Nuclear medicine regs face fresh opposition

Rankled by proposed revisions to the long-standing regulations that govern diagnostic nuclear medicine, two trade organizations have filed a joint petition asking the Nuclear Regulatory Commission to revoke a portion of a pending rule that would impose additional constraints.

In their petition, the Society of Nuclear Medicine and the American College of Nuclear Physicians ask the federal agency to revoke much of Part 35, which governs the by-product materials that are used in nuclear medicine procedures.

"The NRC is very good at regulating nuclear power plants," said William Uffelman, director of public affairs and general counsel for the SNM. "But they're applying the same level of regulation to nuclear medicine, where the element of risk is very small."

Revisions to Part 35 have been in the works for more than two years, according to the SNM. They were approved by the NRC in 2000 and are scheduled to take effect in late 2001. The petition objecting to the proposed revisions has been under consideration by the organizations for about a year, Uffelman said.

In question are nuclear by-products used to create some of the tracer elements injected into patients during various nuclear medicine procedures, including certain lung and bone scans. Under the Atomic Energy Act, those by-products are now regulated by the NRC. The NRC does not regulate manufactured isotopes such as those used in PET scans.

In their petition, the SNM and ACNP allege that the NRC did not realistically reform the regulatory burden of Part 35. Instead, it plans to impose numerous licensing conditions, establishing requirements that do not appear elsewhere in the regulations. Those requirements could cost the U.S. healthcare system up to $1 billion in coming years, according to the SNM.

The petition asks that all license conditions, except for simple identification-name, address, telephone number, and other routine information-be removed as requirements. The organizations also seek to eliminate routine facility inspections.

"Part 35 is far more stringent than it needs to be relative to diagnostic nuclear medicine," Uffelman said.

Lending support to that position, a National Academy of Sciences Institute of Medicine report concluded that Part 35 regulations governing diagnostic nuclear medicine are more severe than those governing chemotherapy, anesthesia, and the use of general pharmaceuticals. As a result, the cost of running a nuclear medicine practice would increase under the changes proposed by the NRC for Part 35, resulting in higher procedural costs being passed along to the patient or insurer.

"We are asking the NRC to remove the prescriptive regulations and license conditions that purport to tell highly qualified individuals how to achieve...safety standards," the petition states.

The organizations asked the NRC to instead refocus its regulatory emphasis on legitimately ensuring the health and safety of both patients and those who work in the field.

"Many years ago, the NRC commissioned the NASIM to prepare a report giving the NRC recommendations on how to regulate nuclear medicine," said Jonathan Links, president of the SNM. "The report said that for the most part the NRC needed to get out of the regulation of nuclear medicine. However, the NRC ignored the report. Our petition is really nothing more than a request to be regulated at a level specified by the NASIM report that they, the NRC, commissioned."