[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]



 ========================================================================
 Rules and Regulations
                                                 Federal Register
 ________________________________________________________________________
 
 This section of the FEDERAL REGISTER contains regulatory documents 
 having general applicability and legal effect, most of which are keyed 
 to and codified in the Code of Federal Regulations, which is published 
 under 50 titles pursuant to 44 U.S.C. 1510.
 
 The Code of Federal Regulations is sold by the Superintendent of Documents. 
 Prices of new books are listed in the first FEDERAL REGISTER issue of each 
 week.
 
 ========================================================================
 

  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.

-----------------------------------------------------------------------

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]

BILLING CODE 7590-01-P