ML23151A580

PR-020,035 - 60FR04872 - Medical Administration of Radiation and Radioactive Materials

ML23151A580
Person / Time
Issue date:	01/25/1995
From:	Hoyle J NRC/SECY
To:
References
PR-020, PR-035, 60FR04872
Download: ML23151A580 (1)

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ADAMS Template: SECY-067 DOCUMENT DATE: 01/25/1995 TITLE: PR-020,035 - 60FR04872 - MEDICAL ADMINISTRATION OF RADIATION AND RADIOACTIVE MATERIALS CASE

REFERENCE:

PR-020,035 60FR04872 KEY WORD:

• RULEMAKING COMMENTS Document Sensitivity: Non-sensitive - SUNSI Review Complete

STATUS OF RULEMAKING PROPOSED RULE: PR-020,035 OPEN ITEM (Y/N)_N RULE NAME: MEDICAL ADMINISTRATION OF RADIATION AND RADIOACTIVE MATERIALS PROPOSED RULE FED REG CITE: 60FR04872 PROPOSED' RULE PUBLICATION DATE: 01/25/95 NUMBER OF COMMENTS:. 4 ORIGINAL DATE FOR COMMENTS: 04/10/95 EXTENSION DATE: I I FINAL RULE FED. REG. CITE: 60FR48623 PINAL RULE PUBLICATION DATE: 09/20/95 NOTES ON: FINAL RULE EFFECTIVE 10/20/95. FILE ON Pl.

STATUS OF RULE:

HISTORY OF THE RULE PART AFFECTED: PR-020, 03,5 RULE TITLE: MEDICAL ADMINISTRATION OF RADIATION AND RADIOACTIVE MATERIALS PROPOSED RULE PROPOSED RULE DATE PROPOSED RULE SECY PAPER: 94-282 , SRM DATE: 01/05/95 SIGNED BY SECRETARY: 01/19/95 FINAL RULE FINAL RULE DATE FINAL RULE SECY PAPER: 95-195 SRM DATE: 08/31/95 SIGNED BY SECRETARY: 09/14/95 STAFF CONTACTS ON THE RULE CONTACT!: STEPHEN A. MCGUIRE MAIL STOP: T9-C24 PHONE: 415-6204 CONTACT2: MAIL STOP: PHONE:

DOCKET NO. PR-020,035 (60FR04872)

In the Matter of MEDICAL ADMINISTRATION OF RADIATION AND RADIOACTIVE MATERIALS DATE DATE OF TITLE OR DOCKETED DOCUMENT DESCRIPTION OF DOCUMENT

- 01/19/95 01/19/95 FEDERAL REGISTER NOTICE - PROPOSED RULE 02/07/95 02/02/95 COMMENT OF DAVID CLOSE, MED HEALTH PHYSICIST ( 1) 03/13/95 03/07/95 COMMENT OF KENTUCKY CABINET FOR HUMAN RESOURCES (VICKI D. JEFFS) ( 2) 03/20/95 03/17 /95 COMMENT OF GEORGIA DEPARTMENT OF NATURAL RESOURCES (THOMAS E. HILL) ( 3) 04/11/95 04/10/95 COMMENT OF ILLINOIS DEPARTMENT OF NUCLEAR SAFETY (STEVEN C. COLLINS) ( 4) 09/15/95 09/14/95 FEDERAL REGISTER NOTICE - FINAL RULE

DOCKET ED U¥y~~O-Ol-P]

NUCLEAR REGULATORY COMMISSION*95 SEP 15 All :0 6 10 CFR Parts 20 and 35 OFFI E OF SECRETARY DOCK ETING ~ SERV ICE RIN 3150-AFIO BRM~CH Medical Administration of Radiation and Radioactive Materials AGENCY: Nuclear Regulatory Commission. DOCKET NUMBER R PROPOSED RULE p ~o ~ &5 (Coo f=R.~~7a")

ACTION: Final rule.

SUMMARY

The Nuclear Regulatory Convnission 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: \c\.;;)c\9:5' (30 days following publication in the I

Federal Register).

ADDRESSES: Examine comments received at: The NRC Public Document Room, 2120 L Street NW. (Lower Level), Washing t on, DC. 20555-0001 I

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(~C FR.. ~ilo.Q:~J

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 § 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 § 35.2 because the specified quantities or doses are not exceeded, and therefore part 35 does not require notific~tion of the NRC ~r the individual.

Separate from the requirements for misadministrations, § 20.130l(a)(l) contains a dose limit for members of the public of 0.1 rem (1 millisievert).

2

However, the scope of Part 20 in§ 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

§ 20.130l(a)(l) for a member of the public. The question that arose was whether§ 20.1301(a)(l) 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 Connission proposed an amendment to 10 CFR Part 20 to clarify the regulations (60 FR 4872, January 25, 1995). The proposed rule explained that the Convnission believed that, in general, the administration of radiopharmaceuticals should be r~gulated by Part 35 rather than by ~art 20. The medical administraiion 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 3

believed that an administration to any individual is and should be subject to the regulations in Part 35. That was the Convnission'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 Conrnission's rationale is contained in the Federal Register notice for the proposed rule (60 FR 4872; January 25, 1995).

II. Connents 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 conrnent 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 coment 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, § 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 conwnittee on rulemakings and other initiatives related to the medical ~se of byproduct materials, has a~sured the NRC that standard medical practice is that a physician who becomes aware that a medical procedure has 4

been perfonaed on the wrong individual shouldt and almost always would, notify the individual of the mistake.

Two coninents 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 infonnation fr011 the individual. The other, from an Agreement State, opposed such a requirement because it would be inconsistent with the NRC's medical policy statement~ wThe 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 tne 1ess serious errors.

III. Sulll'l'lary of the Changes.

Neither the conments received nor any other information available to the Conmission 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 ajopting the amendment~ as described below.

s

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 § 20.l30l(a)(l) 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 § 20.130l(a)(l), but is within the scope of Part 35.

The changes in Part 20 replace the word "patientn 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 § 20.1002, t,he 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 tt.~ sake of consistency and clarity, the same words are used in

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

individual members of the public.* Also for consistency and clarity, the exclusion of dose frOJA background radiation and from voluntary participation in aedical research programs that are now included in §§ 20.1002 and 20.1003 are added to§ 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§ 20.llOl(a)(l). When that amendment of

§ 20.130l(a)(l) is published in final fonn, the wording on what is excluded from the dose limit will be inserted in§§ 20.1002 and 20.1003 (in the definitions ~f 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

§ 35.2, *Definitions,* and in the misadministration*reporting requirements in

§ 35.33, *Notifications, reports, and records of misadministrations,* is replaced by the word *1ndividual." Note that § 35:33(a)(3) also requtres 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§ 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.

7

IV. Consistency with the 1979 Medical Policy Statement.

On February 9, 1979 (44 FR 8242), the NRC published a nstatement 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 r~ .. sistent with the 1979 medical policy statement.

8

V. Coordination with the Advisory Comittee on Medical Uses of Isotopes.

The subject of this final rule was discussed with the NRC's Advisory Comittee 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 of an individual of an error in administration below the misadministration threshold is the current medical practice and should not be regulated. A trans&ipt 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 rulemak1ng 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 convnented on the rule, and both fully supported the rule.

The NRC believes that the modification of Part 20 should be a Division l matter of compatibility consistent with past practice of requiring basic definitions to be essentially identical for effective collltlunication of basic radiation concepts. One Agreement State coltlllenting on the compatibility issue supported a Division 1 level. Another Agreement State supported Division 1 9

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 Cormiission'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.

ThJ regulatory analysis prepare1 for tha proposed rule and published as part of the Federal Register notice on the proposed rule is still valid for this final rule.

10

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, § 50.109, does not,*apply to this rule and; therefore, that a backfit analysis is not requifed for this rule, because these amendments do not involve any provisions which impose backfits as defined in§ 50.109(a)(l).

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.

11

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 Atoaic Energy Act of 1954, as amended; the Energy Reorganization Act of 1974, as all8nded; 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:

§ 20.1002 Scope.

The regulations in this part apply to persons licensed by the Conlllission 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, 7.0, 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 ad inistration the individual has received, or due to voluntary participation in medical research programs.

3. In § 20.1003, the definitions of occupationa1 dose and pub1ic dose are revised to read as follows:

§ 20.1003 Def1n1t1ons.

Occu.p1ttona1 dose means the dose received by an individual .in the course of emplo~nt in which the individual's assigned duties in~olve 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.

Pub1ic gose means the dose received by a member of the public from exposure to radiation and/or radioactive material released by a licensee, or 13

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§ 20.1301, paragraph {a){l) is revised to read as follows:

§ 20.1301 Dose limits for individual members of the public.

{a) * *

{l) 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 admi'nistration the individual has received, voluntary participation in medical research programs, and the licensee's disposal of radioactive material into sanitary sewerage in accordance with § 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).

14

§ 36.2 [AIMH'lded]

6. In § 35.2, the definition for misadministration is amended in paragraphs (l)(i), (2)(i), (3)(1), {4)(1), (5)(1), (6){i), and (6)(ii) by removing the tenn "patient or huaan research subject" and inserting the word "individual.*

7. In § 35.33, paragraphs (a)(2), (a)(3), (a){4), (b), and (c) are

- revised to read as follows:

§ 36.33 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 --~,

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misadministration. The written report must include the licensee's name; the prescribing physician's name; a brief description of the event; why the event :ft

- occurred; the effect on the individual who received the misadministratfon; 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 infonnation 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.

15

(3) The licensee shall notify the referring physician and also notify the individual receiving the misadministration of the misadministration no 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 infonns 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:

(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 SPC *rity number or otner identification number if one has been assigned, a brief description of the 16

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 l'I f~ 1,/rl

-day of ~~, 1995 .

• *,J For the Nuclear Regulatory Commission.

John~f!.z.

Ses,,etary of the Convnission.

17

Jim Edgar Governor April 10, 1995 .

DOCKET NUMBER PR -

Secretary of the Commission PROPOSED RULE.:..:,:.~ :5:-:r"::'*

U.S. Nuclear Regulatory Commission Cloo~R..~~ 1 a)

Washington, D.C. 20555

- Attention: Docketing and Service Branch Re: 60 FR 4872-4877, 10 CFR Parts 20 and 35. Proposed Rule, "Medical Administration of Radiation and Radioactive Materials" Gentlemen:

The Illinois Department of Nuclear Safety (Department) hereby submits its comments on the referenced proposed ru l emaking. The Federal Register notice indicates that the proposed modifications should be a Division 1 matter of compatibility since basic definitions sho uld be uniform for communication of basic radiation concepts. We realize t hat NRC is still working on the Compatibility Policy, and we would agree that these modifications to definitions should be Division 1, provided that Division 1 compatibility means the intent, but not the language must be identical.

NRC's interpretation that medical admi nistration of radiation or radioactive material to the wrong individual should be regulated in accordance with 10 CFR Part 35 is paral l el to th e Department's interpretation. The proposed language mod ifying "patient" to "individual" should clarify this situation for licensees.

In summary, the Department agrees with the proposed changes described in this Federal Register notice, but cautions against the assignment of compatibility levels when there is no compatibility policy. I you have any questions regarding these comments, please contact me or Kathy Allen at (217) 785-9947.

Sincerely,

~C,.~

Steven C. Collins, Chief Division of Radioactive Materials cc: Jim Lynch, State Agreements Officer "AP!f f 4 199

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U.S MUC~EA Rt*su:..ATCRY COMMISSlO~

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Georgia Department of Natural Resources 4244 International Parkway, Suite 1 tl 1~\c\_nta, Georgia 3_0~54 0 v \~ Joe.Di. Tanner, Comm 1ss1oner LJ R*blcl(F. Reheis, Assistant Director DOCKET NUMBER PR '- t nviro'nmental Protection D ivision 404/362-2675 PROPOSED RULE oto

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° -- *95 MAR 20 P3 :Q4 (l,oFR.o~'1~ ~arch 17 1995 OFFIC. . r ,_,. ~ rr r_.. P DOCK r..rr1 **..1 "\. .-, )c. t i,. q* ,J' f-J ['

Secretary 8h'.A .

U.S. Nuclear Regulatory Commission Washington, DC 20555 Attn: Docketing and Service Branch

Dear Mr. Secretary:

This is in reference to the notice that appeared in the Federal Register in which the Nuclear Regulatory Commission (NRC) is proposing to amend its regulations to clarify that the medical administration of radiation or radioactive materials to any 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.

Basically we are in agreement with the proposed changes; however, we have the following comments:

1. The question is asked if the administration of radioactive materials to the wrong individual should result in informing that individual if the dose or the amount is less than the misadministration threshold. We concur with the NRC's Advisory Committee on Medical Uses of Isotopes (ACMUI) position 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. We feel this type of decision concerns the practice of medicine and as such the decision should rest with the physician.

2. It is indicated that the proposed modification of Part 20 will be a Division 1 matter of compatibility item. Since there has always been a requirement that basic definitions contained within the NRC and Agreement State regulations be uniform for effective communication of basic radiation concepts we have no problem with this requirement.

Thank you for the opportunity to comment on the proposed rulemaking and if there are questions do not hesitate to contact me.

Sincerely, "dk ~r}M Thomas E. Hill, Manager Radioactive Materials Program TEH/klc

U.S. NUCLEAR REGULATORY COMMISSIOt1 DOCKETING & SERVICE SECTION OFFICE OF THE SECRETARY OF THE COMMISSION Document Statistics Postmark Dat Copies Received, _ _,___ _ _ _ __

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CABINET FOR HUMAN RESOURCES COMMONWEAL TH OF KENTUCKY FRANKFORT 40621-0001 DEPARTMENT FOR HEALTH SERVICES March 7, 1995 SECRETARY US NUCLEAR REGULATORY COMMISSION WASHINGTON DC 20555

Dear Secretary:

This letter provides comments to the proposed rulemaking "Medical Administration of Radiation and Radioactive Materials" published in the Federal Register on January 25, 1995.

we suppor t Alternative 2 for Part 35 to regulate doses to wrong ind ividual s.

If you require any additional comments, please contact me.

Sincerely,

~,..;L,~~

Vicki D. Jeffs, Supervisor Radioactive Materials Section Radiation Control Branch VDJ/tg

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"An Equal Opportunity Em ployer M/F/H"

U.S. NUCLEAR REGULATORY COMMISSIO~

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IIIIALLINCKRODT DOCKET NUMBER

- Nuclear Medicine PROPOSED RULE p so B

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I Mallinckrodt Medical, Inc.

NMA Medical Physics Consultation CD OOCKE 1 9457 Midwest Avenue Garfield Heights, Ohio 44125 Telephone (2 16) 663-7000 February 2, 1995 Facsimile (2 16) 663-6234 Secretary U.S. Nuclear Regulatory Commission Washington, D.C . 20555 Attn: Docketing and Service Branch RE: RIN3150-AF10 To Whom It May Concern :

These are comments regarding the proposed rule change published in the January 25, 1995 Federal Register (60FR4872) dealing with the medical administration of radiation and radioactive materials. I support and concur with the proposed rule change in its entirety. As described in the Federal Register publication, the administration of a radiopharmaceutical or radiation dose to the wrong individual should be regulated by the more specific requirements of Part 35 rather than Part 20. Limiting the exposure to such individuals to the values specified in 20.1301, places unnecessary burdens on medical licensees. Further, this would be in contrast to the recommendations of the international and national agencies that promulgate radiation safety recommendations. These agencies recognize that individuals receiving a dose in excess of 100 mrem in unusual situations does not represent a significant hazard to the individual. Therefore, the proposed changes should be made as published.

As regards the request for comment on notification, it is felt that Part 35 should require that, when the wrong ind iv idual receives an administration, t he individual should be notified of the error . It is agreed t hat it is current practice t hat such individuals are routinely notified. In such cases, the requirement to notify the individual wou ld not pose any additional requirement s on the licensees. However, there are those who would attempt to keep this information from the individual.

Considering the t rend in ri ght-t o-know laws, t he NRC should assure the appropriate information is provided to the individual. As all therapeutic administrations to the MAR - 1 f§~f Acknowledged by card.......................... ""

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wrong patient are currently considered misadministratlons, only administrations of radlopharmaceuticals not currently defined as misadministrations, would need to be considered. Part 35 should require that in the event of any radiopharmaceutical administration to the wrong individual, the Individual must be notified as described in 35.33. Other than requiring a record of the notification be made, no other action should be required of the licensee.

As regards whether the proposed modification to Part 20 should be made a Division I matter of compatibility, this should be so done. The basic definitions utilized by the States must be uniform with the NRC and with each other in order for effective commU.nicath;m. This item should also be a Division I matter of compatibility to assure 41 that the States address this basic concept in the same manner.

These comments represent my personal position. Thank you for considering these comments.

Sincerely, David Close Medical Health Physicist DC/kl p /Proprule.chg

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10 CFR Parts 20 and 35 RIN 3150-AFlO Medical Administration of Radiation and Radioactive Materials AGENCY:. Nuclear Regulatory Commission.

ACTION: Proposed rule.

SUMMARY

The Nuclear Regulatory Commission is proposing to amend 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 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 4\10\95 (75 days following publication in the Federal Register). 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.

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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.

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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§ 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§ 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 an misadministration is that some 3

relatively low dose diagnostic administrations of radiopharmaceuticals to individuals for whom they were not intended are not misadministrations as defined in§ 35.2.

If a misadministration occurs, § 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 threshJld for a misadministration, the administration is nJt a misadministration as defined in§ 35.2, and Part 35 does not require notification of the NRC or the individual.

Separate from the requirements for misadministrations, § 20.130l(a)(l) contains a dose limit for members of the public of 0.1 rem {I millisievert).

However, the scope of Part 20 in§ 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 4t 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 (I millisievert) dose limit in

§ 20.130l(a)(l) for a member of the public. Was there a violation of

§ 20.130l(a)(l} 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 4

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, 11 (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.

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Therefore, the relevant questions are: what steps are appropriate to reduce the likelihood of 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 rnisadministrations. 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§ 35.32, "Quality management program." In adopting those requirements, the Commission decided to apply the requirements in§ 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§ 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

§ 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.

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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§ 20.1301(a)(l) 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§ 20.l30l(a)(l), 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 11 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."

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Replacing patient with 11 11 11 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

§ 35.2, "Definitions," and in certain locations in paragraph (a)(2) of§ 35.33 would be replaced by the word "individual. 11 In§ 20.1002, the phrase "for the purpose of medical diagnosis and therapy" would be replaced by the phrase 11 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 +hat 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

§ 20.1002, 11 Scope, 11 in§ 20.1003. 11 Definitions," (in the definitions of both public dose and occupational dose), and in § 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§§ 20.1002 and 20.1003 would be added to§ 20.1301(a).

The existing§ 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§§ 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 8

concerning dose from sewer disposal will be made consistent in§§ 20.1002, 20.1003, and 20.l30l(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§ 20.130l(a)(l). When that amendment of§ 20.130l(a)(l) is published in final form, the wording on what is excluded from the dose limit will be inserted in§§ 20.1002 and 20.1003 (in the definitions of public dose and occupational dose) so that the same parallelism will exist throughout.

In additio,,, 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, § 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, 9

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 {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.

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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 aaditional regulations are not considered necessary.

The second statement of the policy states, "The NRC wi 11 regul afe 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 havind 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. 11 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.

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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, 11 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 4lt 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 I matter of compatibility consistent with past practice of requiring 6asic 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.

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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 NRG has not prepared a separate environmental assessment. The following discussion constitutes the dSSessment. 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§ 20.l30l{a){l) 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.

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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 regula~ory analysis for this proposed rulemaking is as follows:

1. ALTERNATIVES.

Alternative I: 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 I millisievert -

{0.1 rem} would be a violation of§ 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§ 20.2203, "Reports of exposures, radiation levels, and concentrations of radioactive material exceeding the limits" and the individual involved would receive notification of the exposure from the licensee pursuant to§ 19.13(d), "Notifications and reports to individuals."

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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§ 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.

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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 16

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, § 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§ 50.109(a)(l).

XI. 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.

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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 I. 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:

§ 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.

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3. In§ 20.1003, the definitions of occupational dose and public dose are revised to read as follows:

§ 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 pos:2ssion 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§ 20.1301, paragraph (a)(l) is revised to read as follows:

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§ 20.1301 Dose limits for individual members of the public.

( a) * * *

{l} 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§ 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§ 35.2, the definition for misadministration is revised at paragraphs (l)(i), (2)(i), (3)(i), (4)(i), (5)(1), (6)(i), and (6)(ii) by removing the word 0 patient" and inserting the word 0 individua7. 0

7. In§ 35.33, paragraph (a)(2) is revised to read as follows:

Section 35.33 Notifications, reports, and records of misadministrations.

(a) * *

• 20

(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 j_J__1ay of _J~~~~/-' 1995.

For the Nuclear R Commission.

of the Commission.

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