[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]]


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].


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]