[Federal Register Volume 67, Number 79 (Wednesday, April 24, 2002)]
[Notices]
[Pages 20187-20188]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-9992]


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NUCLEAR REGULATORY COMMISSION

[NUREG-1600]


NRC Enforcement Policy; Modification, Medical Use

AGENCY: Nuclear Regulatory Commission.

ACTION: Policy statement: Modification.

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SUMMARY: In conjunction with a major revision of 10 CFR part 35, 
published in today's Federal Register, the Nuclear Regulatory 
Commission is amending its ``General Statement of Policy and Procedure 
for NRC Enforcement Actions,'' NUREG-1600 (Enforcement Policy). This 
change to the Enforcement Policy revises the examples of severity 
levels for violations associated with the requirements to use written 
directives for certain medical uses of byproduct material; and to 
develop, implement, and maintain certain procedures for medical uses 
that require a written directive (10 CFR 35.40 and 35.41). These 
examples are used in the enforcement process to provide guidance for 
determining the significance of a particular violation.

DATES: Consistent with the rulemaking to revise 10 CFR part 35, this 
action is effective November 25, 2002. Comments on this change to the 
NRC's Enforcement Policy should be submitted not later than 30 days 
following the effective date and will be considered by the NRC before 
the next revision of the Enforcement Policy.

ADDRESSES: Submit written comments to: Michael T. Lesar, Chief, Rules 
and Directives Branch, Division of Administrative Services, Office of 
Administration, Mail Stop: T6D59, U.S. Nuclear Regulatory Commission, 
Washington, DC 20555-0001. Hand deliver comments to: 11555 Rockville 
Pike, Rockville, Maryland, 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, Public File area O-1F21, 11555 Rockville Pike, 
Rockville, Maryland.

FOR FURTHER INFORMATION CONTACT: Frank Congel, Director, Office of 
Enforcement, (301) 415-2741, E-mail: [email protected] or John Lubinski, 
Office of Enforcement, (301) 415-2740, E-mail: [email protected].

SUPPLEMENTARY INFORMATION:

Background

    In a separate action published in today's Federal Register, the NRC 
is revising its regulations in 10 CFR part 35 governing the medical use 
of byproduct material to make the requirements risk-informed and more 
performance-based. Before this revision, 10 CFR 35.32 required a 
quality management program to provide high confidence that byproduct 
material or radiation from byproduct material would be administered as 
directed by the physician who is the authorized user of the material 
under the NRC license. Among other things, the quality management 
program had to assure that, for certain medical uses, a written 
directive was prepared and signed by the authorized user. Before this 
revision to the regulations, the term ``misadministration'' was used to 
denote certain errors in administering byproduct material, or the 
radiation from byproduct material, to humans. The terms ``written 
directive'' and ``misadministration'' were defined in 10 CFR 35.2.

[[Page 20188]]

    In the revision of 10 CFR part 35 published today, the requirement 
to use written directives has been moved to Sec. 35.40. The terms 
``quality management program'' and ``misadministration'' are no longer 
used. The term ``medical event'' is used to denote certain errors in 
administering byproduct material, or the radiation from byproduct 
material, to humans. This term is now defined in 10 CFR 35.2. The new 
Sec. 35.41 requires that the licensee develop, implement, and maintain 
written procedures for medical uses that require a written directive. 
Among other things, the written procedures must provide high confidence 
that each administration of byproduct material, or radiation from 
byproduct material, is in accordance with the written directive.
    Minor conforming changes are being made to the examples in the NRC 
Enforcement Policy that formerly referred to the terms ``quality 
management program'' and ``misadministration.'' The examples are being 
changed to reflect the new terms ``written procedures for 
administrations requiring a written directive'' and ``medical event.''
    The last substantive change to the examples in the NRC Enforcement 
Policy that relate to errors in medical uses was published at 58 FR 
17321 (April 2, 1993). At that time, the examples were changed to 
provide greater emphasis, and attach greater importance, to violations 
that are indicative of, or flow from, deficiencies of a programmatic 
nature. Programmatic deficiencies have, as their root cause, an 
underlying weakness in some part of the licensee's program for 
preventing medical events that is more widespread than simple 
occasional human error (e.g., failure to develop and implement adequate 
written procedures for administrations that require a written 
directive, failure to train personnel on the procedures, or failure to 
follow procedures). Programmatic deficiencies are correctable, and pose 
the risk of additional occurrence if effective corrective action is not 
taken.
    Conversely, the 1993 changes reflected a reduced severity level for 
individual violations that represent isolated mistakes involving human 
error made in the diagnosis or treatment of individual patients with 
byproduct material. The Commission continues to believe that the 
examples established in 1993 are appropriate, with minor modifications 
to conform to the terminology used in the newly revised 10 CFR part 35.
    The examples use the terms ``substantial programmatic failure'' and 
``programmatic weakness.'' To differentiate between these two terms, 
``substantial programmatic failure'' applies in cases where the 
licensee fails to establish or effectively implement one or more of the 
requirements in 10 CFR 35.40 or 35.41. The failure could be due to a 
serious omission in the procedures required under 10 CFR 35.41 or to a 
failure to train employees to follow procedures. ``Programmatic 
weakness'' indicates that the failure is more widespread than simple 
occasional human error. For example, the term ``programmatic weakness'' 
would apply in a situation where licensee employees are trained to 
check the calculation of radiation dose to be administered for a 
certain treatment and normally do so; however, there have been failures 
to meet this requirement on a number of occasions because of staffing 
shortages, and one of those occasions results in a medical event.

Paperwork Reduction Act

    This final change to the NRC Enforcement Policy does not contain 
new or amended information collection requirements subject to the 
Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.).

Public Protection Notification

    If a means used to impose an information collection does not 
display a currently valid OMB control number, the NRC may not conduct 
or sponsor, and a person is not required to respond to, the information 
collection.

Small Business Regulatory Enforcement Fairness Act

    In accordance with the Small Business Regulatory Enforcement 
Fairness Act of 1996, the NRC has determined that this action is not a 
``major'' rule and has verified this determination with the Office of 
Information and Regulatory Affairs, Office of Management and Budget.
    Accordingly, the NRC Enforcement Policy is amended to read as 
follows:

General Statement of Policy and Procedure for NRC Enforcement 
Actions

* * * * *

SUPPLEMENT VI--FUEL CYCLE AND MATERIALS OPERATIONS

* * * * *
A. Severity Level I--Violations involving for example:
* * * * *
    4. Failure to use a properly prepared written directive as required 
by 10 CFR 35.40; or failure to develop, implement, or maintain 
procedures for administrations requiring a written directive as 
required by 10 CFR 35.41; that results in a death or serious injury 
(e.g., substantial organ impairment).
B. Severity Level II--Violations involving for example:
* * * * *
    3. A substantial programmatic failure to implement written 
directives or procedures for administrations requiring a written 
directive, such as a failure of the licensee's procedures to address 
one or more of the elements in 10 CFR 35.40 or 35.41, or a failure to 
train personnel in those procedures, that results in a medical event.
C. Severity Level III--Violations involving for example:
* * * * *
    5. A substantial programmatic failure to implement written 
directives or procedures for administrations requiring a written 
directive, such as a failure of the licensee's procedures to address 
one or more of the elements in 10 CFR 35.40 or 35.41, or a failure to 
train personnel in those procedures, that does not result in a medical 
event. Failure to report a medical event. A programmatic weakness in 
the implementation of written directives or procedures for 
administrations requiring a written directive, whether or not a medical 
event occurs.
D. Severity Level IV--Violations involving for example:
* * * * *
    3. Failure to use a properly prepared written directive as required 
by 10 CFR 35.40 or failure to follow procedures for administrations 
requiring a written directive as required by 10 CFR 35.41, whether or 
not a medical event occurs, provided that the failures: (1) Are 
isolated; (2) do not demonstrate programmatic weakness in 
implementation; and (3) have limited consequences if a medical event is 
involved.

    Dated at Rockville, Maryland, this 18th day of April, 2001.

    For the Nuclear Regulatory Commission.
Annette Vietti-Cook,
Secretary of the Commission.
[FR Doc. 02-9992 Filed 4-23-02; 8:45 am]
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