[Federal Register Volume 60, Number 16 (Wednesday, January 25, 1995)]
[Proposed Rules]
[Pages 4872-4877]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-1817]
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NUCLEAR REGULATORY COMMISSION
10 CFR Parts 20 and 35
RIN 3150-AF10
Medical Administration of Radiation and Radioactive Materials
AGENCY: Nuclear Regulatory Commission.
ACTION: Proposed rule.
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SUMMARY: The Nuclear Regulatory Commission is proposing to amend its
regulations to clarify that the medical [[Page 4873]] 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 the dose limits in the NRC's regulations
concerning standards for protection against radiation. The proposed
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: The comment period expires April 10, 1995. Comments received
after this date will be considered if it is practicable to do so, but
the Commission is able to assure consideration only for comments
received on or before this date.
ADDRESSES: Send comments to: Secretary, U.S. Nuclear Regulatory
Commission, Washington, DC 20555. ATTN: Docketing and Service Branch.
Hand deliver comments to: 11555 Rockville Pike, Rockville, Maryland
between 7:45 am and 4:15 pm on Federal workdays.
Examine comments received at: The NRC Public Document Room, 2120 L
Street NW. (Lower Level), Washington, DC.
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.
II. Summary of the Proposed Changes.
III. Request for Comment on Notification.
IV. Consistency With the 1979 Medical Policy Statement and
Coordination With ACMUI.
V. Coordination With and Issue of Compatibility With Agreement
States.
VI. Finding of No Significant Environmental Impact: Availability.
VII. Paperwork Reduction Act Statement.
VIII. Regulatory Analysis.
IX. Regulatory Flexibility Certification.
X. Backfit Analysis.
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 by mistake to an individual for whom it is not intended.
For the years 1989 and 1990 combined, the NRC is aware of about 200
cases out of 5 to 6 million administrations performed under NRC license
in which a diagnostic radiopharmaceutical was administered to the wrong
individual.
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 or the radiation therefrom to the wrong
individual, using the wrong radiopharmaceutical, in the wrong amount,
by the wrong route, or to the wrong treatment site. This proposed rule
only concerns administrations to the wrong individual.
An administration to the wrong individual is a misadministration,
as defined in Sec. 35.2, if it involves: (1) A radiopharmaceutical
dosage greater than 30 microcuries of either sodium iodide I-125 or I-
131; (2) any therapeutic administration other than sodium iodide I-125
or I-131; (3) any gamma stereotactic radiosurgery radiation dose; (4)
any teletherapy dose; (5) any brachytherapy radiation dose; or (6) a
diagnostic radiopharmaceutical dosage, other than quantities greater
than 30 microcuries of either sodium iodide I-125 or I-131, when the
dose to the individual exceeds 5 rems effective dose equivalent or 50
rems dose equivalent to any individual organ. The practical effect of
this definition of a misadministration is that some relatively low dose
diagnostic administrations of radiopharmaceuticals to individuals for
whom they were not intended are not misadministrations as defined in
Sec. 35.2.
If a misadministration occurs, Sec. 35.33 requires that the NRC,
the referring physician, and the individual receiving the
administration (or a responsible relative or guardian) be informed of
the misadministration (unless the referring physician makes a decision
based on medical judgement that telling the individual or responsible
relative or guardian would be harmful.) If the dose from a diagnostic
administration to the wrong individual does not exceed the threshold
for a misadministration, the administration is not a misadministration
as defined in Sec. 35.2, and 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
specific 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. Was there a violation of Sec. 20.1301(a)(1) or do 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?
The Commission concludes that, in general, the administration of
radiopharmaceuticals should be regulated by part 35 rather than part
20. The medical administration of radioactive materials is a very
special use of radioactive materials that is best dealt with by
specific regulations covering those administrations. In particular, the
Commission believes that an administration to any individual is and
should be subject to the regulations in part 35. This was the
Commission's intent when the current misadministration requirements
were adopted in the final rule, ``Quality Management Programs and
Misadministrations,'' (July 25, 1991; 56 FR 34104) and continues to be
the Commission's intent.
In establishing which errors in administration should be under the
misadministration reporting requirements, the NRC sought to optimize
the cost effectiveness of the rule by concentrating its regulatory
requirements on those events with the greatest risk and placing fewer
requirements on those with relatively low risk, such as most diagnostic
uses of radiopharmaceuticals. In the final rule on ``Quality Management
Programs and Misadministrations'' (July 25, 1991; 56 FR 34104), the
Commission stated that the proposed requirements that would have had
minimal impact on risk were eliminated to make the final rule more cost
effective (e.g., deleting the diagnostic components of the proposed
rule).
In reaching its conclusion, the Commission recognized that in the
event of administration of radioactive material to the wrong
individual, the ability to control the dose to that individual has been
lost. One cannot decide to terminate the exposure at a certain point to
prevent exceeding a dose limit. Therefore, the relevant questions are:
What steps are appropriate to reduce the likelihood of [[Page 4874]] an
administration to the wrong individual; what corrective actions should
be taken if the mistake occurs; and what regulatory response is
appropriate if such a mistake occurs?
Each of these questions was dealt with in developing the rule on
quality management programs and misadministrations. The Commission
considered, in the rulemaking on quality management program and
misadministrations, what steps should be taken to avoid the
administration of radioactive materials to an individual not supposed
to receive the administration. Those steps are contained in Sec. 35.32,
``Quality management program.'' In adopting those requirements, the
Commission decided to apply the requirements in Sec. 35.32 only to
administrations with the potential for relatively high doses and to
exclude most diagnostic administrations from the requirements. For
those diagnostic administrations not covered by Sec. 35.32, it was
considered adequate to rely on the normal and traditional methods and
techniques that medical care providers use to ensure that medications
are given to the right individual in the right amount at the right
time.
Similarly, the NRC's requirements that licensees take appropriate
corrective actions in response to a misadministration are contained in
Sec. 35.32. The specific requirements dealing with corrective actions
apply to any administration requiring a quality management program.
With regard to the appropriate regulatory response to mistakes in
administrations, the Commission decided that violation of the quality
management program requirements, which apply to the more significant
administrations, were significant enough that they may result in a
civil penalty.
Thus, in the quality management program and misadministrations
rulemaking, the Commission clearly addressed the issue of when the
administration of a radioactive material to the wrong individual was
sufficiently significant to warrant certain actions. Specific
thresholds were established and codified to reflect the Commission's
view of a reasonable balance between harm and burden. In particular,
the Commission concluded that lower thresholds would not significantly
reduce risk and would divert resources that should be directed toward
reducing the more serious of those errors. The Commission continues to
endorse the judgement that it made in that rulemaking.
II. Summary of the Proposed Changes
To clarify the meaning and intent of part 20, the NRC is proposing
to amend 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 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 proposed changes in part 20 would 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'' would clarify that the statement refers to anyone
receiving a medical administration. For consistency, in terminology
between parts, the word ``patient'' in the definition of
misadministration in Sec. 35.2, ``Definitions,'' and in certain
locations in paragraph (a)(2) of Sec. 35.33 would be replaced by the
word ``individual.''
In Sec. 20.1002, the phrase ``for the purpose of medical diagnosis
and therapy'' would be 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
proposed wording would make 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 would be
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 would be added to
Sec. 20.1301(a).
The existing Sec. 20.1301(a) also excludes dose contributions from
the licensee's disposal of radioactive material into sanitary sewerage.
That exclusion would not be added to Secs. 20.1002 and 20.1003 because
the question of dose from sewer disposal of radioactive material is now
under consideration by the NRC. When that issue is resolved, it is
intended that the wording concerning dose from sewer disposal will be
made consistent in Secs. 20.1002, 20.1003, and 20.1301(a).
Another recently published proposed rule (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.
In addition, another proposed rule (February 3, 1994; 59 FR 5132)
would amend the definitions of public dose and occupational dose in 10
CFR part 20. However, that proposed rule would only amend the first
sentence in the definitions and would not change the wording associated
with what is excluded from public dose. Therefore, this proposed rule
and that proposed rule do not conflict.
III. Request for Comment on Notification
Another question related to the administration of radioactive
materials to the wrong individual concerns informing the individual of
the error. 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 mistake be notified of the error. One
fundamental difference in the case in which the wrong individual
receives the administration is that, unlike the intended patient, who
it may be argued may have been informed that he or she will be exposed
to radiation and has thereby implicitly or explicitly consented to the
procedure, the wrong individual has generally not consented to any
radiation dose at all. The question then becomes, should part 35
require that the individual be notified of the error regardless of the
dose that would be received?
The Commission was divided on whether the individual should be
notified. The NRC's Advisory Committee on Medical Uses of Isotopes
[[Page 4875]] (ACMUI) has assured the NRC that standard medical
practice is that a 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. The current quality
management program and misadministrations rule does not require the
physician to notify the individual if the dose or amount is below the
threshold for a misadministration. The NRC is now seeking comment on
whether it should continue to rely on standard medical practice below
the misadministration threshold or whether it is appropriate to impose
an NRC requirement for notification below the misadministration
threshold if the administration is to the wrong individual. For
example, the NRC would like comments on whether a broader notification
requirement would implicitly impose recordkeeping and procedural
requirements upon licensees beyond those explicitly set forth in part
35.
IV. Consistency With the 1979 Medical Policy Statement and
Coordination With ACMUI
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 proposed
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 proposed 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 proposed 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 proposed 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 proposed rule is considered to be consistent with the
1979 medical policy statement.
The subject of this proposed rule was discussed with the NRC's
Advisory Committee on Medical Uses of Isotopes (ACMUI) on May 19, 1994.
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 part 20. The ACMUI stated that
notification of an individual of an error in administration below the
misadministration threshold is the current practice and should not be
regulated.
V. Coordination With and Issue of Compatibility for Agreement
States
This proposed rulemaking was discussed with representatives of
Agreement States at a meeting, ``Organization of Agreement State
Managers Workshop and Public Meeting on Rulemaking,'' in Herndon, VA,
on July 12, 1994. There was some concern that the NRC approach was
different from how State regulations address inadvertent x-ray
exposures, but no strong opposition. The proposed rule was revised to
address the concerns of the States and then discussed at a subsequent
meeting of the Agreement States 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 would regulate the
administration the same way as in this proposed rule.
The NRC believes that the proposed modification of part 20 should
be a Division 1 matter of compatibility consistent with past practice
of requiring basic definitions to be uniform for effective
communication of basic radiation concepts. The Commission specifically
requests comments on whether the proposed modification to part 20
should be made a Division 1 matter of compatibility.
VI. 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, if adopted, would not be a major Federal
action significantly affecting the quality of the human environment.
Therefore, an environmental impact statement is not required.
The NRC has not prepared a separate environmental assessment. The
following discussion constitutes the assessment. The proposed rule
would not change the NRC's requirements concerning the administration
of radiation and radioactive materials. Those requirements are and
would continue to be contained in part 35 of the NRC's regulations.
When the potential ambiguity concerning application of part 20 and part
35 requirements was recognized, the Commission specifically informed
the staff of its view that the proper interpretation was that the more
specific part 35 requirements should govern all medical administrations
and directed that action be taken to remove from the regulations any
ambiguity on this issue. The staff has, accordingly, not interpreted
Sec. 20.1301(a)(1) as applying to any medical administrations, but has
proceeded with this rulemaking to remove any ambiguity in the
regulations. The proposed rule would merely amend part 20 to make it
clear that part 20 does not address medical administrations. Thus, the
proposed rule, if adopted, would clarify the NRC's requirements rather
than change them, and there would be no environmental impact.
VII. Paperwork Reduction Act Statement
This proposed 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.
VIII. Regulatory Analysis
The regulatory analysis for this proposed rulemaking is as follows:
1. Alternatives
Alternative 1: Part 20 Regulates Doses to Wrong Individuals
In this alternative, a medical administration of radiation or
radioactive material to an individual when no administration is
intended that results in a total effective dose equivalent greater than
1 millisievert (0.1 rem) would be a violation of Sec. 20.1301. If the
event did not meet the threshold definition of a misadministration, NRC
would receive a notification of the event from the licensee pursuant to
Sec. 20.2203, ``Reports of exposures, radiation levels, and
concentrations of radioactive material exceeding the limits'' and the
individual involved would receive notification of [[Page 4876]] the
exposure from the licensee pursuant to Sec. 19.13(d), ``Notifications
and reports to individuals.''
Under this alternative, notification and recordkeeping requirements
of 10 CFR parts 19 and 20 would apply to the medical administration of
radiation or radioactive material to the wrong individual that involves
a dose to the individual above 1 millisievert (0.1 rem) but less than
the threshold definition of a misadministration.
Alternative 2: Part 35 Regulates Doses to Wrong Individuals
In this alternative, the medical administration of radiation or
radioactive material to any individual would be the exclusive province
of the regulations in 10 CFR part 35. Section 20.1301 would not be
applicable. Under this alternative, errors in the administration of
radiation or radioactive material to individuals would be subject to
the reporting and notification requirements of 10 CFR part 35 rather
than the reporting and notification requirements in 10 CFR parts 19 and
20. This alternative is consistent with the Commission's determination,
published in the rule on quality management programs and
misadministrations (July 25, 1991; 56 FR 34104), that licensees should
direct their resources toward preventing the more serious errors in the
administration of byproduct material.
However, there would be no requirement in the event of errors in
the administration of byproduct material to individuals who were not
intended to receive any administration for the medical licensee to
notify either the NRC or the individual of the error unless the error
meets the threshold definition of a misadministration in Sec. 35.2. In
general, standard medical practice is that a physician who becomes
aware that a medical procedure has been performed on the wrong
individual would notify the individual of the mistake.
Preferred Alternative
Alternative 2 (Part 35 is controlling) is preferable because it
maintains the intent of the rulemaking on quality management programs
and misadministrations by concentrating regulatory requirements on
those events with the greatest risk and placing fewer requirements on
those with relatively low risk, such as most diagnostic uses of
radiopharmaceuticals. Also, this alternative would allow the Commission
to treat all medical administrations of licensed material consistently
under the regulations in Part 35.
2. Impact of Proposed Action
Licensees. There is no anticipated impact on licensees, except that
licensees will more clearly understand the meanings of the regulations.
Individuals. There is no anticipated impact on an individual
because this action will not increase or decrease the error rate for
administrations of radiation or radioactive material.
NRC Resources. No NRC resources would be required to implement the
rule.
IX. Regulatory Flexibility Certification
As required by the Regulatory Flexibility Act of 1980, 5 U.S.C.
605(b), the NRC certifies that, if adopted, this proposed rule would
not have a significant economic impact on a substantial number of small
entities. The impact of the revised regulation would not be significant
because the proposed amendment represents a continuation of current
practice and merely clarifies existing requirements.
X. Backfit Analysis
The NRC has determined that the backfit rule, Sec. 50.109, does not
apply to this proposed rule and, therefore, that a backfit analysis is
not required for this proposed rule, because these amendments do not
involve any provisions which would impose backfits as defined in
Sec. 50.109(a)(1).
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
recordkeeping 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. 553; the NRC is
proposing to adopt 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 (42 U.S.C.
2073, 2093, 2095, 2111, 2133, 2134, 2201, 2232, 2236), 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 35, 39, 40, 50, 60, 61, 70,
or 72 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 a
restricted area or in the course of employment in which the
individual's assigned duties involve exposure to radiation and to
radioactive material from licensed and unlicensed sources of radiation,
whether in the possession of the licensee or other person. Occupational
dose does not include dose 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
general public.
* * * * *
Public dose means the dose received by a member of the public from
exposure to radiation and to radioactive material released by a
licensee, or to another source of radiation either within a licensee's
controlled area or in unrestricted areas. It 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:
[[Page 4877]]
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 mSv)
in a year, exclusive of the dose contributions from background
radiation, any medical administration the individual has received,
voluntary participation in medical research programs, and the
licensee's disposal of radioactive material into sanitary sewerage in
accordance with Sec. 20.2003.
* * * * *
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).
6. In Sec. 35.2, the definition for misadministration is revised at
paragraphs (1)(i), (2)(i), (3)(i), (4)(i), (5)(i), (6)(i), and (6)(ii)
by removing the word ``patient'' and inserting the word ``individual.''
7. In Sec. 35.33, paragraph (a)(2) is 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;
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 (this person will be
subsequently referred to as ``the patient'' in this section), and if
not, why not, and if the patient was notified, what information was
provided to the patient. The report must not include the patient's name
or other information that could lead to identification of the patient.
* * * * *
Dated at Rockville, Maryland, this 19th day of January, 1995.
For the Nuclear Regulatory Commission.
John C. Hoyle,
Acting Secretary of the Commission.
[FR Doc. 95-1817 Filed 1-24-95; 8:45 am]
BILLING CODE 7590-01-P
