Nuclear Energy Institute; Receipt of a Petition for Rulemaking

NUCLEAR REGULATORY COMMISSION

10 CFR Part 70

[Docket No. PRM-70-7]

Nuclear Energy Institute; Receipt of a Petition for Rulemaking

AGENCY: Nuclear Regulatory Commission.

ACTION: Petition for rulemaking; Notice of receipt.

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SUMMARY: The Nuclear Regulatory Commission (NRC) has received and

requests public comment on a petition for rulemaking filed by the

Nuclear Energy Institute (NEI). The petition has been docketed by the

Commission and assigned Docket No. PRM-70-7. The petitioner requests

that the NRC amend its regulations to require uranium processing,

uranium enrichment, and fuel fabrication licensees to use an integrated

safety assessment (ISA), or an acceptable alternative, to confirm that

adequate controls are in place to protect public health and safety. The

petitioner also requests that a backfitting provision be established to

ensure regulatory stability for these types of licensees.

DATES: Submit comments by February 10, 1997. Comments received after

this date will be considered if it is practical

[[Page 60058]]

to do so, but assurance of consideration cannot be given except to

those comments received on or before this date.

ADDRESSES: For a copy of the petition, write: Rules Review Section,

Rules Review and Directives Branch, Division of Freedom of Information

and Publications Services, Office of Administration, U.S. Nuclear

Regulatory Commission, Washington, DC 20555-0001.

Submit comments to: Secretary, U.S. Nuclear Regulatory Commission,

Washington, DC 20555-0001. Attention: Docketing and Service Branch.

Deliver comments to 11555 Rockville Pike, Rockville, Maryland,

between 7:45 a.m. and 4:15 p.m. on Federal workdays.

For information on sending comments by electronic format, see

``Electronic Access,'' under the Supplementary Information section of

this notice.

FOR FURTHER INFORMATION CONTACT: Michael T. Lesar, Office of

Administration, U.S. Nuclear Regulatory Commission, Washington, DC

20555-0001. Telephone: 301-415-7163 or Toll Free: 800-368-5642, or e-

mail [email protected]

SUPPLEMENTARY INFORMATION:

Petitioner

NEI represents that it is responsible for establishing unified

nuclear industry policy on matters affecting the nuclear energy

industry, including the regulatory aspects of generic operational and

technical issues. NEI's members include all utilities licensed to

operate commercial nuclear power plants in the United States, nuclear

plant designers, major architect/engineering firms, fuel fabrication

facilities, materials licensees, and other organizations and

individuals involved in the nuclear energy industry.

Background

The petitioner is aware that the NRC staff has considered a

possible revision of 10 CFR Part 70 for several years. The petitioner

believes that the NRC staff is motivated to amend 10 CFR Part 70

because of its assessment of certain conditions and events that have

occurred at fuel facilities in the past, and the NRC Materials

Regulatory Review Task Force report of 1992, ``Proposed Method for

Regulating Major Materials Licensees'' (NUREG-1324).

However, the petitioner does not believe NUREG-1324 should serve as

a blueprint for a major revision to 10 CFR Part 70. It further believes

that possible future NRC regulation of Department of Energy facilities

does not warrant a major revision to 10 CFR Part 70 and that wholesale

changes to the part are not necessary. Instead, the petitioner is

proposing a focused and performance-based addition to the existing

regulation to address the NRC's concern about possible hazards at 10

CFR Part 70 licensed facilities.

Petitioners Request

The petitioner requests that the NRC amend 10 CFR Part 70 to

require that uranium processing, uranium enrichment, and fuel

fabrication licensees ensure that their safety programs are evaluated

and modified, as necessary, on the basis of an ISA, or an acceptable

alternative, within an appropriate time period. The petitioner also

requests that 10 CFR Part 70 be modified to ensure regulatory stability

for 10 CFR Part 70 licensees through the inclusion of a comprehensive

backfitting requirement similar to the backfitting regulation

applicable to 10 CFR Part 50 licensees.

The petitioner states that the proposed amendments would require 10

CFR Part 70 licensees to evaluate and enhance, if appropriate, their

overall safety program on the basis of data generated from an ISA, or

an acceptable alternative, and specifically defined performance

criteria. According to the petitioner, the three principal hazards for

10 CFR Part 70 facilities are nuclear criticality, fire, and chemical

accidents. The petitioner believes that its proposed changes would

establish performance criteria for the evaluation of these three

hazards, as well as for general radiation safety.

Discussion of Petitioner's Request

The petitioner's basis for the recommended revisions is that the

fuel facilities are being operated safely under existing regulations

and that the NEI's members have reviewed most of the conditions and

events on which the NRC staff apparently has based its concerns. In

each case reviewed, the petitioner states 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 these events, as well as continuing

efforts to make cost-effective improvements to operations, have

provided the industry with an even larger margin of safety than existed

several years ago.

The following discussion presents the principal components of the

petitioner's suggested amendments and their supporting bases.

1. Integrated Safety Assessment

The petitioner states that an ISA is a process conducted to

identify hazards and the potential for initiating event sequences and

to assess the potential event sequences and their consequences relative

to the performance objectives for the facilities, the plant structures,

systems and components (SSCs), and programs relied on to prevent or

mitigate these consequences. The petitioner states that subsequent to

the integrated assessment, safety-related SSCs and programs would be

ranked on the basis of their importance to safety and a balanced safety

program. The petitioner believes that this ranking of SSCs and programs

would optimize safety program implementation because the establishment

of importance-to-safety rankings and interrelationships would focus

facility resources effectively.

2. Performance Criteria

The petitioner believes that the establishment of performance

criteria that comprise the safety template against which licensees will

be required to judge the effectiveness of their safety programs must be

part of the proposed regulations. The performance criteria would be

based on the criticality, radiation protection, chemical safety, and

fire protection aspects of the SSCs and programs deemed important to

safety. The petitioner recommends performance criteria that would:

(1) Satisfy the requirements of 10 CFR Part 20;

(2) Avoid accidental criticalities; and

(3) Make it unlikely that any member of the public off the site

would 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 under

accident conditions.

3. Reference to Industry Practices

The petitioner states that while the petitioner's suggested rule

does not specifically reference the American Institute of Chemical

Engineer (AIChE), ``Guidelines for Hazard Evaluation Procedures, Second

Edition With Worked Examples,'' 1992, this publication is frequently

referenced by the NRC staff as an acceptable guide for performing the

hazard-evaluation portion of an ISA. The petitioner believes the that

AIChE document provides reasonable approaches and that other formal

methods may also be acceptable.

[[Page 60059]]

The petitioner states that 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 Environmental Protection Agency's (EPA)

Risk Management Program regulations. The petitioner believes that

analyses performed under these other regulations should be considered

an acceptable means of meeting the ISA requirement for evaluating

hazards within the NRC's jurisdiction.

4. Graded Approach

The petitioner states that 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 any

such postulated event. If credible-event or accident sequences are

examined and, on the basis of a realistic evaluation, determined not to

be reasonably capable of producing effects in excess of the performance

criteria, no further action would be required by a licensee.

The petitioner believes that events or accidents of lesser

significance would continue to be prevented and mitigated through

existing licensee safety programs. The petitioner states that where an

accident or event could credibly produce consequences exceeding those

specified in the suggested regulations, 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 and its potential effects would be evaluated by a

licensee in the process of grading the safety programs. Using these

criteria, the petitioner suggests one approach to grading would be to

classify SSCs and programs on the basis of their safety significance

and to apply controls equal to that classification. Other approaches

also may be appropriate.

5. Changes in Facility Operations

The petitioner states that, upon completion of the ISA, each

licensee would determine what, if any, changes in existing controls are

needed to provide reasonable assurance that the threshold performance

criteria are not exceeded. The licensee would then implement these

changes in a timely manner. The petitioner 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.

6. Alternative Approaches

The petitioner states that 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 have an alternative approach or program

for which it believes may assure and demonstrate the safety of its

operations. The petitioner believes that the proposed regulations would

provide flexibility for licensees to offer alternative approaches for

the NRC's consideration. The petitioner states that these approaches

might not conform to a formal ``hazards analysis'' but could still

provide the NRC and the licensee with adequate confidence in facility

safety. The petitioner believes that the proposed regulations should

allow for these alternative approaches, and require the licensee to

obtain NRC approval of, and complete its efforts, as the suggested rule

would require for formal ISAs.

7. License Format

The petitioner states that under its suggested regulations, 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 on to ensure that the performance

criteria are not exceeded and the bases for concluding these controls

are adequate. The petitioner states that a formal submittal to the NRC

of an ISA report would not be required and, most importantly, the ISA

would 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 necessary as a result of that

review and updating.

The petitioner states that incorporation of the ISAs into the

license would necessitate significant changes in the current license

application format by dramatically expanding the description of the

plant site, facilities, equipment, processes and controls that form the

basis of the license. The petitioner states 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

process descriptions and safety (accident) analyses. The petitioner

believes that this could potentially represent a significant

administrative burden for licensees and the NRC Staff, producing no

measurable improvement in the safety of licensed 10 CFR Part 70

facilities.

The petitioner states that 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 petitioner states that the existing system provides adequate

control over necessary license parameters while providing licensees

with sufficient flexibility to accommodate changes within the safety

envelope established by license conditions. The petitioner states that

the industry does not believe that the administrative effort required

to comply with a new license format--which would be similar to a

reactor licensee's SAR and which would presumably include a

``Sec. 50.59'' type change process--is warranted or necessary.

8. Backfitting Provision

The petitioner states that inclusion of a backfitting provision

would 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. The

petitioner states that modifications resulting from new or different

NRC requirements or NRC staff positions should be subjected to an

appropriate analysis before implementation to ensure that the benefits

obtained justify the burden that the proposed regulations would impose

on licensees. The petitioner states that once its suggested regulations

are issued, any subsequent plant or program modifications imposed as a

result of the NRC's interpretation of the rule would require a cost-

benefit review in accordance with the petitioner's rule. The petitioner

believes that the concern is to seek, for example, protection from

requirements to conduct highly complex

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and very costly probabilistic risk assessments for these low-risk

facilities. The petitioner believes that this would be consistent with

other NRC guidance.

The Petitioner's Proposed Amendment

1. The definition of a uranium processing and fuel fabrication

plant is added to read as follows:

Section 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 reactor fuel containing uranium,

including any of the following:

(i) Preparation of fuel material;

(ii) Formation of fuel material into desired shapes;

(iii) Application of protective cladding;

(iv) Recovery of scrap material; or

(v) Storage associated with such operations.

(2) Research and development activities involving any of the

operations described in paragraph (1) of this definition except for

research and development activities utilizing insubstantial amounts of

uranium.

* * * * *

2. Section 70.40 is added to read as follows:

Section 70.40 Integrated Safety Assessment.

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

plant licensees licensed under 10 CFR Part 70, shall perform an

integrated safety assessment (ISA), or provide an acceptable

alternative integrated approach to safety, to determine the SSCs and

programs that will be used by the licensee to protect public health and

safety and, on the basis of the results of the ISA, implement changes

to SSCs or associated licensee programs that provide reasonable

assurance that the performance criteria set forth in Sec. 70. 40(b) are

not exceeded. Licensees will classify SSCs on the basis of safety

significance and will apply controls commensurate 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 adequate controls and protective measures are in

place to provide reasonable assurance that:

(1) the requirements of 10 CFR Part 20 are satisfied;

(2) accidental criticalities are avoided; and

(3) for accident conditions, it is unlikely that any member of the

public off the site will receive a radiation dose of 25 rem total

effective dose equivalent, 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.

(c) The ISA will be completed before issuance of an initial license

to operate, or for existing 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 (Sec. 70.38)

are not required to perform an ISA per this section.

(e) The results of the ISA shall be maintained at the licensee's

facilities. Licensees will update the ISA for significant facility

changes.

3. Section 70.76 is added to read as follows:

Section 70.76 Backfitting Provision.

(a)(1) 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 licensee-performed analyses, a new or amended provision in the

NRC's regulations, or the imposition of a regulatory staff position

interpreting the NRC's regulations that is either new or different from

a previous NRC staff position.

(2) Except as provided in paragraph (a)(4) of this section, the NRC

shall require a systematic and documented analysis, pursuant to

paragraph (c) of this section for backfits that it seeks to impose.

(3) Except as provided in paragraph (a)(4) of this section, the NRC

shall require the backfitting of a plant only when it determines, on

the basis of the analysis described in paragraph (b) of this section,

that there is a substantial increase in the overall protection for

public health and safety or common defense and security to be derived

from the backfit and that the direct and indirect costs of

implementation for that plant are justified in view of this increased

protection.

(4) The provisions of paragraphs (a)(2) and (a)(3) of this section

are inapplicable and, therefore, backfit analysis is not required and

the standards in paragraph (a)(3) of this section do not apply where

the Commission or NRC 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;

(ii) That regulatory action is necessary to ensure that the plant

provides adequate protection to public health and safety 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 public health and safety or common defense

and security should be regarded as adequate.

(5) The Commission shall always require backfitting of a plant if

it determines that the regulatory action is necessary to ensure that

the plant provides adequate protection to public health and safety and

is in accord with common defense and security.

(6) The documented evaluation, required by paragraph (a)(4) of this

section, must conclude a statement of the objectives of and reasons for

the modification and the basis for invoking the exception. If immediate

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 that is adequate, then ordinarily the licensee is free to

choose the way that 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 factor in selecting the way, provided that the objective

of compliance or adequate protection is met.

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

this section, the Commission will consider how the backfit should be

scheduled, in light of other ongoing regulatory activities at the plant

and, in addition, will consider information available concerning any of

the following factors, as may be appropriate, and any other information

relevant and material to the proposed backfit:

(1) Statement of the specific objectives that the proposed backfit

is designed to achieve;

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

the licensee in order to complete the backfit;

(3) Potential change in the risk to public health and safety from

the accidental release of radioactive

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material or chemical hazards per Sec. 70.40(b)(iii);

(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 downtime;

(6) The potential safety impact of changes in plant or operational

complexity, including the relationship to proposed and existing

regulatory requirements;

(7) The estimated resource burden on the NRC associated with the

proposed backfit and the availability of such resources;

(8) The potential impact of differences in plant type, design, or

age on the relevancy and practicality of the proposed backfit; and

(9) Whether the proposed backfit is interim or final and, if

interim, 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 regulations.

(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 Director for Operations or

his or her designee.

Summary

The petitioner believes that this proposed amendment has the

potential to benefit both licensees and the NRC by requiring a clear,

outcome-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. The petitioner

believes that issuing the proposed regulations would focus both

licensee and NRC resources on those areas in which public health and

safety will benefit, and away from low risk, low consequence issues.

Electronic Access

Comments may be submitted electronically, in either ASCII text or

WordPerfect format (version 5.1 or later), by calling the NRC

Electronic Bulletin Board (BBS) on FedWorld. The bulletin board may be

accessed using a personal computer, a modem, and one of the commonly

available communications software packages, or directly via Internet.

Background documents on the petition for rulemaking also are available,

as practical, for downloading and viewing on the bulletin board.

If using a personal computer and modem, the NRC rulemaking

subsystem on FedWorld can be accessed directly by dialing the toll free

number 800-303-9672. Communication software parameters should be set as

follows: parity to none, data bits to 8, and stop bits to 1 (N,8,1).

Using ANSI or VT-100 terminal emulation, the NRC rulemaking subsystem

then can be accessed by selecting the ``Rules Menu'' option from the

``NRC Main Menu.'' Users will find the ``FedWorld Online User's

Guides'' particularly helpful. Many NRC subsystems and data bases also

have a ``Help/Information Center'' option that is tailored to the

particular subsystem.

The NRC subsystem on FedWorld also can be accessed by a direct dial

telephone number for the main FedWorld BBS, 703-321-3339, or by using

Telnet via Internet: fedworld.gov. If using 703-321-3339 to contact

FedWorld, the NRC subsystem will be accessed from the main FedWorld

menu by selecting the ``Regulatory, Government Administration and State

Systems,'' then selecting ``Regulatory Information Mall.'' At that

point, a menu will be displayed that has an option ``U.S. Nuclear

Regulatory Commission'' that will take the user to the NRC online main

menu. The NRC online area also can be accessed directly by typing ``/go

NRC'' at a FedWorld command line. If the user accesses NRC from

FedWorld's main menu, he or she may return to FedWorld by selecting the

``Return to FedWorld'' option from the NRC online main menu. However,

if the user accesses NRC at FedWorld by using NRC's toll-free number,

he or she will have full access to all NRC systems but will not have

access to the main FedWorld system.

If the user contacts FedWorld using Telnet, he or she will see the

NRC area and menus, including the Rules Menu. Although the user will be

able to download documents and leave messages, he or she will not be

able to write comments or upload files (comments). If the user contacts

FedWorld using FTP, all files can be accessed and downloaded but

uploads are not allowed; all the user will see is a list of files

without descriptions (normal Gopher look). An index file is available

listing and describing all files within a subdirectory. There is a 15-

minute time limit for FTP access.

Although FedWorld also can be accessed through the World Wide Web,

like FTP that mode only provides access for downloading files and does

not display the NRC Rules Menu.

For more information on NRC bulletin boards, call Mr. Arthur Davis,

Systems Integration and Development Branch, NRC, Washington, DC 20555-

0001, telephone 301-415-5780; e-mail AXD[email protected].

Single copies of this petition for rulemaking may be obtained by

written request or telefax ((301) 415-5144) from: Rules Review and

Directives Branch, Division of Freedom of Information and Publications

Services, Office of Administration, Mail Stop T6-D59, U.S. Nuclear

Regulatory Commission, Washington DC 20555-0001. Certain documents

related to this petition for rulemaking, including comments received,

may be examined at the NRC Public Document Room, 2120 L Street NW.

(Lower Level), Washington, DC. These same documents may also be viewed

and downloaded electronically via the Electronic Bulletin Board

established by NRC for this petition for rulemaking as indicated above.

Dated at Rockville, Maryland, this 20th day of November, 1996.

For the Nuclear Regulatory Commission.

William M. Hill, Jr.,

Acting Secretary of the Commission.

[FR Doc. 96-30149 Filed 11-25-96; 8:45 am]

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