ML20056H520
| ML20056H520 | |
| Person / Time | |
|---|---|
| Issue date: | 07/06/1993 |
| From: | Taylor J NRC OFFICE OF THE EXECUTIVE DIRECTOR FOR OPERATIONS (EDO) |
| To: | Rogers, Selin I, The Chairman NRC COMMISSION (OCM) |
| References | |
| FRN-59FR30724 AE41-1-239, AE41-1-241, NUDOCS 9309090475 | |
| Download: ML20056H520 (46) | |
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UNITED STATES
[ Mij NUCLEAR REGULATORY COMMISSION WASHINGTON. D.C. 20555 0001 o
July 6, 1993 MEMORANDUM FOR:
The Chairman Commissioner Rogers Commissioner Remick Commissioner de Planque FROM:
James M. Taylor Executive Director for Operations
SUBJECT:
DISTRIBUTION OF WORKING DRAFT OF PROPOSED RULEMAKING TO THE AGREEMENT STATES In accordance with the procedures in SECY-91-121, if the staff determines it is desirable to distribute working drafts of proposed rules to the Agreement States, the staff will provide the Commission with a copy prior to distribution and place a copy of the document marked, " Working Draft" in the Public Document Room (PDR).
To meet the Commission's requirements for "early and substantial involvement," a working draft of the following proposed rule will be sent to the Agreement States and the following action is being requested.
1.
Title:
Proposed Rule on Patient Release Criteria; 10 CFR Parts 20 and 35 2.
Fecuested Action:
Agreement State Review and Comment 3.
Peauested Completion Date:
September 1, 1993 4.
State Acreements Procram
Contact:
Jim Myers Distribution of this rule will be made three working days after the date of this letter as our present procedure requires.
The Agreement States' comments received by the Office of State Programs will be forwarded to the Office of Nuclear Regulatory Research for consideration and inclusion into the proposed rulemaking.
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/
ae lor E ecutive irector for Operations
Enclosure:
As stated cc:
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O(m),1yf 9309090475 930706 E
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1 dORKING DRAFT I
[7590-01]
NUCLEAR REGULATORY COMMISSION 10 CFR Parts 20 and 35 RIN 3150-0010 Reporting Changes to the Regulations on Release of Patients Administered Radioactive Material AGENCY:
Nuclear Regulatory Commission.
t ACTION:
Proposed rule.
SUMMARY
- The Nuclear Regulatory Commission (NRC) is proposing to amend the criteria for release of patients administered radioactive material under 10 CFR Part 35 to permit a maximum dose to an individual member of the public of 5 mSv (0.5 rem) total effective dose equivalent (TEDE) in a year. The 2
l NRC is also proposing to exempt licensees from meeting the dose limit for members of the public in 10 CFR 20.1301 for patients released in accordance with s 35.75. The proposed action constitutes the partial granting of two petitions for rulemaking regarding the criteria for release of patients containing radioactive material [56 FR 26945 and 57 FR 21043).
DATES: The comment period expires (75 days following publication in the Federal Register). Comments received after this date will be considered if it is practicable to do so, but the Commission is able to assure consideration only for comments received on or before this date.
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'As defined under 10 CFR 20.1003.
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e ADDRESSES: Send comments to: Secretary, U.S. Nuclear Regulatory Comission, Washington, DC 20555. ATTN: Docketing and Service Branch.
Hand deliver comments to 11555 Rockville Pike, Rockville, Maryland f
between 7:45 a.m. and 4:15 p.m. Federal workdays.
Examine comments received, the environmental assessment and finding of no significant impact, and the regulatory analysis at: The NRC Public Document Room, 2120 L Street NW. (Lower Level), Washington, DC.
Obtain single copies of the environmental assessment and finding of no significant impact and the regulatory analysis from:
Stewart Schneider, Office of Nuclear Regulatory Research, U.S. Nuclear Regulatory Commission, Washington, DC 20555, telephone:
(301) 492-3588.
l FOR FURTHER INFORMATION CONTACT: Stewart Schneide,r, Office of Nuclear Regulatory Research, U.S. Nuclear Regulatory Commission, Washington, DC 20555, telephone (301) 492-3588.
SUPPLEMENTARY INFORMATION:
Table of Contents I.
Background.
11.
Petitions for Rulemaking.
l 111.
Public Comments and NRC's Responses.
IV.
Public Workshops.
The Agreement States.
Advisory Committee on Medical Uses of Isotopes.
V.
Summary of Proposed Rule Requirements and the Rationale for Their Inclusion.
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VI.
Proposed Regulatory Guidance.
VII. Alternatives Considered in Developing the Proposed Rule.
l VIII. Agreement State Compatibility.
j IX.
Finding of No Significant Environmental Impact: Availability.
X.
Paperwork Reduction Act Statement.
t XI.
Regulatory Analysis.
l XII. Regulatory Flexibility Certification.
f XIII. Backfit Analysis.
XIV. List of Subjects in 10 CFR Parts 20 and 35.
r I. Background i
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f Under the provisions of 10 CFR Part 35, " Medical Use of Byproduct i
Material," l 35.75, " Release of patients containing radiopharmaceuticals or t
I permanent implants," a licensee may not authorize release from confinement any patient administered a radiopharmaceutical until either:
(1) the measured l
dose rate from the patient is less than 0.05 mSv (5 mrem) per hour at a distance of one meter; or (2) the activity in the patient is less than 1110 MBq (30 mci).
On May 21, 1991, the NRC published a final rule that amended i
10 CFR Part 20, " Standards for Protection Against Radiation" [56 FR 23360].
l Section 20.1301(a), " Dose limits for individual members of the public,"
l requires each licensee to conduct operations so that the TEDE to individual members of the public from the licensed operation does not exceed I mSv (0.1 rem) on an annual basis.
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e Each year, more than 10 million medical administrations of radioactive material are performed in the United States. Approximately 80% of these involve the diagnostic use of Tc-99m, in amounts less than 740 MBq (20 mci) per study. A conservative estimate of the maximum dose to a member of the public can be calculated by using the National Council on Radiation Protection 1
and Measurements (NCRP) Report No. 37' figures for total integrated dose to decay at a distance of 1 meter from the patient and to assume an exposure correction factor of 25%.
For administrations of 740 MBq (20 mci) of Tc-99m, this results in a dose of 0.035 mSv (3.5 mrem).
The diagnostic use of I-131 usually involves administered activities less than 3.7 MBq (100 Ci) with a corresponding dose to a member of the public, as calculated above, of less than 16 ySv (1.6 mrem). However, for l
diagnosis of metastatic disease, doses up to 367 MBq (10 mci) may be used.
There are also nearly 32,000 cases of the therapeutic use of I-131 each year.
l Nearly all of these are for hyperthyroidism for which the administered activity is typically 1110 MBq (30 mci). The dose to a member of the public for these administrations would be approximately 4 mSv (0.4 rem).
The balance of medical administrations of radioactive material are for i
the treatment of primary and metastatic cancer. These are performed at roughly 300 NRC licensed facilities across the country. Typical administered activities are in the range of 5550 to 9250 MBq (150-250 mci) of 1-131.
In these cases, the patient is required to be under licensee control following administration until the licensee can demonstrate that the dose to the
' National Council on Radiation Protection and Measurements (NCRP),
" Precautions in the Management of Patients Who Have Received Therapeutic Amounts of Radionuclides, " NCRP Report No. 37 (October 1, 1970).
(Available for sale from the NCRP, 7910 Woodmont Avenue, suite 800, Bethesds, MD 20814-3095.)
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maximally exposed member of the public does not exceed the established dose i
limits pursuant to i 20.1301.
l It is likely that a patient who has been administered a quantity of I
sealed or unsealed radioactive material for medical use, particularly I-131, i
t and released in accordance with the release criteria set forth in i 35.75, could expose a member of the public with a resulting radiation dose in excess l
of the revised Part 20 limit of 1 mSv (0.1 rem) TEDE in a year. With implementation of the 1 mSv (0.1 rem) dose limit in i 20.1301, a situation will exist in which two different limits apply under these _ circumstances.
In this situation,-the more limiting is controlling (i.e., Part 20).
f Medical administrations of radioactive material may result in a dose to I
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a member of the public in excess of the Part 20 limits of I mSv (0.1 rem) TEDE i
in a year about 15% of the time. Generally, only an individual closely I
associated with the patient, typically a family member, would be in j
sufficiently close proximity to the patient for a sufficient time to receive a i
dose in excess of the 1 mSv (0.1 rem) TEDE limit in the revised Part 20. To i
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have a patient remain under the control of a licensee when it is not medically j
necessary, only to avoid a one-time dose in excess of the Part 20 limit to (typically) a family member may not be reasonable.
It is unlikely that a single member of the public would be routinely exposed to patients released under these criteria, since medical treatments do not continue.for many.
years *.
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'The occupational dose limits in Part 20 apply to all members of a licensee's staff that are likely to exceed the annual dose limit of 1 mSv (0.1 rem) TLDE from assigned duties involving routine exposure to patients containing rtdioactive material-(e.g., hospital discharge nurse).
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Although the issue of patient release was not the focus at the time when revising Part 20, consideration was given for special circumstances which i
would justify an increase in the limit for dose to members of the public from i
licensed activities from 1 mSv (0.1 rem) TEDE to 5 mSv (0.5 rem) TEDE per year. Consequently, 9 20.1301(c) permits a licensee to apply for prior authorization to operate up to an annual dose limit of 5 mSv (0.5 rem) for an i
l individual member of the public.
In specifically incorporating this exemption into the regulations, the NRC intended such exemptions to be applied primarily to temporary situations where operation of a facility, or the person's exposure to radiation and radioactive emissions, is not expected to result in doses above 1 mSv (0.1 ram) over long periods of time. Regarding the circumstances surrounding the release of patients containing radioactive material, the NRC believes that the same philosophy applies; i.e., that exposures in excess of the public dose limit from a released pstient are typically one time events and it is unlikely that any one individual would receive repeated exposures as discussed cbove.
1 II. Petitions for Rulemaking l
On June 12, 1991, the NRC published in the Federal Register j
[56 FR 26945] a notice of receipt of, and request for comment on, a petition for rulemaking [PRM-20-20] from Dr. Carol S. Marcus. Dr. Marcus requested that the NRC amend 10 CFR Part 20 (May 1991) and 10 CFR Part 35 to:
(1) raise the annual radiation dose limit to all members of the public from patients receiving radiopharmaceuticals for diagnosis or therapy from 1 mSv (0.1 rem) to 5 mSv (0.5 rem); (2) delete 1 20.1301(d) which requires lice.1 sees to l
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comply with provisions of EPA's applicable anvironmental standards in addition to complying with the requirements of Part 20; and (3) amend i 35.75(a)(2) to retain the 1110 MBq (30 mci) limit for I-131, but vary the maximum activity of other radionuclides consistent with the calculational methodology employed in r
NCRP Report No. 37 to allow more flexibility regarding patient release than is now available.
l On March 9,1992, the NRC published a notice of receipt and request for comment in the Federal Register [57 FR 8282] for a similar petition for rulemaking [PRM-35-10} from the American College of Nuclear Medicine (ACNM).
On May 18, 1992, the NRC published notice in the Federal Register
[57 FR 21043] an amendment to the original ACNM petition [PRM-35-10A), also i
l submitted by the ACNM. The ACNM requested that NRC revise 10 CFR Part 35 to:
(1) Delete the requirement in 10 CFR 35.75(a)(2) that licensees may not authorize release from confinement for medical care any patient administered a radinpharmaceutical until the activity in the patient is less than 30 millicuries.
l (2) Amend i 35.75(a)(2) to allow for an outpatient option instead of mandating confinement for patients receiving oral or ictravenous l
radiopharmaceuticals in amounts greater than 30 millicuries.
(3) Allow doses greater than 30 millicuries to be used in diagnostic studies, in addition to radioisotope therapy.
(4) Define " confinement" to mean remaining in a hospital or a private residence.
Since the petitions submitted by Dr. Marcus and the ACNM both address the patient release criteria set forth in 10 CFR 35.75, the NRC has decided to l
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resolve these petitions simultaneously. An analysis of the public comments submitted on the notices of receipt of petitions follows.
III. Public Comments and NRC's Responses i
The flRC has had the benefit of receiving and reviewing many comments which have been valuable in preparing a resolution to these petitions. A total of 140 responses were received on the Marcus petition and a total of 88 responses were received on the ACNM petition (original and amended). All of the comments were combined into a single set and were evaluated based on the issues raised without regard to the specific petithn referenced.
Commenters represented hospitals and clinics, professional associations, citizens groups, Agreement States and Government agencies, State radiation advisory boards, universities, consulting firms, public utilities, a utility.
association, and a labor union. The majority of the commenters were e
physicians who expressed concerns primarily related to the cost of hospitalization.
Other commenters included health and medical physicists, pharmacists, nuclear medicine technicians, professors, as well as one former t
nuclear medicine patient.
l Overall, the majority of all comments supported the general initiative of the petitions, that is, to relax patient release criteria. A summary of l
the issues raised and NRC's responses follows.
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1 1.
Raise the Annual Dose Limit in i 20.1301 from 1 mSv (0.1 rem) to 5 mSv (0.5 rem) for a Member of the Public from Exposure to a Released Patient J
Comments:
The majority of commenters favored raising the limit to 5 mSv (0.5 rem)
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in a year for members of the public exposed to released patients. Many stated j
that increasing the dose limit from 1 mSv (0.1 rem) to 5 mSv (0.5 rem) per f
year for a member of the public is in line with the recommendations of NCRP Report No. 91' based on the assumptions that (1) only an individual member of the public that gives physical or emotional care and support (e.g., a family-or household member) is likely to spend significant time in close proximity i
with the patient and receive a dose greater than 1 mSv and (2) that the individual is unlikely to be exposed by the patient routinely year after year.
l t
A few of the commenters in favor of the petitions believed that raising the i
limit would be beneficial to the patient and family.
One commenter suggested that no limit should be applied to the patient's j
t family, just maintain doses ALARA, because there is an indirect benefit to the family. A physician commented that many patients come from homes in which no l
l member of the family is under the age of thirty, and therefore, contended that there was very little risk in terms of radiation exposure. Other comments in favor included:
(1) hospitalization can be a distressing experience for many cancer patients and patients can develop hospital acquired infection-if kept f
too long, (2) confining patients in a hospital until the release criteria is-
' National Council on Radiation Protection' and Measurements,
" Recommendations on Limits for Exposure to Ionizing Radiation," NCRP Report No. 91 (June 1, 1987).
(Available for sale from the NCRP, 7910 Woodmont Avenue, Suite 800, Bethesda, MD 20814-3095.)
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met increases the dose to hospital personnel and other patients, and (3) confinement to the home is no hazard to the public.
On the other hand, a comment made by a citizens group is that any amount of radiation, no matter how small, is detrimental to the recipient. A few l
commenters insisted that the licensee apply for a license amendment to gain relief or apply for exemption on a case-by-case basis. The only patient l
providing comments strongly opposed the limit increase. He said that it was much more stressful for his family, once he came home from the hospital, to l
have to avoid contatt with him, and implement contamination control, such as
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wearing gloves to prevent contaminating family members.
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Response.
l NCRP Report No. 91 has been updated and replaced by NCRP Report l
5 No. 116. The recommendations contained in the current report are similar to i
l those in NCRP Report No. 91. NCRP Report No. 116 recommends adoption of a l
l 1 mSv (0.1 rem) annual effective dose limit for " continuous" or " frequent exposure" to the general public.
Furthermore, the report recommends a maximum annual effective dose limit of 5 mSv (0.5 rem) to provide for " infrequent" l
i annual exposures.
Regarding the latter dose limit, the NCRP states "An annual effective dose limit recommendation of 5 mSv is made because annual exposures i
in excess of the 1 mSv recommendation, usually to a small group of people, need not be regarded as especially hazardous, provided it does not occur often i
' National Council on Radiation Protection and Measurements, " Limitation of Exposure to Ionizing Radiation," NCRP Report No. 116 (March 31, 1993).
(Available for sale from the NCRP, 7910 Woodmont Avenue, Suite 800, Bethesda, MD 20814-3095.)
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to the same groups and that the average exposure to individualt.n these groups does not exceed an average annual effective dose of about 1 mSv."
NRC has generally followed the basic recommendations of the NCRP in formulating its radiation protection standards. NCRP Report No. 116 is the latest in a series of NCRP reports providing guidance on limits for exposure to ionizing radiation. The 1 mSv (0.1 rem) was adopted by the Commission as an annual limit with provision for allowing members of the public to receive doses up to 5 mSv (0.5 rem) TEDE in a year. Under the revised Part 20, a 5 mSv (0.5 rem) TEDE annual limit is available only upon specific application to and approval by the Commission (120.1301(c)); the 5 mSv (0.5 rem) value was retained, in part, to apply to transient situations.
(See discussion under Section I, " Background," for additional information.)
Section 20.1301(c) requires that the licensee application for exemption to the public dose limit include the following information:
(1) A demonstrated need for and the expected duration of operations in excess of the 1 mSv (0.1 rem) TEDE limit in a year; (2) A program to assess and control the TEDE within 5 mSv (0.5 rem) in
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a year; and (3) The procedures which would be followed to maintain the TEDE as low as is reasonably achievable.
Since the NRC believes that the philosophy behind i 20.1301(c) also applies to the proposed rule, under the proposed rule analogous criteria as above would be imposed to permit a licensee to operate up to an annual dose limit of 5 mSv (0.5 rem) TEDE for an individual member of the public from exposure to a released patient. Thus, licensees will be required to:
(1) have a program to assess and control dose to a member of the public 11
within the 5 mSv (0.5 rem) TEDE annual limit, and (2) issue written instructions to the patient upon release providing procedures on maintaining doses to members of the public ALARA, when the patient's 'ntal body content of radioactive material is likely to result in an annual dose to an individual member of the public in excess of 1 mSv (0.1 rem) TEDE. Methods acceptable to the NRC to demonstrate compliance with these requirements will be incorporated into a Regulatory Guide.
(See discussion under Section VI, " Proposed l
Regulatory Guidance," for additional information.)
The additional risk of cancer posed by the proposed 5 mSv (0.5 rem) TEDE annual limit is small compared to the potential risk from all other sources l
combined. According to the International Commission on Radiological Protection (ICRP) Publication No. 60', the attributable lifetime probability l
of death from radiogenic cancer for an average member of the U.S. population is about 2.5 x 10" for 5 mSv (0.5 rem), whereas, the " natural" probability of death from cancer' is around 2 x 10".
(The ICRP risk coefficient is commensurate with those of the "1988 Report of the United Nations Scientific Committee on the Effects of Atomic Radiation (UNSCEAR-88)*" and the "1990 Report of the National Research Council's Committee on the Biological Effects t
' International Commission on Radiological Protection (ICRP),
"1990 Recommendations of the International Commission on Radiological Protection," ICRP Publication No. 60 (November 1990).
(Available for sale from Pergamon Press, Inc., Elmsford, NY 10523.)
'American Cancer Society " Cancer Facts & Figures-1993," (1993).
(Available for sale from the American Cancer Society, 90 Park Avenue, New York, NY 10016.)
l
' United Nations Scientific Committee on the Effects of Atomic Radiation (UNSCEAR), " Sources, Effects and Risks of Ionizing Radiation," 1988 Report to the General Assembly, Sales Section, United Nations, NY 10017 (1988).
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' of Ionizing Radiation (BEIR-V)'.") The provision of physical or emotional l
l care and support by an individual who has willingly chosen to spend time in close proximity to a released patient are of great importance that compensates the very low potential risk from the overall 5 mSv (0.5 rem) dose limit.
l Amending the regulations to permit an annual dose limit of 5 mSv l
(0.5 rem) TEDE to an individual member of the public was adopted in contrast i
to the granting of an exemption to the dose limit on a case-by-case basis i
l because demonstration of the need for and the expected duration of operation in excess of the 1 mSv (0.1 rem) TEDE annual limit are clearly defined for the l
release of patients containing radioactive material.
Hence, it is unnecessary for a licensee to have to demonstrate these requirements on a case-by-case basis in be granted an exemption from the public dose limits as required under s 20.1301(c).
Regarding the anxiety of being in close contact with a released patient,
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the proposed rule requires licensees to provide written instructions to the patient at release on maintaining doses ALARA.
Issuance of written instructions will serve to reduce what otherwise could be a stressful situation for the family or household members.
(See discussion under t
Section VI, " Proposed Regulatory Guidance," for additional information.)
Comment. Opinion of the Nuclear Power Industry.
l The nuclear power industry was unanimous in its opinion that the NRC should apply uniform standards to all licensees. Several utilities stated t
' National Academy of Sciences -National Research Council, Committee on the Biological Effects of Ionizing
' ition, " Health Effects of Exps ce to Low Levels of Ionizing Radiation, (btIR-V)," National Research Councii
'ational Academy Press, Washington, DC 20418 (1990).
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l that if the limit for annual dose to the public is increased to 5 mSv l
(0.5 rem) for patient releases, it should apply to all exposures to the l
public, including those from nuclear power plant.s. One utility stated that such discrimination is unreasonable.
I Response.
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l The philosophy behind the proposed rule does not apply in general to the 1
operation (s) of nuclear power plants. As previously discussed, for a single member of the public exposure to a released patient containing radioactive l
material is typically a one time event for a short duration of time.
(See j
discussion under Section I, " Background," for additional information.)
l Although a similar claim cannot be made regarding the operation (s) of nuclear power plants, individual cases that do apply may occur.
In these situations the licensee can apply for authorization to operate up to an annual dose limit i
for an individual member of the public of 5 mSv (0.5 rem) TEDE under i20.1301(c).
Comment. New Radionuclides and Techniques.
Some commenters and one petitioner (ACNM) discussed the inadequacy of the current Part 35 to deal with new techniques such as the use of l
radiolabeled antibodies.
i Response.
I Whereas the existing release criteria are appropriate for the techniques and quantities of radionuclides currently used, newer techniques such as the therapeutic use of radiolabeled antibodies involve perhaps as much as several 14 i
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GBq (hundreds of mci).
In the latter case, the patient is required to remain uncer the control of the licensee for a much longer period of time before the current release criteria can be met. By changing the basis for the release of patients in the proposed rule to an annual dose limit for an individual member of the public, identity (i.e.,1-131) and quantities of radionuclides administered are no longer the only limiting factors upon which a patient release is based. One possible method to demonstrate compliance with the proposed rule permits the licensee to estimate the dose to the individual by incorporating other factors such as actual maximum occupancy time, patient metabolism and shielding values to reduce the dose that would have resulted if only the total quantity of radioactive material released had been considered.
The NRC believes that the proposed rule will provide sufficient assurance of adequate protection of the public regardless of the technique or the radionuclide used.
l Comment.
Regulatory Guide.
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Several of the commenters requested the development of a Regulatory Guide to assist with compliance upon modification of the dose limit.
Response.
As part of the effort to revise the regulations, the NRC will develop a l
Reoulatory Guide to assist licensees with the implementation of the revised 10 CFR 35.75.
(See discussion under Section VI, " Proposed Regulatory Guidance," for additional information.)
Comment. Documenting Public Dose.
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Some commenters suggested that licensees cannot document the dose any member of the public will receive from a released patient, so it will be impossible to demonstrate compliance with this or any dose limit.
Response.
f Licensees are responsible for demonstrating compliance with NRC dose limits for individual members of the public. Although a licensee cannot be i
absolutely certain of the actual dose that an individual receives from exposure to a released patient, the proposed rule provides adequate assurance that a dose exceeding the annual limit of 5 mSv (0.5 rem) TEDE is unlikely if the written instructions provided to the patient at release on maintaining doses ALARA are willingly followed.
Comment.
No Confirmation that Part 20 Dose Limits are Exceeded.
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A few commenters suggested that there is no scientific evidence that j
external radiation exposure to the public in this application will exceed the limitations published in Part 20 when treatment is on an outpatient basis.
t Response.
Based on the mcdels used by the NRC to estimate dnse from a released patient, the dose to an individual member of the public is likely to exceed the annual dose limit of 1 mSv (0.1 rem) TEDE in a majority of the therapeutic administrations of radioactive materials. On the other hand, it is-unlikely that an individual-exposed to a patient released after the diagnostic administration of radioactive material will exceed the annual dose limit.
l (Further information on this subject is containN in the regulatory analysis 16
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prepared for the proposed rulemaking. See discussion' under Section XI,
" Regulatory Analysis," for details on obtaining a copy of the document.)
Comment.
NCRP Report No. 37.
The recommendations and guidance contained in NCRP Report No. 37 should be adopted by the NRC when revising the Part 35 dose limits.
t Response.
NCRP Report No. 37 contains standard approaches for calculating integrated dose at 1 meter from a patient following administration of certain radionuclides. However, the report does not completely address current radiation protection philosophy or all presently used radioisotopes. The NRC has contracted with the NCRP to produce (1) a commentary on " Patient Release Criteria" and (2) a revision to NCRP Report No. 37, " Criteria for Release from Hospitals of Patients Containing Therapeutic Amounts of Radionuclides." Both documents are expected to include radionuclides and techniques not previously covered.
Upon completion of these efforts, the NRC will evaluate the I
l appropriateness of endorsing the recommendations presented.
I 2.
Deletion of the 1110 MBq (30 mci) Patient Release Criterion Comment. Retention Versus the Deletion of the Activity Limit.
Some commenters suggested that if a patient is medically capable of self-care, informed and cocperative, outpatient treatment in amounts greater than 1110 MBq (30 mci) is sensible and that the NRC should therefore delete l
l the activity requirement. Many commenters, however, noted that while the 17 l
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1110 MBq (30 mci) criteria were not well founded scientifically, the criteria provide a simple method to demonstrate compliance with NRC regulations and it should ne retained.
t Response.
The proposed revision to 10 CFR 35.75 is dose based. Unlike the current
! 35.75, no activity or dose rate is specified. However, the proposed j
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Regulatory Guide will contain a table of commonly used radionuclides for medical use, that in part, specifies the cumulative annual activity per isotope with which a patient can be released to demonstrate compliance with the proposed annual dose limit.
In those cases where the activity listed in the table for a specific radionuclide is overly restrictive, the proposed regulatory guidance offers the licensee the option to calculate actual doses, j
allowing patients to be released containing larger quantities of radioactive l
l material and still demonstrate compliance with the proposed annual dose limit.
(See discussion under Section VI, " Proposed Regulatory Guidance," for additional information.)
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i Comment.
Patient Release Containing 14,800 MBq (400 mci).
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l A petitioner (ACNM) and many commenters stated that patients should be released containing quantities equal to or greater than 14,800 MBq (400 mci) i I
of I-131, often citing as justification the study of one physician that release of such patients would not adversely affect public health and safety.
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Other commenters disagreed. Some of them referenced the same physician's l
l study and disagreed strongly with its conclusion. They expressed the belief j
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that release activities of this magnitude are dangerous to the public's health and safety.
Response.
Based on the previously described exposure modeling (see Section I,
" Background"), the dose to a member of the public from a patient released with 14,800 MBq (400 mci) of I-131 is 62.5 mSv (6.25 rem). Such a dose to a member of the public is unacceptable to the NRC.
Under the proposed regulatory guidance, licensees may allow any quantity of radioactive material to remain in a patient upon release if they can demonstrate that the individual likely to receive the maximum dose does not exceed 5 mSv (0.5 rem) TEDE in a year, based on an accurate modeling of the actual exposure scenario and they take steps to reduce the dose to levels that will be ALARA. The NRC believes that it is unlikely that a licensee could demonstrate compliance with (1) the annual 5 mSv (0.5 rem) TEDE limit, l
as w< ll as (2) the ALARA requirement of the proposed rule, were a patient to l
be released containing 14,800 MBq (400 mci) or more of I-131, but it is conceivable.
3.
Confinement l
l Comment.
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A number of comments were received on the use of the term confinement.
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The comments included:
(1) exempting the use of radiopharmaceuticals from mandatory inpatient confinement, (2) permitting home confinement is a safe l
alternative to hospitalization, (3) permitting exceptions to hospital i
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s confinement on a case-by-case basis, authorized by the physician or radiation safety officer, and (4) concern that confinement does not address transport to
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the confined area, or prohibit a patient from taking a bus home. The 1
Conference of Radiation Control Program Directors (CRCPD) stated that a l
definition of the term confinement was not warranted.
1 Response.
Currently, the term " confinement" is undefined. However, confinement as i
l defined by the ACNM, does not assure that the spread of contamination or the dose to members of the public can be controlled, because the ACNM does not specify that patient activities are under the licensee's contro'i.
I The proposed revision to 5 35.75 does not include the term
" confinement." Instead, the proposed rule language now uses the phrase
" licensee control." For the purpose of demonstrating compliance with the release criteria in the proposed 5 35.75, the NRC believes that the phrase j
" licensee control" presents no confusion at all regarding a patient's quarters before and after release, in contrast to the different possible
\\
interpretations of the term " confinement." The phrase " licensee control" does not restrict a patient to a hospital. While the location is not limited to a l
i hospital, it must be listed as a place of use on the license or a license l
amendment must be issued pursuant to i 35.13(e). Additional choices would be e
available (e.g., hospices or nursing homes) as long as the licensee can demonstrate that it can control doses to members of the public and the spread of contamination. The decision to reside a patient outside the hospital environment, yet remain under licensee control, may lessen the burden in terms r
of medical cost.
I 20
4.
Duplicative NRC and Environmental Protection Agency (EPA) Regulations i
Comment.
Mort comments from physicians and medical associations expressed concern over duplicative regulations resulting from the EPA's limitation on air effluent from NRC licensed facilities and NRC regulations.
i Response.
The referenced EPA regulations were published as 40 CFR Part 61 and deal with airborne emissions from facilities. Such releases are not related to the release of patients.
EPA has proposed rulemaking which would rescind Subpart I to the National Emission Standard for Hazardous Air Pollutants (NESHAP) of 40 CFR 61 (Clean Air Act), and which, if codified, will eliminate the duplicative regulations.
5.
Providing Written Instructions to Patients Upon Release l
Ccmment.
Some commenters suggested that the proposed rule should require licensees to give written instructions to the patient upon release; written instructions should also be given to the family and othercare care givers.
l Another commenter stated that instructions regarding patient activities significantly increase apprehension needlessly.
l l
21
)
i
1 Response.
Under the proposed s 35.75, patient releases involving a total body content of radioactive material which might reasonably be expected to result in an annual TEDE less than or equal to 1 mSv (0.1 rem) to a member of the public (the allowable limit under i 20.1301(a)(1)) do not require issuance of written instructions to the patient to implement ALARA. However, when a patient release will result in an annual TEDE that is more than 1 mSv (0.1 rem) TEDE, licensees must provide written instructions to the patient on maintaining doses to household members and members of the public ALARA.
The issuance of written instructions provides the patient (as well as
)
the family and any other individual member of the public likely to spend significant time in close proximity with the patient) a document that is readily referenced at any time after the patient release. Written instructions prevent misinterpretation of guidance. The NRC also believes the benefit of clear rational instructions will outweigh the apprehensions of patient or family, serving in most situations to alleviate such concerns. The proposed Regulatory Guide will specify the contents of the written instructions necessary to demonstrate compliance with the ALARA requirement.
(See discussions under Section V, " Summary of Proposed Rule Requirements and the Rationale for Their Inclusion," and Section VI, " Proposed Regulatory Guidance," for additional information.)
22
)
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1 1
6.
Increased Cost:
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Comment.
Controlling the cost of medical care was one of the most cited reasons l
to prompt change in the regulations. Concern was expressed that the costs to all parties involved (i.e., patients, physicians, hospitals, insurance companies, etc.) would dramatically rise if no modifications were forthcoming.
One physician remarked that current medical cost philosophy is attempting to transfer all medical procedures to an outpatient basis, even to the point of 1-day surgery. One professional organization firmly believed that the iiRC 1
must carefully weigh the need for protection of the general public against the cost associated with additional days of hospitalization before making any change.
Response.
A fundamental concern of the NRC in making any decision is the l
protection of the public health and safety. The NRC believes that the l
l proposed rule allows licensees adequate flexibility to mitigate cost without l
adversely impacting the health and safety of the public by permitting l
licensc2s to release some patients earlier than 10 CFR 20.1301(a) would otherwise permit.
l 23 l
I
i IV. Public Workshops l
i The Agreement States The NRC conducted a public workshop with representatives of the Agreement States on July 15 and 16, 1992, to discuss a variety of medically related issues, including the proposals for modifying the revised Part 20 and the existing Part 35. The workshop was held in Atlanta, Georgia. Twenty-one of the Agreement States were represented, as well as a representative from the City of New York. The major recommendations provided by the representatives may be summarized as follows:
(1) Guidance in the form of written safety instructions should be given to the outpatient and any individual member of the public likely to spend significant time in close proximity with the patient.
1 (2) The philosophy of the proposed rule should be based on the total dose to decay to a member of the public.
(3) Use the 1110 MBq (30 mci) limit specifically for 1-131 and the recommendations of NCRP Report No. 37 for all other radionuclides.
l (4) Retain a dose rate less than 0.05 mSv (5 mrem) per hour at a j
distance of 1 meter and add a total dose to decay requirement of 5 mSv l
(0.5 mrem) in 1 year to a member of the public.
t l
(5) Revise 10 CFR Part 20 (May 1991) to exclude doses to a member of the public pursuant to the proposed 6 35.75.
l (6) Do not add a specific definition of confinement in Part 35.
l (7) The proposed changes to Part 35 should not be a matter of compatibility for Agreement States.
24
i I
The NRC agrees with the majority of these recommendations and has incorporated them into the proposed rulemaking. A transcript of the meeting has been placed in the NRC Public Document Room.
Advisory Committee on Medical Uses of Isotopes (ACMUI)
The NRC staff presented their suggestions for a proposed rule to the ACMUI during a public meeting in October 1992 in Rockville, Maryland. The ACMUI is an advisory body established for advising the NRC staff on matters involving the administration of radioactive material and radiation from radioactive material. The membership of the ACMUI consists of five physicians, one nuclear pharmacist, two medical physicists, one nuclear medicine technologist, one representative with the States' perspective, one I
patients' rights and care advocate, and one U.S. Food and Drug Administration (FDA) representative. The physicians have three primary specialties: two specialize in therapeutic radiology, with expertise in teletherapy and j
brachytherapy; two specialize in nuclear medicine; and one specializes in l
cardiology. The major ACMUI recommendations on formulation of the proposed l
rule were-j (1) Add the limit of 5 mSv (0.5 rem) TLDE in 1 year to a member of the public as a result of exposure to a patient released with radionuciides.
(2) Retain both the 1110 MBq (30 mci) and the maximum dose rate
-l criteria in the existing 5 35.75 because they are a simple means to show i
compliance, without the need to implement a computational methodology.
(3) Develop a Regulatory Guide including a set of standardized calculations with very conservative factors (e.g., occupancy factor) for 25 1
l
licensees to determine compliance with patient release criteria on an l
individual basis. Table (s) of acceptable release activities should also be provided which are radionuclide specific, based on exposure at I meter for routine patient releases, with built-in safety factors to avoid exposures to members of the public near the 5 mSv (0.5 rem) limit.
(4) Require written instructions be provided to the patient upon release from confinement linked to the Quality Management Rule.
The NRC agrees with some of these recommendations and has incorporated them into the proposed rule.
The NRC staff presented a status report on the requirements of the proposed rule as they appear under Section V, " Summary of Proposed Rule Requirements and the Rationale for Their Inclusion," to the ACMUI during a j
public meeting in May 1993, in Bethesda, Maryland. The ACMUI was generally supportive of the approach formulated for the proposed rule by NRC staff.
Transcripts of both meetings have been placed in the NRC Public Document Room.
V. Summary of Proposed Rule Requirements and the Rationale for Their Inclusion Part 20-Standards for Protection Against Radiation 1
Section 20.1301.
Dose limits for individual members of the public.
[
Paragraph (f) is added to i 20.1301. For exposure of a member of the public to a patient relea:ed with radioactive material for medical use, paragraph (f) provides an exemption to the annual do.ce limit of 1 mSv i
i 26 l
(0.1 rem) TEDE in i 20.1301(a) for patients released under the provisions of 6 35.75.
The NRC believes that there are adequate reasons to justify the granting of an exemption.
In some cases, retaining a patient in a hospital when there is no medical necessity, may not be reasonable.
Generally, only an individual member of the public that gives physical or emotional care and support (e.g.,
a family or household member) is likely to spend significant time in close proximity with the patient and receive a dose in excess of the Part 20 annual limit of 1 mSv (0.1 rem) TEDE.
It is unlikely that an individual member of the public would be routinely exposed to a released patient containing radioactive material.
(See discussion under Section I, " Background," for additional information.)
Under this revision, licensees will be able to release patients sooner than allowed under the more restrictive 6 20.1301(a) without adversely affecting the level of protection for the general public. This exemption grants a portion of the regulatory relief requested by the petitioners. The balance of the petitions are denied.
Part 35-Medical Use of Byproduct Material Section 35.75 Release of oatients containina sealed or unsealed sources of radioactive material for medical use.
The Commission proposes to retitle this section by using the phrase " sealed or unsealed sources of radioactive material for medical use," in place of, "radiopharmaceuticals or permanent implants." Use of the term " unsealed 27 1
i
radioactive material for medical use" instead of "radiopharmaceutical" is intended to indicate that the Commission's regulations regarding the medical use of radioactive material are focused on-radiation safety and are separate from the Food and Drug Administration's regulations regarding radioactive drugs. Thus, ti e word "radiopharmaceutical" would be equivalent to " unsealed radioactive material for medical use" in tie sections that are not modified by this proposed rule. Correspondingly, the term " permanent implant" is replaced by " sealed radioactive material for medical use."
Section 35.75(a).
The proposed & 35.75(a), establishes the patient release criterion as a dose to the member of the public likely to receive the highest dose. The estimated dose to an individual member of the public shall not exceed 5 mSv (0.5 rem) TEDE in a year. This is consistent with the philosophy used in the development of the revision to 10 CFR Part 20 published in 1991.
In addition, all releases under this paragraph shall be in accordance with the requirements set forth in the proposed paragraph (b) of this section.
Sections 35,75(a)(1) and 35.75(a)(2).
The Commission proposes to delete these sections in their entirety. The proposed rule does not specify either a quantity of activity or dose rate as methods to show compliance with the annual dose limit in paragraph (a). A Regulatory Guide will be developed that includes, in part, approaches which the NRC finds to be acceptable means of demonstrating compliance with the 28
I regulations.
(See discussion under Section VI, " Proposed Regulatory l
Guidance," for additional information.)
Section 35.75(b',.
The proposed 5 35.75(b) specifies that if a released patient contains a total body content of radioactive material which might reasonably be expected to result in an annual dose to an individual member of the public in excess of I mSv (0.di*p491IEDE) then the licensee is required to (1) provide written instructions and (2) maintain a record of the release pursuant to the requirements of the proposed il 35.75(b)(1) and 35.75(b)(2), respectively.
Section 35.75(b)(11.
Section 35.75(b)(1) is added. The proposed paragraph states the requirement for the provision of the written instructions as indicated under the conditions of the proposed 5 35.75(b). The written instructions shall include information on maintaining exposures to household members and members of the public ALARA.
In cases where patient release is likely to result in an annual TEDE to a member of the public that does not exceed 1 mSv (0.1 rem),
l the licensee need not issue written instructions to the patient.
l One benefit of such a document is that it minimizes the chance of l
l misunderstanding the licensee's guidance. Also, verbal instructions alone lack the assurance that information will be properly conveyed to family members not present at the time of release or that guidance will remain constant in routine situations.
(See discussion under Section VI, " Proposed Regulatory Guidance," for additional information.)
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29 i
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(
Section 35.75(b)(2).
I Section 35.75(b)(2) is added.
Paragraph (b)(2) as proposed, states the requirement for a licensee to maintain records, as indicated under the conditions of the proposed i 35.75(b), to demonstrate compliance with the annual TEDE limit to a member of the public in paragraph (a) of the proposed 5 35.75.
In situations where the patient is released with a total body content of radioactive material that is likely to result in an annual TEDE to a member of the public that does not exceed 1 mSv (0.1 rem), the licensee is not required to demonstrate compliance with the annual dose limit, and l
therefore, no record need be maintained. - Jemonstrate compliance with the proposed annual dose limit for multiple administrations over the course of a i
year, the cumulative annual activity shall be base _d only on those releases 1
(and a record maintained of each) that are likely to result in an annual TEDE l
to a member of the public that exceed 1 mSv (0.1 rem).
Also, paragraph (b)(2) defines the records retention period as 5 years, t
Recordkeeping is necessary so that the past exposure history to the individual member of the public likely to receive the highest dose from a patient release can be reconstructed and that compliance with the NRC' regulations can be documented. Typically, medical use of radioactive material licensees is inspected by the NRC once during a 3-year period with some on a 4-or 5-year schedule. Consequently, a record retention period that is less than 5 years i
does not ensure that the records for all patients released between NRC inspections will be available for NRC review.
30
The proposed action constitutes a partial granting of the petitions by Dr. Carol S. Marcus and the ACNM. The remaining portions of the petitions are denied.
VI.
Proposed Regulatory Guidance The NRC will develop a Regulatory Guide regarding patient release.
Regulatory Guides are not regulations and compliance with the position in a guide is not required. However, the NRC has found that Regulatory Guides are-l very useful in providing licensees with approaches which the NRC finds to be 1
acceptable for demonstrating compliance with the regulations.
There are four sections in a Regulatory Guide. They are:
(1) Introduction, (2) Background, (3) Regulatory Positions, (4) Implementation. The " introduction" contains information on the section of l
the Commission's regulations which are being addressed in the guide.
i l
The " background" section of the proposed Regulatory Guide will include, in part, a discussion on (1) why doses need to be calculated for the member of the public likely to receive the highest dose, (2) the philosophy behind the issuance of written instructions, and (3) information on additional available guidance on the subject.
The " regulatory position" section will elaborate on methods acceptable to the NRC to demonstrate compliance with the regulations. The guide will contain a table of commonly used radionuclides, specifying for each, the cumulative annual activities corresponding to an estimated dose to a member of the public of 1 mSv (0.1 rem) and 5 mSv (0.5 rem)) based on conservative models (i.e., NCRP Report No. 37 and to assume an exposure correction factor 31 i
1
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of 25%). The cumulative annual activities listed under the 1 mSv (0.1 mSv) will correspond to the levels above which a licensee should provide written instructions to the patient and maintain release records to comply with the release criteria of the proposed 5 35.75. The second category, the 5 mSv l
(0.5 rem) column, will state the cumulative activity for each radionuclide, above which, release of a patient would result in an overexposure to a member of the public based on the standard model.
(Also, a case specific model can be used for dose evaluation to demonstrate compliance.) Thus, use of this table is a relatively simple method by which licensees could demonstrate compliance with the proposed i 35.75(a) for routine patient releases. Also, l
the table could be updated as new medical procedures employ isotopes not now commonly in use, for example--radiolabeled antibodies.
In those cases where the activity listed in the table under the annual dose limit column is overly restrictive (for single or multiple administrations over the year), the Regulatory Guide will provide licensees the flexibility to perform a dose estimate on a case-by-case basis. The approach will use a simple calculational methodology that incorporates case specific exposure correction occupancy factors to estimate the dose to the individual likely to receive the highest dose from the released patient.
Using a simple calculation of total dose to decay or removal, licensees can apply appropriate exposure correction factors such as actual maximum occupancy i
time, patient metabolism and shielding values. The NRC believes the use of l
this alternative approach is justified because it is unlikely that an l
individual member of the public would be routinely exposed to patients j
containing radioactive material. Utilizing the alternative method, a licensee could release a patient with radioactive material in excess of the activity 32 i
i
l.
listed in the table described above and still demonstrate compliance with the annual dose limit of the proposed rule, if the actual home situation is significantly different than the standard model parameters.
In calculating the estimated TEDE, medical use of radioactive material licensees could take into account the actual physical and chemical characteristics of the radioactive material, occupancy factors, the residential arrangements for the patient after release (for example--whether the patient sleeps alone and l
whether the patient uses the same sanitary facilities as other household members) and the ability of individuals to minimize their exposure (by using the techniques such as limiting the time they spend in the immediate proximity of the patient) in keeping with the principle of ALARA.
In addition, an I
appendix of example dose calculations will be provided.
Also under the " regulatory position" section, there will be a discussion recommending specific written instructions which should be provided to the patient or their family to maintain doses ALARA.
In those cases where the patient release is based on the calculational methodology issuance of written t
l instructions is of utmost importance, as occupancy and distance correction 1
factors are based on the informed cooperation of the patient, the family, visitors and any other individual member of the public likely to spend significant time in close proximity with the patient. Written instructions can include:
(1) the need to avoid public transportation, (2) contamination control, (3) avoidance of public places, (4) separate sanitary facilities, (5) maintaining distance from family members (e.g., separate sleeping arrangements), and (6) length of time the procedures should be exercised.
l Finally, this section will address the contents of patient release records necessary to demonstrate compliance with the annual dose limit of the 33 l
r i
i j
l proposed rule.
Such records may be as simple as indicating the release l
activity on a form (i.e., compliance under the tabulated activities).
Whereas, a record for a release involving a specific dose calculation would include the patient specific calculational analysis performed by the licensee.
When the patient release is likely to result in an annual TEDE to a member of the public that does not exceed 1 mSv (0.1 rem), the licensee will not be I
l requiNd to maintain a record to demonstrate compliance with the annual dose limit.
l The Commission requests that the public provide comments on the proposed contents of the Regulatory Guide.
l VII. Alternatives Considered in Developing the Proposed Rule l
1.
Grant the Marcus petition without modification.
The Marcus petition raised 3 issues.
First, raise the z.nnual dose limit for members of the public to 5 mSv (0.5 rem) from licensed activity. To l
generally raise the annual dose limit to 5 mSv (0.5 rem) woulc be unacceptable t
I in terms of risk to the health and safety of the public, except in cases where the exposure is known to be infrequent and there is significant benefit.
Therefore, in the proposed rule, the limit is raised only in the case of patient release because the NRC believes that a dose greater than 1 mSv (0.1 rem) to any individual is likely to be a one time event.
(See discussion j
under Section I, " Background," for additional information.) Second, delete the requirement that NRC licens, 3 also comply with EPA standards.
NRC cannot exempt its licensees from compliance with EPA regulations. This was included 34 l
l
in Part 20 only to remind licentees that other agencies had jurisdiction in the area of air effluents. However, the NRC has continued to work with EPA to provide a regulatory framework which would allow EPA to rescind the potentially duplicative regulations. On December 1, 1992, the EPA published in the Federal Register [57 FR 56877) a notice of proposed recision to 5"% art I as applied to facilities licensed by the NRC or Agreement States which are not involved in the generation of nuclear power. Finally, the t
petition requests that an activity limit for each radionuclide in use in nuclear medicine be codified. The NRC staff has not adopted this approach because it is inadequate to properly control new procedures and radionuclide therapies which could he developed due to the time necessary for revision of a regulation.
Instead, the NRC staff will develop a Regulatory Guide (as p*eviously discussed) that includes, in part, a table that lists the total activity per year with which a F.tiant can be released for the currently available radionuclides, gi' en a standard set of assumptions. This way, the table can be revised n needed by NRC staff without amending the regulations.
2.
Grant the ACNM petition without modification.
The ACNM petition requested that the 1110 MBq (30 mci) limit for release of patients be raised to perhaps as much as 14,800 MBq (400 mci). NRC staff believes that this proposal is not in keeping with the NRC mission to protect the health and safety of the public. However, the proposed Regulatory Guide allows the flexibility to demonstrate compliance with the annual dose limit for members of the public by estimating actual doses in cases where the i
tabulated activity for release as listed in the regulatory guidance is I
35
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unnecessarily restrictive.
Finally, the amendment to the ACNM petition requested that NRC regulations recognize that confinement can mean staying at home. The proposed rule does not include the term " confinement." Instead, the proposed rule language now uses the phrase " licensee control," which does not restrict a patient to a hospital. When a licensee cannot demonstrate l
compliance with the proposed release criteria, additional locations are available at which the patient may reside, as long as the location is a place where the licensee can control' doses to members of the public and the spread i
of contamination (e.g., hospices or nursing homes).
In such cases, the location must be listed as a place of use on the license or a license amendment must be issued pursuant to i 35.13(e).
3.
Leave Part 35.75 and Part 20 as they are now.
In this situation, (1) the potential exists that a licensee might release a patient in compliance with Part 35, but containing quantities of i
radiopharmaceuticals which would likely result in a dose to a member of the public in violation of the revised Part 20 limit; (2) confinement is undefined and the intent of the rule can be circumvented by an overly liberal l
interpretation; and (3) there v
. ' be no requirement to provide written instructions to patients upon re a a shich help patients understand and implement the ALARA philosophy.
4.
Address the inconsistency between Parts 20 and 35 in a Regulatory Guide and/or a NUREG.
36
The inconsistency of the revised Part 20 with the current Part 35 cannot' be corrected in this manner because the regulations as currently written do j
not make the limits in Part 35 the controlling criteria, and.thr.nfore, can j
only be changed through rulemaking.
)
i VIII. Agreement State Compatibility The Commission believes that 9i 20,1301(c) and 35.75 should be l
Division 2 items of compatibility because the patient release criteria, required by the rule, are necessary to ensure adequate protection of the l
public health and safety. However, the Commission requests that the Agreement' l
States provide comments on the choice of division level (s).
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IX.
Finding of No Significant Environmental Impact: Availability
?
i The Commission has determined under ~the National Environmental Policy j
f Act of 1969, as amended, and the Commission's regulations in Subpart A of j
10 CFR Part 51, that the proposed amendments, if adopted, would not be a major l
Federal action significantly affecting the quality of the human environment, and therefore an environmental impact statement is not required..The proposed amendment revises the release criteria for patients receiving radioactive i
material for medical use te permit a maximum annual dose to an individual i
member of the public of 5 mSv (0.5 rem); and exempts licensees from meeting the dose limit for members of the public in 10 CFR 20.1301.for patients i
released in accordance with 5 35.75. This amendment also proposes, in'some cases, to require written instructions be provided patients upon release which l
I 37 i
l help patients understand and implement the ALARA philosophy, and that, records be maintained for 5 years to show compliance with the annual dose limit. This amendment will result in enhanced patient safety in a cost-effective manner while allowing the flexibility necessary to minimize intrusion into medical judgments.
The Commission believes the proposed amendment would result in appropriate patient care while continuing to adequately protect public health and safety.
It is expected that there would be no increase in radiation exposure to the public or to the environment beyond the exposures currently resulting from the medical use of radioactive material. The environmental assessment and finding of no significant impact on which this determination is based is available for inspection at the NRC Public Document Room, 2120 L Street NW. (Lower Level), Washington, DC. Single copies of the environmental assessment and the finding of no significant impact are l
available (see FOR FURTHER INFORMATION CONTACT heading).
X. Paperwork Reduction Act Statement This proposed rule amends information collection requirements that are subject to the Paperwork Reduction Act of 1980 (44 U.S.C. 3501 et seq.). This rule has been submitted to the Office of Management and Budget for review and approval of the paperwork requirements.
The public reporting burden for this collection of information is estimated to be 18,400 hours0.00463 days <br />0.111 hours <br />6.613757e-4 weeks <br />1.522e-4 months <br /> per year for 1,350 licensee, or en average 13.6 hours6.944444e-5 days <br />0.00167 hours <br />9.920635e-6 weeks <br />2.283e-6 months <br /> per year per licensee, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, 38
-I i
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l and completing and reviewing the collection of information. Send comments I
regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden, to the Information and Reports Management Branch (MNBB-7714), U.S. Nuclear Regulatory Commission, Washington, DC 20555; and to the Desk Officer, Office of Information and Regulatory Affairs, NE0B-3019, (3150-0010), Office of Management and Budget, Washington, DC 20503.
XI. Regulatory Analysis The Commission has prepared a regulatory analysis for the proposed amendment. The analysis examines the benefits and impacts considered by the NRC. The regulatory analysis is available for inspection at the NRC Public Document Room at 2120 L Street NW. (Lower Level), Washington, DC. Single copies are available (see FOR FURTHER INFORMATION CONTACT heading).
XII. Regulatory Flexibility Certification The NRC is seeking public comment on the initial regulatory flexibility analysis. The NRC is particularly seeking comment from small entities ** as to how the regulations will affect them and how the regulations may be tiered or otherwise modified to impose less stringent requirements on small entities while still adequately protecting the public health and safety. Any small entity subject to this regulation who determines that, because of its size, it I
As defined under the NRC's size standards (56 FR 56672; November 6, 1991).
39 l
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_.. -.= -
a i
is likely to bear a disproportionate adverse economic impact should offer l
comments that specifically discuss the following items (a) The licensee's size and how the proposed regulation would result in a significant economic burden or whether the resources necessary to implement this amendment could be more effectively used in other ways to optimize public health and safety, as ' compared to the economic burden on a larger licensee; (b) How the proposed regulation could be modified to take into account i
the licensee's differing needs or capabilities; f
?
(c) The benefits that would accrue, or the detriments that would be avoided, if the proposed regulation were modified as suggested by the licensee; i
(d) How the proposed regulation, as modified, could more closely i
equalize the impact of NRC regulations or create more equal access to the benefits of Federal programs as opposed to providing special advantages to any-individual or group; and
[
(e) How the proposed regulation, as modified, would still adequately l
protect the public health and safety.
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XIII. Backfit Analysis l
l l
t The NRC has determined that the backfit rule,10 CFR 50.109 does not.
I apply to this proposed rule, ano therefore, that a backfit analysis is not required for this proposed rule, because these amendments do not involve any provisions which would impose backfits as defined in 10 CFR 50.109(a)(1).
f
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e 40
XIV. List of Subjects l
10 CFR 20 Byproduct material, Licensed material, Nuclear materials, Nuclear power plants and reactors, Occupational safety and health, Packaging and containers, Penalty, Radiation protection, Reporting and recording requirements, Specizi nuclear material, Scurce material, Waste treatment and disposal.
10 CFR 35 Byproduct material, Criminal penalty, Drugs, Health facilities, Health professions, Incorporation by reference, Medical devices, Nuclear materials, Occupational safety and health, Penalty, 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 adopting the following amendments to 10 CFR Parts 20 and 35.
41 l
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i 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, i,d Stat.
1242, as amended, 1244, 1246 (U.S.C. 5841, 5842, 5846). Section 20.408 also issued under secs. 135, 141, Pub. L.97-425, 96 Stat. 2232, 2241 (42 U.S.C.
l 10155,10161).
l For the purposes of sec. 233, 68 Stat. 958, as amended (42 U.S.C. 2273);
Section 20.101, 20.102, 20.103 (a), (b), and (f), 20.104 (a) and (b),
20.105(b),20.106(a),20.201,20.202(a),20.205,20.207,20.301,20.303, 20.304, 20.305, 20.1102, 20.1201-20.1204, 20.1206, 20.1207, 20.1208, 20.1301, 20.1302, 20.1501, 20.1502, 20.1601 (a) and (d), 20.1602, 20.1603, 20.1701, 20.1704, 20.1801, 20.1802, 20.1901(a), 20.1902, 20.1904, 20.1906, 20.2001, 20.2002, 20.2003, 20.2004, 20.2005 (b) and (c), 20.2006, 20.2101-20.2110, 20.2201-20.2206, and 20.2301 are issued under sec. 161b, 68 Stat. 948, as amended (42 U.S.C. 2201(b)); Section 20.2106(d) is issued under the Privacy Act of 1974, Pub. L.93-579, 5 U.S.C. 552a; and Section 20.102,20.103(e),
20.401-20.407, 20.408(b), 20.409, 20.1102(a) (2) and (4), 20.1204(c), 20.1206 (g) and (h), 20.1904(c)(4), 20.1905 (c) and (d), 20.2005(c), 20.2006(b)-(d),
20.2101-20.2103, 20.2104(b)-(d), 20.2105-20.2108, and 20.2201-r0.2207 are issued under sec. 1610, 68 Stat. 950, as amended (42 U.S.C. 2201(o)).
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2.
In i 20.1301 paragraph (f) is added to read as follows:
1 20.1301 Dose limits for individual members of the public.
(e) The dose limits for individual members of the public specified in i20.1301(a) shall not apply to doses received as a result of exposure to patients released under the provisions of f 35.75.
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PART 35--MEDICAL USE OF BYPRODUCT MATERIAL l
i 3.
The authority citation for Part 35 is revised to read as follows:
Authority:
Secs. 81, 161, 182, 183, 68 Stat. 935, 948, 953, 954, as amended. (42 U.S.C. 2111, 2201, 2232, 2233); sec. 201, 88 Stat. 1242, as amended (42 U.S.C. 5841).
For the purposes of sec. 223, 68 Stat. 958, as amended (42 U.S.C. 2273);
51 35.11, 35.13, 35.20(a) and (b), 35.21(a) and (b), 35.22, 35.23. 35.25, 35.27(a), (c) and (d), 35.31(a), 35.32(a), 35.49, 35.50(a)-(d), 35.51(r)-(c),
35.53(a)-(b), 35.59(a)-(c), (e)(1), (g) and (h), 35.60, 35.61, 35.70(a)-(f),
35.75, 35.80(a)-(e), 35.90, 35.92(a), 35.120, 35.200(b) and (c), 35.204(a) and (b), 35.205, 35.220, 35.300, 35.310(a), 35.315, 35.320, 35.400, 35.404(a),
35.406(a) and (c), 35.410(a), 35.415, 35.420, 35.500, 35.520, 35.605, 35.606, 1
35.610(a) and (b), 35.615, 35.620, 35.630(a) and (b), 35.632(a)-(f),
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35.634(a)-(e), 35.636(a) and (b), 35.641(a) and (b), 35.643(a) and (b),
35.645(a) and (b), 35.643(a) and (b), 35.645(a) and (b), 35.900, 35.910, 35.920, 35.930, 35.932, 35.934, 35.940, 35.941, 35.950, 35.960, 35.961, 43 l
35.970, and 35.971 are issued under sec. 161b, 68 Stat. 948, as amended (42 U.S.C. 2201(b)); and if 35.14, 35.21(b), 35.22(b), 35.23(b), 35.27(a) and l
(c),35.29(b),35.32(b)-(f),35.33(a)-(b),35.36(b),35.50(e),35.51(d),
35.53(c), 35.59(d) and (e)(2), 35.59(g) and (i), 35.70(g), 35.80(f), 35.92(b),
35.204(c), 35.310(b), 35.315(b), 35.404(b), 35.406(b) and (d), 35.410(b),
35.415(b),35.610(c),35.615(d)(4),35.630(c),35.632(g),35.634(f),
35.636(c), 35.641(c), 35.643(c), 35.645, 35.647(c) are issued under sec. 1610,
[
68 Stat. 950, as amended (42 U.S.C. 2201(o)).
4.
Section 35.75 is revised to read as follows:
5 35.75 Release of patients containing sealed or unsealed radioactive material.
(a) A licensee shall not authorize release from licensee control for l
medical' care any patient administered sealed or unsealed sources of radioactive material if the estimated total effective dose equivalent (TEDE) to an individual member of the public from exposure to the released patient exceeds 5 mSv (0.5 rem) in a year pursuant to the requirements in paragraph (b) of this section.
(b)
If the total effective dose equivalent to the individual likely to i
receive the highest dose from the released patient containing sealed or unsealed sources of radioactive material exceeds 1 mSv (0.1 rem) for a single administration, upon release the licensee shall:
(1)
Provide the patient with written instructions on maintaining exposures to household members and members of the public ALARA; and 44
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l (2) Maintain a record of the release and the calculated dose to the l
l individual member of the public likely to receive the highest dose-for a l
period of 5 years.
Dated at Rockville, Maryland, this day of 1993.
For the Nuclear Regulatory Commission.
Samuel J. Chilk, Secretary of the Commission.
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