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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 MEMORANDUM TO: The
Diagnostic Nuclear Medicine Community FROM: Jeffry
Siegel, Ph.D., Chair, 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
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