ML20210A499
| ML20210A499 | |
| Person / Time | |
|---|---|
| Issue date: | 08/31/1986 |
| From: | NRC OFFICE OF NUCLEAR REGULATORY RESEARCH (RES) |
| To: | |
| Shared Package | |
| ML20210A481 | List: |
| References | |
| TASK-FC-601-4, TASK-RE REGGD-10.010, REGGD-10.XXX, NUDOCS 8609170224 | |
| Download: ML20210A499 (5) | |
Text
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DRAFT VALUE/ IMPACT STATEMENT
- 1. BACKGROUND
, For many uses of byproduct material that are licensed by the NRC, the ,
radioactive material is contained in a sealed capsule that in turn is contained in a shielded source housing. The source housing may have a shutter mechanism whereby an operator can direct a beam of radiation from the housing. The radi-ation beam is then available for such purposes as radiation treatment of people or examination of heavy metal castings for flaws. The source housing with its shutter mechanism and any other radiation control mechanisms is commonly called a " device." Examples of devices are teletherapy units, industrial radiographic equipment, and industrial thickness gauges.
Before authorizing the distribution and use of Dyproduct material in a device, the NRC determines the adequacy of the radiation safety properties of the device. This determination is reached by reviewing the information submitted by the manufacturer or distributor of the device.
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- 2. THE PROPOSED ACTION 2.1 Description An applicant for a radiation safety evaluation of a device containing by-product material must submit information about the radiation safety features of the device. The proposed action-is to issue guidance on preparing and submitting requests for radiation safety evaluations of devices containing byproduct material. l 2.2 Need Presently, guidance on applications for radiation safety evaluation of a device is provided, upon request, in letters to manufacturers / distributors or by
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NRC staff meetings and telephone conversations with manufacturers / distributors.
8609170224 860831 PDR REGGD y/I-1 10.XXX R PDR
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These means of communication, although effective, are less efficient than pub-lished guidance.
The proposed action is needed to improve efficiency in communicating with manufacturers / distributors and other interested persons about requests for radiation safety evaluations of devices.
- 2. 3 Value/ Impact 2.3.1 NRC The proposed action should help facilitate communications between NRC and manufacturers / distributors, other regulatory groups, and other interested persons when addressing the expected content of a request for radiation safety evalua-tion of a device. The guidance now provided in letters is the basis for the substantive content of the proposed action. Accordingly, the proposed action would not change the technical evaluation now performed on devices; however, its use should improve the efficiency of communications.
2.3.2 Other Government Agencies The Food and Drug Administration (FDA) occasionally provides assistance to the Agreement States in their evaluation and regulatory approval for distribu-tion of-devices containing radium and other naturally occurring and accelerator-produced radioactive materials (NARM). Guidance in the proposed action for devices containing byproduct material is comparable to guidance provided in the FDA's NARM guide for devices containing naturally occurring and accelerator-produced radioactive materials.
The Agreement States evaluate and approve devices containing byproduct mater-l ial when the devices are produced in the Agreement States. NRC and the Agree-ment States provide reciprocity to the safety reviews performed by their respec-tive staffs. The proposed action would make NRC guidance in this area more generally available and thus should eliminate a possib'.e communication problem-j between NRC and the State regulatory groups.
2.3.3 Industry The proposed action sets forth the expected content of a request for radia-tion safety evaluation of a device and thus reduces uncertainty as to what the V/I-2
NRC staff considers in its evaluation. The wide distribution of this guidance should be particularly useful to both foreign and domestic manufacturers that are contemplating the U.S. market and to manufacturers / distributors that are preparing their first request for a radiation safety review by NRC.
2.3.4 Workers The proposed action should improve communication between manufacturers /
distributors and regulatory groups and thus help ensure the distribution and use of devices with adequate radiation safety features. Use of well-designed and well-constructed devices should help ensure that individuals engaged in activities licensed by the NRC and Agreement States do not receive unacceptable levels of exposure.
2.3.5 Public The proposed action is intended primarily to improve communication between the NRC and manufacturers / distributors of devices and thus help ensure distribu-tion and use of devices with adequate radiation safety features. Use of well-designed and well-constructed devices should help ensure that the publ < does not receive unacceptable levels of exposure.
The proposed action should improve public understanding of NRC activities concerning devices containing byproduct material. It also provides opportunity for public comment on the NRC's radiation safety evaletion.
2.4 Decision on Proposed Action Guidance should be issued on the radiation safety evaluation of devices containing byproduct material.
- 3. TECHNICAL APPROACH This section is not applicable since the proposed action is publication of guidance that is presently in use in a less convenient and less available form.
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- 4. PROCEDURAL APPROACH 4.1 Alternatives The alternative is to continue to communicate with applicants individually by letters, telephone conversations, and meetings.
4.2' Discussion A regulatory guide is the most effective way to transmit guidance about information needed by the NRC staff to perform a radiation safety evaluation.
A regulatory guide ensures uniform announcement of those needs to interested'per-sons. The use of individual communications to applicants is inherently ineffi-cient, and this approach is best reserved for followup communications, if they are needed. Also, issuance of a regulatory guide provides an opportunity for both technical and procedural comments on the content of a radiation safety review. Issuance of a regulatory guide is the preferred procedural approach.
- 5. STATUTORY CONSIDERATIONS 5.1 NRC Authority l
l Authority for the proposed action is derived from the Atomic Energy Act of 1954, as amended, and the Energy Reorganization Act of 1974, as amended, and implemented through the Commission's regulations.
5.2 Need for NEPA Assessment Issuance or amendment of guides for the implementation of regulations in Title 10, Chapter I, of the Code of Federal Regulations is a categorical exclu-sion under paragraph 51.22(c)(16) of 10 CFR Part 51. Thus, an environmental impact statement or assessment is not required for this action.
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- 6. RELATIONSHIP TO OTHER EXISTING OR PROPOSED REGULATIONS OR POLICIES There are no conflicts or overlaps with other agencies' requirements.
Issuance of this guide for the preparation of applications for radiation safety evaluation of devices.containing bynroduct material would be consistent with guidance provided to the States in " Guides for Naturally Occurring and Accelerator-Producea Radioactive Materials (NARM)," published by the U.S.
Department of Health and Human Services.
The proposed guidance does not involve changes in regulatory requirements-or substantive changes in administrative practices. The guide would improve communications with manufacturers and distributors of devices. Accordingly, neither tightening of present requirements.nor backfitting of requirements to completed or ongoing radiation safety evaluations of devices are involved in the proposed guidance.
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SUMMARY
AND CONCLUSIONS The proposed regulatory guide would inform manufacturers and distributors about the expected content of and submission procedures for applications for radiation safety evaluation of devices containing byproduct material. The guide should assist applicants in the preparation and submission of requests for radi-ation safety evaluations and should promote effective and efficient comunica-tion between the applicants and the NRC. The proposed regulatory guide should I
be issued.
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