Petition to Alter NRC Training Regs Denied

Written By: Sam Savage

Published Date: December 23, 2007 Last Edited: December 23, 2007

By Anonymous

The U.S. Nuclear Regulatory Commission (NRC) announced in the Federal Register on October 24 that it had denied a petition for rulemaking (PRM35-19) originally submitted by William Stein, III, MD (Metairie, LA), on June 14, 2006. Stein had requested that the NRC amend Title 10 Code of Federal Regulations (CFR) 35 regulations governing training for parenteral administration of ^sup 153^Sm- lexidronam (Quadramet), ^sup 131^I-tositumomab (Bexxar), and ^sup 90^Y-ibritumomab tiuxetan (Zevalin). During the 2002 revision to 10 CFR part 35, the NRC increased the required amount of training and experience from 80 to 700 hours for most medical uses of unsealed byproduct material requiring a written directive. In 2005, the NRC noted that to properly cover the topics important for safety for these uses, the minimum amount of classroom and laboratory training was 200 hours for the alternate pathway to authorized status. To achieve authorization via the board certification pathway, the individual must successfully complete multiple-year residency training in a radiation therapy or nuclear medicine training program or a program in a related medical specialty, each of which also includes a total of 700 hours of training and experience. Stein asserted in his petition that these regulations were burdensome and requested that they be amended to stipulate that 80 hours of laboratory and classroom training, supervised work experience, and written attestation should be sufficient for physicians seeking authorized user status for therapeutic administrations of these unsealed byproduct materials. Stein provided 3 options for addressing this issue, but, after review and a period for public comment, the NRC rejected both the petition and the proposed remedies.

In summarizing the 25 comments received, the NRC noted that 18 supported the petition. In general, “these commenters stated that not granting the petition would intrude into the practice of medicine, discourage physicians from treating patients, and establish barriers to the use of potentially effective therapies, thus adversely affecting patient access to these therapies and increasing health care costs.” Commenters also noted that the activity administrations of Quadramet, Bexxar, and Zevalin are from a radiation safety perspective less hazardous than oral administration of 1311, for which the NRC requires only 80 hours of classroom and laboratory training.

Among the 7 letters opposing the petition were statements from the American Association of Physicists in Medicine, the American College of Radiation Oncology, the American College of Radiology, and the American Society for Therapeutic Radiology and Oncology. Many of these commenters raised concerns about radiation safety issues and exposure of patients to additional risk if medical oncology/ hematology training does not include the extensive background necessary for administering these radiopharmaceuticals.

In denying the petition, the NRC noted that current 10 CFR 35.390 and 35.396 regulations establish “the appropriate amount of training and experience for a physician to become an authorized user for the parenteral administration of unsealed byproduct material requiring a written directive, including Quadramet, Bexxar, and Zevalin.” In reviewing the various reasons for this decision, the complexity of product-specific variations in training was noted: “The current approach to training and experience for the medical use of unsealed byproduct material accommodates the introduction of new radiopharmaceuticals without requiring additional rulemaking, with its associated costs to the Agreement States. Attempting to tailor the training and experience requirements to specific uses of unsealed byproduct material and to the amount of flexibility that a user may wish to have would significantly increase the complexity of the regulatory oversight. The NRC does not believe that such added complexity would be of benefit to patients, the Agreement States, licensees, current and prospective authorized users, or the medical specialty boards.”

The full NRC ruling is available at http://a257.g.akamaitech.net/ 7/257/ 2422/01 jan20071800/edocket.access. gpo.gov/2007/E7- 20918.htm.

U.S. Nuclear Regulatory Commission

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