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SNM/ACNP Briefing on the NRC's New Part 35



Please see the attached briefing summary from the Society of Nuclear Medicine/American College of Nuclear Physicians.

 

Roy W. Brown

SNM/ACNP Government Relations Committee

 

 

 

 

July 31, 2001  

 

MEMORANDUM      

 

TO:                  The Diagnostic Nuclear Medicine Community  

 

FROM:            Jeffry Siegel, Ph.D., Chair,

American College of Nuclear Physicians/Society of Nuclear Medicine Government Relations Committee

 

RE:                   New Part 35

 

            What are we doing?

 

The purpose of this memorandum to is to bring you up to date on the activities of the ACNP/SNM Government Relations Committee concerning the NRC’s revision of its medical use regulations contained in Part 35 of the Code of Federal Regulations.  With the approval of the boards of both organizations, we have asked Congress to prevent the NRC from implementing the new Part 35 regulations because they are not a meaningful improvement over the current Part 35.  The Senate has adopted our proposal; the House bill was passed before we asked for legislative relief so the issue will be resolved by a joint House-Senate conference committee sometime in September.  If  the provision we are supporting is adopted, then the existing Part 35 would remain in place for the time being.

 

            Why are we taking this action?

 

In 1996, the National Academy of Sciences/Institute of Medicine (NAS/IOM) reported that, "Compared to the regulatory systems in place for the other 90 percent of medical use of ionizing radiation, the more detailed reporting and enforcement systems required by byproduct materials [subject to NRC regulation] do not seem to result in even a marginal decrease in risk to providers, patients, or members of the public."  Further, the NAS/IOM Report concluded that:

 

[r]egulation of reactor-generated byproducts exceeds in intensity and burden that of all other aspects of ionizing radiation in medicine. The regulation of reactor-generated byproduct material is also more vigorous than that of any other aspect of high-risk health care.  It greatly exceeds the regulation of chemotherapy, surgery, anesthesia, and the use of general pharmaceuticals except for controlled substances, all of which are unregulated at the federal level.

 

The NAS/IOM accordingly recommended that Congress eliminate all aspects of the NRC’s medical use program.  In an effort to preserve its jurisdiction, the NRC announced that it would begin a major overhaul of its medical use program and adopt a “risk-based” regulatory scheme.  Because the risks posed by diagnostic nuclear medicine procedures are minute, we hoped that the NRC would adopt new regulations that would bring meaningful change to the program.  Instead, despite a lengthy and expensive rulemaking, the Commission has adopted a new Part 35 that is largely a rearrangement of the deck, rather than a new game.  Despite the uncontested safety of diagnostic nuclear medicine, it will still be subject to the extreme over-regulation and intrusion into the practice of medicine that the NAS/IOM condemned in 1996.  The new Part 35 will do nothing to improve patient or worker safety, yet its implementation will divert dollars from patient care and radiation safety programs.

 

            What do we hope to accomplish?

 

When the College and the Society complained about the proposed new regulations to the Commission, we were asked to file a citizen petition.  We did, and like every comment with which it disagrees, the Commission ignored our comments, denied the petition and adopted the onerous new regulatory scheme unchanged.  We consider the denial of the petition and the adoption of the new regulations as proof that the NRC is incapable, on its own, of reforming its unrealistic and vastly expensive regulation of diagnostic nuclear medicine.  Thus, we have asked Congress to intervene, just as the NAS/IOM proposed.  The action we have taken is the first step in a program whose goal is to assure that the regulation of diagnostic nuclear medicine is appropriate to the very low risk posed by the procedures.  We want this done as quickly as possible so that we can all realize the beneficial provisions of the new rule like the reduced T&E requirements. The costs associated with the current level of unnecessary regulation is strangling diagnostic nuclear medicine and will continue to force the closure of nuclear medicine programs, especially in smaller and rural facilities.       

           

For additional information, please feel free to contact Bill Uffelman, General Counsel and Director of Public Affairs, at ACNP/SNM at 703-708-9773 or wuffelman@snm.org.