e-4 months <br /> /FTE x $50/hr = $725,000). NRC would_ continue its evaluation of Agreement State programs for adequacy and compatibility. _

Costs for Alternative 3 are summarized below:

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Annual? Burdens < ,, ,

NRC and Agreement State Licensees $2,000,000 NRC and Agreement State Governments Report Review 6,000 NRC and Agreement State Governments Inspection 690,000 TOTAL $2,696,000 One TimeLExpenditures, FTE~ Co'sts x

NRC Rulemaking 0.5 $50k NRC Inspection / Licensing Procedures and Training 1.4 140k r

NRC Regulatory Guidance Development 0.5 50k Agreement State Regulations Development 7.25 725k EPA Subpart I Rescission Rulemaking 0.5 50k TOTALS 10.15 51,015k 28 4

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S. Decision Rationale l

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 dosc of 10 mrem (0.1 mSv) per year TEDE to the maximally exposed member of the public. Under Alternatives 1'(dual regulation) and 2 (eliminate NRC regulation of air caissions), the EPA Subpart I dose standard would remain in effect. Under Alternative 3 (constraint rule), NRC would enact a rule imposing a constraint dose of- 10 mrem per year and EPA would rescind Subpart I.

It may be appropriate to select alternative 1, dual regulation, because licensees have been subject to dual regulation for more than 3 years without any j undue harm to public health and safety. Although not 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, and also allow NRC to discontinue work on revising inspection guidance, and finalizing regulatory guidance. Additional experience could provide the necessary information to support a decision by EPA to rescind Subpart I, without the need for additional NRC regulation.

In amending the CAA in 1990 to specifically address the issue of duplicate regulation, the NRC believes that Congress intended that dual regulatory

. oversight by EPA and NRC be eliminated if it could be done effectively.

Alternative 1 (dual regulation) does not support the finding required by the CAA, Section ll2(d)(9) and dual regulation would not be eliminated.

Alternatives 2 and 3 are intended to be responsive to the congressional mandate to reduce duplicative regulations. Alternative 2 achieves this goal- by  ;

- discontinuing NRC inspection and enforcement of dose to members of the public 4 29

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'from air emissions, but is not the most cost effective choice. Alternative 3 l

, , achieves this goal by pr.ovidiiig assurance that the NRC regulatory framework 'will -[

provide an ample margin of safety at a significant savings in cost. This j i

(7 alternative will support an EPA finding to that effect, and thereby, support a subsequent rescission of Subpart I. 1 4 . . .  :

EPA has historically identified two components of the finding of l l sufficiency. First,' NRC and Agreement State licensees must be in compliance l A i With the quantitative emission limits of Subpart I (i.e.,10 mrem per year,

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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 i by licensees. The second component is that the NRC's and Agreement States'  ;

compliance programs provide sufficient continued assurance that emissions would i remain below the Subpart I standard, thereby protecting the public and environment with an " ample margin of safety." Of the alternatives, only l Alternative 3 would be effective in achieving this second component.

Alternative 1 would not support the goals of eliminating dual regulations.

Alternative 2 would achieve the stated goals, but not at a savings in cost.  !

For Alternative 3, that of imposing controls by regulation, the relatively i

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straightforward rule has been estimated to require 2 person-year of Federal Government effort (including finalization of the rule, regulatory guidance; inspection guidance, inspector training and EPA rescission of Subpart I).

1 Assuming all twenty-nine Agreement States would process parallel rules, this

- effort has been estimated to require an additional 7.25 staff-year (0.25 staff-

-year per State). This lower level of effort for rulemaking by an Agreement l State has been assumed considering the precedent established by NRC's  ;

rulemaking.

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• 2 The total cost of each option is summarized in the table below:

2 Option

• One Time Annual Costs

. Costs.

I - No Action / Dual Regulation $5,820,650 2 - Eliminate NRC~Regulhtiva ei Air Emissions $540,000 $5,820,650

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3 - Constraint Rulea'n'd Rescis"sion of Subpart I '$1,015,000 $2,696,000 Although Alternative 1 would be acceptable from a public health and safety I perspective, it would not eliminate dual regulation. Alternative 2 would also j be acceptable from a public health and safety perspective but would be far more

burdensome to licensees than Option 3, because it would not support a rescission by EPA of Subpart I.

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6. Implementation No impediments to iraplementation of the recommended alternative have been 1

identified. The documents necessary to support a final rule have been i

developed. The level of effort required for completing the rulemaking has been estimated at 0.5 staff-year, over a 6-month time period.

The NRC staff has prepared regulatory guidance that further clarifies the i

applicability of the rule and provides guidance on acceptable methods for i

demonstrating compliance, and for evaluating and reporting elevated effluents if the constraint level is exceeded. The final regulatory guide will be available at the time-the final rule becomes effective. 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.

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,< References 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 ,

Facilitiss," ' .-J S. Nuclear Regulatory Comission, 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.  ;

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5. ICRP Publication 64, " Protection from Potential Exposure: A Conceptual l Framework," Annals of the ICRP, Volume 23, No.1, published for the l International Commission on Radiological Protection by Pergamon Press,  !

1993. l 4 6. Draft Regulatory Guide DG-8016, " Constraint Level for Air Emissions of g

Radionuclides."

7. Inspection Procedure 80745, " Class I Non-Power Reactor Effluent and Environmental Monitoring."

j 8. Inspection Procedure 40750, " Class II Non-Power Reactors."

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