This section of the FEDERAL REGISTER

contains notices to the public of the proposed

issuance of rules and regulations. The

purpose of these notices is to give interested

persons an opportunity to participate in the

rule making prior to the adoption of the final

rules.

Proposed Rules Federal Register

76178

Vol. 65, No. 235

Wednesday, December 6, 2000

NUCLEAR REGULATORY

COMMISSION

10 CFR Part 50

[PRM–50–62]

Changes to Quality Assurance

Programs; Withdrawal of Remaining

Issues Concerning a Petition for

Rulemaking

AGENCY: Nuclear Regulatory

Commission.

ACTION: Petition for rulemaking:

withdrawal.

SUMMARY: The Nuclear Regulatory

Commission (NRC) is terminating its

plans to develop a voluntary option

alternative to its regulations to allow

licensees to make unilateral changes to

their quality assurance (QA) program

descriptions. This action is being taken

because the petitioner, the Nuclear

Energy Institute (NEI), has withdrawn

the remaining issues raised in its

petition for rulemaking submitted on

June 8, 1995 (Docket No. PRM–50–62).

NEI’s action is related in part to a

revision dated February 23, 1999, to the

Commission’s regulations that was

implemented in response to the petition

and provided the industry with a

reduction of unnecessary regulatory

burden. The effect of this action is that

further revisions to the Commission’s

quality assurance regulations are not

being developed.

ADDRESSES: Copies of the petition for

rulemaking, the public comments

received on the notice of receipt of the

petition (60 FR 47716; September 14,

1995), NRC’s response to the petitioner,

public comments received on the direct

final rule (64 FR 9029; February 23,

1999), NRC’s response to comments

received on the direct final rule partially

granting the petition (64 FR 42823;

August 6, 1999), the Petitioner’s letter

(Accession No. ML003755305), stating

that it is not necessary to pursue further

changes, and NRC’s confirmation letter

(Accession No. ML003747685),

pertaining to the withdrawal of the

petition are available for public

inspection or copying for a fee in the

NRC Public Document Room (PDR), One

White Flint North, Room O–1F21, 11555

Rockville Pike, Rockville, Maryland

20852. These documents are also

available for perusal at the NRC’s

rulemaking website http://

ruleforum.llnl.gov. Questions or

comments regarding this website should

be directed to Carol A. Gallagher at 301–

415–5905 or CAG@NRC.GOV.

FOR FURTHER INFORMATION CONTACT:

Michael T. Bugg, Office of Nuclear

Reactor Regulation, U.S. Nuclear

Regulatory Commission, Washington,

DC 20555–0001, telephone 301–415–

3221, e-mail mtb@nrc.gov.

SUPPLEMENTARY INFORMATION:

Background

By letter dated June 8, 1995, NEI

petitioned the NRC to amend its

regulations controlling changes to

nuclear power plant licensee QA

programs. The petition was received by

the Commission on June 19, 1995, and

assigned Docket No. PRM–50–62. The

petitioner requested that the NRC

modify 10 CFR 50.54(a) to permit a

nuclear power plant licensee to make a

broader range of changes to its QA

programs without prior NRC approval.

At the time of the petition submittal, 10

CFR 50.54(a)(3) allowed a licensee to

‘‘* * * make a change to a previously

accepted quality assurance program

description included or referenced in

the Safety Analysis Report, provided the

change does not reduce the

commitments in the program

description previously accepted by the

NRC.’’ NEI requested that the

Commission amend this requirement to

allow a licensee to ‘‘* * * make a

change to a previously accepted quality

assurance program description included

or referenced in its Safety Analysis

Report without prior Commission

approval unless the proposed change

involves a change in the technical

specifications incorporated in the

license or involves an unreviewed safety

question,’’ consistent with the criteria of

10 CFR 50.59. According to NEI’s

proposal, changes involving unreviewed

safety questions (USQs) would require

NRC approval before implementation.

The Petition

NEI stated that 10 CFR 50.54(a) is

sometimes interpreted by the NRC as

requiring NRC approval for any changes

in the QA program, regardless of the

safety significance associated with the

change. As a consequence, there are

often prolonged and sometimes

unnecessary regulatory debates about

the correct interpretation of the term

‘‘reduction in commitment.’’ NEI

presented the following examples of

changes that it believed could be made

without the need for prior NRC approval

but that have been viewed as

‘‘reductions in commitment,’’ requiring

prior NRC approval:

1. Changes in the level of approval of

administrative, implementation, or

policy procedures, regardless of the

safety significance;

2. Changes in the company

organization as it is described in a

licensee’s original quality plan;

3. Changes in frequency for audit,

review, or surveillance activities that

have minimal, if any, safety

significance;

4. Adoption of a more recent national

standard that may, or may not, have

been endorsed by the NRC staff, that

results in a different implementation

methodology, yet fulfills the same

function and achieves the same

objective as the original standard

described in the QA program

description through the use of enhanced

technology or other developments; and

5. Adoption of quality processes

different or more effective and efficient

than those described in a licensee’s

original quality plan based on the safety

significance and past operating

performance.

NEI estimated that NRC review and

approval of these types of changes cost

the industry in excess of $1 million per

year. In addition, NEI asserted that

licensees occasionally were hesitant to

pursue QA program improvements

because of the resources required for

NRC approval, even though the ultimate

result would be improvements in

efficiency, quality, or safety.

NEI also noted that the NRC’s main

purpose for the current requirement in

10 CFR 50.54(a) (which was adopted in

1983) was to preclude licensees from

making certain changes to QA programs

without prior NRC approval because, in

the past, some QA programs had been

changed and no longer conformed to

NRC regulations. NEI claimed that its

proposed approach in PRM–50–62

would still address the NRC’s concerns

Federal Register / Vol. 65, No. 235 / Wednesday, December 6, 2000 / Proposed Rules 76179

because QA program changes would

continue to be reported periodically to

the NRC as required by 10 CFR 50.71(e)

as program updates, and changes that

involve a USQ or cause a change to the

technical specifications would be

submitted to the NRC for approval

before they are implemented. The

petitioner reiterated that this is the same

process used for change control for

many other aspects of the facility design

and operation, and should be used for

QA programs as well. NEI further stated

that the proposed amendment would

improve the consistency of the

regulatory process and would result in

increased safety of commercial nuclear

power plants through more efficient use

of NRC and industry resources.

Comments Received on the Petition

On September 14, 1995 (60 FR 47716),

the NRC published a notice of receipt of

the NEI petition for rulemaking and

provided an opportunity for public

comment. The document requested that

public comment on eight specific

questions on critical regulatory aspects

of the NEI petition. Seventeen comment

letters were received, plus one comment

letter that supplemented one of the

original letters.

Eleven of the public comment letters

were sent by nuclear power plant

licensees and NEI; all supported the

proposed change in the regulations. The

six non-NEI/non-licensee letters were

sent by individual concerned citizens

(two are currently employed in the

nuclear field); all expressed opposition

to the relaxation of current requirements

that address changes in QA programs.

All of the comment letters addressed

issues raised in the petition, particularly

the appropriateness of using the 10 CFR

50.59 criteria for QA program changes.

Commission Decision

The Commission agreed with NEI that

the 10 CFR 50.54(a) criteria under

which a licensee was allowed to make

unilateral QA program changes was too

stringent because it prevented a licensee

from making QA program changes of

minor safety significance without first

obtaining NRC approval. The

Commission decided that new criteria

should be adopted to broaden the scope

of changes that could be made by a

licensee without prior NRC approval.

Therefore, the Commission accepted the

petition in part and issued a direct final

rule (64 FR 9029; February 23, 1999)

that revised 10 CFR 50.54(a) to allow a

licensee to make additional changes to

selected elements of its QA program

without having to obtain prior NRC

approval. As of April 26, 1999, a

licensee is permitted to make the

following types of unilateral changes to

its QA programs:

1. The use of a quality assurance

standard approved by the NRC that is

more recent than the QA standard in a

licensee’s current QA program at the

time of the change;

2. The use of a quality assurance

alternative or exception previously

approved by an NRC safety evaluation,

provided that the bases of the NRC

approval are applicable to a licensee’s

facility;

3. The use of generic organizational

position titles that clearly denote the

position function, supplemented as

necessary by descriptive text, rather

than specific titles;

4. The use of generic organizational

charts to indicate functional

relationships, authorities, and

responsibilities, or, alternately, the use

of descriptive text;

5. The elimination of quality

assurance program information that

duplicates language in quality assurance

regulatory guides and quality assurance

standards to which a licensee is

committed; and

6. Organizational revisions that

ensure that persons and organizations

performing QA functions continue to

have the requisite authority and

organizational freedom, including

sufficient independence from cost and

schedule considerations, when these

concerns are in conflict with safety

considerations.

Licensees shall continue to conform

to the requirements in Appendix B to 10

CFR Part 50 and 10 CFR 50.34(b)(6)(ii)

and to notify the NRC of these changes

as required by 10 CFR 50.71(e). The

direct final rule provided immediate

relief to licensees by clearly defining six

categories of QA program changes that

do not require NRC approval prior to

implementation. On June 7, 2000, the

NRC staff conducted a public workshop

to solicit feedback on the

implementation of the revision to 10

CFR 50.54(a) and to gather information

to determine the need for and feasibility

of developing a voluntary alternative

rule based on the NEI petition.

Workshop participants acknowledged

the significant burden reduction already

achieved through the 1999 revision to

10 CFR 50.54(a). As a result of the

discussions at the workshop, NEI

concluded, and the NRC agreed, that a

separate rulemaking on 10 CFR 50.54(a)

is not needed at this time. By letter

dated August 15, 2000 (Accession No.

ML003755305), NEI documented its

belief that ‘‘it is not necessary to

pursue’’ further changes to 10 CFR

50.54(a) related to its petition. By letter

to NEI dated September 5, 2000, the

NRC staff confirmed NEI’s intent to

withdraw the remainder of the 1995

petition.

In the direct final rule published on

February 23, 1999 (64 FR 9029), the

NRC noted that completion of the NEI

petition should be accomplished in two

stages. The first stage was the immediate

burden relief of partially granting the

NEI petition through the direct final

rule. The second stage proposed was a

follow-on rulemaking action in which

criteria would have been developed for

determining other areas in which

unilateral changes could be made by

licensees without prior NRC approval

that would not negatively impact on the

effectiveness of the licensee’s QA

program. However, given the

petitioner’s belief that it is not necessary

to pursue further changes and based

upon feedback from a public workshop

on the implementation of the direct

final rule, the NRC has decided not to

pursue the previously planned second

rulemaking.

For these reasons, the NRC finds that

all outstanding issues relating to PRM–

50–62 are resolved. This completes NRC

action on PRM–50–62.

Dated at Rockville, Maryland, this 30th day

of November, 2000.

For the Nuclear Regulatory Commission.

Annette L. Vietti-Cook,

Secretary of the Commission.

[FR Doc. 00–31100 Filed 12–5–00; 8:45 am]

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