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

40975

Vol. 62, No. 147

Thursday, July 31, 1997

NUCLEAR REGULATORY

COMMISSION

10 CFR Part 35

RIN AF77

License Term for Medical Use Licenses

AGENCY: Nuclear Regulatory

Commission.

ACTION: Proposed rule.

SUMMARY: The U.S. Nuclear Regulatory

Commission is proposing to amend 10

CFR part 35 to eliminate the five-year

term limit for medical use licenses in 10

CFR 35.18. License terms for licenses

issued pursuant to part 35 would be set,

by policy up to ten years, as are the

license terms for other materials

licenses. The NRC would issue some

licenses for shorter terms, if warranted

by the individual circumstances of

license applicants. The amendment

would reduce the administrative burden

of license renewals for both NRC and

licensees, and would support NRC’s

goal of streamlining the licensing

process.

DATES: Submit comments by October 14,

1997. Comments received after this date

will be considered, if it is practical to do

so, but the NRC is able to assure

consideration only for comments

received on or before this date.

ADDRESSES: Send comments to:

Secretary, U.S. Nuclear Regulatory

Commission, Washington, DC 20555–

0001. Hand-deliver comments to: 11555

Rockville Pike, Rockville, Maryland,

between 7:45 a.m. and 4:15 p.m.,

Federal workdays.

Copies of any comments received may

be examined at the NRC Public

Document Room, 2120 L Street NW

(lower level), Washington, DC.

For information on submitting

comments electronically, see the

discussion under Electronic Access in

the Supplementary Information section.

FOR FURTHER INFORMATION CONTACT:

William B. McCarthy, Office of Nuclear

Material Safety and Safeguards, U.S.

Nuclear Regulatory Commission,

Washington, DC 20555–0001, telephone

(301) 415–7894; e-mail WBM@nrc.gov.

SUPPLEMENTARY INFORMATION:

I. Background

In 1995, the NRC Office of Nuclear

Material Safety and Safeguards (NMSS)

initiated a review to determine whether

the license term for material licenses

could be increased so that NRC’s

licensing resources could be redirected

to other areas of the materials program.

The resources devoted to renewals

constituted over 50 percent of the total

resources expended for licensing. NMSS

undertook this review as a part of NRC’s

business process redesign efforts.

The license renewal process has been

used as an opportunity for the

Commission to review: (1) The history

of the licensee’s operating performance

(e.g., the record on compliance with

regulatory requirements); and (2) the

licensee’s program. This review is

performed to ascertain if the licensee

employs up-to-date technology and

practices in the protection of health,

safety, and the environment, and

complies with any new or amended

regulations. As part of a license renewal,

the licensee is asked to provide

information on the current status of its

program as well as any proposed

changes in operations (types and

quantities of authorized materials),

personnel (authorized users and

radiation safety officers), facility,

equipment, or applicable procedures.

The renewal process has been perceived

to benefit both the licensee and NRC

because it requires both to take a

comprehensive look at the licensed

operation. However, in practice, most of

the proposed changes are identified and

requested by licensees as amendments

rather than during the license renewal

process.

License terms have been reviewed on

numerous occasions since 1967. On

May 12, 1967 (32 FR 7172), the

Commission amended 10 CFR part 40 to

eliminate a three-year limit on the term

of source material licenses. At that time,

there was no restriction on the term of

byproduct licenses under 10 CFR part

30 or special nuclear material licenses,

under 10 CFR part 70. In the notice of

proposed rulemaking associated with

this rule, dated December 22, 1966, NRC

indicated that if the proposed

amendment to eliminate the three-year

restriction were adopted, licenses would

be issued for five-year terms, except

when the nature of the applicant’s

proposed activities indicated a need for

a shorter license period. At that time,

the Commission believed there was

little justification for granting licenses

under 10 CFR parts 30, 40, and 70 for

terms of less than five years, in view of

the cumulative experience up to that

time and the means available to NRC to

suspend, revoke, or modify such

licenses if public health and safety or

environment so required. Licenses have

been issued for five-year terms since

1967.

In March 1978, NMSS conducted a

study (SECY–78–284, ‘‘The License

Renewal Study for parts 30, 40 and 70

Licenses’’) to consider changing the

five-year renewal period for parts 30, 40,

and 70 licenses. The study concluded,

in part, that the NRC should continue its

practice of issuing specific licenses for

five-year terms and should retain an

option to write licenses for shorter

terms, if deemed necessary for new

types of operations, or if circumstances

warranted.

On July 26, 1985 (50 FR 30616), NRC

proposed revising 10 CFR part 35,

‘‘Medical Use of Byproduct Material.’’

The proposed rulemaking indicated that

the Commission had selected a term of

five years for a license. It was believed

that a term shorter than five years would

not benefit health and safety because

past experience indicated that medical

programs did not generally change

significantly over that period of time.

The notice also indicated that a longer

term may occasionally result in

unintentional abandonment of the

license. On October 16, 1986 (51 FR

36932), NRC issued the final rule that

consolidated and clarified radiation

safety requirements related to the

medical use of byproduct materials, and

included a license term of five years.

On June 19, 1990 (55 FR 24948), the

Commission announced that the license

term for major operating fuel cycle

licensees (i.e., licenses issued pursuant

to 10 CFR parts 40 or 70) would be

increased from a five-year term to a tenyear term at the next renewal of the

affected licenses. This change enabled

NRC resources to be used to improve the

licensing and inspection programs. The

bases for this change were that major

operating fuel cycle facilities had

become stable in terms of significant

changes to their licenses and operations,
40976 Federal Register / Vol. 62, No. 147 / Thursday, July 31, 1997 / Proposed Rules

and that licensees would be required to

update the safety demonstration

sections of their licenses every two

years.

On July 2, 1996, the Commission

approved the NRC staff’s proposal to

extend the license term for uranium

recovery facilities from five years to ten

years. Extending the license terms

reduces the administrative burden

associated with the license renewal

process for both the NRC staff and the

uranium recovery licensees. Also, the

extension reduces the licensee fees,

brings the license term for these

facilities more commensurate with the

level of risk, and supports NRC’s goal of

streamlining the licensing process.

Licensees were informed of the

extensions in July 1996.

On February 6, 1997 (62 FR 5656), the

Commission gave notice of the policy

that the license term for material

licenses issued pursuant to 10 CFR parts

30, 40, or 70 would be increased from

a five-year term to up to a ten-year term

at the next renewal of the affected

licenses. The term for licenses issued

pursuant to 10 CFR part 35 is

established by regulation at five years.

The ten-year term for other licenses has

been set by policy. Part 35 license terms

would be set by this policy after the

final rule is effective that removes the

reference to a five-year license term

from 10 CFR 35.18. The NRC may issue

a license for a shorter term, depending

on the individual circumstances of the

license applicant.

II. Discussion

The change in policy under which the

license term for materials licenses is up

to ten years, has created an

inconsistency between the license terms

for medical use and non-medical use

materials licenses. NRC believes that the

license duration period may also be

extended without adverse impacts on

public health and safety, such as

increases in the unintentional

abandonment of licensed material, or

decreases in the licensees’ attention to

licensed activities, for the following

reasons:

(1) Licensees would continue to be

required to adhere to the regulations

and their license conditions, and to

apply for license amendments for

certain proposed changes to their

programs;

(2) No changes in either the frequency

or elements of the medical inspection

program are being proposed;

(3) NRC would continue to be in the

position to identify, by inspection or

other means, violations that affect

public health and safety, and to take

appropriate enforcement actions;

(4) Cases of abandonment of NRC

licenses would be identified through

nonpayment of the annual licensing fees

and regional follow-up;

(5) The staff would continue to make

licensees aware of health and safety

issues through the issuance of generic

communications (such as information

notices, generic letters, bulletins, and

the NMSS Licensee Newsletter); and

(6) NRC efforts are moving to a more

performance-based regulatory approach,

where emphasis is placed on the

licensee’s execution of commitments

rather than on re-review of the details of

the licensee’s program.

III. Proposed Regulatory Action

The NRC is proposing to revise Part

35 to eliminate the five-year term limit

in 10 CFR 35.18 for medical use

licenses, so that the term for medical

licenses can be set by policy for up to

ten years.

IV. Compatibility for Agreement States

No problems have been identified

regarding Agreement State

implementation of this rule change.

Section 35.18 is a Division 3

requirement. For purposes of NRC and

Agreement State compatibility

requirements, Division 3 rules apply to

a number of the provisions in NRC

regulations that would be appropriate

for Agreement States to adopt, but they

do not require any degree of uniformity

between NRC and State rules. Such

rules are strictly matters for the

regulatory agency and the regulatory

community within its jurisdiction. NRC

encourages states to adopt the regulatory

approach taken by NRC in such rules,

but states are not required to do so.

Under the new Commission Policy

Statement on Agreement State

Compatibility, Division 3 rules will be

classified as compatibility category D

with the same description as Division 3.

V. Electronic Access

Comments may be submitted

electronically, in either ASCII text or

WordPerfect format, by calling the NRC

Electronic Bulletin Board on FedWorld.

The bulletin board may be accessed

using a personal computer, a modem,

and one of the commonly available

communications software packages, or

directly via Internet. Background

documents on the rulemaking are also

available, as practical, for downloading

and viewing on the bulletin board.

If using a personal computer and

modem, the NRC rulemaking subsystem

on FedWorld can be accessed directly

by dialing the toll-free number (800)

303–9672. Communication software

parameters should be set as follows:

parity to none, data bits to 8, and stop

bits to 1 (N,8,1). Using ANSI or VT–100

terminal emulation, the NRC

rulemaking subsystem can then be

accessed by selecting the ‘‘Rules Menu’’

option from the ‘‘NRC Main Menu.’’

Users will find the ‘‘FedWorld Online

User’s Guides’’ particularly helpful.

Many NRC subsystems and data bases

also have a ‘‘Help/Information Center’’

option that is tailored to the particular

subsystem.

The NRC subsystem on FedWorld can

be accessed by a direct dial phone

number for the main FedWorld BBS

(703) 321–3339, or by using Telnet via

Internet: fedworld.gov. If using (703)

321–3339 to contact FedWorld, the NRC

subsystem will be accessed from the

main FedWorld menu by selecting the

‘‘Regulatory, Government

Administration and State Systems,’’

then selecting ‘‘Regulatory Information

Mall.’’ At that point, a menu will be

displayed that has an option ‘‘US

Nuclear Regulatory Commission’’ that

will take you to the NRC Online main

menu. The NRC Online area also can be

accessed directly by typing ‘‘/go nrc’’ at

a FedWorld command line. If you access

NRC from FedWorld’s main menu, you

may return to FedWorld by selecting the

‘‘Return to FedWorld’’ option from the

NRC Online main menu. However, if

you access NRC at FedWorld by using

NRC’s toll-free number, you will have

full access to all NRC systems, but you

will not have access to the main

FedWorld systems.

If you contact FedWorld using Telnet,

you will see the NRC area and menus,

including the Rules menu. Although

you will be able to download

documents and leave messages, you will

not be able to write comments or upload

files (comments). If you contact

FedWorld using FTP, all files can be

accessed and downloaded but uploads

are not allowed; all you will see is a list

of files without descriptions (normal

Gopher look). An index file listing all

files within a subdirectory, with

description, is available. There is a 15-

minute time limit for FTP access.

Although FedWorld also can be

accessed through the World Wide Web,

like FTP, that mode only provides

access for downloading files and does

not display NRC Rules menu.

You may also access the NRC’s

interactive rulemaking web site through

the NRC home page (http://

www.nrc.gov). This site provides the

same access as the FedWorld bulletin

board, including the facility to upload

comments as files (any format), if your

web browser supports that function.

For more information on the NRC

bulletin boards call Mr. Arthur Davis.
Federal Register / Vol. 62, No. 147 / Thursday, July 31, 1997 / Proposed Rules 40977

Systems Integration and Development

Branch, NRC, Washington DC 20555–

0001, telephone (301) 415–5780; e-mail

AXD@nrc.gov. For information about

the interactive rulemaking site, contact

Ms. Carol Gallagher (301) 415–6215; email CAG@nrc.gov.

VI. Finding of No Significant

Environmental Impact: Availability

No Environmental Assessment will be

needed because the rulemaking is

covered by the categorical exclusion in

10 CFR 51.22(c)(3)(i) for amendments to

Part 35 that relate to renewals of

licenses.

VII. Paperwork Reduction Act

Statement

This proposed rule will reduce the

burden for both medical licensees and

NRC, because terms could be

established by policy, for up to ten

years, as is the case for other material

licensees. However, the reduced burden

from less frequent license renewal will

not be realized in the near future

because the affected licenses are

operating under a five-year extension of

their current licenses which were

granted in 1995. The impact of that onetime extension is addressed in the

current supporting statement for NRC

Form 313, ‘‘Application for Material

License’’ which was approved by the

Office of Management and Budget

(OMB) under OMB clearance No. 3150–

0120, and expires on July 31, 1999. The

data on the reduced burden from

extension of the license term for all

material licenses, as well as from other

actions taken to streamline the licensing

process, will be included in the request

for renewal of the information collection

requirements on NRC Form 313, in

1999. This is appropriate because the

next OMB clearance extension will

cover 1999–2002, during which time the

medical licenses currently under the

five year extension will expire and be

affected by this rulemaking.

Public Protection Notification

The NRC may not conduct or sponsor,

and a person is not required to respond

to, an information collection unless it

displays a currently valid OMB control

number.

VIII. Regulatory Analysis

Problem

The current rule requirement,

regarding the term of medical licenses,

is codified in Section 35.18 and states

that, ‘‘The Commission shall issue a

license for the medical use of byproduct

material for a term of five years.’’ The

License term of other materials licenses,

as established by Commission policy, is

up to ten years. There is thus an

inconsistency as to duration and

manner of determination of the license

term of medical use licenses and all

other materials licenses. Based on the

above, the following options were

considered.

Alternative Approaches

1. Take no action: Maintain the

requirement that licenses issued

pursuant to Part 35 would be issued for

five years.

This option would continue the

inconsistency between how license

terms for medical licenses, and all other

materials licenses, are established.

Terms for medical use licenses are

established in codified regulations,

whereas the term for other materials

licenses are set by policy. Also, this

option would result in disparities in the

duration of the term for material

licenses, because medical use licenses

would continue to be issued for fiveyear terms whereas the duration of the

term for other materials licenses would

be up to ten years.

2. Revise 10 CFR 35.18: Revise the

regulations to delete any reference to the

license term for licenses issued

pursuant to Part 35.

This option would result in

consistency between how license terms

for medical licenses and all other

material licenses are established and in

the duration of such licenses.

Commission decisions regarding the

duration of a materials license could

therefore apply uniformly to all types of

material licenses. After final rulemaking

action to revise 10 CFR 35.18, the

license term for licenses issued

pursuant to Part 35 would be set by

already established policy for up to ten

years.

Value and Impact

The license renewal process is

resource-intensive for both the licensee

and NRC. At the time of license

renewal, licensees submit to NRC any

changes in operations, personnel,

facility, equipment, or applicable

procedures. Because NRC is in contact

with the licensees on an ongoing basis,

many of these changes are identified

during the inspection and license

amendment process. Therefore, the

rulemaking to remove the five-year

license term for medical use of

byproduct material would not change

the health and safety requirements

imposed on licensees.

If the reference to the five-year term

in 10 CFR 35.18 is removed, and with

the Commission’s approval (February

1997) given to extend the license term

up to ten years for all material licenses

issued pursuant to Parts 30, 40, and 70,

there would be a reduction in the

regulatory burden for approximately

2,000 NRC licensees that use byproduct

material for medical procedures.

Estimated savings are based on the

assumption that these licensees would

only be required to submit a renewal

application every ten years as opposed

to every five years, resulting, on average,

in a savings of 200 applications per

year. However, countervailing these

savings, medical licensees may need to

submit an average of one additional

amendment during the ten year period

to account for changes in operations that

would have routinely been addressed

when the license was renewed on a five

year cycle. Assuming that a typical

license renewal application and typical

amendment involves ten hours and two

hours of licensee professional effort,

respectively, there would be a net

savings per licensee of eight hours.

Based on an industry professional labor

rate of $70 per hour, the annual

industry-wide savings would

approximate $112,000. Over a 30-year

time frame, based on a 7 percent real

discount rate, the present worth savings

to industry would approximate $1.4

million.

Similarly, this rulemaking would also

be cost effective for the NRC because

fewer resources would be required to

review and process renewal

applications. On average, it takes

approximately 14 hours of NRC

professional time to renew a medical

license and four hours to review an

amendment. This translates to a net

savings to the NRC of 10 hours per

license. Assuming an NRC labor rate of

$70 per hour, and on average, 200

application per year, the annual NRC

savings would equal $140,000. The 30

year present worth savings to the NRC

would approximate $1.7 million.

Conclusion

This rulemaking, to remove the fiveyear license term for medical use of

byproduct material, is proposed so the

term for medical licenses will be

consistent with that of other materials

licenses (set by policy to be up to 10

years). The extension will reduce the

administrative burden of license

renewals for both NRC and the licensee

and will support NRC’s goal of

streamlining the licensing process

without any reduction in health and

safety. NRC may issue some licenses for

shorter terms, if warranted by the

individual circumstances of license

applicants.
40978 Federal Register / Vol. 62, No. 147 / Thursday, July 31, 1997 / Proposed Rules

Decisional Rationale

Based on the consistency which is

created between license terms for

medical licenses and all other material

licenses by the rulemaking, and the cost

effectiveness of a license term of up to

ten years, the NRC is proposing to

amend 10 CFR part 35 to eliminate the

five-year term limit for medical use

licenses and allow the license term to be

set by the established policy for up to

ten years.

IX. Regulatory Flexibility Certification

As required by the Regulatory

Flexibility Act of 1980, 5 U.S.C. 605(b),

the Commission certifies that this rule,

if adopted, will not have a significant

impact on a substantial number of small

entities. If any small entity subject to

this regulation determines that, because

of its size, it is likely to bear a

disproportionate adverse economic

impact, the entity should notify the

Commission of this in a comment that

indicates the following:

(a) The licensee’s size and how the

proposed regulation would result in a

significant economic burden upon the

license compared to the economic

burden on a larger licensee;

(b) How the proposed regulation

could be modified to take into account

the licensee’s differing needs and

capabilities;

(c) The benefits that would accrue, or

the detriments that would be avoided, if

the proposed rule were modified as

suggested by the licensee;

(d) How the proposed regulation, as

modified, would more closely equalize

the impact of NRC regulations or create

more equal access to the benefits of

Federal programs, as opposed to

providing special advantages to any one

individual or group; and

(e) How the proposed regulation, as

modified, would still adequately protect

public health and safety.

X. Backfit Analysis

The NRC has determined that the

backfit rule, 10 CFR 50.109, does not

apply to this rule, and therefore a

backfit analysis is not required because

the amendment does not involve any

provisions that would impose backfits

as defined in 10 CFR 50.109(a)(1).

List of Subjects in 10 CFR Part 35

Byproduct material, Criminal

penalties, Drugs, Health facilities,

Health professions, Nuclear materials,

Occupational safety and health,

Radiation protection, Reporting and

record 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. 552 and 553;

the NRC is adopting the following

amendments to 10 CFR part 35.

PART 35—MEDICAL USE OF

BYPRODUCT MATERIAL

1. The authority citation for part 35

continues to read as follows:

Authority: Secs. 81, 161, 182, 183, 68 Stat.

935, 948, 953, 954, as amended (42 U.S.C.

2111, 2201, 2232, 2233); sec. 201, 88 Stat.

1242, as amended (42 U.S.C. 5841).

2. The introductory text of § 35.18 is

revised to read as follows:

§ 35.18 License issuance

The Commission shall issue a license

for the medical use of byproduct

material if:

* * * * *

Dated at Rockville, Maryland, this 10th day

of July, 1997.

For the Nuclear Regulatory Commission.

Hugh L. Thompson, Jr.,

Acting Executive Director for Operations.

[FR Doc. 97–20189 Filed 7–30–97; 8:45 am]

BILLING CODE 7590–01–P

NUCLEAR REGULATORY

COMMISSION

10 CFR Parts 50 and 73

[PRM 50–59 and PRM 50–60]

RIN 3150–AF63

Frequency of Reviews and Audits for

Emergency Preparedness Programs,

Safeguards Contingency Plans, and

Security Programs For Nuclear Power

Reactors

AGENCY: Nuclear Regulatory

Commission.

ACTION: Proposed rule.

SUMMARY: The Nuclear Regulatory

Commission is proposing to amend its

regulations to change the frequency of

licensees’ independent reviews and

audits of their emergency preparedness

programs, safeguards contingency plans,

and security programs. This amendment

is being proposed in response to

petitions for rulemaking submitted by

Virginia Power Company. Specifically,

instead of conducting reviews every 12

months, as is currently required, the

proposed amendment would require

nuclear power reactor licensees to

conduct program reviews and audits in

response to program performance

indicators, or after a significant change

in personnel, procedures, equipment, or

facilities, but in no case less frequently

than every 24 months.

DATES: Submit comments October 14,

1997. Comments received after this date

will be considered if it is practical to do

so, but the Commission is able to assure

consideration only for comments

received on or before this date.

ADDRESSES: Comments may be sent to:

Secretary, U.S. Nuclear Regulatory

Commission, Washington, DC 20555–

0001. Attention: Rulemakings and

Adjudications Staff.

Deliver comments to: 11555 Rockville

Pike, Rockville, Maryland, between 7:30

a.m. and 4:15 p.m. on Federal workdays.

For information on submitting

comments electronically, see the

discussion under Electronic Access in

the Supplementary Information Section.

Certain documents related to this

rulemaking, including comments

received, may be examined at the NRC

Public Document Room, 2120 L Street

NW. (Lower Level), Washington, DC.

These documents may also be viewed

and downloaded electronically via the

Electronic Bulletin Board established by

NRC for this rulemaking as discussed

under Electronic Access in the

Supplementary Information section.

FOR FURTHER INFORMATION CONTACT: Dr.

Sandra D. Frattali, Office of Nuclear

Regulatory Research, U.S. Nuclear

Regulatory Commission, Washington,

DC 20555–0001, telephone (301) 415–

6261, e-mail sdf@nrc.gov.

SUPPLEMENTARY INFORMATION:

Background

On January 7, 1994, the Commission

docketed a petition for rulemaking from

Virginia Power, dated December 30,

1993, (PRM–50–59) to change the

required audit frequency for safeguards

contingency plans and security

programs at nuclear power reactors. On

January 19, 1994, the Commission

docketed, as a separate petition for

rulemaking (PRM–50–60), Virginia

Power’s request that the NRC change the

required audit frequency for emergency

preparedness programs at nuclear power

reactor facilities. NRC published these

two petitions for public comment in the

Federal Register. PRM–50–59 was

published on May 6, 1994 (59 FR

23641). PRM 50–60 was published on

April 13, 1994 (59 FR 17449).

The Commission’s regulations

currently require power reactor

licensees to conduct independent

reviews and audits of each of these

programs at least every 12 months.

Virginia Power requested that the

frequency be changed to nominally

every 24 months. This rulemaking

addresses the issues raised in these

petitions.