NRC Enforcement Policy; Modification, Medical Use

[Federal Register: April 24, 2002 (Volume 67, Number 79)]
[Notices]
[Page 20187-20188]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr24ap02-146]

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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: fjc@nrc.gov or John Lubinski,
Office of Enforcement, (301) 415-2740, E-mail: John.Lubinski@nrc.gov.

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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