[Federal Register Volume 60, Number 182 (Wednesday, September 20, 1995)]
[Rules and Regulations]
[Pages 48623-48626]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-23288]
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Rules and Regulations
Federal Register
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Federal Register / Vol. 60, No. 182 / Wednesday, September 20, 1995 /
Rules and Regulations
[[Page 48623]]
NUCLEAR REGULATORY COMMISSION
10 CFR Parts 20 and 35
RIN 3150-AF10
Medical Administration of Radiation and Radioactive Materials
AGENCY: Nuclear Regulatory Commission.
ACTION: Final rule.
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SUMMARY: The Nuclear Regulatory Commission is amending its regulations
to clarify that the medical administration of radiation or radioactive
materials to any individual, even an individual not supposed to receive
a medical administration, is regulated by the NRC's provisions
governing the medical use of byproduct material rather than by the dose
limits in the NRC's regulations concerning standards for protection
against radiation. The rule does not represent a change in policy, but
is necessary to indicate clearly that this is the NRC's policy and to
clarify the relationship of NRC's regulations.
DATES: Effective date: October 20, 1995.
ADDRESSES: Examine comments received at: The NRC Public Document Room,
2120 L Street NW. (Lower Level), Washington, DC 20555-0001.
FOR FURTHER INFORMATION CONTACT: Stephen A. McGuire, Office of Nuclear
Regulatory Research, U.S. Nuclear Regulatory Commission, Washington, DC
20555, telephone (301) 415-6204.
SUPPLEMENTARY INFORMATION:
I. Background
Radioactive materials are administered in the practice of medicine
to roughly 8 to 9 million patients per year for the diagnosis or
treatment of disease. Occasionally, a radioactive material is
administered to an individual for whom it is not intended.
The misadministration of radiopharmaceuticals is dealt with in NRC
regulations in 10 CFR Part 35, ``Medical Use of Byproduct Material.''
As defined in Sec. 35.2, misadministrations include administrations of
licensed radioactive material to the wrong individual in excess of
certain specified quantities (``30 microcuries of either sodium iodide
I-125 or I-131'') or doses (``5 rems effective dose equivalent or 50
rems dose equivalent to any individual organ''). The practical effect
of the definition of a misadministration is that some diagnostic
administrations of radiopharmaceuticals to individuals for whom they
were not intended are not misadministrations as defined in Sec. 35.2
because the specified quantities or doses are not exceeded, and
therefore part 35 does not require notification of the NRC or the
individual.
Separate from the requirements for misadministrations,
Sec. 20.1301(a)(1) contains a dose limit for members of the public of
0.1 rem (1 millisievert). However, the scope of Part 20 in Sec. 20.1002
states that, ``The limits in this part do not apply to doses due * * *
to exposure of patients to radiation for the purpose of medical
diagnosis or therapy * * *''
A question arose about the applicability of those words in a
particular case in which an individual mistakenly received an
administration of a diagnostic radiopharmaceutical because of an error
on the part of the physician requesting the test. In that particular
case, the dose to the individual receiving the administration was below
the threshold for reporting of the misadministration, but above the
0.1-rem (1-millisievert) dose limit in Sec. 20.1301(a)(1) for a member
of the public. The question that arose was whether Sec. 20.1301(a)(1)
had been violated or did the words in the scope of Part 20 exclude this
event from being subject to the dose limits in Part 20. In other words,
does the exclusion from the Part 20 dose limits exclude any medical
administration to any individual, even an individual not supposed to
receive an administration?
This same issue was raised in a Petition for Rulemaking (PRM-35-11)
filed by the American Medical Association (59 FR 37950; July 26, 1994).
That petition requested, in part, that Part 20 specifically exclude all
medical administrations.
Because of these concerns, the Commission proposed an amendment to
10 CFR Part 20 to clarify the regulations (60 FR 4872, January 25,
1995). The proposed rule explained that the Commission believed that,
in general, the administration of radiopharmaceuticals should be
regulated by Part 35 rather than by Part 20. The medical administration
of radioactive materials is a special use of radioactive materials that
is best dealt with by specific regulations covering those
administrations. In particular, the Commission believed that an
administration to any individual is and should be subject to the
regulations in Part 35. That was the Commission's intent when the
current misadministration requirements were adopted in the final rule,
``Quality Management Programs and Misadministrations,'' (56 FR 34104;
July 25, 1991). Further explanation of the Commission's rationale is
contained in the Federal Register notice for the proposed rule (60 FR
4872; January 25, 1995).
II. Comments on the Proposed Rule and Petition for Rulemaking PRM-35-11
Four comment letters were received on the proposed rule, three from
Agreement States and one from a medical health physicist. All supported
the proposed rule. Three comment letters were received on PRM-35-11.
Each of the letters supported the petition.
The Federal Register notice on the proposed rule specifically asked
for comment on whether to adopt a requirement to inform an individual
of the error in the case of administration of a radiopharmaceutical to
the wrong individual, but in a quantity below the misadministration
threshold. Section 35.33 generally requires notification of the
individual in the case of a misadministration. However, if the dose or
the amount is less than the misadministration threshold, Sec. 35.33
does not require that the individual who received an administration of
a radiopharmaceutical by error be notified of the error. The NRC's
Advisory Committee on Medical Uses of Isotopes (ACMUI), an advisory
committee on rulemakings and other initiatives related to the medical
use of byproduct materials, has assured the NRC that standard medical
practice is that a
[[Page 48624]]
physician who becomes aware that a medical procedure has been performed
on the wrong individual should, and almost always would, notify the
individual of the mistake.
Two comments addressed this question. One, from an employee at a
medical facility, favored an NRC regulation requiring notification of
the individual regardless of the dose because sometimes an attempt
might be made to keep this information from the individual. The other,
from an Agreement State, opposed such a requirement because it would be
inconsistent with the NRC's medical policy statement, ``The NRC will
minimize intrusion into medical judgements affecting patients and into
other areas traditionally considered to be a part of the practice of
medicine.'' The NRC has decided to retain the notification requirements
that it established in the misadministration rulemaking and thus not
amend the notification requirements. Therefore, the NRC will require
notification only for the more serious errors. Notification
requirements for less serious errors are left to the medical profession
and to State and local regulations. The NRC sees no need to interject
itself into medical judgements or to override State and local
regulations for the less serious errors.
III. Summary of the Changes
Neither the comments received nor any other information available
to the Commission give any reasons for not adopting the amendments
substantially as proposed, which would regulate administrations to
individuals under Part 35 and not Part 20. Therefore, the NRC is
adopting the amendments as described below.
To clarify the meaning and intent of Part 20, the NRC is amending
the scope of Part 20, the definitions of public dose and occupational
dose, and the wording in Sec. 20.1301(a)(1) on public dose limit to
clarify that the dose limit for individual members of the public does
not apply to dose contributions from any medical administration the
individual has received. Thus, the medical administration of
radioactive materials or radiation to any individual, even to an
individual not supposed to receive an administration, is not subject to
the public dose limit in Sec. 20.1301(a)(1), but is within the scope of
Part 35.
The changes in Part 20 replace the word ``patient'' with the word
``individual.'' The word ``patient'' has sometimes been taken to mean
only the individual intended to receive the administration. At other
times, the view has been that anyone who receives a medical procedure
is a ``patient.'' Replacing ``patient'' with ``individual'' clarifies
that the statement refers to anyone receiving a medical administration.
In Sec. 20.1002, the phrase ``for the purpose of medical diagnosis
and therapy'' is replaced by the phrase ``any medical administration
the individual has received.'' The existing wording raised the question
of whether an administration was within the scope of Part 20 if the
administration had no valid medical purpose. The new wording makes it
clear that regardless of the purpose or lack of purpose, dose to an
individual from any medical administration the individual has received
is not within the scope of Part 20, but is within the scope of Part 35.
For the sake of consistency and clarity, the same words are used in
Sec. 20.1002, ``Scope,'' in Sec. 20.1003, ``Definitions,'' (in the
definitions of both public dose and occupational dose), and in
Sec. 20.1301, ``Dose limits for individual members of the public.''
Also for consistency and clarity, the exclusion of dose from background
radiation and from voluntary participation in medical research programs
that are now included in Secs. 20.1002 and 20.1003 are added to
Sec. 20.1301(a).
A proposed rule published on June 15, 1994 (59 FR 30724), which
deals with criteria for the release of individuals administered
radioactive material, would also amend Sec. 20.1301(a)(1). When that
amendment of Sec. 20.1301(a)(1) is published in final form, the wording
on what is excluded from the dose limit will be inserted in
Secs. 20.1002 and 20.1003 (in the definitions of public dose and
occupational dose) so that the same parallelism will exist throughout
Part 20.
In Part 35, for consistency in terminology between parts, the
phrase ``patient or human research subject'' in the definition of
misadministration in Sec. 35.2, ``Definitions,'' and in the
misadministration reporting requirements in Sec. 35.33,
``Notifications, reports, and records of misadministrations,'' is
replaced by the word ``individual.'' Note that Sec. 35.33(a)(3) also
requires the licensee to notify the referring physician of a
misadministration. If a misadministration occurs because the material
was administered to the wrong individual, there may be no referring
physician. If there is no referring physician, the licensee is relieved
of the responsibility of notifying the referring physician, but must
comply with all other requirements of Sec. 35.33.
The changes made by these amendments have the effect of granting
the request in PRM-35-11 that Part 20 specifically exclude all medical
administrations.
IV. Consistency With the 1979 Medical Policy Statement
On February 9, 1979 (44 FR 8242), the NRC published a ``Statement
of General Policy on the Regulation of the Medical Uses of
Radioisotopes.'' The first statement of the policy states, ``The NRC
will continue to regulate the medical uses of radioisotopes as
necessary to provide for the radiation safety of workers and the
general public.'' The rule is consistent with this statement because it
continues to provide for administrations of radioactive materials to be
regulated under 10 CFR Part 35. The rule further clarifies that
additional regulations are not considered necessary.
The second statement of the policy states, ``The NRC will regulate
the radiation safety of patients where justified by the risk to
patients and where voluntary standards, or compliance with these
standards, are inadequate.'' The rule is consistent with the statement
because it clarifies that existing requirements concerning
misadministrations continue to be concentrated on administrations
having the greatest risk significance.
The third statement of the policy states, ``The NRC will minimize
intrusion into medical judgements affecting patients and into other
areas traditionally considered to be a part of the practice of
medicine.'' The rule is consistent with this statement because it
limits its specific regulatory requirements for notification to the
most serious errors in administration and minimizes requirements on
errors in administrations that have less risk significance.
Thus, the rule is considered to be consistent with the 1979 medical
policy statement.
V. Coordination With the Advisory Committee on Medical Uses of Isotopes
The subject of this final rule was discussed with the NRC's
Advisory Committee on Medical Uses of Isotopes (ACMUI) on May 11, 1995.
The ACMUI is an advisory body established to advise the NRC staff on
matters that involve the administration of radioactive material and
radiation from radioactive material. The ACMUI agreed that medical
administrations, including those to an individual not supposed to
receive an administration, should be regulated by Part 35 rather than
by Part 20. The ACMUI stated that notification
[[Page 48625]]
of an individual of an error in administration below the
misadministration threshold is the current medical practice and should
not be regulated. A transcript of the meeting is available for
examination at the NRC Public Document Room, 2120 L St., NW. (Lower
Level), Washington, DC.
VI. Coordination With and Issue of Compatibility for Agreement States
This rulemaking was discussed with representatives of Agreement
States at a meeting in Portland, ME, on October 24, 1994. The States
were polled on how they regulated an administration to the wrong
individual, and it was found that they appear to regulate such
administrations consistent with this rule. Two States commented on the
rule, and both fully supported the rule.
The NRC believes that the modification of Part 20 should be a
Division 1 matter of compatibility consistent with past practice of
requiring basic definitions to be essentially identical for effective
communication of basic radiation concepts. One Agreement State
commenting on the compatibility issue supported a Division 1 level.
Another Agreement State supported Division 1 compatibility ``provided
that Division 1 compatibility means the intent, but not the language
must be identical.''
VII. Finding of No Significant Environmental Impact
The NRC has determined under the National Environmental Policy Act
of 1969, as amended, and the Commission's regulations in Subpart A of
Part 51, that this rule is not a major Federal action significantly
affecting the quality of the human environment. Therefore, an
environmental impact statement is not required.
The NRC prepared an environmental assessment for the proposed rule,
which was contained within the Federal Register notice for that rule.
That assessment continues to stand for the final rule.
VIII. Paperwork Reduction Act Statement
This rule does not contain a new or amended information collection
requirement subject to the Paperwork Reduction Act of 1980 (44 U.S.C.
3501 et seq.). Existing requirements were approved by the Office of
Management and Budget, approval numbers 3150-0014 and 3150-0010.
IX. Regulatory Analysis
The regulatory analysis prepared for the proposed rule and
published as part of the Federal Register notice on the proposed rule
is still valid for this final rule.
X. Regulatory Flexibility Certification
As required by the Regulatory Flexibility Act of 1980, 5 U.S.C.
605(b), the NRC certifies that this rule will not have a significant
economic impact on a substantial number of small entities. The impact
of the revised regulation will not be significant because the amendment
represents a continuation of current practice and merely clarifies
existing requirements.
XI. Backfit Analysis
The NRC has determined that the backfit rule, Sec. 50.109, does not
apply to this rule and; therefore, that a backfit analysis is not
required for this rule, because these amendments do not involve any
provisions which impose backfits as defined in Sec. 50.109(a)(1).
XII. List of Subjects
10 CFR Part 20
Byproduct material, Criminal penalties, Licensed material, Nuclear
materials, Nuclear power plants and reactors, Occupational safety and
health, Packaging and containers, Radiation protection, Reporting and
recording requirements, Special nuclear material, Source material,
Waste treatment and disposal.
10 CFR Part 35
Byproduct material, Criminal penalties, Drugs, Health facilities,
Health professions, Medical devices, Nuclear materials, Occupational
safety and health, Radiation protection, Reporting and Recordkeeping
requirements.
For the reasons set out in the preamble and under the authority of
the Atomic Energy Act of 1954, as amended; the Energy Reorganization
Act of 1974, as amended; and 5 U.S.C. 552 and 553; the NRC is adopting
the following amendments to 10 CFR Parts 20 and 35.
PART 20--STANDARDS FOR PROTECTION AGAINST RADIATION
1. The authority citation for part 20 continues to read as follows:
Authority: Secs. 53, 63, 65, 81, 103, 104, 161, 182, 186, 68
Stat. 930, 933, 935, 936, 937, 948, 953, 955, as amended, sec. 1701,
106 Stat. 2951, 2952, 2953 (42 U.S.C. 2073, 2093, 2095, 2111, 2133,
2134, 2201, 2232, 2236, 2297f), secs. 201, as amended, 202, 206, 88
Stat. 1242, as amended, 1244, 1246 (42 U.S.C. 5841, 5842, 5846).
2. Section 20.1002 is revised to read as follows:
Sec. 20.1002 Scope.
The regulations in this part apply to persons licensed by the
Commission to receive, possess, use, transfer, or dispose of byproduct,
source, or special nuclear material or to operate a production or
utilization facility under Parts 30 through 36, 39, 40, 50, 60, 61, 70,
or 72 of this chapter, and in accordance with 10 CFR 76.60 to persons
required to obtain a certificate of compliance or an approved
compliance plan under part 76 of this chapter. The limits in this part
do not apply to doses due to background radiation, due to any medical
administration the individual has received, or due to voluntary
participation in medical research programs.
3. In Sec. 20.1003, the definitions of occupational dose and public
dose are revised to read as follows:
Sec. 20.1003 Definitions.
* * * * *
Occupational dose means the dose received by an individual in the
course of employment in which the individual's assigned duties involve
exposure to radiation and/or radioactive material from licensed and
unlicensed sources of radiation, whether in the possession of the
licensee or other person. Occupational dose does not include doses
received from background radiation, from any medical administration the
individual has received, from voluntary participation in medical
research programs, or as a member of the public.
* * * * *
Public dose means the dose received by a member of the public from
exposure to radiation and/or radioactive material released by a
licensee, or to any other source of radiation under the control of the
licensee. Public dose does not include occupational dose or doses
received from background radiation, from any medical administration the
individual has received, or from voluntary participation in medical
research programs.
* * * * *
4. In Sec. 20.1301, paragraph (a)(1) is revised to read as follows:
Sec. 20.1301 Dose limits for individual members of the public.
(a) * * *
(1) The total effective dose equivalent to individual members of
the public from the licensed operation does not exceed 0.1 rem (1
millisievert) in a year, exclusive of the dose contributions from
background radiation, any medical administration the individual has
received, voluntary participation in
[[Page 48626]]
medical research programs, and the licensee's disposal of radioactive
material into sanitary sewerage in accordance with Sec. 20.2003.
* * * * *
PART 35--MEDICAL USE OF BYPRODUCT MATERIAL
5. The authority citation for Part 35 continues to read as follows:
Authority: Secs. 81, 161, 182, 183, 68 Stat. 935, 948, 953, 954,
as amended (42 U.S.C. 2111, 2201, 2232, 2233); sec. 201, 88 Stat.
1242, as amended (42 U.S.C. 5841).
Sec. 35.2 [Amended]
6. In Sec. 35.2, the definition for misadministration is amended in
paragraphs (1)(i), (2)(i), (3)(i), (4)(i), (5)(i), (6)(i), and (6)(ii)
by removing the term ``patient or human research subject'' and
inserting the word ``individual.''
7. In Sec. 35.33, paragraphs (a)(2), (a)(3), (a)(4), (b), and (c)
are revised to read as follows:
Sec. 35.33 Notifications, reports, and records of misadministrations.
(a) * * *
(2) The licensee shall submit a written report to the appropriate
NRC Regional Office listed in 10 CFR 30.6 within 15 days after
discovery of the misadministration. The written report must include the
licensee's name; the prescribing physician's name; a brief description
of the event; why the event occurred; the effect on the individual who
received the misadministration; what improvements are needed to prevent
recurrence; actions taken to prevent recurrence; whether the licensee
notified the individual (or the individual's responsible relative or
guardian), and if not, why not; and if there was notification, what
information was provided. The report must not contain the individual's
name or any other information that could lead to identification of the
individual. To meet the requirements of this section, the notification
of the individual receiving the misadministration may be made instead
to that individual's responsible relative or guardian, when
appropriate.
(3) The licensee shall notify the referring physician and also
notify the individual receiving the misadministration of the
misadministration no later than 24 hours after its discovery, unless
the referring physician personally informs the licensee either that he
will inform the individual or that, based on medical judgement, telling
the individual would be harmful. The licensee is not required to notify
the individual without first consulting the referring physician. If the
referring physician or the individual receiving the misadministration
cannot be reached within 24 hours, the licensee shall notify the
individual as soon as possible thereafter. The licensee may not delay
any appropriate medical care for the individual, including any
necessary remedial care as a result of the misadministration, because
of any delay in notification.
(4) If the individual was notified, the licensee shall also
furnish, within 15 days after discovery of the misadministration, a
written report to the individual by sending either:
(i) A copy of the report that was submitted to the NRC; or
(ii) A brief description of both the event and the consequences as
they may affect the individual, provided a statement is included that
the report submitted to the NRC can be obtained from the licensee.
(b) Each licensee shall retain a record of each misadministration
for 5 years. The record must contain the names of all individuals
involved (including the prescribing physician, allied health personnel,
the individual who received the misadministration, and that
individual's referring physician, if applicable), the individual's
social security number or other identification number if one has been
assigned, a brief description of the misadministration, why it
occurred, the effect on the individual, improvements needed to prevent
recurrence, and the actions taken to prevent recurrence.
(c) Aside from the notification requirement, nothing in this
section affects any rights or duties of licensees and physicians in
relation to each other, to individuals receiving misadministrations, or
to that individual's responsible relatives or guardians.
Dated at Rockville, Maryland, this 14th day of September, 1995.
For the Nuclear Regulatory Commission.
John C. Hoyle,
Secretary of the Commission.
[FR Doc. 95-23288 Filed 9-19-95; 8:45 am]
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