ML20148A207

Provides Commission W/Info on Addl Alternative for Regulating Safety of Fuel Cycle Facilites

ML20148A207
Person / Time
Issue date:	05/02/1997
From:	Callan L NRC OFFICE OF THE EXECUTIVE DIRECTOR FOR OPERATIONS (EDO)
To:
References
SECY-96-079-C, SECY-96-79-C, SECY-97-097, SECY-97-097-R, SECY-97-97, SECY-97-97-R, NUDOCS 9705080133
Download: ML20148A207 (23)

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May 2, 1997 SECY-97-o97 FOR: The Commissioners FROM: L. Joseph Callan Executive Director for Operations

SUBJECT:

ADDITIONAL ALTERNATIVE FOR REGULATING THE SAFETY OF FUEL CYCLE FACILITIES: NUCLEAR ENERGY INSTITUTE PETITION FOR RULEMAKING l

PURPOSE:

To provide the Commission with information on an additional alternative for regulating the safety of fuel cycle facilities (Attachment 1). This additional alternative reflects the basic features of the Nuclear Energy Institute (NEI) Petition for Rulemaking (PRM-70-7) (Attachment 2). This alternative is in addition to the alternatives in SECY-96-079. " Alternatives l for Regulating Fuel Cycle Fa'cilities." dated April 16, 1996, and is provided '

l in response to a December 4. 1996. Staff Requirements Memorandum (SRM).

BACKGROUND:

i SECY-96-079 presented the Commission, for consideration and decision, six l alternatives for regulating the safety of fuel cycle facilities, along with the aros and cons for each alternative. The alternatives range from no changa to t1e current rule to a restructure and rewrite of the rule.

On July 2. 1996, the Commission was briefed by the staff and industry on the proposed alternatives. At the briefing, industry representatives stated that the U.S. Nuclear Regulatory Commission's and industry's mutual goal of i

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a6 The Commissioners 2 maintaining and improving the margin of safety at fuel cycle facilities would best be served if some carefully designed regulatory changes were implemented.

Although inductry representatives had opposed revisions to 10 CFR Part 70 in l the past, they stated that certain additions to the existing rule could be '

potentially beneficial and. "They could embrace a specific change to the existing Part 70 that would require licensees to address plant safety hazards using an integrated safety assessment or an acceptable alternative." Since industry representatives concluded that certain rule changes would be beneficial. the Commission encouraged them to present their proposed changes to NRC in the form of a petition for rulemaking (PRM). On September 30, 1996.

NEI filed a PRM on behalf of certain Part 70 licensees and potential licensees. On December 4. 1996, an SRM was issued that requested staff to

... evaluate the effect, if any, that the NEI petition has on its analysis presented in SECY-96-079."

DISCUSSION:

The PRM requests that Part 70 be amended by adding three new provisions.

These provisions include: (1) a requirement to perform an integrated safety assessment (ISA) or an acceptable alternative, for uranium processing and fuel fabrication plants and enrichment )lants, to confirm that adequate controls are in place to protect the pu]lic health and safety; (2) the addition of a backfitting provision: and (3) the addition of a definition of a uranium processing and fuel fabrication plant. (Petitioners request that the requirement to perform an ISA be limited to uranium processing and fuel fabrication plants and enrichment plants. They do not believe that the -

" possibility" that NRC may be asked to regulate U.S. Department of Energy facilities provides an appropriate basis for imposing significant new programmatic changes on an entire industry that has operated successfully under the existing requirements.)

Staff has reviewed the PRM and reexamined the six alternatives in SECY-96-079.

It concludes that the proposed amendment could be considered as an additional alternative for Commission consideration and that no changes are needed to the alternatives in SECY-96-079.

Although the PRM includes many recommendations similar to features of Alternative 3 addressed in SECY-96-079. there are important differences when these features are examined in detail. A summary of the major features of the PRM and of how they relate to similar features addressed in SECY-96-079 is arovided in Attachment 1. The final analysis of the proposed revisions in the

)RM. a summary of public comments received, and a proposed formal resolution to the PRM will be provided in a separate Commission Paper by June 30. 1997.

The Commissioners 3 COORDINATION:

The Office of the General Counsel has reviewed this paper and has no legal objection. There is no information technology or financial impact that would result from this paper.

L. Jos eph Callan Execut4ve Director for Operations Attachments: As stated (2)

DISTRIBUTION:

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ADDITIONAL ALTERNATIVE FOR REGULATING FUEL CYCLE FACILITIES The proposed amendment to 10 CFR Part 70 that was submitted by the Nuclear '

Energy Institute (NEI) in a Petition for Rulemaking (PRM-70-7) can be considered.as an additional alternative to those presented in SECY-96-079. .

" Alternatives for Regulating Fuel Cycle Facilities."

The topics relevant to this petition are: (1) the performance of an integrated safety assessment (ISA). or its equivalent: (2) a backfitting i provision: (3) limits on the applicability of a revised Part 70: (4) event i reporting: and (5) supporting guidance documents.  ;

Each of these topics is discussed below. For each topic, a summary of the discust an in SECY-96-079 is provided, followed by a summary of the petition 1 proposal. (An analysis of the proposed revisions in the PRM. summary of

,public comments received, and a proposed resolution to the PRM will be l

provided in a separate Commission Paper.)

~1. 1 16  :

With regard to the ISA. the following subtopics are listed and separately discussed below:  ;

i

a. Hazards Identification and Analyses  ?

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b. Consecuence Limits

c. Gradec Level of Protection  !

d. Alternative Approaches to ISAs  !

e. License Format and-ISA Documentation - l

f. Timeframe for Completing ISAs  ;

a. Hazards Identification and Analyses  ;

SECY 96 079 Summary: The 3erformance of an ISA for a licensee subject I to Part 70 would involve t1e following- >

1) Identification of all hazards (radiological, chemical, and fire)  ;

at the facility:  :

2) Integrated analysis of all hazards to determine potential accidents or events that could exceed certain consequence limits:

and

3) Identification of items (e.g. structures, systems, equipment, components, and activities of personnel) that are relied on for safety (i.e. to prevent the occurrence or mitigate the consequences of potential accidents or events).

l1 I The term " consequence limits." which is used in SECY 96-079 or " performance criteria." '

which is used in PRM-70-7 refers to the adverse consequences of potential accidents or events that licensees must protect against. l l

ATTACHMENT 1 '

i

2 Based on the ISA results, a licensee would provide in its application a summary of the hazards: an identification of those structures, systems.

equipment, components and activities of personnel relied on for safety to protect against the hazard: and a commitment to implement measures to ensure the continued availability and reliability of those items relied on for safety. The results of the ISA would be submitted to the U.S.

Nuclear Regulatory Commission and would become part of the license. A time limit would be specified for a licensee to complete its ISA, identify the items relied on for safety, and implement measures necessary to ensure the continued availability and reliability of these items.

PRM 70 7 Summary: The 3erformance of an ISA for a licensee subject to Part 70 would involve t1e following: i

1) Identify and evaluate those hazards that ". .could result in not meeting. . ." any of the performance criteria.

2) Determine whether adequate controls and protective measures are in place to provide reasonable assurance that the performance criteria will not be exceeded.

Based on the ISA results, licensees would implement changes to their structures, systems, and components (SSCs) or associated licensee programs that would provide reasonable assurance that the 3erformance criteria are not exceeded, but would not identify to NRC t1ose items relied on for safety or commit to their continued availability and -

reliability in their license applications. Licensees would implement facility changes in a timely manner. If the ISA results indicated that relaxation of some controls or reallocation of resources were justified, licensees would be able to do so, in accordance with applicable license amendment or commitment change procedures. The NEI petition states that "A formal submittal to the NRC of an ISA report will not be required." ,

Instead. ISA results would be available for review at all licensees

• sites, but would not become part of the licenses.

b. Consecuence Limits SECY 96 079 Summary: Consequence limits would be established to identify the adverse consequences that licensees must protect against.

In establishing these limits, staff would consider the requirements imposed by the Occupational Safety and Health Administration (OSHA) and the U.S. Environmental Protection Agency (EPA). The specific limits were not discussed in SECY-96-079.

PRM 70 7 Summary: " Measurable performance criteria" would be established for judging the effectiveness of licensees

• safety programs  !

to protect against certain adverse consequences (i.e.. potential accidents or events). The proposed performance criteria call for the  ;

following-  :

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(1) The requirements of Part 20 to be satisfied.  :

' (2) The avoidance of accidental criticality events, and (3) For accident conditions, the avoidance of a dose to a member of  !

the public of 25 rem, an iritake of 30 mg uranium in soluble form, or an exposure to hydrogen fluoride in air equivalent to immersion for  :

30 minutes in a concentration of 25 mg/m. l

c. . Graded level of Protection SECY % 079 Summary: The consequence limits would allow for a graded i level of protection against potential accidents or events identified in  !

ISAs. - For example, a higher level of protection would be needed to 1 prevent or mitigate the consequences of severe accidents (e.g.,

criticality events, exposures to high levels of radiation and chemicals) ,

than would be needed for less severe accidents with lesser consequences.

In addition, appropriate measures would be established, commensurate  ;

with the risks, to ensure the availability and reliability of items-relw on for safety (e.g_. , training, maintenance). l l

PRM 70 7 Summary: "The anticipated likelihood of an event or accident, as well as its potential impacts would be evaluated by a licensee, in  !

the process of grading the safety programs. Using these criteria, one approach to grading would be to classif SSCs and programs based on ,

safety significance and to app y contro s commensurate with that classification. Other approac es may also be appropriate." '

In this graded approach, the PRM stated that " Events or accidents of lesser significance would continue to be prevented and mitigated through L existing licensee safety programs."

d. Alternative Acoroaches to ISAs ECY 96-079 Summary: Alternative approaches to ISAs were not discussed in SECY-96-079. However, a variety of hazard evaluation techniques is included in the draft NRC ISA Guidance Document, which was distributed ,

and discussed with industry at the August 1993 and September 1994 NRC-  ;

sponsored public workshops. In performing ISAs. licensees and license applicants could select from among these various techniques that are

• recognized by the American Institute of Chemical Engineers (AIChE) to  !

analyze process systems and to identify potential accidents. Also, l licensees could select other methods, which would be subject to NRC ..

approval.

PRM 70 7 Summary: Licensees would have the flexibility to offer l

!- alternative approaches for NRC's consideration in performing ISAs. The )

PRM stated that "Such approaches might not conform to a formal

• hazards i analysis.' but could still provide the NRC and the licensee with adequate confidence in facility safety." Any alternative approach would i be subject to NRC approval. l It was stated that "...the AIChE document provides reasonable approaches, and that other formal methods may also be acceptable." It l is requested that hazard analyses being performed under OSHA and the EPA Risk Management Program regulations be considered an acceptable means of I

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4 meeting the ISA requirements for evaluating hazards within NRC's jurisdiction.

e. License Format and ISA Documentation SECY 96 079 Summary: The license applications would include licensees' commitments to identify and implement the items relied on for safety and the measures needed to ensure their continued availability and reliability. These would be determined on the basis of the performance of ISAs. To reflect changes made to facility processes that affect the safety bases. licensees would provide NRC with revisions to their ISA documentation and their licenses. Licenses would become "living licenses" in that they would reflect the current configurations of the nuclear process, and major renewals would not be necessary.

PRM 70 7 Summary: The results of an ISA, which would include " ..a discussion of the controls relied upon to ensure that the performance criteria are not exceeded and the bases for concluding such controls are adequate," would be available for review at each licensee's site. This information would ng1 become part of the license. Also, an ISA report would not be submitted to NRC, and a commitment would not be made to ensure the continued availability and reliability of items relied on for safety.

When "significant" plant changes are under consideration, licensees would review and update their ISAs and implement any new controls that might be necessitated from these reviews and updates, without NRC review -

and approval. The updated information would also remain at licensees

• sites. i

f. Timeframe for Comoletina ISAs i

SECY 96-079 Summary: For newly constructed facilities or for new i construction at existing facilities, " preliminary" ISAs would be  !

performed and the results submitted to NRC for approval before construction. The ISA results would serve as the design bases for the facilities (i.e., the safety features incorporated into the designs that provide protection against credible internal and external accidents or events). Before the commencement of operations at the facilities. l licensees would review and update their ISAs to reflect as-built conditions and submit the results for approval as part of the license applications. 1 For existing licersees ISAs would be completed within a specified time period. This time period would allow for com)letion of cuality ISAs, ,

correction of vulneratilities identified in tie ISAs, anc submissions of l 2

The safety basis is comprised of the potential accidents or events that exceed the consequence limits; items that are relied on (e.g., site. structures, systems. equipment.

components. and activities of personnel) to prevent or mitigate the consequences of accidents or events; and measures implemented to ensure the continued availability and reliability of these items.

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5 the ISA information to NRC. The specific time period was not discussed  ;

.in SFCY-96-079.

ERM 70 7 Summary: For new facilities. ISAs would be completed before NRC issued the initial" licenses to operate. For existing licensees.  :

ISAs would be completed within five years after promulgation of the l amended rule and implementation of the associated guidance. The ISA  :

results would not be submitted to NRC for approval, as previously  ;

4 discussed.

2. Backfittina

.SECY 96 079 Summary: A backfitting provision was not discussed in j

SECY-96-079.  !

PRM 70 7 Summary: A backfitting provision would be included in the amended rule. The recommended provision is similar to the regulation in 10 CFR i

50.109 "Backfitting." which applies to power reactors. (Plant changes  ;

resulting from " licensee-performed analyses" [e.g. ISAs] would also be subject to a backfit analysis.)

3. ADolicability of Part 70 l

L SECY 96 079 Summary: The licensing of new facilities (e.g., U.S. Department of Energy [00E] facilities or new processes) was considered in identifying -

possible regulatory changes. One of the objectives is to develop a rule that is risk-based and that could be used to effectively license or certify new licensees as well as existing licensees.

Besides the proposed changes discussed in Sections 1.a - 1.f above, other rule i

changes that would assist new license applicants include creating a new U.S.

Code of Federal Regulations Part (CFR). This new Part would avoid adding

additional patches (multiple amendments) to the current Part 70 and would  ;

distinguish the requirements for licensees that are authorized to possess

- critical cuantities of s)ecial nuclear material (SNM) from those for licensees  !

authorizec to possess su) critical quantities of SNM, The requirements transferred to the new CFR Part would be rewritten to: (1) present the requirements in more performance-oriented language wherever possible: (2) eliminate redundant requirements: (3) address and correct inconsistent requirements that are now difficult to administer and are presented in a disjointed format: and (4) identify and delete any unnecessary requirements.

' These changes would be made in the interests of minimizing the '

misinterpretation of the rule and expediting the learning process regarding 4 NRC regulations since the rule would be organized and structured in a more systematic and: logical manner and would be more " user-friendly." i i

PRM 70 7 Summary: Petitioners "...do not believe that the

• possibility' that i

. the NRC may be asked to regulate DOE facilities provides an appropriate basis l for imposing significant new programmatic changes on an entire industry that  !

has operated successfully under the existing requirements." (These t "significant new programmatic changes" were not specifically identified in the j

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6 PRM.) It was also stated that "...it is not clear that the NRC should, or i j even could at this stage attempt to develop a set of meaningful regulatory }

changes given the very wide range of facilities, hazards and operations within t the DOE complex." Thus. -it is requested that:the amended rule apply to  !

uranium processing and fuel fabrication facilities that conduct specified operations or activities.

4 Event Reoortina SECY-96 079 Summary:- The voluntary reporting function established by Bulletin I

i 91-01, which addresses licensee reporting to NRC of the loss of criticality safety controls.. would be codified and broadened.  ;

PRM 70 7 Summary: Reporting requirements subject to Part 70 were not discussed. j i )

5. Sucoortina Guidance Docunents  ;

SECY-96 079 Summary: A new Standard Review Plan and a revised Standard Format ,

and Content Guide would be develo)ed as guidance to support Part 70. Also, a .

guidance document would be pub 11 sled that provides guidance on how to perform i an-ISA and document the results. (A draft NRC ISA guidance document was  !

distributed and discussed with industry at the August 1993 and September 1994 l

NRC-sponsored public workshops.)  ;

1

=j PRM 70-7 Summary: Supporting guidance documents for Part 70 are mentioned j

only in the context of when licensees would be required to complete their ISAs I (i.e. within 5 years after the promulgation of the rule and associated guidance).

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f OCI - p I886 Mr. John C. Hoyle 5

• N Secretary U.S. Nuclear Regulatory Commission 4 s

Washington, D.C. 20555-0001 p ,,

A'ITENTION: Chief, Docketing and Service Branch

Dear Mr. Hoyle:

The Nuclear Energy Institute (NEI)," on behalf ofits members who are 10 CFR Part 70 licensees, hereby submits a Petition for Rulemaking pursuant to i 10 CFR 2.800 et seq. NEI requests that the U.S. Nuclear Regulatory Commission .

(NRC) amend 10 CFR Part 70 to require uranium processing, uranium enrichment, and fuel fabrication licensees to ensure their safety programs are evaluated and modified as necessary, based on the conduct of an Integrated Safety Assessment (ISA), or an acceptable alternative, within an appropriate time period. Further, the industry requests that Part 70 be modified to bolster regulatory stability for Part 70 licensees through the inclusion of a comprehensive backfitting requirement similar to that for Part 50 licensees.

As outlined in the Petition, the proposed rule would require Part 70 licensees to evaluate and enhance, if appropriate, their overall safety program based on data generated from an ISA or an acceptable alternative, and predicated on specifically-defined performance criteria. As indicated from past studies, the three principle hazards for Part 70 facilities are nuclear criticality, fire, and chemical accidents.

Performance criteria are established in the proposed rule for the evaluation of these three hazards, as well as general radiation safety.

• NEI is the organization responsible for establishing unified nuclear industry policy on matters affecting the nuclear energy industry, including the regulatory aspects of gerwric operational and technical issues. NErs membert 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.

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Mr. John C. Hoyle September 30,1996

- Page 2 The specification of performance criteria, the disciplined conduct of an ISA, and the use of the ISA results as a basis to adjust the licensees' safety programs, as needed, are the seminal portions of this Petition for Rulemaking. Our proposed rule bac +he potential to benefit both licensees and the NRC by requiring a clear, outcomes-based understanding of the risks, their consequences, and established levels of safety, and by focusing regulatory and licensee attention on those areas that have the greatest risks. Implementing the proposal would focus both licensee and NRC resources on those areas where public health snd safety will benefit, and away from low risk, low consequence issues.

We would be pleased to discuss this Petition and to respond to any questions the NRC may have regarding its content or application.

Sincerely, 4 l Marvin S. Fertel  !

1 Enclosure l

l 1

4 0

- UNITED STATvE OF AMERICA NUCLEAR REGULATORY COMMISSION In the Matter of a )

Proposed Rulemaking )

Regarding Amendments to ) Docket No.

10 CFR Part 70 )

)

PETITION FOR RULEMAKING This Petition for Rulemakingis submitted pursuant to 10 CFR 2.800 et seq. by the Nuclear Energy Institute (NEI), on behalf of certain 10 CFR Part 70 licensees and potential licensees. Petitioners request that the U.S. Nuclear Regulatory Commission (NRC), following notice and opportunity for comment, amend Part 70 by requiring uranium processing, enrichment, and fuel fabrication licensees to utilize either an Integrated Safety Assessment (ISA), or an acceptable alternative approach to confirm that adequate controls are in place to protect public health and safety. The proposed rule would also establish a backfitting provision in Part 70 for the purpose of ensuring regulatory stability.

STATEMENT OF PETITIONER'S INTEREST NEI is the organization of the nuclear energy industry responsible for coordinating the combined efforts of materials licensees, electric utilities and other nuclear industry organizations in all matters involving generic regulatory policy issues and regulatory aspects of generic operational and technicalissues affecting the nuclear industry. NEI's members include electric utilities, major architect / engineering firms, all of the major nuclear fuel supply vendors and all of the major manufacturers of radionuclides and radiopharmaceuticals. Because some cf NEI's materials licensee members are subject to the requirements of Part 70, NEI is an

" interested person" within the meaning of 10 CFR 2.802.

BACKGROUND The subject of revising Part 70 has been under consideration by the NRC Staff for several years. The apparent impetus for the NRC Staffs desire to amend Part 70 has been its assessment of certain conditions and events that have occurred at fuel facilities in the past, as well as the 1992 report of the NRC's Materials Regulatory

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

Review Task Force entitled " Proposed Method for Regulating Major Materials

• Licensees"(NUREG-1324). A brief summary of the history of the NRC's deliberations on amending Part 70 follows.

In response to the 1992 issuance of NUREG-1324, the Staff developed an action plan for implementing regulatory changes applicable to major materials licensees.

(SECY-92-337, October 5,1992). After being briefed on the action plan, the Commission directed the Staff to reconsider various aspects of the plan. (Staff Requirements Memorandum (SRM), January 15,1993). Subsequently, the Staff l

i amended its approach and explicitly recommended a " major revision" to Part 70.

~ (SECY-93-128, May 12,1993). The Commission endorsed the Staffs l l

recommendations (SRM, June 7,1993). l 2

The Stafflater concluded that it would not be practical to work within the ,

framework of the existing Part 70 and therefore recommended that a completely i new version be developed. A six month extension of the schedule for preparation of  :

a proposed rule was also proposed. (SECY-94-057A, April 13,1994). The Staff then proposed an additional five month extension until June,1995. (SECY-94-288, November 29,1994). In March 1995, the Commission directed the StafTto

" reconsider the current plan to revise 10 CFR Part 70 in its entirety . . . ." The Commission directed the Staff to " determine [ major fuel cycle licensee] attitudes towards revising Part 70, . . [and] the cost to revise and implement a new Part 70 . .

. , as well as to consider and evaluate " alternative approaches . . . ." (SRM, March 28,1995).

A draft of the Ce9's proposed r'evisions was first made available to licensees and the public in Spring 1995. (SECY-95-151, June 12,1995).' Once the draft became available and the Staff held a public meeting to discuss licensees' views, the Staff recommended that the rulemaking be "placed on hold" to permit further dialog with interested parties. The Commission approved that recommendation. (SRM, l

June 29,1995). After a November 1995 public workshop, the Staffissued SECY-96-079, setting forth six alternative approaches for regulating fuel cycle facilities. (SECY-96 079, April 16,1996). A July 2,1996 Commission briefing then followed.

At the July 2 Commission briefing, NEI stated that in the interest of maintaining and improving the margin of safety of fuel facilities, and achieving some resolution of this issue, it would support certain carefully designed additions to Part 70.

(Previously, NEI had taken the position that no rule changes were necessary). At the July 2 briefing, the Commission noted the change in the industry's position on revising Part 70 and strongly encouraged NEI to submit a rulemaking petition. In

a letter dated July 11,1996, NEI advised the Commission of the industry's intent to submit such a petition in early Fall 1996.

\

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GROUNDS FOR PROPOSED ACTION 1

There are two fundamental principles underlying NEI's recommended approach.

First, as recognized by the NRC Staff, fuel facilities are being operated safely under existing regulations. Recently completed NRC Plant Performance Reviews at three major facilities confirm that conclusion.

Second, the NEI's members have reviewed most of the conditions and events upon which the Staff apparently has based its concerns.1 In each of the cases reviewed, we found that: (1) substantial margins of safety and conservatisms existed; (2) the double contingency principle and conservative assumptions built into criticality t

safety analyses operated effectively to prevent an accidental criticality event; and (3) lessons learned from such events, as well as continuing efforts to make cost-effective improvements in industry's operations, have provided the industry with an

' even larger margin of safety than existed several years ago. In our analysis, we also explained why NUREG-1324 should not serve as a blueprint for a major revision to Part 70,2 and why possible future NRC regulation of DOE facilities does not warrant a major revision to Part 70.3 Therefore, the industry does not believe that wholesale changes.to Part 70 are '

necessary. We are proposing a focused and performance-based addition to the existing rule to address the NRC Staffs concern about possible hazards at Part 70 licensed facilities.

1 NErs review is documented in " Additional Discussion of Part 70 Industry Experience," which was

' discussed at the July 2,1996, Commission briefing, and made part of the record of that proceeding.

2 NUREG-1324 documented the results of an e&rt to propose an " ideal method" for regulating major materials licensees," unfettered by any existing regulations or regulatory guidance, concerns about backfitting, or limitations on resources . . . ." 'Ihe Director of NMSS at the time described the regulatory approach offered in NUREG 1324 as " admittedly highly idealistic." (Memorandum, Robert L. Bernero to NUREG-1324 recipienta). Furthermore, two senior NRC managers

' documented their " independent analysis" of the NUREG, and found that "[ilt will require a very substantial increase in resources and take years to complete action on all of the Report's recommendations. Given the characteristics of the facilities at which the Report's regulatory improvements are directed, the reality of agency resource constraints, and the availability of required skills,it is essential to prioritize the Report's recommendations." NUREG-1324, Appendix A,p.33.

3 'Ihe NRC Staff has expressed the desire to improve the " clarity" of Part 70 given the " possibility l l that NRC will be given the responsibility for regulating DOE facilities in the future . . ." SECY 96-079, at Attachment 1, p.4. NEI does not believe that the " possibility" that the NRC may be asked to '

regulate DOE facilities provides an appropriate basis for imposing significant new programmatic changes on an entire industry that has operated successfully under the existing requirements. In fact, it is not clear that the NRC should, or even could at this stage, attempt to develop a set of meaningful regulatory changes given the very wide range of facilities, hazards and operations within the DOE complex. See, for example, the Commission's recently released " Direction Setting Issue Paper" on " Oversight of the Department of Energy," released as part of the strategic l

. assessment effort (September 16, 1996).

3 i

i Attachment A to this Petition presents NEI's propoxd rule in response to the Commissioners' guidance at the July 2,1996, briefing. NEI recommends the l addition of three new provisi:ns to the existing Part 70. First, a new Section 70.40 would be added to require the use of an ISA or an approved, alternative integrated approach to safety, hereafter referred to as ISA, for convenience to the reader. Second, a "backfit" provision would be added. Third, a defmition would be added to clarify the scope of applicability of the proposed rule.

The ISAs would identify and evaluate those hazards that could imperil certain specified performance criteria, using methods similar to those described in the

- American Institute of Chemical Engineers'(AIChE) 1992 Guidelines for Hazard i Evaluation Procedures or other acceptable methods. After the conduct of the assessment, the plant Structures, Systems and Components (SSCs) and programs relied on for safety would be ranked, based on their importance to safety. This ranking process would yield the foundation fin a graded approach to safety, an approach that would focus resources on those SSCs and program areas that have l l

the greatest risks (consequence and frequency).

l l J

Upon completion of the ISAs, licensees would modify their facility or health and

]

safety programs, if necessary, to provide reasonable assurance that the specified l

performance criteria would not be exceeded. In doing so, licensees would use a  !

graded approach to safety to ensure that the focus of attention remained on those  :

matters wiih the most significant potential to adversely affect public and worker )

health and safety. Licensees and license applicants would be required to maintain the results of the ISA, and make those results available at their respective sites for l NRC review.

.l 1

Over the past decade, while the formal requirements of Part 70 have not changed significantly,its application has. Licensees' documentation requirements have evolved significantly and additional requirements on the facilities have been imposed through the inspection and license renewal processes. Regulatory predictability and stability associated with the licensing and oversight of Part 70 facilities has suffered as a result. The industry believes that the ISA requirement to evaluate risks (consequence and frequency) and the graded approach to safety ,

l (implementation and assurance), coupled with a backfit provision, would help to promote a stable and effective regulatory environment, The principle components of the industry's proposed rule and their supporting j bases are discussed below.

l

1. Integrated Safety Assessment l

An ISA is a process conducted to identify hazards and their potential for initiating event sequences, assess the potential event sequences and their consequences relative to the performance objectives for tlie facilities, the SSCs and programs relied on to prevent or mitigate such consequences.

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1 m . - , - - . -.

--s , .-- .

Subsequ:nt to the integrated assessment, safety-related SSCs and programs will be ranked based on their importance to safety and a balanced safety program. This ranking of SSCs and programs would optimize safety program implementation because the establishment ofimportance-to-safety rankings =d interrelationships would focus facility resources effectively.

2. Performance Criteria A cornerstone of this regulatory process is the establishment of performance criteria that comprise the safety template against which licensees will be required to judge the effectiveness of their safety programs. The establishment of performance criteria must therefore be part of the new rule. The performance criteria will be based on the criticality, radiation protection, chemical safety and fire protection aspects of the SSCs and programs deemed important to safety. We recommend the following performance criteria.

. The requirements of Part 20 are satisfied;

• Avoidance of accidental criticalities; and

. For accident conditions, it is unlikely that any member of the public offsite will receive a radiation dose of 25 rem total effective dose equivalent, an intake of 30 milligrams of uranium in a scluble form, or an exposure to hydrogen fluoride in air equivalent to immersion for 30 minutes in a cor. centration of 25 j

milligrams per cubic meter.

i Draft. NUREG-1513 stated that "(a]ppropriate controls must be in place to provide reasonable assurance that any accidents identified in the ISA having these consequences will not occur." We fully agree, and we feel it is essential that the rule itself contain measurable xdoenance criteria to that end.

3. Reference to Industry Practices I

While the rule does not specifically reference the American Institut4 of Chemical Engiacers (AIChE)

• Guidelines for Hazard Evaluation Procedures, Second Edition l with Worked Examples," 1992,it is frequently referenced by the NRC Staff as an acceptable guide for performing the hazard-evaluation portion of an ISA. NEI believes the AIChE document provides reasonable approaches, and that other ,

formal methods may also be acceptable. l j

Some licensees are currently performing hazard analyses under other applicable l requirements, such as the Occupational Safety and Health Administration's l (OSHA) Process Safety Management regulations and the Environmental Protection l' Agency's (EPA) Risk Management Program regulation. These analyses performed under these regulations should be considered acceptable means of meeting the ISA ]

5

requirement for evaluating hazards within the NRC's jurisdiction -- namely hazards associated with radioactive materials, nuclear criticality, and those fire and cheroical hazards that could affect nuclear safety? The NRC's draft NUREG-1513 states that the "ISA guidance . . . is intended to he consistent with the requirements of OSHA and EPA . . ." so long as the ISA addresses " radiological, nuclear criticality, and certain chemical hazards (i.e., UF6 release) not covered under other regulations."

4. Graded Approach Once any credible event is identified by an ISA, licensees will confirm that there is reasonable assurance that the performance criteria will not be exceeded, and that adequate controls are in place at their facilities to prevent or mitigate such postulated events. If credible event or accident sequences are examined and, based on a realistic evaluation, determined not to be reasonably capable of producing impacts in excess of the performance criteria, no further action by a licensee would be required. Events or accidents oflesser significance would continue to be

' prevented and mitigated through existing licensee safety programs. Where an accident or event could credibly produce consequences exceeding those specified in the rule, however, the licensee would evaluate the controls relied upon to prevent or mitigate the incident, and take additional measures as necessary. The anticipated likelihood of an event or accident, as well as its potential impacts would be evaluated by a licensee, in the process of geading the safety programs. Using these criteria, one approach to grading would be to classify SSCs and programs based on safety significance and to apply controls commensurate with that classification.

Other approaches may also be a'ppropriate.

5. Changes in Facility Operations Upon completion of the ISA, each licensee will determine what,if any, changes in existing controls are needed to provide reasonable assurance that the threshold performance criteria are not exceeded, and will implement such changes in a timely manner. If the ISA results indicate that relaxation of some controls or reallocation of resources is justified, the licensee may do so, in accorda ace with applicable license amendment or commitment change procedures.

• In accordance with the existing NRC/ OSHA Memorandum of Understanding, the NRC would not regulate purely chemicalhazards. " Memorandum of Understanding Between the Nuclear Regulatory Commission and the Occupational Safety and Health Administration; Worker Protection at NRC Licensed Facilities." 53 Fed. Reg. 43590 (October 31,1988).

6

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- 6. . Alternative Approaches '

e Efforts underway at a number of fuel cycle facilities to reevaluate and/or  !'

redocument the safety basis for their operations may fulfill :'.e requirement for the conduct of an ISA. In other cases, a licensee may feel that it has an alternative

- approach or program for assuring itself of, and demonstrating to the NRC, the -l

. safety ofits operations. The rule should provide flexibility for licensees to offer alternative approaches for the NRC's consideration. Such approaches might not l conform to a formal " hazards analysis," but could still provide the NRC and the ^

licensee with adequate conEdence in facility safety. The rule should allow for such alternative approaches, but would require the licensee to obtain NRC approval of, and complete its efforts, as the rule requires for formal ISAs. p

7. License Format '

4

.Under the industry's proposed rule, ISA results would be available for review, at each licensee's site, but would not become part of the license. These results would l include a discussion of the controls relied upon to ensure that the performance j criteria are not exceeded and the Hes for concluding such controls are adequate.

A formal submittal to the NRC of an ISA report will not be required. Most  :

, j importantly, the ISA will not become part of the license, which may only be changed through a codified change process. In accordance wRh licensees' configuration l control programs, when significant plant changes are considered, licensees would be required to review and update the ISA, and to implement any new controls that 1 may be necessitated as a result'of that review and updating. -j l Incorporation of the ISAs into the license would necessitate significant changes in the current license application format, dramatically expanding the description of i the plant site, facilities, equipment, processes and controls which would form the basis of the license. We note, for example, that the certification applications  ;

l submitted by the United States Enrichment Corporation (under criteria similar to those in the draft Part 70 SRP and SF&CG) included over 1,000 pages per plant l dedicated to site, facility, and process descriptions and safety (accident) analyses. l l i This could potentially represent a sigaificant administrative burden for licensees l

and the NRC Staff, producing no measurable improvement in the safety oflicensed Part 70 facilities. l 1

Furthermore, incorporation of an ISA into an NRC license, in a manner similar to a reactor licensee's Safety Analysis Report (SAR), would represent a fundamental i

departure from the traditional two-part license format used by many fuel cycle licensees. Under these licenses, one part establishes binding license conditions and l

- the other provides a " safety demonstration"in support of those license conditions. l A request for a license amendment is needed to change the license conditions i portion; however, the " safety demonstration" part may be modified without prior l NRC approval, as long as the licensee continues to adhere to the binding license  !

conditions. The existing system provides adequate control over necessary license l parameters while providing licensees with sufficient flexibility to accommodate ,

o i

i changes within the safety envelope established by tne license conditions. The '

[~ ,

industry does not believe that the administrative effort required to comply with a new license format -- which would be similar to a reactor licensee's SAR and whichi would presumably include a "50.59" type change process -- is warranted or necessary.

.Backfitting Provision l 8.

i. -

To assure that future modifications to Part 70 licenses brought about by new i regulatory requirements are based on public health and safety considerations, and l are appropriately cost justified, NEI requests inclusion of a backfitting provision in

- the revised Part 70; Modifications resulting from new or different NRC .

l j

requirements or Staff positions should be subjected to an appropriate analysis before impleme:itation to ensure that the benefits obtained justify the burden that the proposed cSange would impose upon licensees. It is imperative that once the

- rule is promulgated, siny subsequent plant or program modifications imposed as a result of the Staffs interpretation of the rule would require a cost-benefit review in i accordance with the rule. Here the concern is to seek, for example, protection from requirements to conduct highly complex and very costly Probabilistic Risk Assessments for these low-risk facilities. This would be consistent with other NRC guidance.

STATEMENT IN SUPPORT OF PROPOSED ACTION For the reasons stated herein, consistent with the guidance given to the industry by the Commission during the July 2,1996, public briefing (to consider submitting a Petition for Rulemaking to address the NRC's concerns in a manner that the industry thought would be most productive), this Petition to amend 10 CFR Part 70 was prepared. The proposed rule will provide forlicensees' safety programs to be grounded in the results of an integrated assessment of all aspects of safety. The rule would establish well-defined performance criteria and would require licensees to take steps to provide reasonable assurance that the performance criteria are not exceeded. In addition, a backfitting provision should be added. These additions to Part 70 will provide a more focused and performance-based rule without the imposition of costly new generic programmatic requirements that would not substantially contribute to increased safety margins.

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i ATTACHMENT A y 3

DISCUSSION OF PROPOSED RULE BY SECTION j

i 1

. I. Introduction and Scope Section 70.4 provides a definition of uranium processing and fuel fabrication l

facilities, and the proposed Section 70.40 provides the basis to assure the plant is being operated with an adequate safety margin. Section 70.76 establishes  !

2 enhanced regulatory stability, as it establishes specific requirements that proposed ,

regulatory changes must be evaluated against in order to assure that the benefit of l the change is justified by its economic impact. ,

II. General Requirements l The regulation of Part 70 facilities has evolved significantly since Part 70 was first promulgated; however, Part 70 has not been comprehensively modi 6ed or updated to reflect the changes in regulatory philosophy that have occurred since that time.

Concerns related to chemical and fire safety have been raised bv the NRC Staff, j

j along with a continuing concern related to a potential criticality incident. The l' industry has concluded that the conduct of Integrated Safety Assessments (ISA's) 4 would be beneficial. As a result, the industry has proposed the incorporation of an ISA requirement in Part 70, which will ensure that licensees grade their facilities'

. l Structures, Systems and Compo6ents (SSCs) and programs important to safety, l

and evaluate their respective facilities against established safety performance '

criteria in a disciplined manner. The criteria target fire, nuclear and radiation safety so that, as an example, an offsite release under off-normal conditions, will not exceed 25 rem, total effective dose equivalent, and normal operations would not produce doses in excess of the limits established in Part 20. For radiation and

chemical safety, performance criteria are, as an example, under accident conditions, a member of the public will receive less than an intake of 30 milligrams of uranium in soluble form, or an exposure to hydrogen fluoride in air equivalent to immersion for 30 minutes in a concentration of 25 milligrams per cubic meter.

If the ISA indicates that the performance criteria could be exceeded under reasonably anticipated conditions, the licensee would be required to take necessary i

steps to ensure that modi 6 cations are mtde to the facility's SSCs and programs important to safety, to meet those performee criteria.

The inclusion of a backfitting provision is intended to assure that regulatory 1 I

changes that are demonstrated to be cost effective are incorporated by the licensee

in a timely manner, and that any changes that do not provide benefits

- commensurate with the burden they would impose, are not implemented.

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1

1. TEXT OF PROPOSED RULE

^

70.4 Definitions I

Uranium processing and fuel fabrication plant means a plant in which the following operations or activities are conducted: (1) Operations for manufactum of reactor fuel containing uranium including any of the following: (i) Preparation of fuel material; (ii) formation of fuel material into desired shapes; (iii) application of j protective cladding; (iv) recovery of scrap material; and (v) storage associated with such operations; or (2) Research and development activities involving any of the operations described in item (1) of this definition except for msearch and development activities utilizing insubstantial amounts of uranium.

70.40 Integrated Safety Assessment J

(a) Uranium processing, fuel fabrication, and uranium enrichment plant

) l licensees licensed under 10 CFR Part 70, shall perform an Integrated Safety Assessment (ISA), or provide an acceptable alternative integrated approach to  :

" safety, to determine the SSCs and programs that will be used by the licensee to  :

protect public health and safety and, based on the results of the ISA, implement changes to SSCs or associated licensee programs that provide reasonable assurance I

- that the performance criteria set forth in 70.40(b) are not exceeded. Licensees will classify SSCs based on safety significance and will apply controls commensurate with that classification.

(b) The ISA will identify and evaluate those hazards that cotJd result in not meeting any of the following performance criteria, and will determine whether adequate controls and protective measures are in place to provide reasonable assurance, that: (i) the requirements of 10 CFR Part 20 are satisfied;(ii) accidental criticalities are avoided; and (iii) for accident conditions, it is unlikely that any r

member of the public offsite will receive a radiation dose of 25 rem total effective

dose equivalent, an intake of 30 milligrams of uranium in soluble form, or 'an i

exposure to hydrogen fluoride in air equivalent to immersion for 30 minutes in a

> concentration of 25 milligrams per cubic meter.

(c) The ISA will be completed before issuance of an initial license to operate,  ;

j or for existing facilities, within 5 years after the promulgation of the rule and i

associated implementation guidance, .

(d) Licensees who have notified the NRC of plans to decommission their '

facilities in accordance with the Timeliness Rule (70.38) are not required to perform an ISA per this section.

i (e) The results of the ISA shall be maintained at the licensee's facilities. l Licensees will update the ISA for significant facility changes.  ;

i .

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I e r ,-e ,m, f

. 70.76 Backfitting Provision (aX1) Backfitting is defined as the modification of, or addition to, systems, l

structures, or components of a plant; or to the procedures or organization required to operate a plant; any of which may result from licenesee-performed analyses, a  !

new or amended provision in the Commission rules or the imposition of a regulatory staff position interpreting the Commission rules that is either new or different from a previous NRC staff position. I (2) Except as provided in paragraph (aX4) of this section, the Commission j

shall require a systematic and documented analysis, pursuant to paragraph (c) of this section for back6ts which it seeks to impose. ,

j (3) Except as provided in paragraph (aX4) of this section, the Commission j

shall require the backfitting of a plant only when it determines, based on the analysis described in paragraph (b) of this section, that there is a substantial l increase in the overall protection of the public health and safety or the common defense and security to be derived from the backfit and that the direct and indirect

. costs ofimplementation for that plant are justified in view of this increase d l protection.

(4) The provisions of paragraphs (aX2) and (aX3) of this section are inapplicable and, therefore, backfit analysis is not required and the standards in paragraph (aX3) of this section do not apply where the Commission or Staff, as appropriate, finds and declares, with appropriately documented evaluation for its finding, any of the following.

(i) That a modification is necessary to bring a plant into compliance with the rules or orders of the Commission, or into conformance with written ,

commitments by the licensee; or (ii) That regulatory action is necessary to ensure that the plant provides adequate protection to the health and safety of the public and is in accord with the common defense and security; or (iii) That the regulatory action involves defining or redefining what

• level of protection to the public health and safety or common defense and security should be regarded as adequate.

(5) The Commission shall always require the backfitting of a plant ifit determines that the regulatory action is necessary to ensure that the plant provides adequate protection to the health and safety of the public and is in accord with the l L

common defense and security.

(6) The documented evaluation, required by paragraph (aX4) of this section, must include a statement of the objectives of, and reasons for the modification and

' the basis for invoking the exception. Ifimmediately effective regulatory action is required, then the documented evaluation may follow, rather than precede the regulatory action.

(7) If there are two or more ways to achieve compliance with the rules or orders of the Commission, or with written licensee commitments, or there are two or more ways to reach a level of protection which is adequate, then ordinarily the i

licensee is free to choose the way which best suits its purposes. However, should it be necessary or appropriate for the Commission to prescribe a specific way to comply with its requirements, or to achieve adequate protection, then cost may be a l-.

11

factor in selecting the way, provided that the ,bjecth a of compliance or adequate s~ protection is met.

1 (b) In reaching the determination required by paragraph (a)(3) of this i i

section, the Commission will consider how the backfit should be scheduled, in light i

of other ongoing regulatory activities at the plant and, in addition, will consider information available concerning any of the following factors, as may be I appropriate, and any other information relevant and material to the proposed backfit:

(1) Statement of the specific objectives that the proposed backfit is designed to achieve; '

(2) General description of the activity that would be required by the

-licensee in order to complete the backfit; (3) Potential change in the risk to the public from the accidental release of radioactive material or chemical hazards per 70.40(b)(iii);

(4) Potential impact on radiological exposure of facility employees; (5) Installation and continuing costs associated with the backfit, i

j including the direct and indirect costs of plant downtime; (6) The potential safety impact of changes in plant or operational complexity, including the relationship to proposed and existing regulatory requirements; (7) The estimated resource burden on the NRC, associated with the proposed backfit and the availability of such resources;  ;

(8) The potential impact of differences in plant type, design, or age on J the relevancy and practicality of the proposed backfit; and (9) Whether the proposed backfit is interim or final and, ifinterim, the -

i justification for imposing the proposed backfit on an interim basis.

(c) No license will be withheld during the pendency of backfit analyses l required by the Commission's rules.

(d) The Executive Director for Operations shall be responsible for l implementation of this section, and all analyses required by this section shall be approved by the Executive Director for Operations or his or her designee.

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