[Federal Register Volume 85, Number 71 (Monday, April 13, 2020)]
[Proposed Rules]
[Page 20430]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-07383]
========================================================================
Proposed Rules
Federal Register
________________________________________________________________________
This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.
========================================================================
Federal Register / Vol. 85, No. 71 / Monday, April 13, 2020 /
Proposed Rules
[[Page 20430]]
NUCLEAR REGULATORY COMMISSION
10 CFR Part 35
[Docket No. PRM-35-21; NRC-2020-0037]
Patient Release Criteria for Radioactive Iodine
AGENCY: Nuclear Regulatory Commission.
ACTION: Petition for rulemaking; notice of docketing.
-----------------------------------------------------------------------
SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) has received a
petition for rulemaking from Peter Crane, on behalf of the
organization, Sensible Controls on Administrations of Radioactive
Iodine, dated November 15, 2019. The petitioner requests that the NRC
revise its regulations regarding the criteria for patient release after
the administration of radioactive iodine. The petition was docketed by
the NRC on January 24, 2020 and has been assigned Docket No. PRM-35-21.
The NRC is examining the issues raised by the petition to determine
whether they should be considered in rulemaking. The NRC is not seeking
public comment on this petition at this time.
DATES: The NRC received PRM-35-21 on November 15, 2019 and docketed it
on January 24, 2020.
ADDRESSES: Please refer to Docket ID NRC-2020-0037 when contacting the
NRC about the availability of information for this action. You may
obtain publicly-available information related to this action by any of
the following methods:
Federal Rulemaking Website: Go to https://www.regulations.gov and search for Docket ID NRC-2020-0037. Address
questions about NRC dockets to Carol Gallagher; telephone: 301-415-
3463; email: [email protected]. For technical questions, contact
the individual listed in the FOR FURTHER INFORMATION CONTACT section of
this document.
NRC's Agencywide Documents Access and Management System
(ADAMS): You may obtain publicly-available documents online in the
ADAMS Public Documents collection at https://www.nrc.gov/reading-rm/adams.html. To begin the search, select ``Begin Web-based ADAMS
Search.'' For problems with ADAMS, please contact the NRC's Public
Document Room (PDR) reference staff at 1-800-397-4209, 301-415-4737, or
by email to [email protected]. The ADAMS accession number for each
document referenced (if it is available in ADAMS) is provided the first
time that it is mentioned in this document.
NRC's PDR: You may examine and purchase copies of public
documents at the NRC's PDR, Room O1-F21, One White Flint North, 11555
Rockville Pike, Rockville, Maryland 20852.
FOR FURTHER INFORMATION CONTACT: Pamela Noto, Office of Nuclear
Material Security and Safeguards, U.S. Nuclear Regulatory Commission,
Washington, DC 20555-0001; telephone: 301-415-6795, email:
[email protected].
SUPPLEMENTARY INFORMATION:
I. The Petitioner
Peter Crane is the Acting Secretary for Sensible Controls on
Administrations of Radioactive Iodine (SCAR). Most of the members of
SCAR have been treated with radioactive iodine. The petitioner requests
that the NRC amend part 35 of title 10 of the Code of Federal
Regulations (10 CFR) to revise the criteria for patient release after
the administration of radioactive iodine. The petition can be found in
ADAMS at Accession No. ML20024F779.
II. The Petition
The petitioner requests that the NRC revise the patient release
criteria in Sec. 35.75 to ensure the availability of inpatient
treatment when required. The petitioner summarized the history of the
NRC's patient release regulations before, and after, the 1997
rulemaking that amended the criteria for the release of patients
following medical treatments involving radioactive isotopes. The
petitioner states that the current NRC patient release regulations
neglect internal radiation dose and are based solely on the external
radiation exposure from radioactive iodine. The petitioner further
states that, according to the Centers for Disease Control and other
national and international authorities, internal radiation dose is
critically important, particularly for children as they are far more at
risk from the effects of radiation exposure than adults. The petitioner
also states that the NRC's patient release regulations have been
interpreted to permit newly treated patients to be released, resulting
in five times the radioactive iodine exposure to the patient's family
and the public than is allowed by national and international standards.
The petitioner asserts that the responsibility to protect the public
has shifted from medical providers to individual patients, who may not
be adequately informed of the risks to the public. The petitioner
asserts that the NRC's patient release regulations allow insurance
companies to dictate whether patients and their families receive
adequate radiation protection. The petitioner states that the patient
release regulations need to be amended, and that this can be
accomplished in different ways. The petitioner suggests that the NRC
could reinstate an activity cap at 10 or 15 millicuries of radioactive
iodine or reduce the current dose limit from 500 millirems to 100
millirems, which the petitioner says is consistent with national and
international standards. The petitioner observes that guidance on
patient release is non-binding; therefore, to enforce new requirements,
the petitioner requests that the NRC conduct rulemaking.
III. Docketing
The NRC has determined that the petition satisfies the requirements
for docketing a petition for rulemaking in Sec. 2.802(c). The NRC is
reviewing the merits of the petition. The NRC has sufficient
information to understand and evaluate the merits of the petition;
therefore, NRC is not seeking public comment at this time.
Dated at Rockville, Maryland, this 3rd day of April, 2020.
For the Nuclear Regulatory Commission.
Annette L. Vietti-Cook,
Secretary of the Commission.
[FR Doc. 2020-07383 Filed 4-10-20; 8:45 am]
BILLING CODE 7590-01-P