Federal Register / Vol. 62, No. 180 / Wednesday, September 17, 1997 / Notices 48903

contention will not be permitted to

participate as a party.

Those permitted to intervene become

parties to the proceeding, subject to any

limitations in the order granting leave to

intervene, and have the opportunity to

participate fully in the conduct of the

hearing, including the opportunity to

present evidence and cross-examine

witnesses.

If a hearing is requested, the

Commission will make a final

determination on the issue of no

significant hazards consideration. The

final determination will serve to decide

when the hearing is held.

If the final determination is that the

amendments requested involve no

significant hazards consideration, the

Commission may issue the amendments

and make them immediately effective,

notwithstanding the request for a

hearing. Any hearing held would take

place after issuance of the amendments.

If the final determination is that the

amendments requested involve a

significant hazards consideration, any

hearing held would take place before

the issuance of any amendment.

A request for a hearing or a petition

for leave to intervene must be filed with

the Secretary of the Commission, U.S.

Nuclear Regulatory Commission,

Washington, DC 20555–0001, Attention:

Rulemakings and Adjudications Staff, or

may be delivered to the Commission’s

Public Document Room, the Gelman

Building, 2120 L Street, NW.,

Washington, DC, by the above date. A

copy of the petition should also be sent

to the Office of the General Counsel,

U.S. Nuclear Regulatory Commission,

Washington, DC 20555–0001, and to

Michael I. Miller, Esquire; Sidley and

Austin, One First National Plaza,

Chicago, Illinois 60690, attorney for the

licensee.

Nontimely filings of petitions for

leave to intervene, amended petitions,

supplemental petitions and/or requests

for hearing will not be entertained

absent a determination by the

Commission, the presiding officer or the

presiding Atomic Safety and Licensing

Board that the petition and/or request

should be granted based upon a

balancing of the factors specified in 10

CFR 2.714(a)(1) (i)–(v) and 2.714(d).

For further details with respect to this

action, see the application for

amendment dated September 2, 1997,

which is available for public inspection

at the Commission’s Public Document

Room, the Gelman Building, 2120 L

Street, NW., Washington, DC, and at the

local public document room located at

the Wilmington Public Library, 201 S.

Kankakee Street, Wilmington, Illinois

60481.

Dated at Rockville, Maryland, this 11th day

of September 1997.

For the Nuclear Regulatory Commission.

M. D. Lynch,

Senior Project Manager, Project Directorate

III–2, Division of Reactor Projects, Office of

Nuclear Reactor Regulation.

[FR Doc. 97–24675 Filed 9–16–97; 8:45 am]

BILLING CODE 7590–01–P

NUCLEAR REGULATORY

COMMISSION

[Docket No. 030–00001; License No. 24–

04206–01; EA 97–155]

Mallinckrodt Medical, Inc. Maryland

Heights, Missouri; Order Imposing

Civil Monetary Penalty

I

Mallinckrodt Medical, Inc. (Licensee)

is the holder of Materials License No.

24–04206–01 which was first issued by

the Nuclear Regulatory Commission

(NRC or Commission) on January 6,

1975, and renewed in its entirety on

October 12, 1990. The license authorizes

the Licensee to prepare and package for

distribution Mo–99/Tc–99m generators

and other radioactive materials in

accordance with the conditions

specified therein.

II

An inspection of the Licensee’s

activities was conducted during January

10–12, 1997, with continuing review

through April 8, 1997. The results of

this inspection indicated that the

Licensee had not conducted its

activities in full compliance with NRC

requirements. A written notice of

violation and Proposed Imposition of

Civil Penalty (notice) was served upon

the Licensee by letter dated May 30,

1997. The Notice states the nature of the

violation, the provision of the NRC’s

requirements that the Licensee had

violated, and the amount of the civil

penalty proposed for the violation.

The Licensee responded to the notice

in a letter dated June 30, 1997. In its

response, the Licensee admitted that the

violation occurred and agreed that a

civil penalty is warranted. The Licensee

contested the fact that the NRC

categorized it as a ‘‘b’’ category,

industrial processor, as listed in Table

1A-Base Civil Penalties of NUREG–

1600, ‘‘General Statement of Policy and

Procedures for NRC Enforcement

Actions.’’

III

After consideration of the Licensee’s

response and the statements of fact,

explanation, and argument for

mitigation contained therein, the NRC

staff has determined, as set forth in the

Appendix to this Order, that the

violation occurred as stated and that the

penalty proposed for the violation

designated in the Notice should be

imposed.

IV

In view of the foregoing and pursuant

to Section 234 of the Atomic Energy Act

of 1954, as amended (Act), 42 U.S.C.

2282, and 10 CFR 2.205, It is hereby

ordered that:

The Licensee pay a civil penalty in the

amount of $13,750 within 30 days of the date

of this Order, by check, draft, money order,

or electronic transfer, payable to the

Treasurer of the United States and mailed to

James Lieberman, Director, Office of

Enforcement, U.S. Nuclear Regulatory

Commission, One White Flint North, 11555

Rockville Pike, Rockville, MD 20852–2738.

V

The Licensee may request a hearing

within 30 days of the date of this Order.

Where good cause is shown,

consideration will be given to extending

the time to request a hearing. A request

for extension of time must be made in

writing to the Director, Office of

Enforcement, U.S. Nuclear Regulatory

Commission, Washington, D.C. 20555,

and include a statement of good cause

for the extension. A request for a

hearing should be clearly marked as a

‘‘Request for an Enforcement Hearing’’

and shall be addressed to the Director,

Office of Enforcement, U.S. Nuclear

Regulatory Commission, Washington,

D.C. 20555, with a copy to the

Commission’s Document Control Desk,

Washington, D.C. 20555. Copies also

shall be sent to the Assistant General

Counsel for Hearings and Enforcement

at the same address and to the Regional

Administrator, NRC Region III, 801

Warrenville Road, Lisle, Illinois 60532–

4351.

If a hearing is requested, the

Commission will issue an Order

designating the time and place of the

hearing. If the Licensee fails to request

a hearing within 30 days of the date of

this Order (or if written approval of an

extension of time in which to request a

hearing has not been granted), the

provisions of this Order shall be

effective without further proceedings. If

payment has not been made by that

time, the matter may be referred to the

Attorney General for collection.

In the event the Licensee requests a

hearing as provided above, the issue to

be considered at such hearing shall be:

Whether on the basis of the violation

admitted by the Licensee, this Order should

be sustained.
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