ML20202B470
| ML20202B470 | |
| Person / Time | |
|---|---|
| Site: | 03007609 |
| Issue date: | 02/06/1998 |
| From: | NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION III) |
| To: | |
| Shared Package | |
| ML20202B469 | List: |
| References | |
| 30-07609-97-01, 30-7609-97-1, EA-97-582, NUDOCS 9802120025 | |
| Download: ML20202B470 (3) | |
See also: IR 07100117/2012005
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Mallinckrodt Veterinary, Inc.
Docket No. 030-05798
Terre Haute, Indiana
License No. 13 01264-05
EA 97 582
During an NRC inspection conducted on November 17 and 18,1997, with continuing NRC
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review through December 5,1997, violations of NRC requirements were identified, in
accordance wl;h the " General Statement of Policy and Procedure for NRC Enforcement
Actions, NUREG 1600, the violations are listed below:
1.
Programmatic issues
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A.
10 CFR 30.36(d) requires, in part, that licensees shall provide notification to NRC
in writing within 60 days of the occurrence that no principal activities have been
conducted for a period of 24 months in any separate building or outdoor aren
that contains residual radioactivity such that the building or outdoor area is
unsuitable for release in accordance with NRC requirements.
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Centrary to the above, as of November 17,1997, the licensee did not notify NRC
In writing within 60 days as required. Specifically, no principal activities (activities
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authorized by the license which are essential to achieving the purpose (s) for
which the license was issued or amended) were conducted in buildings 201 and
209 since December 1993. The buildings contained residual radioactivity and
were unsuitable for release in accordance with NRC requirements, in addition,
notification was not made to the NRC of two outdoor burial sites which contain
residual radioactivity and are unsultable for release in accordance with NRC
requirements. (01013)
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B.
10 CFR 30.56(j) requires, in part, that as the final step in decommissioning, the
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licensee shall: (1) certify disposition of all licensed malertal, including
accumulated wastes, by submitting a completed NRC Form 314 or equivalent
information; and (2) conduct a radiation survey of the premises where licensed
activities were carried out and submit a report of the results of this survey unless
the licensee demonstrates that the premises were suitable for release in some
other manner.
Contrary to the above, as of November 17,1997, as a final step in
decommissioning two buildings, the licensee did not: (1) certify disposition of all
licensed material, including accumulated wastes, by submitting a completed
NRC Form 314 or equivalent information to the NRC; and (2) did not submit a
report of the radiation sutvey results or demonstrate in any other manner that the
premises were suitable for release. Specifically, Buildings 3 and 84 located at
1331 S. First Street, Terre Haute, Indiana, were used for licensed activities
before they were demolished in 1995 and 1996 respectivdy. The licensee did
not certify to the NRC that alllicensed material within those buildings had been
disposed of or demonstrate that the premises were suitable for release. (02013)
9902120025 990206
ADOCK 03007609
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C.
Condition 11, of License No.13 01264-05 authorizes a specifically named
individual as the Radiation Safety Officer (RSO),
Contrary to the above, as of April 1995, the Individual specifically named as RSO
left the licensee's nmploy and was not replaced. (03013)
These violations represent a Severity level ill problem (Supplement VI).
II.
Licensing Issue
10 CFR 30.34(b) requires, in part, that no NRC license nor any right under a license
shall be transferred or assigned through transfel of control of any license to any person,
unless the Commission gives its consent in writing.
Contrary to the above, on June 30,1997, control of NRC License No. 13-01264-05 was
transferred from Matt!nckrodt Veterinary, Inc., to Schering Plough Animal Health
Corporation without prior written consent from the Commission. (01014)
This is a Severity Level IV violation (Supplera,)t VI).
Pursuant to the provisions of 10 CFR 2.201, Mallinckrodt Veterinary Inc., is hereby required to
submit a written statement or explanation to the U.S. Nuclear Regulatory Commission,
ATTN: Document Control Desk, Washington, D.C. 20555, with a copy to the Regional
Administrator, Region Ill, within 30 days of the date of the letter transmitting this Notice of
Violation (Notice). This reply should be clearly marked as a " Reply to a Notice of Violation" and
should include for each violation: (1) the reason far the violation, or, if contested, the basis for
disputing the violation, (2) the corrective steps that have been taken and the results achieved,
(3) the corrective steps that will b3 taken to avoid further violations, arid (4) the date when full
compliance will be achieved. Your response rnay reference or include previous docketed
correspondence,if the correspondence adequately addresses the required response, if an
adequate reply is not received within the time specified in this Notice, an order or a Demand for
Information may be issued as to why the license should not be modified, suspended, or
revoked, or why such other action as may be proper should not be taken. Where good cause is
shown, consideration will be given to extending the response time,
if you contest this enforcement action, you should also provide a copy of your response to the
Director, Office of Enforcement, United States Nuclear Re0ulatory Commission, Washington,
D.C. 20555-0001.
Because your response will be placed in the NRC Public Document Room (PDR), to the extent
possible, it should not include any personal privacy, proprietary, or safeguards information so
that it can be placed in the PDR without redaction if personal privacy or proprietary information
is necessary to provide an acceptable response, then please provide a bracketed copy of your
response that identifies the information that should be protected and a redacted copy of your
response that deletes such information. If you request withholding of such material, you mum
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specifically identify the portions of your response that you seek to have withheld and provide in
detall the bases for your claim of withholding (e.g., explain why the disclosure of information will
create an unwarranted invasion of personal privacy or provide the information required by
10 CFR 2.790(b) to support a request for withholding confidential commercial or financial
information). If safeguards information is necessary to provide an acceptable response, please
provide the level of protection described in 10 CFR 73.21.
Dated at Lisle, Illinois
this 6 day of February 1998