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

53249

Vol. 62, No. 198

Tuesday, October 14, 1997

NUCLEAR REGULATORY

COMMISSION

10 CFR Part 35

Medical Use of Byproduct Material;

Workshops

AGENCY: U.S. Nuclear Regulatory

Commission.

ACTION: Notice of workshops.

SUMMARY: The Nuclear Regulatory

Commission has initiated a rulemaking

for a comprehensive revision of its

regulations governing the medical use of

byproduct material in 10 CFR part 35.

As part of this rulemaking, the

Commission intends to solicit the active

input of the various interests that may

be affected by the rulemaking early in

the rulemaking process. One of the

mechanisms that will be used to obtain

the comments and recommendations

from affected interests will be the

convening of workshops to discuss the

fundamental approaches and issues that

must be addressed in the revision of

part 35. The first NRC public workshop

will be held in Philadelphia,

Pennsylvania on October 28, 29, and 30,

1997. The second NRC public workshop

will be held in Chicago, Illinois on

November 12, 13, and 14, 1997. Both

workshops will be open to the public.

Francis X. Cameron, Special Counsel for

Public Liaison, in the Commission’s

Office of the General Counsel, will be

the convener and facilitator for the

workshops.

DATES: The first workshop will be in

Philadelphia on October 28, 1997, from

9 a.m. to 5 p.m.; October 29, 1997, from

8:30 a.m. to 5 p.m.; and October 30,

1997, from 8:30 a.m. to noon. The

second workshop will be in Chicago on

November 12, 1997, from 9 a.m. to 5

p.m.; November 13, 1997, from 8:30 a.m.

to 5 p.m.; and November 14, 1997, from

8:30 a.m. to noon.

ADDRESSES: The Philadelphia workshop

will be held at the Korman Suites Hotel,

2001 Hamilton Street, Philadelphia, PA

19130, 215–569–7000. The Chicago

workshop will be held at the Ramada

Congress Hotel, 520 South Michigan

Avenue, Chicago, IL 60605, 312–427–

3800.

FOR FURTHER INFORMATION CONTACT:

Francis X. Cameron, Special Counsel for

Public Liaison, Office of the General

Counsel, Nuclear Regulatory

Commission, Washington D.C. 20555,

Telephone: 301–415–1642.

SUPPLEMENTARY INFORMATION:

Background

The NRC has examined the issues

surrounding its medical use program in

great detail during the last four years.

This process started with NRC’s 1993

internal senior management review

report; continued with the 1996

independent external review report by

the National Academy of Sciences,

Institute of Medicine; and culminated in

NRC’s Strategic Assessment and

Rebaselining Project (SA). In particular,

medical oversight was addressed in the

SA Direction-Setting Issue Paper

Number 7 (DSI 7) (released September

16, 1996). In its ‘‘Staff Requirements

Memorandum (SRM)—COMSECY–96–

057, Materials/Medical Oversight (DSI

7),’’ dated March 20, 1997, the

Commission directed the staff to revise

part 35, associated guidance documents,

and, if necessary, the Commission’s

1979 ‘‘Medical Policy Statement.’’ The

Commission SRM specifically directed

the restructuring of part 35 into a riskinformed, more performance-based

regulation.

A June 30, 1997, SRM informed the

staff of the Commission’s approval, with

comments, of the staff’s proposed

program in SECY–97–131,

Supplemental Information on SECY–

97–115, ‘‘Program for Revision of 10

CFR part 35, ‘Medical Uses of

Byproduct Material,’ and Associated

Federal Register Notice,’’ dated June 20,

1997.

After Commission approval of the

staff’s program to revise part 35 and

associated guidance documents, the

staff initiated the rulemaking process, as

announced in 62 FR 42219 (August 6,

1997). The rulemaking is being

conducted using a group approach. A

Working Group and Steering Group,

consisting of representatives of NRC, the

Organization of Agreement States, and

the Conference of Radiation Control

Program Directors, have been

established to develop rule text

alternatives, rule language, and

associated guidance documents. State

participation in the process is intended

to enhance development of

corresponding rules in State regulations,

to provide an opportunity for early State

input, and to allow State staff to assess

potential impacts of NRC draft language

on the regulation of non-Atomic Energy

Act materials used in medical diagnosis,

treatment, or research, in the States.

As directed by the Commission, the

staff has developed alternatives, with

draft regulatory text, for the more

significant issues associated with the

regulation of the medical use of

byproduct material. These alternatives

to regulation in specific areas are

intended to help focus the discussion

during workshops and meetings during

the Fall of 1997 and to assist the staff

in developing the text of the proposed

rule. Alternative regulatory text has

been developed for: (a) The quality

management program; (b) training and

experience for authorized users,

radiation safety officers, and medical

physicists; (c) radiation safety

committee; (d) patient notification of

reportable events; and (e) the threshold

for reportable events. In addition,

alternative recommendations for

revision of NRC’s 1979 Medical Policy

Statement have been developed. The

alternatives represent a broad range of

possibilities and are being provided to

stimulate input from members of the

public in an effort to encourage all

interested parties to contribute to the

development of the revised regulation.

The staff has not selected any

alternatives at this time and is open to

additional alternatives that might be

proposed, which are consistent with the

guidance provided by the Commission.

Workshops

The Commission believes that it is

important for interests affected by the

medical use rulemaking to not only

have an early opportunity to comment

on the rulemaking issues, but also to

have an opportunity to discuss the

rulemaking issues with one another and

the Agency. Accordingly, the

Commission is convening two public

workshops where the representatives of

the interests that may be affected by the

rulemaking will have an opportunity to

discuss the rulemaking issues. Although

the workshops are intended to foster a

clearer understanding of the positions

and concerns of the affected interests, as
53250 Federal Register / Vol. 62, No. 198 / Tuesday, October 14, 1997 / Proposed Rules

well as to identify areas of agreement or

disagreement, it is not the intent of the

workshop process to develop a

consensus agreement of the participants

on the rulemaking issues.

To have a manageable discussion, the

number of participants in each

workshop will be limited. The

Commission, through the facilitator for

the workshop, will attempt to ensure

participation by the broad spectrum of

interests that may be affected by the

rulemaking. These interests include:

Nuclear medicine physicians; physician

specialists, such as cardiologists and

radiologists; medical physicists; medical

technologists; nurses; medical education

and certification organizations;

radiopharmaceutical interests; hospital

administrators; patients rights

advocates; Agreement States; Federal

agencies; and experts in risk analysis.

Other members of the public are

welcome to attend, and the public will

have the opportunity to comment on the

rulemaking issues and the workshop

discussions at periodic intervals during

the workshops. Questions about

participation may be directed to the

facilitator, Francis X. Cameron.

To ensure that each workshop

addresses the issues in a consistent

manner, the workshops will have a

common pre-defined scope and agenda

focused primarily on the alternatives,

with draft regulatory text, developed by

the Part 35 Working and Steering

Groups. However, the workshop format

will be sufficiently flexible to allow for

the introduction of additional related

issues that the participants may want to

raise. The workshop commentary will

be transcribed and made available to the

participants and the public.

Copies of the issue papers developed

by the staff will be provided to the

workshop participants. Also, copies will

be available for members of the public

in attendance at the workshops, as well

as available through NRC’s Public

Document Room (U.S. Nuclear

Regulatory Commission, Attention: NRC

Public Document Room, Washington,

DC 20555–0001) and on the Internet via

NRC’s Technical Conference Forum

(http://techconf.llnl.gov/noframe.html).

Public input is solicited during the

development of the proposed rule but,

to be most helpful, should be received

by March 1, 1998. Comments received

after this date will be considered if it is

practical to do so, but the Commission

only is able to ensure consideration of

comments received on or before this

date. Written input and suggestions can

be sent to Secretary, Nuclear Regulatory

Commission, Washington, DC 20555–

0001, Attention: Rulemakings and

Adjudications Staff. Hand-deliver

comments to 11555 Rockville Pike,

Rockville, MD, between 7:30 a.m. and

4:15 p.m. on Federal workdays.

Dated at Rockville, Md., this 6th day of

October 1997.

For the Nuclear Regulatory Commission.

Donald A. Cool,

Director, Division of Industrial and Medical

Nuclear Safety, Office of Nuclear Material

Safety and Safeguards.

[FR Doc. 97–27084 Filed 10–10–97; 8:45 am]

BILLING CODE 7590–01–P

NUCLEAR REGULATORY

COMMISSION

10 CFR Part 50

RIN 3150–AE38

Acceptability of Plant Performance for

Severe Accidents; Scope of

Consideration in Safety Regulations

AGENCY: Nuclear Regulatory

Commission.

ACTION: Advance notice of proposed

rulemaking: Withdrawal.

SUMMARY: The Nuclear Regulatory

Commission (NRC or Commission) is

withdrawing an advance notice of

proposed rulemaking that outlined

alternative approaches to generic

regulation addressing the challenges

from severe accidents for future light

water reactors. The Commission has

decided that a rule change to provide

generic requirements for performance

during postulated severe accidents is

not warranted at this time. The basis for

this decision is that a purpose for the

rule was to provide guidance for future

designs and to facilitate then ongoing

design certification rulemaking. With all

current design certification rulemaking

either complete or nearing completion

and future applicants not foreseen,

expenditure of the resources to

promulgate the rule is not warranted.

FOR FURTHER INFORMATION CONTACT:

Charles E. Ader, Office of Nuclear

Regulatory Research, U.S. Nuclear

Regulatory Commission, Washington,

DC 20555–0001, telephone (301) 415–

5622.

SUPPLEMENTARY INFORMATION: On

September 28, 1992, (57 FR 44513), the

Commission published an advance

notice of proposed rulemaking

(ANPRM) to consider amending its

regulations to provide generic

requirements to address the challenges

from severe accidents for future light

water reactors. The advance notice of

proposed rulemaking outlined three

alternative approaches to the

specification of requirements addressing

severe accident performance. The first

alternative, described as a hardware

oriented rule, would specify reasonable

design features or design characteristics

directed towards prevention or

mitigation of explicitly identified risk

significant phenomena. The risk

significant phenomena identified were:

hydrogen generation, transport and

combustion, high pressure melt ejection,

core concrete interactions and basemat

ablation, long term containment

overpressurization, steam explosions

from fuel-coolant interactions, and

containment bypass. These phenomena

represent the potential contributors to

containment failure or bypass and thus

the mechanisms for large offsite

radioactive release. Alternative 2,

described as a phenomena oriented rule,

was a modification of the first

alternative wherein an overall

containment performance goal would be

specified along with the phenomena to

be considered, as identified above. The

designer would then be required to

perform analyses of the impact of those

phenomena and develop and propose

the design features to meet the goal.

Regulatory guides would address

analytical methods, acceptance criteria

and design criteria for hardware. This

approach, similar to Alternative 1,

would be an overlay on the existing

design basis specified in 10 CFR part 50

and justified on an enhanced safety

basis. The third alternative, described as

a general design criteria (GDC) oriented

rule, involved development of a set of

new design requirements to address

specific challenges and issued as

changes to Appendix A, ‘‘General

Design Criteria’’ to 10 CFR part 50. Each

new design criterion would describe the

nature of the challenges as well as the

success criterion and involve the

development of Regulatory Guides to

provide additional guidance on analysis

methods and assumption. This

approach was similar to the other

alternatives, especially Alternative 2,

but differs in that the existing 10 CFR

part 50 design basis would be modified

to include severe accidents.

A primary purpose for the generic

severe accident rulemaking was to add

consistency and standardization to the

resolution of severe accident issues for

future designs based on current

technical information. While, in general,

consistency among many design reviews

is best achieved through generic rules,

as a practical matter, since the number

of new applicants is likely to remain

quite limited, it is more efficient to

proceed with design-specific reviews. In

fact, the Commission is not aware of any

new applicants in the foreseeable future.