ML23152A238

PR-020 - 60FR63984 - Constraint Level for Air Emissions of Radionuclides

ML23152A238
Person / Time
Issue date:	12/13/1995
From:	Hoyle J NRC/SECY
To:
References
PR-020, 60FR63984
Download: ML23152A238 (1)

Text

ADAMS Template: SECY-067 DOCUMENT DATE: 12/13/1995 TITLE: PR-020 - 60FR63984 - CONSTRAINT LEVEL FOR AIR EMISSIONS OF RADIONUCLIDES CASE

REFERENCE:

PR-020 60FR63984 KEYWORD: RULEMAKING COM MENTS Document Sensitivity: Non-sensitive - SUNSI Review Complete

STATUS OF RULEMAKING PROPOSED RULE: PR-020 OPEN ITEM (Y/N) N RULE NAME: CONSTRAINT LEVEL FOR AIR EMISSIONS OF RADIONUCLIDES PROPOSED RULE FED REG CITE: 60FR63984 PROPOSED RULE PUBLICATION DATE: 12/13/95 NUMBER OF COMMENTS: 39 ORIGINAL DATE FOR COMMENTS: 03/12/96 EXTENSION DATE: I I FINAL RULE FED. REG. CITE: 61FR65120 FINAL RULE PUBLICATION DATE: 12/10/96 NOTES ON: WOULD AMEND PART 20 TO ESTABLISH A CONSTRAINT OF 10 MREM/YR TOTAL STATUS EFFECTIVE DOSE EQUIVALENT. FILE LOCATED ON Pl.

-OF RULE :

HISTORY OF THE RULE PART AFFECTED: PR-020 RULE TITLE: CONSTRAINT LEVEL FOR AIR EMISSIONS OF RADIONUCLIDES PROPOSED RULE PROPOSED RULE DATE PROPOSED RULE SECY PAPER: 95-133 SRM DATE: 11/13/95 SIGNED BY SECRETARY: 12/07/95 FINAL RULE FINAL RULE DATE FINAL RULE SECY PAPER: 96-172 SRM DATE: 10/18/96 SIGNED BY SECRETARY: 01/09/97

- STAFF CONTACTS ON THE RULE CONTACT!: CHARLENE RADDATZ, RES MAIL STOP: T9-C24 PHONE: 415-6215 CONTACT2: MAIL STOP: PHONE:

DOCKET NO. PR-020 (60FR63984)

In the Matter of CONSTRAINT LEVEL FOR AIR EMISSIONS OF RADIONUCLIDES DATE DATE OF TITLE OR DOCKETED DOCUMENT DESCRIPTION OF DOCUMENT

- 12/08/95 12/07/95 FEDERAL REGISTER NOTICE - PROPOSED RULE 12/26/95 12/21/95 COMMENT OF GENCORP AEROJET (ARTHUR E. EXTEN) ( 1) 01/11/96 01/05/96 COMMENT OF KENNECOTT URANIUM COMPANY (OSCAR PAULSON) ( 2) 01/16/96 01/10/96 COMMENT OF WYOMING MINING ASSOCIATION (MARION LOOMIS, EXECUTIVE DIRECTOR) ( 3) 01/17/96 01/16/96 COMMENT OF JOHN STEPHENS ( 4) 01/22/96 01/12/96 COMMENT OF MICHIGAN DEPARTMENT OF PUBLIC HEALTH (JAMES K. HAVEMAN, JR, ACTING DIR) ( 5) 01/29/96 01/24/96 COMMENT OF WALSTON CHUBB ( 6)

- 02/01/96 01/26/96 COMMENT OF RODGER W. GRANLUND ( 7) 02/06/96 12/15/95 COMMENT OF DOUGLAS A. JOHNSON ( 8) 02/15/96 02/09/96 COMMENT OF CHEM-NUCLEAR SYSTEMS, INC (MICHAEL T. RYAN) ( 9) 02/20/96 02/06/96 LTR FM DANIEL CASTRO REQUESTING COPIES OF PROPOSED AMENDMENT AND DOCUMENTS ON RADIATION DOSE LIMITS OF AIR EMISSIONS 03/04/96 03/01/96 COMMENT OF CALIFORNIA CHAPTER - ACNP (CAROLS. MARCUS) ( 10) 03/04/96 02/28/96 COMMENT OF NUCLEAR FUEL SERVICES, INC (ANDREW M. MAXIN) ( 11) 03/05/96 03/05/96 COMMENT OF MACK L. RICHARD ( 12) 03/08/96 03/05/96 COMMENT OFT. P. (PAT) BARTON ( 13) 03/11/96 03/08/96 COMMENT OF UNIVERSITY OF MISSOURI-COLUMBIA (RONALD J. DOBEY, JR.) ( 14)

DOCKET NO. PR-020 (60FR63984)

DATE DATE OF TITLE OR DOCKETED DOCUMENT DESCRIPTION OF DOCUMENT 03/12/96 03/11/96 COMMENT OF KERR-MCGEE CHEMICAL CORP.

(RICHARD A. MESERVE) ( 15) 03/13/96 03/06/96 COMMENT OF ENVIRONMENTAL COALITION ON NUCLEAR POWER (JUDITH H. JOHNSRUD, DIRECTOR) ( 16) 03/13/96 03/07/96 COMMENT OF SEQUOYAH FUELS CORP (JOHN H. ELLIS, PRESIDENT) ( 17) 03/13/96 03/08/96 COMMENT OF TENNESSEE VALLEY AUTHORITY (JESSE H. COLEMAN) ( 18) 03/13/96 03/11/96 COMMENT OF COMMITTEE TO BRIDGE THE GAP (JOSEPH LYOU) ( 19) 03/13/96 03/11/96 COMMENT OF HPS STATE AND FEDERAL LEGISLATION COMMITTEE (JAMES G. TRIPODES, CHAIRMAN) ( 20) 03/13/96 03/12/96 COMMENT OF NATIONAL MINING ASSOCIATION (RICHARD L. LAWSON) ( 21) 03/13/96 03/12/96 COMMENT OF NUCLEAR ENERGY INSTITUTE (JOHN F. SCHMITT) ( 22) 03/13/96 03/12/96 COMMENT OF B. GEARY ( 23) 03/13/96 03/12/96 COMMENT OF NUCLEAR INFORMATION &RESOURCE SERVICE (DIANE D'ARRIGO) ( 24) 03/13/96 03/12/96 COMMENT OF DOOLEY KIEFER ( 25) 03/13/96 03/12/96 COMMENT OF UNITED STATES ENRICHMENT CORP (ROBERT L. WOOLLEY) ( 26) 03/13/96 03/12/96 COMMENT OF AMERICAN COLLEGE OF NUCLEAR PHYSICIANS/SOC NUC MED (DAVID R. BRILL/PETER T. KIRSHNER) ( 27) 03/14/96 03/10/96 COMMENT OF WALBRIDGE J. POWELL ( 28) 03/14/96 03/12/96 COMMENT OF NATIONAL INSTITUTES OF HEALTH, RADIATION SAFETY BR (ROBERT A. ZOON/SHAWN W. GOOGINS) ( 29) 03/14/96 03/11/96 COMMENT OF E. I. DUPONT DE NEMOURS MEDICAL PRODUCTS (LEONARD R. SMITH) ( 30) 03/14/96 03/12/96 COMMENT OF NEW YORK DEPARTMENT OF ENVIRONMENTAL CONSERVATION (PAUL J. MERGES) ( 31) 03/15/96 03/07/96 COMMENT OF STATE OF NJ DEPT. OF ENVIRONMENTAL PROTECTION (ROBERT C. SHINN, JR., COMMISSIONER) ( 32)

DOCKET NO. PR-020 (60FR63984)

DATE DATE OF TITLE OR DOCKETED DOCUMENT DESCRIPTION OF DOCUMENT 03/15/96 03/11/96 COMMENT OF SIERRA CLUB - PENNSYLVANIA CHAPTER (P. GILBERT/J. JOHNSRUD) ( 33) 03/15/96 03/12/96 COMMENT OF VIRGINIA POWER (M.L. BOWLING) ( 34) 03/18/96 03/12/96 COMMENT OF SIERRA CLUB NATIONAL NUCLEAR WASTE TASK FORCE (JUDITH JOHNSRUD) ( 35) 03/18/96 03/06/96 COMMENT OF RALPH GRUNEWALD ( 36)

- 03/18/96 03/19/96 03/14/96 03/07/96 COMMENT OF SAINT BARNABAS MEDICAL CENTER (IRA M. GARELICK) ( 37)

COMMENT OF AMERICAN NUCLEAR SOCIETY (JOHN GRAHAM, PRESIDENT) ( 38) 03/26/96 03/15/96 COMMENT OF SHEPARD MILLER, INC (JANET A. JOHNSON) ( 39) 12/04/96 12/03/96 FEDERAL REGISTER NOTICE - FINAL RULE

DOCKET NUMBER PROPOSED RULE .:/D

( ~o fl<frJ3 ~gtJ)

NUCLEAR REGULAiJRY COMMISSION 10 CFR Part 20 RIN 3150-AF31 Resolution of Dual Regulation of Airborne Effluents of Radioactive Materials; Clean Air Act AGENCY: Nuclear Regulatory Commission .

ACTION: Final rule.

SUMMARY

The Nuclear Regulatory Commission is amending its regulations to establish a constraint of 10 mrem (0.1 mSv) per year total effective dose equivalent {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: {l) provide assurance to the Environmental Protection Agency (EPA) that future emissions from NRC l icensees will not exceed dose levels that EPA has determined will provide an ample margin of safety; and (2) to provide EPA a basis upon which to rescind its C1ean Air Act (CAA) regulations as defined in 40 CFR Part 61 for NRC 1icensed facilities (other than power reactors) and Agreement State licensees, thereby relieving these licensees from unnecessary dual regulations.

EFFECTIVE DATE: This rule will become effective 30 days after publication in the Federal Register.

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FOR FURTHER INFORMATION CONTACT: Alan K. Roecklein, Office of Nuclear Regulatory Research, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, telephone (301) 415-6223.

SUPPLEMENTARY INFORMATION:

Background

The EPA promulgated National Emission Standards for Hazardous Air Pollutants (NESHAPs) for radionuclides on October 31, 1989. Under 40 CFR Part 61, Subpart I, emissions of radionuclides must be limited so that no member of the public would receive an effective dose equivalent greater than 10 mrem (0.1 mSv) per year 1

• Subpart I of 40 CFR Part 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 accrrdance with 40 CFR Part 192. Radon-222 emissions from tailings were covered by 40 CFR Part 61, Subparts T (addressing non-operational uranium mill tailings piles) and W (addressing operating mill tailings piles). EPA rescinded Subpart T for NRC licensees after Appendix A to 10 CFR Part 40 was amended by the Commission to conform to changes EPA issued to 40 CFR Part 192. Subpart W still applies to NRC licensees. Because Radon-222 is adequately addressed in 1 Subpart I expresses dose in effective dose equivalent (EDE). NRC expresses dose in total effective dose equivalent (TEDE). These terms are essentially equivalent.

2

10 CFR Part 40, Appendix A, and other provisions of 10 CFR Part 20, it is not covered in this final rulemaking.

In 1990, Congress enacted amendments to the CAA. Section 112(d)(9) of these amendments to the CAA (the Simpson amendment) states:

No standard for radionuclide emissions from any category or 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 amp*le margin of safety to protect 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 condur:ted two studies of the air emissions from NRC and Agreement State materials licensees. The first was a survey of 367 randomly selected nuclear materials licens~es. EPA determined that the highest estimated dose to a member of the public from air emissions from these facilities was 8 mrem (0.08 mSv) per year, based on very conservative modeling. In addition, 98 percent of the facilities surveyed were found to have doses to members of the public resulting from air emissions less than 1 mrem {0.01 mSv) per year. The second study evaluated doses from air emissions at 45 additional facilities that were selected because of their potential for air emissions resulting in significant public exposures. EPA found that 75 percent of these licensees had air 3

. ,..:..~

emissions resulting in an estimated maximum public dose less than 1 mrem (0.01

• mSv) per year. For the licensees evaluated, none exceeded 10 mrem (0.1 mSv) per year.

In its initial proposal to rescind Subpart I for NRC licensees other than power reactors, EPA stated that:

'\

Based on the results of the survey undertaken by EPA and the commitments 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 public health (57 FR 56880; December 1~ 1992).

However, EPA continued to express concern regarding the adequacy of the measures to assure that future emissions from NRC licensees will not exceed levels that will provide an ample margin of safety.* The stay on Subpart I expired on November 15, 1992, and Subpart I became effective on November 16, 1992. Subsequently, in July of 1993, the EPA Administrator determined that there was insufficient basis at that time to rescind Subpart l. Consequently, NRC and Agreement State licensed facilities were subject to dual regulation of e airborne effluents of radionuclides under both the AEA and the CAA, including regulatory oversight by EPA (or authorized State) and NRC (or Agreement State).

NRC licensees subject to EPA's 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 Li~its for Individual Membe~s of the Public" (Subpart D). Under Subpart D, licensees shall ensure that doses to members of the public are less than 100 mrem (1.0 mSv) per year from all pathways 4

• (including airborne effluents) and all sources associated with the licensee's operation. In addition, under Subpart B, entitled "Radiation Protection Programs," licensees must ~nsure tha~~doses to members of the public be kept as low as is reasonably achievable (ALARA). Based on the studies conducted by EPA and licensee reporting of doses to members of the public from airborne effluents to EPA, it is evident that less than 10 mrem( 0.1 mSv) per year to the maximally exposed member of the public from airborne radioactive effluents to the environment is reasonably achievable.

NRC power reactor licensees subject to 10 CFR 50.34a must keep doses to members of the public from airborne effluents consistent with the numerical guidelines in Appendix I to 10 CFR Part 50. These licensees have reported estimated doses to members of the public from air emissions well below the Subpart I value for many years. Based_on the combination of a continuing regulatory basis for reduced air emissions and documented proof of the effectiveness of the NRC program for these licensees, EPA rescinded Subpart I for power reactors licensed by NRC (60 FR 37196; September 5, 1995).

Amendments The amendments proposed on December 13, 1995 (60 FR 63984), and finalized in this rule establish a constraint of 10 mrem (0.1 mSv) per year TEDE to members of the public from airborne radioactive effluents to the environment from NRC-licensed facilities, other than power reactors, as a part of its program to maintain doses ALARA. These amendments codify num~rical values for NRC's application of ALARA guidelines for 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 existing facility 5

-licensing conditions. These final amendments ensure that air emissions are maintained at very low levels and, taking into consideration the elimination of dual regulation, at some reduced cost to licensees. This action brings*

consistency between the EPA's dose standard and the NRC's ALARA application, and is expected to be the final step in providing EPA with the basis to rescind Subpart I as it applies to NRC-licensed facilities other than power reactors. NRC has been working cooperatively with EPA to achieve rescission of EPA's standards in 40 CFR Part 61, Subpart I, under Section 112(d)(9) of

• the CAA. EPA published a proposed rescission of 40 CFR Part 61, Subpart I, on

,December 1, 1992 (57 FR 56877). On September 28, 1995, EPA published a notice in the Federal Register reopening the comment period on rescission of Subpart I (60 FR 50161). The objective of this effort is to eliminate duplicative regulations that provide no incremental benefit in terms of public and environmental protection.

The regulatory framework that NRC is providing as a basis for rescission of EPA's Subpart I consists of the requirement in 10 CFR Part 20 to limit doses to members of the public to 100 mrem (1.0 mSv) per year, and the requirement*

to constrain doses to members of the public from airborne effluents of radioactive materials to the environment from a single licensed operation to 10 mrem (0.1 mSv) per year.

Currently, under§ 20.1501 licensees are required to make or cause to be made surveys that may be necessary to comply with the regulations in 10 CFR Part 20~ This data would be made available to inspectors upon request. If the licensee estimates or measures a dose to the nearest resident from air emissions greater than 10 mrem (0.1 mSv) per year, the licensee would be required to report the dose to NRC in writing within 30 days, which would 6

include the circumstances that led to the greate~ than 10 mrem (0.1 mSv) per year dose, a description of the corrective steps the licensee had taken or proposed to take to ensure that the constraint is not again exceed~d, a timetable ~r implementing the corrective steps, and the expected results.

Records of the results of measurements and calculations needed to evaluate the release of radioactive effluents to the environment will still be required pursuant to 10 CFR 20.2103(b)(4).

Exceeding this constraint will not result in a Notice of Violation (NOV) as

- would be the case if a limit needed for adequate protection of public health and safety were exceeded. In the case*of the constraint rule, an NOV will be issued only if and when (1) a licensee fails to report an actual or estimated dose from airborne. effluent releases from a facility that has exceeded the constraint value; or (2) if a licensee fails to institute agreed upon corrective measures intended to prevent further airborne effluents in excess of those which would result in doses exceeding_the constraint leveli The rule applies-to a~rborne effluents of radioactive materials to the environment, other than Radon-222 and daughters, from all NRC licensees except power reactors. Power reactors are exempt from this rul~ because they are already required, under 10 CFR 50.34a, to identify design objectives and the means to be employed for keeping doses to members of the public from air effluents ALARA in their license ~pplication. Appendix I to 10 CFR Part 50 contains the numerical guidelines to meet this requirement.

Response to Comments Fifty-seven individuals and organizations provided written comments on the proposed rule and Draft Regulatory Guide DG-80i6. Among the 57 commenters, 24 7

were licensees, seven were professional organizations, five were States, 16 were members of the public, and five were environmental organizations .

. Because many letters commenting on the Draft Regulatory Guide DG-8016 also included comments on the rule, th~se comments were also considered in developing the final rule.

Issue !--Proposed Rule Approach Comments: A total of thirty-one individuals and organizations commented on the basis for the rule. Five commenters agreed with the approach and need for the constraint. Four commented that the rule should not be finalized and that EPA's Subpart I should remain in effect. Twenty-two commenters stated that existing NRC programs provided an ample margin of safety and that the constraint was not needed. However, of these, seven agreed that the constraint was preferable to dual regulation or Subpart I alone.

Those commenting thatexisting NRC programs are adequate to protect the public cited the two EPA studies on doses from air emissions. Two-thirds of these commenters were opposed to going forward with the constraint because they believed it was not needed and that licensee and regulator costs could not be justified given the expectation that risk to public health and safety 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 of an equally unnecessary regulation. A few commenters stated that I

the risk was considerably less than estimated because excessively conservative calculational methods were used by E~A. A few commenters compared the 10 mrem (0.1 mSv) per year constraint to variability in background or doses from 8

commercial air traffic as evidence that the dose and the risk is trivial.

Seven commenters cited burden reduction ar.d single-agency oversight as the reasons for agreeing* that the constraint was* preferable to dual regulation *or EPA's Subpart I al one.

• 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 pub l .i c. One commenter stated that NRC does

• not perform confirmatory measurements and therefore, .NRC juri sdi ct ion was not

- adequate.

Response: NRC and EPA have been working .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 (0.1 mSv) per year to a member of the public.

This has been demonstrated through the two studies by EPA and by licensee reporting of actual air emissions. The second component is a program to*

ensure that doses remain at this level. In the absence of rulemaking requiring licensees to maintain doses to levels of no more than 10 mrem (0.1 mSv) per year, EPA would not rescind Subpart I and dual regulation would continue.

The Federal Radiation Council (FRC) was formed in 1959, to provide recommendations to the President for Federal policy regarding radiation matters that affect health. In May 1960, FRC set forth .basic principles for protection of both workers and the public. The council was abolished in 1970 when its functions were transferred to the EPA Administrator. In 1981, EPA published proposed recommendations for new Federal guidance for occupational 9

exposure. In 1987, President Reagan approved recommendations by the EPA Administrator for new "Radiation Protection Guidance to Federal agencies for Occupational Exposure." EPA has not Jet issued recommendations on limits for the public. A working group comprised of representatives from affected Federal agencies and exp~rts on radiological health matt~rs has been developing these recommendations for several years and expects to provide them during the next year ..

In 1977, the Internatio~al Council on Radiological Protection (ICRP) i~sued its Report No. 26 "Recommendations of the International Council on Radiological Protection" in 1977. These recommendations concluded that the average doses to member~ of the public should not exceed 100 mrem (1.0 mSv) per year with a limit of 500 mrem (~.O mSv) per year to any individual.

The National Council on Radiation Protection and.Measurements (NCRP) is required by Congress to recommend limits for exposure to ionizing radiation.

In June 1987, NCRP issued its Report No. 91, "Recommendatioris on Limits for Exposure to Ionizing Radiation." This report contains recommendations on exposur~ 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 rnrem (1.0 mSv) per year averaged over a lifetime. not to exceed 500 mrem (5.0 mSv) in 1 year.

In 1991, NRC revised 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 (5.0 mSv) in any one year, the NRC established a limit of 100 mrem (1.0 mSv) per year because it was impractical to control dose in terms of lifetime average without keeping track of individual exposures. In addition, 10 CFR Part 20 10

.requires that licensees use procedures and engineering controls to maintain doses ALARA .

. Both the NRC and EPA regulatory programs are designed to achieve protection of the public with an ample margin of safety. The approaches of the two agencies differ. NRC limits TEDE, requires that doses are maintained ALARA, and maintains an active inspection program. EPA limits dose from individual pathways *of exposure and individual radionucl ides to ensure that the total dose does not exceed recommended levels. Both p*rograms achieve similar 1evel s 9 of protection.

NRC agrees that adoption of the constraint in§ 20.ll0l(d) is preferable to dual regulation due to the reduction in burden on 1i censees as we 11 as s;tate and. Federal agencies~ Under the provisions of 40 CFR Part 61, licensees with doses to members of the public greater than 1 mrem {0.1 mSv) per year but less thani! 10 mrem (0.1 mSv) per year must submit reports. However, under 10 CFR 20.ll0l(d), these licensees will not have to file reports for doses below the.

constraint level because doses cah be ~valuated during routine inspections~

e Under the finai rule, the burden of calculating doses should be reduced for most licensees because the proptised guidance foi demonstrating compl.iance with 10 CFR 20.ll0l(d) allows significantly more flexibility and simpler methods for calculating doses than the model currently used to demonstrate compliance with 40 CFR Part 61. These new methods for calculating doses should result in fewer reporting and corrective actions, as unde~ EPA's Subpart I.

Licensees are required under§ 20.2103 to maintain records of surveys required to demonstrate compliance with the public dose limit. Review of licens*ee records used to demonstrate compliance with the public dose limit is part of the.NRC inspection program. Confirmattiry measurements would generally 11

not be useful since most licensees in this category do not have routine ongoing effluent releases.

Finally, concerning those commenters that believe NRC's requirements are*

less safe than Subpart I, Congress enacted legislation comprehensively amending the Clean Air Act (CAA), .which included a section addressing the issue of regulatory duplication between EPA and NRC in 1990. The 1990 CAA amendments permit the EPA Administra~or to rescind the CAA standards as they apply to radionuclides, at sites licensed by NRC, and the Agreement States, if he or she finds that the NRC regulatory program provides an ample margin of safety to protect public health ..

EPA's analysis of the NRC. regulatory program foc~sed 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 Qf the public with an ample margin of safety. The implementation of this rul~ will ensure that doses to members of the public from air effluents will continue to remain below 10 mrem (0.1 mSv) per year and provide evidence to EPA that the current level of protection will continue.

The purpose of this rulemakin~ is not to reduce doses, because it has already been demonstrated that doses are sufficiently low. The purpose is to ensure that doses are maintained at the low level currently achieved by NRC licenseesi eliminate unnecessary dual regulation, and reduce costs associated 12

with the current level of protection, by providing a basis upon which EPA can find that doses will not increase as a result of rescission of Subpart I.

Issue 2 --Promulgation of the Constraint as ALARA Comments: There were a number of commenters who objected to the ALARA basis for the proposed constraint rule. Some commenters objected on the giound that ALAR.~ is a matter of operating philosophy, good radiation protection practice and licensee judgment, and cannot be translated into an enforceable dose number. Other commenters objected on the basis that ALARA is inherently site specific and cannot be defined generically or that the proposed dose constraint cannot be ALARA but must be a limit because the constraint contemplates some enforcement actions for exceedance even if the licensee has followed all good radiation protection practices. Some commenters argued that the rule cannot be ALARA because it adds costs with no I-safety benefit. Other commenters stated that the constraint is inconsistent with a prior NRC decision in 10 CFR Part 20 (56 FR 23360) on the use of "reference levels."

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 10 CFR 20.1003 is an operating philosophy which requires good radiation protection practice and the exercise of expert lice~see judgement. The ALARA concept is site specific in that some of the factors to be considered may vary from case to case, as the court so found in York Committee for a Safe Environment v.

NRC, 527 F. 2d 812 (D.C. Cir. 1975). The Commission has presumed, without 13

deciding, that the ALARA concept in§ 20.1003 can be enforced in a particular case so as to require a specific radiation protection practice, but it is clear that the existing regulation does not translate readily into a generic dose number, which, if exceeded, will lead to enforcement action.

The NRC intended the constraint rule to be a somewhat broader concept found in the governing statute, the Atomic Energy Act of 1954, as amended (Act).

The Act, as construed by both the Commission (e.g., 10 CFR 50.109) and the c~urts (Union of Concerned Scientists v. NRC, 824 F.2d 108 (D.C. Cir. 1987)),

contemplates two distinct approaches to radiological regulation. First, a level of "adequate protection" must be defined and enforced without regard to economic ~ost. 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 FR 20603; June 6, 1988). It is important to note that Section 161b of the Act authorizes the Commission to adopt and enforce generic requirements using either approach.

Many recent NRC regulations (e.g., 10 CFR 50.63) have been directed at incremental risk reduction under the second approach based on a generic regulatory or backfit analysis which considered and balanced economic and other costs and safety backfits. These "minimize danger" regulations provide "limits" because they establish generic requirements directly enforceable against licensees. However, in a broad sense they are also ALARA regulations because cost, feasibility, and other relevant factors identified in 10 CFR 20.1003 are evaluated.

Viewed in its larger statutory context, the use of ALARA in 10 CFR 20.1003 is one means to implement the second approach to radiological regulation.

14

However, other similar requirements can also be part of this second approach.

While the ALARA concept in 10 CFR 20.1003 may not be consistent with a generic Enforceabl2 dose requirement, other concepts of ALARA premised on generic considerations are appropriate. This concept of ALARA as a broadly applicable dose requirement based on a generic weighing and balancing* of health and safety~ feasibility, and other factors is the basis for the longstanding lfmits on nuclear power reactor emis~ions in 10 CFR Part 50, Appendix I, and is the basis for the constraint rule. The ALARA rule imposes a limit in the sense that exceedance will lead to corrective action, but it is not a limit in the seriie that exceedance p~r s~ would.constitute a violation of any regula_tory requirement. A violation occurs only when a licensee fails td*t

• report an exceedance or fails to take appropriate correctfve actions. A limit would be appropriate if compliance were needed to ensure adequate protect i ori -

- of public health and safety. In thi~ case, the co~straint is needed only to ensure that currently afforded levels of protection are not reduced: This will provide the basis for rescission of 40. CFR Part 61, Subpart I by EPA.

• • -** Thus, to say that the constraint rule cannot.be based on AL.ARA because it is in effect a "limit," interchanges-a na_rrow concept of ALARA" with a broad

• conce_pt.of "limit."

If a broad definition is used, the constraint rule witffstands scrutiny as both ALARA and a limit; In the statutory context of the Atomic Energy Act and general principles of administrative law, the constriint rule is a limit based on generic ALARA considerations. The constraint rule is not a limit needed for adeqµate protection and th~

constraint rule is somethi~g more than a narrow translation of the particula~

ALARA concept contained in 10 CFR 20.1003. The term "constraint" was used for 15

the rule to avoid confusion with the narrow concepts of ALARA ind the limit employed in radiation pr6tection discussion ..

Three matters must be addressed:

( 1) The comment that* the rule cannot be based on ALARA because it *wn l result in increased cost.with no safety.benefit; (2) The problem of the licehsee*who cannot meet the dose constraint despite ~sing all good rad~ation protection practicei; and (3) The allegedly inconsistent Commission discussion of reference levels in a recent revision to 10 CFR Part 20.

• . The Commission disagrees w_ith the premi$e of the first comment. There was*

no disagreement with the Coml!ii.ssion's conclusion that all of the licensees affected by*the *rule are~achievinga level of control such that doses are*

• oe low the 10 mrem (0 .1 .mSv) per year level and so there is no factual ai spute over whether th~s level of r~diation protecti~n is readily achievable. The final rule and EPA's resc:iss*ion of.*tts*ciean Air Act emission limits and --

related requirements will result in a sigriificant net cost savings to licensees. The NRC acknowledges that the positive direct health effects are likely to be small.and possibly nonexistent in the near future, given the current level of-~ontrols. However, the rule can be said to offer a small, but positive, net health and safety benefit in that it will prevent a decrease in the level of protection afforded the public if Subpart I were rescinded in the absence of a rule like the constraint.* Under the ALARA concept, it is appropriate to base a requirement on a small positive health and safety benefit wHen cost savings are also likely.

The NRC does not expect that any licensee subject to the rule will be unable to demonstrate that doses to members of the public from releases of 16

-airborne radioactive materials to the environment are less than 10 mrem (0.1 mSv) per year. In the unlikely case that this dose is exceeded or is projected to be exceeded, due to some temporary circumstances or lapse in

• controls, the NRC expects the licensee to take whatever corrective actions are necessary (if any) to protect public health and safety, *to report the dose, to recommend further corrective actions if necessary, and take those corrective actions agreed upon with NRC. N~C staff will review and approve corrective actions to ensure that they are appropriate to reduce airborne emissions

• sufficiently to comply with the constraint in the future. In the unlikely case that a licensee is unable to take adequate corrective actions, because of limits in technology or cost constraints, these issues can be addressed tn the future on a case-by-case basis.

The application of the ALARA principle used in this rule is not the same as the concept of reference level which wa~ rejected by the Commission when 10 CFR Part 20 was recently revised. Commenters on the 1991 revision to 10 CFR Part 20 objected to the use of reference levels because they were~

implemented exactly the same as adequate protection limits. For that reason, the Commission did not adopt reference levels in the 1991 revision.

Implementation of the constraint is different than such a limit because exceeding the constraint is ~ot a violation, and only requires the license~ to report the dose and take corrective actions to reduce future doses.

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 commenters believed that the constraint.was no 17

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 :ha: a second exceedance of the constraint would result in enforcement action and therefore the constraint is a limit. Three commenteis indicated that the rule should be a strict limit. They expressed

• concern that the constraint was less protective than EPA requirements.

Response: If a licensee exceeds a limit that is needed to protect health and safety, the NRC may take immediate enforcement action. If a licensee exceeds a constraint, the licensee will be required to notify NRC, take any actions that may be necessary to protect public health and safety, and implement any further corrective actions that NRC staff agrees are adequate to prevent further doses in excess of the constraint. However, if the licensee failed to report a measured or calculated dose in excess of the constraint to NRC or failed to implement appropriate corrective actions as agreed upon, enforcement action would be expected. This is because, unlike an adequate protection limit, the constraint is not needed to provide adequate protection of public health and safety.

The NRC does not agree that the constraint is less protective than current EPA requirements. Both EPA's Subpart I and the NRC constraint require licensees to take actions to ensure that doses to members of the public do not exceed 10 mrem (0.1 mSv) per year from ambient air emissions. NRC routinely inspects licensed facilities to ensure that air effluents do not result in doses to members of the public that exceed the requirements in 10 CFR Part 20.

The inspection and enforcement program will be amended as a result of this 18

final rule to review licensee records used to demonstrate compliance with the constraint.

Issue 4 --Citizen Suits.

Comments: Three commenters opposed finalization of the constraint. .on the basis that it forfeits citizen rights to sue a licensee who exceeds the constraint.

• Response: The Commission's regulations in 10 CFR 2.206 provide the public with the right to petition the NRC to take enforcement action against a licensee for a violation of the Commission's regulations. This would incTude the final constraint rule.

Issue 5 --Agreement State Compatibility.

Comments: Four commenters addressed the proposal that the constraint:be a e Division 2 matter of compatibility. Under Division 2, States could adopt similar or more stringent. requirements. Three commenters agreed that this rule should not be codified as a Division 2 requirement, but rather as a Division 1 matter of compatibility. Under Division 1, the States would be required to adopt regulations that were essentially identical. These commenters believed that if stricter standards were permitted, reactor and non-reactor licensees would be under different requirements and certain practices, such as nuclear medicine, could be jeopardized. One commenter noted that because this is really a limit, it should be under 10 CFR 20.1301 and would be a Division 1 matter of compatibility. Another commenter stated 19

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 2pend scar:e resources to develop a co~patible rule.

Response: Section 116 of the Clean Air Act specifies that nothing precludes States from imposing air emission requirements that are more stringent*than those developed by EPA. Section 116(d){9), which contains the provisions related to EPA's margin of safety determination for NRC or Agr~ement 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 r~specting 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 ~revision clarifies that EPA's determination regarding NRC and Agreement State licensees has no effect on the e~isting authority of States to impose air emission standards that are ~ore stringent than those of EPA.

With regard to the comment concerning involvement of t_he 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 {OAS) and the Conference of Radiation Control Program Directors {CRCPD) at each of their an~ual meetings. The Agreement States were consulted extensively on this issue over the last several years.

There were extensive discussions of the concept with the individual States and with the Executive Board of the OAS.

20

Issue 6 --Demographic Information Contained in Required Reports.

Comments: Seven commenters addr~wsed the application of the requirement contained in 10 CFR 20.2203(b)(2) to the constraint. This section requires reports to contain demographic information on the exposed individual. These commenters expressed concern that a member of the public would be under no obligation to provide demographic information to licensees and that licensees would not always be able to comply with the requirement.

Response: NRC agrees that members of the public may choose to withhold the demographic information from licensees. Such information is only needed for occupationally exposed individuals to ensure that lifetime exposure records are accurate. Section 20.2203 has been changed to only require such information on occupationally exposed individuals.

Issue 7 --Effective Date.

Comment: One commenter requested that an effective date be added to the final rule to coincide with EPA's rescission of Subpart I.

Response: The NRC and EPA will, to the extent possible, publish both final rules so that they become effective concurrently.

Issue 8 --Enforcement.

Comments: Five commenters stated that NRC should establish a limit rather than a constraint. They believed that if the limit has been exceeded, a notice of violation and civil penalties should always result. One commenter 21

expressed concern that "self-reporting and confession" is not adequat~.

Another stated that because ALARA is only guidance, it is not enforceable.

Response: ALARA is not guidance. As stated previously, the 1991 revisfon to 10 CFR Part 20 codified ALARA as a required part of the licensee's radiati~ri protection program. A limit often implies that doses must be controlled below that level in ord~r to provide adequate protection of health and safety of the public and workers. To meet ALARA requirements licensees are currently controlling effluents to levels below that which would be required under the const~aint.

• If a licensee exceeds the constraint, the rule requires that this be reported and that corrective actions be promptly taken.

If i licensee does not comply with the obligation to report and take corrective actions, enforcement action will result. In NRC's judgement, as a matter of enforcement policy, it is not necessary to issue a notice of violation or civil penalties upon exceedence of the constraint level; it is sufficient that this be reported and that prompt corrective action is taken.

Issue 9 -~Exemptions Comments: Five commenters stated that the rule should only apply to members of the public off site. They cited the EPA's Subpart I requirement to calculate dose to th*e nearest resident or offsite individual likely to receive the highest dose. Under Subpart I, licensees would not calculate doses from air emissions to. visitors in hospitals. workers that are not radiation workers within the facility, or other members of the public within the facility ..

Response: The language in the rule ~as been changed to reflect that it is intended to apply to radioactive airborne effluents to the environment. The 22

Draft Regulatory Guide DG-8016 will be revised to indicate .that the dose limit is to be calculated or measured at the nearest resident or individual offsite likely to receive the highest dose. The final regulatory guide will be available when the rule becomes effective.

Comments: Two commenters stated that air emissions from adjacent nearby exempt ur~nium mills should not be includ~d in the calculation of dose. One commenter stated that materials from un l i cens.ed portions of the facility. such.

as ore stbckpiles should not be considered in the calculation *of dose.

Response: Subpart I does not apply to disposal at facilities regulate~,

under 40 CFR Part 191,- Subpart 8, or to any uranium mi 11 tailings pile af,ter it has been disposed of under 40 CFR Part 192. The constraint applie~ to airborne effluents of only licensed materials to the environment. Draft Regulat~ry Guide DG-8016 will be changed to clarify that windblown particulates from other licensed facilities o~ unlicensed material~ do not need to be considered in the calculation of doses used to demonstrate compliance with the constraint.

Comments: Four commenters stated that air emissions from patients should be exempted from this rule.

Response: The regulatory impact analysis (NUREG-1492) for a recent NRC rulemaking analyzed potential .doses from exposure to patients who were released after administration of radiopharmaceuticals. This analysis concluded* that internal doses from innalation of radioactive materials in the exhaled air of a released patient are trivial. For licensees using an inventory approach to demonstrating compliance with the rule, such as the 23

.COMPLY ccimputer code, the~e is no need to acco~nt specifically for the materials that might be released to the air through respiration or transpiration by patients. The Regulatory Guide will make it clear that dose from air emissions from patients do not need to be speciffcally addressed in th~ calculation of dose used to demonstrate compliance with the constraint.

Comments: Four commenters*stated that in addition to Rn-222; all daughters produced after release.should alsQ be excluded.

Response:

• EPA's Subpart I exempts both Rn-222 and ahy daughters. produced after release of Rn-222 because these types of releases are 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.

Comments: Two commenters recommended that in addition to Rn-222, Rn-22O

• and its daughters should al so be exempted. One comme.nter stated that it was an EPA oversight that led to this erroneous omission from the final Subp~rt I.

Response: Rn-22O is normally attributable to licensed activities. EPA*

does not exempt Rn-22O or its daughters from consideration. in the dose calculations in support of demonstrating compliance with Subpart I. The commenter's suggestion that an oversight led to the erroneous omission of this exemption from Subpart I is incorrect, and Rn-22O should not be excluded from the calculations that are used to demonstfate compliance with the constraint.

Comments: Six commenters requested t~at in addition to sealed source$,

sealed containers should also be excluded from the rule.

24.

Response: Paragraph 2(a) of Appendix D to 40 CFR Part 61 states:

Radioactive materials in sealed packages that remain unopened, and have not leaked during the assessment period should not be included in the calculations:n Subpart I exempts sealed packages, because any package that has remained sealed cannot contribute to airborne effluents; When a total inventory of licensed materials possessed during the year is used to model potential doses, it is unnecessary to include materials that could not have contributed to airborne effluents, The Regulatory Guide will provide further.

e guidance on this issue.

Issue 10 ~-Measurability of 10 mrem (0.1 mSv) per year.

Comments: Three commenters stated that 10 mrem (0.1 mSv) per year was not measurable. One commenter stated that although 10 mrem (0.1 mSv) per year might be easily achievable, it is not easily measurable.* Another stated that the exposure rate corresponds to 1 microR (0.01 micro-Sv) per hour and lannot.

be m~asured accurately.

Response: Draft Regulatory Guide DG-8016 provides several methods for demonstrating compliance with the constraint, and only one of the methods described would require direct measurement at the receptor location. If this method is not practical due to the emission characteristics of the radionuclide releases, ~here are other options cited in Draft Regulatory Guide OG-8016 that do not require a direct measurement to demonstrate compl_iance with the constraint.

25

. \

Issue 11 --Scope of the Rule Comments: . One commenter stated th.:.t if there must be a constraint, it.

should apply to all licensees, including power reactor licensees.

Response:. Although this ,*ule only applies to licensees other than power reactor licensees, the Commission's existing regulations in 10 CFR Part 50, Appendix I, already establish a similar regulatory framework for power reactors. Appendix I includes separate requirements to develop design objectives and operational levels sufficient to 'demonstrate compliance with EPA's Subpart I. In. addition, reactor licensees must annually report quantities of radioactive materials yeleased into the environment, as well as the resulting doses.

Issue 12 --Location of Constraint in.NRC Regulations.*

The Commission requested specific comment on the question of whether the 10 mrem (0.1 mSv) per year constraint should be established in 10 CFR Part 20 as proposed or whether it should be established separately in each appropriate part of-Title 10 instead.

Comments: Two comments were received in response to this issue. One commenter stated that the constraint should be in 10 CFR Part 20. The other commenter stated that the constraint should be in each appropriate part. Two other commenters stated that it should be in § 20 .1301 with the dose limits.

Response: While the constraint could just as easily be included under other parts of the regulations, including it in 10 CFR Part 20 provides 26

uriiformity. Because 10 CFR Part 20 is the designated area for radiation protection standards and related requirements, it is the appropriate location for the constraint. The rule ~ill be codified under§ 20.1101 to make it clear that although the constraint is not the same as a limit, licensees are expected to develop radiation programs to ~nsure that doses from air emissions are below 10 mrem (0.1 mSv) per year.

Agreement State Compatibility The Commission believes that the Division 2 compatibility designation for th~ rule is consistent with state authoritj in this area as described in the Clean Air Act. The Division 2 designation means that Agreement States mqst address these rules in their regulations but may adopt requirements more .::I

• "I restrictive than those of NRC. Accordingly, the authority of the Agreement States to impose air emi ssi ans standards _under their Atomic Energy Act authority after the effective date of this rule will be consistent with their existing authority.* Under Section 274 of the Atomic Energy Act the Commission reviews Agreement State programs to ensure that adequacy and compatibility of the State Program is maintained.* The Commission has also approved procedures to suspender terminate programs that are not adequate or compatible.

Summary of Changes in the Final Rule Based on the responses to comments, a few chang~s were made in the final rule. Otherwise, the provisions of the final rule are the same as those presented in the proposed amendments. Specific changes to the final rule are summarized as follows:

27

(1) Section 20.2203(b)(2) has been changed to r~quire the name, social security number, and date of b~rth only for occupationally overexposed individuals and not for members of the public who have received doses in excess of the public limits, including the constraint.

(2) The language of the rule has been changed to indicate that Rn-:-222and all daughters produced after the release of the radon are categorically excluded'fiom this rule.

(3) The language of the rule has been changed to indi.cate .that the constraint applies only to release of airborne radioactive ~ffluents to the environment and, thus~ dose to the nearest resident, offsite business or school, is to be constrained.

In addition, the following changes will be made to.Draft Regulatory Guide DG-8016:

. (1) An inventory of radioactive materials used to model a potential dose to a member o_f the public need not include radioact_ive materials in sealed

• containers that have remained sealed throughout the compliance period.

(2). Airborrie emissions of-radioactive materials from patients does not need to be considered if the materials have already been in.eluded in the sit2 inventory.

The Regulatory Guide was., issued in draft for public comment concurrent with the proposed rule.* The final regulatory guide will be available by the effective date of this rule.

Conforming Amendments To NRC's tnforcement Policy By separate notice in the Federal Register, the Commission is modifying its "General Statement of Poli*cy and Procedures for NRC Enforcement Actions" 28

.(Enforcement Policy}, to address the new regulation, and to provide an example Severity Level IV violation of the constraint. This change will also be reflected when the Enforcement Policy is reprinted in its entirety in the next revision of NUREG-1600.

Small Business Regulatory Enforcement Fairness Act In accordance with the Small Business RegulatQry Enforcement 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, Office of Management and Budget.

Finding of No Significant Environmental Impact The Commission has determined under the National Environmental Policy Act of 1969, as amended, and the NRC's regulations in Subpart A of 10 CFR P~~t 51,

- that this rule, if adopted, would not be a major Federal action significantly affecting the quality of the human environment and therefore, an environmental impact statement is not* required. This action is not expected to have any significant environmental impact because the programs will provide equivalent protection. Also, airborne effluents of radioactive materials to the environment are not expected to increase. The changes to the final rule are to the procedural methods for demonstrating compliance as well as licensing and inspection procedures. The environmental assessment and finding of no significant impact.on which this determination is ba'sed are available for 29

• inspection and photocopyiny 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.

The public reporting burden for this collection of information is estimated -

to average 80 hours9.259259e-4 days <br />0.0222 hours <br />1.322751e-4 weeks <br />3.044e-5 months <br /> per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. Send comments on any aspect of*this collection of information, including suggestions for further reducing this burden, to the Information and Records Management-Branch (T-6 F33), U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, or by Internet electronic mail to bsjl@nrc.gov; and to the Desk Officer, Office of Information and Regulatory Affairs, NEOB-10202, (3150- -

0014), Office of Management and Budget, Washington, DC 10503.

Public Protection Notification The NRC may not conduct or sponsor, and a person is not required t~ respond to, a collection of information unles~ it displays a currently valid 0MB control number.

30

Regulatory Analysis The NRC has prepared a regulatory analysis for .this final rule. The analysis 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 may be obtained from Alan K. Roecklein, Office of Nuclear Regulatory Research, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, telephone'(301}

415-6223.

Regulatory Flexibility Certification In accordance with the Regulatory Flexibility Act of 1980, (5 U.S.C.

- 605(b, the Commission certifies that this rule 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 of radioactive material who would be required to report the exceedance to the NRC. It will relieve licensees from the unnecessary burden of dual regulation. The level of air emissions from NRG-licensed facilities has historically been well below the NRC dose limit and except for a few unusual cases, readily met the EPA standard. 31

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, a backfit analysis is not required for this final rule because these amendments do not involve any provisions which would impose backfits as defined i~ 10 CFR 50.109(a)(l). 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 disposal. 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

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, 32

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§ 20.1003, the definition of Constraint is added to read as follows:

    § 20.1003 Definitions.

Constraint (rlose constraint) means a value above which specified licensee

 - actions are required.

3. In § 20.1101, paragr~ph (d) is added to read as follows:

     § 20.1101 Radiation Protection Programs.

(d) To implement the ALARA requirements of§ 20.1101 (b), and. notwithstanding the requirements in§ 20.1301 of this part, a constraint on - air emissions of radioactive material to the environment, excluding Radon-222 and its daughters, shall be established by licensees other than those subject to§ 50.34a, such that the individual member of the.public likely to receive the highest dose will not be expected to receive a total effective dose equivalent in excess of 10 mrem (0.1 mSv) per year from these emissions. If a licensee subject to this requirement exceeds this dose constraint, the licensee shall report the exceedance as provided in§ 20.2203 and promptly take appropriate corrective action to ensure against recurrence. 33

4. In§ 20.2203 a new paragraph (a)(2)(vi) is added and paragraphs (b)(l)(iv) and (b)(2) are revised to read as follows:

-§ 20.2203 Reports of exposures, radiation levels, and concentrations of _radioactive material exceeding the constraints or limits. (a) * * * (2) * * * (vi) The ALARA constraints for air emissions established under

§  20.llOl(d); or (b}                  *          *

(1} * * (iv) Corrective steps taken or planned to ensure against a recurrence, including the schedule for achieving conformance with applicable limits, _ALARA constraints, generally applicable environmental standards, and *associated license conditions. (2} Each r.eport filed pursuant to paragraph (a) of this section must include for each occupationally overexposed7 individual: the name, Social Security account number, and date of birth. The report must be prepared so 'that this information is stated in a separate and detachable part of the report. 4- _- Dated at Rockville, Maryland, this J- day of December, 1996. For the Nuclear Regulatory Commission. Commission. 34

~~ t Dcsic..µ~ '04-

                                                            ~

DOCKETED to< (i:, USNRC -9..,:1c,.;.,..~~...__~

~l::fl..S                                  SHEPHERD                          MILLER ii,ii-,.14-l*i-iii*i "96 MAR 26 P4 :02 March 15, 1996 Ms Charlene Raddatz Office of Nuclear Regulatory Research U.S. Nuclear Regulatory Commission DOCKET NUMBER PR PROPOSED RULE...:...;....-ca., _ _ _

Washington, DC 20555 (bDrR~9~~

Dear Ms Raddatz,

The following are comments regarding Draft Regulatory Guide DG-8016 issued in conjunction with the Proposed Rule "Constraint Level for Air Emissions of Radionuclides" published in the Federal Register on Wednesday December 13, 1995 (FR Vol. 60, No. 239, p 63984):

1. The preamble to the proposed rule refers to estimation or measurement of dose to a member of the general public. However, the Draft Regulatory Guide, in its section on acceptable methods of calculating dose to an individual, does not include the use of measured air concentrations at the point of exposure, only measured concentrations at the point of release.

While the use of real measurements can involve some uncertainty, in general, modeling introduces greater uncertainty. The Regulatory Guide should include acceptable criteria and methodology for using real concentration measurements in estimating potential doses to members of the public. In addition, in the formula for determining average air concentration at the receptor, the fraction of the time the wind blows toward the receptor of interest is assumed to be 1.0 for a single "puff" release; however, there is no provision in the equation given to account for the short period of time for the "puff" release. The example given in the Sample Report does incorporate a method for determining the annual average concentration, but it is not explicitly given in the body of the Draft Regulatory Guide.

2. The calculation of dose in the Sample Report given in the draft regulatory guide appears to include several errors. The calculation apparently assumes that the 1-131 is completely mixed in the laboratory air and that the concentration at the doorway remains constant over a 24 hour period. Using this assumption, the average concentration for the three 24-hour periods is not the sum of the amounts of I-131 used divided by the room volume as described in the sample, but is the average of the three source activities.

(1.2 + 0.8 + 0.6)µCi/3 = 0.88 µCi Dividing that value by the volume of the room, 2.7 E7 ml, gives an average concentration of 3.2 x 10-3 µCi/ml: Consulting Environmental t!r Geotechnical Enginem t!r Scientists 3801 Automation Way, Suite 100 Fort Collins, CO 80525 kkn wfed 'PlAR 2 8 199& Phone: (970) 223-9600 o ged by card .................~.~. Fax: (970) 223-7 17 1

U.S. NUCLEAR REGULATORY COMMISSIOI\ DOCKETING & SERVICE SECTION OFFICE OF THE SECRETARY OF THE COMMISSION Document Statistics Postmark Date~ 'QQ ~ C.:J<r£iiO~ Coples Received_1--- - - - -* C.) Add'! Copies Reprodueed ~ - - - - Special Dlstribubon _q;MM,1;w.a>>:.M>.--.,.._- -

0.88 µCi/2.7 X 107 ml = 3.2 X 10-s µCi/ml As per the Sample Report dose calculation, the annual dose can be estimated by comparison of the estimated concentration, adjusted for exposure time, to the 10CFR20 Appendix B, Table 2 effluent limit, 2.0 E-10 µCi/ml, which represents a committed effective dose of 50 mrem. Dose = (50 mrem/y)(3 .2 x 10-8/2.0 x 10-10)(72 hours/8760 hours/yr) = 65 .8 mrem The sample calculation in the Draft Regulatory Guide appears to be in error in two ways.

1) The total activity used in the lab over the period of time in question was used to calculate an average concentration over a 24 hour period, rather than the average activity used.

2) The comparison to the effluent limit is low by a factor of 10. The average annual concentration given in the sample calculation, 7.9 E-10 µCi/ml, is 400% of the effluent limit, 2.0 E-10 µCi/ml not 40 %.

In addition, the assumptions on which the sample calculation were based are unreasonably conservative. Assuming an instantaneous release of the activity and a very low ventilation rate, 0.2 air changes per hour, the average activity concentration over a 24 hour period would be approximately 14 mrem, less than the concentration given in the example. While the method of calculation used in the Draft Regulatory Guide Sample Report is conservative, it may give misleading doses and result in the assumption that the constraint has been exceeded when, in fact, the dose is less than 10 mrem/year. I appreciate your willingness to consider these comments even though the comment period officially ended on March 12, 1996. Please call me at 970-223-9600 if you have any questions .

AMERICAN NUCLEAR SO 555 North Kensington Avenue Tel: 708/ 352-6611 La Grange Park, Illinois E-Mail: NUCLEUS@ans.org

                                                       '96 MAR 19 p 4 :s 1                          60526 USA                                Fax: 708/ 352-0499 OF lrE    1.,   ul
                                                                      . s,-,,,
                                                                           ,_v .....;-T, 1,Jy Doc       rE-"'f' ,. r--*                 1c 1-Dr. Shirley Jackson Chairman 1\ . 1 I, .,L: c. . ,., .: .*\ , 1  * .*

DOCKET PROPOSED NlNBERPR RULE ~ Nuclear Regulatory Commission Mailstop 16015 ((oDFRJo~9~~ Washington, DC 20555 Thursday, March 07, 1996 Draft Regulatory Guide DG-8016

Dear Dr. Jackson,

The attached letter to the Rules Review and Directives Branch of your agency is the official comment by the American Nuclear Society on the proposed rescission of 40 CFR Part 61 Subpart I and the implementation of DG-8016 (Revision 1 to Regulatory Guide 8.37.) In summary, we agree with the proposed action in the interests of avoiding dual regulatory oversight, making note of the need to exclude radon from the 'constraint limit' and noting also that the proposed consn*aint should not be coupled with the ALARA concept. So much for the rule. I would now like to raise, in this covering letter, a wider issue. As a you know, the emission constraint level of 10 mRem/yr is illustrative of the lack of realism which has crept into US regulations over the last two decades. First, the value is nonsense when measured against the everyday variability of dose rates to the public; second, it is a constraint based on an contrived calculation rather than a measured occurrence; and third, it is an example of creeping regulation in which a voluntary constraint later can become a hard-line regulation. I am particularly concerned on the first count, for, as you know, recent data shows that reducing radioactive doses as close to background as possible is not necessarily to the benefit of the human population involved. The data, derived principally from the RERF studies of 70,000 bomb survivors, and their 90,000 progeny over two human-generation times, is not in question. It is supported by a wealth of excellent epidemiological investigations as well as studies at the cellular level which show well-defined thresholds to harm. What is in question appears to be the will of those involved in producing standards upon which regulations are based. We need to spend available funds in limiting high risks to the public -- maybe through regulatory oversight of DOE facilities and operations, but surely not in limiting doses in the millirem range. We need to prepare for change. _, __ mR- *r Acknowledged by card ............:_._::~-:,::, Leaders in the development, dissemination and application of nuclear science and technology to benefit humanity. JOHN GRAHAM, PRESIDENT BNFL, Inc. Tel: 303 / 694-0700 5655 S. Yosemite Street, Suite 100 E-Mail: JGraham@ans.org Englewood, CO 80111 USA Fax: 303/ 694-1816

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The American Nuclear Society urges the Nuclear Regulatory Commission to support responsible risk-based regulation firmly based on available data, rather than forty-year-old conservatism. That conservatism was based on an absence of data and was appropriate for its time -- it is not now. The NRC is charged with making a risk determination in regulating the use of nuclear materials, and we believe that that responsibility involves more than just an acceptance of existing standards. There should be an ongoing program which addresses changing views of risk with the intention of reviewing the data and, perhaps, relaxing regulatory limits in the years ahead. We are willing to assist. The American Nuclear Society, as an association of professionals engaged in work across the whole spectrum of nuclear science and technology, is in a unique position to assist the NRC by independently compiling and evaluating the available data outside the context of any commercial operations. If you feel that there is value in our offer, I and my colleagues, would be happy to meet with your staff on the issue. Yours sincerely John Graham President

AMERICAN NUCLEAR SOCIETY 555 North Kensington Avenue Tel: 708/ 352-6611 La Grange Park, Illinois E-Mail: NUCLEUS@ans.org 60526 USA Fax: 708/ 352-0499 March 6, 1996 Rules Review and Directives Branch DFIPS, Office of Administration U.S. Nuclear Regulatory Commission Washington, DC 20555 Re: Comments of Draft Regulatory Guide DG-8016 (Proposed Revision 1 to Regulatory Guide 8.37); Constraints for Air Effluents for Licensees other than Power Reactors Gentlemen: The American Nuclear Society is a 15,000-strong professional association of members who work in the nuclear industry, nuclear medical facilities, universities, national laboratories, government, and elsewhere. Our members are employed in all aspects of nuclear technology, from fundamental research to nuclear medicine, electric power generation, and general industrial activities. As a general matter, the American Nuclear Society (ANS) supports the rescission of 40 C.F.R. Part 61 Subpart I and implementation of Revision 1 to Regulatory Guide 8.37, as long as NRC's constraint rule excludes radon from the 10 mrem/yr "constraint" limit. ANS believes Subpart I imposes unnecessary, confusing and complicated duplicative regulatory requirements that burden licensees without producing commensurate public health benefits. Subpart I facilities are already more than adequately regulated under 40 C.F.R. 190 (the so-called 25 mrem rule) promulgated by EPA pursuant to the Atomic Energy Act (AEA) and conformed to and enforced by NRC in 10 C.F.R. 20.1101 and 20.1301. EPA provides no sound information to suggest that the current AEA regulatory program applicable to these sites has not provided an ample margin of public health and safety. To the contrary, EPA's own surveys and computer models show that even without a constraint rule, "virtually all of the facilities would cause doses to members of the public which are below 10 mrem/yr" (60 Fed. Reg. 50163). EPA's survey of Subpart I licensees found that "all surveyed facilities are presently in compliance with the quantitative emission limit in Subpart I [1 0 mrem/yr limit]" -- a far higher compliance percentage than exists in any EPA regulatory program (57 Fed. Reg. 56879, December 1, 1992.) Additionally, the EPA/NRC AEA program is more comprehensive than Subpart I because, unlike the Clean Air Act which addresses only airborne radioactivity, the AEA regulations cover exposure from all pathways. Thus, while the constraint rule is totally unnecessary, it would indeed assure that emissions remain below 1o mrem/yr. Specific comments on the draft regulatory guide (DG-8016) include the following:

1. This proposed 10 mrem/yr constraint should nQ1 be coupled to the ALA RA concept. ALA RA is an operating philosophy, not a quantifiable entity. By defining 10 mrem/yr as an "ALARA constraint,* the NRC is attempting to regulate a philosophy with that may evolve into a de facto limit. Paragraph 20.1101 (b) in 10CFR20 is sufficient to ensure that ALARA principles are incorporated into radiological operations. The following changes to the proposed 10CFR20 Leaders in the development, dissemination and application of nuclear science and technology to benefit humanity.

JOHN GRAHAM, PRESIDENT BNFL, Inc. Tel: 303/ 694-0700 5655 S. Yosemite Street, Suite 100 E-Mail: JGraham@ans.org Englewood, CO 80111 USA Fax: '303/ 694-1816

• ,. Rules Review and Directives Branch, U.S. NRC March 6, 1996 Page 2 language will define the 10 mrem/yr constraint concept while retaining ALARA as an operating philosophy.

(a) In proposed Sec 20.1101 (d), delete the phrase "To implement the ALARA requirements of Sec 20.1101 (b), and ....

• Begin Sec 20.1101 (d) with "notwithstanding the requirements .... *

(b) In proposed Sec 20.2203(a)(2)(vi}, delete the word "ALARA." (c) In proposed Sec 203(b)(1)(iv), delete the word "ALARA."

2. The ANS supports the rescission of Subpart I provided that radon and its decay products are excluded from the calculated effective dose equivalent to determine compliance with the proposed ten (10) millirem (mrem) total effective dose equivalent (TEDE) constraint level". The exclusion for doses due to radon and its progeny, already a part of Subpart I should be carried over into any newly developed constraint level when Subpart I is rescinded and NRC assumes sole regulatory responsibility.

3. Since the proposed constraint level applies only to emissions from NRC licensed facilities and operations, emissions from adjoining unlicensed operations or unlicensed portions of operations which include an NRC licensed restricted area, should be categorically excluded.

4. Individual licensees should be allowed latitude in methodology used to determine compliance with the new constraint level, due to: (1) differing types of emissions, or differing combinations and forms of radionuclides; and (2) variability in natural background. The draft regulatory guide limits the licensee to only three methods of determining compliance, including (1) measurement of air concentration at point of release; (2) modeling; and (3) use of NCRP commentary No. 3, but provides that "the simplest model that will adequately address the problem should be applied first...* The EPA has allowed use of measurements of radionuclide concentrations at critical receptor locations to determine compliance with 40 CFR Part 61 Subpart I. This method is superior to the three proposed in the draft regulatory guide in that actual data are used (rather than modeling) and is more appropriate useful when nonpoint sources are involved.

The American Nuclear Society appreciates the opportunity to comment on this matter. I can be reached at (303) 594-0700. Sincerely, John Graham President JG/ab

SAINT BARNABAS MEDICAL CENTE&cKETED US, PC RONALD J. DEL MAURO President and Chief Executive Officer .96 MAP 18 Pl :14 OFFICE r r . C::' R . TA RY DOCKETlilu 3E RV ICf w Br<ANCH DOCKET NUMBER PR PROPOSED RULE~~ ---- March 14, 1996 (locRe..(oS~~ ~ @ U.S. Nuclear Regulatory Commission Attn: Docketing and Services Branch Washington, D.C. 20555-0001 Gentlemen: This is in response to the NRC's recent proposed rule regarding Constraint Level for Air Emissions of Radionuclides (60 FR 63984). I believe that medical licensees should be exempt from this requirement, should it be enacted. Except for those few facilities that use Xe.-133, medical licensees will not have any air emissions into the environment. Licensees should not have to perform calculations, with numerous assumptions, for events that will not occur. In addition, only actual events should be reported, not estimates. With respects to Xenon, those users are currently required to calculate clearance times and internal exposures. These measures take into account estimates of "spills" and are the basis for instructions should one actually occur. Again, I believe due to lack of emissions for the vast majority of medical uses of radiation, these licensees should be exempt from any such regulations. Sincerely yours, Ir~ M.S. DA ~ R Health Physicist IMG/ji L3USNURE Acknowtedged by card ...  !:~~.:.~~~2~ . .:. OLD SHORT HILLS ROAD LIVINGSlON, NEW JERSEY 07039 (201) 533-5000 A nonprofit, nonsectarian medical center, founded in 1865, and a major affiliate of the University of Medicine and Dentistry of New Jersey

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                                                       '96 MAR 18 P1 :18 March 6, 1996 c1rc nr;:- ~rr RF TARY Rules Review and Directive Branch                     DO  I\LI BHA ** .., i1 DFIPS Office of Administration U.S. Nuclear Regulatory Commission Washington, D.C. 20555                             DOCKET PROPOSED RULE             el:Q                -

(bDf'R~.39~~ @ To Whom it May Concern: The regulation proposed for 10 CFR 20.1101 (d) should be withdrawn and allow the EPA to continue to implement the NESHAPS for the moment and then the 10 mrem/year regulation should be deleted from the EPA regu lations. The process developed by the NRC will be much more difficult to implement operationally, based on the proposed regulation. Considerable more staff time, documentation, measurement, and reporting will be required to be in compliance with the proposed regulation with no benefit to individual members of the public. A major concern that comes out of the proposed regulation is that it implies that there is a danger associated with 10 mrem/year. Radiation exposures of 1 0 mrem/year do not have any significance. If the 10 mrem/year is implemented the public, and more importantly, aggressive legal and anti-technology groups, will take that number and advocate that the 10 mrem/year is a limit above which harm could result, otherwise the government would not have promulgated that as a maximum level of exposure for an individual member of the public. Since all individual events inside of a facility that could potentially expose a member of the public must be reported, it implies that harm could result from exposures exceeding 10 mrem/year. The natural cosmic and terrestrial levels of radiation exposure, not including radon, in the U.S. ranges from a low of 63 mrem/year in Florida to a high of 142 mrem/year in Colorado. Since the difference is about 80 mrem/year, how does that give any credibility to a 10 mrem/year maximum allowed exposure to a member of the public? I have enclosed a table comparing natural radiation exposure and the rates of cancer for selected states. The states that were selected were the six with natural radiation levels above 100 mrem/year and the six that have the lowest annual exposures. The data clearly show that to reduce the risk of cancer, in general, it is better to live in a state that has an annual radiation exposure level above 100 mrem/year than one with exposures in the 60 to 70 mrem/year. An individual member of the public living in Mississippi one year and moving to Wyoming would increase their natural radiation Acknowled ed b card "MAR- 2 8 19i:.-- g y ...................."***** **** .,

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exposure by just over 60 mrem/year with a reduction in the overall cancer rate from 180 down to 155/100,000 of population for the states. Millions of members of the public will get greater that 10 mrems/year additional radiation exposure from flying the "friendly skies" at 37,000 feet during their normal travels for busines and pleasure. In about 25 hours of flying time, about 10 mrem of additional radiation exposure is accumulated. Airline staff are each individual members of the public and receive hundreds of mrem/year as they go about their normal work of getting passengers from place to place. The regulation proposed as 20.1101 (d) does not conform to the ALARA process. Recall that under ALARA we attempt to keep exposures to less than 1 0% of the allowed exposure. When the exposure is greater than 10% and 30%, we conduct an evaluation and if it warranted, take action, as described in Reg. Guide 10.8, Rev 2, for example. There are no reporting requirements if exposures stay below regulatory limits. The proposed regulation requires reporting if 10 mrem is exceeded, and a commitment that the 10 mrem will never be exceeded again. The information in DG-8016 describes that compliance must be shown by calculation or measurement. By measurement it would require the use of multiple expensive ultrasensitive environmental dosimeters. Calculation using the methodology shown in Appendix A is not possible as there are errors in the methods used for the calculations. By either method compliance cost will be very high without any benefit to an individual member of the public. Millions of individual members of the public exceed 10 mrem/year from medical procedures. Medical and dental x-rays, nuclear medicine, and radiation therapy diagnostic procedures and treatment methods result in exposures from 20 mrem to more than 20,000 mrem, many getting multiple procedures in a year. The proposed regulation will only affect the radiation exposure of a few individual members of the public that are present in or near restricted areas inside of licensed facilities while many millions of members of the public will exceed 1 0 mrem/year from many other sources such as natural, medical, flying, etc. Since an exposure of 10 mrem/year to an individual member of the public has no significance the regulation as proposed for 20.1101 (d) should not be implemented. Ralph Grunewald, Ph.D.

SOME NATURAL RADIATION EXPOSURE AND CANCER MORTALITY RATES STATE EXPOSURE CANCER RATIO MONTANA 105 161 1.53 IDAHO 106 148 1.4 UTAH 114 125 1. 1 NEW MEXICO 125 146 1.17 WYOMING 126 155 1.23 - COLORADO 142 148 1.04 FLORIDA 63 167 2.65 LOUISIANA 64 193 3.01 MISSISSIPPI 64 180 2.81 DELAWARE 72 196 2.72 ARKANSAS 73 178 2.44 - MARYLAND 73 192 2.63 Exposure is in mrem/year average for the state as reported in ORP/SID 72-1, prepared by U. S. Environmental Protection Agency, Office of Radiation Programs, "Natural Radiation Exposure in the United States," by Donald Oakley, June 1972. The exposure is based on terrestrial and cosmic radiation and does not include exposure from Radon gas and decay products. Cancer is the average annual mortality rate for the state for all forms of cancer in deaths per 100,000 from 1987 to 1991 as reported in "Cancer Facts and Figures - 1995," prepared by the American Cancer Society. Ratio is the average annual cancer rate / average annual radiation exposure.

March 1996 HPS Newsletter Health Physics Society* Position Statement "RADIATION RISK IN PERSPECTIVE" in individuals exposed to small doses (less than 10 rem) delivered in a period of many years. Kenneth L. Mossman, Marvin Goldman, Frank Mass~, William A. Mills, Keith J. Schiager, Richard J. Vetter Limit Quantitative Risk Assessment to Doses l n accordance with current knowledge of radiation health risks, the Health Physics Society recommends against quantitative estimation of health risk below an individual at or Above S Rem per Year or 10 Rem Lifetime In view of the above, the Society bas concluded that estimates of risk should be limited to individuals receiving dose ef5 rem1 in one year or a lifetime dose of JO rem in a dose of at least 5 rem in one year or a lifetime dose of addition to background radiation. Risk estimation in this at least 10 rem in addition to natural background. Below dose range should be strictly qualitative accentuating a these doses, risk estimates should not be used; expressions ronge if hypothetical health outcomes with an emphasis on of risk should only be qualitative emphasizing the inability the likely possibility of zero adverse health effects. The to detect any increased health detriment (i.e., zero health current philosophy of radiation protection is based on the effects is the most likely outcome). asswnption that any radiation dose, no matter how small, may result in human health effects, such as cancer and Impact On Radiation Protection hereditary genetic damage. There is substantial and con- Limiting the use of quantitative risk assessment, as vincing scientific evidence for health risks at high dose. described above, has the following implications for radia-Below 10 rem (which includes occupational and environ- tion protection: mental exposures), risks of health effects are either too (a) The possibility that health effects might occur at small to be observed or are non-existent. small doses should not be entirely discounted. Conse-Current radiation protection standards and practices are quently, risk assessment at low doses should focus on based on the premise that any radiation dose, no matter how establishing a range of health outcomes in the dose range small, can result in detrimental health effects, such as of interest including the possibility of zero health effects. cancer and genetic damage. Further, it is assumed that (b) Collective dose (the sum of individual doses in an these effects are produced in direct proportion to the dose exposed population expressed as person-rem) remains a received, i.e., doubling the radiation dose results in a useful index for quantifying dose in large populations and doubling of the effect. These two assumptions lead to a in comparing the magnitude of exposures from different dose-response relationship, often referred to as the linear, radiation sources. However, for a population in which all no-threshold model, for estimating health effects at radia- individuals receive lifetime doses of less than 10 rem above tion dose levels of interest. There is, however, substantial background, collective dose is a highly speculative and scientific evidence that this model is an oversimplification uncertain measure of risk and should not be quantified for of the dose-response relationship and results in an overesti- the purposes of estimating population health risks. mation of health risks in the low dose range. Biological mechanisms including cellular repair of radiation injury, 'The rem is the unit of effective dose. In international units, I which are not accounted for by the linear, no-threshold rem=0.01 sievert (Sv). model, reduce the likelihood of cancers and genetic effects. qhe Health Physics Society is a non-profit scientific organization Radiogenic Health Effects dedicated exclusively to the protection of people and the environment from radiation. Since its formation in 1956, the Society has grown to . Have Not Been Observed Below 10 Rem more than 6,800 scientists, physicians, engineers, lawyers, and other Radiogenic health effects (primarily cancer) are observed professionals representing academia, industry, government, national in humans only at doses in excess of 10 rem delivered at laboratories, trade unions, and other organizations. The Society's high dose rates. Below this dose, estimation of adverse objective is the protection of people and the environment from health effects is speculative. Risk estimates that are used unnecessary exposure to radiation, and its concern is understanding, to predict health effects in exposed individuals or popula- evaluating, and controlling the risks from radiation exposure relative to the benefits derived from the activities that produce the exposures. tions are based on epidemiological studies of well-defined Official Position Statements are prepared and adopted in accordance populations (e.g., the Japanese survivors of the atomic with standard policies and procedures of the Society. The Society bombings in 1945 and medical patients) exposed to rela- may be contacted at: 1313 Dolley Madison Blvd., Suite 402, tively high doses delivered at high dose rates. Epidemiolog- McLean, VA 22101; Telephone: 703-790-1745; FAX: 703-790-2672; e-mail: hpsburkrngt@aol.com. ical studies have not demonstrated adverse health effects 3

March 1996 HPS Newsletter Scottsdale Radon Panel years gives 120 CWLM. At 4-8 pCi L*1, exposures in homes would give about 1-2 WI.M y*1 or 30-60 CWLM Raymond Johnson, President, Radon Section for 30 years. She reported that the latest NCRP risk as-sessment at 1-2 WI.M y*1 is expected to result in a 1-6 T he Radon Section hosted a panel on radon health risks at the HPS Midyear meeting with presentations by myself, William Mills, and Naomi Harley. percent increase in lifetime lung cancer risk. Audience Response Otta Raabe asked for a show of hands on how many I discussed "Why Some Scientists and the Public Do believed that radon caused more than 10,000 lung cancer Not Believe in Radon Risks.* I suggested that most of the deaths a year in the U.S. No one raised a hand. Most of radon risk controversy is about the estimates of effects the audience voted for a number less than 1,000. This for radon exposures at levels found in homes. Such esti- response was interesting as an indication of radon risk mates rely upon linear extrapolations from observed lung perceptions among HPs. Naomi indicated that the esti-cancer incidence in miners. Risk coefficients derived mate of 14,000 lung cancer deaths y*1 may be overesti-from miner studies, adjusted for differences between mated by 2-3X. I asked if HPs should ignore radon if the miner exposures and home exposures, are then multiplied real risks are only a 1,000 y*1? I also asked, if we agree by the estimated population exposure to estimate popula- that radon is the largest source of radiation dose at 1-2 tion risks. For example, EPA has determined that life- mSv y*1, how can we discount radon risks and still justify time exposure to a million person-WI.M y*1 should result our jobs as HPs when we are implementing ALARA pro-in 224 lung cancer deaths a year. When multiplied by the grams to protect workers at a few tenths of a mSv y*'? estimated U.S. exposure of 62 million person-WIM y*1, Ken Mossman said that our message to the public the radon risk in the U.S. is estimated at 14,000 lung should be "stop smoking." Naomi said the HPS should cancer deaths y*1

• focus on radon, but note that smoking and radon greatly Radon risks are not easily understood by the general increase lung cancer risk. One HP indicated that public public and most people are not too concerned about radon funds would be better spent on promoting child immuni-unless that they are buying a home. In light of the uncer- zation. He received a large round of aPPlause.

tainties on radon risk, what do we tell the public? I con-cluded that the prudent public health message should con-tinue to be "test your home for radon and mitigate if the levels are above 4 pCi L* 1 according to EPA and State protocols." Bill Mills described the origins of the radon action level at 4 pCi L*1 (150 Bq m *3 ). He noted that the 1970 Surgeon General's guidelines called for remediation for radon above 0.05 WL. Remediation was indicated for levels between 0.01 to 0.05 WL and no action was rec-ommended below 0.01 WL. These guides were above a background of 0.01 WL. When these guidelines were implemented in Colorado, the decision was made for remediation at 0.01 WL above background. Thus the action level of 0.02 WL (4 pCi L" 1) was derived. He con-cluded that 4 pCi L* 1 is too low. Naomi Harley discussed the limitations with epidemi-ology studies of miners. She noted that risk models de-rived from such studies usually overestimate risks. She emphasized that some miner cohorts are outliers and should not be used. She felt that the Colorado miner co-hort still represented the best data with a relative risk of about 0.004 WLM* 1

• Naomi gave a dose conversion factor of 1 mSv y- 1 for 1 pCi L* 1 (37 Bq m *3 ) and noted that this corresponds to the current population dose limit of 1 mSv y**. She noted that, at the current occupational limit, 4 WLM y** for 30 15
• Contrary to the DAYA Radiation
• UST be Dangerous

SIERRA oOCKET NUMBERnD -- - DOCKETED

 'CLUB                          PROPOSED RULE rn 0-.0 (iooFR-lo~'\~-\)   @
                                                              -                US~JRC NATIONAL NUCLEAR WASTE TASK FORCE                 March 12. 199;96         MAR 18 A8 :28 Secretary of the Commission             In the Matter of: 60 U.S. Nuclear Regulatory Commission Washington, D.C. 20555-0001 ATTN: Docketing and Services Branch     FAX: 301-415-1672 As a member of the Sierra Club National Nuclear Waste Task Force. I am asked to submit comment on behalf of the Task Force on the NRC's Proposed Rule nconstraint Level for Air Emissions of Radionuclides.n This matter is of significance for members of the Sierra Club who live or work near nuclear facilities, nationwide, and who will be affected by promulgation of this ruie.

We recognize the potentially positive gain for protection of the public from an enforceable NRC regulation that will reduce the level of radioactive air emissions to the environment. However. we regret that this proposed rule has not been posed in a way that guarantees that actual doses received by individual members of the public offsite will in the future conform with the requirements that the Environmental Protection Agency <EPAJ must meet before the Administrator may relinquish EPA's statutory duty imposed by the Clean Air Act to promulgate air emission standards for radionuclides. The Task Force recommends that NRC withdraw this proposed rule. At the minimum. the rule should be revised to provide for promulgation of an air emission standard for exposure of members of the public from radionuclides that is mandatory and must be rigorously and consistently enforced by the NRC. rather than a constraint level that is simply a regulatory guidance with which a licensee may or may not properly comply. and may or may not be charged with violation or penalized by the regulator. An NRC constraint level air emission and dose limit designed to operate with the ALARA program must set an enforceable maximum dose to a member of the public that not only sometimes meets the EPA's NESHAPS standard of 10 mrem/yr EDE but results in a certainty that an ample margin of safety is truly achieved by requiring facility operations that reduce air emissions we! I below the 10 mrem/yr TEDE that NRC proposes as guidance. The reason for this reduction is to assure that the margin of safety wil I be ample -- that is, well below the level set as a maximum by EPA in its 1989 NESHAP standard for radionuclides. The NRC must also make unequivocal provision for citizen litigation in the event that the ALARA constraint level is not met. The current situation would preclude appeal to courts, in part because the only avenue is NRC's 2.206 provision and in part because it is impossible to mount an effective challenge to a limit that is merely a guideline that a licensee is not required to meet. Actual measurement of doses to actual people is sorely needed; NRC should incorporate such a program into a mandatory program of ALARA with constraint level. The NRC should also initiate and require a program of independent con-tinuous measurement of air releases from nuclear facilities to replace the NRC's present system that permits licensees to provide the data w~tb ou ~ any independent monitoring cf the accuracy of what they submit to NRc : * ** lMR 2 s* J~ Acknowledged by card .......................... =*~

1ur* ~ * \1 :11=,.. '*.' TORY COMMISSIOI\ DUCKE TING vERVICE SECTION OFFICE OFT E SECRETARY OF THE CO 't. \ISSION DocU,rnel'lt StatisticS

P. 2 ot Sierra Club National Nuclear Waste Task Force Comments When the NRC issued construction permits for nuclear production and utilization facilities, the applicants had to demonstrate (or promise) that their designs were capable of maintaining routine radioactive releases at a level that results in a maximum dose to a member of the public that is no greater than 5 mrem/yr. This was called a "design basis release." In view of al I that has subsequently been learned about the adverse health effects of low-dose irradiation and protracted or repetitive low-dose exposure, it would now be prudent for the NRC to make that dose limit mandatory tor all nuclear facility licensees. This is a reasonable regulatory position for the NRC to adopt, since the agency has claimed to EPA that its licensees' releases already are giving doses to the public that are within one to three mrem/yr of that level. [t is, after all, on the basis of this NRC assurance that EPA is proposing to rescind its NESHAPS standards-setting authority under the Clean Air Act and turn over that authority to NRC. Now NRC must take the necessary steps to be certain that the margin of safety is consistently met by all, not just some, licensees, state and federal, at all times in the future. The best way to do so is to require by regulation, not mere guidance, the conservative dose limit we are recommending, along with the additional safeguards of independent monitoring and measurement of emissions and doses received. The recommendations that we offer relate directly to the protection of public health and safety and quality of the environment with respect to the problems of isolating radioactive wastes from the biosystem for their very long periods of biological toxicity. That task has proven far more difficult than NRC, Agreement States, Congress, and the nuclear waste industry anticipated. Waste isolation is not likely to become easier; here, too, is a strong reason for the NRC to adopt a conservative mandatory enforceable regulatory stance that is consonant with the Commission's long-standing claim of its commitment to defense in depth and redundancy of safeguards. We ask that the NRC adopt these suggestions in order to improve the protection of health, safety, and the environment that are the fundamental concerns of the Sierra Club.

                                                                              //J/

Respectfully submitted by Judith Johnsrud for the Sierra Club National Nuclear Waste Task Force I certify that this document has been placed in the U.S. Mail, first class, postage paid, on the /~f.S day of March 1996.

5000 Dominion Boulevard Glen Allen, Virginia 23060 DOCKETED US,.RC March* 12, 1996 U.S. Nuclear Regulatory Commission Washington , DC 20555-0001 "96 MAR 15 P3 :54 OFFICE' Gf ~;_ .RETARY OOCKETI. :- ~ J.R 'LE s- 11.t'Ct{

                                                                            *VIRGINIA POWER Serial No. GL 95-087 NL&OS/EJL ATIN: Docketing and Services Branch

Dear Sir:

PROPOSED RULE - 10 CFR PART 20 CONSTRAINT LEVEL FOR AIR EMISSIONS OF RADIONUCLIDES FEDERAL REGISTER / Vol. 60, No. 239 / DECEMBER 13, 1995 / p. 63984 This letter provides Virginia Power's comments regarding the subject proposed rule. Th e Nuclear Regulatory Commission (N RG) is proposing to establish a constraint of 1O mrem/yr total effective dose equivalent (TEDE) for dose to members of the public from air emissions of radionuclides from NRG licensed facilities other than power reactors. This proposed rule is necessary to provide assu rance to the Environmental Protection Agency (EPA) that future emissions from NRG licensees wi ll 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 its Clean Air Act (CAA) regulations for NRG licensed facil ities (other than power reactors) and Agreement State licensees, thereby relieving these licensees from unnecessary dual regulations. We agree with the objective of the proposed rule - to eliminate unnecessary dual regulations , and agree that the proposed rule will help accomplish this objective. However, it appears that some clarification would appear to be warranted. More specifically, it is not clear whether or not the general exclusion that the proposed rule provides to power reactors would also apply to an Independent Spent Fuel Storage Installation (ISFSI) that is located on the same site with a power reactor, especially since there are typically no air emissions of radionuclides associated with the operation of an ISFSI. It would be very helpful if the rule and the statements of consideration explicitly addressed how the rule applies to ISFSls that are located on the same site as commercial power reactors.

                                                                       /

Additionally, we fully endorse the comments sent separately to the NRC by the Nuclear Energy Institute. We appreciate the opportunity to provide comments on this proposed ru le. Very truly yours, 1#-8~ M. L. Bowling, Manager Nuclear Licensing & Programs

U.S. NUCLEAR REGULATORY COMMISSIOt-. OOCKETING & SERVICE SECTION OFFICE OF THE SECRET ARY OF THE COMMISSION Document Statls1ics Postmark Date . .'3,."'--ll~\~-~..___Co,.___ __ 1 Coples Received_....__ _ _ _ __ Md'l Copies Reproduced ~ - - - - ~:§.~~

10 CFR Part 20 Constraint Level For Air Emissions Of Radionuclides Serial No. GL 95-087 page 2 of 2 cc: Mr. Ralph Anderson Project Manager, Radiological Protection , Emergency Preparedness, and Waste Regulation Department Nuclear Energy Institute 1776 I Street N.W. Suite 400 Washington, DC 20006-3708

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                  ===== Reply to: -=====================:=lh.
                                  =                          '96 MAR 5 P 3 :33 P. 0. Box 606 Harrisburg, PA 17108 Committee on Radiation and the Environment            OFFICE OF1 :cRE TA. RX
                                                       ,..,... ,.,1JrTt' ' Jr. :.:["V \CE BR*, ,.;,::,i March 11, 1996 Secretary ot the Commission                                        DOCKET NUMBER           PR U.S. Nuciear Regulatory Commission                                 PROPOSED RULE                ~

Washington. D.C. 20555-0001 ((oo~b!>C\~~ @ ATTN: Docketing and Services Branch

1. For the Pennsylvania Chapter of Sierra Club, the Committee on Radiation and the Environment tCOREl submits these comments on NRC Proposed Rule entitled "Constraint Level for Air Emissions of Radionuclides." The NRC suggests that the main purpose of the rule is to eliminate duplicative regulations. The Chapter's CORE believes that this proposed NRC guidance will have far more serious impacts that relate to health, safety, and environmental protection.

2. We cannot support the constraint levei as it has been proposed at Code of Federal Regulations, vol. 60, no. 239, p . 68984ft, December 13, 1995, for reasons detailed below. We ask that these comments be included in the record and given full consideration by the Commission. We also request that NRC extend the comment period. Publication of this proposal in mid-December meant that the Federal Register was not timely received and available to the public due in part to Federal government shut-down and in part to winter weather that interfered also with our scheduled Chapter meetings. Thus, affected Sierra Club members have only begun to learn of this issue at our March 9-10 Chapter meeting. We ask tor a 60-day extension. The EPA NESHAPS issues have been in process for a decade; most of the radionuclides in question will remain: no unreasonable burden will be imposed on any party by such an extension.

3. Commenters' Interest: In the Commonwealth of Pennsylvania, there are many dozens -- some hundreds -- of nuclear production, utilization, treatment, storage, and, at least potentially in the future, waste disposal facilities that are and will be affected by this proposed rule. Sierra Club Chapter members reside and work in the immediate vicinity of some of these facilities or are located in downwind sectors that are or will be affected by air emissions from one or more of these sites.

4. The NRC constraint level rule was developed in response to the Environ-mental Protection Agency's unwillingness to relinquish its Clean Air Act authority to set air emi~sions standards for radionuclides for all NRC- and Agreement State-licensed facilities other than nuclear power reactors, certain Federal faci ii ties, those possessing only sealed sources or emitting Radon-222, remediated uranium mill tailings piles, and high-level waste repositories tif any are eventually built and cperatedJ, ijf~ 1 ~ f~\ijpfijnp~ W~~ ~A~~~ Rn it~

uncertainty that NRC would assure that these non-reactor nuclear facilities could and would consistently meet the Court-ordered EPA tests of "acceptable risk" and "ample margin of safety to protect the public health," allowing air emissions that result in doses to members of the public at or below the 1989 EPA NESHAPS limit of 10 miilirem per year effective dose equivalent. 00.

                               ~~    PRINTED ON RECYCLED PAPER

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2 The Sierra Club CORE must conclude that NRC cannot now provide an adequate assurance to EPA so long as the nuclear facility licensees are allowed to report their emissions without any independent monitor or measurement. More-over, because the NRC does not do direct measurement of doses received by off-site individuals, it is impossible for EPA to confirm whether or not its 10 mrem/yr NESHAP standard is currently being met. We conclude, therefore, that the "ample margin of safety" has not been shown by NRC. S. The constraint level proposed by NRC is also 10 mrem per year total effective dose equivalent, but this limit is to be used in conjunction with the NRC's As Low As Reasonably Achievable <ALARA) program. Our objection lies in the indisputable fact that NRC's ALARA program is not a required regulation; its application by NRC is discretionary, and may or may not be enforced, where-as EPA is required under the Clean Air Act to promulgate NESHAPS standards that must be met by a licensee.

6. The Clean Air Act allows citizens to file law suits if EPA fails to enforce its promulgated standards. The NRC's Part 2 regulations that govern citizen suits and the right to appeal do not provide this capability in the event that the NRC fails to enforce its regulatory guidelines. The constraint rule does not state clear provision for citizen law suits. Courts have thus tar not found that NRC's Part 2.206 lets citizens challenge Commission decisions. The constraint rule, like the ALARA program, is not a mandatory limit: it is only guidance to licensees. An unenforceable guidance, or recom-mendation to a licensee provides no grounds for litigation.

7. The wording of this proposed rule suggests merely that the licensee must report to NRC if its air emissions exceed the limit for a calculated TEDE to a member of the public and describe its plans to improve its performance and meet the ALARA constraint level in the future. The Sierra Club CORE believes that this is not adequate to assure protection of public health and safety or environmental quality from unacceptable radiation exposures.

8. The ability of NRC to exercise sufficient regulatory authority in the future has been cast in doubt by Congressional proposals to limit or eliminate regulatory authority of Federal agencies, without clear distinctions drawn among the agencies with respect to the impacts on health and safety or the environment. Similarly, Agreement States -- all states -- are also feeling the pinch of declining funds to devote to stringent regulation of nuclear facility licensees land others, as well). The lack of certainty of assured regulation, inspection, and enforcement at all levels of government militates against reliance on NRC's proposed ALARA constraint level guidance.

9. The Sierra Club CORE must conclude that this NRC proposal is not drawn rigorously enough to assure that the resultant health risks will acceptable to our affected members or that a discretionary ALARA constraint level guidance will in the future provide and continuously provide a margin of safety that is ample, i.e., well below the maximum air emission dose level permitted by the EPA NESHAP standard.

3 For these reasons, among others, we ask that the NRC revise this ALARA-related 10 mrem/yr TEDE constraint level to accomplish the following:

a. Set a mandatory regulatory limit which must be enforced and which is equal to or more restrictive than the EPA's 1989 NESHAP air emission standard for radionuclides.

b. Set forth in the regulation the requirement for continuous actual dose measurement at members of the public who. according to their location and to micro-meteorological conditions, may reasonably be expected to receive the highest doses.

c. Clarify conditions under which EPA can and must reclaim its authority to set Clean Air Act NESHAPS air emissions standards for radionuclides

d. Require an independent entity to monitor the accuracy of air emissions data submitted by licensees.

e. Stiffen NRC rules for issuance of violations, setting of monetary penalties twith rebuttable presumption that clearly placing burdens ot proof on the licensee, collection of all financial penalties assessed without waivers or reductions, and rigidly enforce all regulations, including license suspensions and revocations for repetitive violators.

The Sierra Club Pennsylvania Chapter CORE urges NRC to adopt. at minimum, the recommendations outlined above. Respectfully submitted, P. Gilbert and J. Johnsrud. Co-Chairs Sierra Club Pennsylvania Chapter Committee on Radiation and the Environment

OOCKETEO U$, PC 1

                                    ~tate of ~£fu 3'J£rS£tf Christine Todd Whitman           Department of Environmental Protectio             MAR 15 p3 '.34obert C . Shinn, Jr.

Governor CN 402 Commissioner Trenton, NJ 08625-0402 L,HETARY El

• t" March 7, 1996 Docketing and Services Branch U.S. Nuclear Regulatory Commission Washington, DC 20555-0001 re: RIN 3150-AF31:

The following are the comments of the State of New Jersey, Department of Environmental Protection concerning the proposed constraint level for air emissions of radionuclides in Federal Register, Vol. 60, No. 239. pp. 63984-63987. The New Jersey Department of Environmental Protection (the Department) has supported the U.S. Environmental Protection Agency's (EPA) National Emission Standards for Hazardous Air Pollutants (NESHAPs) in the past, and still agrees that the EPA 10 millirem (mrem) annual dose limit is protective of the public health. The Department also considers the specific hierarchical methods set forth in 40 CFR 61 for determining compliance wi th this limit to be scientifically sound. The Department is concerned with the proposed U.S. Nuclear Regulatory Commission's (NRG) changes to 10 CFR 20 for several reasons. We are particularl y interested in possible changes to the current regulatory position because there are a number of facilities (predominantly radiopharmaceutical companies, hospitals, research and academic institutions) located in populated areas of New Jersey which have the potential for emission of radionuclides. Since the EPA has established the 10 mrem/year limit to meet the "ample margin of safety" requirement of the Clean Air Act (CAA), it is clear that the NRG regulatory program must assure that routine radionuclide emissions result in doses which are consistently and predictably no greater than 10 mrem/year. The Department is of the opinion that the proposed NRG regulatory program will be sufficient only when the proposal satisfactorily addresses the following issues.

1) In limiting the total effective dose equivalent (TEDE) to 10 mrem/year, the EPA considers a number of potential exposure pathways due to air releases; i.e., inhalation, immersion, external exposure from ground deposition, and internal exposures from resuspension and the vegetable, milk, and meat pathways. The proposed NRG regulatory method for determining compliance with air derived dose limits allows for the use of 10 CFR 20, New Jersey is an Equal Opportunity Employer Recycled Paper

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Page 2 Appendix B, Table 2 which was derived by evaluating only the immersion and inhalation pathways for air emissions. The proposed NRG constraint rule can therefore significantly underestimate the actual radiation dose delivered to an individual. Even if the NRG allowed concentrations are reduced by a factor of S to represent a "numerical" SO mrem/year to 10 mrem/year reduction, the resulting air concentration values still are significantly higher than the allowed air concentration values in the current EPA NESHAP rule (40 CFR 61, Appendix E, Table 2) as shown in Enclosure 1. If the dose to a member of the public is calculated correctly (utilizing all potential pathways) from the allowed concentrations in the scaled down NRG Table 2, the 10 mrem annual limit is actually exceeded by significant factors. The proposed NRG effluent concentrations still do not provide the same level of protection of human health and the environment as do the current EPA concentrations. Therefore, the proposed rule cannot be considered to be equivalent to the existing EPA rule.

2) The NRG currently requires licensees to take actions to further reduce risk below the dose limits in keeping with the principle that exposures should be as low as is reasonably achievable (ALARA). This is an NRG intended goal for radiation protection programs. In Regulatory Guide 8. 37, "ALARA Levels for Effluents from Materials Facilities," it is maintained that if the licensee chooses to demonstrate compliance with the dose limit by calculating the TEDE, all significant environmental pathways should be evaluated. Further reference is made to NCRP Commentary No. 3, "Screening Techniques for Determining Compliance with Environmental Standards" for use in dose calculations. This publication includes the use of all pathways in its calculations. Unfortunately, the use of Regulatory Guide 8.37 is not a requirement for determining compliance with the 10 mrem/year limit and the licensee is still free to use Appendix B, Table 2 to demonstrate compliance.

Even though Draft Regulatory Guide DG-8016 (Proposed Revision 1 to Regulatory Guide 8.37) contains the EPA COMPLY computer code as an acceptable method for determining compliance with the constraint, the Department believes that regulatory language requiring the use of all relevant pathways as an essential part of determining compliance with the dose limit should be included in the NRG rule. This would involve adoption by the NRG of the EPA COMPLY code or other equivalent code directly in the rule. A tiered regulatory procedure, perhaps similar to EPA's, would provide confidence that the 10 mrem annual dose limit was not exceeded.

3) The NRG should adopt consistent implementing procedures for determining compliance with its established dose limits. The method of determining compliance with the dose limits in 10 CFR 20 is not consistent with that of 10 CFR SO, Appendix I, which considers all pathways.

4) There is no discussion or mention of why the EPA sublimit of 3 mrem/year for radioiodines was not included in the proposed rule. The NRG rule should include the EPA' s sublimi t of 3 mrem/year for radio iodines or explain why this limit has been deleted. Again, the proposed rule can significantly underestimate the actual radiation dose delivered to an individual for this series of biologically important radionuclides.

Page 2 If the NRC adopts a rule including a provision to make emissions exceeding 10 mrem/year a reportable event, the Department believes that the NRC will have sufficient authority to require a facility to reduce its emissions. However, this proposal is rendered ineffective at t h e outset because, as stated above, NRC has not required to date a consistent, scientifically valid methodology for a licensee to define when the 10 mrem limit is being exceeded. Additionally the public's recourse to compel compliance would be substantially narrowed under NRC rules as contrasted with the citizen suit provisions under the CAA (Sec. 304). To summarize, the Department believes that the NRC rule proposal does not provide the required legal and regulatory equivalence of the EPA program. The NRC program apparently will continue to allow regulatory use of its Appendix B, Table 2 that may, depending on the nuclide, significantly understate actual dose received, and does not yet provide for a consistent clear method to calculate and thus report exceedences of the 10 mrem level. In order to address these issues, the Department believes that, at a minimum, the NRC should either recalculate the values in 10 CFR 20, Appendix B, Table 2 to include all relevant pathways, or disallow use of this table to demonstrate compliance with the 10 mr em/year requirement, and instead require the use of the COMPLY or an equivalent computer code. In addition, NRG needs to establish consistent regulatory procedures and parameters for licensees to use in estimating the dose received. Thank you for the opportunity to comment. If there are any technical questions pertaining to our comments please contact Dr. Jill Lipoti, Assistant Director for Radiation Protection Programs at 609-984-5520. Enclosure

Enclosure I Comparison of Allowed Air Concentrations Under Proposed 10 CFR 20 Revisions and 40 CFR61 NRC* EPA** Ratio of Nuclide IO CFR 20 (pCi/m3) 40 CFR 61 (pCi/m3) 10CFR20:40CFR6 l 3H 20,000 1,500 13 14 C (compounds) 600 10 60 1251 60 0.13 460 3 2J> (as phosphates) 100 0.3 330 3 ss (elemental) 600 1.3 460 4SCa 200 1.3 150 s1cr 12,000 31 390

           ~o                   800                     14                    57 99mJ'c             60,000                  1,700                   35 1311               40                    .21                   190 133 Xe            120,000                63,000                  1.9 90y                180                     13                    14
*Current values in 10 CFR 20, Appendix B, Table 2 reduced by a factor of 5

• • Current values in 40 CFR 61, Appendix E, Table 2

New York State Department of Environmental Conservation Division of Solid & Hazardous Materials OO CKETi: D Bureau of Pesticides & Radiation USNRC 50 Wolf Road, Albany, New York 12233-7255 518-45 7-2225 FAX 51 8-485-8390

                                             '96 MAR 14 P3 :04                      Michael D. Zagata Commissioner OFFI Cf OF SECfffTARY DOCK ETl NG & '~ f_ HVi CE MAR    rtroos DOCKET NUMBER PR PROPOSED RULE                   ~

( Coo FR. fo.5C\~ ~ Rules Review and Directives Branch @ DFIPS Office of Administration U.S. Nuclear Regulatory Commission Washington, DC 20555 Docketing and Services Branch U.S. Nuclear Regulatory Commission Washington, DC 20555-0001

Dear Addressees:

Re: 10 CFR 20, Proposed Rule, Constraint Level For Air Emissions of Radionuclides Draft Regulatory Guide DG-8016, Constraints for Air Effluents for Licensees Other than Power Reactors The New York State Department of Environmental Conservation has reviewed the United States Nuclear Regulatory Commission's December 7, 1995 (NRC) Notice of Proposed Rulemaking (NPR) on the Constraint Level for Air Emissions of Radionuclides 10 CFR Part 20 and the Draft Regulatory Guide DG-8016 (Proposed Revision 1 to Regulatory Guide 8.37), Constraints For Air Effluents For Licensees Other Than Power Reactors. In response to both proposals, we recommend that the NRC evaluate better the alternative of leaving the responsibility for implementing Subpart I with the EPA. We understand the long history of the EPA's duplicative regulation of emissions from NRC and Agreement State licensees, and we agree that it would be desirable to eliminate it. However, this proposed rule appears to merely transfer to NRC the EPA's role in imposing a new dose limit on radioactive materials licensees. As explained in more detail in our enclosed comments, the proposed "constraint" appears to be a dose limit in all but name. Yet, there will be no health and safety benefit from this MAR 1 8" 1996-Acknowledged by card ..........".............. ::.J

lf.S. NUCLEAR 8:::...,...., ;. .,,-; ) COMMISSIOI\ DOCKETING & SERVICE SECTION OFFICE OF THE SECRETARY Of THE COMMISSION Document Statistics Postmark Date .~=+<-=~- Corws Received_,___ _ __ __ Add'! Coples Reproducoo _,__,,---_ __ ~~~~

Page 2 regulation. Both the EPA and the NRC have ackn owledged that almost all facilities will meet this "constrain t." In its September 28, 1995, Notice of Reopening of Comment Period, the EPA stated, "EPA concluded that virtually all of the facilities would cause doses to members of the public which are below 10 mrem/yr." [60 FR 50163] In the NPR, the NRC supports its NEPA Finding of No Significant Impact, in part by stating, "Actual air emissions are not expected to change." The NRC estimates that licensees will have to devote an average of 80 hours to meet the reporting requirements of this proposed rule. NRC also proposes to make this a Division 2 rule, forcing Agreement States to spend their own sc a rce resources on adopting a rule that will have no effect on the environment or public health and safety. Since the EPA is already administering this program under its own existing regulations, and there is no public health benefit to be gained, we question whether this rulemaking should be undertaken. At the least, the NRC should explain in the NPR the benefit of adopting this rule compared to leaving the existing EPA program in place. Our detailed comments are enclosed. Please call me if you have any questions. Sincerely,

                            =1:~r::::.,              Chief Bureau of Pestic i des & Radiation Division of Solid & Hazardous Materials

Comments of the New York State Department of Environmental Conservation on 10 CFR 20, Proposed Rule, Constraint Level For Air Emissions of Radionuclides and Draft Regulatory Guide DG-8016, Constraints for Air Effluents for Licensees Other than Power Reactors March 12, 1996 INTRODUCTION The NRC is proposing to revise two sections of 10 CFR 20: Section 20.1101, Radiation protection programs, and Section 20.2203, Reports of exposures, radiation levels, and concentrations of radioactive material exceeding the limits. These Sections are to be expanded to incorporate new requirements for a 10 mrem "dose constraint." The new proposed Section 20.ll0l(d) would require materials licensees to constrain air emissions of radioactive materials (other than radon-222) so that a member of the public would not receive a dose in excess of 10 mrem/yr total effective dose equivalent (TEDE). A licensee exceeding the proposed dose constraint would be required to report the exceedance to the NRC under the new proposed Section 20.2203(a) (2) (vi) and to promptly take corrective actions to ensure against recurrence. Draft Regulatory Guide DG-8016 identifies those methods acceptable to NRC for implementing the proposed rule.

GENERAL COMMENT

S

1. The NRC has not yet finalized its compatibility policy for Agreement States, yet at the same time has made it clear that this rulemaking will be designated as a Division 2 rule (i.e., Agreement States must adopt a rule that is at least as stringent as NRC's rule). Since NRC has apparently decided to make this rule a Division 2 (or its equivalent) compatibility matter, NRC should have provided Agreement States with the opportunity to participate in its development at an earlier stage. For example, NRC could provide states with a draft of the proposed rulemaking prior to publishing the NPR in the Federal Register. In addition, NRC should give additional weight to comments submitted by Agreement States. NRC has verbally committed to both approaches during past Agreement States' meetings.

2. It is not clear whether the NRC will allow licensees to exceed the dose constraint if they have taken appropriate steps to keep their emissions as low as reasonably achievable (ALARA). Both the NPR and DG-8016 do not appear Page 1 of 4

to allow for such a situation. According to DG-8016, a constraint is a dose value "above which specified licensee actions are required." Those required actions include reporting and taking appropriate and timely corrective actions to prevent recurrence, or else NRC will take an enforcement action. The NPR states that a Notice of Violation would be issued upon licensee failure to report the exceedance and/or failure to institute appropriate measures to correct and prevent recurrence. This language implies that any exceedance of the proposed dose constraint, coupled with failure to take appropriate corrective action, will be treated as a violation. Hence, a corrective action that does not ensure that the constraint will not be exceeded -- even if that action ensures that emissions will be maintained ALARA -- apparently will not be deemed an adequate corrective measure by NRC. It appears that the dose constraint is a requirement and, therefore, a de facto limit.

3. The word constraint is a poor choice of words. Webster defines constraint as "something that restricts, limits, or regulates." This definition, however, appears to contradict the NPR and DG-8016, which state that a constraint is not a limit. To reduce confusion, the NRC should use a different word or phrase. Examples: action level, reference level, ALARA goal, etc.

In 10 CFR 50, Appendix I sets ALARA guidelines for many different sources from nuclear power plants, including gaseous and airborne particulate discharges. Contrasted to "constraint level," Appendix I uses the term "design objectives and limiting conditions for operation." Of note, however, is the value proposed for the ALARA level. Appendix I to 10 CFR 50 limits the dose due to releases of airborne particulates to 15 mrem/year to any organ, and the dose due to gaseous effluents to 5 mrem/year to the total body and 15 mrem/year to the skin. NRC should not contribute to the proliferation of different dose limits for different types of facilities. If NRC intends to establish a new public dose limit, the new limit should be codified in Section 20.1301.

4. The explanatory language in the NPR and DG-8016 suggests that NRC believes the proposed dose constraint would only be exceeded under atypical operating conditions (i.e.,

accidental or higher-than-expected radioactive air emissions, equipment failure, or operator error). In fact, on page 3, DG-8016 states that "NRC believes that the constraint level . . is easily achievable by NRC materials licensees." However, the draft guide also states that "It is understood that the constraint dose could be approached Page 2 of 4

routinely (page 3) 11 These appear to be contradictory. Instead of making the proposed dose constraint a de facto limit, NRC could designate the dose constraint as an "ALARA goal." Rather than require licensees' corrective actions to "ensure against recurrence," NRC could instead require that licensees' corrective actions "ensure that emissions are maintained ALARA. 11 To implement this approach, NRC should change the last sentence of the proposed Section 20.ll0l(d) to read, 11

• the licensee shall . . promptly take appropriate corrective actions to ensure that emissions are ALARA." Likewise, the proposed Section 20.2203 (a) (2) (iv) should be reworded to include the statement, 11 corrective steps taken or planned to ensure that emissions are ALARA when constraint levels have been exceeded."

6. We find that NRC's proposed dose constraint for air emissions of radioactive material is a reasonable goal.

However, NRC has not presented the dose constraint proposal as an ALARA goal, but rather as a de facto limit. For the reasons presented above, NRC should revise the NPR and DG-8016 to clarify that the dose constraint is an ALARA goal, not a limit. By doing so, NRC would confirm that it is not lowering the current public dose limit of 100 mrem/yr, which should lesson public confusion about the adequacy/safety of the current 100 mrem/yr public dose limit. SPECIFIC COMMENTS on NPR

7. The language proposed to be added to 10 CFR 20 appears to treat identified exceedances of the dose constraint (even when reported as required) as a violation of a standard if not corrected to prevent recurrence. Why will licensees be required, by regulation, to prevent the recurrence of a failure to meet a standard that has clearly been described as "not a limit"? How will the NRC ensure compliance with something that is not a limit?

8. The proposed 10 mrem/yr dose constraint contradicts NRC's previously stated ALARA philosophy. The NPR states that"

         . the rulemaking proposed would codify numerical values for application of ALARA guidelines .          11 However, during the last major revision of 10 CFR 20, a published public comment requested that the NRC institute "reference levels" for licensee action. The NRC responded to that comment as follows:
            .. . i f the NRC were to specify generic reference levels for licensee action, the impact might be similar to lowering the magnitude of the dose limits. The Commission believes that the use of the ALARA philosophy is a preferable means to keep exposures well Page 3 of 4

below the limits established by the Commission. It appears that the NRC has modified its ALARA philosophy to define and codify what is ALARA. However, no explanation for this change was given in either the NPR or DG-8016. NRC should provide an explanation for this apparent change. SPECIFIC COMMENTS on DG-8016

9. According to DG-8016, the draft guide deals with controlling doses resulting from the release of air effluents to levels below the proposed 10 mrem dose constraint. However, it is not clear where air effluents must be controlled to meet the proposed dose constraint - does this mean in uncontrolled areas inside and/or outside of a licensed facility? It is unclear if the dose constraint is to be limited to effluents outside the facility (e.g., in the environment), because the one example given in DG-8016 dealt with air effluents to an uncontrolled area inside the facility.

The final regulatory guide should clearly define where radioactive air effluents must be controlled to ensure that public doses are less than the proposed 10 mrem/yr dose constraint.

10. Appendix A to the Draft Regulatory Guide contains a mathematical error. Appendix A is a sample report of an exceedance of the 10 mrem/year "constraint level." The average annual concentration of I-131 discharged to the air from the facility is stated as 7. 9x10- 1 0 µ.Ci/ml. It is then stated that this annual average concentration is 40% of the 10 CFR 20 Appendix B, Table 2, Column 1 value of 2.ox10 -1 0

    µ.Ci/ml, and that this would yield a dose of 20 mrem/year.

7. 9x10- 10 is actually 395% higher than the Table 2 value, and the resulting dose would be 197.5 mrem/year. It is possible that the annual average concentration should have been printed as 7.9x10- 11 µCi/ml, in which case the percent and dose estimate are correct.

Thank you for the opportunity to comment on the Notice of Propose Rulemaking on the new constraint level and Draft Regulatory Guide DG-8016. We are hopeful that NRC will give full consideration to our comments on the proposed rule and guide, as well as our comments regarding the lack of opportunity for Agreement States participation in the development of this proposed rule. Page 4 of 4

              ~   flaG ...... ' ... o,,

DOCKETED E.I. DU PONT DE NEMOURS & Co. (INC.) US RC MEDICAL PRODUCTS DEPARTMENT

                                                                                               .96 MAR 14 P2 :Q4 March l l, 199'bFFI Ct OF S CREiARY DOCK£ I It ... &. !:.FRY!CE 8 AN H Nuclear Regulatory Commission                                    DOCKET NUMBER Washington, DC 20555-0001                                        PROPOSED RULE    p c:!.o

(<oOrR~~ ~ @ Attn.: Docketing and Services Branch

Reference:

NRC Proposed Rule: Constraint Level for Air Emissions of Radionuclides. Federal Register. Vol. 60, No. 239. December 13, 1995. Page 63984 These comments are submitted on behalf of NEN Products, Medical Products, E . I. DuPont de Nemours and Company. NEN Products is a major manufacturer and supplier of radioactive materials for biomedical and industrial research applications. The manufacture and use of radionuclides necessarily results in low level emissions, consequently this proposed rule applies to our facility and those of our customers. At NEN Products we have long experience in testing various models for predicting the effects of emissions and have assisted numerous customers in environmental monitoring. We are therefore in a particularly good position to judge the efficacy of regulatory requirements concerning radionuclide emission control. As indicated in the attached comments to the EPA, we have supported the EPA proposal to rescind 40 CFR 61 Subpart I because it is an unnecessary and duplicative regulation that burdens NRC and agreement state licensees with additional costs of demonstrating compliance without any benefit to the public. We believe that the rescinding of 40 CFR 61 Subpart I and adoption of the proposed NRC constraint rule will be of some benefit because it will return regulatory control to one agency and reduce the cost of demonstrating compliance. Furthermore we recognize that the NRC has provided viable alternative methods for demonstrating compliance which could be easier to implement, give more accurate results and/or be already in place for some licensees. However while we concede that the NRC constraint rule is preferable to dual regulations, we strongly urge that this proposal is not necessary and that current emission standards expressed in 10 CFR 20 are sufficient to assure that the public is adequately protected from licensee emissions. Furthermore current NRC regulations have the important distinction that they are compatible with International Commission on Radiological Protection and National Council on Radiation Protection and Measurements recommendations. kMowle(Jged by card-~~~-:::!.~~~**- MEDICAL PRODUCTS DEPARTMENT 549 Albany Street, Boston, Massachusetts 02118 Telephone 617-482-9595 Fax (617) 542-8468

U.S. NUCLEA9 v-AIORY COMMISSIO~ DOCKETING & SERVICE SECTION OFFICE OF THE SECRETARY OF THE: COMMISSION

                  * ~tatistias Postmark Da Copies R Addl Co     F-

Consequently we recommend that the NRC deletes the proposed constraint rule and the EPA rescinds 40 CFR 61 Subpart I for NRC and agreement state licensees. These actions should be completed expeditiously to remove the adverse impact these burdensome requirements have on essential life saving medical and research services. Attached are detailed comments on the proposed rule. We have also sent by separate cover comments on Draft Regulatory Guide DG-8016. We appreciate the opportunity to comment on this proposed rule and would be glad to provide clarification or further information. Sincerely yours,

• Leonard R. Smith, CHP Radiation Protection Consultant

March, 1996 NEN PRODUCTS COMMENTS ON PROPOSED NRC CONSTRAINT RULE FOR AIR EMISSIONS OF RADIONUCLIDES

1. Page 63985, column 3, paragraph 1.

    "Based on the... studies conducted by EPA and licensee reporting... it is evident that less than 10 mrem/yr. to the maximally exposed member of the public from air emissions is reasonably achievable."

We agree with the above conclusion. In fact licensees have been reporting to the regulators and in public comments long before the EPA conducted studies that controls were sufficient to maintain public exposures to as low as reasonably achievable below NRC limits. However the ability of licensees to control emissions is not the issue here. The concern is the cost of demonstrating compliance. Accurate radiological assessments are complex and costly exercises. While it is relatively easy to demonstrate compliance with the 100 mrem/yr. public dose limit, it becomes increasingly more difficult and expensive to demonstrate compliance with lower limits such as the proposed constraint level. Furthermore this cost does not result in reduction of emissions or any benefit to the public and has the counterproductive effect of removing finite resources from more important safety functions and increasing the cost and availability of life saving biomedical research and medical applications.

2. Page 63985, column 3, paragraph 1.

    "The NRC is proposing to establish a constraint of 10 mrem/yr... to members of the public ... as part of its program to maintain doses ALARA."

We disagree that the establishment of a 10 mrem/yr. constraint rule can be considered ALARA or will have any affect on public dose. In fact the proposed rule violates the ALARA principle because its implementation will add cost of demonstrating compliance without affecting the actual dose to members of the public. Increase cost with no benefit is not ALARA. 1

3. Page 63986, column 1, paragraph 2.

    "... NRC proposes to provide a basis for rescission of [EPA] Subpart I. .. to constrain dose to members of the public ... to 10 mrem/yr."

While we agree that one benefit of establishing a constraint rule is that it might result in the EPA rescinding Subpart I, this is not sufficient justification. The proper action that should be taken is to rescind Subpart I unconditionally. The failure of the NRC and EPA to achieve the proper result expeditiously implies that the two agencies are not capable of resolving their differences in a manner that is beneficial to the public and that further Congressional action is necessary to resolve this issue .

• 4. Page 63986, column 1, paragraph 3.

    "... the licensee would be required to report the dose to NRC in writing within 30 days ... "

The proposed reporting requirements and corrective actions are not justifiable considering the current status of licensee emissions. The EPA has determined that more than 99% of licensees routinely demonstrate compliance with the 10 mrem EPA limit. Furthermore it is well recognized that the reason that a few licensees can't demonstrate compliance is because the EPA requires them to use a computer program that can grossly over estimate the dose to the public from emissions. Consequently the appropriate corrective actions are likely only to involve recalculating dose and not reducing emissions that are already negligible. A much better approach to demonstrating compliance is for the NRC to require each licensee to determine current emissions and corresponding dose initially. If the estimate adequately demonstrates compliance with current NRC limits and ALARA requirements then in subsequent years licensees should only need to demonstrate compliance when emissions have increased or other changes have occurred that could result in significant increase in off site dose. By these means licensees can assure the public that they are protected without generating an interminable quantity of redundant records every year. 2

E.I. DU PONT DE NEMOURS & CO. (INC.) MEDICAL PRODUCTS DEPARTMENT November 16, 1995 Central Docket Section LE-131 Environmental Protection Agency Attn.: Air Docket No. A-92-50 Washington, DC 20460

Reference:

Proposed EPA Rule: National Emissions Standards for Radionuclide Emissions From Facilities Licensed by the Nuclear Regulatory Commission and Federal Facilities Not Covered by Subpart H. Federal Register, Vol. 60, No. 168, September 28, 1995, Page 50161 . These comments are submitted on behalf of NEN Products, Medical Products/Imaging Systems, E. I. :quPont de Nemours and Company. NEN Products is a major manufacturer and supplier of radioactive materials for biomedical and industrial research applications. The manufacture and use of radionuclides necessarily results in low level emissions, consequently this rule applies to our facility and those of our customers. At NEN Products we have long experience in testing various models for predicting the effects of emissions and have assisted numerous customers in environmental monitoring. We are therefore in a particularly good position to judge the efficacy of regulatory requirements concerning radionuclide emission control. As reported to the EPA in numerous comments we find EPA emission standards to be redundant and an unnecessary regulatory burden to NRC and Agreement State licensees. We therefore strongly recommend that subpart I be rescinded for NRC and Agreement State licensees without any further conditions. The proposed NRC constraint level ALARA rule will have no effect on emissions because NRC and Agreement State licensees already comply. However, duplicate EPA regulations and additional constraints make it much more complicated and costly for licensees to demonstrate compliance. We strongly agree with the numerous EPA findings that NRC regulations have and continue to assure an ample measure of protection to the public and support the EPA proposal to rescind EPA emission standards for NRC and Agreement State licensees. Detailed comments are attached. We thank you for the opportunity to comment on this proposed rule and would be glad to provide clarification or further comments. Sincerely y o u r s ~ ( ; ( Leonard R. Smith, CHP, Radiation Protection Consultant MEDICAL PRODUCTS DEPARTMENT 549 Albany Street, Boston, Massachusetts 02118 Telephone 617-482-9595 Fax (617) 542-8468

COMMENTS ON EPA PROPOSED RULE, NATIONAL EMISSIONS STANDARDS FOR RADIONUCLIDE EMISSIONS FROM FACILITIES LICENSED BY THE NUCLEAR REGULATORY COMMISSION. FEDERAL REGISTER, VOL. 60, NO. 188, SEPTEMBER 28, 1995, PAGE 50161.

1. Page 50161, column 3, paragraph 2.

                                                                          "On December 1, 1992, EPA proposed to rescind 40 CFR part 61 subpart L.."

We believe that it is important that the public is amply protected from airborne emissions of all potentially hazardous materials. We support regulations that are effective in assuring public protection. We are aware that regulations promulgated by the Nuclear Regulatory Commission (NRC) have provided ample protection in the past and provide ample protection no}\'. The EPA's 40 CFR part 61 subpart I serves no useful purpose, is duplicative and should therefore be promptly rescinded.

2. Page 50161, column 3, paragraph 3.

                                                                          "This document reaffirms the EPA proposal to rescind subpart I for NRC and Agreement State Licensees... "

We agree that subpart I should be promptly rescinded to remove a duplicative, costly and unnecessary regulatory burden that provides no benefit to the public.

3. Page 50161, column 3, paragraph 3.

                                                                         "[the EPA] invites additional comment on the sufficiency of the revisions of the NRC program to support the finding required by Section 112 (e) (9)."

On October 1984 and December 15, 1989 the EPA published in the Federal Register their finding that the current NRC regulations .already assured an ample margin of safety to the public. At that time NRC regulations required emissions to be controlled to limit public dose to 500 mrem in any 12 month period. The NRC also required licensees to have adequate radiation protection programs which in practice further limited emission to as low as reasonably achievable (ALARA) below the limits. The 500 mrem limit and ALARA practices were effective in ensuring that actual public doses were far below 500 mrem per year and generally far below EPA standards of 10 and 3 mrem per year. ry . * ** * * , * * . *. * - . . . ______ ___ _ __ ,.., . * , * * , , , *, _, - * ** * - - , - - . - ... - *,- * , ~* - - - - --- - ~ - - - - - - - * * * * . ** . , ., , . * * * * * ** * * * * * * * * * * * ** * * ** * * * * . . . . . - - * **** . * * .* ** - .. - * * *, - . . . . .. *** * - * * - - ..... .. - . * * * ** -~ ... " . ---- ..... - ---- .-~-

Furthermore since 1994 NRC and Agreement States have promulgated a lower public dose limit of I 00 mrem per year and have made ALARA a requirement. Past licensee performance and more restrictive NRC requirements are more than sufficient to assure ample protection of the public.

4. Page S0163, column 2, paragraph 1 "When the results for the survey were statistically extrapolated to the entire population of NRC and Agreement State licensees, EPA concluded that virtually all of the facilities would cause doses to members of the public which are below 10 mrem/year."

While we agree with EPA's conclusion, it is clear that the EPA finding has

• understated the case. The EPA uses the COMPLY computer program to estimate doses to the public. The COMPLY code is simply a sequence of screening programs that can be used with various degrees of conservatism to demonstrate compliance with the EPA's stfndards. The code is not constructed to accurately determine public doses but instead makes estimates that have been shown to be much higher than indicated by more accurate methods.

This problem of overestimating public doses is exacerbated due to most small licensees with low emissions not having detailed measurements necessary to use the higher levels of the code. Instead these licensees must use lower levels of the code which grossly exaggerate public doses. Doses estimated by this method have been shown to be billions of times higher than actual doses. Consequently EPA's survey is based on dose constructions that are orders of magnitude higher than actual doses. The actual protection assured by current NRC and Agreement State licenses is orders of magnitude greater than that implied by the EPA's survey.

5. Page 50164, column 1, paragraph 1 "EPA concluded that there was no element in the NRC regulatory program which expressly required or assured that licensees...would maintain emissions below the 10 mrem/yr. EPA standard."

We disagree with this conclusion. The EPA's own survey showed that 18,000 licensees are in compliance with the standard. When adjustments are made for the tendency of the COMPLY code to overestimate, the survey shows that licensees are far below the EPA standard. That licensees comply with EPA and NRC standards is to be expected. Generally licensees do not possess enough radioactive material to cause significant public exposure through emissions. In these circumstances the public is adequately protected and regulations are redundant.

I *. I

6. Page 50164, column 8, paragraph 3.

  "the ALARA" constraint level" rule [is to be] a matter of Division Level 2 compatibility..."

The EPA seeks assurance from the NRC that licensees in Agreement States will be subject to the same emission standards as the NRC licensees. However the EPA already has this information. NRC has always required Agreement States to be strictly compatible with NRC in limiting public dose. The EPA has not shown that licensees in Agreement States are less able to comply with the emission standard than NRC licensees.

7. Page 50165, column 2, paragraph 3.

  "Out of the thousands of licensees subject to the standard, only 16 facilities are presently reporting radionuclide emissions exceeding the EPA standard, and EPA expects that most of these reported violations will be resolved through EPA approval of adjustments in the COMPLY methodology for calculating doses."

This statement implies that licensees exceed the emission standard and the EPA accepts this. However we are aware that some licensees are unable to demonstrate compliance because the COMPLY code grossly overestimates the dose. In otherwords these licensees are in full compliance with the standard but EPA's prescribed methods for demonstrating compliance are not accurate. This is a clear indication of the counterproductive nature of the EPA radionuclide emission standards. The time that a licensee's health physicist must spend in resolving such issues with the EPA is time removed from activities that can improve the control of radioactive material. When the EPA emission standards were implemented for NRC and Agreement State Licensees in 1992 licensees were already in compliance with the standard and did not need to change practices to reduce emissions. However, the new standards greatly increased the cost and complexity of demonstrating compliance. Hence EPA regulations have increased costs without any benefit to the public.

8. Page 50165, column 3, paragraph 5.

  "(l) If NRC adopts the proposed ALARA constraint level rule, will the resultant C regulatory program assure that routine radionuclide emissions from NRC licensees... result in doses which are consistently and predictably no greater than 10 mrem/year?"

Current NRC regulations already assure that public doses are consistently and predictably below 10 mrem/year. Furthermore public doses are generally far below 10 mrem/year. NRC and Agreement State regulations have provided sufficient

I I

I protection to the public. EPA regulations and the proposed NRC constraint rule will not provide any further benefit to the public but simply increase the regulatory burden on licensees.

   -9. Page 50165, column 3, paragraph 6.
         "(2) If NRC adopts the proposed ALARA constraint level rule, will NRC have sufficient authority to require affected facility with routine radionuclide emissions at a level which results in a dose exceeding 10 mrem/yr. to reduce its emissions to a level resulting in a dose no greater than 10 mrem/year?"

The NRC already has sufficient authority to rule that such emissions are not ALARA and to impose license conditions to further restrict emissions. The proposed ALARA constraint level rule is redundant, serving the same purpose.

10. Page 50165, column 3, paragraph 'i.

        "(3) If NRC makes the proposed ALARA constraint level rule a matter of Division Level 2 compatibility, will this assure that each individual Agreement State establishes an ALARA constraint level for its licensees which is no greater than 10 mrem/yr., and requires it licensees to report and correct exceedances of that level?"

Agreement State rules that are classified as Division Level 2 compatibility must be strictly compatible with NRC rules. Agreement States are currently required to implement regulations to protect the public that are strictly compatible with NRC Regulations. There is already ample assurance that licensees in individual Agreement States comply with the proposed ALARA constraint level.

11. Page 50165, column 3, paragraph 8.

        "(4) Are the NRC policies establishing criteria to evaluate the adequacy and compatibility of Agreement State programs, and adopting procedures fo permit suspension of termination of Agreement State programs, sufficient to enable NRC to take necessary action if it determines that an Agreement State program is inadequate or incompatible?"

NRC currently has the authority to suspend Agreement State programs that are inadequate or incompatible and has exercised this authority in the past. Current NRC policies do not change this status.

I

12. Page 50166, column 1, paragraph 2.

   "(5) Do these four actions, in addition to other actions taken by NRC combine to provide an ample margin of safety to protect public health."

The EPA has on several occasions shown that the public is protected with an ample margin of safety. This condition was detennined when the only regulation was the NRC 500 mrem/yr. public dose limit. It still applies now under the NRC I 00 mrem/yr. limit and ALARA requirements. Neither the above four actions nor the EPA standard will significantly increase public protection because current practices already result in exposures well below the proposed constraint level. It is, however, necessary that the EPA standard and proposed NRC constraint level be promptly rescinded. What is needed is one regulation that implements the International Commission on Radiological Protection (ICRP) and National Council

• on Radiation Protection and Measurement (NCRP) recommendation to constrain public dose to below 100 mrem per year. ICRP and NCRP recommendations are respected for their ability to provide the necessary protection to the public. The EPA standard and proposed NRC constraint level should be rescinded to remove a costly regulatory burden from licensees who manufacture and use radionuclides in biomedical research and medicine. This is especially important since these unnecessary costs severly impact patients who rely on life-saving radiopharmaceutical procedures.

DEPARTMENT OF HEALTH&. HUMAN SERVICES Public Health Service OOCK~TED

                                                                 ,... I National Institutes of Health Bethesda, Maryland 20892
                                                          '96 t1AR i 4 l\iG:53 March 12, 1996 Rules Review and Directives Branch, DFIPS Office of Administration U.S. Nuclear Regulatory Commission Washington, D.C. 20555-0001                                  oocm             BER PR PROPOSED RULE               .J.o l_G:.cFe.loS9"t? ~   

Dear Madam/Sir:

• The Radiation Safety Branch (RSB), National Institutes of Health (NIH) wishes to provide comments regarding the proposed rule "Constraint Level for Air Emissions of Radionuclides."

Federal Register Vol. 60 No. 239, December 13, 1995 and Draft Regulatory Guide DG-8016, "Constraints for Air Effluents for Licensees Other than Power Reactors", December 1995. The NIH is a large facility licensee conducting biomedical research, medical diagnosis and treatment. Our management of extensive and varied uses of radioactive material within a large and diverse community comprised of research, patient, and ancillary services personnel at NIH, provides us with the experience and knowledge to offer pertinent and realistic comments on the consequences of the proposed rule. NIH was one of the over400 NRC licensees studied by EPA during its implementation of NESHAPS and was a "beta" test site for the COMPLY computer code. Furthermore, the professional staff of the RSB includes a number of past employees of EPA, one of whom was responsible for the implementation of radionuclide NESHAPs and who has intimate knowledge of the intended application of the EPA regulation under consideration for NRC adoption. The premise of the proposed rule is to provide a basis for the withdrawal of the U.S. Environmental Protection Agency's regulation under 40 CFR 60, Subpart I. However, the U.S. Nuclear Regulatory Commission's proposal appears to have redefined the conditions for the application of NESHAPs to the point that the regulatory analysis performed by NRC is not accurate. This is particularly true for location of the member of the "general public" which the NRC has redefined as an individual inside the facility, rather than outside, and the release point has been inappropriately moved (as noted in the example in the draft regulatory guide) to a laboratory door inside the facility. The proposed rule 10 CFR 20.1003, 20.1101, 20.2203 elicit the following concerns: The reporting conditions are overly burdensome due to the redefinition of the "individual member of the general public likely to receive the highest dose" to be an individual inside the licensed facility. Clearly the EPA intended this limit to apply to members of the general public outside the facility, not inside. A conflict exists as the NRC defines a member of the public in 10 CFR 20.1003 and the EPA definition which considers "emissions of radionuclides, including iodine, to the ambient air from a facility [not within the facility] regulated under this subpart... " (40 CFR 61.102(a) Standard). The NRC already limits dose to non-occupationally exposed individuals within a facility under 20.1003 and 20.1301 (100 mrem/yr TEDE.) The NRC should specifically

U.S. l~UCLt:AR REGULATORY COMMISSIOl\o DOC ETING & SERVICE SECTION OFFICE OF THE SECRETARY Of THE COMMISSION DocuMent St1tii;tic! Postmark Da 4P !l i' (3\ ,~) Coples R

Review and Directives Branch, USNRC 2 March 12, 1996 exclude the public inside the facility from consideration in this proposed rule. 20.1101 should specifically address exposure "offsite" or "outside the licensed facilities". Requiring licensees to report individual names, social security numbers etc, for an "exceedance" of the dose constraint is not only unnecessary but may be impractical as the doses are calculated to a "hypothetical" receptor. What purpose would such reporting serve when no data exists to demonstrate any harm or effect from a dose which is a small fraction of annual background? Requiring the reporting of trivial or minimal exposures contributes to the public's escalating fear of all levels of radiation. Requiring reports of trivial, "hypothetical" doses, against an established "constraint" implies absolute and determinable risk for all exposures, and reinforces and perpetuates the public's perception that all levels of radiation are potentially harmful. Furthermore, this reporting level is completely inconsistent with the recent position statement "Radiation Risk in Perspective," articulated by the Health Physics Society. In addition, the proposal creates a reporting inconsistency where the reporting limit for a member of the public is 100 mrem for any other circumstances, but exposure from an airborne route must be reported if calculated above 10 mrem. What basis is there for this inconsistency? The NRC or the EPA has not provided proof that the airborne radioactivity exposure pathway is more harmful than any other mode of radiation exposure, such that a reporting "quality factor" of ten is now required. The proposed rule is unnecessary and inconsistent with the NRC's own guidance "Use of Probabilistic Risk Assessment in Nuclear Regulatory Activities; Final Policy Statemenf' Federal Register Vol 61, No.154, August 16, 1995, Notices. Based on the studies performed by EPA, over 98% of 367 initial licensees studied in the category considered by this rulemaking are already operating below 1 mrem/yr and all of the remainder are below 10 mrem/yr using the exceedingly conservative assumptions of the COMPLY code. An additional 43 facilities, which were expected to produce the highest potential exposure, demonstrated that 75% were below 1 mrem/yr and none exceeded 10 mrem/yr. Given this data, there is no basis for the proposed rule, let alone the cost of reporting. All natural and non-byproduct radioactive materials are not within the control of the NRC to regulate. However, the new section 20.1101 does not specifically exempt anything from its regulation except 222 Rn. It is suggested that the phrase "licensed materials" replace "radioactive materials" in 20.1101(d). The proposed rule neglects the cost of the rule to the licensee and time to use COMPLY as well as time spent compiling the data necessary to perform the calculations through COMPLY or other method. The cost estimates and regulatory impact conclusions are therefore not complete. The COMPLY code is not "user friendly" and must be fixed prior to the NRC recommending its use. The code, as currently configured, requires repeated entry of data and costs licensees significant time to run without any demonstrated benefit. The regulatory guide does not provide a list of physical forms exempt from consideration such as sealed containers, syringes for patient administration, 99Mo- 99mTc generators, patients, etc. The regulatory guide example contains numerous technical errors. These are as follows:

Review and Directives Branch, USNRC 3 March 12, 1996

• The example sums total activity used over three separate days and then divides this sum by the room volume to get the "average concentration during 24 hours following use." Obviously this is not the average, but the sum of the concentrations for the three days. To calculate the "average annual concentration" the example then divides this value by approximately 121.5 (is this 365 divided by 3 ?) arriving at the result 7.9 E-10 µCi/ml. It then states that this result is 40 % of the Appendix B, Table 2, Column 1 limit of 2.0 E -10 µCi/ml, which it is obviously not since it is greater than that limit. This example defies analysis and neglects the EPA approved use of release fractions or of the practical aspects of occupancy times for such a situation.
• All of the release fraction criteria and guidance for use as provided by EPA in its COMPLY code is omitted from the guide. The release fractions used in the example are inconsistent with those of the EPA compliance methodology. The release fraction for iodine in liquid form is 0.001 not 1.0; i.e. one hundred percent of the material is not volatilized .
• The guide does not use an effective clearance time for the room or hallway, some air turnover is present and this has been neglected.
• The EPA regulations do not consider a member of the public to be present in the licensed facility, particularly at a laboratory door for 24 hours on three separate days.
• The commonly used terminology for the device that provides air flow and negative pressure for chemical fume hoods or glove boxes is a "fan", not a "pump."
• Licensee possession limits are not correct. The EPA used the quantities possessed over a period of one year.

We would appreciate your consideration of these critical comments on the proposed regulation . Sincerely, ~n~.a:- Radiation Safety Officer, NIH M.S., C.H.P. fety Officer, NIH

Al:l!llowledged by card k 1 a* 199i-- MNIIIIHRIINI-tt1.r.~

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DOCKETED USNRC American College of Nuclear Physicians/Society of Nuclear Medicine GOVERNMENT RELATIONS OFFICE .% MAR 13 A9 :48 March 12, 1996 U.S. Nuclear Regulatory Commission Attn: Docketing and Services Branch Washington, DC 20555-000! RE: U.S. Nuclear Regulatory Commission Proposed Rule, "Constraint Level for Air Emissions ofRadionuclides," December 13, 1995, 60 FR 63984.

Dear Sir/Madam:

The American College of Nuclear Physicians (ACNP) and the Society of Nuclear Medicine (SNM) are pleased to comment on this proposed rule. ACNP and SNM represent 14,000 physicians, technologists, pharmacists, and scientists who provide quality diagnostic and therapeutic nuclear medicine services to patients and perform research and development in this specialty. Each year over 10 million nuclear medicine procedures are performed in the United States. The ACNP and SNM are concerned about the implementation of the NRC proposed rule as currently written. While we support NRC jurisdiction over EPA jurisdiction in this area, we believe there are several aspects of the NRC rule that need to be addressed. We will attempt to outline those points below. The Clean Air Act (CAA) referred to uncontrolled airborne emissions beyond the boundary of the licensee's property. Limits for the public w~re off-site limits. Airborne emissions within the licensee's establishment are completely and adequately covered by NRC's extensive requirements for facility operation. NRC needs to change § 20.1101 (d) to read, " ... so that individual member of the public likely to receive the highest off-site dose ... " which simply adds the clarification of "off-site" to the regulation. ACNP and SNM are concerned that NRC regulations could be interpreted as controlling air emissions for a member of the public within the facility. This concern of ours is directly derived from Appendix A of the regulatory guide which cites an example that is not off-site. ACNP and SNM are also very concerned about problems that could arise in the states if the compatibility level remains at division 2. This determination could potentially allow states to set a more restrictive standard that could jeopardize the field of nuclear medicine. Airborne radionuclides cross state lines and we believe that addressed as a radiation safety issue, a federal standard is justified. Also with a level as low as 10 mrem/yr., any level lower than that threatens the practice of nuclear medicine. We strongly believe that the compatibility levels should be consistent with the regulations for power plants and be changed to division level 1. 1850 Samuel Morse Drive, Reston , Virginia 22090-5316 * (703) 708-9773 / Fax: (703) *708-9777 * - Acknowledged by card ...MAa.J...8.~.l9S6:=~

U.S. NUCLE.A,n R:,... !LJ70~Y COMMISSIO~ [X)CKETING & SERVICE SECTION OFFICE OF TH[ SEC9ETARY OF Tl,f CO,

ACNP/SNM Comments March 12, 1996 Page2 Finally, we urge the NRC to consider provisions that would allow facilities to avoid the burden of calculating air emissions every year. The EPA has already demonstrated that all 22, 000 materials licensees are under the allowable limits at present. We strongly recommend that unless facilities alter their current activities they not be required to complete the calculations requested by NRC in the supplementary information section of this proposed rule. Nuclear medicine facilities have been safe for 60 years, and it is unnecessary to require calculations every year simply to prove that the licensee is consistent with EPA and NRC data already gathered. This would not however, change the reporting structure if a licensee had reason to believe that new activities led to a level that exceeded 10 mrem/yr. We urge the NRC to consider these comments in conjunction with comments submitted on the Regulatory Guide before publishing a final rule in this area. If the ACNP and SNM can offer any assistance or answer any additional questions feel free to contact Mr. David Nichols, Associate Director of Government Relations, at (703) 708-9773. Sincerely, David R. Brill, M.D. Peter T. Kirchner, M.D. President President American College of Nuclear Physicians Society of Nuclear Medicine

Enclosure:

ACNP/SNM comments on the constraint rule regulatory guide

American College of Nuclear Physicians/Society of Nuclear Medicine GOVERNMENT RELATIONS OFFICE March 12, 1996 Rules Review and Directives Branch Division of Freedom of Information and Publications Services Office of Administration U.S. Nuclear Regulatory Commission Washington, DC 20555 Re: Draft Regulatory Guide DG-8016 (proposed revision 1 to Regulatory Guide 8.37), December 1995.

Dear Sir/Madam:

The American College of Nuclear Physicians (ACNP) and the Society of Nuclear Medicine (SNM) are pleased to comment on this regulatory guide. ACNP and SNM represent 14,000 physicians, technologists, pharmacists, and scientists who provide quality diagnostic and therapeutic nuclear medicine services to patients and perform research and development in this specialty. Each year over 10 million nuclear medicine procedures are performed in the United . States. The ACNP and SNM are concerned about the implementation of the NRC proposed rule as currently written. While we support NRC jurisdiction over EPA jurisdiction in this area, we believe there are several aspects of the NRC regulatory guide that need to be addressed. The comments below represent a synthesis of the opinions formed by several of our knowledgeable scientists. The example chosen in Appendix A needs to be changed to that of an off-site example. In addition the example has the wrong volatility fraction (1.0E-3, not 1); the average concentration is missing division by 3, and combination with the rest of the year; the mathematics of a first order rate equation is avoided erroneously; no member of the public stands at an open laboratory door for 24 straight hours; the division of 7.9E-10 by 2.0E-10 is ten times too small; the exposure dose is grossly in error and far too large. Another equation with which ACNP and SNM found fault with was in Section 2.1 on page 4. The equation is currently written as c = fQ_/v, where Q is defined as the effluent release rate. The rate in this case is irrelevant however. The equation would be more accurate as c = fA/VT, where A = total activity released in one year and T= I year. "f' should be redefined as "the fraction of activity released when the wind is blowing toward the receptor of interest." This would account for any change in the wind. 1850 Samuel Morse Drive, Reston, Virginia 22090-5316 * (703) 708-9773 I Fax: (703) 708-9777

ACNP/SNM Comments March 12, 1996 Page2 NRC has also omitted default levels needed to immediately exempt a large number of licensees from more detailed and expensive analyses. They are in 40 CFR part 61 and belong in NRC's

'rule as well. These values provide a base for NRC to use, however we recommend review before incorporating them into this regulatory guide. The default quantities in Part 61 would be adequate if medical and research licensees could apply realistic release fractions, based on 60 years of experience, to their annual throughput of radioactive materials. For example, we could 4

use 10-6 or less for nonvolatile forms and 10 for volatile forms. Then calculations should only be needed for new processes exceeding these values. NRC should consider adopting certain exemptions recognized by EPA such as those addressing sealed containers. EPA recognized that sealed containers, like sealed sources, do not contribute air emissions. This exemption should be added to NRC's regulatory guide. An example of this is sterile, pyrogen-free radiopharmaceuticals in sealed vials, or radionuclide generator columns. EPA also exempted airborne emissions from patients, just as NRC exempts patient's excreta going into sewers. NRC should explicitly state that in this regulatory guide. The ACNP and SNM can not advocate recommending use of the COMPLY code based on problems licensees have experienced already. However, if NRC does insist on making this recommendation then we would point out that the COMPLY code currently exempts emissions from patients, and requires data for activity possessed per year, not possession limits at any particular time as stated in error by NRC in the draft regulatory guide. We would like to make one final suggestion. The NRC should incorporate EPA's guide for "Determining Compliance with Clean Air Act Standards for Radionuclide Emissions from NRC licensed and Non-DOE Federal Facilities." This represents a simple method of demonstrating compliance and is already in use by many smaller facilities. This should be incorporated into the regulatory guide. We urge the NRC to consider these comments in conjunction with comments submitted on the proposed rule before publishing final guidance in this area. If the ACNP and SNM can offer the assistance of any of our members who worked on this letter or answer any additional questions feel free to contact Mr. David Nichols, Associate Director of Government Relations, at (703) 708-9773.

    ~'~

Sincerely, David R. Brill, M.D. Peter T. Kirchner, M.D. President President American College of Nuclear Physicians Society of Nuclear Medicine

Enclosure:

ACNP/SNM Comment on Air Emissions Proposed Rule.

United States Enrichment Corporation us Uni ten States DOCKETED US, RC "96 MAR 13 A9 :as 2 Democracy Center 6903 Rockledge Drive Bethesda, MD 20817 Tel : (301 ) 564-3200 Fax : (301 ) 564-3201 Enrichment Corporation March 12, 1996 OFFICE OF SE RETAR Y DOCKEfi G& .. [RVICE BRANCH U .S. Nuclear Regulat ry Commission SERIAL: GDP 96-0052 Washington, D .C. 20555-0001 Attention: Docketing and Services Branch DOCKET NUMBERPR PROPOSED RULE..!...:.!~ =----

Dear Sir or Madam:

(looi=R.. los:\~"\--) @ The United States Enrichment Corporation (USEC) wishes to submit comments in support of the proposed revision to 10 CFR Part 20, Constraint Level for Air Emissions ofRadionuclides, which appeared in the Federal Register on December 13, 1995 (60 FR 63984). USEC supports this revision to the Nuclear Regulatory Commission's (NRC's) radiological protection regulations because the revision facilitates the Environmental Protection Agency's (EPA' s) proposed recision of 40 CFR Part 61, Subpart I, National Emissions Standards for Radionuclide Emissions for facilities licensed by the NRC, other than commercial nuclear power reactors. USEC believes that the proposed revision assures the EPA that the level of radionuclide releases from NRC regulated facilities will continue to be kept as low as reasonably achievable (ALARA), and that air emissions will be maintained below the level of 10 mrem/yr Effective Dose Equivalent (EDE) established in the National Emissions Standards for Hazardous Air Pollutants (NESHAPs) regu]ations. USEC appreciates that the NRC and the EPA have been working together to develop an appropriate regulatory method to ensure that once EPA rescinds Subpart I, the traditionally low levels of air emissions from NRC's regulated facilities and the operational philosophy of ALARA continue to be maintained. Once this proposed revision to 10 CFR Part 20 is promulgated, EPA can, as authorize-d under Section l 12(d)(9) of the Clean Air Act Amen-tmcnts, rescind its regulations under 40 CFR 61 , Subpart I for NRC regulated facilities other than commercial nuclear power reactors. Please feel free to contact me if you would like to discuss this matter further. I can be reached at (301) 564-3413 . Sincerely, vJ_by Robert L. Woolley Nuclear Regulatory Assurance and Policy Manager MAR 1*s-~ Acknowledged by card ..- **-.~.......... ...." Offices in Paducah, Kentucky Portsmouth, Ohio Washington, DC

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NRC PDR TEL : 202-634 - 3343 Mar 12'96 15 : 15 No . 008 P.0 2102 DOCK ED dSNRC "96 MA 13 A7 :59 71'.X to 202 634- 3343 To: u.s. NUclea.r Regulatory CO?tmlission Oockel:.lny d.lld Service :eranch F-C'u111; Dooley 1eieter DOCKET NUMBER PR - 629 Highland rd., Ithaca, NY 1 4850 PROPOSED RULE o10 (._iobf"te. toeH~~

Subject:

Standards for radioactive air emissions @ Date; 12 March 1996 No. of pagess l

Dear Sir/Madwn,

I underetand ~hat US EPA i ~ bowil'l~ ouL u.r t:.he ~.icture and leavin9 it to the NRC to regulate a i r emissions from Nuclear rec.cot.ore o.nd other 11.uelea;i; .(4i.:lll.tlt!1.i. I ha~ two strong coilllJlents:

1) Please adopt th~ EPA's proposed 10 millirem/year effectivn dose equivalent as a rea~ sta."ld*a*r d*t not as a 'vol~ta.ry "constraint: ".

2) such a st.-:u1tl~~~ n~eds to be enro~ceable; 1~ NkC dOes not intend to enforce, then allow citizen enforcement suits.

I feel strongly about this, ~ince radiation is not good for livinq thin;s! Thankd you for. ~hP. r.hRn~~ to eommQilt. Sil'l("!A:r"A l y, Acknowledged by card **..MA!!...t1J.IO.:...~

U.S. NUCLEAR Rf ATORY COMMISSIOl'-t DOCKETING & SfRVICE SECTION OFFICE OF THE SECRETARY OF THE COMMISSION Ooco ent S tistics Postmark Da Cople

NRC PDR TEL:202-634-3343 Mar 12'96 15:14 No . 008 P . 01 1 02 NRC FORM 386 U.S. NUCLEAR REGULATORY COMMISSION DATE 5 - I 2. ~CJ~ (12-82) TELECOPIER TRANSMITTAL TIME WARNING: Most facsimile machines produce copies on thermal paper. The image produced is highly unstable and will deteriorate significantly in a few years. Reproduce copies onto plain paper prior to filing as a record. TO NAME TELEPHONE

7) 0 c.N_.t_.ri,-~ d £e-h'"~-- *-- ~*** . ~ .

NAME AND LOCATION OF COMPANY (If other than NRC) TELECOPY NUMBER VERIFICATION NUMBER I":R~ (lJL__.1 ~~ FROM ITElE'HONE IMAlLSTOP TELECOPY DATA I NUMBER OF PAGES PRIORITY IMMEDIATE THIS PAGE + I PAGES = 2-- TOTAL OTHER (Speeifo/) SPECIAL INSTRUCTIONS A

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DOCKETED Nuclear Information and Resource Service 1424 16th Street NW suite 404 MAR 1 3 1996 Washington, DC 20036 DOCKETING& 202-328-0002; 202-462-2183 fax SERVICE BRANCH SECV-NRO Comments on US Nuclear Regulatory Commission Proposed Rule Constraint Level for Air Emissions ofRadionuclides IO CFR 20, RIN 3150-AF3 l 60 FR 239:63984-63987, Wednesday, December 13, 1995 USNRC March 12, 1996 Washington, DC 20555-0001 ATTN: Docketing and Service Branch 11555 Rockville Pike oocm tdBEAM PROPOSED RULE rn ~ Rockville, Maryland (fob~b~~~ The Nuclear Information and Resource Service opposes the Constraint Rule. It is completely inadequate as substitute for the Environmental Protection Agency's National Emission Standards on Hazardous Air Pollutants for radionuclides from NRC and Agreement State licensed facilities. The constraint level of 10 millirems TEDE is not a limit but a goal, _whereas the NESHAPS are. ALARA is not an enforceable regulation. NRC's operative regulations, 10 CFR 20, allow higher levels of radionuclide emissions and employ less comprehensive methods for calculating millirem doses than required by the EPA None of these (Constraint rule, ALARA, 10 CFR 20) provide as much protection as the EPA NESHAPS nor the ample margin of safety required by federal law. Additionally, 10 CFR 61, which allows 25 millirems annual exposure from "low-level" radioactive waste sites is less protective than the EPA's NESHAPS. There appears to be no penalty in the proposed rule for repeated exceedences of the 10 millirem constraint level, no enforcement and no opportunity, as provided under the EPA regime, for citizen suits. It appears that self-reporting and confession of exceedences will be relied on for enforcement. Only failure to take self-imposed steps to prevent exceeding the level is a violation, even if those measures do not prevent future exceedences. This is unacceptable as the operative protection of the public from radionuclide 'air emissions. We fully support the comments submitted on this proposed "Constraint" Rule and its associated draft regulatory guide, environmental assessment, analysis and the FONSI, by the Committee to Bridge the Gap. NIRS comments to EPA on their proposed rescission of Subpart I NESHAPS are enclosed for the record. kknowJedged by card ..!.'!J..!..!!~!.......~ ~  : 1J1teS ~ -ftJ8PA M~ l,r. u

U.S. NUCLEAR R GU ATORY COMMISSIOl'- DOCKETING & SERVICE SECTION OFFIC OF THE SECRETARY OF THE COMMISSION Document Statistics Postm Copl s Re . Adcfl

../ . 1: .. Nuclear Information ~nd-Resource Service 1424 16th Street NW, Suite 404 Washington, DC 20036

                                               *202-328-:-0002; 202-467-2183 fax *                           '\

Comnients on Environmental Protection Agency 40 CFR 61, *[FRL-5301-1 ]* National' Emission Standards for Radionuclide Emissions From Facilities Licensed by the Nuclear Regulatory Commission and Federal Facilities*Not Covered by Subpart H *. 60 FR 188:50161, Thurs. 9/28/95; [RIN 2060-AE39]

• Central Do-cket Section LE~ 131 ,

Environmental Protection Agency

• _

Attn: Air Docket No. A-92.,.50 .

         .*Washington, DC *20460 202-23f,;9629 fax *
          *February 29, ~996 The Nuclear Infonmition and Resource Service (NIRS), many :of its mern:bers and. associated *.
     ,

• organizations, including the Safe Energy ~ommunication Cou~cil, continue to* oppose the * * * :

Environmental Protection Agencys (E~A) proposal to rescind 40 CFR 61 Subpart I for facilities. (other than *commercial nuclear power reactors) licensed by the Nuclear Regulatory Commission. (NRC) and Agreement States. (In_therelat~d~ but now separate decision, NIRS is challenging the , EPA's final decision to rescind Subpart I for reacto~s.).. . In response to the September 28,.1995 reopening of the comment period, *we submit the following

        . comments:

EPA's NESHAP of 10 inillirems ede (effective* dose equivalent) per year for radioactive air .

• a emissions is a legal limit. Exceeding that level is violation. It appears that citizen suit provii,ions, are possible to increase the potential for enforcement, under EPA authority. * *
• Rescinding EPA's respo~sibility and authority to NRC, based on the proposed Constraint Rule . .

     ** * (Constraint Level for Air Emissions ofRadionuclides~ *60 .FR 239:63984-63987, 12/13/95),

• replaces a legal limit with a design goal and appears to sac~ce *citizen suits.

I( as NRC. an_d EPA claim, the facilities can meet the 10 mill~em ede/year goal~ why not make it .

          ,enforceable? Why remove this level of protection from public?

• It is clear from page 63 986 of the NRC's proposed rule that ".'.. The constraint on dose fr(?m air :

a

       . emissions is different than limit. Exceeding' this *constraint would not result in a Notice of .

Violation... " It's not illegal to release levels that lead to doses greater than 10 rnillirems TEDE . (total effective dose eqllivalent) per year. Incentives *and design goals are ni~e, but legal limits are

• necessary:

                                                                      '1*
  , I

/ NIRS. ~uggests that ifa design goal is desired, it ~hould be a zero release, -zer~ dose goal . _accompanied by a legal, enforceable limit. We contend tha~ adequat~ protection of.the public m~ans preventing exposure to radiation'. In practice, since nuclear fa~ti~s routinely release . radi.oactive materials into the air,*there must be a legal,* enforae~ble limit~ not reliance on the good

        -*intentions_ of the licensee to self-report and correct to a Commission that J}as a history of failing to enforce technical specifications. _In addition, the Nuclear Regulatory Commission is just now compiling a list of the exemptions it has granted in the pa_st. -                .      -     .

Procedurally, the public. comment on this proposed rescission should-be AFTER the NRC has - _adopted its Constraint Rule, or preferably something -enforceable.. What we are *no~ being asked to comment on is-~ proposed.rule-which niight never be adopted, might be adopted asis and later. _reyised or rescinded, or be adopted in a.different form'than*proposed. Even though EPA has

       *-'stated the intent not to* finalize its rescission until after the final adoption *of the NRC rule, the a* _         public-comment period should be _reopened at that time. What legaijy-binding assurances*~e there W            that. the. NRCwill. adopt~ enforce, and r¢tain constraints? _-                   '                 **

What mechanism 'is ther~ for implementing more protecti~e stan_dai-ds as knowledge about

      -. low-dose health effects continues to indicate greater cancer and non-cancer negative health; .
        . effects? This is necessary to provide .an ample margin ~f safety. A listing of relevant studies.

• indicating that the:health effects oflow-dose radi1;t:tion are ~ore harmful than previously believ~

         *will be provided. Studies with which EPA may be unfamiliar can be provided for the ~ecorcL
                         ,

• I 1'hose that are published by national and international radiation-bodies and government agencies are referenced since they_ would _be expected to be easily available to the EPA staff dealing with
• radiation prbtection.- .
• _-

With regard to "!ow-level" radioadive disposal sites and radioactive incinerators, we strongly support co~tinued regulatory control by EPA. The EPA level appears to be more protective than . NRC or Agreement States.would require. Existing facilities are presumably already complying. If : . , so*~ such protection should not be.sacrificed. 1 (We. do question' th.is presumption.) We also have concerns about nuclear laundries, fuel fabrication,-conversion and radioactive metal-processing facilities, among others:

• Responses to Questions pos.ed: -

1) No, NRC's Constraint rule will not assure that routine radionuclide releases result in doses that are consistently and predictably no greater than 10 millirems per year. Ifit were .a verifiable legal limit with enforcement mechanisms -~eyo~d self~reporting by licensees,' it might,- but it' is clearly only a design goal. - .

The proposed Constraint rule clearly allows doses greater than 10 millirems per yr. The rule itself, as proposed does not require the licensees to limit exposures to 1Omillirems/y_ear--10 is the goal-which if exceeded requires so~e unstated action by the licensee to get back down under 10. Even if enforced, 10 'millirems/year ede presents a fatal cancer risk _of 1 in 2860 people--which is not an adequate level of protection.

2) No, NRC can't make that assurance because it'is not required legally of its.licensees~ The

• _. ..
• Constraint. rule is not an enforceable provision. ALARA is not enfor~eable. in_°cotirt and therefore *. ,

not aregulation. It doesn't appear to be any stronger than a reg guide. . . . .

      ,   .   '           I           *          *. *    ..              .     .          *     . *    . *     ' '

3) If states adopt the same constraint rule as NRC proposes, the same limitations will ~pply. *

• States .can, of course, with or without the Constraint rule, set stricter enforceable. st~dards * . * .

regardless* ~f what NRC or EPA do. * *. * * * ** *,. *

4) States have authority to set stricter standards,

_S)No .. EPA is-relying on past-perfonriance to predict the future performance. EPA is relying,:_~n good .

   .faith ofNRC and its licensees. EPA is rescinding: a potentially enforceable legal limit and greater            '

opportunities for public input, to *NRC based on a goaL This f~ unfounded/ .. *. * *

• I .

  -Dianep'Arrigo *                       ...

Radioactive Waste ~roject Director NIRS . 2/29/96- , r

40 COMMITTEE TO BRIDGE THE,GAP, 1637 BUTLER A VENUE, SUITE 203 . . LOS ANGELES, CALIFORNIA 90025 (310) 478-0829

                                           * *Comments

• of .
• The-Cominittee to.Bridge-the Gap*

on

          .      __ The*Propos~d Constraint" Rule for Air Emissions _          . . *.

and Associated Draft Regulatory 'Guide, Enviro~ental Assessment,

          . Finding' 9£ No Significant Impact, cU.1d Regulatory.Analysis
                               .                   b                           .

y . ' '

                       -The U.S~

Nuclear Regulatory Conmµssion

• 11 March-19% ' . '
• The U.S. Nuclear Regulatory Commission (~C) has published for public comment a:proposed."con_straint" rule for air ~missions. Certain other documents, associated with the proposed rule, have also been .

published, particularly a draff regulatory guide (]X;-8016), a Regulatory.-

• Analysis, an Environmental Assessment (EA) and Finding of No **

. Signifi<ant Imp.act.(FONSI) .. The Committee.to Bridge the Gap, atos Angeles-based nuclear policy organization, h~reby submits the follo':Ving"

• comments on the prop~sed:constraint rule and associated documen~.
• Introduction

     . , The Clean Air Act (CAA) requires the U.S. Environment~, Protection .

Agency* (EPA) to regulate air emissions from a wide variety of domestic nuclear facilities'. EPA, under presswe from the nuclear 'industry, has for

• years resisted exercising that statutory responsibility, requiring several-court orders to force compliance. Its latest approach_ to thwarting lhe intent of the CAA is to prop.use recission of its regulatory powers over hazardous *

  . arr emissions fr~m NRC-licensed nuclear facilities other than nuclear                        .

power plants (it has already rescinde'ddts* authority over the power plants.) In or<;J.er to rescind the E:P A r~gulatory authority, ho-wever, EPA must tind *

• . that.the NRC program to regulate such air emissions ptovi_des an ample

 *

• margin of safety, a standard that'- EPA has set as a 10 mrem *effective dose

. . equjvalent for the w-hole body for the maximally exposed _individual, of

• which no more than 3 mrern can be from rachoiodines~ .EPA has further defined*this standard as requiring-regulatory limit,s ,that are*not to be '

 .. exceeded and are to be calculated in a certain fashion, or via certain* .-

specified alternative_ methods. * * ** * *

               *

• NRC has rio~ published a draft'rule which would establish not a .*

   *. binding *regul_atory limit but' a constraint level, a level which if exceeded 11              11 would not:constih1.te aviolation of lh.etegnlations. The proposed rule 01_1.

its* face does riot meet the EPA.' standard~ *The rule, as proposed, is clearly

    *. unacce~table. . .                        ,
  *,'       :      '..   ',    '  ' :       *..   :  .       . .* ,\ :    '   . . . . .   .        '
 * , * ** In testimonybeforethe EPA (copy attached), we delineated detailed*
 . defide11des in the.NRC proposed rule and*why those defects made it , * .
 *. legally impossible for EPA. to rescind its_ regulatory au.thority in the aiea.

Rather tha,n repe'1t those ¥gun:tents here, our testimony ,and the points.

• ** raised .therein* are incorporated herein by .reference..

  **                         l   ~

In what follo,ws, we 8:dd to those points~.*

   .    .     .        .    -)          .              .

The Proposed NRC "Constraint" Rule

    .     *.* .. -Toe proposed rule isa transparent.attempt toprovide EPA with. .

sufficient superficial basis to rescind it$ ownregulatory program without substantively altering N;RC's standards, which are markedly less protective of the public and provide markedly less margi~ of safety. At the core of the.. differei1ce between the *two agei1ciest standards and*programs is a ten~fold- , or rnore difference in permissible exposures from air emissions. _The NRC:s re~latory limit for members of-the public sets the limit normally at 100 . milFrem per year [10 CFR 20.1301(a)(1)1' althorigh with permission from , NRC facili1:ies can legally op.erate so as to produce*public exposures five

     *times that, or 500 mrein [10 CFR ~0.1301( c)].                                         * *

             * .These "permissible" doses qre 10 to 50 times higher thari EP A's, air

• emissions standards of 10 Il).l'em. The NRC -limits oflOO to 500 mr,em pe:r year are roughly 10 to-50 chest X-ray equivalents-per ye~. Doctors are extremely reluctant to order even a single X-ray if notdearly.medkally

     . needed, because of the risks associated with the extra radiation e~posuie ..

It is-difficult to believe-the public would find. acceptable these permissible** radiation exposure levels-set by NRC were they to l,e informed NR,C vie~ed as acceptable the exposures to members_of the public.equal to hundreds or thous.ands of additional chest X-:-rays over one's lifetime. _Indeed, the ~rrent.NRc*regulato'ry lirpits aie equivhl~rtfto a 1 ~ 300

• lifetime risk of cancer (at the 100 mrem* standard) and 1 in 60 risk (at the *
• _... 500 mrem. standard)._ [Sourc;e:
• U,.S; General Accounting Office, "Consensus :.

   .* ?ri Acceptable Radiation:Risk to th~_Public is Lacking,"S~ptember* 1994,                          __ _
     , GAO /RCED-94-1,90.J This estimate by GAO is ba,sed on somewhat - .
      .outdated tjsk estirria~es; if one uses lhe estjmates of the National Academy _-

_ . of Sciences**committee on-Biological Effects-of Ionizing Radiation (BEIB. V), *

   - the risk factors ~e even higher-1 in-180',and l~in-36 respectively. By-

• _.conb(ast, "acceptable" riskfor c;arcinogeh exposure under EPA standards is

      ,generally .set at 1 in a million. T~us, NRG's radiation standards for                 . _:
     *exposures of 'the public -are currently four to five orders of magnitude less

_protective than th~ risk level. generally copsidered acq?ptable by EPA.

        . . Furt~ermot(tNRC's method of calculating doses, found in 10 CFR ?O ~                       .
    . Appendix.B, are substantiallyless protective            than.- EP A:'s, even for the same
  '* exposures: As WqS pointed out to EPA in*a 27 November 1995.letter by *                             --*-

.. .-_ Robert C Spirin, Jr. Commissioner of the New Jers~y:Deparfinent of* *_

  * ];:nvirorimental rrotedion, allowed air concentrations"'."'"for the same '.
 .. presumed dose- *are--genera}Jy ten~ to* hundreds of times higher_under NRC regulatory methods of calculation than EPA'.s_~_ The dose conver~i9.n factors
       .used by-'NRC in 10 CFR 20 _Appendix B, Table 2, ar~ up to 460 times less.

protective than are the factors used by' EPA in 10-CFR 61, Appendix . E, Table2. . - *. It is thus dear. that NRC's current regulatory limits for ;radiation-* exposure to members of the public froIJ1, air .emissions are orders of . magnitudeJess protective than EPA stahdards. The question then becomes .

• whether theproposed*"constraint" rule adequately improves that situation

     . -or, indeed, whether it change~ it ~~ all. -The answer is clearly no. _                *

                                                                                                                                                    *

• I 1  :

                ., 'It is' self-evident, -~o!h fr_omthe-contentand stated purpose. of the
      *proposed rule, that its intention is to preserye t1i.e current relaxed

• _,

reguiatory po~ture of th~ NRC 'with regards to radiation exposures to the public while attempting to present to EPA a "basis"'for rescinding*its-01-vn; more protective regulatiqhs. Indeed, i..JRC states at the oµtset ihat the _ . purpose of the proposed is not to provi~e _stricter -regulatory }iinits- for its licensee~ and thus greater, protection for the public, but ins~~~d merely to- * . provide a basis for,bPA to rescind its own regulatory progtam ii1'the_area.

 . As shall be.seen pelow, the NRC rule is ci.riefully constructed so as to not : , **
  ' c:teate a regulatory limit mote protecn ve- tl;t.an the ~rrent i'1R~ permisbib!~ : .
  . levels*of 10-to 50 ~est-X-ray equivalerit_s,per. ye~ to member~ of the public.

-. -. {Over 70_years, that-i~ al'permissibht exposure*of 700to 35()0additional * .. *

     .che~t X-rays ~o an :individual from-nuclear facµ,ities, as astonishingly 1~                                                                 *
       ~e01 la1/4-or;y
     *..:.t)a11 L

fi.am_~'!;ATork.'

                            ..L.a. _.,,.,A_,/      r

_ 1 , 1 The NRC Pr-oposed "Constraint" Rule-*is ~ ot a Regulat~ry tinpt; Exce~ding

     *it vVould N of Constitute a Violation                                        . *           * *-          -.         .     :*       _,
  , . , The "EPA :1h:nits are regulatory ~imits; exceeding the,m ~ violation.;_ _* -                                 i~;

NRC ha$ been careful to not produce an equivalent level of protection.-_ The 1

,_ proposed rttle se~s *a level. wh'.ich is not a violation to ~xc~ed. **_ **_* *._. * *_ . - , .

• _ If ~ne breaches the "consh'ainf'.level, all_one:has to ~l9 is.submit a ._

report a..~d identify corrective me~sures to be taken.* Failure to carry* out the. corrective II1.easures wouid be il violati_on, but under the-language as -. - . i,vritten, failure of th.~ corrective measures to prevent a second breach of the:

  . constraint level would noi                         _be~      It appears one could_ violate the constraint level ti~e and time again, so l9ng as one submits a report each time and

• ca..-ries out the corte~ive 1..ueasures prorri.i.sed~-- -, ;_***.. *- _-

The "constt;"aint l~vel is tied to the ALARA (as lo~ as reasonably .

ac.hievable) requirement. Ho,vever, ALARA is <;lefined in theNRC* * , __ regttlations as mereiy*a goal, and ~he necessity of achievement of the goal is

      --.A.

rJpf1*-nPd

            .LL-
                       *~s necess:::1n,J only* to t11P exre*n:t tl,at factors* *su.("h*ai:;;:. technolo&y
                       -.          ,*  ~JI.. ~ L-IPo.     '1,.&, -     .. .A.. AL     ~  ._       ._..._ ,'-'   ...        L      it, and *

a.

• f economics make it acceptable. In other words, .ALARA is not a * . . ~
• _

requirement, but, merely a sugg~stion to keep emissions as 1ow as readily . ad1ievable givn the ecbno:rn:icsand other fact9rs of reducing err.issions. On the other hand, regulat_ory limits such as EP A's NtSHAP are real limits

       -one must not exceed certain exposures to the public, or a violation exists._*

an

• :NRC has created empty shell of a_ standard, one that .is n.ot ~andatory*. . *.

  *. Non-mandatory limits are'no limits at all-that is why_NRC has called this a: .
      *"con~aint" level, not a regulatory limit. As such, it is unacceptable._ -
        ,      '

• I ' **

The,draft regulatory guide furtherrelaxes-1:natters urtaccepfably, by permittjng far less stringent methods of cal~ulating estimated expo_sures than under the EPANESHAP~- * - _** Furthermore, NRC has riot incorporated the p*roposed "constt"aint

   "*- level" into any other section of the regulaJions. than f0 CFR 20, so it has not become part_ of anyHcensfr1g*standard (see, e~g~, , 10 CFR 30; 61, or 70).,-*__ * ,*

• Conclusion*

       * * -- The proposed NRC constra:µit rul¢'*' is a hollow shell desi~ed to" *_

give EPA- a superf1c~al basis fqr rescinding its stricter regulations withqiit

     . alteringthe_trertlend,o~ly laiNRCregulatory'standards. and program~.

• _.AfterJhe constraint rule, the !'permissible" levels of exposure to members of

'*.' the pul',lic'(roin aii:' emissions will be what they-were'before _the rule~thel ..*
   -. eqtiiv~eht *of up_ to th~usands of additional. ~hest X"".rays to an individual_ *.

()Ver his or her lifetime. Of i:l million people exposed to the NRC . . * . .*

     . "permissible!'" levels, 5,000 to 28,000 would die from cancers caused *by that
    . *"acceptable" exposure from the nti¢lear *enterprise. And t},.is does no~ even compensatefortheNRC method_qf conv~rting'conc~ntration of radioactive -* *
 , material to dose, which is 10 to 100 times more 1ax*t1::tan EPA's. (One should note that even were       the 10-mrem level to b~ not a ",onstraint" level but an actual regulatory limit,*and were the NRC conversion factors for *
      .dose as lax as. they are, the 10 mrem level is the equivalent of a 1_ in 1800 lifetime risl<_ of cancer, five hund:r,ed. time~ more lax than the general EPA one-:-in-a-million level-for accept~ble risk.)

I ' -

          ,     _The proposed NRC "constraint" rule is* not a regulatory-limit; . .

exceeding the 10 mrein figure is perinissible,'notprohibited; it does not. indu~e the EPA require:ment_ of limiting radioi_odine exposures to 3 mrem;

• morelax cakulational techniques are permitted, making frue ex'posures *far

   . higher than unde~ tj:,.e EPA scheme; and the only regulatory limits_now                       in .

exis~ence for the public (100 to 500 frrrem* annually) would remain the ori~y - -_. limits after the "constraint" rule is finaljzed: The proposal, to put it gently,*

is a sham, le~ving:the ~RC regulatory li~ts as lax as they were before.the rule, but with the public less protected than under the current situation. This is because the purpose of the rule ~s to get EPA to ,resd.nd its regulatory prog:i;am1and- standards, which are substantiai,_y more protective _of the public than either the curre1.1t or proposed N~C radiation prpgrams. The rule should be subshm.tially strength~ned; the EA and FONSI rejected, having failed *to analyze either the alternatives of a stronger rule or .* the effect of the weak rule on the environment by contrib~t~ng to* rescission. ' . of the more protective EPA r.egulati<Jns and regulatory program; ',llld the . . draft Reg. *qwde rejected, as it pemiits* calcitlation of expo~ure'by means far* . less protective than EPAr~.. _-. . ,

 ./

1 r ,-

                                           , 6

COMMITTEE TO BRIDGE THE GAP 1637 BUTLER AVENUE, SUITE 203 . LOS ANGELES, CALIFORNIA 90025 (310) 478-0829 Testimony of Committee to Bridge the Gap Befoie the Office of Radiation and Indoor Air Radiation Protection Division U.S. Environmental Prqtection Agency . Regarding EPA's Proposals to Rescind Its Authority to Regulate. Radion~clide Air Emissions from All Civil Nuclear Facilities Washington, D.C.

• 29 February 19%
• Introduction This testimony is.presented on behalf of the Committee to Bridge the Gap (CBG), a Los Angel~s-based nudear policy organization. Officers of CBG regret that, due to.the distance and expense involved in traveling three thousand miles to Washington, D.C.; they cannot be *
• physically present at this hearing.
• On 30 October 1995, in timely response to EPA's Federal Register notice of 28 September 1995 (60 FR 5016.1),
• ten organizations, including CBG, wrote to EPA requesting hearings on its proposal to rescind its authority under the. Clean Air Act to protect the public from haz.ardous air emissions from all civil nuclear facilities, many thousands of such facilities in
• total. As*we said in that letter, the EPA final rescission of its regulatory authority over air emissions from nuclear po"ver plants and its proposed rescission of authority over all other -

licensed nuclear facility "entail wholesale removal of hard-won public protections from excessive emissions of radionuclides from the entire civil riuclear sector." In our October 1995 letter to EPA, the.ten grcmps requested, "to avoid the hearing being soiely an 'inside-the-Beltway affair,"' that hearing sessions be held elsewhere in the nation. Most of the groups requesting the hearings were not based in Washington; half were based in

• California. The groups requested expressly that one of the hearings be held in California.

As we concluded in that letter: The abdication of EPA regulatory auth01ity over hazardous air emissions from all non-Department of Energy nuclear facilities is a serious matter, one which could lead to significant diminution of public protection from radionuclides of

        ~ignificant toxicity. It should be entertained only after thorough review of the issues.

Nonetheless, as of this date, we have received no response from EPA to our October letter. EPA did publish a notice in the Federal Register announcing a hearing in Washington, D.C. Since we

have had no response to our request for hearings in California, we do not know if EPA will grant* that request. On the chance that it will not, we hereby submit testimony to the hearing in Washington, but are handicapped by-not being able to be present in person, with the opporhmity to ask questions, rebut or comment upon other testimony, and the like. Process Conceri1s

        .* EPA published its n~tice c:>t' proposed rescission ~n 28 Septemh.er 1995, based on a        .

proposed NRC "constraint" rule which had not even been published for public comment at that time. The NRC draft rule was not published until 13 December. It is not yet a final rule, and . may be changed prior to finalization. Additionally, a draft regulatory guide was to be issued in connection-with the NRC draft rule. The draft regulatory guide is to provide guidance .as to how to meet the-draft "constraint" rule. _Notice of the availability of the draft regulatory guide for public review and comment was not published in the Federal Register until 22 January'. We have so far been unable-to obtain it Nonetheless, it_too is not yet final and may be substantially

revised in response to *comments. Furthermor~. NRC-policy statements and procedures attempting to re1iledy EPA concerns about the adequacy and criteria for the NRC Agreement.

State program have not been finalized to date. Additionally, NRC inspection procedures appear not to have yet been modified.to reflect the proposed "constr~int" mle..

            -. EPA has previously indicated that the currentNRC regulatory program did not provide

. the assurance of an ample margin of safety required by the Clean Air Act (CAA) for EPA to

 .-rescind its regulatory authority. in the arena of hazardous air emissions from NRC lic'ensed

• facilities. It has insisted upon.a new rule adopting the 10 mrem standard; a revised regulatory . _

guide detailing.how to comply with that rule; new inspection procedures detailing how to enforce. it; and new NRC policy and procedures to remedy inadequacies in the NRC Agreement State program. Not one of the~e is yet final. Yet EPA has proposed rescinding its authority anyway,' and insisted upon public comment on the adequacy of NRC steps not yet taken. This makes little sense. It puts the cmt before the horse. To be rational, and not arbitrary and capricious, EPA should await.finalization of any prospective NRC actions, and then solicit public comment as to whether thos.e "final II NRC actions are adequate to provide _the "ample margin of safety" assurance required by the CAA for EPA rescission. On J7 January 199,6, the Nuclear Infonnation and Resource Service (NIRS), the Environmental Coalition on Nuclear Power, the Sierra Club, and CBG wrote to EPA requesting the comment period on EPA's proposal to rescind its NESHAPs be extended until after final action by the NRC on the matters fuat are supposed to- provide equivalent protection to that of the EPA NESHAPs. To date, we have had no response to.that request, either.

                       .                                                                        I
        - - -we hereby-renew our request in this regard; specifying in detail-the rule, reg: guide, inspection procedures, and Agreement State policy and procedures identified above. Public comment on these issues is premature until those items are finalized by NRC.

Scope of Comments Solicited on EPA Propo~d Resc~sion We object to EPA's assertion in its 28 September 1995 Federal Register notice attempting

• to severely restrict the scope of public comments peIIllitted on its proposed. rescission of its NESHAP authority. All issues relevant to that proposed rescission should ht within the scope of peIIllitted comments. In particular, important developments have occu.ITed in the last few years; prohibiting comments on those matters would arbitrarily shut the agencies ears, so to speak, to
• new facts that should be considered in determining whether public health would be harmed were

  .EPA to rescind its NESHAP authority.

Comments on the Sufficiency of the Revisions of the NRC Program to Support the Fin~ _ Required by CAAS,ection 1U_(d)(9)~ * -

1. EPA ha~ det~rinined th~t a 10 mrem total effect dose equivalent_(TEDE) from all

• pathways from air emissions, with no.more than 3 :mrem coming from radioiodines, is
• .
• necessa*ry to meetthe CAA requirements. The NRC proposed "constraint!l.rule includes neitti,er requirement * * *

              - NRC has inexplicably dropped the 3* mrem standard from ra,dioiodines, and the proposed rule *is therefore on its face not equivalent to the standard.set by EPA. Addition~ly, NRC. . .

appears to permit calculations based on. 10 CFR 20 Appendix B, air limits, _which does not . .

     *. include.all pathways (e~g;, ingestion of agricultural prooucts contam,i1µ1ted by '1ir emissions)that are included in the EPA NESHAP. Thus;-10 mrem.TEDE under the NRC proposed "constraint11 rule is ~so on its face not equivalently protective arid would result in. doses above .19 mrem - ..
    ,., TEDE when all pathways are included,_- as requir.ed by EPA.. . *                          , **

2. !he EPA NESHAP limits are enforceable regulations, hreach which of m prohibited as

   . -*violations. The proposed NRC ."constraint" goals are unenforceable ~ggestions, breach o(

which are perniitted and not ~ee:med violatio~ As such, they are notequivalently '

       .pro~ective.. Indeed, NRC would pennitb:reach of the 10 mremlevel,solong asit_is ..
  .

• reported; EPA NES.HAP _regulations prohibit l)reach of .the 10 ~em l~vel. * *

               , EPA has -found that compliance with 'CAA ~equires prevention **of.doses from hazard~us air emissions exceeding 10 mrem TEDE and 3 mrem from radioiodines. As such, exceedance of those limits is a.violation of the EPA NESHAPs. The NRC draft rule declares doses in excess oL *

• 10 nirem TEDE to not be a violation. The c1urent EPA ml~. prohibits doses -greater than 10 mrem; .the NRC proposed rule permits. such doses. The two* niles o"b:viously do not produce
• equivalent protection. , *

        -3. The d~aft NRC regtilatiop merely requ.i~ reporting when one exceeds 10 mre~ and ..

• identifying proposed corrective actions. It~ ambiguous as to whether, if the 10 mremlevel

       *_is subsequently breached again, there is even then aviolatio~ so long asone*has.taken the,, .
 -- actions .

one previously. .proposed. _ The NRC draft rule im'.plies that, so 1ong,~s one has taken the corrective actio~s on~ '_ *

    . identifie_d,.at the time of the first ~reach, there is no violation if one subsequently goes over,the 10 mrem figure again. Fo~ example, if the secon~ b.reaking of the 10 ~rem figure is due to a *

• different cause than the first or, even if due-to the same cause, if one had taken the cmTective***

       *me~ures promised, it would appear no violation would exist *                "       *
       . 4. The                               the
                   ~le does not reqlrlre use of the CO:MPLy code tbr calculating compliance with the NESHAP limit, orspecified alternativ~, as required by EPA. lttherefore would potentially    .

permit a calculational_method- less protective than.the EPA role.

                 , The rule is completely-silent as to how it is to be detennined if one ha~ gone. ov~r the* 10 mrem figure. One can always calculate a dose*to be as low. as one wishes for regulatory .

purposes; if there is no mandatory calculational method, estimated doses will always be far

• below true doses. * ,* . , -' * ** .* '

           .     . Apparently, the ckaft revised Regulatory Guid~ prpvides some guidance on these matters; but NRC Regulatory Guides are not mandatory. Furthermore, it appears the Reg. Guide permits the, licensee to ignore COMPLY and the_ EPA-approved alternatives and invent _an alternative it*

• wishes. NRC estimates it will take only 1 hour to demonstrate that any alternative code prepared . ,

by or used by a lice:p_see has been "yalidated 'I against COMPLY or the other approved methods

  -rcr demonstrating compliance and to "verify that each calculation performed by the code is being completed correctly." (NRC Supporting Statement for 10 CFR 20 AURA Constraint and Draft Regulatory Guide DG-8016). Clearly, one cannot in a mere hour adequately validate an alternative code and Yerify that each calculation is being pelfcrmed correctly; thtij, NRC is tacitly
   .admitting inadequately validated and verified, alternative calculational methods will be tolerated.

5. The EPA NESHAP has a provision for citizen snits to require compliance. The NRC "constraint" rule has none.

A significant part of the EPA program is the provision for citizen suits. This public right

 . to action has had a salutary effect on the agency, prodding it to enforce the NESHAP more vigorously. It has had a salutary effect on the regulated entities, prodding them to more accurately report emissions and more aggressively try to limit them, knowing that their actions can result in court action brought by the public. And, when both the *agency and the-regulated
  . entities fail, this mechanism has resulted in the public being able to obtain from the courts binding intervention requiring rectification of violations. EPA knows that this citizen right to action, found in the CAA, has not infrequently resulted in courts 1:U.andating corrective actions

• not voluntarily undertaken by polluters nor enforced by EPA prior to the court intervention.

Taking away this protection can only result in a diminution of protection of public health and safety.* The NRC rule in this regard too is not equivalent, and provides significantly less of a margin of safety than the EPA rule. - * *

6. The Agreement States frequently regulate even more weakly than does NRC. NRC has .

• never revoked an Agreement, thus never enforced the compatibility requirement In *

. addition, NRC will permit Agreement States three years to adopt parallel regulations to the *
    "constraint rule. 11 Thus, there will be a period of three years from the time of the proposed rescission of EPA authority to the time Agreement States even have constraint rules in -

place (if they comply in a timely fashion). The public would therefore. be bereft of ,* p:rotedion from hazardous air emissions for several years--clearly not in keeping with the .

    "ample margin of satety" reqnirement.
  .         While some Agreement States have comparable or better regulatory programs to those of the NRC, many are disastrously weak. Inspections are often very much less frequent than under

• the NRC. Regulation is often limited to receiving annual reports from licensees and app~oving
• license amendment requests. It has recently been revealed tqat the State of Nevada, for example, failed to detect illegal dumping of liquid wastes by NECO (now US Ecology) at its Beatty,
• t\evada, radioactive \¥aste facility for something on- the order of a decade. Radioactively contaminated tools were 'being taken from waste barrels and distributed in the nearby town for

, years before being caught by state regulators. We have seen the same weaknesses and excessive coziness with.licensees on the part of state regulators in California NRC just gives carte blanche to Agreement States, It has never revoked an Agreement, no mqtter how egregiously weak the Agreement State's program may be. It has no way of ensuring adequacy of those programs if it fails to enforce the compatibility requirements: its only enforcement mechanism is revocation, a measure it has never taken. Therefore, the current and proposed NRC practices with regards Agreement States are inadequate to assure public protection with regards the

   )."ESHAPs.

7.

• The existing EPA rule requires that proposed facilities demonstrate that tlley will meet the NE;SHAP in order to obtaiil a permit to construct The pr.opos~d NRC rule contains no such provision. *

  .       Currently, in order to.obtain pennission.to construct a facility that may emit"hazardous air pollutants such as radionuclides, an applicant must demonstrate that it will comply with the NESHAPlimits, and EPA inust approve or deny app_roval on that basis. The proposed NRC rule deals only, with operations, not with pennits to construct (or operate). Now, EPA cannot pennit a facility to even be constructed if it can't demonstrate NESHAP *compliance will result; underthe NRC rule, there will be no such requirement, and constru.ction will be permitted no matter what.

This represents a serious lack of equivalency on the part of the NRC program and a significant reduction-in.public protectimL *

8. EPA has no basis for determining that the current or proposed NRC regulatory program is indeed keeping air emissions* below the NESHAP le':els. Much evidence, not reviewed by EPA, demonstrates the*opposite. - ' . , _ -*

         -EPA's review of this issue is based on data s~ven years older or older. It is arJ)itrarf an capricious to not consider data more recent and relevant Additionally, EPA did no actual measurements or even review of measurements to mak~ a determination in this regard It merely asked a select group of licensees to provide estimates of its releases._ There was no verification of these numbers, no independent measurements. Most importantly, there was no review of actual dose/exposure data..* Self-reporting is a grossly inadequate means of detennining

• compliance. It is like asking a group of accused criminals which among them is guilty. The innocent among them may answer honestly, but it is a rare guilty person who will. Enforcement requires independent determination of whether limits are being breached.; not asking people .

whether they have breached limits. *

• Just one example of why r~lyiiig on self-reporting is dangerous: The UCLA research

.reactor for years reported its Argon-41 emissions as a fraction of a curie per year. Years- later,

. calibration errors and other violations of the license were detected, indicating that for years the Argon-41 emissions were under-reported by 'orders of magnitude. One ye;ar 0.303 curies had _been reported; the true figure turned out to be _124.9. The next year 0.1046 Ci was reported; the corrected figure, corrected years later, was 41.9 .. And so on. Self-reported values without independent verification cannot be relied upon. _. Additionally, it is very dangerous to rely upon models for estimating dose instead of looking at hard data; *Given again the UCLA reactor example, the Argon--41 releases, even when. corrected, are abou~ an order of magnitude lower than those reported to EPA by MIT for its larger research reactor. EPA, using a computer model, estimated maximum doses from the MIT

.Argon-41 as well below the NESHAP of 10 mrem. Yet UCLA, with its lower emissions, used TLDs to measure doses from Argon-41 which were many times the )IBSHAP. Indeed, the NRC estimated doses inside the Math.Sciences Building adjacent to the reactor as several times greater than the NESHAP value, because the exhaust stack for the reactor was lower than and directly upwind of the main air inlet for the Math_ Building.                                            -

EPA claims thatlow-level radioactive waste facilities, for example, ar"e well below the NESHAP. It bases that claim, however, on US Ecology's applications for NESHAP permits to construct for its California and Nebraska facilities. Self-serving claims by applicants are not evidence of compliance. EPA has not yet even approved* or given final endorsement to the California application (we presume the same is true for >Iebraska). Indeed, several COMPLY runs perfonned by US Ecology for its California project (and not provided to EPA) showed the project to not be in,compliance with the NESHAP-by wide margins. 5

• EPA's claims regarding existing LLRW dumps are even*more incorrect EPA claims that

  *no exposures in excess of background have ever been reported at either the Richland or Beatty sites. No source is given for these extraordinary claims, but recent data make clear that both claims are false.

US Ecology's Richland. dump, in the desert of western Washington State, has reported elevated 1:ritiurn rn vegetation at the site. In order to confirm it was coming r:i-om the trenches, th~ State authorities directed the creation of a vadose zone monitoring program, which identified

 .elevated tritium in soil moisture, far in excess of standards. Tritium at a control location, far from the trenches, was orders of magni_tude lower, confirming that the tritium was coming from US Ecology operations and not. some other source on the Hanford site.

Thermoluminescentdosim.eters (l'LDs) measuring gamm~ radiation rm~tinely report . doses there many times*the exposures pennitted ~nder EPA's National Emission Standards for _ Hazardous Air Pollutants (NESHAP) or NRC's standards for low-level radioactive waste

• facilities.

. ,

• The Thermo:-Luminescent Dosimeters (TLDs} mpnitoring gamma radiation at .

US Ecology's Richland, Washington LLRW duinp routinely show doses far in excess of both EPNs 40 CFR §61.102 NESHAPs (10 mrem/yr whole body) and NRC's 10 CFR §61 standards {or LLRW sites (25 mremlyr \Yhole body). For exampl~. in 1991, the TLDs at the southwest . comer of US Ecology'~dump (i.e., outside US Ecology's property line) recorded 172 mrern. That is more than twice background for that area. The nearby town of Richland, chosen as a * . background location, was at 74 inrem. Indeed, the northeast co~er of the US Ecology property, farther from the trenches than the southwest corner, was at 86 mrem. Thus, the dose off the

US Ecology property was on the order of 100 mrem above background-far in excess of NESHAP .or 10 CFR §61 standards. Washington State Department of Health, Environmental

 *Healthy Programs; l!:nviromnental Radiation Program 1991 Annual Report, August 1993, p; 34, 134-6, 243. .                                     ~            .
            , The radiation is clearly coming.from US Ecology's operations and not other activities
 . elsewhere on the Hanford property. The TLDs on the southern edge of US Ecology's property, dose to the radioactive waste trenches, are consistently higher than those on the northern edge of the property, which are considerably further away from the trenches. Seep, 243, id.                 '
         - This pattern is reinforced in US Ecology's TLD measurements, which likewise show elevated readings, highest along the south fence. Readings as high as 270 mrem/yr. above background were reported in 1991, according to US Ecology's annual report. (p. *5-118) The elevated fenceline readings-elevated along all skies of the property--contin~es each year. The.

TLD fenceline reading in 1992, for example, led to this conclusion in US Ecology's Annual Rep01t for 1992. p. 5-123, "The exposure attributable to site operations was 170 mrem. ~ EPA's NESHAP standard is 10 mrem/yr annuhl exposure; the 10 CFR 6t standard for "low-level" radioactive, waste sites is 25 mrem/yr from all exposure pathways combined. It is clear US Ecology's Richland operations are well above those standards. Usir:ig theoretical doses

• calculated by US Ecology for Ward Valley of a few mrem per year is clearly irrational, when the measured values at its other sites (including its arid sites) is one or two orders of magnitude *
• higher.

In a 16 September 1994 letter to US Ecology, the NRC states that monitoring data for the Richland facility "clearly point to the U.S. Ecology facility as the source of elevated radiation."

• The letter refers to TLD measurements in excess of 100 millirem per year above background ( 10 times the NESHAPs) and reminds US Ecology that the NRC's fonner limit of 500 millirem per year had been reduced to lOG millirem and that th~ reported doses would thus be in excess of the 6

NRC 100 millirem standard. Clearly, if that is true, the facility is far in excess of the NESHAPs . as well. At US Ecology's Beatty site, the- saine is true. Recent data, including a comprehensive review of the full operating record of the Beatty site just recently released by the Conference of Radiation Control Protection Directors (CRCPD), document widespread contamination, far in excess of background and far over the NESHAP standard. Vegetation has been reported . significantly elevated in radioactivity. Soil samples have also been repeatedly contaminated. TLDs at the fenceline have shown quarterly doses of 500-700 millirem in 1965, 1.2.Rem the next year, and 480 mrem in 1967. EPA then commenced independent monitoring; six measurements exceeded 100 mrem/qUatter. In 1976 they measured 1.14 Rem in a single quarter.* Beginning in Im, US Ecology monitored 14 locations using TLDs. The maximum annual exposures during that period was 415 mrem, *with doses between two hundred and four hundred. mrem per year fairly standard between 1977 and the early 1980s.- The releases were clearly coming from the facility, as doses at the south boundary remained significantly higher than all

• other locations (the south boundary is closest to the trenches). Doses rem~ed many multiples of the NESHAP throughout the life of the facility, up through the most recent data reported by
• CRCPD, for the early 1990s. * . *
• These dose data are so far above the NESHAP that were ~y member-ofttiepublic. to -

 *spend just a fe\v days in a year near the site, they would get exposures in excess of the NESHAP limits. And numerous members of the public (truckers, people delivering supplies, visitors, etc.)

do spend in aggregate more than .a few days per year near the facilities. - A thorducl1 review of more recent data and a reliance on actual data instead of self-

-reporting by licensees, is essential if EPA is. to* avoid making ~ arbitrary decision on the . ,

adequacy of the NRC program to provide an ample margin of safety and meet the NESHAP levels. . - * . - * * * .* . _ Conclusion _ NRC's regulatory limit is 100 mrem per year; with permission, one can go up to 500 . . _ mrem. These regul.atory limits are ten times and fifty times EPA's NESHAPs, not counting other. factors involving the method for calculating doses that result in NRCactually pennitting doses even higher relative to EPA's*NESHAPs. * .. _ In order to eliminate the more stringent regulations by EPA, NRC has propo~d, not a

• new regulatory limi.t equivalent to EPA'sNESlli\P, but an ffALARA constraint~ level, _breach of which would not be even a violation of the regulations. NRC's ALARA principle is a goal that one should reduce radiation to levels "reasonably achievable," taking into account economics and*

other factors not related to public health protection. It is clear that NRC has created a Potemkin Village type proposed ruled, an empty shell with nothing behind it, solely in order to provide . EPA with an argument for rescinding its own authority.to regulate emissions. The sole purpose in getting rescission is relief for industry from having to comply with what is clearly recognized. to be a stricter standard, more adequately enforced. It is precisely because the NRC proposed is rule so much weaker, and the NRC's regulatory program so much-weaker as well, that EPA cannot make the finding required by the Clean Air Act to justify rescinding its own regulatory * - progrnm. - Let us be frank about the mc1-tter. The CAA N.ESHAP authority was a hard-won victory for public health and safety. EPA for many years now has resisted assuniing the authority mandated itby law. Now it is attempting to eliminate that hard-won protection for the public. The );RC "constrai:ht" rule provides markedly less protection for the public than the EPA NESHAP, and to rescind the latter would be to,place the public at increased risk:. 7 /

0 96 4:38P FR MED-X#ll POl to FAX 301-415-1672 from B. Geary DOCKETED 2545 s. Birmingham ;Pl, US RC Tulsa, OK 74114

                                          '96 MAR 13 A7 ;59 US Nuclear Regulatory Commission Washington, DC   20555-0001 OOC1(ET NtNBERPR Attn:   Docketing and Service Branch                  PROPOSED RULE       ~

((obrR..b&C\~~ @ Concerning standards for radioactive air emissions from nuclear power plants: The NRC's proposed standards for radioactive air emissions are inadequate. First of all, a real LIMIT on emissions is needed. Exceeding that limit would be a VIOLATION. Any company exceeding the limit should receive a NOTICE OF VIOLATION. Secondly, citizens absolutely MUST BE ALLOWED TO SUE a company which exceeds regulatory limits or constraints (whichever they may be called) as to radioactive air emissions.

U.S. NUCLEAR REGULATORY COMMISSIO~ DOCKETING & SERVICE SECTION OFFICE OF THE SECRETARY OF THE COMMISSlON Document StatistlCS Postmark Da ~ Coples Recel Aden Co

                                                               ~OCKETED US .RC NUCLEAR     ENERGY      INSTITUTE
                                                           '96 MAR 13 P2 :09

_ . _- *

• Jphn F. Schmitt, CHP OFFICE [IF SE ,_,Rt I At~1 d lRECTOR, OOCrl' E : I'r *.:~ .r~ - r.. :-, \' I C EMERGENCY 1'" C' l '\

ffADIOLOGICAL PROTECTION, PREPAREDNESS [i RL1Y (: \. & WASTE REGULATION March 12, 1996 oocm NUMBERPR . . . __ Information and Records Management PROPOSED RULE ca.o Branch (T-6 F33) (<oof'R.63~~ @) U.S. Nuclear Regulatory Commission Washington, D.C. 20555-0001 ATTENTION: Docketing and Services Branch

SUBJECT:

NRC Proposed Rule - 10 CFR Part 20, "Constraint Level for Air Emissions of Radionuclides," (60 Fed. Reg. 63984, dated December 13, 1995) This letter provides comments from the Nuclear Energy Institute (NEl) 1 on behalf of the nuclear energy industry in response to the Nuclear Regulatory Commission's (NRC's) request for public comment on the subject proposed rule. These comments have been prepared considering the nuclear energy industry's interest in the continued safe and beneficial use of radiation and radioactive materials without the burden of unnecessary duplicative regulation that provides no added benefit to public health and safety or protection of the environment. In the supplementary information, NRC notes that the Environmental Protection Agency (EPA) has previously made the 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, dated December 1, 1992). However, according to NRC, "EPA continued to express concern regarding the adequacy of measures to assure EPA that future emissions from NRC licensees will not exceed levels that will provide an ample margin of safety." NRC expects that this action will be the final step in " ...providing EPA with a basis upon which to rescind Subpart I [of 40 CFR 61] for NRC licensees other than power reactors." Based on this understanding of NRC's rationale for pursuing this additional regulation of radionuclides in air 1 NEI is the organization responsible for establishing unified nuclear industry policy on matters affecting the nuclear energy industry, including the regulatory aspects of generic operational and technical issues. NEI's members include all utilities licensed to operate commercial nuclear power plants in the United States, nuclear plant designers, major architect/engineering firms, fuel fabrication facilities, materials licensees, and other organizations and individuals involved _, ... in the nuclear energy industry. - kknowJedged bv card lWr 1*a* 199& ~ I ""....." ............. ,,,,,,," l//6 I STRt::ET NW Slllff 400 WASHINGTllN DC 20006-3708 PHOr'JE 2()2 7.lQ 8000 FA/ 202 785 401?

.S. NUCLHR RfGULATORY COMMISSIOl'- OOCKETING & SERVICE SECTION OFFICE OF THE SECRETARY OF THE CO MISSION oocumeit Sta'istics ostmark Date ....-..,""-"=--- - - - - oples Received._,,\_ _ _ __ __

       . ~

U.S. Nuclear Regulatory Commission March 12, 1996 Page 2 emissions from licensee facilities (other than power reactors), we concur with the intent of the proposed action and strongly encourage NRC to pursue this matter to conclusion, i.e., rescission by EPA of its Clean Air Act regulations for NRC and Agreement State licensees. From our review of the subject Federal Register notice and the regulatory analysis contained in SECY-95-133, dated May 24, 1995, and SECY-95-229, dated September 8, 1995, we offer the following comments for consideration in the final rule making:

1. NRC should clarify explicitly that current NRC regulations, i.e., the limit of 100 mrem/yr on public dose and implementation of the ALARA principle, provide an adequate level of protection of public health and safety. Without such clarification, this action may incorrectly be taken to infer that maintaining the dose from radionuclides in air emissions at or below 10 mrem/yr is necessary to adequately protect health and safety. In fact, the intent of the rule is to address EPA's concern that the existing adequate level of protection of health and safety be maintained in the future, and thereby to support EPA's decision to rescind Subpart I of 40 CFR 61. As stated by NRC, "there is expected to be little if any direct benefit to the health and safety of the public as a result of this rulemaking' (SECY-95-229). The rulemaking's principal justification is that it will have the beneficial effect of reducing burden on licensees, if it leads to EPA's rescission of Subpart I to 40 CFR 61. Explaining this situation in the final rulemaking will help clarify that NRC is not redefining the existing adequate level of protection of health and safety.

2. The wording in the proposed rule may be taken to infer that the 10 mrem/yr constraint is a generic ALARA value for dose from radionuclides in air emissions for licensee facilities (other than power reactors). Examples include the wording in section 20.ll0l(d)," .. .[t]o implement the ALARA requirements of§ 20.ll0l(b),"

and in section 20.2203, which refers to "ALARA constraints." It is our understanding that *~ .. there is no data currently available to indicate that 10 mrem I yr is ALARA or that any single value would be an appropriate generic ALARA value" (SECY-95-229). Therefore, we suggest wording be used in the final rule that better clarifies the intent, for example, wording in section 20.ll0l(d) such as, "consistent with the ALARA principle codified in§ 20.ll0l(b)," and use of the term "dose constraint" in section 20.2203.

3. We generally do not support regulation of a specific exposure pathway, rather than regulation of the total dose to members of the public from a source or practice. The proposed use of a dose constraint for a specific exposure pathway, e.g., air emissions, is not consistent with its use by other pertinent organizations, e.g., the International Commission on Radiological Protection

U.S. Nuclear Regulatory Commission March 12, 1996 Page 3 (ICRP), International Atomic Energy Agency (IAEA), and National Council on Radiation Protection and Measurements (NCRP), which have more commonly recommended application of constraints that are inclusive of the total dose from all exposure pathways with regard to a source or practice. However, we recognize in this case that use in the rule of a constraint on air emissions appears necessary to bring consistency between the different regulatory approaches of NRC and EPA and to be able to move forward to eliminating the unneeded duplicative regulation.

4. In the absence of a rescission by EPA of Subpart I to 40 CFR 61, the proposed rule, when issued and effective, will introduce additional regulatory burden on non-power reactor licensees. In light of NRC's stated intent to reduce the burden on licensees by eliminating unnecessary duplicative regulation, we suggest that NRC, in issuing the final rule, establish that the rule will not become effective until the rescission of Subpart I of 40 CFR 61 is completed by EPA and in effect.

In summary, we view the proposed rulemaking as a means for bringing some consistency between NRC and EPA regulatory approaches and thereby enhancing the basis for EPA to rescind Subpart I of 40 CFR 61, as provided by the 1990 amendments to the Clean Air Act. Rescission of Subpart I will have the effect of reducing burden on licensees because it will eliminate unnecessary duplicative regulation. The rule is not expected to, nor is it necessary or intended to, affect the existing adequate level of protection of health and safety assured by current NRC regulations. In light of this, the final rule should be promulgated in a manner that assures continuation in the future of the existing adequate level of protection of health and safety, while minimizing disruption of the underlying regulatory concepts and structure which has successfully assured that level of protection. NEI appreciates the opportunity to comment on behalf of the nuclear energy industry on this proposed rule. If you have any questions or wish to discuss our comments, please contact Ralph Andersen (202/739-8111), Felix Killar (202/739-8126), or me (202/739-8108). Sincerely, ~~~ John F. Schmitt JFS/RLA/ec

DOCKETED USMRC National Mining Association Foundation For America's Future

                                                                                    '96 MAR 13 P2 :01 OFF iCE F SECRETARY OOC KETlt ;G &. SEf~VI CE BRAHCH March 12, 1996 DOCKET NUMBER  PR Mr. John C. Hoyle                                                        PROPOSED RULE,,.!..::.~ ---

Secretary ( tO~lc:i5~ 4) U.S. Nuclear Regulatory Commission 115 5 5 Rockville Pike Rockville, Maryland 20855 ATTN: Docketing and Services Branch Re: Proposed Rule for Constraint Level For Air Emissions of Radionuclides And Draft Regulatory Guide DG-8016

Dear Mr. Hoyle:

The National Mining Association (NMA) submits these comments in response to the Nuclear Regulatory Commission's (NRC) proposed rule to establish a constraint level of 10 millirem a year (mrem/yr) total effective dose equivalent (TEDE) for dose to members of the public from air emission releases of radionuclides (other than Radon-222) from NRC licensed facilities (except power reactors). 60 Fed. Reg. 63984 (December 13, 1995). These comments also address NRC's modifications to Regulatory Guide 8.37 (Draft Regulatory Guide DG-8016, "Constraints for Air Effluents for Licensees Other Than Power Reactors," December 1995) (Draft Guidance). While NMA believes the proposed rule is unnecessary, it will support the constraint rule provided that the final rule excludes radon-222 and its decay products. NMA's 381 members represent producers of most of America's coal, metals, industrial and agricultural minerals; manufacturers of mining and mineral processing machinery equipment and supplies; transporters; financial engineering firms; and other businesses related to coal and hardrock mining. These comments are submitted by NMA on behalf of its member companies who are NRC licensees. These members include the owners and operators of uranium mills and mill tailings sites and in situ uranium production facilities. 12, l ...\63-2625 FAx, 1202 461 6152

U.S. NUCLE/.R R, GUL'iOR : COMMISSIOtli DOCKETING & SERVICE SECTION OFFICE OF l 1!~ c:C,1El AR Y OF THE COM \il -" ,O,*J Doc,* Postmark Da~ ~ - ~ eQ__ Copies Reet 1 \ Add'! Copies r. SpeclaJ Distrl t

Mr. John C. Hoyle March 12, 1996 Page 2 Proposed Constraint Rule NMA continues to believe that NRC's existing comprehensive regulatory scheme provides an ample margin of public health and safety. If, however, as it appears, it is necessary for NRC to promulgate a constraint goal of 10 mrem/yr in order for the Environmental Protection Agency (EPA) to finally rescind Subpart I for facilities other than power reactors, NMA does not oppose a constraint rule if NRC excludes doses caused by radon-222 and its decay products. Specifically, NMA requests that the language in the constraint rule track the language of Subpart I so that it reads: "licensees ... shall constrain air emissions of radioactive materials other than radon-222 and its decay products 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 emissions." For consistency reasons, it is important that the language of the two provisions match. Moreover, NMA believes it is appropriate for NRC to also exclude radon-220 and its daughter products as these appear to have been inadvertently left out of the final Subpart I rule's exclusion. As proposed, Subpart I provided that "[f]or purposes of this subpart doses caused by radon-220, radon-222 and their decay products formed after their release from the facility are not included." 54 Fed. Reg. 9612, 9653 (March 7, 1989). The final rule did not mention radon-220. 54 Fed. Reg. 51654, 51697 (December 15, 1989). This seems to be more of an oversight than a reasoned decision and is not a mistake that should be carried over byNRC. Subpart I facilities are already more than adequately regulated under 40 C.F .R. § 190 (the so-called 25 mrem rule) promulgated by EPA pursuant to the Atomic Energy Act (AEA) and conformed to and enforced by NRC in 10 C.F.R. §§ 20.1101 and 20.1301, in conjunction with the ALARA (as low as reasonably achievable) principle. The current AEA regulatory program already provides an ample margin of public health and safety. As NRC acknowledges, even without a constraint rule, air emissions from NRC licensed facilities will not exceed 10 mrem/yr. EP A's surveys and computer models show that even without a constraint rule, "virtually all of the facilities would cause doses to members of the public which are below 10 mrem/yr." 60 Fed. Reg. 50161, 50163 (September 28, 1995). NRC's notice even notes that "98% of the facilities surveyed [by EPA] reported doses to members of the public resulting from air emissions less than 1 mrem/yr." 60 Fed. Reg. at 63985. EPA's survey of Subpart I licensees found that "all surveyed facilities are presently in compliance with the quantitative emission limit in Subpart I [10 mrem/yr limit]" -- a far higher compliance percentage than exists in any other EPA regulatory program. 57 Fed. Reg. 56789 (December 1, 1992). Indeed, the NRC AEA regulatory program is more comprehensive than

Mr. John C. Hoyle March 12, 1996 Page 3 Subpart I because, unlike the Clean Air Act which addresses only airborne radioactivity (excluding radon), the AEA regulations cover exposure from all pathways (excluding radon). According to NRC, the proposed constraint rule "would codify numerical values for NRC's application of ALARA guidelines on radioactive air emissions from its licensees, other than power reactors." 60 Fed. Reg. at 63985. NMA is concerned that codifying the ALARA concept may create unnecessary implementation problems. As defined by NRC, ALARA by its very nature must take into account "the state of technology, the economics of improvement in relation to the state of technology, the economics of improvements in relation to benefits to the public health and safety, and other societal and socioeconomic considerations, and in relation to utilization of nuclear energy and licensed materials in the public interest." 10 C.F .R. § 20.1003. These are often site-specific and ever-changing elements that cannot be codified in any meaningful fashion. Indeed, the D.C. Circuit has held that NRC cannot establish a single numerical value under the "as low as practicable" standard, the precursor to ALARA: [as low as practicable] requires consideration of health and safety effects, costs, the state of technology, and utilization of atomic energy in the public interest. While the last two factors may be constant for any reactor built or operating during a particular time period, the first two will presumably vary depending on the circumstances of each reactor. Since two of the four factors which determine whether radioactive emissions are "as low as practicable" are not constant, the Commission is precluded from determining that any particular positive level of emissions satisfies its requirement in all cases. York Committee For A Safe Environment vs. NRC, 527 F.2d 812, 814-15 (D.C. Cir. 1975). Even though, as NRC's draft regulatory guidance for the proposed constraint rule states, "a constraint is not a limit.. .. A constraint is a dose value above which specified licensee actions are required," 11 ALARA still cannot be reduced to a single number. NMA does not oppose the constraint goal, although, for the reasons noted above, it is unnecessary and cannot be deemed ALARA. 11 Draft guidance, p. 3 (emphasis added).

Mr. John C. Hoyle March 12, 1996 Page4 NMA believes the constraint goal should be set forth in 10 C.F.R. Part 20 as proposed, rather than separately in each appropriate part of Title 10 as it is generic guidance and belongs with the other generally applicable standards for radiation protection. Regulatory Guidance The guidance notes that " [e]nforcement action would only be expected if a licensee fails to report an exceedence of the constraint or fails to take appropriate corrective action." (p. 3) In this context, NRC needs to recognize that there is uncertainty inherent in determining whether or not the constraint level has been exceeded. For example, if a model changed or new data were obtained it could affect the determination. A licensee also could be unaware that the 10 mrem level had been exceeded because of problems with the model or the data. In many instances, these sites are in very remote areas and the nearest individual who would receive the highest dose may be five miles or more away. Since the proposed rule, in effect, is an exercise in compliance by model, the Commission should build in reasonableness in the application of the rule in terms of licensee knowledge that the 10 mrem constraint limit has been exceeded. In this vein, NRC needs to give licensees flexibility in determining compliance to account for the differences in radionuclide emissions from different sources (e.g., hospitals versus uranium mill tailings impoundments), and the variability in natural background levels. Background levels ofradiation vary depending on the climate, geography, weather, meteorology, topography, and time. These variations account for differences among sites and even across time at one particular site. Application of NRC's constraint rule guidance must account for such factors in the licensee's selection of a scientifically sound methodology to determine compliance with the rule. Subpart I allows licensees to use other, better methods of determining compliance. NMA urges NRC to include in the constraint rule the methodologies allowed in §61.107 of Subpart I. In addition, NMA requests that NRC clarify that NRC licensees only need to include in their calculations emissions from NRC licensed facilities and operations. Part 20 "establishes standard for protection against ionizing radiation resulting from activities conducted under licenses issued by" NRC. 10 C.F.R. § 20.l00l(a). Emissions from unlicensed adjoining operations or unlicensed portions of operations, therefore, should not be part of the calculations. For example, for uranium recovery licensees, this means that windblown emissions from an adjoining uranium ore stockpile would not be included in the compliance determinations as unrefined and unprocessed ore is not subject to NRC regulation.

Mr. John C. Hoyle March 12, 1996 Page 5 Finally, in explaining what information should be reported to NRC if the 10 mrem/yr is exceeded, NRC requires that, among other things, the following be included in the report: "[t]he estimate of dose to actual or modeled individuals (if actual individual doses are calculated, include the name, social security number, and date of birth for each individual exposed to concentrations in excess of the constraint)." It may not, however, always be possible for the licensee to identify the specific individual or obtain all the information requested. Accordingly, NMA requests that the phrase "if available" be added so that the language reads: "(if actual individual doses are calculated, include, if available, the name, social security number, and date of birth for each individual exposed to concentrations in excess of the constraint)". NMA appreciates the opportunity to comment on this matter. If you have any questions or if we can be of assistance, please contact Katie Sweeney, NMA Associate General Counsel at 202/463-2627. Sincerely,

                              ~c<:             Richard L. Lawson 270105-0 1 I DOCSDCI

UNIVERSITY OF CALIFORNIA, IRVINE BERKELEY

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U.S. Nuclear Regulatory Commission Washington, DC 20555-001 Attn: Docketing and Services Branch RE: Comments on RIN3 l 50-AF31: Proposed Constraint Level for Air Emissions of Radionuclides (60FR 63984), Draft Regulatory Guide DG-8016: Constraints for Air Effluents for Licensees other than Power Reactors, and Regulatory Analysis for the NRC Constraint Rule on Radionuclide Air Emissions from NRC and Agreement State Licensees other than Nuclear Power Reactors The Health Physics Society' s State and Federal Legislation Committee appreciates the opportunity to present the following comments on NRC's proposed rule, its guidance for implementation and regulatory analysis. These comments are those of this committee and do not necessarily represent those of the entire membership of the HPS or any committee member's employer.

GENERAL COMMENT

S The Simpson Amendment to the Clean Air Act Amendments of 1990 requires that before promulgating any new standard the Administrator of the Environmental Protection Agency must determine if the NRC' s regulatory program pursuant to the Atomic Energy Act provides an "ample margin of safety to protect the public health" from airborne radionuclide emissions. In order to make such a determination, the EPA conducted two studies and required non-power reactor and Agreement-State licensees to perform evaluations and submit reports to EPA. The results showed that airborne radionuclide emissions from these categories of licensees are below EPA' s arbitrary limit of l0mrem TEDE per year. Indeed, using very conservative assumptions (thereby overestimating doses), 98% of those licensees randomly selected for one of those studies showed less than lmrem TEDE per year. Even so, the EPA Administrator expressed concern that future licensed activities could exceed the arbitrary 10mrem per year limit, thus requiring NRC to propose a new rule calling this value a "constraint" dose.

U.S. NUCLEAR' rc~,LATORY COMMISSIOt-. DOCKETING & SERVICE SECTION OFFICE OF THE SECRETARY OF THE COMMISSION 0ocurne1t Sta'istics

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U.S. Nuclear Regulatory Commission March 11, 1996 Page 2 Scientifically, the NRC's present annual limit of lO0mrem (from all licensed activities) and the EPA's present annual limit of25mrem (from nuclear fuel cycle activities) to any member of the public already provide an ample margin of safety. These numerical values are consistent with the recommendations of the National Council on Radiation Protection and Measurements. In September 1992, the Health Physics Society's "Position Statement on Radiation Dose Limits for the General Public" stated that the Society "endorses the dose limits recommended by the NCRP and adopted by the NRC and EPA noting that (1) they are sufficiently conservative for public health protection, (2) compliance can be verified by actual measurement, (3) they can be achieved in most cases without sacrificing significant public benefits, and (4) they can be applied without discrimination to essentially all manmade sources." Thus, there is no need to establish any new constraints or limits for airborne radionuclide emissions. However, if the NRC choses to continue with this rulemaking, please consider the following specific comments. COMMENTS ON THE PROPOSED RULE

1. The proposed limit of 10 mrem/y TEDE is only a very small fraction of the differences in natural background radiation levels which occur within the United States. The NCRP has estimated that the average resident of the United States receives (in round numbers) about 300 mrem/y TEDE from natural background radiation, including radon progeny, and about 60 mrem/y TEDE from medical radiation exposures as a patient. However, mountainous areas have higher natural background levels, from increased levels of cosmic rays due to altitude and higher quantities of naturally occurring radioactive materials in the soils and in building materials. In fact, natural background levels in much of Colorado and Wyoming average 100 to 200 mrem/y higher than in coastal regions. Thus, the 10 mrem/y TEDE constraint level is only 5 to 10 percent of the difference in background levels between coastal areas and the mountainous states.

2. The Clean Air Act limits airborne emissions to the environment--to areas outside the boundary of the facility. Airborne releases within the licensee's facility are more than adequately regulated by current NRC regulations. If the proposed dose constraints are kept, Section 20.1 l0l(d) should be changed to apply to the individual member of the public likely to receive the highest offsite dose.

U.S. Nuclear Regulatory Commission March 11, 1996 Page 3

3. Airborne radionuclide emissions from all current materials licensees have already been shown to be below the 10mrem/y level, even with the unrealistic methods of the COMPLY code (yielding very conservative overestimates). Licensees have already spent a considerable amount of funds to show that they are in compliance (in the order of 100 million dollars). They should not have to do this again unless they increase their present uses of radioactive materials by a considerable amount-

      -at least by several orders of magnitude.

4. Default values for each radionuclide should be included in the regulation to provide guidance on when licensees would need to do additional analyses (e.g., as an appendix to the rule). The values used for EPA's analyses would be a start.

4 With improved and more realistic release fractions (such as 10 for volatile forms 6 and 10- for nonvolatile forms) applied to the annual throughput of radioactive materials used by a licensee, calculations would only be needed for new processes, experiments and operations exceeding these values. Such evaluations should be conducted during the licensing process, rather than as a separate exercise.

5. Sealed containers, not just sealed sources, should be exempted from the calculations. For example, many radioactive compounds used in research are routinely stored in ultracold freezers for extended periods of time. These will not become airborne while frozen. Another example are the "multi-dose" or "single dose" vials, from which the contents are removed by hypodermic needles and syringes, then injected into patients or experimental systems, with no airborne releases.

6. Just as the present regulation of airborne emissions from all NRC-licensed facilities is adequate, so too is the regulation of airborne emissions from patients under present regulatory programs. To require extended patient stays in medical facilities after undergoing routine nuclear medicine procedures would be a further waste of the nation's limited resources.

                                                                                            -i U.S. Nuclear Regulatory Commission March 11, 1996 Page4 COMMENTS ON THE PROPOSED REGULATORY GUIDE I. Appendix A should be changed so that it contains an example to show calculations for an offsite release, rather than for airborne contamination within a licensee's building.

2. Incidentally, the inappropriate example in Appendix A has several significant errors in the equations and calculations, and should be corrected if it is used for any purpose.

3. The COMPLY code is very difficult to use and should be replaced by a much more user-friendly version in Windows with adjusted release fractions as stated above.

COMMENT ON THE REGULATORY ANALYSIS The Regulatory Analysis neglects the significant amount of time required for licensees to obtain an extensive amount of detailed information and for making the calculations. We estimate that each licensee will spend 50-100 hours on the initial analyses, and perhaps 20 to 30 hours per year to accumulate data and show that no significant changes have occurred; to reconfirm the results of previous studies and reports prepared for the EPA! This unnecessary burden will likely cost the nation more than 100 million dollars, in addition to that already spent. CONCLUSIONS The proposed rule is scientifically amd economically unjustifiable. Existing regulatory limits are more than sufficient to provide an ample margin of safety for members of the public from all licensed activities, especially considering that detrimental human health effects do not occur until doses reach several orders of magnitude higher than those limits. The proposed rule is unnecessary, considering the EPA's studies and reports which demonstrate that airborne radioactive emissions are not only well below NRC's existing safe limits, they are also below the proposed constraint level. The only action necessary to comply with the Simpson Amendment is the EPA's recission of its National Emission Standard for Hazardous Air Pollutants (NESHAP) for all radionuclide emissions.

U.S. Nuclear Regulatory Commission March 11, 1996 Page 5 If the NRC goes forward with this rulemaking, changes should be made ( 1) to clarify that it applies only to offsite environmental releases, (2) to provide exemptions for materials in sealed containers, and (3) to specify annual usage values for each radionuclide with appropriate release fractions. Also, the regulatory guide needs to provide a more appropriate mathematically correct example and the regulatory analysis needs to include a realistic estimate of the costs to the regulated community and an estimate of any societal benefits. Please contact me if you desire any clarification of our concerns on this matter or if we can assist you by reviewing future rulemakings on any radiation protection issue. Sincerely, James G. Tripodes, Chairman HPS State and Federal Legislation Committee cc: Chairman Shirley A. Jackson Commissioner Kenneth C. Rogers Commissioner Greta J. Dicus EDO James M. Taylor Deputy EDO Hugh Thompson EPA Administrator Carol Browner Troy Hillier, 0MB

COMMITTEE TO BRIDGE THE GAP 1637 BUTLER A VENUE, SUITE 203 LOS A GELES, CALIFORNIA 90025 (310) 478-0829 DOCKETED Conwnents of MAR 1 3 1996 The Committee to Bridge the Gap DOCKETING& SERVICE BRANCH on SECY-NRC The Proposed "Constraint" Rule for Air Emissions £ and Associated Draft Regulatory Guide, Environmental Assessmen'r--,_._ Finding of No Significant Impact, and Regulatory Analysis by The U.S. Nuclear Regulatory Commission 11 March 1996 DOCKET NUMBER PR PROPOSED RULE ~ ( <oc FR \o3q "8 "\J The U.S. Nuclear Regulatory Commission (NRC} has published for public comment a proposed "constraint" rule for air emissions. Certain other documents, associated with the proposed rule, have also been published, particularly a draft regulatory guide (DG-8016), a Regulatory Analysis, an Environmental Assessment (EA) and Finding of No Significant Impact (FONSI}. The Committee to Bridge the Gap, a Los Angeles-based nuclear policy organization, hereby submits the following comments on the proposed constraint rule and associated documents. Introduction The Clean Air Act (CAA} requires the U.S. Environmental Protection Agency (EPA} to regulate air emissions from a wide variety of domestic nuclear facilities. EPA, under pressure from the nuclear industry, has for years resisted exercising that statutory responsibility, requiring several court orders to force compliance. Its latest approach to thwarting the intent of the CAA is to propose recission of its regulatory powers over hazardous air emissions from NRC-licensed nuclear facilities other than nuclear power plants (it has already rescinded its authority over the power plants.) In order to rescind the EPA regulatory authority, however, EPA must find that the NRC program to regulate such air emissions provides an ample margin of safety, a standard that EPA has set as a 10 mrem effective dose equivalent for the whole body for the maximally exposed individual, of which no more than 3 mrem can be from radioiodines. EPA has further defined this standard as requiring regulatory limits that are not to be exceeded and are to be calculated in a certain fashion, or via certain specified alternative methods. NRC has now published a draft rule which would establish not a binding regulatory limit but a "constraint" level, a level which if exceeded would not constitute a violation of the regulations. The proposed rule on its face does not meet the EPA standard. The rule, as proposed, is clearly unacceptable. In testimony before the EPA (copy attached), we delineated detailed deficiencies in the NRC proposed rule and why those defects made it legally impossible for EPA to rescind its regulatory authority in the area. Rather than repeat those arguments here, our testimony and the points raised therein kknowJedged by earr1**:!B.................. 1 s* iggq;:

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U.S. NUCLEAR REGULATORY COMMISSIQt,. DOCKETING & SERVICE SECTION OFFICE OF THE SECRETARY Of THE CO, MISSION Document Statistics Postmark Da~~ ~ ~ 1 ~ Coples Received_.___ _ _ _ __ Addi Coples Reproduced --L- - - - Speclal Distrlbution~ ,Cl.C)s&;,; J~ ~ , ~ i: R ,:t>S (j \l .. *~ - ~

are incorporated herein by reference. In what follows, we add to those points. The Proposed NRC "Constraint" Rule The proposed rule is a transparent attempt to provide EPA with sufficient superficial basis to rescind its own regulatory program without substantively altering NRC's standards, which are markedly less protective of the public and provide markedly less margin of safety. At the core of the difference between the two agencies' standards and programs is a ten-fold or more difference in permissible exposures from air emissions. The NRC's regulatory limit for members of the public sets the limit normally at 100 millirem per year [10 CFR 20.130l(a)(l)], although with permission from NRC facilities can legally operate so as to produce public exposures five times - that, or 500 mrem [IO CFR 20.130l(c)]. These "permissible" doses are 10 to 50 times higher than EPA's air emissions standards of 10 mrem. The NRC limits of 100 to 500 mrem per year are roughly 10 to 50 chest X-ray equivalents per year. Doctors are extremely reluctant to order even a single X-ray if not clearly medically needed, because of the risks associated with the extra radiation exposure. It is difficult to believe the public would find acceptable these permissible radiation exposure levels set by NRC were they to be informed NRC viewed as acceptable the exposures to members of the public equal to hundreds or thousands of additional chest X-rays over one's lifetime. Indeed, the current NRC regulatory limits are equivalent to a I in 300 lifetime risk of cancer (at the 100 mrem standard) and I in 60 risk (at the 500 mrem standard). [Source: U.S. General Accounting Office, "Consensus on Acceptable Radiation Risk to the Public is Lacking," September 1994, GAO/RCED-94-190.) This estimate by GAO is based on somewhat outdated risk estimates; if one uses the estimates of the National Academy of Sciences' Committee on Biological Effects of Ionizing Radiation (BEIR V), the risk factors are even higher--! in 180 and I in 36 respectively. By contrast, "acceptable" risk for carcinogen exposure under EPA standards is generally set at I in a million. Thus, NRC's radiation standards for exposures of the public are currently four to five orders of magnitude less protective than the risk level generally considered acceptable by EPA. Furthermore, NRC's method of calculating doses, found in 10 CFR 20 Appendix B, are substantially less protective than EPA's, even for the same exposures. As was pointed out to EPA in a 27 November 1995 letter by Robert C Shinn, Jr. Commissioner of the New Jersey Department of Environmental Protection, allowed air concentrations--for the same presumed dose--are generally tens to hundreds of times higher under NRC regulatory methods of calculation than EPA's. The dose conversion factors used by NRC in 10 CFR 20 Appendix B, Table 2, are up to 460 times less protective than are the factors used by EPA in 10 CFR 61, Appendix E, Table 2. It is thus clear that NRC's current regulatory limits for radiation exposure to members of the public from air emissions are orders of magnitude less protective than EPA standards. The question then becomes whether the

proposed "constraint" rule adequately improves that situation--or, indeed, whether it changes it at all. The answer is clearly no. It is self-evident, both from the content and stated purpose of the proposed rule, that its intention is to preserve the current relaxed regulatory posture of the NRC with regards to radiation exposures to the public while attempting to present to EPA a "basis" for rescinding its own, more protective regulations. Indeed, NRC states at the outset that the purpose of the proposed is not to provide stricter regulatory limits for its licensees and thus greater protection for the public, but instead merely to provide a basis for EPA to rescind its own regulatory program in the area. As shall be seen below, the NRC rule is carefully constructed so as to not create a regulatory limit more protective than the current NRC permissible levels of 10 to 50 chest-X-ray equivalents per year to members of the public. {Over 70 years, that is a "permissible" exposure of 700 to 3500 additional chest X-rays to an individual from nuclear facilities, as astonishingly lax regulatory framework.) The NRC Proposed "Constraint" Rule is Not a Regulatory Limit; Exceeding it Would Not Constitute a Violation The EPA limits are regulatory limits; exceeding them is a violation. NRC has been careful to not produce an equivalent level of protection. The proposed rule sets a level which is not a violation to exceed. If one breaches the "constraint" level, all one has to do is submit a report and identify corrective measures to be taken. Failure to carry out the corrective measures would be a violation, but under the language as written, failure of the corrective measures to prevent a second breach of the constraint level would not be. It appears one could violate the constraint level time and time again, so long as one submits a report each time and carries out the corrective measures promised. The "constraint" level is tied to the ALARA {as low as reasonably achievable) requirement. However, ALARA is defined in the NRC regulations as merely a goal, and the necessity of achievement of the goal is defined as necessary only to the extent that factors such as technology and economics make it acceptable. In other words, ALARA is not a requirement, but merely a suggestion to keep emissions as low as readily achievable given the economics and other factors of reducing emissions. On the other hand, regulatory limits such as EPA's NESHAP are real limits--one must not exceed certain exposures to the public, or a violation exists. NRC has created an empty shell of a standard, one that is not mandatory. Non-mandatory limits are no limits at all--that is why NRC has called this a "constraint" level, not a regulatory limit. As such, it is unacceptable. The draft regulatory guide further relaxes matters unacceptably, by permitting far less stringent methods of calculating estimated exposures than under the EPA NESHAP. Furthermore, NRC has not incorporated the proposed "constraint level" into any other section of the regulations than 10 CFR 20, so it has not become part of any licensing standard {see, e.g., 10 CFR 30, 61, or 70).

Conclusion The proposed NRC "constraint rule" is a hollow shell designed to give EPA a superficial basis for rescinding its stricter regulations without altering the tremendously lax NRC regulatory standards and program. After the constraint rule, the "permissible" levels of exposure to members of the public from air emissions will be what they were before the rule--the equivalent of up to thousands of additional chest X-rays to an individual over his or her lifetime. Of a million people exposed to the NRC "permissible" levels, 5,000 to 28,000 would die from cancers caused by that "acceptable" exposure from the nuclear enterprise. And this does not even compensate for the NRC method of converting concentration of radioactive material to dose, which is 10 to 100 times more lax than EPA's. (One should note that even were the 10 mrem level to be not a "constraint" level but an actual regulatory limit, and were the NRC conversion factors for dose as lax as they are, the 10 mrem level is the equivalent of a 1 in 1800 lifetime risk of cancer, five hundred times more lax than the general EPA one-in-a-million level for acceptable risk.) The proposed NRC "constraint" rule is not a regulatory limit; exceeding the 10 mrem figure is permissible, not prohibited; it does not include the EPA requirement of limiting radioiodine exposures to 3 mrem; more lax calculational techniques are permitted, making true exposures far higher than under the EPA scheme; and the only regulatory limits now in existence for the public (100 to 500 mrem annually) would remain the only limits after the "constraint" rule is finalized. The proposal, to put it gently, is a sham, leaving the NRC regulatory limits as lax as it was before the rule, but with the public less protected than under the current situation. This is because the purpose of the rule is to get EPA to rescind its regulatory program and standards, which are substantially more protective of the public than either the current or proposed NRC radiation programs. The rule should be substantially strengthened; the EA and FONS! rejected, having failed to analyze either the alternatives of a stronger rule or the effect of the weak rule on the environment by contributing to rescission of the more protective EPA regulations and regulatory program; and the draft Reg. Guide rejected, as it permits calculation of exposure by means far less protective than EPA's.

Attachment Testimony of Committee to Bridge the Gap Before the Office of Radiation and Indoor Air Radiation Protection Division U.S. Environmental Protection Agency Regarding EPA's Proposals to Rescind Its Authority to Regulate Radionuclide Air Emissions from All Civil Nuclear Facilities Washington, D.C. 29 February 1996 Introduction This testimony is presented on behalf of the Committee to Bridge the Gap (CBG), a Los Angeles-based nuclear policy organization. Officers of CBG regret that, due to the distance and expense involved in traveling three thousand miles to Washington, D.C., they cannot be physically present at this hearing. On 30 October 1995, in timely response to EPA's Federal Register notice of 28 September 1995 (60 FR 50161), ten organizations, including CBG, wrote to EPA requesting hearings on its proposal to rescind its authority under the Clean Air Act to protect the public from hazardous air emissions from all civil nuclear facilities, many thousands of such facilities in total. As we said in that letter, the EPA final rescission of its regulatory authority over air emissions from nuclear power plants and its proposed rescission of authority over all other licensed nuclear facility "entail wholesale removal of hard-won public protections from excessive emissions of radionuclides from the entire civil nuclear sector." In our October 1995 letter to EPA, the ten groups requested, "to avoid the hearing being solely an "inside-the-Beltway affair," that hearing sessions be held elsewhere in the nation. Most of the groups requesting the hearings were not based in Washington; half were based in California. The groups requested expressly that one of the hearings be held in California. As we concluded in that letter: The abdication of EPA regulatory authority over hazardous air emissions from all non-Department of Energy nuclear facilities is a serious matter, one which could lead to significant diminution of public protection from radionuclides of significant toxicity. It should be entertained only after thorough review of the issues. L_

Nonetheless, as of this date, we have received no response from EPA to our October letter. EPA did publish a notice in the Federal Register announcing a hearing in Washington, D.C. Since we have had no response to our request for hearings in California, we do not know if EPA will grant that request. On the chance that it will not, we hereby submit testimony to the hearing in Washington, but are handicapped by not being able to be present in person, with the opportunity to ask questions, rebut or comment upon other testimony, and the like. Process Concerns EPA published its notice of proposed rescission on 28 September 1995, based on a proposed NRC "constraint" rule which had not even been published for public comment at that time. The NRC draft rule was not published until 13 December. It is not yet a final rule, and may be changed prior to finalization. Additionally, a draft regulatory guide was to be issued in connection with the NRC draft rule. The draft regulatory guide is to provide guidance as to how to meet the draft "constraint" rule. Notice of the availability of the draft regulatory guide for public review and comment was not published in the Federal Register until 22 January. We have so far been unable to obtain it. Nonetheless, it too is not yet final and may be substantially revised in response to comments. Furthermore, NRC policy statements and procedures attempting to remedy EPA concerns about the adequacy and criteria for the NRC Agreement State program have not been finalized to date. Additionally, NRC inspection procedures appear not to have yet been modified to reflect the proposed "constraint" rule. EPA has previously indicated that the current NRC regulatory program did not provide the assurance of an ample margin of safety required by the Clean Air Act (CAA) for EPA to rescind its regulatory authority in the arena of hazardous air emissions from NRC licensed facilities. It has insisted upon a new rule adopting the 10 mrem standard; a revised regulatory guide detailing how to comply with that rule; new inspection procedures detailing how to enforce it; and new NRC policy and procedures to remedy inadequacies in the NRC Agreement State program. Not one of these is yet final. Yet EPA has proposed rescinding its authority anyway, and insisted upon public comment on the adequacy of NRC steps not yet taken. This makes little sense. It puts the cart before the horse. To be rational, and not arbitrary and capricious, EPA should await finalization of any prospective NRC actions, and then solicit public comment as to whether those "final" NRC actions are adequate to provide the "ample margin of safety" assurance required by the CAA for EPA rescission. On 17 January 1996, the Nuclear Information and Resource Service (NIRS), the Environmental Coalition on Nuclear Power, the Sierra Club, and CBG wrote to EPA requesting the comment period on EPA's proposal to rescind its NESHAPs be extended until after final action by the NRC on the matters that are supposed to provide equivalent protection to that of the EPA NESHAPs. To date, we have had no response to that request, either. We hereby renew our request in this regard, specifying in detail the rule, reg. guide, inspection procedures, and Agreement State policy and procedures identified above. Public comment on these issues is premature

until those items are finalized by NRC. Scope of Comments Solicited on EPA Proposed Rescission We object to EPA's assertion in its 28 September 1995 Federal Register notice attempting to severely restrict the scope of public comments permitted on its proposed rescission of its NESHAP authority. All issues relevant to that proposed rescission should be within the scope of permitted comments. In particular, important developments have occurred in the last few years; prohibiting comments on those matters would arbitrarily shut the agencies ears, so to speak, to new facts that should be considered in determining whether public health would be harmed were EPA to rescind its NESHAP authority. Comments on the Sufficiency of the Revisions of the NRC Program to Support the Finding Required by CAA Section 112(d)(9).

1. EPA has determined that a 10 mrem total effect dose equivalent (TEDE) from all pathways from air emissions, with no more than 3 mrem coming from radioiodines, is necessary to meet the CAA requirements. The NRC proposed "constraint" rule includes neither requirement.

NRC has inexplicably dropped the 3 mrem standard from radioiodines, and the proposed rule is therefore on its face not equivalent to the standard set by EPA. Additionally, NRC appears to permit calculations based on 10 CFR 20 Appendix B, air limits, which does not include all pathways (e.g., ingestion of agricultural products contaminated by air emissions) that are included in the EPA NESHAP. Thus, 10 mrem TEDE under the NRC proposed "constraint" rule is also on its face not equivalently protective and would result in doses above 10 mrem TEDE when all pathways are included, as required by EPA.

2. The EPA NESHAP limits are enforceable regulations, breach of which are prohibited as violations. The proposed NRC "constraint" goals are unenforceable suggestions, breach of which are permitted and not deemed violations. As such, they are not equivalently protective. Indeed, NRC would permit breach of the 10 mrem level, so long as it is reported; EPA NESHAP regulations prohibit breach of the 10 mrem level.

EPA has found that compliance with CAA requires prevention of doses from hazardous air emissions exceeding 10 mrem TEDE and 3 mrem from radioiodines. As such, exceedance of those limits is a violation of the EPA NESHAPs. The NRC draft rule declares doses in excess of 10 mrem TEDE to not be a violation. The current EPA rule prohibits doses greater than 10 mrem; the NRC proposed rule permits such doses. The two rules obviously do not produce equivalent protection.

3. The draft NRC regulation merely requires reporting when one exceeds 10 mrem and identifying proposed corrective actions. It is ambiguous as to whether, if the 10 mrem level is subsequently breached again, there is even then a violation, so long as one has taken the actions one previously proposed.

The NRC draft rule implies that, so long as one has taken the corrective actions one identified at the time of the first breach, there is no violation if one subsequently goes over the 10 mrem figure again. For example, if the second breaking of the 10 mrem figure is due to a different cause than the first or, even if due to the same cause, if one had taken the corrective measures promised, it would appear no violation would exist.

4. The rule does not require the use of the COMPLY code for calculating compliance with the NESHAP limit, or specified alternatives, as required by EPA. It therefore would potentially permit a calculational method less protective than the EPA rule.

The rule is completely silent as to how it is to be determined if one has gone over the 10 mrem figure. One can always calculate a dose to be as low as one wishes for regulatory purposes; if there is no mandatory calculational method, estimated doses will always be far below true doses. Apparently, the draft revised Regulatory Guide provides some guidance on these matters; but NRC Regulatory Guides are not mandatory. Furthermore, it appears the Reg. Guide permits the licensee to ignore COMPLY and the EPA-approved alternatives and invent an alternative it wishes. NRC estimates it will take only 1 hour to demonstrate that any alternative code prepared by or used by a licensee has been "validated" against COMPLY or the other approved methods for demonstrating compliance and to "verify that each calculation performed by the code is being completed correctly." (NRC Supporting Statement for 10 CFR 20 ALARA Constraint and Draft Regulatory Guide DG-8016). Clearly, one cannot in a mere hour adequately validate an alternative code and verify that each calculation is being performed correctly; thus NRC is tacitly admitting inadequately validated and verified alternative calculational methods will be tolerated.

5. The EPA NESHAP has a provision for citizen suits to require compliance.

The NRC "constraint" rule has none. A significant part of the EPA program is the provision for citizen suits. This public right to action has had a salutary effect on the agency, prodding it to enforce the NESHAP more vigorously. It has had a salutary effect on the regulated entities, prodding them to more accurately report emissions and more aggressively try to limit them, knowing that their actions can result in court action brought by the public. And, when both the agency and the regulated entities fail, this mechanism has resulted in the public being able to obtain from the courts binding intervention requiring rectification of violations. EPA knows that this citizen right to action, found in the CAA, has not infrequently resulted in courts mandating corrective actions not voluntarily undertaken by polluters nor enforced by EPA prior to the court intervention. Taking away this protection can only result in a diminution of protection of public health and safety. The NRC rule in this regard too is not equivalent, and provides significantly less of a margin of safety than the EPA rule.

6. The Agreement States frequently regulate even more weakly than does NRC.

NRC has never revoked an Agreement, thus never enforced the compatibility requirement. In addition, NRC will permit Agreement States three years to adopt parallel regulations to the "constraint rule." Thus, there will be a

period of three years from the time of the proposed rescission of EPA authority to the time Agreement States even have constraint rules in place (if they comply in a timely fashion). The public would therefore be bereft of protection from hazardous air emissions for several years--clearly not in keeping with the "ample margin of safety" requirement. While some Agreement States have comparable or better regulatory programs to those of the NRC, many are disastrously weak. Inspections are often very much less frequent than under the NRC. Regulation is often limited to receiving annual reports from licensees and approving license amendment requests. It has recently been revealed that the State of Nevada, for example, failed to detect illegal dumping of liquid wastes by NECO (now US Ecology) at its Beatty, Nevada, radioactive waste facility for something on the order of a decade. Radioactively contaminated tools were being taken from waste barrels and distributed in the nearby town for years before being caught by state regulators. We have seen the same weaknesses and excessive coziness with licensees on the part of state regulators in California. NRC just gives carte blanche to Agreement States. It has never revoked an Agreement, no matter how egregiously weak the Agreement State's program may be. It has no way of ensuring adequacy of those programs if it fails to enforce the compatibility requirements; its only enforcement mechanism is revocation, a measure it has never taken. Therefore, the current and proposed NRC practices with regards Agreement States are inadequate to assure public protection with regards the NESHAPs.

7. The existing EPA rule requires that proposed facilities demonstrate that they will meet the NESHAP in order to obtain a permit to construct. The proposed NRC rule contains no such provision.

Currently, in order to obtain permission to construct a facility that may emit hazardous air pollutants such as radionuclides, an applicant must demonstrate that it will comply with the NESHAP limits, and EPA must approve or deny approval on that basis. The proposed NRC rule deals only with operations, not with permits to construct (or operate). Now, EPA cannot permit a facility to even be constructed if it can't demonstrate NESHAP compliance will result; under the NRC rule, there will be no such requirement, and construction will be permitted no matter what. This represents a serious lack of equivalency on the part of the NRC program and a significant reduction in public protection.

8. EPA has no basis for determining that the current or proposed NRC regulatory program is indeed keeping air emissions below the NESHAP levels.

Much evidence, not reviewed by EPA, demonstrates the opposite. EPA's review of this issue is based on data seven years older or older. It is arbitrary an capricious to not consider data more recent and relevant. Additionally, EPA did no actual measurements or even review of measurements to make a determination in this regard . It merely asked a select group of licensees to provide estimates of its releases. There was no verification of these numbers, no independent measurements. Most importantly, there was no review of actual dose/exposure data. Self-reporting is a grossly inadequate means of determining compliance. It is like asking a group of accused criminals which among them is guilty. The innocent among them may answer honestly, but it is a rare guilty person who will. Enforcement requires

independent determination of whether limits are being breached; not asking people whether they have breached limits. Just one example of why relying on self-reporting is dangerous: The UCLA research reactor for years reported its Argon-41 emissions as a fraction of a curie per year. Years later, calibration errors and other violations of the license were detected, indicating that for years the Argon-41 emissions were under-reported by orders of magnitude. One year 0.303 curies had been reported; the true figure turned out to be 124.9. The next year 0.1046 Ci was reported; the corrected figure, corrected years later, was 41.9. And so on. Self-reported values without independent verification cannot be relied upon. Additionally, it is very dangerous to rely upon models for estimating dose instead of looking at hard data. Given again the UCLA reactor example, the Argon-41 releases, even when corrected, are about an order of magnitude lower than those reported to EPA by MIT for its larger research reactor. EPA, using a computer model, estimated maximum doses from the MIT Argon-41 as well below the NESHAP of 10 mrem. Vet, UCLA, with its lower emissions, used TLDs to measure doses from Argon-41 which were many times the NESHAP. Indeed, the NRC estimated doses inside the Math Sciences Building adjacent to the reactor as several times greater than the NESHAP value, because the exhaust stack for the reactor was lower than and directly upwind of the main air inlet for the Math Building. EPA claims that low-level radioactive waste facilities, for example, are well below the NESHAP. It bases that claim, however, on US Ecology's applications for NESHAP permits to construct for its California and Nebraska facilities. Self-serving claims by applicants are not evidence of compliance. EPA has not yet even approved or given final endorsement to the California application (we presume the same is true for Nebraska). Indeed, several COMPLY runs performed by US Ecology for its California project (and not provided to EPA) showed the project to not be in compliance with the NESHAP--by wide margins. EPA's claims regarding existing LLRW dumps are even more incorrect. EPA claims that no exposures in excess of background have ever been reported at either the Richland or Beatty sites. No source is given for these extraordinary claims, but recent data make clear that both claims are false. US Ecology's Richland dump, in the desert of western Washington State, has reported elevated tritium in vegetation at the site. In order to confirm it was coming from the trenches, the State authorities directed the creation of a vadose zone monitoring program, which identified elevated tritium in soil moisture, far in excess of standards. Tritium at a control location, far from the trenches, was orders of magnitude lower, confirming that the tritium was coming from US Ecology operations and not some other source on the Hanford site. Thermoluminescent dosimeters (TLDs) measuring gamma radiation routinely report doses there many times the exposures permitted under EPA's National Emission Standards for Hazardous Air Pollutants (NESHAP) or NRC's standards for low-level radioactive waste facilities. The Thermo-Luminescent Dosimeters (TLDs) monitoring gamma radiation at

US Ecology's Richland, Washington LLRW dump routinely show doses far in excess of both EPA's 40 CFR n61.102 NESHAPs {10 mrem/yr whole body) and NRC's 10 CFR n61 standards for LLRW sites {25 mrem/yr whole body). For example, in 1991, the TLDs at the southwest corner of US Ecology's dump {i.e., outside US Ecology's property line) recorded 172 mrem. That is more than twice background for that area. The nearby town of Richland, chosen as a background location, was at 74 mrem. Indeed, the northeast corner of the US Ecology property, farther from the trenches than the southwest corner, was at 86 mrem. Thus, the dose off the US Ecology property was on the order of 100 mrem above background--far in excess of NESHAP or 10 CFR n61 standards. Washington State Department of Health, Environmental Healthy Programs, Environmental Radiation Program 1991 Annual Report, August 1993, p. 34, 134-6, 243. The radiation is clearly coming from US Ecology's operations and not other activities elsewhere on the Hanford property. The TLDs on the southern edge of US Ecology's property, close to the radioactive waste trenches, are consistently higher than those on the northern edge of the property, which are considerably further away from the trenches. Seep. 243, id. This pattern is reinforced in US Ecology's TLD measurements, which likewise show elevated readings, highest along the south fence. Readings as high as 270 mrem/yr. above background were reported in 1991, according to US Ecology's annual report. {p. 5-118) The elevated fenceline readings-- elevated along all sides of the property--continues each year. The TLD fenceline reading in 1992, for example, led to this conclusion in US Ecology's Annual Report for 1992, p. 5-123, "The exposure attributable to site operations was 170 mrem." EPA's NESHAP standard is 10 mrem/yr annual exposure; the 10 CFR 61 standard for "low-level" radioactive waste sites is 25 mrem/yr from all exposure pathways combined. It is clear US Ecology's Richland operations are well above those standards. Using theoretical doses calculated by US Ecology for Ward Valley of a few mrem per year is clearly irrational, when the measured values at its other sites {including its arid sites) is one or two orders of magnitude higher. In a 16 September 1994 letter to US Ecology, the NRC states that monitoring data for the Richland facility "clearly point to the U.S. Ecology facility as the source of elevated radiation." The letter refers to TLD measurements in excess of 100 millirem per year above background {10 times the NESHAPs) and reminds US Ecology that the NRC's former limit of 500 millirem per year had been reduced to 100 millirem and that the reported doses would thus be in excess of the NRC 100 millirem standard. Clearly, if that is true, the facility is far in excess of the NESHAPs as well. At US Ecology's Beatty site, the same is true. Recent data, including a comprehensive review of the full operating record of the Beatty site just recently released by the Conference of Radiation Control Protection Directors {CRCPD), document widespread contamination, far in excess of background and far over the NESHAP standard. Vegetation has been reported significantly elevated in radioactivity. Soil samples have also been repeatedly contaminated. TLDs at the fenceline have shown quarterly doses of 500-700 millirem in 1965, 1.2 Rem the next year, and 480 mrem in 1967. EPA then commenced independent monitoring; six measurements exceeded 100 mrem/quarter. In 1976 they measured 1.14 Rem in a single quarter. Beginning in 1977, US

Ecology monitored 14 locations using TLDs. The maximum annual exposures during that period was 415 mrem, with doses between two hundred and four hundred mrem per year fairly standard between 1977 and the early 1980s. The releases were clearly coming from the facility, as doses at the south boundary remained significantly higher than all other locations (the south boundary is closest to the trenches). Doses remained many multiples of the NESHAP throughout the life of the facility, up through the most recent data reported by CRCPD, for the early 1990s. These dose data are so far above the NESHAP that were any member of the public to spend just a few days in a year near the site, they would get exposures in excess of the NESHAP limits. And numerous members of the public (truckers, people delivering supplies, visitors, etc.) do spend in aggregate more than a few days per year near the facilities. A thorough review of more recent data, and a reliance on actual data instead of self-reporting by licensees, is essential if EPA is to avoid making an arbitrary decision on the adequacy of the NRC program to provide an ample margin of safety and meet the NESHAP levels. Conclusion NRC's regulatory limit is 100 mrem per year; with permission, one can go up to 500 mrem. These regulatory limits are ten times and fifty times EPA's NESHAPs, not counting other factors involving the method for calculating doses that result in NRC actually permitting doses even higher relative to EPA's NESHAPs. In order to eliminate the more stringent regulations by EPA, NRC has proposed, not a new regulatory limit equivalent to EPA's NESHAP, but an "ALARA constraint" level, breach of which would not be even a violation of the regulations. NRC's ALARA principle is a goal that one should reduce radiation to levels "reasonably achievable," taking into account economics and other factors not related to public health protection. It is clear that NRC has created a Potemkin Village type proposed ruled, an empty shell with nothing behind it, solely in order to provide EPA with an argument for rescinding its own authority to regulate emissions. The sole purpose in getting rescission is relief for industry from having to comply with what is clearly recognized to be a stricter standard, more adequately enforced. It is precisely because the NRC proposed rule is so much weaker, and the NRC's regulatory program so much weaker as well, that EPA cannot make the finding required by the Clean Air Act to justify rescinding its own regulatory program. Let us be frank about the matter. The CAA NESHAP authority was a hard-won victory for public health and safety. EPA for many years now has resisted assuming the authority mandated it by law. Now it is attempting to eliminate that hard-won protection for the public. The NRC "constraint" rule provides markedly less protection for the public than the EPA NESHAP, and to rescind the latter would be to place the public at increased risk.

March 13, 1996 NOTE TO: Emile Juli an Chief, Docketing and~ Servicesi Br~~~~~V FROM: Carol Gallagher ~-. RES, ORA

SUBJECT:

DOCKETING OF COMMENTS ON PROPOSED RULEMAKING ON CONSTRAINT ON AIR EMISSIONS FROM NRC LICENSED FACILITIES OTHER THAN POWER REACTORS Attached for docketing is a comment letter related to the above noted proposed rulemaking. This letter was received on our electronic bulletin board on March 11, 1996 at 11:55 p.m. The user logged on at time of receipt of the comment was Joseph Lyou, The Committee to Bridge the Gap. Please send a copy of the docketed comment to Charlene Raddatz (mail stop T9-C24) for her records.

Attachment:

As stated cc w/o attachment: C. Raddatz J. Glenn

OOCKETEO usr,Rc nm Tennessee Valley Authority, Post Office Box 1010, Muscle Shoals, Alabama 35662-101 O "96 tt~R 13 P2 :09 orF\C t. (IF SECRETARY 1 OOCK[T \I '~ & CER \CE C f, 'CH B;r,M March 8, 1996 U.S. Nuclear Regulatory Commission ATTN: Docketing and Services Branch Washington, DC 20555-0001

Dear Sir or r.1adc:

.m:

The Tennessee Valley Authority appreciates this opportunity to comment on proposed changes to 10 CFR 20 contained in Draft Regulatory Guide DG-8016, CONSTRAINTS FOR AIR EFFLUENTS FOR LICENSEES OTHER THAN POWER REACTORS. We wish to comment on only one aspect of the proposed regulation. If the calculated dose (total effective dose equivalent or TEDE) to an actual individual exceeds the constraint level of 10 mrem in a year, then a report must be sent to the NRC within 30 days and the report must include the individual's name, social security number, and date of birth. The term "actual individual" is not defined and it is not clear what the term is intended to mean. For example, suppose that a licensee calculates the TEDE at their facility boundary and an occupied dwelling is at that location. Has the TEDE to an "actual individual," the occupant of that dwelling, been calculated? It could be very difficult to gather the name, social security number, and age of any person not directly employed by the licensee. Many people consider this information to be personal and may refuse to divulge it. Also, attempting to gather it could cause undue alarm or hostility in members of the public. Indeed, even asking a member of the public for this information could form the basis for unwarranted litigation against the licensee. The constraint level of a TEDE of only 10 mrem is extremely low. This fact and the great uncertainty and conservatism built into the models employed in COMPLY and NCRP Commentary No. 3 make the collection and reporting of this personal information an unnecessary burden on licensees.

                                                                                       'MAR- 1*a- 199&

kkllowledged by card ................................... ., Pnnted on recvcled paper

U.S. NUCLr !,., r- "'i" A~ORY t,OMMISSIOt-. DOCKET1i G ., !:,fRVICE SECTION OFFICE OF Tfff SECRETARY OF THE COMMISSION DOCI merit ~ nstics

U.S. Nuclear Regulatory Commission Page 2 March 8, 1996 Therefore, we request that this reporting requirement be deleted. If you decide to retain the requirement, then please clearly define the term "actual individual." Thank you for this opportunity to comment on the proposed regulations. If you have any questions, please call me at (205) 386-2993. i::::: c!ma~n Program Operations, Safety MPB lB-M Safety Officer

t, SEOUOVAH FUELS

  ~    A G EN ERA L A T O M/CS COM PA N Y DOCKET ED USNRC March 7, 1996                                                                                           RE: 9626-N
                                                                    '96 MAR i 3 P2 :05 Certified Mail Return Receipt Requested Office of the Secretary Attn: Docketing and Service Branch                                              DOCKET NUMBERnn -..

Mail Stop: 0-16 G15 PROPOSED RULE rn ~ - U.S. Nuclear Regulatory Commission Washington, DC 20555-0001 (~FR-lo59~~ @

Subject:

Comments on Constraint Level for Air Emissions of Radionuclides (RIN 3150-AF31) 60 FR 63984; December 13, 1995

Dear Sir/Madam:

Sequoyah Fuels Corporation has recently reviewed the above referenced proposed change to 10 CFR Part 20 and recommends that the proposed change should not be made for the following reasons: Proposed Change is a New Limit NRC is proposing a new Section 20.llOl(d) that would require licensees to implement a "constraint" upon air emissions from facilities. Although NRC states in the notice of the proposed rule change that this "constraint" is not a new limit, it clearly is. The proposed change would "constrain air emissions of radioactive materials other than radon-222 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 emissions. If a licensee subject to this requirement exceeds this dose constraint, the licensee shall report the exceedence as provided in § 20.2203 and promptly take appropriate corrective action to ensure against recurrence." As defined in Webster's dictionary1, constrain means, "to force by imposed stricture, restriction, or limitation." The fact that NRC requires that an exceedence of the "constraint" be reported and actions taken to ensure against recurrence means that this proposed change is a new limit. Therefore, if NRC has determined that the dose limit for members of the public should be reduced from 100 mrem/yr to 10 mrem/yr, a proposed rule change to take this action should be published. This change should apply to all licensees from all sources. 1 Webster's Ninth New Collegiate Dictionary, Merriam-Webster Inc., 1988. HIGHWAY 10 & 1-4 0 PO BOX 610, GORE, OKL AH OMA 744 3 5 1918) 489- 55 11 FAX: 1918 1 489-2291

l:J'.S NUCLEAR R~GULATORY COMMISSfO~ DOCKETING & SFWICE SECTION OFFICE OF THE SECRETARY OF THE COMMISSION Document ~tatistics Postmark Date -~--i\r,-.,..l9_1,p Co~esReceived ________ Addi Copies Reµr0uucb'd _-; ;t-- ------- Speclal Distribution~ ~ ~ ~ ~+---

Docketing and Services Branch March 7, 1996 Page 2 No Benefit from Proposed Change NRC states in proposed Regulatory Guide DG-8016, Constraints for Air Effluents for Licensees Other Than Power Reactors," that NRC licensees have consistently reduced doses from air effluents to small fractions of the dose limits using the ALARA process. In 1992, the Environmental Protection Agency (EPA) reported the results of two studies of materials facilities [57 FR 43173; September 18, 1995]. The first w.as a survey of 367 randomly selected nuclear materials lic.ensees, and indicated that the highest estimated dose to a member of the public from effluents was 8 mremiyr, based on consetvative modeling. In addition, 98% of the facilities examined had doses to members of the public resulting from: effluents less than 1 mrem/yr. The second study evaluated effluents from 43 additional facilities that were selected because of their potential for effluent that could result in significant public exposures. Of these 43 facilities, none exceeded 10 mrem/yr to a member of the public, and 75% of them reported less than 1 mrem/yr to a member of the public. This indicates that licensees are applying ALARA to their operations as ALARA was intended to be applied. There is absolutely no need for additional regulation in this area. Licensees have been proactive and demonstrated that the ALARA principle is fully protective of the health and safety of the public. Although the proposed constraint level may be easily achieved, there is no need to take the action. ALARA Guidelines Should Not be Codified as Numeric Values The ALARA principle reduces any given dose to "as low as is reasonably achievable" taking into account the state of technology, and the economics of improvements in relation to benefits to the public health and safety, and other societal and socioeconomic. considerations. The ALARA concept has long been a part of radiation protection programs of NRC licensed faciiities. The Nuclear Regulatory Commission first promulgated the ALARA concept in its *radiation protection regulations in 1975. A 1991 revision established a requirement for all licensees to have a radiation protection program that includes ALARA provisions. ALARA guidelines should. not be codified as numeric values. However, the proposed change referenced above does just that. Imposition of this proposed change, and otheri, like it, will make ALARA meaningless. Under the ALARA concept, a licensee would take measures to reduce emissions and radiation doses to workers and the public to levels which are ALARA balancing the benefit with the risk. In the case of i,ystem upsets, licensees would look at the incident, evaluate what happened and take actions to prevent recurrence. However, with a regulatory limit

Docketing and Services Branch March 7, 1996 Page 3 in place, a report would be filed, a regulatory review would likely take place and special inspections may be performed. This level of response is not be justified. If NRC continues to reduce the limits to slightly above operating levels, a point will be reached where any upset in normal operating conditions will exceed a limit, even though it represents an insignificant health concern. Likewise, licensees will cease to improve their operations and take a strict compliance posture. Sequoyah Fuels Corporation does not believe that increased regulation is necessary of the air emissions of NRC licensed facilities, and suggests that this proposed change is contrary to the stated congressional and executive direction which is to reduce the regulatory burden on industry. Sincerely, [f;LII. ~ John H. Ellis President JHE:jp

ENVIRONMENTAL COALITION ON NUCLEAR POWER 433 Orlando Avenue, State College, PA 16803 March 6, 1996 Mr. John C. Hoyle Secretary of the Commission RE: 60 FR 63984 U.S. Nuclear Regulatory Commission Constraint Le vel Washington, D.C. 20555-0001 of Radionucli des ATTN: Docketing and Services Branch FAX: 301-415-1672DQCKET NlUBERPR

Dear Secretary Hoyle:

PROPOSED RULE o1-o ((c.oFRb89'8~ @ The following comments on 60 FR 63984, NRC's Proposed Rule on Constraint Level for Air Emissions of Radionuclides, are submitted by the Environmental Coalition on Nuclear Power (ECNP>, a not-for-profit public-interest Pennsyl-vania-based citizens' organiza tion, founded in 1970. ECNP has participated in numerous NRC reactor license proceedings, other NRG reguiatory matters, and EPA's prior NESHAPS proceedings. With Sierra Club and Nuclear Information and Resource Service <NIRS), EC~ has challenged EPa's rescission of its NESHAPS standards-setting authority for radionuclides under the Clean Air Act. The ALARA constraint rule is proposed by the Commission to respond to EPA's reluctance to relinquish its NESHAPS authority to NRC for all non-reactor NRC and Agreement State licensees. The EPA air emission standard was promulgated on October 31, 1989, 40 CFR 61, Subpart I, to establish a 10 millirem per year Effective Dose Equivalent (EDE> dose limit for members of the public. Its effectiveness was stayed; when the stay expired, the standard was implemented for non-reactor NRC and Agree-ment State licensees. Now, however, EPA staff's proposed rescission indicates that the Administrator may be satisfied that both "acceptable risk" and "ample margin of safety" will be provided in the future by NRC. This conclusion rests - on promulgation of this 10 mrem/yr TEDE ALARA constraint level proposed by NRC. Position on the Proposed Rule and Recommendation of the Environmental Coalition on Nuclear Power: ECNP does not believe that the ALARA constraint level, as it is described by the NRC staff in the Proposed Rule, will in practice provide adequate assurance that an ample margin of safety will in actuaiity be consistently met by Agreement State and NRClicensees in the future. We therefore oppose the ALARA constraint level as it has been proposed. £CNP requests, and urges, the NRC to withdraw this proposal and to refuse to accept EPA's ofter and effort to transfer its Clean Air Act statutory responsibility to the NRC for reasons discussed in the comments that follow. Request of the Environmental Coalition on Nuclear Power for Extension of the Comment Period:

               £CNP also respectfully requests that the NRC extend the public comment period for this 60 FR 63984 constraint level rule tor an additional sixt._y days. We ask for this extension for several reasons.

(1) The shutdown of Federal agencies in December and January delayed intormation dissemination ot this proposal. EPA's hearing on its draft

.S. NUCLEAR RE '_, ~TORY COMMISSIOt-. DOCKETING & ;,t: '/ICE SECTION OFFICE OF THE c-ECRETARY OF THE COMMISSION Document Statistics stmark Date .S:\ 1a\9 lo (4~o9) ples Received_..,___ _ _ _ __ d'! Copies Reproduced ____ _ __

Page two CECNP Comments on NRC Proposed ALARA Constraint Level Rule) rescission for non-reactor NRG and Agreement State licensees was also postponed and took place only on February 29. (2) We are finding that scarcely anyone we have been able to contact who is living near non-reactor NRC- or Agreement State-licensed facilities or proposed sites for nuclear facilities, potentially including low-level waste treatment and disposal sites, had been aware of the constraint level proposal or its connection with the EPA's NESHAPS standards-setting authority for radionuclide air emissions under the Clean Air Act and proposed rescission -- or the significance of these related matters to air emissions in the vicinity of their residences. It is only reasonable for the NRC to afford such affected persons full opportunity to comment on this propo~ed rule, and on its relationship to an EPA finding of ample margin of safety and health risks that are or are not acceptable to them, since they are potentially the most exposed populations. (3) Because the ALARA constraint level rule is designed to alleviate EPA's reluctance to give up its responsibility and is central to that decision, members of the public who live and work in the vicinity of quite literally thousands of nuclear facility sites will be affected by both this rule and EPA's NESHAPS rescission decision; the EPA proceedings with respect to NESHAPS have now gone on for more than a decade; they are extraordinarily intricate -- Byzantine -- in their complexities; and responses to this NRG proposal perforce require affected citizens to dig back through a maze and mass of background materials in order properly to evaluate and comment on this ALARA constraint level rule and how it will affect their health and safety and, with respect to the NRC's recent incorporation of its economic determination of the revised costs to licensees for avoidance of person-rem dose (NUREGiBR-0058, Rev. 2, dated November 1995, but not widely available to members of the public). Comments of the Environmental Coalition on Nuclear Power on 60 FR 63984:

1. Accompanying this letter and the requests it contains (and rather than completely rewriting our recent lengthy comments on these topics), ECNP submits as our comments on 60 FR 63984 for the NRC's record in this proceeding our comments on EPA's NESHAPS rescission for non-reactor NRG and A~reement State licensees.

• We particularly draw NRC staff's attention to, and we recommend that the staff absorb and adopt, both our critiques and recommendations:

(a) EGNP's February 17, 1996, comments, EPA Air Docket No. A-92-50, especially pp. 8 through 14; Cb) Summary of ECNP's oral comments at the February 29, 1996, EPA hearing on EPA's proposed rescission, same Air Docket, at pp. 1-2; (c) Letter to Mr. Weinstock, et tl-, March 1, 1996, ECNP Responses to EPA Staff Question on ECNP Proposals and Supplemental Rebuttal Comments, same EPA Air Docket, pp. 1-4.

• The three sets of ECNP comments to EPA total nearly 30 pages and are being placed in the U.S. mail, first class, on March 12, 1996, with these comments to NRC on its ALARA Constraint Level Proposed Rule. The latter are being faxed to the Secretary of the Commission today, March 12, 1996.

Page three CECNP Comments on NRG Proposed ALARA Constraint Level Rule)

2. ECNP recommends that any Memorandum of Understanding between EPA and NRG, or any other agreements between these agencies, with respect to EPA's rescission of NESHAPS air emissions standards-setting authority for radio-nuclides and transfer to NRG include NRC's formal and binding adoption of the proposals we suggest. This course of action is recommended in part as a good faith demonstration by the Commission of its earenst intent to tighten and improve its regulatory authority over all licensees, the Jack of which was more than amply described in the recent (March 4, 1996) Time magazine special investigation, "Blowing the Whistle on Nuclear Safety." Nothing could go further to restore public confidence in the NRC than the Commission's replace-ment of its use of mere regulatory "guidance" with promulgation and rigorous enforcement (no exceptions, exemptions, or waivers) of the mandatory release and dose limit that we suggest: the design basis level of 5 millirem per year to be the maximum dose, TEDE, to any member of the public from the routine operations of any NRC or Agreement State nuclear facility licensee.

3. Our fundamental concerns about, and disagreement with, NRC's proposed ALARA constraint level are:

(al The constraint level is only a guidance limit, as is stated .in the NRC Draft Revised Regulatory Guide 8.37. It is not a regulatory rule promulgated in accordance with the Federal Administrative Procedure Act of 1946 that is mandatory, binding upon licensees, or enforceable. (b) The constraint level is intended by NRG, according to the staff document, to supplement NRC's ALARA guidance program, which is also not a madated regulation that is enforceable. (c) The Commission may chose to issue a violation and penalize a licensee for failing to meet ALARA or the constraint level, but it is not required to do so. (d) The air emissions are self-reported by licensees. With due regard to them and to NRG and Agreement States, not all of NRG's and Agreement States' licensees, nor the NRC itself or all Agreement States, have perfect records of honesty and openness. It may be in the economic interests of a licensee to provide less than complete data to its regulator(s). (el Neither licensees nor NRG nor Agreement States conduct continuous dose monitoring to measure real doses actually received by members of the public from air emissions from nuclear facilities. The computer codes and models used by NRC and licensees in the calculations of estimated doses to individuals in the public are uncertain: the accuracy and comprehensiveness of some codes have been called into question in the recent case of Maine Yankee and earlier with respect to, among others, Three Mile Island and Pilgrim. (fl The NRC has recently adopted Regulatory Guidelines to clarify and formalize its "value-added guidance" for the "dollar per person-rem conversion factor policy," implementing a $2000/person-rem avoided dose but subjecting it to present worth considerations and limiting its scope to health effects. However, by so doing, the future application of this ALARA defining limit on an economic basis may result in less, rather than greater. protection of public health and safety. The health effects basis must incorporate tlJ_ health impacts and forms of health effects and their true economic costs to the

Page four (ECNP Comments on NRC Proposed ALARA Constraint Level Rule) victims, including the effects of low-dose and chronic low-dose non-cancer and non-fatal impacts, such as those that result from impairment of functioning of the human immune system. (g) The NRC fails to provide for citizen law suits in the event of the agency's failure to abide by its responsibility to maintain air emissions and consequent independently measured doses well below EPA's 1989 NESHAP for radionuclides of 10 mrem/yr.EDE, only thereby assuring that an ttample margin of safetytt has in fact been met. It is for all of these reasons plus others enumerated in the referenced ECNP comments to EPA which accompany this filing submitted to the NRC that we have requested the Commission to withdraw this ALARA constraint level rule and instead to promulgate an enforceable standard for maximum TEDE to a member of the public of no more than 5 mrem/yr, a figure reasonably ample to provide a margin of safety below EPA's NESHAP dose limit from radionuclide air emissions. The fax version of these comments is being submitted to the Secretary of the Commission at 3:45 p.m. on March 12th. The hard copy with all attachments is being mailed on this same day. Thank you for accepting and we hope heeding our recommendations for assuring public health and safety. Sincerely,

                                        /~-:II I/./du,~

Judith H. Johnsrud, Ph.D. Director, ECNP

BEFORE THE U.S. ENVIRONMENTAL PROTECTION AGENCY OFFICE OF RADIATION AND INDOOR AIR. RADIATION PROTECTION DIVISION Comments on 60 FR 61681 and 60 FR 63984 (extended comment period): National Emissions Standards tor Radionuclide Emissions from Facilities Licensed by NRG and Federal Facilities Not Covered by Subpart H; and NRC Proposed Rule Constraint Level tor Air Emissions of Radionuclides Submitted by Judith H. Johnsrud, Ph.D.~ Director Environmental Coalition on Nuclear Power February 17, 1996 The following comments address 60 FR 61681, 60 FR 63984 CNRC's proposed "constraint level" rule>, and related issues pertaining to EPA's proposed rescission ot its Clean Air Act authority to set ambient air emission standards tor radionuclide emissions for non-power reactor NRC- and Agreement State-licensees and other non-DOE Federal facilities not covered by Subpart Hof 40 CFR 61 (non-reactor NESHAPS>. They are submitted on behalf of the Environment-al Coalition on Nuclear Power <ECNP>, a Pennsylvania-based pub~ic-interest citizens organization with a long-standing interest in issues of radiation pro-tection and several active participations in EPA's prior NESHAPS proceedings. We oppose the proposed rescission by EPA. ECNP requests that <a> the EPA Administrator withdraw this proposal; and (bl EPA retain its standards-setting responsibility over NESHAPS air emissions of radionuclides from all sources. Request 1: We request Cal inclusion of these comments in the record of EPA Air Docket No. A-92-50 1 and Cb) that they be given full consideration by the Staff. We also (c) incorporate by reference in this record our previous state-ments before EPA, o~al and written, in prior proceedings on NESHAPS regulatory matters, includlni our comments (and those of Food and Water, Inc.) on the use of "acceptable risk" and "ample margin of safety" in EPA's 1987 draft benzene NESHAP rule <which we understand to have been EPA's first application of this regulatory approach after the vinyl chloride decision> We also Cd> incorporate by reference all health studies cited in all of those, and these, comments. __ , i I Reguest 2: For the following reasons, ECNP also requests that EPA keep open the record in this proceeding until the public has not only seen and commented on NRC's draft "constraint level" proposal, but also reviewed and evaluated NRC's final decision on "constraint level" and submitted further comment to EPA on this rescission if NRC should alter its proposed constraint level when it promulgates the Final Constraint Level Rule. The NRC's proposed 10 millirem/year total effective dose equivalent CTEDE> "constraint level" for air emission of radianuclides is open for comment until March 12, 1996. ECNP had earlier asked EPA to keep the record in this proceeding open at least until the closing date for comments on NRC's constraint rule., Due ta Federal agency closures, agency budget and staff restrictions, and public requests, that comment period may be extended. But NRC also may alter its draft proposal in the Final Rule, to be either more or less restrictive. Therefore NRC's Proposed Rule (60 FR 63984) cannot here be relied on by EPA to assure an "ample margin of safety." An EPA decision reliant on the adequacy of NRC's "ample margin of safety" in this rescission cannot be finalized prior to the NRC Final Rule on the 10 mrem/yr TEDE constraint level. lt is a major justification that EPA deems critical to its NESHAPS rescission for non-reactor NRC and Agreement State licensees in this proceeding. For EPA now to promulgate a Final Rule

rescinding its standards-setting authority over radionuclide NESHAPS for NRC-and Agreement State-licensed non-DOE nuclear facilities in advance of a final decision in NRC's "constraint level" rulemaking will be both arbitrary and* capricious, and will clearly be contrary to the Clean Air Act Section 112(d)(9) directive that requires a finding by the Administrator that NRC will provide both "acceptable risk" and an "ample margin of safety" now and in the future. Background and Introductory Comments The history of EPA actions on NESHAPS and radionuclide air emissions and associated litigations relating to "acceptable risk" and "ample margin of safety" and to Clean Air Act <CAA> Section 112(d)(9) is long and convoluted. It is described at 60 FR 50161, as well as in EPA's 60 FR 46206 Final Rule on NESHAPS rescission for _NRG-licensed nuclear power reactors and in Background Information Documents for both~ )t has*be~n the subject of many hearings and comments, but many of the comments have not.received adequate agency response. The U.S. public has not in general even been aware that EPA is determining for the public what this agency considers an "acceptable" lifetime risk of fatal cancer -- the risk which EPA will condone to be caused by the operation of each nuclear facility. Moreover, the EPA has not assessed the total health and safety risk to an individual from the summation and synergisms of all of the irradiating and otherwise contaminating technologies, facilities, hazardous emissions, effluents, and wastes taken altogether to which each individual is exposed. Risks to environmental quality and secondary <or indirect) health risks to humans are not adequately considered. Nor is the full range of adverse health effects of exposures to ionizing radiation accounted for in this NESHAPS history, especially-non-cancer effects from chronid1bw-dose exposures. Radiation recipients whose health and safety will be adversely affected by this EPA decision and by future regulatory actions of the agency to which EPA wishes to abdicate its statutory authority have had no real opportunity to con-cur or disagree with EPA's estimate of the cancer risk and other health and - safety risks that EPA claims are acceptable for the unconsulted citizenry and their progeny. In this and prior radionuclide NESHAPS proceedings, the broad public's opinions on acceptability of suffering and premature death from cancer ,or. leukemia, __ gene(ic damage for themselves and their children, and other lethal and/or non-lethal i.nfuries to hea*rth have***not,,,been,.*'X-p:Hcitly s9ught or con-sulted -- but in a democratic society must be -- along with the v{e~s of the Nuclear Regulat~ry Commission. The NRC, as the recipient of the authority that EPA is abandoning, is a party with a clear conflict of interest. It is highly prejudicial to the public's interest that EPA's decision has been reached in consultation with NRC but not, until this end point, with the public. It is of utmost significance in the latter regard for the EPA to take into account that the NRC is charged by Chapter 1, Section 1 of the 1954 Atomic Energy Act <AEA> to continue to promote "to the maximum extent" the uses of nuclear energy for domestic as well as -- and as its "paramount objective"

<according to the wording of that law) -- for military purposes. Protection of health, safety, and the environment is not among the mandates enumerated in the AEA's Declaration of national nuclear energy policy. Health protection isn't even mentioned until later in the law. EPA, by contrast, is directed by the Congress to protect environmental quality and human health and safety.

Furthermore, the National Academy of Sciences, in the 1990 BEIR V Report at the National Research Council's Committee on the Biological Effects of Ionizing Radiation, concluded what had been well understood for many years, dating back at least ta the Nobel Prize-winning genetics research of Dr. Herman Muller and freely admitted by the Atomic Energy Commission (AEC), even in its publicity series, "Understanding the Atom" thirty years ago -- namely that there is mutational risk associated with every exposure to ionizing radiation, including exposures from naturally-occurring background radiation. The non-cancer and often non-lethal but highly debilitating effects of chronic low-dose radiation exposures have only recently begun to be investi-gated seriously, with findings that damage ta human health does result either directly from low doses received repetitively through consumption of slightly radioactively contaminated foods and water or from inhalation of slightly radio-active particulates or both, or indirectly from the combined impacts of chronic low-dose irradiation interferen6e'with functioning of the human im~urie systi-: in concert with exposures to other environmental contaminants. Consequences for individuals in the public are loss of robust good health, chronic sickness and disorders, and economic burdens on society both from added direct health care costs and through inability of chronically ill persons to contribuie in full measure to the nation's economic wellbeing. These consequences and costs, in contrast to ALARA costs of dose reduction per person-rem of avoided dose, have not been but must be included in EPA's analysis of ample margin of safety. ECNP has raised these issues repeatedly before EPA (see citations in our referenced comments), apparently to little or no avail. The proposed, very Ion~ overdue, revision of the 1962 Federal Radiation Council's guidelines (59 FR 66412) that address permissible total radiation exposures still does not sufficiently assess the adverse effects on human health (or, obviously, on other components of the biosystem on which our human health depends) of the synergistic relationships of exposures to ionizing radiation and the host of other pollutants to which individuals are subject, nor of variations in the conditions of health, age, or prior illnesses of radiation recipients. The totality of short- and long-term impacts upon individual and collect-ive health and safety and upon the environment of this and other NESHAPS rescis-sions as proposed and approved by EPA must be included and addressed in a full Programmatic EIS. The cursory review conducted by EPA is woefully inadequate to accomplish this goa-1. This-'issue is particuiar iy important due to Congress-ional and regulatory uncertainties and actions both already undertaken and pro-posed by the agency to which EPA is abdicating its authority to set radiation standards. The Environmental Coalition on Nuclear Power asks that EPA complete and publish a Programmatic Environmental Impact Statement on effects of all NESHAPS rescissions before taking further action toward finalizing this Rule. More than a decade has passed since EPA was first taken to task, and to court, for failing to exercise its responsibility to set radiation protection standards for public exposures (Environmental Defense Fund, Natural Resources Defense Council, and Sierra Club, 1985) and then for setting other NESHAPS limits that were based improperly and impermissibly on the economics of pollution control rather than on health effects (decided in the 1987 NRDC vinyl chloride case). Although EPA's directive in 60 FR 50162 for these comments specifies that they are to address "only the contents of this document," the

significance of this EPA rescission extends far beyond that narrow boundary and ls intimately interwoven with the contents of this Notice. Moreover, much time has e(apsed and many affective events have taken place since EPA promulgated its 1989 NESHAPS for radionuclides. stayed effectiveness of the rule, and began the rescission process. For these reasons, our comments of necessity will go beyond a narrow interpretation of the bounds of this Notice, but they are all included for purposes that are related to the rescission under consideration. are thus pertinent, and we ask the agency to give them full consideration. Too often regulatory failure results from construing the issues too narrowly. Comments Relating to EPA's Draft NESHAPS Rescission Rule Reopened for Comment:

1. The 1990 Clean Air Act Section 112(d)(9) allows but does not reguire the EPA Administrator to relinquish to the NRC EPA's NESHAPS standards~setting authority over radionuclides. EPA states Cp. 50163, c. 1> that its initial analysis fo~used on "whet}1er NRC's. regulator:y progra~ Jn practice _results iJI..

sutiiclent.l,Y low doses to prot.ect,pubiic health with *an. ample m~r'gin of .

• safety." This analysis was based on information provided by NRC. and presum-ably by other nuclear industry sources and proponents of the uses of nuclear technologies, about past and then-current practices and performances of the licensees under review. Self-reported licensee data must not be accepted uncritically bv EPA. EPA states that it also considered "whether the NRC program is sufficiently comprehensive and thorough and administered in a manner which will continue to protect public health in the future." Yet, at p. 50161 of its September 28th Notice, EPA states that this document "describes the expected proposed revisions to the NRC program [i.e., "constraint level"J which support such rescission." (italicized emphasis added throughout>

Given the above EPA questions and comments, our fundamental question that EPA must consider ind fully answer is thus posed: Using as a hypothetical assumption -- which ECNP questions and does not accept -- that the licensee-supplied emissions data, and NRC's COMPLY computer code calculations, and real doses received were all accurate and that EPA's sample of facilities was valid and included the extremes of exposures, and further as~uming that EPA's 10 mrem per year EDE will in the future be found to provide adequate protection for human health from the full range of risks associated with radiation exposures, In view of the many future uncertainties and the alterations of NRC regulatory practice already underway (some of which are addressed below), on what*bases does, or can, EPA conclude that NRC's future regulatory

     *program, and any associated radiation protection standards that may be set by that agency, will continue "to protect the public health in the future" to the degree that EPA's 1989 NESHAPS standard (and/or revised radiation protection guidance> would have provided?

2. EPA suggests, at p. 50162, c. 3, that its proposed action is justified because it "enables EPA to eliminate duplication of effort between EPA and NRC." This reasoning is indefensible with respect to EPA's statutory duty to protect the public health and safety. Quite to the contrary -- although ECNP has never found AEC or NRC regulations to be adequate to provide proper public protection from radiation hazards -- NRC's past (but far less so its present>

regulatory philosophy and program had been claimed to be ones of "defense in depth" and multiple "redundant safeguards." If protection of public health and

safety is indeed EPA's legal obligation (which EPA has stated and we believe to be the case>. then the very existence of dual regulation and any consequent "duplication of effort" by these agencies must be seen*as a desirable augmented defense in depth. The public's well-being is much better protected through multiple safeguards and additional redundancy in the cross-checking by the two agencies, both legally assigned to and responsible for assuring health and safety. (Compare with the shameful performances of the AEC and Department of Energy operating without regulatory oversight.) This factor gains in signif-icance as commercial' reactors and other nuclear facilities approach the end of their design life, suffer major component failures, and experience materials fatigue and management or worker fatigue or inattention, all of which increase severe "normal accident" probabilities. (See. inter alia, the research of Yale Professor, Dr. Charles Perrow, on "norm~! accidents" in complex systems.)

3. Furthermore, future "acceptable risk" and "ample margin of safety" are adversely affected by changes in (1) NRC's regulatory approach, from its past claims of a conservative prescriptive philosophy to a performance-based and risk-based regulatory philosophy; (2) its pri~rams to lessen or eliminate cer-tain regulatory requirements and their rigorous enforcement; and (3) proposed regulatory criteria for deregulation of radioactive materials and wastes, and for decommissioning, decontamination, and the restricted or unrestricte~~

release of sites for which licenses are terminated. The NRG staff has already proposed (June 1994) release from regulatory control of "a few tens" of contaminated sites "despite the failure to meet the 100 mrem/yr cap" for dose to an "average member of the critical group" that would be exposed at such a site released for restricted use after decommission-ing. The NRG Commissioners have already proposed to meet budget reductions by cancelling their entire "Low-Level" Radioactive Waste regulatory program in 1999. The staff already plans to promulgate in 1997 a "recycle rule," which will be designed, according to staff, to reduce the amount of radioactive waste requiring regulated disposal (BRC all over again). Congress has already proposed imposing wholesale deregulation. Free trade treaties (NAFTA and GATT) already may have sufficient authority to override NRC's supposedly adequate protective health and safety measures and environmental protection. Licensees are already restructuring and downsizing, potentially reducing safety. All of these factors must be taken into account by EPA in forecasting the future; they are only suggestive of many *changes negating EPA's rescission conclusions.

4. EPA's responsibility for protection of public health through standards-setting far transcends just what happens at any one licensed facility at any given moment. EPA states that it "surveyed a randomly selected subset of all licensed facilities, as well as a group of 'targeted' facilities chosen because of an expectation that they would have higher emissions," but the agency also states that its study used the COMPLY computer code; there is no indication if other methods were employed to cross-check the accuracy and adequacy of this code. As EPA is surely aware, the correctness and applicability of some NRG-approved computer codes have recently been questioned at Maine Yankee, as well as the safety of the basic spent fuel pool design at the Susquehanna plant.

Therefore, rigorous independent confirmation of the veracity of this code itself is essential to the validity of EPA's analysis. EPA uses qualifications in its conclusion (at 60 FR 50164, c. 2>: "None of the facilities evaluated appeared to cause a dose exceeding the 10 mrem/yr limit .*.. "

In addition, facility closure, clean-up, and long-term waste isolation lie ahead for each licensee; all associated costs are aspects intimately linked to the management decisions and daily operations of each facility and, in turn, to the sufficiency of control that will in truth achieve, not merely promise, an "ample margin of safety." EPA must therefore also take all these factors into full consideration in a NESHAPS rescission decision. EPA has not done so. We offer one example of the kinds of implications that EPA must include in its considerations. In July 1995 NRC approved an Import/Export Rule for radio-active materials and wastes. Immediately, a Specific License application was filed with NRC by one small company, "Master International Systems, USA," for export of U.S. "low-level" radioactive wastes by air to the politically and seismically unstable trans-Caucasus region of the former Soviet Union, the Republic of Daghestan. The NRC Rule specifies, and NRC Staff have confirmed, that the Commission will not examine the environmental or other regulations or impacts of materials and waste disposal in the recipient country *. In addition, in its July 1995 Import/Export Rule, the NRC has now defined a category of "incidental radioactive materials" as those that are contained in or contaminate otherwise non-radioactive materials (e.g., equipment, tools, etc.,> that are destined for resource recovery or recycle without removal of the radioactive contamination. In other words, NRC will approve indirect deregulation of "low-level" waste and its reappearance in entirely unregulated unmonitored consumer products, adding to public doses CBRC all over yet again). The health and safety of the Daghestani nation's people, as well as our own and others, are adversely affected in the event of failures of radioactive waste control, transport accidents, or recycle, either now or in the future. EPA cannot ignore this NRG position -- that can only be called negligence on the part of that agency -- with respect to the final disposition of nuclear materials and wastes that NRC's licenses have permitted and continue to permit to be generated. Such related potential air imissions and their health, safety, and environmental consequences must be accounted for in a full PElS.

5. In its description of "Events Subsequent to the 1992 Proposal," EPA does not accurately portray NRC's 10 CFR Part 20 revised dose limit for members of the public. The revised Part 20 does lower the allowable dose to members of the public to 100 mrem/yr TEDE, but it also allows applicants and licensees to receive an exemption from that limit and expose members of the public to doses as high t.he *"old 500 mrem/yr limH *;if.*,accompanted,-*by**appropr*iate reports-of'--*

plans to try to reduce the exposures.* The exercise of that discretionary authority by the NRG may be expected to become more common as facilities age, as licensee's costs rise for compliance with the 100 mrem/yr dose limit and the non-compulsory ALARA, or as NRC and Agreement States' regulatory authority may decline in response to political decision-making. EPA must recalculate its ample margin of safety and acceptable risk to account for these factors.

6. ln this same section (60 FR 50163, c. 2-3), EPA quotes NRC's definition of ALARA: "making every reasonable effort to maintain exposures *.* as far below

• The BID accurately describes these dose limits at p. A-25-26, EPA 430-R 011, November 1992.

the dose limits as is practical ...* " As a party in the AEC's original generic rulemaking on "As Low As Practicable" <ALAP> c. 1971-72 (before ALAP evolved into ALARA) ECNP well recalls that the major concern of AEC (and later its successor NRG> in establishing this guidance was, and still is, primarily costs to licensees. EPA then states that the term "practical" is defined as:

      *** taking into account the state of technology, the economics of improve-ments in relation to state of technology, the economics of improvements in relation to benefits to the public health and safety, and other societal and socioeconomic considerations, and in relation to utilization of nuclear energy and licensed materials in the public interest.

In the past, with respect to regulatory value-impact, the NRC has utilized a cost figure of $1000 per person-rem of avoided dose as the dollar cut-off for required equipment improvements to lower an ALARA exposure. There is no indication that EPA has taken into account NRC's revised figure of $2000 per person-rem conversion factor which is now subject to present worth considera-tions discounting at an MB-recommended seven percent real discount rate. See "Regulatory Analysis Guidelines of the U.S. Nuclear Regulatory Commission," Final Report, NUREG/BR-0058, Revision 2. This change in NRC's ALARA g01dance had been well advanced before EPA published its Final Rule on rescission, and impacts of the change must be assessed by EPA in this rescission proceeding. We question, too, whether EPA has given due weight to advances in the state of the technologies involved, including substitute technologies that do not require utilization of nuclear energy or nuclear materials. We question whether EPA has incorporated the costs that will be incurred and uncertainties of success in the short- and long-term isolation of the radioactive wastes generated by these activities, or the full costs of decommissioning and decon-tamination, the criteria for which have not yet been finalized by NRC. Absent a PEIS on all NESHAPS rescission, we question if EPA has done an appropriate analysis of the economics of improvements in relation to bene~its to the public health and safety, and other societal and socioeconomic considerations in a nation that is nearly five trillion dollars in public debt, not to mention corporate and private indebtedness that will further constrain societal capability to prevent future damage to public health and safety and quality of the environment with respect to NRG and Agreement State licensees <not to mention the irradiated mess created by DOE). EPA must review and assess all of these -- and adopt some:societally acceptable definition of'.what constitutes "the public interest" in this regard. A PEIS is clearly needed.

7. At p. 50164, c. 1, EPA openly admits that NRC's regulatory program con-tained "no element ... which expressly required or assured that [the licensees in question] would maintain emissions below the 10 mrem/yr EPA standard." This conclusion should have ended any consideration of EPA NESHAPS rescission. It is noteworthy that EPA states the agency relied on an [unspecified] NRC Regula-tory Guide issued pursuant to the 1992 Memorandum of Understanding between EPA and NRG. Regulatory "guidance" of the NRC is merely guidance; it imposes no regulatory requirements on NRC licensees; therefore it is not enforceable, and subsequent NRC changes and proposals basically do not alter that situation.

Surely NRG has told EPA this. Instead of finding justification for rescission, what EPA found is precisely the opposite: good reasons for EPA to retain its NESHAPS standards-setting authority for radionuclides.

Moreover, EPA cites a conclusion of the April 1993 General Accounting Office report, entitled "Nuclear Regulation: Better Criteria and Data Would Help Ensure Safety of Nuclear Materials" CGAO-RCED-93-90) that "NRC lacks criteria and data to evaluate the effectiveness of its two materials programs [agreement and non-agreement state]," and "For agreement states programs. NRC does not have specific criteria or procedures ta determine when ta suspend or revoke an inadequate or incompatible program.~ This ECNP commenter has been an invited participant in NRC workshops on compatibility requirements, and, serv-ing in a state advisory capacity, has also observed previously unanticipated policy and agency changes and regulatory relaxations at the level of state government. Although the Commissioners have given interim approval to new procedures to govern compatibility requirements imposed by NRC on Agreement States and criteria for suspension and termination of these state reaulatory programs, to the best of our knowledge, NRC's new Agreement State regulatory criteria, procedures, and programs have not yet been formally adopted as an NRC Rule. Thus they cannot be rel~ed upon here sith~~ to iupport an EPA findin~-of "ample margin at safety" in this proceeding or to assure that future state programs will be as restrictive as, or required to conform with, NRC guidance or regulations for licensees -- not if devolution of responsibility and power sought by the existing Congressional majority and some states is approved. As for state program assurances of compliance with an EPA 10 -rem/yr stand-ard: At an NRC workshop on Agreement State Compatibility Requirements (in which this commenter participated c. July 1993), at least one Agreement State radia-tion control officer had stated that in his state less restrictive. but not more restrictive, radiation exposure standards than those of the NRC would be adopted if the NRC permitted latitude to the states to do so. Such an outcome must now be taken into account by EPA, in light of various 1995 proposals and actions by the Congressional majority to eliminate much regulatory authority of Federal agencies. In addition. this Congress appears to fail to discriminate between "nuisance" and "necessary" regulations; its actions, however, can curtail even the "best will" of NRC to promulgate, regulate, and enforce to a. standard equal to that promulgated by EPA. Despite EPA's assertions to the contrary, these current conditions of uncertainty alone reconfirm EPA's 1994 concerns Cat 50164, c. 2) that neither NRC nor Agreement States would in future be able to compel their licensees to adhere "consistently and predictably" to an ALARA air emissions level that would be sufficiently below the EPA 10 mrem/yr limit to offer adequate assurance of "acc~ptabie risk" or ,,-ample.'mar'gln o*f safet*y." *

• Role of NRC's proposed "Constraint Level" Rule:

Moreover, despite NRC's promises of a 10 mrem/yr "constraint level," that limit would only be equal to, not better than, EPA's 10 mrem/yr EDE NESHAPS. The NRC's proposed "constraint level" would not provide any additional <much less more ample> margin of safety for ALARA compliance. Licensee compliance with ALARA is itself a matter of self-reporting of emissions, regulatory agency "guidance," and licensees' promises to obey the quidelines; ALARA is not a regulation that is required to be enforced. A licensee is allowed simply to file a report and promise to try to do better;* NRC can decide not to issue a Notice of Violation, nor fine the violator, nor suspend or terminate facility operation. The NRC "Constraint Level" proposed rule states Cat 60 FR 63985):

NRG power reactor licensees *** must keep doses to members of the public from air emissions consistent_with the numerical guidelines in Appendix to 10 CFR Part 50. In addition, these licensees have for many years reported estimated doses to members of the public ..** The NRG is proposing to establish a constraint of 10 mrem/yr TEDE for dose to members of the public from air emissions for radionuclides .** to maintain doses ALARA. The rulemaking being proposed would codify numerical values for NRC's application of ALARA guidelines.... (emphasis added) NRC "guidance" does not mandate licensee compliance as does "regulation" established by formal rulemaking in accordance with the Administrative Proced-ure Act. Thus to the best of our understanding and past experience. guidance is not enforceable by the regulatory agency; and that is key to this EPA decision *

• . Moieover,- the Commission states {at 60-FR 6398~):*

If the licensee estimates or measures a dose to a member expected to receive the highest dose from air effluents to mrem/yr, the licensee would be required to record the dose tion used to calculate it consistent with the requirements of the public be less than 10 and the assump-of 20.2103. A licensee is allowed merely to estimate and then calculate doses. The result is merely an "expected" dose; actual measurement is not required, nor, to the best of our knowledge, are actual doses to members of the public normal-ly and routinely conducted by either NRC or its licensees to ascertain the accuracy of the assumptions, calculations, estimate, or identification of the individual who in reality receives the highest annual dose from air emissions. It's called smoke and mirrors. Must NRC inspectors request the data, and their underlying assumptions? Or are such queries left to an inspector's discretion? e The NRC's proposed "constraint level" rule goes on to state that, if the calculated estimated highest dose is expected to exceed 10 mrem/yr,

       **. the licensee would be required to report the dose to NRC in writing within 30 days [after the event, and] include ... the circumstances, ...

description of the corrective steps the licensee has taken or proposes to take to ensure that the constraint is not again exceeded, a timetable for implementing the corrective ~teps, and the expected results. The Commission next plainly, unequivocally, states (also at 60 FR 63986): The constraint on dose from air emissions is different from a limit. Exceeding this constraint would not result in a Notice of Violation (NOV>. Rather a NOV would be issued only upon failure ~o report that actual or estimated doses ... have exceeded the constraint value and/or failure to institute appropriate measures to correct and prevent further emissions in excess of ..* the constraint level. (emphases added here and above) Based on these statements by the agency to which EPA intends to abdicate its NESHAPS standards-setting authority, EPA can only conclude, as we argue, that the NRC cannot assure an ample margin of safety with respect to ALARA and the "constraint level" rule, because neither is in fact enforceable regulation.

Suggestion for Possible Alternative EPA Action*: In exempting power reactors from its constraint rule, .NRC noted Cat 60 FR 63986) that those licensees are required in 10 CFR 50.34a to identify ftdesign objectives and the means to be employed for keeping doses ALARA.ft If we recall ancient reactor PSAR's correctly, the "design objective" with which applicants promised to be able to comply was a maximum dose to a member of the public of 5 mrem/yr. If they could, they should. EPA, as a condition of any NESHAPS rescis-sion, must insist that NRC convert its ALARA "guidance" design objective into a mandatory enforceable 5 mrem/yr dose limit regulation. It is the level which approximates what licensees claim to be historically able to meet for reactors; it is closer to a real "safety margin" if enforced. In any event if rescission is implemented, EPA must conduct periodic reviews of NESHAPS for radionuclides standards and enforcement; and EPA should insist upon an MOU condition in which NRC guarantees that it will rigorously enforce this dose limit as a regulation and as a condition for continued operation of a facility and as a condition tor any continuation of NRC atithorny* to set the air emissions standards.* . ,.,,. NRG/Agreement State Compatibility: The one positive aspect of NRC's proposed constraint rule with which ECNP strongly concurs, and which we have repeatedly requested for years and still very strongly support, is the Agreement State Compatibility proposal that, in accordance with the Clean Air Act, would authorize individual Agreement States to adopt an air emissions rule that is more restrictive but nri less restrictive .. , than the one approved by the Commission. However, EPA should insist that NRC apply this compatibility, as a Division 2 matter, "across the board" to tll NRC .: and/or Agreement State licensees, including nuclear power reactors. NRC Claim of Finding of No Significant Impact: Of all agencies, EPA should -- must -- demand that this rule, if it is even remotely to be considered, must be preceded by a full Environmental Impact, Statement and public comment, for the rule is beyond question a major Federal action and it will also without question affect the "quality of the human environment" -- not to mention human health. Although EPA claims that "[alctual air emissions are not expected to change," in actual fact~ EPA does not know what those actual emissions are nor what their resultant actual doses to the public really are, absent independent emissions measurement and actual dose measurement, neither

                   -~ ,, . ' .

of w.hich the. NRC

                                                   ..!'.outJ!'.e.)y.:or, r_e.liably conducts ...

Lack of Assurance of Continuing NRC Regulatory Control: Coincident with EPA's consultations with NRC on these issues, in recent years the Commission had been basically altering its regulatory philosophy and programs in ways that will have major and potentially serious negative future impacts on the subject of this proposed EPA NESHAPS rescission. The Commission, in its 1992 internal policy, "Exercise of Discretion Not to Enforce Compliance with License Conditions" CSECY-92-043>, and in its ongoing program entitled "Elimination of [Regulatory] Requirements Marginal to Safety," has increased

• Members of ECNP do not necessarily endorse or recommend this suggestion.

its compliance with the demands for decreased regulation on the part of its licensees, led by the increasingly financially distressed nuclear utilities. The very significant point lacking in EPA's analysis is the ever-declining commitment of the NRC, and its capability under fiscal reductions, to guarantee that either an "acceptable" (to whom?) risk oi an ample margin of safety will continue to be maintained by the NRG -- assuming, which we do not, that either one is provided by NRC at present. In recent years the Commission has moved steadily away fro*m its historical claims of effective functioning on the twin foundations of nuclear regulation:

 "defense in depth" and "redundancy of safeguards." Conservatism in NRC's prescriptive standards and regulations has been, and increasingly is being, replaced with "risk-based" and "performance-based" approaches to setting and

• enforcing stand_ard;:; and _regulations. We urgently- request. EPA to review, and incorporate in !ti decision-makink, these.changes~ and their trend~, over*t~e past decade in, at the minimum, all of the following:

NRG Information and Enforcement Notices Guidance Communications to Licensees

• Generic Letters
• Regulatory Guides
• Reporting Requirements
• Maintenance Requiremertts
• License Amendments
• Technical Specifications.

We observe that these changes constitute a pattern of NRG regulatory relax-ation and that they destroy any certainty that NRG is now providing or can in future reasonably be expected to provide an ample margin of safety. That being the case, it is arbitrary of EPA to relinquish its Clean Air Act authority to set NESHAPS for radionuclides; and it is capricious of EPA to ignore its statut-ory obligations to protect public health and safety and the quality of the environment under NEPA, Clean Air Act, and other statutes designed to proiect the quality of air and the overall health and safety of human populations. A telling confirmatory example of NRC's lack of assured future regulatory diligence and reliability is to be found in NRC's December 4, 1995, request for "Interested Party" comment on the NRG Staff Policy Issue entitled "Alternatives to Terminating the Nuclear Regulatory Commission Low-Level Radioactive Waste Disposal Program" CSECY-95-201, July 31, 1995). The latter d6cument states that, as long ago as August 1994, "in ordet t6*meet reduced targets for Agency and NMSS staffing levels" in respO~se to the Adniiriistrafion's "Reinventing Government Initiative, the Commission had submitted to the Office of Management and Budget COMB) its future NRC budget projections. These projections included "for FY99 and beyond" the complete "zeroing out" of the entire NRC LLRW disposal program, "meaning that no staff would be devoted to the activities performed within that program element" Cat p. 2; emphasis added).* Noting that this is only one area of NRC's anticipated reduction in its regulatory capability, we further reproduce in full from page 2 of SECY-95-201,

• An EPA Radiation Program staff person, with whom I spoke about this NRG plan to cancel or markedly reduce its LLRW disposal program, claimed total ignorance of it as of February 16. Did NRG fully inform and consult with other EPA staff?

a document signed by James M. Taylor, Executive Director for Operations, who in turn quotes the Commission's 1994 budget submission to 0MB:

    "The description of the reduction and its impact submitted and approved by the Commission follows:

Eliminate the NRC LLW program. States would conduct independent oversight of LLW disposal. NRC would not develop further guidance for LLW disposal facilities, interact with Environmental Protection Agency (EPA) to resolve issues associated with duplication of*regulatory requirements for the regulation of radionuclides, maintain the capability to respond to the sub-mission of a LLW facility application from a non-Agreement State, provide assistance to the States as they develop plans for low-level disposal facil-ities, participate in reviews of State programsf conduct inspections at the current LLW facilities or at reactors, or conduct research. Also, LLW disposal site regulation by States may not be consistent nationwide. No

    ~igniticant i~pact on LLW sit~ tegulatt6ri if the States provide the same*

level of oversight that NRC has provided. Delays may occur tor new LLW sites without NRC assistance. The Low-Level Radioactive Waste Policy Amend-ments Act CLLRWPAA> will probably have to be amended." (emphasis added) We quote this description in full; it is what the Commission has already submitt~d as its "solutiori" to budgetary shortfalls. It provides more than an ample margin of evidence to EPA that EPA cannot relv upon NRC's assurances that NRG will set, maintain, monitor, regulate, and/or enforce radiation protection standards in time to come that will meet EPA's own 1989 NESHAPS radionuclide standard or EPA's statutory mandate to set standards for radiation exposure limits to protect public health and safety in the ambient environment. By reference we submit this NRG SECY-95-201 for the record in this proceeding. EPA must review this document and other related anticipated budgetary and staff reductions that may similarly negatively affect NRC's regulatory capability. Comment on EPA's Initial Determination Conce~ning Sufficiency of NRC Proposals and Actions to Support Rescission: At 60 FR 50165, c. 2, EPA states that it must determine that NRC's regula-tion will result in doses to the public that are "consistently and predictably" below EPA's NESHAPS dose limi~ of 10 mrem/yr EDE, and that NRG and/or Agreement States "can and_will require any individual licensee *** exceeding 10 mrem/yr to reduce the _emissio~s sufficiently that the-dose,wilJ not exceed 10 mrem/yr. EPA's selective review has not produced such a.showing: EPA stated at p. 50163 merely that "Cn]one of the facilities evaluated appeared to cause a dose exceed-ing the 10 mrem/yr level ..* " (though they might have if real doses to real people were measured>; and that, when the survey results were extrapolated to all NRG and Agreement State licensees, the EPA "concluded that virtually all of the facilities would cause doses *** below 10 mrem/yr." But not all of them. Neither statement indicates the projected number of facilities that would fail to meet the EPA NESHAPS dose limit in the future, nor how high the doses might be from those that failed. Yet EPA argues that CAA Section 112(d)(9) gives it the option of abdicating its standard~-setting authority if it merely judges that the "NRG program as a whole will assure *** doses below the EPA standard," and even if the individual facilities fail to meet that limit. That is not what the Simpson Amendment says, nor was that Congressional intent.

But EPA chooses to draw its conclusions (at p. 50165, c. 2> "based on the information presented to date that emissions *.. are generally well below the level [resulting] in a dose exceeding 10 mrem/yr." Later EPA notes that 16 out of thousands of licensees "are presently reporting radionuclide emissions exceeding the EPA standard." (emphases added) Each of these statements con-tains what are sometimes called "weasel words," that is, language that is super-ficially satisfying but that, on careful examination, is found to be vague and ambiguous, allowing a lot of latitude in interpretation. The questions raised by this wording are compounded by EPA's statement that "EPA expects that most of these reported violation~~will be resolved through EPA approval of adjust-ments in the COMPLY methodology for calculating doses." You don't "fix" viola-tions by fiddling about with the method of calculating doses; you do it by penalizing licensees or terminating licenses until licensees obey regulations. For EPA to take the means described here to "solve" -- or allow NRC to "solve" the problem of violations of EPA's standard -- is clearly an abuse of regula-tory -philosophy and agency ethical behavior; 1~ !mpermissi~l~; and*w~uld h~~e to be deemed an unconscionably arbitrary and cipricious agency action. ECNP Responses to Requests for Comments: Question 1 <Paraphrased): If NRC adopts the proposed ALARA constratnt level rule, will the NRC regulatory program assure that routine emissions will* result in doses consistently and predictably no greater than 10 mr'em/year? Answer: No, for, but not limited to, the following reasons: (1) Earlier, EPA was talking about doses "well bel~w" it~ 10 mrem/y~ NESHAPS limit as being necessary to provide an ample margin of safety; here, the question *1s now posed in terms of doses "no gr~ater than" that maximum dose limit, and therefore EPA is not now requiring that NRC must in the future provide an ample margin ~f safety. (2) As described above, NRC has already proposed and in part implemented reductions and complete elimination of portions of its regulatory programs that would be essential to the Commission's capability to evaluate compliance with the EPA NESHAPS dose limit. (3) The NRC ALARA program and propos~d constraint leveJ rule are only* guidance, not mandatory reg~lation pr~~ulgated under reqiiirements of the_ 1946 Federal Administrative Procedure ~ct that is ~riforceable Ciee a6ovej:* Question 2: If NRC adopts the constraint level rule, will NRC have sufficient authority to require any affected facility ... to reduce its emissions to a level resulting in a dose no greater than 10 mrem/yr? Answer: No. See responses 1, 2, and 3 above. The NRC's proposed constraint level rule would be guidance, as is ALARA, and would not be a mandatory regulation with which a licensee must comply. Question 3: If NRC makes the constraint -level rule a matter of Division Level 2 compatibility, will this assure that each individual Agreement State establishes an ALARA constraint level for its licensees no greater than 10 mrem/yr and requires its licensees to report and correct exceedances [sic]?

i.

                                                                                          .r Answer: Not necessarily. The NRG is subject to Congressional action that may well forbid the exercise of regulatory authority of this nature over the states. The NRG Compatibility Requirements have always contained hedges in the wording, calling for ttalmost the same,n "virtually identical,n "essentially verbatim" language but not actually requiring exact conformance with NRG regula-tions. This is a matter that ECNP has raised repeatedly with NRG State Programs staff for many years. We do not see that the proposed but not yet promulgated NRG Revised Agreement State Compatibility Requirements can and will assure adoption of an equal constraint level or its enforcement. lt is not clear that a failure to do so would evoke an NRG suspension or termination of an Agreement State's regulatory program. It is likely that any such case would be challenged in court. Certainly if NRC goes ahead with its plan to cancel its LLRW disposal program, that entire regulatory realm and qui_t_e possi9ly decom-mission as well would not be under future NRC control, or if reduced would have enough staff to exercise full regulatory authority over Agreement States.

Altho1igh EPA may wish t*o'*'d1smis**s: such speculations as only fantasies/'"the* agency must give sober consideration to precisely such events and situations that, in the past, could have been shrugged off as beyond the scope of reasonable possibilities. Times and things and funding have changed and will do so even more and quite likely more rapidly and unpredictably in even the near future. Question 4: Are NRC policies establishing criteria to evaluate the adequacy and compatibility of Agreement State programs, and adopting procedures to permit suspension or termination of Agreement State programs, sufficient _to enable NRC to take action if *** an Agreement State program is inadequate or. incompatible? Answer: ECNP, having pushed hard for years for both strong oversight of state programs and for the abi.lity for states to be more restrictive, but never less restrictive, in radiation standards and safety regulations than is the NRC, wotild like to believe that the answer to this question could be yes. But unfortunately, the NRC, during these same _years and more, has not demonstrated that it is willing, or perhaps even [politically?] able to exercise a strong regulatory control over its licensees or the states. As budgets shrink, de-regulation expands, devolution gains in popularity (as it may or may not continue to do), we see nothing in NRC's past performance to give adequate assurance that NRG will take effective actions to correct a deficient state program. The response must therefore be no. Question 5: Do these four actions [plus] other NRG actions, provide an ample margin of safety to protect public health? Answer: No. They do not. For the numerous reasons, deficiencies, contra-dictions, uncertainties, changes in regulatory philosophy, practice, and fund-ing capability, failures to enforce, and many other factors cited above, EPA must withdraw its proposed rescission of NESHAPS for radionuclides for non-reactor NRC- and Agreement State licensees. We strongly urge EPA to reverse the rescission decision already taken with respect to nuclear power reactors.

Selected Bibliographic References That Support the Need for EPA to Retain Its Clean Air Act Authority to Set More Protective Radionuclide NESHAPS Air Emissions Standards Than NRG Can Be Expected to Provide: We attach with these lengthy comments a partial bibliography citing some recent research findings that pertain to the adverse health effects of exposures to ionizing radiation. Contrary to nuclear industry research that finds little or no radiation injury to human health and on which EPA and NRG may be tempted to rely, these research findings support the conclusion that radiation impacts in addition to the customarily recognized ones of cancer, leukemia, and genetic defects are more prevalent than they have been credited to be in the setting of radiation protection standards. The negative impacts of low doses and chronic low-dose exposures must be included in EPA's NESHAPS rescission decision-making, and we commend these to the agency's staff as relevant to this matter before EPA. As a not-for-profit public-interest citizens g~oup, ECNP lacks the financia~ resources to reproduce-&}t of these documents for the Federal government.' if EPA has difficulty obtaining some obscure ones, ECNP will attempt to provide them, upon request, at a copying fee no greater than that charged by EPA and NRC.

== Conclusion:==

Based on more than twenty-five years now of ECNP's observation of perform-ances of AEC, NRG, DOE, and EPA (not to mention DOT, FDA, and DOD>, unhappily we must conclude that the NRG cannot be trusted to provide either acceptable risk or ample margin of safety in its regulation of the nuclear industry, nor can the states be depended upon to have the resources or the will do so. This does not necessarily mean that EPA's past performances inspire our boundless confidence; but, given the choice -- and the Clean Air Act explicitly gives the EPA Administrator the choice -- ECNP will opt for the better intent and actions of EPA over NRG to determine an acceptable risk and ample margin of safety to protect public health and safety and environmental quality in good faith. The EPA in 1994 had decided that it could not proceed with this NESHAPS rescission. At that point, EPA should have exercised its good judgment to end this matter. We respectfully urge that EPA now do so: withdraw this proposed rescission of its NESHAPS standards-setting authority for NRG and Agreement State non-reactor licensees -- and rescind its prior rescission for reactors.

ATTACHMENT TO COMMENTS ON 60 FR 50161 AND 63984 OF THE ENVIRONMENTAL COALITION ON NUCLEAR POWER Selected References on Health Effects of Ionizing Radiation Pertinent to EPA Retention of Clean Air Act Authority to Set More Protective NESHAPS Radionuclide Air Emissions Standards Than NRC Can Be Expected to Provide Adams, W.H., "Late Biological Effects of -Internal and External Exposure," Brook-haven National Laboratory, BNL 37087 DEB6-001181, 1986 Adelstein, S.J., "Uncertainty and Relative Risks," JAMA 258:655-657, 1987 Alberts, B., et tl,, Molecular Biology of the Cell, 2nd edition, New York, Garland Publishing, 1989 Albright, D., "Gamma Radiation from Activation Products Induced in the Soil by Neutrons from Atmospheric Nuclear Explosions," Report to Environmental Policy Institute, Washington, DC, 1982 Aldhous, P., and S. Shulman, "Lower Dose Limits, Nature 348:274, 1990 Aldrich, J.E .. and B. Pass, "Comments on ESR Dosimetry for Atomic Bomb Surviv-ors and Radiologic Technologists" (letter) Nuclear Instruments and Methods

• in Physics Research A273:451-2, 1988 Allan CAltanl, D.J., "Radiation-Induced Apoptosis: Its Role in a MADCAT Scheme of Cytotoxicity Mechanisms," International Journal of Radiation Biology 62(2):145-152, 1992 Anderson, R.E., and N.L. Warner, "Ionizing Radiation and the Immune Response,"

in F.J. Dixon and H.G. Kunkel <eds.) Advances in Immunology, vol. 24, New York, Academic Press, 1976 Arena, V., Ionizing Radiation and Life, _St. Louis, C.V. Mosby; 1971 Asimov, I., and T. Dobzhansky, "The Genetic Effects of Radiation," Understand-ing the Atom Series, Washington, D.C., U.S. Atomic Energy Co~mission, 1966 Au, W.W., "Monitoring Human Populations for Effects of Radiation and Chemical Exposures Using Cytogenetic Techniques," in G.S. Wilkinson (ed)~~Occupa- * ~~ tional Meditine: State of the Art Reviews 6(4), 597-611, Philidj1phia, Hanley and Belfus, 1991 Barinaga, M., "Cell Suicide: By ICE, not Fire," Science 263:754-6, 1994 Baverstock, K., et tl,, "Thyroid Cancer after Chernobyl,"* (letter>, Nature 359(6390):21-22, 1992 A Behrens, C.F., Atomic Medicine, New York, Thomas Nelson, 1949

• Bertel!, R., "Handbook for Estimating Health Effects from Exposure to Ionizing Radiation," Ministry of Concern for Public Helath, Buffalo, NY, i984 Bertel!, R., No Immediate Danger: Prognosis for a Radioactive Earth, Toronto, Women's Educational Press, 1985 Bertinshamps, A.J., "Preface" in J. Huttermann et tl,, Effects of Ionizing Radiation on DNA: Physical. Chemi-cal and* Biologi-cal Aspects, pp.- vii-viii, Berlin, Springer-Verlag, 1978 Bfshop, J.M., "Oncogenes," in J.B. Wyngaarden et 21_. (eds.>, Cecil Textbook of Medicine, 19th ed., vol. 1, Philadelphia, W.B. Saunders, 1992 Bithell, et tl-, "Distribution of Childhood Leukemias and Non-Hodgkin's Lymphomas near Nuclear Installations in England and Wales," British Medical Journal 309:501-5, 1994 Black, et tl-, "Incidence of Leukemia and Other Cancers in Birth and School Cohorts in the Dounreay Area," British Medical Journal 304:1401-5, 1994 Boardman, D.W., Radiation Impact: Biologic Response <Pre-publication 3), Center for Atomic Radiation Studies, Cambridge, ~A, 1995 Boardman, D.W., "Recent Research Suggests a New Radiation Injury: Indirect Genetic Damage Caused by Alpha Particles," Issue Paper t2. Radiation Events Monitor, 9, Cambridge, Center for Atomic Radiation Studies, 1992

Attachment Page 2 Babrow, M., "Radiation-Induced Disease," CIBA Foundation Symposium 175:182-192, 1993 Bradley, D., Na Place ta Hide, Hanover, N.H., University Press of New England, 1946, 1984 Breitenstein, B.D., et tl*, "The Probability that a Specific Cancer and a Specified Radiation Exposure Are Causally Related," Health Physics 55(2): 397-947, 1988 Brestel, E.P., and K. VanDyke, "Lipid Mediators of Homeostasis and Inflamma-tion," in C.R. Craig and R.E. Stitzel (eds.), Cardiovascular Drugs of Modern Pharmacology, 2nd ed., New Yark, Little, Brawn, 1986 Bross, I.D., Crimes of Official Science: A Casebook, Buffalo, NY, Biamidical Metatechnalagy Press, 1987 Bross, I.D., Twenty Years of Folly and Fraud in the Name of Science, 1994 Brawn, H.N., and G.E. Vaillant, "Hypachandriasis," Archives of Internal Medicine 141:723-26, 1981 Burlakova, E.* ful I citation unavailable, Moscow State University*~ 1995 Caulfield, C., Multiple Exposures: Chronicles of the Radiation Age, New Yark, Harper and Raw, 1990 Cerutti, P.A., "Praoxidant States and Tumor Promotion" Science 227:375-81, 1985 Chabner, B.A., "Introduction," in J.B. Wyngaarden, Q.P.. cit., 1992 Chomsky, N., Necessary Illusions, Baston, South End Press, 1989 Christensen, D. "Of Craters and Crevices: A Scientist Challenges Traditional Views of Cell Shapes," Science News 145:266-8, 1994 Cline, M.J., "The Molecular Basis of Leukemia," New England Journal of Medicine 330(5):328-36, 1994 Caggle, J.E., Biological Effects of Radiation, London, Taylar & Francis, 1983 Coleman, C.N., "Introduction," Conference an the Interaction of Radiation Therapy and Chemotherapy (1986], Williamsburg, VA, National Cancer Institute Monographs, Na. 6, 1988 Committee for the Compilation of Materials on Damage Caused by the Atom Bombs in Hiroshima and Nagasaki, Hiroshima and Nagasaki: The Physical, Medical and Social Effects of the Atomic Bombings, New York, Basic Books, 1981 Conneally, P.M., "Molecular Genetic Basis of Amyotraphic Lateral Sclerosis," New England Journal of Medicine 324:1430, 1991 Cronkite, E.P., and V.P. Bond, Radiation Injury in Man, Springfield, Charles Thomas, 1960 Cross, C.E. et tl*, "Oxygen Radicals and Human Disease," Annals of Internal Medicine 107:526-45, 1987 Cuddihy, R.G., and G.J. Newton,_ "Human Radiation Exposures Related to Nuclear Weapons industries," Inhal.ation Toxi,coiogy Research *Jn~ti tute, Lovelace Biomedical and Environmental Research Institute, Albuquerque, N.M., 1985 Darby, S.C., and R. Doll, Childhood Leukaemia, Fallout and Radiation Doses Near Daunreay," in R.R. Janes and R. Southwood (eds.) Radiation and Health: The Biological Effects of Law-Level Exposure ta Ionizing Radiation, New Yark, Jahn Wiley, 1987 Darby, S.C., and R. Dall, "Radiation and Exposure Rate," (letter) Nature 344:824 Dvaretsky, A. I. et tl*, "Ionizing Radiation Action an Transport Systems of Na+ and K+ of Neuronal Membranes, Potassium Reaccumulation with Brain Slices," Studia Biaphysica 136(1):55-64, 1990 Fabrikant, J. I., "Public Health Regulation and Control of Population Exposures to Ionizing Radiation," Preventive Medicine 19:705-22, 1990 Fajardo, L.F., Pathology of Radiation Injury, New York, Masson, 1982

Attachment Page 3 Finch, S.C., "Acute Radiation Syndrome," JAMA 258(5):664-7, 1987 Fish, E.M., and B.A. Molitoris, "Alterations in Epithelial Polarity and the Pathogenesis of Disease States," New England Journal of Medicine 330(22) 1580-88, 1994 Fridovich, I., "The Biology of Oxygen Radicals: The Superoxide Radical Is an Agent of Oxygen Toxicity; Superoxide Dismutases Provide an Important Defense," Science 201:875-80, 1978 Fry, R.J.M., and J.B. Storer, "External Radiation Carcinogenesis," Advances in Radiation Biology 13:31-90, 1987 Funtowicz, S.O., and J.R. Ravetz, "Global Environmental Issues and the Emerg-ence of Second Order Science," (Preprint) Commission of the European Communities, Joint Research Centre, Ispra Site, Institute for Systems Engineering and Informatics, EUR 12803 EN, 1990 Gale, R.P., and A. Butturini, "Medical Response to Nuclear and Radiation Accidents," in G.S. Wilkerson (ed. l Occupational .Medicine: State of tfie A Art Reviews, Philadelphia, Hanley and Belfus, 1991 W Gardner, M.J., et tl,, "Results of a Case-Control Study of Leukaemia and Lymphoma Among Young People Near Sellafield Nuclear Plant in West Cumbria," British Medical Journal 300(6722):423-29, 1990 Gardner, M.J., et tl,, "Methods and Basic Data of a Case-Control Study of Leukaemia and Lymphoma Among Young People Near Sellafield Nuclear Plant in West Cumbria, British Medical Journal 300(6722):429-34, 1990 Geiger, H.J., et tl,, Dead Reckoning: A Critical Review of the Department of Energy's Epidemiological Research, Washington, DC, Physicians for Social Responsibility, 1992 George, A.M., and W.A. Cramp, "The Effects of Ionizing Radiation on Structure and Function of DNA," Progr~ss in Biophysics and Molecular Biology 50:121-69, 1987 Gofman, J.W., Breast Cancer, San Francisco, C.N.R. Book Division, c.1994 Gofman, J.W., "The Byelorussia Chernobyl Monitoring Project," Draft Curriculum, 1991 Gofman, J.W., Radiation and Human Health San Francisco, Sierra Club Books, 1981 Gofman, J.W., Radiation-Induced Cancer from Low-Dose Exposure: An Independent Analysis, San Francisco, C.N.R. Book Division, 1990 Gofman, J.W., and E. O'Connor, X-Rays: Health Effects of Common Exams, San Francisco, 1985 Goodhead, D.T., "Spatial and Temporal Distribution of Energy," Health Physics 55(2): 231-40, 1988 Goodhead, D.T., ".The Initial Physica,1 Damage Produced by Ionizing Radiations," lnterna~ional Journal of Radiation Biology 56:623-34, 1989 Goodhead, D.T. tl tl*, "Effects of Radiations of Different Qualities on Cells: Molecular Mechanisms of [DNA] Damage and Repair," Weiss Lecture, 1993 Goodhead, D.T., "Initial Events in the Cellular Effects of Ionizing Radiations: Clustered Damage in DNA," International Journal of Radiation Biology 65(1):7-17, 1994 Greenberg, M., "The Evolution of Attitudes to the Human Hazards of Ionizing Radiation and to Its Investigators," American Journal of Industrial Medicine 20(6):717-21, 1991 Greer, D.S., and L.S. Rifkin, "The Immunological Impact of Nuclear War," in The Medical Implication of Nuclear War, Institutes of Medicine, National Academy of Sciences Ced.), Washington, DC, National Academy Press, 1986 Grosovsky, A.J., tl tl,, "Base Substitutions, Frameshifts, and Small Deletions Constitute Ionizing Radiation-Induced Point Mutations in Mammalian Cells," Proceedings of the National Academy of Sciences, USA 85:185-88, 1988

Attachment Page 4 Halliwell, B., and J.M.C. Gutteridge, Free Radicals in Biology and Medicine, Oxford, Oxford University Press, 1985 Hanford E~~ironmental Health Foundation, "The US Transuranic Registry Report on the Am Content of a Whole Body," Health Physics 49(4):559-676, 1985 Harach, R.J., et tl_., "Occult Papillary Carcinoma of the Thyroid," Cancer 56: 531-38, 1985 Harris, C.C., and M. Hollstein, "Clinical Implications of the p53 Tumor-Suppressor Gene," New England Journal of Medicine 329(18):1318-27, 1993 Harris, R.J.C., Cellular Basis and Aetiology of late Somatic Effects of Ionizing Radiation, New York, Academic Press, 1963 Hirsch, E.F., and G.J. Bowers, "Irradiated Trauma Victims: The Impact of Ionizing Radiation an Surgical Considerations Fallowing a Nuclear Mishap," World Journal of Surgery 16:918-23, 1992 Hodges, G.M., and C. Rowlatt (eds.), Developmental Biology and Cancer, Boca Raton, CRC Press, 1994 _ H6ffman, 6.A.j and E.P~-R~dford, "A Review ~j the C~rcinogenic 'Eff~c~s of Low Doses of Ionizing Radiation," Draft, Philadelphia, TMI Public Health Fund, 1985 Howell, R.W., et tl_., "Relative Biological Effectiveness of Alpha-Particle Emitters In Viva at Low Doses," Radiation Research 137:352-60, rg*94 Huberman, E., and Barr, S.H. (eds.>, The Role of Chemicals and Radia~ton in the Etiology of Cancer, Val. 10 of Carcinogenesis: A Comprehensive Survey, New York, Raven Press, 1985 Imlay, J.A., and S. Linn, "DNA Damage and Oxygen Radical Toxicity,: Science 240~1302-9, 1988 Jerne, N.K., "Generative Grammar of the Immune System" Science 229:1057-9, 1985 Jiang, T.N., et tl_., "Alpha Particles Are Extremely Darning to Developing Hemo-poiesis Compared to Gamma* Irradiation," Radiation Research 137:380-4, 1994 Johnsrud, J.H., "Below Regulatory Concern," Issue Paper No, 1, Radiation Events Monitor, No. 8, Winter, 1991-92, Center For Atomic Radiation Studies, Cambridge, MA, 1992 Johnson,.R.H., "Radiation Litigation in Retrospect," Radiation Research 117: 172-7, 1989 Jones, R.R. and R. Southwood (eds.), Radiation and Health: The *Biological Effects of Low-Level Exposure to Ionizing Radiation. New York, John Wiley, 1987 Joseph, P.G., "Preface to the Physicians For Social Responsibility Edition," in R.F. Woolard and E.R. Young (eds.)~ Health Dangers of the Nuclear Fuel Chain and .Low-LeveL .Ioni'zing *Radiation, PSR, Berkeley, 1979 K~dhim, M.A. et tl_., "Transmission of Chramoso*maI Instability-.after'Plutonium Al~ha-Particle Irradiation," (letters> Nature 355:738-40, 1992 Kazakov, V.S. et tl_., "Thyroid Cancer after Chernobyl," (letter) Nature 359(6390):21, 1992 Kempner, E.S., "Damage to Proteins Due to the Direct Action of Ionizing Radia-tion," Quarterly Reviews of Biophysics 26(10:27-48, 1993 Kneale, G.W. and A.M. Stewart, "Childhood Cancers in the UK and Their Relation to Background Radiation," in Jones and Southwood, Q..Q., cit., 1987 Kneale, G.W. and A.M. Stewart, "Reanalysis of Hanford Data: 1944-1986 Deaths," American Journal of Industrial Medicine 23:371-89, 1993 Koteles, G.J., "Radiation Effects on Cell Memberanes," Radiation and Environ-mental Biophysics 21:1-18, 1982 Koteles, G.J., "The Plasma Membrane as Radiosensitive Target," Acta Biochimica et Biophysica Hungarica 21(1-2):81-97, 1986

Attachment Page 5 Lambert, S.D., "The Medical Evaluation of Atomic veterans with a Diagnostic Protocol," unpublished paper, Dodd Project for Radiation t1~dies, 1983 Liber, H.L. et tl*, "Toxicity and Mutagenecity of X-rays and [ l]dUrd or 3 [ HJTdR Incorporated in the DNA of Human Lymphoblast Cells," Mutation Research 111:387-404, 1983 Libshitz, H.l, "Radiation Changes in the Lung," Seminars in Roentgenology 28: 303-320, 1993 Little, J.B., "Cellular Effects of Ionizing Radiation," New England Journal of Medicine 278:308015; 369-76, 1968 Little, J.B., "Environmental Hazards: Ionizing Radiation," New England Journal of Medicine 275:929-39, 1966 Little, J.B. "Influence of Noncarcinogenic Secondary Factors on Radiation .* Carcinogenesis," Radiation Research 87:240-50, 1981 Little, J.B., "Mechanisms of Malignant Transformation of Human Diploid Cells," in E. Huberman and S.H. Barr (eds.), The Role of Chemicals and.Radiation in the Etiology of Cancer, vol. 10 of Carcinogenesis: A Comprehensive Survey, New York, Raven Press, 1985 Little, J.B., "Low Dose Radiation Effects: Interactions and Synergism," Health Physics 59(1):49-55, 1990 Little, J.B. et tl-, "Delayed Appearance of Lethal and Specific Gene Mutations in irradiated Mammalian Cells," International Journal of Radiation Oncology, Biology and Physics 19:1425-9, 1990 Little, J.B., "Cellular, Molecular, and Carcinogenic Effects of Radiation," Hematology/Oncology Clinics of North America 7(2):337-52, 1993 Little, J.B., "Biologic Effects of Low-Level Radiation Exposure," in J.M. Taveras and J.T. Ferrucci (eds.), Radiology, vol 1, Philadelphia, J.B. Lippincott, 1993 Makhijani, A. and D. Albright, "Irradiation of Personnel During Operation Crossroads: An Evaluation Based on Official Documents," Washington, D.C., International Radiation Research and Training Institute, 1983 Marlowe, S.K., Radiation Victims Before Chernobyl, pre-publication draft, 1994 Martell, E.A., "Tobacco Radioactivity and Cancer in Smokers," American Scientist 63:404-12, 1975 Martell, E.A., "Bibliography on Radiation-Induced Atherosclerosis," unpublished paper, National Center for Atmospheric Research, Boulder, CO, 1984 Maruyama, Y., and Feola, J.M., "Relative Radiosensitivity of the Thymus, Spleen and Lymphopoietic Systems," Advances in Radiation Biology 12:1-70, 1987 Mathur-DeVre, R., and J. Binet, "Molecular Aspects of Tritiated Water and Natural Wate~ in Radiation Biology," Progress in Biophysics and Molecular Biology 43L161-93, 1984 - . . . . . Marx, J.L., "Oxygen Free Radicals Linked to Many Diseases, Science 235:529-31, 1987 Medvedev, G., The Truth About Chernobyl, New York, Basic Books, 1991 Medvedev, Zh., Nuclear Disaster in the Urals, New York, Vintage, 1980 Medvedev, Zh., The Legacy of Chernobyl, New York, W.W. Norton, 1990 Mettler, F.A., and R.D. Moseley, Medical Effects of Ionizing Radiation, Orlando, Grune and Stratton, 1985 Morgan, K.Z., "ICRP Risk Estimates -- An Alternative View," in Jones and Southwood, Q.Q., cit., 1987 Murphy, B.C., et tl*, "Atomic veterans and Their Families: Responses to Radia-tion Exposure," American Journal of Orthopsychiatry 60(3):418-27, 1990 Murray, D.R., Biology of Food Irradiation, Taunton, England, Research Studies Press, Ltd., 1990

Attachment Page 6 Nagasaw, H., et 2.l_., "Effect of Dose Rate on the Survival of Irradiated Human Skin Fibroblasts," Radiation Research 132:375-379, 1992 Nakagawa, Y., "The Origin of Underestimation of Late Radiation Effects Among the Atomic Bomb Survivors," International Perspectives in Public Health 4:18, 1988 Neel, J.V., Physician to the Gene Pool: Genetic Lessons and Other Stories, New York, John Wiley and Sons, 1994 Nesterenko, V.B., and E. Burlakova, Chernobyl Catastrophe, Byelorussian Institute of Radiation Safety, Minsk, 4 vol., in Russian, 1993 Nishizawa, K. et 2.l_., "Atm~!pheric Nuclear Weapon Test History as Characterized by the Deposition of C in Human Teeth" Health Physics 59(2):179-82, 1990 Oleinick, N.L, "Ionizing Radiation Damage to DNA: Molecular Aspects," Radiation Research 124:1-6, 1990 Paic, G. (ed.), Ionizing Radiation: Protection and Dosimetry, Boca Raton, CRC Press, 1988 Parker, et 2.l_., "Geographical Distribution of Preconceptional Radiation Doses to Fathers Employed at the Sellafield Nuclear Installation, West Cumbria," British Medical Journal 307:966-71, 1993 Peter, et 2.l_., "Chronic Cutaneous Damage after Accidental Exposure to Ionizing Radiation: The Chernobyl Experience," L Am Academy of Dermatology 30:719-23,1994 Pershagen, G., et 2.l_., "Residential Radon Exposure and Lung Cancer in Sweden," New England Journal of Medicine 330(3):159-64, 1994 Petkau, A., "The Role of Superoxide Dismutase in Radiation Injury," in L.W. Oberley (ed.) Superoxide Dismutase, Pathological States, Vol. 3, Boca Raton, CRC Press, 1985 Petkau, A., "Protection and Repair of Irradiated Membranes," in J.E. Johnson, et 2.l_., Free Radicals, Ageing, and Degenerative Diseases, New York, Liss, 1986 Petkau, A., "Role of Superoxide Dismutase in Modification of Radiation Injury," British Journal of Cancer 55Csuppl. VIIl):87-95, 1987 Preston, D.L. et tl,, "Life Span Study," Report 10: Part 1, Cancer Mortality Among A-Bomb Survivors in Hiroshima and Nagasaki: 1960-82, Radiation Effects Research Foundation TR 1-86, 1986 Preston, D. and D.A. Pierce, The Effects of Changes in Dosimetry on Cancer Mortality in the Atomic Bomb Survivors, RERF TR 9-87, 1987 Reichlin, S., "Neuro-Endocrine-lmmune Interactions," Review Article: Mechanisms of Disease, 1993 Rosenthal, N., "DNA and the Genetic Code, n' New England Journ~l of Medicine 331(1):39-41, 1994 Samet, J.M., and A.V. Nero, Jr., "Indoor Radon and Lung Cancer," New England Journal of Medicine 320 (9): 591-94, 1989 Sankaranarayanan, K., "Ionizing Radiation and Genetic Risks," Mutation Research Series of 4 papers, 258:3-49; 51-73; 75-97; 99-122, 1991 Schmitz-Feuerhake, et 2.l_., "Leukemia Near Water Nuclear Reactor," Lancet 342: 1484, 1993 Scholz, Roland, Bedrohung des Lebens durch radioaktive Strahlung, International Physicians for the Prevention of nuclear War, Berlin, 1995 Singh, A., and H. Singh, "Time-Scale and Nature of Radiation-Biological Damage: Approaches to Radiation Protection and Post-Irradiation Therapy," Progress in Biophysics and Molecular Biology 39:69-107, 1982 Stark, G., "The Effects of Ionizing Radiation on Lipid Memberanes," Bichemica et Biophysica Acta 1071:103-22, 1991

Attachment Page 7 Sternglass, E.J., and J. Gould, "Breast Cancer: Evidence for a Relation to Fission Products in the Diet," International Journal of Health Services 23: 783-804, 1993 Sternglass, E.J., and W. Giebel, "Krypton-85 Releases from Nuclear Reprocessing Facilities as a Co-Factor in the Destruction of the Stratospheric Ozone Layer," Strahlentelex 172-173:1-8, 1994 Sternglass, E.J., and J. Gould, "Nuclear Fallout, Low birth Weight, and Immune Deficiency," International Journal of health Services 24:311-35, 1994 Sternglass, E.J., and J. Gould, "Breast Cancer Mortality Near Nuclear Reactors," forthcoming, 1995-6 Stewart, A.M., "Delayed Effects of A-Bomb Radiation: A Review of Recent Mortality Rates and Risk Estimates for Five-Year Survivors," Journal of Epidemiology and Community Health 36:80-6, 1992 Stewart, A.M., "Radiation Exposure -- Links to Childhood Cancers and Infant Mortality," Lecture, Harvard School of Public Health, Boston, 1987 Stewart, A.M., Evaluation of Delayed Effects of Ionizing Radiation: An Histor-ical Perspective," Ainetican Journal o-f,-Industrial Medicine 20:805-10, 1991 Schwartz, R.S., "A New Series on "Molecular Medicine for Clinicians," New England Journal of Medicine 331(1):47ff, 1994 Stine, G.J., The New Human Genetics, Dubuque, W.C. Brown, 1989 Szekely, J.G. et tl-,"Simulated Responses to Lognormally Distributed Continuous Low Radiation Doses," Health Physics45(3):699-711, 1983' Taubes, G., "No Easy Way to Shackle the Nuclear Demon" Science 263:629-31, 1994 Thilly, W.G., "Towards Mutational Spectra in Human Beings," Center for Environ-mental Health Science, MIT, Cambridge, MA, 1990 Veys, C., "Ionising Radiation and Childhood Cancer in Seascale: Research Must Continue," British Medical Journal 307:444-5, 1993 Vicker, M.G., et el_., "Ionizing Radiation at Low Doses Induces lnflammatory Reactions in Human Blood," Radiation Research 128:251-7~ 1991 Viel, J., "Radon Exposure and Leukemia in Adulthood," International Journal of Epidemiology 22:627-31, 1993 Walburg, H.E., Jr., "Radiation-Induced Life shortening and Premature Aging," in J.T. Lett and H. Adler (eds.), Advances in Radiation Biology, Vol. 5, New York, Academic Press, 1975 Waldren, C., et li*, "Measurement of Low levels of X-ray Mutatgenesis in Relation to Human Disease," Proceedings of the National Academy of Sciences 83:4839-43, 1986 Wasserman, H., et e.l_., Killing Our Own: The Disaster of America's Experience with Atomic Radiation, New York, Delta, 1982 Waters, L.C., "mutations, Nonrandom, Induced by Ionizing Radiation," Radiation Research 127:190-201, 1991 Wilkinson, G.S. Ced.), Occupational Medicine: State of the Art Reviews 6(4): The Nuclear Energy Industry, Philadelphia, Hanley and Belfus, 1991 Zaret, B.L., and F.J. Wackers, "Nuclear Cardiology,n New England Journal of Medicine 329 (11):775-831 329(12):855-63, 1993

ENVIRONMENTAL COALITION ON NUCLEAR POWER Director: Judith H. Johnsrud, Ph.D. 433 Orlando Avenue, State College, PA 16803 Telephone/FAX: 814-237-3900.

SUMMARY

(AND EXPANSION> OF ORAL COMMENTS TO EPA ON EPA'S PROPOSED NESHAPS RESCISSION FOR NON-REACTOR NRC AND AGREEMENT STATE LICENSEES Judith Johnsrud, Ph.D., Director Environmental Coalition on Nuclear Power February 29, 1996

1. The Environmental Coalition on Nuclear Power opposes this EPA proposal to rescind its NESHAPS standards-setting authority for radionuclides for at least three sets of reasons:

Ca) Legal and philoso0hical: EPA has a statutory obligation to set enforceable standards. versus NRC's reliance on (and use of> ALARA "guidance." even with a "constraint l*vel" which is. as described in NRC's draft rule *. also

               *merely "guidance." NRC-isbound*.bY -the~AEA-*Decl-aration of national.nuclear
                ~nergy policy to "develop, use~ and control" nuclear en~rgy "~o the maximum" extent for both domestic and military purposes, not to maximize protection of public health and safety or quality of the environment.

Cb) Reality and experience: NRC's regulatory record does not justify EPA~s placing its faith in NRC's "assurances" that it will in the future pfbvide an "ample margin of safety." There is a somewhat higher level of public trust in E?A than in NRC that EPA must take into account. ~ Cc) Judicial access: The Clean Air Act provides for citizen law suits: NRC reg-ulations do not: NRC claims, and courts have held. that NRC'~ 10 CFR Part 2.206 petition mechanism for relief is not subject to judicial review.

                                                                                                             . ' j,'

l

2. Procedural request: We repeat our request that EPA keep this rulemaking open for public comment until after NRC has finalized its ALARA "constraint level" rule and associated. Regulatory Guide so that EPA and we know the final r~le,

-        3. Health effects: Recent research indicates that low-dose and chronic low-dose radiation exposures pose a more serious threat to the human immune system than existing standards reflect, giving rise to greater susceptibility to infectious diseases. other chronic and debilitating illnesses, loss of robust good health.

This additional health hazard from chronic exposures to residual radioactivity has been confirmed in the former Soviet Uniod and in other studies listed in ECNP's bibliographic submission with our written comments to EPA.

4. Uncertainties: The high degree. and variety, of uncertainties surrounding NRC's measuring and enforcing capability (and regulatory will> militate against EPA's justification of its decision to rescind, which rests on NRC's assurances of rigorous regulation of its licensees by means of ALARA and constraint level, neither of which has the force of regulatory rule. See ECNP's basic question posed in the text of our written comments.

5. Dual regulation: Two regulatory heads (and responsibilities) are better than one: and the combined efforts of EPA and NRC will best uphold NRC's traditional stance of "redundancy of safeguards" and "defense in depth." EPA must consider the concept <and increasing probabilities> ot catastrophic "normal accidents,"

i.e .* those that are predicted with certainty to occur although we cannot know precisely where. when, what facility, or complexity ot the failure mod~. EPA must factor into its analysis the worst case consequences of catastrophic nuclear tacility accidents, not rely on the best case at strictly monitored. inspected and enforced regulation and unfailingly truthful licensee compliance.

  /Jc....,,_. - /i~4,~* /*.""*

/;'~ ,?, /1./ e ~.J 6. NRC regulatory chan~es: Recentiy emerging very serious issues include: {a) accuracy at .computer codes used in dose models and other safety factors (bl steam generator tube integrity;  ; lc) NP.G program tor elimination of regulatory requirements margin. to safety

                        <d>    Exercise of discretion not to enforce compliance with license conditions le)     [mpacts of utility restructuring. mergers. and deregulation on offsite electric power availability and reliability
                       <t> Congressional intent to impose "regulatory retormsn that weaken agency authority (g) shift of NRG from a conservative prescriptive regulatory philosophy to regulation based on risk assessment. performance, and reliance on generic communications -- to name oniv a few pending changes.

7. Part 20, ALARA 1 oiant aging: For enforceable regulation, NRG uses recently revised 10 CFR Part 20, which -- contrary to statements in E?A's BID -- still permits doses to individuals as high as 500 mrem/yr it NRC approves licensee's request t,o exceed the 100 mremiyr 1 im! t ... _ALARA a_nd. NRG' s proposed constrai.nt level are "guidance" and do not have tne regulatory force of tormai regulatory -

rule promuigated under the Federal Adm:nistrative Procedure Act. Materials fatigue and stress corrosion are only two at the greater hazards of facility aging that require more, not less, stringent public radiation protection.

8. Agreement State comoatibility: NRC's revised Compatibility Requirements have not yet been promulgated; as proposed and partially approved, they retain NRC's preemptive authority over Agreement States with respect to exact conformance of wording of state standards to meet NRC's intent. Continued applicability of CAA authority for states to set air emission standards tor radionuclides that are more restrictive than those of Federal agencies is in question. Moreover, even before devolution has been effected. some states have begun to demand to regulate less, not more, restrictively than NRC: it is not certain that NRG will be able to continue to impose its will on state agencies.

9. Utiiity mergers and restructuring: There are significant uncertainties with respect to issues such as effects of retailing wheeling, deregulation. competi- A tive pricing, demand, load fluctuations, and reliability of offsite power to w, nuclear facilities in the event at emergency back-up system failures.

10. NRC nconstraint level": EPA has no assurance -- in enforceable regulations promulgated under the APA -- that NRC will, or can, require its licensees or those in Agreement States to meet EPA's NESHAP individual exposure Jimit. Nor is EPA assured NRC or any other entity will measure real doses to real people.

11. Requlatorv orphans of the nuclear industry: Historically NRC has been more attentive to rapidly expanding demands tor reactor safety and to the nuclear power industry. Now increasingly overburdened with issues of nuclear facility aging, -~ew safety problems, decommissioning, decontamination, radioactive waste management, and reductions in budget and staff, the NRC has treated non-reactor licensees more casually than its nuclear power licensees. State programs, which are often poorly understood or ignored by state legislators, may be even less reliabiy capable of imposing and enforcing an equivalent of EPA's 10 mrem/yr EDE NESHAP air emissions limit on Agreement State licensees.

12. Suggested alternatives: See attached ECNP letter to EPA.

March 1. 1996 RE: 60 FR 50161 EPA National Emissions Standards Central Docket Section for Radionuclide Emissions from Facilities Environmental Protection Agency Licensed by the NRC and Federal Facilities Attention: Air Docket No. A-92-50 Not Covered by Subpart H; and 60 FR 63984 401 M Street SW NRC: Constraint Level for Air Emissions of Washington. DC 20460 Radionuclides Res0onse to Question Posed by EPA Hearing Board, February 29, 1996; and Sup0lemental Rebuttal Comments of ECNP on 60 FR 50161

Dear Mr. Weinstock and Radiation Programs Staff:

Ms. Rosenbaum, Ms. Bonanno, Hs. Thornton: During EPA's NESHAPS ~escission-hearing. *-*~,.- Ms.. Bonanno asked for clarifica-tlon ot our stlggestions to improve, or strengthen, future public health and safety protection, with NRC implementation and enforcement of its proposed 10 mrem/yr TEDE constraint level, in the event that EPA does decide to rescind its NESHAPS for non-reactor NRC and Agreement State licensees. On the long drive home. I tried to think through ways that could satisfy public concerns. Within the context and limits of the following ECNP positions that: (a) no risks should be imposed on individual members of the public from radiation exposures that are additive to the unavoidable~aturally-occurring background levels to which-each person is exposed; Cb) all reactors and most other nuclear utilization activities and facilities sho~ld be phased out promptly to stop waste production; and Cc) no "routine" radioactive emissions should be permitted under th~: i~ise of posing as an "acceptable risk" to recipients of the exposures~ first let me try to clarify the clarification. We are suggesting that a final EPA NESHAPS rescission decision for non-reactor licensees-~ if there is to be one, despite our *strong opposition to such an action by EPA -- should impose additional mandatory conditions designed to accomplish the following: CU Retain EPA's _legal authority and its ability both to .(a) re.view NRC and. Agreement State radionuclide air emissi~ns regulation periodically and independently; and (b) measure independently the doses actually received.

    <2> Reclaim and exercise EPA's NESHAPS standards-setting and enforcement authority under the Clean Air Act in the event that either NRC or an Agreement State fails to provide continuous regulation that keeps maximum doses to the public far enough below EPA's 10 mrem/yr EDE limit. toward zero. to assure that an ample margin of safety is met.

(3) Specify-clearly EPA's process and timetables for periodic reviews of both NRC and Agreement State programs and regulatory actions. including: Ca) independently-assessed measurements of actual exposures of members of the public to ascertain if EPA's NESHAP limit is in fact being met;

it!'.~ --r~~-!"'-~.r /,',~/J*y.,*

          .... -":~

Cb> verification of NRC and Agreement States effectiveness in exercising their regulatory authority, including the ways in which they monitor licensee compliance with the ALARA constraint level, the frequency and repetitiveness of violations, and rigor of enforcement actions. C4) Require that NRC and Agreement States add as a regulatory requirement a zero release design goal for any new licenses or permits; and promulgate backfit requirements for existing licensees to reach that capability without any weakening of radiation protection provisions. (5) Since NRC has historically required applicants to provide a Design Basis Release capability to meet a dose level of 5 mrem/yr, and because NRC ~ow claims to EPA that NRC's ALARA program achieves dose levels at or near that amount, EPA should require as a condition of NESHAPS rescission that NRC and Agreement States shall have promulgated binding regulations prior to E?A's Final Decision,, requiring a 5 mrem/yr maximum permissible dose limit CTEDE) for members of the public rather than the presently propos~d ALARA constraint level gu1dance that's non-mandatory and non-enforceable. Until such requirement is in place, EPA would retain and enforce its existing 10 mrem/yr NESHAPS requirement for all non-reactor licensees. (We stress that, in offering this recommendation, ECNP in no way intends to suggest that a 5 mrem/yr dose from non-naturally-occurring radiation gives an acceptable level of dose or risk. It is, however, yet another step in the right direction for radiation protection. and EPA should impose it for reactors as well.> With these added requirements and safeguards, -which are meant to ensure that EPA's "acceptable risk" (with which we also disagree) and "ample margin of safety" will be met by NRC and Agreement States -- or else they will lose their right to set the standards -- the public might have at least slightly greater confidence that health and safety would receive appropriate attention in the future -- ll EPA improves its own reguiatory performance. Second, in rebuttal to assurances by the nuclear industry that NRC's ALARA and constraint level will be administered as regulatory rule rather than mere "guidance" to licensees, we also supplement our February 19th comments by noting vitally important statements in the NRC's Draft Regulatory Guide DG (or C; illegible copy)-8016, Proposed Revision 1 to Regulatory Guide 8.37, dated January 23, 1996 -- which was not availabie to us earlier.

1. At page 1, NRC states that 10 CFR Part 20.1301 "requires that each licensee conduct riperations so that the CTEDEl to individual members of the public from the licensed operation does not exceed 0.1 rem Clmsv) in a year, exclusive of the dose contribution from the licensee's disposal of radioactive material into sanitary sewerage." The additional 100-500 mrem/yr dose allowed to a member of the public from the sewer pathway is presumably assumed by NRC to be in liquid form. - Nothing indicates the portion of that liquid release that might evaporate, becoming an additional source of exposure from breathing air contaminated via that pathway. There seems to be no indication that NRC or EPA has incorporated that source and pathway in NRC's proposed constraint level document or in EPA' s proposed recis2lon. EPA mt..fst address this issue clearly.

,,,,. _., - r-"~ t-l'--

1/c.-e../'J >>e..; 2. Also at page 1 of the Draft Revision 1 of Regulatory Guide 8.37, the NRC states very plainly that the proposed 10 mrem/yr constraint level for air emissions is merely guidance, not formal regulation with which a licensee must comply or be cited and penalized for violation: Regulatory guides are issued to describe and make available to the public such information as methods acceptable to the NRC staff for implementing specific parts of the Commission's regulations, techniques used by the NRC staff in evaluating specific problems or postulated accidents and guidance to applicants. Regulatory guides are not substitutes for regulations, and compliance with regulatory guides is not required. <emphasis added)

3. At page 2 of this same proposed revision of Regulatory Guide 8.37. the Commission states -- as EPA makes clear it is well aware in its proposed rescission -- that:

A constraint is not a limit ..** A constraint is a dose value above which specified licensee actions are required. It is understood that the constraint dose could be approached routinely. Enforcement action would only be expected Cn.b., The Draft Guide does not say "would be_,-. required"] if a licensee fails to report an exceedance of the constraint or fails to take appropriate and timely corrective actions. In other words, the Guide tells licensees that they have only to file a report when they exceed the 10 mrem/yr constraint level and take unspecified "appropriate and timely corrective actions" to avoid citations for violation and to avoid penalties for exceeding the limit. From these statements in the NRC's Draft Regulatory Guide it is indisputably evident that the NRC's reliance on ALARA and constraint level cannot be depended on to assure that an ample margin of safety will be met by NRC, or, by extension, its Agreement States. Third, there are other troubling omissions or uncertainties of importance for determining acceptable risk and safety margins. (1) No limit on iodine exposure, comparable with EPA's 3 mrem/yr NESHAP limit, is stated by NRC *. (2) There is no discussion or explanation of how NRC would factor into its dose assessments a situation in which a licensee experiences an accidental release that exceeds the ALARA constraint level, since the "unanticipated" "accident-related" exposure is dealt with separately. from emissions during routine, or normal, operations. Many Y.ears ago, NRC staff testimony in the TMI-1 Restart proceedings included the admission that, '1n the event of an accident in which releases and consequent doses to members of the public ~xceeded the maximum permissible Part 20 limit under normal operations Cthen 500 mrem/yr; now 100 to 500 mrem/yr TEDE>, there was no maximum dose level beyond Cabovel which evacuation of the public would b~ required. It was made clear that the staff viewed routine releases and accident-related releases separately. But EPA's NESHAP standard is meant to set a maximum annual dose limit EDE tram air emissions. surely not just from normal or routine releases. Moreover, in the event of an accidental release from some other nuclear facility, an individual could receive exposures from more than one source, resulting in an annual dose to that recipient well in excess of EPA's 10 mrem/yr dose that is an "acceptable risk" in the opinion ot EPA. This matter must be addressed.

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.l' :1r.!  -r~.. /~J
  /i  t "<! n s\* ~..,-                                                                           So long as the nuclear industry continues to operate in the United States and abroad, both routine and accidental releases of radionuclides will continue to occur, and radioactive wastes will continue to be produced. Releases to the biosystem from permissible emissions and effluents plus accidents will continue to augment total environmental radiation n1oading.n They will add to the total exposures that members of the public will receive, without either their permis-sion or any benefit to compensate the individual recipients for their added and quite probably unacceptable risks.

We strongly recommend that EPA.develop and implement techniques for assess-ing the totality of individuals' exposures from all environmentally hazardous materials and wastes and assessing their full effects on human health and well-being and on the biosystem as a whole. This total exposure assessment CTEA> should be fully devised and implemented by EPA before any further consideration of rescission of EPA's Clean Air Act responsibilities. If, however, EPA insists on taking this action to rescind its Clean Air Act NESHAPS authority -- an action we strongly oppose and believe to be arbitrary, capricious, detrimental to public health, and contrary to the intent of the law -- we respectfully urge that the Administrator adopt the conditions we have proposed to strengthen the EPA's Final Rule. Sincerely, Judith H. Johnsrud, Ph.D. Director

COVINGTON & BURLING 1201 PENNSYLVANIA AVEN L{y:OBK'f TED P . O . BOX 7566 USNRC WASH I NGTON , D .C . 20044 - 7566 LECONFIEL0 HOUSE 1202 ) 662 - 6000 C URZON STREET

                                                                      '96 MAR 12 AlO :51             LONDON WIY BAS T E LEFAX:     (2021 662

• 6 29 1 ENGLAND TEL E X: B 9 -!5 93 (C0VLING WSHI RICHARD A . MESERVE TELEPHONE: 44-l? l- 495- 5655 OIRECT DIAL NUMBER C AB LE : cov'O'Ff"ICE OF SEC RETARY TELEFAX: 44-1?1- 4 9!5 - 3101 (2021 66 2
• 5304 DOCK ET!~ G & SE VICE BRUSSELS CORRESPONDENT OFFICE BRANCH 4 4 AVENUE 0£5 ARTS BRUSSELS 1040 BELGIUM TELEPHONE: 32 !512- 9890 TELEFAX; 32 !502 - 1!598 March 11, 1996 By Federal Express Docketing and Services Branch U.S. Nuclear Regulatory Commission 11555 Rockville Pike Rockville, Maryland 20852 Re: Constraint Level for Air Emissions of Radionuclides (10 CFR Part 20) ,

60 Fed. Reg. 63.984 {Dec. 13. 1995)

Dear Sir:

I enclose two sets of comments submitted by Kerr-McGee Chemical Corporation in connection with the above-captioned proposed rule . I would appreciate it if you would include these comments in the rulemaking docket. Please contact me if you have any questions . truly y o u L Enclosures

U.S. NUCLEAR RFGUL.ATORY COMMISSIOI\ DOCKETING & SERVICE SECTION 0 FIC _OF THE S CRETARY OF THE COMMISSION Coples Rece1 Add'I Copies R Special Distr1t).

I I I BEFORE THE UNITED STATES I NUCLEAR REGULATORY COMMISSION I Constraint Level for Air Emissions of Radionuclides

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'I 10 CFR Part 20                            )
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se _____________________ 60 Fed. Reg. 63,984 (Dec. 13, 1995)

                                            }
                                             )

I I COMMENTS OF KERR-McGEE CHEMICAL CORPORATION I I

,-                                Richard A. Meserve COVINGTON & BURLING 1201 Pennsylvania Ave., N.W.

P.O. Box 7566 Washington, D.C. 20044 'I (202) 662-6000 Counsel for Kerr-McGee Chemical Corporation I Date: March 11, 1996 I I I I

1:,

1~.

II 1 BEFORE THE UNITED STATES NUCLEAR REGULATORY COMMISSION I Constraint Level for Air

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                                                     )

I ,_-

Emissions of Radionuclides 10 CFR Part 20

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   ~       60 Fed. Reg. 63,984 (Dec. 13, 1995)       )
                                                     )

I COMMENTS OF KERR-McGEE CHEMICAL CORPORATION l.1 These comments are submitted by Kerr-McGee Chemical Corporation ("Kerr-McGee") concerning the proposed rule to I establish a constraint level for air emissions of radionuclides from NRC-licensed facilities other than power I reactors. 60 Fed. Reg. 63,984 (Dec. 13, 1995). Kerr-McGee

.1'.-      holds licenses from the NRC and the State of Illinois (an Agreement State) for facilities covered by the proposed rule
'\
.,**'.,\,,

and, as a result, Kerr-McGee is directly affected by the NRC's proposal . As explained in the preamble to the proposed rule,

• \1 NRC seeks to promulgate a constraint level for air emissions from certain licensed facilities that would parallel an EPA

*1         National Emission Standard for Hazardous Air Pollutants (NESHAPs") that was promulgated under the Clean Air Act. Id.

I at 63,985-86; see 40 C.F.R. Part 60, Subpart I. The NRC

'I, I*

,., .I anticipates that its actions will enable EPA to rescind its regulation. 1 Kerr-McGee strongly endorses and encourages the efforts by the NRC to eliminate duplicative regulation. However, the NRC has perpetuated an error in EPA's regulations ,,:, in its proposed rule. Kerr-McGee submits these comments to explain the error and to urge the NRC to correct it before

.fl      final promulgation. We also urge the NRC to require compatibility by Agreement States with the resulting final

.I *- rule.

Ii I. The NRC Rule Should Exclude Both Radon-220 And Radon-222.

The EPA NESHAPs for emissions from NRC-licensed facilities state in pertinent part that 11 [f]or purposes of this subpart doses caused by radon-222 and its decay products '** formed after the radon is released from the facility are not included." 40 C.F.R. § 61.l0l(b). The NRC proposed rule is similar in that it would "constrain air emissions of 1\ radioactive materials other than radon-222. 11 60 Fed. Reg. at 63,987 (proposed 10 C.F.R. § 20.ll0l(d)). Kerr-McGee presumes ',,I that the NRC rule, like the EPA rule, would exclude the dose from daughters of radon-222 that are formed after release. Whe~e both the EPA rule and the NRC proposal err, however, is in the failure to exclude radon-220 (thoron) and its daughters from the dose limit.

1

,I,

',,)I

                                   - 3  -

A. The EPA Erred In Its Treatment of Radon-220. As it happens, the failure of EPA to exclude both radon-222 and radon-220 was the apparent result of a last-minute scrivener's error in the most recent promulgation of 0 the NESHAPs for radionuclides. EPA first promulgated its NESHAPs for radionuclides in February 1985. The original rule I provided in pertinent part: te Doses due to radon-220, radon-222, and SO their respective decay products are excluded from these limits . Fed. Reg. 5,190, 5,195 (Feb. 6, 1985) C.F.R. § 61.102) (Exhibit 1). (final rule, 40 Obviously, in this incarnation, I' both radon and thoron (and daughters) were excluded from the I dose standard. _, As it happened, the EPA rule was reconsidered by the agency as a result of the decision by the U.S. Court of

 ~

Appeals for the D.C. Circuit in Natural Resources Defense 1* Council v. EPA, 824 F.2d 1146 (D.C. Cir. 1987); see 54 Fed. 1* Reg. 9,612, 9,614-15 (Mar. 7, 1989). The reason for the reconsideration related to the court's guidance as to how risk I; should be considered in the NESHAPs rulemaking process. The

,. need for EPA to undertake a new rulemaking did not relate in any fashion to the exclusion of radon and thoron from the dose

• 1 standard.

In the new rulemaking, EPA did not initially modify

1 the aspect of its previous rule relating to radon and thoron.

The proposed rule provided: I I

.I, For purposes of this subpart doses caused I                by radon-220, radon-222, and their decay products formed after their release from
,,\               the facility are not included.

., 54 Fed. Reg. 9,612, 9,653 (Mar. 7, 1989)

       § 61.101 (b)) (Exhibit 2).

(proposed 40 C.F.R . Thus, like the prior rule, the proposed rule would exempt both radon and thoron from the dose

1 limit.

In the final rule -- the currently effective version te EPA removed the exclusion for radon-220, while maintaining it for radon-222. 40 C.F.R. § 61.l0l(b). We are not aware of I anything in the rulemaking record, however, that explains this I' modification of the proposed rule. There is no discussion of this significant change from the proposed rule in the preamble. See 54 Fed. Reg. 51,654 (Dec. 15, 1989). And, documents that were prepared in connection with the rulemaking I

 ,-    show that the final rule was intended to exclude both radon-220 and radon-222.

For example, an EPA Background Information Document

'I*
 ,,    concerning procedures for demonstrating compliance -- a document that was prepared shortly before final promulgation
       -- provides that  11

[t]he standard specifically excludes doses 1: caused by radon-220 or radon-222 and their decay products that are formed after release." EPA, Background Information I Document: Procedures Approved for Demonstrating Compliance with 40 CFR Part 61, Subpart I, 1-3 (Oct. 1989) (Exhibit 3); I* see 54 Fed. Reg. at 51,667 (describing document as providing i the "system for implementing this NESHAP"). Similarly, the I

 .I I                                       COMPLY computer code that provides a means of demonstrating I  compliance (see 40 C.F.R. § 61.103) does not include either I   radon-220 or radon-222, thus showing that EPA intended to exclude both. See EPA, User's Guide for the Comply Code, App.

I II E (EPA 520/1-89-003) (Oct. 1989) (Exhibit 4). It is apparent that EPA intended its rule to exclude I' both radon-220 and radon-222 (and daughters), but that an inadvertent error was introduced in the drafting of the final rule.!1 The NRC should not perpetuate the error in its 1, rulemaking. B. The Rationale For Excluding Dose From Radon-222

 *1                 Applies To Radon-220 As Well.
  ,.           There is no discussion in the 1989 EPA rulemaking of which we are aware that explains the basis of the exclusion for radon-222. The matter was considered, however, in I   connection with the original NESHAPS rulemaking in 1985. In 1e  the preamble to that final rule, the EPA explained:

This standard . . . does not apply to

 'I*           radon-220, radon-222, and their respective decay products. Facilities covered by this standard are likely only to have relatively small quantities of the sources of these radionuclides and are expected to take appropriate control action to limit emissions as part of the NRC's ALARA program.
     !I   On September 8, 1994, Kerr-McGee presented this I  information to EPA's Region Vin connection with a facility that is affected by the error. Although Region V stated that it would consult with EPA's Office of Radiation Programs on I  the matter, Region V has not rebutted Kerr-McGee's showing.

I.

I I - 6 50 Fed. Reg. 5,190, 5,192 (Feb. 6, 1985). This rationale I provides no foundation for drawing a distinction between 1 radon-220 and radon-222. The exclusion of both radon and thoron from the dose I limit is fully consistent with existing requirements and guidance in other areas. EPA's environmental standards for I the uranium fuel cycle exclude the dose from radon and its ~ daughters (without specification of the radon isotopes). 40 C.F.R. § 190.l0(a). The counterpart EPA standards for thorium I mills explicitly exclude the dose for radon-220, the relevant isotope for such facilities. 40 C.F.R. § 192.41(d); see 10 I C.F.R. Part 40, Appendix A, criterion 8 (excluding thoron from I dose limit for thorium mills). EPA's guidance to federal agencies on radiation protection standards for members of the I public excludes radon doses (without specifying the radon --1 isotope). 11 59.Fed. Reg. 66,414, 66,427 (Dec. 23, 1994) .Y In connection with its proposed radiological criteria for decommissioning, the NRC staff observed: The NRC staff believes that it is not possible to measure or distinguish I concentrations of radon which will produce radiation doses of a few mrem TEDE/y above background using current technology. This I belief is based on: (1) Recognition of the ubiquitous nature I of radon in the general environment; (2) Large uncertainties in the models used to project radon concentrations in. I indoor air based on soil concentrations of precursors; and I (continued ... ) I

I I * *

• In light of these considerations, the NRC should not perpetuate EPA's error; the proposed rule should exclude both radon-220 and radon-222.

II. The NRC Should Require Strict Agreement State ,,, Conformance To The Final Rule. The NRC states in the preamble to the proposed rule that it is the NRC's intention to allow an Agreement State to te choose to adopt a rule that is more restrictive (but no less restrictive) than one approved by the Commission. 60 Fed. I Reg. at 63,986. It is Kerr-McGee's view that the better I course is to require strict Agreement State compliance with all radiation-related NRC rules, including the final rule I arising from this rulemaking. t A requirement for strict compatibility would assure that licensees are confronted with uniform policies throughout 1e the country and thereby would avoid the confusion arising from disparate standards. See 59 Fed. Reg. 37,269, 37, 273 (July I 21, 1990) (Draft Statement of Policy for Agreement State Compatibility). We thus urge the NRC to reconsider its I I ~I( **

• continued)

(3) Limitations of existing measurement techniques in distinguishing between I elevated radon concentrations and radon attributed to natural sources. I 59 Fed. Reg. 43,200, 43,210 (Aug. 22, 1994). These same considerations justify exclusion of all radon isotopes from the criteria at issue here. I I

                               -  8 -

position. The NRC should require literal and strict I conformance by Agreement States with this final rule. I Conclusion In light of the foregoing, we urge the NRC to avoid the error in EPA's NESHAPs and to modify its proposed rule so as to exclude both radon-220 and radon-222 (and their daughters formed after release) from the dose limit. The NRC should also require strict compatibility with its final rule by Agreement States. Respectfully submitted,

                                 ~k COVINGTON & BURLING 1201 Pennsylvania Ave., N.W.

P.O. Box 7566 Washington, D.C. 20044 (202) 662-6000 Counsel for Kerr-McGee Chemical Corporation Date: March 11, 1996 I .I I 1* I

I 1 I I I I I I I

• 1

--1 g I . C 2 en* I-I ;...J 0 I-I ~ 1-u

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I Wednesday I February 6, 1985 'I 1! I

*r.*1, Part Ill 11 Environmental I        Protectior1 Agency 40 CFR Part 61
*1       National Emission Standards for Hazardous Air PollUJtants; Standards for I        Radionuclldes; Final Rules I,
,1 11 I

I I I

I Federal Register / Vol. 50, No. 25 / Wednesday, February 6, 1985 / Rules and Regulations (v) Estimate of dose equivalent rate to from all sources, excluding natural due to the quality of radiation and its 5195 the member of the public at the point of background and medical procedures. distribution in the body. The unit of dose I maximum annual air concentration in an unrestricted area where an individual resides or abides, The application shall include the following: (a) An assessment of the additional equivalent is the rem. (c) "NRC-licensed facility" means any facility licensed by the Nuclear (vi) A description of the existing effective dose equivalents to the Regulatory Commission or any I of control equipment for each emission point. (A) Primary control device(s) for individual receiving maximum exposure from the facility due to all other sources. (b) The information required in Agreement State to receive title to, receive, possess, use, transfer, or deliver any source, byproduct, or special

• radionuclide emissions. § 61.94. nuclear material. except facilities 1 (B) Secondary control device(s) for radionuclide emissions.

(C) Estimated control efficiency (c) The effective dose equivalent shall be calculated using the following weighting factors: regulated by 40 CFR Parts 190, 191, or 192. (d) "Critical organ" means the most I *;

. Ir (percent) for each control device.

(vii) A statement by the owner or ope1ator of the source as to whether he can comply with the standards Organ CfleservedJ Weighting !actor CRe~edl exposed human organ or tissue exclushie_ of the integumentary system [skin) and the cornea. (e) "Radionuclide" means any nuclide JI prescribed in this part within 90 days of the effective date. Requests for alternative emission that emits radiation. (A nuclide is a All information collection provisions in standards shall be sent to the Assistant species of atom characterized by the this subpart are not effective until the Administrator for Air and Radiation constitution of its nucleus and hence by I, (ANR-443), U.S. Environmental .,I Office of Management and Budget the number of protons, the number of approves them. Protection Agency, 401 M Street, neutrons, and the energy content.) (c) In addition to the reporting Washington, D.C. 20460. (0 "Whole body" means all organs or requirements described in paragraphs § 61.98 Exemption from reporting and tissues exclusive of the integumentary (a) and (b) of this section, DOE shall* testing requirements of 40 CFR 61.10. system (skin) and the cornea. submitto EPA an annual report, by June ,1 Facilities having emissions of (g) "Effective dose equivalent" means I 1.1986, and annually thereafter, that/ includes the results of monitoring emissions from points subject to this radionuclides to air that do not.exceed those amounts that cause a dose the sum of the products of the dose equivalents to individual organs and equivalent of 5 mrem/y to the whole tissues and appropriate weighting final rule and associated dose body or 15 mrem/y to the critical organ factors representing the risk relative to calculations. This information shall be of any member of the public residing or based on data collected during the that for an equal dose to the whole abiding at the point of maximum annual body. calendar year immediately preceding air concentration in an unrestricted I 10 the required date of submission of the annual report. This report shall be sent to the Assistant Administrator for Air* and Radiation (ANR-443), U.S. area, are exempt from the reporting - requirements. of 40 CFR 61.10. Subpart I-National Emission Standard

                                                                                                       § 61.102 Emission standard.

Emissions of radionuclides to air from facilities subject to this subpart shall not I Environmental Protection Agency, Washington, D.C. 20460,

         § 61.95    Recordkeeplng. [Reserved]

for Radlonucllde Emissions From Facllltles Ucensed by the Nuclear Regulatory Commission (NRC) and Federal Facllltles Not Covered by exceed those amounts that cause a dose equivalent of 25 mrem/y to the whole body or 75 mrem/y to the critical organ of any member of the public. Doses due SubpartH to radon-220, radon-222, and their

         § 61.96    Waiver of compliance.                                                              respective decay products are excluded
                                                      § 61.100     Designation of tacllltles.

To request a waiver, applicants shall from these limits.

• provide the information required in The provisions of this subpart apply

          § 61.11 and § 61.94 [a) and (b). Waiver     to NRC-licensed facilities and to                § 61.103 Emission monitoring and I         requests shall be sent to the Assistant Administrator for Air and Radiation

[ANR-443), U.S. Environmental facilities owned or operated by any Federal agency other than the Department ofEnergy that emit compliance procedures. To determine compliance with the standard, radionuclide emissions shall Protection Agency, Washington, D.C. radionuclides to air. This subpart does I 20460.

          § 61.97   Alternative emlalon atandanfL not apply to facilities regulated under 40 CFR Parts 190, 191, or 192, to any low energy accelerator, or to any user of the

• be determined and dose equivalent to members of the public shall be calculated using EPA-approved sampling procedures, EPA codes' sealed radiation sources.

I If a facility may exceed the values established in § 6L92, DOE may apply to EPA for an alternative emission standard. The Administrator will review

                                                       § 81.101     Definitions.

[a) "Agreement State" me.ans any State with which the Atomic Energy AIRDOS-EPA and RADRISK, or other procedures, including thos~ based on environmental measurements, that EPA has determined to be suitable. In most such applications and will establish an Commission or the Nuclear Regulatory cases, compliance with this standard appropriate alternative emission Commission has entered into an will be i;Ietermined by calculating the standard that will ensure that no effective agreement under subsection dose to members of the public at the member of the public being exposed to 274(b) of the Atomic Energy Act of 1954, point of maximum annual air emissions from the facility will receive a as amended. concentration in an unrestricted area

       ~ continuous exposure of than 100 mrem/y           [b) "Dose equivalent" means the               where any member of the public resides
       ~  effective dose equivalent and a              product of absorbed dose and                     or abides.

noncontinuous exposure of more than appropriate factors to account for 500 mrem/y effective dose equivalent differences in biological effectiveness List of approved procedures: [Reserved) I I

i ti 5196 Federal Register / Vol. SO. No. 25 / Wednesday, February 6, 1985 / Rules and Regulations

        § 81.104    Reporting. [Reserved]              can comply with the standards                    subpart. calciners and oodulizing kilns f 61.105    Rec:orclkeepfng. [ReNrVed]

prescribed in this part within 90 days of are considered to be. similar units. the effective date. (c) "Curie" is a unit of radioactivity

        § 61.106 Exemption from reporU119 and                                                           equal to 37 billion nuclear testing requirements of 40 CFR 61.10.          § 61.108     Alternative emission standard.

transformations (decays) per second. Facilities in possession of a If a facility may exceed the emission radionuclide in annual quantities less standard established in § 61.102, the § 61.122 EmlNlon standard. than the activity shown in Table 1 are operator may apply to EPA for an alternative emission standard. The Emissions of polonium-210 to air from exempt from the reporting requirements calciners and nodulizing kilns at an of 40 CFR 61.10. If a facility possesses Administrator will review such elemental phosphorus plant shall not more than one radionuclide, and the applications and will establish an exceed a total of 21 curies in a calendar ,. sum of the annual amount possessed appropriate alternative emission standard that will ensure that no year. I divided by the equivalent activity in Table 1 is summed for all radionuclides in possession, and the sum is less than member of the public being exposed to emissions from the facility receives a

                                                                                                        § 81.123     Emission testing.                I unity, then the facility is exempt from the reporting requirements of 40 CFR continuous exposure of more than 100 mrem/y effective dose equivalent and a (a) Unless a waiver of emission testing is obtained under § 61.13, each owner or operator of an elemental il 61.10. For radionuclides not on this list,     noncontinuous exposure of more than 500 mrem/y effective dose equivalent              phosphorus plant shall test emissions         ~

a facility may apply to the 11 -I Administrator for an exemption from the reporting requirements. Table 1 [Reserved] from all sources, excluding natural background and medical procedures. The application shall include the from his plant according to the following requirements: (1.) Within 90 days of the effective

                                                                                                                                                       \

following: date of this standard for a source that "r,

        § 61.107 Waiver of compliance.                     (a) An assessment of the additional           has an initial start-up date preceding the (a) To request a waiver, applicants         effective dose equivalents to the                effective date of this standard; or shall follow the requirements of § 61.10       member of the public receiving                        (2) Within 90 days of start-up for a (b)-{d).                                       maximum exposure from the facility due            SOUl"Ce, that has an initial startup after
          * (b) The following provisions also           to all other sources. The natural                the effective date of the standard.

apply: radiation background shall be part of (b) The Administrator shall be (1) the owner or operator of any this assessment. notified at least 30 days prior to an 11 existing source, or any new source to which a standard prescribed under this part is applicable which had an initial (b) The information required in

                                                        § 61.107.

(c)The effective dose equivalent shall be calculated using the following emission test so that EPA may, at its option, observe the test. (c) An emission test shall be startup which preceded the effective conducted at each operational calciner date of a standard prescribed under this weighting factors:

• or nodulizing kiln. If emissions from a I part shall, within 90 days after the effective date, provide the following information in writing to the

                                                                  °'9an               WeighUng laClor

[Reserved] calciner or nodulizing kiln are discharged through more than one stack, then an emission test shall be conducted f I Administrator: at each stack and the total emission*rate l ,i 1 (i) Name and address of the owner or operator. (ii) The location of the source. Requests for altemative emission standards shall be sent to the Assistant from the calciner or kiln shall be the

                                                                                                       . sum of the emission rates from each of Administrator for Air and Radiation               the stacks.

(iii) The types of radionuclides emitted by the stationary source and the (ANR--443), U.S. Environmental (d) Each emission test shall consist of Protection Agency, 401 M Street SW., three valid sampling runs. The I annual quantity (in Ci/y for the most recent calendar year) of each Washington, D.C. 20460. This action phosphate rock processing rate during radionuclide emitted. shall be taken. for existing facilities by each run shall be recorded. An emission (iv) A brief description of the nature. April 17, 1985. rate in curies per metric ton of size, design, and method of operation of phosphate rock processed shall be* Subpart K-NatlonaJ Emlssk>n calculated for each run. The average of the stationary source including the Standard for Radlonuctkle Emissions all three runs shall apply in computing operating design capacity of such

                                                      . From Elemental Phc,sphoru8 Plants                 the emission rate for the test. The source. Identify each point of emission I:      for each hazardous pollutant.

(v) Estimate of dose equivalent rate to the member of the public at the point of

                                                         § 81.120 AppDcabmty.

The provisions of this subpart are applicable to owners and operators of annual polonium-210 emission rate from a calciner or nodulizing kiln shall be determined by multiplying the measured maximum annual air concentration in an calciners and nodulizing kilns at polonium-210 emission rate in curies per unrestricted area where any member of metric ton of phosphate rock processed elemental phosphorus plants. the public resides or abides. . by the annual phosphate rock (vi) A description of the existing §61.121 Definitions. processing rate in metric tons. In control equipment for each emission (a) "Elemental phosphorus plant" determining the annual phosphate rock point. means any facility that processes processing rate, the values used for (A) Primary control device (s) for phosphate rock to produce elemental operating hours and operating capacity radionuclide emissions. phosphorus using pyrometallurgical shall be values that will maximize the (BJ Secondary control device(s) for techniques. expected procesaing rate. For radionuclide emissions. * (b) :*ealciner" or "Nodulizing kiln" determining compliance with the (C) Estimated control efficiency means a unit in which phosphate rock is emission standard of Section 61.122 the (percent) for each control device. heated to high temperatures to remove total annual emission rate is the sum of (vii) A statement by the owner or organic material and/or to convert it to the armual emission rates for all I operator of the source as to whether he a nodular form. For the purpose of this operating calciners or nodulizing kilns. I

ANDREWS OFFICE PRODUCTS CAPITOL HEIGHTS, MD (K)

                                                - .. .. .... - -l- ..  -

I\)

I Tuesday

• March 7, 1989 I

I 1 I 1 I

                  . Part IV I

I Environmental* Protectior,1 Agency\ *

• I 1* *.~ 40 CFR Part* 61 National Emission !itandards for

.   . -.'.~t).:. Hazardous Air Pollu1tants; RegulaUon of:.

Radlonuclldes; Prop,osed Rule and Notice 1 I fJ.. of* Publlc Hearing * * .. - I ~~-I t~ It'*. I i *'. I l__:

                                                       . l I

I

• ii} It can be shown that the obtaining the l:nfcrmation. [ believe that prescribed in I ln..9Z. The effective dcR I requirement& of paragraph l 61.93(h) are impractical for the effluent stream:.

(HJ The alternative procedure will :aot significantly u.nderestim.ate the the submitted information is mze. accurate and complete. I am aware that there are significant penalties for submitting raise infomtatim im:mding equivalent aball be. calculated using the ~ source term derived uing Appendix D *, as input to the mspenion and other computer modela desaibed in § 61.93. In I emissions. (iii) The alternative procedure is fully documented. (iv) The opemtor hes received priar the ponibility of fine and imprisomilfflt. See, 18 U.S.C. 1001." (c} If tnlf facility ilt not in e:ompliimce with the emission limibt oft 81.92 in the addition. based on its last annual re"Dort the facility ill in compliance with thi~ subpart.

                                                                                                       § 51.97      Exemption from the reporting   and I       approval from EPA.
       § 51.94 Co;npllucaaad~

(a) Compliance with thia standard calendar ~ COTeTed by ~ report then the facility must ~ r t to the Adminimator on a monthly basis the information listed in paragraph fb} af tntlng requtrenenta of 40 CFA 81. tO All facilities designated u.a.der this subpart a.re exempt from the reporting shall be determined by cau:wating the this section. for the preceding month. requirements of 40 CFR 61.10. I effective dose equivalent to any member of the public a.t the ofhi.te point of maximum annual air concenttation, These reports will be due 30 days-following the end of each month. This increased level of reporting wiU

3. By revising Subpart l l0 read as follows:

• Subpart ~ ErnuisHxt Slandarda tor where there is a residence. school. conti?rue 1mtil the Admfniatrator has I business or office. The operators of ea.ch RadloAUCide EIIIINk>M From Fadlllln detennined that the monthly reports 11re UcenMd by the Nudear Re9u&atcry facility shall submit an annual report to no longer necessary. ht addition ta all Commtuk>n and Federal FaclDtla Not EPA by June 30 which Includes the the information required in pamgraph CoveNCI by Subpart K t' results of the monitoring and the dose calculations required by f 61.93 for the previous calendar year.

(b} In addition to the requirements of paragraph (a) of the section. an annual (b) of this section. monthly reports shall also include the following information: (1) All controltt or other c h ~ in operation of the facility that win be or are being installed to bring the facility Sec. 81.100 81.101 Applicability. Definitions. e1.10z Standard. 81.103 Determining Compliance. I report shall inchlde the following informllltion: (1) The name af the facility. (2) A liat of the radiQacttre materials into compliance. (2) If the faetlity is under a judicial or administrative enforcement decree the report will describe the facilittee 81.104 Reporting requirements. 81.105 Recordkeeping requin!ml!nts. 61.106 Applications to construct or modify. 81.107 Emission Determination. UBed at the facility. 61.108 Exemption from the reporting and I (3} A deecriptiml of the handling and proceuing that the radioactive materials undergo at the facility. performance under the tenM of the decree.

                                                      § 61.95    Aecordkeeplng ...... IMllta.

testing requirements of 40 CFR 81.10 Subpart I-National Emission Standards tor Radionuclide Emtaslona (4) A lilt 0£ the ataaa or vents or All facilities must maintain records I other point.a where radioactive materials are released to the atmosphere. (S} A description of the effluent documenting the source of input parameters including the results of all measurements upon which they are From Facllltlff UceMed by the Nuclear Regulatory Commission and Federaf Facllltlea Not Covered by

  ,,~

corrtrols that are Wied on each stack. Subpart H based. the calculatiorui an,i/or ,I ll;r vent. or other release point and an. analytical methods UBed to darive § IS 1.100 App(lcahllity. estimate of the efficiency of each control values for input parameters. and the-device. The provisions of this subpdrl a.pply procedure used to determine dose. In to NRC-licensed facilities and to (6} Distance* from the points of addition. the documentation should be i:eleaae to the nearest Nsidence, school, facilities owned or operated by any sufficient to allow an independent Federal agency other than the buainess or office and the nearest farms auditor to verify the correctness of the producing vegetables. milk. and meat. Department of Energy. except that thili determination made cow:ernin8 the subpart does not apply to disposal sl (7) The values used for all other user- facility's compliance with the standard. facilities under 40 CFR Part 191 subpart I supplied input parameters for the computer-models (e.g., meteorological data) and the source of these data. (8) All information required in an These records must be kept al the site of the facility for at least five yeara and upon request be made available fclr inspection by the Administrator. or his B, or to low energy accelerators or lo any NRC-licensee that posesaef and uses radionuclidea only in lhe form of application to construct or modify a sealed sources. I facility under 61 subpart A. for conetruction and modificatioM which an ere completed in the calendaT ye&l' for authorized representative.

                                                       § 81.98 modify.

AJ>t)llcationa to eonatruct or I IS 1.101 DeflnWonL

                                                                                                             ,.. UHd in this 911bpart, ell terms nol which the report ts prepared, but for            (a) In addition to any activity that is        defined here have the meaning given I         which the requirement to apply for approval to Cl>Mtrtrct or modify was waived under I 61.98.

defined as construction under 61 subpart A. any fabrication, erection or installation of a new buildiq or them in the Clean Air Act or subpart A of Part 61. The following terms shall have the rollowing specific meanings: (a) "Agreement State" mean.a a State (9) Each report shall be ligned and structure within a facility is also defined I dated by the principal executive officer or pnb& official in dlarge of ilie facility end. contain the following declaration as new CDD&tmcuon for parpoea of 40 CFR Part 61. subpart A. (b) All application for approval under with which the Atomic F.nergy Commission or the Nuclear Regulatory Commission bu entered into rm effective agreement undu aubeecuon immediately above the aignature line: "I I 6L07 doea not need to be filed for any I certify under penalty of law that l ba*e persona.Uy examined and IUJl £smil.i.pr with the information wbmitted helem and based on my inquiry of tlxlse new comtruction of or moclificauon within an. ex.iatiDg £ac:ility if lae aff'Ktive do1e eqwvalent. caused by all emiaaiona fnlm taa naw QH18tnu:tioa o, 274(b} of the Atomic Energy Act of 1964, as amended. (b) NEffective doee eqnivaltml means the 1nm of the prodiacts of abaarbed dose and appropriate facton to accoant I individuals immediatejy rupODaibla £or modification, ia lna than l'li of the limit I

I i;-?!~~~~~F~ed~e~ral~R~e~gis~ter~/~V~ol~.~54~,~N~o~.~43~/~T~u~e~sd~a~y;~,~M~arch~~7~.~1ll~989~~/~Pro~po11~ed.~R~ul~es~~~~~9653-~

  ,    ,- for differences' in biological
         *effectiveness due to the quality of
                                                          § 61.107 or the emission factors in AppendixD*.

I certify under penalty of law that I baTtt* personally examined and am familiar with I .:.radiation and its distribution in the

         .body. The unit of the effective dose
        ' equivalent is the rem. For purposes of
                                                          § 81.104 Reporting requirements.

(a) The owner or operator of a facility the information submitted herein and hued on my Inquiry of those individual9 immediately responsible for obtal.nin8 the Information. I believe that the submitted _this subpart doses caused by radon-220, must submit an annual report to the EPA I ,kradon-222 ~d their decay products

formed after their release from the Jacility are not included. The method for by March 30 of the following year.

(1) The report or application must provide the following information: (i) The name of the facility. information ill true, accurate and complete. I am aware that there are significant penalties for submitting false information including the possibility of fine end lmprisonmenL See. 18

• calculating effective dose equivalent is u.s.c. 1001.

I outlined in the International Commission on Radiological Protection'* Pnblication No. 26. (ii) The name of the person responsible for the operation of the facility and the name of the person (b) Facilities emitting radionuclide, in an amount that would cause lesa than .I .;  ; (c) "Facility means all buildings, structures and operations on one

contiguous site.

preparing the report (if different). (iii) The location of the facility, including Strite and/or building number, 10% of the dose listed in I 61.102~ as detennined by the compliance procedures from § 61.103, are exempt { (d) "Federal facility" means any street, city, county, state, and zip code.

• from the reporting requirements of

-,      \ facility owned or operated by any department. commission. agency, office.

(iv) The mailing address of the facility, if different from item (iii).

                                                                                                          § 61.104. Facilities shall annually make a new determination whether they are I           .bureau or other unit of the government i _of the ~~ted States of America except

• for {iic1hties owned or operated by the (v) A list of the radioactive materials used at the facility.

(vi) A description of the handling and exempt from reporting. (c) If the facility is not in compliance with the emission linlits of I 61.102 in epartment of Energy. processing that the radioactive materials the calendar year covered by the report (e) "NRG-licensed facility" means any undergo at the facility. then the facility must report to the acility licerised by the Nuclear (vii) A list of the stacks or vents or Administrator on a monthly basis the egulatory Commission or any other pointl where radioactive materials information listed in paragraph (a} of Agreement State to receive title to, - are released to the atmosphere. this section, for the preceding month. I_

    . *receive, poaaeaa. use, transfer, or deliver

{any source. by-product. or special

           -nuclear material.

(viii) A description of the effluent controls that are used on each stack. vent, or other release point and an These reports will be due 30 days following the end of each month. This increased level of reporting will t (f) "Radionuclide" means a type of estimate of the efficiency of each device. continue until the Administrator has I )tom which spontaneously undergoes

         ;pdioactlve decay.
         }I 11.102      StandML (ix) Distances from the point of release to the nearest residence, school, buainesa or offlca and the -nearest farms producing vegetables. millc. and meat. .

determined that the monthly reports are no longer niecessary. In addition to all the information required in paragraph (a) of this siectlon, monthly reports shall I * ;Approach A and Approach B

         ;!      Emissio.:.S of radionuclide& to the air ifrom a NRG-licensed or federal facility (x) The effective dose equivalent .

calculated ll8ing the compliance procedures in § 61.103. (xi} The physical form and quantity of also include the following information: (1) All controls or otherchangu in operation of the facility that will be or fJhall not exceed those amounts that

• each radionuclide emitted from each are being installed to bring the facility I 1would cause any member of the public

          ~to receive an effective dose equivalent.
          -~Of 10 m.rem/yr.

stack. vent or other release point. and the method{s} by which these quantities were determined. into compliance. (2) If the facility la under a judicial or administrative enforcement decree the pproachC (xii) The volumetric flow, diameter, report will describe the facilities effluent temperature, and release height performance under the terms of the Emissions of radionuclide& to the air - decree.

_from a NRCUcensed or federal facility for each stack. vent or other release

• shall not exceed those a.mounts that point where radioactive materials are § 81.105 Rocordkeeplng requnments.

would cause any member of the public emitted. the method(s) by which these I to receive an effective dose equivalent of 3 mrem/yr.

ApproachD were determined. (xiii] The height and width of each building from which radionuclidea are The owner or operator of any facility must maintain records documenting the source of input parameters including the results of all measurements upon which emitted. I they are baaed. the calculations arui/or I Emisaions of radionuclides to the air (xiv) The values used for all other from a NRC-licensed or federal facility user-supplied input parameters (e.g.. analytical methods used to derive shall not exceed those amounts that meteorological data) and the source of values for input parameters, and the would cause any member of the public these data. procedure med to determine compliance. In addition, the I to receive an effective dose equivalent of 0.03 mrem/yr. (xv) All information required in an application to construct or modify a facility under 61 subpart A, for all documentation should be sufficient to allow an independent auditor to verify

     .        I 81.103 Detennlnlng compllance.

The only criteria by which compliance with the emission standard in this construction and modifications which were completed in the relevant calendar year but for which the requirement to the correctness of the determination made concerning the facility's compliance with the standard, and. if subpart shall be determined is the doses claimed. qualification for exemption I~ calculated by either the EPA computer code COMPLY or the alternative apply for approval to construct or modify was waived under I 61.106. (xvi) Each report shall be signed and from reporting. These recorda muat be kept at the site of the facility for at least I requirements of Appendix E. The source I terms to be used for input into GOMPLY dated by the principal executive officer or public official in charge of the facility five years and upon request be made available £or inspection by the I

• shall be determined through the use of the measurement procedures listed in and contain the following declaration immediately above the signature line:

Administrator, or his authorized - representative; I

I 9654 Federal Register / Vol. 54, No. 43 / Tuesday, March 7, 1989 / Proposed Rules

    § 81.106 Applications to construct or         sampling (grab samples) may be used          calciners and nodulizing kilns at I    modify.

(a) In addition to any activity that is

                                                . only with EPA's prior approval. Such approval may be granted in cases where defined as construction under 61 subpart continuous sampling is not practical and A, any fabrication, erection or               radionuclide emission rates are elemental phosphorus plants .
                                                                                               § 61.121    Definitions.

(a) "Elemental phosphorus plant" or "plant" means any facility that I installation of a new building or structure within a facility is also defined

  . as new construction for purposes of 40 CFR Part 61, subpart A.

relatively constant. (iii) Radionuclides shall be collected and measured using procedures based on the principles of measurement processes phosphate rock to produce elemental phosphorus. A plant includes all buildings, structures, operations, (b) An application for approval under described in Appendix B, Method 114. calciners and nodulizing kilns on one

    § 61.07 does not need to be filed for any     Use of methods based on principles of        contiguous site.

new construction of or modification measurement different from those (b) "Calciner" or "Nodulizing kiln" within an existing facility if one of the described in Appendix B, Method 114 means a unit in which phosphate rock is following conditions is met: must have prior approval from the heated to high temperatures to remove I (1) The effective dose equivalent calculated by using methods described in § 61.103, that is caused by all Administrator. EPA reserves the right to approve of measurement procedures. (iv) A quality assurance program shall organic material and/or to convert it to a modular form. For the purpose of this subpart, caloiners and nodulizing kilns emissions from the facility including the be conducted that meets the are considered to be similar units. proposed new construction or performance requirements described in (c) "Operator" means any Pf!r&on who modification, is less than 10% of the Appendix B, Method 114. owns, operates or controhl elemental limit prescribed in § 61.102. (3) When it is impractical to sample phosphorous plant. (2) The effective dose equivalent an effluent stream-at an existing source calculated by using methods described in accordance with the site selection § 81.122 Emiulon standard. in I 61.103, that is caused by all and sample extraction -requirements of emissions from the new construction or Approach A llDd B paragraphs I 61.107(b)[2), the facility modification, is less than 1% of the limit operator may use alternative site Emissions of polonium-210 to air from I prescribed in § 61.102.

    § 81.107 Emission determination.

(a) Facility owners or operators may, selection and sample extraction procedures provided that: (i) It can be shown that the all caAciners and nodulizing kilns at an elemental phosphorus plant shall not exceed a total of 10 curies a year. in lieu of monitoring, estimate requirements of paragraphs Approach C I radionuclide emissions in accordance with Appendix D. (b) Radionuclide emission rates from

                                                   § 61.107(b)[2) are impractical for the effluent stream.

(ii) The alternative procedure will not significantly underestimate the Emissions of polonium-210 to air from all calciners and nodulizing kilns at an elemental phosphorus plant shall not point sources (stacks or vents) shall be exceed a total of 0.6 curies a year. measured in accordance with the emissions.

• following requirements: (iii) The alternative procedure is fully ApproachD (1) Effluent flow rate measurements documented.

(iv) The operator has received prior Emissions of polonium-210 to air from shall be made using the following .all calciners and nodulizing kilns at an methods: approval from EPA. elemental phosphorus plant shall not (!) Reference Method 2 of Appendix A

                                                  § 81.108 Exemption from the Reporting         exceed a total of 0.006 curies a year.

to Part 60 shall be used to determine and Testing Requlrementa of 40 CFR 81.10 velocity and volumetric flow rates for § 81.123 Emlaalon tnUng. stacks and large vents. All facilities designated under this subpart are exempt from the reporting (a) Each owner or operator of an (ii) Reference Method 2A of Appendix requirements of 40 CFR 61.10. elemental phosphorus plant shall test A to Part 60 shall be used to measure eminsions from the plant according to flow rates through pipes and small 4. By revising subpart K to read as vents.

• follows: the following requirements:

I (2) Radionuclides shall be extracted, collected and measured using the following methods: Subpart K-Natlonal Emlaalon Standards for Radionuclide Emlaalona From Etemental Phosphorus Planta (1) Within 90 days of the effective date of this standard for a plant ~a'l has an initial start-up date preceding the effective date of this standard; or (i) Reference Method 1 of Appendix A Sec. I to Part 60 shall be used to select sampling sites. (ii) Representative samples of an 61.120 Applicability. 61.121 Definitions. 61.122. Emission standard. (2) Within 90 days of start-up for a plant, that has an initial startup after the effective date of the standard. (b) The Administrator shall be effluent stream shall be withdrawn 61.123 Emission testing. I continuously for the sampling site following the guidance presented in ANSI-N13.1 "Guide to Sampling Airborne Materials in Nuclear 61.124 Recordkeeplng requirements. 61.125 Test methods and procedures. 61.126 Monitoring of operations. 61.127 Certification of stable operation. notified at least 30 days prior to an emission test so that EPA may, at its option, observe the test. (c) An emission test shall be 61.128 Exemption from the reporting and I Facilities" (including the guidance presented in Appendix A of ANSI-testing requirements of 40 CFR 61.10. N13.1), as specified in paragraph § 61.18. Subpart K-Natlonal Emission Samples shall be collected continuously Standards tor Radlonucllde Ernlaalona conducted at each operational calciner or nodulizing kiln. If emissions from a calciner or nodulizing kiln are discharged through inore than one stack, whenever there is potential for I radionuclides to be emitted. The requirements for continuous sampling are applicable to batch processes when From Elemental Phosphorus Plants

                                                   § 61.120 Appllcablltty.

• The provisions of this subpart are then an emission test shall be conducted at each stack and the total emission rate from the calciner or kiln shall be the sum of the emission rates from each of the unit is in operation. Periodic applicable to owners and operators of the stacks.

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A \l I 2.< t ,1 - f3 - s- I I 40 CFR Part 61 EPA 520/1-89-001 I National Emission Standards for Hazardous Air Pollutants I I I --1 Background Information Document: Procedures Approved for Demonstrating Compliance I with 40 CFR Part 61, Subpart I I I I I I Office of Radiation Programs U.S. Environmental Protection Agency I Washington, DC I October 1989 I I

I I applies to an estimated 6,000 government, academic, medical, and I industrial facilities. I 1.2.2 The Standard I The NESHAP limits annual radionuclide emissions to the atmosphere from these facilities to such quantities that will not result in I any member of the public receiving an effective dose equivalent --1 in excess of 10 millirem per year (mrem/yr). Further, not more than 3 mrem/yr effective dose equivalent may be caused by iso-topes of iodine. The standard specifically excludes doses caused by radon-220 or radon-222 and their decay products that are formed after release. I Facilities covered by the NESHAP are also subject to ,the report-ing and approval requirements of 40 CFR Pa~: 61, Subpart I, Sec-I tions 61.104(a) and 61.106(a) of Part 61. ~owever, Sections 61.104(b) and 61.106(b) of Subpart I exemp~ from these require-I ments any facility that, using the specified procedures, demon- .. strates that its total emissions do not cause any member of the public to receive a dose greater than 10 percent of the limits of the standard. Further, the approval requirements are waived if, again using the specified*procedures, the emissions from a newly I constructed or modified facility will not cause any member of t'he public to receive a dose in excess of 1 percent of the standard. I 1* 1.2.3 Demonstrating Compliance I The standard limits doses to the most exposed member of the public. Dose is a complicated function of the quantity of each radionuclide emitted; the physical configuration of the facility I releasing the material; the dispersion, transport, and build-up I 1-3 I

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OSER'S GUIDE FOR THE COMPLY CODE I I

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"I U.S. ENVIRONMENTAL PROTECTION AGENCY Office of Radiation Programs 401 M Street, s.w.

Washington, DC 20460 I October 1989 I -I

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I

I A??ENDIX E - LIST OF NuCLIDES IN COM?:..Y. I Ac-2 25 Ac-227 3::.-207 ai-2i0 Ac-228 ai-2:..2 I Ag-106 Ag-106m ai-22..3 Bi-214 I Ag-108m Ag-llOm Ag-111 Bk-249 Bk-250 Br-77 Al-26 Br-80 I Am-241 Br-80m Am-242 Br-82 I Am-24 2m. Am-243 Br-83 Br-84 --I Am-244 C-11 Am-245 C-14 Am-246 Ca-41 Ar-37 Ca-45 Ar-41 Ca-47 As-72 Cd-109 As-73 Cd-113 I As-74 As-76 Cd-113m Cd-115 As-77 Cd-llSm I At-211 Au-193 Cd-117 Cd-117m I Au-194 ce-139 Au-195 Ce-141 Au-198 Ce-143 Au-199 Ce-144 Ba-131 Cf-248 Ba-133 Cf-249 I Ba-l33m Ba-l35m Ba-139 Cf-250 Cf-251 Cf-252 I Ba-140 Ba-141 Cf-253 Cf-254 Ba-142 Cl-36 I ae-7 Be-10 Cl-38 cm-242 cm-243 Bi-206 I I E-1 I I

I 1* AP?:::t-.J:X :;-

                    - ::.:s:- 0: NuC:.. :J::s =~ cr-,*.*::i* .,.
                                                   '-.,a.,. - -

Cm-244  ::u-:56 I Cm-245 Cm-246 F-18 Fe-52 Cm-247 Fe-55 I Cm-248 Cm-249 Fe-59 Fm-254 Cm-250 Fm-255 I Co-56 Co-57 Fr-223 Ga-66 Co-58 Ga-67 I co-58m Co-60 Ga-68 Ga-72 --I Co-60m Co-61 Cr-49 Cr-51 Cs-129 Gd-152 Gd-153 Gd-159 Ge-68 Ge-71 Cs-131 Ge-77 Cs-132 I cs-134 H-3 Hf-181 Cs-l34m Hg-193m I Cs-135 Cs-136 cs-137 Hg-197 Hg-l97m Hg-203 I Cs-138 Ho-166 .. cu-61 cu-64 cu-67 Dy-157 Dy-165 Ho-166m I-123 I-124 I-125 I-126 I Dy-166 Er-169 I-128 I-129 Er-171 I-130 I Es-253 Es-254 I-131 I-132 I Es-254m Eu-152 Eu-l52m I-133 I-134 I-135 Eu-154 In-lll I Eu-155 In-ll3m I E-2 I I

• 1 A??::tD:::X .... - : :: 57 OE :H.:c:.; JES :N CO~? L. '{

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                     ~m                   t~:::,-95
                                          ~./:>-95m I          ::1-j_:Sm

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Environmental Health & Safety DOC ETEO US~RC Research Park Development Bldg. Columbia, Missouri 65211 Telephone (573) 882-7018 UNIVERSITY OF MISSOURI-COLUMBIA FAX[573]882=7940

                                                      '96 MAR 11 A11 :23                          Hazardous Waste Management        882-7018 Industrial Hygiene Services       882-7018 March 8, 1996                                                                                Radiation Safety Office           882-7221 OFFICE OF SECftE:TARY                          Workers' Compensation              882-7018 DOCKE TihG "                 ~[r,'.1 !C[

U.S. NuclearkR_egulatdoryS C~mmissionh BR A.N CI-'. ATTN: Doc etmg an ervtces Branc DOCKET NUMBERPR ...._ Washington, D.C. 20555-0001 PROPOSED RULE ~

Dear Sir/Madam:

(J,b~,t,..3'1i~ I am commenting in response to the proposed regulations as published in the December 13, 1995 Federal Register on pages 63984-63987 regarding the proposed reporting requirements under Part 20, specifically the constraint of the 10 mrem/year dose limit (TEDE) to members of the general public. First let me state that I can find no rational or scientific reasons for the imposition of these reporting requirements in this proposed regulations other that to keep the NRC and EPA bureaucracies regulating something and justifying their existence. These proposed regulations do nothing to improve the health and safety of individual members of the public. The members of the general public are adequately protected by the constraints of 20.1301 and its 100 mrem limit. Epidemiological evidence does not support imposition of a 10 mrem limit from air emissions, the general 100 mrem limit for members of the general public, or even the 5000 mrem limit for occupationally exposed individuals. The occupational dose limit is based on probabilities and assumptions which attempt to limit detrimental effects of working with ionizing radiation, to those levels of hazards which may be found in other "safe" occupations. The limit of 100 mrem has built into it 1.) A degree of protection which includes a conservative reduction factor for those members of the general public who choose not to be occupationally exposed to radiation and 2.) Considerations of exposures from multiple sources of radiation. If there is valid scientific evidence to support that the 5000 mrem limit for occupational exposures or the 100 mrem limits are not adequate for purposes of radiation protection, then we should work to find a "safe" level of exposure. If the proposed limit of 10 mrem due to airborne radio-nuclides is due to some new evidence which is not incorporated into the current regulations of Part 20, then I would suggest that this information be disseminated to licensees' so that appropriate actions can be taken to safeguard the public's health and safety. If this reporting requirement is necessary to protect members of the general public, then I and all health physicists need to review this evidence because we as a group have missed something extremely important in our professional careers. Licensees' are currently required to limit exposure to members of the general public to less than 100 mrem per year. The Relative Biological Effectiveness of the nuclides to which a member of the general public could likely be exposed to, have already been accounted for in Part 20.1201 and in Appendix B of Part 20, regardless of how the individuals are exposed, whether through external or internal (ingestion or inhalation) pathways. It is currently a requirement that licensees' maintain this limit to less than 100 mrem TEDE per year. Is there now some special concern that exposure via the inhalation pathway is substantially different or more detrimental than other exposure pathways or is this another attempt by the EPA via the NRC to rachet down dose levels further so that we can all feel better that we are "protecting the public"? If this is the case, than of course 10 mrem is "better" than 100 mrem. If however, that this is just another way for the EPA, now through the NRC, to Acknowledged by carctH.!~ an equal opportunity institution

tlS. f;f. "" D. Post. Co ~es

Nuclear Regulato1-y Commission 2 promulgate regulations which ensure the survival of the agencies, then I suggest that they are doing their jobs extremely well! The Simpson Amendment to the CAA clearly states that regulations need not be promulgated if existing regulations provide an adequate margin of safety to the public. I suggest that NRC come up with some reasonable data to support limiting air emissions to 10 mrem per year, if in fact the 100 mrem limit is insufficient to protect public health and safety. It should make no difference whether or not the exposures occur via inhalation, ingestion, or externally, if we are to believe the limits as set forth in Part 20. As stated in NRC's own commentary concerning these proposed regulations, studies show that the vast majority of licensees' are well under the proposed 10 mrem per year limit. I would suggest that if there is a problem with licensees' exceeding a dose limit that this should be addressed during routine licensee inspections when the NRC inspectors are reviewing records for compliance with occupational doses and limits of doses to members of the public. It should be noted that most occu ationall ex osed ersonnel receive far less than their allowable radiation dose limit. It also follows that persons not occupationally exposed to ionizing radiation receive far less than their allowable limits. The vast majority of licensees' whose ALARA programs work well enough to keep their emissions below the 10 mrem limit should be evidence enough that new regulations are not needed to solve a non problem. Ifby the EPA' s own admission, according to their own data, there does not appear to be a problem with 98% of the licensee' s surveyed exceeding even 1 mrem per year, what is the purpose ofrequiring licensees' to report this or greater than one mrem per year infonnation to the NRC? In the past I have worked with the " Comply" code developed for the purpose of assessing air emission dose contributions. I found that this code can be a useful tool for a licensee to assess their particular contribution of air emissions to the total dose to which they may expose members of the general public through their operations. In this sense it fits well into a licensee' s ALARA program. However, it has not been demonstrated that compliance at the 10 mrem level improves the general public' s health. One must also remember that even by the EPA' s own estimates, the "Comply" code provides infonnation which is based on conservative assumptions, thus if anything, overestimating the doses it calculates. In fact by limiting doses to members of the public, no matter how small, you may actually be allowing negative health effects to these persons, based on some data which suggests a beneficial or protective effect below 10 rem. Perhaps you should read the Health Physics Society' s latest position paper (March 1996, Health Physics Newsletter), "Radiation Risk in Perspective" concerning low doses of radiation. It also concerns me that these regulations were stayed by the EPA soon after they were originally promulgated. I assume they were stayed due to some concern that they were not necessary or were duplicative with NRC' s own regulations. When they miraculously reappeared in 1993(?) none of the people that I contacted within the EPA, NRC, or various state agencies, could explain why the stay was lifted. Is this perhaps a pet project of someone at one of the agencies who refuses to let it die in the face of opposition? Perhaps someone at NRC or EPA could tell me! In conclusion, I am firmly opposed to any requirement that licensees' demonstrate compliance with the 10 mrem limit for air emissions until EP A/NRC can provide valid data which suggests how this will benefit society and the general public as a whole. If there is scientific evidence which suggests

Nuclear Regulatory Commission 3 that the current regulations are not sufficient to protect public health and safety, then I suggest that the NRC inform the public and members of the radiation protection community so that appropriate actions can be taken. The use of pseudo science and bowing to political pressure does no one in society any service in the long run! I would however, support the use of computer codes such as "Comply" to help in assessing any doses to which an individual of the general public might be exposed to as part of a facility's ALARA program, however it should not be mandatory, especially considering the fact the licensee is already charged with maintaining doses less than 100 mrem per year and ALARA. These opinions are my own and are shared by some of my colleagues. However, they do not represent the official position of the University of Missouri-Columbia. Sincerely,

  µ'-/df Ronald J. Dobey, Jr., CHP Deputy Radiation Safety Officer

T. P. (Pat) Barton, Ph.D. 10586 Mitchell's Mill Rd OOC KE [Jzardon, Ohio 44024 Certified Health Physicist USN ,i](j) 285-3276 (voice or fax)

                                               '96 MAR -8 P3 :23 OFFI CE OF SECRETA. RY DOCKETING SERV ICE" BR ANCH March 5, 1996 DOCKET UMBER     PR pROPOSED RULE~~ ----

( <oo rR-~9~~ @ Secretary U.S. Nuclear Regulatory Commissi on Washington, DC 20555-0001

Dear Secretary:

Regarding the proposed change to a 10 millirem constraint level for releases from NRC-licensed facilities other than nuclear power plants. There is no public health and safety reason for this change; you, your agency, every competent health physicist and I all know this. Just because everybody can probably live with it and won't complain too loudly doesn't mean it isn't a dumb idea. Inter-agency turf battles don't make for good regulation. Pat Barton

U.S. NUCLEAR REGUt.: rcr COMM:SSIO~ DOCKETING & SERVICE SECTION OFFICE OF THE SECRETARY OF THE COM, II SION DOCI ment tatistics Postmark Date -=-!-"""-4-M'l' - - - - - Co?es Received._.,___ _ _ _ __ Add'! Copies Rr:produced ~ - -- - Special Distributio~ blM,...

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DOCKET NlllBEAftlt -~ PROPOSED RULE~r=-:;: n a::s,-. - DOCKETED ( toDt=R... Co39~ +) @ USNRC From: Mack Richard <MRICHARD@wpo.iupui.edu> To: TWD2. TWP9(ctr) Date: 3/5/96 11 :12am

                                                                         '96 MAR - 5 Pl2 :48

Subject:

Comments on "Constraints for Air Effluents" OFF! ,E ,:- SECRETA RY There is ~o question that dual regulation of radionuclide air en:ii~9Wi j ti..'~ C d

                                                                                          *a the EPA Is redundant and unnecessary. However, the EPA's insistence that the NRC adopt "constraint" levels for air emissions which will result in an effective dose of 10 mrem is ridiculous for a number of reasons.

By their own admission, the EPA has stated that licensees who adhere to the NRC's current air concentration limits do not expose individuals to greater than 10 mrem. That being the case, what can possibly be gained by adding another "limit" for air emissions - (I know the NRC says the constraint level isn't a limit - I'll discuss that later)? The EPA is apparently taking the approach that if routine, radionuclide emissions don't result in individual effective doses in excess of 10 mrem, then the limit should be set at 10 mrem. That is like saying that automobiles are capable of traveling at 30 mph. There are fewer accidents (risk) if all cars would drive no more than 30 mph; therefore, let's make the national speed limit 30 mph. If an individual exceeds 30 mph, he must report it and describe how he plans to prevent exceeding that limit in the future (perhaps modifying his automobile engine). Obviously, such an idea is preposterous but demonstrates the same logic being employed by the EPA. There is absolutely no evidence that indicates EPA's arbitrarily low limit of 10 mrem carries any discernible risk. All risk estimates are based upon extrapolation from higher levels which the majority of experts feel is highly questionable in the mrem range. To establish such a low level based upon questionable methodology is unreasonable. The 100 mrem effective dose limit recommendation for the general public has been reiterated in NCRP Report No. 116. It is difficult to understand the EPA's reluctance to adopt the recommendations of the NCRP. The air concentration which results in an annual, individual exposure of 10 mrem is not measurable. While computer modeling programs (e.g. COMPLY) are available to estimate such low effective doses, there is no way to substantiate their validity. As a result, licensees may simply modify their assumptions to assure they will meet the 10 mrem limit. While this may solve the problem of exceeding the constraint level, why are we going through such calculational gymnastics for 10 mrem!! The NRC goes to some length to explain that the "constraint level" is not a limit. Based upon my review, it appears that the constraint level is basically a limit, "once removed." What is meant by that is a licensee will be allowed to exceed the constraint level one time. Upon submitting the required report, the licensee will then be required to meet the

Lt/'\ , .... _.- i HY COMMISSIO!' KETING & SERVICE SECTION FICE OF THE SECRETARY Of THE COMM\SS\00 ()oQJt\ent StatlltiCI ate~sz!A-'rYf§ . e l d_1-- - - - - - - 11:) ~ _=-=- Distril>o. ~~*

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constraint level or risk being cited. The NRC is certainly trying to eliminate dual regulation of radionuclide emissions. For that, they should be commended. On the other hand, the time has come to attempt to educate the EPA regarding their unreasonable 10 mrem limit. If the NRC goes forward with this constraint level, it will simply substantiate the EPA's inappropriate levels. Sometimes, one has to do what is right rather than what is easiest. The aforementioned comments are my own and do not necessarily represent the opinion of Indiana University. Mack L. Richard, M.S. Radiation Safety Officer I.U. Medical Center

From: Charleen Raddatz To: WND1 .WNP2.ELJ Date: 3/5/96 11:21am

Subject:

Comments on "Constraints for Air Effluents" -Forwarded Please add this comment to the docket for the constraint rule. char raddatz

OOCKfTED Nuclear Fuel SeNlces, Inc. us~~c P.O. Box 337, MS 123 Erwin, TN 37650 (423) 743-914 1 Ctrtifttd Mail

                                           '96 HAR -4 P2 :QQ                                 llG-96-0018 Rttum Receipt Requested                                                                         GOV-01-55 OFFICF er- 3 :m-JARY                                  ACF-96-029 OOC KET H G 8 SEP. VICE                                      Pagt 1 8RAf H                           February 28, 1996 U. S. Nuclear Regulatory Commission Washington D. C. 20555-0001 ATIN: Docketing and Services Branch

SUBJECT:

Nuclear Fuel Services, Inc. (NFS') Comments on the Proposed Rule: Constraint Level for Air Emissions of Radionuclides (60 FR 63984, dated 12/13/95)

Dear Sirs:

Nuclear Fuel Services, Inc., (NFS) respectfully submits the following comments on the Proposed Rule: Constraint Level for Air Emissions of Radionuclides (60 FR 63984, dated 12113/95). NFS opposes the imposition of a new standard for air emissions of radionuclides for the following reasons:

1. Emission standards already exist in 10 CFR Part 20, Subpart D, for all NRC licensees. The largest licensees, fuel cycle facilities, are also regulated by the even more restrictive standard of 40 CFR 190, Subpart B. These standards have proven effective in adequately protecting the public from excessive exposure to radiation and radioactive material.

2. As stated by the NRC, the proposed rule is "necessary to provide assurance to the Environmental Protection Agency (EPA) that future emissions from NRC licensees will not exceed levels that will provide an ample margin of safety. " Due to the same basic reasons, the EPA promulgated the radionuclide emission standards of the Clean Air Act (40 CFR 61, Subpart I) which causes the generation of thousands of dose assessments each year by NRC licensees. These dose assessments show that emissions from licensees are already being controlled adequately to protect the public.

There is a no data known to NFS indicating a public safety problem for which the proposed regulation is needed.

3. The constraint level is a standard. Although presented as part of the ALARA provision, the very act of establishing a set action level which requires reporting and corrective action by the licensee in full public view is indistinguishable from a basic regulatory standard.

MAR 1 *g- 1996=- Acknowfedgad by card ""........ " ........" ............ ti

\J,i, UCL AR 1t:\.Jv-* , vH COMMISSIOI\ OOCKETING & SERVICE SECTION 0 FIC OF THE SECRETARY OF THE COMMISSION Document Statistics Postmark Date ~ _, 19=~"--- - - Co~es Receivcd _ _.___ __ _ __ Add'l Copies RbPW ed -~ --=--- - - - Special Distributi ,~~ ~a~.~~

21G-96-0018 GOV-01-55 ACF-96-029 Page2

4. For most licensees, airborne emissions dominate offsite dose; this new rule would effectively lower the allowable offsite dose limit by a factor of 10. A change of this magnitude should be justified by more scientific evaluation and economic impact studies than are apparent from this rulemaking effort.

5. The assertion that a 10 mrem/yr constraint provides an appropriate level of protection implies that higher levels do not. Since there is no difference in dose received from airborne and direct radiation exposure, one might infer from this action that exposure from direct radiation would seem to be in need of similar constraint. This is not the case. Current standards in 10 CFR 20 limit most licensees to 100 mrem/yr public dose from all sources (except sewer) combined. Thus, the proposed rule begs the

• question: Is 10 mrem/yr from airborne radioactivity and 90 mrem/yr from direct radiation more acceptable than 90 mrem/yr from airborne and 10 mrem/yr from direct? The answer is no. Licensees should be permitted to demonstrate compliance with the cumulative limit of 100 mrem/yr without regard as to whether the dose resulted from mostly airborne or mostly direct exposure. By accepting this airborne constraint level of 10 mrem/yr, one is, in effect, accepting a general ALARA constraint limit.

NFS applauds the effort of the NRC to transfer the regulation of the Clean Air Act (CAA) standard from the EPA to the NRC. However, there is little benefit if the EPA standard continues in a merely altered form. The NRC should continue to argue that adequate protection is provided by its current regulations and should back this up with data from licensees. The EPA should use the data created under the CAA radionuclide standard, which has been in effect for three calendar years, to show that the public is already adequately protected. No new rule should be promulgated unless the existing data clearly demonstrates that the current NRC rules do not provide an adequate level of safety. In conclusion, NFS does not believe that the proposed constraint level is necessary. NFS recommends that the NRC rescind this proposal and work with the EPA to demonstrate the adequacy of the current NRC standards so that the EPA may also rescind or modify the CAA standard to match the proven NRC standards. If you have any questions or need further information, please contact me or Mr. John W. Nagy at (423) 743-1784. Please reference our unique document identification number (21G-96-0018) in any correspondence concerning this letter. Sincerely, NU~"EAR FUEL SERVICES, INC. OJMl Andrew M. Min t-Vice President JWN/rcy Safety and Regulatory

DOCKET N BER Pit - PROPOSED RULE ~ DOCK TED March 1, 1996 ( bOFe..<o~9-S'1/4_) U ~ ,C American U.S. Nuclear Regulatory Commission '96 MAR -4 Al 1 :17 Washington, D.C. 20555-0001 College of Nuclear OFFiCF t*F *~1- R:.:. RY Attn: Docketing and services BranciPOCKE. T*r G & t.R'tl .F Physicians URAt;Ll-i RE: RIN 3150-AF31: Constraint Level for Air California Emissions of Radionuclides. Fed Reg 60(239): Chapter 63984-63987, 13 Dec 95. Dorothy Duffy Price Executive Director and Box 31 Los Altos, CA 94023 Draft Regulatory Guide DG-8016: Constraints for TEL (415) 949-1341 Air Effluents for Licensees other than Power FAX (415) 949-1341 Reactors, Dec. 95. and Regulatory Analysis for the NRC Constraint Rule on Radionuclide Air Emissions from NRC and Agreement State Licensees other than Nuclear Power Reactors.

Dear Sir/Madam:

The California Chapter of the American College of Nuclear Physicians (ACNP) are pleased to comment on the above documents. Each year, over 10 million nuclear medicine patient procedures are performed in the United States, 20% of which are performed in California. We have been deeply concerned with EPA's radionuclide NESHAPS since 1989, because of inappropri~te dual regulation, poor quality science, incorrect risk estimates, flawed compliance methodology, and huge unwarranted cost. We have estimated compliance at over $100 million for the first year. We have repeatedly expressed our concerns, especially with the tightening up of resources for medicine and for academic research. We were very grateful for the Simpson Amendment of 1990, in which the EPA Administrator was obliged to make a determination of whether NRC's airborne radionuclide emissions standards for NRC and Agreement State licensees protected the public with an "ample margin of safety". EPA performed two studies to make this determination. Licensees were forced to use a user-unfriendly and scientifically flawed computer program called "COMPLY", which hugely overestimated (by orders of magnitude) radiation dose to the public. In the first study, 367 randomly selected nuclear Acknowr ed MAR 1 8' 1996 ecfg by card -41*-w*w1NII 11 41NI;

U.S. NUCL ~ LJ-1.fOR CO! ISSIOt-. OOCKETl~G & S VICE SECTION 0 FIC OF TH SECRETARY Of THE COM iSSION

             ~   em C::tatlstics Postmark oa Copes Re Add'! Cope A Speclal DlstriW ~~ .~m..~                I

March 1, 1996 U.S. Nuclear Regulatory Commission Page materials licensees were expected, without compensation, to develop a data base and use the COMPLY program to ascertain public dose. The highest estimated dose was 8 mrem/yr TEDE, and 98% of the facilities caused less than 1 mrem. This is using highly conservative assumptions, and these estimates are in fact gross overestimates. The EPA limit is 10 mrem/yr TEDE, so all were very comfortably within that limit. EPA's second study involved choosing 43 licensees expected to have the highest emissions. None exceeded the 10 mrem standard, and 75% were under 1 mrem/yr TEDE. Again, these estimates were also gross overestimates of actual airborne emissions . In order to put these doses in perspective, recall that the average American receives about 300 mrem/yr TEDE from natural background, and another 63 mrem/yr TEDE from man-made sources, mainly routine medical exposures. In mountainous areas with high levels of naturally-occurring radionuclides, natural background can be 1.5-2 times the national average; in one town in Colorado it is 3 times higher. Thus, 1 mrem/yr TEDE is only about half of 1% of the difference in background radiation dose between Washington, D.C. and Denver, co. (Colorado is tied for the third lowest cancer death rate in the United States. The District of Columbia has the highest cancer death rate in the nation.) In addition, we have the whole issue of airplane flight. Passengers and flight crews receive 1 mrem TEDE/1000 miles flown. This is a completely unregulated source of radiation exposure, and rightly so. However, in an abuse of logic to satisfy an antinuclear pressure group, the EPA administrator determined that NRC's standards provided an ample margin of safety only at present. As it was always possible for NRC to fail to do so in the future, EPA refused to relinquish its role. EPA insisted that NRC change its existing regulations to essentially look like EPA's. After a prolonged negotiation period that produced much more heat than light, NRC published EPA's forced rule change on 13 Dec. 95. The NRC version is far worse than EPA's even though they were meant to be similar. The nuclear medicine community cannot possibly support NRC's Proposed Rule, its draft regulatory guide, or its economic analysis. Detailed comments will follow to endeavor to make a repeat NRC effort respectable. However, we believe that even a vastly improved NRC document is only the fourth best solution to the problem.

March 1, 1996 U.S. Nuclear Regulatory Commission Page One excellent solution to the problem is for the EPA Administrator to stop being in contempt of the Simpson Amendment. She made the determination that NRC keeps us to a safe standard. She spent a great deal of our money and time accomplishing that. Good. Now the EPA Administrator should withdraw Subpart I completely, as the Simpson Amendment so instructs her. Ms. Browner is at present showing contempt for the law, contempt for President Clinton's Executive Order 12866, and contempt for science. This behavior should not be permitted to continue. Another excellent solution would be for Congress to understand that this regulatory cat fight is very destructive to the nation. and therefore stop it by amendina the Clean Air Act (CAA) to remove radioactive airborne emissions from the CAA's jurisdiction. We would then revert to NRC's present, entirely adequate standards. Better yet, Congress could go further and end EPA's entire radiation program. reinstating a Federal Radiation Council (FRC) for standard-setting resembling the FRC that existed until a 1970 Executive Order transferred those tasks to the newly-formed EPA. That would permit the establishment of excellent quality, highly respected, uniform radiation standards by the most qualified experts in the United States. This would be an extraordinary improvement over what we have now from both EPA and NRC. SPECIFIC COMMENTS: THE PROPOSED RULE

1. The CAA referred to uncontrolled airborne emissions beyond the boundary of the licensee's property. Limits for the public were offsite limits. Airborne emissions within the licensee's establishment are completely and adequately covered by NRC's extensive requirements for facility operation. NRC needs to change §20.ll0l(d) to read, " ..... so that the individual member of the public likely to receive the highest offsite dose *..* ".

2. The nuclear power plants were exempted from EPA control when found to be kept to an ample margin of safety by analyzing NRC's calculation of dose at the facility boundary, not inside the power plant. The nuclear power plants did not use the COMPLY code; they chose their own method of calculation.

March 1, 1996 U.S. Nuclear Regulatory Commission Page The nuclear power plants have high enough airborne emissions that they can be measured. Almost all our facilities are so low they cannot be measured, but they can only be calculated. We cannot have two different airborne emissions standards within the same agency. NRC's airborne emission standards, and its "constraint" rule, if we must have one, must apply to everyone, power plants and hospitals alike.

3. This rule should not be an item of compatibility at level 2. We cannot tolerate more restrictive standards on a state-by-state basis. Airborne radionuclides cross state lines, and a national standard is appropriate.

Level 2 compatibility simply invites antinuclear groups to lobby for state airborne emissions standards low enough to close down all biomedical research and nuclear medicine in the state. To make nuclear power plant airborne emission levels untouchable {level 1), yet hold materials licensees to a standard 5 times more restrictive than nuclear power plants and also permit antinuclear groups to influence states to make them even more restrictive than that, is absurd. NRC is surely aware that "antinukes" have attacked nuclear medicine and medical research licensees because we are loudly supportive of low level radioactive waste sites. Why is NRC "setting us up"? Why NRC would be irresponsible and malevolent enough to set the stage for such mischief we do not comprehend, but we urge Chairman Jackson and the Commissioners to reconsider, oppose staff and management if necessary, and keep the standard at level 1. SPECIFIC COMMENTS: THE DRAFT REGULATORY GUIDE

1. The example chosen in Appendix A needs to be changed completely to that of an offsite example. In addition, the example has the wrong volatility fraction (1.0E-3, not 1); the average concentration is missing division by 3, and combination with the rest of the year; the mathematics of a first order rate equation is avoided erroneously; no member of the public stands at an open laboratory door for 24 straight hours; the division of 7.9E-10 by 2.0E-10 is ten times too small; the exposure dose is grossly in error and far too large.

2. NRC has omitted default levels needed so that a large number of licensees will immediately be exempt from more detailed and expensive analyses. They are in 40

March 1, 1996 U.S. Nuclear Regulatory Commission Page CFR Part 61, and belong in NRC's rule as well. The calculations that led to them should be reviewed and improved upon. These default values are too conservative. ACNP/SNM were repeatedly unable to get EPA's or its contractor's actual calculations under FOIA. There may not be very valid calculations to begin with. The default quantities in Part 61 would be adequate if medical and research licensees could apply realistic release fractions, based on 60 years of experience, to their annual throughput of radioactive materials. For example, we could use 10~ or less for nonvolatile forms and 104 for volatile forms. Then, calculations should only be needed for new processes exceeding these values.

3. EPA appreciated that sealed containers. not only sealed sources. do not contribute airborne emissions.

Therefore sealed containers were exempt. NRC needs to exempt sealed containers as well. Sterile, pyrogen-free radiopharmaceuticals in sealed vials, for example, were exempted by EPA, as well as radionuclide generator columns.

4. EPA exempted airborne emissions from patients, just as NRC exempts patient's excreta going into sewers. NRC should explicitly state that here.

5. The COMPLY Code is of poor quality, and should not be recommended by NRC. Nevertheless, if used, the COMPLY Code exempts emissions from patients, is only defined for offsite emissions, and requires data for activity possessed per year, not possession limits at any particular time, as stated erroneously by NRC in the draft regulatory guide.

6. The equation in 2.1, p. 4, is incorrect. The equation is written c = fQ/v, where Q is defined as the effluent release rate. The rate is irrelevant. The equation would be more accurate as c = fA/VT, where A= total activity released in one year and T=l year. "f" should be redefined as "the fraction of activity released when the wi nd i s b l owi ng toward the receptor of i nterest".

Winds change.

March 1, 1996 U.S. Nuclear Regulatory Commission Page 7. The draft Regulatory Guide permits three methods for demonstrating compliance, but omits a very simple method used by many smaller facilities described in EPA 520/1-89-002, a Guide for Determining Compliance with the Clean Air Act Standards for Radionuclide Emissions from NRC-Licensed and Non-DOE Federal Facilities, Revision 2, October, 1989. This should be added.

8. The NRC directed the costliest, most paperwork-intensive possible manner of showing compliance with emissions standards. As EPA has demonstrated that all 22,000 materials licensees are "safe" at present, why do we have to repeat this pointless exercise every year? Why not permit facilities to ignore this unless they significantly alter their activities? New activities could be studied up front and "vetted" for the whole country, such as a new I-131-labeled therapy antibody. Nuclear medicine facilities have been "safe" for 60 years, and it is foolish and expensive to pretend that we need to show how safe we are, over and over again, so that an inspector will have more paper to inspect.

SPECIFIC COMMENTS: THE REGULATORY ANALYSIS

1. The Regulatory Analysis is astounding. It calculates the cost to the regulators, but omits costs to licensees. NRC appears to believe that licensees produce analyses like these for zero dollars. If the average licensee spends 80 hours a year on this, and this is a realistic estimate, at $120/hr (NRC's rate),22.000 = 11,000 licensees will spend 2

    $105,600,000. EPA has shown that none of this is necessary. $100 million is real money, and it is downright careless for NRC to leave it out of its submission to 0MB.

2. NRC states that 15 of its FTE's worked for 6 years with EPA on this issue. At NRC's rate of $120/hr x 2000 hrs.

x 15 FTE's, we have already paid $3.6 million in User Fees and received a completely unusable package from NRC. Although NRC estimates i ts costs to complete this regulation, we believe it is not a credible number. How much would NRC have to spend to do a good job?

March 1, 1996 U.S. Nuclear Regulatory Commission Page We recommended that different individuals at NRC redo this regulation. We cannot afford to pay such prices for unusable material. CONCLUSION

1. We recommend that NRC submit a new Proposed Rule, Draft Regulatory Guide, and Regulatory Analysis, and that it be done promptly by individuals with education, training, and experience in airborne emissions. ACNP and other professional societ i es would be happy to help NRC further in this effort.

2. Ideally, Administrator Browner will review her obligations under the Simpson Amendment and do the honorable thing. Perhaps Congress could induce her to reevaluate her position.

3. Hopefully Congress will remove radionuclides from the CAA and end this misery. In a perfect world, Congress would end EPA's radiation program entirely, reinstating a Federal Radiation Council using guidance recommended by ACNP and the Society of Nuclear Medicine.

Thank you for your attention and consideration. Sincerely, Carols. Marcus, Ph.D., M.D. Di rector, Nuclear Med. Outpt. Clinic and Professor of Radiological Sciences, UCLA and President, American College of Nuclear Physicians, California Chapter NRCCMI'2.CSM

March 1, 1996 U.S. Nuclear Commission Page - a-cc: Chairman Shirley Jackson Commissioner Kenneth Rodgers Commissioner Greta Dicus Hugh Thompson, Deputy, EDO Carol Browner, Administrator, EPA Senator Alan Simpson Senator Bob Dole Representative Newt Gingrich - Troy Hillier, 0MB CSM:sfd NRCCMI'l.CSM

tf ,S, 1Juc/'-L4Y- f ~u ~':) ~m,j-5.,J 4 ~ ~ P~ck.-h~ 04' S"JU1"t.1l~'e $h::lvid '96 FEB 20 P2 :02 U/d.J/,,;9b J L>r C, ,21),5T"~- 00 " / OFFICE OF SF.CRETi RY i/ OOCKETI G. Sl:.R 1cr BR NCH DOCKET NUMBER PR PROPOSED RULE ~ ((oC Fe Co-5C\-g4) ff~--J,; ec-ci r- a.--r

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L. .., .. : ;c., __:..,* ' fOAY COMMISSIOfl. OOCKE IN & SERVICE SECTION OFFICE OF THE SECRETARY OF THE COMMISSION Document Statisticl Postmark Date ~µ=1:-_:............_ _ __ ~ ~-- .._~ ---- Ad<fl Copes Rep SpeciaDISlrl .

February 15, 1996 NOTE TO: Charlene Raddatz, RES Emile Julian asked me to forward the attached letter to you for response. Thanks, Je;J;Sh~emaker Docketing & Service Branch Office of the Secretary I I I I L

CHEM-NUCLEAR SYSTEMS, INC. 140 Stoneridge Drive

• Columbia, South Carolina 2921 0 * (803) 256-0450 USNRC February 9, 1996 '96 FEB 1S Pl2 :45 RA-0063-96 OFFICE f1F SEC RETARY U.S. Nuclear Regulatory Commission DO CKET i,{G (._ ~E , 'llC Washington, DC 20555-0001 BRA H ATTN: Docketing and Services Branch DOCKET NlNBEAPR .=.

Dear Sir or Madam:

ffiOP0SED RULE ~ wa'\ (Co<:::>FR..(o3C\"3~ '-.lJ Chem-Nuclear Systems, Inc. appreciates the opportunity to comment on proposed revision to 10 Nuclear has previously commented on the EPA proposal to rescind 40 CFR part 61, subpart I. CNSI agrees with the EPA proposal and expects that eliminating this dual regulation will be a benefit to the regulated community, the regulatory agencies, and the public. CNSI does not agree with the NRC's proposed rule since the requirement has simply been passed from the EPA to the NRC without an attempt to eliminate the inconsistencies between the two methods of emission control, i.e. a dose limit to a member of the public versus concentration limits in the unrestricted area. In addition, it must be noted that to achieve the laudatory goal of eliminating dual regulation the EPA has caused the NRC to establish a contradictory position between occupational and public dose control. The current occupational limits require that internal and external doses be controlled consistently, i.e. a mrem is a mrem. The new proposed ALARA rule requires that doses to the public which result from air emissions be controlled more stringently than doses from external sources, e.g. a dose of 90 mrem/yr from external sources would be acceptable as long as the dose from air emissions doesn't exceed 10 mrem/yr. Further, the NRC has stated to justify a Finding of No Significant Impact that "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"(emphasis added). Thus, this rule will cause licensees additional work and expense to demonstrate that their emissions result in less than 10 mrem/yr in addition to meeting the current requirement of 10 CFR 20.1302(b)(2)(i). In addition, the t-lRC is txpending limited resources to develop guidance for iicense~:s on m~thods fur de,no.-,Slf&tir1G LOiY1plia11cc vvith a ,*u!e that *,vii:, ~-, the NRC's ov.-r'. admission, have no effect on actu?! emis"ions,. Simply passing the EPA standard to NRC does not solve the problem of inconsistent regulation. It would be more appropriate for the EPA to recognize that licensees are conscientiously minimizing air emissions and these rules are a waste of valuable resources. The NRC should not change existing requirements. Sincerely, CHEM-NUCLEAR SYSTE¥f, INC.

                                                             )7}~\_ __J      9-_,c \~\-.,)(~) ( /-/                   p
                                                             ~or Michael T. Ryan, Ph.D., CHP Vice President, Regulatory Affairs FEB 2 9 199f Acknowfedged by card ............................H).

U.S. NUCLEAR Mt.uuu"' 1 vii COMMISSIOI\. DOCKETING & SERVICE SECTION OFFICE OF THE SECRETARY OF THE COM llSSI Document Statistics

DOCKETED From: Douglas A. Johnson <doug@nucleus.tamu.edu> US'4RC To: TWD2. TWP9(ctr) Date: 12/15/9511:57am "96 FEB -6 P3 :33

Subject:

Re: 10 mrem annual limit Char1een OFF ICE OF SiL ~TARY DOCKE TI' 1 U' ' - ~ l-r;**1cr-v ,..

                                                                                               \ J  .._

Just to get it off my chest, the 10 has no technical merit, period. NRC has ma ~ fi~r~~sonable aspects, EPA is clear1y irrational. I am sorry conditions exist where you and we, are forced into this. Keep a clear head and when the political climate changes be prepared to return to being simply unreasonable. Standard disclaimers. Doug DOCKET NlllEA" PROPOSED RULE .gc - ~-- Douglas A. Johnson ( <cic~ 1c,5q~~ Senior Health Physicist/Laser Safety Officer Texas A&M University Office of Radiological Safety College Station, Texas 77843-3261 phone 409-845-1392 fax 409-845-1348 e-mail: doug-johnson@tamu.edu

U.S. NUCLEAti h.;L ULA*, <JR COMMI IOt-. DOCKETING & SERVICE SECTION OFFICE OF THE SECRETARY OF THE COMMISSION Document Statistics Postmark Date ....L\'~ :111...>,j~o...-1.~ ::::.-- Coples Rece Adcfl Copies

Dear Mr. Julian:

Please add to PR-20 Docket (Constraint Rule). Thank you, Charleen Raddatz

DOCKETED Rodger W. Granlund USHRC 133 Old Mill Road State College, PA 168~6 FEB - 1 A9 :36 814 865-3459 26 Jan 96 DOCKET NUMBER p PROPOSED RULE AA U.S. Nuclear Regulatory Commission (~FR..{~~Hg~ G) ATIN: Docketing and Services Branch Washington, DC 20555-0001 Re: RIN 3150-AF31

Dear Sir or Madam:

The following comments are in response to the publication of a notice of proposed rulemak:ing on constraint levels for air emissions of radionuclides in the Federal Register on 13 Dec 95. It is a positive step to eliminate the dual regulation of airborne emissions and place it under the NRC with other radioactive material regulations. The elimination of annual reports for the EPA and allowing the use of calculations and measurements other than the cumbersome ones required by the EPA is also an improvement. However, there are some basic flaws in the proposed regulation, as explained below. The information presented as Supplementary Information is more than adequate to show that this rulemaking and the EPA regulation that it replaces are unnecessary. The EPA study of 367 randomly chosen NRC licensees clearly showed that exposure of the public to airborne releases was insignificant. Even the second study of 43 licensees, selected to be those most likely to have airborne effluents that would produce a significant public dose, showed that effective doses were less than 10 mrem. Instead of using this as a reason to drop further consideration of a regulation, it was used by the EPA to justify a regulation requiring these same licensees to prove that the maximum effective dose to a member of the public did not exceed 10 mrem. This has to be a classic case of an unnecessary regulatory burden. The proposed NRC regulation, under the guise of eliminating dual regulations, merely transfers this unnecessary regulation to the NRC. The licensee will see very little relief, because the NRC will use at least some of the same cumbersome techniques instituted by the EPA to show compliance with the regulations, according to the Draft Regulatory Guide DC-8016. The proposed regulation essentially revokes a concept of the ALARA principle. The definition of ALARA in 20.1003 is "AI.ARA means making every reasonable effort to maintain exposures to radiation as far below the dose limits in this part as is practical .. . ". Thus, ALARA levels are not and should not be a set value, except for identical operations. In the proposed 20.1 lOl(d) 1

!JS. N~Cl ~,. . , .. : . ... *.JR\ COMMtSSIOf'- DOCKET!N,,_ & SERVICE SECTION of1=1cF OF lHE SECRETARY OF THE COMMISSION Postmark Data ~~1------- Coples eceived Add'l Copies Re'lr 1.ice Special Distributicrf"]\,,.i)Qc&-=>

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and 20.2203(b)(l)(iv) it requires that 10 mrem be adopted as an ALARA limit. This precludes an operation by a licensee where the TEDE from airborne releases might exceed 10 mrem but still be ALARA. This seems to prove the position of those who argued against adoption of the ALARA regulations on the grounds that ALARA values would become limits. The NRC stated that this would not happen. The proposed regulation adds a new definition for constraint in 20.1003 "Constraint (dose constraint) means a value above which specified licensee actions are required". The proposed Regulatory Guide DG-8016 state that "A limit is an upper permissible bound ... " and "A constraint is a dose value above which specified licensee actions are required". According to the proposed regulation changes the actions to be taken by the licensee are " ... promptly take appropriate corrective action to ensure against recurrence." The only difference I can see between a constraint and a limit is that a notice of violation is not issued the first time a constraint value is exceeded. After that it is effectively a limit. Thus, in the space of a few years the NRC dose limit for individuals in the general public from airborne releases has gone from 500 mrem/year to 50 mrem/yr (the current limit for all but submersion exposures) to the proposed limit of 10 mrem/yr. This has been accomplished without any indication of harm to the public, even at the 500 mrem/yr level. The NRC has sufficient authority to require licensees to reduce emissions to ALARA levels, if a licensee does not operate according to the ALARA philosophy. Issuing a notice of violation may be more difficult for an ALARA violation than for a limit, but it can be done if the deviation from ALARA is significant. Thus, I see little need for either the existing EPA regulation or the proposed NRC changes. As a health physicist I want to see that the public is protected from unnecessary and harmful radiation doses. However, there is no evidence that there is a problem which justifies these regulations. Each unnecessary regulation consumes a fraction of the limited resources available for radiation safety and other problems. Regulations addressing problems that do not exist, are not simply a nuisance, they squander resources that could be put to better use on problems that do pose a significant risk to the public. In summary, I recommend that the EPA regulation of airborne radionuclides be terminated. Regulation of these emissions is more than adequately controlled by the existing NRC regulations and the 10 mrem limit, which is disguised as a constraint, should not be adopted. Sincerely, q,-,,w~ Rodger W. Granlund \RWG\261AN96a 2

DOCKET NUMBER PROPOSED RULE PII ao (.~~<a"tJ U. S . Nuclear Regulatory Commission @ attn. Docketing and Service Branch Washington, DC 20555 - OOUl *96 JAN 29 P 3 :35 RE: The E.P.A.'s proposed dose limit of 10 mrem/yr. OFFICE OF SEC?~,iARY It 1s a mistake to extrapolate empirical eq- ~~~ 4~ ~e $VICE or magni~ude from tneir data sets; as from rems to mrems. IBRlWC~n error to assume tnat the origin (zero , zero) is a datum point . Second order phenomena tend to invalidate the predictions of large extrapolations . The second order effect which the fear-mongers ignore is the bodily process of repair of the fatigue-like effects of radiation . Prompt deaths from radiation require a short-time exposure of over 200,000 mrem . Clearly, bodily repair is capable of handling the damage caused by such large doses . Apparently, bodily repair is extremely efficient at low doses . External natural radiation produces a dose of over 125 mrem per year 1n high altitude areas but less than 90 mrem at sea level . Cancer mortality rates are half as hign in high altitude areas as they are near sea level . Thus, the empi~ical equation expressing cancer mortality rates as a function of dose reaches a minimum at a dose above 125 mrem per year . The 1'irst amendment to the Constitution prohibits tne government from promoting the erroneous belief and fear that an additional dose of 10 mrem/yr of radiation can cause bodily harm. This sort of dose can be received frgm the gaseous emissions of all stoves, heaters, engines , incinerators, kilns, and furnaces burning carbonaceous materials . Also, from X-rays, air travel, and medical radioisotopes . The courts have sustained this Constitutional prohibition in case after case involving persons who have developed cancers after being exposed to trivial doses of radiation . If any court should accept the notion that 10 mrem/yr can and always does cause bodily harm, the potential costs to America in terms of fear and damage suits are staggering . The E.P . A.'s proposed dose limit of 10 mrem/yr is alarmist, unreasonable, impractical, and prejudiced . Such unreason is likely to work against the E. P.A . The current budget cutting exercises are driven by the fact that the U.S. government has reached its "credit card limit". It can no longer afford to pay the interest on the national debt . The first government econom1* ing will involve cost-benefit studies.

• Fear-mongering activities are counter-productive .

Over 400,000 people die each year from breathing tobacco smoke . Sincerely, 1'~ ~ Walston Chubb 3450 acArthur Drive urrysville, PA 15068 412-327-8592 ffEB" 1 2 1996 Aclcnowtedged by card .....""~-.............. ......

U.S. NUCLEAR REGULATORY COMMISSIOh OOCKETING & SERVICE SECTION OFFICE OF THE SECRETARY OF TH~ COMMISSION Document StatlsticS Postmark Date -4'~ ~t . . - - - - - Copes Received__.L,_ __ _ __ Ad<rt Copies Reproduced _'f.,______ Special Distriblh O J4,aal&l~Oi¥+- - -

STATE OF MICHIGAN DOCKETED USNRC JOHN ENGLER, Governor '96 JAN 22 P 1 :16 DEPARTMENT OF PUBLIC HEALTH 3423 N. MARTIN L. KING JR. BLVD. P.O. BOX 30195, LANSING, MICHIGAN 48909 James K. Haveman, Jr., Acting Director DOCKET NUMBER PR PROPOSED RULE o10 January 12, 1996 (Co:::,f"~Cc~9"8~ U.S. Nuclear Regulatory Commission Attention: Docketing and Services Branch Washington, D.C. 20555-0001 This is to respond to a Federal Register notice (Vol. 60, No. 239, December 13, 1995) on a proposed rule by the U.S. Nuclear Regulatory Commission (NRC) for a constraint level for air emissions of radionuclides. Based upon the review ofmy staff, this department has no objection to the NRC's proposed rule, as described, and is supportive of the overall goal of implementing appropriate regulatory changes to effect the elimination of unnecessary dual regulation. However, we feel that NRC should be aware of this department's concerns related to the recent associated proposal by the U.S. Environmental Protection Agency (EPA) to rescind 40 CFR Part 61, Subpart I, as it pertains to NRC licensed facilities. The enclosed letter from me to EPA, dated January 11, 1996, describes our concerns. Should you have any questions concerning this matter, please contact my staff in the Division of Radiological Health, Bureau of Environmental and Occupational Health, at (517) 335-8200. 1rdially,

       . I  ~

( ~ s K. H eman, Jr. Enclosure

                                                                                                            -JMf ? 5 1996'"

Ac1mow1edged by card"***--.................,,.***~ Z-25 5/94

U.S. NUCi.:::* ;~ :-~::\:*_:11,-:;;:;v Ul*.~t/1, to~ DOCKETING & SER VICE SECTl N OFFICE OF THE SEC!1ETAAV OF THE COf ~, IS ION Po~ ,a~ 01:a ~ -'-'-1~~ - - - - Cop!es , ?Ct:iVG,J_ .,___ _ _ _ __ Add'I Copi~s R~',iOJ~-~j -L..----- Speclal Distribut'. o -'-!f::).lb!~~ ~...- - -

STATE OF MICHIGAN JOHN ENGLER, Governor DEPARTMENT OF PUBLIC HEALTH 3423 N. MARTIN L. KING JR. BLVD. P.O. BOX 30195, LANSING, MICHIGAN 48909 James K. Haveman, Jr., Acting Director January 11, 1996

• Central Docket Section LE-13 1 U.S. Environmental Protection Agency Attention: Air Docket No. A-92-50 Washington, D.C. 20460 This letter is in response to a Federal Register notice (FR Vol. 60, No. 188, September 28, 1995) on the reopening of the comment period on a U.S. Environmental Protection Agency (EPA) proposal to rescind 40 CFR Part 61, Subpart I, as it applies to facilities, other than commercial nuclear power reactors, licensed by the U.S. Nuclear Regulatory Commission (NRC) or NRC Agreement States.

Based upon a review by my staff, the following general comments are submitted:

1. This department supports the overall goal of eliminating unnecessary or duplicative federal regulation of air emissions involving radionuclides. However, we note that EPA's current proposal is unclear on its impact on facilities whose air emissions may include naturally-occurring and accelerator-produced radioactive materials (NARM). For those facilities, the recision action by EPA may eliminate potentially necessary controls for NARM emissions that are not considered duplicative and that go beyond the regulatory authority of NRC. In our reading of 40 CFR Part 61, Subpart I, and the associated provisions of the Clean Air Act, as amended, it seems that all radionuclides, including NARM, are covered for those NRC licensed facilities subject to EPA's regulation. Jn contrast, the regulatory authority of NRC and the applicability of NRC regulations do nm extend to NARM. In particular, NRC regulations in 10 CFR Part 20 cannot be assumed to apply to NARM air emissions by NRC licensees. Similarly, NRC cannot be expected to enforce 10 CFR Part 20 requirements as they relate to NARM. Only in NRC Agreement States could the regulatory authority and sufficiency be considered adequately extended to cover NARM emissions.

Therefore, EPA's proposed recision of 40 CFR Part 61, Subpart I, would not necessarily assure EPA that the public dose limit of 10 millirem per year from air emissions from NRC licensed facilities in non-NRC Agreement States would be met if the air emissions included NARM, for which no controls are available on the basis of NRC regulatory authority. As an example of the potential significance of the NARM issue, our records indicate that over 40% of all NRC licensed facilities in Michigan (a non-NRC Agreement State) are also authorized to possess NARM. Ackn Z-25 5/94 v--,

U.S. Environmental Protection Agency January 11, 1996 Page2

2. If, in consideration of comment # 1, above, EPA chose to retain the applicability of 40 CFR 61, Subpart I, to those NRC licensed facilities whose air emissions include NARM, it is not clear to us what enforcement mechanism EPA would use to assure compliance. The enforcement mechanism is especially uncertain in non-NRC Agreement states, like Michigan, where the regulatory authority and resources at the state agency level may be severely limited and/or fragmented.

I recommend that EPA clarify the impact of its proposal as it relates to the control of air emissions involving NARM from NRC licensed facilities and clarify the associated enforcement impact on the various state radiation control programs. Thank you for the opportunity to provide comment on this issue.

C61ly, LL-"---=

I Jamf K. Havem , Jr. cc: U.S. NRC I

DOCKET NUMBER PR PROPOSED RULE M ((coFR.~~9~~ (+/-) DOCKETED From: John Stephens <stephens@lamar.colostate.edu> USNRC To: TWD2. TWP9(ctr) Date: 1/16/96 7:42pm '96 JAN 17 A9 :19

Subject:

constraint levels OFF IC E OF SECRETAR Y Mr. Charlene Raddatz, DOCK ETJt~G &_SERV'CE On the Health Physics BB (radsafe), there has been many criticisms of changinf~ ~~sk based limit for regulatory concern to 10-15 mrem/yr from the generally accepted 100 mrem/yr. Below are some of the main points:

1. The exposure rate corresponds to 1 microR/hr, can not measure this accurately.

2. The cost does not out weigh the benefit, since populations living in regions with several times higher exposure have no significant adverse health effects .

John Stephens

U.S. NUCLEAR REGULATORY COMMISSIOt;i DOCKETING & SERVICE SECTION OFFICE OF THE SECRET ARY OF THE COMMISSION Document Statistics Po.stmark Date~ ,cv*Q,__ ~ 7'f.~ Copies Received, _ _.__ _ _ _ __ Add'! Copies Reproduced ___,__ _ _ __ Special Distribution ~ .Qi} ...4:;... ,, 3?,;:,R,,. :::Xw>S I

                                        °:cp .J4.>-. )

(f _l) - ~~ -

From: Char1een Raddatz To: WND1. WNP2.ELJ Date: 1/17/96 6:33am

Subject:

constraint levels -Forwarded Please docket the attached comment on the proposed Constraint Level of Air Emissions of Radionuclides published in the FR on December 8, 1995. The docket number is PR-20. Thanks char raddatz

~~~   W Y O M I N G M I N I N GD%:K.filS O C I A T I O N PHONE 635-0331 10 January 1996                         '96 JAN 16 P4 :Q 2                 AREA CODE 307 HITCHING POST INN Nuclear Regulatory Commission          OFF IC E c:- :.fr,RETAR               P. o. Box 866 Washington, D.C. 20555-0001            nocK ETI ' G r.:.' " : " / er:     Cheyenne , Wyoming Attn: Docketing and Services Brandfi            p ~1 *t                          02003
                                                   . ;-. ~DOCKET NUMBER           PR PROPOSED RULE               ao                   .

Gentlemen: ((oore_k,&q~0 @

Subject:

comments on the Proposed Rule: constraint Level for Air Emissions of Radionuclides

• The Wyoming Mining Association (WMA) is an industry association of mining companies and associates (suppliers, contractors, service companies, etc.) in the state of Wyoming. The WMA's membership includes a number of uranium recovery licensees licensed by the Nuclear Regulatory Commission and also subject to 40 CFR Part 61 Subpart I. The Wyoming Mining Association reviewed a copy of the Nuclear Regulatory Commission's (NRC's) proposed Constraint Level for Air Emissions of Radionuclides (Federal Register Volume 60, Number 239, Wednesday, December 13, 1995, pages 63984 - 63987) and has the following comments:

1. General The WMA supports the rec1s1on of 40 CFR Part 61 Subpart I provided that radon and its decay products are excluded from the calculated effective dose equivalent used to determine compliance under the proposed ten (10) millirem (mrem) Total Effective Dose Equivalent (TEDE) As Low As Reasonably Achievable (ALARA) dose "constraint level". 40 CFR Part 61 Subpart I states (40 CFR 61.lOl(b)):

             * *

• The unit of effective dose equivalent is the rem.

11 For purposes of this subpart doses caused by radon-222 and its decay products formed after the radon is released from the facility are not included ***. " The WMA strongly believes that the exclusion for doses due to radon and its decay products, already a part of 40 CFR Part 61 Subpart I, should be carried over into any newly developed constraint level when Subpart I is rescinded and regulatory responsibility is passed on to the NRC. The present language of the NRC's proposed constraint level fails to carry over the intent of Subpart I. The proposed constraint level as published by the NRC states:

          " ... shall constrain air emissions of radioactive materials other than radon-222 so that the individual member of the "IDr 2 s 199r Acknowledged by card ..................................

 .S. NUCLEAR REGUL.ATORY COMMISSIOt--

DOCKETING & SERVICE SECTION OFFICE OF THE SECRETARY OF THE COW..:ISSIO l Postma:. Dat!l \ 1.ei-\9....,.___ __ __ Copies Ree1,\*,1_ 1 /\dd'I Copies Re')"c~*- vJ - - - - - Special Oistributio~ ~ ~~a>~~

Docketing and Services Branch Nuclear Regulatory commission page 2 public likely to receive the highest dose will not be expected to receive a dose in excess of 10 mrem/yr TEDE from these emissions." The WMA requests that the language in the NRC's constraint level be consistent with the language currently in 40 CFR Part 61 Subpart I. Since the NRC's proposed constraint level applies only to emissions from NRC licensed facilities and operations, emissions from unlicensed adjoining operations or unlicensed portions of operations which include an NRC licensed restricted area should be categorically excluded. Emissions from adjoining unlicensed operations can be excluded through the method used to calculate emissions from adjoining NRC licensed operations. This issue is of special concern to uranium recovery licensees whose facilities and restricted areas may adjoin uranium mines with attendant uranium ore stockpiles. Uranium mines and unrefined and unprocessed ore are exempt from NRC regulation and licensing under 10 CFR 40.13(b) which states: (b) Any person is exempt from the regulations in this part and from the requirements for a license set forth in section 62 of the act to the extent that such person receives, possesses, uses, or transfers unrefined and unprocessed ore, containing source material; provided that, except as authorized in a specific license, such person shall not refine or process such ore. Uranium ore piles associated with a uranium mine are exempt from NRC licensing, but still could be a source of airborne radionuclides which, depending upon the relative locations of the exempt mine and the NRC licensed mill and prevailing wind direction, could become included in measurements of airborne radionuclides taken for the purposes of assessing the dose from the mill. The WMA requests that the agency recognize this fact and grant the licensees flexibility in the methodology used to determine dose, so that only emissions from the NRC licensed facilities or the NRC licensed portions of facilities are used to determine dose to the member of the public likely to receive the highest dose from that facility.

2. Flexibility in Determination of Compliance The individual licensees should be allowed flexibility in the methodology used to determine compliance with the new constraint level. This flexibility should be allowed for the following reasons:

Docketing and Services Branch Nuclear Regulatory Commission page 3 2.1.1 Differing Radionuclide Emissions Different licensees will emit different types and combinations of radionuclides in different forms. Radium-226,thorium-230 and natural uranium potentially blown out of a uranium mill tailings impoundment will probably exist as radionuclides attached to sand and dust sized particles. Natural uranium emissions from a uranium mill dryer will exist as descrete particles of yellowcake. Given the broad range of types of emissions, licensees should be allowed flexibility in selecting an appropriate method of determinng compliance. The only requirements on the method selected should be that it is suited to the type of emission and scientifically justifiable. 2.1.2 Variability in Natural Background The dose limit in 40 CFR Part 61 Subpart I and the level in the NRC's proposed constraint level is 10 mrem Total Effective Dose Equivalent (TEDE). This level is very low. Naturally occurring background levels of radionuclides can be higher than 10 mrem near some sites and also be highly variable from year to year depending on the strength of the prevailing winds and the prevailing wind direction for the given year.

3. Exclusion of Dose from Non-Licensed sources The WMA requests that sufficient flexibility be allowed licensees in determining compliance with the NRC's proposed constraint level so that the licensee can exclude radionuclides from sources other than the NRC licensed facility, operation and/or restricted area. This problem is discussed in section 1. In the case of a uranium mill in proximity to an operating uranium mine, determination of compliance could be difficult if windblown material from a uranium mine stockpile, which is exempt from NRC licensure, is measured along with the emissions from the NRC licensed mill due to the relative locations of the mill and mine and the prevailing wind directions.

4. conclusions Regarding the proposed recision of 40 CFR Part 61 Subpart I, the WMA believes:

4.1 The subpart should be rescinded and replaced with an NRC constraint limit, provided that the constraint limit continues to exclude the total effective dose from radon and its progeny as does the subpart.

Docketing and Services Branch Nuclear Regulatory commission page 4 4.2 The total effective dose from radon and its progeny should continue to be excluded because: 4.2.1 Small doses from radon and its progeny are hard to measure. 4.2.2 Small doses from radon and its progeny become lost in the natural variation of background. 4.3 The Wyoming Mining Association believes that emissions from non-licensed neighboring sources should be categorically excluded from inclusion of the dose estimate. In order to accomplish this the licensee should be given flexibility in the method of computing dose from the NRC licensed portion of his operation so that doses from non-licensed sources are not included. This problem could be experienced by a uranium recovery licensee in close proximity to an exempt uranium mining operation with a uranium ore stockpile. Depending on the relationship of the licensed uranium recovery operation and the exempt uranium mine stockpile and the prevailing wind direction particulant radionuclides from the uranium ore stockpile could be included in measurements of emissions from the licensed facility. The WMA appreciates the opportunity to comment on this matter. If you have any questions please do not hesitate to contact me. Sincerely yours,

/??~~

Marion Loomis Executive Director 27e.DEC cc: Katie Sweeney, National Mining Association Anthony J. Thompson, Shaw, Pittman, Potts and Trowbridge

I 4 Sweetwater Uranium Faclllty Kennecott Uranium Company 42 Miles NW of Rawlins DOCKETED PO Box 1500 Rawlins Wyoming 82301 USNRC (307) 328-1478 Fax (307) 324-4925

                                                                     '96 JAN 11 P4 :30 S January 1996                                                                                                            Kennecott OFFIC E O SECRETAR ,

OOCKETI G & "E' V1CE Energy Nuclear Regulatory Commission BRA CH Attn: Docketing and Services Branch Washington, D.C. 20555-0001 oOCKET UM ER PROPOSED LE..!..!!~ ~ - (4oFR.~~~ Gentlemen:

Subject:

Comments on the Proposed Rule: Constraint Level for Air Emissions of Rad ion uclides Kennecott Uranium Company is the operator and manager of the Sweetwater Uranium Project, a uranium recovery facility licensed by the Nuclear Regulatory Commission under Source Material License SUA-1350. The Sweetwater Uranium Project is located in the center of the Great Divide Basin in Sweetwater County, Wyoming. This facility is regulated under Subpart I. The following are Kennecott Uranium Company's comments on the Nuclear Regulatory Commission's (NRC's ) proposed Constraint Level for Air Emissions ofRadionuclides (Federal Register Volume 60, Number 239, Wednesday, December 13, 1995, pages 63984 - 63987):

1. General Kennecott Uranium Company supports the recision of 40 CFR Part 61 Subpart I provided that radon and its decay products are excluded from the calculated effective dose equivalent used to determine compliance under the proposed ten (10) millirem (mrem) total effective dose equivalent (TEDE) As Low As Reasonably Achievable (ALARA) dose "constraint level". 40 CFR Part 61 Subpart I states (40 CFR 61.101 (b )):

                      "... The unit of effective dose equivalent is the rem. For purposes of this subpart doses caused by radon-222 and its decay products formed after the radon is released from the facility are not included .... "

Kennecott Uranium Company strongly believes that the exclusion for doses due to radon and its decay products, already a part of 40 CFR Part 61 Subpart I, should be carried over into any newly developed constraint level when Subpart I is rescinded and regulatory responsibility is passed on to the uclear Regulatory Commission. The present language of the NRC's proposed constraint level fails to carry over the intent of Subpart I. The proposed constraint level as published by the NRC states:

                      "... shall constrain air emissions of radioactive materials other than radon-222 so that the individual member of the public likely to receive the highest dose will Kennecoll Uranium Company II Manager ol the Green Mountain Minong Ventu'Jl    knowledgecJ b     ref i   s ,996 "c                 y ca ......."....."..."...... ... . . .

Kennecott Energy Company proVldes marketing and other services on behalf of Cordero Mining Company, Anlelopa Coal Company, Spnng Creek Coal Company and KllrVMICOII Urlllllum Compony.

U.S. ~uv ... DOCKETiN OFFICE OFT

Nuclear Regulatory Commission Page 2. 5 January 1996 not be expected to receive a dose in excess of 10 mrem/yr TEDE from these emissions." This language excludes only radon-222 from the dose, not radon-222 and its decay products formed after the radon-222 is released from the facility, as does the language in 40 CFR Part 61 Subpart I. Kennecott Uranium Company requests that the language in the NRC's constraint level be changed to explicitly state " ... radon-222 and its decay products formed after the radon is released from the facility ... " in place of merely " ... radon-222 ... " . Since the NRC's proposed constraint level applies only to emissions from NRC licensed facilities and operations, emissions from unlicensed adjoining operations or unlicensed portions of operations which include an NRC licensed restricted area should be categorically excluded. Emissions from adjoining unlicensed operations can be excluded through the method used to calculate emissions from adjoining NRC licensed operations. This issue is of special concern to uranium recovery licensees whose facilities and restricted areas may adjoin uranium mines with attendant uranium ore stockpiles. Uranium mines and unrefined and unprocessed ore are exempt from NRC regulation and licensing under 10 CFR 40.13(b) which states: (b) Any person is exempt from the regulations in this part and from the require-ments for a license set forth in section 62 of the act to the extent that such person receives, possesses, uses, or transfers unrefined and unprocessed ore, containing source material; provided that, except as authorized in a specific license, such person shall not refine or process such ore. Uranium ore piles associated with a uranium mine are exempt from NRC licensing, but still could be a source of airborne radionuclides which, depending upon the relative locations of the exempt mine and the NRC licensed facilities and prevailing wind direction could become included in measurements of airborne radionuclides taken for the purposes of assessing the dose from the facility. Kennecott Uranium Company requests that the agency recognize this fact so that only emissions from the NRC licensed facilities or the NRC licensed portions of facilities are used to determine dose to the member of the public likely to receive the highest dose from that facility.

2. Rationale for the Continued Exclusion of Radon Decay Products Concentrations of radon decay products in ambient air are notoriously variable temporally and laterally. A substantial portion of the background total effective dose-equivalent (TEDE) dose and most of the internal background TEDE dose is from radon decay products. In fact, at 100% equilibrium between radon-222 and its decay products, 1% of the total dose is from

Nuclear Regulatory Commission Page 3. 5 January 1996 radon-222 alone, while 99% of the total dose is from the radon daughters. (Notes to Radon Daughter Dose - Effective Dose Equivalent (EDD-EDE) Table provided by NRC). 40 CFR Part 61 Subpart I establishes an emission standard of 10 mrem TEDE to any member of the general public at the site boundary, excluding any dose from radon and its decay products formed after the radon is released. It would be extremely difficult to accurately measure any dose from radon decay products which would be within the 10 mrem standard, - thus radon decay products should continue to be excluded from any new constraint limit. The reason that it is extremely difficult to measure a very low dose (under 10 mrem TEDE) from radon decay products is because of the large natural variation in background concentrations of radon progeny both laterally and temporally. Small (under 10 mrem) doses of radon decay products become lost in the background "noise". At the Sweetwater Uranium Project, which is located in Sweetwater County, in the center of the Great Divide Basin in Wyoming background radon concentrations vary widely. The following chart shows the range of background radon-222 concentrations and associated total effective dose equivalents from the decay products assuming a measured equilibrium factor of0.28 for the radon decay products:

Background

Measured Concentration Dose (pCi/L) (Rems-TEDE) High: 6.57 0.81 Low: 2.4 0.29 The natural variability of dose and TEDE for this area is 279% or 520 mrems. It is easy to see how a 10 mrem dose due to radon decay products could become lost within this natural variability since the regulatory dose limit is 1.9% of the natural variation. In addition, requiring licensees to measure radon daughters derived from radon emitted from their facilities would increase environmental monitoring costs and complexities for the licensees without commensurate benefits.

3. Flexibility in Determination of Compliance The individual licensees should be allowed latitude in the methodology used to determine compliance with the new constraint level. This latitude should be allowed for the following reasons:

3.1 Differing Radionuclide Emissions Different licensees will emit different types and combinations of radionuclides in

Nuclear Regulatory Commission Page 4. 5 January 1996 different forms. Iodine-131 emitted from a hospital, for example, will be emitted as a gas while radium-226, thorium-230 and natural uranium potentially blown out of a uranium mill tailings impoundment will probably exist as radionuclides attached to sand and dust sized particles. Natural uranium emissions from a uranium mill dryer will exist as discrete particles of yellowcake. Given the broad range of types of emissions, licensees should be allowed latitude in selecting an appropriate method of determining compliance. The only requirements on the method selected should be that it is suited to the type of emission and scientifically justifiable. 3.2 Variability in Natural Background The dose limit in 40 CFR Part 61 Subpart I and the level in the NRC's proposed constraint level is 10 mrem Total Effective Dose Equivalent (TEDE). This level is low. Naturally occurring background levels of radionuclides can be high near some sites and also be highly variable from year to year depending on the strength of the prevailing winds and the prevailing wind direction for the given year. The methods used in determining compliance with the NRC's proposed constraint level must be able to account for natural variability in background.

4. Exclusion of Dose from Non-Licensed Sources Kennecott Uranium Company requests that licensees exclude radionuclides from sources other than the NRC licensed facility, operation and/or restricted area. This problem is discussed in section 1. In the case of a uranium mill in proximity to an operating uranium mine, determination of compliance could be difficult if windblown material from a uranium mine stockpile, which is exempt from NRC licensure, is measured along with the emissions from the NRC licensed mill due to the relative locations of the mill and mine and the prevailing wind directions.

5. Conclusions Regarding the proposed recision of 40 CFR Part 61 Subpart I, Kennecott Uranium Company believes:

5.1 The subpart should be rescinded and replaced with an NRC constraint limit, provided that the constraint limit continues to exclude the total effective dose from radon and its progeny as does the subpart. 5.2 The total effective dose from radon and its progeny should continue to be excluded because: 5.2.1 Small doses from radon and its progeny are hard to measure.

Nuclear Regulatory Commission Page 5. 5 January 1996 5.2.2 Small doses from radon and its progeny become lost in the natural variation of background. 5.3 Kennecott Uranium Company believes that emissions from non-licensed neighboring sources should be categorically excluded from inclusion of the dose estimate. In order to accomplish this the licensee's method of computing dose from the NRC licensed portion of his operation should exclude doses from non-licensed sources. This problem could be experienced by a uranium recovery licensee in close proximity to an exempt uranium mining operation with a uranium ore stockpile. Depending on the relationship of the licensed uranium recovery operation and the exempt uranium mine stockpile and the prevailing wind direction particulant radionuclides from the uranium ore stockpile could be included in measurements of emissions from the licensed facility. Kennecott Uranium Company appreciates the opportunity to comment on this matter. If you have any questions please do not hesitate to contact me. Facility Supervisor 20B.DEC cc: M. H. Gibson Pat Lorello Bob Green George Worman Dave Crouch Kenneth J. Webber D. P. (Mike) Svilar Katie Sweeney Anthony J. Thompson

DOCKETED GeNC RP USNRC P.O. Box 399 AcRJcT Jonesborough, Tennessee 37659

                                    *~ OEC 26 A10 :14 Tel:  423-753-1200 Fax:  423-753-8645 OFF ICE OF SECRETARY DOCKE TING & SEHV'CE BRA CH December 21, 1995                                         DOCKET NUMBER        PR PROPOSE ULE                   ~o

( <coFR.. (c3cri+; CD U.S. Nuclear Regulatory Commission Washington, DC 20555-0001 ATIN: Dockeiing and Services Branch

Subject:

Proposed Rule, "Constraint Level for Air Emissions of Radionuclides" The following comments are provided concerning the subject proposed rule:

1. §20.llOl(d) reads in part, "... [licensees] shall constrain air emissions of radioactive materials other than radon-222 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 emissions."

      "these" should read "the licensee's air" to clarify that the licensee need account only for his own air emissions in determining the dose to an individual member of the public and not other licensees who may be contributing to that dose. This language is consistent with the rationale given in the supplementary information, "... to constrain dose to members of the public from air emissions of radioactive materials from a single source to 10 mrem/yr.

2. §20.2203(a)(2)(vi) reads, "the ALARA constraints for air emissions established under

      §20.ll0lU:); or"
      §20.2203(a)(2)(vi) should read, "... established under §20.1101(.9).
                                                                                *oEc 2 1 1995 Acknowledged by card .......................... ..... .

U.S. NUCLEAR REC.u,..,".; 0RY COMMISSIOf\ DOCKETING & SERVICE SECTION OFFICE OF THE SECRETARY OF THE COMMISSION Docurn 'nt Stalist'cs ~o~ark Da_te ~_.__,~ - - - _,op:es R ~ *VtJ_ --4-_ _ _ __ _ 'dd'I Co,.,i s R-i*_, .. uced ...,_,_ _ _ __ Soociaf Distribu :on~c;,. D,Q.,.-v:;.._ 3'.!})R

'                    7               o'        1

3. Appendix E to 40CFR61 provides methods for determining compliance with the standard the proposed rule is to replace, including "Screening Techniques for Determining Compliance with Environmental Standards," from NCRP Commentary No. 3 and EPA's COMPLY computer code. Does NRC intend to accept any or all of these procedures to demonstrate compliance with the dose constraint?

Sincerely, Url2.gl. Arthur E. Exten Senior Environmental Analyst

DOCKETED USNRC L7590-01-P] NUCLEAR REGULATORY COMMISSION

                                                        *95 DEC -8 A10 :1 9 10 CFR Part 20 RIN 3150-AF31       OFFI CE: o- S~CfiETARY DOC KE T!' ~j :c 3ER'/ICE Constraint Level for Air Emissions of Radionu l ~t~~H-:H AGENCY:   Nuclear Regulatory Commission.        DOCKET NUMBER       R PROPOSED RULE     p c:Q...O

(~FR.. (o~9 ~ ~) ACTION: Proposed rule.

SUMMARY

The Nuclear Regulatory Commission (NRC) is proposing 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 proposed rule is necessary to provide assurance to the Environmental Protection Agency (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 its Clean Air Act (CAA) regulations for NRC licensed facilities (other than power reactors) and Agreement State licensees, thereby relieving these licensees from unnecessary dual regulations.

                                 ~ \'o\, \99~

OATES: Submit comments by ego d ~ t h e date of ~HblieatioA}. Comments received after this date will be considered if it is practical to do so, but the Commission is able to assure consideration only for comments received on or before this date.

ADDRESSES: Send comments to: U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, ATTN: Docketing and Services Branch. Hand deliver comments to: 11555 Rockville Pike, Rockville, Maryland, between 7:45 a.m. and 4:15 p.m. Federal workdays. Comments may be submitted electronically, in either ASCII text or Wordperfect format (version 5.1 or later), by calling the NRC Electronic Rulemaking Bulletin Board (BBS) on FEDWORLD. The BBS is an electronic information system operated by the National Technical Information Service of the Department of Commerce. The purpose of this bulletin board BBS is to facilitate public participation in the NRC regulatory process, particularly rulemakings. With publication of this notice, proposed rulemakings and appropriate supporting documents will be available for review and comment on the BBS. These same documents are also available for review and comment at the NRC's Public Document Room, 2120 L Street NW. (Lower Level), Washington, DC. The BBS may be accessed using a personal computer, a modem, and one of the commonly available communications software packages, or directly via Internet. The NRC rulemaking bulletin board (rulemaking subsystem) on FEDWORLD can - be accessed directly by using a personal computer and modem, dialing the toll free number at 1-800-303-9672. Communication software parameters should be set as follows: parity to none, data bits to 8, and stop bits to 1 (N,8,1). Using ANSI or VT-100 terminal emulation, the NRC rulemaking subsystem can then be accessed by selecting the "Rules Menu" option from the "NRC Main Menu." For further information about options available for NRC at FEDWORLD consult 2

the "Help/Information Center" from the "NRC Main Menu." Users will find the "FEDWORLD Online User's Guides" particularly helpful. Many NRC subsystems and databases also have a "Help/Information Center" option that is tailored to the particular subsystem. The NRC ~ubsystem on FEDWORLD also ~an be accessed by a direct dial phone numb.er for the main FEDWORLD BBS at 703-321-3339; or ~Y using Telnet via Internet: fedworld.gov. Using the 703 number to contact FEDWORLD, the NRC subsystem will be accessed from the main FEDWORLD menu by selecting the "Regulatory; Government Administration and State Systems," then selecting "Regulatory Information Mall." At that point, a menu will be displayed that has the option "U.S. Nuclear Regulatory Commission" that will take you to the NRC Online main menu. The NRC Online area also can be accessed directly by typing "/go nrc" at a FEDWORLD command line. If you access NRC from FEDWORLD's main menu, then you may return to FEDWORLD by selecting the "Return to FEDWORLD" option from the NRC Online Main Menu. However, if you access NRC at FEDWORLD by using NRC's toll-fre.e number, then you will have full access to all NRC systems, but you will not have access to the main FEDWORLD system. If you contact FEDWORLD using Telnet, you will see the NRC area and menus, including the "Rules Menu". Although you will be able to download documents and leave messages, you will not be able to write comments or upload. files. If you contact FEDWORLD using FTP, all files can be accessed and downloaded, but uploads are not allowed, and all you will see is a list of files without descriptions (normal Gopher look). An index file listing all files within a subdirectory, with descriptions, is available. There is a 15-minute time limit for FTP access. 3

Although FEDWORLD also can be accessed through the World Wide Web as well, like FTP, that mode only provides access for downloading files, and does not display the NRC "Rules Menu." For more information on NRC bulletin boards call Mr. Arthur Davis, Systems Integration and Development Branch, U.S. Nuclear Regulatory

                                                                           \

Commission, Washington, DC 20555, telephone (301) 415-5780; e-mail AXD3@nrc.gov. Comments received on this proposed rule may be examined and/or copied for a fea at the NRC Public Document Room, 2120 L Street NW. (Lower Level), Washington, -DC. 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; e-mail CTR@NRC.GOV. SUPPLEMENTARY INFORMATION: 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 subject to the requirements of Subpart I. Initially, Radon-222 emissions from tailings were covered by 40 CFR 61, Subparts T and W. Subpart Twas rescinded for NRC licensees after 4

Appendix A to Part 40 was amended by the Commission to conform to changes EPA issued to 40 CFR 192 that adopted the provisions of subpart T (Subpart Wstill applies to NRC licensees). Since Radon-222 is adequately addressed in Appendix A to Part 40 and other provisions of Part 20 it is not covered in this proposed rulemaking. Under Subpart I, emissions of radionucli?es must be limited so that no member of the public would receive an effective dose equivalent of greater than 10 mrem/yr 1 *

• 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 categor,y or subcategory provides an ample margin of safety to protect the public health. Subpart I expresses dose in effective dose equivalent (EDE). NRC expresses dose in total effective dose equivalent (TEDE). These terms are essentially equivalent. For the sake of consistency, this paper will refer to all doses in terms of TEDE. 5

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 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 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 6

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 are currently subject to dual regulation of air emissions of radionuclides under both the AEA a*nd the CAA, including regulatory oversight by EPA (or authorized State) and NRC (or Agreement State). NRC li_censees 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) ~-hd all ;J 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 9 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 for many years reported estimated aoses to members of the public from air 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 proposed to rescind Subpart I for power reactors licensed by NRC (56 FR 37196; August 5, 1991). 7

r The NRC is proposing to establish a constraint of 10 mrem/yr TEDE for dose to members of the public from air emissions of radionuclides from NRC licensed,facilities other than power reactors as a part of its program to maintain doses ALARA. The rulemaking being proposed would 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 established within 10 CFR 50 and facility licensing conditions. This regulatory action would ensure that air emissions are maintained at a very low level and, taking into consideration the elimination of dual regulation, at lfttle or no cost . This action would also 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. 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 112(d)(9) of the CAA. The fundamental objective of this effort has been to eliminate unnecessary duplicative regulations that provide no incremental benefit in terms of public and environmental protection. The regulatory framework within which NRC proposes to provide 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 8

dose to members of the public from air emissions of radioactive materials from a single source to 10 mrem/yr. If the licensee estimates or measures a dose to a member of the public expected to receive the highest dose from air effluents to be less than 10 mrem/yr, the licensee would be required to record the dose and the assumption used to calculate it consistent with the requirements of§ 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 tri report the dose to NRC in writirig within 30 days. In additio~,

the licensee would be required to include in that report the circumstan&es that led to the greater than 10 mrem/year dose, a description ot the corrective steps the licensee has taken or proposes 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 would not result in a Notice of Violation (NOV). Rather, a NOV would be issued only upon failure to report that actual or estimated doses, from air effluent releases from a facility, have exceeded the constraint value and/or failure to institute appropriate measures to correct and prevent further emissions in excess of those which would result in dose exceeding the-constraint level. The proposed rule would apply to airborne releases, other than Radon-222, from all NRC licensees except power reactors. Power 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 9

employed for keeping doses to members of the public from air effluents ALARA. r Appendix I to Part 50 contains the numerical guidelines to meet this requirement. In addition to the discussion above, the Commission is soliciting comments on the question of whether the lU mrem constraint should be established in 10 CFR Part 20, as proposed, or whether it should be established separately in each appropriate Part of Title 10 instead. Regulatory Guide Regulatory Guide 8.37, "ALARA Levels for Effluents From Materials Facilities," is being modified to reflect the introduction of the constraint on air emissions in the proposed rule and to identify those methods acceptable to the NRC for implementing the rule. To afford m~mbers of the public with an opportunity to comment on the rule and guide as a complete package, publication of the guide for comment is expected to be coincident with J,"; publication of the proposed rule, or within a few weeks of the date of publication of the proposed rule. Agreement State Compatibility Section 116 of the CAA authorizes individual States to establish more restrictive requirements than those presented in Subpart I. In view of the CAA precedent, the NRC staff is recommending that this rule be a Division 2 matter of compatibility under the existing compatibility policy. As such,

Agreement States could choose to adopt a rule which is more restrictive but no less restrictive than the one approved by the Commission. The NRC is* in the process of revising its co~patibility policy and has issued a proposed policy for pu~lic 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 .

• Finding of No Significant Environmental Impact The Commission has determined under the National Environmental Policy Act of 1969; as amended, and the NRC's regulations in Subpart A of 10 CFR Part 51, that this rule, if adopted, would not be a major Federal action significantly affecting the quality of the human environment and therefore an environmental impact statement is not required. This action is not expected 9 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 and inspection procedures. The environmental assessment and finding of no significant impact on which this determination is based are available for inspection and photocopying fo~ a fee at the NRC Public Document Room, 2120 L Street NW. (Lower Level), Washington, DC.

11

Paperwork Reduction Act Statement This proposed rule amends information collection requirements that are subject to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq). This ~ule has been submitted to the Office of Management and Budget (0MB) for review and approv_a l of the information co 11 ect ion requirements. The public reporting burden for this collection of information is estimated to average 80 hours 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. The U.S. Nuclear Regulatory Commission is seeking public comment on the potential impact of the collection of information contained in the proposed rule and on the following issues:

1. Is the proposed collection of information necessary for the proper performance of the functions of the NRC, including whether the information will have practical utility?

2. Is the estimate of burden accurate?

3. Is there a way to enhance the quality, utility, and clarity of the information to be collected?

4. How can the burden of the collection of information be minimized, including the use of automated collection techniques?

12

Send comments on any aspect of ti.is proposed collection of information, including suggestions for reducing the burden, to the Information and Records Management Branch (T-6 F33), U.S. Nuclear Regulatory Commission, Washington, DC 20555-001, and to the Desk Officer, Office of Information and Regulatory Affairs, NEOB-10202, (3150-0014), Office of Management and Budget, Washington, DC 20503. Comments to 0MB on the collections of information or on the above issues should be submitted by (insert date 30 days after publication in the Federal Register). Comment~ received afte~ this date will be considered if it is practical to do so, but assurance of consideration cannot be given to 26mments recetved after this date. Publ1c 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 0MB control number. Regulatory Analysis The Commission has prepared a draft regulatory analysis on this proposed regulation. The analysis examines the costs and benefits of the alternatives considered by the Commission. The draft analysis is available for inspection in the NRC Public Document Room, 2120 L Street NW. (Lower Level), Washington, 13

DC. Single copies of the analysis m~y be obtained from Charleen T. Raddatz, (301) 415-6215. The Commission requests public comment on the draft analysis. Comments on the draft analysis may be submitted to the NRC as indicated under the ADDRESSES heading. Regulatory Flexibility Certification In accordance with the Regulatory Fle~ibility 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 rule onl~ impacts NRC licensees with emissions of significant quantities of radioactive material. This category of licensee includes only a few small businesses. Backfit Analysis The NRC has determined that the backfit rule, 10 CFR 50.109, does not apply to this proposed rule because it does not apply to power reactor licensees, and therefore, that a backfit analysis is not required for this proposed rule because these amendments do not involve any provisions which would impose backfits as defined in 10 CFR 50.109(a)(l). 14

List of Subjects In 10 CFR Part 20 Byproduct material, Criminal penalties, Licensed material, Nuclear materials, Nuclear power plants and rea~tors, Occupational safety and health, Packaging and containers, Radiation protection, Reporting and recordkeeping requirements, Source material, Special nuclear material, Wast~ treatment and disposal. For.the reasons set put 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 proposing to adopt the fo 11 owi*ng

• amendments to 10 CFR Part 20.

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).

2. In§ 20.1003, the definition of Constraint is added to read as follows:

15

§ 20.1003 Definitions.

Constraint (dose constraint) means a value above which specified licensee actions are required.

3. In§ 20.1101 paragraph (d) is added to read as follows:

§ 20.1101 Radiation Protection Programs (d) To implement the ALARA requirements of§ 20.ll0l(b), *and notwithstanding the requirements in'§ 20.1301 of this part, licensees other than those subject to§§ 50.34a or 50.36b, shall constrain air emissions of radioactive materials other than radon-222 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 emissions. If a licensee subject to this requirement exceeds this dose constraint, the licensee shall report the exceedence as provided in§ 20.2203 and promptly take ~ppropriate corrective action to ensure against recurrence. 16

4. In§ 20.2203 a new paragraph (a)(2)(vi) is addeq and paragraph (b)(l)(iv) is revised to read as follows:

  § 20.2203 Reports of exposures, radiation levels. and concentrations of radioactive material exceeding the constraints or limits.

(a) * * * (2) * * * (vi) The ALARA constraints for air emissions established under

• § 20.ll0l(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 constraints, generally applicable environmental standards, and associated license conditions. rt-t. /) . Dated at Rockville, Maryland, this/ -day of V ~ , 1995. For the Nuclea~ Regulatory Commission .

                                             . Hoyle, tary of the Commission.

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