48904 Federal Register / Vol. 62, No. 180 / Wednesday, September 17, 1997 / Notices

1The footnote defining industrial processors as

‘‘Large firms engaged in manufacturing or

distribution of byproduct, source or special nuclear

material’’ was inadvertently left out of the June 30,

1995, Federal Register Notice.

Dated at Rockville, Maryland this 9th day

of September 1997.

For the Nuclear Regulatory Commission.

Mark A. Satorius,

Deputy Director, Office of Enforcement.

Appendix

Evaluation and Conclusion

On May 30, 1997, a Notice of Violation and

Proposed Imposition of Civil Penalty (notice)

was issued for a violation identified during

an NRC inspection. Mallinckrodt Medical,

Inc. (Licensee) responded to the Notice in a

letter dated June 30, 1997. The Licensee

admitted the violation but requested

mitigation of the proposed civil penalty

based on its contention that the civil penalty

was assessed at an inappropriate level. The

NRC’s evaluation and conclusion regarding

the licensee’s request is as follows:

Restatement of Violation

10 CFR 71.5(a) requires that a licensee who

transports licensed material outside the

confines of its plant or other place of use, or

who delivers licensed material to a carrier for

transport, comply with the applicable

requirements of the regulations appropriate

to the mode of transport of the Department

of Transportation (DOT) in 49 CFR parts 170

through 189.

49 CFR 173.441(a) requires, in part, with

exceptions not applicable here, that each

package of radioactive materials offered for

transportation be designed and prepared for

shipment so that under conditions normally

incident to transportation the radiation level

does not exceed 200 millirem per hour at any

point on the external surface of the package.

Contrary to the above, on December 30,

1996, the licensee delivered to a carrier for

transport licensed material, a 12 curie Ultra

Techna-Kow Mo–99 generator, in a package

that arrived at its destination, Mallinckrodt

Nuclear Pharmacy in Saginaw, Michigan,

with a radiation level of 210 millirem per

hour on contact with the outer surface of the

package.

This is a Severity Level III violation

(Supplement V). Civil Penalty—$13,750

Summary of Licensee’s Request for Mitigation

The Licensee agrees in its June 30, 1997

letter that a civil penalty regarding this

apparent violation is warranted. However,

the Licensee contests the level at which the

NRC categorized the civil penalty (i.e.;

placement of Mallinckrodt Medical, Inc. into

the ‘‘b’’ category (industrial processor) of

Table 1A–Base Civil Penalties of Section

VI.B.2.d. of the NRC Enforcement Policy,

NUREG–1600).

The Licensee does not believe that its

operations present the magnitude of risk

implied by the examples of types of licensees

listed in the ‘‘b’’ category. The Licensee

indicates that category ‘‘c’’ or ‘‘d’’ of the

referenced table is more appropriate for the

nature of its operations.

NRC Evaluation of Licensee’s Request for

Mitigation

The NRC published a revised ‘‘General

Statement of Policy and Procedure for

Enforcement Actions’’ (Enforcement Policy)

in the Federal Register on June 30, 1995 (60

FR 34381). A significant policy change

incorporated into the revised Enforcement

Policy was the strategy for assessing civil

penalties. According to Table 1A-Base Civil

Penalties of the NRC’s Enforcement Policy,

the current base civil penalty for fuel

fabricators, industrial processors, and

independent spent fuel and monitored

retrievable storage installations is $27,500.

The civil penalty for a Severity Level III

violation is 50% of the base civil penalty—

$13,750. For the purposes of this

enforcement action, the staff has determined

that the Licensee was properly classified as

an industrial processor under category ‘‘b’’ of

Table 1A-Base Civil Penalties and that the

level of the proposed civil penalty was in

accordance with the Enforcement Policy.

Mallinckrodt Medical, Inc. is a large

organization that obtains or produces

radiopharmaceuticals for worldwide

distribution, and the Mallinckrodt Maryland

Heights Production Facility is one of the

largest manufacturing facilities of diagnostic

and therapeutic radiopharmaceuticals in the

United States. The Licensee is authorized to

possess up to 100 curies of any byproduct

material within atomic numbers 1 through

83. In addition, the Licensee may posses up

to 10,000 curies of Molybdenum-99, 500

curies of Iodine-131, 200 curies of Selenium75, 450 curies of Xenon-133, and 200 curies

of Rhenium-186. The Licensee employs

approximately 280 individuals at its

Maryland Heights Production Facility and

processes on average 4,000 curies of

Molybdenum-99, 70–100 curies of Iodine131, and 50 curies of Xenon-133 weekly.

Previously, when the Enforcement Policy

was published as 10 CFR Part 2, Appendix

C, the term ‘‘industrial processors’’ was

defined as ‘‘Large firms engaged in

manufacturing or distribution of byproduct,

source or special nuclear material’’ in a

footnote to Table 1A-Base Civil Penalties

(e.g.; see footnote 3 to Table 1A-Base Civil

Penalties on page 147 of 10 CFR Ch. I (1–1–

94 Edition)). On page II.D–39 of the basis

document for the revised Enforcement

Policy, NUREG–1525, ‘‘Assessment of the

NRC Enforcement Program,’’ the stated

purpose for revising Table 1A-Base Civil

Penalties was to simplify it by combining

categories of licensees with the same base

civil penalty amounts. The proposed Table

1A-Base Civil Penalty Amounts in NUREG–

1525 contained a footnote describing

industrial processors as ‘‘Large firms engaged

in manufacturing or distribution of

byproduct, source or special nuclear

material.’’ Although the footnote that

specifically defined the term industrial

processors was omitted 1 when the

Enforcement Policy was reprinted as

NUREG–1600, there is no indication that the

term means anything different now than it

has in recent years.

Mallinckrodt Medical, Inc. fits the

definition of an industrial processor as

previously defined in the Enforcement Policy

and is appropriately categorized as an

industrial processor for purposes of assessing

the civil penalty. On a daily basis, the

Licensee manipulates, prepares, and/or

distributes to hospitals and radiopharmacies

multi-curie quantities of Molybdenum-99,

Iodine-131, and other radioactive materials.

As a large producer and distributor of

radioactive materials, Mallinckrodt’s

operations involve greater nuclear material

inventories and have a greater potential for

adverse consequences, if not properly

controlled, than many other material

licensees (i.e.; those classified as category ‘‘c’’

or ‘‘d’’).

In accordance with the NRC’s Enforcement

policy, under the revised civil penalty

assessment strategy, the base civil penalty for

a violation is determined using Table 1ABase Civil Penalties. Under the revised civil

penalty assessment strategy, a violation

involving transportation of radioactive

materials can be assessed the same base civil

penalty as a violation involving plant

operations or health physics. This is a

significant change from the NRC’s prior

strategy, which used both the category of the

licensee and the type of activity being

conducted (e.g.; plant operations, health

physics, or transportation) to assess a base

civil penalty. Under the prior civil penalty

assessment strategy, the base civil penalty for

a violation involving transportation of

radioactive materials was different than the

base civil penalty for a violation involving

plant operations or health physics. In

accordance with the Enforcement Policy,

under the revised civil penalty assessment

strategy, the staff does not consider the type

of activity (e.g.; the magnitude of risk

associated with a particular type of activity

such as transportation of radioactive

materials versus plant operations) when

assessing a civil penalty.

NRC Conclusion

The NRC has concluded that an adequate

basis for changing the penalty category was

not provided by the Licensee. Consequently,

the proposed civil penalty in the amount of

$13,750 should be imposed.

[FR Doc. 97–24678 Filed 9–16–97; 8:45 am]

BILLING CODE 7590–01–P

NUCLEAR REGULATORY

COMMISSION

Consolidated Guidance about

Materials Licenses: Program-Specific

Guidance about Industrial

Radiography Licenses, Availability of

Draft NUREG

AGENCY: Nuclear Regulatory

Commission.

ACTION: Notice of availability and

request for comments.

SUMMARY: The Nuclear Regulatory

Commission is announcing the

availability of and requesting comment

on draft NUREG–1556, Vol. 2,

‘‘Consolidated Guidance about Materials

Licenses: Program-Specific Guidance
Federal Register / Vol. 62, No. 180 / Wednesday, September 17, 1997 / Notices 48905

about Industrial Radiography Licenses,’’

dated August 1997.

NRC is consolidating and updating

numerous guidance documents into a

series of program specific guidance

documents to be published in a NUREG

format. All NUREGs in the series will

carry the number and title: NUREG

1556, Volume X, ‘‘Consolidated

Guidance About Materials Licenses.’’

Each specific guidance document will

have an identifying volume number,

and the title of the specific guidance

will appear as the sub-title of the

NUREG. This draft NUREG is the

second guidance document to be

published in this series; therefore it is

listed as Volume 2.

This draft NUREG report is intended

for use by applicants, licensees, NRC

license reviewers, and other NRC

personnel. This guidance corresponds

with the revision to 10 CFR part 34

published in May 1997. It combines and

updates the guidance for applicants and

licensees previously found in draft

Regulatory Guide FC 401–4, ‘‘Guide for

the Preparation of Applications for the

Use of Sealed Sources and Devices for

Performing Industrial Radiography,’’

(dated October 1984), and the guidance

for licensing staff previously found in

Policy and Guidance Directive FC 84–

15, ‘‘Standard Review Plan for

Applications for the Use of Sealed

Sources and Devices for Performing

Industrial Radiography,’’ dated October

1994. In addition, this draft report also

contains information found in pertinent

Technical Assistance Requests and

Information Notices. This draft report

takes, where applicable, a more graded

(or risk-informed) and performancebased approach to licensing industrial

radiography consistent with the current

regulations.

This draft NUREG report has been

distributed for comment to encourage

public participation in its development.

It represents the current position of the

NRC staff, which is subject to change

after the review of public comments.

Comments received will be considered

in developing the final NUREG report

that represents the official NRC staff

position. Until the final NUREG report

is published, this draft NUREG report

represents the best available guidance,

and may be used when preparing

requests for licensing actions. Once the

final NUREG report is published, NRC

staff will use it in its review of requests

for licensing actions. The draft and final

NUREG reports may differ. If a license

was issued or amended based on

recommendations in the draft NUREG

report and the final guidance is believed

to be more advantageous, licensees may

choose to request an amendment.

DATES: The comment period ends

November 17, 1997. Comments received

after that time will be considered if

practicable.

ADDRESSES: Submit written comments

to: Chief, Rules and Directives Branch,

Division of Administrative Services,

Office of Administration, U. S. Nuclear

Regulatory Commission, Washington,

DC 20555–0001. Hand deliver

comments to 11545 Rockville Pike,

Rockville, Maryland, between 7:15 a.m.

and 4:30 p.m. on Federal workdays.

Comments may also be submitted

through the Internet by addressing

electronic mail to DLM1@NRC.GOV.

Those considering public comment

may request a free single copy of draft

NUREG–1556, Volume 2, by writing to

the U.S. Nuclear Regulatory

Commission, ATTN: J. Bruce Carrico,

Mail Stop TWFN 8F5, Washington, DC

20555–0001. Alternatively, submit

requests through the Internet by

addressing electronic mail to

JBC@NRC.GOV. A copy of draft

NUREG–1556, Volume 2, is also

available for inspection and/or copying

for a fee in the NRC Public Document

Room, 2120 L Street, NW. (Lower

Level), Washington, DC 20555–0001.

FOR FURTHER INFORMATION CONTACT:

J. Bruce Carrico, Mail Stop TWFN 8–F5,

Division of Industrial and Medical

Nuclear Safety, Office of Nuclear

Materials Safety and Safeguards, U.S.

Nuclear Regulatory Commission,

Washington, DC 20555, telephone (301)

415–7826; electronic mail address:

JBC@NRC.GOV.

Electronic Access

NUREG–1556, Volume 2, is also

available electronically by visiting

NRC’s Home Page (http://www.nrc.gov)

and choosing ‘‘Nuclear Materials,’’ then

‘‘Business Process Redesign project,’’

then ‘‘Library,’’ and then ‘‘draft

NUREG–1556, Volume 2.’’

Dated at Rockville, Maryland, this 28th day

of August, 1997.

For the Nuclear Regulatory Commission.

Larry W. Camper,

Chief, Medical, Academic, and Commercial

Use Safety Branch, Division of Industrial and

Medical Nuclear Safety, Office of Nuclear

Material Safety and Safeguards.

[FR Doc. 97–24677 Filed 9–16–97; 8:45 am]

BILLING CODE 7590–01–P

OFFICE OF MANAGEMENT AND

BUDGET

Budget Analysis Branch;

Sequestration Update Report

AGENCY: Office of Management and

Budget—Budget Analysis Branch.

ACTION: Notice of transmittal of

sequestration update report to the

President and Congress.

SUMMARY: Pursuant to Section 254(b) of

the Balanced Budget and Emergency

Control Act of 1985, as amended, the

Office of Management and Budget

hereby reports that it has submitted its

Sequestration Update Report to the

President, the Speaker of the House of

Representatives, and the President of

the Senate.

FOR FURTHER INFORMATION CONTACT:

Ellen Balis, Budget Analysis Branch—

202/395–4574.

Dated: September 10, 1997.

Clarence C. Crawford,

Associate Director for Administration.

[FR Doc. 97–24640 Filed 9–16–97; 8:45 am]

BILLING CODE 3110–01–P

OFFICE OF MANAGEMENT AND

BUDGET

Cumulative Report on Rescissions

and Deferrals

September 1, 1997.

This report is submitted in fulfillment

of the requirement of Section 1014(e) of

the Congressional Budget and

Impoundment Control Act of 1974

(Public Law 93–344). Section 1014(e)

requires a monthly report listing all

budget authority for the current fiscal

year for which, as of the first day of the

month, a special message had been

transmitted to Congress.

This report gives the status, as of

September 1, 1997, of ten rescission

proposals and seven deferrals contained

in three special messages for FY 1997.

These messages were transmitted to

Congress on December 4, 1996, and on

February 10 and March 19, 1997.

Rescissions (Attachments A and C)

As of September 1, 1997, ten

rescission proposals totaling $407

million had been transmitted to the

Congress. Congress approved six of the

Administration’s rescission proposals,

totaling $285 million, in P.L. 105–18.

Attachment C shows the status of the FY

1997 rescission proposals.

Deferrals (Attachments B and D)

As of August 1, 1997, $882 million in

budget authority was being deferred

from obligation. Attachment D shows

the status of each deferral reported

during FY 1997.

Information From Special Messages

The special messages containing

information on the rescission proposals

and deferrals that are covered by this