[Federal Register Volume 61, Number 229 (Tuesday, November 26, 1996)]
[Proposed Rules]
[Pages 60057-60061]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-30149]
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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
[[Page 60060]]
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
[[Page 60061]]
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 AXD3@nrc.gov.
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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