ML20129E991

Informs of NRC Intent to Publish in Fr Encl Final Amends to 10CFR20 & 35.W/o Encl

ML20129E991
Person / Time
Issue date:	09/08/1995
From:	Rathbun D NRC OFFICE OF CONGRESSIONAL AFFAIRS (OCA)
To:	Faircloth L, Schaefer D HOUSE OF REP., HOUSE OF REP., ENVIRONMENT & PUBLIC WORKS
Shared Package
ML20007C611	List: ML20128Q103 ML20128Q110 ML20128Q152 ML20128Q159 ML20128Q165 ML20128Q171 ML20128Q176 ML20129E192 ML20129E235 ML20129E387 ML20129E415 ML20129E451 ML20129E928 ML20129E991
References
FRN-60FR48623, FRN-60FR4872, RULE-PR-20, RULE-PR-35 950908, AF10-2-025, AF10-2-23, AF10-2-25, NUDOCS 9610010228
Download: ML20129E991 (5)

Text

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en arou g' & UNITED STATES g j NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20666 4001 e% ...../ .

The Honorable Dan Schaefer, Chairman Subcommittee on Energy and Power Committee on Commerce United States House of Representatives Washington, DC 20515

Dear Mr. Chairman:

In the near future, the Nuclear Regulatory Commission (NRC) intends to publish in the Federal Register the enclosed final amendments to the Commission's rules in 10 CFR Parts 20 and 35. The amendments revise Parts 20 and 35 to make clear that the dose to an individual from a medical administratinn of radiatior, or radioactive materials, even to an individual not supposed to receive an administration, is regulated by Part 35 of NRC's regulations, not by Part 20.

Sincerely, 4

t Dennis K. Rathbun, Director Office of Congressional Affairs

Enclosure:

Federal Register Notice cc: Rep. Frank Pallone S

9610010228 960917 PDR PR

,,20,,60FR48623 , ,P,DR

The Honorable Dan Schaefer, Chairman Subcommittee on Energy and Power Committee on Commerce United States House of Representatives Washington', DC 20515

Dear Mr. Chairman:

In the near future, the Nuclear Regulatory Commission (NRC) intends to publish in the Federal Register the enclosed final amendments to the Commission's rules in 10 CFR Parts 20 and 35. The amendments revise Parts 20 and 35 to make clear that the dose to an individual from a medical administration of radiation or radioactive materials, even to an individual not supposed to receive an administration, is regulated by Part 35 of NRC's regulations, not by Part 20.

Sincerely, Dennis K. Rathbun, Director Office of Congressional Affairs

Enclosure:

Federal Register Notice cc: Rep. Frank Pallone Distribution:

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The Honorable Lauch Faircloth, Chairman  :

Subcommittee on Clean Air, Wetlands, Private '

Property and Nuclear Safety Ccir..lttee on Environment and Public Works Washington, DC 20510

Dear Mr. Chairman:

In the near future, the Nuclear Regulatory Commission (NRC) intends to publish in the Federal Reaister the enclosed final amendments to the Commission's rules in 10 CFR Parts 20 and 35. The amendments revise Parts 20 ,

2 and 35 to make clear that the dose to an individual from a medical l administration of radiation or radioactive materials, even to an individual not supposed to receive an administration, is regulated by Part 35 of NRC's regulations, not by Part 20.

Sincerely, Dennis K. Rathbun, Director Office of Congressional Affairs

Enclosure:

Federal Register Notice cc: Senator Bob Graham I

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• The Honorable Lauch Faircloth, Chairman Subcommittee on Clean Air, Wetlands, Private Property and Nuclear Safety Committee on Environment and Public Works Washington, DC 20510 '

Dear Mr. Chairman:

In the near future, the Nuclear Regulatory Commission (NRC) intends to publish in the Federal Register the enclosed final amendments to the Commission's rules in 10 CFR Parts 20 and 35. The amendments revise Parts 20 and 35 to make clear that the dose to an individual from a medical administration of radiation or radioactive materials, even to an individual not supposed to receive an administration, is regulated by Part 35 of NRC's regulations, not by Part 20.

Sincerely, Dennis K. Rathbun, Director Office of Congressional Affairs

Enclosure:

Federal Register Notice cc: Senator Bob Graham Distribution: ,

RPHEB R/F '

FACostanzi LRiani DOCUMENT NAME: g:\mcguire\wrongpat\fairclot.let To receive a copy of this document, indicate in the box "C" - copy without attachment / enclosure, "B" = copy with attachment / enclosure, "N" - No copy

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The Honorable Lauch Faircloth, Chairman Subcommittee on Clean Air, Wetlands, Private Property and Nuclear Safety -

Committee on Environment and Public Works

Washington, DC 20510 1

Dear Mr. Chairman:

In the near future, the Nuclear Regu tory Commission (NRC) intends to publish in the Federal Reaistc the cr.cNsed final amendments to the Commission's rules in 10 CFR Parts 20 and 35. The amendments revise Parts 20 and 35 to make clear that the dose 6 an individual from a medical administration of radiation or ra oactive materials, even to an individual l not supposed to receive an admin stration, is regulated by Part 35 of NRC's ,

i regulations, not by Part 20.

i j Sincerely, l

[ Dennis K. Rathbun, Director Office of Congressional Affairs l

1 #

Enclosure:

Federal Register Notice f cc: Senator Bob Graham f l

Distribution:  !

l RPHEB R/F FACostanzi I LRiani f

DOCUMENT NAME: g:\e.cguire\wrongpat\fairclot.let 1

To receive a copy of this document, indicate in the box "C" - copy without attachment / enclosure, "B" - copy with attachment / enclosure, "N" - No copy Offc:

Name: SM M

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Y' NUCLEAR REGULATORY COMISSION 10 CFR Parts 20 and 35 0FFl;E OF SECRETARY

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DOCKETimBRANCH t ?ERNICE RIN 3150-AF10 Medical Administration of Radiation and Radioactive Materials DOCKET NUMBERam AGENCY: Nuclear Regulatory Commission.

PROPOSED RULE rR so-M (Go1%% la)

ACTION: Final rule.

The Nuclear Regulatory Commission is amending its regulations to

SUMMARY

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 regulation The rule does not concerning standards for protection against radiation.

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.

Effective date: tedgo\M (30 days following publication in the DATES:

Federal Register).

The NRC Public Document Room, ADDRESSES: Examine comments received at:

2120 L Street NW. (Lower Level), Washington, DC. 20555-0001 l l 1

.t CD NO M 'I g (J.ove A % c)

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FOR FURTHER INFORMATION CONTACT: Stephen A. McGuire, Office of Nuclear Regulatory Research, U.S. Nuclear Regulatory Commission, Washington, DC 20555, telephone (301) 415-6204.

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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 i 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 j 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 5 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, i 20.1301(a)(1)

I contains a dose limit for members of the public of 0.1 rem (1 millisievert).

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g states that, "The limits in this However, the scope of Part 20 in i 20.1002 part do not apply to doses due...to exposure of patients to radiation for t 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 In that particular case, the dose to the physician requesting the test. I individual receiving the administration was below the threshold for reporting of the misadministration, but above the 0.1-rem (1-millisievert) dose limit in The question that arose was i 20.1301(a)(1) for a member of the public.

whether i 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? I This same issue was raised in a Petition for Rulemaking (PRM-35-11)

That filed by the American Medical Association (59 FR 37950; July 26,1994).

petition requested, in part, that Part 20 specifically exclude all medical administrations. )

i Because of these concerns, the Commission proposed an amendment to 95). The

.10 CFR Part 20 to clarify the regulations (60 FR 4872, January 25,19 j

proposed rule explained that the Commission believed that, in general, the administration of radiopharmaceuticals should be regulated by Part 35 rather 1

than by N rt 20. The medical administration of radioactive materials is a special use of radioactive materials that is best dealt with by specific In particular, the Commission regulations covering those administrations.

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e 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). l i

II. Comments on the Proposed Rule and Petition for Rulemaking PRM-35-II.

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i Four comment letters were received on the proposed rule, three from p

, Agreement States and one from a medical health physicist. All supported the proposed rule. Three comment letters were received on PRM-35-ll. Each of the j letters supported the petition. .

1

! 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  ;

i f in the case of administration of a radiopharmaceutical to the wrong l i

individual, but in a quantity below the misadministration threshold. Section i

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 l

mi administration threshold, 6 35.33 does not require that the individual who

).

j received an administration of a radiopharmaceutical by error be notified of the error. The NRC's Advisory Committee on Medical Uses of Isotopes (ACMUI),

l an advisory committee on rulemakings an'd other initiatives related to the medical use of byproduct materials, has assured the NRC that standard medical practice is that a physician who becomes aware that a medical procedure has  !

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a been performed on the wrong individual should, and almost always would, notify the individual of the mistake.

Two consents 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 The other, from an Agreement to keep this information from the individual.

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 Therefore, the rulemaking and thus not amend the notification requirements.

Notification NRC will require notification only for the more serious errors.

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 amendment: as described below.

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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 i 20.1301(a)(1) on public dose limit to clarify that the dose i

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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 i 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."

i Replacing " patient" with " individual" clarifies that the statement refers to anyone receiving a medical administration.

1 In i 20.1002, the phrase "for the purpose of medical diagnosis and

) therapy" is replaced by the phrase "any medical administration the individual e

has received." The existing wording raised the question of whether an administration was within the scope of Part 20 if the administration had no j

valid medical purpose. The new wording makes it clear that regardless of the lr

! purpose or lack of purpose, dose to an individual from any medical I

administration the individual has received is not within the scope of Part 20, i but is within the scope of Part 35. ,

i For the sake of consistency and clarity, the same words are used.in ,

i 20.1002, " Scope," in i 20.1003, " Definitions," (in the definitions of both public dose and occupational dose), and in i 20.1301, " Dose limits for 6

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.. ..__ -- . = . . ._-. - _- . - . _ . - -_. - -

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individual members of the public." Also for consistency and clarity, the exclusion of dose from background radiation and from voluntary participation '

20.1002 and 20.1003 j in medical research programs that are now included in il are added to i 20.1301(a).

15,1994 (59 FR 30724), which deals

! A proposed rule published on June with criteria for the release of individuals administered radioactive material, would also amend 1 20.1301(a)(1). When that amendment of i 20.1301(a)(1) is published in final form, the wording on what is excluded

)

from the dose limit will be inserted in il 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 l

" patient or human research subject" in the definition of misadministration i l

6 35.2, " Definitions," and in the misadministration reporting requirements in l

5 35.33, " Notifications, reports, and records of misadministrations," is Note that i 35.33(a)(3) also requires the replaced by the word " individual."

If a licensee to notify the referring physician of a misadministration.

l misadministration occurs because the material was administered to the wrong h

If there is no referring individual, there may be no referring physician.

physician, the licensee is relieved of the responsibility of notifying the f

! referring physician, but must comply with all other requirements of 6 35.33.

The changes made by these amendments have the effect of granting the i

request in PRM-35-11 that Part 20 specifically exclude all medical administrations.

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IV. Consistency with the 1979 Medical Policy Statement.

On February 9,1979 (44 FR 8242), the NRC published a " Statement of The General Policy on the Regulation of the Medical Uses of Radioisotopes."

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 addititenal 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 The

voluntary standards, or compliance with these standards, are inadequate."

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  !

i intrusion into medical judgements affecting patients and into other areas f

traditionally considered to be a part of the practice of medicine." The rule l

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 I

significance. i

Thus,_the rule is considered to be cm..sistent with the 1979 medical 4

policy statement.

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1 V. Coordination with the Advisory Committee on Medical Uses of Isotopes. i The subject of this final rule was discussed with the NRC's Advisory

The ACMUI is [

'ommittee on Medical Uses of Isotopes (ACMUI) on May II, 1995.  ;

s an advisory body established to advise the NRC staff on matters that involve .

the administration of radioactive material and radiation from radioa l

material. The ACMUI agreed that medical administrations, including those to an individual not supposed to receive an administration, should be regulated .

i' oy Part 35 rather than by Part 20. The ACMUI stated that notification of an j

! individual of an error in administration below the misadminist A transcript of is the current medical practice and should not be regulated.

l the meeting is available for examination at the NRC Public Document Room, 1

2120 L St., NW. (Lower Level), Washington, DC.

j i

VI. Coordination with and Issue of Compatibility for Agreement States.

' This rulemaking was discussed with representatives of Agreement States The States were polled on at a meeting in Portland, ME, on October 24, 1994.

how they regulated an administration to the wrong individual, and it was fo j

that they appear to regulate such administrations consistent with this rule.

Two States commented on the rule, and both fully supported the rule.

f The NRC believes that the modification of Part 20 should be a matter of compatibility consistent with past practice of requiring basic

j I

definitions to be essentially identical f or effective communication of basic radiation concepts. One Agreement State commenting on the compatibility issue Another Agreement State supported Division 1 supported a Division 1 level.

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compatibility "crovided that Division I compatibility means the intent, but not the lanauaae 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 4

statement is not required.

The NRC prepared an environmental assessment for the proposed rule, 1 which was centained within the Federal Register notice for that rule. That 1

assessment continues to stand for the final rule.

]

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! 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 4

(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.

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IX. Regulatory Analysis.

J Tha 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.

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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 agulation 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, s 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 950.109(a)(1).

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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 an disposal .

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l

10 CFR Part 35  !

Byproduct material, Criminal penalties, Drugs, Health facilities, Health '

professions, Medical devices, Nuclear materials, Occupational safety and 7

health, Radiation protection, Reporting and Recordkeeping requirements.

For the reasons set out in the preamble and under the authority of l 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, 124G (42 U.S.C. 5841, 5842, 5846).

2. Section 20.1002 is revised to read as follows:

E 20.1002 Scope.

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The regulations in this part apply to persons licensed by the Commission to receive, possess, use, transfer, or dispose of byproduct, source, or 12

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 certificat The compliance or an approved compliance plan under part 76 of this chapter.

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 i 20.1003, the definitions of occupational dose and public dose are revised to read as follows:

1 20.1003 Definitions.

4 Occucational dose means the dose received by an individual in the course l

t of employment in which the individual's assigned duties involve exposure to l

f radiation and/or radioactive material from licensed and unlic  ;

1 s

radiation, whether in the possession of the licensee or other person.

i Occupational dose does not include doses received from background radia from any medical administration the individual has received, from voluntary l

f participation in medical research programs, or as a member of the public.

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Public dose means the dose received by a member of the public front l

exposure to radiation and/or radioactive material released by a licensee, or \

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I Public to any other source of radiation under the control of the licensee.

dose does not include occupational dose or doses received from background radiation, from any medical administration the individual has received, or

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from voluntary participation in medical research programs.

4. In i 20.1301, paragraph (a)(1) is revised to read as follows:

5 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 medical research programs, and the licensee's disposal of radioactive material into sanitary sewerage in accordance with 6 20.2003.

PART 35 - MEDICAL USE OF BYPRODUCT MATERIAL i

i

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).

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6 35.2 [ Amended]

6. In s 35.2, the definition for misadministration is amended in

=i paragraphs (1)(1), (2)(i), (3)(i), (4)(1), (5)(1), (6)(i), and (6)(fi) by removing the term " patient or human research sukject" and inserting the word

" individual."

7. In 5 35.33, paragraphs (a)(2), (a)(3), (a)(4), (b), and (c) are revised to read as follows:

1 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 The written report must include the licensee's name; the misadministration.

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 The report must not contain the notification, what information was provided.

individual's name or any other information that could lead to identification To meet the requirements of this section, the notification of the individual.

of the individual receiving the misadministration may be made instead to that individual's responsible relative or guardian, when appropriate.

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O (3) The licensee shall notify the referring physician- and also notify the individual receiving the misdainistration of the misadministration no l

later than 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> 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 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br />, 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:

(1) 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 3e obtained from the licensee. >

(b) Each licensee shall retain a record of each misadministration for L

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 ser :rity number or otner identification number if one has been assigned, a brief description of the i

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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.

1

_ 1995.

Dated at Rockville, Maryland, this /Y day of

$ e For the Nuclear Regulatory Commission.

. h2Y k John C. Hoyl6, ' )

Segretary of the Commissior..

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PDL

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eq 48623 Rules and Regulations ad-m~

Vol. 60. No.182 Weilnesday. September 20,1995 Ths section of the FEDERAL REGISTER The misadministration of Because of these concerns, the contaris regulatory documents having general radiopharmaceuticals is dealt with in Commission proposed an amendment to apphcability and legal effect, most of which NRC regulations in 10 CFR Part 35, 10 CFR Part 20 to clarify the regulations .

are keyed to and codshed in the Code of Federal Regulations, which ts put)lished under " Medical Use of Byproduct Material." (60 FR 4872, January 25,1995). The 50 titles pursuant to 44 U.S.C.1510. As defined in S 35.2, misadministrations proposed rule explained that the Include administrations of licensed Commission believed that, in general, The Code of Federal Regulations is sold by radioactive material to the wrong the administration of - ~

the Superintendent of Documents. Prices of individual in excess of certain specified radiopharmaceuticals should be new books are hated in the frst FEDERAL quantities ("30 microcuries of either regulated by Part 35 rather than by Part REGISTER issue of each week. sodium lodido 1-125 or I-131") or doses 20. The medical administration'of -

cial use of

("5 rems rems effectivetodose dose equivalent equivalent any individual or 50 radioactivo radioactive materials that ismaterials is a s%'be NUCLEAR REGULATORY organ"). The practical effect of the COMMISSION with by specific regulations coverin def nition of a misadministration is that those administrations. In'p' articular,g the -

10 CFR Parts 20 and 35 some diagnostic administrations of Commission believe'd that an radiopharmaceuticals to individuals for administration to any individualis'and RIN 3150-AF10 whom they were not intended are not should be subject to the regulations in misadministrations as defined in S 35.2 Past 35. That was the Commission's Medical Administration of Radiation because the specified quantitles or doses intent when the current and Radioactive Materials are not exceeded, and therefore part 35 misadministration mquirements were AGENCY: Nuclear Regulatory d es not require notification of the NRC adopted in the final rule," Quality Commission' or the individual. Management Programs and ACTION: Final rule. Separate from the requirements for Misadministrations," (56 FR 34104: July i misadministrations, S 20.1301(a)(1) 25,1991). Further explanation of the

SUMMARY

The Nuclear Regulatory contains a dose limit for members of the Commission's rationale is contained in Commission is amending its regulations public of 0.1 rem (1 millisievert). the Federal Register notice for the fo clarify that the medical flowever, the scope of Part 20 in proposed rule (60 FR 4872; January 25, administration of radiation or S 20.1002 states that, "The limits in this 1995).

radioactive materials to any individual, Part do not apply to doses due * * *

• t even an individual not supposed to exposure of patients to radiation for the II. Comments on the Proposed Rule and receive a medical administration,is purpose of medical diagnosis or therapy Petition for Rulemaking PRM-35-11

-regulated by the NRC's provisions Four comment letters were received governing the medical use of byproduct A question arose about the on the proposed rule, three from material rather than by the dose limits applicability of those words in a Agreement States and one from a in the NRC's regulations concerning Particular case in which an individual medical health physicist. All supported standards for protection against mistakenly received an administration the proposed rule. Three comment radiation. The rule does not represent a of a diagnostic radiopharmaceutical letters were received on PRM-35-11, change in policy, but is necessary to because of an error on the part of the Each of the letters supported the indicate clearly that this is the NRC's physician requesting the test. In that petition.

policy and to clarify the relationship of Particular case, the dose to the The Federal Register notice on the NRC's regulations. Individual receiving the administration proposed rule specifically asked for DATES: Effective date: October 20.1995. was below the threshold for reporting of comment on whether to adopt a the snisadministration, but above the requirement to inform an individual of

^hy' gc k*g*N Pu IIc D ument OSmm (1.millislevert) dose limit in the error in the case of administration of ,

Room,2120 L Street NW. (Lower Level)' S 20.1301(a)(1) for a member of the a radiopharmaceutical to the wrong  ;

Washington. DC 20555-0001' public. The qu'estion tht,t arose was individual, but in a quantity below the

< whether S 20.1301(a)(1) had been misadministration threshold. Section FOR FURTHER INFORMATION CONTACT:

Stephen A. McGuire, Office of Nuclear violated or did the words in the scope 35.33 generally r uires notification of Regulatory Research. U.S. Nuclear of Part 20 exclude this event from being the individual in e case of a subject to the dose limits in Part 20. In misadministration. Ilowever,if the dose Regulatory Commission, Washingtona other words, does the exclusion from DC 20555, telephone (301) 415-6204. or the amount is less than the the Part 20 dose limits exclude any misadministration threshold, S 35.33 SUPPLEMENTARY INFORMATION: medical administration to any does not require that the individual who

• E*""d individual, even an individual not received an administration of a supposed to receive an administration? radiopharmaceutical by error be notified .

Radioactive materials are This same issue was raised in a of the error.The NRC's Advisory administered in the practice of medicine Petition for Rulemaking (PRM-35-11) Committee on Medical Uses of Isotopes to roughly 8 to 9 million patients per filed by the American Medical (ACMUll, an advisory committee on year for the diagnosis or treatment of Association (59 FR 37950; July 26, rulemakings and other initiatives related disease. Occasionally, a radioactive 1994). That petition requested, in part, to the rnedical use of byproduct material is administered to an ' that Part 20 specifically exclude all materials, has assured the NRC that individual for whom it is not intended. medical administrations. standard medical practice is that a

411G24 Federal Register / Vol. 60, No.182 / Wednesday, September 20, 1995 / Rules and Regulations physician who becomes n' ware that a medical procedure is a " patient." The changes made 1sy these medical procedure has been performed Replacing " patient" with " individual" on the wrong hidividual should, and amendments have the effect of granting clar"les that the statement refers to the request in PRM-35-11 that Part 20 almost always would, notify the anyone receiving a medical specifically exclude all medical individual of the mistake. administration. administrations.

Two comments addressed this In S 20.1002, the phrase "for the question. One, from an employee at a purpose of medical diagnosis and IV. Consistency With the 1979 Medical medical facility, favored an NRC Policy Statement mgulation requiring notification of the therapy"is replaced by the phrase "any 2 medical administration the individual On February 9.1979 (44 FR 8242), the individual regardless of the dose NRC published a " Statement of General because sometimes an attempt might raised be has received." The existing wording the question of whether an P licy on the Regulation of the Medical made to keep this information from the individual. The other, from an administration was within the scope of . Uses of Radioisotopes rw nw Agreement State, opposed such a Part 20 if the administration had no statement of the policy states,"The N,R{

requirement because it would be valid medical purpose.The new will c ntinue t regulate the medical- ,

wording nuikes it clear that mgardless of uses,of radioisotopes as necessary to inconsistent with the NRC's medical the purpose or lack of purpose, dose to Provide for the radiation safety of m ; . ,_

policy statement, "The NRC will ,

on individual from an medical w rkers and the general public. _ The.

minimize intrusion into medical rule is c nsistent with this statement ; .

judgements affecting Patients and into administration the in ividual has received is not within the scope of Part because it continues to provide for a .. %

other areas traditionally considered to

.be a part of the practice of medicine " 20, but is within the scope of Part 35. administrations of radioactive materials 7 For the sake of consistency and to be regulated under 10 CFR Part 35. .

The NRC has decided to retain the notification requirements that it clarity, the same words are used in The rule further clarifies that additional':

S 20.1002. " Scope." in $ 20.1003, regulations are not considered .y established in the misadministration rulemaking and thus not amend the " Definitions."(in the definitions of both necessay, notification requirements. Therefore, the public dose and occupational dose), and The second statement of tim policy, .-

1 NRC will require notification only for in $ 20.1301," Dose limits for individual states, %e NRC wW mgulato um .

" ft}ep }ic.~ so for radiation safety of patients where ,

the more serious errors. Notification requirements for less serious errors are [

dose from nc ackgroun! radiation and

,7 justified by the risk to patients and j

li '""'"IY left to the medical profession and t '

State and local regulations. The NRC from volunta'Y ParticiPation in medical C mP ance with these standards,are .

madequate. The rule is consistent with sees no need to interject itselfinto [*"*' g[h medical ludgements or to override State n 2010 a d 201003 are a statenant ecause it dames that and local regulations for the less serious added to S 20.1301(a). existing requirements concerning errort A Proposed rule published on June misadministrations continue to be 15.199,4(5 concentrated on administrations having 111. Summary of the Changes - with ,

criten,9 FR 30724), which deals a for the release of the hreatest risk significance.

Neither the comments received nor individuals administered radioactive T e third statement of the policy any other information available to the material, would also amend states, "The NRC will minimize Commission give any reasons for not intrusion into medical judgements 5 20.1301(a)(1). When that amendment affecting patients and into other areas adopting the amendments substantially of S 20.1301(a)(1)is published in final as proposed, which would regulate form, the wording on that is excluded traditionally considered to be a part of administrations to individuals under the practice of medicine."The rule is from the dose limit will be inserted in Part 35 and not Part 20. Therefore, the SS 20.1002 and 20.1003 (in the consistent with this statement because it NRC is adopting the amendments as definit;ons of public dose and limits its specific regulatory described below. occupational dose) so that the same requirements for notification to the most To clarify the meaning and intent of parallelism will exist throughout Part serious errors in administration and Part 20, the NRC is amending the scope 20. minimizes requirements on errorsin of Part 20, the definitions of public dose in Part 35, for consistency in administrations that have less risk  !

significance.

and occupational dose and the wording terminology between parts. the phrase Thus, the rule is considered to be l

in S 20.1301(a)(1) on public dose limit to " patient or human research subject"in j clarify that the dose limit for individual the definition of misadministration in consistent with the 1979 medical policy  !

statement.

members of the public does not apply to S 35.2," Definitions," and in the dose contributions from any medical misadministration reporting V, Coordination With the Advisory administration the individual has requirements in S 35.33," Notifications, Committee on Medical Uses ofIsotopes received. Thus, the medical reports, and records of The subject of this final rule was administration of radioactive materials misadministrations,"is replaced by the or radiation to any individual, even to discussed with the NRC's Advisory word " individual." Note that Committee on Medical Uses of Isotopes an individual not supposed to receive S 35.33(a)(3) also requires the licensee to (ACMUI) on May 11,1995.The ACMUI an administration, is not subject to the notify the referring physician of a public dose limit in S 20.1301(a)(1), but is an advisory body established to misadministration. If a advise the NRC staff on matters that is within the scope of Part 35. misadministration occurs because the The changes in Part 20 replace the involve the administration of word " patient" with the word material was administered to the wrong radioactive material and radiation from individual, there may be no referring radioactive material. The ACMUI agreed

" individual." The word " patient" has physician. If there is no referring that medical administrations, including sometimes beentotaken individualintended to the receive mean only the physician, the licensee is relieved of the those to an individual not supposed responsibility of notifying the referring receive an administration, should be administration. At other times, the view physician, but must comply with all regulated by Part 35 rather than by Part has been that anyone who receives a other requirements of 9 35.33,

20. The ACMUI stated that notification

~

-Federal Register / Vol. 60, No.182 / Wednesday, Septe,tibur 20, 1995 / Rules and Regulations 48625 of an inliividual of an error in proposed rule is still valid for this final $ 20.1002 scope. 1 administration below the rule.

misadministration threshold is the The regulations in this part apply to current medical practice and should not X. Regulatory Flexibility Certification pers ns licensed by the Commission to receive, possess, use, transfer, or he regulated. A transcript of the meeting 1

M required by the Regulatory dispose of byproduct, source, or special I is available for examination at the NRC Flexibility Act of 1980,5 U.S.C. 605(b), nuclear material or to operate a i Pub'.ic Document Room,2120 L St., NW, the NRC certifies that this rule will not production or utilization facility under (Lower Levell, Washington, DC. 1 have a significant economic impact on Parts 30 through 36,39,40,50,60,61, }

VI. Coordination With and Issue of a sta a u ro n s. o g,

Compatibility for Agreement States g ed e ordan with 0 C 76 6 to This rulemaking was discussed with will not be significant because the Persons required to obtain a certificate l

representatives of Agreement States at a arnendment represents a continuation of of compliance or an approved meeting in Portland. ME, on October 24, current practice and merely clarifies compliance plan under part 76 of this existing requirements. cha ter. *Ihe limits in this part do'not 1994. The States were olled on how they regulated an adm pistration to the XI. Ilackfit Analysis ap y to doses due to background ra ation, due to any medical wrong individual, and it was found that they appear to regulate such The NRC has determined that the ; administration the individual has  !

administrations consistent with this backfit rule,5 50.109, does not ap ly to received, or due to voluntary rule. Two States commented on the rule

• this rule and; therefore, that Participation a bachit in medical research u and both fully supported the rule. analysis is not required for this rule' Programs. .

The NRC believes that the because these amendments do not 3, In S 20.1003, the definitions of involve any provisions which impose CCUPational dose and public dose are {

modification of Pan 20 should be a  ;

Division 1 matter of compatibility backfits as defined in 9 50.109(s)(1). sd to mad as Mowo consistent with ast practice of XII. List of Subjects 9 20.1003 DennWons.

e al1y enti r effect e 10 JR Pan 20 Occupat onaldose means the dose communication of basic radiation By roduct material, Criminal received by an Individual in the course )

concepts. One Agreement State ,

pena ties, Licensed material, Nuclear I P " hi commenting on the compatibility issue materials, Nuclear power plants and di id al s supported a Division 1 level. Another reactors. Occupational safety and exposure to radiation8. d dand/or t s involve .

radioactive l

Agreement State supported Division I health, Packaging and containers, compatibility "provided that Division 1 material from licensed and unlicensed '

Radiation protection Reporting and sources of radiation, whether in the compatibility means the intent, but not the language must be identical." recording requirements, Special nuclear Possession of the licensee or other material, Saurce material. Waste "

VII. Finding of No Significant tmatment and disposal. Qd "P oya s se gm dob kg"" ]md EnvironmentalImpact radiation, from any rnedical to CFR Part 35 The NRC has determined under the administration the individual has National Environmental Policy Act of Hyproduct material. Criminal [eceived, from voluntary participation 1969, as amended, and the penalties. Drugs, flealth facilities, in medical research programs, or as a llealth professions, Medical devices, member of the pubhc.

Commission's regulations in Subpart A * * * *

• of Part 51, that this rule is not a major Nuclear materials, Occupational safety Federal action significantly effecting the and health, Radiation protection, Public dose means the dose received quality of the human environment. Reporting and Recordkeeping by a member of the public from requirements. exp sure t radiation and/or radioactive ,

Therefore, an environmental impact statement is not required. For the reasons set out in the matenal released by a licensee, or to any The NRC prepared an environmental preamble and under the authority of the other source of radiation under the assessment for the proposed rule, which Atomic Energy Act of 1954, as amended; control of the licensee. Public dose does was contained within the Federal not include occupational dose or doses the Energy Reorganization Act of 1974, Register notice for that rule. That received from background radiation, as amended;and 5 U.S C. 552 and 553; from any medical administration the assessment continues to stand for the the NRC is adopting the following I' mal rule, individual has received, or from amendments to 10 CFR Parts 20 and 35. voluntary participation in medical VIII. Paperwork Reduction Act #ma pmgramt Statement PART 20--STANDARDS FOR ,

PROTECTION AGAINST RADIATION This rule does not contain a new or .

4. In S 20.1301, paragraph (a)(11 is amended information collection 1. The authonty citat. ion for part 20 revised to read as follows--

requirement subject to the Paperwork c ntinues : mad as follows:

5 20.1301 Dose umits for individual Reduction Act of 1980 (44 U.S.C. 3501 Authority: Secs. 53,63,65,8t,103,104, members of the public.

et seq.). Existing requirements were 161.182,186,68 St.st 930. 933,935,936 approved by the Office of Management (a) * *

• 937.948.953,955.as amended. sec.1701, and liudget, approval numbers 3150- 106 Stat. 2951,2952,2953 (42 U.S.C. 2073, (1) The total effective dose equivalent 0014 and 3150-0010. to individual members of the public IX. Regulatory Analysis 2l 2o1, a e ded,20 ', frorn the licensed operation does not

• xc 2 .8a sta 1 2 as ame ed.1244,1246 The regulatory analysis prepared for ,xc siv o t e os or t ibuti ns r the proposed rule and published as part background radiation, any medical of the Federal Register notice on the 2. Section 20.1002 is revised to read administration the individual has as follows:

received, voluntary participation in

, a e

4802G Federal Register / Vol. 60. No.182 / Wednesday September 20, 1995 / Rules and Regulations medical research programs, and the to notify the individual without first licensee's disposal of radioactive consulting the referring physician. If the material into sanitary sewerage in referring physician or the individual accordance with 5 20.2003. receiving the misadministration cannot

• * * *

• be reached within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br />, the licensee shall notify the individual as soon as -

PART 35-MkDICAL USE OF ,

possible thereafter. The licensee may BYPRODUCT MATERIAL not delay any appropriate medical care 5.The authority citation for Part 35 for the individual, including any continues to read as follows: necessary remedial care as a result of the misadministration, because of any Authority: Secs. 81,161,182,183. 68 Stat.

935,948,953,954, as amended (42 U.S.C delay in notification.

2111,2201,2232,2233); sec. 201,88 Stat.

1242, as amended (42 U.S.C 5841). (4) If the individual was notified, the licensee shall also furnish, within 15

$ 35.2 [Amendall . days after discovery of the

6. In $ 35.2, the definition for misadministration, a written report to m/sodministration is amended in the individual by sending either:

paragraphs (1)(i), (2)(1), (3)(1), (4)(i),

(5)(1), (6)(1), and (6)(11) by removing the (i) A copy of the report that was ,

' term " patient or human research submitted to the NRC; or subject" and inserting the word -

" individual." (II) A brief description of both the event and the consequences as they may affect the individual, provided a (a) ) ( ) an (c rev to a statement is included that the report follows',

submitted to the NRC can be obtained 5 35.33 Notificauons, reports, and records from the licensee.

• • dd""*""*'

(b) Each licensee shall retain a record (a) * *

• of each misadministration for 5 years. ~

.(2) The licensee shall submit a written The record must contain the names of report to the appropriate NRC Regional all individuals involved (including the l Office listed in to CFR 30.6 within 15 prescribing physician, allied health days after discovery of the personnel, the individual who received misadministration. The written report the misadministration, and that must include the licensee's name; the individu1s referring physician,if prescribing physician's name; a brief applicable), the individual's social description of the event; why the event security number or other identification ,

occurred; the effect on the individual number if one has been assigned, a brief i

who received the misadministration; description of the misadministration, what improvements are needed to why it occurred, the effect on the prevent recurrence; actions taken to individual, improvements needed to prevent recurrence; whether the prevent recurrence, and the actions i licensee notified the individual (or the taken to prevent recurrence. I individual s responsible relative or guardian), and if not, vhy not; and if (c) Aside from the notification there was notification, what information requirement, nothing in this section was provided. The report must not affects any rights or duties of licensees contain the individual's name or any and physicians in relation to each other, other information that could lead to to individuals receiving identification of the individual. To meet misadministrations, or to that the requirements of this section, the individual's responsible relatives or notification of the individual receiving the misadministration may be made 8"* 'd "" *'

instead to that individual's responsible Dated at Rockville Maryland,this 14th day relative or guardian, when appropriate. of September,1995.

(3) The licensee shall notify the For the Nuclear Regulatory Commission.

referrind Physician and also notify the individual receiving the John c Hoyle, misadministration of the ,

misadministration no later than 24 S'C 'T l'h' C **i"i "- i hours after its discovery, unless the IFR Doc. 95-23288 Filed 9-19-95; 8.45 aml referring physician personally informs I amo cm iswou' 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

, _ _ <