[Federal Register Volume 59, Number 142 (Tuesday, July 26, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-18112]


[[Page Unknown]]

[Federal Register: July 26, 1994]


                                                   VOL. 59, NO. 142

                                             Tuesday, July 26, 1994

NUCLEAR REGULATORY COMMISSION

10 CFR Parts 20 and 35

[Docket No. PRM-35-11]

 

American Medical Association

AGENCY: Nuclear Regulatory Commission.

ACTION: Petition for rulemaking; Notice of receipt.

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SUMMARY: The Nuclear Regulatory Commission (NRC) is publishing for 
public comment a notice of receipt of a petition for rulemaking, dated 
March 28, 1994, which was filed with the Commission by the American 
Medical Association (AMA). The petition was docketed by the NRC on 
April 20, 1994, and has been assigned Docket No. PRM-35-11. The 
petitioner requests that the NRC amend its regulations to recognize 
that current medical practice concerning the therapeutic uses of 
I\131\, particularly in outpatient settings, is effective and safe for 
the public. The petitioner also requests that the NRC formally 
recognize that adequate home confinement precautions reduce the hazards 
associated with radioisotopes sufficiently to eliminate the need for 
hospitalization following therapeutic administration of 
radiopharmaceuticals. The petitioner also requests that the NRC 
increase the external radiation limit for the public from 100 mRem/year 
to 500 mRem/year.

DATES: Submit comments by October 11, 1994. Comments received after 
this date will be considered if it is practical to do so, but the 
Commission is able to assure consideration only for comments received 
on or before this date.

ADDRESSES: Submit written comments to the Secretary of the Commission, 
U.S. Nuclear Regulatory Commission, Washington, DC 20555, Attention: 
Docketing and Service Branch. Hand deliver comments to: 11555 Rockville 
Pike, Rockville, Maryland, between 7:45 am and 4:15 pm Federal 
workdays.
    For a copy of the petition, write the Rules Review and Directives 
Branch, Division of Freedom of Information and Publications Services, 
Office of Administration, U.S. Nuclear Regulatory Commission, 
Washington, DC 20555.
    The petition and copies of comments received may be inspected and 
copied for a fee at the NRC Public Document Room, 2120 L Street, NW. 
(Lower Level), Washington, DC.

FOR FURTHER INFORMATION CONTACT: Michael T. Lesar, Chief, Rules Review 
Section, Rules Review and Directives Branch, Division of Freedom of 
Information and Publications Services, Office of Administration, U.S. 
Nuclear Regulatory Commission, Washington, DC 20555, Telephone: 301-
415-7163 or Toll Free: 800-368-5642.

SUPPLEMENTARY INFORMATION:

Background

    The petitioner states that in order to ``provide adequate 
protection of public health and safety'' and to observe ``the principle 
of keeping all radiation exposures `as low as is reasonably 
achievable,''' the NRC has revised its standards for protection against 
radiation. NRC proposed a revision of the regulations governing 
radiation use and exposure limits in 1976. Modifications of the revised 
regulation were proposed in 1979, 1980, 1983, 1985, and 1986. Revised 
regulations were published May 21, 1991 (56 FR 23360), to become 
effective June 21, 1991, and to be fully implemented by January 1, 1993 
(later extended to January 1, 1994, see 57 FR 38588; August 26, 1992). 
The petitioner states that the section of the final rule relevant to 
outpatient treatment with I\131\ or other radiopharmaceuticals 
(Sec. 20.1301) reduces the radiation exposure limit to the public from 
500 mRem/year to 100 mRem/year.
    The petitioner believes that Sec. 20.1301 will have an adverse 
impact on the availability and the cost of treatment of thyroid 
disease, which will outweigh the advantages of reduced radiation 
exposure to the public. Therefore, the petitioner requests that this 
provision be amended to restore the previous external radiation limit 
of 500 mRem/year.

Petition

    The AMA, following a report of its Council on Scientific Affairs 
(CSA Report F (A-92)), submitted a petition for rulemaking to the NRC. 
The petitioner also submitted CSA Report F in support of the petition. 
The petitioner states that the medical use of inorganic sodium I\131\ 
has been an effective component of medical practice for over 35 years. 
The petitioner also states that radioactive biologicals, such as 
monoclonal antibodies labeled with I\131\, have been added to the 
physician's armamentarium. The petitioner believes that the ability of 
the physician to administer I\131\ on an outpatient basis has 
maintained the accessibility and minimized the costs of these 
treatments. According to the petitioner, patients treated with I\131\ 
must contain no more than 30 mCi total body activity before they may be 
released from the treatment facility. The petitioner states that 
therapeutic use of I\131\, particularly in the treatment of thyroid 
carcinoma, often requires doses in excess of 30 mCi, and may require 
doses as great as 400 mCi.
    The petitioner states that because doses of 30 mCi of I\131\ are 
substantially below the doses typically used to treat thyroid 
carcinoma, treatment of up to 10,000 cancer patients annually with 
appropriate doses would require the hospitalization of the patients 
under the revised regulation (10 CFR 20.1301). The petitioner argues 
that this new radiation exposure limit set by the NRC is inconsistent 
with medical experience and is not necessary in order to protect the 
public from radiation hazards. The petitioner states that the new 
radiation exposure limit will reduce both early release of patients and 
the treatment of patients at home, thus creating potentially avoidable 
hospital inpatient costs and burdens on the health care delivery 
system.

Suggested Changes to the Regulations

    The petitioner requests that the following amendments to the NRC's 
regulations be made:
    1. Reinstate Sec. 20.107 from the regulations in effect before the 
1991 amendments to Part 20. The added section would read as follows:

Section 20.107  Medical Diagnosis and Therapy.

    Nothing in the regulations of this part shall be interpreted as 
limiting the intentional exposure of patients to radiation for the 
purpose of medical diagnosis or medical therapy.

    2. Section 35.75 should be revised to read as follows:

Section 35.75  Release of Patients Containing Radiopharmaceuticals or 
Permanent Implants.

    A licensee may not authorize release from confinement for medical 
care any patient administered a radiopharmaceutical or a permanent 
implant until the measured dose rate from the patient is less than 5 
millirems per hour at a distance of one meter or the cumulative dose to 
individual members of the public will be less than 500 millirems per 
year.

    3. In Sec. 35.310(a), the introductory text of paragraph (a) should 
be revised to read as follows:

Section 35.310  Safety Instruction.

    (a) A licensee shall provide reasonable and adequate radiation 
instruction for all personnel caring for the patient receiving 
radiopharmaceutical therapy and confined for compliance with Sec. 35.75 
of this chapter.
* * * * *
    4. In Sec. 35.315(a), the introductory paragraph should be revised 
to read as follows:

Section 35.315  Safety Precautions.

    (a) For each patient receiving radiopharmaceutical therapy and 
confined for compliance with Sec. 35.75 of this chapter, a licensee 
shall:
* * * * *
    The AMA believes that these amendments will have a beneficial 
impact on the availability and cost of treatment of thyroid disease 
while maintaining safeguards to the health of the public.

Related Petitions and Proposed Rule

    On December 26, 1990, Carol S. Marcus, MD, filed a petition for 
rulemaking with the NRC (PRM-20-20). Dr. Marcus requested that the NRC 
restore the radiation dose limit in the amended standards for 
protection against radiation that can be absorbed by members of the 
public from patients receiving radiopharmaceuticals for diagnosis or 
therapy from 100 mRem/year to 500 mRem/year. Dr. Marcus opposed the 
newly effective radiation dose limit in 10 CFR 20.1301 because of the 
impact of this lower limit on outpatient medical procedures. She 
believed that therapeutically effective doses of I\131\ may result in 
exposure to the public within the immediate surroundings of greater 
than 100 but less than 500 mRem/year. She stated that some procedures 
utilizing radioisotopic materials that have routinely been performed on 
an outpatient basis would require hospitalization for regulatory rather 
than medical reasons. She also believed that enforced hospitalization 
would significantly increase the cost of medical care and possibly 
result in the patient's inability to receive that care.
    On October 5, 1991, the American College of Nuclear Medicine (ACNM) 
filed a petition for rulemaking with the NRC (PRM-35-10). On April 14, 
1992, the ACNM filed an amendment to its original petition (PRM-35-
10A). The ACNM requested that the NRC adopt a dose limit of 500 mRem/
year for nonpatients and permit licensees to authorize release from 
hospitalization any patient administered a radiopharmaceutical 
regardless of the activity in the patient by defining ``confinement'' 
to include not only confinement in a hospital, but also confinement in 
a private residence. The ACNM stated that their request is in the best 
interest of patients who require access to affordable quality care 
while allowing them to be diagnosed and treated on an outpatient basis 
instead of being confined to a hospital. The ACNM believed that 
temporary home confinement should be allowed instead of mandating 
hospitalization. The ACNM stated that published scientific papers 
attest to the safety of outpatient radiopharmaceutical therapy in doses 
of up to 400 millicuries of I\131\ NaI.
    On June 15, 1994 (59 FR 30724), the Commission published a proposed 
rule addressing the issues raised in PRM-20-20 and PRM-35-10. The 
petitioner and commenters are advised to review and comment on this 
proposed rule. It provides the Commission's position on the fundamental 
concern underlying the current petition. In the proposed rule, the 
Commission states that the provisions of 10 CFR 35.75 govern the 
release of patients, not the provisions in 10 CFR 20.1301. 
Consequently, commenters should comment on PRM-35-11 in this context 
because most of the issues raised in this petition are addressed in the 
proposed rule. The NRC staff also issued NRC Information Notice No. 94-
09, dated February 3, 1994, entitled ``Release of Patients with 
Residual Radioactivity from Medical Treatment and Control of Areas Due 
to Presence of Patients Containing Radioactivity Following 
Implementation of Revised 10 CFR Part 20,'' which provided the NRC 
staff's interim guidance governed by 10 CFR 35.75.

    Dated at Rockville, Maryland, this 20th day of July 1994.

    For the Nuclear Regulatory Commission.
John C. Hoyle,
Acting Secretary of the Commission.
[FR Doc. 94-18112 Filed 7-25-94; 8:45 am]
BILLING CODE 7590-01-P