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"
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