ML20210R998
| ML20210R998 | |
| Person / Time | |
|---|---|
| Issue date: | 06/30/1997 |
| From: | Callan L NRC OFFICE OF THE EXECUTIVE DIRECTOR FOR OPERATIONS (EDO) |
| To: | |
| References | |
| SECY-97-137, SECY-97-137-01, SECY-97-137-1, SECY-97-137-R, NUDOCS 9709040232 | |
| Download: ML20210R998 (46) | |
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RELEASED TO THE! FDil l'
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we' ie d RULEMAKING ISSUE (Notation Vote)
June 30. 1997 SECY-97-137 EQB:
The Commissioners FROM:
L. Joseph Callan 97 SEP -2 A11:20 Executive Director for Operations l$liC DCCU".E'ii *
SUBJECT:
PROPOSED RESOLUTION TO PETITION FOR RULEMAKING FILED BY Tile NUCLEAR ENERGY INSTITUTE I
PURPOSE:
To obtain Commission approval of staff's proposed resolution to the Petition for Rulemaking (PRM 70 7) filed by the Nuclear Energy Institute (NEI), which includes staff's recommendations to revise 10 CFR Part 70, " Domestic Licensing of Special Nuclear Material" [SNM).
BACKGROUND:
On September 30,1996, NEl filed a petition for rulemaking on behalf of certain Part 70 licensees and potential licensees. The Petition requests that Part 70, " Domestic Licensing of Special Nuclear Material," be amended by adding three new provisions. On November 26,1996, a summary of the Petition and a request for public comments were published in the Federal Bgaister; five comment letters were received in response to this request.
CONTACT: Theodore S. Sherr, NMSS/FCSS NOTE: TO BE MADE PUBLICLY AVAILABLE 301-415 7218/TSS WHEN THE FINAL SRM IS MADE AVAILABLE
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9709040232 970630 PDR SECY 97,137 R PDR
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The Commissioners.
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Before submission of'the Petition, staff provided the Commission with a paper, l
SECY 96-079, " Alternatives for Regulating Fuel Cycle Facilities." Subsequent to the s
submission of the Petition, staff provided a second paper, SECY 97-097, " Additional j
Alternative for Regulating the Safety of Fuel Cycle Facilities: Nuclear Energy Institute Petition for Rulemaking." The staff recommendations in this paper supercede the alternatives in the previous papers and are the staff recommended course of action for rulemaking associated with fuel cycle facilities.
DISCUSSION:
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The Petition requests that the current Part 70 be amended by adding three new provisions l
that would:
3 (1) Add a definition of a uranium processing and fuel fabrication plant; (2) Require the performance of an integrated safety assessment', or an acceptable alternative, for uranium processing, fuel fabrication, and enrichment plants, to I
confirm that adequate controls are in place to prctect the public health ar d safety; and i
(3) Require a backfit analysis, under certain circumstances, j
Five comment letters vrere received in response to the Federal Realster Notice, which requested public comments on the NEl petition. Four letters wars from current Nuclear Regulatory Commission fuel cycle facility licenseen and the remaining letter was from a current NRC certificate holder. In summary, the comment letters support the Petition's i
provisions regarding the performance of an integrated safety assessment and backfitting.
in addition, one comment letter provided certain suggested changes to the proposed rule text, and another comment letter recommended that NRC should develop supporting guidance, in the form of regulatory guides, which should be available for public comment i
before a rule is finally promulgated. - All the public comments were considered in staff's p
i review and development of the proposed resolution to the Petition. The results of staff's i
review of the Petition and its recommended resolution are presented in Attachment 1.
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RECOMMENDATIONS:
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Staff agrees in principle with the Petition and recommends thr t the Commission direct the staff to proceed with rulemaking, which would include the b sic elements of the Petition, with some modifications. Staff's recommendations for the Sesolution of the Petition, including these modifications, are presented in Attachment 1. These recommendations j
would establish a risk informed framework for revising Part 70.8 A summary of staff's recommendations is presented in Attachment 2. Copies of the Petition and the five ccmment letters received are contained in Attachments 3 and 4, respectively.
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f Terminology used by staff is integrated safety walysis (ISA),
3 2Note that a Regulatory impact Analysis would be performed ami considered in the development of a proposed rule. The revision of Part 70 would not be subject to NRC bacLi i requirements in 10 CFR 50.109 which only apply
- to reactor facilities.
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The Commissioners 3-In summary, the staff proposes to revise Part 70, as reque-ted by the NEl Petition, with staff's modifications, to include the followin0 major elements:
(1) Perfortnance of a formalISA, which would form the basis for a facility's safety program. This requirement would apply to all facilities (except reactors and the
's gaseous diffusion plants) or activities, subject to NRC regulation, that are authorized i
to posr.ess SNM in quantities sufficient to constitute a potential for nuclear criticallty; (2) Establishment of limits tu identify the adverse consequences that licensees must protect against; (3) inclusion of the safety bases in a license (i.e., the identification of the potential accidents, the items relied on to prevent or mitigate these acidents, and the measures needed to ensure the continual availability and reliability of these items).
(This is in sharp contrast to Petition's approach, where the ISA results would not be included in the license);
(4) Based on the results of an ISA, licensees would be able to make 10 CFR 50.59 type changes as long as such changes do not decrease the effectiveness of the program being changed or involve unreso!ved safety issues; and (5) After initial conduct and implementation of the ISA by the licensees, the Commission would consider a qualitative backfitting mechanism to enhance regulatory stability.
There are no significant resou ce, information technology, or information management impacts that would result from this paper. Resources to conduct this rulemal'.ing are included in budget.
COORDINATION:
i The Office of the General Counsel has reviewed this paper and has no legal objection.
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L eph Callan Executive Director for Operations Attachments:
- 1. Proposed Resolution to Petition for Rulemaking
- 2. Summary of Staff's Proposed Resolution to Petition for Rulemaking
- 3. Copy of Petition
- 4. Public Comment Letters i
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' Coassissioners' coitments or consent should be provided directly to the Office of the Secretary by COB Thursday, Juli 17, 1997.
Comunission C.r.af f Office comuments, if any, should be submitted to the Comunissioners NLT July 10, 1997, with an information copy to the Office of the Secretary.
If the paper is of such a nature that it requires additional review and comment, the Commaissioners and the Secretariat should be apprised of when comuments my be expected.
DISTRIBUTION:
Coannissioners 00C OMA OIG OPA OCA EDO SECY 1
PROPOSED RESOLUTION TO PETITION FOR RULEMAKING This attachment presents a discussion of staff's wiew of, and recommended resolution to, the Petition for Rulemaking (PRM 70 7) filed with the Nuclear Regulatory Commission on September 30,1996, by the Nuclear Energy institute, on behalf of certain 10 CFR Part 70 licensees and potential licensees. The Petition requests that Part 70, " Licensing of Special Nuclear Material," be amended by odding three new provisions. - These provisions would: (1) add a definition of a uranium processing and fuel fabrication plant; (2) require uranium processing and fuel fabrication plants and enrichment plants to perform an integrated safety assessment,' or "... an acceptable altomative integrated approach to safety"; and (3) require a backfit analysis, under certain circumstances.
Five comment letters' were received in response to a request for public comments published in the Federal Reaister on November 26,1996. (Copies of these letters are provided in Attachment 4.) Four letters were from current NRC fuel cycle facility licensees, and the fifth letter was from an NRC certificate holder. All five comment letters support the Petition's provisions regarding the performance _ of an integrated safety assessment and the addition of a backfit provision. In addition, one comment ietter provided certain suggested changes to the proposed rule text, and another comment letter also stated support for those proposed rule text changes. Another comment letter stated that NRC should develop supporting guidance and that it should "...be made available for public review and comment before the rule is finally promulgated so that the public has due notice and opportunity to be heard on the features and impact of thu rule as it will be interpreted and applied by NRC staff." All public comments were considered in the development of a proposed resolution to the Petition.
The Petition addosses a number of different topics. The following sections present a discussion of the Petition's proposed rule text, along with staff's proposed resolution. The topics addressed include:
- 1. Performance of an ISA
- 2. Changes in Facility Operations
- 3. Graded Level of Protection
- 4. Consequence Limits
- 5. Timeframe for Completing ISAs
- 6. Performance of an ISA after Notice of Decommissioning
-7. Incorporation of ISA Results into License
- 8. Backfitting
- 9. Supporting Guidance Documents.
- 10. Definitions 3Terminology used by staff is integrated safety analysis (ISA).
2 Letters were received from ABB Combustion Engineering, incorporated; GE Nuclear Energy; Siemens Power Corporation; Westinghouse Electric Corporation; and United States Enrichment Corporation.
ATTACHMENT 1
2 1.0 Performance of an ISA In the proposed provision under "70.40, integrated Safety Assessment," Petitioners request that the rule language include the following:
" Uranium processing, fuel fabrication, and uranium enrichment pIL... licensees licensed under 10 CFR Part 70, shallperform an Integrated Safety Assessment (ISA), or provide an agceptable attemative integrated approach to safety, to determine the SSCs (structures, systems, and components] and programs that will be used by the licensee to protect public health and safety.... " (NEl petition,
- p. 10)*
The two issues addressed in this portion of the proposed provision are: (1) the scope of applicability, and (2) the flexibility of licensees to provide an alternative to the ISA, which, as Petitioners stated, "...might not conform to a formal ' hazards analysis' but could still provide the NRC and.the licensee with adequate confidence in facility safety." These issut: are discussed below.
Scone of Acolicabilitv The Petition requests that Part 70 be revised to require the performance of an ISA and that this requirement be limited to uranium processing, fuel fabrication, and uranium enrichment plants. The basis for the limited scope of applicability is that Petitioners "...do 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." They also stated that
...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." (p. 3)
Resolution:
Staff strongly agrees that " Uranium processing, fuel fabrication, and uranium enrichment plant licensees licensed under 10 CFR Part 70..." should perform an ISA, in addition to the Petition's proposal, staff recommends that the ISA requirements apply to all types of facilities (except reactors and the Gaseous Diffusion Plants) subject to NRC regulation
. (e.g., existing NRC licensees or potential activities such as atomic vapor laser isotope separation (AVLIS), mixed oxide fuel (MOX), and other proposed Department of Energy (DOE) activities) that are authorized to possess special nuclear material (SNM) in quantities sufficient to constitute a potential for nuclear criticality. Broadening the scope of applicability of the ISA requirement beyond what the Petition proposes will not impose extra burdens on NRC's current fuel cycle licensees (i.e., with or without this broadened scope, the same requirements would apply to fuel cycle licensees). Thus, staff recommends that a risk-informed approach (consistent with Commiss:on policy) for 3Italics are used to denote Petition's proposed rule language. Page references refer to the NEl petition.
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3 regulating safety be applicable to all facilities and activities that are authorized to possess specific threshold quantitles of SNM.*
As mentioned above, the Petitioner's expressed concern about "...significant new programmatic changes..." that NRC may impose on industry. However, examples or the specifics of the concerns were not included in the Petition. Staff is not recommending any
"...new significant programmatic changes". to address the specific needs associated with the regulation of new fecilities. Recommended changes are in response to weaknesses that were identified by numerous socrces, which include the recommendations contained in NUREG 1324, " Proposed Method for Regulating Major Materials Licensees."
Certain features of the April 1995 draft rule did include the establishment of " multiple safety programs" (e.g., fire protection, chemical process safety, criticality, management controls, configuration management, quality assurance, maintenance, and training).
However, the possibility of licensing or certifying new facilities was not the reason for including these features in the draft rule. At the various 1995 NRC sponsored public workshops, where proposed revisions to Part 70 were discussed, industry representatives stated that they oppose the proposal of multiple safety programs. In response to licensees' concerns, staff is now proposing thet, rather than require multiple safety programs to ensure the continual availability and reliability of items relied on for safety (see SECY-96-079), licensees have the flexibility to determine, based on the ISA results, the specific elements of the safety program that would be needed.
Alternative to an ISA The Petition discussion includes a statement that:
"The rule should provide flexibility for licensees to offer alternative approaches (to an ISA) for the NRC's consideration. Such approaches might not conform to a formal nazards analysis,' but could still provide the NRC and the licensee with adequate confidence 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)
Within the framework of an ISA, Petitioners stated that "...the AIChE [American Institute of Chemical Engineers) document provides reasonable approaches, and that other formal methods may also be acceptable." They also request that the analyses being performed under the Occupational Safety and Health Administration's (OSHA's) Process Safety Management regulations and the Environmental Protection Agency's (EPA's) Risk Management Program regulation be considered acceptable means of meeting the ISA requirement for evaluating hazards within NRC's jurisdiction.
Resolutiom Staff supports the Petition request to consider attemative approaches for conducting an ISA. However, the staff has concerns about alternative approaches that are not considered a formal and integrated " hazards analysis." Staff's view is that a " formal" Bold text highlights the major elements of the staff's proposed resolution.
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4 hazards analysis, as compared with an informal or unstructured approach to hazards analysis, is one that involves a systematic, comprehensive, and well-documented approach for the conduct of an ISA. In addition, the ISA should consider all types of potential hazards (e.g., criticality, chemical, radiological, fire) in an integrated manner. The ISA will form the basis of a facility's safety program. The process of providing an increased confidence in the margin of safety relies on, among other things, a thorough and comprehensive facility analysis, with licensees' commitments to identify and implement the items relied on for safety and the measures needed to ensure their continual availability and reliability. Thus, staff is concerned that an approach that does not " conform," or correspond, to a " formal". hazards analysis would not provide confidence in the margin of safety. (The Petition did not include examples nor the specifics of what methodology or structure might be used in lieu of that used in the formal hazards analysis.)
Within the ISA framework, licensees should have the flexibility to choose from a variety of hazard evaluation, techniques, in particular those that are recognized by AlChE. Reference to the AIChE document, Guidelines for Hazard Evaluation Procedurgg Second Edition with Worked Examoles. and the AIChE hazard analysis methods are 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. The current draft guidance document identifies a number of methods from the AIChE document, as well as other methods that were developed in other industries, that would be suitable, under certain circumstances, for licensees or license applicants to use in performing a detailed analysis of facility hazards, in addition, other techniques, including those def;ned by licensees or by license applicants, could be used, but these would be subject to NRC review and approval. Such approval would be based on whether the technique met the objectives of performing an ISA (i.e., to:
. (1) identify radiological and non-radiological hazards related to the processing of licensed material; (2) determine potential accident sequences and thei consequences resulting from such hazards; and (3) identify the items (i.e., SSCs and activities of staff), that are relied on to prevent or mitigate the potential accidents, needed to assure protection of public health and safety.
With regard to hazard analyses performed under other applicable requirements, such as the OSHA's Process Safety Management regulations and EPA's Risk Management Program regulation, such analyses could be used in part to satisfy the NRC requirements. However,.
licensees' analyses must be extended to include radiological hazards, since these particular OSHA and EPA regulations do not address such hazards. In addition, licensees would need to include all chemicals that may constituto a hazard from the activities associated with the processing of licensed material, and not limit the analyses to those hazardous chemicals where the inventory exceeds a certain limit. (OSHA and EPA only require analyses of hazardous chemicals when large amounts that could lead to catastrophic consequences are present (e.g.,4536 kilograms (10,000 pounds) of anhydrous ammonia). (See section 4.0 of this attachment, " Consequence Limits," for further discussion.)
5 2.0 Q anaes in Facility Ooerations According to the Petition's proposed rule change, licensees would:
".. based on the results of the ISA, implement changes to SSCs or associated licensee programs that provide reasonable assurance that the performance criteria set forth in 70.40(b) are not exceeded. " (p.10) in addition, the Petition states that:
"If the ISA results indicate that relaxation of.some controls or reallocation of resources is justified, the licensee may do so, in accordance with applicable license amendment or commitment change procedures." (p. 6)
Resolution:
Staff agrees that licensees will need to make changes to structures, systems, and components or associated licensee programs, if the results of the ISA, conducted in conformhy with the revised regulation, indicate that they are needed to ensure adequate protection of public health and safety. On the other hand, if the results of the ISA demonstrate that certain licensee commitments are unnecessarily restrictive, changes to these commitments would be permitted, subject to review in accordance with license amendment procedures. Furthermore, changes could be made through a 10 CFR 50.59-type process as long as the proposed changes do not decrease the effectiveness of the program being changed and do not involve unresolved safety issues. For NRC to have confidence in the margin of safety, it must have the responsibility for reviewing and approving licensee actions involving safety-significant changes in facility operations.
3.0 Graded Level of Protection The Petition requests a graded approach to safety be applied (i.e., focus on those SSCs and programs that protect against those accidents that have the greatest risks). The following is the Petition's proposed rule language.
" Licensees will classify SSCs based on safety significance and willapply controls commensurate with that classification."(p.10)
According to the Petition's discussion:
"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. Usirg 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 appropriate." (p. 6)
6 in addition, the Petition stated
" Events or accidents of lessor significance would continue to be prevented and mitigated through existing licensee safety programs.". (p. 6)
Resolution:
Staff strongly agrees with the Petition that a graded approach should be followed in identifying the level of protection needed (i.e., items (SSCs) relied on for safety and the measures used to ensure their continual availability and reliability), to prevent potential accidents or to mitigste their consequences, in general, accidents resulting in severe consequences should require a higher level of protection than those having less severe consequences, in addition, the staff agrees with the Petition's proposal that grading take into account the " anticipated likelihood" of an accident, in addition to the consequences of the accident.
Regarding the Petition's statement on the use of existing licensee safety programs to prevent or. mitigate the consequences of " events or accidents of lesser significance," staff believes that the effectiveness of these programs will need to be demonstrated by licensees through the ISA process.
4.0 Consecuence Limits The Petition proposes that " performance criteria"5 be established against which licensees will be required to judge the effectiveness of their safety programs. The following is the Petition's proposed rule text:
"The ISA willidentify and evaivate those &~:Js that could result in not meeting any of the following performance criter.a, and willdetermine whether adequate controls and protective measures are in place to provide ooesonable assurance, that: (i) the requirements of Part 20 are satisfied; (ii) accidental criticalities are
- avoided; and (iii) for accident conditions, it is unlikely that any member of the public offsite willreceive a radiation dose of 25 rem total effective dose equivalent, an intake of 30 mg 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. " (p.10)
One comment letter stated:
"The language of the proposed rulemaking should be revised to explicitly clarify -
the intended use of the performance criteria; namely, that the purpose of the criteria is to guide the Commission and the licensee in their evaluation of the suitability of: (1) the events chosen for evaluation (i.e., those with consequences of concern) and (2) the determination as to the safety significance of SSCs....
The current language of the proposed rulemaking might be interpreted to suggest that the performance criteria are absolute hmits, exceedance of which implies 8
Petition uses the term
- performance criteria" in the same sense that the staff uses the term
- consequence limits."
7 that the public health and safety cannot be reasonably assured.... The regulation should provide a mechanism for determining whether there is reasonable assurance of public health and safety and not reasonable assurance that the criteria are not exceeded."
The comment letter also stated that "Because worker safety appears to be a key underlying motive _behind the NRC staff's interest in revising 10 CFR 70 and imposing new requirements on fuel c~ycle facilities, it is essential that this issue be explicitly recognized and considered in this rulemaking proceeding." However, the comment letter does not propose any additional rule language to address worker safety. In addition, a suggestion was made to remove the requirement in the Petition that the ISA "... determine whether adequate controls and protective measures are in place to provide reasonable assurance that (l) the requirements for 10 CFR Part 20 are satisfied...." According to the comment letter, "... analysis is not required to comply with 10 CFR Part 20."
Resolution:
Staff agrees that consequence limits should be established to identify the adverse consequences that licensees must protect against. Further, the ISA will need to identify and consider all radiological and non-radiological hazards related to the processing of lloonsed material. With regard to non-radiological hazards, the Petition would limit consideration of chemical hazards to those associated with hydrogen fluoride. Staff's view is that chemicals other than hydrogen fluoride will need to be considered. Specific consequence limits will be established during the rulemaking process. In establishing these limits, staff will consider the Petition's recommendations and the relevant requirements of NRC, OSHA, and EPA. Edaff agrees that worker safety (i.e., accidental exposure of a worker to radiological or chemical hazards) is an important issue and plans to address it in the proposed rule. The ISA requirement is intended to focus on the identification of potential accidents and the items relied on to prevent or mitigate the consequences of those accidents, it is not intended to focus on the protection of workers during routine operations as currently required under 10 CFR Part 20; the rule language is expected to reflect that position.
Staff believes that all hazards should be identified and considered to determine which -
hazards could result in accidents that would exceed consequence limits. The Petition stated that only those hazards that "...could result in not meeting" the performance criteria would be identified and evaluated. The Petition did not state how, a priori, without identification and consideration of all hazards, licensees could determine that certain
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hazards would not lead to consequences of concern.
With respect to the comment regarding " reasonable assurance of public health and safety "
staff believes it is important to go beyond the abstract concept of protecting "public health and safety" and define in practical terms what such protection would consist of. In essence, if NRC is reasonably assured that the consequence limits will not be exceeded, then NRC should be reasonably assured that the public health and safety will be protected.
In addition, staff agrees that the idenutication, in the ISA, of accidents that could result in exceeding the consequence limits, should not imply that "...the public health and safety cannot be reasonably assured." Staff agrees with the comment letter statement that the performance criteria should not be viewed as " absolute limits."' As long as the licensee or
___.__s.
8 applicant provides adequate protection against these potential accidents, NRC will have reasonable assurance of public health and safety.
5.0 Timeframe for Comoletina ISAs Petitioners request that the rule language include the following provision regarding a timeframe for completing an ISA:
"The ISA willbe completed before issuance of an inilallicense to operate, or for existing facilities, within 5 years after the promulgation of the rule and associated implementation guidance. " (p.10)
Resolution:
An ISA should be completed before operations are allowed to commence at newly constructed facilities or at newly constructed processes at existing facilities. For existing facilities, a reasonable timeframe should be established for licensees to complete their ISAs.
At existing facilities, the timeframe should allow for: (1) the performance of a quality ISA; (2) the correction of vulnerabilities identified in the ISA; and (3) the incorporation of the ISA results in the license. Although the proposed 5-year timeframe appears to be reasonable, staff is not recommending the adoption of a definite timeframe at this time.
When the proposed rule revisions are developed, staff will prepare a proposed estimate of time and the 5-year timeframe requested in the Petition will be considered.
With regard to the performance of an IS'A at newly constructed facilities or at newly constructed processes at existing facilities, staff recommends that preliminary ISAs be performed and the results submitted to NRC for approval before construction. The preliminary ISA results would facilitate the establishment of the design bases for the facilities (i.e., the safety features, incorporated into the design, that provide protection against credible accidents or events). Before the commencement of operations at the facilities, licensees would review and update their ISAs to reflect as-built conditions and submit the results to NRC for review and approval as part of the license application.
6.0 Performance of an ISA after Notice of Decommissionina Petitioners request that an ISA not be required for facilities that are being decommissioned.
The following is the proposed Petition's rule change:
" Licensees who have notified the NRC of plans to decommission their facilities in accordance with the Timeliness Rule (10 CFR 70.38) are not required to perform an ISA per this section. " (p.10)
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Resolution:
Notification of decommissioning by itself would not eliminate the hazards or eliminate a need for an ISA. Once principal activities cease at a facility, the performance of an ISA should not be a prerequisite for routine decommissioning activities. However, for non-routine activities, the determination of whether an ISA would be required would be based on the extent to which special processes, such as chemical treatment of wastes or other hazardous processing, are involved in decommissioning.
NRC's concern regarding hazards during the decommissioning process is recognized in the existing 10 CFR 70.38, which includes a requirement for the submittal of a decommissioning plan if "...the procedures and activities necessary to carry out decommissioning...have not been previously approved by the Commission and these procedures could increase potential health and safety impacts to [on) workers or to lon]
the public...." Among other things, the decommissioning plan calls for "...a description of methods used to ensure protection of workers and the environment against radiation hazards during decommissioning." For non-routine decommissioning activities, an ISA, if needed, would address the decommissioning process and consider both radiological and non-radiological hazards pertinent to protection of workers and the environment.
7.0 incorooration of ISA Results into License The Petition requests that the ISA results remain at each licensee's site. The Petition's proposed rule text is as follows:
"The results of the ISA shallbe maintained at the licensee's facilities. Licensees will update the ISA for significant facility changes. " (p.10)
Under the NEl proposed rule change, the ISA results would ag_t become part of the license, and thus licensees would ng_t commit to ensure the continual availability and reliability of items relied on for safety. The Petition proposes that ISA results would be available for review at each licensee's site. The Petition states that the ISA results 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."
It is also proposed that when "...significant" plant changes are under cons, teration, licensees should review and update their ISAs and implement any new contiols (i.e., item::
relied on for safety to prevent or mitigate the consequences of accidents) that might be necessitated from these reviews and updates. The updated information would also remain at licensees' sites.
The Petition also expressed concern that the "... incorporation of the ISAs into the license would necessitate significant changes in the current license application format, dramatically expanding the description of the plant site, facilities, equipment, processes, and controls which would form the basis of the license." In addition, "... 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 departure from the traditional two-part license format used by many fuel cycle licensees."
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10 Resolution:
Staff strongly believes that the safety bases, including the results of the ISA, should be an essential part of the license. The safety bases consist of the identifloation of: (1) potential accidents at the facility; (2) items relied on to prevent or mitigate those accidents; and (3) measures that would ensure the continual availability and reliability of these items.
Together, this information forms: - (a) the basis on which NRC determines that adequate preh is provided; (b) the information from which NRC has on-going confidence in the margin of safety; and (c) the basis for a risk informed inspection program.
By including the safety bases in the license, NRC is assured of specific licensee commitments to maintain adequate protection at its facility. To reflect changes made to facility processes that affect the safety bases, the licSnsee should provide NRC with revisions to its documented safety bases (including revisions to its ISA) for incorporation into the license. The license would thus become a "living license" in that it would reflect the current configuration of the nuclear process, and safety measures on a continuing basis. This provides a basis for NRC confidence in the margin of safety and would s
eliminate a major licensee and NRC resource-intensive effort to periodically renew fuel cycle licenses.
With respect to the Petition's concern about incorporating the ISA results into the license
"...in a manner similar to a reactor licensee's Safety Analysis Report...," staff's view is that such incorporation is_ a major cornerstone of the reactor backfit process. Thus, without incorporating the ISA results into the license, the adoption of a backfitting provision for fuel cycle facilities would be precluded.
8.0 Backfittino The Petition requests a backfitting provision for Part 70. The Petition's proposed rule text is similar to that in 10 CFR 50.109, "Backfitting," which applies to power reactors, and defines backfitting as follows:-
"...the modification of, or addition to, systems, structures, or components of a plent; or to the pmcedures or organization required to operate a plant; any of
- which may result from licensee-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 imm a previous NRC staff position. " (The remaining perposed rule text is provided in the -
. Pttition.) (p.11)
The proposed provision would require, except under certain conditions, that NRC perform
"...a systematic and documented analysis for backfits which it seeks to impose." Such analysis would need to demonstrate that: (1) the proposed backfit results in a substantial increase iri the overall protection of the public health and safety; and (2) the costs of implementing any modifications are justified in view of this increased protection.
A significant difference between the Petition's proposed backfit provision and 10 CFR 50.109 is that, under the proposed provision, NRC required modifications of SSCs resulting from the initial ISA would be subject to a backfit analysis.
I 11 Resolution:
St'aff proposes that a qualitative "backfit" mechanism, similar in purpose to
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a 10 CFR 50.109 provision, be considered after the safety bases, including the results of the IS A, are estateshed and incorporated in the license, and after licensees and staff have gained a few years of experience with ;w-Ac;.tation of the ISA requirement. This mechanism would et apply to modifications identified as a result of the initial ISAs that d
are needed to assure protection of public health and safety; these modifications would be required for ca.Zr.cs with the revised Part 70.
The Commission's experience with backfitting has been limited to the regulat!on of power
- reactors. As noted above, the proposed provision is similar to the reactor backfitting provision in 10 CFR 50.109. However, the information that would be available to NRC staff for fuel cycle facilities, under the Petition's proposal, or even under staff's proposed changes, is less quantitative than the information available to staff through the reactor licensing process.
Before the issuance of a license, reactors must establish well-defined licensing bases.
Although all current elements of the required analysis were net available durit.g NhC's initialimplementation of a backfit provision, enough elements were present to convey a substantial quantitative understanding of the risks from reactor operations. Currently, the licensing bases for reactors include detailed information in the Final Safety Analysis Report (FSAR), which is developed in accordance with 10 CFR Part 50, its appendices, associated guidance documents, and industry codes (e.g., probabilistic risk assessment (PRA) results, technical specifications, etc.) As a result of this process, NRC and its licensees have a qualitative and quantitative understanding of the risks at reactors. Furtheimore, the FSAR is updated on a regular basis, which provides a continuing licensee and NRC understanding of the identification and bases for licensee operations and activities.
In contrast to reactors, fuel cycle facilities do not currently have well defined safety bases.
The performance of an ISA and the incorporation of the ISA results in the license' would
. help establish qualitative facility safety bases. However, since the_ISA will not be required to provide a quantitative analysis of facility hazards, licensees and NRC staff will have a-considerab y less quantitative understanding of the risks at fuel cycle facilities, compared-with the risks at reactor facilities. For equivalent quantitative information to be available at fuel cycle facilities, the ISA would have to us,t the PRA approach. (The iMustry has consistently commented that quantitative-based ISAs [i.e., PRAs1 should not be required, and staff draft guidance on ISAs is consistent with that position.) Without the performance of a PRA,'it would be difficult, if not impot tible, to quantify the benefits of any proposed changes to the facility or its processes. Thus, any backfit analysis not based on the results of a PRA would be primarily qualitative in nature.
Staff agrees with the Petition that some backfit provision should be considered. However, for the reasons explained above, a 10 CFR 50.109 provision would not be suitable. : Staff recommends that a qualitative "backfit" mechanism is appropriate to consider after the safety bases, including the results of the ISA, are established and incorporated in the
'As indicated above (Section 7.0) the petition proposes DQ1 to incorporate the ISA results in the license.
'thus, the safety basis for the facility would not be formally established and committed to by the licensee.
g
-- - - ~ -
i 4j l
1 i
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~ license, and after licensees and staff have gained a few years of experience with the 4
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implemer.tation of the ISA requirement.
l-
- 9.0 Sunoortino Guidance Documents
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The Petition mentions supporting guidance documents for Part 70 only in the context of when licensees would be required to ccmplete their ISAs (i.e., within 5 years after the promulgation of t,he rule and associated guidance). However, specific comments on the need for supporting guidance were provided by two comment letters.-
l With regard to guidance for performing an ISA, one comment letter stated that " Guidance i
should be promulgated on the required formet and content of the analysis required." In f
addition, "The AIChE ' Guidelines for Hazard E' valuation Procedures, Second Edition with j
Worked Examples /.1992,is representative of the types of analysis that should be j
required."
l The other comment letter stated that once the rule is formalized "... implementation and
. review documentation guidance must be developed that tracks the rule and results in
- effective and efficient implementation...." The comment letter also stated that the guidance "...must be available for public review and comment before the rule is finally promulgated so that the public has due notice and' opportunity to be heard on the features I
and impact of the rule as it will be interpreted and applied by NRC staff."
Resolution:
l Staff agrees with the comment letters' requests for eupporting guidance documents to reflect the revised Part 70 and the need for these documents to be published for public j-comment before implementing a final rule.
Concurrent with developing the April 1995 draft revised Part 70 rule, a number of guidance j
documents were developed related to the performance of an ISA, the format and content l
of license applications, and acceptance criteria for staff review of license applications.-
t (These documents were distributed to the public for_ review and comment at several of the
[
NRC-sponsored workshops that discussed the proposed rule revisions.) Once the proposed rule text is finalized, the draft documents will be modified to be consistent with the rule L
' revisions and published for public comment concurrent with the' proposed rule. In addition, a Regulatory impact Analysis will be performed and considered in the development 'of the i
proposed rule. This analysis will be made available to the public.
I^
With regard to the ISA, Draft NUREG 1513, " Integrated Safety Analysis Guidance Document," was-developed to provide guidance to license applicants on how to perform an j.
~
facility's safety program, identifies and describes several generally accepted ISA methods,-
ISA and document the results. This guidance also d; fines an ISA, identifies its role in a F
l and provides guidance in choosing an acceptable method. As mentioned in the discussion of the."lSA Requirement" in this attachment, reference is made to the AIChE document, Guidelines for Hazard Evaluation Procedures, Second Edition with Worked Examoles. The i
4
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AIChE ISA methods are 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. _ The current draft guidance document identifies a number of methods from the AIChE document, as well as other methods that were developed in other i.
13 industries, that would be suitable, under certain circumstances, for licensees or license I
applicants to use in performing a detailed analysis of facility hazards, in addition, draft guidance documents will be revised to address the type and depth of information required for the license applications submitted under the revised rule, and to provide acceptance criteria to support a standardized approach for staff's review of license applications submitted under the revised rule.
10.0 Definitions The Petition requests that the following definition of a " uranium processing and fuel fabrication plant" be added to Section 70.4, " Definitions":
" Uranium processing and fuel fabrication plant means a plant in which the following operations or activities are conductenf: (1) Operations for manufacture of reactor fuel containing uranium including any of the following: (i) Preparation of fuelmaterial; (ii) formation of fuel materialinto desired shapes; (iii) application of protective cladding; (iv) recovery of scrap material; and (vi 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 research and development activities utilizing insubstantial amounts of uranium. " (p.10)
The Petition's proposed definition of " uranium processing and fuel fabrication plant" is intended to provide clarification as to the applicability of the Petition's proposed requirement to perform an ISA. It is pmposed that the ISA requirement apply to only those facilities identified in this definition and to enrichment plants. (The ISA requirement is discussed in section 1.0.)
in addition to the above definition, one comment letter requested that a definition of
" double contingency" be included in the proposed revisions to Part 70.
Resolution:
- The selection of terms to be included in the " Definitions" section will be determined from the text of the proposed rule.
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SUMMARY
OF STAFF'S PROPOSED RESOLUTION TO PETITION FOR RULEMAKING Based on the recognized needs for improving the regulatory process at fuel cycle facilities and staff's review of the Petition for Rulemaking (PRM 70-7), which presents a proposed amendment to 10 CFR Part 70, and of the public comments received, staff proposes that Part 70 be revised. These proposed revisions would be
- the development of a risk informed regulation, consistent with Commission policy, that could be used as a core regulation for the licensing and certifyi,ng of any fuel cycle facility (including enrichment facilities) and other types of facilities that possess special nuclear material (SNM) in quantities sufficient to constitute a potential for nuclear criticality.
The following is a summary of staff's recommended changes to Part 70; these recommendations are discussed in Attachment 1.
o Performance of an intearated Safety Analysis (ISA)
The performance of a formalISA would be required for all types of facilities (except reactors and the gaseous diffusion plants) or activities, subject to Nuclear Regulatory. Commission regulation, that are authorized to possess SNM in quantities sufficient to constitute a potential for nuclear criticality.
The ISA would consider all types of hazards (e.g., criticality, chemical, radiological, fire) in an integrated manner with licensees' commitments to identify and implement the items relied on for safety and the measures needed to ensure their continual availability and reliability.
Licensees or license applicants could propose, for NRC appr;. val, alternative approaches for performing an ISA. These approaches shoulc' conform or correspond to a " formal" hazards analysis (i.e., a systematic,, comprehensive, and well-documented approach) that considers all hazards in an integrated manner.
A single comprehensive sefety program would be established to ensure the continual availability and reliability of items relied on for safety.
e incomoration of ISA Resuks into License The safety bases, including the results of the ISA, would be included in a facility's license and woul:1 consist of identification of: (1) potential accidents at the facility; (2) the items relied on to prevent or mitigate these accidents; and (3) maasures that would ensure the continual availability and reliability of these
' items.
Revisions to the documented safety bases (including revisions to the ISA) would be provided to NilC for incorporation into the license. (The license would reflect the current configuration of the nuclear process and overall safety program.)
A*ITACHMENT 2
i j-2 e Channes in Facility Operations k
NRC review and approval, in accordance with license amendment procedures, would be required before licensees could make safety significant changes to facility _ operations. Licensees could also make changes through a 10 CFR 50.59-type process as long as the proposed changes do not decrease the effectiveness of the program and do not involve unresolved safety issues.1 e Graded Level of Protection A graded approach would be used to provide the level of protection needed, commensurate with the risk (i.e., items (structures, systems, and components) relied on for safety, and the measures used to ensure their continual availability and reliability), to prevent potential accidents, or to mitigate their consequences.
In general, accidents resulting in severe consequences would require a higher level of protection than those having less severe consequences.
The graded approach would also take into consideration "the anticipated likelihood" of an accident, in addition to the consequences of the accident.
- Conseauence Limits Consequence limits would be established to identify the adverse consequences that licensees must protect against. The relevant requirements of NRC, the Occupational Safety and Health Administration's Process Safety Management regulations, and the Environmental Protection Agency's Risk Management Program regulation will be considered in establishing these limits.
Criteria for hazardous chemicals, which are not I!mited to hydrogen fluoride, will be included in these limits,'along with criteria that address accidental exposure of a worker to radiological or chemical hazards (i.e., worker safety).
e Timefram An ISA would be completed before construction and operations are allowed to begin at newly constructed facilities or at newly constructed processes at existing facilities. For existing facilities, a reasonable timeframe should be established for licensees to complete their ISAs.-
At existing facilities, the timeframe would allow for: (1) the performance of a quality ISA; (2) the correction of vulnerabilities identified in the ISA; and (3) the submission of the ISA results to NRC for review and approval, and inclusion in
'the license.
3 e Performance of an ISA durina Decomm!se!sina Once prir.cipal activities cease at a facility, the requiremer.c to perform an ISA would not apply to routine decommissioning activities. However for non-routine activities, the determination of whether an ISA is required would be based on the extent to which special processes, such as chemical treatment of wastes or other hazardous processing, are involved in decommissioning, e-Backfittina A qualitative "backfit" mechanism, similar in purpose to a 10 CFR 50,109 provision, would be considered after the safety bases are established and incorporated in the license, and after licensees and staff have gained a few years of experience with implementation of the ISA requirement. The mechanism would agf apply to modifications identified as a result of the initial ISAs, and required for compliance with the revised Part 70.
e - Reoortina Reauirements Although the Petition did not address revisions to the current Part 70 reporting requirements, staff believes that revisions are needed in light of the recommended rule changes, in particular the reporting of events related to the loss or degradation of items relied on for safety (e.g., reporting of loss of criticality controls as currently reported under the provision of NRC Bulletin 9101).
- Format of Revisad Part 70 To minimize any confusion licensees would have in understand. ig the applicable requirements in Part 70, staff proposes that the safety requirements applying to licensees who are authorized to possess SNM in quantities suff'.ent to constitute a potential for nuclear criticality be organized into a new section within Part 70.
The requirements applying to facilities that are authorized to possess SNM in
_ quantities not sufficient to constitute a potential for nuclear criticality would remain unchanged. This would avoid any impact on Agreement State programs.
4
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September 30,1996 OCT
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6 D6 Mr. John C. Hoyle N
Secretary U.S. Nuclear Regulatory Commission
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Washington, D.C. 20555-0001 s
9 ATTENTION:
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 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 we 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 requesta 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.
- NEIis the organization responsible for establishing unified nuclear industry policy on matters affecting the nuclear energy industry, including the regulatory aspect.s 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.
ATTACHMENT 3 j
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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, an the seminal portions of this Petition for Rulemaking. Our proposed rule b= +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 hed h and 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 agarding its content or application.
Sincerely,
.b y
Marvin S. Fertel Enclosure
9 UNITED STATES OF AMERICA NUCLEAR REGUfuATORY COMMISSION In the Matter of a
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Proposed Rulemaking
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Regarding Amendments to
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Docket No.
)
)
PETITION FOR RULEMAKING
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This Petition for Rulemaking is 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 genene operational and technicalissues affecting the nuclear industry. NEI's membero include electric utilities, major architect / engineering firms, all of the major nuclear fuel supply vendors and all of the major manufacturers of radionuclides and radiopharmaccuticals. Because some of 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 Staff's desire to amend Put 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
S Review Task Force entitled " Proposed Method for Regulating Major Materials Licensees"(NUREG-1324k A brief summary of the history of the NRC's deliberations on amanding Part 70 follows.
In response to the 1992 issuance of NUREG-1324, the Staff developed an action l
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 amended its approach and explicitly recommended a "mWor revision" to Part 70.
(SECY-93128, May 12,1993). The Commission endorsed the Staffs mcommendations (SRM, June 7,1993).
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 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, che Commission directed the Staff to
" reconsider the current plan to revise 10 CFR Part 70 in its entirety...." The Commission directed the Staff to " determine (major fuel cycie 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 Staffs proposed revisions 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 en hold" to permit further dialog with interested parties. The Commission approved that mcommendation. (SRM, 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, 2
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GROUNDS FOR PROPOSED ACTION There are two fundamental principles underlying NEI's reconunended approach.
First, as recognized by the NRC Staff, fuel facilities are being operated safely under existing regulations. Recently comy.leted 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 concems.1 In each of the cases revie ved, we found that: (1) substantial margins of safety and conservatisms existed; (2) the double contingency principle and conservative assumptions built into criticality 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 ts Pau 70,2 and why possible future NRC reguletion of DOE facilities does not warrant a major revision to Part 70.a 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 NEI's resiew 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 effort to propose an " ideal methml" for regulating major materials licensees," unfettered by any existing ngulations or regulatory guidance, concerns about backfitting, or limitations on resources...." 'Ihe Dimetor of NMSS at the time described the regulatory approach offered in NUREG-1324 as " admittedly highly idealistic." (Memorandum, Robert L. Bernero to NUREG-1324 recipients). Furthermore, two senior NRC managers documented their " independent analysis" of' the NUREG, and found that "[i}t will require a very substantialincrease 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 The NRC Staff has expressed the desire to improve the " clarity" of Part 70 given the " possibility that NRC will be given the responsibility for regulating DOE facilities in the future..." SECY 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 assessment effort (September 16, 1996).
3
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Attachment A to this Petition presents NEI's propo.ed rule in response to the Commissioners' guidance at the July 2,1996, bnefing. NEI recommends the I
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, hereafler referred to as ISA, for convenience to the reader. Second, a "backfit" provision would be added. Third, a definition would be added to clarify the scope of applicability of the proposed rule.
The ISAs would identify ahd evaluate those hazards that c;uld imperil certain specified performance criteria, using methods similar to those described in the
'z American Institute of Chemical Engineers'(AIChE) 1992 Guidelines for Hazard Evaluation Procedums or other acceptable mechods. 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 for a graded approach to safety, an approach that would focus resources on those SSCs and program areas that have the greatest risks (consequence and frequency),
Upon completion of the ISAs, licensees would moaify their facility or health and safety programs, if necessary, to provide reasonable assurance that the specified 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 with 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 NRC review.
Over the past decade, while the formal requirements of Part 70 have not changed-i significantly,its application has. Licensees' documentation requirements have evolved significantly and additional requimments 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 (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 bases a-e discussed below.
1.
Integrated Safety Assessment 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 the facilities, the SSCs and programs relied on to prevent or mitigate such consequences.
4
Subsequent 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 ofimports.rgo-to safety rankings and interrelationships would focus facility resources effer.dvely.
L 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 e
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 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.
Draft NUREG-1513 stated that "[alppropriate 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 feelit is essential that the rule itself contain measurable performance criteria to that end.
3.
Reference to Industry Practices While the rule does not specifically reference the American Institute of Chemical Engineers (AIChE)
- Guidelines for Hazard Evaluation Procedures, S"cond Edition with Worked Examples," 1992, it is frequently referenced by the NRC Staff as an acceptable guide for perforning the hazard-evaluation portion of an ISA. NEI belie;a the AIChE document provides reasonable approaches, and that other formal methods may also be acceptable.
Some licensees are currently performing hazard analyses under other applicable requirements, such as the Occupational Safety and Health Administration's (OSHA) Process Safety Management regulations and the Environmer cal Protection 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 chemical hazards that could affect nuclear safety.4 The NRC's draft NUREG-1513 states that the *ISA guidance... is intended to be 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 sequencas are examined and, based on a realistic evaluation, determined not to be masonably capable of producing impacts in excess of the performance criteria, no further action by a licensee would be required. Events or accidents oflesser signi6cance 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 potentialimpacts would be evaluated by a licensee,in the process of grading 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 appropriate.
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 thmshold performance criteria are not exceeded, and will implement such changes in a timely manner. If the ISA results indicate that alaxation of some controls or reallocation of resources is justified, the licensee may do so, in accordance with applicable license amendment or commitment change procedures.
4 - In accordance with the existing NRC/ OSHA Memorandum of Understanding, the NRC would not regulate purely chemical hazards. " Memorandum of Understanding Between the Nuclear Regulatory Commission and the Occupational Safety and Health Administration; Worker Prctection at NRC-Licensed Facilities," 53 Fed. Reg. 43590 (October 31,1988).
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6.
Alternative Approaches l
Efforts underway at a number of fuel cycle facilities to reevaluate and/or redocument the safety basis for their operations may fulfill the 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 safety ofits operations. The rule should provide flexibility for licensees to offer alternative approaches for the NRC's consideration. Such approaches might not conform to a formal "hazartis analysis," but could still provide the NRC and the licensee with adequate confidence 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.
7.
License Format 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 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.
A formal submittal to the NRC of an ISA report will not be required. Most importantly, the ISA will not become part of the license, which may only be changed through a codified change process. In accordance with licensees' configuration 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 may be necessitated as a result of that review and updating.
Incorporation of the ISAs into the license would necessitate significant changes in the current license application format, dramatically expanding the description of the plant site, facilities, equipment, processes and controls which would form the basis of the license. We note, for example, that the certification applications 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 dedicated to site, facility, and proces s descriptions and safety (accident) analyses.
This could potentially represent a s.gaificant administrative burden for licensees and the NRC Staff, producing no measurable improvement in the safety oflicensed Part 70 facilities.
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 departure from the traditional two-part license format used by many fuel cycle licensees. Under these licenses, one part establishes binding license conditions and the other provides a " safety demonstration"in support of those license conditions.
A request for a license amendment is needed to change the license conditions portion; however, the " safety demonstration" part may be modified without prior NRC approval, as long as the licensee continues to adhere to the binding license conditions. The existing system provides adequate control over necessary license parameters while providing licensees with sufficient flexibility to accommodate 7
changes within the safety envelope established by tne license conditions. The l
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 which l
would presumably include a "50.59" type change process - is warranted or necessary.
8.
Backfitting Provision To assure that future modifications to Part 70 licenses brought about by new regulatory requirements are ba' sed on public health and safety considerations, and are appropriately cost justified, NEI requests inclusion of a backfitting provision in the revised Part 70. Modifications resulting from new or different NRC requirements or Staff positiom, should be subjected to an appropriate analysis before implementation to ensure that the benefits obtained justify the burden that the proposed change would impose upon licensees. It is imperative that once the rule is promulgated, any subsequent plant or program modifications imposed as a result of the Staffs interpretation of the rule would require a cost benefit review in accordance with the rule. Here the concern is to seek, for example, protection from requirement: +o 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 re ssons 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 Petitian to amend 10 CFR Part 70 was prepared. The proposed rule will provide for licensees' 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 perforraance criteria are not exceeded. In addicion, 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.
8
ATTACHMENT A DISCUSSION OF PROPOSED RULE BY SECTION 1.
Introduction and Scope Section 70.4 provides a definition of uranium processing and fuel fabrication facilities, and the pmposed Section 70.40 prcvides the basis to assure the plant is being operated with an adequate safety margin. Section 70.76 establishes enhanced regulatory stability, as it establishes specific requirements that proposed regulatory changes must be evaluated against in order to assum that the benefit of the change is justified by its economic impact.
II.
Generalleguirementa The regulation of Part 70 facilities has evolved significantly since Part 70 was first pmmulgated; however, Part 70 has not 1,een comprehensively modified 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 by the NRC Staff, along with a continuing concern related to a potential criticality incident. The industry has concluded that the conduct ofIntegrated Safety Assessments (ISA's) would be beneScial. As a result, the industry has proposed the incorporation of an ISA requirementin Part 70, which will ensure that licensees grade their facilities' Structures, Systems and Components (SSCs) and programs important to safety, and evaluate their respective facilities against established safety performance criteria in a disciplir.ed 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 c-iteria could be exceeded under reasonably anticipated conditions, the licensee would be required to take necessary steps to ensure that modifications are made to the facility's SSCs and programs important to safety, to meet those performance criteria.
The inclusion of a backfitting provision is intended to assure that regulatory -
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.
)
9
1 4
t TEXT OF PROPOSED RULE 1
70.4 Definitions Uranium processing and fuel fabrication plant means a plant in which the following operations or activities are conducted- (1) Operations for manufacture of l
(i) Preparadon of reactor fuel containing uranium including any of the fo!!owing:
fuel material; (ii) formation of fuel material into desind shapes; (iii) applicadon of
{
protecdve 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 meearch and development activities utilizing insubstantial amounts of uranium.
f, 70.40 Integrated Safety Assessment I
(a) Uranium pmcessing, fuel fabrication, and uranium enrichment plant s
l licensees licensed under 10 CFR Part 70, shall perform an Integrated Safety Assessment (ISA), or pmvide an acceptable alternative integrated approach to l
safety, to determine the SSCs and programs that will ha 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 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 connensurate with that classification.
(b) The ISA will identify and evaluate those hazards that could result in not meeting any of the following performance criteria, and will determine whether j
adequate controls and protective measures are in place to provide reasonable assurance, that: (i) the requirements of 10 CFR Pad 20 are satis 6ed; (ii) accidental criticalities are avoided; and (iii) for accident condiMons, it is unlikely that any l
member of the public offsite will receive a radiation dose of 25 rem total effective
[
dose equivaleat, an intake of 30 milligrams of uramum in soluble form, or an i
exposure to hydrogen fluoride in air equivalent to immersion for 30 minutes in a
- concentrati>m af 25 milligrams per cubic meter, E
I (c) The ISA will be completed before issuance of an initiallicense to operate, or for cristing facilities, within 5 years after the promulgation of the rule and 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 i
i an ISA per this section.
t L
(e) The results of the ISA shall be maintained at the licensee's facilities.
F Licensees will update the ISA for significant facility changes.
(
10
~
70.76 Backfitting Provision (aX1) Backfitting is defined as the modification of, or addition to, systems, 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.
(2)- Except as provided in paragraph (aX4) of this section, the Commission shall require a systematic and documented analysis, pursuant to paragraph (c) of this section for backfits which it seeks to impose.
(3) Except as provided in paragraph (aX4) of this section, the Commission 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 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 justitied in view of this increased protectma.
(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 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 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 11
.a
-l factor in selecting the way, provided that the objecti,e of compliance or adequate protection is met.
P (b) In reaching the determination required by paragraph (aX3) of this section, the Commission will consider how the backfit should be scheduled, in lig of other ongoing regulatory activities at the plant and, in addition, will consider information available conceming any of the following factors, as may be appropriate, and any other information televant and material to the proposed backfit:
(1) Statement of the speci6c 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 dak to the public from the accidental release of radioactive matrdal or chemical hazards per 70.40(bXiii);
(4) Potential impact on radiological exposure of facility employees; (5) Installation and continuing costs associated with the backfit, including the direct and indirect costs of plant. downtione; (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 diff'erences in plant type, design, or age on the relevancy and practicality of the proposed backfit; and (9) Whether the proposed back6t is interim or final and, ifintedm, the justification for imposing the proposed backfit on an interim basis.
(c) No license will be withheld during the pendency of backfit analyses required by the Commission's rules.
(d) The Executive Director for Operations shall be responsible for implementation of this section, and all analyses required by this section shall be approved by the Executive Direttor for Operations or his or her designee.
12
DOCKETf.WBER 00CKETED l
PEll1K)N FlULE PRM 70-7 9
(&lFR (,0059) 8 Westinghouse CommercialNuclear 97 JM 28 P3 57 8% sc.m Bectric Corporation fuel Olylslon
$n,otsro OfflCE OF SECRETARY NRC 96-003 00CKETitlG A SERVICE BRANClf
' January 24,1997 Secretary, U. S. Nuclear Regulatory Commission ATTN: Docketing and Service Branch Washington, DC 20555-0001
SUBJECT:
SUPPORT OF NEl PETITION FOR RULEMAKING, DOCKET PRM 70 7 Secretary:
This is to extend Westinghouse Electric Corporation's Columbia Fuel Fabrication Fecility support for the Nuclear Energy Institute (NEI) petition for miemaking concerning integrated safety assessment (ISA) and an attendant backfitting provision.
We were actively involved in the process to request NRC to amend its regulations to require uranium processing, uranium eruichment, and fuel fabrication licensees to use an integrated safety assessment, or an acceptable attemative, to confirm that adequate controls are in place to protect public health and safety. We believe that this is the responsible thing for licensees to do.
We were also ectively involved in preparing the request for a backfitting provision to ensure that future modifications to 10 CFR Part 70 licenses, brought about by new regulatory requirements, are based on public health and safety considerations and are appropriately cost. justified. We believe that tnis is the responsible thing for NRC to do.
'Ihank you for the opportunity to participate in the rulemaking process.
Sincerely, 3
WESTINGliOUSE ELECTRIC CORPORATION
%k ames A. Fici Manager Columbia Fuel Fabrication Facility rao97-003 ATTACHMENT 4 9702030025 970124 1 510 7
PDR 1
DOCKETNUMBER
4 ETITION RULE PRW '70,,r/
00CKETED USNRc (blFR Goos 1)
January 30,1997 W FEB -4 Al0 01 Secretary, U. S. Nuclear Regulatory Commission OFFICE OF SECRETARY ATrN: Docketing and Service Branch 00CNETING & SERYlCE BRANCH Washington, DC 20555-0001
Subject:
NEI PETITION FOR RULEMAKING, DOCKET PRM-70 7
Dear Secretary:
This letter is to express Combustion Engineering, Inc.'s support for the Nuclear Energy Institute (NEI) petition for rulemaking conceming integrated safety assessment (IS A) and the associate' backfitting provision.
We v re actively involved in the process leading to the request that NRr amend its regulations to require uranium fuel fabrication licensees to use integiated t.rJety assessment, or an acceptable attemative, to confirm that adequate controls are in place to protect public health and safety. We believe that this is the best approach to assuring the continued safe operation of our facilities We were also actively involved in drafting the request for a backfitting provision to ensure that future modifications ta licenses issued' pursuant to 10 CFR Part 70, as a result of new regulatory requirements, are based on public health and safety considerations and are appropriately cost-Justified.
We appreciate the opportunity to participate in the rulemaking process.
Cordially yours.
COMBUSTION ENGINEERINO,INC.
W Robert W. Sharkey Director, Regulatory AfTairs RA97/545 l
ABB CENO Fuel Operations 76/0 10M06 2:t"%
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unded States E nrichment Corporat,on
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000)$TE'O 2 0emocracy Center 6903 Rockledge L.ve Betheada.MD 20817 i
((n 9 Tel. (301)564 3200 O. r.,,,y 3
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Far(301)564 32C1 Uniini States
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sacy.n g Enrichment Corporation y'
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I February 10,1997 Efffi *,.. ;'J y yQ 8
DIF60051)
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Secretary SERIAL: GDP 97-005 US Nuclear Regulatory Conunission Washington, D.C. 20555 0001 Attention: Docketing and Service Branch Paducah Gaseous Diffusion Plant (PGDP)
Portsmouth Gaseous Diffusion Plant (PORTS)
Docket Nos. 70-7001 and 70-7002 PRM-70-7, NEI's Peution for Rulemaking on 10 CFR Part 70
Dear Sir:
On behalfof the United States Enrichment Corporation (USEC), I am pleased to provide comments on NErs " Petition for Rulemaking on 10 CFR Part 70" as noticed in the Federal Register on November 26,1996. Although the gaseous diffusion plants managed by USEC are certi6ed under 10 CFR Part 76 and, therefore, not subject to the proposed revisions to Part 70, USEC offers these comments 1) in the interest of the USEC AVLIS facility which is docketed under Part 70,2) to share USEC's expedence assessing the integrated safety of the gaseous diffusion plants, and 3) to provide as much consistency as is appropdate between Part 70, Part 76, and other NRC guidance and regulations.
As noted in the enclosed comments, USEC endorses NErs petition and is providing certain suggested changes to further the objectives of the petition. USEC believes that the language of the proposed rulemaking should be revised to explicitly clarify the intended use of the performance criteria; namely that the purpose of the cdteda is to guide the Commission and licensee in their evaluation of the suitability of(1) the events chosen for evaluation (i.e., those with consequences of concem) and (2) the identification determination as to the sr.fety significance of Structures, Systems and Components (SSCs).
The revisions proposed by USEC are intended to ensure that the pdmary intent of the rule is to provide reasonable assurance of public health and safety rather than that specific performance criteria are not exceeded Revisions are also suggested to the criteria themselves.
Finally, USEC suggests revising the proposed language of Q70.40 to clarify that the backfit provision applies to the results of the ISAs.
9702180336 970210
?,PRM n
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. FED-10-1937 10:44 SIEMENS EsE 4'
yt FEB 11 P2 38 February 10,1997 0FFICE OF SECRETARY LB/REV:008:07 00CKETlHG & EERVICE BRANCH Secretary, U. S. Nuclear Regulatory Commission ATTN Docketing and Servico Branch Washington, D. C. 20555-0001 DOCKETNUMBER PETITION HULE _N %7 (bI FR60051) ~
Dear Mr. Secretary:
Subject:
Support of NEl Petition for Rulemaking, Docket PRM.70 7 This is to extend Siemens Power Corporation's (SPC) support for the Nuclear Energy Institute (NEI) petition for rulemaking requiring Integrated safety assessment (ISA) and an attendant backfitting provision.
We worn actively involved in the process to request NRC to amend its regulations to require uranium processing, uranium enrichment, and fuel fabrication licensees to use an integrated safety assessment, or en acceptable alternative, to confirm that adequate controls are in place to protect public health and safety. We were also actively involved in preparing the request for a backfitting provision to ensure that future modifications to 10 CFR Part 70 licenses, brought about by new regulatory requirements, are based on public health and safety considerations and are appropriately cost-justified.
We have also reviewed the U.S. Enrichment Corporation's (USEC) suggested changes to 10 CFR 70 as proposed in the petition in their letter dated February 10,1997 and agree that the changes they suggest will enhance the rulernaking. SPC, therefore, supports modifying the petition v/th the changes suggested by USEC.
Very trul yours, i
i
__ x R. E. Vaughan, an Safety, Securi y & Licen ng
/mah 4
cc: Felix Killar - NEl Siemens Power Corporation Nuclear DivWoon 2101 Horn Rapida Road Tel:
(509) 375 8100 f.ngineering & Manuf acturing P.O. Box 130 Fax:
(6091 375 6402
' J Si GE Nucker Energy DOCKETED USNRC c4 r.w um i.,, eu,.,
Cemot Menegu Ce.e!Ekctre Company P0 Don 180. Wkungtwt NC18402 0180 ErIs'#
YI FEB 14 A9:41
- 3ss, in9106156666 1
February 5,1997 0FFICE OF SECRETARY 00CMETING & SERVICE BRANCH Secretary, U. S. Nuclear Regulatory Commission Attn: Docketing and Service Branch D07'GT,R')],nER Washington, DC 20555 0001
.y r *C * *
. FM y (bI FR 40054)~9 Secretary:
4 l
Subject:
Support ofNE1Petitionfor Rulemaking. Docket PRM 70 7 GE Nuclear Energy supports the subject Nuclear Energy Institute (NEI) petition which incorporates the use ofintegrated safety assessment based rules for defin!ng safety 5ptems at fuel fabricatio,e facilities and includes backfit provisions consistent with the Commission's regulation of similar nuclear facilities.
In a letter to Chairman Shirley A. Jackson dated March 26,1995, Steve Specker, Vice President of GE Nuclear Energy outlined three basic conclusions that GE had reached in regard to changes in the regulatory framework which would result in improved safety margin for a segment of the industry that is already operating very safely by world standards. As committed at that time, GE has worked with NEl in the preparation of PRM 70-7 and believe that it represents an appropriate course of action for the Commission to adopt zis well as embraces those three basic items addressed in Dr. Specker's letter.
1 The rules must (1) integrate the total safety requirements in a balanced, risk based manner, (2) be performance orientated and (3) include backfit provisions.
Once the proposed rule is formalized, implementation aad review documentation guidance must be developed that tracks the rule and results in efTective and efficient implementation including guidance that will promote consistent licensing action and meaningful inspections. This guidance, presumably in the form of proposed Regulatory Guides must be available for public review and comment before the rule is finally promulgated so that the public has due notice and opportunity to be heard on the features and impact of the rule as it will be interpreted and applied by NRC Staff, Thank you for the opportunity to participate in an open rule making process.
Sincerely, hM W RtN-h Craig Ki >p, General Manager Nuclear inergy Production
9 Docketing and Service Branch February 10,1996 GDP 97 005 Page 2 We would be pleased to discun these comments with you. Please contact me a I
Ms. Usamarie Janiel at (301) 564-3247.
Sincerely, f
Robert L. Woolley Nuclear Regulatory Assurance and Policy Manager Enclosure cc:
M. Fertel, NEI
4 UNITED STATES ENRICilMENT CORPORATION Comments on NEI's Petition for Rulemaking on 10 CFR Part 70, PRM-70-7 Introduction USEC has been engaged with the NRC since 1993 in rulemaking and certification of the two gaseous d% plants under 10 CFR Part 76, which bears a very close relationship to Part 70. Indeed, in the Part 76 Statements of Consideration, the Commission wrote:
'In developing Part 76, the staff took into account the ongoing effort to revise Part 70, which applies to licensing of other fuel cycle facilities. The staff believes that Part 76 will be compatible with anticipated future changes to Part 70. However, if the final revisions to Part 70 (in 1996) call for a revision to Part 76, appropriate revisions wih be considered and the backfit rule would apply."
USEC clearly has an interest in the content of Part 70 due to its relationship to Part 76. Based on our experience, we believe that formalization, by rulemaking, of criteria for determining areas of concern and the importance of SSCs for fuel cycle facilities is essential.
'Ihere is little stored crwrEy at the fuel cycle facilities nor are there large concentrations of radioactivity that would pose a significant public safety concern offsite except in the most extreme and unusual scenarios. However criticality, exposure to chemical hazards from radioactive materials of either the public or workers, and material diversion are areas of concem. To date, the NRC has not established clearly identified safety criteria or goals for these hazards. Explicit goals against which these plants can be evaluated should be established clearly and unambiguously as part of this rulemaking Key policy issues that should be considered by the Commission as part of the rulemaking include:
- Worker Safety
- Prevention of Accidental Criticalities
- Operptslity Assurance of Systems, Structures and Components c.
These fundamental policy issues were integral to the GDP certification experience, are embedded in this rulemaking and, USEC beheves, are best addressed through the rulemaking process. The follow comments address each of these issues and how they relate to our clarifying comments on NEl's Petition.
USEC's Comunets an PRM.70 7 Enclosse to ODP 97 005 Page 2 of 5
)
i l
C--u c-NEl's L--y" R#'m to Fad 70 USEC fuuy supports the concept, and many of the details, of the NEI proposed revisions to Part 70 In particular, we support the requirement that similar integrated safety analyses be performed for th existing ibel cyde facdities; that standards be established to determine the areas of concem to be an and that a badde provision be included to assure that costs, as well as beno6ta, are considered for chan to the theilities. Incorporating the backSt provision into the rulemsking will ailow fo'r reasoned evaluation of the need for changes to these fadlities and the most cost effective means of obtaining those changes.
NErs proposed revisions would require these analyses to be completed before the NRC imposes change in programs or procedures which might not prove necessary aAer the results of the analyses are eva USEC recommends certain modi 6 cations to NErs proposal as fouows:
n--u. V== af PC' Haale and hfety The language of the proposed rulemaking should be revised to explicitly clarify the intended use of the performance criteria; namely that the purpose of the criteria is to guide the Commission and the licensee in their evaluation of the suitability of(1) the events chosen for evaluation (i.e., those with consequences of concern) and (2) the determination as to the safety signi6cance of SSCs. Nume;i limits can not represent the correlation of all factors signi6 cant to the question of rr#'= assurance of public heahh and safety. Factors that go to the credibility of the event such as, probability of occurrence, existing administrative controls, existing physical and engineering controls, and the h=* nature of these hazards (i c., visible and noxious) need to be appropriately considered before l
making a Ending that " reasonable assurance" has not been provided. The airrent language of the l
proposed rulemaking might be laterpreted to suggest that the performance criteria are absolute li excW of which implies that the public health and safety cannot be reasonably assured. Rather, the criteria should be used to identify the events of concern to be considered in the IS A and SSCs of importance. *Ihe regulation should provide a mechanism for determining whether there is reason assurance of public health and safety md not reasonable assurance that the criteria are not exceeded.
USEC has proposed a modification to the NEI wording to strengthen this concept.
Worker Safety A key challenge in certifying the gaseou., duiuJon plants has been addressing the NRC staffs appropriate concern for the protection of onsite workers under accident conditions. Besides NRC oversight, the fuel cycle facilities are also regulated in this area by OSHA and, under these regulation perform Process Safety Management and Hazard Analyses.10 CFR 76 does not explicitly addre chemical toxicity from radioactive materials for workers. However, many of the systems that have been identified for additional quality controls at the gaseous diffusion plants and many of the l
restrictions in the Technical Safety Requirements were established speinc211y in response to worker safety considerations under accident conditions. Imposition of requirements without a clear basis against which to demonstrate adegate safety is not an appropriate way to establish regulatory requirementr. Because worker safety appears to be a key underlying motive behind the NRC sta interest iri revising 10 CFR 70 and imposing new requirements on fuel cycle facilities, it is essential that this issue be explicitly recognized md considered in this rulemaking proceeding.
NErs proposalin this regard suggests that the requirements of 10 CFR 20 be satisfied. We believe NErs intention was to make it clear that the IS A be used to demonstrate compliance with 10 CFR 20.
Fuel cycle facilities are currently required to comply with 10 CFR 20. First, USEC believes that
i USEC's Commanu an PRM 70 7 ranta==e to ODP 97 005 Page 3 of 5 l *.
analysis is not required to comply with 10 CFR 20. Compliance with this requirement has been achiwed to date through the implementation of Radiation Safety Programs and without speci6c analysis requirements. Second, this would be a new use of analysis to demonstrate compliance with this 10 CFR 20 requirement. The analytical methods to demonstrate compliance with 10 CFR 20 are not demonstrated and, without further guidance on how to demonstrate :-agm using analysis, the requirements to do so remain unclear. Therefore, USEC has proposed to delete reference to 10 CFR 20 in NEI's rule language.
Accidental Cdelealities Fuel cycle facilities are already required to detect accidental criticalities under 10 CFR 70.24. This reguladon does not, however, speciscally addras prweetion of accidental criticalitia Currently, the Nuclear Cdticality Safety Program requires analyses of the potential for accidental criticalities during operations. Criticality has long been a risk at fbel cycle facilities that has been considered acceptable if cw?'he with the double contingency principle is demonstrated. The double contingency principle as stated in ANSI /ANS-8.1-1984, Section 4.2.2 is as follows: 'Piscus designs should, in general, incorporate sufficient factors of safety to require at least two unlikely', independent, and concurrent changes in process conditions before a criticality accident is possible." USEC has proposed a modhanan to 70.24 to clarify that licensees be required to demonstrate that adequate controls and protective measures are in place to provide reasonable assurance tiuit accidental criticalities are prevented and that compliance with this requirement may be achieved through satisfaction of the double contingency principle.
Assurance The last sentence of NEI's proposed 70,40(a)' indicates that SSCs be classi6ed on the basis of safety signi6cance and commensurate controls applied. USEC understands this to allow for the imposition of controls to assure operability based on the imponance to safety of SSCs and the risk to the facuity their inoperability poses. The determination of the safety signi6cance of SSCs and commensurate controls to assure opera' ility has been a chkilenging issue for certification of the gaseous ais'ision o
plants. Indeed, no clear criteria or standards were adopted as part of the certification procea to clasaily SSCs. Lacking a cler.r method of determining the safety signi6cance of SSCs and approrniste quality controls, we believe a larger number of SSCs were selected as safety signi6 cant taan if consistent classi6 cation criteria had been utilized in the process. Signi6cantly, SSC's that are relied on to demonstrate compliance with the double contingency principle for criticality prevention were
~
included in the quality program. Tnis may or may not have been appropriate. USEC believes the ISA should provide the basis for determining the importance of the SSCs and that operability assurance should then be applied commensurate with risk. USEC has proposed a modification to the NEl wording to strengthen this concept.
Backfit Provinnon USEC especially suppons the inclusion of the backfit provi; ion ({70.76) as a sound basis for determining if modifications or additions to systems, structures or components of a plant, or to the procedures or organization required to operate the plant are justified by considering both their benefits and associated costs. The existing facilities that will be rubject to this proposed rule, like our gaseous diffusion plants, have been operated safely for many years. While safety can almost always be
_ iQroved, the key _ question for existing facilities is what improvements to safety, if any, are necessary to achieve an acceptable level of safety, and, beyond that,'what changes are clearly beneficial given
USEC's Comments on PRM.70 7 Enclamme to ODP 97 00$
Pese 4 of $
?
fair consideration of =~4=*M costs. The backfit proposal provides for these determinations to be made in an open, public process. To assure that there is no ambiguity about the timing of the applicability of the pmposed backfit provision, USEC suggests an addition to the proposed larguage of $70.40. This addition would make it clear that plant or procedure changes proposed by the NRC as a result ofits consideration of the results of the ISAs for existing facilities would be subject to the backfk nde. This is consistent with NErs intent as reflected on page 8 ofits petition, but it should be made clear in the mie text itself.
Innelmananting Gaklance l
Establishment of the requirement is only _the first step. Guidance should be promulgated on the required format and content of the analysis required. This guidance would logically follow imposition
)
of the requirement t'y rule, but, as discussed in reference to 10 CFR 20, it should be clear before rulemaking that guidance is indeed available. The AIChE ' Guidelines for Hazard Evaluation Procedures, Second Edition with Worked Examples," 1992 is representative of the types of analysis j
that should bq required, i,
a i
s e
9 O46
~-~~~'----------u-_,___
4 USEC's Comments on PRM.70 7 i*
Encloswe to GDP 97 005 Page 5 ot5 4
1 i
I 2
USEC's Modifications to NEI's Fred Rule Lannuanc USEC's tr W w:ans to the NEI proposed 10 CFR 70 language reflect the recommendations discussed above. USEC recommends that the NRC approve the NE! petition, as modified by below:
f ILL_OtAnitions
,~
.5;
,NO.
s "
g__
'_ g,.g,.._ a 4
f 70.40 InterroledSafety Assessnent.
(a) Uranium processing,fuelfabrimtion, and uranium enrichment plant licensees licensed under 10 CFR Part 70, shallperform an integrated safety assessment (ISA), or provide an acceptable alternatne integranedqproach no safety, to determine the Spiniskgig(dh%tph)fik]hikGl(SSCs) i andprograms that will be usedby the licensee toprotectpublic health amisqfety and on the basis of
)
the results of the ISA, inplement chages so SSCs or associated licenste programs WMki not provide reasonable assurance WMhkilGniidM :'.: :'.; p.;l;.=; ;;;;;-:: x:jb.-:!. i::}
(U a; ;='. :;&i Licensees will classtfy SSCs on the basis ofsqfety sigmpcance amiwill 1
gpply eenrode Meommensurate with that classspcation.
(b) the 154 willidentify and enluate than haards Ihat could result in not meeting any of the followirgperformance criteria and willdetermine whether adequate controls andprotecttw measures arc inplace toprovide reasonable azurance afjibhWhihtiRr%nikM hat:
e
.u _
_,__m_2 i.n,....,-.....-.. y..o r,r.o..n
..o (2);;;lh..::!;;-:::::'!.y ;..w !hd;;;;d fly)for accident conditions, it is unlikely that any member of the public of the site will receive i
a radiation dose of 25 rem total efective dose equimlent, an intake of 30 milligrams of uranium in solubleform, or an exposure to hydrogenfluoride in air equimlent to immersiortfor 30 minutes in a concentration of 25 milligrams per cubic meter.
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