Notification of the above must be made within 30 days of occurrence.
Change or addition of areas of use for uptake and dilution (10CFR35.100)
and for localization and imaging (10CFR35.200) need not be amended.
Licenses with Type A specific license of broad scope are exempt from these
requirements.
Authority and Responsibilities of the Licensee
According to 10CFR35.24, the licensee’s management is responsible for the
overall implementation of the radiation protection program in the medical
uses of by-product material. The licensee’s management shall approve in
writing all new authorized users, radiation safety officer, or nuclear phar-
macist, and ministerial changes in the radiation safety program that do not
require license amendment (10CFR35.26).
The licensee’s management shall appoint a Radiation Safety Officer
(RSO), who accepts in writing responsibilities to implement a radiation pro-
tection program. It may appoint one or more temporary RSOs for 60 days
in a year, if all conditions of an RSO are met.
The licensee’s management also must appoint a Radiation Safety Com-
mittee (RSC), if the licensee is authorized for two or more different types
of uses of by-product material. Examples are the use of therapeutic quan-
tities of unsealed by-product material (10CFR35.300) and manual
brachytherapy (10CFR35.400), or manual brachytherapy and low-dose-rate
therapy units (10CFR35.600), or teletherapy units (10CFR35.600) and
gamma knife units (10CFR35.600). Use of by-product materials for both
uptake and dilution (10CFR35.100) and imaging and localization
(10CFR35.200) does not require an RSC. The RSC must include as a
minimum an authorized user of each type of use permitted in the license,
the RSO, a representative of the nursing service, and a representative of
management, and in addition, other members, if appropriate. The NRC does
not prescribe any definite frequencies of the RSC meetings nor record-
keeping of the minutes.
Supervision
According to 10CFR35.27, a licensee that permits an individual to work
under an authorized user or authorized nuclear pharmacist using by-
product material must instruct the supervised individual to follow strictly
all regulations and conditions of the license and all procedures involving
by-product material. There is no requirement for periodic review of the
supervised individual’s work and records. The licensee is responsible for the
acts and omissions of the supervised individuals.
284 16. Radiation Regulations and Protection