The U.S. Nuclear Regulatory Commission (NRC) has denied a petition to modify its proposed regulation of diagnostic nuclear medicine. The January 4 petition, authored by the Society of Nuclear Medicine (SNM) and the American College of Nuclear Physicians (ACNP), sought to change the NRC's proposed regulations to make them less burdensome for nuclear medicine providers.
Jonothan Links, Ph.D., president of the Reston, VA-based SNM, was disappointed that the NRC had turned down the petition, which he said NRC members had encouraged the organizations to file. The regulations will make it more costly for Americans to receive nuclear medicine studies, Links said, adding that the proposed rules are wholly out of proportion to the minor risk proposed by the modality.
In its April 16 denial, the NRC said the petition amounted to too little, too late.
"In summary, the petition is being denied because the commission approved the final rule after an extensive rulemaking process that provided an unprecedented level of enhanced public participation," the NRC wrote. "The commission believes that ACNP/SNM had many opportunities to present their concerns as part of that process; and the petition does not appear to present any significant new information or recommendations that the commission has not already considered."
The NRC has spent several years revising its regulations governing the use of byproduct materials in medicine, promising to make them more "risk-informed," according to the ACNP and SNM. Instead, however, the NRC not only left the regulatory burden in Part 35 virtually unchanged, it increased the use-license conditions to impose additional requirements.
The SNM and ACNP said the new regulations will cost nearly $500 million in first-year compliance costs. In a statement released today, ACNP president Sue Abreu said the organizations must now look beyond the NRC to institute realistic regulation of nuclear medicine.
"We will continue to press for regulation of diagnostic nuclear medicine that is appropriate to the level of risk presented," Abreu said. "It is clear that the NRC cannot reform itself, and so we will seek assistance for that task elsewhere."
By AuntMinnie.com staff writersApril 18, 2001
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