Policy and Guidance Directive FC 92-03, "Exemptions from 10 CFR 35.400 for Uses Not Currently Authorized for Iridium-192 Seeds Encased in Nylon Ribbon and Palladium-103 Seeds as Brachytherapy Sources"

HPPOS-260 PDR-9306070194

See the memorandum from R. E. Cunningham to R. W. Cooper, II, (and others) dated August 17, 1992.

This directive provides guidance on granting exemptions from 10 CFR 35.400, "Uses of Sources for Brachytherapy" for iridium-192 (Ir-192) and palladium-103 (Pd-103). An exemption from the regulation is needed when the licensee proposes to use brachytherapy sources in a manner not listed. Regional personnel receiving license amendment requests for authorization of gold-198 (Au-198) and iodine-125 (I-125) seeds for intracavitary and topical applications should not follow the exemption guidance herein, but continue to forward the proposed amendment response to the Medical, Academic, and Commercial Use Safety Branch via a Technical Assistance Request for review and concurrence.

It is not the intent of 10 CFR Part 35 to prohibit appropriate medical practices. One of the objectives of the listing of 10 CFR 35.400 is to ensure that sealed sources used in brachytherapy procedures have undergone appropriate safety review. The current sources listed in 10 CFR 35.400 , with their specific types or conditions of use, i.e, intracavitary, interstitial, and topical, have been subjected to specific testing criteria to evaluate the integrity of the source when used in that manner. When a manufacturer or end user requests that a safety review be performed for a proposed type of use, the integrity of the source is tested against the criteria for the type of use requested and not against all testing criteria associated with the other types of use.

Ir-192 and Pd-103 seeds authorized for interstitial use only, appear to have been routinely used for intracavitary use for many years with no apparent health and safety problems. The Sealed Source Safety Section concludes that registered sources which have passed the testing criteria for interstitial use could be used in intracavitary or topical applications without requiring the licensee to commit to additional administrative controls to ensure safe use of these sources.

For Ir-192 seeds encased in nylon ribbon and Pd-103 seeds, the region may approve a request for exemption from the requirements of 10 CFR 35.400 (d) and (g) to allow other than interstitial treatment of cancer. The region may amend the license without additional radiation safety procedures. The region should amend the license with the following license condition.

"Notwithstanding the requirements of 10 CFR 35.400 (d) and (g) the licensee may use iridium-192 seeds encased in nylon ribbon and Pd-103 as a sealed source in seeds for topical, interstitial, and intracavitary treatment of cancer. The licensee may deviate from the manufacturer's radiation safety and handling instructions to the extent that the instructions are not applicable to the type of use proposed by the licensee."

Requests for exemptions from the uses specified for other sealed sources will be handled on a case-by-case basis.

Regulatory references: 10 CFR 35.400

Subject codes: 3.8, 11.1

Applicability: Byproduct Material

Page Last Reviewed/Updated Wednesday, October 18, 2017