ML23151A394

PR-002 - 58FR17321 - Policy and Procedure for NRC Enforcement Action: Policy Statement (Modifications)

ML23151A394
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Issue date:	04/02/1993
From:	NRC/SECY
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PR-002, 58FR17321
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ADAMS Template: SECY-067 04/02/1993 PR-002 - 58FR17321 - POLICY AND PROCEDURE FOR NRC ENFORCEMENT ACTION; POLICY STATEMENT (MODIFICATIONS)

PR-002 58FR17321 RULEMAKING COMMENTS Document Sensitivity: Non-sensitive - SUNSI Review Complete

STATUS OF RULEMAKING PROPOSED RULE:

PR-002 OPEN ITEM (Y/N) N RULE NAME:

POLICY AND PROCEDURE FOR NRC ENFORCEMENT ACTION; POLICY STATEMENT (MODIFICATIONS)

PROPOSED RULE FED REG CITE:

58FR17321 PROPOSED RULE PUBLICATION DATE:

04/02/93 ORIGINAL DATE FOR COMMENTS: 05/03/93 NUMBER OF COMMENTS:

EXTENSION DATE:

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4 FINAL RULE FED. REG. CITE: 58FR17321 FINAL RULE PUBLICATION DATE: 04/02/93 NOTES ON PUBLISHED AS A FINAL POLICY STATEMENT. FILE LOCATED ON Pl.

TATUS OF RULE TO FIND THE.STAFF CONTACT OR VIEW THE RULEMAKING HISTORY PRESS PAGE DOWN KEY HISTORY OF THE RULE PART AFFECTED: PR-002 RULE TITLE:

PROPOSED RULE SECY PAPER:

FINAL RULE SECY PAPER:

POLICY AND PROCEDURE FOR NRC ENFORCEMENT ACTION; POLICY STATEMENT (MODIFICATIONS)

PROPOSED RULE SRM DATE:

FINAL RULE SRM DATE:

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DATE PROPOSED RULE SIGNED BY SECRETARY:

03/26/93 DATE FINAL RULE SIGNED BY SECRETARY:

03/26/93 STAFF CONTACTS ON THE RULE CONTACTl: JAMES LIEBERMAN CONTACT2:

MAIL STOP: 7-H-5 MAIL STOP:

PHONE: 504-2741 PHONE:

DOCKET NO. PR-002 (58FR17321)

DATE DOCKETED 03/29/93 04/19/93 04/19/93 04/19/93 05/18/93 In the Matter of POLICY AND PROCEDURE FOR NRC ENFORCEMENT ACTION; POLICY STATEMENT (MODIFICATIONS)

DATE OF TITLE OR DOCUMENT DESCRIPTION OF DOCUMENT POLICY STATEMENT 03/26/93 04/14/93 COMMENT OF SOUTHERN NUCLEAR OPERATSING COMPANY 04/16/93 04/16/93 05/17/93 (J. D. WOODARD, V. P.) (

1)

COMMENT OF GEORGIA POWER COMPANY (J. T. BECKHAM, JR., V. P.) (

2)

COMMENT OF NUCLEAR MANAGEMENT AND RESOURCES COUNCIL (RON SIMARD) (

3)

COMMENT OF ACNP/SNM (DR C. E. NAGLE & DR. P.H. MURPHY) (

4)

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PROPOSED RULE

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American College of Nuclear Physicians (202) 429-5120

. !hNi\\C Fax (202) 223-4579 May 17, 1993 Secretary Samuel Chilk U.S. Nuclear Regulatory Commission Washington, DC 20555

• 93 MAY 18 A9 :40 The Society of Nuclear Medicine RE:

10 CFR Part 2; Policy and procedures for NRC enforcement actions; Policy statement. 58 FR 17321-17322, April 2, 1993.

Dear Secretary Ch~:

The American College of Nuclear Physicians (ACNP) and the Society of Nuclear Medicine (SNM) wish to have the following comments considered in the evaluation of the above cited policy change.

ACNP and SNM are composed of over 15,000 nuclear medicine physicians, nuclear pharmacists, nuclear medicine scientists, and nuclear medicine technologists involved in the delivery of essential healthcare services utilizing unsealed radioactive material.

The Policy Statement cited above represents a profound change in interpretation of the Quality Management Rule, and has severe implications for the availability of patient care by threatening the cancellation of therapy licenses. It also impacts the cost of medical care, and the application of this policy to diagnostic practices which perform occasional byproduct therapy procedures.

We believe that this Policy Statement changes the entire character of the "Quality Management" Rule, and should be reconsidered by the Commission. The severe effects this policy will have on patients, health care providers and third party payers leads us to believe that NRC should stay this policy immediately and at least allow a 120-day comment period for other affected entities who are not yet appraised of this policy change and its ramifications. This includes the Health Care Financing Administration (HCFA), other portions of the Department of Health and Human Services (HHS),

the Office of Management and Budget (0MB), the Small Business Administration (SBA), the Veterans Administration (VA), the 29 Agreement States, various congressional committees, and other interested professional, governmental, and consumer groups.

Conrad E. Nagle, M.D.

President American College of Nuclear Physicians CEN/PHM:dn Sincerely, Paul H. Murphy, Ph.D.

President Society of Nuclear Medicine Acknowledged by card.. ~~!.......

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NUCLEAR MANAGEMENT AND RESOURCES COUNCIL 1776 Eye Street. NW

• Suite 300

• Washington. DC 20006-3706 c202)872-1280

• 93 APR 19 P4:57 Mr. Samuel J. Chilk Secretary U.S. Nuclear Regulatory Commission Washington, D.C. 20555 April 16, 1993

SUBJECT:

10 CFR Part 2, Appendix C, Policy and Procedures for Enforcement Actions; Policy Statement (58 Fed. Reg. 14308 - March 17, 1993)

Dear Mr. Chilk:

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T~t>se comments are submitted on behalf of the Nuclear Management and Resources Council (NUMARC) 1 in response to the published policy statement modification in 10 CFR Part 2, Appendix C, Policy and Procedures for Enforcement Actions; Policy Statement ( 5 8 Fed. Reg.

14308 - March 17, 1993).

We are pleased that the Commission has more fully described the conditions under which it may exercise enforcement discretion. We believe that this better description will be helpful to both the NRC staff and the licensee in evaluating conditions for enforcement discretion where there is minimal or no safety impact. The use of the provisions of this policy should also be less cumbersome than a temporary waiver of compliance. In general, we believe that the approval of judiciously submitted requests for enforcement discretion will increase the overall level of safety.

Although we realize that this modification to the policy statement is rather straightforward, we encourage the Commission to continue seeking and considering public comments before making future changes to the policy statement. As both the industry and the Commission have active programs to study regulations and associated regulatory guidance to eliminate or revise those which are marginal to safety, we believe that early consideration of 1 NUMARC is the organization of the nuclear power industry that is responsible for coordinating the combined efforts of all utilities licensed by the NRC to construct or operating nuclear power plants, and of other nuclear industry orga...:...:zz.u~ns, i~ all matters involving generic regulatory policy issues and ca the regulatory aspect:; of generic operational and technical issues affecting the nuclear power industry. Every utility responsible for constructing or operating a commercial nuclear power plant in the United States is a member ofNUMARC. In addition, NUMARC's members include major architect/engineering firms and all of the major nuclear steam supply system vendors.

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Mr. Samuel J. Chilk April 16, 1993 Page2 public comments will lead to more effective regulatory requirements as well as capturing industry experience and improvements.

We welcome the opportunity to discuss these comments further with the appropriate NRC personnel.

ALM/

Sincerely, i:i~

Industry Reiations and Administration Division

Georgia Power Company 40 Inverness Center Parkway Post Office Box 1295 Birmingham, Alabama 35201 Telephone 205 877-7279 DOCKET NUMBER PROPOSED RULE PR 2 CSrFR 17 2,-2.---:1)~--

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J. T. Beckham, Jr.

Vice President-Nuclear Hatch Project

• 93 APR U A 8 :48 Georgia Power the southern electnc system Docket Nos.

50-321 50-366 50-424 50-425 Mr. Samuel J. Chilk Secretary of the Commission April 16,, l~SJ.3

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U.S. Nuclear Regulatory Commission Washington, DC 20555 ATTENTION: Docketing and Service Branch Comments on Policy Statement "Policy and Procedure for NRC Enforcement Actions" (58 Federal Register 14308 of March 17, 1993)

Dear Mr. Chilk:

HL-3246 ELV-05386 Georgia Power Company has reviewed the policy statement "Policy and Procedure for NRC Enforcement Actions," published in the Federal Register on March 17, 1993.

In accordance with the request for comments, Georgia Power Company is in total agreement with the NUMARC comments which are to be provided to the NRC.

Should you have any quest ions, please advise.

JTB/JDK Respectfully submitted,

MAY 111993 Acknowledged by card..... _,,..,,,,,"-;~

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Georgia Power A U. S. Regulatory Commission cc: Georgia Power Company C. K. McCoy, Vice President, Plant Vogtle W. B. Shipman, General Manager - Plant Vogtle H. L. Sumner, Jr., General Manager - Plant Hatch NORMS U. S. Nuclear Regulatory Commission. Washington. DC K. N. Jabbour, Licensing Project Manager - Hatch D. S. Hood, Licensing Project Manager - Vogtle U. S. Nuclear Regulatory Commission, Region II S. D. Ebneter, Regional Administrator L. D. Wert, Senior Resident Inspector - Hatch B. R. Bonser, Senior Resident Inspector - Vogtle State of G::orqia Page 2 J. D. Tanner, Commissioner, Department of Natural Resources 700775 HL-3246 ELV-05386

Southern Nuclear Operating Company Post Office Box 1295 DOCKET NUMBER PR P:10?0SED RULE

2.

Birmingham, Alabama 35201 Telephone 205 868-5086

( srFR 17 32..I)

J. D. Woodard Vice President Farley Project I'! e1j--

• 93 APR 26 As :48 Southern Nuclear Operating Company Docket Nos.

50-348 50-364 Mr. Samuel J. Chilk Secretary of the Commission r,

April 14, 1993 U.S. Nuclear Regulatory Commission Washington, DC 20555 ATTENTION: Docketing and Service Branch Comments on Policy Statement the southern electric system "Policy and Procedure for NRC Enforcement Actions "

(58 Federal Register 14308 of March 17, 1993)

Dear Mr. Chilk:

Southern Nuclear Operating Company has reviewed the policy statement "Policy and Procedure for NRC Enforcement Actions," published in the Federal Register on March 17, 1993.

In accordance with the request for comments, Southern Nuclear Operating Company is in total agreement with the NUMARC comments which are to be provided to the NRC.

Should you have any questions, please advise.

Respectfully submitted,

~~~

Woodard JDW/JDK MAY 111993 Acknowledged by card....................... :::::::

U_IS.. NUCLF.N. t~EGULATORY COMMISSIO~

ooc:<ET!~Vi & SERVICE SECTION Offl~E OF THE SECRETARY OF THE COMMISSION

U. S. Regulatory Commission cc: Southern Nuclear Operating Company R. D. Hill, Plant Manager U. S. Nuclear Regulatory Commission. Washington. D. C.

G. F. Wunder, Licensing Project Manager, NRR U. S. Nuclear Regulatory Commission. Region II S. D. Ebneter, Regional Administrator G. F. Maxwell, Senior Resident Inspector State of Alabama Donald E. Williamson, M.D., State Public Health Officer Page 2

be: Mr. w. G. Hairston, II I Mr. K. W. McCracken Mr. J. W. McGowan Mr. G. Bockhold Commitment Tracking System (2)

Document Control

DOCKET NUMBER Pl r: --io, OSED RULE-=-=-------

(s YfR /7 3-J-1)

[7590-01-P]

• 93 MAr 29 P 3 :55 AGENCY:

ACTION:

NUCLEAR REGULATORY COMMISSION 10 CFR Part 2 POLICY AND PROCEDURE FOR NRC ENFORCEMENT ACTIONS; POLICY STATEMENT RIN 3150-AE59 Nuclear Regulatory Commission.

Policy Statement:

Modification.

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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 by 10 CFR 35.32.

This policy is codified at Appendix C to 10 CFR Part 2 (57 FR 5791 et seq., February 18, 1992).

DATES:

This revised policy statement is effective on [insert Lj /-;_/ ttJ date of publication].

Submit comments on or before [insert 30 s J5lq3 days after effective date].

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

2 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 Pike, Rockville, Maryland 20852, between 7:30 a.m. and 4:15 p.m., Federal workdays.

Copies of comments received may be examined at the NRC Public Document Room, 2120 L Street, NW.,

(Lower Level), Washington, DC.

FOR FURTHER INFORMATION CONTACT:

James Lieberman, Office of Enforcement, U.S. Nuclear Regulatory Commission, Washington, DC 20555, (301) 504-2741.

SUPPLEMENTARY INFORMATION:

on July 25, 1991, the Commission published in the Federal Register (56 FR 34121) a final rule, effective January 27, 1992, requiring persons subject to the requirements of 10 CFR Part 35 to establish a quality management program and meet certain reporting requirements for misadministrations.

As part of that Notice, the Commission modified its Enforcement Policy to provide examples in Supplement VI of severity levels for potential violations associated with the new requirements.

The examples of severity level are used in the enforcement process to provide guidance in determining the safety and regulatory significance of a particular violation.

The enforceinent action taken is, in

3 part, based upon the severity level decision.

As a result of comments on the rulemaking, NRC has reconsidered the severity level examples for misadministrations.

The NRC is revising examples B.3, C.6, and D.4 of Supplement VI, which are the examples of violations of Severity Levels II, III, and IV, respectively.

The basic purpose and thrust of the revisions is to provide greater emphasis, and attach greater importance, to violations which are indicative of or flow from deficiencies of a programmatic nature.

Such deficiencies are preventable and are more likely to have a widespread or severe impact than are isolated mistakes involving human error made in the treatment of individual patients.

The revisions also reflect a reduced Severity Level assignment for individual violations which represent isolated mistakes or errors of limited consequences that qualify as reportable misadministrations but are not indicative of or due to any programmatic failure or weakness.

The current examples for Severity Levels II and III, examples B.3 and C.6, reflect the assignment of severity Level based on whether or not a misadministration occurred and the magnitude of overdose involved.

Under the current examples, any failure to follow quality management program procedures resulting in an overdose of 50 percent or more is automatically a Severity Level II event; any misadministration not involving an overdose

4 of 50 percent or more is automatically a Severity Level III event, regardless of whether there is an overexposure or underexposure.

Neither of these examples considers the causes of the misadministration.

These examples do not provide for any assessment of the scope or magnitude of any programmatic deficiencies, nor do they depend, in any way, on whether or not the misadministration represented an isolated an~ inconsequential event resulting purely from human error.

While the consequences of a misadministration are important, as reflected in example A.4 for Severity Level I which addresses misadministrations involving death or serious injury to a patient, it is appropriate in less consequential misadministrations to give consideration to the root cause in determining the severity level.

This approach to enforcement is more likely to focus licensee attention on the need to address programmatic deficiencies with corrective action.

Therefore, examples B.3 and C.6 are being revised to consider the degree of programmatic weakness in the causes of a misadministration.

Under revised example B.3, Severity Level II is assigned whenever a misadministration occurs as a result of a substantial failure to implement the quality management program required by

5 10 CFR 35.32, regardless of whether or not an overdose of SO percent or more is involved.

The assignment of Severity Level II is no longer dependent on the occurrence of an overdose of at least so percent.

Under revised example C.6, Severity Level III is assigned:

(1) whenever there is a substantial failure to implement the quality management program required by 10 CFR 35.32 even if there is no resulting misadministration; (2) if programmatic weakness in implementation of the quality management program results in a misadministration; or (3) if a misadministration is not reported.

Example D.3, the example for a Severity Level IV violation, is being revised to include instances where failure to follow the quality management program, including procedures, results in a reportable misadministration provided that such failures are isolated, have limited consequences, and do not demonstrate a programmatic weakness in the implementation of the quality management program.

A lower Severity Level may be assigned to those events where simple human error results in an isolated violation despite the development and implementation of a fully adequate quality management program as required by 10 CFR 35.32, including appropriate instruction, training, policies and procedures, written directives, and supervision.

However, such violations involving misadministrations with potential for

6 residual consequences will be considered for a Severity Level III categorization.

The Commission, nonetheless expects that All. violations of NRC regulations and the licensee's quality management programs will be addressed with appropriate corrective actions so as to provide a high degree of confidence that byproduct material or radiation from byproduct material is administered to patients only as intended and directed by authorized user physicians.

In this regard, the Commission emphasizes that all such violations are of concern, and that repetitive Severity Level IV violations may result in escalation of the sanctions applied, and could lead to the imposition of civil penalties or other sanctions, e.g..

suspension or revocation of a license, as the Commission may determine to be either necessary or appropriate to enforce compliance.

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 weakness, depending on the circumstances, it may.

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.

7 List of Subjects in 10 CFR Part 2 Administrative practice and procedure, Antitrust, Byproduct material, Classified information, Civil penalty, Enforcement, Environmental protection, Nuclear materials, Nuclear power plants and reactors, Penalty, Sex discrimination, Source material, Special nuclear material, Violations, and Waste treatment and disposal.

PART 2 - RULES OF PRACTICE FOR DOMESTIC LICENSING PROCEEDINGS

1.

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

PART 2 - RULES OF PRACTICE FOR DOMESTIC LICENSING PROCEEDINGS AND ISSUANCE OF ORDERS AUTHORITY:

Secs. 161, 181, 68 stat. 948, 953, as amended (42 u.s.c. 2201, 2231); sec. 191, as amended, Pub. L.87-615, 76 stat. 409 (42 u.s.c. 2241); sec. 201, 88 stat. 1242, as amended (42 u.s.c. 5841); 5 u.s.c. 552.

Section 2.101 also issued under secs. 53, 62, 63, 81, 103, 104, 105, 68 Stat. 930, 932, 933, 935, 936, 937, 938, as amended (42 u.s.c. 2073, 2092, 2093, 2111, 2133, 2134, 2135); sec. 114(f), Pub. L.97-425, 96 Stat. 2213, as amended (42 u.s.c.

10134(f)); sec. 102, Pub. L.91-190, 83 Stat. 853, as amended (42 u.s.c. 4332); sec. 301, 88 Stat. 1248 (42 u.s.c. 5871).

Sections

J 8

2.102, 2.103, 2.104, 2.105, 2.721 also issued under secs. 102, 103, 104, 105, 183, 189, 68 Stat. 936, 937, 938, 954, 955, as amended (42 u.s.c. 2132, 2133, 2134, 2135, 2233, 2239).

Section 2.105 also issued under Pub. L.97-415, 96 Stat. 2073 (42 u.s.c.

2239).

Sections 2.200-2.206 also issued under secs. 161b, i, o, 182, 186, 234, 68 Stat. 948-951, 955, 83 Stat. 444, as amended (42 u.s.c. 2236, 2282); sec. 206, 88 stat 1246 (42 u.s.c. 5846)

• Sections 2.600-2.606 also issued under sec. 102, Pub. L.91-190, 83 Stat. 853, as amended (42 u.s.c. 4332).

Sections 2.700a, 2.719 also issued under 5 u.s.c. 554. Sections 2.754, 2.760, 2.770, 2.780 also issued under 5 u.s.c. 557.

Section 2.764 and Table 1A of Appendix c also issued under secs. 135, 141, Pub. L.97-425, 96 Stat. 2232, 2241 (42 u.s.c. 10155, 10161).

Section 2.790 also issued under sec. 103, 68 Stat. 936, as amended (42 u.s.c. 2133) and 5 u.s.c. 552.

Sections 2.800 and 2.808 also issued under 5 u.s.c. 553.

Section 2.809 also issued under 5 u.s.c. 553 and sec. 29, Pub. L.85-256, 71 Stat. 579, as amended (42 u.s.c. 2039).

Subpart K also issued under sec. 189, 68 Stat.

955 (42 u.s.c. 2239); sec. 134, Pub. L.97-425, 96 Stat. 2230 (42 u.s.c. 10154).

Subpart L also issued under sec. 189, 68 stat. 955 (42 u.s.c. 2239).

Appendix A also issued under sec. 6, Pub. L.91-560, 84 Stat. 1473 (42 U.S.C. 2135). Appendix B*also issued under sec. 10, Pub. L.99-240, 99 Stat. 1842 (42 u.s.c.

2021b et seq.).

J 9

2.

Appendix C, Supplement VI is amended by modifying examples B.3, C.6, and D.3.

Appendix C - General statement of Policy and Procedure for NRC Enforcement Actions Supplement VI - Severity Categories B.

severity Level II - Violations involving for example:

3.

A substantial programmatic failure in the implementation of the quality management program required by 10 CFR 35.32 that results in a misadministration.

c.

Severity Level III - Violations involving for example:

10

6.

Substantial failure to implement the quality management program as required by §35.32 that does not result in a misadministration; failure to report a misadministration; or programmatic weakness in the implementation of the quality management program that results in a misadministration.

D.

severity Level IV - Violations involving for example:

3.

Failure to follow the quality management program, including procedures, whether or not a misadministration occurs, provided the failures are isolated, do not demonstrate a programmatic weakness in the implementation of the QM program, and have limited consequences if a misadministration is involved; failure

11 to conduct the required program review; or failure to take corrective actions as required by §35.32; or Dated at Rockville, Maryland, this~ day of \\u.,_S\\J\\~

1993.

Regulatory Commission.

e Commission