[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]
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