ML090500018 

UNITED STATES 

NUCLEAR REGULATORY COMMISSION 

OFFICE OF FEDERAL AND STATE MATERIAL AND 

ENVIRONMENTAL MANAGEMENT PROGRAMS 

WASHINGTON, DC 20555-0001 

July 29, 2009 

NRC INFORMATION NOTICE 2003-22, HEIGHTENED AWARENESS FOR 

SUPPLEMENT 1: PATIENTS CONTAINING DETECTABLE 

AMOUNTS OF RADIATION FROM 

MEDICAL ADMINISTRATIONS 

ADDRESSEES

All U.S. Nuclear Regulatory Commission (NRC) medical-use licensees and NRC master 

material licensees, all Agreement State Radiation Control Program Directors and State Liaison 

Officers. 

PURPOSE 

The NRC is issuing this supplement to Information Notice (IN) 2003-22, “Heightened Awareness 

for Patients Containing Detectable Amounts of Radiation from Medical Administrations” 

(December 9, 2003), to provide additional information regarding medical-use licensees’ 

provision of instruction and information to individuals released in accordance with Title 10, 

Section 35.75, “Release of Individuals Containing Unsealed Byproduct Material or Implants 

Containing Byproduct Material,” of the Code of Federal Regulations (10 CFR 35.75) and to 

remind addressees of the importance of various NRC requirements, guidance, and 

communications on this topic. 

Recipients should review the information for applicability to their facilities and consider 

appropriate actions to ensure the adequacy of the information they provide to individuals 

released in accordance with 10 CFR 35.75. However, suggestions contained in this IN are not 

new NRC requirements; therefore, no specific action or written response is required. 

The NRC is providing this IN to the Agreement States for their information and for distribution to 

their medical-use licensees, as appropriate. 

BACKGROUND 

Requirements

The requirements of 10 CFR 35.75 provide in part the following: 

(a) A licensee may authorize the release from its control of any individual 

who has been administered unsealed byproduct material or implants 

containing byproduct material if the total effective dose equivalent [TEDE] 

to any other individual from exposure to the released individual is not 

likely to exceed 5 mSv [millisievert] (0.5 rem). 
IN 2003-22, Supl. 1 

Page 2 of 5 

(b) A licensee shall provide the released individual, or the individual’s parent 

or guardian, with instructions, including written instructions on actions 

recommended to maintain doses to other individuals as low as is 

reasonably achievable [ALARA] if the total effective dose equivalent to 

any other individual is likely to exceed 1 mSv (0.1 rem). 

Guidance

The NRC has provided guidance on licensee compliance with 10 CFR 35.75 in the form of a 

model procedure. The latest version of this guidance appears in NUREG-1556, “Consolidated 

Guidance About Materials Licenses,” Volume 9, “Program-Specific Guidance About Medical 

Use Licenses,” Revision 2, issued January 2008. Appendix U, “Model Procedure for Release of 

Patients or Human Research Subjects Administered Radioactive Materials,” to this NUREG 

provides specific guidance and sample instructions that licensees can issue to patients and 

human research subjects upon their release, in compliance with 10 CFR 35.75(b). 

On May 12, 2008, the NRC issued Regulatory Issue Summary (RIS) 2008-11, “Precautions to 

Protect Children Who May Come in Contact with Patients Released after Therapeutic 

Administration of Iodine-131,” which provides licensees with a supplement to the guidance 

found in NUREG-1556, Volume 9, Revision 2. Specifically, RIS 2008-11 provides licensees 

with additional suggested patient release instructions that licensees should give to iodine-131 

therapy patients who are about to be released from licensee control and who will or may have 

contact with infants and young children. These recommended additional instructions, as listed 

in Enclosure 1 to RIS 2008-11, include the following: 

• A recommendation to have patients avoid direct or indirect contact (e.g., 

indirect contact includes contamination from shared living space) with 

infants and young children for a specific period of time (e.g., consider 

having children stay outside the home with other family members). 

• A recommendation for patients to have adequate living space at home 

(e.g., bedroom, bathroom) that can be used exclusively by the patient for 

a specific period of time. 

• Information on the potential consequences, if any, from failure to follow 

these recommendations. 

Additionally, in Enclosure 1 to RIS 2008-11, the NRC recommends that licensees consider not 

releasing patients who have been administered I-131 and whose living conditions may result in 

the contamination of infants and young children. 

Generic Communications

The original IN 2003-22 indicates that licensees should consider the following voluntary actions 

for all patients who, after receiving diagnostic or therapeutic quantities of radiopharmaceuticals 

or brachytherapy implants, emit detectable amounts of radiation at the time of release: 

1. Released patients who are administered diagnostic or therapeutic 

quantities of radiopharmaceuticals or brachytherapy implants should be 

aware that their treatment may have additional implications, because of 
IN 2003-22, Supl. 1 

Page 3 of 5 

heightened security measures. Accordingly, provide all patients that still 

emit detectable amounts of radiation with an appropriate explanation 

about the potential of alarming radiation monitoring equipment. 

2. To assist the patient and avoid unnecessary concern by law enforcement 

authorities and other public officials, consider providing the patient with 

the licensee’s business card and written information for law enforcement 

use, stating that the radiation received by the patient poses no danger to 

the public and that it is allowed by NRC medical use regulations. 

DESCRIPTION OF CIRCUMSTANCES 

In 2006 and 2007, the NRC collaborated with the Centers for Disease Control and Prevention 

(CDC) in collecting information during routine unannounced inspections of NRC medical-use 

licensees. This information collection was designed to assess how health care facilities 

informed patients released in accordance with 10 CFR 35.75 about radiation and security 

checkpoints. The goal of the study was to examine the range of patient release procedures and 

practices among NRC-licensed health care facilities—not to evaluate the adequacy of the 

existing regulation or the degree of compliance. The results of the study appeared in The 

Journal of Nuclear Medicine in December 2007.1

 

The sampling included facilities located in 12 states and ranging in size from 0 to 1,700 beds 

and performing inpatient and outpatient procedures involving both diagnosis and therapy. Thus, 

the information collection represented a range of practices in a variety of clinical settings. 

Important findings from the CDC study include the following: 

1. At 5 of the 66 surveyed facilities (8 percent), contrary to the regulatory 

requirement in 10 CFR 35.75(b), no instruction was provided to patients 

when the TEDE to other individuals was likely to exceed 1 mSv 

(0.1 rem).2

 On the other hand, 74 percent of the surveyed facilities (49 of 

66) exceeded the regulatory requirement and provided verbal or written 

instructions (or both) to patients when the TEDE to other individuals was 

not likely to exceed 1 mSv (0.1 rem). 

2. At 34 of the 66 surveyed facilities (51 percent), communication 

procedures for patients being released in accordance with 10 CFR 35.75 

had not changed in the past 5 years, despite the 2003 NRC Information 

Notice. 

3. Twelve of 78 respondents (15 percent) were not familiar with IN 2003-22. 

Eleven of these 12 respondents were based in outpatient facilities, and 

most of these 12 respondents (10 of 12) were at facilities that offered only 

diagnostic procedures. 

 

1

 Katz, Luba, and Ansari, Armin, “Survey of Patient Release Information on Radiation and Security Checkpoints,” 

Journal of Nuclear Medicine Vol. 48, Issue 12: 14N–23N, 2007. 

2

 These five licensees with released patient instruction deficiencies were identified by NRC inspectors 

during on-site inspections - follow up actions for these licensees would have been consistent with NRC 

inspection procedures. 
IN 2003-22, Supl. 1 

Page 4 of 5 

4. Of the 54 respondents that were involved in the release in accordance 

with 10 CFR 35.75 of patients that had undergone diagnostic procedures, 

eleven (20 percent) indicated that it was possible for a patient to leave the 

facility without the knowledge that their treatments had caused them to 

emit detectable levels of radiation. 

5. At 39 of the 66 surveyed facilities (59 percent), special instruction was 

provided to persons who cared for young children. 

DISCUSSION 

A report from the National Council on Radiation Protection and Measurements3

summarizes the work of numerous investigators who had published on the subject of 

patient release as follows: “The release of patients treated with therapeutic amounts of 

radiopharmaceuticals is not likely to expose any member of the public, inclusive of both 

external and internal dose contributions, >5 mSv provided that adequate instructions are 

provided at discharge to the patient and the family members.” [Emphasis added.] The 

caveat in this statement directly supports the NRC requirement in 10 CFR 35.75(b) for 

the provision by the licensee of instructions, including written instructions, on actions 

recommended to keep doses to other individuals ALARA if the TEDE to any other 

individual is likely to exceed 1 mSv (0.1 rem). This supplement to IN 2003-22 

reemphasizes the importance of compliance with all of the requirements in 

10 CFR 35.75. 

The CDC findings suggest that many individuals involved in the administration of 

radiopharmaceuticals to patients are unaware of the voluntary actions that the NRC 

recommends in IN 2003-22 for all patients who, after receiving diagnostic or therapeutic 

quantities of radiopharmaceuticals or brachytherapy implants, emit detectable amounts 

of radiation at the time of release. The vast majority of these individuals appear to be 

involved exclusively in the administration of diagnostic quantities at outpatient facilities. 

The CDC study also indicates that there are facilities providing therapeutic 

administrations that have not adopted the recommendations of IN 2003-22. The CDC 

study notes that informed and aware patients will tend to keep radiation doses to others 

ALARA. This supplement to IN 2003-22 reemphasizes the importance, for all 

individuals at all facilities involved in the administration of radiopharmaceuticals to 

patients, of being aware of and following the recommendations in the original 

IN 2003-22. 

At the time of the CDC information collection in 2006–2007, which preceded RIS 2008-11 

discussed above in the background section, 59 percent of surveyed facilities recognized the 

importance of providing special instruction to patients being released who cared for young 

children. For the other 41 percent, this supplement to IN 2003-22 reemphasizes the importance 

of licensees providing additional instructions in order to protect infants and young children from 

unnecessary exposure. 

This supplement to IN 2003-22 also notes the importance of licensees assessing the nature of a 

patient’s anticipated living accommodations after release and tailoring the instructions to prevent 

 

3

 National Council on Radiation Protection and Measurements, Report No. 155, “Management of 

Radionuclide Therapy Patients,” 2006. 
IN 2003-22, Supl. 1 

Page 5 of 5 

contamination transfer to infants and young children based on the nature of those 

accommodations, whether in the house or elsewhere. Under current regulations, a licensee 

may release a patient to any destination as long as the patient meets the release criteria in 

10 CFR 35.75. However, licensees should consider the destination to which a patient may be 

released, consider the potential for exposure to others, and provide release instructions specific 

to the patient’s circumstances. 

CONTACT 

This IN requires no specific action or written response. Please direct any questions to the 

technical contact listed below or the appropriate regional office. 

Robert J. Lewis, Director /RA/

Division of Materials Safety 

 and State Agreements 

Office of Federal and State Materials 

 and Environmental Management Programs 

Technical Contact: Ronald Zelac, FSME 

(301) 415-7635 

E-mail: Ronald.Zelac@nrc.gov 

Enclosure: “List of Recently Issued Office of Federal and State Materials and 

Environmental Management Programs (FSME) Generic 

Communications”
IN 2003-22, Supl. 1 

Page 5 of 5 

contamination transfer to infants and young children based on the nature of those 

accommodations, whether in the house or elsewhere. Under current regulations, a licensee 

may release a patient to any destination as long as the patient meets the release criteria in 

10 CFR 35.75. However, licensees should consider the destination to which a patient may be 

released, consider the potential for exposure to others, and provide release instructions specific 

to the patient’s circumstances. 

CONTACT 

This IN requires no specific action or written response. If you have any questions about the 

information in this notice, please notify the technical contact listed below or the appropriate 

regional office. 

Robert J. Lewis, Director /RA/

Division of Materials Safety 

 and State Agreements 

Office of Federal and State Materials 

 and Environmental Management Programs 

Technical Contact: Ronald Zelac, FSME 

(301) 415-7635 

E-mail: Ronald.Zelac@nrc.gov 

Enclosure: “List of Recently Issued Office of Federal and State Materials and 

Environmental Management Programs (FSME) Generic 

Communications” 

ML090500018

OFFICE MSSA/MSEA MSSA/MSEA Tech. Editor MSSA/MSEA 

NAME RZelac: sxg6 CFlannery QTE via e-mail AMcIntosh 

DATE 8/ 18 /08 11/ 14 /08 12/ 9 /08 01/ 02 /09 

OFFICE MSSA/MSEA OGC-NLO DMSSA 

NAME CEinberg BJones RLewis 

DATE 01/ 13 /09 01/ 29 /09 07/29/09 

OFFICIAL RECORD COPY
Enclosure 

IN 2003-22, Supl. 1 

Page 1 of 1 

List of Recently Issued Office of Federal and State Material and Environmental 

Management Programs Generic Communications 

Date GC No. Subject Addressees 

05/13/08 RIS-2008-10 Notice Regarding Forthcoming 

Federal Firearms Background 

Checks 

All U.S. Nuclear Regulatory Commission 

licensees, certificate holders, and 

applicants for a license or certificate of 

compliance who use armed security 

personnel as part of their physical 

protection system and security 

organization. All Radiation Control Program 

Directors and State Liaison Officers. 

06/16/08 RIS-2008-13 Status And Plans for Implementation 

of NRC Regulatory Authority for 

Certain Naturally Occurring and 

Accelerator-Produced Radioactive 

Material 

All U.S. Nuclear Regulatory Commission 

materials licensees, Radiation Control 

Program Directors, State Liaison Officers, 

and the NRC’s Advisory Committee on the 

Medical Uses of Isotopes 

07/18/08 RIS-2008-17 Voluntary Security Enhancements 

for Self-Contained Irradiators 

Containing Cesium Chloride 

Sources 

All U.S. Nuclear Regulatory Commission 

Materials Licensees Authorized to Possess 

Self-Contained Irradiators Containing 

Cesium Chloride (CsCl) ; all Agreement 

State Radiation Control Program Directors 

and State Liaison Officers; all members of 

the Advisory Committee on the Medical 

Uses of Isotopes. 

10/03/08 RIS-2008-23 The Global Threat Reduction 

Initiative (GTRI) Domestic Threat 

Reduction Program & Federally 

Funded Voluntary Security 

Enhancements For High-Risk 

Radiological Material 

All U.S. Nuclear Regulatory Commission 

Materials Licensees authorized to possess 

Category 1 or Category 2 quantities of 

radioactive materials. All Agreement State 

Radiation Control Program Directors and 

State Liaison Officers. Members of the 

Advisory Committee on the Medical Uses 

of Isotopes 

10/03/08 RIS-2008-24 Security Responsibilities Of Service 

Providers and Client Licensees 

All U.S. Nuclear Regulatory Commission 

licensees that hire service providers to 

install, service, repair, maintain, relocate, 

exchange, or transport radioactive 

materials in quantities of concern, service 

provider licensees, Agreement State 

Radiation Control Program Directors, and 

State Liaison Officers 

12/22/08 RIS-2008-10, 

Suppl. 1 

Notice Regarding Forthcoming 

Federal Firearms Background 

Checks 

All U.S. Nuclear Regulatory Commission 

licensees, certificate holders, and 

applicants for a license or certificate of 

compliance who use armed security 

personnel as part of their physical 

protection system and security 

organization. All 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/doccollections/gen-comm/index.html