ML20056E043
| ML20056E043 | |
| Person / Time | |
|---|---|
| Issue date: | 06/25/1993 |
| From: | Surmeier J NRC OFFICE OF STATE PROGRAMS (OSP) |
| To: | GENERAL |
| Shared Package | |
| ML20056C038 | List: |
| References | |
| NUDOCS 9308190250 | |
| Download: ML20056E043 (5) | |
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QUESTION 72 focg
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ALL AGREEMENT AND NON-AGREEMENT STATES REGULATORY RESPONSIBILITY FOR THE MEDICAL USES OF IONIZING RADIATION (SP-93-062)
The Senate Committee on Governmental Affairs met on May 6,
- 1993, to consider issues regarding the allocation of regulatory responsiblilty for radiation safety in the medical uses of ionizing radiation.
The Committee requested a report from the Commission on options for improving the current regulatory program.
Chairman Selin of the Nuclear Regulatory Commission (NRC) committed to provide a preliminary report by. August 6, 1993.
A task force having NRC and Food and Drug Administration (FDA) representation was convened to develop this report to the Congress.
This matter was one of several regulatory initiatives discussed at the public meeting for States held in San Francisco, California, on May 20, 1993 as announced in Vol. 58, No. 90 of the Federal Reaister, Wednesday, May 12, 1993.
At the San Francisco meeting, five options for regulatory change were discussed and we appreciate State comments received at and following that meeting on the five options.
As a result of the comments received to date and other guidance, the. task force has.
identified a number of issues which may affect the central issue of radiation safety in the medical use of ionizing radiation.
We are seeking views on these issues from a broad range of affected parties and would appreciate your careful consideration of the enclosed draft issues prepared by the task force.
Your views on the importance of this issues to the overall patient and worker protection is requested.
Also, we would appreciate receiving specific additional input that you believe would address any of these issues.
In order for the task force to provide its report to the Commission by July 22, we would appreciate your comments-by July 9 for inclusion in our report.
You may provide your comments to Lloyd Bolling in writing or by telefax (301-504-3502).
We recognize that the response time is short and we appreciate your indulgence on this point.
R M.J U s
John J. Surmeier Acting Assistant Director i
for State Agreements Program Office of State Programs
Enclosure:
As stated j
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1 ISSUES RELATIVE TO RADIATION SAFETY IN THE MEDICAL USES OF IONIZING RADIATION The Central Issue:
Does the present allocation of authority and responsibilities among Federal and State regulatory bodies meet the nationwide goal of ensuring adequate protection of the radiological health and safety of the public, including patients and health care workers in the medical uses of ioniv.ing radiation?
The following is a preliminary list of subissues we believe need further study or resolution prior to making recommendations on the central issue.
These subissues have been grouped into six broad categories.
The task force would appreciate your suggestions on these or other subissues that should be added to this list.
Also, please indicate if any of these subissues should be. deleted from this list.
We would appreciate receiving your specific. options to resolve any of these subissues that you believe should be addressed.
Options may range from no change or minor modifications to the current regulatory system up to and including recommending legislative changes (e.g., to the Atomic Energy Act).
For each of these, we would like you to describe the associated pros and Cons.
In your development of options, a major consideration should be whether they accomplish the nationwide goal of ensurigg adequate protection of radiological health and safety.
Other considerations include impacts on resources (e.g., personnel, funding, and sources of funding), as well as impacts on the responsible regulatory bodies considering current responsibilities and regulatory or legislative ramifications.
(2)
Uniformity (a) need for national uniformity in_ regulations and their implementation for each source of ionizing radiation (i.e., byproduct, NARM, and machine produced)
(b) need for national uniformity in misadministration reporting requirements for each source of ionizing radiation 1
(c) need for one national regulatory authority to ensure uniformity in areas that are now handled by multiple agencies (e.g., certification of sealed sources and devices and notification of referring physicians and patients of a misadministration and the likely consequence) l
e (2)
Reculatory Oversicht (a) need for a national program to monitor uses of ionizing radiation (including emerging technologies and new trends) and identify radiation safety issues that need new or additional regulatory oversight t
(b) need to identify effective enforcement sanctions for each regulatory authority (i.e., Federal and State) for each source of ionizing radiation (c) need to identify source of funding for regulation development and implementation (3)
Database (a) need to develop common definitions of administration and misadministration for each source of ionizing radiation (b) need to determine the number of administrations for each source of ionizing radiation (e.g., drugs, devices) and the uncertainty in each estimate
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(c) need to determine the number of misadministrations for each source of ionizing radiation and the uncertainty in each estimate (d) need to determine the number of adverse incidents involving medical devices that deliver ionizing radiation and the uncertainty in the estimate (FDA)
(4)
Health and Safety Imolications (a) need to establish a common definition of serious injury for each source of ionizing radiation (b) need to determine the frequency of occurrence of serious injury related to the use of each source of ionizing radiation and the uncertainty in each estimate (c) need to compare the individual frequencies of occurrence developed in (a) above, and compare the frequency of occurrence of serious injury related to-all ionizing radiation therapy procedures versus other individual cancer therapy procedures (e.g., surgery, chemotherapy)
(d) need to compare frequency of occurrence.of serious injury from misadministration versus properly conducted administrations for each source of. ionizing radiation l
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(e) need to establish a safety goal for the medical uses of i
ionizing radiation (5)
Trainina and Exoerience (a)
Physicians need to have a regulatory authority establish
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training and experience criteria for physician authorized users for each source of ionizing radiation need to have a regulatory authority implement e
physician authorized user training and experience l
criteria, including history of regulatory and
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legal compliance need to have a regulatory authority periodically e
reassess the qualifications of each physician authorized user (b)
Ancillary Personnel need to have a mandatory licensing or certification program for activities utilizing each source of ionizing radiation j
I need to have a regulatory authority establish and implement the training and experience criteria for ancillary personnel need to have a regulatory authority periodically e
reassess the qualifications of ancillary personnel (c)
Radiation Safety Officer r
need to have a regulatory authority establish the e
duties, responsibilities, and authorities to include each source of ionizing radiation need to have a regulatory authority establish and e
implement minimum training and experience requirements to include each source of ionizing radiation need to have a regulatory authority periodically e
reassess the qualifications of each radiation safety officer i
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(6)
Communication (a) among Federal Agencies (primarily in this case, NRC and FDA) need to clarify respective responsibilities need to coordinate device reviews e
need to coordinate regu.ations for the manufacture e
and distribution, compounding, and use of radiopharmaceuticals and radiolabelled biologicals, and the manufacture and use of radiation therapy devices need to share information on events and incident reports and coordinate the responses (b) among States and between each State and the Federal Government need to share information on topics including event reports, proposed and final regulations, regulatory guides, information notices, enforcement cases, and product recalls f
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