U.S. Nuclear Regulatory Commission

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

Title: 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"

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