ML20034D498
| ML20034D498 | |
| Person / Time | |
|---|---|
| Issue date: | 11/25/1992 |
| From: | Taylor J NRC OFFICE OF THE EXECUTIVE DIRECTOR FOR OPERATIONS (EDO) |
| To: | |
| References | |
| SECY-92-395, NUDOCS 9212020006 | |
| Download: ML20034D498 (10) | |
Text
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l RELEASED TO THE PDR 7""%
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\\.~....j, POLICY ISSUE secv-92-395 November 25, 1992 (Notation Vote) f_ol:
The Commissioners o
From:
James M. Taylor Executive Director for Operations Subiect:
PROPOSED CHANGE TO THE GENERAL STATEMENT OF POLICY AND PROCEDURE FOR NRC ENFORCEMENT ACTIONS, 10 CFR PART 2, APPENDIX C
Purpose:
To obtain Commission approval for a change to the Enforcement Policy concerning the enforcement of the Quality Management Program and Misadministration Rule (QM rule).
Discussion:
As part of its effort in developing appropriate implementation policies for the rule, the staff has reconsidered the examples of severity level for violations of the QM rule.
These are found at examples A4, B3, C6, D3, and D4 of Supplement VI of the Enforcement Policy (10 CFR Part 2, Appendix C).
The existing examples tend to focus on the result of the misadministration and not on the root cause of the misadministration.
While the result may be significant, the root cause of the failure should be given more emphasis becauca that is where the corrective action will need to be focused.
This should also increase the deterrent value where misadministrations occur which are not significant but where there is clear potential for more significant occurrences.
Contact:
James Lieberman, OE 504-2741 NOTE:
TO BE MADE PUBLICLY AVAILABLE k'EEN THE FINAL SRM IS MADE AVAILABLF i
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f The Commissioners Therefore, the staff proposes to the Commission that it amend the Enforcement Policy to provide that:
(1) a Severity Level II violation would be a failure to meet the QM rule resulting in a misadministration where there was a substantial programmatic failure in implementing the QM rule; (2) a Severity Level III violation would now be a substantial failure to implement the QM rule that does not result in a misadministration, or if a misadministration occurs, there was a programmatic weakness in implementation of the QM rule; and (3) a Severity Level IV violation would be those which are isolated and do not demonstrate a programmatic weakness, whether or not a misadministration O': curred.
The other examples in the supplement for the QM rule would not change.
The attached draft Federal Becister Notice explains the changes in greater detail.
i These changes we're discussed during the November 9,1992, public meeting to discuss the implementazion of the QM rule including inspection and enforcement activities.
The comments were generally favorable to the proposed changes to the Policy.
Coordination:
The Office of General Counsel has no legal objection to this proposal.
Recommendations:
That the Commission:
1.
Approve the enclosed Federal Reaister Notice for publication.
j 2.
Note :
a.
That the policy statement will be published in the Federal Register effective immediately allowing 30 days for public comments.
b-The change does not contain information collection requirements that are subject to the Paperwork Reduction Act.
c.
That the Subcommittee on Nuclear Regulation of the Senate Committee on Environment and Public Works, j
f The Commissioners.
the Subcommittee on Energy and the Environment of the House Committee on Interior and Insular Affairs, and the Subcommittee on Energy and Power of the House Committee on Energy and Commerce will be informed of this action.
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i Tay r
xecutive Director for Operations 5
Enclosure:
As stated i
Commissioners' comments or consent should be provided directly to the Office of the Secretary by COB December 10, 1992.
Commission Staff Office comments, if any, should be submitted to the Commissioners NLT December 3, 1992, with an information copy to the Office of the Secretary.
If the paper is of such a nature that it requires additional review and comment, the Commissioners and.he Secretariat should be apprised of when comments may be expected.
I-DISTRIBUTION:
Commissioners OGC CAA OIG CA PA DCD Central Files EDO ASLB i
SECY 4
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NUCLEAR REGULATORY COMMISSION j
l-l 10 CFR Part 2 l
i POLICY AND PROCEDURE FOR NRC ENFORCEMENT ACTIONS;
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I POLICY STATEMENT l
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RIN 3150-AD97 AGENCY:
Nuclear Regulatory Contmission 1
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ACTION:
Policy Statement:
Modification l
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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 i
i by 10 CFR 35.32.
This policy is codified at Appendix C to 10 CFR f
f Part 2 (57 FR f791 et sec., February 18,1992) t DATES:
This revised statement policy is effecitve on [-
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while comments on the changes are being received.
Submit comments l
on or before [30 Days after effective date).
Comments received i
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after this date will be considered if it is practical to do so, but l
the Commission is able to assure consideration only for comments received on or before this date.
Comments may be considered in l
t future revisions of the statement of policy.
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ADDRESSES:
Send comments to:
Secretary, U.S.
Nuclear Regulatory Commission, Washington, DC 20555, ATTN:
Docketing and Service Branch. Deliver comments to One White Flint North,11555 Rockville l
l Pike, Rockville, Maryland 20852, between 7:30 a.m. and 4:15 p.m.,
l federal workdays.
Copies of comments received may be examined at j
the NRC Public Document Room, 2120 L Street, NW.,
(Lower Level),
Washington, DC.
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1 FOR FURTHER INFORMATION CONTACT:
James Lieberman, Office of Enforcement, U.S.
Nuclear Regulatory Commission, Washington, DC i
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20555, (301) 504-2741.
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l SUPPLEMENTARY INFORMATION:
l On July 25, 1991, the Commission published in the Federal Reaister
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(56 FR 34121) a final rule, effective January 27, 1992, requiring j
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persons subject to the requirements of 10 CFR Part 35 to establish 4
a quality management program and meet certain reporting l
requirements for misadministrations.
As part of that Notice, the l
l Commission modified its Enforcement Policy to provide examples in l
Supplement VI of severity levels for potential violations associated with the new requirements.
The examples of severity l
level are used in the enforcement process to provide guidance in i
determining the safety and regulatory significance of a particular violation.
The enforcement action taken is, in part, based upon i
the severity level decision.
As a result of comments on the l
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.l rulemaking, NRC has reconsidered the severity levels examples for
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t misadministrations.
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f Examples B.3 and C.6 of Supplement VI focus on the result of the administration. Example B.3, the example for a Severity Level II classification, addresses violations where a patient receives an overexposure of greater than 50% of the prescribed dose.
Depending
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f on the condition of the patient; plan of treatment; kind of application; and type, form, and quantity of the radioisotope, such I
an exposure may or may not be clinically significant or compromise i
the patient's health and safety.
Example C.6, the example for a i
Severity Level III classification, adaresses violations resulting in a misadministration regardless of whether there'is an over or under exposure.
Neither of these examples consider the c4uses of f
a the misadministration.
While the consequences of a
misadministration are important, as reflected in example A.4 which addresses misadministrations involving serious injury to a patient, i
it is important in less significant misadministrations to consider the root causes of misadministrations in determining the severity f
I classification. This approach to enforcement may more likely focus i
licensee attention on the need for broad corrective action to I
l address programmatic issues.
Therefore, examples B.3 and C.6 are being revised to consider the degree of programmatic veakness in f
the causes of a misadministration.
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-4 Example D.4, the example for a severity level IV classification, is h
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
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patients despite pressures that make it difficult to avoid unintentional errors.
Nevertheless, such errors, if found to be violations of the Quality Management Program, need to be addressed with appropriate corrective actions to provide high confidence that byproduct material or radiation from byproduct materials l
i administered to the patient as intended and directed by an authorized user physician.
Such violations are more than a minor concern, and if not corrected, may result in a significant concern.
This revision should also provide added incentives for licensees to identify and correct violations in accordance with the Enforcement Policy, which allows for the use of noncited violations for licensee identified and corrected Severity Level IV violations. On the other hand, repetitive Severity Level IV violations may result in civil penaltjes and escalation.
The determination of severity level based on the degree of programmatic weaknesses will be fact dependent.
While generally a
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single failure that resulted in a misadministration would not be i
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. indicative of a programmatic weakness, it may be depending on the circumstances.
For example, the failure to train one technician may indicate a programmatic weakness for a small_ program or where the technician not trained is the sole technician on a weekend shift.
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List of Subjects in 10 CFR Part 2 l
t PART 2
Administrative practice and procedure, Antitrust, l
Byproduct
- material, Classified information, Civil
- penalty,
!l 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.
4 PART 2 - RULES OF PRACTICE FOR DOMESTIC LICENSING PROCEEDINGS i
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l 1.
The authority citation for Part ' 2 continues to read as l
follows:
1 AUTHORITY:
Sec. 161, 68 Stat. 948, as amended (42 ' US.C. 2201);
sec. 201, 88 Stat. 1242, as amended (4 2' U.S.C. 5841).
2.
Appendix C,
Supplement VI is amended by modifying examples i
B.3, C.6, and D.3.
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i General Statement of Policy and Procedure for NRC I
Appendix C Enforcement Actions i
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Supplement VI - Severity Categories l
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B.
Severity Level II - Violations involving for example:
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A substantial programmatic failure in the_ implementation of i
the quality management program required by 10 CFR 35.32 that result in a misadministration.
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Severity Level III - Violations involving for example:
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Substantial failure to implement the ' quality -management l
l program as required by 35.32-that does not result in a-i misadministration; failure to report a_ misadministration;' or j
programmatic weakness in the implementation of the quality.
I management pr'ogram that results in a misadministration.
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D.
Severity Level'IV - Violations involving for example:
l 3.
Failure to follow the quality management program, including procedures, whether or not a misadministration occurs, provided the failures are isolated and do not demonstrate a programmatic weakness in the implementation of the QM program or a Severity i
Level I violation; failure to conduct the required program review; i
or failure to take corrective actions as required by 35.32; or i
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Dated at Rockville, Maryland, this day of 1992.
l FOR THE NUCLEAR REGULATORY COMMISSION i
I Samuel J.
Chilk Secretary of the Commission l
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