ML103620153 

UNITED STATES 

NUCLEAR REGULATORY COMMISSION 

OFFICE OF FEDERAL AND STATE MATERIALS 

AND ENVIRONMENTAL MANAGEMENT PROGRAMS 

WASHINGTON, D.C. 20555 

January 25, 2011 

NRC REGULATORY ISSUE SUMMARY 2011-01

NRC POLICY ON RELEASE OF IODINE-131 THERAPY PATIENTS 

UNDER 10 CFR 35.75 TO LOCATIONS OTHER THAN PRIVATE 

RESIDENCES 

ADDRESSEES

All medical and Master Materials Licensees. All Radiation Control Program Directors and State 

Liaison Officers. 

INTENT

The U.S. Nuclear Regulatory Commission (NRC) is issuing this regulatory issue summary (RIS) 

to inform addressees of NRC’s policy on the release of iodine-131 therapy patients (i.e., patients 

and human research subjects) under Title 10 of the Code of Federal Regulations (10 CFR) Part 

35.75 to locations other than private residences. No specific action or written response is 

required. NRC is providing this RIS to the Agreement States for their information and for 

distribution to their licensees as appropriate. 

BACKGROUND

When the staff developed the patient release rule in 10 CFR 35.75, the staff’s intent was to 

create a rule that would allow licensees to release patients where the dose to third parties was 

not likely to exceed 5 mSv. As the rulemaking record and regulatory guidance make clear, the 

NRC anticipated that the 5 mSv standard, in contrast to the standard of 1 mSv generally 

applicable to the public under 10 CFR 20.1301(a)(1), would apply principally to the patient’s 

family or other caregivers, typically in a home setting (See for example, NUREG-1492 (pp. 11-

12); NUREG-1556 (Appendix U, p. U-18)). 

The regulations require that instructions on how to keep doses as low as reasonably achievable 

(ALARA) be given to patients if there is a possibility that doses to third parties would exceed 1 

mSv. To develop instructions adequate to meet this requirement, licensees need to analyze 

each patient’s specific circumstances to determine the appropriate recommendations to give to 

the patient prior to the patient being released. The NRC is aware of continuing concerns 

regarding instances when patients are released to hotels or motels and this RIS provides 

information in response to those concerns. 
RIS 2011-01 

Page 2 of 4 

SUMMARY OF ISSUE

The NRC regulations in 10 CFR 35.75 permit a licensee to "authorize the release from its 

control any individual who has been administered unsealed byproduct material or implants 

containing byproduct material if the total effective dose equivalent to any other individual from 

exposure to the released individual is not likely to exceed 5 mSv (0.5 rem)." Although release to 

family or other caregivers in a home setting is the longstanding practice by most licensees, 

current NRC regulations neither authorize nor restrict release of patients to particular 

destinations. But in all cases the patient must meet the release criteria in 10 CFR 35.75. If the 

total effective dose equivalent to any third party is likely to exceed 1 mSv, licensees must 

provide sufficient instructions to patients which, if followed, will assure that doses to other 

individuals will be ALARA. Licensees therefore must necessarily consider the destination (such 

as a private home, apartment, hotel, dormitory, etc.) to which a patient will be released, and 

consider the potential for exposures to others, to assure instructions compliant with 10 CFR 

35.75 are provided to the patient. 

Although 10 CFR 35.75 does not expressly prohibit the release of a radioactive patient to a 

location other than a private residence, the NRC strongly discourages this practice because it 

can result in radiation exposures to members of the public for which the licensee may not be 

able to fully assess compliance with 10 CFR 35.75(a) and may result in doses which are not 

ALARA. Licensees are reminded that the ability of the licensee to provide adequate instructions 

under 10 CFR 35.75(b) of necessity may depend upon the licensee’s consideration of the 

destination to which the patient will be released. When the licensee is aware of the likely patient 

destination, the licensee can best estimate the likely cumulative exposures to other members of 

the public (e.g., hotel workers and guests) and direct appropriate protective measures. In 

accordance with the requirements of 10 CFR 35.75(b) licensees must provide specific 

instructions highlighting the steps to follow by the patient if there is a possibility that doses to 

surrounding individuals may exceed 1 mSv. 

When an iodine-131 therapy patient is released to a private residence, the patient is likely able 

to fully describe details of the living situation that allow the licensee to make reasonable 

estimates of exposures to other individuals. The NRC recognizes, however, that there may be 

infrequent cases in which patients who would potentially be eligible for release to a private 

residence under 10 CFR 35.75(a) will be adamant on not being hospitalized or going to a 

private residence and will select an alternative location (e.g., hotel, motel, etc.) as their 

post-therapy destination. In any case, if the potential dose to third parties would exceed 1 mSv, 

licensees must provide adequate instructions to assure that, if followed, the dose to members of 

the public from the released patient meets the ALARA requirement. 

While not specifically required by 10 CFR 35.75, as part of a licensee’s approach for 

determining safe patient release, a licensee may choose to encourage patients who share living 

space with individuals whose exposure to radiation may pose a higher risk (e.g., young children 

and pregnant females) to temporarily relocate such individuals to alternative locations. This 

recommendation is in keeping with the additional instructions provided in RIS 2008-11, 

“Precautions To Protect Children Who May Come In Contact With Patients Released After 

Therapeutic Administration with Iodine-131,” and is consistent with the recommendations of the 

International Commission on Radiological Protection, Publications 94 and 103. Furthermore, as 

also recommended in RIS 2008-11, licensees should consider not releasing patients whose 

living conditions may result in the contamination and exposure of infants and young children. 
RIS 2011-01 

Page 3 of 4 

10 CFR §35.75(b) also lists specific requirements for instructions related to nursing infants and 

children. 

Licensees are reminded that, in accordance with 10 CFR 35.2075(a), they are required to 

maintain a record of the basis for authorizing the release of a patient. 

BACKFIT DISCUSSION 

This RIS requires no action or written response. Any action on the part of addressees in 

accordance with the guidance contained in this RIS is strictly voluntary and, therefore, is not a 

backfit under any requirement. Consequently, the staff did not perform a backfit analysis. 

FEDERAL REGISTER NOTIFICATION 

A notice of opportunity for public comment on this RIS was not published in the Federal Register

because it is informational and does not represent a departure from current regulatory 

requirements. 

CONGRESSIONAL REVIEW ACT 

This RIS is a rule as designated in the Congressional Review Act (5 U.S.C. §§ 801–808). The 

NRC has determined this RIS is not a major rule and has verified this determination with the 

Office of Information and Regulatory Affairs of the Office of Management and Budget (OMB). 

RELATED GENERIC COMMUNICATIONS

RIS 2008-11, “Precautions To Protect Children Who May Come In Contact With Patients 

Released After Therapeutic Administration with Iodine-131.” 

PAPERWORK REDUCTION ACT STATEMENT 

This RIS contains and references information collection requirements subject to the Paperwork 

Reduction Act of 1995 (44 U.S.C. 3501 et seq.). Existing information collection requirements 

were approved by the Office of Management and Budget, approval number 3150-0010.

PUBLIC PROTECTION NOTIFICATION

The NRC may not conduct or sponsor, and a person is not required to respond to, a request for 

information or an information collection requirement unless the requesting document displays a 

currently valid Office of Management and Budget control number.
RIS 2011-01 

Page 4 of 4 

CONTACT 

This RIS requires no specific action or written response. If you have any questions about this 

summary, please contact the technical staff member listed below or the appropriate regional 

office. 

 /RA/ 

Robert J. Lewis, Director 

Division of Materials Safety 

 and State Agreements 

Office of Federal and State Materials 

 and Environmental Management Programs 

Contact: Said Daibes, PhD, FSME/MSSA 

 (301) 415-6863 

 E-mail: Said.Daibes@nrc.gov 

Enclosure: 

List of Recently Issued FSME 

 Generic Communications 
RIS 2011-01 

Page 4 of 4 

CONTACT 

This RIS requires no specific action or written response. If you have any questions about this 

summary, please contact the technical staff member listed below or the appropriate regional 

office. 

 /RA/ 

Robert J. Lewis, Director 

Division of Materials Safety 

 and State Agreements 

Office of Federal and State Materials 

 and Environmental Management Programs 

Contact: Said Daibes, PhD, FSME/MSSA 

 (301) 415-6863 

 E-mail: Said.Daibes@nrc.gov 

Enclosure: 

List of Recently Issued FSME 

 Generic Communications 

 ADAMS Accession Number: ML103620153 

OFC FSME: RMSB FSME: RMSB FSME:RMSB FSME: RMSB 

NAME SDaibes AMcIntosh MFuller CEinberg (DBH for) 

DATE 12/29/10 12/29/10 1/3/11 1/3/11 

OFC DNMS: RI DNMS: RIII DNMS: RIV OIS 

NAME JKinneman 

(email /c/) 

ABoland (email 

/c/ PLouden for) 

CCaniano TDonnell 

DATE 1/13/11 1/14/11 1/13/11 1/13/11 

OFC OGC – CRA OGC - NLO FSME:LID FSME:MSSA 

NAME SCroston BJones JLuehman RLewis 

DATE 1/20/11 1/5/11 1/13/11 1/20/11 

OFFICIAL RECORD COPY
RIS 2011-01 

Enclosure 

Page 1 of 2 

List of Recently Issued Office of Federal and State Material 

and Environmental Management Programs Generic Communications 

Date GC No. Subject Addressees 

11/13/09 IN-2009-27 Revised International Nuclear and

Radiological Event Scale User’s Manual 

All holders of an operating license or construction 

permit for a power reactor, test reactor or research 

reactor issued under 10 CFR Part 50; holders of or 

applicants for an early site permit, standard design 

certification, standard design approval, 

manufacturing license, or combined license issued 

under 10 CFR Part 52; holders of a materials license, 

certificate, approval, or registration issued under 10 

CFR Parts 30, 31 through 36, 39, 40, 61, 70, 71, 72, 

and 76; Agreement State Radiation Control Program 

Directors and State Liaison Officers. 

11/19/2010 IN-2010-24 Notice of Possible Source Leakage During 

Non-Routine Maintenance on a Gammacell 

40 Irradiator 

All academic Type A broad scope licensees; all 

medical institutions; all self shielded irradiators 

less than or equal to 10,000 cues licensees; all 

Radiation Control Program Directors and State 

Liaison Officers. 

12/03/09 RIS-2009-15 National Source Tracking System Annual 

Inventory Reconciliation 

All licensees possessing Category 1 or Category 2 

quantities of radioactive materials. All 

Radiation Control Program Directors and State 

Liaison Officers. 

01/21/10 RIS-2010-02 The Global Threat Reduction Initiative (GTRI)

Federally Funded Voluntary Security 

Enhancements for High-Risk Radiological 

Material 

All holders of operating licenses for nuclear power 

reactors and research and test reactors 

under the provisions of Title 10 of the Code of 

Federal Regulations (10 CFR) Part 50, “Domestic 

Licensing of Production and Utilization Facilities,” 

except those that have ceased operations and 

have certified that fuel has been permanently 

removed from the reactor vessel and have no 

spent fuel stored on-site. All U.S. Nuclear Regulatory 

Commission (NRC) fuel cycle facilities licensed under 

10 CFR 

Part 40, “Domestic Licensing of Source Material” or 

10 CFR Part 70, “Domestic Licensing of 

Special Nuclear Material” and gaseous diffusion 

plants certified under 10 CFR Part 76, 

“Certification of Gaseous Diffusion Plants.” 

All holders of site-specific licenses for independent 

spent fuel storage installations (ISFSIs) 

under the provisions of 10 CFR Part 72, “Licensing 

Requirements for the Independent Storage 

of Spent Nuclear Fuel, High-level Radioactive Waste, 

and Reactor-related Greater than Class C 

Waste,” and all holders of 10 CFR Part 50 licenses 

with ISFSIs under the general license 

provisions of 10 CFR Part 72. 

All NRC materials licensees authorized to possess 

Category 1 or Category 2 quantities of 

radioactive materials, under the provisions of 10 CFR 

Parts 30, “Rules of General Applicability 

to Domestic Licensing of Byproduct Material,” 40, 

and 70. 
RIS 2011-01 

Enclosure 

Page 2 of 2 

List of Recently Issued Office of Federal and State Material 

and Environmental Management Programs Generic Communications 

Date GC No. Subject Addressees 

05/25/10 RIS-2010-04 Monitoring the Status of Regulated Activities

During a Pandemic 

All holders of operating licenses for nuclear power 

reactors and research and test reactors under the 

provisions of Title 10 of the Code of Federal 

Regulations (10 CFR) Part 50, “Domestic Licensing of 

Production and Utilization Facilities,” except those 

that have ceased operations and have certified that 

fuel has been permanently removed from the 

reactor vessel and have no spent fuel stored on-site. 

All U.S. Nuclear Regulatory Commission (NRC) fuel 

cycle facilities licensed under 10 CFR Part 40, 

“Domestic Licensing of Source Material” or 10 CFR 

Part 70, “Domestic Licensing of Special Nuclear 

Material” and gaseous diffusion plants certified 

under 10 CFR Part 76, “Certification of Gaseous 

Diffusion Plants.” All holders of site-specific licenses 

for independent spent fuel storage installations 

(ISFSIs) under the provisions of 10 CFR Part 72, 

“Licensing Requirements for the Independent 

Storage of Spent Nuclear Fuel, High-level Radioactive 

Waste, and Reactor-related Greater than Class C 

Waste,” and all holders of 10 CFR Part 50 licenses 

with ISFSIs under the general license provisions of 10 

CFR Part 72. All NRC materials licensees authorized 

to possess Category 1 or Category 2 quantities of 

radioactive materials, under the provisions of 10 CFR 

Parts 30, “Rules of General Applicability to Domestic 

Licensing of Byproduct Material,” 40, and 70.

09/10/10 RIS-2010-09 Radiation Safety Officers For Medical-Use 

Licenses Under 10 CFR Part 35 

All U.S. Nuclear Regulatory Commission (NRC) 

medical-use licensees, NRC master material 

licensees, Agreement State Radiation Control 

Program Directors, and State Liaison Officers.

Note: This list contains the six most recently issued generic communications, issued by the Office of Federal and State Materials and 

Environmental Management Programs (FSME). A full listing of all generic communications may be viewed at the NRC public website at the 

following address: http://www.nrc.gov/reading-rm/doc-collections/gen-comm/index.html