B ackfitting Guidelines

U.S. Nuclear Regulatory Commission

Office for Analysis and Evaluation of Operational Data

D. P. Allison, J. M. Conran, and C. A. Trottier

NUREG-1409

i I . . ~~~a,
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NUREG-1409

Backfitting Guidelines

Manuscript Completed: June 1990

Date Published: July 1990

D. P. Allison, J. M. Conran, and C. A. Trottier

Office for Analysis and Evaluation of Operational Data

U.S. Nuclear Regulatory Commission

Washington, DC 20555
ABSTRACT

The backfitting process is the process by which the U.S.

Nuclear Regulatory Commission (NRC) decides whether

to issue new or revised requirements or staff positions to

licensees of nuclear power reactor facilities. Backfitting is

expected to occur and is an inherent part of the regulatory

process. However, it is to be done only after formal, systematic review to ensure that changes are properly justified and suitably defined. Requirements for proper justification of backfits and information requests are provided

by two NRC rules, Title 10 of the Code of Federal Regulations, Sections 50.109 and 50.54(f). Three types of backfits

are recognized. Cost-justified substantial safety improvements require backfit analyses and findings of substantial

safety improvement and justified costs. Two types of exceptions, compliance exceptions and adequate protection

exceptions, do not require findings of substantial safety

improvements and costs are not considered. However,

they are still backfits and they require documented evaluations to support use of the exceptions. Information requests (as opposed to backfits) require an analysis of the

burden to be imposed to ensure that they are justified in

view of the potential safety significance of the information requested. NRC procedures on backfitting include

the Charter of the Committee to Review Generic Requirements for generic communications and NRC Manual Chapter 0514 and individual office procedures for

plant-specific communications. Considerable guidance

has been developed, control mechanisms are in place, and

training has been provided to NRC and industry personnel. The Director of the Office for Analysis and Evaluation of Operational Data is responsible for oversight of

backfitting programs, including obtaining industry comments. Initiatives are under way to better explain the

process and conduct further training for industry and

NRC personnel. Further initiatives are being considered

in response to industry comments obtained in a recent

survey concerning the effects of the regulatory process on

licensees.

iii NUREG-1409
Contents

Page

Abstract ................................................................................. iii

Executive Summary ....................................................................... vii

1 In tro ........................................................................... d u c tio n 1

2 Discussion ............................................................................ 2

2.1 Nature and 'Iypes of Backfits ........................................................ 2

2.1.1 Background ................................................................... 2

2.1.2 Backfit Determination ......................................................... 3

2.1.3 Justification for Imposing Backfits ............................................... 3

2.2 Information Requests ......................................... . 5

2.3 Staff Process for Identifying and Imposing Generic Backfits ............................... 6

2.4 Staff Process for Identifying and Imposing Plant-Specific Backfits .......................... 7

2.5 Filing a Backfit Claim or Appeal .............................. . 9

2.6 Current Status ......................................................... 11

3 Questions and Answers on Backfitting ..................................................... 12

3.1 Backfit Determination and Imposition . ................................................ 12

3.2 Generic Backfits . ......................................................... 14

3.3 Plant-Specific Backfits .................. ............................................ is

3.4 Backfit Analysis . ......................................................... 18

3.5 Appeals ......................................................... 19

3,6 General questions . ......................................................... 19

Appendices

A The 1985 Backfit Rule

B The 1988 Backfit Rule

C Committee To Review Generic Requirements Charter

D NRC Manual Chapter 0514, NRC Program for Management of Plant-Specific Backfitting

of Nuclear Power Plants

E Background Information for CRGR Review of Gi-70 and Gi-94 Resolutions

F Sample Backfit Discussion (taken from NRC Bulletin 90-01)

v NUREG-1409
EXECUTIVE SUMMARY

The backfitting process is the process by which the U.S.

Nuclear Regulatory Commission (NRC) decides whether

to issue new or revised requirements or staff positions to

licensees of nuclear power reactor facilities. Backfitting is

expected to occur and is an inherent part of the regulatory

process. However, it is to be done only after formal, systematic review to ensure that changes are properly justified and suitably defined. The requirements of this process are intended to ensure order, discipline, and

predictability and to enhance optimal use of NRC staff

and licensee resources.

Title 10 of the Code of FederalRegulations, Section 50.109

(10 CFR 50.109), contains the backfit rule, which the

NRC revised in 1985 to provide specific guidance and

standards for backfitting decisions. The 1985 rule and the

NRC manual chapter that implemented it were vacated

by the U.S. Court of Appeals in 1987. The court stated

that the rule was ambiguous about whether economic

costs would be considered in ensuring or redefining adequate protection for the public health and safety or the

common defense and security. In 1988 the NRC issued an

amended backfit rule that was again subjected to court review and was upheld. The amended rule states clearly that

economic costs will not be considered in cases of ensuring,

defining, or redefining adequate protection or in cases of

ensuring compliance with NRC requirements or written

licensee commitments.

The backfit rule applies to both generic backfits and

plant-specific backfits for power reactors. It defines a

backfit as a modification of or addition to plant systems,

structures, components, procedures, organization, design

approval, or manufacturing license that may result from

the imposition of a new or amended rule or regulatory

staff position that became effective after specific dates.

The rule recognizes three types of backfits. For backfits

that do not meet one of the exceptions discussed below, a

backfit analysis is required and it must be determined,

based on that analysis, that the backfit will provide a substantial increase in overall protection of the public health

and safety (or common defense and security) and that the

direct and indirect costs for the facility are justified in view

of the increased protection. Two types of exceptions are

recognized, involving compliance and adequate protection. Such exceptions are still backfits, but they are justified differently. A documented evaluation is required,

which states the objectives and purpose of the backfit and

the basis for invoking the exception.

The rule (10 CFR 50.54(f)) requiring licensee responses

to both generic and plant-specific information requests

was revised along with the backfit rule. The rule stipulates

that, except for information sought to verify licensee compliance with the current licensing basis, the NRC must

prepare the reasons for the request to ensure the burden

imposed on licensees is justified in view of the potential

safety significance of the issue to be addressed.

One of the controls on generic backfitting and generic information requests is review by the Committee to Review

Generic Requirements (CRGR). This committee of senior managers from various NRC offices was established in

November1981. Its objectives include eliminating unnecessary burdens on licensees, reducing radiation exposure

to workers while implementing requirements, and optimizing use of NRC and licensee resources to assure safe

operation. Following its review of a proposed generic

communication the CRGR recommends approval, revision, or disapproval to the NRC Executive Director for

Operations (EDO). If the office proposing the communication does not agree with the CRGR recommendation it

may refer the issue to the EDO for decision. The CRGR

operates under a charter that specifically identifies the

documents to be reviewed and the analyses, justifications,

and findings to be provided. Thus, although the primary

responsibility for proper backfit considerations belongs to

the organization proposing a communication, the CRGR

charter is a key implementing procedure for generic

backfitting.

Plant-specific backfits and requests for information are

governed by NRC Manual Chapter 0514. In addition, all

regional offices and the Office of Nuclear Reactor Regulation have approved procedures that implement the

manual chapter. All levels of the NRC staff are responsible for identifying potential backfits, which then are to be

handled in accordance with procedures that provide detailed guidance on identification, analyses, justification,

and tracking of backfitting items. Training is provided at

all staff levels in the principles of management and control of plant-specific backfitting.

Manual Chapter 0514 also provides for licensee claims or

appeals regarding plant-specific backfitting determinations. A licensee may claim that an action, which the staff

did not consider to be a backfit, is in fact a backfit. In an

appeal, a licensee may

* ask that denial of a prior claim of backfit be reversed

* assert that a recognized backfit, which the staff

considered to be an adequate protection or compliance exception, does not meet the criteria for

the exception

vii NUREG-1409
* ask that a proposed backfit, which the staff considered to be a cost-justified substantial safety improvement, be modified or withdrawn

The EDO delegated oversight responsibility of the plantspecific backfitting process to the Director of the Office

for Analysis and Evaluation of Operational Data

(AEOD). This includes reviewing and concurring with office procedures, conducting training for NRC staff and industry, and informing licensees of program and procedure

changes. AEOD conducts an annual assessment of the

backfitting process by reviewing plant-specific backfits

identified by staff or industry and office procedures and

selected records, interviewing office and regional staff,

and obtaining industry comments.

In 1989 AEOD conducted the most recent series of NRC

staff training sessions at the regional offices and conducted a survey of licensees to determine their perceptions of the back!itting process and obtain specific cost information. In late 1989 and. early 1990, the NRC staff

conducted a broader survey of licensees concerning the

effects of the regulatory process. With regard to backfitting, these surveys indicate that licensees are concerned

about the number and overall burden of generic communications, the adequacy of the NRC's consideration of the

effects of cost and scheduling, the basis for issuing requirements involving backfits, the NRC's treatment of

optional actions and requests as if they were requirements, the negative effects if NRC perceives licensees to

be nonresponsive because they do not implement optional actions or because they file backfit claims or appeals, and a need for additional training in backfitting for

industry and NRC personnel.

The NRC staff is taking several initiatives to improve the

backfitting process and is considering further initiatives.

To make backfitting considerations and bases clear to

readers, a summary of backfitting considerations was

added to generic letters and bulletins beginning in December 1989. This report was prepared to explain the

backfitting process to industry and NRC staff. Workshops

with industry and NRC staff are planned for the near future. Changes have been proposed to the programs for

systematic assessment of licensee performance that

would reduce any potential for penalizing licensees for

submitting appeals. Senior NRC managers are considering the information gathered from the broad survey of the

effects of the regulatory process on licensees to determine what changes may be appropriate. For example, the

preliminary report on the broad survey, Draft

NUREG-1395, indicates that the staff will examine

methods that will take into account the cumulative effects

of new requirements.

NUREG-1409 viii
1 INTRODUCTION

Over the years, issues with regard to what constitutes a

backfit and questions on agency policy and practices have

been raised inside and outside the agency. This report is

intended to address these issues and promote a clearer

understanding of the backfit rule and both the generic

and plant-specific backfit policies and associated processes that have been adopted by the U.S. Nuclear Regulatory Commission (NRC).

The Commission revised the backfit rule (itle 10 of the

Code of Federal Regulations, Section 50.109 [10 CFR

50.109]) in 1985 to provide more specific guidance for

backfitting decisions and to provide for management control and accountability of backfits. Although the 1985 rule

has been superseded, it is included as Appendix A because its statement of considerations provides background information on the development of current practice.

The 1985 rule and the NRC Manual Chapter, which implemented the rule, were vacated by the U.S. Court of

Appeals in 1987. The court stated that the rule was ambiguous about whether economic costs would be considered in ensuring or redefining adequate protection of the

public health and safety. In 1988, a revised backfit rule

was published to clearly state that economic costs cannot

be considered (1) when a modification is necessary to

bring a facility into compliance with Commission rules or

written licensee commitments, (2) when regulatory action

is necessary to ensure adequate protection of public

health and safety, or (3) when the regulatory action involves defining or redefining the adequate protection

standard. The court upheld the 1988 revised rule, which is

included as Appendix B.

Backfits are expected to occur as part of the regulatory

process to ensure the safety of power reactors. It is important for sound and effective regulation, however, that

backfitting be conducted by a controlled and defined

process. The NRC backfitting process is intended to provide for a formal, systematic, and disciplined review of

new or changed positions before imposing them.

The backfit process enhances regulatory stability by ensuring that changes in regulatory staff positions are justified and suitably defined. For example, even if not needed

to meet the standard of adequate protection or to ensure

compliance, backfitting is proper if a substantial safety

benefit is realized and the costs are justified by the safety

benefit.

In its implementing procedures, the Commission has defined two types of backfits, generic and plant-specific.

Generic backfits apply to more than one facility while

plant-specific backfits apply to only one facility. After

management makes appropriate findings, proposed generic backfits are reviewed by the Committee to Review

Generic Requirements (CRGR) to determine their compliance with the requirements of the backfit rule and to

ensure that new requirements and staff positions contribute effectively and significantly to the health and safety of

the public and lead to optimal utilization of NRC and

licensee resources. The CRGR Charter (Appendix C to

this report) provides specific procedures for handling generic backfits.

Plant-specific backfits are implemented through use of

NRC Manual Chapter 0514, "NRC Program for Management of Plant-Specific Backfitting of Nuclear Power

Plants," 1988 (Appendix D to this report). This procedure

defines the NRC staff responsibilities for implementing

the backfit rule for plant-specific applications. The NRC

staff, at all levels, is responsible for identifying plantspecific backfits. The cognizant NRC office director or

regional administrator determines if the backfit is warranted and the type of analysis or evaluation required, and

ensures the proper implementation of the backfitting

process.

In late 1989 and early 1990, the NRC conducted a broad

survey throughout the industry regarding the effects of

NRC regulatory programs on licensees. The results were

documented in Draft NUREG-1395, "Industry Perceptions of the Impact of the U.S. Nuclear Power Plant

Activities," February 1990. The comments received about

backfitting generally confirmed and expanded on concerns that had been expressed in an earlier backfitting

survey conducted in April 1989. Senior NRC managers

are considering the information received in response to

the survey to determine if the NRC should change its

regulatory approach. Therefore, this report, which describes the backfitting process as it exists now, could be

superseded in some areas by future changes. However, it

was considered appropriate to explain the current process

and provide documented support for planned training

and workshops with industry and NRC staff at this time

rather than waiting for ultimate resolution of the issues

identified in the survey.

Questions about the backfit process or this report may be

addressed to the NRC Office for Analysis and Evaluation

of Operational Data (AEOD), which has responsibility

for monitoring the backfit process.

1 NUREG-1409
2 DISCUSSION

2.1 Nature and Types of Backfits

2.1.1 Background

Backfitting is defined in 10 CFR 50.109 as

(1) the modification of or addition to

* systems, structures, components or design of a

facility; or

to be imposed on responders, but this analysis has a limited scope and depth relative to that required for a 10

CFR 50.109 backfit.

The backfit rule applies to actions that impose positions

or requirements on licensees; it does not apply to requested actions that areoptional or voluntary. Generall,

it does not apply to relaxations.' However, i requirements are reduced but iadeiiandatory, the backfit rule

would apply if licensees are required to make the changes

in order to achieve a greater level of safety.

* the design approval or manufacturing license

for a facility; or

* the procedures or organization required to design, construct, or operate a facility;

and

(2) may result from

The backfit rule does not apply to specific requirements

imposed by statute. For example, if a statute requires a

revision to license fee schedules, the backfit rule does not

apply.

The backfit rule does not apply to purely administrative

matters. For example, a change in the number of copies of

safety analysis reports that licensees must submit to the

NRC would not be covered by the backfit rule.

* a new or amended provision in Commission

rules or

* the imposition of a regulatory staff position

that is either new or different, from a previously applicable staff position

and

(3) effective after specific dates keyed to the effective

date of the backfit rule (see Section 2.1.2 of this report).

Different standards apply to the imposition of more stringent safety requirements for standard design certifications (SDCs) or early site permits issued under 10 CFR

Part 52. For example, during the pendency of an SDC,

backfits of the SDC are permitted only for the sake of

compliance or adequate protection. Those standards are

not covered in this report.

In its amended (1988) form, the rule requires a backfit

analysis, including consideration of associated implementation costs, for all proposed backfits with the following

exceptions:

Note that the backfit rule and the definition of backfitting

apply to cases of compliance and cases of adequate protection as well as to cases of cost-justified substantial

safety improvement. They are all backfits, but require

different types of justification as discussed further in Section 2.1.3(1) of this report.

The backfit rule applies to nuclear power reactors. The

scope of the rule includes all design and hardware aspects

of systems, structures, and components as well as supporting activities reflected by procedures and organization.

The rule is intended to encompass only positions or requirements that bring about improvements in safety.

Therefore, NRC actions that merely request information

and do not impose changes (specifically in hardware, procedures, or organization) are not covered under 10 CFR

50.109, but may be addressed under 10 CFR 50.54(f). The

use of 10 CFR 50.54(f) requires an analysis of the burden

* modifications necessary to bring a facility into compliance with its license or into conformance with

written commitments by the licensee

* actions necessary to ensure adequate protection

* actions that involve defining or redefining what constitutes adequate protection

For these exceptions, instead of a backfit analysis, the rule

requires a documented evaluation including a statement

of the objectives of and the reasons for the backfit and the

basis for invoking the exception.

Since 1985, the NRC has issued a number of bulletins,

generic letters, and regulatory guides that have been

For generic requirements, the CRGR Charter contains standards for

relaxations that do not appear in the backfit rule, as discussed in Section 2.1.3 of this report.

NUREG-1409 2
considered backfits.* Many of these actions were exempted from the requirement for a backfit analysis, including cost considerations, because they were considered necessary for adequate protection or compliance.

Others were considered to be cost-justified substantial

safety enhancements on the basis of a backfit analysis.

2.1.2 Backfit Determination

A backfit involves a modification to the plant, design

approval, manufacturing license, procedures, or organization. In addition, (1) a new or revised staff position or

requirement must be involved, that is, there must be a

change in content or applicability of the previously applicable regulatory staff position (in the direction of increased safety requirements) and (2) this change must be

issued after specified dates or milestones.

* Applicable Regulatory Staff Position

A requirement or position already specifically imposed on or committed to by a licensee is called an

applicable regulatory staff position. There are several different types of positions, such as

- legal requirements, as in explicit regulations,

orders, and plant licenses and in amendments,

conditions, and technical specifications

- written licensee commitments such as those

contained in the final safety analysis report, licensee event reports, and docketed correspondence, including responses to NRC bulletins,

generic letters, inspection reports, or notices of

violation and confirmatory action letters

- NRC staff positions that are documented explicit interpretations of more general regulations and are contained in documents such as

the Standard Review Plan, branch technical

positions, regulatory guides, generic letters,

and bulletins

For the purpose of this report, a change in the applicable regulatory staff position will be subsequently

referred to as a new or revised position.

*As a legal matter, the backfit rule does not strictly apply until the point

at which a backfit is required by, for example, a rule or an order. However, for the purpose of this discussion, that legal distinction is not imortant. The NRC backfit process, including the CRGR Charter and

WRCManual Chapter 0514, is defined on the principle that newpositions or requirements are to meet the standards of the rule before they are issued to the licensee(s) New generic positions in documents, such as generic letters, bulletins, and regulatory guides, as well as plantspecific positions, are to be considered and justified as backfitsbefore

they are Issued. Forthisreason, they often are discussed in the same way as legally required backfits.

* Date of Issuance

When a new or revised position is issued, it is considered a backfit if it is issued after

- the issuance of the construction permit for the

facility for facilities with construction permits

issued after May 1, 1985

- 6 months before the date of docketing of the

operating license application for the facility for

facilities with construction permits issued before May 1, 1985

- the issuance of the operating license for the facility

- the issuance of the design approval under Appendix M, N or 0 of 10 CFR Part 50 (now 10

CFR Part 52)

2.1.3 Justification for Imposing Backfits

Section 2.1.3(1) addresses the basic elements of findings,

documented evaluations, and backfit analyses required by

in the backfit rule. The NRC's internal procedures for

implementing the backfit rule address all of these same

elements but actually go beyond the rule and contain

additional justification requirements as well; these additional requirements are discussed in Sections 2.1.3(2) and

2.1.3(3).

(1) Basic Backfit Justification (Backfit Rule)

The NRC staff is responsible for identifying plantspecific and generic backfits and for determining if

proposed new or revised positions would constitute a

backfit. Staff positions are not communicated to licensees unless the NRC official communicating that

position determines whether the position is a backfit. At any point during the process, it may be decided to drop the position because further work is

not likely to show (a) that the resulting safety benefit

is required for compliance or adequate protection or

(b) that the action would provide substantial additional overall protection and the direct and indirect

costs of implementation would be justified.

(a) Documented Evaluation (Compliance and

Adequate Protection)

In the case of ensuring compliance with existing

requirements or commitments, a backfit analysis is not required. Instead, a documented

evaluation of the type discussed in 10 CFR

50.109(a)(6) is prepared and a finding is made

that the action is necessary to ensure compliance. The documented evaluation includes a

statement of the objectives of and the reasons

3 NUREG-1409
for the action and the basis for invoking the

compliance exception.

Similarly, in the case of a backfit needed to ensure adequate protection of public health and

safety, a backfit analysis is not required. A

documented evaluation of the type discussed in

10 CFR 50.109(aX6) is prepared and a finding

is made that the action is necessary for adequate protection. The documented evaluation

includes a statement of the objectives of and

the reasons for the backfit and the basis for invoking the adequate protection exception. The

concept of what constitutes adequate protection is an evolving standard. It is expected that

this standard will continue to change to keep up

with new information and with improvements

in nuclear power technology. For example, an

amendment was recently proposed to 10 CFR

50.61, "Fracture Toughness Requirements for

Protection Against Pressurized Thermal Shock

Events." This was a case where new knowledge

indicated adjustments were needed in the provisions for dealing with vessel embrittlement in

order to maintain adequate protection.

For either the compliance case or the adequate

protection case, if immediately effective regulatory action is needed, the required documented evaluation may follow the issuance of

the regulatory action.

(b) Cost-Justified Substantial Safety Enhancement

For backfits providing a cost-justified substantial safety enhancement, the staff must develop

a backfit analysis of the type discussed in 10

CFR 50.109(a)(3) and 10 CFR 50.109(c) and a

finding is made that there is a substantial safety

benefit to be achieved and that the costs are

justified by the benefit. The backfit analysis

considers

* how the backfit should be scheduled in

light of other ongoing regulatory activities

at the facility

* information available concerning any of

the following factors as may be appropriate:

- statement of the specific objective

that the proposed backfit is designed

to achieve

- general for description of the activity

that would be required by the

licensee or applicant in order to

complete the backfit

- potential for change in the risk to the

public from the accidental offsite release of radioactive material

- potential impact of radiological exposure to facility employees

- installation and continuing costs associated with the backfit, including

the cost of facility downtime or the

cost of construction delay (ie., resource burden on licensees)

- the potential safety impact of

changes in plant or operational complexity, including the relationship to

proposed and existing regulatory requirements

- the estimated resource burden on

the NRC associated with the proposed backfit and the availability of

such resources

- the potential impact of differences in

facility type, design, or age on the

relevancy and practicality of the proposed backfit

- whether the proposed backfit is interim or final and, if interim, the justification for imposing the proposed

backfit on an interim basis

For this type of backfit, there first must be a

substantial increase in overall protection (or

common defense and security), even for requirements that might bring about a net-cost

savings. If there is a substantial increase, then

the cost justification must be considered. The

backfit rule requires the NRC to consider the

cost of facility downtime or construction delay

as costs associated with the backfit.

Averted onsite costs can arise when it is estimated that the backfit will save money for licensees, such as by reducing forced outage

rates. These savings are not treated as a benefit

(safety enhancement). They are, however, considered as a negative cost, that is, an offset

against other licensee costs. Averted offste

costs can result from an estimated decrease in

accident frequency or severity. These reductions are tied directly to the public health and

safety and are considered as a benefit (safety

NUREG-1409 4
enhancement). "Regulatory Analysis Guidelines of the U.S. Nuclear Regulatory Commission" (NUREG/BR-0058, Rev. 1, May 1984)

provides further guidance on this subject.

For this type of backfit, the backfit rule does

not require a strict quantitative showing that

benefits exceed costs, but rather "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 of implementation for that facility are justified in

view of this increased protection" (emphasis

added). Qualitative factors can be considered.

Many of the factors to be addressed in the

analysis may not be easily quantified and the

backfit rule permits consideration of other

relevant and material factors.

(2) Regulatory Analyses (Staff Procedures)

Regulatory analyses are generally performed in accordance with the directives and guidance of

NUREG/BR-0058 (Rev. 1, May 1984) and

NUREG/CR-3568 ("A Handbook of Value-Impact

Assessment," December 1983), which describe the

need for regulatory analyses and their preparation.*

The complexity and comprehensiveness of the

analyses should be limited to what is necessary to

provide an adequate basis for a decision. NUREG/

BR-0058, Section I.A.2, "Scope of the Analysis,"

states: "The emphasis [in doing the analysis] should

be simplicity, flexibility, and common sense, both in

terms of the type of information supplied and in the

level of detail provided."

For plant-specific backfits, Section 043 of NRC

Manual Chapter 0514 requires preparation of regulatory analyses for backfits other than those that fit

the adequate protection or compliance exceptions.

It also specifies the factors to be included in the

regulatory analyses, which include those of a backfit

analysis as well as other factors. Thus, this type of

regulatory analysis would be the same as a backfit

analysis, except that it would contain additional information as well.

For generic backfits, Item IV(b)(5) of the CRGR

Charter specifies preparation of regulatory analyses

for CRGR review packages. In this case the regulatory analyses may omit some of the factors of abackfit analysis, such as the priority and schedule for implementation, and they may contain additional

factors, such as an analysis of alternatives to the pro-

'It should be noted that the staff is in the process of revising these two

guidance documents.

posed action. Atypical way of handling this situation

for CRGR review packages is to address each backfit

analysis factor (which also is specifically listed in the

CRGR Charter), making reference to the regulatory

analyses if it contains the necessary information. An

example of this approach is provided in Appendix E.

Regulatory analyses generally contain a value impact (or cost benefit) analysis; however, as discussed

earlier, it would not be appropriate (or permissible)

for an adequate protection or compliance backfit to

consider the cost in deciding on imposition of the

backfit (except for deciding which among several acceptable alternatives to prescribe).

(3) Further Justification (Staff Procedures)

In addition to backfit analyses and regulatory analyses, NRC procedures contain further justification

requirements.

For generic backfits, Section IV.B of the CRGR

Charter contains a number of other factors to be addressed in all CRGR review packages for new generic requirements or positions. For example, item

IV.B(iv) specifies the proposed method of implementation and the concurrence (with any comments) of the Office of the General Counsel. Item

IV.B(ix) specifies the necessary findings and standards for relaxations in requirements, which are not

addressed in the backfit rule. Finally, Section II.D of

the charter exempts compliance and adequate protection cases from the backfit analysis factors and

specifies the documented evaluations needed in accordance with the backfit rule.

For plant-specific backfits, Section 043 of NRC

Manual Chapter 0514 specifies some of the same additional factors as the CRGR Charter, but only for

backfits that are not compliance or adequate protection backfits. The manual chapter further specifies

that a proposed plant-specific backfit must be considered for generic backfitting.

2.2 Information Requests

Informal oral information requests are not considered to

be backfitting and they should not be used by the staff or

accepted by licensees for the purpose of imposing backfits. When written requests cite 10 CFR 50.54(f), requiring a response under oath or affirmation, a statement of

the reasons for the request must be prepared and must be

approved by the Executive Director for Operations

(EDO) or his designee (regional administrators, office

directors and their deputies) except when the information

is needed to verify compliance with the current licensing

basis. As specified in the rule, this is done to ensure that

the burden imposed on respondents is justified in view of

5 NUREG-1409
the potential safety significance of the issue to be addressed. As further specified in NRC Manual Chapter

0514 for plant-specific requests, such justification is not

needed when seeking information of the type routinely

sought for licensing reviews of plants under construction

or when there is reason to believe that there is not adequate protection.

Some information requests promulgate new or revised

staff positions and request that licensees, in their responses, state whether they will adopt the new positions.

Even though these actions do not impose backfits, as a

matter of internal staff practice they are identified as

backfits and justified accordingly before they are issued,

as required by NRC procedures. As discussed in Section

2.1.1, this is often the case with generic letters and bulletins. In the past, backfitting considerations have not been

explicitly addressed in the generic letters and bulletins

themselves and this has contributed to confusion about

whether the actions are backfits. In the future, generic

letters and bulletins will contain an explicit statement as

to whether the action is considered to be a backfit and, if

so, the type of backfit it is considered to be (see Appendix

F for a sample).

2.3 Staff Process for Identifying and

Imposing Generic Backfits

Backfits that have been identified and justified by the staff

and that are intended to apply to one or more classes of

commercial nuclear power licensees, first go through the

office concurrence chain. The appropriate office director

will review the proposed action and disapprove or approve it as a backfit (1) that falls under one of the backfit

rule exceptions previously identified or (2) that provides a

substantial increase in the overall protection of public

health and safety with direct and indirect costs of implementation that are justified in view of this increased protection.

When the office director approves the package, the proposed action and associated justification are forwarded to

the Committee to Review Generic Requirements

(CRGR) for review. The six-member CRGR normally

will discuss the proposal with the sponsoring office to

ensure the proposal is well understood, to review its justification, and to make a recommendation to the EDO

whether the proposed generic requirement should be

issued, issued with modifications, or not issued. If the

CRGR recommends disapproval, or recommends major

modifications of a proposed requirement, it submits a

statement of the reasons for its recommendations to the

EDO.

The CRGR was formed in November 1981 and has reviewed the generic requirements or staff positions imposed by the NRC staff since that date. Its charter was

revised in 1986 to reflect the 1985 changes to the backfit

rule (10 CFR 50.109) and again in 1987 to reflect changes

to the NRC organization. The responsibility for supporting CRGR activities and oversight of backfitting was delegated from the EDO to the Director, Office for Analysis

and Evaluation of Operational Data (AEOD), in April

1987.

The objectives of the CRGR process are to eliminate or

remove any unnecessary burdens placed on licensees, to

reduce the exposure of workers to radiation in implementing new requirements, and to ensure the effective

use of licensee and NRC resources, while at the same

time ensuring the adequate protection of the public

health and safety and furthering the review of new, costeffective generic requirements and staff positions. The

committee is chaired by the Director of AEOD and consists of a member each from the Office of the General

Counsel (OGC), Nuclear Reactor Regulation (NRR),

Research (RES) Nuclear Material Safety and Safeguards

(NMSS), and a regional representative. CRGR members

are appointed by the EDO (the NRC General Counsel

concurs in the appointment of the OGC member).

The types of documents to be considered by the CRGR

include

* staff papers proposing the adoption of rules or policy

statements affecting power reactors

* staff papers proposing new or revised rules including

advanced notices

* proposed new or revised regulatory guides, Standard

Review Plan (SRP, NUREG-0800) sections, and

branch technical positions

* proposed generic letters, multi-plant orders, show

cause orders, and generic information requests under 10 CFR 50.54(f)

* proposed bulletins and unresolved safety issue

NUREGs

* new or revised standard technical specifications

* any generic correspondence to licensees that may reflect or interpret new NRC staff positions

Evaluations and approvals of generic topical reports are

examples of documents that sometimes need review. A

large majority of these documents do not contain any new

requirements or positions; however, some of them do and

they are reviewed by the CRGR.

Examples of approved requirements that do not require

CRGR review are (1) positions or interpretations

contained in the above documents that were issued before November 12, 1981 or (2) positions taken after

NUREG-1409 6
November 12, 1981, that already have been approved

through the established generic review process.

In reviewing proposed new staff positions or requirements, the committee specifically focuses on (1)_the need

for a new requirement and whether it may have any adverse ecton safety and (2) if not required for adequate

protectioior compiance, whether the new requirement

provides a substantial improvement in safety and is costjystdfed. In-conducting this review, the CRGR normally

will consider the factors specified for backfitting as discussed in Section 2.1.3(1) as well as additional factors as

discussed in Sections 2.1.3(2) and 2.1.3(3).

For those rare instances where it is judged that an emergency action is needed to protect the health and safety of

the public, no prior review by the CRGR is necessary.

However, the CRGR Chairman is notified by the office

originating the action. The objective of and reason for the

emergency action requirements are documented and reported to the committee for information and are included

in a report to the Commission.

For each proposed requirement not requiring emergency

action, the proposing office identifies the requirement as

either Category 1 or 2. Category 1 requirements are those

that the proposing office rates as urgent and are approved

or otherwise dealt with within two working days of receipt

by the CRGR. Category 2 requirements are those that do

not meet the criterion for designation as Category 1.

These are scrutinized carefully by the CRGR on the basis

of oral discussion and written justification. Such justification is submitted by the proposing office along with the

proposed requirements in advance of CRGR discussions.

Meetings are generally held at regular intervals and agendas are issued by the CRGR Chairman one to two weeks

in advance of each meeting, except for Category 1 items.

Available background material on each item to be considered by the committee is issued to each CRGR member as

it is received to permit sufficient advance review.

Fifteen copies of each review package are submitted to

CRGR. The following type of information is submitted

(see the CRGR Charter, Appendix C, for specific details):

* the proposed generic requirement or staff position

* supporting documents

* the proposed method of implementation

* a backfit analysis for cost-justified enhancements,

generally conforming to the directives and guidance

of NUREG/BR-0058 and NUREG/CR-3568

* category of reactor to which the generic requirement

or staff position is to apply

* the office director's determinations

The CRGR may recommend approval, revision, or disapproval or that further work be done by the staff and/or

public comment be sought.

A written response is required from the cognizant office

to report agreement or disagreement with the CRGR

recommendations documented in CRGR meeting minutes.

The CRGR staff ensures that there is an archival system

for keeping records of all packages submitted, actions by

the staff, summary minutes of CRGR consideration of

each package, including corrections and recommendations by the committee. The submitted packages and the

summary minutes for a meeting are released to the Public

Document Room after the NRC has taken action on the

matters discussed (e.g., issuance of a generic letter or

bulletin) or after the Commission has considered the

matters in a public forum (e.g., public meeting on a proposed rule).

The CRGR staff prepares a report that is submitted by

the EDO to the Commission each month. The report

provides a brief summary of CRGR activities. The report

is distributed as an enclosure to the EDO Weekly Highlights.

Figure 1 provides a schematic representation of how new

generic requirements and staff positions are developed,

revised, and implemented.

2.4 Staff Process for Identifying and

Imposing Plant-Specific Baclfits

As noted previously, plant-specific backfitting involves

positions unique to a particular plant, whereas generic

backfitting involves the imposition of the same or similar

positions on more than one plant. To be a plant-specific

backfit, the requirement or position will involve (1) only

one plant (sometimes including identical units at one

site), (2) a new or revised requirement or staff position,

and (3) a schedule for the imposition after key dates

specified in the backfit rule.

It is important that the necessity for making backfit determinations not inhibit the normal informal dialogue between NRC staff (e.g., technical reviewers and inspectors) and the licensee. The intent is to manage backfit

imposition and not to constrain or eliminate suggestions

or inquiries in areas within the scope of 10 CFR 50.109.

Only when these conversations convey a staff position

that a licensee must change the design, construction, or

7 NUREG-1409
Unresolved safety issues Prioritize and

Generic issues develop proposed Regulatory guides requirement

Bulletins & orders including

Proposed rules regulatory analysis

Other IL II

Technical management

review

Optional discussions CRGR* review

with industry

-

Discussions with

industry, ACRS,

public .4-

-

-

t

-

I

.

Executive Director I

I

I. Revise proposal

or

solicit public comment

or

no further work

I Further review

ACRS, Commission

A__ .

LV

I I

I

t Integrate

I into

composite _

I schedule Agreed-upon

plant-specific implementation schedule

Advisory Committee on Reactor Safeguards "Committee To Review Generic Requirements

Figure 1 Schematic representation of new requirements review

NUREG-1409 8
operation of a facility would a backfit determination be

needed.

In this context, it should be noted that actions proposed by

the licensee are not backfits, even though such actions

may result from normal discussions between the staff and

the licensee concerning an issue and even though the

change or additions proposed by the licensee may otherwise meet the definition of a backfit.

The imposition of plant-specific backfits is governed by

NRC Manual Chapter 0514, which establishes the staff

requirements and guidance for implementation for this

aspect of the backfit rule. The primary objective of the

manual chapter is to ensure that plant-specific backfits

are required only (1) if necessary to provide an adequate

level of safety, (2) if necessary to ensure compliance with

Commission rules, orders, or written licensee commitments, or (3) to provide a cost-justified safety enhancement after approval of the required backfit analysis. If no

backfit analysis is required, the appropriate office director or regional administrator is to provide a documented

evaluation that provides the basis for invoking one of the

exceptions.

The manual chapter identifies the NRC staff members

responsible for implementing the procedure and assuring

that process controls are in place. For example, staff

members at all levels are responsible for identifying potential plant-specific backfits. The office directors for

NRR and NMSS and the regional administrators are responsible for the final decision on whether a backfit is

required and, if so, to approve the backfit analysis or the

documented evaluation. Further, each office is required

to have a specific office procedure providing guidance in

the identification, handling, imposition, and tracking of

plant-specific backfits.

Following approval of the regulatory analysis (backfit

analysis) or documented evaluation by the appropriate

office director or regional administrator, review (if any) by

the EDO, and issuance of the backfit requirement to the

licensee, the licensee may implement the backfit or appeal it. Following an appeal and subsequent final decision

by the appropriate office director or EDO, if the appeal

has been denied the licensee will normally implement the

backfit. If the licensee still does not elect to implement

the backfit, it may be imposed by order of the appropriate

office director.

Implementation of a plant-specific backfit is normally

accomplished on a schedule negotiated between the licensee and NRC. Scheduling criteria include the importance of the backfit relative to other safety-related activities under way, such as the plant construction or

maintenance planned for the facility in order to maintain

a high-quality of construction or operations. For plants

that have integrated schedules, the integrated scheduling

process is used for this purpose.

A staff-proposed backfit may be imposed by order before

completing any of these procedures, if the NRC official

who authorizes the order determines that immediate imposition is necessary to ensure public health and safety or

the common defense and security. In such cases, the EDO

shall be notified promptly of the action and a documented

evaluation prepared (if possible in time to be issued with

the order).

If immediate imposition is not necessary, staff-proposed

backfits should not be imposed, and plant construction,

licensing action, or operation should not be interrupted

or delayed by NRC actions during the staff's evaluation

and backfit transmittal process, or a subsequent appeal

process, until final action is completed.

The proposing headquarters office or regional office

manages each proposed plant-specific backfit using the

NRC plant-specific backfit tracking system. This system

provides references to all documents issued or received

by NRC staff relative to plant-specific backfits, including

requests, positions, statements, and summary reports.

Specific details on this system are found in office implementing procedures.

As stated earlier, the EDO has delegated responsibility

for oversight of the plant-specific backfitting process to

the Director of AEOD. This includes reviewing and concurring with office procedures, conducting training for

NRC staff and industry, and informing licensees of program and procedure changes. An annual assessment is

conducted that includes review of plant-specific backfits

identified by staff or industry, review of office procedures

and selected records, interviews with office and regional

staff, and obtaining industry comments on the backfitting

process.

A graphical description of the plant-specific backfit process is given in Figure 2.

2.5 Filing a Backfit Claim or Appeal

A proposed staff position not identified by the NRC staff

as a backfit may be claimed to be a backfit by a licensee.

All licensee claims are to be sent in writing to the office

director or regional administrator of the NRC employee

who issued the position with a copy to the EDO. A licensee claim that a requested action is a backfit needs to be

promptly addressed and evaluated to determine whether

it is, in fact, a backfit. A report to the EDO and a response

to the licensee should be forwarded within three weeks

after receipt of the claim indicating the results of the

determination and the plan for resolving the issue.

Appeals with regard to backfit determinations are generally of two types and involve two different situations:

9 NUREG-1409
Notes: 1. Copy to be addressed to the Executive Director for Operations. 2. Report to Executive Director for Operations and inform licensee within 3 weeks of results of determination and plans to resolve issue.

3. Report to Executive Director for Operations within 3 weeks on plan for resolving and inform licensee promptly and periodically of plans.

4. Staff may decide the backfit is not likely to be justified and close the action.

5 Approval by Executive Director for Operations before issuance is not required.

Figure 2 NRC plant-specific backfit, claim and appeal process defined in NRC Manual Chapter 0514
(1) appeal to an office director or regional administrator

proposing to modify or withdraw a backfit for which a

regulatory analysis has been prepared and transmitted to the licensee

(2) appeal to the responsible program office director (a)

to reverse a denial of a prior licensee claim that an

action is a backfit or (b) to determine that a backfit

that the staff found to meet the adequate protection

exception or the compliance exception does not

meet the exception

Licensees should address an appeal of a proposed backfit

to the appropriate office director or regional administrator with a copy to the EDO. The appeal should indicate

deficiencies in the staff's analysis or provide other information in support of the appeal. In all cases, the appeal

should include sufficient documentation to justify the

position taken. The office director or regional administrator, within three weeks, reports to the EDO on the plan

for resolving the issue and informs the licensee in writing

of the staff plan. Appropriate documents should be included in the backfit tracking system. Licensees shall not

be penalized by the staff for raising backfit questions or

filing backfit appeals. As stated in NRC Manual Chapter

0514, if immediate imposition is not necessary, staff proposed backfits should not be imposed and plant construction, licensing action, or operation should not be delayed

during an appeal.

The decision of the office director or regional administrator on a plant-specific backfit appeal may be appealed to

the EDO, in which case the EDO will resolve the appeal

and state the basis.

Summaries of all appeal meetings are prepared promptly,

provided to the licensee, and placed in appropriate public

document rooms. After an appeal and subsequent final

decision by the appropriate office director or regional

administrator or the EDO, if the appeal has been denied,

the licensee may implement the backfit resulting from the

decision. If the licensee does not elect to implement the

backfit, it may be imposed by order of the appropriate

office director. Additional details on the backfit claim and

appeal process can be found in NRC Manual Chapter

0514. A graphical description of this process is given in

Figure 2.

The regional offices and the Office of Nuclear Reactor

Regulation have procedures that govern the specific

methods of reviewing backfit appeals. These procedures

provide further detail beyond the requirements of NRC

Manual Chapter 0514 and the details differ somewhat

among the offices. However, all of the procedures conform to the provisions of Manual Chapter 0514 discussed

above

2.6 Current Status

In 1989 the Office of AEOD conducted the most recent

series of NRC staff training sessions at the regional offices. AEOD also, in April 1989, conducted a survey of

licensees to determine their perceptions of the backfitting process and obtain specific cost information. In

addition, in late 1989 and early 1990, the NRC staff conducted a broader survey with regard to the effects of the

regulatory process on licensees. With regard to backfitting, licensees expressed concern about the number and

overall burden of generic communications, the adequacy

of NRC's consideration of cost and schedule impacts, the

basis for issuing requirements involving backfits, the

treatment of optional actions and requests as if they were

requirements, the negative effects if NRC perceives licensees to be unresponsive because they do not implement optional actions or because they file backfit claims

or appeals, and a need for additional training in backfitting for industry and NRC personnel.

The NRC staff is taking several initiatives to improve the

backfitting process and is considering further initiatives.

To make backfitting considerations and bases clear to

readers, a summary of backfitting considerations was

added to generic letters and bulletins beginning in December 1989. This report has been prepared to explain

the backfitting process to industry and NRC staff. A series

of workshops with industry and NRC staff is planned for

the near future. Changes have been proposed to the

program for systematic assessment of licensee performance that would reduce any potential for penalizing licensees for submitting appeals. Senior NRC managers are

considering the information gathered from the broad survey of the effects of the regulatory process on licensees to

determine what changes may be appropriate. For example, the preliminary report (Draft NUREG-1395) indicates that the staff will examine methods to take into

account the cumulative effects of new requirements.

11 NUREG-1409
3 QUESTIONS AND ANSWERS ON BACKFITING

During the conduct of staff training and in the communication with licensees, a number of questions and observations have been raised regarding the NRC policies and

practices for backfitting. These questions and observations have been grouped into six general categories and

are presented below followed by the approved staff response.

3.1 Backfit Determination and

Imposition

(1) A number of generic letters and bulletins recently issued

request or require actions, yet there is no backflit analysis

accompanying the documents. Is this appropriate?

Many of the bulletins and generic letters issued in

1988 and 1989 were not justified by a backfit analysis

simply because they were determined to fall under

the compliance exception listed in 10 CFR 50.109.

When action is needed to ensure compliance with

existing regulations or to ensure that an adequate

level of protection is maintained, a backfit analysis is

not required. However, a documented evaluation is

needed to support the use of the exception.*

The backfit analyses or documented evaluations are

available in the Public Document Room. However,

this was not readily apparent in the past because

they were not cited in the generic letters and bulletins themselves. In the future, backfit analyses or

documented evaluations will be cited in the generic

communications. An example is provided in Appendix F to this report.

(2) Where does a confuimatory action letter fall in the backfit process?

A confirmatory action letter (CAL) is issued to confirm a licensee's agreement to implement specific

actions, which can include agency requirements and

staff positions. The CAL merely documents a licensee's agreement and does not impose or implement

any new or revised staff positions or requirements.

Thus, it falls outside of the backfit process because

the licensee has volunteered to take the course of action identified in the letter.

'As was stated earlier, generic letters and bulletins do not impose backfits. Therefore, theyare not required byregulation tobe accompanied by backfit analyses or documented evaluations. Nonetheless, it is

NRC practicetojustifythem asbackfits, if appropriate,before issuing them.

(3) The backfit rule does not provide a clear explanation of

the criteria the NRC will use to document the needfor a

new "level of protection. "

Specific criteria have not been established to determine when it may be necessary to redefine adequate

protection. See Federal Register, Vol. 53, No. 108,

(June 6, 1988), pages 20608 (col. 3) and 20609 (col.

1) (Appendix B to this report).

(4) How does the backfit rule apply to new staff positions

that reflect an evolving understanding of technical issues?

New or revised staff positions are backfits when they

are imposed on licensees and result in a change in

structures, systems, design, or procedures (as described in 10 CFR 50.109). A backfit analysis is required whenever new or revised positions are imposed to achieve cost-justified substantial safety

enhancements. A backfit analysis is not required if

the new or changed position is imposed to bring a facility into compliance or if it is necessary to provide

assurance of adequate protection. In those cases,

however, a written evaluation is needed to provide

the objectives of and reasons for the modification

and the basis for invoking the exception.

An evolving understanding of issues does not, by itself, define which category fits a particular backfit.

Judgment must be applied to the facts of each particular case to determine whether the backfit is for

compliance, to provide adequate protection, to redefine adequate protection, or to achieve a costjustified substantial safety enhancement. For example, with regard to compliance, the 1985 statement

of considerations for 10 CFR 50.109 indicates that

"the compliance exception is intended to address

situations where the licensee has failed to meet

known and established standards of the Commission

because of omission or mistake of fact....new or

modified interpretations of what constitutes compliance would not fall within the exception...."

(5) Must backflts be identified by the staff when they are

imposed?

Yes, plant-specific and generic backfits must be

determined in advance and the proper procedures

followed before imposition. For example, a backfit

analysis is required for actions that are cost-justified

substantial safety enhancements. If a new requirement or staff position meets the compliance

exception or the adequate protection exception, a

backfit analysis is not required, but the action is still

NUREG-1409 12
considered as a backfit and a documented evaluation

providing the objectives of and the reasons for the

modification and the basis for invoking the exception

is needed.

(6) Is a backfit analysis neededfor information requests that

are verbally communicated? Many such requests can

represent a significant burden to a licensee.

Oral information requests do not fall under the

backfit rule. They should not be used by the staff or

accepted by licensees for the purpose of imposing

backfits.

NRC management should be informed of inappropriate requests for information in order to assure

proper authorization and justification. NRC supervisors and managers are sensitive to this issue and

licensees should not be penalized by the staff for

raising it.

(7) Is it appropriate for the NRC staff to rely on informal or

formal communications to other licensees as official

NRC positions? What about NRC tacit approval of

documents?

Informal or formal communications to one licensee

are not official positions to all licensees. Section 053

of Manual Chapter 0514 identifies what can be applied as official staff positions in a plant-specific context. They are legal requirements such as contained

in explicit regulations, orders, and plant licenses;

written commitments such as contained in final

safety analysis reports, licenses event reports, and

docketed correspondence; and documented, approved explicit interpretations such as contained in

the SRP, branch technical positions, regulatory

guides, generic letters, and bulletins. Orders,

licenses, and written commitments are applicable

only to a particular licensee.

If the staff previously exempted a licensee from a legal requirement or approved position, it is not applicable to that licensee for the purpose of backfit consideration. Explicit exemption would be done

formally in writing. The Appendix to NRC Manual

Chapter 0514 discusses tacit approval under

reanalysis of issues. Two situations are covered. In

the first case, staff review of a previously accepted

licensee action or program may result in a requested

change. This would be classified as a backfit because

it represents a change in a previous staff position and

would require a backfit analysis (or a documented

evaluation if it meets one of the exceptions listed in

the backfit rule). In the second case, a licensee submittal committing to a specific course of action that

has not received timely NRC staff review is implemented by the licensee. In this case, it is considered

that the NRC staff tacitly accepted the licensee's action since timely notice to the contrary was not given.

If the NRC staff subsequently adopts a different position and requests a change in the licensee action,

this change may be classified as a backfit and thus require a backfit analysis (or a documented evaluation

if it meets one of the exceptions listed in the backfit

rule).

(8) Is it a plant-specific backflt to apply an approved and

issued regulatory guide to an operating plant?

As part of the generic review process, the responsible office director determines and the CRGR reviews which plants or groups of plants are affected

by new or modified regulatory guide provisions. Implementation in accordance with the generic applicability is not an additional plant-specific backfit and

is, therefore, not governed by the plant-specific

backfit procedures. A licensee may appeal, however,

and assert that the generic analysis does not justify

the backfit.

Any staff-proposed plant-specific implementation

of a regulatory guide provision, whether orally or in

writing, for a plant not encompassed by the generic

implementation determination is, however, considered a plant-specific backfit. In other words, staff action with regard to a specific licensee that expands

on, adds to, or modifies a generically approved regulatory guide, such that the position taken is different

than intended in the generic positions, is a plantspecific backfit.

(9) How is a compliance backfit affected if a licensee formally withdraws or substantially revises the commitment that forms the basis for the compliance backfit?

Licensees are free to change commitments that have

not been imposed by rule or order. However, doing

so may raise questions about staff acceptance of licensee programs. Of course, if the revised commitment is fully acceptable to the staff, then the superseded or outdated commitment would not be used as

a basis for a compliance backfit. If, on the other

hand, the revised commitment is not acceptable,

then the previous commitment or its equivalent may

form the basis for a compliance backfit. Circumstances and judgment would play a significant role in

this case. For example, the date of the original commitment and that for the revised commitment could

be important. It would not be appropriate for the

NRC staff to cite a previous commitment that had

been revised with staff knowledge and tacit approval

for several years.

(10) How does one appeal a generic backflit?

Licensees may certainly appeal generic backfits as

they may appeal any staff position. However, the

13 NUREG-1409
CRGR Charter, which is the NRC's generic backfitting procedure, does not address appeals. Thus, in

appealing generic backfits, the staff advises licensees to follow the guidelines in NRC Manual Chapter 0514 for appealing plant-specific backfits to the

extent practical. (In the recent past the EDO has

referred such appeals to the CRGR to obtain its recommendations before making a decision.)

3.2 Generic Backfits

(1) Does CRGR look at the difference between generic

letters and bulletins?

Yes, when CRGR reviews generic communications

consideration is given to the form and its application.

The general guidelines used by the CRGR are that

bulletins should be used to request action by licensees on a short-term basis to correct or address a

safety concern for which timely action is necessary

and that generic letters should be used to request information from licensees and to transmit information regarding a new staff position. In general, generic letters are used to clarify NRC policy on how

the agency intends to implement a regulatory requirement, assist the agency in determining whether

new requirements are needed, or seek information

on licensees conformance to existing staff positions.

(2) Why is 10 CFR 50.54() cited in many generic letters?

When 10 CFR 50.54(f) is cited in a generic letter, it is

to establish a basis for requiring a response. This

may be to determine whether the agency will take

action regarding the specific license or it may be

done to determine whether a generic requirement is

needed based on the information obtained.

(3) It seems like the staff too frequently claims that a new

staff position is consistent with existing Commission

rules and positions just to avoid performing a backfit

analysis.

The compliance exception in 10 CFR 50.109 is certainly meant to be used only when specifically

authorized and justified by the appropriate office director. Further, the CRGR Charter provides added

assurance that new requirements and staff positions

are fully consistent with the provisions of the backfit

rule. In reviewing proposed generic requirements

that are identified as compliance issues, the committee considers whether they are needed to ensure

compliance with existing requirements or whether

they represent a new staff position that needs to be

reviewed under other provisions of 10 CFR 50.109.

(4) It has been our observation that the staff estimate of installation and continuing costs associated with the

backfit is often grossly underestimated

During its review, CRGR takes into account staff estimates of the required licensee and staff resources

to implement the requested action. Frequently staff

estimates are given in terms of a range as well as an

average cost because it is recognized that some licensees may be required to spend more than other licensees. The CRGR review usually focuses on what

is projected to be an average cost over all affected

facilities. For adequate protection and compliance

actions, cost estimates provided to CRGR have been

used for background information and not as a condition for acceptance.

As part of the AEOD April 1989 survey, a questionnaire requesting estimates with actual costs was included. The purpose for requesting this information

was to assist the staff and CRGR in evaluating estimated costs for proposed actions. A preliminary review of the licensee's responses indicate that, for the

most part, the staff estimates have been reasonable

and have not been grossly underestimated in relation to average costs.

(5) How does the agency ensure that the backfit rule is

properly implemented in issuing generic communications such as bulletins and generic letters?

As discussed in the responses to other questions, before any generic communications such as bulletins

and generic letters are issued, the proposed staff positions are reviewed for the method and impact of

implementation by the responsible office director

and, in turn, by the CRGR. A specific focus of the

CRGR review is the basis for the generic communication and whether backfit considerations have been

appropriately addressed by the staff.

(6) It seems that the staff is circumventing the requirements

of 10 CFR 50.109 by citing 10 CFR 50.54(f) as the basis

for imposing major new regulatory requirements.

When 10 CFR 50.54(f) is cited in a generic letter or

bulletin, it simply establishes a requirement to submit a response to the letter. Thus, there is no intent

in citing 10 CFR 50.54(f) to circumvent 10 CFR

50.109. To the contrary, although generic letters and

bulletins do not impose new or revised staff positions, they are reviewed by the CRGR to ensure that

the provisions of the backfit rule are implemented.

In the future, generic letters and bulletins will cite

the backfit analysis or other evaluation performed in

this regard.

(7) The spirit and intent of the backfit rule does not appear

to have been met in all cases, as an example, issuance of

NUREG-1409 14
Bulletin 88-11 is completely lacking any 10 CFR 50.109

justification.

Although the justification was not printed in the bulletin, NRC Bulletin 88-11, "Pressurizer Surge Line

Thermal Stratification," was justified as a backfit. It

is an example of a backfit that was determined by the

responsible NRC official to be required as a matter

of compliance with existing requirements and commitments. The CRGR reviewed the bulletin and

concurred. The regulations currently require licensees to meet the applicable codes of the American

Society of Mechanical Engineers (ASME), Boiler

and Pressure Vessel Code. Because of the staff's concern with the integrity of the surge line, licensees

were requested to perform their fatigue analysis in

accordance with the latest ASME Section III requirements that incorporate high cycle fatigue

analysis. The justification provided by the staff was

that previously unconsidered thermal stratification

phenomenon may invalidate the existing analysis

performed to confirm the integrity of the surge line.

Subsequently, it was understood that some licensees

believed that the staffs rationale was in error because they were not committed to the latest ASME

Section III requirements by virtue of their license

commitment. However, the issue became moot because these licensees undertook the analysis voluntarily in view of the safety importance of the issue

and the fact that previous versions of the ASME

Code did not completely address the concern.

3.3 Plant-Specific Backfits

(1) If an inspector has previously accepted (ie, provided

tacit approval of) a licensee's method, does a specific request for change constitute a backflit and if so, is a backfit analysis required?

A new or revised staff position affecting the design

of systems, structures, and components or the procedures or organization required to design and construct or operate a facility after issuance of the operating license is a backfit. Whether a backfit analysis

is required depends on the basis for the backfit. A

backfit analysis is required when the backfit would

result in a cost-justified substantial safety enhancement. If a determination is made that the action is

needed to provide an adequate level of protection or

required to bring a facility into compliance, then no

backfit analysis is required. In these cases, a documented evaluation of lesser scope is needed as discussed in the response to previous questions.

Cases where an inspector provides tacit approval are

relatively rare. Simply not challenging a licensee's

practice normally would not be considered tacit approval. The only example provided in Manual Chapter 0514 is a case where the NRC has indicated tacit

approval by not acting in a reasonable time on a licensee submittal and the licensee has moved ahead

to implement the proposal described in the submittal. For the purpose of this question, it would most

likely arise in connection with review of a licensee

response to an inspection report.

Explicit approval could be provided in an inspection

report that states that a particular approach is acceptable. However, conclusions of that nature are

usually made in safety evaluation reports rather than

inspection reports.

(2) What is the definition of "timely" in the context of

approval?

The appendix to Manual Chapter 0514 provides the

following:

* when the licensee has made a submittal committing to a specific course of action to meet an

applicable position

* the licensee has moved ahead in the intervening time to implement the proposed action

* the staff did not provide a response for an extended period (or within a reasonable time not

delaying the applicants implementation plans

then subsequent staff action to make changes is (or

may be considered) a backfit.

There is no specific time period assigned. Some submittals may require a detailed analysis and could be

expected to take several months to complete, while

others are administrative and can be completed in

several weeks. Discussions need to be held with licensees relating to the agency's progress in reviewing submittals in order to reduce the probability of

misunderstandings, excessive delays, and the need

for backfit determinations.

(3) Is the guidance contained in the NRC Inspection

Manual approved positions?

No, inspection procedures are not approved staff

positions, which is the reason they are not reviewed

by CRGR. They exist only for staff use in conducting

inspections. NRC inspection procedures govern the

scope and depth of staff inspections associated with

licensee activities, such as design, construction, and

operations. They define those items the staff is to

consider in its determination of whether the licensee

is conducting its activities in a safe manner.

15 NUREG-1409
Licensees cannot be required to implement positions discussed in an inspection procedure or manual

unless the same positions exist in the form of an

approved regulatory staff position. Examples of approved staff positions are described in Manual

Chapter 0514 and include the SRP, branch technical

positions, regulatory guides, generic letters, and bulletins.

(4) Are NRR office letters considered approved staffpositions?

No, office letters issued by the Office of Nuclear Reactor Regulation (NRR) fall into the same category

as inspection procedures and do not constitute approved staff positions. They are not reviewed by

CRGR and exist solely as guidance for staff within

NRR.

(5) Are staffpositions that reject an industry practice that

waspreviously approved (either tacitly or explicitly) considered to be backfits?

A change in staff position regarding previously approved industry practice would be considered a

backfit as described in the appendix to Manual

Chapter 0514. A backfit analysis is required (or a

documented evaluation is required if the action

meets the exceptions listed in 10 CFR 50.109). If the

revised staff position had generic implications,

CRGR review would be needed.

Tacit approval is not broadly defined. The only example given in Manual Chapter 0514 is where the

NRC has indicated tacit approval by not acting in a

reasonable time on a licensee submittal and the licensee has moved ahead to implement the proposed

action described in the submittal.

(6) The distinction between a staff recommendation that

asks a licensee to consider a proposed action and one

that directs the licensee to take a proposed action is

sometimes difficult to determine. How does the backfit

process address this fine but important difference?

In the conduct of agency business, there are many

occasions when the staff will suggest or even recommend that licensees consider various actions. Such

suggestions and recommendations are not necessarily backfits and licensees may evaluate such recommendations and make the appropriate decision on

implementation.

Discussion or comments by the NRC staff identifying deficiencies or weaknesses, whether in meetings

or written reports, do not constitute backfits. Definitive statements to the licensee directing a specific action to satisfy staff positions are backfits unless the

action is consistent with an explicit regulatory staff

position applicable to that facility (see the response

to Question 3.1(8) for further discussion). In a similar manner, pressure upon a licensee to adopt a

specific staff position (for example to have a program found acceptable) would be prohibited unless

the action is consistent with an explicit staff position

applicable to that facility.

(7) There seems to be an apparent trend to inspect licensees

to a rising standard of acceptability without an attendant modification to the specific regulatory requirements. How does the backfit process ensure that the inspection standards are properly controlled?

Inspectors are expected to look beyond mere compliance with regulations and to focus on the safety

implications and margins at each facility. As a result,

licensees may be encouraged to consider program

enhancements and other actions. Licensees are expected to evaluate such suggestions and recommendations and make a decision on implementation;

however, such informal requests are not requirements or staff positions. Further, such suggestions

or recommendations are not within the scope of the

backfit process. The staff should be questioned regarding the safety significance, authority, or justification of any recommendations whenever the basis

is not clear. Licensees shall not be penalized by the

staff for such questioning.

(8) Howfar can an inspector go in interpreting NRCrules in

developing inspectionfindings and requiring licensee actions without performing a backflt analysis?

In the normal course of inspecting to determine

whether the licensee's activities'are being conducted

safely, inspectors may examine and make findings in

specific technical areas where prior NRC positions

and licensee commitments do not exist. Examining

such areas and making findings are not considered

backfits. Likewise, discussion of findings with the licensees is not considered a backfit. If during such

discussions, the licensee agrees that it is appropriate

to take action in response to the inspectors findings,

such action is not a backfit provided the inspector

does not indicate that the specific actions are the

only way to take corrective actions. On the other

hand, if the inspector indicates that a specific action

must be taken, such action is a backfit unless it is

consistent with an applicable regulatory staff position (see the response to Question 3.1(8) for further

discussion). Further, if the licensee provides a written claim that the inspector's findings are a backfit,

the staff must make a specific backfit determination.

Examples can be found in the appendix to Manual

Chapter 0514 (see Appendix D to this report).

(9) Wat are the ground rules for applying the Standard

Review Plan in operating license reviews? Can the staff

NT RFG-1409 1

16
modify the acceptance criteria for specific cases or when

a safety concern has been identified?

The SRP delineates the scope and depth of staff review of licensee submittals associated with various licensing activities. It is an NRC staff interpretation of

measures which, if taken, will satisfy the requirements of the more generally stated, legally binding

body of regulations primarily found in 10 CFR. Since

October 1981, changes to the SRP are reviewed and

approved through a generic review process involving

the CRGR and the extent to which the changes apply to classes of plants is defined. Consequently, application of a current SRP in a specific operating license review is not, in general, a plant-specific

backfit, provided the SRP was effective six months

before the start of the operating license review. Asking questions of an applicant for an operating license

to clarify staff understanding of proposed actions to

determine whether the actions will meet the intent

of the SRP is not considered a backfit.

On the other hand, using acceptance criteria more

stringent than those contained in the SRP or taking

positions more stringent than or in addition to those

specified in the SRP, whether in writing or orally, is a

plant-specific backfit. During meetings with the licensee, staff discussion or comments regarding issues and licensee actions volunteered that are in excess of the criteria in the SRP usually do not

constitute plant-specific backfits; however, if the

staff indicates that a specific action in excess of the

already applicable staff position is the only way for

the staff to be satisfied, the action is considered a

plant-specific backfit whether or not the licensee

agrees to take such action. It should also be recognized, however, that a verbally implied or suggested

action should not be accepted by a licensee as an

NRC position of any kind, backfit or not; only written and authoritatively approved position statements should be taken as NRC positions.

(10) Is it appropriate for the staff to use the latest version of

the SRP in the review of license amendment requests and

other changes?

There is not a single answer. In the review of a license amendment request, the staff should consider

the guidance in the implementation section of the

SRP and in Manual Chapter 0514 and exercise judgment in determining the applicability of current

*SRP.

During reload or other reviews subsequent to issuance of the operating license, staff-proposed

positions with regard to technical matters not related to the changes proposed by a licensee are considered to be backfits.

(11) Assume that a plant has not complied with an approved

staff position that is committed to in the FSAR and the

staffs safety evaluation report (SER) was written on the

basis that the staff position would be implemented.

However, the position has not been implemented. Is it a

backfit to impose the position on the licensee after issuance of the operating licensee?

Generally, it does not appear that the staff would be

changing its position in this case. If there is no

change of positions, imposing the licensee's commitment would not be a backfit.

(12) Do plant-specific orders come within the scope of the

backfit rule? What about those that confirm licensee actions?

An order issued to cause a licensee to take actions

that are not otherwise applicable regulatory staff positions is a plant-specific backfit. An order effecting

prompt imposition of a backfit may be issued before

completing any of the backfit procedures, if the appropriate office director determines that prompt imposition is necessary.

A confirmatory action order is intended to confirm a

voluntary licensee commitment to specific action

and may involve a compliance backfit.

(13) What about a notice of violation requesting a description of the licensee's corrective action orstaffrequestsfor

licensees to consider certain additional actions. Are

these backfits?

A notice of violation requesting a description of a licensee's proposed corrective action is not a backfit.

The licensee's commitments in the description of

corrective action are not backfits.* A request by the

staff for the licensee to consider some specific action

in response to a notice of violation also is not a backfit. If the staff is not satisfied with the licensee's proposed corrective action, however, and requests that

the licensee take additional actions, those additional

actions are a backfit, unless they are an applicable

staff position.

Discussions during enforcement conferences and responses to the licensee's requests for advice regarding corrective actions are not backfits.

Definitive statements to the licensee directing a specific action to satisfy staff positions are backfits, however, unless the action is consistent with an applicable regulatory staff position.

(14) Can bulletins and generic letters be applied in all respects to every facility or will there be cases where the

plant-specific backfit process is to be used?

Generally, adequate corrective actions would be required pursuant to

10 CFR 50, Appendix B, Criterion XVI.

17 NUREG-1409
NRC bulletins undergo generic review by the

CRGR. Therefore, it is not necessary to apply the

plant-specific backfit review process to the actions

requested in a bulletin (see the response to Question 3.1(8) for further discussion). If the staff expands the actions requested in a bulletin for a specific licensee, however, such expansion is considered

a plant-specific backfit.

(15) What happens when a review concludes that a licensee's

program in a specific area does not satisfy a regulation,

license condition, or commitment?

Where the staff previously accepted the licensee's

program as adequate, any staff-specified change in

the program would be classified as a backfit.

For example, in the case of a plant with an operating

license, once the SER is issued signifying staff acceptance of the programs described in the safety analysis report (SAR), the licensee should be able to conclude that its commitments in the SAR satisfy the

NRC requirements for a particular area. If the staff

were to subsequently require that the licensee agree

to additional action other than that specified in the

SAR for the particular area, such action would constitute a backfit. In the case described in the question, it is likely that the compliance exception in 10

CFR 50.109(a)(4) would apply (i.e., it would be a

compliance backfit).

A somewhat different situation exists when the licensee has made a commitment to a specific course

of action and the staff has not yet responded. If the

licensee has moved ahead in the intervening time to

implement the actions the licensee proposed in the

submittal and the staff has failed to provide a timely

response, the staff position may be considered a

backfit. Thus, if a licensee has implemented a technical resolution intended to meet an applicable

regulatory staff position, and the staff for an extended period simply allows the licensee resolution

to stand with tacit acceptance, indicated by nonaction on the part of NRC, a subsequent action to

change the licensee's design, construction, or operation is a backfit.

3.4 Backfit Analysis

(1) When is a backfit analysis needed?

A backfit analysis is needed when a new staff position or legal requirement goes beyond what is necessary for adequate protection and it is not needed to

bring a facility into compliance. In other words, if the

proposed action would provide a substantial enhancement to safety, the backfit rule provides a

mechanism for imposition as long as the cost of the

new position or requirement can be demonstrated to

be justified.

(2) There isincreasingevidence of the Commission's apparent willingness to accept subjective cost/benefit analysis

How can such analyses be consistent with the backfit

rule?

The backfit rule requires an analysis. This analysis

will vary depending on the nature of the issue, the

extent and type of information available, and the

ease to which a complex situation can be analyzed by

either quantitative or qualitative factors. In some

cases, the Commission makes decisions on the basis

of qualitative factors. Some of the factors to be addressed in the backfit analysis are not easily quantifiable. In addition, the rule includes consideration of

other "relevant and material" factors, some of which

may be qualitative.

Quantitative factors, where known, are used, but

need not be the only basis for approving a backfit

analysis. The complexity and comprehensiveness of

the analysis should be appropriate (limited) to what

is necessary to provide an adequate base for making

a decision. Section III, A.2, "Scope of the Analysis,"

of NUREG/BR-0058 states: The emphasis [in doing the analysis] should be simplicity, flexibility, and

common sense, both in terms of the type of information supplied and in the level of detail provided." All

backfit analyses are to be approved by the cognizant

office director or regional administrator and, if generic requests or requirements are involved, a further review by CRGR is also necessary.

(3) In issuing Generic Letter 88-01, "NRC Position on

IGSCC in BWR Austenitic Stainless Steel Piping, "why

did the staff not consider plant-specific differences that

might affect the conclusion of the generic cost-benefit

analysis?

Generic Letter 88-01 was issued on the basis of ensuring compliance with existing regulations; thereby

meeting one of the exceptions in the backfit rule for

not performing a backfit analysis. Accordingly, a

cost-benefit analysis was not required for this action.

In the case of a cost-justified substantial safety enhancement, the costs are analyzed, a finding that

they are justified is made by the cognizant office

director and is further evaluated by the CRGR.

Plant-specific differences and the associated cost information are used when such information is available. In these cases, the estimated range of costs is

used by the committee in its review. The overall impact on the industry is generally known with reasonable accuracy, but the development of a specific and

NUREG-1409 18
detailed cost estimates for each facility is generally

not practical.

3.5

(1)

Appeals

Sometimes a licensee will state that a specific action

looks like a backfit, but will choose not to pursue the issue at the time. Is the inspector required to do anything?

No, the inspector need not take any action. Manual

Chapter 0514 provides a mechanism for licensees to

file a backfit claim whenever they believe an unidentified backfit is imposed on them. The procedure

provides guidance on how to file and to whom the

claim should be addressed. There are no provisions

for verbal claims and no action would be required of

inspectors in the circumstances posed unless the

claim is filed in writing. Licensees should be advised

to file a claim in writing in accordance with the procedures of Manual Chapter 0514.

(2) How does the staff handle a situation where in response

to enforcement action the licensee claims that a backfit

is involved? For example, some licensees are claiming

backfit in responses to the 10 CFR 50.49 rule. How

should any inspector handle such claims particularly if

they involve a generic requirement?

Backfit claims need to be in writing and each claim

should be handled on its individual merits by the office responsible for the requested action. At this

time, no specific appeal process has been established for generic issues that have been evaluated

and reviewed by the CRGR and/or implemented by

the Commission. Thus, in such cases licensees

should be advised to implement claims of improper

backfit in accordance with the plant-specific procedures contained in Manual Chapter 0514.

(3) In response to a notice of violation, if the licensees use

the word backfit, " is the agency required to respond?

As with any response to a notice of violation, the

staff will review and act, as appropriate, on the

licensee's response. However, indicating that an unauthorized backfit may have occurred in a response

to a notice of violation does not constitute a proper

backfit claim that initiates the appeal process set out

in Manual Chapter 0514. While the NRC may consider the information surrounding the licensee's

claim, no specific agency action is required unless

the licensee files a formal backfit claim in accordance with Manual Chapter 0514.

(4) Does the utility have to formally say it isfiling a claim of

backfit under 10 CFR 50.109? With whom does the icensee file the backfit claim?

Manual Chapter 0514 states that a written claim of

backfit should be sent to the appropriate office director or regional administrator with supporting rationale and backup information. There is no need to

reference the rule since the manual chapter exists to

implement the backfit rule. However, the claim

must be in writing and should clearly state its

purpose.

(5) Some individuals believe that the staff is attempting to

impose new standards on the industry through enforcement. How can licensees use the backfit process to resolve these issues?

The benchmark which the staff uses in requiring licensee actions is the assurance of safety. If there is a

disagreement between the staff and the licensee on

what actions are necessary to ensure an adequate

level of safety, it can usually be resolved through discussion. If the staff requires actions beyond applicable regulatory staff positions, a backfit would seem

to be involved. The nature and justification for backfitting actions are to be consistent with 10 CFR

50.109 and relevant staff guidelines. For further information, refer to the appeal process in Manual

Chapter 0514.

3.6 General Questions

Why is there a backflit standard in senior executive

service (SES) contracts? Doesn't that send a message

that there should not be backfits?

The backfit standard in SES contracts holds NRC

managers responsible for proper implementation of

the backfit process. SES contracts also contain a

standard on ensuring safety, which is of overriding

importance and works with the backfit standard. The

purpose for including the backfit standard is to emphasize to the staff that management needs to be

aware of and to control staff activities to ensure the

agency's adherence to the backfit rule and Manual

Chapter 0514. Backfits are expected, but they

should be properly identified as backfits and handled

in accordance with specified procedures. The

purpose of instituting controls is to eliminate unauthorized backfits, and the preparation of the SES

contract item is to help ensure appropriate management review and oversight over these controls.

19 NUREG-1409
APPENDIX A

THE 1985 BACKFIT RULE

NUREG-1409
38097

Rules and Regulations Federal Register

Vol. 5. No. 13

Friday. September 20. 9as

This secton of the

contams regilatory

general £Oalty of which are keyed

the Code of Fedefa

published uer SO

U.S.C. 110.

The Cods of Federi

by the Snntende

Prices of ew booki

rs FEDERAL REG

week.

~EDERAL REGISTER xcuments having

nrd legal effect. most

to nd codfd n Regulations. which is

tlS pursuant to 44

FRegulations is sold

t o Documents. are suted in the

TER issue of each

I --

DEPARTMENT OF IGRICULTURE

Food Safety and spection Service

9 CFR Part 351

(Docket No. 530071

New Turkey Inspeltlon System

Correction

In FR Doc: 85-224

page 37508 in the i

September5. 19

following correctio

On page 37513 fi

section number in I

which reads " 321

'I 381.76..

62 beginning on ue of Monday.

making the

t column the e section heading.

7C. should rad

which may result from a new or amended provision in the Commission

rules or the imposition of new or different regulatory staff position

Interpreting the Commission rules after

(i) the date of issuance of the

construction permit (CP) for the facility

for facilities having construction permits

issued after October 21. 1985: or (ii) six

months before the date of docketing of

the operating license (OL) application for the facility for facilities having

construction permits issued before

October 21. 1985: or (ill) the date of

issuance of the operating license for the

facility for facilities having operating

licenses: or (iv) the date of issuance of

the design approval under Appendix M.

N. or 0 of 10 CFR Part S0. 

EFFECIVz DaT October 21 1985.

FOR FURTHER INFORMATION CONTACT:

James R. Tourtellotte. Chairman.

Regulatory Reform Task Force. U.S.

Nuclear Regulatory Commission.

Washington. DC 20555. Phone: (202) 634-

SUPPLEIEC1ARY INFORMATIOM

Background

The Commission initiated this

rulemaking proceeding for the purpose

of establishing requirements for the

future management of backfitting for

power reactors. Backfltting can include

both plant-specific changes and genenc

changes applicable to one or more classes of power reactors.

Section 50.109 of the Commission's

current power reactor regulations

provides the following standard for

backfitting decisiona Backfitting may be

required where the Commission finds

"that such action will provide -.

substantial additional protection which

is required for the public health and

safety or the common defense and

security." On its face this appears to be a relatively high standard. In practice.

however. 50.109 has rarely been

formally invoked, and t s therefore

difficult to tell the extent to wnich this

standard has actually been applied to

previous backfitting decisions. The

Commission has decided that a new.

more specific standard and related

procedures should be applied by rule to

backfitting decisions.

The Commission published an advance notice of proposed rulemaking and policy statement on this subject at

48 FR 44217 (September 28 19031 and

more recently, a notice of proposed

rulemaking at 49 FR 47034 (November

30.1984). The complete record of this

proceeding is available for review in the

Commission's Public Document Room at

1717 H Street. NW. Washington. DC.

Public Comments

The comment period officially closed

January 29. 198S A number of comments were received after that time, the last of

which was filed on March 1185. by

the Advisory Committee on Reactor

Safeguards. All comments were considered in formulation of the final

rule.

Fifty-seven comments were filed as

follows: utilities. 30: vendors. J architect

engineers and service companies. 3;

industry groups and trade associations.

J; consulting engineering firms. 3

various individuals and groups. 10:

federal agency. I (DOE1 states. I

(Ilinois) Advisory Committee on

Reactor Safeguards. 1.

As a result of the responses to the

advance notice of proposed rulemaking. *he ,ar "eierm aigvd ely numbered

questions and other unnumbered

questions in the notice of proposed

rulemaking. The responses to these

questions have assisted the Commission

in reaching its determination on the

content of the final rule.

Question 1. Should I 50109 also apply

to backfitting imposed through

rulemaking? When a modification is

imposed by rule or regulation. should

the affected licensee be afforded an

appeal to the EDO? What is the basis for

this position? The Union of Concerned Scientists

(UCS) stated that I S5109 should not

apply to rulemaking. They assert that

the Atomic Energy Act and prevailing

case law do not permit the consideration

of cost In determining minimum safety

standards. (See UCS 1983 comments.

pages 4-7.) An appeal to the EDO from a

requirement imposed by rule cannot be

legally permitted, according to UCS. and

the Commission may not circumvent the

legal requirements of the Administrative

Procedure Act. 5 USC Section 553. by

permitting appeals outside of the public

forum to the Executive Director for

Operations.

The Ohio Citizens For Responsible

Energy (OCRE) also oppose application

of j 50.109 to rulemaking because they

say licensees are afforded enough

opportunities in the rulemaking and

administrative process to contest the

aCU COOE 1os0"s-M

NUCLEAR REGULATORY

COMMISSION

10 CFR Parts 2 and 50

Revision of Sackfitting Process for

Power Reactora

ACENcv: Nuclear Regulatory

AcTioN: Final rule.

suMMARy. The Nuclear Renulatory- Commission is revising its regulations to

esqlblish stadndards and an agency

discipline for future management of

backfitting for power reactors.

BatkMilting is a process which can

include both plant-specific changes and

generic chiir'ses as applied to one or

more classes of power reactors As

described in the rule. backfittzng is

defined as the modification of or addition to svstems. structures.

components. or design of a facility; or the design approval or manufacturing

license for a facilitry or the procedures or organization required to design,

construct or operate a facilitry any of

Appendix A I NUREG-1409
,"MR Federul Rezister / Vol. 50. No. 183 Friday. September 20. 1985 / Rules and Regulations !tRit Fee0lRsse o 0 o 8 'Fia. etme 0 95i ue n euain

rules: They suggest that a petition for

waiver of a rule under 10 CFR 2.758 or an exemption under 10 CFR 50.12

provides sufficient remedies for

licensees.

The Nuclear Utility Backfitting and

Reform Group (NUBARG) believes that

backifitting controls should apply to

icitity modifications imposed by Alemaking. They state four reasons for

their position. First in terms of public

health and safety. they state the

practical impacts of backfitting by rulemaking or backfitting on a plant specific basis are the same. Therefore.

NRC regulations should require a documented analysis of a backfit

regardless of the source of the

requirement. Second. there is no apparent justification for excluding backfit modifications imposed by rulemaking. They suggest that the N`RC

should satisfy itself of the need for and

efficacy of any backfit required. Third.

if the backfitting rule did not apply to

rulemaking, ther may be a natural

temptation by the staff to avoid the

effects of the backfitting rule by imposing requirements through rulemaking. Fourth. there would be no additional burden because much of

what the rde would require already takes place during the CRGR review of

propose d-rul es NUnMCI sttes IhiTW

does not advocate the preparation of a plant-pecific backfitting analysis for

backfits proposed in the context of a rulemaking. NUBARG also believes that an opportunity for an appeal to the

Executive Director for Operations should exist. The licensee, they say. should be given the opportunity to

demonstrate that the modification

established by rule or regulation should

not be required for its facility because

that facility is substantially different

from the type. design. or vintage of

facilitie evaluated in the modification

! ;- i as a resulL findings made

puirsant to I 50.109 are not applicable. They go on to cite the need for flexibility

in the ruiemaking process as a basis fpr their position The Atomic Industrial

Forum (AIF) and other industry

commenters appear to be in general

agreement with the positions taken by

NUBARG.

DOE also states that 1 50.109 should

apply to rulemaking since rulemaking and orders are "the only two avenues through which a backfit should be

imposed by the Commission." They

oppose appeal to the EDO. however.

and suggest use of a waiver request under 10 CFR 2.758

Question L Should i 50.109 limit

backfitting to backfits imposed by rule.

regulation or order? If the unposition of

backfits is not limited to rules.

regulations or orders, what other

mechanisms should be employed? UCS opposes such a limitation, stating that the effect would "undoubtedly be to

eliminate the condition which the

Supreme Court found legally necessary

to justify two-stage licensing: citing Power Reactor Development Company v. Union. 387 US. 396 414 (1981).

OCRE takes a somewhat different

position. They state that the Atomic

Energy Act"clearly states that the

Commission's safety standards are to be

Imposed by rule or order... However.

the NRC Is in the habit of mposing

regulatory requirements through non- enforceable means (e.g. Reg. Guides.

SRP) OCRM states that because legally binding requirements are those reached

through rulemaking or adjudication and

because these processes inherently

involve weighing pros and cons of.

adverse parties. they are reasoned. open deliberated processes subject to judicial review and therefore need no further

analyticsl requirements OCRE

continues. -While it would be preferable if all regulatory requirements resulted

from rules or orders. it is a fact of life

that the staff imposes regulatory requirements on its own.' OCRE

appears to not take a position either

way on the question but is willing to

accept current staff practice as a "fact of

life "

NUBARG takes a strong position that

1 50.109 should limit backfitting to those

modifications imposed by rules.

regulations or order. They state that

current and past staff practice of

requiring licensees to backfit facilities on the basis of non-binding guidance requirements is illegaL Regarding the

second part of the question. NUBARG

states that there are no means other

than rules. regulations or orders by

which the Commission may lawfully

require a licensee to modify its facility.

In short, it is NUBARGs position that

Section 50.109 would violate the statute

if it permitted imposition of backfits by

any means other than rules, regulations or order. The AIF and other industry

commenters appear to be in general agreement with NUBARG's position.

DOE states that backlfitting should

only be imposed by rule, regulation or order and that all analyses, reviews and

decisions required by the proposed rule

should apply to al methods of

backfitting. Question I3 Should a documented

analysis of a proposed backfit come before the backfit is issued or only after an affected licensee lodges an appeal?

USC urges that there be no requirement for a detailed analysis

unless the licensee appeals because such

analyses in absence of an appeal would

in their words. "be an utter waste of time

and resources."

OCRE suggests that to require analysis of every proposed backfit

would create too great a burden on the

staff OCRE appears to reserve the term

"backfit" for "non enforceable

regulatory requirements' and therefore.

"licensees should reel free to contest a proposed backfit."

NUBARG takes the position that there

should be a documented analysis by the

NRC whenever its proposes to require licensees to modify their facilities. They

state. "a plant modification has the

same impact regardless of who initiates

I Therefore, just as the licensee must

always develop a sound technical basis

in support of a proposed facility modification. so should the staff." Such an analysis is necessary they argue. so that the NRC can be assured that the

backfit It wishes to impose is truly needed to enhance safe reactor

operations and that it will have the

intended effects.

AIF suggests that such evaluations are needed to determine whether the

proposed backfit does increase safety.

to what extent and at what costs.

Further It is needed "to impose discipline into the backfit process AiF

also suggests that licensees should not

be placed in position of having to

Invoke procedure in order to initiate

backflit analysis. To do so. they say. places the licensee {i a position of

having to jeopardize its relationship with the staff by opposing a change that

the staff is requiring.

AIF also suggests that. in addition to

the seven factors proposed in the

Federal Register notice, the following factors should be considered in making

an analysis of a proposed backfit.

1. A precise statement of the specific objectives that the proposed modification is designed to achieve.

2. A general description of the activity that would be required by the licensees or applicants in order to complete the

modification

3. Alternatives to the proposed backfit

and how these alternatives including the recommended alternative) will affect

other proposed or imposed facility

backfits and

4. A priority ranking by safety significance of each proposed backfit

relative to other proposed or imposed

backfits.

5. Whether after balancing of all

appropriate factors (including those in

this paragraph) the demonstrations

required in 1 50.109(a) have been made.'

DOE states that the burden of proof for demonstrating that an increase in

NUREG-1409 2 Appendix A
Federal Register Vol. 50. No. 183 Friday. September 20. 1985 1 Rules and Regulations 3BS99

safely is needed should rest with the

staff rather tan requiring the licensee to

prove that such an increase is

unnecessary. Their reasoning is that.

'"reuiring a written basis and analysis

of proposed backfit before it Is

imposed will increase the likelihood of

improved safety and increase

confidence that its effects are

understood."

Question 4. Should backfitting be

defined as the imposition of new regulatory requirements or the

modification of previous requirements"

(the causel or defined as a "modification or addition required by the Commission

to the facility or to the structure.

systems or components of such facility.

the design thereof or the procedures or organization required to construct or operate such facility" (the effect)? What

is the basis for this position?

UCS believes that neither definition is

appropriate, citing its 1983 comments

pages 1030. in support of its position.

UCS further suggests that exclusion of

rules. regulations and orders from the

definition of regulatory requirements

raises questions about what Is meant.

OCRE states that backfitting should

be defined as "the imposition of new requirements ie the cause, not the

effect Its reasoning is that -Since we interpret backfit to apply only to the

non-enforceable requirements. licensees are free to use alternative methods to

comply. This. again, is a difficult point

which should be resolved by bringing

the NRC's practices into line with the

Atomic Energy Act (AEAJ: i.e.. all

requirements imposed by rule or order."

ALF suggest that the definition should

he stated in terms of the effect which

they suggest should read:

As used in this section. "bacifitting" of a

prodiction or utimzrtion facility means a

modsici on: or addition required by the

Commisswn to the desin approval.

marnur.c.:unng license. or faciity or to the

siruc:ure.s. systems or components of such

fmci iiy. the design thereof. or the procedures or organization required to construct or- opee ate such facility after... tines

specified in proposed rulel.

They also suggest thal backfits should

include requirements to perform

extensive analytical efforts or tests.

regardless of whether modifications or additions to the structures. systems or components of a facility or design result

from such analytical efforts or tests The

basis for rejecting regulatory

requirements as a part of the definition

is directly related to their previous

argument that backfits may only be

legally imposed by rule, regulations or I~der. AlFs position is generally

supponed by other industry comments.

DOE would recommend the following

in lieu of either the 'cause' or effect"

definition:

1. A "modification." means a change

required by the Commission to a site

permit: a design approval: a production or utilization facility, or the structures.

systems or components of a facility- to

the procedures pursuant to which a facility is to be constructed or operated; or to the organization required to

construct or operate such a facility.

2. A backfit" means "a modification

not imposed by the Commission for

achieving compliance with a construction permit or operating license.

at the time of issuance or as amended. or contained in the requirements -

incorporated by reference in the permit or license."

The State of Illinois rejects the use of

"regulatory requirements' as too

ambiguous and suggests the definition

be more precise for clarity and scope.

Question 5. The industry's proposed

standard for justification oNa backfit is

"substantial improvement in the overalil

safety of the plant considered over its

remaining life.' Is it appropriate to

include the concept of -over its

remaining life"? What other standard

could be used?

UCS suggest that it is not appropriate

to consider the concept of "over its

remaining life" for the following reasons:

1. Such analysis can only be based on probabilistic risk assessment and that

methodology is not appropriate. 2. The concept creates an incentive for

delay and obstructionism and rewarded

those who delav the mosL

3. "Benefits' are currently expressed

by NRC in terms of annual average dose

"avoided" and this is inconsistent with

the concept of -remaining life".

4. The concept does not account for

problems cause by aging and

deterioration of equipment which are likely to increase as a plant ages. 5 There is no justification in law or policy for subjecting people around

older plants to a greater risk than those

who live around newer plants.

OCRE also objects to the use of the

standard because of what they perceive

to be implication of required use of

probabilistic risk assessments.

NUBARG suggests that use of the

concept is appropriate as being one factor among many that should be

considered when a backflit is required.

Industry commenters generally suppon

this position.

Question 6. To what extent may the

Commission consider cost, including the

economic costs in backfitting decisions

under standards and processes

proposed in 50.109?

USC cites its previous 1983 comments

in support of Its position that costs may

not be considered under the Atomic

Energy Act and established case law.

OCRE also opposes cost consideration as a part of the decision process.

AIF takes the position that cost may

be considered and that such costs

should include:

1. Costs of evaluation engineering.

construction. material procurement.

Allowance for Funds Used During

Construction. (AFUDC) and

investigations:

Z An attributable portion of

replacement power costs during down

time for implementation:

3. Operating costs due to changes in

specifications procedures operator

retraining and training manuals.

increases in manpower requirements

and net generation losses.

.4. Impact on preoperational startup.

operator training procedure

development and system turnover

during plant construction and

5. Any incremental increase in man rem exposure as a result of installation

and subsequent operation of the

modification.

As a basis for the position stated. AIF

attaches to their comment a legal

memorandum entitled. "Consideration

of Cost and Benefits in Connection with

Backfitting." This memorandum takes

the position that the Atomic Energy Act

and its legislative history court

decisions. Commission regulations and

documents, the Energy Reorganization

Act and Executive Order 12292 and the

NRCs General Counsel memorandum

dated May 4. 1984. all support the

conclusion that costs may be considered

in connection with backfitting Idustry

comment generally supported the AIF

position.

DOE also conducted a legal analysis

of the cost question. They stated:

The legal conclusion which emerges from

the foregoing is that except for deciding the narrow question of whether a backfit should

be required for construction permittees to

eliminate or reduce to threshold level a

particular nsk in order to meet the -adequate protection" lest the NRC has broad

discretion to consider the relationship between benefits and costs in deciding whether to impose a backfit.

The Commission also requested

comments on whether reliance upon

probabilistic risk assessments is

prohibited by the Atomic Energy Act as

suggested by UCS. OCRE agreed with

the UCS position.

AIF takes the position that UCS

mischaracterizes the industry position on the use and value of probabilistic risk

assessment (PRA. They point out that

Appendis A 3 NUREG-1409
!IR1110 Federal Register Vol. 50. No. 183 Friday. September 20. 1985 Rules and Regulations 2R100 Federal Register / Vol. 50. No. 183 I Friday. September 20. 1985 I Rules and Regulations

PRAs should support not supplant

determinative requirements. NUBARG

points out that neither the industry nor

the proposed backfitting rule mandates

the use of PRAs. They point to the fact

that the proposed industry rule would

require the use of PRAs only 'where

appropriate and where pertinent data is

available. They also suggest that the

Atomic Energy Act does not prohibit the use of PRA.

The Commission requested comments on the correctness of the UCS position

that -the Commission exercises its

rulemaking authority to establish

nuclear reactor safety standards. and

licenses may avoid those standards only

by obtaining a waiver under 10 CFR

2.758. NUBARG states that UCS

misunderstands I 2758 and the

operation of the backlit rule. They

further suggest that neither of the

proposed backfitting rules can reasonably be read as permitting

licensees to avoid requirements

applicable to their facilities Those rules,

they state. would simply require the

staff to document the basis for its

conclusion that a backfit Is required.

The Commission requested comments an whether the elements of the proposed

backfitting rule are too prescriptive and are truly needed to ensure that the staff

considers all factors that are appropriate before it imposes a backfit.

NUEARG points out that virtually all of

the elements of the analysis have been

used by NRC before and are sufficiently

broad to be applied in most. if not all, by

backfitting situations The State of

Illinois remarked. "The Department

IStatel believes that the seven factors

contained in the proposal provide an

appropriate means for balancing all

factors in determining whether

backfitting should apply.' AIF agreed

with the seven factors but suggested the

addition of five more. The Commission also expressed a concern over whether preparation of a -.acfitting analysis should be required as a condition precedent to the issuance

of a license amendment NUBARG

stated that -unless requested by a licensee the staff should not be

requested to prepare a backfitting

analysis as a condition precedent to

issuance of a license amendment if the

licensee requests an amendment

pursuant to 10 CFR I 5090 NUBARG

points out that application for significan

amendments requries a description of

the proposed modification and the

preparation of a safety analysis report

by the licensee. Since the licensee

presumably will have subjected the

amendment to an internal cost

effectiveness review, a backfitting

analysis by the NRC would appear to be

neither necessary nor appropriate. AIF was in general agreement with this

position and stated further that the

option to allow a licensee to request a backfitting analysis should be retained.

ALF suggested that there are instances

when licensees are under informal but

Intense regulatory pressure to submit an amendment request In this

circumstance. backfitting analysis

should precede the issuance of a license

amendment according to AlM General

comments from other members of the

industry tend to support the NUBARG

and AlF postions

Comments on the Additional Views of

Commissioner Asselstine

Commissioner Asselstine's additional

views were generally supported by

Ecology/Alert Federal Conservationist

of Westchester County. Inc. Ohio

Citizans for Responsible Energy and

UCS Industry comment generally

opposed Commissioner Asselstine s approach. Similarly, the Departnent of

Energy did not support Commissioner

Asselstine's alternative backfit rule. and

the State of Illinois had a mixed

response..

Although UCS endorses

Commissioner Asselstine's position. It

suggests two changes. First. it takes

exception to Commissioner Asselstine's

rule to the extent that it prohibits

consideration of monetary costs at the

operating license stage only for backfits

related to safety matters that were left

unresolved at the time of issuance of the

construction permit. UCS believes that so long as construction permits are to be

granted on the basis of preliminary

design concepts It is not legitimate to

consider as backfits, changes required

between the construction permit and

operating license or to consider costs at

that stage. Second. USC objects because

Commissioner Asselstine's proposal does not provide for formal public

participation in backfitting decisions.

USC believes that the decisionmaking

process should be open and accessible

to all persons who might be affected.

OCRE also suggested two changes to

Commissioner Asselstines proposaL

First, they would remove review by

CRGR because, they say. CRGR does

not further the mission of the

Commission but serves only to

discourage new safety improvements

ISecond. they, like UCS. would provide an opportunity for public comment for

both generic and plant specific backfita

In its discussion rejecting the

proposed use of "regulatory

requirements" in the definition of

backfitting. the State of Illinois endorses

"the more precise definitions of

backfitting proposed by Commissioner

Asselstine and the industry" and to that

extent, could be considered as endorsing

Commissioner Asselstine's approach.

However the State of Illinois also sited

that they did not agree with

Commissioner Asselstine s proposals to

specify In the regulations a presumption

in favor of the backfiL They believe that seven factors contained in the proposal

provide an appropriate means for

balancing all factors in determining

whether backfitting should apply.

The thrust of the industry position

appears to be that many of the terms

used by Commissioner Asseistine in his

proposed rule are ambiguous and

undefined and in other instances, where

the standard is well understood it is

simply misconceived. For example.

NUBARG points to Commissioner

Asselstine's proposal to define backfits

in terms of changes to facility design.

construction or operation 'imposed by

the staff to .. satisfy a regulatory staff

position" developed after a specified

period. NUBARG complains that

regulatory staff position" is not

defined. AIF states that the word

.satisfy' in this context cannot be

anchored to any applicable statutory

standard not to any prevailing doctrine

of administrative jurisprudence.

NUBARG questions the ultimate

effectiveness of such an alternative rule

because they argue. backfits may notVii

legally imposed on the basis of such

documents.

Industry takes a different tack with

regard to the position espoused by

Commissioner Asselstine that the basic

premise of nuclear regulation should be

to "reduce the risk to the public caused

by these facilities to a level that is as low as reasonably achievable."

NUBARG suggests that this approach reverses the presumption of regularity

associated with past NRC licensing

decisions. Those who have already been

granted licenses and thus have been

deemed "safe enough" by the NRC

could. according to NUBARG. find

themselves having to justify routinely

why their licenses should not be

modified This NUBARG states raises

serious legal questions of fundamental

fairness and due proces and appears

to be at odds with the Administrative

Procedure Act. NUBARG also complains

that the standard suggested by

Commissioner Asselstine is potentially

open-ended.

AIF further suggested that the Atomic

Energy Act requires "reasonable

assurance of the public health and

safety" and reasonable assurance is no Iequated with -as low as reasonably

achievable:' AIF further states that this

NUREG-1409 4 Appendix A
Federal Register I Vol. 50, No. 183 Friday, September. 20, 1985 1. Rules nc.keg

standard is at odds with section 103(b]

of the Atomic-Energy Act. which 

provides, in part. that "The Commission

shall issue such licenses . .. to persons

applying therefor . .. (to) who are

equipped to observe and who agree to

observe such safety standards to protect health and to minimize danger to life or property as the Commission may, by _ rule, establish: . . :' AIF suggests that

this language has been interpreted by the Commission in its regulations to

require -reasonable assurance-that

licensed activities of the Commission can be conducted without endangering

the health and safety of the public.

citing. for example. 10 CFR 50.S7(aJ(3).

They also cite Citizens for Safe Power,

Inc. v. Nuclear Reulatory Commission.

524 Fed. Second 1291.1297 (D.C. Circuit

1975) for the proposition that "absolute or perfect assurances are not required by AEA and neither present technology or public policy admit of such a standard." '

The Department of Energy also does

not support Commissioner Asselstines

alternative proposed backfit rule. This

proposed rule. DOE states. detracts

from the basic purpose for instituting a new backfit rule and. if adopted. would

perpetuate tiesignificant deficiencies of

backfitting practices of the past." DOE

further suggests that Commissioner

Asselstine's definition of backfitting is

too narrow; that the -as low as is - reasonably achievable" standard is

inappropriate, and would probably be

inconsistent with safety goals should

those be established; that the limitations on the use of quantitative cost benefit

balancing would be -overly restrictive"

and would be "a regressive step for

modem analysis techniques" that the

decision criteria are not identified in

Commissioner Asselstine's rule, and

that the implementation procedures have several deficiencies.

Commission Position

The Commission is appreciative of the

time and effort expended by those who

submitted comments. Backfitting is a matter of considerable importance and

the views expressed in the comments

have been very helpful to the

Commission in its deliberation. To some extent, the final rule will be modified'-

from the proposed rule to reflect the

views expressed.

Since there is no practical difference

pursuant to a iote or a station

JfteM6Te fina Hit 1ere-

-bWume'nWre A--Wlrired

-brC~lliSirIartjSS ot th; source. A

prtaift- di c alisll not

be required in rulemaking and the'

factors specified in the rule will be

reviewed only on a generic basis for

rulemaking purposes. Because there

must be safety reasons for the agency to

impose any changes to a regulatory

requirement or a staff position.

applicable to the licensee, because the

safe consequences are unknown until

analyzed and because the Commission

should fully understand the effects of a proposed backfit before its imposition it

is of little consequence how a backfit is

imposed. Safety and sound management

require that analysis precede imposition

of a new or modified regulatory requirement or staff position. It follows

that those backlits imposed by

rulemaking should undergo the same scrutiny as proposed by other means. It

also follows that changes in regulatory

requirements or staff positions for

procedures and organization should also

be analyzed before implementation to

determine; inter alia, the safety

significance of any such proposed

change. The final rule reflects this

position - Many of the most important changes

in plant design, construction. operation;

organization and training have been put

in place at a level of detail that is

expressed in staff guidance documents

which interpret the intent of broad.

generally worked regulations. The NRC

has determined that the correct focus for

backlit regulation is the establishment of

effective management controls on existing staff processes for the

interpretation of regulations that are known to result in valuable upgrades in

industry safety performance. Thus. the

Commission opts to adopt a managementprocess not only for the

promulgation of regulations as backfit

instruments, but also for the lower tier

staff review and inspection processes known to result in reactor plant changes.

The Commission agrees with those

who suggest that the Staff should not be

required to prepare a backfitting - analysis as a condition precedent to

issuance of a license amendment if the

licensee requested the amendment

pursuant to 10 CFR 50.90. If a licensee

believes that the amendment process is

being used by the staff to impose a backfit, the licensee may invoke the rule

under § 50.209. It is unnecessary to

amend the rule in this regard since

mention of the point here provides adequate direction to the Staff and

licensees. -

Considerable attention was given to

the question of whether backfitting should be defined in terms of its cause- or its effects. After due consideration.

the Commission believes that the

definition for backfitting should take

into account both the cause and the

effects. Therefore, the definition is

modified accordingly.

Question 5 concerned the industry's

proposed standard for justification of a backfit and the suggestion that the

substantial improvement in overall

safety of the plant considered over its

remaining life" should be incorporated

into the rule. In our view, the concept of .over its remaining life" is already

incorporated in the rule under

§ 50.109(dl(8). There is no need to place

that concept in the rule at another place.

The additional factors suggested by the industry for inclusion under

§ 50.109(c) generally appear to be

reasonable and not unduly'burdensome.

Therefore. the thrust of the additional

factors will be included as appropriate

in the final rule.

As the accountable manager for

backfitting, the Commission has directed

the EDO to establish backfit procedures

and to ensure appropriate rights of

appeal. The Commission believes it Is

unnecessary to include In-the rulea.

section establishing appeal rights to the

Executive Director for Operations.-

Consideration of Costs in Ba'xt-i

Decisions -: .

ln the current rulenaking, comments were filed by UCS and AIF stating

strongly contrasting legal views

concerning the Commission's authority

to consider the costs of new'safety

requirements which the Commission

would impose if costs were not a facor

in the decision.- (See Question 6, supro.)

In view of the importance of the cost

issue and the strongly divergent views

stated in the comments, it is important

to set forth the Commission's legal and

policy views on this matter.

The costs associated with proposed new safety requirements may be

considered by the Commission provided that the Atomic Energy Act finding 'no

undue risk" to the public health and

safety can be made. There may be any

number of ways by which the

Commission can arrive at such a conclusion. Each approach could haie

different costs associated with it and it

cannot be seriously argued that in such

circumstances the Commission is

statutorily prevented from choosing the

most cost effective means of protecting

public health and safety.

Similarly, it may be presumed that the

current body of NRC safety regulations

provides adequate protection. Where. new information indicates that.:_' , - improvements are needed to ensure,

there is "no undue risk" on either a plant-specific or generic basis which the

Commission believes to be the minimum

Appendix A 5s NUREG-1409
38102 Federal Register Vol. 5, No. 183 / Friday. September. 20. 1985 /Rules and Regulations

necessary. such requirements must be

imposed. However, where there are alternatives for achieving the

improvements which have different ' associated costs, such costs may be

considered. -,

Cost cnsiderations have been a part

of the Commission's regulatory

approach In many other instances. For

example, the ALARA principle requires

Commission licensees to meet an absolute set of radiation exposure

standards but also requires further

reductions in exposure where the cost of

the exposure avoided outweighs the cost

of implementing controls to avoid the,

exposure.Commenters who addressed

the proposed backfit rule and opposed

the use of costs did not address this

point. It would appear that the only

situation where the consideration of

cost may be seriously challenged is

where a neiv reqirement is necessary

to provide an absolutely minimum level

of protection to the public health and.

safety'and no alternative means of.

achieving such protection are apparent.

In geneial, the consideration of costs

associated with incremental safety.

improvements is within the NRC's

statutory mandate. However, the cost of new safety requirements will not be

considered where uch requirements are necesar to ensure there is no undue

risk to th ublic health and safety and

*no altrn atiies are available. ,

Afteireviewin all of the comments

anid positins stated, the Commission

belfieves 'that there is sufficient authority iitte statutes. case law, and ..

Commission practice to justifymaking

cost considerations in backfitting

decisions. Since consideration of costs ws a part o the proposed rule, the rule

will remain unchanged in this regard.

The-Commission'also rejects as without

mit the suggestion that probabilistic

risk assessments are precluded by law.

* Description of Final Rule

The proposed amendment of 50.54(1f) ensures that except for information

sought tverify licensee compliance with the urrent licensing basis for that

facility; the reasoii or reasons for each

information request must be prepared

prior to its issuance to determine

whether the request is for information

already in'the possession of the

applicant or licensee or instead will

require the institution of studies.

procedures, or other extensive effort to

generate the necessary data to'respond.

if extensive effort is reasonably .

anticipated. theiir4uest waili be

evaluated to determine whether the

burden Imposed by the information.

reuest is justified in view of the

potential safety significance of the issue Nevertheless, staff interpretations of"

to be addressed. . - broadly stated rules are often necessary

It should be noted that. 50.54W does to give a rule effect and in somr-i- - : not by its terms apply to the review of; instances may be a causal factor. in"'

applications for licenses or . - initiating a backfiLt :' - : '

amendments. Consequently. if the staff. Section 50.109(a)(2) requires -

seeks information of a type routinely : systematic and documented analysi as

sought asa part' of the standard a condition precedent the'impoltloiif

procedures applicable to the review of "of a backfit This will ensure that the""

applications. no analysis will be - safety significance of any modificatod'

necessary. If the request is not part of and its relation to other relevant factori

routine licensing reiew and falls within is well understood before chiges are'"

the purview of 50.109. however, a full required. - . .

analysis is most likely indicated. The standard against which prdposed

Requests for information to determine backfits would be measured Is stated i

compliance with exsin faciity, : 5 5(fl59(a)(3) as "substantial iciaie ii

requirements or for fact-fidin reviews. the ovierall protection of the public tt -

inspections and investigations of . - health and safety or the common accidents or incidents. owever usually defense and security. Substantial are not made pursuant to § 50.54(0 nor means"important or'significant in a-'-' are such requests normally considered large amount, extent or degree. Under

within the scope of the backfit re., such a standard. the Conimisson would

Amendment of this section also not ordinarily expect tat safe ' .

provides for management control and improvements would be rquired as accountability for backfits by requiring backfits which result in an insignificant that staff evaluations be reviewed by or small benefit to publidhealth nd'

the Executive Director for Operations or safety or the common defense and ' his designees prior to the issuance of. the safrty or the cm de an request. . .. ~~~~security, regardless of the request. P~~~~~~iementation costs.'On the othei The amendment of 50.54(f) should be hand the ntanis nt intedd t be

read as indicating a strong concern on interpreted in'a mnner thatwould 

the part of the Commission that result.'i disapprovals of worthil

extensive infornatioti requests be~ carefuly scrutinized by staff '-' safety or &ecurity mprovementahavmg

managemnt prir fo iitiatig such costs that are justified n viw of thie~.'

requests. The Com~ission rcognizes increased protection that would be

that there may be instances where it is provied. . -....... - -,

not clear whether a backlt wil follow The phrase "overall'protectonof Ie

an information request Those cases public halth and safety or the comon, should be resolved in favor of analysis. defense and seurity" lthe propoed. I hr;safaaeeshol backft standard also deserves some,

in short staff nianagement should ~ develop an internal review process to dicussion The rncipal purpoe o Max ensure that there is a rational basis for requiring consideration of the overall

all information requests. even where it protection that would be provided by t

is not clear that a backfit will result' proposed backfit is to ensure that both

Section 50.109(a) sets out the its neative aiid positive effects aredefinition of backfitting, the analysis taken into account in deciding whether

requirement the standard to be used in the backfit s justified. A backfit for a

determining whethe a backfit should be part of a plant should be evaluated in

imposed and the exceptions to the rule. light of the net incresie in overall 

The definition focuses on modifications protection that the entire plant ould

to systems. structures, components. :: provide as a result of the backfit, taking

designs, procedures or organization - into account the effects it would have on

which may be caused by new or - other aspects of the plant Thus, the net

modified Commission rules or orlers or benefit of a backfit to the protection

staf interprtations of Commission , provided by the plant as a whole Ii th

rules or orders. Thus, this defintion : overriding consideration; not Just the -

includes both cause and effect of , -benefit to the part of the plant beint'"i

backfitting. It may also be noted that backfitted : . . -

"cause" includes not only Commission- ; However, the Commission does not '

rules and orders. but staff . intend use of the phrase' overall

interpretations of-those rules and orders. protection.in the backfit standard-to -

This is not to say that staff - signal a departure from its tradtionali'

interpretations of rules are viewed by- reliance on defense In depth and t''

the Commission as being legal , - diversity for proteboof public halth.

requirements. Clearly, they are not. - and safety.Therefoesafety" -' ' ' ;__*__-___ improvements inone lint of defense 

The1tenreglulationC is not in the text agstundbe'risk'sfoidd i' not be' '

that term is synonymous with -rule- disipipoved orapproved based solely

NUREG-1409 6 Appendix A
Federal Register Vol. 50. No. 183 / Friday. September 0. 1985 I Rules and Regulations 38103

on the presence or absence of another

line of defense to cope with the failure

of the first. For example. safety

improvements in the integrity of the

reactor coolant system should not be

dismissed merely because an emergency core cooling system has been provided

to protect public health and safety with

high confidence in the event that the

integrity of the reactor coolant system is

lost. On the other hand, such a suggested improvement may be

precluded because it does not meet the

substantial test. or does not Increase

overall protection provided by the plant

due to. for example. the negative

impacts on other aspects of the plant

The proposed requirement that the costs

of backfits be considered and justified in

view of the increased protection to

public health and safety or security is

based on the Commission's view that it

should. in these circumstances. consider

the direct and Indirect costs of

implementation in making safety

decisions under the Atomic Energy Act

The consideration and weighing of

costs contemplated by the rule applies

to backfits that are intended to result in

incremental safety improvements for a plant that already provides an

acceptable level of protection. In this

area the Commission believes that

direct and indirect implementation costs

are especially relevant. Without cost as a competing consideration in these

circumstances the regulatory process

takes on the characteristics of a quest

for a risk-free plant. an unattainable

objective as recognized by Congress in

establishing the standard of no undue

risk in the Atomic Energy Act.

Section 50.109(al(4 creates exceptions

for modifications necessary to bring a

facility into compliance or to ensure through immediately effective regulatory

action that a licensee meets a standard - o undue risk to public health and

*-lv n cases involving the c mpilidnce exception. backfit analysis

is not required and the standard does

not apply. The compliance exception is

intended to address situations in which

the licensee has failed to meet known

and established standards of the

Commission because of omission or mistake of fact It should be noted that new or modified interpretations of what

constitutes compliance would not fall

within the exception and would require a backfit analysis and application of the

standard.

IThe exception for immediately

effective regulatory actions that are necessary to ensure that a licensee

meets the standard of no undue risk to

the public health and safety permits the Commission to act in

emergency situations to ensure that

operation of the backfit rule will not

preclude the Commission from ensuring that minimum standards are met to

protect public health and safety. The

exception anticipates the existence of

significant new information or the occurrence of an event which clearly

demonstrates that the standard of no undue risk to the public health and

safety cannot be maintained without the

designated modification. Moreover the

presumption of safety which ordinarily

accompanies the issuance of any license

must be overcome in order for the

'exception to be used. As with the

compliance exception. there is no intent on the part of the Commission to include

within the scope-of the exception new or modified interpretations of what

constitutes no uridue risk to the public

health and safety. In such a case the

rule applies.The rule also provides that

a backfit Imposed by immediately

effective regulatory action shall not

-relieve the Commission of performing an analysis after the fact to document the

safety significance and appropriateness

of the action taken.

For those modifications which are to ensure that the facility poses no undue

risk to the public health and safety and

which are not deemed to require

immediately effective regulatory action.

analyses are required; these analyses.

however, should not involve cost

considerations except only insofar as cost contributes to selecting the solution

among various acceptable alternatives

to ensuring no undue risk to public

health and safety.

To ensure that the discipline is

maintained in the process and that the

exceptions do not become the rule the

Commission directs the staff to

document each exception

Documentation shall include a precise

statement of the specific objectives of

and reasons for the modification and the

basis for the exception. It may also serve useful regulatory purposes to

include such matters as a general

description of the activity that would be

required by the licensees or applicants

in order to complete the modification

and the identification by type, design

and vintage of the design approvals.

manufacturing licenses for production or utilization facilities to which the

modification would apply.

Section 50.109(b) grandfathers"

backfits imposed prior to the effective

date of this rule.

Section 50.109(c) sets out nine factors

to be used by the staff in its backfit

analysis. Finally. I 50.109(d) explicitly

recognizes the responsibility of the

Executive Director for Operations to

manage the Commission's backfitting

program in general and requires

approval of backfit analyses by the

Executive Director for Operations or his or her designee.

As a matter of information, it may be

noted that the nine factors in 50.109(c)

have precedent in existing NRC

practices as seen in the Regulatory

Analysis Guidelines of the US. Nuclear

Regulatory Commission. NUREG/BR0M8. the approved CRGR Charter and

the Commission's approved plan for the

management of plant-specific

backfiting. SECY-83-321.0

The nine factors to be used by the

Staff for a systematic and documented

analysis are listed under I 50.109(c) and

read as follows (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 or applicant in order to complete the

backfit: (3) potential change n risk to

the public from the accidental offsite

release of radioactive materials; (4)

potential impact on radiological

exposure of facility employees; (51

installation and continuing costs

associated with backfirt including the

cost of facility down time for the cost of

construction delay; (6) the potential

safety impact of changes in plant or operational complexity including the

effect on other proposed and existing

regulatory requirements: (7) the

estimated resource burden an the NRC

associated with the proposed backfit.

and the availability of such resources (8) the potential impact of differences in

facility type, design or age on the

relevancy and practicality of the

proposed backfit: 19) whether the

proposed backfit is interim or final and.

if Interim, the justification for imposing

the proposed backfit on an interim

basis. These nine factors are to be used as balancing mechanisms in the

decisionmakirg process for backfitting. During internal review of the rule a

question was raised as to whether

licensing action should be withheld

during backfit review. The answer is

that the rule never contemplated such a withholding. To the contrary, until a backfit analysis is complete. licensing

action should continue along a course

'The Requlatory Analyri Cuidelines of the US

Nuder Reuliory Commisso. NURECIaR-Os&

is ariable for npectbon or copying for a e in the

NRC Public Document Room. 1717 H Street. NW_

Wahinvton. D.C. This eponm my be purchased from the U.S. Governmenl Prining Office IGPO) by

calms -275-200 or by writing the M. P.O.

Box 37IR6. Washingion. DC 2XIM11-7012. It may wito

be purchased from te National Technical

Infurnation Service. U.S. Department of Commerce.

52S Pouri Hoval Road. Springfield. VA 7101.

Appendix A 7 NUREG-1409
38104 Federal Register J Vol. 50. No. 183 Friday, September 20. 1985 I Rules and Regulations 38104~~~~~~~~~~ Rese Feea o o 8 rdy etebr2.18 ue n euain

consistent with normal practice. For

clarification of the point. I 50.09(d) was added to the final rule.

Section 50.109(a) emphasizes and

codifies the Commission's intent that

backlit management is of paramount

importance to responsible regulatory

practice. Acrgly, the Executive

Director for Operations is responsible

for implementation of the backflt rule.

It may be noted that the resolution of

any backflt case can be by Commaission

rule or order. or by written commaitment

of a licensee. Recognition of th point

complees the design of the baditl

management process and establishes

that licensee compliance with approved

backflts may be accomplished by

voluntay commitment but that the legal instrument of a rule or order can and

will be used If necessary.

The proposal to amend 10 CFR Part

50. Appendix 0 necessary to conform

Appendix 0 to the ial rule. The

amendment provides that information

requests to the approval holder

regarding an approved design shall be

evaluated prior to Issuance to ensure that the burden to be imposed on respondents is jutified In view of the

potential safety significance of the issue

to be addressed in the requested

information. Each such evaluation

performed by the NRC staff shall be in

accordance with 10 CFR 50P4(f) and

shall be approved by the Executive

Director for Opertions or his designees prior to issuance of the request

Section 2.X4 is amended to ensure that any order for modification of a

license involving a backlit is subject to

tnP provisions of the new 50.109

Commissioner Asselstine and

Comm issioner ernthal disapprove this

final rule. The separate views and

comments of Commissioners follow.

Separate Statement of Chains

Pailaio

5si :erure as Oiautman. I have

tcoha. new system of bacifit controls

for NRC that would ensure that s backfit

-is analyzed and that an explicit

judgment of its safety and cost

Comsequences is made This new rule

:3C5 just tht

Although a previous verion of an

NRC backfit rule has been on the books.

it has rarely been followed In addition.

documentation in too many cases has

been non-exitent or inadequate to

identify and justify the safta and cost

consequences of past NRC-imposed

backfitsc

The steps to this new backfit rule nave been deliberate and I believe

thorough. In 1983 we issued a policy

statement announcing intend backfit

controls and our tent to conduct

rulemaking to establish a new backfit

rule. 48 FR 44173 (1983). At the same time. we published an advanced notice

of rulemaking soliciting public

comments on various proposals for the

long-term management of the backlitting

process both plant-specific and generic.

48 FR 44217 983) In November 194. we published a notice of proposed

rulemaking, seeking public comment on an NRC proposal and on a number of

specific questions designed to elicit

public views on significant issues and

alternatives. The Commission held a number of public meetings on backfittiog. and received the advice of

the Regulatory Reform Task Force and

senior agency officials.

The rule that emerged is a good one. Contrary to the claim of Commissioner

Asselstine. the rule is not designed to

stymie regulation. What the rule

requires is an analysts and an explicit

judgment that a proposed safety

requirement is justified. A Commission

concerned about the protection of public

health and safety-which this

Commission is. Commissioner

Asselstine's comments

notwithstandig-will find ample

freedom to make sound safety decisions

based on analysis. Further the rule

provides that its requirements do not

apply if a proposed safety measure Is

needed to assure compliance with NRC

requirements or protection against

imminent public risk.

It seems somewhat late in the day for a Commissioner now to argue for the

first time that this backfit rulemaking.

which we Initiated almost two years

ago. is unnecessary. To my knowledge.

when we started all Commissioners

agreed that our experience under the

existing NRC backfit rule had not been

satisfactory and that backfit controls of some sort were needed. The decision to

incorporate controls into a rule will mean that the Commission can be held

accountable in the future for how it

implements those controls. Further. the

decision to adopt a rule also means that

modifications of the controls will

involve public participation

Similarly unfounded is Commissioner

Asselstine's criticism of the backfit

standard in this rule. The Commission

gave considerable attention to the

standard during the rulemaking and

adopted the following explanation of

"substantial increase" in protection of

health and safety

Substantial means "Important or significant in a largoe amount extent or degree." Under

such a tsndard. the Commission would not

ordinarily expect that safety improvements would be required as backfits which result in an insignificant or small benefit to public health and safety or the common defense and

security, regardless of the implementation

costs. On the other and. the standard is not

intended to be interpreted in a manner that

would result in disapproval of worthwhile

safety or security improvements having costs

that are justified in view of the increased

protection that would be provided.

I do not believe that this standard can reasonably be criticized as Intended to

block new safety requirements.-

Commissioner Asselstine simply

ignores the words of the rule when he

contends that it requires a backfit

analysis that is skewed against new safety requirements Section 50109(c)

provides that any... information

relevant and material to the proposed

backfit" may be considered .in the

analysis and. thus taken into account in

the safety decision. This language

provides. in my judgement ample room for Commission reliance on. among

other things. the expertise of its staff to

supplement other analytical tools in

order to provide an adequate basis for a particular backfit decision.

In response to Commissioner

Bernthal's statement. I an disappointed

that we could not agree on how to apply

backfit controls to future rulemakings. I

believe that our differences are really

very small.

Modifications to plants or plant

procedures can result from new or modified NRC requirements adopted by

rulemaking. Therefore. future

rulemakings should be covered in

principle by backfit controls. The

alternative would be a system where

plant specific bsckfits are analyzed and

documented but generic rule backfits are not. Such an alternative would leave a significant area of backfitting formally

uncontrolled without apparent reason.

Moreover. I believe that the

Commission would be creating

questions without apparent answers if it

chose to control plant specific backfits

by a backfit rule and generic rule

backfits by internal agency management

and guidance. By subordinating generic

rule backfits to internal agency

management for the stated reason of

preserving llexibility." the Commission

could be seen as sending the message

that it does not wish to be held

accountable for the application of

backfitting controls to future

rulemakings. This outcome could well serve to undermine the agency s efforts

to manage backfitting.

Application of the backfit rule will not

result in the Commission making

unsound safety or backfit decisions in

future rulemakings. The main thrust of

the backfit rule is to apply analvsis

including analysis of costs. before a backfit is imposed The rule only

NUREG-1409 8 Appendix A
Federal Register I Vol. 50. No. 183 Friday. September 20. 1985 / Rules and Regulations 38105

requires analysis of "such. . . actors as may be appropriate. . . The decisional

standard is only that the costs of the

backfit be justified in view of the

protection to public health and safety

afforded by the backfit.' Further. as noted earlier, the rule provides that its

requirements do not apply if a proposed

safety measure Is needed to assure compliance with NRC requirements or protection against imminent public risk.

Thus. the backfit rule provides sufficient

flexibility for the Commission in future

rulemakings. Finally, the Commission can suspend

the backfit rule in a future rulemaking if

there is good reason. Thus. while It is our intent that this rule apply to

backfitting that arises from future

rulemaking. the final judgment on this

issue will rest with the Commission. If it

believes that there is good cause the

Commission could state, in the notice of

proposed rulemaking for a future rule.

that it was proposing not to apply some or all of the provisions of this backfit

rule and request public comment on the

underlying reasons. If. after considering

public comments the Commission finds

good cause, it can so state in the notice

of final rulemaking.

I concur in the views of

Commissioners Roberts and Zech.

Comments of Commissioner Roberts and

Commissioner Zech

Safety is paramount to the execution

of our mission. We believe that the

backfit rule is entirely compatible with

and supportive of this principle.

Unmanaged. uncoordinated and

inadequately analyzed backfits. on the

other hand. are not. There is nothing in

the backfit rule which would stand in

the wiv of a Commission action which

is needed to protect the public health

aind safety or in the way of the adoption

of pulicy changes which a majority of

the Commission believes are warranted

in the circumstances. . believe that in the execution of our mission to provide reasonable assurance that the public health nd

safety are protected. we must have in

place criteria and a system for the

Timely application of justified changes in

regulatory requirements. The so-called

backfitting regulation which has been in

place for many years has not completely

sat sfied this need. Although it

established a broad standard, it did not

also provide for a system to assure that

backfitting decisionmaking to apply the

standard is done in a disciplined.

systematic manner. The regulatory

svstem needs a backfitting rule which is

complementary to our overall regulatory

mission and which is practical to

implement. Our chief reason for voting

to adopt this backfit rule is that it

provides for a disciplined and

formalized review of regulatory

requirements to assure that there is a rational basis for modifications to a nuclear power plant. The rule along

with its explanatory statement, also

provides guidance and direction to the

staff regarding backfit management and

control. This disciplined approach to

backfitting will, in our judgment.

improve the overall effectiveness and

certainty in the regulatory process. thus

enhancing our regulatory mission.

Discipline and management of

backfitting do not mean that safety

actions which are justified will be

obstructed, or that the Commission will

not continue to have the discretion ta

adopt policies and rules which it

believes will serve to enhance the

protection of the public health and

safety. Instead, they mean that attention

and priorities will be focused on areas where action is justified to carry out our regulatory responsibilities. Inadequately

managed and controlled backfitting. on the other hand provide no assurance that modifications. Individually and

collectively are in the best overall

interest of protecting the public health

and safety.

We have carefully considered the

views of our dissenting colleagues. and

although we respect them, we see the

matter quite differently. As we have

noted, we believe that this backfitting

rule serves a vital regulatory need. We see no reason why the important subject

of rulemaking which may involve

generic backfitting should be excluded

from coverage. It is true, as one of our colleagues points out, that rulemaking is

subject to the procedures in the

Administrative Procedure Act. It is also

correct that we have in place a Committee to Review Generic

Requirements CRGRJ and have

informal practices which. in their

totality may. in an individual case serve the purpose of the rule if everything falls

into place properly in a rulemaking

proceeding. The chance of this

happening however. is not to us an acceptable substitute for the system

which is being put in place as a matter

of overall Commission policy in the

backfitting rule. And even assuming

that, under its present charter and under

its incumbent chairman, the CRGR did cover all of the elements of the

backfitting rule, this is not the

equivalent of published Commission

policy which states the applicable

criteria and procedures. The policy and

system which are set forth in the backfit

rule provide a much sounder foundation

for Commission control over future

rulemaking requirements than relying

exclusively on existing procedures.

We believe that the procedural

requirements of the Administrative

Procedure Act and the functions of the

CRGR are compatible with the

objectives of the backfit rule. However. we also believe that application of the

rule to rulemaking is necessary to assure consistent application of the backfitting

policy under a prescribed uniform

system. regardless of whether a proposed change is generic or plant

specific.

The APA does not provide such a system, but does of course, provide for

the important procedural requirement of

assuring that there is adequate public

notice and opportunity to comment. This

does not provide the assurance needed

that the substantive matters covered in

the backfit rule will be considered either

by the staff or the Commission in the

Commission's rulemaking decision.

There is no requirement for anyone to

participate in a rulemaking proceeding.

and even for those who choose to

participate there is no provision to assure that there will be systematic and

comprehensive coverage of backlitting

issues. Indeed. It appears unusual for

either the staffs recommendation to the

Commission or for the fwl rulemaking

decision to address in any detail If at

all, the application of new requirements

to existing licenses and applications. A

rulemaking proceeding which meets all

of the procedural requirements of the

APA would not necessarily assure that

the subject matter in the backfit rule is

indeed covered. This is not surprising

because the objectives of the APA and

the backfit rule are. as noted.

fundamentally different. Furthermore. we are not able to distinguish. for

purposes of the objectives of this

backfitting rule between backfitting

modifications which are imposed by

individuals in specific plant-by-plant

situations and modifications which are imposed by a change In a regulation in a rulemaking proceeding. In each instance a disciplined system should be followed

to assure that the backfit Is fully

understood and justified in terms of its

safety relationship and Its related costs.

If the backfitting policy and system are sound and are needed. as we believe

they are. the straightforward way to go

about dealing with the backfit problem

is to publish a Commission policy. This

is what the backfitting rule does.

We do not share the concern of our dissenting colleague regarding the

litigative risks because rulemaking is

covered. We are informed that that risk

should be minimal. But regardless of

whether it is or it isn't. if the rule is

Appendix A 9 NUREG-1409
38106 Federal Register I Vol. 5. No. 183 I Friday. September 20. 1985 I Rules and Regulations

needed. if it makes sense. and if it is a

responsible regulatory action on our part. we should be prepared to defend our decisions in its application In summary. we support fully the

backfit rule. induding its coverage of

rulemaking. The rule will bring

discipline and accountability to the

imposition of plant modifications by the

Commission by establishing criteria and a system for rational decisionmaking. Without any question. we believe this

approach will enhance the quality of our mission to assure that the public health

and safety are protected In our licensing

and regulatory requirements decisions

Separate Views of CommIssIoner

Aielstie

In adopting this backfitting rule. the

Commission continues its inexorable

march down the path toward non- regulation of the nuclear industry In

two previous decisions the Commission

found acceptable the present level of

risk of a severe accident at the most

highly populated site for an operating nuclear plant in this country. See.

Consolidated-Edison Company of New

York (Indian Point. Unit No. 2 CU 85-4

21 NRC 1043 98s). The Commission's

decision was made without an adequate explanation or rationale: it was made

without an adequate analysis of the

issues and it was made by ignoring the

enormous uncertainties in our methods

for estimating risks The Commission

then extended that decision to all

nuclear plants through its Severe

Accident Policy Statement. See Policy

Statement on Severe Reactor Accidents

Regarding Future Designs and Existing

Plants 50 FR 3158 (August a 1985). This backfitting rule is another part of

the Commission's withdrawal from

active regulation of the industry.

The Commission's rule in effect says that nuclear reactor risks a so acceptable and o well nderstood that

the burden of proof for lowering the risk

to the public must be placed on the

proponent of improved safety even if

that proponent is the Commission itself.

This optimistic view of the risks posed by nuclear power plants Is unjustified.

The Commission's adoption of this rule

is truly an unprecedented step n the

annals of regulation I can think of no other instance in which a regulatory

agency has been so eager to stymie its own ability to carry out its

responsibilities. Indeed, the adoption of

this rule is the most compelling evidenci

to date of the Commission majority's

open hostility to the regulatory mission

of this agency.

I do not believe that there is a need

for a formal Commission regulation restricting the Commission's ability to

require safety improvements for nuclear

power reactors. My opinion is shared by our reactor safety technical staff,

including the Commission's chief safety officer. The Commission's purported reason for promulgating this rule Is to

add "discipline" lothe backfltting

process The Commission can add

discipline to the backfitting process without at the same time unnecessarily

limiting its own discretion to impose new safety requirements by fettering itself with this rule. Further. by adding layer upon layer of procedures to the

backfittling process the Commission bas

created a lawyer's paradise in which

litigation over procedural Irregularities

may hamper the Commission's ability toimpse needed safety requiemnentre Even if I felt that a backlt rule were appropriate. I would not support a rule as poorly thought out as is this one. This

rule sets a threshold standard for

improvements to safety which Is much

too high given our present understanding of risk and the

uncertaints associated with our methods of estimating risk. Further the

factors to be considered in determining whether a backfit should be Imposed are skewed against Imposing new requirements. In addition the.

Commission's determination of risk in

the cost-benefit balance is to be based on unreliable risk analyses. The consequence of this rule is to limit

the NRC staffs and even the

Commission's ability to identify and

correct safety weaknesses at the nuclear

power plants in operation and under

construction in this country. As a result.

these weaknesses are likely to persist

until they cause serious operating events or accidents which pose a direct threat

to the health and safety of the public.

This rule, then. further ensures a continuation of the piecemeal. reactive

approach to safety which has been

responsible for many of the failures of

the past. By this step, the Commission is

moving in the wrong direction-a

direction that will likely result in furthei

serious operating events. mor accidents and a lower level of safety

than that achieved in many more forward-thinking countries in the world.

I discuss each of my reasons for

opposing this rule in more detail below.

The Nature of the Backfttg Problem

When asked to describe the

backfitting problem. most of our e licensees point to the substantial

number of hardware modifications.

procedural changes and human factors

improvements which have been require by the NRC in recent years. The bulk of

these now requirements can be traced I

three sources: the Commissios fire

protection rule: its rule requiring the

environmental qualification of electrical

equipment: and the Commission s response to the Three Mile Island

accident. It is worth noting that each of

these broad safety initiatives was adopted by the Commission itself in

response to the identification of

significant areas of safety vulnerability

within the industry.

Typically, the industry does not

challenge the need for improvements in

fire protection or the need to assure that

safety-related electrical equipment will

be able to function under serious

accident conditions. Nor does the

industry deny the need to address the numerous safety weaknesses brought to

light by the Three Mile Island accident.

Rather. Xie industry largely focuses its

criticisms on the process used to

translate those broad areas of needed

improvement into specific modification

to plant hardware, procedures and

operations.

The industry raises five specific

complaints. First. our licensees argue

that new requirements often fail to

define clearly what Is expected of the

industry. Second. they contend that the

Implementation of these requirementsthe process by which more general directives are translated into specific modifications-is not well managed. In

support of this argument the industry

points to some past failures in

documenting proposed modifications. in

ensuring consistency in making plant- specific implementation decisions. in

providing effective management

oversight of plant-specific decisions and

in providing a fair opportunity to appeal

objectionable staff-proposed

modifications, Third. our licensees

assert that specific plant modifications

are proposed by staff members who

have a single narrow area of interest.

and little consideration is given to the

overall safety impact of the proposed

change. Fourth. the induc argues that

the staffs Implementation process all

too often fails to provide a final decision

from the staff on the adequacy of the

licensees efforts to comply with a

requirement until after the licensee has

made the modification to its plant. This

process. they contend. exposes the

industry to second-guessing by the NRC

staff and sometimes leads to making repeated modifications to address the

same problem. Finally, the licensees

argue that the Commission sometimes

adopts arbitrary and unrealistic

,d deadlines for the implementation of new requirements. More than anything else.

,o these complaints focus on the

management of the backfitting process.

NUREG-1409 10 Appendix A
Federal Register Vol. SD. No. 183 I Friday. September 20. 1985 Rules and Regulations 38107

In the literally thousands of

backfitting decisions made by the NRC over the past several years I am sum that some examples can be found to

support each of these complaints.

However. I believe that each of the

industry's valid concerns is addressed

by the administrative backfitting

management improvements already

adopted by the Commission.

WhyA Rule?

The Commission claims that this rule

is necessary to provide a "management process" for the adoption of Commission

regulations and staff interpretations of

those regulations. Implicit in the

Commission's explanation of this rule Is a feeling on the part of the Commission

that it is necessary to add discipline to

the backfitting process. The Commission

never clearly explains why if added

discipline is necessary they must embed

that discipline or management process

in a formal agency rule. The

Commission also refuses to explain the

connection between discipline and the

necessity for a substantial threshold that

must be surmounted before safety can be improved. Further the Commission never adequately explains why it cannot

accomplish improved management of

the backfitting process without at the same time imniting its own discretion to

require safety improvements by

requiring that Commission rules comply

not only with the Administrative

Procedure Act, but also with this rule.

By choosing to adopt this rule the

Commission admits failure. The

Commission admits that it has been

incapable of solving administratively

whatever problems it sees with the

management of the backfitting process.

By adopting this rule, the Commission savs to the world that it so mistrusts its own ability to act in a sensible manner and it so mistrusts its ability to control

the NRC staff that it must have a formal

rnle which limits the Commission's

delbetion and which can be used as a bludgeon to control the staff.

The irony of this all is that the

administrative actions taken by the

Commission to formalize the backfiUting

process have already been successful in

adding discipline to the process and in

addressing the valid concerns of the

industrv. A senior official of one of the

Utilities involved most actively in the

backfit debate recently told me that

when his company first expressed its concerns about backfitting all it wanted was to get NRC management to pay

attention to backfitting problems. The

company simply wanted a brief-written

statement for each proposed backfit

describing the proposed change and the

%RC stafis reasons for requtring the

change. together with the right to appeal

to upper NRC management the decisions

being made at the lower levels of the

NRC staff. Their objective, this official

said. is already being achieved by the

Commission's internal management

directions to the NRC staff.

Whatever -backfitting problem"

exists is really a management problem.

The Commission's statement of

considerations acknowledges that. And.

the problem is being corrected

independently of this rule. Why then

must this rule be promulgated without

delay? Apparently it is because the

movement to put in place a backfit rule

is much like an avalanch-once it starts

rolling it cannot be slowed down or changed in course.

Lawyer's Paradise

By embedding the Commission's

backfit management process in the form

of a rule, the Commission has chosen to

formalize a process which ought to be a purely internal management tooL In

doing so. the Commission has imposed

upon sif a particular management

process as a legal requirement which

cannot be ignored. adapted to

circumstances or changed without once again going through formal rulemaking

procedures. The rule provides a myriad

of opportunities for licensees to invoke

procedural irregularities in challenging

the Commission's rules and its

backfitting decisions. The rule lends

itself readily to being used as a delaying

tactic by uncooperative licensees and it

has the potential for hamstringing the

Commission's ability to impose needed

safety improvements while the legal wrangling goes on and on and on. The Commission's decision to include

Commission rulemaking within the

coverage of the backfit rule is an excellent example of the

overproceduralization of the backfit

process. The Administrative Procedure

Act and cases interpreting it set out

requirements for rulemaking. Interested

parties are given an opportunity to

comment on the proposed agency action

before it goes into effect. The

Commission must then take those

comments into account before

promulgating a final rule. The courts can then review Commission action and test

it for reasonableness and rationality.

The Commission wishes to add on to

these legal requirements a very high

standard or threshold the Commission

must meet before it can institute safety improvements. Further the rule requires a strict cost-benefit balance. something

the courts have not found is required by

the Atomic Energy Act or the

Administrative Procedure Act. Contrary

to Chairman Palladino's assertion the

Commission cannot decide whether to

follow these new more stringent requirements in individual rulemaking

proceedings on a case-by-case basis.

This regulation now becomes binding on the Commission and must be followed

in all future rulemakings.

In addition to this. the backlit rule

applies to staff interpretations of

Commission rules. By the rule's literal

terms any staff interpretation of a Commission rule would also have to

meet the requirements of the backfit

rule. Thus, the Commission would be

required to meet a high threshold and

perform a cost-benefit balance for shy

rule It issues, and the staff would then

have to again meet the same high

threshold and perform a new cost.

benefit balance before it could interpret

that rule. That is absurd but that Is

what the rule appears to require.

Even if rulemaking were not to be

included within the scope of this rule.

staff interpretations of Commission

rules would be This presents an interesting dilemma. The Commission's

1985 Policy and Planning Guidance

states: The Commission Intends to shift

its regulatory emphasis away from

detailed. prescriptive requirements

toward performance criteria" See.

NUREG-885 Issue 4. "U.S. Nuclear

Regulatory Commission Policy and

Planning Guidance as5. This means that new rules will tend to be general in

nature. It is difficult for safety reviewers

and inspectors to review and inspect

generalities. They need to develop

positions on acceptance criteria

hardware requirements. applicable

quality assurance provisions technical

specifications etc. The rule would

require that these interpretations meet

the requirements of the backfit rule.

Thus. if rulemakings are outside the

scope of the backfit rule but

interpretations of those rules are not it

may create a situation where the staff

cannot adequately interpret the rule

because the interpretations would not

meet the backfitting requirments even though the Commission's rule has been

otherwise legally promulgated.

if these are the results the

Commission intended, then the

Commission's backfit rule makes no sense whatsoever. If this is not what the

Commission intended. then the

Commission should make that

absolutely clear. Such ambiguities do

nothing but provide fodder for litigation.

These problems illustrate further how

poorly written and how poorly

explained is this rule. These are the

kinds of issues one should not have to

make guesses about.

Appendix A 1 1 NUREG-1409
38108 Federal Register I Vol. 5 No. 183 Friday. September 2. 1985 / Rules and Regulations

It Is interesting to note that my colleagues constantly complain about

the length and over-legalization of the

licensing process. often arguing that

-ere are too many procedures and that

; e process is too formaL Yet those

same Commissioners who want to make

tne licensing process as simple and

informal as possible have here added

layer upon layer of procedures to the

backfltting process. In fact, they have

added procedures far beyond those

which are legally required. and In the

process have added new opportunities for litigation.

Barrier to Impraoed Safety

The Commission'a rule sets up a

threshold standard that the Commission

-ust meet before it can adopt new

safety requirements. Under this rule. the

Commission cannot reduce the

radiological risks to the public unless it

first determines that a proposed safety improvement provides a -substantial

increase in the overall protection of the

public health and safety or the common

defense and security:' Section

50.109(a)(3. Thus. the Commission

creates a significant banter to reactor

safely improvements. The Commission's explanaton In the

statement of considerations of what it

means by Isubstantial Increase Is so

unclear as to be useless. However an

indication of what the Commission

really intends can be found in the

Commission's recent Indian Point

decision. 21 NRC 1042 In that

Poceeding. the Commission's technical

aff and Licensing Board urged the

amission to require a set of safety improvements for the reactors sited at

the most highly populated locations in

this country. Upon learning that those

improvements only cut the risks to the

public in hail the Commission rejected them as not providing a "substantialr

Increase in protection. 21 NRC 1043.

I would prefer a standard which does

not set such a high threshold for the

imposition of safety improvements In

fact. I proposed such a standard. Under

my proposed standard the Agency would require improved safety upon a

determination that a proposed measure provides a net increase in the protection

of the public health and safely and that

the costs of this improvement are not

incommensurate with the increased

protection. This standard would allow

more improvements in safety than

would the Commission's standard but

would still exclude proposed changes which would result in only trivial safety improvements. The Commission rejecteE this standard because it does not

present a high enough barrier to block

new safety requirements Apparently

the Commission is Interested in more

than simply bringing discipline to the

backfitting process. Rather It s really Interested in tying its own and the stfra

hands-to restrict the number of safety Improvements. If the Commission really onywanted dbscplIne and sound

think ing to be brought to the backlitting

process t would not fee the need to

propose such a stringent threshold for

safety improvement

Tipping the Sce ZAgainst Safety

The rule specifies nine factors that

.are to be used as balancing mechanisms in the decisionrmaking

process for backfltting'. See. 50.209(c)

for list of factors. If one cuts through the

extraneous matter in that section of the

rule. one finds that the Commission

requires cost-benefit analyses to be

performed on ail proposals for backfits.

Ocourse. In cost-benefit analyses the

bottom line depends on what factors.

one chooses to put on the ale.

Not satisfied that a high threshbid

standard will sufficiently limit the

number of backfits, the Commission has

also decided to stack the cost-benefit

balance. The only benefit the

Commission Is able to identify as being appropriately considered In deisos on

whether safety should be improved is

the "potental chane in the risk to the

public froin the accidental off-site

release of radioactive material" Secton

50109(c13). Risk Is typically defined as

the probability of an accident multiplied

by the consequences with the latter

expressed as the collective dose to the

public(person-rem) However even here

the Agency's typical practice is to ignore societal doses beyond a 20-mile radius.

As calculations of accident

consequences indicate, this procedure

captures less than hel of the health

consequences of core meltdown

accidents

The Commission refuses to include

among the "balancing factors' the

averted costs of off-site property

damage resulting from radiological releases. The Commission does not

seem to realize that core meltdown

accidents can contaminate off-site

property to hazardous radiation levels

and that there is real benefit in

preventing that from occurring. Averting the necessity to decontaminate such

property is a real benefit of backifits

which lessen the likelihood of off-site

releases of radioactive materials. Since

these costs in some instances

substantially exceed the monetized

value of averted health effects resulting from accidents the Commission has no

defensible basis for omitting from the

"balancing factors' off-site property

decontamination costs.

The Commission also rejects the

inclusion of the benefits derived from

averting damage to the plant itself. The

TMI-2 accident, which apparently did

not result in extensive melting of the

reactor core or substantial offsite

releases of radioactivity resulted in

billions of dollars in plant damage. plant clean-up and power replacement costs

The Commission s rule fails to recognize that preventing such costs has a public benefit The Commission chooses to

ignore averted replacement power costs

associated with safety improvements that prevent accidents. However. In

order to inflate the costs side of the

equation which weighs against backfitting. the rule requires consideration of the replacement power

costs for the facility downtime

associated with implementing a backlit.

At the same time the Commission

Ignores the benefits of backfits. the

Commission trIes to include every conceivable "cost' of the backfit In the

balance The rule includes costs such as

Installation and other costs associated

with physically changing the plant the

cost of facility downtime. e. 8

replacement power costs. etcr the coSt of

construction delay; and, radiological Impact on facility emnployees. The

Commission has even thrown the cost to

the NRC (resource burden on the NRC) into the balance. Obviously this stacking of the deck against safety improvements indicates once again that the

Commission is interested in more than

just adding discipline to the backfitting

process.

The Commission majority tries to

argue that the balance of costs and

benefits is not slanted because other

benefits beyond those enumerated in the

rule can be considered Their own

actions contradict this argument In

adopting this rule the Commission

majority expressly rejected proposals to

include additional health and safety and

economic benefits of proposed backfits

that would have resulted in a fair and

even-handed consideration of oil

relevant costs and benefits. Given Its

own actions the true intent of the

Commission majority is beyond doubt.

Reliance on Indefensible Analyses

The Commissions rule places great reliance on Probabilistic Risk Analyses

(PRA's. In determining the "change in

riWsk as required by this rule the

Commission intends to rely on the

bottom-line results of PRA's

Unfortunately, numbers produced by these analyses amount really to only estimated guesses: yet. the Commission

intends to rely heavily on these

numbers. which nearly all PRA

12 Appendix A

NUREG-1409
Federal Register Vol. 50. No. 183 / Friday September 20. 1985 I Rules and Regulations 381Q9

practitioners agree are unreliable in

determining whether to require

improvements in safety.

Preparation of a PRA requires that the

analyst calculate the core meltdown

probability. Given a particular core meltdown scenario, the analyst must

then calculate the containment failure

mode. the quantity of radioactive fission

products released from the containment

Ithe "source term"). the dispersion of the

fission products in the atmosphere and

finally the radiation doses to the public.

The calculated probabilities from all of

the above are multiplied by the

aggregate doses to the public. This is the

risk to the public.

To calculate the change in risk, as required by this rule the analyst must

first calculate the risk to the public

before a proposed safety improvement is

implemented. and then calculate the risk

assuming the Improvement is made.

Unfortunately the necessary

calculations cannot be made based on data, and scientifically accepted

principles and methodologies. Because

of major inadequacies in the data base.

because of the vast complexity of

nuclear plants. because a tremendous

number of assumptions must be made.

because all contributors to risk cannot

be quantified and because core meltdown phenomena are poorly

understood no one calculation of risk

yields a remotely meaningful value of

risk. I discussed the meaningless nature

of these risk estimates in more detail in

my separate views on the Severe

Accident Policy Statament.

Our experience with the Davis Besse

plant provides an excellent example of

the inadequacies of PRAs for truely

predicting risk. It also illustrates the

shortcomings of a system which relies

heavily on strict cost-benefit balances

for making decisions on safety

improvements. The Davis Besse plant .u3 one of the most (if not the most) - ia'b!e emergency feedwater systems

(EFS) of any nuclear plant in this

country. The NRC staff has been trying

to require Davis Besse to upgrade its

EFS reliability. However for the last

several years. the licensee has been

using reliability and cost-benefit

analyses to argue that substantial

upgrades should not be required. Two

independent reliability analyses (one by

the utility and one by the NRC staff) were performed on the EFS at Davis

Besse. The results of these two studies

differed by a factor of 100 in their

estimate of the reliability of the systems.

The studies also differed an what was the most cost-effective way to upgrade

the svstem. The utility argued that its

cost benefit analyses showed that only

some low-cost minor changes were justifiable while the staff argued that its

cost-benefit analyses supported more significant modifications. Because the

Commission-required cost-benefit

analyses could not demonstrate the

necessity of a particular way to upgrade

the EFS reliability the staff could not

require a substantial upgrade of that

system even though the plant continued

to operate with an unreliable but crucial

safety system during the several years

of the PRA debate between the staff and

the utility.

The une 9 1985 Davis Besse event

demonstrated that the PRA analyses

were wrong. Davis Besse had a loss of

all feedwater that involved the failure of

24 separate pieces of equipment. (See.

NUREG-1154. "Loss of Main and

Auxiliary Feedwater Event at the Davis.

Besse Plant on June S. 1985"). The event

led the Agency's chief safety officer to

observe: "I believe that the recent

Davis-Besse event illustrates that. in the

real world, system and component

reliabilities can degrade below those we and the industry routinely assume in

estimating core melt frequencies.' (See

memorandum from Harold R Denton to

William . Dircksa. dated June 27.1985).

Further it appears that the steam and

feedwater rupture control system had a significant role in causing the loss of

emergency feedwater. Yet that system was not even included as a possible

contributor to the unreliability of the

emergency feedwater system in either of

the independent reliability studies.

Despite this clear evidence of the

weaknesses in PRA studies and their

potential for manipulation and

distortion. the Commission persists in

using them and in requiring their use by the staff in this rule as the basis for

deciding on safety improvements.

Although this rule will have a negative impact on all aspects of the

Commission's reactor safety activities.

its effects are likely to be greatest in the area of improving human performance.

Recent operating experience indicates

that roughly half of all significant

operating events can be traced to

inadequate human performance in such areas as reactor operations surveillance

testing and maintenance. A number of

the Commission's post-TMI

requirements have focused on human

performance but recent operating

experience demonstrates the need for

further improvements in this area. Indeed. virtually all members of the

Commission have advocated further measures to improve the qualifications.

experience and training of plant

personnel. Specifically, members of the

Commission have spoken in favor of

increasing the engineering knowledge

and skills of plant operators and

requiring the use of plant-reference

simulators for operator training and

testing. Common sense and sound

engineering judgment tell us that such measures will have a positive effect in

improving plant performance. Yet it will

be especially difficult to assess how

such proposed requirements will reduce

the risk of a core melt accident which

might result in harm to the public. Thus.

the practical effect of this rule will be to

thwart the efforts of the NRC staff to

develop new safety requirements in the

area of human performance where such

requirements could be of the greatest

safety benefit

Ignoring Uncertainties

The Commission also fails to deal

with the huge uncertainties associated

with the risks of nuclear reactors. The

actual risks could be up to 100 times the

value frequently fcked by the

Commission. One would think that the

uncertainties about the level of safety

achieved at the operating reactors

would have a bearing on whether

reactor safety should be improved. I

proposed that the Commission articulate

its expectations on the handling of

uncertainties in the backfitting

decisionmaking process before allowing

this rule to become effective. The

Commission rejected my proposal.

There is no reference in this rule to

uncertainties in reactor risks or to how

uncertainties are to be factored into

safety decisions. The Commission's

silence simply reaffirms its practice of

ignoring the enormous uncertainties in

nuclear risks when deciding whether to

improve the protection of the public

health and safety.

Selective Applicotion of the Rule

The Commission's stated manner of

applying this rule is also troubling. First.

according to the statement of

Considerations. a licensee may request an amendment to Its license and the

NRC staff is not required to consider

whether the amendment represents a "substantial increase in the overall

protection of the public health and

safety" However if the NRC staff

wants to amend a license to establish a more stringent standard the staff must

first demonstrate that the amendment

meets that backfitting standard. Thus.

the rule stacks the deck in favor of the

industry and against the NRC staff.

But more troubling is the

Commission's apparent intent to apply

this backfit rule with its high threshold

and cost-benefit analysis only to those new Commission requirements which

Appendix A 13 NUREG-1409
38110 Federal Register / Vol. 50. No. 13 1 Friday. September 20. 1985 Rules and Regulations

are intended to Improve safety. If one reads the Commission's rule literally. it

applies to any change in Commission

requirements both a change to make

requirements more stringent and one to

relax requirements Further the

Cummission states in its statement of

.:siderations: 'lhere s no Intent on tne part of the Commission to Include

within the scope of the exceptions (to

the rule) new or modified interpretations

of what constitutes no undue risk to the

public health and safety. In such a case. the rule applies: All of this seems to

indicate that the backfit rule applies across the board to new Commission

regulations and Interpretations.

However. the Commiuion's actions

and rhetoric would seem-to Indicate

otherwise. Te Commission has been

devoting and continues to devote

considerable agency resources to

relaxing the current emergency core cooling regulations and the emergency

planning regulations Fot example. the

staff Is developing new and relaxed

(relative to the current staff positionl

acceptance criteria for emergency core cooling systems that would effectively

allow the licensees to increase the

power level of the operating reactors.

Likewise the Commission assigns resources to work on a rule that would

allow less comprehensive evacuation

planning. Both activities involve new or modified interpretations of what

constitutes compliance, involve a modified interpretation of what

constitutes "no undue risk.' and do not

fall within any of the exemptions to the

backfit rule. Thus, if one reads the

backfit rule literally, the Commission

must determine that increasing the

power level of reactors and diminishing

the level of emergency preparedness

result in a "substantial increase in the

overall protection of the public health a no saiety or common defense and

security." It would take quite a bit of

convoluted argument to find that

relaxing safety standards meets the

rule's substantial increase requirement.

One can only conclude that either the

Commission is wasting resources on

these activities or that it does not intend

to apply the backfit rule to actions

which relax existing safety standards.

This problem of interpretation is

another example of how poorly thought

out and how poorly written is this rule.

Ihe Commission should mnake clear

exactly what is the scope of this rule,

and should revise the rule accordingly.

Otherwise, this apparent ambiguity once again produces nothing but fuel for

litigation.

Conclusion

*I might be as sanguine as is the

Commission about the current state of

reactor safety, and I might be willing to

restrict the Commission's ability to

require safety Improvements if there were a clear understanding of the level

of safety already achieved at plants and

if that understanding demonstrated that

the potential for severe accidents is

Indeed very remote. Unfortunately the

Commission does not have a clear

understanding of the level of safety of

current reactors.

The Commission does not know

where we are on the learning curve for

reactor performance, and there is a distinct possibility of one or more severeaccidents in the foreseeable future.

Operating experience indicates that a total loss of a safety system is not a rare event that multiple independent failures

do occur that there are component and

reliability problems, that operating,

practices are frequently derfciemt and

that thee re a wide range of adverse

systems interactions.r The Commission is

reluctant to face these facts and to

demand Improved safety because that

might suggest to the public that the

existing reactors are unsafe and might

hinder the further development of the

nuclear industry.

In my view, another severe accident

may well bring to a halt further

development of the nuclear industry

and. if people are injured may

jeopardize continued operation of

existing reactors. The Commission has

said there is about a 50-50 chance of

another severe accident in the next

twenty years. The Commission finds

that risk so acceptable that it can now through this rule, put roadblocks in the

way of further safety improvements I

find the Commission's actions to be not

only unwise but harmful to the public

interest and potentially hazardous to the

public health and safety.

The Commission will next turn its

attention to the forth and final action

that will complete the framework for

deciding whether the NPC and the

industry will pursue safety issues before

accidents occur Ie. the Safety Goal

Policy Statement. That will be the final

opportunity to come to grips with the

pivotal issues the Commission has

steadfastly avoided over the last several

years. As I wrote In my separate views

on the Severe Accident Policy

Statement. It is encouraging that there

appears to be an emerging consensus within the NRC senior technical staff

and within the ACRS in favor of safety

Iimprovements to reduce severe accident

risks. However. it s dismaying that the

Commission, having lost all sight of the

broadest lessons learned from the TMSI2 accident. has chosen to hinder

enhancing the protection of the public

health and safety through this backfit

rule.

Views of Commissioner Bernthal

I had fully expected to support the

Commission's final rule on backfitting.

Unfortunately an eleventh-hour

decision by the majority has added a destructive provision that at best can only confuse the public and out

licensees by Its misrepresentation of the

role and options of the Commission in

rulemaking at worst it contains the

seeds for rulemaking chaos with

litigative risks, unpredictability and,

lengthened timetables that will result in

more, rather than less uncertainty in the

Commission's entire licensing and

regulatory process. Such a backfitting

rule Is surely not in the public interest or in the interest of our licensees.

In a word. my principal quarrel with

the rule adopted by the Commission is

its nclusion of rulemaking in the

definition of backfitting. Indeed the mere idea of imposing its own rule on the statutory procedures for rulemaking as set forth in the Administrative

Procedures Act should have given the

Commission majority long pause to say

the least.

But In its apparent desire to appear to

have voluntarily circumscribed its own authority and flexibility for rulemaking (when it cannot of course, ultimately do

so) the Commission has instead chosen

to run the risk of creating new, legally

binding requirements for rulemaking.

requirements which will only widen the

target for anyone seeking to challenge a final rule.

It is not even clear just who it is the

Commission believes will be served by

this action. Far from lending discipline

and order to the rulemaking process

what the Commission majority has done

will help insure that our often long and

tortured consideration of rules will

become even longer more tortured. and more confusing. More ominously, should a future Commission find common-sense public health and safety measures unduly confused and obstructed by the

backfit rule. it may in frustration choose

simply to begin issuing by order rules"

that today would be subjected to the

carefuL disciplined process set forth in

the Administrative Procedures Act.

The only rationale the majority has

offered for wanting to include

rulemaking under the backfit rule is to

"discipline" the Commission (i.e to

protect the Commission from itself If

the Commission is incapable of

disciplining itself in the rulemaking

NUREG-1409 14 Appendx A
Federal Register Vol. 50. No. 183 Fridav. September 20. 1985 Rules and Regulations 38112 Federl RegsterI 13 I Fiday Vol 50.No. Septmber20. 185 I ulesarid egultions 3811

process as it stands (what with the

existing Committee to Review Generic

Requirements and the Commission's

incontestable authority and ineluctable

responsibility to instruct the staff), then

I doubt that nule laid upon rule will do

much to teach the Commission the virtue

of self-discipline.

More specifically. the Commission

majority presumably knows that the

backfit threshold criteria applied to

rulemaking would apply not just on a plant-specific basis (which it should be

recalled was the intent of the original backfitting initiative). But to generic

decisions that may affect dozens of

plants. and in fact to rulemaking on all

but procedural matters. rulemaking that

may or may not have the remotest

connection to what the public and our licensees normally consider a plant "backfit". The scope of Commission

rulemaking responsibilities thus often

involves broad public policy considerations. and those

considerations can rise above elements as simple as cost-benefit analysis to

reach issues as fundamental as fairness

and individual rights. The Commission's

backfit rule. if applied to rulemaking

itself, will thus serve only to trivialize in

appearance and confuse in practice the

many factors to be weighed in

rulemaking.

As one small example of the morass into which the Commission majority has

wandered. consider (as the Commission

currently is considering) whether there

should be a requirement that radiation

workers be provided their dose records

annually. The "benefit" of this "backfilt

cf Commission rules may seem clear.

but it might very well never pass the

cost benefit test. Indeed. it is difficult to

imagine a rule that would involve the

human-factors element of plant operations, and that would also be

amenable to straightforward costbenefit analvsis.

pol!ernsking as it exists involves

.;xieious inherent procedural checks

and balances to insure that each -

proposal is carefully considered prior to

adoption. Indeed, rulemaking is the

forum which provides the greatest

number of checks against arbitrary action by the Staff or Commission. Much

of the analysis (including cost-benefit)

which the new backfitting rule would

require is already done informally

throughout the process of considering and adopting new regulations. If the Commission wishes to insure

still more structure in the rulemaking

process. structure which could take into

account every single factor set forth in

the backfit rule and more. there are ample means of doing so by simple internal agency management Such

methods would reaffirm existing

Commission guidelines to the Staff

without opening the door to additional

needless litigation as a consequence of

vague new, legally enforceable.

Commission-created rights added to

those already available to all parties

under the APA.

The entire backfit rulemaking was undertaken to bring order and

accountability to plant modifications

heretofore sometimes imposed without

the benefit of systematic evaluation and

justification. In rulemaking per se. that

objective has always been well within

the Commission's grasp-it is. after all.

the Commission that makes rules. For

good measure. the Commission also has

the Administrative Procedures Act as a matter of law, and its own Committee to

Review Generic Requirements as a matter of internal administrative policy

to assist it in carrying out such

considered decision-making. Casting the

net of the new backfit rule bver

Commission rule-making (almost as an afterthought as it happened in this case)

is thus at best an exercise in pointless

symbolism. and at worst potentially

destructive of the Commission's entire

rule-making process.

Unneeded law is bad law, and

unneeded regulation is bad regulation.

The Commission majority has imposed on this agency new regulatory

obligations in rulemaking that are not

only unneeded. but which the

Commission majority itself hopes and

trusts will be of little practical (i.e.

legally enforceable) consequence. To the

extent that this rule will affect

rulemaking. it will therefore be a bad

rule. In sum the Commission majority

has inexplicably insisted on fixing not

only what is. but what ain't broke. I will

not be a party to such poor judgment.

Environmental Impact: Categorical

Exclusion

The NRC has determined that this

final rule is the type of action described

in categorical exclusion 10 CFR

51.22(c)(3). Therefore, neither an

environmental impact statement nor an

environmental assessment has been

prepared for this final rule.

Paperwork Reduction Act Statement

This final rule does not contain a new

or amended information collection

requirement subject to the Paperwork

Reduction Act of 1980 (44 U.S.C. 3501 et

seq.). Existing requirements were

approved by the Office of Management

and Budget. Approval Number 3150-

0011.

Regulatory Flexibility Act Certification

In accordance with the Regulatory Flexibility Act of 1980. 5 U.S.C. 605(b). the Commission hereby certifies that

this final rule. if promulgated, will not

have a significant economic impact on a substantial number of small entities. The

affected facilities are licensed under the

provisions of 10 CFR 50.21(b) and 10

CFR 50.22. The companies that own

these facilities do not fall within the

scope of "small entities" as set forth in

the Regulatory Flexibility Act or the

Small Business Size Standards set forth

in regulations issued by the Small

Business Administration in 13 CFR lart

121.

List of Subjects

10 CFR Port 2

Administrative practice and

procedure. Nuclear power plants and

reactors, hazardous waste.

10 CFR Part 50

Antitrust. Classified information. Fire

prevention. Incorporation by reference.

Intergovernmental relations. Nuclear

power plants and reactors. Penalty. Radiation protection. Reactor siting criteria. Reporting and recordkeeping requirements.

For the reasons set out in the

preamble and under the authority of the

Atomic Energy Act of 1954. as amended.

the Energy Reorganization Act of 1974.

as amended and 5 U.S.C. 553. the NRC

is adopting the following amendments to

l0 CFR Parts 2 and 50.

PART 50-DOMESTIC LICENSING OF

PRODUCTION AND UTILIZATION

FACIUTIES

1. The authority citation for Part 50

continues to read as follows:

Authority Sec3. 103. 104. 161. 182. 183 186.

189. 68 Stat. 936. 937. 948. 953. 954 955. 956. as amended. sec. 234 83 Stat. 1244. as amended

(42 U.S.C. 233.2134.220 232. 2233.2236

239. 22821: secs. 201. 202 268 UStat. 1242.

1244. 1246. as amended 42 U.S.C. 5841. 5842

58461. unless otherwise noted.

Sec. 50.7 also issued under Pub. L 95-601. sec. 10. 92 Stat. 2951 (42 U.S.C. 58511. Sections

5057(d. 40.8. 30.91. and 50.92 also issued

under Pub. L 97-415. 96 Slat. 2071. 2073 142

U.S.C 2133. 22391. Section 50.78 also issued

under sec. 122. 68 Stat. 939 42 U.S.C. 21521.

Sections 50.1050.1( also issued under sec. 184. 68 Sta 954. as amended 42 U.S.C. 22341.

Sections 50.100-50.102 also issued under sec. I86 68 Stat. 955 142 U.S.C. 2236.

For the purposes of sec. 223. 6 Stat. 958. as amended (42 U.S.C. 22731. i 50.10 ia. (I. and c. 50.44.50.48.50.48 5054. and 50 tsl are issued under sec. 161b. 68 Stat. 948. as amended 142 U.S.C. 2201bl: I 5010 bl and

(ci and 50.54 are issued under sec. 161i. 68

Appendix A 15 NURE3G-1409
38112 Federal Rescister I Vol. SO. No. 183 / Friday. September 20. 1985 Rules and Regulations

38112 Federal Register f Vol. 50. No. 183 / Friday. September 20. 1985 / Rules and Regulations

Stat. 94. as amended (42 US.C 2201t1)): and

II solutel, 50.59(bl. 50.m 50.71.502.5 0.73. , and 50.78 are issued under sec. 11o. 68 Stat.

950 as amended (42 US.C 2 01o).

2. n 50.54 paragraph (If) is revised to

Toad as follows

1 50.54 Conditions of lcensee.

(f The licensee shall at any time

efore expiration of the license, upon .-quest of the Commission submit

written statements. signed under oath or affirmation, to enable the Commission to

determine whether or not the license

should be modified suspended or

revoked. Except for information sought

to verify licensee compliance with the

current licensing basis for that facility.

the NRC must prepare the reason or reasons for each information request

prior to issuance to ensure that the

burden to be imposed on respondents s

justified in view of the potential safety significance of the issue to be addressed

in the requested information. Each such

justification provided for an evaluation

performed by the NRC staff must be

approved by the Executive Director for

Operations or his or her designee prior

to issuance of the request.

3. In 50.109. paragraph (a) Is revised.

paragraph (b) is removed. paragraph (cl

is revised and redesignated as (b). and new paragraphs c (d) and (e) are added to read as follows:

S 50.109 Sackfttini.

(alil) Backfiltting is defined as the

modification of or addition to systems.

structures. components. or design of a facility: or the design approval or manufacturing license for a facility. or the procedures or organization required

lo design. construct or operate a facility;

any of which may result from a new or

amended provision in the Commission

rules or the imposition of a regulatory

ni rLiot interpreting the

Commission rules that is either new or different from a previously applicable.

staff position after

(I) The date of issuance of the

Jnstruction permit for the facility for

facilities having construcuon permits

Issued after October 2. 198: or (ii) Six months before the date of

docketing of the operating license

application for the facility for facilities

having construction permits issued

before October 21. 1985; or

(ii;) The data of issuance of the

operating license for the facility for

facilities having operating licenses: or iv) The date of issuance of the design

approval under Appendix Me N or 0 of

this part.

(2) The Commission shall require a systematic and documented analysis

pursuant to paragraph (c) of this section

for backfits which it seeks to impose.

Imposition of a backfit pursuant to

paragraph (a)(4)(liJ of this section shall

not relieve the Commission of

performing an analysis after the fact to

document the safety significance and

appropriateness of the action taken.

(3) The Commission shall require the

backfitting of a facility only when it

determines, based on the analysis

described in paragraph (c) 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 of implementation for that

facility 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 theI

standard does not apply where the staff

finds and declares, with appropriate

documented evaluation for its finding.

either

(II That a modification Is necessary to

bring a facility into compliance with a license or the rules or orders of the

Commission or into conformance with

written commitments by the licensee; or (ii) That an immediately effective

regulatory action is necessary to ensure that the facility poses no undue risk to

the public health and safety.5

Such documented evaluation shall

include a statement of the objectives of

and reasons for the modification and the

basis for invoking the exception

(b) Paragraph (a) of this section shall

not apply to backfits imposed prior to

October 21. 19.

(c) In reaching the determination

required by paragraph (a) of this section.

the Commission will consideihQw the

backfit should beipriorizdiand

scheduled in light of other regulatory

activities ongoing at the facility 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;

I For those modifications which am to ensure that

the facitity posn no undue risk to the public health

and salaty and which ar not deerned to require

immediately effective resutatory action. analyses

are required: thee analyse. however should not

involve cost conaidernniona except only insofor as

cool contributes o selecting the solution a*msu

vanous acceptable alternatives to enaunng no

undue nisk la public health and safety. '

(2) General description of the activity

that would be required by the licensee or applicant In order to complete the

backit;

[3) Potential change in the risk to the

public from the accidental off-site

release of radioactive material

(4) Potential Impact on radiological

exposure of facility employees.

(5) Installation and continuing costs

associated with the backflit. including

the cost of facility downtime or the cost

of construction delay;

(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 facility type. design or age on the

relevancy and practicality of the

proposed backfit

(9) Whether the proposed backfit Is

Interim or final and. if Interim the

justification for Imposing the proposed

backflt on an Interim basis.

(d} No licensing action will be

withheld during the pendency of backfit

analyses required by the Commission's

rules

(e) The Executive Director for

Operations shall be responsible for

implementation of this section and all

analyzes required by this section shall

be approved by the Executive Director

for Operations or his designee.

4. In Appendix 0 to 10 CFR Part 5 a new section (8) is added to read as follows:

Appendix 0-Standardization of

Design; Staff Review of Standard

Designs

* . * * 

& Information requests to the approval holder regarding an approved design shall be

evaluated prior to isuance to ensre that the

burden to be imposed on respondents is

justified in view of the potential safety significance of the issue to be addressed in

t he requested information Each such

evaluation performed by the NRC staff shall

be in accordance with 0 CFR 50,54(nl and

shall be approved by the Executive Director

for Operations or his or her designee prior to

Issuance of the request.

PART 2- AMENDED]

5. The authority citation for Part 2

continues to read as follows:

Authority Seca. 11. 181.88 Stat. 948. 953.

as amended (42 USC 221. 2231: sec. 191. s

amended. Pub. L 8015. 7 Sat. 408142

NUREG-1409 1 6 16 Appendix A
Federal Register Vol. 50. No. 83 / Friday, September 20. 1985 / Rules and Regulations 38113

U.S.C. Z2411: sec. 201.88 Stat. 1342. as

amended (42 U.S.C. 58411:5 U.S.C 552.

Sec. Z101 as issued under secs. 52.62. 63.81.

103. 104. 105. 8 Stat. 930. 932. 933. 935. 938.

937. 938. as amended 142 U.S.C. 2073. 2092.

2093. 2111. 2133. 2134.21351: sec. 102. Pub. L

91-190. 63 Slat. 853. as amended (42 U.SC.

43321: sec. 301. 8 Slat. 1248 (42 U.S.C. 58711.

Sections .12O Z103 2.104. 2105. 2.721 also

issued under secs. 102. 103.104. 105. 183. 189.

68 Stat. 936. 937. 3 954. 955. as amended (42

US.C. 2132. 2133. 2134. 2235. 2233. 2Z391.

Section 2.105 also issued under Pub. L 97-

415.96 Stat. 2073 (42 U.S.C. 2239). Sections

22.206 also issued utder secs188. Z34.

68 Slat. 955. 83 Stat. 444. as amended 142

U.S.C. 22 2282): sec. 206.8 Slat. 1246142

US.C. 5841. Sections 2.300-2.309 also issued

under Pub. L 27-415. 96 Stat. 2071 (42 US.C.

2133) Sections 28-2.606 also issued under

sec. 102. Pub. L 91-190. 83 Slat. 853 as

amended (42 U.S.C. 43321. Sections 2.700.

2.78 also issued under s U.S.C. 554. Sections

2.754. 2.760. 770. Z2.780 also issued under 5

U.S.C. s57. Section 2790 also issued under

sec. 103. 68 Stat. 36 as amended 142 U.S.C.

21331 and S U.S.C. 552 Sections 2.t00 and

2J08 also issued under 5 U.S.C. 553. Section

2.809 also issued under 5 U.S.C. 553 and sec.

29. Pub. L 85-256 71 Stal. 579. as amended

(42 U.S.C. 20391. Appendix A also issued

under sec 6. Pub. L 1-580. 84 StaL 1473 (42

USC 2235).

a. Section 2.204 is revised to read as

follows

1 2.204 Order for modification of ceanse.

The Commission may modify a license

by issuing an amendment on notice to

the licensee that the licensee may

demand a hearing with respect to all or

any part of the amendment within

twenty (201 days from the date of the

notice or such longer period as the

notice may provide. The amendment

will become effective on the expiration

of the 20-day period during which the

licensee may demand a hearing. If the

licensee requests a hearing during this

20-day period the amendment will

become effective on the date spetified

in an order made following the hearing..

When the Commission finds that the

public health safety or interest so

requires. the order may be made

immediately effective. If the amendment

involves a backfit. the provisions of

I 50.109 of this chapter shall be

followed.

Dated at Washington. D.C this 17th day of

September. 198.

For the Nuclear Regulatory Commission.

Samuel I. C*lk.

Secretary of the Commission.

IFR Doc. as-22572 Filed 9-19-5: 8:45 aml

sBm COOK 75041-U

DEPARTMENT OF

HUMAN SERVICE!

iEALTH AND Food and Drug A4dninistration

Social Security Adjilnistration

20 CFR Part 404

21 CFR Part 520

Oral Dosage Form

Not Subject To Ce

Meglumine Paste

AGENCY: Food and

ACTtOk: Final rule.

New Animal Drugs

tlficatlon; Flunixin

)rug Administration. I Regulation No. 41 

Federal Old-Age,

Disabillity Insuran

Impairments-Me

Correction

In FR Doc. 8-20

35038 in the issue

28. 1985. make the

1. On page 35040

seventh line from

should read "or".

2. On page 35044

fourth Comment. si

word -only" betwe

3. On page 35045

third Comment. si

read "be".

4. On page 35046

fourth Comment. s

bottom. "patient's

"patients..

5. On page 3504

second Comment

should read "large

8. On page 35049

first Response. twe

should read "nece

7. On the same pi

in the first Respons

the bottom. "indivi

"individuals". Also

'720J Menta/Ret

"7.05 Mental Reza

8 On page 35068

complete paragrap

read "include".

Bnlue COot 150"1-1

irvivors, and

; Usting ot

al Disorders

52 beginning on page

Wednesday. August

llowing corrections:

third column

e bottom. "of'

first column in the

:th line, insert the

-n "if" and "one".

third column in the

line, "by" should

first column in the

ond line from the

hould read

first column in the

t line. -larger"

first column in the

fth line. "necessary'

arily".

ge. second column.

second line from

ual should read

in the third column

dation" should read

dotion .

third column, first

'including' should

SUMMARY: The Foo 

Administration 

animal drug regula a

approval of a new n

application (NAD

Corp., providing fo f

paste. The paste is a to alleviate inflam a musculoskeletal di o

EFFEcTItV DATE: S

FOR FURTHER INFO

Sandra K. Woods.

Medicine (HFV-11

Administration

Rockville. MD 208

SUPPLEMENTARY tN t

Schering Corp_ Ga

Kenilworth. NJ 070

137-409 for Banam

meglumine). Fluni

for the alleviation

pain -associated wi

disorders in horses

approved and the

amended to reflect

basis for approval

freedom of inform

In accordance w

information provis

CFR Part 20) and I

CFR 514.11(e)(21(ii

safety and effectiv

information submi

approval of this p

in the Dockets Ma

(HFA-305). Food

Administration. R

Lane. Rockville.

to 4 p.m.. Monday

The agency has

CFR 25241d)(1lliii)

16636) that this act

does not individua

have a significant 

environment. There

environmental asse environmental impi

required. _

and Drug

) is amending the ns to reflect

imal drug

riled by Schering

lunixin meglumine

ir oral use in horses

tion and pain from

rders.

tember 20. 1985.

tAllOK CONTACT.

enter for Veterinary

Food and Drug

I Fishers Lane.

301-433420

ORtAuIOtC The

oping Hill Rd.

1. has filed NADA

ie® Paste (flunixin

i meglumine paste is

inflammation and

musculoskeletal

The NADA is

gulations are he approval. The

discussed in the

ion summary.

h the freedom of ns of Part 20 21

514.11(e)(2)fiil 21 a summary of ness data and

ed to support

lication may be seen gement Branch

d Drug

4-2. 5600 Fishers

20857, from 9 e.m.

rough Friday.

termined under 21

April 26.1985: 0 FR n is of a type that

y or cumulatively

ct on the human

Ore. neither an sment nor an ct statement is

C

20 CFR Part 404

Soal Secuy

Employees of P

Organizations, W

States, Etc.

Correction

In FR Doc. 85-2i:

36571 in the issue c 9. 185 make the ft

On page 36572. 

DATEs paragraph.

1. In the first an date of publication

"September 9. I1

2 In the eleventl

should have read IltC coo so.e1.6

leflts; Coverage of

kte Nonprofit

' Outslde United

21. beginning page

Monday. September

owing coections:

t column, in the

second lines. "(insert

should have read

line "received"

eceive 

List of Subjects in CFR Part 520

Animal drugs. or

Therefore. under

Drug. and Cosmeti

authority delegatec

of Food and Drugs

the Center for Vete

520 is amended as

I use.

he Federal Food.

Act and under

to the Commissioner

nd redelegated to

nary Medicine. Part

llows

Appendix A 1 7 NUJREG-1409
APPENDIX B

THE 1988 BACKFIT RULE

NUREG-1409
Federal Register / Vol. 53. No. 10 / Monday, June . 1988 / Rules and Regulations 20603

TABLE I-Continued

EfeCOV3 p3aod 

Avocado VWAIet

. a3rd Mm S0 151 an 1 *2 l6 Guateatall S~dq 2 - on O. ... t S. a IS

St Mon Oct - I_ st Sun 13

. 'i. Sat Mon SW- - 3rd Su ft 2 4216I "d Mon SqL_ _ 5th S 00 Z U4 441116

Brooks 97 54 'st Mm -W S _ U $-US

2nd Mn Sept _. 3d Sat Sept _0 3-1116

3rd Mon S1pL - 2nd Sun Oct I t-14/t6

2nd Mon Sep-- 2nd Sun t6 Is 310116

PAIS____Mm_________ _ ___ __ r dSonuSn _ 30 44/16

3rd Mon 1gt loSt 84 _151111

tst Lon 3rd Od t16 3-616

lii ___k __o_ 2nld Mon0 S . _oo . 1 SW12 3-1/16

4UI M st S S} to O T 3

SW& - 3rd Mon Sept- - 2SanOct 16 "Il6

ChOqutte _ * _epL. _ rd Sn Oc 2S 4-4116

3rd Mon Oct S 5th Su Oct 84 4-1/16

5th MmOCIt- 21d Sun l N 20 V_ 3-14116

__ _ _ _ _............... 4th Mon Sept. . .. _ rd San Oct IS 5-14f16

Lsonn- iJdsunOct 16 3-10416

MaR-.1--- __ __ - - 2W sun Oct *6 3-46

Al~d th SUII X40 OctOdg 20 "is/6

*th Mof 1lt 90 N~~~f_ U8 4/16

-_______ 1gt _ t6 s_ ll ~lW 34116gt -

"armark- ~ ~ ~ ~ ~ ~ a Ct _S Sn Ort N S4t16 so sun Oct ~14. 34/116

____ ____________1lS 90 O~t __ _1 3rd SunS Oct 6 341116 31 _______ Sn Otct. 14 3-I16

on M oct... - _ 2nd Sun Nov.___ 12 34116

x t *_* 2nd MM 1n Oct. th Sun Oct 18 3-14116

Ta1or __ ____ .2nd Mon Oct _ 4th Sun Oct 14 -6/16

Ist Sun Now 12 34116

000th 3. .. 2nd L..n Ot_____ Oct1 3jdun SW611

ad Mlon Oct -_ _ 51h Sun O t_ 14 3.116

Id..... th Mon Oct..... Wrd Sun Nov _ __ 6 312116

Moroe - _ _ - t on No- _.---. W Sun Now 26 44/16

3rd Mon Nov... -st 5Sun 0.c 24 4-1116

1st Mon Dec.__ _. 3rd Sun Dc. _ 20 3-14116

3rd Mon aqc_~~ Ist Son Jan_.... 16 3-6/16

Booh I ___ _m __2nC WM onov __ Sun N6 1 3-tV6

/ 4g ~on No-_ _ 2nd Sun O-_ 12 3-6

MiO f - - - __ 2nd Mon _ov.__ _ 4_ Sun N 12 3-1U16

4th Mon N- _ 2 Sun O 2-t4/t6

I~g___ _ __ ___ ___ 3rd Mon Nov- . t tSun Oe 12 3C16

I at Mon oc _ 3W Sun Dc _ t-VI6 0 

Drooksla__ 2nd Mon Dc. c -_ 3rd Sun Doc t6 313t6

3rd Mon Doc_- 4th Sun Doc_ 16 310116

431 Mon Doc_- -2nd Sun Jn 14 316

2nd Mon Jan ___ 4th Sun Jn 12 35/16

4th Mon Jan I at 6n F tO

MO" () _ __ ___ 2nd Mon Dc___ 451 Sun 0 _ 13 "le

41 Mon Doc_ -- 2nd Sun Jan - _ IS 3

Afed () _ ____ Mon __Dec. ___2nd - 4th Sun DOC.... 12 3-4/16

4th Mon Dc- . 2nd Sun Jan 10 34r16

2nd Mon Jam Sun Jan __| 6 a

6th MM Oct. --.. 4th S.n N.13 3 6

!vdos V W lWlndian st p vanriet and th West inan type dings not listed eIsewere hi Table L

Avocados o Ow Gutoanmsna t vaiet. hWW varieties, and unidantiied seedirg not ised alswher. hi Table .

Dated: I

Robedt C.

,Deputy Di

Divisoft

[FR Doc. I

sIatIN co

* * .

wCtor Fruit and Vegetable

-12551 filed 8-3-; 6:4S mam

E t4104241

NUCLEAR REGULATORY

COMMISSION

10 CFR Part 50

RevisIon of Backfltwtng Process for

Power Reactors

AGENCr: Nuclear Regulatory

Commisslon

ACTIOK Final rule.

sUmMiAR The Nuclear Regulatory

Commission Is promulgating an

amended rule which governs the

backfitting of nuclear power plants. This

action Is necessary in order to have a

backfit rule which unambiguously conforms with the August 4. 198

decision of the U.S. Court of Appeals for

the District of Columbia in Union of

Concerned Scientists. et al. v. U.S.

Nuclear Regulatory Coznmisslon. Th1is

action Is intended to clarify when

economic costs may be considered in

backfitting nuclear power plants.

EFFECTIVE DATE: July 6 1988.

Appendix B 1 NUREG-1409
-

20604 Federal Register / Vol. 53, No. 108 / Monday, June 8. 1988 / Rules and Regulations

FOR FURTHER INFORMATON CONTACT:

Steven F. Crockett. Office of the General

Counsel. U.S. Nuclear Regulatory

Commission, Washington. DC 20555.

'one: (202) 492-1800

SUPPLiMENTARY FORMATION:

Background

; On September 20.1985. after an extensive rulemaking proceeding which

included sequential opportunities for

public comment on an advanced notice

of proposed rulemaking (48 FR 44217:

September 8 1988) and a notice ofproposed rulemaking (49 FR 47034;

November 30.1984), the Commission

adopted final amendments to its rule

which governs the backfitting of nuclear

power plants. 10 CFR 50109(50 FR

38097 September 20 1985). Backfitting Is

defined in some detail in the rule, but for

purposes of discussion here it means measures which are directed by the

Commission or by NRC staff in order to

improve the safety of nuclear power

reactors, and which reflect a change In a prior Commission or staff position on the safety matter in question.

judicial review of the amended

bacdfit rule and a related internal NRC

Manual chapter which partially implemented it was sought and, on August 4,1987, the U.S. Court of

Appeals for the DC Circuit rendered its

decision vacating both the rule and the

NRC Manual chapter which

implemented the rule in part. UCS v. NRC. 824 F2d 103. The Court concluded

that the rule, when considered along with certain statements in the rule

preamble published in the Federal

Register, did not speak unambiguously in terms that constrained the

Commission from considering economic

costs in establishing standards to ensure adequate protection of the public health

and safety as dictated by section 182 of

the Atomic Energy Act. At the same time, the Court agreed with the

Commission that once an adequate level

of safety protection had been achieved

under section 18Z the Commission was fully authorized under section 1vi of the

Atomic Energy Act to consider and take

economic costs into account in ordering further safety improvements. The Court

therefore rejected the position of

petitioners In the case. Union of

Concerned Scientists. that economic

costs may never be a factor in safety decisions under the Atomic Energy AcL , Because the Courts opinion regarding Ehe circumstances in which costs may

be considered in making safety decisions on nuclear power plants was completely in accord with the

Commission's own policy views on this

important subject. the Commission

decided not to appeal the decision.

Instead, the Commission decided to

amend both the rule and the related

NRC Manual chapter (Chapter 05141) so that they conform unambiguously to the

Court's opinion. On September 10. 1987.

the Commission published proposed amendments to the rule (52 FR 34223) and provided for a comment period

ending on October 13,19871 The final

rule as set out in this document is

substantially the same as the proposed rule (52 FR 34223; September 10. 1987).

In this rulemaking the Cpmmisslon has adhered to the following safety

principle for al of its backfltting decisions. The Atomic Energy Act

commands the Commission to ensure that nuclear power plant operation Erovides adequate protection to the

ealth and safety of the public. In

defining. redefining or enforcing this

statutory standard of adequate protection, the Commission will not

consider economic costs. However.

adequate protection is not absolute

protection or zero risk Hence safety improvements beyond the minimum

needed for adequate protection are possible. The Commission is empowered under section 161 of the Act to impose additional safety requirements not

needed for adequate protection and to

consider economic costs in doing so. The 1985 revision of the backflit rule,

which was the subject of the Court's

decision, required, with certain

exceptions, that backfits be imposed only upon a finding that they provided a substantial increase in the overall

protection of the public health and

safety or the common defense and

security and that the direct and Indirect

costs of implementation were justified in

view of this increased protection. The

amended rule, set out in this document.

restates the exceptions to this

requirement for a finding, so that the

rule will clearly be in accord with the

safety principle stated above.

IIn its comments on th proposed amendments.

the Union of Concerned Scientists asserts that de

Federal Register notice of the proposed amendmentrwas technically delective. UCS argues that since the Court had vacated the entire rule, the

Fedeesl Register notice should have proposed

nactmnent of an entir amended. rule. rather then

simply amendments to the vacated rule. In weihins

the technical merit of uCW argument. It should be

noted that as of the date of the Fed Rsistwr

notice, the mandate of the Court had not yd issued

and the rub wa thus still legally in effet

However, the more important consideration Is that

the notice dearly revealed the Commission's Intent to reissue the backfut rule once Ithad been

conformed to the Court's decision UCS understood

this intent and took the op ty to resubmit the comments It had submitted during the rulemaking leading up to the 1I55 revision of the rule. In any event the Commission ia publishing the entire rule

In this document

Particularly in response to the Court's

decision. the rule now provides that it

the contemplated baclit involves

defining or redefining what level of

protection to the public health and

safety or commnon defense and security should be regarded as adequate, neither

the rule asubstantial ncrease standard, nor its "costs Justified"

standard, see i 50.109(a)(3), is to be

applied (See I 50 109(a)(4)(iil).] Also In

response to the Courts decision, see 824

F.2d at 119, the rule now also explicitly

says that the Commission shall always require the backfitting of a facility if It

determines that such regulatory action is

necessary to ensure that the facility provides adequate protection to the

heat and safey of the public and lin r accord with the common defense and

security. 

On instruction from the Commission,

the NRC staff has amended its Manual

chapter on plant-specific backfitting to ensure consistency with the Couirts -

opinion. Copies of the revised chapter are available for public inspection in the

Commnission's Public Documtent Room,

1717 H Street NW, Washington. DC

20S55.2

Response to Commients

Comments were received from 12

utilities. one Federal agency (DOE). one vendor, seven individuals, seven citizens groups, and two industry

groups. Lengthy and detailed comments were submitted by the Union of

Concerned Scientists (UCS) and the

Nuclear Utility Backfitting and Reform

Group (NUBARG). Both organizations were active in the rulemaking which led

to the 1985 revision of the rule. The

comments submitted by these two

groups encompassed most of the

comments made by others. Below, the

Commission paraphrases the chief

comments and responds to them. The

Commission has given careful

consideration to every comment. The

original comments may be viewed in the

NRCs Public Document Room in

Washington, DC

several commentes rgue that the revised

Menual chapter should undergo what amounts to

otice and comment rulemakng However. the

Manual chapter. U It isa rule at all. ta a rule'of

agency organiation procedure. or practice. and

therefore lanot sublect te the notice end comment requirements of the Administrative Procadure Act.

Sees U.SC. 350(bNA); se also I SnXe)(2, The

Commission did publish for comment en earlier versioe of Manuel Chapter (49 FR Im April 2

1941. but that version was aready in eff1at when It was published for comment, and It was pubis hd

for comment only beeupa the C ommssion was stie In the process of making fundamental changes to

the bckfitting procss end wantedcomment on th

procedure then in effect. see id.

NUREG-1409 2 Appendix B
Federal Register / Vol. 53, No. 108 Monday, June . 1988 1 Rules and Regulations 20605

'Adequate Protection"

The great majority of the commenters

raised issues about the rule's use of the

phrase "adequate protection". This

phrase Is used in the rule's exception

provisions. See I 50.109(a](4). Generally,

the rule requires, among other things,

that It be shown for a given proposed backfit that implementation of the

backfit would bring about a 'substantial

increase" in overall protection to public

health and safety, and that the direct

and indirect costs of the backfit are Justified by that substantial increase.

See I 50.109(a)(3). However.

I 50.109(a)(4) also requires that these

two standards not be applied In three

situations.

First where the backfit Is required to

bring a facility into compliance with

NRC requirements or the licensee's own written commitments:

Second, where the backfit is

necessary to ensure that the facility

provides adequate protection to the

health and safety of the public and is in

accord with the common defense and

security, and

Third. as noted above, where the

backfit involves defining or redefining what level of protection to the public

health and safety or common defense

and security should be regarded as adequate. The comments on the rule's use of the

phrase "adequate protection" generally

took two forms, each discussed more fully later on in this notice. The first

form, most fully represented by UCS'

comments was that the rule itself

should actually include a definition of

"adequate protection" (the final rule set

out in this document does not), a phrase nowhere explicitly defined in general

terms, either in the Atomic Energy Act.

from which the phrase comes, or in the

Pommission's regulations. The second, more modest, form of the

comments on "adequate protection".

most fully represented by NUBARC's

comments, was that one or another of

the three-exception provisions in the

rule was redundant (none is). While not

amounting to a call for a definition of

.adequate protection", NUBARG's

comments displayed some of UCS'

uncertainty about what the Commission

meant by the phrase. Each group had difficulty applying the

phrase to characterize past Commission

action in backfitting. UCSclaimed that

the Commission had never bacfitted in

order to achieve something beyond 'adequate protection." NUBARG.

however, claimed tLtat the Comnission

had never required a backfit on the

grounds that compliance with the

regulations was not enough to provide

adequate protection. These views.

differing in emphasis, reflect the two

groups' opposite concerns about the

possibility that the Commission would use the phrase 'adequate protection7 arbitrarily. UCS is concerned that the

Commission might interpret the phrase 'adequate protection" to refer to a level

of safety such that every proposed improvement would be subjected to

cost-benefit analysis. Conversely, the

Industry appears concerned that the

Commission might interpret the phrase "adequate protecion" to refer to a level

of safety such that no proposed

Improvement would be subjected to

cost-benefit analysis. The Commission certainly did not

Intend that this rulemaking should focus on the meaning of the phrase "adequate

protection". The main point of this

rulemaking was simply to negate the

misimpression left by two statements In

the preamble to the 1985 version of the

backfit rule. UCS puts forward two

grounds for its emphasis on the phrase 'adequate protection". First. UCS

asserts that "(t~he crucial decision as to

whether cost benefit analysis will be

used in assessing the need for

backfitting is dependent on whether the

particular backfitting under

consideration is needed to ensure adequate safety * . " Second. UCS

claims that the Court "ordered" the

Commission to "stop trying to obscure

its intentions through ambiguous and

vague language 

However, as will be explained more fully below, the Court's decision turned

not on the rule's lack of a definition of ..adequate protection" but rather on two

statements which seemed to the Court to

imply that the Commission intended to

take costs into consideration in

determining what "adequate protection"

required; the meaning of "adequate protection was simply not an issue In

the litigation. Moreover. UCS

overestimates the role the phrase "adequate protection" plays in the

backfit rule. The threshold decision in

considering a proposed backfit. and very

often the only decision that need be

made,' is not whether adequate protection is at stake but rather whether

the facility Is In compliance with the

Commission's requirements and the

licensee's written commitments.

Even if UCS is right about the

importance of the phrase 'adequate

protection, there Is nothing unusual or

9 For instance. a majodty of the pfant-spedtic bacikfts carried out during the fint year after the

1955 re*ren of the backltt rule became uffectie were for the sake of compliance. See SECY-SS-40.

Evaluation of Managing Plant-Speciflc Bacill

Requirements November 21.1986t. EnclosureS.

imprudent, and certainly nothing illegal.

about decisions which ultimately turn on the application-by duly constituted

authority and after full consideration of

all relevant information-of phrases which are not fully defined Consider

for instance, the "reasonable assuran;e"

determination the Commission must

make before Issuing an operating

license. 4 Indeed, most of the

Commission's rules and regulations are ultimately based on unquantified and. as we note below presently unquantifiable

ideas of what constitutes "adequate

protection'.

Were there something peculiarly

critical about the role of "adequate protection" in the backfit rule, the issue

of the phrase's meaning could have been

raised in the rulemaking for the 1985

rule. Two of the three exception provisions set out above were in the

1985 revision of the rule where they

used the equivalent phrase "undue risk"

instead of "adequate protection'. Also. as the Court in UCS v. NRC noted, 824

F.2d at 119 the statement of

considerations which accompanied the

1985 version of the rule quite explicitly

at least twice limited the consideration

of costs in backfiting decisions to

situations where "adequate protection" was already secured.'

Nonetheless an Issue which Is a concern of almost every commenter in

this rulemaking should not be ignored.

Therefore, the Commission will answer as best It can the questions the

commenters have raised concerning the

rule's use of the phrase "adequate protection". We begin with UCS' call for an objective and generally applicable

definition of adequate protection". We

argue that such a definition is not

possible in the near future, but that the

public and licensees are nonetheless

protected against misuse of the phrase.

In the course of responding to UCS'

comments we shall, of necessity be

making at least preliminary responses to

most of NUBARG's comments also.

UCS argues that the rule permits the

agency to escape its legal responsibility

4 l in operating license may be Issued by the Commission ' upon finding that ' tlihere is reasonable assuran . * that t.

activities authorized by the operating license can be

conducted without endangerto t health and

safety of the public ' ' ' o CFR 5057e1(3l I

The considertion nd velshins of coat s contemplated by the rute ppliestobockfits *At are intended to result In incremental safety I

improvements for a plant that already prorides an acceptable degne o protectiorijr r i 3im. cot

1: also. the costs asociated with proposed new afey requirements may be considered by the

Commission provided that the Atomic Enr At

finding 'no undue risk' can be made Id. at 3OL

col 3

Appendix B 3 NUREG-1409
20605 Federal Register / Vol. 53. No. 108 / Monday June 8 1988 / Rules and Regulations

to articulate the factors on which It

bases its backfitting decisions. UCS

asserts that the rule should 'enunciate

criteria and guidelines about what

constitutes redefining and defining

-adequate protection levels, what

constitutes an adequate as opposed to a beyond adequate protection level and

what factors place a particular circumstance within the rule or within

the exceptions." Another comment

asserts that any definition of "adequate protection" should include the resolution

of all outstanding safey issues. Yet

another calls for "objective criteria.

"some real numbers on releases.

accident consequences and the like.

There does not exist and cannot

exist, at least not yet, a generally

applicable definition of "adequate protection" which would guard against

every possible misuse of the phrase.

Congress established "adequate

protection" as the standard the

Commission is to apply in licensing a plant see 42 U.S.C. 2232(aJ. and gave the

Commission authority to issue rules and

regulations necessary for protection of

public health and safety see 42 U.S.C.

2201. but Congress did not define

"adequate protection', nor did t

command the Commission to define It.

Such a definition would have to take one of two forms, one of them Incapable

of preventing the abuses the

commenters are concerned about and

the other simply not possible yet. The

first of these would be a verbal

definition of the kind encountered in, for

instance, the various "reasonable man"

standards in the common law. After the

pattern of these the Commission could

say. correctly, that "adequate protection" is not zero risk, that it is the same as "no undue risk" that it has

long-term and short-term aspects, and

that it Is that level of safety which the

Atomic Energy Act requires for initial

and continued operation of a nuclear

power plant. However, such a definition

clearly will not, of itself, prevent the

abuses UCS and NUBARG am concerned about nor is such a standard

sufficiently helpful to the NRC staff in

actual practice.

Thus, if there is to be a useful and

generally applicable definition of

"adequate protection" it must take

another more precise form, namely,

quantitative. Several of the commenters seem to have such a definition in mind

whexn they call for "objective criteria". J m e "real numbers" and the like. In

atthe Commission is actively

pursuing reliable quantitative measures of safety, and some quantitative and

generally applicable definition of

"adequate protection" may eventually

emerge as a byproduct of the

Commission's efforts, still in their early

stages. to implement its general safety

goals, which take a partly quantitative

form. (See 51 FR 30028; August 21 1988.

Policy Statement on Safety Goals.]

However given the state of the art in

quantitative safety assessment it Is not

reasonable to expect that the

Commission could make licensing

decisions-let alone decisions on whether to consider cost n backfittingwholly on a quantitative definition of

adequate protection". Surprisingly some of the commenters who call for

objective criteria. "some real

numbers", and the like, have in the past criticized quantitative risk assessments.

Nonetheless even in the absence of a useful and generally applicable

definition of "adequate protection", the

Commission can still make sound

judgments about what "adequate

protection" requires. by relying upon

expert engineering and scientific

judgment acting in the light of all

relevant and material information As

UCS itself said in Its comments on the

proposed 1985 revision of the rule,

"(ujitimately, the determination of what

standards must be met in order to

provide a reasonable assurance that the

public health and safety will be

protected comes down to the reasoned

professional judgment of the responsible

official:

The Commission's exercise of this

judgment will take two familiar forms

of which the most important is rule and

regulation. An essential point of the

Commission's having regulations is to

flesh out the "adequate protection"

standard entrusted to the Commission

by Congress. See UCS v. NRC, 824 F.2d

at 117-18 Exercising engineering and

scientific judgment in the light of all

relevant and material Information the

NRC identifies potential hazards and

then requires that designs be able to

cope with such hazards with sufficient

safety margins and reliable backup

systems. Regulations and guidance arrived at in this way do not, strictly speaking "define" adequate protection.

since there will be times when the NRC

issues rules which require something

beyond adequate protection.

Nonetheless, compliance with such

'regulations and guidance may be

presumed to assure adequate protection

at a minimum. As the Commission has

said on many occasions, compliance with the Commission's regulations and

guidance "should provide a level of

safety sufficient for adequate projection

of the public health and safety and common defense and security under the

Atomic Energy Act." (49 FR 47034, 47038.

col. 2 November 30 1984. proposed 1985

rule; see also 50 FR 38097 3101. col. 3.

September 20,1985 final 1985 rule; 51 FR

3002 col I August 211988, Policy

Statement on Safety Goals.)

Because "adequate protection" is

presumptively assured by compliance

with the regulations and other license

requirements. all the versions of the

backfit rule-the 1970 rule, the 1985 rule,

and the one set out in this document see

I 50.109(a(4(i)-have a "compliance exception: plants out of compliance may

be backfitted without findings of

"substantial increase" in protection or a "justification" of costs.

However-and here is where the lack

of a general definition for "adequate

protection' poses a challenge-

"adequate protection" is only

presumptively assured by compliance.

As the Commission said in promulgating

the 1985 revision. the presumption may

be overcome by for instance, new information which indicates that

improvements are needed to ensure adequate protection. (50 FR 38101 col.

3.) Such new informatfon may reveal an unforeseen significanthazard or a substantially greater potential for a known one, or insufficient margins and

backup capability. Engineering udgment

may in the light of such information

conclude that restoration of the level of

protection presumed by the regulations

requires more than compliance. Thus

both the 1985 revision and the revision

below contain exemptions for backfits

necessary to assure 'adequate

protection", or, as the 1985 rule

equivalently said. "no undue risk". See

I 50.109(a)(4J(ii) of the rule set out in this

document.

If compliance does not assure adequate protection, the Commission

must be able to determine how much more protection is required, and a precise and generally applicable

definition of "adequate protection'

would facilitate that determination. But

such a definition would have only a limited role to play. The first and most

crucial question is whether the proposed

backfit Is required to bring a plant into

compliance. Only if the proposed backfit

requires more than compliance with

NRC regulations and license conditions

need there be a determination as to

what "adequate protection" requires.

Given this relation between compliance

and "adequate protection", the industry might be more concerned than UCS is

about the lack of a general definition of

adequate protection", for UCS will at

least have the comfort of knowing that

compliance will be secured before cost

Is considered but the industry cannot be

NUREG-1409 4 Appendi B
Federal Regdster I VoL 53. No. 108 Monday, June 6, 1988 Rules and Regulations 20637

sure how much more than compliance

may be asked of it despite the cost.

Where, as in the cases contemplated

by the second exception provision of the

rule, more than compliance Is required

and quantitative criteria do not define

"adequate protection", the agency must

fall back on the second familiar form in

which engineering judgment is exercised

by the Commission, namely, case-by- case. Administrative agencies are not

required to proceed by rule alone, for

the method of case-by-case judgment Is

quite capable of meeting the

requirement that the factors on which

administrative decisions are based be

articulated. Rather than proceeding by an almost ministerial application of

"objective criteria", the Commission

must fashion a series of case-by-case

judgments Into a well-reasoned and

factually well-supported body of

decisions which, acting as reasoned

precedent, can control and guide the

Commission's exercise of the discretion

granted it by Congress in precisely the

way in which common-law precedents

control and guide the common law

judge's exercise of his or her judgment Se Nader v. Ray, 363 FSupp. 946,954-

55 (D.D.C. 1973) (determining what

constitutes adequate protection calls for

exercise of discretion in a udgmental

process very different from acting in

accord with a clear, non-discretionary legal duty).

The Commission foresaw the need to

proceed case-by-case on occasion and

therefore made it a principal aim of the

backfit rule to centralize the

responsibility-and document the bases

for case-by-c e decisions for such

decisions. The Commission thereby

hoped to better assure that such

decisions as might of necessity be case- by-case would form a reasoned and

coherent body.'

UCS alleges that in three Instances the

Commission has abused its discreticn by applying coat considerations In specific casa, where ... licensees are In compliance but adequate protection o *t sake. However. UCS i misinformed about the

first or se three cases. and its allegations about the - other two radice simple to disagreetment over what

constitutes adequate protection. We briefly disrcus the three cas below,

Citing trade journal articles which quote unnamed

KRC sources. UCS claims that the backifi rule caused the NRC slg so change Its mind about requiring two licensegs to conduct certain

inspections and analyses In order to jastify continued operations The two plants In question had reactor pump coolant shafts similar to ones which elsewhere had shown a lgh probability of

shearing off under certain condilons. IJCS aerte

that iwl. learn from this example the - inherent tack do logic and circularity embedded n the rule: nRC Is prevented by operation or the rule. from asking questions needed to learn the degree of

risk of a known equipment problem because they do

not know the answers In adsvnce."

Nothing in the Court's ruling in UCS v. NRC forbids the Commission's approach

However. the facts of the eituatlonr. we net

what UCS alleges lhem to have been: Indeed the

backit rule was not Involved. latters wee sent on

April 23. ta requiring the licensees to stubmit

within 20 days Information which would "enable

the Comtission to determine whether or not (their)

icense(s) shoulo be modified.' Such Information

Included Ioformtion on design. operational iBtory

schedules for Inspection, plans for operator trainIng.

end any analysis performed subsequent to thoe

done for the ISAR (Final Safety Analysts Raport) which would address the consequences ofa lockd

,otor or broken shaft event during plant operation."

Ihe e letters were sent under'the first part of I0

CFR t.Il This part authorizes such infornation

requests without conaiderationof cost. As an earlIer

draft of the April 23 letter available in the NRC`s

Public Document Room shows. the NRC had

plbnred to ask for Dew analyses under a later part

of I .0.54(f) whlh authorizes requests not required

tn assure adequate protection if -the burdsn to be

imposed I justified In view of the potential

safety significance of the issue lo be addressed in

the requested informati:eL" 10 CFR 504%1). (This

"safety significance" standard by its emphasis on 'potential:. requires less than is required by the

lecturel substantial Increase standard in the

backfit rule end also avoids the circularity UCS

alleges.) However. the stall sensibly opted for first

asking whether such analyses had already been

done. In fact they had or were underway when the

latters wre setL The backfit rulc played no part

her.

UCS second Instance of alleged abuse Involves

the Mark I containment about whose performance

In beyond-devtigrbasi accidents (ones which

Involve damage to the reactor core) there to substantial uncertainty UCS aserts that coat

considerations have blocked staff action wich

would have brought about a significant reductin In some of the figure whilh estimate the probability

that the Mark I would fil In certatn kinds of

beyond-drsign-basis accidents. IUCS adds in passing

that those figures represent undue risk. Ie NRC

staff has already made a formal reply to similar

ctar2es of undue risk See, e.g.. Boston Edison Co.

(Pilgrim Nuclear Generating Staioil. Interim

Director's Decision under 10 CFR L20 DD417-t4.

21 NRC V7. a5-1OB pes9. Suffice It here to say that

the NRC staff has by no means completed Its

considerations of the Merk I contaminent but that

gIven present Information the staff has concluded

Ot overall severe-accident risks at plants with

Mark I contaInments are not undue. 14. at 1I0 6.

UCS [a content to put forward only unsupported assertions to the contrary. Thus the stiff may

leg!timately consider coat when deciding whether to

beckfil the Mark I containments.

UCS third allegation of abuse rehearses part of

Its February 10. 1987 2.SC Petition to the

Commission for Immtediate action to relieve

allegedly undue risks posed by nuclear power

plants designed by the Babcok a Wilcox Company. The NRCs Director of Nuclear Reactor Reguletion

responded fully to the Petition, denying L un October 9 It7 (tCS! comments on thr proposed backfit rule were submitted on October 13 See

Directors Decaion Under 10 CFR 1.206. D-4-I1.

28 NRC-(October 19. 197) The Director concluded

that -there are no substantial health and safry

issues that would warrant the suspension or revocation of any lrens or permit for such

facilities Slip Opinion at 63. Simply because UCS

disagrees wIth such conclusions does not mean that

the Commission Is misusing the "adequate

probetion trandard

to "adequate protection". UCS boldly

asserts that the proposed rule

"completely failledl to comport With the

orders and directions of the Court of

Appeals in UCS v. NRC", that the Court

"could not have been more clear abtut

the defects of the backfit rule".thatlthe

proposed revised rule "suffers from the

exact same defects" as the one vacated,

that, indeed, "the new proposal is even more devoid of objective guidance or -

criteria I than was Its predecessor."

UCS' criticisms are based on part of a single paragraph In the Courts decision.

In pertinent palrt that paragraph says

"I I In our view the backflting nile

Is an exemplar of ambiguity and

vagueness: indeed. we suspect that the

Commission designed the rule to

achieve this very result. The rule does

not explicate the scope or meaning of

the three listed 'exceptions'. The rule

does not explain the action the

Commission will (in Italics) take when a backfit falls within one of these

exceptions. In short, the rule does not

speak in terms that constrain the

Commission from operating outside the

bounds of the statutory scheme.' 824

F.2d at 11.

UCS says that this portion of a paragraph was an "order" by the Court

to get the Commission to "stop trying to

obscure Its intentions through ambiguous and vague language Whether the Court's language amounts

to an 'order" or only strong advice, we have followed it. For one thing, the rule.

explicitly says that backfits falling within the exceptions will be imposed (inexplicably. UCS asserts that the

proposed rule did not have this

provision). See 50-109(a)(4). For

another, both in what we have already

said, and in what we shall be saying in

response to NUBARG's comments on the exceptions provisions. we shall have

explicated the scope and meaning of the

three listed exceptions.

However, we have not taken the

quoted language of the Court to mean tliat. after years of making rules and

adjudicating cases which ultimately

depend on the Commission's judgment about what -adequate protection"

requires, the Commission should be

obliged to give a mechanically applicable definition of "adequate

protection" in order to avoid using the

time-honored method of case-by-case.

precedent-guided. judgment to I

implement only a part of the backfit,

rule. Certainly, the Cou.-t never even noted a lack of a gene-al definition of

"adequate protection" in the rule. let

alone "ordered" the Commission to

provide such a definition.

Append B 5s NUREG-1409
2GG8 Federal Register I Vol M3 No. 08 / Monday, June & 1988 / Rules and Regulations

UCS position lacks all sense of

proportion We must emphasize the core of the Court's decision. rather than get bogged down by transforming a suspicion and a few criticisms of the

rule into an order to undertake an Unprecedented task of defiitlon.

Reviewing the exceptions In the le.

and various statements in the Federal

Regater notice accompanying the rule.

the Court said. "We conceivably could

read the terms of this rule to comply with the statutory scheme we have

described above (that i. a scheme In

which economic costs can play no part

in establIshIng what adequate protection

requires)" Id. Moreover, the Court says

this despite the lack of any sumary. general "objective" definition of

"adequate protection" in the nAle.

But the Court then went on to say,

"Statements that the Commission has

made in promulgating the rule and in

defending it before this court, however

disincline us from interpreting the rule in

this fashion." Id. Aain. it is not the lack

of a definition of adequate protection that disinclined the Court from saving the rule, but rather certain statements

the Commission had made which

seemed to suggest that the Commission

might consider economic cost when

deciding what adequate protection

required.

The Three Exceptions

Echoing the Court's remark that the

rule "does not explicate the scope or meaning of the three listed -

.exceptions". Id. NUBARG believes

that there Is a substantial amount of

overlap in these exceptions and that

they have not been adequately defined or explained In the proposed rule."

NUBARG and others representing the

Industry are concerned that the two

exception provisions which use the

phrase "adequate protection. II 51109(a)(4) (Ii) and (Iil. may

swallow" the rule. One industry

commenter objects to the notion. implied by So9(a)(4J(l) that adequate protection might require more than

compliance. Another Is concerned that

I 50109(a)(4)(dl) the exception whicb

has been added in response to the

Court's rling, might lead to

redefinitions of "adequate protection" that would threaten loss of licenses.

To avoid these results. NUBMARG and

others recommend deleting one of the

two exception psions wich use the

phrase "adequate protection".- 

NU8ARC'a choke is I 50.109(a)(4Jf i)

retained from the 1983 version of the

rule, where it used the equivalent

phrase. "no undue risk. This section

provides that the substantial increase

and "costs justifieda standards will not

apply to backflt necessary to provide

adequate protection to public health and

safety. NUBARO cals this provision

redundant to the exception for backfitb

required for the sake of compliance.

1 5O.109(a)[4)(. A was notd above.

NUBARG reports that its research has

uncovered no case in which the 

Commission "has recognized that some

additional measures not contained in

existing requirements are necessary to ensure that a facility continues to meet

the current level of adequacy." Two

other commenters believe that the

exception provision added because of

the litigaton. 50109(a)(4)(iii). should

be deleted. as being redundant to the

provision NUBARG would like to see. deleted.

No matter which of the two provisions

the commenter would like to see deleted, the commenter would like some restrictions placed on the use of the

remaining one. The restriction by far the

most frequently proposed Is that no action may be taken under the

remaining exception provision In the

absence of "significant new information or the occurrence of an event which

clearly shows" that the action Is

necessary.

In sum. these commenters either

reopen an issue settled in 1985 or they recommend deleting that part of the rule

which directly responds to the Court's

ruling. We take neither course for, even putting the 1985 rule and the Court's

ruling aside, If either of the two

provisions were to be deleted, an

essential power of the Commission

would be remain unimplemented.

First, the exception for backfits

necessary to secure adequate protection.

I 50.109(a)(4)(ii). must be retained,

because it must be made clear that

Commission action Is not to be

obstructed by cost considerations In a

situation where compliance has indeed

proved to be insufficient to secure the

el of protection presumed In the rule.

order, or commitment in qviestion. Despite the results of NURARGs

research, such situations have arisen.

See. eog SECY-8348. "Evaluation of

Managing Plant-Specific Backit

Requirements". November 21.19881.

Accordingly, this exception provision is

not redundant to the exception for

backlits necessary to restore

compliance. Neither is It redundant to

the exception for backfits involving the

defining or redefining of "adequate

protection", for the latter exception assumes some change in the NRCs

judgment of what level of protection

should be regarded as "adequate".

Retainrng I S0.109(a)(4)(li) will not

give the Commission the power to

proclaim at will that compliance Is not

enough As we said In the statement of

considerations accompanying the 1983

rule, and have in part reiterated in th

response to UCS comments the

reguliations, though thsey do not define

"adequate protection", are presumed to ensure It. and. in the absence of a

redefinition of "adequate protection".

that presumption can be overcome only

by significant new Information or some showing that the regulations do not

address somse significant safety Isue.

"(it may be presumed that the current

body of NRC safety regulations provides

adequate protection. Where new information indicates that improvements are needed to ensure there is 'no undue

risk'on * a * basis which the

Commission believes to be the minirpm

necessary, such requirements must be

Imposed." (50 FR at 38101-102.)

Second, the exception provision for

backfits which are necessary under a

defining or redefining of "adequate

protection'. I 5O.109(a)(4)(iil). must be

retained because It must be made clear

that, as the Court held, cost may not be a factor in setting the level of protection judged a "adequate". s NUBARG

acknowledges, ciing Power Reactor

Development Co. v. International Union

of Electrical. Radio and Machine

Workers. AFL-CIO. 387 U.S. 396. 408

(1981). the Commission has both the

power to define "adequate protection".

and the power to re-define IL Without

this last exception provision, It might

appear from thu rule either that the

Commission had no such power or that

it was restricted by cost considerations.

contrary to the Court's ruling. Nor

should this exception provision be

limited to situations involving

"significant new information as proposed in several comments.

This last exception may be thought by some to threaten to swallow the backflit

rule. We believe, however, that

instances of backfilts based on a "redefinition" of "adequate protection" will be rare. Moreover the case-by-case

approach which is required In the

IAs the rule notes I solo(sli14 coat may

nonethaless be a consideration In chop ingthe means of achleving adquats protecton

OThewd defings or redefintn is ithi third

axccpton should rot be construed neceasartly to

mean providing a useful and Senerafly applicable

detltion. at ast not sail such a definition

becomes possible. Under present conditiona the

Commission wil bave "defried or redefined what

level orprotactlon l tobe regarded as adequate" 6

Is makes a udgment that although cOmnpildlct assue the level of protection that had been

thoughe of ae adequate. that level of protection

should no longer be considered adequate.

NUREG-1409 6 Appendix B
Federal Register / Vol. 53. No. 108 / Monday; une 6. 1988 / Rules and Regulations 2WG9

absence of * general definition of

"adequate protection' provides licensees -and the public-a large measure of protection from arbitrary action by the Commission. Citing case law NUBARG says that, In applying this

last exception provision. the

Commission 'Must act rationally and

consistently in light of available

evidence", and -must apply a reasoned

analysis indicating the prior policies and

standards are being changed not.'

casually Ignored * ." We wholly.

agree and believe that the approach envisioned by the backfit ale will

facilitate the Commission's acting accordingly.

Other Matters

Two other comments bearing on the

phrase "adequate protection" require an explicit response. First several

commenters from the Industry would

prefer that the rule state that the

"documented evaluation" which the

NRC must prepare in connection with

any action under one of the exception provisions, see i 50.109(a)(4). should

include consideration of as many of the

factors which i 50.109(c) requires of a 'backfit analysis" as are appropriate. The suggested modification of the rule

would have only limited utility. Few of

the factors listed In i 50.109(c) of the

rule are appropriate for consideration in a documented evaluation justifying action under the compliance exception

In the rule. It Is true that several of the

factors in I 50.109(c), indeed, all of them

but those in paragraphs (c) (5) and (7)

and some of those in paragraph (c)(8) are appropriate for consideration under

the -adequate protection" exception. to

the extent that they require a showing of

exactly what the licensees must do and a showing that the backflt in question *actually contzlbutes to safety. However,

the Commission believes th~at the rule's

requirement that the documented

evaluation 'Include a statement of the

objectives of and reasons for the

modification and the basis for Invoking

the exception" adequately assures that

the factors in I 50.109(c) will be

considered to the extent relevant.

without their being listed and labeled as If they were a part of a I 50.o(c)

analysis. Thus, little, if anything is to be

gained by an explicit requirement that

150109(c) factors be considered In a documented evaluation.

Second, one citizens' group asserts

that the backfit rule should not apply to

rulemaking. This Issue was thoroughly

discussed in 1985. However, this group's

comment puts the issue In a slightly altered light and provides another

opportunity to clarify the meaning of

'adequate protection". The group argues

that since rules "defne" "adequate protection", the Commission cannot

apply the rule's "substantial ncrease"

and "cost justified" standards In

rulemaking without applying cost

considerations in setting the standard of

adequate protection contrary to the

Court's holding. -

*The answer to this comment is, of

course, that the rules do not, strictly

speaking "define" "adequate

protection", and they only presumptively assure IL Not only may

there, as stated above be Individual cases that require actions that go

beyond what is necessary under the

regulations to assure adequate

protection. there will also be times when

the NRC issues a rule which requires

something beyond adequate protection.

This follows directly from the

Commission's power under section 181

of the Atomic Energy Act affirmed by the Court. to Issue rules or orders to

"minimize danger to life or property."

See 42 U.S.C. 2201; see also USC v. NRC,

824 F.2d at 118. If a proposed rule

requires something more than adequate

protection, applying a cost standard to

the proposed rule will not be introducing

cost considerations into the setting of

the adequate protection standard and Is

therefore permitted. Of course if the rule

Is directed at either establishing what

level of protection is "dequate" or assuring that such a level of protection

is met, then cost will play no role.

The backfit rule as set out below is

substantially the same as the rule

proposed in the Federal Register. (See 52

FR 34223 September 10 1987.)

Provisions which appeared at the end of

I 50.109(a)(4) of the proposed rule or in

the footnote to that paragraph appear

below In new paragraphs (a) (5) through

(7).

Environmental Impact Categorical

Exclusion

-The NRC has determined that this

final rule the type of action described

in categorical exclusion 10 CFR

51.22(c)(3). Therefore. neither an environmental impact statement nor an environmental assessment as been

prepared for this final rule.

Paperwork Reduction Act Statement

This final rule does not contain a new or amended Information collection

requirement subject to the Paperwork Reduction Act of 1980 44 U.S.C. 350 et

seq.). Existing requirements were approved by the Office of Management

and Budget, Approval Number 3140-

0011.

Regulatory Analysis

The revision to 10 CFR 50.109 will

bring It into conformance with the

holding in Union of Concerned

Scientists. et El, v. U.S. Nuclear5

Regulatory Commission. DC. a$. Nos.

85-1757 and 8-1219 (August 4 187)

The revision clarifies the backfit rule to

reflect NRC practice that in determining whether to adopt a backfit requirement

economic costs will be considered only when addressing those backfits

Involving safety requirements beyond those needed to ensure the adequate protection of public health and safety. Such costs are not considered when

establishing the adequate protection of

public health and safety. This revised

rule does not have a significant Impact on State and local governments and

geographical regions, public health and

safety, or the environment nor does It

represent substantial costs to licensees.

the NRC. or other Federal agencies. This

constitutes the regulatory analysis for

this rule.

Regulatory Flexibility Act Certification

In accordance with the Regulatory

Flexibility Ad of 1980 5 U.S.C. 605(b

the Commission hereby certifies that

this final rule, if promulgated. will not

have a significant economic impact on a substantial number of small entities. The

affected facilities are licensed under the

provisions of 10 CFR 50.21(b) and 10

CFR 50.22. Tbe companies that own these facilities do not fail within the

scope of "small entities" as set forth in

the Regulatory Flexibility Act or the

Small Business Size Standards set forth

in regulations issued by the Small

Business Administration In 13 CFR Part

121.

Backfit Analysis

The NRC has determined that a backfit analysis Is not required for this

rule because It does not impose requirements on 10 CFR Part 50

licensees.

Ist of Subjects n 0 CFR Part So

Antitrust Classified information.Fe

prevention, Incorporation by reference.

Intergovernmental relations Nuclear

power plants and reactors Penalty Radiation protection, Reactor siting criteria, Reporting and Recordkeeping

-requirements. . .

For the reasons set out In the 

preamble and under the authority of the

Atomic Energy Act of 1954 as amended

the Energy Reorganization Act of 1974, as amended. and 5 USC. 552 and 553

the NRC Is adopting the following

amendments to 10 CFR Part 50.

Appendi B 7 NUREG-1409
20S10 Federal Register I Vol. 53. No. 205 / Monday, June I. 198 Rules and Regulations

PART SO-DOMCSTIC UCENSIN3 OF

PRODUCTION AND UTIULZATION

FACIUTIES

1. Ibe authority citation ror Part 501

revised to read as follows:

Auhordty Sc$. 102. 103.104. IM 10 t. I=

15 188 189. Stat 938 937. 93 946 963.

5&. 953. 958. as amended. sec 234,3 StaL

=K as amended (42 U.S.C. 213z 2133.214.

2135 2201223Z 2233.2236.2239.2282k sa

201. as amended. 202 206. 8 Stat. 1242. as amended, 1244.12U (42 U.S.C 54 35842.

Section 5W also issued under Pub. L 95-

Bn, secI 192, StaL 2951 (42 U.SC 3851)

Section 50.10 also issued under sec. 101. I83, e. Stat 93A 9m " amended (42 U.S.C 2131.

235: sec. 102. Pub. L 91-190. 83 Slat 853 (42

U.SC 432. Sections 50.23. 50136503 and 5W58 also issued under sE 1868 Stat 955

(4Z US.. 22351. Sections 50.33a50.55e and

Appendix Q also Issued under sec. W Pub.

L 9n-190 33 Stat 353(42 US.C. 4332). SectIons 5034 and 50.54 also Issued under sec. M4.S Stat. 1245 (42 MC 5844)

Sections 50.53 501. and 50.82 also issued

under Pub. L 97-415. 96 StaL 2073(42 U.SC

2Z39). Section 50.78 also issued under sec. 122. 68 Stat. 939 (42 U.S.C. 2152). Section

50.80-40.81 also issued under sec 164 .8 Stat.

954. as amended 142 U.S.C 22341. Section

50.103 also Issued under sec 10 68 Slat 939. as amended (42 US.C 2138) Appendix F also issued under sec. 187. 8

Stat. 95 (42 U.S.C 2237).

For the purposes of sec. 223 68 Stat. 958 as amended (42 U.S.C. z2731; II 50.10 (a). (b.

:ad (el 5050.4s.50.4s 504 and 50.80(al

*re issued under sec IM. 8 Stat 948. as amended (42 U.SC 2201(b)) ; t s010 tb) and

lc. and 50.54 re issued under sac. ISIL St

Slat 949. as amended (42 U.S.C. 2z20(i)y and

550.9. 50.55(e). 50.59(b). 50.70. 50.71.50.7Z.

50.73. and 50.78 are issued under sec. Mo.61

St 9t. as amended (42 U.S.C. 2C01to)).

2. Section 50102 is revised to read as follws:

150.109 Backfitting.

(a](1l Backfitting is defined as the

modification of or addition to systems.

structures. components. or design of a facility or the design approval or manufacturing license for a facility-, or the procedures or organization required

to design, construct or operate a facility

any of which may result fsr a new or amended provision in the Commission

rules or the Imposition of a regulatory staffposition interpreting the

Commission rules that Is either new or different from a previously applicable

staff position after

() The date of issuance of the

construction permit for the facility for

ficilities having construction permits

bsued *fer October 21. 1985 or -N Sfi'Sx months before the dale of

utcketing of the operating license

application for the facility for facilities

having eanstruction permits Issued

before October 21. 1sfl5: or

(il]) Tha date of Issuance of the

operatinig ieense for the facility for

facilities baying operating licenses or (lv) The date of Issuance of the design

approval under Appecdbh hi. N or 0 of

th part.

() Except as provided In paragraph (aJ(4i of this section. the Commission

shall require a systematic and

documented analysis pursuant to

paragraph Cc] of this section for backfits

which it seeks to Impose. (31 Except as provided In paragraph

(a)(4) of this section. the Commission

shall require the backfitting of a facility

only when it determines, based on the

analysis described in paragraph (c) 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 fnnm

the backfit and that the direct and

indirect costs of Implementation for that

facility are justified in view of this

increased protection. (4) The provisions of paragraphs (aX2)

and (a)(31 of this section are inapplicable and, therefore. backlit

analysis is not required and the

standards in paragraph (a)(3) of this

section do not apply where the

Commission or stalff as appropriate.

finds and declares, with appropriated documented evaluation for its findig. either.

(il That a modification is necessary to

bring a facility into compliance with a license or the rules or orders of the 

Commission, or Into conformance with

written commitments by the licensee; or * Iii That regulatory action Is necessary

to ensure that the facility provides

adequate protection to the health and

safety of the public and Is in accord with

the common defense and security; or 1iii) 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 backlitting of a facility if It

determines that such regulatory action t

necessary to ensure that the facility

provides adequate protection to tha

health and safety or the public and Is in

accord with the common defense and

security (0)The documented ealuatlon

required by paragraph (a)t4) of this

section shall Include a statement of the

objectives of end reasons for the

modification and the basis for invoking the exception. if immediately effiective

regulatory action is required then the

documented evaluation may follow

rather than precede the regulatory

action. -

(7) If there are two or more way,, to

achieve compliance with a license or 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 applicant or 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 factor in selecting the way.

provided that the objective of

compliance or adequate protection Is

met.

(bl Paragraph (a)(3) of this sectiob

shall not apply to backfits Imposed prior

to October Z1 1985.

(c) In reaching the determination

required by paragraph (a)(3) of this r section. the Commission will consider

how the backfit should be scheduled in

light of other ongoing regulatory

activitles at the facility and. in addition.

will consider information available

concerning any of the fpllowing 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

or applicant in order to comnplete the

backf~t

(3) Potential change in the risk to the public from the accidental off-dite

release of radioactive material;

(4) Potential inpact on radiological

exposure of facility employees

(5) Snstallation end continuing costs

assciated with the backftt including

the cost of facilty downtime or the cost of construction delay: 

(6) The potential safety impact of

changes In plant or operationdl

complexity. including the relationship to

proposed and existing regulatory

requirements;

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

backfit and the availability of such resourcesx

(8) The potential impact of differences

in facilty type, design or age on the

relevancy and practicality of the

proposed backfit;

(9) Whether the proposed backefit ba

Interim or final and If interim, the L iusbficatfon for imposing the proposed backfit on an Interimn basis

(d) No licensing action will be

witheldd during thse pendeancy of be tl

analyses required by the Commisslon's

rules.

NUREG-1409 8 Appendix B
Federal Register I VoL 53. No. 108-/ Monday. une , 1988 / Rules and Regulations 2620161

(e) 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 designee.

Dated at Rodcville.Maylan this 31st day of May. 198.

For the Nuclear Relstory Commission.

Samuel 1. Chilk.

Secwt ry of the Commission.

(FR Doc. 88-12624 Filed 6-3-83; :45 am]

SILUING COE moall

Regulatory Flexibility Act

A Regulatory Flexibility Analysis is

required only for rules issued for notice

and comment. Because this fird ile

pertains to office organization and is

therefore exempt from notice and

comment procedures. no Regulatory

Flexibility Analysis will be prepared.

Executive Order 12281

Section 1(a)(3) of Executive Order

12291 exempts from the requirements

that a Regulatory Inpact Analysis be

FEDERAL HOME LOAN BANK 10

12 CFR P" S63 

(NU. 42./71

Miscellaneous Confon u

Technical Amendments 

Date: Bay L 1988.

AGENCY: Federal Home Bank

Board.

ACTION: Final rule" ml aneouJ

conforming and techn al amendments.

DEPARTMENT OF E TREASURY

Comptroller of the urrency

12 CFR Part 4

[Docket No. 3-1

Description of Offi , Procedures,

Public Information; eputy Chief

Counsel (Operation et l.

AGENCY. Comptrolle of the Currency.

Treasury.

ACTION Final rule.

SUMmARY: The truc

Department of the

Comptroller of the

has recently been n rule sets forth the ne the positions of Dep

(Operations) and D

(Policy.

EFFECTIVE OATE u

FOR FURTHER INtOR

Feme Fisherman Ru

Advisory Services

1880 Office of the C

Currency, 490 L'En

Washington. DC 202

SUPPLEMENTARY IN

i6 1988. the OCC-s

announced certain

positions of Deputy

(Operations) and D

(Policy); this amend

changes.

Notice and Commen

The OCC has dete

and comment are US.C. 553(b)3)(A) 1

pertains to rules of a and procedure.

Reason for Immediat

This final rule Infoi

about a change in tf

organization that has

Confusion could resu position descriptions

immediately.

ire of the Law

ice of the

rrency ('OCC'J nged. This final

;descriptions for

y Chief Counsel

uty Chief Counsel

8.1988.

kTION CONTACT.

n, Attorney. Legal

don. (202) 447-

nptroller of the

t Plaza East. SW,

.

RMATION: On April

ef Counsel

anges to the

hief Counsel

uty Chief Counsel

ent reflects these

mined that notice

ecessary under S ce this final rule

ency organization

Effective Date

m the public

Law Department's

already occurred.

.t if the proper are not employed

prepared those regulations related to SUMMARY The Fede l Home Loan Bank

agency organization. managemet or Board ("oard a the operating head

personnel Since this final rule is so of the Federal Say and Loan.

classified. no Regulatory Impact Insurance Corpo n FSLC} s Analysis required. amending its re alons in order to

List of Subjects in 2 CFR Part correc typogr hical and other technical a s. and to correct a National banks, Organization and reference o Board's recordkeeplng

functions (government agencies), Public requireme with respect to accounts

information. Official forms. District held in In itutions the deposits of which

offices, Field offices. Procedures. are insur d by the FSLIC ("insured

Delegation. instilu'

For the reasons given in the preamble. FFE YE DATE June S.198

Part 4 of Chapter!. Title 12 of the Code FOR RTHER INFORMATION CONTAO

of Federal Regulations Is amended as Jer e L Edelstein. (202) 377-7057.

follows: D uty Director or Carol J. Rosa. {202

317-7037. Paralegal Specialist. PART 4-DESCRIPTION OF OFFICE. egulations and Legislation Division.

PROCEDURES. PUBUC INFORMATION Office of General CounseL Federal

Home Loan Bank Board. 1700 G Street 1. The authority citation for Part 4 NW, Washington. DC 20552.

continues to read as follows: SUPPLEMENTARY INFORAIO a

Asuthority: U US.C. 1 t seq 5 USC. August 15 .1988, the Board adopted final

unless otherwise noted. amendments expanding and clarifying

2. In Part 4, 41a is amended by its regulation concerning basic loan

revising paragraph (a) (20) and l to records that Institutions chartered by

read as follows: the Board or Insured Institutions and 'their service corporations are required

1 4.1a Central and Ild organ z on; to maintain. 51 FR 30848 (August29. delegations. i988). One of the amendments revised

a)* * * 12 CF 563.17-11c) by providing that

records related to accounts held in (20] Deputy Chief Couns 1 insured institutions reflect the Board's

(Operations). The Deputyuef Counsel recent deletion of the requirement that

(Operations) is responsi le for Law for insurance of accounts purposes the

Department administr on. the District insured institution's records disclose the

Counsels, and the La slative and names of the settlor Igrantor) and

Regulatory Analysis aivison of the Law trustee of a trust and contain signature

Department card for the trust executed by the

(21) Deputy Chi Cunsel (Policy). trustee The Board's deletion ofttds

The Deputy CliCounsel (Policyl is recordkeeping requirement was adopted

responsible for a Enforcement and on April 4, 1986. Si FR 12122 April 9.

Compliance gal Advisory Servces. 198). The April 988 revision of 12 CFR

Ligation. Securities and Corporate 564.2 to delete paragraph (b)(3) was

Practices D' ns of the Law intended to decrease the recordkeepirg Departm requirements associated with obtaniqg .* . . . - trust account Insurance coverage and to

at ayv. 96L expedite settlement of insurance claims

Robee O y .ls, on such accounts.is amendment was Compiderofd> ah e fflmL7~ * not intended to apply to loan

ofmp therc~ine CQrrnv. recordkeeping requirements of an

1FR 88 ZM Filed -3-8t am) insured Institution or Its service

COoE 4Clews corporations but only to Insurance

Appendix 9 NUREG-1409
APPENDIX C

CHARTER

COMMITTEE TO REVIEW GENERIC REQUIREMENTS

(Revision 4, April 1987)

NUREG-1409
Revision 4

April 1987

TABLE OF CONTENTS

Page

I. Purpose ............................................................ 1

1I. Membership ......................................................... 2

III. CRGR Scope ......................................................... 2

IV. CRGR Operating Procedures .......................................... 5 

V. Reporting Requirements ............................................. 9

Attachment 1: New Generic Requirement and Staff Position Review Process

Attachment 2: Procedures to Control Communication of Generic Requirements and

Staff Positions to Reactor Licensees

APPROVED

REVISION

REVISION

REVISION

REVISION

BY THE COMMISSION

1 APPROVED BY THE

2 APPROVED BY THE

3 APPROVED BY THE

4 APPROVED BY THE

JUNE 16, 1982 (SECY-82-39A)

COMMISSION (SECY MEMO DT JANUARY 6, 1984)

COMMISSION (COMSECY-86-5, JUNE 20, 1986)

COMMISSION (SECY MEMO DTD AUGUST 13, 1986)

EDO (MEMO TO COMMISSIONERS, APRIL 6, 1987)

Appendix C iii NUREG-1409
Revision 4-

April 1987

I. PURPOSE

The Committee to Review Generic Requirements (CRGR) has the responsibility to

review and recommend to the Executive Director for Operations (EDO) approval or

disapproval of requirements or staff positions to be imposed by the NRC staff

on one or more classes of power reactors. This review applies to staff proposals of requirements or positions which reduce existing requirements or positions and proposals which increase or change requirements. The implementation

of this responsibility shall be conducted in such a manner so as to assure that

the provisions of 10 CFR 2.204, 10 CFR 50.109 and 10 CFR 50.54(f) as pertaining

to generic requirements and staff positions are implemented by the staff. The

objectives of the CRGR process are to eliminate or remove any unnecessary burdens placed on licensees, reduce the exposure of workers to radiation in implementing some of these requirements, and conserve NRC resources while at the

same time assuring the adequate protection of the public health and safety and

furthering the review of new, cost-effective requirements and staff positions.

The CRGR and the associated staff procedures will assure NRC staff implementation of 10 CFR 50.54(f) and 50.109 for generic backfit matters. The overall

process will assure that requirements and staff positions in place or to be

issued (a) do in fact contribute effectively and significantly to the health

and safety of the public, and (b) do lead to utilization of both NRC and

licensee resources in as optimal a fashion as possible in the overall achievement of protection of public health and safety. By having the Committee submit

recommendations directly to the EDO, a single agencywide point of control will

be provided.

The CRGR will focus primarily on proposed new requirements and staff positions,

but it will also review selected existing requirements and staff positions

which may place unnecessary burdens on licensee or agency resources. In reaching its recommendation, the CRGR shall consult with the proposing office to

ensure that the reasons for the proposed requirement or staff position are well

understood and that the provisions of 10 CFR 50.109, 50.54(f), and 10 CFR

2.204, if applicable, are appropriately addressed by the staff proposal. The

CRGR shall submit to the EDO a statement of the reasons for its recommendations. This statement shall provide a clear indication of the basis for the

recommendation and, when appropriate, relate this basis to the provisions of 10

CFR 50.109, 50.54(f), and 10 CFR 2.204.

Tools used by the CRGR for scrutiny are expected to include cost-benefit analysis and probabilistic risk assessment where data for its proper use are adequate. Therefore, to the extent possible, written staff justifications should

make use of these evaluation techniques. The use of cost-benefit analyses and

other tools should help to make it possible to determine which proposed requirements and staff positions have real safety significance, as distinguished

from those proposed requirements and staff positions which should be given a

lower priority or those which might be dropped entirely. When such techniques

cannot be applied for lack of available, appropriate, or relevant data, other

methods will be used.

The EDO may authorize deviations from this Charter when the EDO, after consulting with the Chairman, finds that such action is in the public interest

and the deviation otherwise complies with applicable regulations including

Appendix C 1 NUREG-1409
Revision 4-

April 1987

10 CFR 2.204, 50.54(f) and 50.109. Such authorization shall be written and

shall become a part of the record of CRGR actions. The rulemaking proposal

presented to and considered by the CRGR, and ultimately, if presented to the

Commission, should include any necessary exemption request with supporting

reasons for the proposed exemption.

I. MEMBERSHIP

This Committee shall be chaired by the Office Director, AEOD, and it shall

consist of, in addition to the CRGR Chairman, one individual each from NRR,

NMSS, the Regions, and RES appointed by the Executive Director for Operations

and one individual from OGC appointed by the EDO with the concurrence of the

General Counsel. The regional individual shall be selected from one of the

regional offices, and this assignment shall be considered developmental, with a

new selection made by the appointing official after that official judges that

sufficient experience has been gained by the incumbent regional representative.

The CRGR Chairman shall assure that process controls for overall agency management of the generic backfit process are developed and maintained. These process controls shall include specific procedures, training, progress monitoring

systems, and provisions for obtaining and evaluating both staff and industry

views on the conduct of the backfit process. The CRGR Chairman is also responsible for assuring that each licensee is informed of the existence and structure of the NRC program described in th Charter. The CRGR Chairman shall

assure that substantive changes in the Charter are communicated to all licensees.

AEOD will provide staff support. The Committee may use several non-NRC persons

as consultants in special technical areas.

New members will be appointed as the need arises. If a member cannot attend a

meeting of the CRGR, the applicable Office Director may propose an alternative

for the appointing official's approval. It is the responsibility of the alternate member to be fully versed on the agenda items before the Committee.

III. CRGR SCOPE

A. The CRGR shall consider all proposed new or amended generic requirements

and staff positions to be imposed by the NRC staff on one or more classes of power reactors. These include:

(i) All staff papers which propose the adoption of rules or policy

statements affecting power reactors or modifying any other rule so

as to affect requirements or staff positions applicable to reactor

licensees, including information required of reactor licensees or

applicants for reactor licenses or construction permits.

(ii) All staff papers proposing new or revised rules of the type described in paragraph (i), including Advanced Notices.

NUREG-1409 2 Appendb C
Revision 4-

ADril 1987

(iii) All proposed new or revised regulatory guides; all proposed new or

revised Standard Review Plan (SRP) sections; all proposed new or

revised branch technical positions; all proposed generic letters;

all multiplant orders, show cause orders, and 50.54(f) letters

all bulletins and circulars; and USI NUREGs; and all new or revised Standard Technical Specifications.

All staff proposed generic information requests will be examined

by the CRGR in accordance with 10 CFR 50.54(f). Except for

information sought to verify licensee compliance with the current

licensing basis for a facility, the staff must prepare the reason

or reasons for each information request prior to issuance to

ensure that the burden to be imposed on respondents is justified

in view of the potential safety significance of the issue to be

addressed in the requested information. CRGR examination of

generic letters will include those letters proposed to be sent to

construction permit holders. For those plants for which an

operating license is not yet issued, an exception to staff analysis may be granted by the Office Director only if the staff seeks

information of a type routinely sought as part of the standard

procedures applicable to the review of applications. If a request

seeks to gather information pursuant to development of a new staff

position, then the exception does not apl.iy and the reasons for

the request must be prepared and approved prior to issuance of the

request. When staff evaluations of the necessity for a request

are required, the evaluation shall include at least the following

elements:

(a) A problem statement that describes the need for the information in terms of potential safety benefit.

(b) The licensee actions required and the cost to develop a response to the information request.

(c) An anticipated schedule for NRC use of the information.

B. The CRGR shall consider all licenses, license amendments, approvals of

Preliminary Design Approvals (PDAs) and Final Design Approvals (FDAs),

minutes of conferences with owners groups, licensees or vendors, staff

approvals of topical reports, information notices, and all other documents, letters or communications of a generic nature which are presented

1 It is expected that the offices will develop internal procedures to ensure

that information requests are developed in accordance with 50.54(f)

Appendix C 3 NUREG-1409
Revision 4.

April 1987

to reflect or interpret NRC staff positions, unless such documents refer

only to requirements or staff positions previously applicable to the

affected licensees and approved by the appropriate officials. The

following are examples of approved staff positions not requiring CRGR

review:

(i) positions or interpretations which are contained in regulations,

policy statements, regulatory guides, the Standard Review Plan,

branch technical positions, generic letters, orders, topical approvals, PAs, FDAs, licenses and license amendments which have

been promulgated prior to November 12, 1981. Any document or communication of this type shall cite and accurately state the position as reflected in a previously promulgated regulation, order,

Regulatory Guide, SRP, etc.

(ii) positions after November 12, 1981 which have been approved through

this established generic review process.

C. For those rare instances where it is judged that an immediately effective action is needed to ensure that facilities pose no undue risk to

the health and safety of the public (10 CFR 50.109(a)(4)(ii)), no prior

review by the CRGR is necessary. However, the staff shall conduct a

documented evaluation which includes a statement of the objer.ives of

and reasons for the actions and the basis for invoking the exception.

The analysis referenced in 50.109(a)(2) may be conducted either before

o- after the action is taken ad shall be subject to CRGR eview. This

analysis shall document the safety significance and appropriateness of

the action taken and consideration of how costs contribute o selecting

the solution among various acceptable alternatives. The CRGR Chairman

should be notified by the Office Director originating the action. These

immediately effective requirements will be reported to the Committee for

information and will be included in the report to the Commission.

0. For each proposed requirement or staff position not requiring immediately effective action, the proposing office is to identify the requirement as either Category 1 or 2.

Category 1 requirements and staff positions are those which the proposing office rates as urgent to overcome a safety problem requiring immediate resolution or to comply with a legal requirement for immediate or

near-term compliance. Category 1 items are expected to be infrequent

and few in number, and they are to be reviewed or otherwise dealt with

within 2-working days of receipt by the CRGR. If the appropriateness of

designation as Category 1 is questioned by the CRGR Chairman, and if the

question is not resolved within the 2 working-day limit, the proposed

2 It is expected that the offices shall develop internal procedures to ensure that the documents and communications referenced above will contain

only previously approved requirements or staff positions.

N UREG-1409 4 Appendix C
Revision 4 -

April 1987

requirement or staff osition is to be forwarded by the CRGR Chairman to

the EDO for decision.

Category 2 requirements and staff positions are those which do not meetthe criteria for designation as Category 1. These are to be scrutinized

carefully by the CRGR on the basis of written justification, which must

be submitted by the proposing office along with the proposed requirement

or staff position.

Staff proposed generic modifications considered necessary to bring facilities into compliance with licenses or the rules or orders of the

Commission, or into conformance with written commitments by licensees,

will not require analyses of the type described in Section IV (B)(vii).

The proposed action shall be presented to the CRGR Chairman with a documented evaluation including a statement of the objectives of and reasons

for the proposed requirement or staff position and the basis for involving the exception under 10 CFR 50.109(a)(4)(i).

E. The CRGR Chairman shall compile and maintain a list of projected generic

requirements and staff positions based on input from the NRC offices.

The CRGR may receive early briefings from the offices on the proposed

new generic requirements or staff positions before the staff has

developed the requirements or positions and held discussions with the

ACRS.

F. The CRGR may V :onsulted on any issue deemed appropriate by the CRGR

Chairman.

IV. CRGR OPERATING PROCEDURES

A. Meeting Notices

Meetings will generally be held at regular intervals and will be scheduled well in advance. Meeting notices will generally be issued by the

CRGR Chairman 2 weeks in advance of each meeting, except for Category 1

items, with available background material on each item to be considered

by the Committee.

B. Contents of Packages Submitted to CRGR

The following requirements apply for proposals to reduce existing requirements or positions as well as proposals to increase requirements or

positions. Each package submitted to the CRGR for review shall include

fifteen (15) copies of the following information:

(i) The proposed generic requirement or staff position as it is proposed to be sent out to licensees.

3 The requirements of the backfit rule and the Commission guidance for relaxation of requirements and staff positions shall continue to apply.

Appendix C 5 NUREG-1409
Revision 4-

April 1987

(ii) Draft staff papers or other underlying staff documents supporting

the requirements or staff positions. (A copy of all materials

referenced in the document shall be made available upon request to

the CRGR staff. Any committee member may request CRGR staff to

obtain a copy of any referenced material for his or her use.)

(iii) Each proposed requirement or staff position shall contain the

sponsoring office's position as to whether the proposal would increase requirements or staff positions, implement existing requirements or staff positions, or would relax or reduce existing

requirements or staff positions.

(iv) The proposed method of implementation along with the concurrence

(and any comments) of OGC on the method proposed.

(v) Regulatory analyses generally conforming to the directives and

guidance of NUREG/BR-0058 and NUREG/CR-3568.

(vi) Identification of the category of reactor plants to which the generic requirement or staff position is to apply (that is, whether

it is to apply to new plants only, new OLs only, OLs after a certain date, OLs before a certain date, all OLs, all plants under

construction, all plants, all water reactors, all PWRs only, some

vendor types, some vintage types such as BWR 6 and 4, jet pump and

nonjet pump plants, etc.).

(vii) For each such category of reactor plants, an evaluation which demonstrates how the action should be prioritized and scheduled in

light of other ongoing regulatory activities. The evaluation

shall document for consideration information available concerning

any of the following factors as may be appropriate and any other

information relevant and material to the proposed action:

(a) Statement of the specific objectives that the proposed action

is designed to achieve;

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

the licensee or applicant in order to complete the action;

(c) Potential change in the risk to the public from the accidental

offsite release of radioactive material;

(d) Potential impact on radiological exposure of facility employees and other onsite workers.

(e) Installation and continuing costs associated with the action,

including the cost of facility downtime or the cost of construction delay;

NUREG-1409 6 Appendi C
Revision 4

April J987

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

complexity, including the relationship to proposed and existing regulatory requirements and staff positions;

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

proposed action and the availability of such resources;

(h) The potential impact of differences in facility type, design

or age on the relevancy and practicality of the proposed

action;

(i) Whether the proposed action is interim or final, and if interim, the justification for imposing the proposed action on an

interim basis.

(viii) For each evaluation conducted pursuant to 10 CFR 50.109, the proposing office director's determination, together with the rationale for the determination based on the considerations of

paragraphs (i) through (vii) above, that

(a) there is a substantial increase in the overall protection of

public health and safety or the common defense and security to

be derived from the proposal; and

(b) the direct and indirect costs of implementation, for the facilities affected, are justifies in view of this increased

protection.

(ix) For each evaluation conducted for proposed relaxations or decreases in current requirements or staff positions, the proposing

office director's determination, together with the rationale for

the determination based on the considerations of paragraphs (i)

through (vii) above, that

(a) the public health and safety and the common defense and

security would be adequately protected if the proposed

reduction in requirements or positions were implemented, and

(b) the cost savings attributed to the action would be substantial

enough to justify taking the action.

C. CRGR Staff Review

CRGR staff shall review each package for completeness. If the package

is not sufficient for CRGR consideration, it shall be returned by the

CRGR Chairman to the originating office with reasons for such action.

Prior notice to the Committee is not needed; however, CRGR members shall

be informed of such actions.

- An accepted package shall be scheduled for CRGR consideration;

however, scheduling priorities shall be at the discretion of the

CRGR Chairman.

Appendix C 7 NUREG-140Q
Revision 4

April 1987

- All requests for particular scheduling shall be made to the CRGR

Chairman.

- The CRGR staff may obtain additional information from industry and

consultants on such proposals, particularly with respect to the

cost of implementation, realistic schedule for implementation and

the ability of licensees to safely and efficiently carry out the

full range of safety-related activities at each facility while

implementing the proposed requirement or staff position. The CRGR

staff normally shall provide a brief summary analysis of each

package to CRGR members prior to the meetings.

D. CRGR Meeting Minutes

At each meeting, for each package scheduled for discussion, the sponsoring office shall present to the CRGR the proposed generic requirement or

staff position and respond to comments and questions. A reasonable

amount of time, within the discretion of the CRGR Chairman, shall be

permitted for discussion of each item by Committee members. At the conclusion of the discussion, each Committee member shall summarize his

position. The minutes of each meeting, including CRGR recommendations

and the bases therefor shall be prepared. Minutes normally shall be

circulated to all members within 5-working days after the the meeting,

and each member shall have 5-working days to comment in writing on the

minutes. It s the responsibility of each member to assure that the

minutes accurately reflect his views. All comments rece vd within that

period shall be part of the minutes of the meeting.

The Committee shall recommend to the EDO, approval, disapproval, modification, or conditioning of generic proposals considered by the

Committee, as well as the method of implementation of such requirements

or staff positions and appropriate scheduling for such implementation,

which shall give consideration to the ability of licensees to safely and

efficiently carry out the entire range of safety-related activities at

each facility. The minutes shall give an accurate description of the

basis for the recommendations and shall accurately reflect the consensus

decision of the Committee. Copies of the minutes shall be distributed

to the Commission, Office Directors, Regional Administrators, CRGR Members, and the Public Document Room. The EDO's action taken in response

to the Committee's recommendations shall be provided in writing to the

Commission.

E. Recordkeeping System

The AEOD Assistant for CRGR Issues will assure that there is an archival

system for keeping records of all packages submitted to the CRGR Chairman, actions by the staff, summary minutes of CRGR consideration of each

package including corrections, recommendations by the Committee, and

decisions by the EDO.

NUREG-1409 8 Appendix C
Revision 4-

April 1987

V. REPORTING REQUIREMENTS

The AEOD Assistant for CRGR Issues shall prepare a report to be submitted by

the EDO to the Commission each month. The report will provide a brief summaryof CRGR activities, including a list of all items that have been sent to the

CRGR and their current status. The report shall be distributed to CRGR

Mimbers, Office Directors, Regional Administrators and the Public Document

Room.

Appendix C 9 NUREG-1409
Attachment 1 to

CRGR Charter

September 1:

Revision i

NEW GENERIC REQUIREMENT AND STAFF POSITION REVIEW PROCESS

The attached chart is a schematic representation of how new generic requireiments and staff positions are developed, revised and implemented.

In the early stages of developing a proposed new requirement or staff position,

it is contemplated that the staff may have discussions with the industry, ACRS

and the public to obtain preliminary information of the costs and safety

benefits of the proposed action. On the basis of this information, the proposing office will prepare the package for CRGR review.

The CRGR may recommend approval, revision, or disapproval or that further

public comment be sought. After CRGR and EDO approval, there may be further

review by the ACRS or the Commission. Decisions by the Commission are

controlling.

Once final approval is received, the individual project managers will normally

work with each licensee to develop a plant-specific implementation schedule

taking into consideration all of the other requirements and staff positions that

are being implemented at ach plant.

NUREG-1409 10 Appendix C
April 1987

SCHEMATIC REPRESENTATION OF

NEW REQUIREMENTS REVIEW

U51t

Generic Issues

Reg tuides

SBuletins & Orders

Proposed Ruls 

Etc.

Prioritize and

Develop Proposed

Requireent

Including Regulatory Analysis

Dtcusslons With

Indwt. ACS,

Pubc

-I- mmmmmmmmmmmmmmmmmmm

-_-

Technical Imanagement Review

-

'pq

Optional Discussions I Wth Industry 1- -

I

I

CPPIR Revftw

EDO

.

I m

Revise Proposal

or

Solicit Public Comient

or

No Further Work

Funher Raview

ACRS, Commission

* .~~~~~~~~~~~~~

t

f Integrfate

I Into

coInposhe r

I Schedu

L___ 

I

Agreed.Upon Plant

Specific Implementation

Schedule Ii

Appendix C 11 NUREG-1409
Attachment 2 to

CRGR Charter

;i.;l 1987

Revision 4

PROCEDURES TO CONTROL

GENERIC REQUIREMENTS AND STAFF POSITIONS

A. Background

In a memorandum from the Chairman to the Executive Director for Operations dated October 8, 1981, the Commission expressed concern over conflicting or inconsistent directives and requests to reactor licensees from various components of

the NRC staff. By that memorandum, the Commission outlined certain recommended

actions to establish control over the number and nature of requirements placed

by NRC on reactor licensees. These included: establishing a Committee to

Review Generic Requirements (CRGR); establishing a new position of Deputy

Executive Director for Regional Operations and Generic Requirements (DEDROGR);

conducting a survey of formal and informal mechanisms to communicate with

reactor licensees; and developing and implementing procedures for controlling

communications involving significant requirements covering one or more classes

of reactors. In February 1987 the Commission approved a NRC reorganization

that, among other changes, placed the CRGR operations under the Office of

Analysis and Evaluation of Operational Data (AEOD). CRGR responsibilities

and authorities were not directed to change under the new organizational

structure; only the organizational location was chang d. The following procedures have been established for controlling generic requirements or staff

positions and are designed to implement the provisions of 10 CFR 50.109,

50.54(f) and 2.204.

B. Committee to Review Generic Requirements (CRGR)

Except for immediately effective actions, the CRGR shall review all proposed

new generic requirements and staff positions to be imposed on one or more

classes of power reactors in accordance with the Charter of the Committee,

before such proposed requirements or staff positions are forwarded to the EDO

and Commission and imposed on, or communicated for use or guidance to, any reactor licensee.

C. Office Responsibility

Each office shall develop internal procedures to assure that the following policy requirements regarding reactor licensees are carried out:

(1) All proposed generic requirements and staff positions (Table 1 attached)

shall be submitted for CRGR review. Such submittals shall conform to the

provisions of the CRGR Charter relating to the contents of such

submittals.

(2) All generic documents, letters and communications that establish, reflect

or interpret NRC staff positions or requirements (Table II attached) shall

be submitted for review by CRGR unless these documents refer only to requirements or staff positions approved prior to November 12, 1981. In the

latter case, the previously approved requirement or staff position should

be specifically cited and accurately stated. Offices should be careful to

NUREG-1409 12 Append C
Attachment 2 to

CRGR Charter

Apy ii 1587

Revision 4

review new or specific interpretations to assure that they are only casespecific applications of existing requirements rather than initial

applications having potential generic use. Case-specific applications are

governed by NRC Manual Chapter 0514.

(3) For all other communications with licensees (Table III, attached), no

-- statements shall be used that might suggest new or revised generic

requirements, staff positions, guidance or recommendations unless such

statements have been approved by the EDO or the Commission.

(4) In developing a proposed new generic requirement or staff position for

CRGR review, an office may determine that it is in possession of important

safety information that should be made available to licensees. It is the

responsibility of that office to take immediate action to assure that such

information is communicated to the licensees by the appropriate office.

Such actions may be taken before completion of any proposed or ongoing

CRGR reviews.

D. Immediately Effective Action

For those rare instances where it is judged that an immediately effective action is needed to ensure that facilities pose no undue risk to the health and

safety of the public (10 CFR 50.109(a)(4)(ii)), no prior review by e CRGR is

necessary. However, the staff shall conduct a documented evaluation which includes a statement of the objectives of and reasons for the actions and the

basis or invoking the exception. Te analysis referenced in 50.109(a)(2) may

be conducted either before or after the action is taken and shall be subject to

CRGR review. This analysis shall document the safety significance and appropriateness of the action taken and consideration of how costs contribute to

selecting the solution among various acceptable alternatives. The CRGR

Chairman should be notified by the Office Director originating the action.

These immediately effective requirements will be reported to the Committee for

information and will be included in the report to the Commission.

Append C 13 NUREG-1409
Attachment 2 to

CRGR Charter

April 1987

Revision 4

TABLE I

PRINCIPAL MECHANISMS USED BY NRC STAFF TO

ESTABLISH OR COMMUNICATE GENERIC REQUIREMENTS AND STAFF POSITIONS

-ITulemaking1

Advanced Notices

Proposed Notices

Final Rules

Policy Statements

Other Formal Requirements2

Multiplant orders including show cause orders and

confirmatory orders

Staff Positions3

Bulletins

Circulars

Multiplant letters (including 10 CFR 50.54f and TMI Action

Plan letters)

Regulatory Guides

SRP (including rinch Technical Positions)

Standard Tech Specs

USI NUREGs

1 While Rulemaking is an action of the Commission rather

most rules are proposed or prepared by the staff.

2 The document itself imposes a legal requirement; e.g.,

or license conditions.

than the staff,

regulatory orders

3 Documents that reflect staff positions which, unless complied with or a

satisfactory alternative offered, the staff would impose or seek to have

imposed by formal requirement.

NUREG-1409 14 Appendix C
Attachment 2 to

CRGR Charter

?.,. 2 .S'7

Revision 4

TABLE II

MECHANISMS OFTEN USED TO INTERPRET GENERIC REQUIREMENTS OR STAFF POSITIONS

Action and Petitions for Rulemaking

Action on 10 CFR 2.206 Requests

Approval of Topicals

Facility Licenses and Amendments

SERs

FDAs, PAs

I&E Manual

I&E (HQ) Positions

NUREG Reports (other than USIs)

Operator Licenses and Amendments

Single Plant Orders

Staff Positions on Code Committees

Unresolved Issues Resulting from Inspections

Appendix C 15 NUREG-1409
Attachment 2 to

CRGR Charter

April 1 wl

Revision 4

TABLE III

ADDITIONAL MECHANISMS SOMETIMES USED TO COMMUNICATE

GENERIC REQUIREMENTS OR STAFF POSITIONS

DES & FES

Entry, Exit and Management Meetings

Information Notices

Licensee Event Reports; Construction Deficiency Reports (Sent to Other

Licensees)

NRC Operator Licensing People Contact with Licensees

Phone Calls or Site Visits by NRC Staff or Commission to Obtain Information

(i.e., Corrective Actions, Schedules, Conduct Surveys, etc.)

Pleadings

Preliminary Notifications

Press Releases

Proposed Findings

Public Meetings, Workshops, Technical Discussions

Resident Inspector Day-to-Day Contact

SALP Reports

SECY Papers (Some Utilities Apparently Sent Operators to College Based on Recent SECY Paper on Operator Qualifications)

Special Reports

Speeches to Local Groups or Industry Associations

Technical Specifications

Telephone Calls and Meetings with Licensees, Vendors, Industry Representatives,

Owners Groups

Testimony

NUREG-1409 16 Appendi C
APPENDIX D

U.S. NUCLEAR REGULATORY COMMISSION

MANUAL CHAPTER 0514

NUREG-1409
U.S. NUCLEAR REGULATORY COMMISSION

NRC MANUAL

Volume: 0000 General Administration

Part : 0500 Health and Safety AEOD

CHAPTER 0514 NRC PROGRAM FOR MANAGEMENT OF PLANT-SPECIFIC

BACKFITTING OF NUCLEAR POWER PLANTS

0514-01 COVERAGE

011 This chapter establishes the requirements and guidance for NRC

staff implementation of 10 CFR 50.109 and the provisions of 10 CFR 50 Appendix 0, 10 CFR 50.54(f), and 10 CFR 2.204, relating to plant-specific backfitting. Staff requirements and guidance for implementing the provisions of

10 CFR 50.109 pertaining to rules and other generic backfitting are beyond

the scope of this chapter. Pertinent requirements and guidance for generic

backfitting are contained in the CRGR Charter. Test and research reactor

licensees are not covered by the provisions of the chapter.

012 This chapter defines the objectives, authorities, and responsibilities and establishes basic requirements for actions to be taken in instances

where the NRC staff imposes new plant-specific regulatory staff positions on

a nuclear power plant licensee. 1 This practice is commonly referred to as

"backfitting" and for the purposes of this chapter is defined as the modification of or addition to systems, structures, components, or design of a facility; or the procedures or organization required to design, construct or operate a facility: any of which may result from 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 previously applicable staff position. It should be clearly understood that backfits are

expected to occur and are a part of the regulatory process to assure and

improve the safety of nuclear power plants. However, it is important for

sound and effective regulation that backfitting be conducted in a controlled

process. Plant-specific backfitting is different from generic backfitting in

that the former involves the imposition on a licensee of positions unique to

a particular plant, whereas generic backfitting involves the imposition of

the same or similar positions on two or more plants. This chapter governs those plant-specific backfits communicated to the licensees or identified by

the licensees after July 6, 1988.

013 The management of plant-specific backfitting, for which guidance is provided in this document, does not relieve licensees from achieving and

'See Section 05 of this chapter for a definition of "licensee."

Approved: August 26, 1988

Appendi D 1 NUREG-1409
NRC PROGRAM FOR MANAGEMENT OF PLANT-SPECIFIC

NRC-0514-02 BACKFITTING OF NUCLEAR POWER PLANTS

maintaining adequate protection of the public health and safety 2 or complying with the Commission's regulations, orders, license, or written licensee commitment. The management process is intended to provide disciplined NRC review

of new or changed positions prior to imposing them.

The plant-specific backfit management process will enhance regulatory stability by assuring that changes in regulatory staff positions are in fact required

to ensure that the facility provides adequate protection to public health and

safety or to provide a substantial increase in the overall protection of the

public health and safety or common defense and security. Such plant-specific

backfitting is entirely proper given the agency's responsibility to ensure an

adequate level of protection and the agency's authority to improve safety beyond this level.

0514-02 OBJECTIVES

021 It is the overall objective of this program to assure that plantspecific backfltting of nuclear power plants is justified and documented and

to specify that the Executive Director for Operations is responsible for the

proper mplementation of the backfit process.

022 The specific objectives of this program are (a) to ensure that facilities provide adequate protection of the public health and safety; and (b) to

allow for substantial improvements In the levels of protection of public health

and safety beyond adequacy while avoiding any unwarranted burdens on the

NRC, public or licensees in implementing backfits.

023 The program should assure to the extent possible that backfits to be

issued will in fact contribute effectively and significantly to the health and

safety of the public or the common defense and security. This objective is

attained by assuring that plant-specific backfits will be communicated to the

licensee only if necessary to provide an adequate level of safety, or after

required regulatory analyses are completed and approved as described in Section 0514-042 of this chapter. The backfit and supporting regulatory analyses

are approved by the appropriate Office Director or Deputy Director, or Reg- ional Administrator or Deputy Regional Administrator, and forwarded to the

Executive Director for Operations before the backfit and appropriate supporting analysis are communicated to the licensee.

0514-03 RESPONSIBILITIES AND AUTHORITIES

031 The Executive Director for Operations (EDO) is responsible to the

Commission for plant-specific backfit actions. The EDO may review and modify

any plant-specific backfit decision at his or her initiative or at the request

2Adequate protection of the public health and safety means the same as no undue risk and reasonable assurance of not endangering public health and safety.

In NRC practice these standards are interchangeable.

Approved: August 26, 1988

NUREG-1409 2 Appendx D
NRC PROGRAM FOR MANAGEMENT OF PLANT-SPECIFIC

BACKFITTING OF NUCLEAR POWER PLANTS NRC-0514-032

of a licensee in accordance with Section 044. The EDO may authorize deviations

from this chapter when the EDO finds that such action is in the public interest and the deviation otherwise complies with the applicable regulations.

032 The Director, Office for Analysis and Evaluation of Operational Data

(AEOD), shall assure that process controls for overall agency management and

oversight of the plant-specific backfit process are developed and maintained

and shall coordinate the implementation of procedures within the other Offices

and Regions. These process controls shall include specific procedures, training, progress monitoring systems, and provisions for obtaining and evaluating

both staff and industry views on the conduct of the backfit process. The Director, AEOD, is also responsible for assuring that each licensee is informed

of the existence and structure of the NRC program described in this chapter.

The Director, AEOD, shall assure that substantive changes in the chapter and

related procedures are communicated to the licensees.

033 The Director, Office of Nuclear Reactor Regulation (NRR), shall assure that an overall procedure for managing plant-specific backfitting that

involves positions taken by NRR is developed, implemented, and maintained, in

accordance with the chapter. The overall procedure shall be coordinated with

AEOD and approved by the EDO. The Director, NRR, shall consult and coordinate with Regional Administrators and the Office of Nuclear Material Safety

and Safeguards, as appropriate, to develop resolutions of proposed plantspecific backfits in program areas for which NRR has responsibility.

For backfits within NRR's program area of responsibility which are proposed by

NRR staff, the Director or Deputy Director, NRR, without further delegation,

shall approve the regulatory analysis prior to communicating the backfit and

analysis to the licensee. For all backfits within the NRR program area of

responsibility which are appealed by a licensee, the Director, NRR, shall make

the decision on imposition of the backfit. The decision is subject to EDO

review under Section 0514-031. The Director, NRR, shall assure NRR staff

performance in accordance with this chapter.

034 The Director, Office of Nuclear Material Safety and Safeguards

(NMSS), shall assure that an overall procedure for managing plant-specific

backfitting that involves positions taken by NMSS is developed, Implemented,

and maintained, in accordance with this chapter. The overall procedure shall

be coordinated with AEOD and approved by the EDO. The Director, NSS,

shall consult and coordinate with Regional Administrators and the Director

of the Office of Nuclear Reactor Regulation, as appropriate, to develop resolutions of proposed plant-specific backfits in program areas for which

NMSS activities may affect reactor plant licensees

For backfits within the NMSS program area of responsibility which are proposed by NMSS staff, the Director or Deputy Director, NMSS, without further

delegation, shall approve the regulatory analysis prior to communicating the

backfit and analysis to the licensee. For all backfits within the NMSS program area of responsibility which are appealed by a licensee, the Director,

NMSS, shall make the decision on imposition of the backfit. The decision

is subject to EDO review under Section 0514-031. The Director, NMSS, shall

assure NMSS staff performance in accordance with this chapter.

Approved: August 26, 1988

Appendi D 3 NUREG-1409
NRC PROGRAM FOR MANAGEMENT OF PLANT-SPECIFIC

NRC-0514-035 BACKFITTING OF NUCLEAR POWER PLANTS

035 Regional Administrators shall assure that an overall procedure for

managing plant-specific backfitting that involves positions taken by a Region

in any program area for which the Region has been delegated authority, is developed, implemented, and maintained, in accordance with the chapter. The

overall procedure shall be coordinated with AEOD and approved by the EDO.

Regional Administrators shall consult and coordinate with the Directors of the

Offices of Nuclear Reactor Regulation and Nuclear Material Safety and Safeguards, as appropriate, to identify issues and develop resolutions of proposed

plant-specific backfits where such backfitting would result from positions

taken by the Region.

For backfits proposed by the Region, the Regional Administrator or Deputy Regional Administrator, without further delegation, shall approve the regulatory

analysis prior to communicating the backfit and analysis to the licensee. For

backfits proposed by the Region and appealed by the licensee, the Administrator is responsible for the conduct of the appeal process within the Region;

however, if agreement cannot be reached at the Regional level, the decision

on imposition of the backfit shall be made by the Director of the program office having responsibility for the program area relevant to the backfit.

The decision is subject to EDO review under Section 0514-031. Each Regional

Administrator shall assure Regional staff performance in accordance with this

chapter.

036 The Directors, Offices of Nuclear Reactor Regulation, and Nuclear

Material Safety and Safeguards, and Regional Administrators, shall approve

regulatory analyses initiated by their staff members, who propose backfits

within other program office areas of responsibility which have been delegated

to them for implementation and decision authority, prior to communicating the

backfit and analysis to the licensee.

037 The Director, Office of Administration and Resources Management,

shall, in coordination with the Office Directors, and Regional Administrators,

develop and maintain the overall NRC data base management system. identified

and described in Section 046 of this chapter.

038 NRC staff positions may be identified as potential backfits either by

NRC staff or by persons who are not members of the NRC staff. Such identifications will be considered by the Office Director/Regional Administrator

having responsibility to develop staff positions on the matter at issue. This

Office Director/Regional Administrator will be responsible to make the determination as to whether the staff position is a backfit and whether the proposed backfit should be imposed on the licensee.

0514-04 BASIC REQUIREMENTS

041 Information Requests Pursuant to 10 CFR 50.54(f). Paragraph 10 CFR

50.54(f) authorizes the NRC to require its licensees to provide additional

safety information to enable the Commission to determine whether or not a

license should be modified, suspended, or revoked. This paragraph (as amended in 50 FR 38097) requires the NRC to justify such information requests by a

Approved: August 26, 1988

NUREG-1409 4 Appendi D
NRC PROGRAM FOR MANAGEMENT OF PLANT-SPECIFIC

BACKFITTING OF NUCLEAR POWER PLANTS NRC-0514-041.a

supporting analysis which finds that the burden to be imposed is justified in

view of the potential safety significance of the issue to be addressed in the

requested information. The exceptions to this requirement are as follows:

a. No finding is required whenever there is reason to believe that the

public health and safety may not be adequately protected and safety information is needed to decide if this is the case and to take any

necessary corrective action.

b. Concerning the review of applications for licenses or amendments, or

the conduct of inspection activities, for plants under construction,

no finding will be necessary if the staff seeks information of a type routinely sought as a part of the standard procedures concerning the review of applications. If the request is not part of routine

licensing review (for example, if it seeks to gather information

pursuant to development of a new staff position), a staff analysis of

the reasons for the request and a finding must be prepared and

approved prior to issuance.

c. Concerning licensing review or inspection activities for operating plants, information requests seeking to verify licensee compliance with the current licensing basis for the facility are exempt from the

necessity to prepare the reason or reasons for the request and to

make a finding. Requests for information to determine compliance with existing facility requirements including fact-finding reviews, inspections and investigations of accidents or incidents, usually

are not made pursuant to Section 50.54(f), nor are such requests normally considered within the scope of the backfit rule or this

chapter.

The Directors of. NRR and NMSS and Regional Administrators shall develop internal office procedures to ensure that there is a rational basis for all

information requests not clearly excepted from the finding, whether or not it

is clear that backfit action would result from staff evaluation of the information supplied by the licensee. The request must be evaluated to determine

whether the burden imposed by the information request is justified in view of

the potential safety significance of the issue to be addressed. The information request and the staff evaluation must be approved by the cognizant Office

Director or Regional Administrator prior to transmittal of the request for

information to a licensee.

NRC staff evaluations of the necessity for an information request shall

include at least the following elements:

a. A problem statement that describes the need for the information in

terms of potential safety benefit.

b. The licensee actions required and the cost to develop a response to

the information request.

c. An anticipated schedule for NRC use of the information.

Approved: August 26, 1988

Appendi D 5 NUREG-1409
NRC PROGRAM FOR MANAGEMENT OF PLANT-SPECIFIC

NRC-0514-042 BACKFITTING OF NUCLEAR POWER PLANTS

042 Identifying Plant-Specific Backfits. The NRC staff shall be respon- sible for identifying proposed plant-specific backfits as defined by Section 05 of the chapter. The staff at all levels will evaluate any proposed plant-specific position with respect to whether or not the position qualifies

as a proposed backfit pursuant to Section 05 of this chapter. No staff posi- tion should be communicated to a licensee unless the NRC official communicating that position has ascertained whether or not the position is to be identified as a backfit. NRC Appendix 0514 provides information to help in identifying backfits arising from selected staff activities. When a staff pro- posed position is identified as a backfit the staff should determine expedi- tiously whether the backfit is needed to ensure adequate protection of the

public health and safety or to comply with Commission rules or orders, the

license, or written licensee commitments. If, and only if the backfit does

not meet this test, the appropriate staff office should proceed promptly with

the preparation of a regulatory analysis (Section 043) for approval in

accordance with this chapter.

Economic cost can never be a consideration either in defining what is an

adequate level of protection or in ensuring that an adequate level of protection is achieved and maintained.

The staff may, at any point in the development of the regulatory analysis, decide that further analysis is likely to show either that the proposed safety benefit Is not likely to be substantial additional overall protection, or

that the direct and Indirect costs of implementation are not likely to be justi- fied. In this case, the issue may be closed, with appropriate notice sent to

all parties and recorded in the recordkeeping system described in Section 046.

When (a) a staff proposed position is necessary to bring a facility into compliance with a license or the rules or orders of the Commission (Sections 052-a, 053-a), or into conformance with written commitments by the licensee

(Sections 052-a, 053-b), or (b) the Director of NRR or NMSS determines that

imposition of a backfit is necessary to ensure that the facility provides adequate protection to public health and safety, no regulatory analysis is

required. Instead, the appropriate Director/Regional Administrator is to pro- vide a documented evaluation to support the action taken.

The evaluation shall include a statement of the objectives of the reasons

for the modification and the basis for invoking the exception. In the case

of a backfit needed to assure that the facility provides adequate protection, the documented evaluation shall also include an analysis to document the

safety significance and appropriateness of the action taken. Should it be necessary or appropriate for the Commission to prescribe a way to achieve adequate protection, the evaluation can include a consideration of how costs

contribute to selecting the solution among various acceptable alternatives.

However, cost will not be a factor in determining what constitutes an adequate level of protection. Such an evaluation is to be issued with the backfit except that, when an immediately effective regulatory action is necessary, and the

safety need is so urgent that full documentation cannot be completed, the documentation may follow the backfit.

A proposed staff position which is not identified by the NRC staff as a

backfit position may be claimed to be a backfit position by a licensee. The

Approved: August 26, 1988

NUREG-1409 6 Appendbi D
NRC PROGRAM FOR MANAGEMENT OF PLANT-SPECIFIC

BACKFITTING OF NUCLEAR POWER PLANTS NRC-0514-043

staff will promptly consider a licensee claim of backfit to determine if the

claimed backfit qualifies as such in accordance with Section 05 of this chapter.

Licensees identifying such items should send a written claim of backfit (with

appropriate supporting rationale) to the Office Director or Regional Administrator of the NRC staff person who issued the position with a copy to the EDO.

If the NRC staff determination is that the issue is a backfit, the appropriate

staff office should proceed immediately with the preparation of any required

regulatory analysis for approval in accordance with this chapter.

If the determination is that the proposed staff position is not a backfit,

the appropriate staff office shall document the basis for the decision and

transmit it together with any documented evaluation required by this section to

the licensee. In any case, the appropriate Office Director/Regional Administrator shall report to the EDO and inform the licensee, within 3 weeks after

receipt of the written backfit claim, of the results of the determination and the

plan for resolving the issue.

When a licensee is informed that a claimed backfit is, in the judgment of

the NRC, not a backfit, the licensee may appeal this determination as

described in Section 044 of this chapter.

043 Regulatory Analysis. Positions identified as plant-specific backfits requiring the regulatory analysis in this section shall be transmitted

to licensees only after a determination 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 of implementation for that facility are justified in view of

the increased protection. The proposed backfit and supporting regulatory

analysis must be approved by the appropriate Program Office Director or

Deputy Director, or Regional Administrator or Deputy Regional Administrator

and forwarded to the EDO before the backfit and its supporting regulatory

analysis are transmitted to the licensee.

The regulatory analysis shall generally conform to the directives and guidance of NUREG/BR-0058 and NUREG/CR-3568, which are the NRC's governing

documents concerning the need for preparation of regulatory analyses. In

preparing regulatory analyses under this section, the staff should note that

the complexity and comprehensiveness of an analysis should be limited to that

necessary to provide an adequate basis for decisionmaking among the alternatives available. The emphasis should be .on simplicity, flexibility, and common sense, both in terms of the type of information supplied and in the level

of detail provided. The following information and any other information relevant and material to the backfit shall be included in the regulatory analysis,

as available and appropriate to the analysis:

a. A statement of the specific objective that the proposed backfit is

designed to achieve. This should also include a succinct description

of the backfit proposed, and how it provides a substantial increase

in overall protection.

b. A general description of the activity that would be required by the

licensee in order to complete the backfit.

Approved: August 26, 1988

Appendb D 7 NUREG-1409
NRC PROGRAM FOR MANAGEMENT OF PLANT-SPECIFIC

NRC-0514-043.c BACKFITTING OF NUCLEAR POWER PLANTS

c. The potential safety impact of changes in plant design or operational complexity, including the relationship to proposed and existing regulatory requirements.

d. Whether the proposed backfit is interim or final and, if interim, the justification for imposing the proposed backfit on an interim

basis.

e. A statement that describes the benefits to be achieved and the cost

to be incurred. Information should be used to the extent that it is

reasonably available, and a qualitative assessment of benefits may be made in lieu of the quantitative analysis where it would provide

more meaningful insights, or is the only analysis practicable. This

statement should include consideration of at least the following factors:

(1) The potential change in risk to the public from the accidental

offsite release of radioactive material.

(2) The potential impact on radiological exposure of facility employees. Also consider the effects on other onsite workers, due

both to installation of procedural or hardware changes and to

the effects of the changes, for the remaining lifetime of the

plant.

(3) The installation and continuing costs associated with the

backfit, including the cost of facility downtime or the cost

of construction delay.

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

proposed backfit and the availability of such resources.

f. A consideration of important qualitative factors bearing on the need

for the backfit at the particular facility, such as, but not limited

to, operational trends, significant plant events, management effectiveness, or results of performance reports such as the Systematic Assessment of Licensee Performance.

g. A statement affirming appropriate interoffice coordination related to

the proposed backfit and the plan for implementation.

h. The basis for requiring or permitting Implementation on a particular schedule, including sufficient information to demonstrate that the

schedules are realistic and provide adequate time for in-depth engi- neering, evaluation, design, procurement, installation, testing, development of operating procedures, and training of operators and

other plant personnel, as appropriate. For those plants with ap- proved integrated schedules, the integrated scheduling process can

be used for implementing this step and the following two procedural steps.

Approved: August 26, 1988

NUREG-1409 8 Appendix D
NRC PROGRAM FOR MANAGEMENT OF PLANT-SPECIFIC

BACKFITTING OF NUCLEAR POWER PLANTS NRC-0514-044

i. A schedule for staff actions involved in implementation and verification of implementation of the backfit, as appropriate.

j. Importance of the proposed backfit considered in light of other

safety-related activities underway at the affected facility.

k. A statement of the consideration of the proposed plant-specific backfit as a potential generic backfit.

044 Appeal Process. The appeal processes described in this section are

of two types, app ie to two distinctly different situations:

a. Appeal to an Office/Region to modify or withdraw a proposed backfit

which has been identified, and for which a regulatory analysis has

been prepared and transmitted to the licensee; or

b. Appeal to an Office/Region to reverse a denial of a prior licensee

claim either that a staff position, not identified by the NRC as a

backfit, is one, or that a backfit which staff believes falls within

one of the exceptions from the requirement for a regulatory analysis, does not.

In the first type of situation described, licensees should address an appeal of a proposed backfit to the Office Director or Regional Administrator whose

staff proposed the backfit with a copy to the EDO. The appeal should provide

arguments against the rationale for imposing a backfit as presented in the

staff's regulatory analysis. The Office Director or Regional Administrator

shall report to the EDO within 3 weeks after receipt of the appeal concerning the plan for resolving the issue. The licensee should also be promptly and

periodically informed in writing regarding the staff plans. The decision of the

Office Director on an appeal of plant-specific backfit may be appealed to the

EDO unless resolution is achieved at a lower management level. The EDO shall

promptly resolve the appeal and shall state his reasons therefor. Summaries of

all appeal meetings shall be prepared promptly, provided to the licensee, and

placed in appropriate Public Document Rooms. During the appeal process, primary consideration shall be given to how and why the proposed backfit provides a substantial increase in overall protection and whether the associated

costs of implementation are justified in view of the increased protection.

This consideration should be made in the context of the regulatory analysis as

well as any other information that is relevant and material to the proposed

backfit.

In the second type of appeal situation the appeal should be addressed to, and

will be decided by, the Director of the program office having responsibility for the program area relevant to the staff position, unless resolution is

achieved at a lower management level. A copy of the appeal should also be

sent to the Executive Director for Operations. The appeal should take into

account the staff's evaluation, the licensee's response, and any other Information that is relevant and material to the backfit determination. The EDO

may review and may modify a decision either at his or her own initiative or

at the request of the licensee. If the licensee appeals to the EDO, the EDO

Approved: August 26, 1988

Appendix D 9 NUREG-1409
-

NRC PROGRAM FOR MANAGEMENT OF PLANT-SPECIFIC

NRC-0514-045 BACKFITTING OF NUCLEAR POWER PLANTS

shall promptly resolve the appeal and shall state the reasons therefor. Backfit claims and resultant staff determinations that are reevaluated in response

to an appeal, and that are again determined by the NRC not to be backfits, or

are excepted from the requirement for a regulatory analysis, are not to be

treated further in the context of this chapter. Such matters are to be dealt

with within the normal licensing or inspection appeal process and are not

subject to the requirements of this chapter.

045 Implementation of Backfits. Following approval of any required reg- ulatory analysis by the appropriate Office Director or Regional Administrator,

review if any by the EDO, and issuance of the backfit to the licensee, the

licensee will either implement the backfit or appeal it. After an appeal and

subsequent final decision by the appropriate Office Director or EDO, the licensee may elect to implement a backfit resulting from the decision. If the

licensee does not elect to implement the backfit, it may be imposed by Order

of the appropriate Office Director.3

Implementation of plant-specific backfits will normally be accomplished on a

schedule negotiated between the licensee and the NRC. Scheduling criteria

should Include the importance of the backfit relative to other safety related

activities underway, or the plant construction or maintenance planned for the

facility, in order to maintain high quality construction and operations. For

plants that have Integrated schedules, the integrated scheduling process can

be used for this purpose.

A staff-proposed backfit may be imposed by Orders prior to completing any of

the procedures set forth in this chapter provided the NRC official authorizing the Order determines that immediate imposition is necessary to provide adequate protection to the public health and safety or the common defense and

security. In such cases, the EDO shall be notified promptly of the action and

a documented evaluation as described in Section 042 performed, if possible, in

time to be issued with the order.

If "immediate imposition" is not necessary, staff proposed backfits shall not

be imposed, and plant construction, licensing action, or operation shall not

be interrupted or delayed by NRC actions, during the staff's evaluation and

backfit transmittal process, or a subsequent appeal process, until final action is completed under this chapter.

046 Recordkeeping and Reporting. The proposing Headquarters Office or

Regional Office shall administratively manage each proposed plant-specific backfit using one agency recordkeeping system that provides for prompt retrieval of current status, planned and accomplished schedules, and ultimate

disposition. The system shall provide reference to all documents issued or

received by NRC staff relative to a plant-specific backfit, including requests, positions, statements, and summary reports. Access to make changes

to the system will be limited to those designated within each Office and

Region. Specific data required will include, but are not limited to:

30nce an Order is issued, whether or not It Is immediately effective, this

chapter no longer applies and appeals are governed by the procedures in 10

CFR Part 2, Subpart B.

Approved: August 26, 1988

NUREG-1409 10 Appendix D
NRC PROGRAM FOR MANAGEMENT OF PLANT-SPECIFIC

BACKFITTING OF NUCLEAR POWER PLANTS NRC-0514-046.a

a. Licensee and facility affected.

b. Whether a backfit is identified by staff or by a licensee.

c. Identification and description of the document that either transmits

a staff-identified backfit or a licensee request for consideration

of a licensee-identified backfit.

d. Substance of the backfit issue.

e. In the case of a licensee-identified backfit, the dates (predicted

and completed) that determinations are made as to whether or not a

staff position qualifies as a backfit, the substance of the determination, and the organization and official responsible for making

the determination.

f. A brief description of what action is pending, and the officials

responsible to complete the action.

g. Action closing date, to include a description of licensee or staff

action and date of agreement or order to implement; responsible

officials and organization for each action.

047 Exceptions. Nothing in this chapter shall be interpreted as authorizing or requiring the staff to make plant-specific backfits or assessments

for generic backfits that are, or have been, subject to review by the CRGR

and approval by the EDO, or for generic backfits approved prior to November

1981, unless the EDO determines that significant plant-specific issues were

not considered during the prior reviews or the EDO authorizes a deviation

under Section 031.

048 References.

a. NUREG/BR-0058, Rev. 1, May 1984, "Regulatory Analysis Guidelines

of the U.S. Nuclear Regulatory Commission"

b. NUREG/CR-3568, December 1983, "A Handbook for Value-impact

Assessment"

c. NUREG/CR-3971, October 1984, "A Handbook for Cost Estimating"

d. Revision of Backfit Rule, Code of Federal Regulations, 53 FR 20603

(June 6, 1988)

0514-05 DEFINITIONS

051 Licensee. Except where defined otherwise, the word licensee as used

in this chapter shall mean that person that holds a license to operate a nuclear power plant, or a construction permit to build a nuclear power plant, or

a Preliminary Design Approval, Final Design Approval, or Design Certification

for a Standardized Plant Design.

Approved: August 26, 1988

Appendix D 11 NUREG-1409
RC PROGRAM FOR MANAGEMENT OF PLANT-SPECIFIC

NRC-0514-052 BACKFITTING OF NUCLEAR POWER PLANTS

052 Plant-Specific Backfit. Backfitting is defined as the modification

of or addition to systems, structures, components, or design of a facility; or

the design approval or manufacturing license for a facility; or the procedures

or organization required to design, construct or operate a facility; any of

which may result from 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 previously applicable staff position after certain specified dates. Backfitting is "plant-specific" when it

involves the imposition of a position that is unique to a particular plant.

It should be noted that to be a plant-specific backfit a staff position must

meet conditions involving both (a) the substance of the elements of a proposed

staff position and (b) the time of the identification of the staff position:

a. A staff position may be a proposed backfit if it would cause a

licensee to change the design, construction or operation of a

facility from that consistent with already applicable regulatory

staff positions. Applicable regulatory staff positions are described

in Section 053.

b. A staff position as described in (a) above is a proposed backfit

if it is first identified to the licensee after certain important

design, construction or operation milestones, involving NRC approvals of varying kind, has been achieved. Those times after

which a new or revised staff position will be considered a backfit

are as follows:

(1) After the date of ssuance of the construction permit for the

facility (for facilities having construction permits issued

after May 1, 1985);

(2) After 6 months before the date of docketing of the OL application for the facility (for facilities having construction

permits issued before May 1, 1985);

(3) After the date of issuance of the operating license for the

facility (for facilities having an operating license on

May 1, 1985);

(4) After the date of issuance of the design approval under

10 CFR 50, Appendix M, N or 0.

NOTE: The EDO directives embodied in chapter NRC-0514 are effective as of

July 6, 1988.

053 Applicable Regulatory Staff Positions. Applicable regulatory staff

positions are those already specifically imposed upon or committed to by a

licensee at the time of the identification of a plant-specific backfit, and

are of several different types and sources:

a. Legal requirements such as in explicit regulations, orders, plant

licenses (amendments, conditions, technical specifications). Note

Approved: August 26, 1988

NUREG-1409 12 Appendix D
NRC PROGRAM FOR MANAGEMENT OF PLANT-SPECIFIC

BACKFITTING OF NUCLEAR POWER PLANTS NRC-0514-053

that some regulations have update features built in, as for example,

10 CFR 50.55a, Codes and Standards. Such update requirements are

applicable as described in the regulation.

b. Written commitments such as contained in the FSAR, LERs, and

docketed correspondence, including responses to Bulletins, responses to Generic Letters, Confirmatory Action Letters, responses to Inspection Reports, or responses to Notices of

Violation.

c. NRC staff positions4 that are documented, approved, explicit interpretations of the more general regulations, and are contained in

documents such as the SRP, Branch Technical Positions, Regulatory

Guides, Generic Letters, and Bulletins; and to which a licensee or

an applicant has previously committed to or relied upon. Positions

contained in these documents are not considered applicable staff

positions to the extent that staff has, in a previous licensing or

inspection action, tacitly or explicitly excepted the licensee from

part or all of the position.5

4Requirements may be imposed by rule or order. Staff interpretations such as

examples of acceptable ways to meet requirements are not requirements in and

of themselves.

SImposition of a staff position from which a licensee has previously been excepted is a backfit.

Approved: August 26, 1988

Appendix D 13 NUREG-1409
NRC PROGRAM FOR MANAGEMENT OF PLANT-SPECIFIC

BACKFITTING OF NUCLEAR POWER PLANTS NRC Appendix 0514

CONTENTS

Guidance for Making Backfit Determinations Page

A. General ......................... 1

B. Licensing ......................... 1

1. Standard Review Plan..........................................

2. Regulatory Guides.............................................

3. Plant-Specific Orders.........................................

1

2

3

C. Inspection and Enforcement ......................... 3

1. Inspections...................................................

2. Notice of Violations..........................................

3. Bulletins.....................................................

4. Reanalysis of Issues..........................................

3

4

4

4

i Approved: August 26, 1988

NUREG-1409 14 Appendi D
NRC PROGRAM FOR MANAGEMENT OF PLANT-SPECIFIC

BACKFITTING OF NUCLEAR POWER PLANTS NRC Appendix 0514

Guidance for Making Backfit Determinations

A. General

In this section selected regulatory activities and documents are discussed in order to enable members of the NRC staff and the regulated industry to better understand the conditions under which a staff position may

be viewed as a plant-specific backfit. It is important to understand

that the necessity for making backfit determinations should not inhibit

the normal informal dialogue between the technical reviewer or inspector

and the licensee. The intent of this process is to manage backfit

imposition, not to quell it. The discussion in this appendix is intended

to aid in identifying backfits in accordance with the principles and the

practices that should be implemented by all staff members. This appendix

is not intended to be an exhaustive, comprehensive workbook in which can

be found a parallel example for each situation that may arise. As is

evident from the definitions in Section 05 of this chapter, a plantspecific backfit has the elements of a change from an already applicable

staff position where an applicable staff position is defined as that

established before certain defined milestones in the affected plant's

licensing history. There will be some judgment necessary to determine

whether a staff position would cause a licensee to change the design,

construction or operation of a facility. In making this determination,

the fundamental question is whether the staff's action is directing,

telling, or coercing, or is merely suggesting or asking the licensee to

consider a staff proposed action.

Actions proposed by the licensee are not backfits under this chapter

even though such actions may result from normal discussions between

staff and licensee concerning an issue, and even though the change or

additions may meet the definitions of Section 0514-052 and 0514-053.

B. Licensing

1. Standard Review Plan (SRP) - The SRP delineates the scope and

depth of staff review of licensee submittals associated with various

licensing activities. It is a definitive NRC staff interpretation of

measures which, if taken, will satisfy the requirements of the more

generally stated, legally binding body of regulations, primarily

found in Title 10 CFR. Since October 1981, changes to the SRP are

to have been reviewed and approved through a generic review process involving the Committee to Review Generic Requirements (CRGR),

and the extent to which the changes apply to classes of plants is

defined. Consequently, application of a current SRP in a specific

operating license (OL) review generally is not a plant-specific

backfit, provided the SRP was effective 6 months prior to the start

of the OL review. Asking an applicant for an operating license

questions to clarify staff understanding of proposed actions, in

order to determine whether the actions will meet the intent of the

SRP, is not considered a backfit.

On the other hand, using acceptance criteria more stringent than

those contained in the SRP or taking positions more stringent than

1 Approved: August 26, 1988

Appendix D 1 5 NAex UR-1409
NRC PROGRAM FOR MANAGEMENT OF PLANT-SPECIFIC

NRC Appendix 0514 BACKFITTING OF NUCLEAR POWER PLANTS

in addition to those specified in the SRP, whether in writing or

orally, is a plant-specific backfit. During meetings with the

licensee, staff discussion or comments regarding issues and licensee actions volunteered which are in excess of the criteria in the

SRP generally do not constitute plant-specific backfits; however,

if the staff implies or suggests that a specific action in excess

of already applicable staff positions is the only way for the staff

to be satisfied, the action is considered a plant-specific backfit

whether or not the licensee agrees to take such action. However,

the staff should recognize that a verbally implied or suggested action should not be accepted by a licensee as an NRC position of

any kind, backfit or not; only written and authoritatively approved position statements should be taken as NRC positions.

Application of an SRP to an operating plant after the license is

granted generally is considered a backfit unless the SRP was

approved specifically for operating plant implementation and is

applicable to such operating plant. It is important to note,

however, that in order to issue an amendment to a license, there

must be a current finding of compliance with regulations applicable

to the amendment. As a specific example, review of a plant owner's

application for a license amendment to authorize installation and

operation of a new reactor core, commonly called a "reload appli- cation," may necessitate review of new fuel designs or new thermalhydraulic correlations and associated operating limits. Such changes that are clearly advances in design or operation may involve new or

unreviewed safety issues, and may warrant review to SRP criteria

which were approved subsequent to initial license issuance to the

licensee. This is not considered a backfit. However, such review to

newer SRP revisions is not necessarily required to determine current

compliance with regulations. Licensee-proposed revisions in design

or operation that raise staff questions only about potential reduced

margins of safety as defined in the basis for any technical speci- fication should be reviewed by reanalysis of the same accident

sequences and associated assumptions as analyzed in the FSAR for

the initial license issuance.

During reload reviews, staff-proposed positions with regard to

technical matters not related to the changes proposed by a licensee shall be considered backfits.

2. Regulatory Guides - As part of the generic review process pursuant

to the CRGR Charter, it is decided which plants or groups of plants should be affected by new or modified Regulatory Guide provisions. Such implementation is therefore not governed by the plant-specific backfit procedures. However, any staff proposed plant-specific implementation of a Regulatory Guide provision, whether orally or

in writing, for a plant not encompassed by the generic implementa- tion determination is considered a plant-specific backfit. A staff

action with respect to a specific licensee that expands on, adds to,

or modifies a generically approved regulatory guide, such that the

position taken is more demanding than intended in the generic positions, is a plant-specific backfit.

Approved: August 26, 1988 2

NLJRi;(;-1409 16 Appendi D
NRC PROGRAM FOR MANAGEMENT OF PLANT-SPECIFIC

BACKFITTING OF NUCLEAR POWER PLANTS NRC Appendix 0514

3. Plant-Specific Orders - An order issued to cause a licensee to take

actions which are not otherwise applicable regulatory staff posi- tions is a plant-specific backfit. As described in Section 0514-045

of this chapter, an order effecting immediate imposition of a backfit may be issued prior to completing any of the procedures set

forth in this chapter provided that the appropriate Office Director

determines that immediate imposition is necessary.

An order Issued to confirm a licensee commitment to take specific action even If that action is in excess of previously applicable staff positions, is not a plant-specific backfit provided the commitment was not obtained by the staff with the expressed or implied

direction that such a commitment was necessary to gain acceptance in the staff review process. Discussion or comments by the NRC staff

identifying deficiencies observed, whether in meetings or written

reports, do not constitute backfits. Definitive statements to the

licensee directing a specific action to satisfy staff positions are

backfits unless the action is an explicit and already applicable regulatory staff position.

C. Inspection and Enforcement

1. Inspections - NRC inspection procedures govern the scope and depth of staff Inspections associated with licensee activities such as

design, construction, and operation. As such, they define those

items the staff is to consider in its determination of whether the

licensee is conducting its activities in a safe manner. The conduct

of inspections establishes no new staff positions for the licensee

and Is not a plant-specific backfit.

Staff statements to the licensee that the contents of an NRC inspec- tion procedure are positions that must be met by the licensee constitute a plant-specific backfit unless the item is an applicable regulatory staff position. Discussion or comment by the NRC staff

regarding deficiencies observed in the licensee conduct of activities, whether in meetings or in written inspection reports, do not

constitute backfits, unless the staff suggests that specific corrective actions different from previous applicable regulatory staff

positions are the only way to satisfy the staff. In the normal

course of Inspecting to determine whether the licensee's activities

are being conducted safely, inspectors may examine and make findings in specific technical areas wherein prior NRC positions and

licensee commitments do not exist. Examination of such areas and

making findings is not considered a backfit. Likewise, discussion

of findings with the licensee is not considered a backfit. If during such discussions, the licensee agrees that it is appropriate

to take action in response to the inspector's findings, such action

is not a backfit provided the inspector does not indicate that the

specific actions are the only way to satisfy the staff. On the

other hand, if the inspector indicates that a specific action must

be taken, such action is a backfit unless it constitutes an appli- cable regulatory staff position. Further, if the licensee decides

3 Approved: August 26, 1988

Appendix D 17 N URI- -1409
NRC PROGRAM FOR MANAGEMENT OF PLANT-SPECIFIC

NRC Appendix 0514 BACKFITTING OF NUCLEAR POWER PLANTS

to claim that the inspector's findings are a backfit, then the

staff must decide whether they are a backfit under this chapter.

For example, If the licensee commits to ANSI-N18.7 in the SAR and

the inspector finds the licensee's implementing procedures do not

contain all the elements required by ANSI-N18.7, telling the licensee he must take action to nclude all the elements in the

implementing procedures is not a backfit. If the inspector finds

the licensee has Included all the required elements of ANSI-N18.7,

but has not Included certain of the optional elements in the imple- menting procedures, inspector discussion with the licensee regard- Ing the merits of Including the optional elements is not a backfit.

On the other hand, if the Inspector tells the licensee that the

implementing procedures must Include any or all of the optional elements in order to satisfy the staff, Inclusion of such elements

is a backfit, whether or not agreed to by the licensee.

2. Notice of Violations (NOV) - a NOV requesting description of a licensee's proposed corrective action Is not a backfit. The licensee's commitments in the description of corrective action are not

backfits. A request by the staff for the licensee to consider some

specific action in response to an NOV Is not a backfit. However,

if the staff is not satisfied with the licensee's proposed corrective actions and requests that the licensee take additional actions, those additional actions (whether requested orally or in

writing) are a backfit unless they are an applicable regulatory staff position.

Discussions during enforcement conferences and responses to the

licensees requests for advise regarding corrective actions are

not backfits; however, definitive statements to the licensee

directing a specific action to satisfy staff positions are backfits, unless the action is an explicit applicable regulatory staff

position.

3. Bulletins - Bulletins and resultant actions requested of licensees

undergo the general review process pursuant to the CRGR Charter.

Therefore, in general, it is not necessary to apply the plant- specific backfit process to the actions requested in a Bulletin.

However, if the staff expands the action requested by a Bulletin

during its application to a specific licensee, such expansion is

considered a plant-specific backfit.

4. Reanalysis of Issues - Throughout plant lifetime, many individuals

on the NRC staff have an opportunity to review the requirements and

commitments incumbent upon a licensee. Undoubtedly, there will be

occasions when a reviewer concludes the licensee's program in a

specific area does not satisfy a regulation, license condition or

commitment. In the case where the staff previously accepted the

licensee's program as adequate, any staff specified change in the

program would be classified as a backfit.

Approved: August 26, 1988 4

NUREG-1409 1 8 AIvi~tix l)
NRC PROGRAM FOR MANAGEMENT OF PLANT-SPECIFIC

BACKFITTING OF NUCLEAR POWER PLANTS K]00G A~znl nAE . . ..-- _. .- .- - IFor example, In the case of an NTOL, once the SER is issued signifying staff acceptance of the programs described In the SAR, the

licensee should be able to conclude that his commitments in the SAR

satisfy the NRC requirements for a particular area. If the staff was

to subsequently require that the licensee commit to additional action

other than that Specified In the SAR for the particular area, such

action would constitute a backfit.

A somewhat different situation exists when the licensee has made a

submittal committing to a specific course of action to meet an applicable position, and the staff has not yet responded, and therefore

has not Indicated that the commitment Is or Is not sufficient to meet

the applicable position. Subsequent staff action, which must be

taken within a reasonable time not delaying the applicant's implementation plans, to cause the licensee to meet the applicable regulatory

staff position Is not a backfit. If the licensee has moved ahead In

the Intervening time to implement that which the licensee proposed to

do in Its submittal and the staff has failed to provide a timely

response, then the staff position may be considered a backfit. Thus,

if a licensee has Implemented a technical resolution intended to meet

an applicable regulatory staff position, and staff for an extended

period simply allows the licensee resolution to stand with tacit acceptance indicated by non-action on the. part of NRC, then a subsequent

action to change the licensee's design, construction, or operation

Is a backfit.

5 Approved: August 26, 1988

Appendix D 19 NUREG-1409
-APPENDIX E

BACKGROUND INFORMATION FOR CRGR REVIEW

OF GI-70 AND GI-94 RESOLUTIONS

NUREG-1409
Enclosure 1

Background Information for CRGRReview

of G-70 and 61-94 Resolutions

The following nformation is provided in the format specified in Section IV

B(M) through IV B(ix) of Revision 4 of the CRGR Charter, dated April 1987. For

each item, the request for information is given followed by a discussion of the

response or a reference to where the information is provided.

(i) The proposed generic requirement or staff position as it is proposed to

be sent out to licensees.

The proposed generic resolution is set forth in the proposed 10CFR50.54(f)

generic letter 89-XX (see Enclosure 2).

(ii) Draft staff papers or other underlying staff documents supporting the

requirements or staff positions. (A copy of all materials referenced

in the document shall be made available upon request to the CRGR staff.

Any committee member may request CRGR staff to obtain a copy of any

referenced material for his or her use.)

The relevant technical information for GI-70 is contained in NUREG1316 (Enclosure 3) and related contractor reports and other references

listed therein. The relevant technical information for GI-94 is

contained in NUREG-1326 (Enclosure 10) and related contractor reports

and other references listed therein. Copies of any references will

be provided upon request.

(111) Each proposed requirement or staff position shall contain the sponsoring

office's position as to whether the-proposal would increase requirements

or staff positions, implement existing requirements or staff positions,

or would relax or reduce existing requirements or staff positions.

Technical findings related to the resolution of G-70 are contained

in NUREG-1316 (Enclosure 3). Technical findings related to the

resolution of GI-94 are contained in NUREG-1326 (Enclosure 10). These

findings have been incorporated in the proposed generic letter

(Enclosure 2). They represent the final staff position on GI-70 and

GI-94 and for certain operating PWR plants are additional requirements.

For certain recently licensed operating plants and certain plants

currently under active construction the GI-70 technical findings do not

represent additional requirements. The GI-94 technical findings do not

represent additional requirements for Babcock and Wilcox plants.

Appendix E l NUREG-1409
2

(iv) The proposed method of implementation along with the concurrence

(and any comments) of OGC on the method proposed.

OGC has no legal objection to the proposed action in Generic Letter 89-XX

(Enclosure 2). All OGC comments have been incorporated in the proposed

generic letter.

(v) Regulatory analyses generally conforming to the directives and

guidance of NUREG/CR-0058 and NUREG/CR-3568.

Regulatory analyses related to the resolution of GI-70 are contained

in Section 5 of NUREG-1316 (Enclosure 3). The Regulatory Analysis for

the resolution of GI-94 is provided in NUREG-1326 (Enclosure 10).

(vi) Identification of the category of reactor plants to which the generic

requirement or staff position is to apply (that is, whether it is

to apply to new plants only, new OLs only, OLs after a certain date,

OLs before a certain date, all OLs, all plants under construction,

all plants, all water reactors, all PWRs only, some vendor types,

some vintage types such as BWR 6 and 4, jet pump and nonjet pump

plants, etc.)

The proposed Generic Letter 89-XX (Enclosure 2) will be sent to PWRs

and is applicable to all operating plants and future plants

including those currently under construction. However, certain

recently licensed operating plants and certain plants currently under

active construction already satisfy the GI-70 recommendations of the

generic letter, and certain plants are not impacted by the GI-70

recommendations (CE plants without PORVs). With respect to the GI-94

recommendation, Babcock and Wilcox plants are not impacted.

(vii) For each such category of reactor plants, an evaluation which demonstrates

how the action should be prioritized and scheduled in light of other

ongoing regulatory activities. The evaluation shall document for

consideration information available concerning any of the following

factors as may be appropriate and any other information relevant and

material to the proposed action:

Potential improvements to PORYs and block valves should be prioritized

and scheduled in conjunction with ongoing regulatory activities such as;

review of inservice testing programs of valves in conformance with

Section XI of the ASME Code. Review of potential modifications to

technical specifications for low-temperature overpressure protection

should be prioritized in conjunction with these same activities.

(a) Statement of the specific objectives that the proposed action

is designed to achieve;

NUREG-1409 2 Appendix E
3

The objectives that the proposed actions are designed to achieve are

to increase the reliability of PORVs and block valves to provide

assurance they will function as required, and to provide additional

assurance that LTOP systems will be available when required.

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

licensee or applicant in order to complete the action;

With respect to GI-70, for operating plants when PORVs and the associated

block valves are used for any of the safety functions discussed in

Section 2.1 of NUREG-1316 the activity that would be required by the

licensee consists of the following actions:*

(1) Include PORVs and block valves in the operational quality

assurance program that is in compliance with 10 CFR 50,

Appendix B.

(2) Provide a maintenance/refurbishment program for PORVs and

block valves.

(3) Testing in accordance with Section XI of the ASME Code for

PORYs and block valves. Additional testing for PORY block

valves will be included in the expanded MOV test program

discussed in NRC Generic Letter 89-XX, "Safety-Related

Motor Operated Valve Testing and Surveillance" dated (Later).

(4) Modify the limiting conditions of operation of PORYs and block

valves in the technical specifications for Modes 1, 2, and 3

as contained in Attachments A-1, A-2, and A-3 of Enclosure

A to the proposed Generic Letter 89-XX (Enclosure 2).

For future PWR plants and those currently under construction-when PORVs

and the associated block valves are used for any of the safety functions

discussed in Section 2.1 of NUREG-1316, these components should be

classified as safety related and a minimum of two PORVs and two block

valves installed. Plants currently under active construction meet these

recommendations.

With respect to GI-94, Combustion Engineering and Westinghouse PWRs

should modify the current plant Technical Specifications for-the

Overpressure Protection System to assure both channels are operable in

Modes 5 and 6, especially when water-solid as contained in Enclosure B

and its attachments to proposed Generic Letter 89-XX (Enclosure 2).

Revisions to the plant cooldown and heatup (or filling and venting)

procedures are also recommended. In addition, verification that

administrative controls and procedures regarding the LTOP design basis

analyses have been implemented is also recommended.

(c) Potential change in the risk to the public from the accidental

offsite release of radioactive material;

*Certain recently licensed operating plants already satisfy these requirements.

Appendi E 3 NUREG-1409
4

GI-70 Contractor analysis showed only a small change in risk based

on Indian Point 3 and Oconee PRA's. However, NUREG/CR-5230

showed that feed and bleed provides a significant reduction

in core melt probability for four representative plants. The

proposed actions would enhance feed and bleed capability.

Even if only a fraction of the core melt reduction indicated

in NUREG/CR-5230 is achieved, this would result in a

substantial reduction in risk to the public.

GI-94 The estimated total dose reduction is 14,500 person-rem over

the remaining license life of the PWRs impacted by the

proposed resolutions.

(d) Potential impact on radiological exposure of facility employees and

other onsite workers.

For GI-70, it is estimated that there would be little or no increase in

exposure because:

(1) Most surveillance testing would be performed remotely

in situ.

(2) Exposure resulting from orderly planned maintenance

activities is considered unlikely to result in exposure

levels any higher than those resulting from unplanned major

repairs after valves malfunction in service.

No additional exposure to facility employees or other onsite workers is

expected for the proposed resolution of GI-94.

(e) Installation and continuing costs associated with the action,.

including the cost of facility downtime or the cost of construction

delay;

The present worth of the utility cost impact for GI-70 for operating

PWR plants with two PORVs and two block valves is $127,200 for items

(b)l through (b)4 discussed above. However, this cost will be more

than offset by the savings from less outage time because of PORV and

block valve problems. This work would be accomplished during scheduled

refueling/maintenance outages as a part of existing plant programs.

The net present value of the estimated replacement power cost resulting

from the proposed resolution of GI-94 is estimated to be 2,000 per

plant, assuming a 5 discount rate and a 24 year average remaining

lifetime for the plants impacted by GI-94. The average annual utility

cost is estimated to be $145.00.

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

complexity, including the relationship to proposed and existing

regulatory requirements and staff positions;

NUREG-1409 4 Appendix E
5

For a certain number of operating plants the proposed revision to the

technical specifications may be more restrictive. The proposed

recommendations for GI-70 are expected to increase the reliability of

PORVs in Modes 1, 2 and 3and therefore overall plant safety.

The proposed recommendations for GI-94 are expected to increase

the availability of the LTOP systems in Modes 5 and 6 (especially

when water-solid) and therefore overall plant safety.

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

proposed action and the availability of such resources;

The estimated resource burden on the NRC is minimal, costs are estimated

in Section 5.5 of the Regulatory Analysis in UREG-1316 (Enclosure 3)

for GI-70, and in Section 5.1.2 of the Regulatory Analysis in NUREG-1326

(Enclosure 10) for GI-94.

(h) The potential impact of differences in facility type, design or

age on the relevancy and practicality of the proposed action;

The potential impact of the proposed actions for GI-70 on PWRs with

PORVs will vary from none to moderate. That is, on plants that received

an OL since 1984 there would be no impact as these plants in general have

safety grade PORYs and block valves. On older PWRs with PORVs the

impact will be variable depending on the degree of compliance with

items (b) through (b)4 discussed above. CE plants without PORts are

not impacted by the proposed resolution for GI-70

The potential impact of the proposed actions for GI-94 are not expected

to be different based on facility type, design or age. However,

Babcock and Wilcox PWRs are not impacted by the proposed resolution

for GI-94.

(I) Whether the proposed action is interim or final, and if interim,

the justification for imposing the proposed action on an interim

basis.

The proposed actions are final with respect to the resolution of GI-70

and 6I-94.

Appendx E 5s NUREG-1409;
APPENDIX F

SAMPLE BACKFIT DISCUSSION

(TAKEN FROM NRC BULLETIN 90-01)

NUREG-1409
Backfit Discussion

The objective of the actions requested in this bulletin is to

ensure that transmitter failures due to loss of fill-oil are

promptly detected. Loss of fill-oil may result in a transmitter not performing its intended safety function.

The actions requested in this bulletin represent new staff

positions and thus, this request is considered a backfit in

accordance with NRC procedures. Because established

regulatory requirements exist but werle not satisfied, this

backfit is to bring facilities into compliance with existing

requirements. Therefore, a full backfit analysis was not

performed. An evaluation of the type discussed in 10

CFR.109(aX6) was performed, including a statement of

the objectives of and reasons for the actions requested

and the basis for invoking the compliance exception. It

will be made available in the Public Document Room with

the minutes of the 179th meeting of the Committee to

Review Generic Requirements.

Appendix F 1 NUREG-1409
NRC FORM 335 US. NUCLEAR REGULATORY COMMISSION .REPORT NUMBER 12421 lAnuipd IbY KPC. Add VOL., St",. Rev..

NRCM 1102, VWd Akbfam NUMIUMM If SPIV.)

3201.3202 BIBLIOGRAPHIC DATA SHEET

(SW JutwnX no the ve N.)

2. TITLE AND SUBTITLE NUREG-1409

3. DATE REPORT PUBLISHED Backfitting Guidelines MONTH " EAR

July 1990

4. FIN OR GRANT NUMBER

.AUTHOR(S) 6. TYPE OF REPORT

Allison, Dennis P.

Conran, James H. 7. PERIOD COVERED

Trottier, Cheryl A.

L PERFORMING ORGANIZATION-NAME ANDADDRESS W NRC.Wovi,*DA On#off eaRb"anUS.1 ?wbRaguktaryiemd igYw,,acM' ma .9dam~kVeddrrLl I r."vd

Office for Analysis and Evaluation of Operational Data

U.S. Nuclear Regulatory Commission

Washington, DC 20555

9. SPONSORING ORGANIZATION -NAME AND ADDRESS 0 NRC. we orwambowfr. emco provid NC Oa, Office a AftRAL U.S NclaudaoioyCm mks,.

Same as above.

10. SUPPLEMENTARY NOTES

11. ABSTRACT IM worm er -W

The backfitting process s the process by which the U.S. Nuclear Regulatory

Comission (NRC) decides whether to issue new or revised requirements or

staff positions to licensees of nuclear power reactor facilities. Requirements for proper justification of backfits and information requests are provided

by two NRC rules (Title 10, Code of Federal Regulations, Sections 50.109 and

50.54(f)). NRC procedures include the charter of the committee to Review

Generic Requirements, NRC Manual Chapter 0514, and individual office

procedures. Three types of backfits are recognized. Cost-justified substantial

safety mprovements require backfit analyses and findings of (1) substantial

safety improvement and (2) justified costs. Compliance exceptions and

adequate protection exceptions do not require findings of substantial safety

improvements and costs are not considered. However, they are still backfits

and require documented evaluations to support the use of the exceptions.

Information requests (as opposed to backfits) require an analysis of the

burden to be imposed to ensure that they are justified in view of the

potential safety significance of the information requested.

12. KEY WORDSIDESCR!PTORS fLint wo'torp1mww atlllnrtmeawhn locadogIMe a arfo 13. AVAILABILITY STATEMENT

backfi t backfit anlssUnlimited backfit analysis 14. SECURITY CLSIFICATION

information request ,Th ,w

regulatory analysis Unclassified

cost-benefit analysis Unclassifie

generic communication Uncl

new requirement 15. NUMBER OF PAGES

16. PRICE

NRC FORM 335 2491
UNITED STATES

NUCLEAR REGULATORY COMMISSION

WASHINGTON, D.C. 20555

OFFICIAL BUSINESS

PENALTY FOR PRIVATE USE, 300

ECIEA FOURTH-CASS ATE

POSTAG IFEES PAID

USNRC

PERMfT No. 0a a

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