[Federal Register Volume 62, Number 180 (Wednesday, September 17, 1997)]
[Notices]
[Pages 48903-48904]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-24678]


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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.


[[Page 48904]]


    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 Selenium-75, 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 
Iodine-131, 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 <SUP>1</SUP> 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.
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    \1\ The 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.
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    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 1A-Base 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]
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