ML20129E235
| ML20129E235 | |
| Person / Time | |
|---|---|
| Issue date: | 04/05/1995 |
| From: | Mcguire S NRC |
| To: | Catherine Haney, Steve Jones, Stewart Schneider NRC |
| Shared Package | |
| ML20007C611 | List: |
| References | |
| FRN-60FR48623, FRN-60FR4872, RULE-PR-20, RULE-PR-35 AF10-2-002, AF10-2-2, NUDOCS 9610010020 | |
| Download: ML20129E235 (22) | |
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l April 5,1995 l To: Working group on wrong patient rule: Stewart Schneider, Sam Jones, f Cathy lianey, Trish Holahan, and Brad Jones From: Stephen A. McGuire h ;
SUBJECT:
TECHNICAL REVIEW OF FINAL RULE ON, " MEDICAL ADMINISTRATION OF RADIATION AND RADIOACTIVE MATERIALS Attached for your technical review is a draft final FRN on the wrong patient rule.
Also attached to aid in your review is a copy of the proposed rule FRN, the comments received on the proposed rule, the FRN for petition for rule making, PRM-35-11, and the comments received on the petition.
I believe.that this final rule should be rather straight forward and that this review by the working group can substitute for the division technical review step. Thus, we will be able to go straight to Office Concurrence after your comments have been resolved.
We will also have a meeting of the working group to discuss your comments if any significant questions arise as a result of your review.
I would appreciate your comments by April 21. A marked up copy of the FRN is fine. i i
Attachment:
as stated CC: John Glenn Cheryl Trottier Ed Powers 9610010020 960917 PDR PR 20,60FR48623 t
_ PDR a . ']
[7590-01-P]
NUCLEAR REGULATORY COMMISSION j 10 CFR Parts 20 and 35 j l
RIN 3150-AF10 i Medical Administration of Radiation and Radioactive Materials l 1
AGENCY: Nuclear Regulatory Commission. ;
ACTION: Final rule.
SUMMARY
- The Nuclear Regulatory Commission is amending its regulations to ;
clarify that the medical administration of radiation or radioactive materials !
to any individual, even an individual not supposed to receive a medical 1 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 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: (30 days following publication in the Federal Register).
ADDRESSES: Examine comments received at: The NRC Public Document Room, 2120 L Street NW. (Lower Level), Washington, DC.
Draft: April 5, 1995 1 Attachment 1
- .l FOR FURTHER-INFORMATION CONTACT: Stephen A. McGuire, Office of Nuclear j Regulatory Research, U.S. Nuclear Regulatory Commission, Washington, DC 20555, j i
telephone (301) 415-6204. i i
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 by mistake 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 5 35.2, misadministrations include administrations of licensed s radioactive material in excess of certain specified quantities to the wrong individual. The practical effect of the definition of an misadministration is that some relatively low dose diagnostic administrations of radiopharmaceuticals to individuals for whom they were not intended are not misadministrations as defined in 5 35.2, and Part 35 does not require notification of the NRC or the individual.
l Separate from the requirements for misadministrations, 5 20.1301(a)(1) contains a dose limit for members of the public of 0.1 rem (1 millisievert).
However, the scope of Part 20 in i 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 ...."
Draft: April 5, 1995 2 Attachment 1
I 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 5 20.1301(a)(1) for a member of the public. The question that arose was whether there was a violation of 5 20.1301(a)(1) 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) i filed by the American Medical Association (59 FR 37950; July 26,1994). That petition requested, in part, that part 20 specifically exclude all medical administrations.
Because of these concerns, the Commission proposed an amendment to 10 CFR Part 20 to clarify the regulations (60 FR 4872, January 25,1995). The l 1
proposed rule explained that the Commission believed 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 1
special use of radioactive materials that is best dealt with by specific regulations covering those administrations. In particular, the Commission believed that an administration to any individual is and should be subject to the regulations in Part 35. That was the Conmission's intent when the current misadministration requirements were adopted in the final rule, " Quality Draft: April 5, 1995 3 Attachment 1
Management Programs and Misadministrations," (July 25, 1991; 56 FR 34104).
Further explanation 'of the' Commission's rationale is contained in the Federal Register Notice for the proposed rule (60 FR 4872, January 25,1995).
II. Comments on the Proposed Rule and Petition for Rulemaking PRM-35-11.
'Three comment letters were received on the proposed rule, two from Agreement States' and one from a medical health physicist. All supported the proposed rule. Three comment letters were received on PRM-35-11. Each of the
-letters supported the petition.
The Federal Register Notice on the proposed rule specifically asked for comment on whether to adopt a requirement to inform an individual of the error in the case of administration of a radiopharmaceutical to the wrong individual, but in a quantity below the misadministration threshold. Section 35.33 generally requires notification of the individual in the case of a misadministration. However, if the dose or the amount is less than the misadministration threshold, 5 35.33 does not require that the individual who received an administration of a radiopharmaceutical by mistake be notified of the error. One fundamental difference in the case in which the wrong individual receives the administration is that, unlike the intended patient, who it may be argued may have been informed that he or she will be exposed to radiation and has thereby implicitly or explicitly consented to the procedure, the wrong individual has generally not consented to any radiation dose at all.
The 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 Draft: April 5,-1995 4 Attachment 1 1
almost always would notify the individual of the mistake. However, the NRC specifically asked whether Part 35 should require that the individual be notified of the error regardless of the dose that would be received.
The comments addressed this question. One favored an NRC regulation requiring notification of the individual regardless of the nose. The other, an Agreement State, opposed a requirement because it would not be consistent 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 that it agrees with this commenter and is not changing its notification requirements.
III. Summary of the Changes.
Neither the comments received nor any other information available to the Commission provide any reasons not to adopt the amendments substantially as proposed, which would regulate administrations to individuals under Part 35 and not Part 20. Therefore the NRC is adopting the amendments as described below.
To clarify the meaning and intent of Part 20, the NRC is amending the Scope of Part 20, the definitions of public dose and occupational dose, and the wording in i 20.1301(a)(1) on public dose limit to clarify that the dose limit for individual members of the public does not apply to dose contributions from any medical administration the individual has received.
Thus, the medical administration of radioactive materials or radiation to any individual, even an individual not supposed to receive an administration, is Draft: April 5, 1995 5 Attachment 1
not' subject to the public dose limit in 5 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 P
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. For consistency, in terminology between parts, the word " patient" in the definition of misadministration in 5 35.2, " Definitions," and in certain locations in paragraph (a)(2) of 5 35.33 are replaced by the word " individual." j In 5 20.1002, the phrase "for the purpose of medical diagnosis and therapy" is replaced by the phrase "any medical administration the individual ;
has received." The existing wording raised the question of whether an i
administration was within the scope of Part 20 if the administration had no i valid medical purpose. The new wording makes it clear that regardless of the l
purpose or lack of purpose, dose to an individual from any medical l administration the individual has received is not within the scope of Part 20, but is within the scope of Part 35.
For the sake of consistency and clarity, the same words are used in 5 20.1002, " Scope," in 5 20.1003, " Definitions," (in the definitions of both public dose and occupational dose), and in 5 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 il 20.1002 and 20.1003 are added to i 20.1301(a).
Draft: April 5, 1995 6 Attachment 1
The existing 5 20.1301(a) also excludes dose contributions from the licensee's disposal of radioactive material into sanitary sewerage. That exclusion was not be added to 55 20.1002 and 20.1003 because the question of dose from sewer disposal of radioactive material is now under consideration by ,
the NRC. When that issue is resolved, it is intended that the wording concerning dose from sewer disposal will be made consistent in 55 20.1002, 20.1003, and 20.1301(a).
A 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 5 20.1301(a)(1). When that amendment of 5 20.1301(a)(1) is published in final form, the wording on what is excluded 1 from the dose limit will be inserted in 55 20.1002 and 20.1003 (in the definitions of public dose and occupational dose) so that the same parallelism will exist throughout.
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 rule is consistent with this statement because it continues to provide for ad,ainistrations of radioactive materials to be regulated under 10 CFR Part 35. The rule further clarifies that additional regulations are not considered necessary. ,
Draft: April 5,1995 7 Attachment 1
The second statement of the policy states, "The NRC will regulate the radiation safety of patients where justified by the risk to patients and where voluntary standards, or compliance with these standards, are inadequate." The rule is consistent with the statement because it clarifies that existing requirements concerning misadministrations continue to be concentrated on administrations having the greatest risk significance.
The third statement of the policy states, "The NRC will minimize intrusion into medical judgements affecting patients and into other areas traditionally considered to be a part of the practice of medicine." The rule is consistent with this statement because it limits its specific regulatory requirements for notification to the most serious errors in administration and minimizes requirements on errors in administrations that have less risk significance.
Thus, the rule is considered to be consistent with the 1979 medical policy statement.
The subject of this final rule was discussed with the NRC's Advisory i
Committee on Medical Uses of Isotopes (ACMUI) on May 11, 1995. The ACMUI ;
I 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. ,
l l
i Draft: April 5, 1995 8 Attachment 1 l
l 1
This rulemaking was discussed with representatives of Agreement States at a meeting in Portland, ME, on October 24, 1994. The States were polled on I how they regulated an administration to the wrong individual, and it was found 3 that they regulate the administration the same way as in this rule. Two States commented on the rule, and both fully supported the rule.
- The NRC believes that the modification of Part 20 should be a Division 1 matter of compatibility consistent with past practice of requiring basic
]
j definitions to be uniform for effective communication of basic radiation l
concepts. The only Agreement State commenting on the compatibility issue ,
- t supported a Division 1 level.
i VI. Finding of No Significant Environmental Impact.
The NRC has determined under the National Environmental Policy Act of I 1969, as amended, and the Commission's regulations in Subpart A of Part 51, that this rule is not be a major Federal action significantly affecting the ,
quality of the human environment. Therefore, an environmental impact statement is not required.
i The NRC prepared an environmental assessment for the proposed rule, l which was contained within the Federal Register Notice for that rule. That
! assessment continues to stand for the final rule.
t a
VII. Paperwork Reduction Act Statement.
This rule does not contain a new or amended information collection requirement subject to the Paperwork Reduction Act of 1980 Draft: April 5, 1995 9 Attachment 1 e ~ , . . . . -
(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.
i VIII. Regulatory Analysis, j The regulatory analysis prepared for the proposed rule and published as !
j part of the Federal Notice on the proposed rule is still valid for this final rule. 7 IX. 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.
X. Backfit Analysis.
The NRC has determined that the backfit rule, 5 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 550.109(a)(1).
XI. List of Subjects. I Draft: April 5, 1995 10 Attachment 1 i
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 i disposal.
10 CFR Part 35 Byproduct material, Criminal penalties, Drugs, Health facilities, Health professions, Medical devices, Nuclear materials, Occupational safety and health, Radiation protection, Reporting and Recordkeeping requirements.
For the reasons set out in the preamble and under the authority of ]
the Atomic Energy Act of 1954, as amended; the Energy Reorganization Act of 1974, as amended; and 5 U.S.C. 553; the NRC is proposing to adopt the following amendments to 10 CFR parts 20 and 35.
PART 20--STANDARDS FOR PROTECTION AGAINST RADIATION i
! 1. The authority citation for part 20 continues to read as follows:
! Authority: Secs. 53, 63, 65, 81, 103, 104, 161, 182, 186, 68 Stat. 930, 933, 935, 936, 937, 948, 953, 955, as amended (42 U.S.C. 2073, 2093, 2095, 2111, 2133, 2134, 2201, 2232, 2236), secs. 201, as amended, 202, 206, 88 Stat.
- 1242, as amended, 1244, 1246 (42 U.S.C. 5841, 5842, 5846).
- Draft: April 5, 1995 11 Attachment 1 t
.l
- 2. Section 20.1002 is revised to read as follows:
1 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 medic?1 administration the individual has received, or due to voluntary participation in medical research programs.
- 3. In 5 20.1003, the definitions of occupational dose and public dose are revised to read as follows:
i 20.1003 Definitions.
Occupational dose means the dose received by an individual in a restricted area or in the course of employment in which the individual's assigned duties involve exposure to radiation and to radioactive material from licensed and unlicensed sources of radiation, whether in the possession of the licensee or other person. Occupational dose does not include dose received from background radiation, from any medical administration the individual has received, from voluntary participation in medical research programs, or as a member of the general public.
Draft: April 5, 1995 12 Attachment 1
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 5 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 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 5 20.2003.
- 5. The authority citation for part 35 continues to read as follows:
Draft: April 5, 1995 13 Attachment 1
IE ,
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 5 35.2, the definition for misadministration is revised at paragraphs (1)(i), (2)(1), (3)(1), (4)(i), (5)(i), (6)(i), and (6)(ii) by removing the word "patlent" and inserting the word " individual."
- 7. In i 35.33, paragraph (a)(2) is revised to read as follows:
4 1
Section 35.33 Notifications, reports, and records of misadministrations.
(a)
(2) The licensee shall submit a written report to the appropriate NRC Regional Office listed in 10 CFR 30.6 within 15 days after discovery of the misadministration. The written report must include the licensee's name; the prescribing physician's name; a brief description of the event; why the event occurred; the effect on the individual; what improvements are needed to prevent recurrence; actions taken to prevent recurrence; whether the licensee notified the individual, or the individual's responsible relative or guardian (this person will be subsequently referred to as the patient in this section), and if not, why not, and if the patient was notified, what information was provided to the patient. The report must not include the patient's name or other information that could lead to identification of the patient.
Dated at Rockville, Maryland, this day of , 1995.
Draft: April 5, 1995 14 Attachment I
For the Nuclear Regulatory Commission.
John C. Hoyle, Secretary of the Commission.
l Draft: April 5, 1995 15 Attachment 1
=
4872 "wleril Regist:r / Vol. 00. No. to / Wednesday, January 25, 1995 / l'roposed Rules 4
l NUCLEAR REGULATORY COMMISSION i 10 CFR Parts 20 and 35 RIN 3150-AF10 Medical Administration of Radiation and Radioactive Materials i AGENCY: Nuclear Regulatory \
Commission.
ACTION: Proposed rule, j __. j
' SUMARY:The Nuclear Regulatory ;
Commission is proposing to amend its 'l
. regulations to clarify that the medical 1
t, J
Fzderal Register / Vol. 60, No.10 / Wednesday, January 25, 1995 / Proposod Rules 4873 administration of radiation or The misadministration of diagnostic radiopharmaceutical because radioactive materials to any individual, radiopharmaceuticals is dealt with in of an error on the part of the physician even an individual not supposed to NRC regulations in 10 CFR part 35, requesting the test. In that particular receive a medical administration,is " Medical Use of Byproduct Material." case the dose to the individual receiving regulated by the NRC's provisions As defined in S 35.2, misadministrations the administration was below the governing the rnedical use of byproduct include administrations of licensed threshold for reporting of the material rather than the dose limits in radioactive material or the radiation misadministration, but above the 0.1 the NRC's regulations concerning therefrom to the wrong individual, rem (1 millislevert) dose limit in standards for protection against using the wrong radiopharmaceutical, in $ 20.1301(a)(1) for a member of the radiation.The proposed rule does not the wmng amount, by the wrong route, public. Was there a violation of represent a change in policy, but is or to the wrong treatment site. " Itis S 20.1301(a)(1) or do the words in the
, necessary to ludicate clearly that this is proposed rule only concerns scope of part 20 exclude this event from the NRC's pc! icy and to clarify the administrations to the wrong individual. being subject to the dose limits in part relationship of NRC's regulations. An administration to the wrong 20? In other words, does the exclusion DATES:The comment period expires individual is a misadministration, as from the part 20 dose limits exclude any April 10,1995. Comments received after defined in S 35.2,ifit involves:(1) A medical administration to any this date will be considered ifit is radiopharmaceutical dosage greater than individual, even an individual not practicable to do so, but the 30 rnicmcuries of either sodium iodide supposed to receive an administration?
Commission is able to assure 1-125 or 1-131; (2) any therapeutic 1 he Commission concludes that, in consideration only for comments administration other than sodium general, the administration of received on or before this date. iodide I-125 or I-131;(3) any gamma radiopharmeceuticals should be ADDRESSES: Send comments fo; stereotactic radiosurgery radiation dose; regulated by part 35 rather than part 20.
Secretary, U.S. Nuclear Res;ulatory (4) any teletherapy dose:(5) any 111e medical administration of brachytherapy radiation dose; or (6) a radioactive materials is a very special Commission.
NITN: DocketingWashinfton, an Service 11 DC 20555. diagnostic radiopharmaceutical dosage, use of radioactive matenals that is best ranch.
liand deliver comments to: 11555 other than quantitles greater than 30 dealt with by specific regulations Rockville Pike, Rockville Maryland microcuries of either sodium iodide 1- covering those administrations. In between 7:45 am and 4:15 pm on 125 or 1-131, when the dose to the particular, the Commission believes that
, Foderal workdays. individual exceeds 5 rems effective dose an administration to any individual is Examine comments received at: The equivalent or 50 rems dose equivalent to and should be subject to the regulations NRC Public Document Room 2120 L any individual organ. The practical in part 35. This was the Commission's a
Street NW, (Lower level), Washington, effect of this definition of a intent when the current 1
DC. misadministration is that some misadministration requirements were FOR FURTNER INFORMATION CONTACT: relatively low dose diagnostic adopted in the final rule," Quality
) Stephen A. McGuire Office of Nucher admmistrations of radiopharmaceuticals Management Programs and 1 Regulatory Research, U.S. Nuclear jo mdividuals for whom they were not Misadministrations," (July 25,1991;56 Regulatory Commission, Washington, intended are not misadmirustrations as FR 34104) and continues to be the defined in S 351 DC 20555, telephone (301) 415-6204.
Commission's intent.
1 If a misadmuustration occurs, S 35.33 In establishing which errors in SUPPLEMENTARY INFORMATION: requires that the NRC, the referring administration should be under the I Dodgmund physidan, and the individual receiving misadministration reporting
! II. Sununary of the Propowd Changes. the administration (or a responsible requirements, the NRC sought to
, Ill. Request for Comment on Notification. relative or guardian) be informed of the optimize the cost sffectiveness of the 4
IV. Cemsistency With the 1979 Medical misadministration (unless the referring rule by concentrating its regulatory Policy Statement and Coordination With physician makes a decision based on requirements on those events with the ACMUI. medical judgement that telling the greatest risk and placing fewer V. Coordination With and issue of individual or responsible relative or {
Compatibility With Agreement States. requirements on those with relatively 1
VI. Finding of No Significant Envimnmental guardian would be harmful.)If the dose low risk, such as most diagnostic uses t from a diagnostic administration to the of radicpharmaceuticals. In the final VII. roL u n Act Statement. wrong individual does no rule on " Quality Management Programs Vill. Regulatory Analysis. threshold for a m,sadmim,t exceed stration, the the i and Misadmmistrations"(July 25,1991; IX. Regulatory Flexibihty Certification. administration is not a 56 FR 34104), the Commission stated X.11adfit Analysis. misadministration as defined in 5 35.2, that the proposed requirements that
" "" and part 35 does not require notification would have had minimalimpact on risk l of the NRC or the individual. were eliminated to make the final rule !
Radioactive materials are Separate from the requirements for more cost effective (e g., deleting the administered in the practice of medicine misadministrations, S 20.1301(a)(1) diagnostic components of the proposed to roughly a to 9 million patients per contains a dose limit for members of the rule).
year for the diagnosis or treatment of public of 0.1 rem (1 millisievert). In reaching its conclusion, the disease. Occasionally, a radioactive flowever, the scope of part 20 in Commission recognized that in the material is administered by mistake to S 20.1002 states that,"The limits in this event of adrninistration of radioactive an individual for whom it is not Part do not apply to doses due * *
- to material to the wrong individual, the intended. For the years 1989 and 1990 exposure of patients to radiation for the ability to control the dose to that l combined, the NRC is aware of about purpose of medical diagnosis or individual has been lost. One cannot l 200 cases out of 5 to 6 million therapy. * * *" decide to terminate the exposure at a administrations performed under NRC A question arose about the certain point to prevent exceeding a license in which a diagnostic applicability of those wonis in a specific dnse limit. Therefore, the relevant radiopharmaceutical was administered case in which an individual rnistakenly questions are: What steps are to the wrong individual. received an administration of a appropriate to reduce the likelihood of l
I
41174 F d ril R gist:r / Vol. 00. No.16 / Wednesday, January.25,1995 / Proposed Rules '
.. _ i on administration to the wrong II. Summary of the Proposed Changes licensee's disposal of radioactive individual: what corrective actions To clarify the meaning and intent of material into sanitary sewerage. That a should be taken if the mistake occurs: part 20, the NRC is proposing to amend exclusi n w uld not be added to and what regulatory response is SS 20.,1002 and 20.1003 because the
}
the scope of part 20, the definitions of appropriate if such a mistake occurs? ".S'*" of dose from sewer disposal of public dose and occupational dose, and 9"dioactn. .
IEch of these questions was dealt the wording in S 20.1301(a)(1) on public ra e materialis now under ;
with in developing the rule on quality c nsideration by the NRC. When that -
dose limit to clarify that the dose limit management programs and for individual members of the public issue is resolved, it is intended that the j misadministrations. The Commission w rding concerning dose from sewer does not apply to dose contributions ,
considered,in the rulemaking on P de "
from any medical administration the 20IO0 003ab2 01 )
quility management program and individual has received. Thus, the ~
misadministrations, what steps should Another'recently publishad proposed medical administration of radioactive '
he taken to avoid the administration of materials or radiation to any individual
- rule radioactive materials to an individual which(June deals15 with1994; 59for criteria FR 30724)[elease ,
the $
even an individual not supposed to ofindividuals administered radioactive not supposed to receive the .
receive on administration, is not subject material, would also amend administration. Those steps are to the public dose limit in ~
contained in 6 35.32, Quality S 20.1301(a)(1). When that amendment S 20.1301(a)(1), but is within the scope of S 20.1301(a)(1) is published in final .
m nagement program., In adopting of part 35, those requirements, the Commission - form, the wording on what is excluded '
The proposed changes in part 20 from the dose limit will be inserted in i decided to apply the requirements in would replace the word " patient" with S 35.32 only to administrations with the the word " individual." The word SS 20.1002 and 20.1003 (in the I definitions of ublic dose and potintial for relatively high doses and to " patient" has sometimes been taken to occupational c[ose) so that the same exclude most diagnostic administrations mean only the individualintended to i from the requirements. For those parallelism will exist throughout, receive the administration. At other in addition, another proposed rule '
dirgnostic administrations not covered times, the view has been that anyone (February 3,1994; 59 FR 5132) would '
by S 35.32,it was considered adequate who receives a medical procedure is a amend the definitions of public dose to rely on the normal and traditional " patient." Replacing " patient" with and occupational dose in 10 CFR part methods and techniques that medical " individual" would clarify that the 20. Ilowever, that proposed rule would c re providers use to ensure that statement refers to anyone receiving a only amend the first sentence in the medications are given to the right medical administration. For
- definitions and would not change the individual in the right amount at the consistency,in tenninology between right time.
wording associated with what is i parts, the word " patient" in the ' excluded from public dose. Therefore, Similarly, the NRC's requirements definition of misadministration in this proposed rule and that proposed that licensees take appropnate S 35.2, " Definitions," and in certain rule do not cer.f!ict.
corrective actions in response to a locations in paragraph (a)(2) of S 35.33 misadministration are contained in would he replaced by the word 111. Request for 02mment on S 35.32. The specific requirements " individual." N tificatmn ,
dealing with conective actions apply to In S 20.1002. the phrase "for the Another questio., : elated to tho ,
any administration requiring a quality purpose of medical diagnosis and administration of radioactive materials management program. therapy" would be replaced by the to the wrong individual concerns With regard to the appropriate phrase "any medical administration the informing the individual of the error. ,
regulatory response to mistakes in Individual has received." The existing Section 35.33 generally requires administrations, the Commission wording raised the question of whether notification of the Individualin the caso decided that violation of the quality an administration was within the scope of a misadministration, flowever,if the ,
- management program requirements. of part 20 if the administration had no dose or the amount is less than the ,
which apply to the more significant valid medical purpose.The proposed misadministration threshold,9 35.33 administrations, were significant wording would make it clear that does not require that the individual who a enough that they may result in a civil regardless of the purpose or lack of received an administration of a 1 penalty. purpose, dose to an individual from any radiophannaceutical by mistake be i Thus,in t' a quality management medical administration the individual notified of the error. One fundamental program and misadministations has received is not within the scope of difference in the case in which the ,
rulemaking, the Commission clearh part 20. but is within the scope of part wrong individual receives the addressed the issue of when the 35. administration is that, unlike the i administration of a radioactive material For the sake of consistency and intended patient, who it may be argued .
to the wrong individual was sufficiently clarity, the same words would be used may have been informed that he or she ,
significant to warrant cedain actions. In S 20.1002," Scope,"in S 20.1003, will be exposed to radiation and has 1 Specific thresholds were established " Definitions."(in the definitions of both thereby implicitly or explicitly a und codified to reflect the Commission's public dose and occupational dose), and consented to the procedure, the wrong ,
view of a reasonable balance between in S 20.1301. " Dose limits for individual individual has generally not consented j harm and burden. In particular, the members of the public." Also for to any radiation dose at all. The Commission concluded that lower consistency and clarity, the exclusion of question then becomes, should part 35 thresholds would not significantly dose from background rediation and require that the individual be notif;ed of i reduce risk and would divert resources from voluntary participation in medical the error regardless of the dose that '
that should be directed toward reducing research programs that are now would be received?
the more serious of thoso errors. The included in $5 20.1002 and 20.1003 The Commission was divided on Commission continues to endorse the would be added to S 20.1301(a). whether the individual should he '
indgement that it made in that The existing 5 20.1301(a) also notified. The NRC's Advisory rolemaking. excludes do ;e contributions from the Conunittee on Medical tIses ofIsotopes '
Fedirzl Register / Vol. 60, No.16 / Wednesday, January 25, 1995 / Proposed Rules 4875 (ACMUI) has assured th , NRC that requirements for notification to the most The NRC has not prepared a separate -
standard medical practice is that a serious errors in administration and environrnental assessment. The physician who becomes aware that a minimizes requirements on errors in following discussion constitutes the medical procedure has been performed administrations that have less risk assessment. The proposed rule would on the wrong individual should and significance. not change the NRC's requirements almost always would notify the Thus, the proposed rule is considered concerning the administration of individual of the rnistake. The current to be consistent with the 1979 medical radiation and radioactive materials.
quality management program and policy statement. Those requirements are and would misadministrations rule does not The subject of this proposed rule was continue to be contained in part 35 of .
require the physician to notify the discussed with the NRC's Advisory the NRC's regulations. When the individual if the dose or am,unt is Committee on Medical Uses ofIsotopes potential ambiguity concerning below the threshold for a (ACMUI) on May 19,1994. The ACMUI application of part 20 and part 35 misadministration. The NRC is now agreed that medical administrations, requirements was recognized, the seeking comment on whether it should including those to an individual not Commission specifically informed the -
continue to rely on standard medical supposed to receive an administration, staff ofits view that the proper practice below the misadministration should be regulated by part 35 rather interpretadon was that the more specific threshold or whether it is appropriate to than part 20. The ACMUI stated that part 35 requirements should govern all impose an NRC requirement for notification of an individual of an error medical administrations cnd directed notification below the in administration below the that action be taken to remove from the misadministration threshold if the misadministration threshold is the regulations any ambiguity on this issue.
administration is to the wrong . current practice and should not be The staff has, accordingly, not individual. For example, the NRC regulated. interpreted $ 20.1301(a)(1) as applying would like comments on whether a to any medical administrations, but has -
broider notification requirement would V. Coordination With and Issue of Compatibility for Agreement States Proceeded with this rulemaking to implicitly impose recordkeepmg and remove any ambiguity in the procedural requirements upon licensees .This proposed rulemaking was regulations. The proposed rule would beyond those explicitly set forth in part discussed with representatives of merely amend part 20 to make it clear
- 35. Agreement States at a meeting. that part 20 does not address medical - I
" Organization of Agreement State administrations. Thus, the proposed IV. Consistency With the 1979 Medical Managers Workshop and Public Meetin8 rule, if adopted, would clarify the NRC's i
)
Policy Statement and Coordination on Ru'amaking," in IIerndon, VA, on With ACMUI re ufrements rather than change them, july 12,1994. There was some concern an there would be no environmental On February 9,1979 (44 FR 8242), the that the NRC approach was different impact.
NRC published a Statement of General from how State regulations address VII. Paperwork Reduction Act policy on the Regulation of the Medical inadvertent x-ray exposures, but no Uses of Radioisotopes. The first strong opposition. The proposed rule Statement ;
statement of the policy states,"The NRC was revised to address the concerns of This proposed rule does not contain I will continue to regulate the medical the States and then discussed at a a new or amended information uses of radioisotopes as necessary to subsequent meeting of the Agreement collection requirement subject to the provide for the radiation safety of States in Portland. ME, on October 24, Paperwork Reduction Act of 1980 (44 workers and the general public." The 1994. The States were polled on how U.S.C. 3501 et seq.). Existing proposed rule is consistent with this they regulated an administration to the requirements were approved by the statement because it continues to wrong individual, and it was found that Office of Management and 13udget, provide for administrations of they would regulate the administration approval numbers 3150-0014 and 3150-radioactive materials to be regulated l the same way as in this proposed rule. 0010. '
under 10 CFR part 35. The proposed The NRC helieves that the proposed rule further clarifies that ' additional modification of part 20 should be a Vill. Regulatory AnalIsis !
i regulations are not considered mvision 1 matter of compatibility The regulatory analysis for this I necessary. con irtent with past practice of proposed rulemaking is as follows:
The second statement of the policy rwiring basic definitions to be uniform J. Alternatives states, "The NRC will regulate the fer effective communication of basic radiation safety of patients where reliation concepts. The Commission Alternatw.e 1:Part 20 Regulates Doses to justified by the risk to patients and specifically requests comments on Wrong Individuals where voluntary standards, or whether the proposed modification to in this alternative, a medical compliance with these standards, are part 20 should be made a Division 1 administration of radiation or inadequate." The proposed rule is matter of compatibility, radioactive material to an individual consistent with the statement because it . .
when no administration is intended that clarifies that existing requirements \,I. I.inding of No Sigmficant results in a total effective dose concerning misadministrations continue Environmental Impact equivalent greater than 1 millisievert to be concentrated on administrations The NRC has determined under the (0.1 rem) would be a violation of having the greatest risk significance. National Environmental Policy Act of S 20.1301. If the event did not meet the The third statement of the policy 1969, as amended, and the threshold definition of a states, "The NRC will minimize Commission's regulations in subpart A misadministration, NRC would receive a intrusion into medical judgernents of part 51, that this rule,if adopted, notification of the event from the affecting patients and into ether areas would not be a major Federal action licensee pursuant to S 20.2203," Reports traditionally considered i > be a part of significantly affecting the quality of the of exposures, radiation levels, and the practice of medicim ," The proposed human environment. Thernfore, an concentrations of radioactive material rule is consistent wiin this statement environmental impact stuement is not exceeding the limits" and the individual because it limits its specific regulatory required. involved would receive notification of I 4
I
1 0 t 1
4876 Federal Register / Vol. 60 No.16 / Wednesday, January 25, 1995 / Proposed Rules the exposure from the licenseo pursuant 2. Impact of Proposed Action PART 20--STANDARDS FOR ,
to S 19.13(d). " Notifications and reports PROTECTION AGAINST RADIATION toindividualsw Licensees. There is no anticipated Under this alternative, notification i Pact on licensees, except that 1.The authority citation for part 20 licensees will more clearly understand continues to read as follows:
and recordkeeping requirements of to CFR parts 19 and 20 would apply to the the meanings of the regulations. Authority: secs. 53,63.65,81,103.t04, medical administration of radiation or radioactive material to the wrong Individuals. There is no anticipated impact on an individual because this gQ ta
, oj3393'fsb e q2t i 2073.2093.2095.2111.2133,2134,2201.
mdividual that involves a dose to the action will not increase or decrease the 2232. 22361. secs. 201, as amended. 202,206 individual above 1 millislevert (0.1 rem) error rate foi administrations of as Stat.1242, as amended, 1244.1246(42 but less than the threshold definition of radiation or radioactive material, ti.S C. 5841. 5842. 5846).
a misadministration. 2. Section 20.1002 is revised to read NRC Resources. No NRC resources I
Alternative 2:Part 35 Regulares Doses to would be required to implement the as follows:
a rung mumuuals rule.
5 20.1002 scope.
In this alternative, the medical IX. Regulatory Flexibility Certification The regulations in this part apply to administration of radiation or persons licensed by the Commission to radioactive material to any individual As required by the Regulatory receive, possess, use, transfer, or would be the exclusive province of the Flexibility Act of 1980,5 U.S.C. 605(b), dispose of byproduct, source, or special regulations in 10 CFR part 35. Section the NRC certifies that,if adopted, this nuclear material or to operate a < <
20.1301 would not be applicable. Under proposed rule would not have a production or utilization facility under a l this alternative, errors in the significant economic impact on a parts 30 through 35,39,40.50.60,61, <
administration of radiation or substantial number of small entities. 70, or 72 of this chapter. The limits in < !
radioactive material to individuals The impact of the revised regulation this part do not apply to doses due to < l would be subject to the reporting and would not be significant because the background radiation, due to any notification requirements of 10 CFR part proposed amendmnt represents a medical administration the individual 4 j 35 rather than the reporting and continuation of current practice and has received, or due to voluntary notification requirements in 10 CFR merely clarifies existing requirements. participation in medical research 1 parts 19 and 20. This alternative is programs. i consistent with the Commission's X, BacMit Analys.is 3. In S 20.1003, the definitions of {
determination, published in the rule on The NRC has determined that the Occupational dose and Public dose are i quality management programs and backfit rule,6 50.109, does not apply to revised to read as follows: 4 misadministrations (July 25,1991; SG I R 34104), that licensees should direct this proposed backfit analysis isrule and, therefore, not required for this that a .$ 20'1003 Dennitions' .
their resources toward ireventmg the pr p sed rule, because tIiese more serious errors in the Occupational dose means the dose l amendments do not involve any received by an individual in a restricted administration of byproduct material. i llowever, there would be no pr visi ns which would impose backfits area or in the course of employment in 85( " n 8 -
which the individual's assigned duties requirement in the event of errors in the <
administration of byproduct material to List of Subjects involve exposure to radiation and to individuals who were not intended to radioactive material from licensed and 10 CFR Part 20 unlicensed sources of radiation, receive any administration for the medical licensee to notify either the whether in the possession of the Byproduct material, Criminal "'"""""'
NRC or the individual of the ermr er pm n. Owupadonal penalties. Licensed material, Nuclear dose does not m.clude dose received unless the error meets the threshold materials Nuclear power plants and ,
definition of a misadministration in " *"" '" " "' * ""Y l reactors. Occupational safety and *" " "" " '" . ""
$ 35.2. In general, standard medical practice is that a physician wh health, Packaging and containers' d as mey" """mm v luntary (
Radiation protection, Reporting an participation in medical research hecomes aware that a medical procedure rec rdkeeping requirements Special programs, or as a member of the general has been performed on the wrong nucle r material Source material, n,aste public.
individual would notify the individual l treatment and disposal. . . .
of the mistake. . .
10 CFR Part 35 Public dose means the dose received Preferred Alternative by a member of1he public from '
Alternative 2 (Part 35 is controlling)is Hyproduct material, Criminal eiposure to radiation and to radioactive preferable because it maintains the penalties. Drugs,llealth facilities, material released by a licensee, or to intent of the rulemaking on quality
- llealth professions, Medical devices, another source of radiation either within management programs and Nuclear materials, Occupational safety a licensee's controlled area or in misadministrations by concentrating and health, Radiation protection, unrestricted areas. It does not include i regulatory requirements on those es ents Reporting and recordkeeping occupational dose or doses received ,
with the greatest risk and placing fewer requirements. For the reasons set out in from background radiation, from any requirements on those with relatively the preamble and under the authority of medical administration the individual ,
low risk, such as most diagnostic uses the Atomic Energy Act of1954, as has received, or from voluntary
! of radiopharmaceuticals. Also, this amended: the Energy Reorganization participation in medical research )
(
alternative would allow the Commission Act of 1974, as amended: and 5 U.S.C. programs. .
to treat all medical administrations of 553: the NRC is proposing to adopt the *
- a a a i licensed material consistently under the following amendments to 10 CFR parts 4. In % 20.1301, paragraph (a)(1) is l regulations in Part 35. 20 and 35. resised to read as follows: 4
Fed:rci Regist:r / Vol. Go, No.16 / Wednesday, January 25, 1995 / Proposed Rules 4877
$ 20.1301 Dose INits for Individual members of the public.
(a) * * *
(1) The total effective dose equivalent to individual members of the public from the licensed operation does not -
exceed 0.1 rem (1 mSv) in a year, exclusive of the dose contributions from background radiation, any medical administration the individual has received, voluntary participation in medical research programs, and the lic;nsee's disposal of radioactive material into sanitary sewerage in accordance with 6 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 smended (42 U.S.C 5841).
- 6. In 5 35.2, the definition for i misadministration is revised at paragraphs (1)(1), (2)(i), (3)(i), (4)(i),
(5)(1), (G)(1), and (6)(11) by removing the word " patient" and inserting the word
" individual."
- 7. In $ 35.33, paragraph (a)(2) is revised to read as follows:
$ 35.33 Notifications, reports, and records af misadministrations.
(a) * ' * *
(2) The licensee shall submit a written report to the appropriate NRC Regional Office listed in 10 CFR 30.6 within 15 days after discovery of the misadministration. The written report must include the licensee's name: the prescribing physician's name; a brief description of the event; why the event occurred; the effect on the individual what improvements are needed to 1
prevent recurrence; actions taken to i prevent recurrence; whether the licensee notified the individual, or the individual's responsible relative or i 4
guardian (this person will be i subsequently referred to as "the patient" in this section), and if not why not, and if the patient was notified.uhat 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. Mary'. tend. this 19th day oflanuary 1995.
For the Nuclear Regulator) Comminion.
John C lloyle.
Acting Serretary of the Commissimt lFR D ac. 95-1817 Filed 1 2 4 -% 8 45 aml '
StLLNG CODE 759041-P 1
.\l ALLINCKRODT DOCKET NUMBERnn DOCKETED PROPOSED RULE rn ao. M -
Nuclear Medicine USHRC Goo?R.@a16)
~95 FEB -7 P 3 :03 i
Malbmkrtxit Medical,Inc. l OFFICE Di O CPF W NMA Medul Physics Consuluton I
" 9457 Mid = ^*""e
' DOCXEIn - -
Garfield Heights, Ohio 44125 1,' Jgf ,.
Telephone (216) 663-7000 February 2,1995 racswac (216) 6656234 ,
l l
I Secretary U.S. Nuclear Regulatory Commission Washington, D.C. 20555 Attn: Docketing and Service Branch i RE: RIN3150-AF10
. l l
To Wnom 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?
[L entirety. As described in the Federal Register publication, the administration of a radiopharmaceutical or radiation dose to the wrong individual should be regulated by '
I 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 35lshould>
irequire that, .when the' wrong individual receives an administration,e the individual <
[should be notified of the error. It is agreed that it is current practice that such individuals are routinely notified, in such cases, the requirement to notify the individual would not pose any additional requirements on the licensees. However, t;there; are those who _woul'1 attempt to: keep.this. Information from the~ individual.
(Considering the trend in right-to-know laws, the NRC should' assure the' appropriate:
(information is provided to the individual. As all therapeutic administrations to the w .oa 1 ,
-o o
i I
wrong patient are currently considered misadministrations, only administrations of radiopharmaceuticals not currently defined as misadministrations, would need to be considered. . Pert 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 10ther than requiring a record of.the notification be made,.no other action I should be required of the licensee.e As regards whether the proposed modification to Part 20 should be made a Division i metter .of compatibility,;this should _b e so done. The basic definitions utilized by the
- States.must be uniform with the NRC and with each other in order for effective communication. This item should also be a Division I matter of compatibility to assure that the States address this basic concept in the same manner.
1 These comments represent my personal position. Thank you for considering these comments.
Sincerely, j
)
David Close Medical Health Physicist DC/kl I
P/Proprule.che I
i i
+
4 4
t
~_ - .
CABINET FOR HUMAN RESOURCES COMMONWEALTH OF KENTUCKY FRANKFORT 40621-0001 OOCE O i ,
USHht.
DEPARTMENT FoR HEALTH SERVICES March 7, 199b Y '
Of f K ,
c7[TARY ggcKEijh~:n,'.<
ri
'~
e A. . -
SECRETARY DOCKET NUMBERnD US NUCLEAR REGULATORY COMMISSION PROPOSED RULE rn glo+ w WASHINGTON DC 20555 gggq
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? support) Alternative 2 for; Parte 351to regulat'e' doses'Jto; wrong >
~
Eindividuals. .J If you require any additional comments, please contact me.
Sincerely, W $
Vicki D. Jeffs, Supervisor Radioactive Materials Section Radiation Control Branch VDJ/tg ag I '
7 "An Equal opportunity Employer M/F/H" h $c-j j g c c f ? , p ,
Georgia D partment of Natural Resources A
4244 International Parkway, Suitegbpel.pta, U Georgia u loe.D. Tanner, 30354 Commissioner
{JRJrld#F. Reheis, Assistant Director DOCKET NUMBER s "**"'""#f31$0T PROPOSED RULE N ach 95 tim 20 P3 :04 SONONIk0Xrch 17,1995 0FFIC. r v .u" DOCKEilh. 1 i ~ GT Secretary 9y 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 Recister in which the Nuclear Regulatory Commission (NRC) is proposing to amend its r6gulations 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.
> BasicallyTwelare 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 ofj c
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, h.
Thomas E. Hill, Manager Radioactive Materials Program TEll/kic 1
W+m+oa. 3 P P -
, e -
37950 Prcposed Rules ad-i w*-
Vol. 59. No.142 Tuesday July 26, 1994 This section of the FEDERAL REGISTER For a copy of the petition, writo the Report F (A-92)), submitted a petition contaens notices to the putdec of the proposed Rules Review and Directives Branch, for rulemaking to the NRC.The iss.ence et rules and regulations. The Division of Freedom of Information and petitioner also submitted CSA Report F purpose of these notices is to grve interested Publications Services, Office of in support of the petition. The petitioner P sone an opponung to part@e b the Administration, U.S. Nuclear Regulatory states that the medical use of inorganic
- "9 P" ' * "O P " ' 'h' # Commission, Washington. DC 20555, sodium Iun has been an effective The petition and copies of comments component of medical practice for over received may be inspected and copied 35 years. The petitioner also states that for a fee at the NRC Public Document radioactive biologicals, such as NUCLEAR REGULATORY Room,2120 L Street, NW. (Lower monoclonal antibodies lahdled with COMMISSION level). Washington, DC. I ui, have been added to the physician's 10 CFR Parts 20 and 35 FOR FURTHER INFORMATION CONTACT: armamentarium. The petitioner believes
- ' that the ability of the physician to Michael T. Lesar, Chief, Rules Review Section, Rules Review and Directives administer I un on an outpatient basis (Docket No. PRM-35-i t) has maintamed the accessibility and 11 ranch, Division of Freedom of American Medical Association Information and Publications Services, minimized the costs of these treatments.
Office of Administration, U.S. Nuclear According to the petitioner, patients ,
AGENCY:Nuchiar Regulatory Regulatory Commission Washington, treated with I un must contain no more l Commission. DC 20555, Telephone: 301-.415-7163 or than 30 mci total body activity before ACTION: Petition for rulemaking: Notice Toll Free: 800-368-5642. they may be released from the treatment ofrec'ipt. facility. The petit'oner states that SUPPLEMENTARY INFORMAllON: therapeutic use of I u s, particularly in
SUMMARY
- The Nuclear Regulatory Background the treatment of thyroid carcinoma, Commission (NRC)is publishing for often requires doses in excess of 30 mCl.
public comment a notice of receipt of a The petitioner states that in order t and may require doses as great as 400 petition for rulemaking, dated March 28, ,, provide adequate protection of pubhc mci 1994, which was filed with the health and safety" and to observe "the
, The petitioner states that because Commission by the American Medical pnnciple of keeping all radiation doses of 30 mci ofI un are substantially Association (AMA).The petition was exposures 'as low as is reasonably below the doses typically used to treat achievable,'
- the NRC has revised its thyroid carcinoma, treatment of up to docketed by the NRC on April 20,1994, and his been assigned Docket No. PRM- standards for protection against . 10.000 cancer patients annually with 35-11. The petitioner requests that the radiation. NRC proposed a revision of
, appropriate doses would require the NRC amend its regulations to recognize the regulations goveming radiation use hospitalization of the patients under the th:1 current medical practice concerning and exposure limits in 1976. revised regulation (10 CFR 20.1301).
thi therapeutic uses of I ui, particularly Modifications of the revised regulation The petitioner argues that this new in cutpatient settings, is effective and wem proposed in 1979,1980,.1983, radiation exposure limit set by the NRC safe for the public. The petitioner also 1985, and 1986. Revised regulations is inconsistent with medical experience requests that the NRC formally were published May 21,1991 (56 FR and is not necessary in order to protect recognize that adequate home 23360), to become effective June 21, the public from radiation hazards.The confinement precautions reduce the 1991 and to be fully implemented by petitioner states that the new radiation hazards associated with radioisotopes January 1,1993 (later extended to exposure limit will reduce bbth early sufficiently to eliminate the need for January 1,1994, see 57 FR 38588; -release of patients and the treatment of N he:pitalization following therapeutic August 26,1992).The petitioner states patients at home, thus creating ridministration of radiopharmaceuticals. that the section of the final rule relevant potentially avoidable hospital inpatient Tin petitioner also rei uosts that the to outpatient treatment with I ni or costs and burdens on the heahh care l
NRC increase the external radiation other radiophannaceuticals ($ 20.1301) delivery system.
limit for the public from 100 mrem / year reduces the radiation exposure limit to Suggested Changes to the Regulations to 500 mrem / year, the public from 500 mrem / year to 100 DATES: Submit comments by October 11, mrem / year. The petitioner requests that the The petitioner believes that 5 20.1301 following amendments to the NRC's 1994. Comments received after this date will have an adverse impact on the regulations be made:
will be considered if it is practical to do availability an8 the cost of treatment of 1. Remstate 5 20.107 from the so, but the Commission is able to assure thyroid disease, which will outweigh regulations in effect before the 1991 consideration ont for comments the advantages of reduced radiation amendments to Part 20. The added rmived on or be ore this date. exposure to the public. Therefore, the section would read as follows:
ADDRESSES: Submit Wntten comments petitioner requests that this provision be to the Secretary of the Commission, U.S. amended to restore the previous Sech.on 20Jo7 Me&amagnosis and Nuclear Regulatory Commission, Therapy.
external radiation limit of 500 mrem /
Washington, DC 20555, Attention: year. Nothing in the regulations of this part Docketing and Service llranch. Hand . shall be interpreted as limiting the deliver comments to: 11555 Rockville Petition intentional exposure of patients to Pike, Rockville, Maryland, between 7:45 The AMA, following a report ofits radiation for the purpose of medical am cnd 4:15 pm Federal workdays. Council on Scientific Affairs (CSA diagnosis or medical therapy.
~
Fedtrzl Regist r / Vol. 59, No.142 / Tuesday, July 26, 1994 / Proposed Rules 37951
- 2. Section 35.75 should be revised to radioisotopic materials that have For the Nuclear Reguistory Commission.
read as follows: routinely been performed on an John C. flayle, outpatient basis would require Acting Secretary of the Commission.
ntoln/rg ad p a ac u o s or hospitalizati n f rregu at ry rather lFR Doc. 94-18112 Filed 7-25-94; a 45 ami Permanent Implants. than medical reasons. She also beheved .wuo com rm w that enforced bospitalization would
- A licensee may not authorize release significantly increase the cost of fiorn confinement for medical care any medical care and possibly result m the DEPARTMENT OF LABOR patient administered a patient's inability to roccive that care.
radiopharmaceutical or a permanent Occupational Safety and Health On October 5,1991, the American implant until the measured dose rate Administration from the patient is less than 5 millitems Colh ge of Nuclear Medicine ( ACNM) per hout at a distance of one meter or filed a petition for rulemaking with the 29 CFR Part 1926 the cumulative dose to individual NRC (PRM-35-10). On April 14,1992, members of the public will be less than the ACNM filed an amendment to its Steel Erection Negotiated Rulemaking 500 millfrems per year. original petition (PRM-35-10A). The Advisory Committee ACNM requested that the NRC adopt a 3, in 5 35.310(a), the introductory text dose limit of 500 mrem / year for AGENCY: Occupational Safety and Health of paragraph (a) should be revised t Administration (OSHA), Department of nonpatients and permit licensees to read as follows: Labor.
authorizo release from hospitalization Section J5.310 SafetyInstruction. any. patient administered a ACT60N: Notice of meetings and agendas.
(a) A licensee s aH provid radiopharmaceutical regardless of the suuMAny: Under the provisions of the act vity in the patient by defining Federal Advisory Committee Act IIs cti n I r al rs el car ng for "wnfmenmnt" to triclude not only (FACA), notice is hereby given of the the patient receiving confinement in a hospital, but als confinement in a private residence. The schedule of two Committee meetings of the Steel Erection Negotiated ,
rr for con w th 5.75 of ACNM stated that their request is in the Rulemaking Advisory Committee this chapter. best interest of patients who require (SENRAC). Notice is also given of the
- * , access to affordable quality care while allowing them to be diagnosed and locations and agendas for the meetings. l
- 4. In $ 35.315(a), the inytroductory treated on an outpatient basis instead of These meetings are open to the public.
paragraph should be revised to read as Information on room numbers will be follows; being confined to a hospital. The ACNM ava table in the lobby of the designated believed that temporary home building. A scimdule of additional Section 35.315 Sofety Precautions. confinement should be allowed instead meetings will be provided in a future (a) For each patient receiving of mandating hospitalization. The notice' ACNM stated that published scientific radiopharmaceutical therapy arul DATES: % Boston: August 16-M, M ccmfined for compliance with 5 35.75 of pa iers attest to the safety of outpatient " # 8"8 "'" ""' ' " ' "
this chapter, a licensee shall:
ra iopharmaceutical therapy in doses of up to 400 millicuries ofI m Nal. Oh,Ih'dn . DC: September 20-On June 15,1994 (59 FR 30724), the 22,1994. The meeting will begin at 10 an e i n s wil ve a r cial Commission published a proposed rule a.m. on September 20,1994.
' addressing the issues raised in PRM- ADDRESSES: (1) Boston: Swissotel, One h*{', 3' "jid i (a d st 7 20-20 and PRM-35-10. The petitioner Avenue de Lafayette Boston, MA maintaining r,afeguards to the iicaIth of and commenters are advised to review the public. and comment on this proposed rule. It 02111, (617) 451-2600' (2) Washington, DC: Quality Hotel-provides the Commission's position on Capitol flill,415 New Jersey Avenue, Related Petitions and Propowd Rule the fundamental concern underlying the NW., Washington, DC 20001, (202) 636-On December 26,1990 Caml S. mwnt petihn. In the proposed rule, m16 Marcus, MD, filed a petition for the Commission states that the ,On rVRTHER INFORMATION CONTACT:
rulemaking with the NRC (PRM-20-20). pr visions of to CFR 35.75 govern the Mr. James F. Foster, OSHA, U.S.
Dr. Marcus requested that the NRC mioaw of patients, not the provisions in Department of Labor Office of restore tne radiatiori dose limit in the 10 CFR 20.1301. Consequently, Information and Consumer Affairs, amended standards for protection mmmentes should comment on PRM- Room N-3647,200 Constitution against radiation that can be absorbed 3M1 in tlas context because most of Avenue, NW., Washington, DC 20210, by members of the public from patients the issues raised in this petition are Telephone: (2021219-8151.
receiving radiopharmaceuticals for addressed in the pmposed rule. The SUPPLEMENTARY INFORMATION: On May diagnosis or therapy from 100 mrem / NRC staff also issued NRC Informatmn 11,1994, OSHA announmd that it had year to 500 mrem / year. Dr. Marcus Notice No. 94-o9, dated February 3, 1994, entitled " Release of Patients with established the Steel Erection opposed the newly effective radiation Negotiated Rulemaking Advisory dose limit in 10 CFR 20.1301 because of Residual Radioactivity from Medical the impact of this lower limit on , Treatment and Control of Areas Due t Committee (SENRAC)(59 FR 24389)in P"Jence of Patients Containing accordance with the Federal Advisory outpatient medical procedures. She .
believed that therapeutically effective Radioactivity Following Implementation Committee Act (FACA), the Negotiated of Revised 10 CFR Part 20 " which Act of 1990 (NRA) and doses ofI m may msult in exposure to pr vided the NRC staff's interim Rulemakinfof section 7(b the Occupational Safet the public within the immediate surroundings of gmater than 100 but guidance governed by 10 CFR 35 75. and Health Act (OSH Act) to resolve Issues associated with the development less than 500 mrem / year. She stated Dated at Ro< kville. Marvland. this ?oth day of a Notice of Proposed Rulemaking on that some pnxedures utilizing of Mv 1w4 Steel Emction Appointees to the
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PETITION RU1.E _PRM35-1j }
(59 F837150)DocKETE0 U3.MPC RA 94-059 ATS Westinghouse Electric Corporation Energy Systems 94 SEP 29 P4 :07 i' p nsi#p eennsrivama 15230 03s5 0FFIC! c r,:' E it.RY DOCKiiP,PN4 fd U MCE September 26,1994 De Secretary of the Commission U. S. Nuclear Regulatory Commission Washington, D. C. 20555 A*lTN: Docketing and Service Branch
SUBJECT:
Ref. 59FR37950 Petition for Rulemaking - "American Medical Association." - -
(10 CFR Parts 20 and 35) a Gentlemen:
4 De Westinghouse Electric Corporation appreciates the opportunity to provide comments on the Petition for Rulemaking referenced above. i l
Westinghouse supports the AMA's petition in general, and particularly in the following areas:
To include the reinstatement of Section 20.107 from the regulations in effect before the 1991 l amendments to Part 20; l
De proposed changes in Section 35.75; The pmvisions of Section 35.310(a); and,
- The revised introductory paragraph of Section 35.315 Rese comments are presented for consideration by the Commission in this Petition for Rulemaking proceeding.
Sincerely, A. T. Sabo, Manager Regulatory Affairs
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PE~l P- October 11, 1994 l AMERICAN (54FR 37950) 3
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MINING S BY HAND DELIVERY 4 l NGRESS
-' N p mo u se m ww.sume ano Secretary of the Commission L 7 soo U.S. Nuclear Regulatory Commission ;-
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'""*"****""' Attention: Docketing and Service Branch // b n." www 01 OU
- m. m Re: American Medical Association's Petition for Rulemaldng -
7.,7." Docket No. PRM-35-11 MET.*".
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Dear Secretary:
I"' " ". " ".'."
E "c"o'".,* The American Mining Congress (AMC) submits these comments in response to the Nuclear Regulatory Commission's (NRC) notice of Z C""_""'.
r, - o.,-o. t. sn receipt of a petition for rulemaking by the American Medical oi Association (AMA). 59 Fed. Reg. 37950 (July 26,1994). AMA's C"'*" # petition requests the Commission to amend its regulations to increase
[,*% , ;,2 u=a n w-* ca* a co the external radiation limit to the public from 100 mrem /yr to 500
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a o."o."."., "",. An mrem /yr for the purpose of medical diagnosis and therapy. AMC supports AMA's petition.
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,,,,., ""* 'Z"1 AMC is a national trade association representing: (1) producers
[ o"'ga*"* => of most of the United States' metals, uranium, coal, and industrial and o- s o.im.n. s.n.o, ui agricultural minerals; (2) manufacturers of mining and mineral M*O*"", % processing machinery equipment and supplies; and (3) engineering and
[^a.*'ag- consulting firms and financial institutions that serve the mining Pa,.a u sn r.ninio industry.
u.,e F. wery, Peabu,gh rmb.et P. La, tin Hou. con Thom W os,g.s #.. Ine.n. PA AMA's petition expressed concern that 10 CFR 20.1301, which Anthony a F.m.nda.. o w.,
n.nvo wo, en co reduced the radiation exposure limit from 500 mrem /yr to 100
,,,'"' , '7'*'*;',""*"' mrem /yr, would have an adverse impact on the availability and cost of J.ny K Eins. San Fr-me treatment with radiopharmaceuticals, which outweighs the advantages of O $,M o",n.n. reduced radiation exposure to the public. AMA also argued that the
,,. C c,,, 100 mrem /yr exposure limit is inconsistent with medical experience and a.= A rami > . amn.av.m not necessary to protect the public from radiation hazards.
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AMC agrees with AMA that the an increased exposure limit for Q""."c.oi nac . se t cwQ*g'"*ad medical diagnosis and therapy is more than adequately justified in the 7", 00.7,, interest of public health. This is particularly true since AMC believes
- ~ o==. Saa.a* that in reducing the exposure limit from 500 mrem /yr to 100 mremlyr, a.m-a T raa. Anwo.nio.
- .w u u n. o e NRC appeared to be making a conservat.ive poh.ey dec..ision rather than
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a scientific determination based on adverse effects seen at higher exposure levels.
n.e e a y. sinnio, .
Pa.t Ch.wm.n te i e
" " MP4M "J-941011 0 PDR 35-11 PDR ff' h1
If you have any questions or we can be of further assistance, please call me at (202) 861-2876 or Katie Sweeney, Counsel, at (202) 861-2812.
Yours very truly, James E. Gilchrist
/P Vice President I
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.- - - ___________-______i
o jDD TT l AJA 120019th Street, N.W.
- Suite 300
- Wgshington D.C. 20036-2401 uG6Kc gcu [ &
(202)429 5120 USNR(Fax (202) 223-4579 The Society American College of of Nuclear Nuclear Medicine W DCT 19 P4 Z0 Physicians OFF la 0" ' ~U'i- r:Y T October 14,1994 DOCKLTIL i i John C. Iloyle BR#C' DOCGT WMBERg g g P ,
Acting Secretary PETIT )
U.S. Nuclear Regulatory Commission Wahingtna.DC 20555 (hy f R b 5g/
Atta: Docketing and Service Branch RE: Comments on Petition for Rulemakmg filed by the American Medical Association; l 59 FR 37950 - July 26,1994. )
i
Dear Mr. Iloyle:
I The American College of Nuclear Physicians (ACNP) and the Society of Nuclear Medicine (SNM)' wish to comment on the petition filed by the Amencan Medical Association. We support the petitioners request that NRC amend its regulations to l' recognize that cunint medical practice concerumg the therapeutic uses ofI *, particularly in outpatient settings, is effective and safe for the public. We also support the petitioncr's request that NRC formally recognize that adequate home confinement precautions reduce the hazards associated with radioisotopes sufficiently to climinate the need for hospitalization following therapeutic admuustration ofradiopharmaceuticals. Finally, we support the petitioner's recommendation that NRC increase the external radiation limit for the public from 100 mrem / year to 500 mrem / year.
The ACNP and SNM refer the NRC to comments filed on the patient release criteria proposed rule (59 FR 30724) which outhnes our support for rasing the level from 100 mrem to 500 mrem / year. In addition to our comments filed on this rule we feel that the construct offered by the petitioner attempts to eliminate the burdensome paperwork discussed by NRC in their proposed rule on patient release criteria. ACNP and SNM wholeheartedly support any effort by NRC to reduce the amount
' of paperwork necessaiy, lower the level of regulatory compliance costs, and implement sound scientific regulations in conjunction with the medical community. In comments to NRC by ACNP/SNM we recommend altemative language similar to that offerrd by petitioners. This language would make it possible to have an effective rule without the burden of unnecessary paperwork.
ACNP and SNM beheve that one major goal for the NRC should be to drastically reduce the amount of paperwork to only that level which is requurd to pmtect public health and safety. Cuntntly NRC far exceeds that level placing an unnecessary burden on Nuclear Medicine practitioners and the public. By altering the language in this petition consistent with ACNP/SNM's comments, without any addi'ional paperwork, NRC would move significantly towards this goal.
In em-Iminn we support the issues and suggestions raised in the petition by the American Medical Association and urge NRC to adopt this language as part of the proposed patient release criteria rule. Ifyou have any questions please feel free to call Mr. David Nichols, Regulatory Affairs Coordinator at (202) 429-5120.
Sincerely, j William II. McCartney, M.D. James J. Conway, M.D.
President President American College of Nuclear Physicians Society of Nuclear Medicine
'ACNP and SNM are composed of over 15,000 nuclear medicine physicians, nuclear phannacists, nuclear medicine scientists, and nuclear medicine technologists involved in the delivery of essential health care.
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9 PWIO 4 DEPARTME,jW, S:Til R SAFETYJ0D o 4 N' gpp"m 10 JE f?62704 SP
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April 10, 1995 ECCKET NUMBER 3ecretary of the Commission PROPOSED RULE bao M -
U.S. Nuclear Megulatory Connission Washington, D.C. 20555 gggg 4 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 connents on the referenced proposed rulemaking. The Federal Reafster notice indicates that the proposed modifications should be a Division 1 matter of compatibility since basic definitions should ha uniform for connunication of basic radiation concepts. We realize that NRC is still working on the Compatibility Policy, and we would agraa that these modifications to definitions should be Division 1, provided that Division 1 compatibility means the intent. but not tha lanaiiane must be identical.
NRC's interpretation that medical administration of radiation or radioactive material to the wrong individual should be regulated in accordance with 10 CFR Part 35 is parallel to the Department's interpretation. The proposed language modifying " patient" to " individual" should clarify this situation for licensecs.
In sunmary, the Department agrees with the proposed changes described in this f_e_deral Recistet notice, but cautions against the assignment of compatibility levtl., when there is no compatibility policy. I you have any questions regarding these comments, please contact me or Kathy Allen at (217) 705-9947.
Sincerely, k0*
teven C. Collins, Chief
- d Division of Radioactive Materials cc: Jim t,ynch, State Agreements Officer g
An 0 Q Q J _I _t . s ,
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. 7DE p)p - to 4 M 3.h April 5,1995 4 i
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To: Working group on wrong patient rule: Stewart Schneider, Sam Jones, Cathy IIancy, Trish Holahan, and Brad Jones From: Stephen A. McGuire
SUBJECT:
TECIINICAL REVIEW OF FINAL RULE ON, " MEDICAL ADMINISTRATION OF RADIATION AND RADIOACTIVE MATERIALS Attached for your technical review is a draft final FRN on the wrong patient rule. ;
Also attached to aid in your review is a copy of the proposed rule FRN, the comments received on the proposed rule, the FRN for petition for rule making PRM-35-11, and the comments received on the petition.
I believe.that this final rule should be rather straight forward and that this review l' by the working group can substitute for the division technical review step. Thus, we will be able to go straight to Office Concurrence after your comments have been resolved.
We will also have a meeting of the working group to discuss your comments if any significant questions arise as a result of your review.
I would appreciate your comments by April 21. A marked up copy of the FRN is fine,
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Attachment:
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NUCLEAR REGULATORY COMMISSION 10 CFR Parts 20 and 35 RIN 3150-AF10 Medical Adninistration of Radiation and Radioactive Materials AGENCY: Nuclear Regulatory Commission.
ACTION: Final rule.
SUMMARY
- The Nuclear Regulatory Commission is amending its regulations to clarify that the medical administration of radiation or radioactive materials to any individual, even an individual not supposed to receive a medical administration, is regulated by the NRC's provisions governing the medical use of byproduct material rather than 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: (30 days following publication in the Federal Register).
ADDRESSES: Examine comments received at: The NRC Public Document Room, 2120 L Street NW. (Lower Level), Washington, DC.
Draft: April 5, 1995 1 Attachment 1
Stephen A. McGuire, Office of Nuclear FOR FURTHER INFORMATION CONTACT:
Regulatory Research, U.S. Nuclear Regulatory Commission, Washington, DC 20555, telephone (301) 415-6204.
.a 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 by mistake to g 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 5 35.2, misadministrations include administrations of licensed ?
radioactive material in excess of certain specified quantities to the wrong individual. The practical effect of the definition of an misadministration is thatsomerelatively(owdose)diagnosticadministrationsof
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radiopharmaceuticals to individuals for whom they were not intended are not misadministrations as defined in 5 35.2, and Part 35 does not require notification of the NRC or the individual.
Separate from the requirements for misadministrations, 5 20.1301(a)(1) contains a dose limit for members of the public of 0.1 rem (1 millisievert).
However, the scope of Part 20 in i 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 ...."
Draft: April 5, 1995 2 Attachment 1
b 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 casej the dose tj the T individual receiving the administration was below the threshold for reporting of the misadministration, but abovet 'he 0.1 rem (1 millisievert) dose limit in 5 20.1301(a)(1) for a member of the public. The question that arose was whether there.was a violation of 5 20.1301(a)(1) 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) I l
filed by the American Medical Association (59 FR 37950; July 26, 1994). That l
1 petition requested, in part, that part 20 specifically exclude all medical administrations. l Because of these concerns, the Commission proposed an amendment to 10 1
CFR Part 20 to clarify the regulations (60 FR 4872, January 25,1995). The proposed rule explained that the Commission believed that, in general, the I 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 believed that an administration to any individuil is and should be subject to the regulations in Part 35. That was the Commis. ion's intent when the current misadministration requirements were adopted in the final rule, " Quality Draft: April 5, 1995 3 Attachment 1
i Management Programs and Misadministrations," (July 25, 1991; 56 FR 34104).
Further explanation of the Commission's rationale is contained in the Federal Register Notice for the proposed rule (60 FR 4872, January 25,1995).
II. Comments on the Proposed Rule and Petition for Rulemaking PRM-35-11.
I Three comment letters were received on the proposed rule, two from Agreement States and one from a medical health physicist. All supported the proposed rule. Three comment letters were received on PRM-35-11. Each of the )
letters supported the petition.
l 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 l 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, 6 35.33 does not require that the individual who received an administration of a radiopharmaceutical by mistake be notified of the error. One fundamental difference in the case in which the wrong individual receives the administration is that, unlike the intended patient, who it may be argued may have been informed that he or she will be exposed to radiation and has thereby implicitly or explicitly consented to the procedure, the wrong individual has generally not consented to any radiation dose at all.
m A tah d e ak a M m f
' The NRC's Advisory Committee on Medical Uses of-Isotopes (ACMUI)-has assured Mt\
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 Draft: April 5, 1995 4 Attachment 1
k i-almost always would notify the individual of the mistake. However, the NRC specifically asked whether Part 35 should require that the individual be notified of the error regardless of the dose that would be received.
k . The commentstaddressed this question. One favored an NRC regulation requiring notification of the individual regardless of the dose. The other, an Agreement State, opposed a requirement because it would not be consist ~nt e
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 that it agrees with this commenter and is not changing its notification requirements.
III. Summary of the Changes.
Neither the comments received nor any other information available to the Commission provide any reasons not to adopt the amendments substantially as proposed, which would regulate administrations to individuals under Part 35 and not Part 20. Therefore the NRC is adopting the amendments as described below.
To clarify the meaning and intent of Part 20, the NRr is amending the Scope of Part 20, the definitions of public dose and occupational dose, and the wording in 5 20.1301(a)(1) on public dose limit to clarify that the dose limit for individual members of the public does not apply to dose contributions from any medical administration the individual has received.
Thus, the medical administration of radioactive materials or radiation to any individual, even an individual not supposed to receive an administration, is Draft: April 5, 1995 5 Attachment I
k not subject to the public dose limit in 5 20.1301(a)(1), but is within the scope of Part 35.
The changes in Part 20 replace the word " patient with the word i
" individual." The word " patient" has sometimes been taken to meang only the individual intended to receive the administration. At other times, the view l 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. For consistency, in terminology I
between parts, the word " patient" in the definition of misadministration in 5 35.2, " Definitions," and in certain locations in paragraph (a)(2) of 5 35.33 are replaced by the word " individual."
In 5 20.1002, the phrase "for the purpose of medical diagnosis and therapy" is replaced by th : phrase "any medical administration the individual has received." The existing wording raised the question of whether an administration was within the scope of Part 20 if the administration had no valid medical purpose. The new wording makes it clear that regardless of the purpose or lack of purpose, dose to an individual from any medical administration the individual has received is not within the scope of Part 20, but is within the scope of Part 35.
For the sake of consistency and clarity, the same words are used in 5 20.1002, " Scope," in 5 20.1003, " Definitions," (in the definitions of both public dose and occupational dose), and in 5 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 55 20.1002 and 20.1003 are added to 5 20.1301(a).
Draft: April 5, 1995 6 Attachment 1
The existing 5 20.1301(a) also excludes dose contributions from the licensee's disposal of radioactive material into sanitary sewerage. That exclusion was not be added to 55 20.1002 and 20.1003 because the question of dose from sewer disposal of radioactive material is now under congideration by the NRC. When that issue is resolved, it is intended that the wording
~
concerning dose from sewer disposal will be made consistent in 55 20.1002, 20.1003, and 20.1301(a).
A 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 5 20.1301(a)(1). When that amendment of 1
5 20.1301(a)(1) is published in final form, the wording on what is excluded J from the dose limit will be inserted in 55 20.1002 and 20.1003 (in the definitions of public dose and occupational dose) so that the same parallelism will exist throughout.
i IV. Consistency with the 1979 Medical Policy Statement and Coordination with >
On February 9 1979 (44 FR 8242), the NRC published a Statement of General Policy on '.he 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.
Draft: April 5, 1995 7 Attachment 1
b 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 ruleisconsistentwiththestatementbecauseitclarifiesthatexjsting requirements concerning misadministrations continue to be concentrated on administrations having the greatest ris'k signir)cance.
lhe 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 I
is consistent with this statement because it limits its specific regulatory l l
requirements for notification to the most serious errors in administration and minimizes requirements on errors in administrations that have less risk significance.
/
Thus, the rule is considered to be consistent with the 1979 medical policy statement. -; - ---
- ~ . _ _._ __
{, -
V. (ot;/d m d n, w i O. . MMUL 7 The subject of this final rule was discussed with the NRC's Advisory Committee on Medical Uses of Isotopes (ACMUI) on May 11, 1995. The ACMUI 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 "e misadministration threshold is the current practice and should not be regulated.
sh. Coordination with and Issue of Compatibility for Agreement States.
Draft: April 5, 1995 8 Attachment 1
M T)DL f}f-/d Y Occupational dose means the dose received by an individual in e MJ ee+t*4eted arce cme the course of employment in which the individual's nub assigned duties involve exposure to radiationAand te radioactive material from licensed and unlicensed sources of radiation, whether in the possession of the h
licensee or other person. Occupational dose does not include dose received A
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.
I Public dose means the dose received by a member of the public from )
e dlo ' l exposure to radiation afeto radioactive material released by a licensee, or a,sy *H r udw Mt co r, trol o f a Gem e to met 4e source of radiatiorweither mitMn licensee's contrciled area or
-Q&G6w 4e unrestricted arenz Jt 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.
1
- * * * *
- 1
- 4. In 5 20.1301, paragraph (a)(1) is revised to read as follows:
j i 20.1301 Dose limits for individual members of the public.
- (a)
(1) The total effective dose equivalent to individual members of the public from the licensed operation does not exceed 0.1 rem (1 mSv) in a year, 19
. . _ . . .