Nuclear Regulatory Commission


Part 35 Training and Experience

As of press time, the NRC had yet to finalize its proposed final rule specifying the training and experience requirements for authorized medical users. The most recent draft of the rule that was circulated to agreement states and the Advisory Committee on Medical Uses of Isotopes (ACMUI) specified the following minimum training requirements:

  • 35.55 (training for an authorized nuclear pharmacist) – 700 hours total, 200 of which are didactic;
  • 35.190 (training for uptake, dilution, and excretion studies) – 60 hours, 8 of which are didactic;
  • 35.290 (training for imaging and localization studies) – 700 hours, 80 of which are didactic;
  • 35.390 (training for use of unsealed byproduct material for which a written directive is required) – 700 hours, 200 of which are didactic.

The ACMUI voted to urge a reduction in the proposed number of didactic hours required under the proposed 35.390 from 200 hours to 80 hours (with the total hours remaining the same). It also recommended changes to a grandfathering provision for authorized medical physicists to provide a more uniform treatment among NRC and agreement state users, and to ensure an adequate supply of authorized medical physicists upon enactment of the regulations.

ACMUI recommendations, along with comments from agreement states, will be taken under advisement by the NRC and may or may not be incorporated into the final rule. NRC staff anticipates the proposed final rule will be published in early 2005. Additional information will be posted on the ACR's Web site as it becomes available.

NRC Heightens Security Requirements

In the wake of September 11, NRC is issuing orders to a spectrum of its licensees to protect against the theft and potentially malevolent use of certain types and quantities of radioactive materials. Over the past several months, NRC has been finalizing additional security measures for the import and export, as well as the transport of, radioactive materials. It is currently vetting draft protective measures among medical user licensees that are intended to enhance the avoidance of, detection of, and response to, security breaches. The ACR has been asked to help coordinate public comments from medical users.

National Institutes of Health

On November 20, 2004, Congress passed a consolidated spending package that included a funding increase for the NIH. The measure appropriated a total of $28.6 billion, $800 million more than last year. Of this, $4.9 billion is designated for the National Cancer Institute, and $300 million is designated for the National Institutes of Biomedical Imaging and Bioengineering. The ACR is actively lobbying for continued health research funding for its clinical trials research initiatives.

Food and Drug Administration

The Food and Drug Administration (FDA) is seeking public input on the need to modify requirements governing the use of radioactive drugs for basic research purposes without an investigational new drug application. The current regulations governing Radioactive Drug Research Committees (RDRC) have been in effect since 1975; FDA acknowledges the need to reconsider the requirements in light of the numerous scientific and technological advancements that affect radioactive drugs. Among the issues specifically highlighted by the FDA are radiation dose limits for adult subjects, safety for pediatric patients, exclusion of pregnant women, quality and purity considerations, pharmacology issues, and RDRC membership. Check the ACR Web site for additional information on the above topics.