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Section Contents
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Draft Report for Comment
Consolidated Guidance About Materials Licenses: Program-Specific Guidance About Medical Use Licenses
NUREG-SR1556, Vol. 9
Manuscript Completed: August 1998
Date Published: August 1998
Prepared by P. A. Lanzisera, A. R. Jones, R. G. Gattone, R. D. Reid
Division of Industrial and Medical Nuclear Safety
Office of Nuclear Material Safety and Safeguards
U.S. Nuclear Regulatory Commission
Washington, DC 20555-0001
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Any interested party may submit comments on this report for consideration by the NRC staff. Please specify the report number, draft NUREG-1556, Vol. 9, in your comments, and send them by October 30, 1998 to:
Chief, Rules Review and Directive Branch
Office of Administration
Mail Stop T-6 D59
U.S. Nuclear Regulatory Commission
Washington, DC 20555-0001
Comments may be accompanied by additional relevant information or supporting data. The staff specifically requests comments on (1) whether information on any other technical methods and models for risk-informed, performance-based applications not covered in the report exist and should be reviewed and included, and (2) risk-informed, performance-based applications beyond those discussed in the report that would provide regulatory focus on risk significant issues, and flexibility to licensees in implementing NRC safety objectives.
You may also provide comments via the Comment Form or at the NRC Web Site, http://www.nrc.gov. See the link under "Technical Reports in the NUREG Series" on the "Reference Library" page. Instructions for sending comments electronically are included with the document, NUREG-1556, Vol. 9, at the web site.
For any questions about the material in this report, please contact:
Sally L. Merchant
Mail Stop T-8 F5
U. S. Nuclear Regulatory Commission
Washington, D.C. 20555
Phone: (301) 415-7874
E-mail: slm2@nrc.gov
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This draft guide has been developed in parallel with the proposed revision of 10 CFR Part 35, "Medical Use of Byproduct Material." Comments received in response to publication of this draft NUREG will be considered in developing the final guide. Development of the final NUREG will continue to parallel the rulemaking, and result in a guidance document that is consistent with the final rule.
As part of its redesign of the materials licensing process, the United States Nuclear Regulatory Commission (NRC) is consolidating and updating numerous guidance documents into a single comprehensive repository as described in NUREG-1539, "Methodology and Findings of the NRC's Materials Licensing Process Redesign," dated April 1996, and draft NUREG-1541, "Process and Design for Consolidating and Updating Materials Licensing Guidance," dated April 1996. Draft NUREG-1556, Vol. 9, "Consolidated Guidance about Materials Licenses: Program-Specific Guidance About Medical Use Licenses," dated August 1998, is the ninth program-specific guidance document developed for the new process and is intended for use by applicants, licensees, and NRC staff and will also be available for use by Agreement States. This guidance document corresponds with the revision to the Code of Federal Regulations (CFR), Title10, Part 35, concurrently published in draft in August 1998. This document combines and supersedes the guidance previously found in Regulatory Guide (RG) 10.8, Revision 2, "Guide for the Preparation of Applications for Medical Use Programs"; Appendix X to RG 10.8, Revision 2, "Guidance on Complying With New Part 20 Requirements"; Draft RG DG-0009, "Supplement to Regulatory Guide 10.8, Revision 2, Guide for the Preparation of Applications for Medical Use Programs"; Draft RG FC 414-4, "Guide for the Preparation of Applications for Licenses for Medical Teletherapy Programs"; Policy and Guidance Directive (P&GD) FC 87-2, "Standard Review Plan for License Applications for the Medical Use of Byproduct Material"; P&GD FC 86-4, Revision 1, "Information Required for Licensing Remote Afterloading Devices"; Addendum to Revision 1 to P&GD FC 86-4, "Information Required for Licensing Remote Afterloading Devices-Increased Source Possession Limits"; P&GD 3-15, "Standard Review Plan for Review of Quality Management Programs"; RG 8.39, "Release of Patients Administered Radioactive Materials"; RG 8.33, "Quality Management Program"; P&GD 3-17, "Review of Training and Experience Documentation Submitted by Proposed Physician User Applicants"; and RG 8.23, "Radiation Safety Surveys at Medical Institutions, Revision 1."
This draft report, where applicable, provides a more risk-informed, performance-based approach to medical use licensing consistent with the proposed regulations.
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Figure 8.1 Location of Use 8-4
Figure 8.2 Decommissioning Records. 8-9
Figure 8.3 Financial Assurance Mechanisms 8-10
Figure 8.4 Gamma Stereotactic Radiosurgery Unit 8-15
Figure 8.5 Beta Radiation Catheter 8-17
Figure 8.6 Stent Implantation. 8-18
Figure 8.7 RSO Responsibilities 8-22
Figure 8.8 Facility Diagram for Nuclear Medicine Suite. 8-31
Figure 8.9 Iodine-131 NaI Administration for the Thyroid Carcinoma Patient 8-32
Figure 8.10 Overhead View of Manual Brachytherapy Patient Treatment Room 8-33
Figure 8.11 Teletherapy and HDR Treatment Room 8-34
Figure 8.12 Annual Dose Limits for Radiation Workers 8-49
Figure 8.13 Proper Security of Licensed Material 8-52
Figure 8.14 Material Receipt and Accountability 8-57
Figure 8.15 Leak Test Sample 8-61
Figure M.1 Diagram of Office and HDR Facility M-3
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| This draft guide has been developed in parallel with the proposed revision of 10 CFR Part 35, "Medical Use of Byproduct Material," which was published for comment in August 1998. It is distributed for comment to encourage public participation in its development. Comments received in response to publication of this draft NUREG will be considered in finalizing this NUREG. Finalization of the NUREG will continue to parallel the rulemaking, and result in a guidance document that is consistent with the final rule. |
The NRC is using Business Process Redesign (BPR) techniques to redesign its materials licensing process. This effort is described in NUREG-1539, "Methodology and Findings of the NRC's Materials Licensing Process Redesign," dated April 1996. A critical element of the new process is consolidating and updating numerous guidance documents into a NUREG-series of reports. Below is a list of volumes currently included in the NUREG-1556 series:
| Volume Number | Volume Title | Status |
|---|---|---|
| 1 | Program-Specific Guidance About Portable Gauge Licenses | Final Report |
| 2 | Program-Specific Guidance About Industrial Radiography Licenses | Draft for Use and Comment |
| 3 | Applications for Sealed Source and Device Evaluation and Registration | Draft for Comment |
| 4 | Program-Specific Guidance About Fixed Gauge Licenses | Draft for Comment |
| 5 | Program-Specific Guidance About Self- Shielded Irradiator Licenses | Draft for Comment |
| 6 | Program-Specific Guidance About 10 CFR Part 36 Irradiator Licenses | Draft for Comment |
| 7 | Program-Specific Guidance About Academic, Research and Development, and Other Licenses of Limited Scope | Draft for Comment |
| 8 | Program-Specific Guidance About Exempt Distribution Licenses | Final Report |
The current document, draft NUREG-1556, Vol. 9, "Consolidated Guidance about Materials Licenses: Program-Specific Guidance About Medical Use Licenses," dated August 1998, is the ninth program-specific guidance document developed for the new process. It is intended for use by applicants, licensees, NRC license reviewers, and other NRC personnel. It combines and updates the guidance for applicants and licensees previously found in RG 10.8, Revision 2, "Guide for the Preparation of Applications for Medical Use Programs," dated August 1987, and the guidance for licensing staff previously found in P&GDs, draft RGs and Standard Review Plans. In addition, this draft report also contains pertinent information found in Information Notices (IN), as listed in Appendix A.
Since this draft report takes a risk-informed, performance-based approach to medical use licensing, it reduces the amount of information needed from an applicant seeking to possess and use relatively safe quantities of byproduct material.
A team composed of NRC and State Department of Health staff drafted this document, drawing on their collective experience in radiation safety in general and as specifically applied to medical use of byproduct material.
This draft report is strictly for public comment and is not for use in preparing or reviewing applications for medical use licenses until it is published in final form. It is being distributed for comment to encourage public participation in its development. NRC is requesting comments on the information provided about medical use of byproduct material, as well as comments on a risk-informed, performance-based approach to licensing. Please submit comments within 90 days of the draft report's publication. Comments received after that time will be considered if practicable.
Address comments to:
Secretary, U. S. Nuclear Regulatory
Commission,
Washington, DC 20555
Attention: Rulemakings and Adjudications Staff.
Hand deliver comments to:
One White Flint North,
11555 Rockville Pike,
Rockville, Maryland
between 7:30 a.m. and 4:15 p.m. on Federal workdays.
Copies of comments received may be examined at: NRC Public Document Room, 2120 L Street, NW (Lower Level), Washington, DC.
Draft NUREG-1556, Vol. 9, is not a substitute for NRC regulations. The approaches and methods described in this draft report are provided for information and comment only.
Donald A. Cool, Acting Deputy Office Director, Office of Nuclear Material Safety and Safeguards
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The guidance development team thanks the individuals listed below for assisting in the development and review of the draft report. All participants provided valuable insights, observations, and recommendations.
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Bolling, Lloyd A.
Cool, Donald A.
DelMedico, Joseph R.
Flack, Diane S.
Haney, Catherine
Hill, Thomas E.
Howard, Marcia
Jones, Samuel Z.
Lohaus, Paul H.
Lieberman, James
Merchant, Sally L.
Paperiello, Carl A.
Rothschild, Marjorie U.
Roe, Mary Louise
Siegel, M.D., Barry
Trottier, Cheryl A.
Treby, Stuart A.
Walter, David
The team also thanks Kay Avery, D. W. Benedict Llewellyn, Grace S. Lee, Steven W. Schawaroch, and Gina G. Thompson, of Computer Sciences Corporation for their assistance in the preparation of this document.
We would also like to recognize the following individuals for their contribution to supporting documents that formed a basis for this draft:
Ayers, Robert
Bhalla, Neelam
Brown, Keith D.
Frazier, Cassandra F.
Fuller, Mike L.
Holahan, Patricia K.
Merchant, Sally L.
Minnick, Sheri A.
Schlueter, Janet R.
Smith, James A.
Taylor, Torre M.
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| AAPM | American Association of Physicists in Medicine |
| ACMUI | Advisory Committee on the Medical Use of Isotopes |
| ALARA | as low as is reasonably achievable |
| ALI | annual limit on intake |
| AMP | Authorized Medical Physicist |
| ANP | Authorized Nuclear Pharmacist |
| ANSI | American National Standards Institute |
| AU | authorized user |
| bkg | background |
| BPR | Business Process Redesign |
| Bq | Becquerel |
| CFR | Code of Federal Regulations |
| Ci | curies |
| cc | centimeter cubed |
| cm2 | centimeter squared |
| Co-57 | cobalt-57 |
| Co-60 | cobalt-60 |
| cpm | counts per minute |
| Cs-137 | cesium-137 |
| DAC | Derived Air Concentration |
| DIS | decay-in-storage |
| DOT | United States Department of Transportation |
| dpm | disintegrations per minute |
| FDA | United States Food and Drug Administration |
| ft | foot |
| G-M | Geiger-Mueller |
| GPO | Government Printing Office |
| GSR | gamma stereotactic radiosurgery |
| HDR | high dose-rate |
| I-125 | iodine-125 |
| I-131 | iodine-131 |
| IN | Information Notice |
| Ir-192 | iridium-192 |
| LDR | low dose-rate |
| mCi | millicurie |
| ml | milliliter |
| mR | milliroentgen |
| mrem | millirem |
| mSv | millisievert |
| NaI(Tl) | sodium iodide (thallium doped) |
| NCRP | National Council on Radiation Protection and Measurements |
| NIST | National Institute of Standards and Technology |
| NRC | United States Nuclear Regulatory Commission |
| NVLAP | National Voluntary Laboratory Accreditation Program |
| OCFO | Office of the Chief Financial Officer |
| OCR | optical character reader |
| OMB | Office of Management and Budget |
| P-32 | phosphorus-32 |
| Pd-103 | palladium-103 |
| PDR | pulsed dose-rate |
| P&GD | Policy and Guidance Directive |
| QA | Quality Assurance |
| Ra-226 | Radium-226 |
| RG | Regulatory Guide |
| RSC | Radiation Safety Committee |
| RSO | Radiation Safety Officer |
| SDE | shallow-dose equivalent |
| SI | International System of Units (abbreviated SI from the French Le Systeme Internationale d'Unites) |
| Sr-90 | strontium-90 |
| SSDR | Sealed Source and Device Registration |
| std | standard |
| Sv | sievert |
| Tc-99m | technetium-99m |
| TEDE | total effective dose equivalent |
| TLD | thermoluminescent dosimeters |
| U-235 | uranium-235 |
| µCi | microcurie |
| WD | Written Directive |
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| This document is strictly for public comment and is not for use in preparing or reviewing applications for medical use licenses until this document is published in final form. |
This draft report provides guidance to an applicant in preparing a medical use license application as well as NRC criteria for evaluating a medical use license application. It is not intended to address the research and development or the commercial aspects of manufacturing, distribution, and service of medical radionuclides or sources in devices.
Radionuclides are used for a variety of purposes in medicine. Typical uses are:
Information in this draft report will also help medical users understand specific regulatory requirements and licensing policies as they apply to medical licenses. Applicants are expected to address all the items on NRC Form 313 and to either follow the specific guidance that will become available in the final version of this draft report or to respond to the items in a manner that assures safe operation and compliance with the regulations that apply.
The format within this document for each item of technical information is as follows:
NRC Form 313 does not have sufficient space for applicants to provide full responses to Items 5 through 11; as indicated on the form, the answers to those items are to be provided on separate sheets of paper and submitted with the completed NRC Form 313.
Appendix C includes sample medical licenses with conditions most often found on these licenses, although not all licenses will have all conditions. Appendix C also contains a checklist to assist the applicant in determining which sections of this document and required procedures apply to the type of medical license requested. Appendices D through Y contain additional information on various radiation protection topics.
In this document, dose or radiation dose means absorbed dose, dose equivalent, effective dose equivalent, committed dose equivalent, committed effective dose equivalent, or total effective dose equivalent (TEDE). These terms are defined in 10 CFR Part 20. Rem, and Sievert (Sv), its SI equivalent (1 rem = 0.01 Sv), are used to describe units of radiation exposure or dose. This is because 10 CFR Part 20 sets dose limits in terms of rem, not rad or roentgen, and the sources commonly used in therapy emit beta and gamma rays, which roughly means that 1 roentgen = 1 rad = 1 rem.
This NUREG not only updates the information and guidance provided in Revision 2 of RG 10.8, "Guide for the Preparation of Applications for Medical Use Programs," but also revises the format in which it is presented to assist with the preparation of a medical use license. Revision 2 was issued in August 1987 to provide guidance for the revised 10 CFR Part 35, which became effective on April 1, 1987. Since then, 10 CFR Part 35 has been revised a number of times. Technology-specific information has been revised and expanded to include technologies that are now more commonly used, for example, computerized remote afterloading brachytherapy [particularly high dose-rate (HDR)] and GSR.
Applicants and licensees should also be aware of two other documents that provide useful information for medical use licensees. The first is the October 1994 Draft RG DG-0005 (second proposed revision to RG 10.5), "Applications for Licenses of Broad Scope," which provides additional licensing guidance on medical use programs of broad scope. The second is the May 1997 NUREG-1516, "Effective Management of Radioactive Materials Safety Programs at Medical Facilities." The guidance in NUREG-1516 emphasizes a team approach to program management as a means to effectively manage radiation protection programs, and provides tools to help licensees manage these programs. Radiation protection team members should include the management of the licensed facility, the Radiation Safety Committee (RSC), if applicable, and the Radiation Safety Officer (RSO). The document also includes discussions on the duties and responsibilities of the RSO and supervised individuals; conduct of required audits; advantages and disadvantages in using consultants or service companies to augment the radiation protection program; resources that may be needed to support the program; and NRC notification and reporting requirements. Specific tools for day-to-day operation of a radiation protection program are provided in several appendices. Additionally, an extensive annotated bibliography lists publications on radiation protection program management at medical facilities.
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NRC regulates the intentional internal or external administration of byproduct material, or the radiation therefrom, to patients or human research subjects for medical use. A specific license of either limited or broad scope is issued to authorize possession and use of licensed material. These licenses are issued pursuant to 10 CFR Parts 30, 33, and 35. NRC issues three types of licenses for the use of byproduct material in medical practices and facilities. These include; general in vitro license, specific license of limited scope, and specific license of broad scope.
NRC usually issues a single byproduct material license to cover an entire radionuclide program -- except for teletherapy, nuclear-powered pacemakers, and GSR. The teletherapy license will also contain the authorization for source material (i.e., depleted uranium) used as shielding in many teletherapy units. Although individual licensees may be issued separate licenses for different medical uses, separate licenses are not usually issued to different departments in a medical facility or to individuals employed by or contracted by the medical facility. Only the facility's management may apply for the license.
An applicant should carefully study this report, related guidance, and all applicable regulations before completing NRC Form 313. When necessary, NRC may ask the applicant for additional information in order to gain reasonable assurance that an adequate radiation protection program has been established.
After a license is issued, the licensee must conduct its program in accordance with the following:
In 10 CFR 30.9, NRC requires that the information in the application be complete and accurate in all material respects. Information is considered to be material if it is likely to change or affect an agency decision on issuing the license.
In 10 CFR 31.11, "General license for use of byproduct material" for certain in vitro clinical or laboratory testing, NRC establishes a general license authorizing physicians, veterinarians, clinical laboratories, and hospitals to receive, acquire, possess, or use certain small quantities of byproduct material for in vitro clinical or laboratory tests not involving "medical use" (i.e., not involving administration to humans). Section 31.11 explains the requirements for using materials listed. If the general license alone meets the applicant's needs, only NRC Form 483, "Registration Certificate -- In Vitro Testing With Byproduct Material Under General License," need be filed. Medical use licensees authorized pursuant to 10 CFR Part 35 do not need to file the form.
In 10 CFR 31.11, NRC limits possession to a total of 200 microcuries, at any time, of photon-emitting materials listed in 10 CFR 31.11. The use of materials listed in 10 CFR 31.11 within the inventory limits of that section are subject only to the requirements of that section and not to the requirements of 10 CFR Parts 19, 20, 21, and 35, except as discussed in 10 CFR 31.11.
An applicant needing more than 200 microcuries of these materials must apply for a specific license and may request the increased inventory limit as a separate line item on the NRC Form 313 application. Such applicants generally request an increased limit of 3 millicuries. If requesting an increased inventory limit, the applicant will be subject to the requirements of 10 CFR Parts 19, 20, 21, and 35, including the requirements for waste disposal.
Specific licenses of limited scope are generally issued to physicians in private practice or in a group practice with a limited number of medical disciplines, and not to physicians located within a licensed medical institution. These licensees are not authorized to perform procedures requiring hospitalization of the patient.
Specific licenses of limited scope are also issued to medical institutions. A medical institution is an organization in which several medical disciplines are practiced. These licenses authorize the medical use of byproduct material by physicians named on the institution's license or authorized by the licensee in accordance with 10 CFR Part 35.
A specific license of limited scope may also be issued to a mobile service (10 CFR 35.80, 10 CFR 35.647): Physicians in private practice and medical institutions may apply for authorization to use byproduct material in a mobile service.
Some medical institutions provide patient care and conduct research programs that use radionuclides for in vitro, animal, and medical procedures. In these cases, the NRC may issue a specific license of broad scope as discussed in 10 CFR Part 33. Specific licenses of broad scope for medical use, i.e., licenses authorizing multiple quantities and types of byproduct material for unspecified uses, are issued to institutions that (1) have had previous experience successfully operating under a specific institutional license of limited scope and (2) are engaged in medical research, as well as in routine diagnostic and therapeutic uses of byproduct material. DG-0005 was issued for comment in October 1994 to offer additional guidance to applicants for specific medical use license of broad scope. Both DG-0005 and the final version of this draft NUREG report should be consulted for guidance on applying for a medical use license of broad scope.
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10 CFR 20.1101 states that "each licensee must develop, document, and implement a radiation protection program commensurate with the scope and extent of licensed activities…" and "the licensee shall use, to the extent practicable, procedures and controls based upon sound radiation protection principles to achieve occupational doses and doses to members of the public that are ALARA." Additionally, this section requires that licensees periodically review the content of the radiation protection program and its implementation.
The success of an ALARA program depends on the cooperation of each person working at the licensed facility. Each individual who is authorized to use byproduct material should appropriately instruct all other individuals who work with or in the vicinity of byproduct material and should ensure that the facility and equipment are adequate for safe use. Each worker should comply with procedures developed to ensure safety and should promptly report incidents and potential problems to the authorized user or RSO.
Management should make a commitment to the ALARA philosophy and implement that commitment with adequate resources. The RSO and management must audit the byproduct material program to ensure the continued safe use of byproduct material. The RSO is responsible for the day-to-day operation of the radiation protection program.
RGs 8.10, "Operating Philosophy for Maintaining Occupational Radiation Exposures ALARA," and 8.18, "Information Relevant to Ensuring That Occupational Radiation Exposures at Medical Institutions Will Be ALARA," provide the NRC staff position on this subject. Several other NRC publications contain background information on the ALARA philosophy and its application in the medical environment. For example, NUREG-0267, "Principles and Practices for Keeping Occupational Radiation Exposures at Medical Institutions ALARA"; NUREG-1134, "Radiation Protection Training for Personnel Employed in Medical Facilities"; and NUREG-1516, "Effective Management of Radioactive Material Safety Programs at Medical Facilities," all contain information, methods, and references useful in establishing radiation protection programs to maintain exposures ALARA in medical institutions. Applicants should consider the ALARA philosophy as detailed in these reports when developing plans for work with licensed radioactive materials.
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10 CFR 35.41 requires medical use licensees to develop, maintain, and implement procedures to provide high confidence that for each administration requiring a WD, the patient's identity is verified prior to the administration and the administration is in accordance with the WD. Information on developing these procedures is found in Appendix S to this document.
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Effective January 1, 1995, the definition of "medical use" contained in 10 CFR 35.2 was revised to include the administration of byproduct material to human research subjects. Also, 10 CFR 35.6, "Provisions for research involving human subjects," was added to allow limited specific and broad scope medical use licensees to conduct "research involving human subjects," which meets specific criteria. Under 10 CFR 35.6, medical use licensees may conduct such research provided that the research is conducted, funded, supported, or regulated by another Federal agency which has implemented the Federal Policy for the Protection of Human Subjects. Otherwise, the licensee must apply for and receive approval of a specific amendment before conducting such research. Also, whether or not a license amendment is required, licensees must obtain informed consent from human subjects and obtain prior review and approval of the research activities by an Institutional Review Board in accordance with the meaning of those terms under the Federal Policy.
Table 1.1 When to Request NRC Approval for Human Research
| Is the licensee one of the 15 Federal Agencies that adopted the Federal Policy? |
YES
|
Research is covered by Federal Policy. No further information is needed.* |
No
|
||
| Is all human research conducted, funded, supported, or regulated by one of the 15 Federal Agencies that adopted the Federal Policy? |
YES
|
Research is covered by Federal Policy. No further information is needed.* |
|
No or not sure
|
||
| Does the licensee have a valid "Multiple Project Assurance" with the Department of Health and Human Services (or other equivalent assurance with one of the other 14 Federal Agencies that adopted the Federal Policy)? |
NO
|
Research not specifically conducted, funded, supported, or regulated by one of these Federal agencies requires an amendment request.* |
|
Yes
|
||
| Did the licensee voluntarily state in the "Multiple Project Assurance" (or other equivalent assurance with one of the other 14 Federal Agencies that adopted the Federal Policy) that all human research would be performed in accordance with the assurance? |
NO
|
Research not specifically under the assurance is not covered by Federal Policy. An amendment request is necessary for this research.* |
|
Yes
|
||
| Research is covered by the Department of Health and Human Services or one of the other 14 agencies that adopted the Federal Policy, and no further information is needed.* | ||
| * If the radiation safety program necessitated by or associated with the research goes beyond the applicant's previously described radiation safety program, a revised radiation safety program should be submitted in an amendment request. | ||
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Certain states, called Agreement States (see Figure 2.1), have entered into agreements with the NRC that give them the authority to license and inspect byproduct, source, or special nuclear materials used or possessed within their borders. Any applicant other than a Federal agency who wishes to possess or use licensed material in one of these Agreement States needs to contact the responsible officials in that State for guidance on preparing an application. These applications are filed with State officials, not with the NRC.
In the special situation of work at Federally-controlled sites in Agreement States, it is necessary to know the jurisdictional status of the land in order to determine whether NRC or the Agreement State has regulatory authority. NRC has regulatory authority over land determined to be "exclusive Federal jurisdiction," while the Agreement State has jurisdiction over non-exclusive Federal jurisdiction land. Licensees are responsible for finding out, in advance, the jurisdictional status of the specific areas where they plan to conduct licensed operations. NRC recommends that licensees ask their local contact for the Federal agency controlling the site (e.g., contract officer, base environmental health officer, district office staff) to help determine the jurisdictional status of the land and to provide the information in writing, so that licensees can comply with NRC or Agreement State regulatory requirements, as appropriate. Additional guidance on determining jurisdictional status is found in All Agreement States Letter, SP-96-022, dated February 16, 1996, which is available from NRC upon request.
Table 2.1 provides a quick way to check on which agency has regulatory authority.
Table 2.1 Who Regulates the Activity?
| Applicant and Proposed Location of Work | Regulatory Agency |
|---|---|
| Federal agency regardless of location (except that Department of Energy [DOE] and, under most circumstances, its prime contractors are exempt from licensing [10 CFR 30.12]) | NRC |
| Non-Federal entity in non-Agreement State, U.S. territory, or possession | NRC |
| Non-Federal entity in Agreement State at non-Federally controlled site | Agreement State |
| Non-Federal entity in Agreement State at Federally-controlled site not subject to exclusive Federal jurisdiction | Agreement State |
| Non-Federal entity in Agreement State at Federally-controlled site subject to exclusive Federal jurisdiction | NRC |
Reference: A current list of Agreement States (including names, addresses, and telephone numbers of responsible officials) may be obtained upon request from NRC's Regional or Field Offices. Or visit NRC's Home Page <http://www.nrc.gov>, choose "Nuclear Materials," then "Review of State Radiation Control Program Query Form," and then "Directories."
The All Agreement States Letter, SP-96-022, dated February 16, 1996, is available by contacting NRC's Office of State Programs; call NRC's toll free number (800) 368-5642, and then ask for extension 415-3340. Or visit NRC's Home Page <http://www.nrc.gov>, choose "Nuclear Materials," then choose "Review of State Radiation Control Program Query Form" and follow the directions for submitting a query for "SP-96-022."
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The NRC recognizes that effective radiation protection program management is vital to achieving safe and compliant operations (see 10 CFR 35.24). NRC believes that consistent compliance with its regulations provides reasonable assurance that licensed activities will be conducted safely.
| "Management" refers to the chief executive officer or that person's delegate or delegates who have authority to provide necessary resources to achieve regulatory compliance. |
To ensure adequate management involvement, a management representative (i.e., chief executive officer or delegate) must sign the submitted application acknowledging management's commitments and responsibility for the following:
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It is the applicant's or licensee's responsibility to have up-to-date copies of applicable regulations, read them, and abide by each applicable regulation.
The following Parts of 10 CFR Chapter I contain regulations applicable to medical uses licensees:
| Part 71 requires that licensees or applicants who transport licensed material or who may offer such material to a carrier for transport must comply with the applicable requirements of the DOT that are found in 49 CFR Parts 170 through 189. For ordering information on the regulations, see the Notice of Availability (on inside front cover of this draft report). |
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Applicants for a materials license should do the following:
| As required by 10 CFR 30.32(c) and 10 CFR 35.12(a), applications must be signed by the management of the facility; see section on "Certification." |
| Using the suggested wording of responses in this draft report will expedite NRC's review. |
All license applications will be available for review by the general public in NRC's Public Document Rooms. If it is necessary to submit proprietary information, follow the procedure in 10 CFR 2.790. Failure to follow this procedure could result in disclosure of the proprietary information to the public or substantial delays in processing the application. Employee personal information, i.e., home address, home telephone number, social security number, date of birth, and radiation dose information, should not be submitted unless specifically requested by NRC.
NRC's new licensing process will be faster and more efficient, in part, through acceptance and processing of electronic applications at some future date. NRC will continue to accept paper applications. However, these will be scanned and put through an optical character reader (OCR) to convert them to electronic format. To ensure a smooth transition, applicants are requested to follow these suggestions:
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As the electronic licensing process develops, it is anticipated that NRC may provide mechanisms for filing applications via diskettes or CD-ROM, and through the Internet. Additional filing instructions will be provided as these new mechanisms become available. The existing paper process will be used until the electronic process is available.
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Applicants wishing to possess or use licensed material in any State or U. S. territory or possession subject to NRC jurisdiction must file an application with the NRC Regional Office for the locale in which the material will be possessed and/or used. Figure 2.1 shows NRC's four Regional Offices and their respective areas for licensing purposes and identifies Agreement States. The Walnut Creek, California, Field Office, can respond to routine telephone inquiries until September 30, 1998. Effective October 1, 1998, the Walnut Creek, California, Field Office will close and any communications previously involving that Field Office should be addressed to the Region IV Office.
In general, applicants wishing to possess or use licensed material in an Agreement State must file an application with the Agreement State, not NRC. However, if work will be conducted at Federally controlled sites in Agreement States, applicants must first determine the jurisdictional status of the land in order to determine whether NRC or the Agreement State has regulatory authority. See Section 2, "Agreement States," for additional information.
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Each application for which a fee is specified, including applications for new licenses and license amendments, must be accompanied by the appropriate fee. Refer to 10 CFR 170.31 to determine the amount of the fee. NRC will not issue the new license prior to fee receipt. Once technical review has begun, no fees will be refunded; application fees will be charged regardless of the NRC's disposition of an application or the withdrawal of an application.
Most NRC licensees are also subject to annual fees; refer to 10 CFR 171.16. Consult 10 CFR 171.11 for additional information on exemptions from annual fees and 10 CFR 171.16(c) on reduced annual fees for licensees that qualify as "small entities."
Direct all questions about NRC's fees or completion of Item 12 of NRC Form 313 (Appendix B) to the Office of the Chief Financial Officer (OCFO) at NRC headquarters in Rockville, Maryland, (301) 415-7544. You may also call NRC's toll free number (800) 368-5642 and then ask for extension 415-7544.
Enter the fee category and the amount of the fee enclosed with the application on NRC Form 313.
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This section explains, item by item, the information requested on NRC Form 313. Items 5 through 11 on the form request specific information about the proposed radiation safety program. To assist the applicant in submitting complete information on these items, the applicable regulations are referenced in the discussion of each item.
Applicants must provide detailed information about the following:
Additionally, in response to Items 9, 10, and 11, the applicant must provide a commitment to develop and implement various procedures to meet the requirements of the applicable regulation. Table 1 in Appendix C is provided to assist applicants determine which procedures must be developed and implemented for the type of medical use requested. Several appendices in this report present sample procedures that the applicant may use in developing their procedures. If a particular item requires the applicant to develop and implement a procedure, the applicant may use the following wording in each response section on the application:
"We have developed and will implement written procedures for ___________ that meet the requirements of 10 CFR _____."
If an applicant or licensee commits to a section of this report, that commitment will be incorporated as a part of the terms and conditions of the license. The licensee will be inspected against the commitments contained in the referenced section, appendix, or document, just as the applicant/licensee will be inspected against more detailed responses.
If a particular part of a section does not apply simply note "NA" for "not applicable." If a particular section applies, but a procedure does not have to be developed, simply note "N" for "no response required." Short sentence responses, "NA" or "N" responses to Items 5 through 10 should run consecutively on one or more sheets separate from responses provided on NRC Form 313. Lengthy responses should be appended as attachments.
| As indicated on NRC Form 313 (Appendix B), responses to Items 5 through 11 should be submitted on separate sheets of paper. Applicants may use Appendix C to assist with completion of the application. Applicants should note that using the suggested wording of responses will expedite NRC's review. |
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THIS IS AN APPLICATION FOR (Check appropriate item)
| Type of Action | License No. |
| [ ] A. New License | Not Applicable |
| [ ] B. Amendment to License No. | XX-XXXXX-XX |
| [ ] C. Renewal of License No. | XX-XXXXX-XX |
Check box A if the application is for a new license
Check box B for an amendment(1) to an existing license, and provide license number.
Check box C for a renewal1 of an existing license, and provide license number.
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List the legal name of the applicant's corporation or other legal entity with direct control over use of the radioactive material; a division or department within a legal entity may not be a licensee. An individual may be designated as the applicant only if the individual is acting in a private capacity and the use of the radioactive material is not connected with employment in a corporation or other legal entity. Provide the mailing address where correspondence should be sent. A post office box number is an acceptable mailing address.
Note: NRC must be notified before control of the license is transferred or when bankruptcy proceedings have been initiated. See below for more details. NRC IN 97-30, "Control of Licensed Material during Reorganizations, Employee-Management Disagreements, and Financial Crises," dated June 3, 1997, discusses the potential for the security and control of licensed material to be compromised during periods of organizational instability.
Regulations: 10 CFR 30.34(b), 10 CFR 35.14(b).
Criteria: Licensees must provide full information and obtain NRC's prior written consent before transferring control of the license, or, as some licensees call it, "transferring the license."
Discussion: Transferring control may be the result of mergers, buyouts, or majority stock transfers. Although it is not NRC's intent to interfere with the business decisions of licensees, it is necessary for licensees to obtain prior NRC written consent before transferring control of the license. This is to ensure the following:
As provided in 10 CFR 35.14(b), if the licensee's name or mailing address changes, and the name change does not constitute a transfer of control of the license as described in 10 CFR 30.34(b), a licensee must file a written 30 day notification with the NRC instead of obtaining prior NRC written consent.
Response from Applicant: No response is required from an applicant for a new license; Appendix D, excerpted from IN 89-25 (Rev. 1), "Unauthorized Transfer of Ownership or Control of Licensed Activities," dated December 7, 1994, identifies the information to be provided about transferring control.
Reference: See the Notice of Availability on the inside front cover of this draft report to obtain copies of IN 89-25 (Rev. 1), "Unauthorized Transfer of Ownership or Control of Licensed Activities," dated December 7, 1994, and IN 97-30, "Control of Licensed Material during Reorganizations, Employee-Management Disagreements, and Financial Crises," dated June 3, 1997.
Regulation: 10 CFR 30.34(h).
Criteria: Immediately following filing of a voluntary or involuntary petition for bankruptcy for or against a licensee, the licensee must notify the appropriate NRC Regional Administrator, in writing, identifying the bankruptcy court in which the petition was filed and the date the of filing.
Response from Applicant: None at time of application for a new license. Licensees must notify NRC immediately (i.e., within 24 hours) of filing a bankruptcy petition.
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Specify the street address, city, and state or other descriptive address (e.g., on Highway 10, 5 miles east of the intersection of Highway 10 and State Route 234, Anytown, State) for each facility. The descriptive address should be sufficient to allow an NRC inspector to find the facility location. A post office box address is not acceptable (see Figure 8.1). If byproduct material is to be used at more than one location under the license, the specific address (e.g., street and building) must be provided for each facility. If applying for a license for a mobile service as authorized pursuant to 10 CFR 35.18(b), the applicant should refer to Section 8.42 and Appendix V of this report for specific licensing guidance.
| Being granted an NRC license does not relieve a licensee from complying with other applicable Federal, State, or local regulations (e.g., local zoning requirements; a local ordinance requiring registration of a radiation-producing device). |
Note: As discussed later under "Financial Assurance and Record Keeping for Decommissioning," licensees do need to maintain permanent records on where licensed material was used or stored while the license was in effect. This is important for making future determinations about the release of these locations for unrestricted use (e.g., before the license is terminated). For medical use licensees, acceptable records are sketches or written descriptions of the specific locations where material is used or stored and any information relevant to spills (e.g., where contamination remains after cleanup procedures or when there is reasonable likelihood that contaminants may have spread), damaged devices, or leaking radioactive sources.
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Identify the individual who can answer questions about the application and include his or her telephone number. This is typically the proposed RSO, unless the applicant has named a different person as the contact. The NRC will contact this individual if there are questions about the application.
Notify NRC if the contact person or his or her telephone number changes so that NRC can contact the applicant or licensee in the future with questions, concerns, or information. This notice is for "information only" and does not require a license amendment or a fee.
The individual named in Item 4 may or may not be the same individual who signs the application as the "certifying official" on behalf of the licensee and has the authority to make commitments to NRC (see Item 13 on Form 313). Any commitments made by the applicant should be signed by the individual named in Item 13 since only that individual is considered by NRC to have the authority to make commitments on behalf of the applicant. Therefore, NRC will not accept license amendments or renewals signed by the individual identified in Item 4, if this person differs from the one named in Item 13.
NRC recognizes that licensees may use a consultant or consultant group to help prepare the license application and provide support to the radiation protection program. Licensees are reminded that regardless of the role of the consultant in radiation protection program management, the licensee remains ultimately responsible for all aspects of the licensed program, including the services performed by the consultant.
| As indicated on NRC Form 313 (Appendix B), Items 5 through 11 should be submitted on separate sheets of paper. Applicants may use Appendix C for guidance and should note that using the suggested wording of responses will expedite NRC's review. |
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Regulations: 10 CFR 30.32, 10 CFR 30.33, 10 CFR 30.34, 10 CFR 30.35, 10 CFR 35.100, 10 CFR 35.200, 10 CFR 35.300, 10 CFR 35.400, 10 CFR 35.500, 10 CFR 35.600, 10 CFR 35.1000.
Criteria: 10 CFR Part 35 divides byproduct material for medical use into seven types of use (10 CFR 35.100, 35.200, 35.300, 35.400, 35.500, 35.600, and 35.1000).
Discussion: Using the table formats below (see Table 8.1), the applicant should indicate the byproduct material requested. For 35.100, 35.200, and 35.300 material, the chemical/physical form may be "Any." For 35.100 and 35.200 material, the total amount requested may be "As Needed." For 35.300 material, the total amount requested must be specified. For 35.400, 35.500, 35.600, and 35.1000 material, express the radionuclide, the chemical/physical form (e.g., sealed source and manufacturer's name and model number), the total amount in Becquerels (Bq), microcuries (µCi), millicuries (mCi), or curies (Ci), and maximum number of sources possessed at any one time.
For sealed sources used in devices, an applicant may wish to request two sources, one to be used in the device and one to be stored in its shipping container, to accommodate the total quantity of material in the licensee's possession during replacement of the source in the device. The maximum activity for a single source or source loading may not exceed the activity specified by the manufacturer for the specific device and source combination as stated in the Sealed Source and Device Registration (SSDR) Certificate. However, it is permissible to request a maximum activity, for the source in the shipping container, that exceeds the maximum activity allowed in the device. To request such authorization, applicants should provide certification that the source transport container is approved for the requested activity. A source that is received with a higher activity than permitted in the device must be allowed to decay to, or below, the device source activity limit prior to installation in the device.
If applicable, the applicant should request authorization for possession of depleted uranium [i.e., uranium depleted in uranium-235 (U-235)] in quantities sufficient to include shielding material in both the device(s) and source containers used for source exchange. The applicant should review the manufacturer's specifications for each device specified in the license request to determine (1) whether depleted uranium is used for shielding the source(s) within the device and (2) the total quantity of depleted uranium present in the device (in kilograms). The applicant should also consult the manufacturer's specifications or the source supplier to determine whether depleted uranium is contained within shielding source containers used during source exchange and determine the total quantity of depleted uranium in such containers (in kilograms).
A separate entry should be made for other items that need to be listed (e.g., more byproduct material for in vitro testing than is allowed under 10 CFR 31.11, depleted uranium for linear accelerator shielding, survey meter calibration source, dosimetry system constancy check source, or material for in vitro, animal, or human research studies). Sources that are authorized by 10 CFR 35.65, "Authorization for calibration and references sources" should not be listed. Applicants should number each line entry consecutively following the 10 CFR Part 35 material.
Table 8.1 Sample Format for Byproduct Material
| Byproduct Material | Chemical/Physical Form | Maximum Amount |
|---|---|---|
| Any byproduct material included in 10 CFR 35.100 | Any | As needed |
| Any byproduct material included in 10 CFR 35.200 | Any | As needed |
| Any byproduct material included in 10 CFR 35.300 | Any | 300 millicuries |
| Cesium 137 (i.e., specific brachytherapy radionuclide) | sealed source (Manufacturer Name, Model #XYZ) | 2 curies total |
| Gadolinium 153 (i.e., specific diagnostic sealed source radionuclide) | sealed source (Manufacturer Name, Model #XYZ) | Not to exceed 500 millicuries per source and 1 curie total |
| Cobalt 60 (i.e., specific teletherapy sealed source radionuclide) | sealed source (Manufacturer Name, Model #XYZ) | Not to exceed 9,000 curies per source and 18,000 curies total |
| Iridium 192 (i.e., specific afterloader sealed source radionuclide) | sealed source (Manufacturer Name, Model #XYZ) | Not to exceed 10 curies per source and 20 curies total |
| Cobalt 60 (i.e., specific gamma stereotactic radiosurgery sealed source radionuclide) | sealed source (Manufacturer Name, Model #XYZ) | Not to exceed 36 curies per source and 6,600 curies total |
| Depleted Uranium | Metal | 99 kilograms |
| Any byproduct material identified in 10 CFR 31.11 | Prepackaged Kits | 50 millicuries |
When determining both individual radionuclide and total quantities, all materials to be possessed at any one time under the license should be included, i.e., materials received awaiting use (new teletherapy or brachytherapy sources for exchange); materials in use or possessed; material used for shielding; and those materials classified as waste awaiting disposal or being held for "decay-in-storage (DIS)."
Response from Applicant: The applicant shall submit the information as described above.
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Regulations: 10 CFR 30.34(b), 10 CFR 30.35.
Criteria: Licensees authorized to possess licensed material in excess of the limits specified in 10 CFR 30.35 must provide evidence of financial assurance for decommissioning.
Even if no financial assurance is required, licensees are required to maintain, pursuant to 10 CFR 30.35(g), in an identified location, decommissioning records related to structures and equipment where licensed material is used or stored, spills or spread of contamination, and leaking sealed sources (see Figure 8.2). Licensees must transfer these records important to decommissioning either to the new licensee before licensed activities are transferred or assigned in accordance with 10 CFR 30.34(b) or to the appropriate NRC Regional Office before the license is terminated.
Figure 8.2 Decommissioning Records.
Discussion: The requirements for financial assurance are specific to the types and quantities of byproduct material authorized on a license. Most medical use applicants and licensees do not need to take any action to comply with the financial assurance requirements because either their total inventory of licensed material does not exceed the limits in 10 CFR 30.35 or the half-life of the unsealed byproduct material used does not exceed 120 days. The limits for some sealed sources are shown in Table 8.2. Applicants requesting more than one radionuclide need to use the sum of the ratios method to determine whether financial assurance is needed. See Appendix E for additional information.
Table 8.2 Minimum Sealed Source Inventory Quantity Requiring Financial Assurance
| Radionuclide | Activity in GigaBq | Activity in Ci |
|---|---|---|
| cesium-137 (Cs-137) | 3.7 x 106 | 100000 |
| cobalt-60 (Co-60) | 3.7 x 105 | 10000 |
| strontium-90 (Sr-90) | 3.7 x 104 | 1000 |
Applicants and licensees wanting to possess licensed materials exceeding the limits in 10 CFR 30.35 must submit evidence of financial assurance or a decommissioning funding plan (10 CFR 30.35 (b)). Figure 8.3 depicts acceptable methods of providing financial assurance. Regulatory Guide (RG) 3.66, "Standard Format and Content of Financial Assurance Mechanisms Required for Decommissioning Under 10 CFR Parts 30, 40, 70, and 72," dated June 1990, contains approved wording for each mechanism authorized by the regulation to guarantee or secure funds, except for the Statement of Intent for government licensees. See Appendix E for the recommended wording for a Statement of Intent.
Figure 8.3 Financial Assurance Mechanisms.
NRC will authorize possession exceeding the limits shown in Table 8.2 without requiring decommissioning financial assurance, for the purpose of normal sealed source exchange for no more than 30 days.
Licensees using sealed sources as authorized by 10 CFR Part 35, in general, use licensed material in a manner that would preclude releases into the environment, would not cause the activation of adjacent materials, or would not contaminate work areas. Moreover, the licensee's most recent leak test should demonstrate that there has been no leakage from the sealed sources while in the licensee's possession. However, any significant leakage of the sealed source would warrant further review of decommissioning procedures on a case-by-case basis.
Response from Applicants: No response is needed from most applicants. If financial assurance is required, applicants must submit evidence as described in RG 3.66.
| Pursuant to 10 CFR 30.35(g), licensees must transfer records important to decommissioning either to the new licensee before licensed activities are transferred or assigned in accordance with 10 CFR 30.34(b) or to the appropriate NRC Regional Office before the license is terminated. |
Reference: See the Notice of Availability on the inside front cover of this draft report to obtain copies of Regulatory Guide 3.66, "Standard Format and Content of Financial Assurance Mechanisms Required for Decommissioning Under 10 CFR Parts 30, 40, 70, and 72," dated June 1990, and Policy and Guidance Directive FC 90-2 (Rev. 1), "Standard Review Plan for Evaluating Compliance with Decommissioning Requirements," dated April 30, 1991.
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Regulation: 10 CFR 30.32(g), 10 CFR 30.33(a)(2), 10 CFR 32.210
Criteria: Applicants must provide the manufacturer's name and model number for each requested sealed source and device (except for calibration and reference sources authorized by 10 CFR 35.65). Licensees will be authorized to possess and use only those sealed sources and devices specifically approved or registered by NRC or an Agreement State.
Discussion: NRC or an Agreement State performs a safety evaluation of sealed sources and devices before authorizing a manufacturer to distribute the sources or devices to specific licensees. The safety evaluation is documented in a SSDR Certificate. Applicants must provide the manufacturer's name and model number for each requested sealed source and device so that NRC can verify that they have been evaluated in an SSDR Certificate or specifically approved on a license. If such a review has not been conducted for the specific source/device model(s), licensees should request a copy of NUREG-1556, Vol. 3, "Consolidated Guidance about Materials Licensees: Applications for Sealed Source and Device Evaluation and Registration," dated September 1997, from the NRC Regional Office and submit the information requested therein to NRC for review.
An applicant may consult with the proposed supplier or manufacturer to ensure that requested sources and devices are compatible and conform to the SSDR designations registered with NRC or an Agreement State. Licensees may not make any changes to the sealed source, device, or source/device combination that would alter the description or specifications from those indicated in the respective SSDR Certificates, without obtaining NRC's prior permission in a license amendment. To ensure that sealed sources and devices are used according to the registration certificates, applicants may want to obtain a copy of the certificate and review it or discuss it with the manufacturer.
Response from Applicant: No response is necessary.
Reference: See the Notice of Availability on the inside front cover of this draft report to obtain a copy of NUREG-1556, Vol. 3, "Consolidated Guidance about Materials Licensees: Applications for Sealed Source and Device Evaluation and Registration," dated September 1997.
Note: Information on SSD registration certificates is also available on the Internet at <http://www.hsrd.ornl.gov/nrc/ssdrform.ht m> or contact the Registration Assistant by calling NRC's toll free number (800) 368-5642 and then asking for extension 415-7217.
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Regulations: 10 CFR 30.33(a)(1), 10 CFR 35.100, 10 CFR 35.200, 10 CFR 35.300, 10 CFR 35.400, 10 CFR 35.500, 10 CFR 35.600, 10 CFR 35.1000.
Criteria: 10 CFR Part 35 divides byproduct material for medical use into seven types of use as follows:
| 10 CFR 35.100 | Medical Use of Unsealed Byproduct Material for Uptake, Dilution and Excretion Studies for Which a Written Directive is not Required |
| 10 CFR 35.200 | Medical Use of Unsealed Byproduct Material for Imaging and Localization Studies for Which a Written Directive is not Required |
| 10 CFR 35.300 | Medical Use of Unsealed Byproduct Material for Which a Written Directive is Required |
| 10 CFR 35.400 | Medical Use of Sources for Manual Brachytherapy |
| 10 CFR 35.500 | Medical Use of Sealed Sources for Diagnosis |
| 10 CFR 35.600 | Medical Use of a Sealed Source(s) in a Device for Therapy-Teletherapy Unit |
| 10 CFR 35.600 | Medical Use of a Sealed Source(s) in a Device for Therapy-Remote Afterloader Unit |
| 10 CFR 35.600 | Medical Use of a Sealed Source(s) in a Device for Therapy-Gamma Stereotactic Radiosurgery Unit |
| 10 CFR 35.1000 | Other Medical Uses of Byproduct Material or Radiation from Byproduct Material (Emerging Technology) |
Discussion: For 35.100, 35.200 and 35.300 material, the applicant must define the purpose of use by stating the applicable section of 10 CFR Part 35 (e.g., 10 CFR 35.100, 10 CFR 35.200) and the description of the applicable modality (e.g., any uptake dilution and excretion procedure approved in 10 CFR 35.100).
The use of unsealed byproduct material in therapy involves the administration of a radiopharmaceutical, either orally or by injection, to diagnose, treat or palliate a particular disease. The most common form of radiopharmaceutical therapy is the treatment of hyperthyroidism with iodine-131 (I-131) sodium iodide. Less common therapeutic procedures include ablation of thyroid cancer metastases, treatment of malignant effusions, treatment of polycythemia vera and leukemias, palliation of bone pain in cancer patients, and radiation synovectomy for rheumatoid arthritis patients. Table 8.3 contains a summary of several therapeutic radiopharmaceuticals and their use.
Table 8.3 Radiopharmaceuticals Used in Therapy
| Agent | Form | Route of Administration | Therapeutic Use |
|---|---|---|---|
| I-131 sodium iodide | solution/capsules | oral | hyperthyroidism
thyroid carcinoma total body scan for thyroid metastases (diagnostic) |
| phosphorus-32 (P-32) chromic phosphate | colloidal suspension | intraperitoneal or intrapleural cavity injection | peritoneal or pleural effusions |
| P-32 sodium phosphate | solution | oral or IV | polycythemia vera
leukemias |
| strontium-89 chloride | solution | IV | skeletal metastases |