ML23153A095

PR-002 - 60FR15878 - Petition for Rulemaking; Procedure for Submission

ML23153A095
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Issue date:	03/28/1995
From:	Bates A NRC/SECY
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PR-002, 60FR15878
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KEYWORD: ADAMS Template: SECY-067 03/28/1995 PR-002 - 60FR15878 - PETITION FOR RULEMAKING; PROCEDURE FOR SUBMISSION PR-002 60FR15878 RULEMAKING COMMENTS Document Sensitivity: Non-sensitive - SUNSI Review Complete

STATUS OF RULEMAKING PROPOSED RULE: PR-002 OPEN ITEM (Y/N) N RULE NAME: PETITION FOR RULEMAKING; PROCEDURE FOR SUBMISSION PROPOSED RULE FED REG CITE: 60FR15878 PROPOSED RULE PUBLICATION DATE: 03/28/ 95 ORIGINAL DATE FOR COMMENTS: 06/12/95 NUMBER OF COMMENTS: EXTENSION DATE: I I FINAL RULE FED. REG. CITE: FINAL RULE PUBLICATION DATE: 12 I I NOTES ON: FRN WITHDRAWING NOTICE OF PROPOSED RULEMAKING PUBLISHED ON 2/ 6/ 96 STATUS AT 61FR4378. FILE ON* Pl. OF RULE HISTORY OF THE RULE PART AFFECTED: PR-002 RULE TITLE: PETITION FOR RULEMAKING; PROCEDURE FOR SUBMISSION PROPOSED RULE PROPOSED RULE DATE PROPOSED RULE SECY PAPER: 95-030 SRM DATE: 03/10/ 95 SIGNED BY SECRETARY: 03 /22/95 FINAL RULE SECY PAPER: FINAL RULE SRM DATE: I I DATE FINAL RULE SIGNED BY SECRETARY: I I STAFF CONTACTS ON THE RULE CONTACTl: T.Y. CHANG, RES CONTACT2: CHRIS ROURK, RES MAIL STOP: T-10C9 MAIL STOP: T-10C9 PHONE: 415-6450 PHONE: 415-5865

DOCKET NO. PR-002 (60FR15878) In the Matter of PETITION FOR RULEMAKING; PROCEDURE FOR SUBMISSION DATE DATE OF TITLE OR DOCKETED DOCUMENT DESCRIPTION OF DOCUMENT 03/23/95 03/22/95 FEDERAL REGISTER NOTICE - PROPOSED RULE 04/22/95 04/14/95 COMMENT OF CLEAN WATER FUND OF NORTH CAROLINA (DR. CARL RUPERT) (

1) 06/12/95 06/08/95 COMMENT OF ENTERGY OPERATIONS, INC (JERROLD G. DEWEASE, V. P.) (

2) 06/12/95 06/08/95 COMMENT OF FLORIDA POWER & LIGHT CO (W. H. BOHLKE, V.P.) (

3) 06/12/95 06/09/95 COMMENT OF DEPARTMENT OF ENERGY (RONALD A. MILNER) (

4) 06/12/95 06/09/95 COMMENT OF YANKEE ATOMIC ELECTRIC CO (JANE M. GRANT) (

5) 06/12/95 COMMENT OF NUCLEAR ENERGY INSTITUTE (ROBERT W. BISHOP) (

6) 06/14/95 06/12/95 COMMENT OF VIRGINIA POWER (MARTIN L. BOWLING, JR.) (

7) 06/15/95 06/12/95 COMMENT OF AMERICAN COLLEGE OF NUCLEAR PHYSICIANS/SOC NUC MED (JAMES J. CONWAY & ROBERT CARRETTA) (

8) 06/19/95 06/13/95 COMMENT OF DUQUESNE LIGHT CO (GEORGES. THOMAS) (

9) 06/19/95 06/13/95 COMMENT OF OHIO CITIZENS FOR RESPONSIBLE ENERGY, INC (SUSAN L. HIATT, DIRECTOR) (

10) 06/21/95 06/13/95 COMMENT OF ILLINOIS DEPARTMENT OF NUCLEAR SAFETY (THOMAS W. ORTCIGER, DIRECTOR) (

11) 06/30/95 06/29/95 COMMENT OF NATIONAL MINING ASSOCIATION (RICHARD L. LAWSON, PRESIDENT) (

12) 03/25/98 01/31/96 FEDERAL REGISTER NOTICE - PROPOSED RULE:

WITHDRAWAL

DOCKET NUMI§~ PROPOSED RULE 2 DOCKETED USMRC [7590-01-P] (~()FA l5"S1B)

• 9a MAR 25 A 8 :24 AGENCY:

ACTION:

SUMMARY

NUCLEAR REGULATORY COMMISSION 10 CFR PART 2 RIN 3150-AF23 Petition for Rulemaking; Procedure for Submission Nuclear Regulatory Commission. Proposed rule: Withdrawal. The Nuclear Regulatory Commission (NRC) is withdrawing a notice of proposed rulemaking published in the Federal Register on March 28, 1995 (60 FR 15878), pertaining to petitions for rulemaking. The proposed rule would have provided incentive of more expeditious disposition by the NRC to those petitioners who submitted detailed supporting information in their petitions which facilitated NRC review. The proposed rule would also have delineated factors that affect priorities for review of the petitions. In lieu of the proposed rulemaking, the information in the proposed rule together with additional guidance wil l be provided in a Regulatory Guide to be developed by the NRC and distributed to the industry and the public. FOR FURTHER INFORMATION CONTACT: T.Y. Chang, Office of Nuclear Regulatory Research, U.S. Nuclear Regul atory Commission, Washington, DC 20555, telephone (301) 415-6450. 1 ()Ad). m 0./1,/q lo td "IF~'/378 - ' F

SUPPLEMENTARY INFORMATION:

Background

On March 28, 1995 (60 FR 15878), the NRC published a notice of proposed rulemaking for public comment in the Federal Register, entitled "Petition for Rulemaking; Procedure for Submission", to amend§ 2.802, Petition for Rulemaking. The proposed rule would have provided incentive of more expeditious disposition by the NRC to those petitioners who submitted detailed supporting information in their petitions which facilitated NRC review. The proposed rule would also have delineated factors that affect priorities for review of the petitions. Twelve comment letters were received on the proposed rule. The industry and various Federal and local governmental agencies generally commended the NRC for proposing ways to improve the process of petitioning for rulemaking, but most commenters thought it is unnecessary to codify the criteria for expedited processing of petitions for rulemaking in the Code of Federal Regulations. Instead, it was suggested that documents such as regulatory guides and information letters, which are guidance rather than rules, were more appropriate vehicles to provide this information. Three of the four nonnuclear, nongovernment commenters also opposed the proposed rulemaking, on the grounds that (1) the NRC was passing off its responsibilities for analysis and documentation to the public, who could not 2

possibly undertake this type of burden, and (2) the NRC might ignore safety issues raised by the public that might not be thoroughly documented in favor of issues that would be beneficial to the industry and that were well documented but were not real safety issues. These two aspects were fully discussed in the proposed rule. The proposed rule stated that "The proposed changes would afford any petitioner two options: submit the minimal threshold information in the petition that is required by the current rule and be subject to the regular processing procedures, or submit more detailed supporting information and analyses in the petition in return for a more expeditious processing procedure by the NRC. The proposed revisions would not change any existing provision regarding petitions for rulemaking if they meet the minimum threshold requirement of the current§ 2.802(c)." Further, the proposed rule stated that "Consideration of safety significance is the first criterion for prioritizing the review and disposition of petitions. It is the primary concern of the NRC to ensure that design and operation of NRC licensed facilities are carried out in a manner which assures adequate protection of public health and safety, of the environment, and of national security. Therefore, petitions found by the NRC to raise a concern in this regard would receive immediate NRC attention." In addition, the proposed rule stated that "Petitions containing supporting information additional to those currently required would improve their priority for review and receive more expeditious disposition." The NRC originally proposed to amend the current§ 2.802 as a rule change. After reviewing comments on the proposed§ 2.802, however, the NRC 3

became convinced that there is strong merit in the comments recommending against codification of the criteria for expedited processing of the petitions for rulemaking, because (1) the proposed procedure does not impose mandatory requirements, and (2) the proposed procedure is clearly of an administrative nature. Therefore, the proposed rule is not required and is being withdrawn, and the information in the proposed rule will be provided in a Regulatory Guide to be developed by the NRC and distributed to the industry and the public. In addition to the information originally intended to be included in the revised § 2.802, the Regulatory Guide will also provide guidance for preparation of more detailed petitions for rulemaking. Furthermore, as mentioned in the proposed rule, the NRC has identified a need to establish an administrative framework to facilitate concerned parties submittal of proposals to issue, amend, or rescind any generic regulatory guidance document. Generic regulatory guidance documents are documents such as regulatory guides, bulletins, generic letters and sections of the Standard Review Plan (including Branch Technical Positions), which do not have the force and effect of a regulation, but are used by the NRC to identify or clarify acceptable NRC staff positions which comply with NRC regulations. A formal procedure which enables interested parties to propose changes to these regulatory guidance documents does not now exist. Therefore, a separate 4

Regulatory Guide will be developed by the NRC to provide guidance for preparation and submission of proposals for generic regulatory guidance documents. Dated at Rockville, Maryland, this 3; o?.r day of {/~d-, 1996. For the Nuclear Regulatory Commission. Johry,c'. Hoye, Secfetary of the Commission. 5

National Mining Association Foundation For America's Future Richard L. Lawson Pres1denr and Chief Executive Officer (202) 463-2647 Secretary Attn: Docketing and Services Branch U.S. Nuclear Regulatory Commission Washington, DC 20555 June 29, 1995 RE: Proposed Rule on Procedures for Submission of Petitions for Rulemaking

Dear Sir:

DOCKETED USNRC '9.5 JJN 30 P 3 :55 OFFICE OF S CRETARY OOCXETI G & SE.:-\\VICE BRA iC.H DOCKET NUMBER p 2. p 0P0SED RULE..!...:!.-~- { 6 o Ffl 15 !--,?) The National Mining Association (NMA) is pleased to have the opportunity to comment on the Nuclear Regulatory Commission's (NRC) proposed amendment of its regulations pertaining to petitions for rulemaking. 60 Fed. Reg. 15878 (March 28, 1995). NMA was established in February 1995, following the merger of the National Coal Association and the American Mining Congress. Its 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 and engineering firms; and other business related to coal and hardrock mining. NMA recognizes the comment period expired June 12, 1995, however, as a result of the need to discuss the proposal with our NRC licensee member companies, we were unable to provide the comments any earlier and since they are relatively brief, we hope they will be considered by the Commission. A variety of NRC programs and experiences have led NRC to conclude appropriately that "(1) an expanded role for the public, including industry, to participate in the process of improving regulations through petitions for rulemaking is desirable and should be encouraged, and (2) the petition for rulemaking process could be improved to make it more responsive to petitioners." 60 Fed. Reg. at 15878. As a result, NRC proposes modifying 10 C.F.R. §2.802 to expand the use and improve the responsiveness of the petition process and to establish factors that help set priorities for reviewing petitions. In essence, NRC proposes to encourage industry and the public to submit far more detailed supporting information with petitions for rulemaking than is presently required, thereby enabling NRC staff to decide whether to grant or deny petitions with a minimal (or at least potentially more minimal) expenditure of staff resources. The proposed amendment would not change the existing procedures for rulemaking petitions, but would add to the t.,u,_ 3 19951 Acknowledged by card 1130 17TH STREET, NW. WASHINGTON, DC 20036-4677 (202) 463-2625 FAX (202) 463-6152

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rule by offering petitioners an alternative within the petition process. Prioritization and scheduling for review would be based on consideration of the merit of each petition and, in particular, its safety significance and the level of detail of the supporting information. In addition, "NRC has decided to provide administrative procedures to make it easier for concerned parties to submit petitions for changes to regulatory guidance documents such as regulatory guides, bulletins, generic letters, sections of the Standard Review Plan (SRP)." 60 Fed. Reg. at 15879. While recognizing that such documents do not have the force and effect of regulations, NRC's staff indeed uses them to address regulatory issues and a formal procedure enabling interested parties to propose changes does not presently exist. NMA fully supports NRC's proposed changes to the rulemaking petition process. NMA believes that prioritization based on the level of safety concern involved as well as the completeness and competence of supporting materials are essentially sound basic criteria for setting priorities. NMA also strongly supports the proposed plan to allow concerned parties to submit petitions to modify regulatory guidance as well as existing rules. In some circumstances, regulatory guidance, is in many respects, on a day-to-day basis, just as, or perhaps even more important than generic rules themselves in addressing proposed license activities. A formal procedure to modify such guidance makes very good sense and will open a new avenue for further streamlining the regulatory process. NMA would like to note, however, that to the extent NRC's rulemaking process does not maintain published schedules and regular contact with petitioners regarding the status of staff or Commission consideration of their petitions, many of the proposed changes may be substantially in vain. One of the major problems with NRC's rulemaking petition process in the past has been that petitions have simply vanished into a dark hole only to appear after the staff and Commission have made a final decision, sometimes years later. NMA, therefore, supports a rigorous schedule of ongoing contact with petitioners, whether the petitions are deemed of major safety significance or not. An electronic bulletin board dealing with petitions is an excellent idea, however, direct communication with petitioners is both appropriate and necessary. Improved communication across the board between NRC and petitioners will do as much to improve the rulemaking petitioning process as allowing petitioners the opportunity to provide more extensive information. NMA also suggests that where NRC believes safety significance is a relatively important factor in establishing a priority for any petition for rulemaking but that it needs additional information to evaluate the petition, NRC should identify as quickly as possible the additional necessary information and contact the petitioner to maintain appropriate prioritization of resources. NMA, also, does not believe that proposed Regulatory Guides are routinely going to be a necessary component of the information that petitioners need to supply. In most cases, proposed Regulatory Guides would be relevant only in the case of major rule changes. 2

If you have any questions or we can be of further assistance, please contact Katie Sweeney, NMA Associate General Counsel, at 202/861-2812. Richard L. Lawson 3

Jim Edgar Governor St. DEPARTME.-,:,*,.,, V..dl t 1 SPRI

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---., ~. BRA CH June 13, 1995 DOCKET NUMBER PROPOSED RULE PR 2 ( 60 F{( I~ J-7 s,-} Secretary U.S. Nuclear Regulatory Commission Washington, D.C. Attention: Docketing and Services Branch RE: Petition for Rulemaking; Procedures for Submission; 60 Federal Re&ister 15878 (March 28, 1995) The Illinois Department of Nuclear Safety (Department) hereby submits its comments on the above-referenced procedures for submission of a petition for rulemaking. The Department believes that this proposal is a sound one and encourages the U.S. Nuclear Regulatory Commission (NRC) to implement this procedure. The Department agrees that two options for submitting a petition for rulemaking should remain in the rule as some entities may not have the time or current resources to submit the additional supporting information necessary for expedited NRC review. However, failure to provide the supporting information should not preclude review and infer that the petition does not have technical merit worthy of NRC consideration. The specific inquiry regarding establishing additional administrative procedures to allow petitions for changes to regulatory guidance documents is also a good idea. Oftentimes the regulatory guides are easier to follow and can explain in more detail the practical application of the regulations. As the regulations and the guidance documents are interrelated both types of documents should be amenable to modification. @ recyclable Arl,('I wlorlii~d hv r.ard....................... ::::

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Secretary, NRC Page Two June 13, 1995 The Department appreciates the opportunity to provide comments on this issue. If you have any questions regarding these comments, please contact Valerie Puccini at 524-0770. Director TWO:vap

DOCKETED USNRC June 13, 1995 "95 JUN 19 P 4 :Q6 COMMENTS OF OHIO CITIZENS FOR RESPONSIBLE ENERGY OFmtE OF ISEIBffl.ElARY ON PROPOSED RULE, "PETITIONS FOR RULEMAKING; PROOEDHRfl'.lttm& SS10i31£E MISS ION," 60 FED. REG. 15878 (MARCH 28, 1995) BRAHCH The proposed changes to the process for submitting petitions for rulemaking purport to provide incentives for petitioners "to submit sufficient supporting information in petitions to facili-tate more expeditious disposition by the NRC, and would also improve openness of the petition for rulemaking process by delin-eating priorities for review of the petitions." OCRE is concerned that some of the provisions in the rule may unfairly impact citizens and public interest tions which file petitions for rulemaking with the NRC. cally: proposed organiza-Specifi-The more detailed supporting information in addition to that required in the current 2.802(c) should include the suggested regulatory text, regulatory analysis, backfit analysis (if required), information required by the National Environmental Policy Act (NEPA), and a guidance document similar in nature to a Regulatory Guide, if needed, in support of a proposed rule, as described in paragraph (d) (2) of the proposed rule. The regulatory analysis is important for petitions seeking either to enhance safety or to reduce regulatory burden, because it would provide information on the changes to risk levels as well as costs associated with proposed alternatives. While OCRE agrees that petitioners should provide the suggested regulatory text, preparation of the other items listed would require resources that are beyond the reach of most individuals and public interest organizations. In many cases, data needed to support these analyses, such as costs to the NRC and

industry, may not even be available to the public.

While it is true that the submission of these additional materi-als is optional, OCRE is concerned that petitioners who have raised a valid safety issue but who do not have the resources to supply regulatory analyses, backfit analyses, etc., would not receive priority consideration of their petitions. It should be sufficient for petitioners seeking the imposition of additional regulatory requirements to simply identify a safety issue and the appropriate remedy. It appears that the primary beneficiaries of this proposal would be industry petitioners seeking the recision of r~ffiu~~tr99S Acknowledm~d bv c~rd..........................--..... ~ 1

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requirements. Industry petitioners would have the resources and data necessary to provide the additional supporting information, and thus, their petitions would receive priority treatment. OCRE is concerned that safety will take a back seat to deregula-tion under this proposal. OCRE is also concerned that the NRC may be abdicating its respon-sibilities under this approach. The preparation of regulatory, backfit, and NEPA analyses is the NRC's responsibility. The NRC should not rely uncritically on such analyses supplied by peti-

tioners, most likely industry petitioners who have a

vested interested in deregulation. RESPONSES TO QUESTIONS POSED IN THE FEDERAL REGISTER NOTICE Q4. Should there be an NRC electronic bulletin board dealing exclusively with petitions? Yes. A section of NRC at FedWorld should be devoted to petitions for rulemaking. This would make it easier for petitioners and commenters to see the comments of interested parties. Q6. Should administrative procedures be established to allow petitions for changes to regulatory guidance documents, such as regulatory guides, bulletins, generic letters, and sections of the Standard Review Plan? Should these procedures be incorporat-ed in a rule? OCRE supports the development of procedures for petitions to change (or to impose new) regulatory guidance documents. Estab-lishing formal procedures would make for a more open and fair process than what OCRE suspects is occurring now regarding guid-ance documents: negotiations between NRC and industry of which the public is largely unaware and to which the public is not a party. OCRE would prefer these procedures to be established in a rule which would be binding. Respectfully submitted, Susan L. Hiatt, Director, OCRE 8275 Munson Road Mentor, OH 44060-2406 (216) 255-3158

Duquesne ug,t Company GEORGES. THOMAS Division Vice President Nuclear Services Nuclear Power Division Beaver Valley Power Station P.O. Box 4 Shippingport, PA 15077-0004 (412) 393-5206 (412) 643-8069 FAX DOCKETED USNRC

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JJN 19 A10 :57 Of.(LC&:-OF x ~RETARY DOCRITING & SERVICE BRANCH Secretary, U.S. Nuclear Regulatory Commission Washington, D. C. 20555-0001 Attention: Docketing and Services Branch DOliKET 'UMBER p 2.. Pi'f..1 OSED RULE...:...:.:~--- (~ 6 FR /Sr7$

Subject:

10 CFR Part 2 Proposed Rule, "Petition for Rulemaking; Procedure for Submission" Duquesne Light Company (DLC) is responsible for the operation of Beaver Valley Power Station Units 1 and 2. DLC is submitting the following on the 10 CFR Part 2 proposed rule, "Petition for Rulemaking; Procedure Submission," which was published in the March 28, 1995, Federal Register (60 FR 15878).. DLC endorses the comments provided by the Nuclear Energy Institute (NEI). The proposed amendments are intended to promote the use of petitions for rulemaking and to improve the Nuclear Regulatory Commission's (NRC's) timeliness in responding to such petitions for rulemaking. To address the concern regarding the NRC's timeliness, DLC concurs with the NEI suggestion that the NRC issue guidance to agency personnel specifying the time periods within which the NRC would have to evaluate, obtain comment( s ), and render a decision on a petition for rulemaking. The NEI proposed time frames are commensurate with DLC's view of a timely review of petitions for rulemaking. Thank you for the opportunity to comment on this issue. If you have any questions on this submittal, please contact Mr. N. R. Tonet, Manager, Nuclear Safety Department, (412) 393-5210. Sincerely, JUL - 3 1995 Acknowf edaed bv e rd....... :.................-.....

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DOCKETED American College of Nuclear Physicians/Society of Nucl~cYI ~dicine WASHINGTON OFFICE

• 95 JUN 15 AS :29 OFFICf or SECR -TARY DOCtL *1ir °' ERViCE June 12, 1995 The Honorable I van Selin Chairman U.S. Nuclear Regulatory Commission Washington, DC 20555 Dear Chairman Selin; 8..... "Nr'J J\\ l-1.

V I [ CKET NUMBER i I 'JPOSED RULE PR.2. ( 6 ° FI< I S-?-7r?-~-- We are writing to you on behalf of the American College of Nuclear Physicians (ACNP) and the Society of Nuclear Medicine (SNM) regarding 10 CFR 2, RIN 3150-AF23, Petition for Rulemaking; Procedure for Submission, published in the Federal Register (volume 60, number 59, pages 15878-15881) on March 28, 1995. We would like to express grave concern over the contents of this Proposed Rule which was recently reviewed by several of our members. This Proposed Rule is meant to establish an alternate pathway for members of the regulated community to petition the NRC to issue, amend, or rescind any regulation. The petition process currently exists (10 CFR 2.802). The NRC states that the petition process could be expedited greatly if the petitioner supplies the majority of the supporting data, data analysis, regulatory analyses, and fulfills various administrative requirements. Currently, the NRC provides for certain of these functions under the existing 10 CFR 2.802. The procedures outlined in this Proposed Rule will result in the burden of these requirements being transferred to the regulated community. This Proposed Rule requires the petitioner to fulfill the administrative requirements traditionally done by the NRC. However, the individuals most qualified to fulfill these administrative requirements in a timely and cost-effective manner are those most familiar with what is required, i.e., the NRC staff. This seems to indicate the NRC has a shortage of resources. Thus, the regulated community bears the burden. It must be recognized by the NRC that while its resources are limited and being continually challenged, the regulated community is faced with even greater cost constraints, to the point that the survival of various segments of this community is now an issue. Thus, it is inappropriate for the NRC to shift its responsibilities and functions to the regulated community, especially when many of the bureaucratic requirements that must be addressed were created by the Agency itself. The NRC has failed to define, explain or quantitate terms. For example (page 15878, top center column), "Inefficient regulations, i.e., regulations that are burdensome and have a minimal safety benefit, could divert NRC and industry resources from issues important to safety, thereby adversely affecting safety." The ACNP/SNM views nearly all the NRC regulations in 10 CFR Part 35 as inefficient, burdensome, and as diverting our resources from important issues (patient care and radiopharmaceutical preparation) and as having no measurable positive impact on safety. 'JOf'2 If 1oor; Acknowf adaed bv card.........................,.::., 1101 17th Street, N.W. Suite 803 Washington, D.C. 20036-4704 202-833-9270 Fax 202-833-9012

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ACNP/SNM Commentary on NRC Proposed Rule Changes to 10 CFR 2 Page 2 The regulated community views safety as a much larger concern than just radiation safety. In fact, 99.6% of nuclear medicine procedures are diagnostic, and essentially risk-free when compared to non-nuclear medicine. It is only logical that the regulated community allot to radiation safety a portion of our resources commensurate with its relative risk. Therefore, without a "gold standard" to use as a reference point defining safety or burdensome, the whole debate is moot. Regardless of how scientific the petition is or how sound the supporting data is, the NRC will always make decisions based on its view of radiation safety, not on the relatively small place radiation holds in the overall picture of safety. Additionally, the NRC has a history of not believing data submitted by the medical community. One merely needs to look at the Taplin Petition, the Radiopharmacy Petition, and the Patient Release Petition. The Taplin Petition required nearly four years for resolution (filed on March 28, 1979; resolved February 28, 1983), and it was only asking to use Tc-99m DTPA in an aerosol form. The Radiopharmacy Petition took about five years to resolve (submitted June 5, 1989; recognized by the NRC September 15, 1989 as 54 FR 38239; resolved January 1, 1995 as 59 FR 61767), and it contained a Statement of Considerations, Proposed Rule Language, and supporting data and rationale. The petitioners have filed in federal court against NRC's "resolution." The NRC requested this petition in the first place. The Patient Release Petition is still unresolved (submitted January, 1991 by Dr. Marcus; recognized by the NRC as Docket Number PRM 20-20 on February 6, 1991), more than four years after submission. This petition was also requested by NRC, satisfied all the requirements for submission, and an addendum included all the background calculations that the office of Regulatory Research requested. The contents of all three petitions exceeded the regulatory requirement at the time of submission. The first two petitions took years to resolve, and one petition is still pending. The AC P/SNM fails to see how additional submission requirements on the part of the regulated community will result in a more expeditious resolution. Therefore, without solid definitions of burdensome and safety, no matter how much data is submitted by the regulated community, it will always be judged by the floating standards of the NRC. Although this Proposed Rule supplies incentive to the petitioner to accept a shift in the burden of requirements, there still remains the issue of liability. The NRC Office of General Counsel (OGC) will never allow the NRC to accept a petition on its face value and initiate the rulemaking based on the language in the petition. Further, it is preposterous to suggest that the petitioner provide "supporting information... to show compliance with legal requirements such as the National Environmental Policy Act, the Paperwork Reduction Act, and the Regulatory Flexibility Act..."; see proposed 10 CFR 2.802(d)(2). A former staffer informs us that the NRC technical staff itself seeks guidance from its administrative staff each time a rulemaking is prepared to ensure the requisite certifications are complete and in proper format. It appears the height of bureaucratic arrogance to tell someone who has identified a public health and safety issue that the Agency cannot work on the problem because he did not submit his " EPA and reg flex" statements. It would seem quite risky for any NRC staffer who explains the requirements for the

ACNP/SNM Commentary on NRC Proposed Rule Changes to 10 CFR 2 Page 3 petition process, because he would be at risk of being viewed as developing "alternative approaches to address matters in the prospective petition," the very heart of the Regulatory Flexibility Act; such activity is proscribed by current 10 CFR 2.802(b )(2). In fact, in previous "petition" rulemakings, the NRC has been criticized for similar stances. A comment from Public Citizen Litigation Group (Public Citizen) states, "The trouble with requiring presentation of the desired product of the proposed rulemaking is that some problems are too complex or unexplored for a petitioner to propose a definite solution" (FR 44(208) 61321). So, it appears that sixteen years ago, the NRC also attempted to require the petitioner to carry the burden of complete rulemaking. In addition, the NRC has previously recognized that some burdens cannot be shifted to the regulated community, and that expedition of some petitions (those requiring non-NRC clearance, such as 0MB review) may not be suitable for expedited handling (see 46 FR 35487). If such a petition were ever to result in a rule, and it resulted in a safety problem, the NRC would be held accountable by Congress. Thus, OGC will always require that each petition be examined, verified, and determined to be 100% compatible with NRC policy. The NRC has stated that all petitions are important and will expedite their resolution. However, we know that expedite is undefined. We have grave concerns that the assumption of additional administrative requirements will not result in any improvement in time required to resolve a petition. A close look will show more undefined terms, "sufficient supporting information," "significant reduced burden," and "minimal impact to overall safety ( safety neutrality)." This could easily tum into an exercise similar to writing an IND/NDA. In the absence of specific criteria or third-party review of what constitutes a significant safety issue, the prioritization for review and disposition of petitions for rulemaking will shift to the amount of detailed information provided in the petition. 10 CFR 2.802(g) states, "If it is determined by the Executive Director for Operations that the petition does not include the information required by paragraphs (c) and. if applicable. (d)(2) of this section and is incomplete, the petitioner will be notified of that determination and the respects in which the petition is deficient and will be accorded an opportunity to submit additional data.---If the petitioner does not submit additional data to correct the deficiency within 90 days from the date of notification to the petitioner that the petition is incomplete, the petition may be returned to the petitioner without prejudice to the right of the petitioner to file a new petition." Thus, it is obvious that unless a petitioner submits detailed data as required in 2.802(g), using terms as yet undefined and lacking specific criteria, the petition will be at substantial risk of receiving a low priority for review and/or will be subject to a "refusal to file" scenario similar to that which has evolved at the FDA. An area of regulation that would greatly benefit from openness to the petition process is curiously left out of this proposed rulemaking. The NRC regulates without public comment or oversight through licensing. In licensing, the NRC often coerces licensees into accepting conditions more restrictive than the regulations. This situation is created by use of Licensing or Regulatory guides

ACNP/SNM Commentary on NRC Proposed Rule Changes to 10 CFR 2 Page 4 that are more restrictive than the regulations. These guides represent the NRC staff position and will be accepted without delay as license conditions. If an applicant chooses to write his own conditions, those will be reviewed by staff. The price to be paid is a terrible delay in time to have the license issued. Thus, the threat of delay in obtaining the necessary license to practice one's profession is the incentive the NRC offers to "voluntarily" accept excessively restrictive license conditions. This "back-door" process of regulation must also be open to the petition process. In conclusion, we suggest the NRC define its terms and list specific criteria. To ensure that petitions are reviewed for scientific accuracy and that their conclusions result in a reduction in regulatory burdens, with either an improvement in safety or safety neutrality, we suggest that an outside (non-NRC) panel of experts do the petition review. Currently, the FDA uses expert panels to review drug applications. There is no reason the NRC cannot do the same thing. Prioritization and scheduling for review and disposition of the petition should be based solely on the safety significance of the issues identified, not on the amount of data submitted. "Safety" should be broadly defined to include the realization that healthcare dollars are limited and shrinking, and that scarce resources spent on needless NRC requirements create unsafe situations for patients deprived of other healthcare needs, virtually all of which are more important than NRC's narrowly focussed interests. This approach would be consistent with the NRC National Performance Review, would be more cost effective for both the NRC and the regulated community, and would better address regulatory changes identified by data analysis. The current regulation 10 CFR 2.802(b) informs the public that administrative guidance is available. We believe this proposed rulemaking motion is a waste of user fee supported human resources. This Proposed Rule would create a scenario where the regulated community could easily and arbitrarily be denied the use of the petition process for rule changes. This becomes especially important as we face the upcoming rewrite of 10 CFR Part 35. The Agency does not need another rule to provide instructions to petitioners. A simple instruction sheet, a NUREG or a regulatory guide, would meet the postulate. There is no need for this rulemaking. Sincerely, ~g-~,,,~- 'fames J~Cfon;ay, rib. President Society of Nuclear Medicine Robert F. Carretta. M.D. President American College of Nuclear Physician

DOCKET NUMBER p /J 5000 Dominion Boulevard Glen Allen, Virginia 23060 f"10 ') ED RULE~~.,L.,~-- (6 o FT<- J 5 8"78:) June 12, 1995 DOCKETED USNRC

6)

°95 JJN 14 P 3 =42 sm1\\?tG 5fi1~1?i~t ! NIAl'OWER B~~r~, No. GL 95-014 Mr. John Hoyle, Secretary United States Nuclear Regulatory Commission Attention: Docketing and Services Branch Washington, D. C. 20555 Gentlemen: COMMENTS ON PROPOSED RULE NRC PROPOSED AMENDMENTS TO 10 CFR 2.802 NL&P/GDM R1 PETITION FOR RULEMAKING: PROCEDURE FOR SUBMISSION FEDERAL REGISTER/ VOLUME 60, NO. 59/ MARCH 28, 1995/ p.15878 The subject Federal Register notice describes the N RC's proposal to amend its regulations regarding petitions for rulemaking to expand the use and improve the responsiveness of the petition for rulemaking process. The amended rule would provide incentive to the petitioner to submit more detailed supporting information for their petitions to facilitate a more expeditious review by the NRC. We have reviewed the proposed rulemaking as well as the comments provided by the Nuclear Energy Institute (NEI) on this subject. (Reference NEl's letter from Mr. R. W. Bishop to Mr. John Hoyle of the NRC dated June 12, 1995.) As noted in NEl's letter, the nuclear industry is often in a better position than the NRC to identify federal regulations that are particularly burdensome and of little safety benefit. The proposed rule allows the industry to submit requests for proposed rulemaking that the NRC might not otherwise consider due to other internal priorities. Therefore, we concur with NEl's comments and their endorsement of the proposed rule. We also concur that implementation of the proposed rule should require accountability by the NRC regarding the timeliness of their reviews and disposition of requests for rulemaking. Petitioners should have a means available to them to obtain the status of their specific petitions, and a realistic expectation of the time required for action on their requests. Although the Electronic Bulletin Board could be used to obtain the status of a particular request, a realistic time frame for each aspect of the NRC review process for a petition should also be made available to the public. If you have any questions, please do not hesitate to contact us. Very truly yours, M~-~~ - Manager Nuclear Licensing and Programs

cc: Mr. Robert Bishop Vice President and General Counsel Nuclear Energy Institute 1776 Eye Street N. W. Suite 400 Washington, DC 20006-3708 Ms. E. Ginsberg Assistant General Counsel Nuclear Energy Institute 1776 Eye Street N. W. Suite 400 Washington, DC 20006-3708

I DOCKETED USNRC NUC LE AR ENERGY INSTITUTE June 12, 1995 Mr. John Hoyle, Secretary Office of the Secretary U.S. Nuclear Regulatory Commission Washington, D.C. 20555-0001 Attn: Docketing and Services Branch

• 95 JJN 13 A 9 :59 Robert Willis Bishop

-TAR ( VICE PRESIDENT & OFFICE Of SE Ct~ \\CE GENERAL COUNSEL DOCKETING l-*._-?l:i-, BRANCH DOCKET NUMBER pn PROPOSED RULE R.2-(60 FJ'l lSY-76

SUBJECT:

Proposed Rule, Petition for Rulemaking; Procedures for Submission (60 Fed. Reg. 15878; March 28, 1995)

Dear Mr. Hoyle:

On behalf of the nuclear industry, the Nuclear Energy Institute (NEI)1 hereby provides comments on the NRC's proposed rule to amend 10 CFR 2.802. Proposed Rule, Petition for Rulemaking; Procedures for Submission (60 Fed. Reg. 15878; March 28, 1995). The amendments encourage licensees and the public to submit to the NRC suggested regulatory improvements, and to set out criteria upon which the assignment of priority for NRC Staff review will be based. While the industry commends the NRC for seeking ways to more expeditiously handle petitions for rulemaking, it is unnecessary to provide the criteria for a "fast track" approach to such petitions through a rulemaking. The assignment of a higher priority to particular petitions for rulemaking clearly is within and should be left to the NRC's discretion. Given that the proposed approach does not impose mandatory requirements, but simply is a description of the criteria that the NRC will employ in appropriating its resources and managing the rulemaking process, there is no reason to include it in the Code of Federal Regulations. Accordingly, the 1 NEI is the organization responsible for establishing unified nuclear industry policy on matters affecting the nuclear energy industry, including 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. 'JUN 2 0 1995

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Mr. John Hoyle June 12, 1995 Page 2 captured in, for example, a Management Directive. Because it is critical also to make this information available to the public, the NRC could publish an Information Brochure (similar to that published on 10 CFR 2.206) or take other steps to effectively convey the information to the public. Also, as noted in our response to Question 1 (see Enclosure 1), the NRC should include in the Management Directive guidance for agency personnel specifying time periods within which the Staff is to evaluate, obtain comment, and render a decision on a petition for rulemaking. This guidance also should be made available to the public. Notwithstanding our view that the proposal should not be made part of the Code of Federal Regulations, we reiterate our support of the agency's efforts to promote the use of petitions for rulemaking and to improve the NRC's timeliness in responding to such petitions. The proposal is consistent with Congress' and the Administration's call for better and less costly regulation. Its implementation will assist in the efficient elimination of unduly burdensome regulations and should help to foster the development of a more cooperative relationship between the NRC and its constituents, i.e., licensees and members of the public. As evidenced by the discussion in the Statement of Considerations for this rulemaking, the NRC recognizes the benefit of enlarging the scope of regulatory initiatives considered by the Staff and of supplementing the Staff's ideas for regulatory change.2 The NRC further recognizes that often the nuclear industry is in the best position to identify regulations that are inefficient or burdensome and without an appreciable safety benefit. By submitting petitions for rulemakings that seek more efficient and streamlined regulations, the industry will help to focus the NRC's attention on regulations or regulatory approaches that the industry believes to be most critically in need of change. Further, the submission of greater supporting information should enable the NRC to address the petition more efficiently and, potentially, more quickly. The NRC requests that the public provide comments on the proposed revisions and respond to the six questions set out in the Federal Register notice. Our response to those questions is provided in Enclosure 1. We appreciate your consideration of the industry's comments on the proposed amendments to 10 CFR 2.802 and would be happy to meet with NRC Staff to discuss our views. If you have any questions regarding our comments, please do 2 We do not believe, however, that the amendments are intended to relieve the Staff of its obligation to continue to seek to identify and implement regulatory improvements.

Mr. John Hoyle June 12, 1995 Page 3 not hesitate to contact Ellen Ginsberg, NEI Assistant General Counsel, at (202) 739-8140, or me. RWB/ECG/bjb Enclosures c: Karen D. Cyr, Esq., General Counsel Martin G. Malsch, Esq., Deputy General Counsel

1.

Is the concept of the proposal sound, namely that all petitioners have the option to submit more detailed supporting information which, if found adequate, would lead to faster NRC disposition? The public interest will be well served by encouraging petitioners to submit petitions for rulemaking accompanied by detailed supporting information. While this requires the petitioner to perform a significant amount of work prior to submitting the petition, it is clearly in the petitioner's interest to undertake such an effort. The industry recognizes that the NRC does not have unlimited resources, and that those resources that are available must be allocated based upon a reasonable priority system. It is entirely reasonable to tie the priority of review assigned to a petition for rulemaking to the depth of supporting information provided, as well as the safety significance of the issue. We would note, however, that the NRC should clarify its statement that "[t]he merit of a petition is judged on its safety significance and the level of detail of supporting information" (60 Fed. Reg. 15878). While it is reasonable for the NRC to assign a higher priority based upon the combination of its safety significance and greater supporting information, the level of detail of the supporting information should not bear on the determination of the petition's merit, except to the extent that it provides a basis for the decision. The merit of the petition should be subjected to the same rigorous evaluation currently applied under 10 CFR 2.802. In the latter part of the question, the NRC inquires whether the submission of additional supporting information "would lead to faster NRC disposition" of a given petition. Certainly submission of additional information should enable the NRC to more quickly process petitions for rulemaking. The industry remains concerned, however, about the NRC's celerity in responding to these petitions based upon the experience with, for example, our petition on Part 21 (which included all or almost all of the analyses required under the amendments proposed here). We calculate (and the treatment of the industry's Part 21 petition for rulemaking supports our calculation) that it takes approximately two to four years to process most NRC rulemakings. That simply is too long. To address our concern regarding the NRC's timeliness, the NRC should issue guidance to agency personnel specifying the time periods within which the NRC would have to evaluate, obtain comment; and render a decision on a petition for rulemaking. This guidance should be made available to the public so that petitioners' expectations are realistic and the NRC is held accountable for accomplishing scheduled milestones. Because a schedule would significantly improve the predictability and stability of the process, the NRC should consider the following time frames for rulemakings that address issues that are safety significant (immediate or near-term impact) or are improvements to existing ecg\\general\\2802cmts

regulations or the regulatory process, including changes that enhance efficiency for licensees or the NRC. Submit Staff Questions to Petitioner Provide Response to Staff Questions Publish in the Federal Register for Comment Prepare Final Rule Within 30 days of receipt of petition Within 30 days from date of receipt of questions Within 30 days of response to Staff questions; 60-90 days for public comment 60-90 days after close of comment period publish rule or decision to reject petition for rulemaking in the Federal Register For certain long-range and complex rulemaking proposals that involve difficult policy judgments and technical issues, it may be necessary to extend the rulemaking periods beyond those described above. These rulemakings may require additional detailed analyses by the NRC, even if the petitioner provides the NRC with an enlarged submission consistent with the NRC's proposal. Accordingly, the NRC should have sufficient discretion to take the time reasonably required to comprehensively evaluate the petition's merit. However, we would suggest that petitions in this category be subject to senior management oversight to ensure that, to the maximum extent possible, these petitions also are handled on an expedited basis. Finally, the industry suggests that the NRC carefully review the other features of its existing rulemaking management to identify reviews and other steps that can and should be eliminated. Because the majority of the time to complete the rulemaking process is consumed by the NRC's internal review processes, the NRC is in a better position than the industry to pinpoint inefficiencies and bottlenecks in the current process. To address any such problems, we would suggest that the NRC provide agency personnel with guidance on rulemaking management consistent with the proposed approach. Additionally, tQ ensure that rulemakings are provided sufficient management oversight, the NRC should consider including in senior level managers' performance evaluations their success in meeting rulemaking milestones. We believe that making rulemaking management an issue for which there is direct personal accountability will have an immediate and significant ameliorative effect on the rulemaking process. 2

2.

Is the description of information required for detailed supporting information in paragraph (d)(2) sufficiently complete to avoid unnecessary correspondence after the petition has been docketed? Paragraph (d)(2) provides sufficient guidance to identify to a petitioner that which the NRC seeks in the way of support for a petition to be considered for expedited treatment. We would note, however, that proposed 10 CFR 2.802(d)(2)(v) includes among the supporting information required a discussion of the application of the Backfit rule, 10 CFR 50.109. In particular, subsection (d)(2)(v) focuses on the analysis required if a petition for rulemaking involves a backfi.t as defined in 10 CFR 50.109(a)(l). We anticipate that most of the petitions for rulemaking submitted by the industry would not involve backfi.ts. Rather, we expect the industry-sponsored petitions to request elimination of requirements for which there is no appreciable safety benefit or to request modification to provide relief from unduly burdensome or inefficient regulations. As noted in NEI's comments to the NRC on the proposed revision to 10 CFR 50, Appendix J,3 the Backfit rule must be considered in all rulemakings. A petition to relax or eliminate a regulatory requirement, however, would not represent a proposed backfi.t because the NRC would not be imposing a new obligation on the licensee. However, petitions for rulemakings that are to provide relief from a current requirement might also contain one or more new requirements. Such requirements would be subject to the Backfi.t rule because a backfit is defined as a change to a licensee's facility, procedures or organization "which may result from a new or amended provision in the Commission rules." In those cases where no exception to the Backfi.t rule applies, the NRC may not promulgate the proposed rules as mandatory requirements. Even if a proposed new requirement would not produce a cost-justified substantial increase in safety, the agency may still act on the petition and promulgate the proposed rule or modify the subject regulation. The NRC has the authority to and should promulgate such proposed rules in the alternative. Promulgating a rule that is a regulatory improvement as an alternative to an existing requirement permits the licensee to decide whether to avail itself of the opportunity to change its program to meet the alternative approach despite the initial costs that may be incurred. If a licensee concludes that the alternative approach would provide long-term cost savings, it is likely that the licensee would adopt the alternative approach. The benefit of retaining the original rule, however, is that for each rule change there may be licensees who, because of their particular circumstances, may determine that it would not be appropriate to adopt the alternative approach. 3 See Industry Comments on Proposed Revision to 10 CFR 50, Appendix J, "Containment Leakage Testing" to Adopt Performance-Oriented and Risk-Based Approaches, dated May 8, 1995. 3

Issuing rules (that otherwise may be backfits) in the alternative is a legal and practical way to handle regulatory improvements. Further, use of the alternative approach fits well with the NRC's long-standing regulatory philosophy, and is clearly consistent with the requirements of 10 CFR 50.109. As the Commission has often recognized, licensees have the primary responsibility for operating power reactors. To meet this responsibility, they must have the freedom to manage their plants and their resources.

3.

Under what circumstances should a guidance document in the form of a Regulatory Guide be required to support a petition? What criteria are appropriate for not requiring it? Guidance documents including Regulatory Guides should not be required, nor should the lack of a guidance document be considered in the NRC's assignment of priority to a given petition. Moreover, often the rule requested by a petition for rulemaking is modified as a result of public comments prior to its final issuance. Because a guidance document, by its very nature, is inextricably tied to the exact language of the rule, it is not reasonable to require its submission with a petition for rulemaking. We anticipate that, for an industry-sponsored rulemaking, much of the work on an accompanying industry-sponsored guidance document, if any is necessary, would be performed in parallel with the NRC's consideration of the petition for rulemaking. As such, we expect that for an industry-sponsored rulemaking, the guidance document would be forthcoming shortly after promulgation of the final rule. In light of the foregoing, the submission of one or more guidance documents should not be a criterion considered in the NRC's assignment of priority to petitions for rulemaking.

4.

Should there be an NRC electronic bulletin board dealing exclusively with petitions? The NRC should retain the discretion to develop an Electronic Bulletin Board (EBB) system or any other computer-based system (e.g., Internet) to provide the public with additional access to information about rulemakings. We strongly urge the NRC, however, to maintain the EBB as a repository of factual information. Because of the significant and, as yet, unresolved problems with such issues as apparent authority and other problems associated with user identity, trade secrets, potential for bad" information, etc., the EBB should not be relied upon as a means to communicate with the NRC or to satisfy the Administrative Procedure Act's requirements. Furthermore, to avoid confusion and potential legal issues regarding the agency's official position, internal communication among NRC Staff regarding a proposed rule should not be available on the EBB. The EBB should contain only 4

the petition submitted, the comments received by the NRC, and other publicly available NRC documents (SECY s, SRMs, etc.) relevant to the rulemaking.

5.

As the NRC attempts to shift rulemaking approaches to be more performance-based and risk-based, what changes would be appropriate for the information requirements under the proposed revision of 10 CFR 2.802? None.

6.

Should administrative procedures be established to allow petitions for changes to regulatory guidance documents, such as regulatory guides, bulletins, generic letters, and sections of the Standard Review Plan? Should these procedures be incorporated in a rule? The industry does not object to the NRC establishing administrative procedures to allow petitions for changes to regulatory guidance. However, we do not believe that it is necessary or appropriate to promulgate change processes as a regulation. 5

YANKEE ATOMIC ELECTRIC COMPANY Telephone (508) 779-6711 TWX 710-380-7619

• DOCKETED USNRC CD 580 Main Street, Bolton, Massachusetts 0 17 40-1398 Mr. John C. Hoyle Secretary of the Commission U.S. Nuclear Regulatory Commission Washington, DC 20555 Attention:

Docketing and Services Branch June 9, 1995 FYC 95-010

• 95 JUN 12 P2 :34 OFFICE OF SECRE TARY DOCKETING & SFRVICE BRANCH D1. -:; 'ET NUMBER PR 2 t *.. ":'S=D RULE ---------

( 6 o F Y{ 1 s 7 J:)

Subject:

YANKEE ATOMIC ELECTRIC COMP ANY COMMENTS -- PROPOSED RULE ON PETITION FOR RULEMAKING; PROCEDURE FOR SUBMISSION (60 FR 15878, DATED MARCH 28, 1995)

Dear Mr. Hoyle:

Yankee Atomic Electric Company (Yankee) appreciates the opportunity to comment on the subject proposed rule change regarding the petition for rulemaking process. Yankee is the owner of the Yankee Nuclear Power Station in Rowe, Massachusetts. The Yankee Nuclear Services Division also provides engineering and licensing services to nuclear power stations in the Northeast. We commend the Commission for continuing its efforts to evaluate new ways to conduct business more efficiently. We support the concept of affording petitioners the opportunity to submit information beyond the minimum required for rulemaking petitions in order to facilitate more expeditious disposition by NRC. We believe that it is sound management practice to establish a program or policy for ranking the priority of submittals. Aside from the question of safety significance, it is reasonable to us that assignment of priorities would be influenced by the "completeness" of a petition package. However, we question the need for codification with regard to this specific proposal as it is clearly an administrative matter and well within management prerogative to establish such a practice. We might add that even NRC's Regulatory Review Group stopped short of recommending codification. In Volumes 1 and 2 of the Regulatory Review Group study, the Group discussed the need for "guidance" that clearly stated the level of detail needed for a petition such that the request could be evaluated by the Staff in a timely manner. We cite two examples of Staff practice which support our contention that codification is unnecessary. In the first example, the Office of Nuclear Reactor Regulation (NRR) developed an 'JUN. 2 0 1995

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Mr. John C. Hoyle June 9, 1995 Page2 approach for assigning priorities to license amendments. Rather than codifying this new practice in 10 CFR 50.90, the NRC chose to explain the details of the priority ranking approach in NRC Memoranda from T. Murley to the Staff: dated April 29, 1988, and March 24, 1989. The new approach was conveyed to licensees by the NRR Project Managers. Subsequently, changes were made to address the Cost Beneficial Licensing Action program. Once again the changes were not codified and instead were communicated to the NRC Staff, licensees and others through NRC Memorandum from Murley, dated June 6, 1993 and Administrative Letter 95-02. While the subject of the first example pertains to licensees only, the second example addresses the public and their need to also understand NRC practice and procedures. In the second example, NRC reviewed the regulations and practices governing the submission of citizen petitions under 10 CFR 2.206. To address concerns regarding the need for a uniform and comprehensive statement of the Staff's procedures governing the 2.206 process and to address publication of that statement, the Staff specifically noted in SECY-93-355 that "for the most part, staff practice and procedures in the 2.206 area are not readily available to the general public or to most petitioners. The Management Directive, publicly available, would alleviate this problem." The Staff went on to also recommend that the Office of Public Affairs develop a citizens information brochure on the 2.206 process. In both examples, administrative means were employed; codification was deemed unnecessary. Because the changes being proposed represent an alternative that goes beyond the minimum required, and the changes are purely administrative in nature, we recommend that the Commission use an Administrative Letter or other publicly available document for conveying the pertinent information. Since Administrative Letters receive broad distribution, including the Public Document Rooms, this vehicle is an appropriate choice for describing how licensees and others can assist NRC in a matter such as making more efficient use ofNRC' s resources. An additional benefit to use of an Administrative Letter is that NRC will maintain the flexibility it needs to address administrative matters and not be constrained by the rulemaking process should changes be deemed necessary in the future. On one final matter, we believe that regardless of whether or not an administrative remedy is chosen, the Staff should identify the schedule which will be used for processing petitions. We agree with the Nuclear Energy Institute (NEI) that a schedule would improve the predictability and stability of the petition process. In general, we support the time frames which NEI has recommended in its comment letter for addressing petitions. However, we urge the Commission to be even more aggressive and move directly to the proposed rulemaking stage for certain petitions. We believe that the Regulatory Review Group characterized the situation correctly when it stated in Volume 2 of its study that "if a petition for rulemaking is technically sound and complete, nothing in the NRC procedures inhibits the staff from performing a timely review, publishina the petition as a proposed rule, and requesting comments" ( emphasis added).

Mr. John C. Hoyle June 9, 1995 Page3 In conclusion, we believe that the subject rulemaking is unnecessary. We recommend that the Commission abandon the subject rulemaking, communicate NRC practices through an Administrative Letter, and reassign the resources which remain allocated to the subject rulemaking to more important regulatory reform, such as that recommended by NEI in its response to the National Performance Review initiative. Sincerely, YANKEE ATOMIC ELECTRIC COMPANY e M. Grant M ager, Regulatory and Industry Affairs

Secretary DOCKET NUMBER p PROPOSED RULE 2,~,. ( 60 F,Z ISJ--,J-2} Department of Energy DOCKETED Washington, DC 20585 USNRC fJUN O 9 1995 '95 JJN 12 P2 :35 U.S. Nuclear Regulatory Commission Attention: Docketing and Services Branch Washington. DC 20555

Dear Sir:

This letter transmits comments by the U.S. Department of Energy's Office of Civilian Radioactive Waste Management (OCRWM) regarding the review of the U.S. Nuclear Regulatory Commission's Proposed Revisions to 10 CFR Part 2. Petition for Rulemaking; Procedure for Submission (60 FR 15878. March 28. 1995). OCRWM supports the Commission's effort in streamlining the petition for rulemaking process and agrees with the concept of expedited reviews by the Commission based on the petition for rulemaking containing more detailed supporting information and analyses than is currently required under 10 CFR Part 2.802. We recommend that the Commission judge the merit of a petition for rulemaking process on its safety, significance. and the level of detail of supporting information. regardless of whether the facility is currently licensed by the Commission. For example. OCRWM should be permitted to seek an expeditious Commission review of a proposed petition for rulemaking that is supported by detailed information despite the fact that OCRWM facilities have not yet been licensed by the Commission. We agree that t he Commission should consider adopting procedures that provide guidance for requesting changes to regulatory guidance documents. These procedures can be provided in regulatory guides. We do not believe the Commission should incorporate procedures for revising guidance documents in a rule. Guidance documents do not have the force or effect of regulation. but rat her are used by the Commission staff to identify methods for compliance with a regulation. Should you have any questions. please contact Christian Einberg of my staff at (202) 586-8869. Sincerely, ~a.'/H~ Ronald A. Milne;, bi rector Office of Program Management and Integration Office of Civilian Radioactive Waste Management @ Printed with soy ink on recycled paper "JUN 2 0 1995 Acknowledged by card.. -...... -::.... -.. -... -~

fJ 3 L'rlf/.;- -,: ~.'t.* '. ORY ~OMMISSIOI'. DOC!<f:-,t,G & SERVICE SECTION OF FICE OF THE SECRETARY OF THE COMMISSION Document Statistics osimaiic Date 1-1~.,,,_t:,1... ol-1 I 1v--t.A---{.l_ Ccp:cs Rc*ceivod / "r1 Co;i*e. Reoroduced]~-------- " * *,.. 'i ~- *,.,.*but.,m w....... :={ rJOrJ ~~ ~1 c.1-i~V'

cc: R. Loux. State of Nevada R. Price. NV Legislative Committee. NV J. Meder. NV Legislative Counsel Bureau. NV M. Murphy. Nye County, NV D. Bechtel. Clark County, NV P. Niedzielski-Eichner. Nye County, NV B. Mettam. Inyo County, CA V. Poe. Mineral County, NV F. Mariani. White Pine County, NV R. Williams. Lander County, NV L. Fiorenzi. Eureka County, NV J. Hoffman. Esmeralda County, NV C. Schank. Churchill County. NV L. Bradshaw. Nye County. NV W. Barnard. NWTRB. Washington. DC E. Lowry, NV Indian Environmental Coalition. NV R. Holden. National Congress of American Indians J. Greeves. NRC J. Holonich. USNRC. Bethesda. MD

Florida Power & Light Company, P.O. Box 14000, Juno Beach, FL 33408-0420 DOCKETED USNRC

• 95 JUN 12 P 1 :44 OFFICE OF SECRETARY Mr. John Hoyle, SecretaryDOCKE TING & ?E VICE Office of the Secretary BRANCH U.S. Nuclear Regulatory Commission Washington, DC 20555-0001 JUN 8 1995 L-95-162 f"OCKET NUMBERPR f'r*

SEO RULE 2 Q) Attn: Docketing and Services Branch ( b o F rz,-s 5'"'_ 7_J-: ____ J_

Subject:

Proposed Rule, Petition for Rulemaking; Procedure for Submission (60 FR 15878; March 28, 1995) Request for Comments

Dear Mr. Hoyle:

On March 28, 1995, the Nuclear Regulatory Commission published for public comment a proposed rule titled, "Petition for Rulemaking; Procedures for Submission. " The proposed changes would provide incentive to submit sufficient supporting information in petitions to facilitate more expeditious disposition by the NRC, and would also improve openness of the petition for rulemaking process by delineating priorities for review of the petitions. These comments are submitted on behalf of Florida Power & Light (FPL), a licensed operator of two nuclear power plant units in Dade County, Florida and two units in St. Lucie County, Florida. The Nuclear Energy Institute (NEI) is providing comments on the proposed rule on behalf of the industry. FPL endorses the NEI comments and recommendations. FPL commends the NRC for its ongoing efforts to provide improved processes supporting continued relief from unduly burdensome or inefficient regulations. We appreciate the opportunity to comment on the proposed amendments to 10 CFR 2.802. ohlke Vice President Nuclear Engineering and Licens i ng cc: Ellen Ginsberg, Esq. (NEI Assistant General Counsel) A k fed 'JtJr 2_ 0 1995' C now ged by cartt................,,,.,.m~-;; an FPL Group company

IJ.S. NUC ..* -.p-f 't;MMISSI0/1. DOC~t, i:. ~-/1CE SECTION Orf!C,,-_ c:* THE.SECRETARY OF THE COMMISSION Document Statistics Postmark D~te - ~6_L_e,_/_l'f_ S __ Copies Rce;v~d / Add'i Cmes Reproduced 3 SpeciJ, D1.:;t, ibution n.12-r:J~-?J-, P .,....,o,...~--- c ~

-===- ENTERGY June 8, 1995 Mr. John C. Hoyle, Secretary Office of the Secretary U. S. Nuclear Regulatory Commission Washington, DC 20555-0001 DOCKETED US RC '95 JJN 12 P 4 :24 OFFICE OF SECRETARY DOCKETING &.. SER 'ICE BRANCH Entergy Operations, Inc. P.O. Box 31995 Jackson, MS 39286-1995 Tel 601 368 5760 Fax 601 368 5768 Jerrold G. Dewease Vice President (j) Operations Support 2 DOCKET NUMBER PR PROPOSED RULE 2 - ( 60 FR J£?'7 r) ATTN: Docketing and Service Branch

Subject:

Comments on Proposed Revision to 10 CFR 2.802 CNRO-95/00012

Dear Mr. Hoyle:

On March 28, 1995, the Nuclear Regulatory Commission published for comment in the Federal Register (60 Fed. Reg. 15878) a proposed revision to 10 CFR 2.802, Petition for Rulemaking. The proposed changes are intended to encourage the submittal of more detailed supporting information in the petition for rulemaking than currently required. The incentive to take this action is the expectation of more expeditious review and processing by the NRC. The Nuclear Energy Institute (NEI), in interaction with and in behalf of the industry, is submitting pertinent comments re these changes for the NRC's consideration. Entergy Operations, Inc. has reviewed and concurs with the NEI comments. Please consider this to be our formal endorsement of the NEI submittal and our request for the NRC' s consideration of the same. Sincerely, cc: (See next page) ~JUN 2 o 19 Acknow!adqed bv card............,,.,,,,,,,,.,,,.!~

Comments on Proposed Revision to 10 CFR 2.802 June 8, 1995 CNRO-95/00012 Page 2 of2 cc: Mr. R. P. Barkhurst Mr. R. W. Bishop Mr. J. L. Blount Mr. L. J. Callan Mr. J. L. Colvin Mr. S. D. Ebneter Mr. C.R. Hutchinson Mr. G. Kalman Mr. H. W. Keiser Mr. J. R. McGaha Mr. R. B. McGehee Mr. P. W. O'Connor Mr. C. P. Patel Mr. N. S. Reynolds Mr. D. L. Wigginton Mr. J. W. Yelverton Central File (GGNS) DCC (ANO) Records Center (WF-3) SDC (RBS) Corporate File [2]

Asheville Office: 29 1/2 Page Ave.

• Asheville, NC 28801
• 704-251-0518 Raleigh Office: P.O.Box 1008
• Raleigh, NC 27602
• 919-_832-7491 14 April 1995 OCKET NUMBER p c:, O 0..,.,

ROPOSED RULE 2 c,-r-, ~

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Secretary (_ b O F P-I §Y 7 ij ,.,. rr -1 CD-,....) -0 US Nuclear Regulatory Commission -;lj.,._-r,

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N Washington DC 20555

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B -~~ 0 Comment on Proposed Revision to 10 CFR 2

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The Clean Water Fund of North Carolina is concerned that the proposed revision to 10 CFR 2, noticed Tuesday 28 March at 60 FR 15878ff, will have the same effect as further limiting citizen petitions to the Commission. The Commission's continuing practice, of allowing the industry ( which the Commission regulates) to retain much information in a privatized form, severely limits citizen access to the detailed information which may be necessary as evidence in a successful petition. The Fund therefore considers that the proposal, to offer the incentive of accelerated response in return for more d!tailed initial submissions, is more likely provide benefits to the industry (which has access to the necessary information, as well as the staff to compile and analyze the information) than to those members of the general public who may submit rulemaking petitions. Consequently, adoption of the proposed rule may result ease the petition process for the regulated industry disproportionately to the ease effected by the proposed rule on the petition process for members of the general public, with substantially less access to information and less staff available to compile and analyze the information. By disproportionately so easing the burden of petitions for regulatory rulemaking for the industry, relative to the general public, the Commission could create conditions under which a significantly larger fraction of the rules were written by the regulated industry than is currently the case. To encourage regulatory balance and fairness, it would therefore be appropriate to offset the proposed easing of the industry burden in regulatory rulemaking by including provisions to make publicly available essentially all license-condition related materials submitted to the Commission by its licensees, thereby allowing citizens access to the information which would necessary for the enjoyment of the advantages of the proposed rule. Carl Rupert, Ph.D. Raleigh Research Director The Clean Water Fund of North Carolina PO Box 1008 Raleigh NC 27602 c::, ([) _o '- C") U>-;,:. .L f"T"

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t!S. NUCLEAR FlECLJi.r>. l ufh L.~M~llSSIOr-; . DOCKETING & s[RViCE Si::CTiON

• OFfiCE OF THE SECRETARY OF THE COMMISSION Docum~ni S*atistics Ffostmark Date -=f-}_~1 ~-----

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AGENCY: ACTION:

SUMMARY

DOCKET NUMBERPR ' PROPOSED RULE ~ (loDrR. \\S'S '1"9) DOC f:TEO U5 RC [7590-01-P]

• 95 MAR 23 /\\ 9 :37 NUCLEAR REGULATORY COMMISSION OFF,C Li S*~t ~ T/..:-'Y DOCK£ r ~, -;,_r~v,rt.::

10 CFR Part 2 RIN 3150-AF23 Petition for Rulemaking; Procedure for Submission Nuclear Regulatory Commission. Proposed rule. BfU~, CH The Nuclear Regulatory Commission (NRC) is proposing to amend its regulations pertaining to petitions for rulemaking. The proposed changes would provide incentive to submit sufficient supporting information in petitions to facilitate more expeditious disposition by the NRC, and would also improve openness of the petition for rulemaking process by delineating ~ priorities for rev\\ew of the petitions. ~ \\~. \\C\\95 DATES: Comment period expires (75 da~ the date of publitati9R). Comments received after this date will be considered if it is practical to do so, but the Comission is able to assure consideration only for coments received on or before this date.

ADDRESSES: Mail written conments to: Secretary, U.S. Nuclear Regulatory Conmission, Washington, D.C. 20555, Attention: Docketing and Services Branch. Deliver conments to: 11555 Rockville Pike, Rockville, Maryland, between 7:45 A.H. and 4:15 P.M. Federal workdays. Copies of comments received may be examined at: the NRC Public Document Room, 2120 L Street NW. (lower Level), Washington, DC. FOR FURTHER INFORMATION CONTACT: T.Y. Chang, telephone (301) 415-6450, or 4t Chris Rourk, telephone (301) 415-5865, Office of Nuclear Regulatory Research, U.S. Nuclear Regulatory Commission, Washington, DC 20555. SUPPLEMENTARY INFORMATION:

Background

NRC and industry resources are limited and becomtng more so. Inefficient regulations, i.e., regulations that are burdensome and have a minimal safety_ benefit, could divert NRC and industry resources from issues important to safety, thereby adversely affecting safety. While maintaining its emphasis on safety, the NRC over the past 10 years has initiated several programs designed to improve the efficiency of its regulatory program. These efforts include notably the Marginal To Safety (MTS) program, the Regulatory Review Group (RRG) and Cost Beneficial Licensing Actions (CBLA) Task Force studies, and the Technical Specification Amendments Screening Panel. These programs have identified a number of inefficient regulatory requirements. They also enabled the NRC to conclude, among other matters, 2

that (1) an expanded role for the public, including the industry, to participate in the process of improving regulations through petitions for rulemaking is highly desirable and should be encouraged, and (2) the petition for rulemaking process could be improved to make it more responsive to petitioners. Description The NRC has prepared a proposed rule that would modify 10 CFR 2.802, Petition for Rulemaking, to expand the use and improve the responsiveness of the petition for rulemaking process. The proposed rule would also delineate factors that affect priorities for review of petitions. This would improve the openness of the rulemaking process. The NRC staff currently expends resources in developing responses to petitions for rulemaking that may or may not result in changes to NRC regulations. The reasons for the granting or denial of petitions sometimes 4lt only become evident after completion of considerable NRC staff effort that may include the development of a regulatory analysis and a backfit analysis. As a consequence, processing and disposition of petitions sometimes is unduly prolonged. On the other hand, the NRC recognizes that licensees are in the best position to provide information to assist the NRC to assess the effect of regulatory actions and are also the primary beneficiaries of efforts to reduce regulatory requirements that are unduly burdensome but have no co1m1ensurable safety benefits. 3

In order to allow petitions to be treated more expeditiously, to facilitate the submission of petitions with strong technical merit, and to improve the likelihood of acceptance of petitions, the NRC proposes to modify § 2.802 to encourage industry and the public to submit more detailed supporting infonnation 1n the petition for rulemaking than currently required. The NRC concluded that this modification would be an effective means to help processing the petitions in a more expeditious manner, because this infonnation would enable the NRC staff to conclude, with a minimal expenditure of staff resources, whether to grant or deny the petition. The incentive for any petitioner to take this action would be that more expeditious review and processing of the petition will result. It is expected that this alternative process will be more efficient 1n the use of NRC staff and industry resources and be more responsive to petitioners. This proposed rule would not change any existing provision regarding petitions for rulemaking, rather it offers an alternative within the petition process which would be available to all petitioners regardless of the nature of the. petitions. The industry is therefore encouraged to identify and propose improvements to regulations that seek to reduce the regulatory burden while providing sufficient supporting infonnation in the petition to demonstrate that the proposed changes will result in significant reduced burden and minimal impact to overall safety (safety neutrality). Similarly, members of the public who seek safety enhancement through the rulemaking process are encouraged to make use of the sizable publicly available safety information to support and expedite their petitions. 4

It is to be noted that the prioritization and scheduling for review and disposition by NRC are based on consideration of the merit of each petition. The merit of a petition is judged on its safety significance and the level of detail of supporting information. Petitions containing supporting information additional to those currently required would improve their priority for review and receive more expeditious disposition. Consideration of safety significance is the first criterion for prioritizing the review and disposition of petitions. It is the primary concern of the NRC to ensure that design and operation of NRC licensed facilities are carried out in a manner which assures adequate protection of public health and safety, of the environment, and of national security. Therefore, petitions found by the NRC to raise a concern in this regard would receive iDITiediate NRC attention. In assessing the safety significance of petitions consideration would be given to the technical information submitted and other information available to the NRC, and to whether the proposal is likely to meet the criteria of the backfit rule. Petitions that are safety neutral, i.e., implementation of which would result in an insignificant change to the level of protection to public health and safety, would be resolved in such a way as to minimize the cost to the NRC and maximize the benefit to the petitioner. The more detailed supporting information. in addition to that required in the current§ 2.802(c} should include the suggested regulatory text, regulatory analysis, backfit analysis (if required), information required by the National Environmental Policy Act (NEPA), and a guidance document similar in nature to a Regulatory Guide, if needed, in support of a proposed rule, as described in paragraph (d){2} of the proposed rule. The regulatory analysis 5

is important for petitions seeking either to enhance safety or to reduce regulatory burden, because it would provide information on the changes to risk levels as well as costs associated with proposed alternatives. The proposed changes would afford any petitioner two options: submit the minimal threshold information in the petition that is required by the current rule and be subject to the regular processing procedures, or submit more detailed supporting information and analyses in the petition in return for a more expeditious processing procedure by the NRC. The proposed revisions would not change any existing provision regarding petitions for rulemaking if they meet the minimum threshold requirement of the current § 2.802{c). Subsequent to the establishment of review priority the NRC would develop a schedule for all petitions that are docketed. This schedule would reflect the priority of each petition based on consideration of the combination of safety significance and level of detail of supporting information. A summary of petitions for rulemaking, including the status of each petition, would be prepared semiannually by the NRC staff, as described in paragraph {h) of the proposed rule. A copy of this report would be available for public review in the NRC Public Document Room. Further, the NRC has decided to provide administrative procedures to make it easier for concerned parties to submit petitions for changes to regulatory guidance documents, such as regulatory guides, bulletins, generic letters and sections of the Standard Review Plan {SRP). These documents do not have the force and effect of a regulation, but they are used by the NRC 6

staff to identify methods that would comply with the regulation. A formal procedure which enables interested parties to propose changes to such regulatory guidance documents does not now exist. The guidance for preparation of more detailed petitions for rulemaking as well as petitions requesting the revision of regulatory guidance documents will be provided in proposed Regulatory Guides 10.XX and 10.XY to be developed in the near future. Specific Considerations Advice and recommendations on the proposed revision to 10 CFR 2.802 and on any other points considered pertinent are invited from all interested persons. Comments and supporting reasons are particularly requested on the following questions:

1.

Is the concept of the proposal sound, namely that all petitioners have the option to submit more detailed supporting information which, if found adequate, would lead to faster NRC disposition?

2.

Is the description of information required for detailed supporting information 1n paragraph (d)(2) sufficiently complete to avoid unnecessary correspondence after the petition has been docketed?

3.

Under what circumstances should a guidance document in the form of a Regulatory Guide be required to support a petition? What criteria are appropriate for not requiring it?

4.

Should there be an NRC electronic bulletin board dealing exclusively with petitions?

5.

As the NRC attempts to shift rulemaking approaches to be more performance-based and risk-based, what changes would be appropriate for the information requirements under the proposed revision of 10 CFR 2.802? 7

6. Should administrative procedures be established to allow petitions for changes to regulatory guidance documents, such as regulatory guides, bulletins, generic letters, and sections of the Standard Review Plan? Should these procedures be incorporated in a rule?

Environmental Impact: Categorical Exclusi'on The proposed regulations involve an amendment to 10 CFR 2.802, and qualify as actions eligible for the categorical exclusion from environmental review in 10 CFR 51.22(c)(l). Therefore, neither an environmental impact statement nor an environmental assessment has been prepared for these proposed regulations. Paperwork Reduction Act Statement The proposed rule amends information collection requirements that are subject to the Paperwork Reduction Act of 1980 (44 U.S.C. 3501 et seq). This rule has been submitted to the Office of Management and Budget for review and approval of the information collection requirements. The public reporting burden for this collection of information is estimated to average an additional 500 hours for each PRM that contains additional supporting information and analyses. Send coments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden, to the Information and Records Management Branch (T-6 F33), U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; and to the Desk Officer, Office of Information and Regulatory Affairs, NEOB-10202, (3150-0136), Office of Management and Budget, Washington, DC 20503. 8

RegulatorJ* Analysis The Administrative Procedure Act requires each Federal agency to give interested persons the right to petition for the issuance, amendment, or repeal of a rule. The proposed changes would facilitate more expeditious disposition by the NRC of petitions with sufficient supporting information, and would also improve the openness of the rulemaking process by delineating petition review priorities. This expended right, however, is available to any interested petitioner. The proposed rule does not affect any existing rights and gives expanded rights to licensees and interested persons. This proposed rule constitutes the preferred course of action and the cost involved in its promulgation and action is necessary and appropriate. The foregoing discussion constitutes the regulatory analysis for the proposed rule. Regulatory Flexibility Certification In accordance with the Regulatory Flexibility Act of 1980 (5 U.S.C. 605(b)), the Cortlllission certifies that this rule will not, if promulgated, have a significant economic impact on a substantial number of small entities. Any interested person has the right to submit a petition for rulemaking under the existing guidelines. If, an interested person voluntarily chooses to develop additional information and perform additional analysis to support a proposed petition, the proposed rule would further encourage petitioners to do so. If the interested person is unable or unwilling to incur the costs associated with developing additional information and performing these analyses, a petition may be submitted under the existing rule. The NRC staff will continue to perform the analyses that may be required to resolve the petition. The proposed rule does not impose any obligations on regulated 9

entities that may fall within the definition of "small entities" as set forth in section 601(3) of the Regulatory Flexibility Act, or within the definition of wsmall business" as found in section 3 of the Small Business Act (15 U.S.C. 632), or within the small business standards contained in 13 CFR Part 121. Backfit Analysis This proposed rule does not involve any new provisions which would impose backfits as defined in 10 CFR 50.109(a)(l). Accordingly, no backfit analysis pursuant to 10 CFR 50.l09(c) is required for this proposed rule. List of Subjects 10 CFR Part 2 Administrative practice and procedure, Antitrust, Byproduct material, Classified information, Environmental Protection, Nuclear materials, Nuclear power plants and reactors, Penalties, Sex discrimination, Source material, Special nuclear material, Waste treatment and disposal. For the reasons set out in the preamble and under the authority of the Atomic Energy Act of 1954, as amended, the Energy Reorganization Act of 1974, as amended, and 5 U.S.C. 553, the NRC is proposing to adopt the following amendments to 10 CFR Part 2. PART 2 - RULES OF PRACTICE FOR DOMESTIC LICENSING PROCEEDINGS

1.

The authority citation for Part 2 continues to read as follows: Authority: Secs. 161, 181, 68 Stat. 948, 953, as amended (42 U.S.C. 2201, 2231); sec. 191, as amended, Pub. L. 87-615, 76 Stat. 409 (42 U.S.C. 10

2241); sec. 201, 88 Stat. 1242, as amended (42 U.S.C. 5841); 5 U.S.C. 552. Section 2.101 also issued und~r secs. 53, 62, 63, 81, 103, 104, 105, 68 Stat. 930, 932, 933, 935, 936, 937, 938, as amended (42 U.S.C. 2073, 2092, 2093, 2111, 2133, 2134, 2135); sec. 114(f), Pub. L. 97-425, 96 Stat. 2213, as amended (42 U.S.C. 10134(f)); sec. 102, Pub. L. 91-190, 83 Stat. 853, as amended (42 U.S.C. 4332); sec. 301, 88 Stat. 1248 {42 U.S.C. 5871). Sections 2.102, 2.103, 2.104, 2.105, 2.721, also issued under secs. 102, 103, 104, 105, 183, 189, 68 Stat. 936, 937, 938, 954, 955 as amended (42 U.S.C. 2132, 2133, 2134, 2135, 2233, 2239). Section 2.105 also issued under Pub. L. 97-415, 96 Stat. 2073 (42 U.S.C. 2239). Sections 2.200-2.206 also issued under secs. 16lb,i, o, 182, 186, 234, 68 Stat. 948-951, 955, 83 Stat. 444, as amended (42 U.S.C. 2236, 2282); sec. 206, 88 Stat. 1246 {42 U.S.C. 5846). Sections 2.600-2.606 also issued under sec. 102, Pub. L. 91-190, 83 Stat. 853, as amended (42 U.S.C. 4332). Sections 2.700a, 2.719 also issued under 5 U.S.C. 554. Sections 2.754, 2.760, 2.770, 2.780 also issued under 5 U.S.C. 557. Section 2.764 and Table IA of Appendix C also issued under secs. 135, 141, Pub. L. 97-425, 96 Stat. 2232, 2241 (42 U.S.C. 10155, 10161). Section 2.790 also issued under sec. 103, 68 Stat. 936, as amended {42 U.S.C. 2133) and 5 U.S.C. 552. Sections 2.800 and 2.808 also issued under 5 U.S.C. 553. Section 2.809 also issued under 5 U.S.C. 553 and sec. 29, Pub. L. 85-256, 71 Stat. 579, as amended (42 U.S.C. 2039). Subpart K also issued under sec. 189, 68 Stat. 955 (42 U.S.C. 2239); sec. 134, Pub. L. 97~425, 96 Stat. 2230 (42 U.S.C. 10154). Subpart L also issued under sec. 189, 68 Stat. 955 (42 U.S.C. 2239). Appendix A also issued under sec. 6, Pub. L. 91-560, 84 Stat. 1473 (42 U.S.C. 2135). Appendix B also issued under sec. 10, Pub. L. 99-240, 99 Stat. 1842 (42 U.S.C. 2021b et seq.). 11

2. Section 2.8 paragraph (b) is revised to read as follows:

(b) The approved infonnation collection requirements contained in this part appear in§ 2.802 and appendix C. [56 FR 29408, June 27, 1991, as amended at 58 FR 14309, Mar. 17, 1993]

3. Section 2.802 is revised to read as follows:

§ 2,802 Petition for rulemakjng. (a) Any 'interested person may petition the Commission to issue, amend, or rescind any regulation. The petition should be addressed to the Secretary, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, Attention: Chief, Docketing and Service Branch. (b) A prospective petitioner may consult with the NRC before filing a petition for rulemaking by writing the Director, Freedom of Information and Publications Services, Office of Administration, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, Attention: Chief, Rules Review and Directives Branch. A prospective petitioner may also telephone the Rules Review and Directives Branch on (301) 415-7158 or toll free on (800) 368-5642. (1) In any consultation before the filing of a petition for rulemaking, the assistance that may be provided by the NRC staff is limited to: (i) Describing the procedure and process for filing and responding to a petition for rulemaking; (11) Clarifying an existing NRC regulation and thebasis for regulation; and (iii) Assisting the prospective petitioner to clarify a potential petition so that the Commission is able to understand the nature of the issues of concern to the petitioner. 12

(2) In providing the assistance permitted in paragraph (b)(I) of this section, the NRC staff will not draft or develop text or alternative approaches to address matters in the prospective petition for rulemaking. (c) Each petition filed under this section shall: (1) Set forth a general solution to the problem or the substance or text of any proposed regulation or amendment, or specify the regulation which is to

• be revoked or amended;

{2) State clearly and concisely the petitioner's grounds for and interest in the action requested; (3) Include a statement in support of the petition which shall set forth the specific issues involved, the petitioner's views or arguments with respect to those issues, relevant technical, scientific or other data involved which is reasonably available to the petitioner, and such other pertinent information as the petitioner deems necessary to support the action sought. In support of its petition, petitioner should note any specific cases of which petitioner is aware where the current rule is unduly burdensome, deficient, or needs to be strengthened. (d) Petitions for rulemak1ng will be prioritized and scheduled for review and disposition by NRC on the basis of the following considerations: (1) Safety significance of the issues identified or alternatives proposed in petitions will be the dominant consideration for the prioritization of petitions. (2) Petitions containing supporting information additional to that described in paragraph (c) of this section, will improve the priority for review and more expeditious disposition. Sufficient supporting information for higher priority should include: 13

(i) The text of a proposed, revised, or amended regulation (Athe proposed rule"); (ii) Supplementary infomat1on constituting the proposed statement of considerations for the regulation; {iii) Supporting material to show conformance with legal requirements such as the National Environmental Policy Act, the Paperwork Reduction Act, and the Regulatory Flexibility Act, as appropriate; (iv) A regulatory analysis. For infomation on the fom and content of a regulatory analysis see NUREG/BR-00581 and NUREG/CR-35682 ; (v) Supporting infomation that responds to 10 CFR 50.109(c), the Backfit rule where applicable; and

1. NUREG/BR-0058, "Regulatory Analysis Guidelines of the U.S. Nuclear Regulatory Commission,A Rev. 1, May 1984. A draft Rev. 2 of this report was issued for conrnent in August 1993, and should be published as final report in the near future.

2. NUREG/CR-3568, "A Handbook for Value-Impact Assessment," December 1983.

The document is currently undergoing revision and will tentatively be titled the "Regulatory Analysis Technical Evaluation Handbook.* NOTE: Copies of NUREG/BR-0058 and NUREG/CR-3568 may be purchased form the Superintendent of Documents, U.S. Government Printing Office, Mail Stop SSOP, Washington, DC 20402-9328. Copies are also available from the National Technical Infomation Service, 5285 Port Royal Road, Springfield, VA 22161. A copy is also available for inspection and copying for a fee in the NRC Public Document Room, 2120 L Street, NW. (Lower Level), Washington, DC 20555-0001. 14

(vi) A guidance document in the form of a Regulatory Guide when* necessary (Note that a Regulatory Guide is usually provided for a performance based regulation). (e) The petitioner may request the Conanission to suspend all or part of any licensing proceeding to which the petitioner is a party pending disposition of the petition for rulemaking. (f) If it is determined that the petition includes the information required by paragraphs (c) and, if petitioner elects, (d)(2) of this section and is complete, the Director, Division of Freedom of Information and Publications Services, or designee, will assign a docket number to the petition, will cause the petition to be formally docketed, and will deposit a copy of the docketed petition in the Commission's Public Document Room. Public co11111ent may be requested by publication of a notice of the docketing of the petition in the Federal Register, or, in appropriate cases, may be invited for the first time upon publication in the Federal Register of a proposed rule developed in response to the petition. Publication will be limited by the requirements of section 181 of the Atomic Energy Act of 1954, as amended, and may be limited by order of the Co11111ission. (g) If it is determined by the Executive Director for Operations that the petition does not include the information required by paragraphs (c) and, if applicable, (d)(2) of this section and is incomplete, the petitioner will be notified of that determination and the respects in which the petition is deficient and will be accorded an opportunity to submit additional data. Ordinarily this determination will be made within 30 days from the date of receipt of the petition by the Office of the Secretary of the Co11111ission. If the petitioner does not submit additional data to correct the deficiency 15

within 90 days from the date of notification to the petitioner that the petition is incomplete, the petition may be returned to the-petitioner without prejudice to the right of the petitioner to file a new petition. (h) The Director, Division of Freedom of Information and Publications Services, Office of Administration, will prepare on a semiannual basis a summary of petitions for rulemaking before the Commission, including the status of each petition. A copy of the report will be available for public inspection and copying for a fee in the C011111ission's Public Document Room, 2120 L Street, NW. (Lower Level), Washington, DC. ~ Dated at Rockville, MD, this _:12:::__ day of }A-c~ 1995. For the Nuclear Regulatory Commission. Andrew L. Bates, Acting Secretary of the Commission. 16}}