ML20035A123

Notation Vote Response Sheet Approving,W/Comments, SECY-92-395 Re Proposed Change to General Statement of Policy & Procedure for NRC Enforcement actions,10CFR2,app C

ML20035A123
Person / Time
Issue date:	12/04/1992
From:	Rogers K NRC COMMISSION (OCM)
To:	Chilk S NRC OFFICE OF THE SECRETARY (SECY)
References
NUDOCS 9303240097
Download: ML20035A123 (4)

Text

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........................e RELEASED TO THE PDR I'

NOTAT10N V0TE gp g

RESPONSE SHEET 3...d93,,,',,,,,,, 83 i 3

T0:

SAMUEL J. CHILK, SECRETARY OF THE COMMISSION FROM:

COMMISSIONER ROGERS

SUBJECT:

SECY-92-395 - PROPOSED CHANGE TO THE GENERAL STATEMENT OF POLICY AND PROCEDURE FOR NRC ENFORCEMENT ACTIONS, 10 CFR PART 2, APPENDIX C APPROVED F kC6 DISAPPROVED ABSTAIN NOT PARTICIPATING REQUEST DISCUSSION COMMENTS:

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RELEASE VOTE

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d 9, [7T7-DATE WITHHOLD VOTE

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ENTERED ON "AS" YES No

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i NUCLEAR REGULATORY COMMISSION i

e 10 CFR Part 2 c

POLICY AND PROCEDURE FOR NRC ENFORCEMENT ACTIONS; POLICY STATEMENT RIN 3150-AD97 AGENCY:

Nuclear Regulatory Commission ACTION:

Policy Statement:

Modification i

SUMMARY

The NRC is modifying Supplement VI of its Enforcement Policy to revise certain of the examples of severity levels for violations associated with the quality management program required by 10 CFR 35.32.

This policy is codified at Appendix C to 10 CFR

[

Part 2 (57 FR 5791 et sea., February 18,1992)

Thisrevisedstatementkolicyiseffecpeon[

]

DATES:

while comments on the changes are being received.

Submit comments on or before [30 Days after effective date).

Comments received after this date will be considered if it is practical to do so, but i

the Commission is able to assure consideration only for comments.

received on or before this date.

Comments may be considered in-future revisions of the statement of policy.

j

-4 Exa=ple D.4, the example for a severity level IV classification, is being revised to address the isolated misadministration that i

neither results in a death or serious injury to a patient nor involves a programmatic weakness in the licensee's implementation of its QM program.

This revision reflects the practical realities with medical licensees where isolated violations may occur despite t

appropriate instruction, training, policies / procedures, written directives, and supervision.

Medical licensees may need to serve patients despite pressures that make it difficult to avoid unintentional errors.

Nevertheless, such errors, if found to be i

violations of the Quality Management Program, need to be addressed i

with appropriate corrective actions to provide high confidence that i

byproduct material or radiation from byproduct materials I

administered to the patient as intended and directed by an authorized user physician.

Such violations are more than a minor j

concern, and if not corrected, may result in a significant concern.

This revision should also provide added incentives for licensees to l

identify and correct violations in accordance with the Enforcement Policy, which allows for the use of noncited violations for licensee identified and corrected Severity ' /el IV violations. On the other hand, repetitive Severity Level IV violations may result i

in civil penalties and escalation.

The determination of severity level based on the degree of programmatic weaknesses will be fact dependent.

While generally a single failure that resulted in a misadministration would not be

/

indicative of a programmatic weakne t may be-depending on the

[(C b

• circumstances.

For example, the failure to train one technician may indicate a programmatic weakness for a small program or where f

the technician not trained is the sole technician on a weekend shift.

l List of Subjects in 10 CFR Part 2 i

PART 2

Administrative practice and procedure, Antitrust, i

Byproduct

material, Classified information, Civil'

penalty, Enforcement, Environmental protection, Nuclear materials, Nuclear power plants and reactors, Penalty, Sex discrimination, Source-i material, Special nuclear material, Violations, and Waste treatment and disposal.

PART 2 - RULES OF PRACTICE FOR DOMESTIC LICENSING PROCEEDINGS 5

l

{

1.

The authority citation for Part 2 continues to read as follows:

i AUTHORITY:

Sec. 161, 68 Stat. 948, as amended (42 US.C. 2201);

sec. 201, 88 Stat. 1242, as amended (42 U.S.C. 5841).

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f 2.

Appendix C,

Supplement VI is amended by modifying examples l

t B.3, C.6, and D.3.

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