Federal Register / Vol. 65, No. 128 / Monday, July 3, 2000 / Notices 41109

NUCLEAR REGULATORY

COMMISSION

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

04206–01; EA–00–143]

Mallinckrodt, Inc., St Louis, Missouri;

Confirmatory Order Modifying License

I

Mallinckrodt, Inc. (Mallinckrodt), is

the holder of NRC License No. 24–

04206–01 issued by the Nuclear

Regulatory Commission (NRC or

Commission) pursuant to 10 CFR part

30. The license authorizes Mallinckrodt

to use byproduct materials in

manufacturing, processing and

packaging of radiopharmaceuticals and

radiochemicals for distribution to

holders of a specific license issued by

the Commission or an Agreement State.

The license also authorizes

Mallinckrodt to use byproduct material

for research and development of

radiopharmaceuticals. The license was

issued on October 8, 1958, was most

recently amended on March 27, 1998,

and is currently in the renewal process.

II

On April 13, 2000, Mallinckrodt

identified a potential extremity

exposure in excess of regulatory limits

to an individual working on the

molybdenum/technetium generator

manufacturing line and immediately

notified the NRC of the incident. The

NRC initiated a special inspection on

April 14, 2000, to review the

circumstances, and root and

contributing causes of the event. On

April 28, 2000, Mallinckrodt identified

additional potential exposures in excess

of regulatory limits involving additional

processing areas. Based on the

additional potential exposures and the

complexity of the processes, the NRC

expanded the special inspection to an

Augmented Inspection Team (AIT). The

AIT inspected Mallinckrodt between

May 4 and May 26, 2000.

Based upon the AIT results, the NRC

concluded that programmatic

deficiencies exist in Mallinckrodt’s

ability to conduct: (1) Comprehensive

assessments of its radiation protection

program; (2) accurate root cause

determinations for deficiencies

identified through its problem

identification program; and, (3)

radiological evaluations of

manufacturing processes. The results of

these deficiencies included the failure

to identify that significant differences

existed in dose rates between fingertips

and extremity monitoring devices when

handling unshielded containers of

radioactive material, the identification

that operating procedures did not reflect

actual work practices, and that

supervisors overseeing laboratory

activities did not recognize the potential

radiological consequences of work

habits in their area. The NRC is

concerned that inadequate controls over

the safe use of licensed material

continue to exist. NRC concerns along

with various remedial and corrective

actions, designed to improve

Mallinckrodt’s radiation safety program,

were discussed with Mallinckrodt

during a telephone call between

members of NRC and Mallinckrodt staff

on June 8, 2000. By letter dated June 9,

2000, NRC proposed conditions that

could be taken to identify and correct

the licensee’s programmatic

weaknesses. By letter dated June 16,

2000, Mallinckrodt agreed to implement

the proposed conditions with minor

modifications. These modifications have

been incorporated into this Order.

III

By letter dated June 16, 2000,

Mallinckrodt has agreed to:

(1) Retain an independent

organization to assess the radiation

safety program and the radiation safety

aspects of its radioactive material

manufacturing processes;

(2) Provide written assurance that

workers have received training and

understand procedures and practices in

place to maintain radiation exposures as

low as is reasonably achievable;

(3) Develop a plan to review

operations for the last five years to

determine if any individuals have

received exposures in excess of

regulatory limits; and,

(4) Request an amendment to its

license incorporating a program that

will identify and correct deficiencies

associated with radiation safety.

On June 16, 2000, Mallinckrodt

consented to issuance of this Order with

the commitments, as described in

Section IV below. Mallinckrodt further

agreed in its June 16, 2000, letter that

this Order is to be effective upon

issuance and has waived its right to a

hearing. Implementation of these

commitments will provide enhanced

assurance that sufficient attention will

be applied to the radiation safety

program, and that the program will be

conducted safely and in accordance

with NRC requirements.

I find that Mallinckrodt’s

commitments as set forth in Section IV

are acceptable and necessary. Further, I

conclude that with these commitments,

the public health and safety are

reasonably assured. In view of the

foregoing, I have determined that the

public health and safety require that

Mallinckrodt’s commitments be

confirmed by this Order. Based on the

above and Mallinckrodt’s consent, this

Order is immediately effective upon

issuance.

IV

Accordingly, pursuant to sections 81,

161b, 161i, 161o, 182 and 186 of the

Atomic Energy Act of 1954, as amended,

and the Commission’s regulations in 10

CFR 2.202 and 10 CFR part 30, It Is

Hereby Ordered, Effective Immediately,

That License No. 24–04206–01 Is

Modified As Follows:

A. Mallinckrodt shall retain the

services of one or more independent

individuals or organizations capable of

evaluating radiation safety program

implementation and manufacturing

processes associated with radioactive

materials at large facilities to perform

the following:

1. An assessment of Mallinckrodt’s

radiation protection program. At a

minimum the assessment shall include:

a. Roles and responsibilities of the

Radiation Safety Office and Officer;

b. Effectiveness of Mallinckrodt’s

Radiation Safety and Dose Reduction

Committees;

c. Current radiation protection

organization staffing levels to determine

if sufficient resources are available to

support plant operations;

d. Effectiveness of the occupational

exposure monitoring program (deepdose equivalent; shallow dose

equivalent, whole body and maximum

extremity; and committed effective dose

equivalent) to assure that all recorded

exposures (e.g., finger and hand

exposures) are representative of

maximum exposures received;

e. Effectiveness of Mallinckrodt in

resolving previous radiation protection

issues; and

f. Effectiveness of Mallinckrodt’s

radiation safety training program,

including on the job training for

radiation workers.

2. A radiation safety assessment of

Mallinckrodt’s radioactive materials

manufacturing processes. At a minimum

the assessment shall include:

a. The radiation safety practices and

related engineering controls associated

with Mallinckrodt’s processes involving

radioactive materials;

b. Adequacy of and adherence to

Standard Operating Procedures affecting

radiation safety; and

c. The process that Mallinckrodt uses

for evaluating radiation safety issues

associated with new and modified

product lines involving radioactive

materials.

Mallinckrodt shall inform NRC

Region III of the individual(s) or

41110 Federal Register / Vol. 65, No. 128 / Monday, July 3, 2000 / Notices

organization(s) hired for each of these

assessments. These notifications shall

be made within seven days of the date

of this Order, and include the audit

plan. Each assessment shall be

completed within 60 days of the date of

this Order. Within 90 days of the date

of this Order, Mallinckrodt shall ensure

that the individual(s) or organization(s)

conducting each assessment submit to

Mallinckrodt and NRC Region III, at the

same time, the results of each

assessment, including the deficiencies

identified.

Mallinckrodt shall evaluate the root

causes and develop corrective actions

associated with any identified findings

and submit to NRC Region III the

schedules to implement those corrective

actions. Mallinckrodt shall provide to

NRC Region III the radiation protection

program assessment corrective actions

within 150 days of the date of this

Order. Mallinckrodt shall provide to

NRC Region III the corrective actions to

the radiation safety assessment of the

radioactive materials manufacturing

processes within 180 days of the date of

this Order. Should Mallinckrodt

disagree with any assessment finding or

plan not to initiate any corrective action

arising from the assessments,

Mallinckrodt must provide a written

explanation of the rationale for such

disagreement to NRC Region III within

the respective 150-day or 180-day

period.

B. Mallinckrodt shall provide to NRC

Region III, a written statement that all

applicable Mallinckrodt workers have

been trained and that Mallinckrodt has

assessed the effectiveness of the training

to ensure workers understand the

procedures and practices in place to

maintain radiation exposures as-low-asis-reasonably-achievable. This written

assurance shall be submitted to NRC

Region III within 15 days of the date of

this Order.

C. Mallinckrodt shall develop a plan

to review past operations to determine

if any individuals could have received

radiation exposures in excess of the

applicable NRC limits in 10 CFR Part

20. This review shall encompass

activities for a period of five years prior

to the date of this Order. Mallinckrodt

shall provide NRC Region III the plan

and implementing schedule within 90

days of the date of this Order. The

provisions of this Order do not relieve

Mallinckrodt from complying with the

reporting requirements in 10 CFR Part

20 should an exposure in excess of

regulatory limits be identified during

the review.

D. Mallinckrodt shall request an

amendment to its license incorporating

a program that will identify and correct

deficiencies associated with radiation

safety. This program shall include, as a

minimum, provisions for: (1) Worker

identification of radiation related safety

issues; (2) prompt notification to

management of significant issues; (3)

root cause analysis, including associated

training for all managers, supervisors,

and radiation protection staff involved

with performing and reviewing root

cause evaluations; and (4) tracking of

identified deficiencies. This amendment

request shall be submitted to NRC

Region III within 180 days of the date

of this Order.

The Regional Administrator, Region

III, may relax or rescind, in writing, any

of the above conditions upon a showing

by Mallinckrodt of good cause.

V

Any person adversely affected by this

Confirmatory Order, other than

Mallinckrodt, may request a hearing

within 20 days of its issuance. 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, DC 20555, and include a

statement of good cause for the

extension. Any request for a hearing

shall be submitted to the Secretary, U.S.

Nuclear Regulatory Commission, ATTN:

Rulemakings and Adjudications Staff,

Washington, DC 20555. Copies also

shall be sent to the Director, Office of

Enforcement, U.S. Nuclear Regulatory

Commission, Washington, DC 20555, to

the Assistant General Counsel for

Materials Litigation and Enforcement at

the same address, to the Regional

Administrator, NRC Region III, 801

Warrenville Road, Lisle, Illinois, and to

Mallinckrodt. If such a person requests

a hearing, that person shall set forth

with particularity the manner in which

his interest is adversely affected by this

Order and shall address the criteria set

forth in 10 CFR 2.714(d).

If a hearing is requested by a person

whose interest is adversely affected, the

Commission will issue an Order

designating the time and place of any

hearing. If a hearing is held, the issue to

be considered at such hearing shall be

whether this Confirmatory Order should

be sustained.

In the absence of any request for

hearing, or written approval of an

extension of time in which to request a

hearing, the provisions specified in

Section IV above shall be final 20 days

from the date of this Order without

further order or proceedings. If an

extension of time for requesting a

hearing has been approved, the

provisions specified in Section IV shall

be final when the extension expires if a

hearing request has not been received.

An answer or a request for hearing shall

not stay the immediate effectiveness of

this order.

Dated this 22nd day of June, 2000.

For the Nuclear Regulatory Commission.

R.W. Borchardt,

Director, Office of Enforcement.

[FR Doc. 00–16729 Filed 6–30–00; 8:45 am]

BILLING CODE 7590–01–P

NUCLEAR WASTE TECHNICAL

REVIEW BOARD

Board Meeting: August 1–2, 2000—

Carson City, NV: Discussions of a

Total System Performance

Assessment for a Potential Yucca

Mountain, Nevada, Repository for

Spent Nuclear Fuel and High-Level

Radioactive Waste; Update on

Scientific and Engineering Studies

Undertaken at the Yucca Mountain

Site; and Update on the DOE’s

Development of a Safety Strategy for a

Potential Yucca Mountain Repository

Pursuant to its authority under

section 5051 of Public Law 100–203,

Nuclear Waste Policy Amendments Act

of 1987, on Tuesday, August 1,

Wednesday, August 2, the Nuclear

Waste Technical Review Board (Board)

will meet in Carson City, Nevada, to

discuss technical and scientific issues

related to evaluating a possible site for

a repository for spent nuclear fuel and

high-level radioactive waste at Yucca

Mountain, Nevada. Among the issues

that will be discussed are a total system

performance assessment (TSPA), a

safety strategy for the potential

repository, and scientific and

engineering studies being conducted to

evaluate the suitability of the Yucca

Mountain site. The Board is charged by

Congress with reviewing the technical

and scientific aspects of the Department

of Energy’s (DOE) civilian radioactive

waste management program, including

disposing of, packaging, and

transporting the waste.

The Board meeting will be held at

Pin ̃on Plaza Resort (Best Western), 2171

Hwy 50 East; Carson City, NV 89701.

The telephone number is (775) 885–

9000; the fax number is (775)–888–8018.

The meeting will start at 8:30 a.m. on

both days and will be open to the

public.

On Tuesday, August 1, the DOE’s

Office of Civilian Radioactive Waste

Management will present a general

overview of the status of the program.

The overview will be followed by