Current through Register Vol. 46, No. 19, March 20, 2024
(1) The licensee in possession of any sealed
source shall ensure that:
a. Each sealed
source, except as specified in 40.32(2), is tested for leakage or contamination
and the test results are received before the sealed source is put into use
unless the licensee has a certificate from the transfer or indicating that the
sealed source was tested within six months before transfer to the
licensee.
b. Each sealed source
that is not designed to emit alpha particles is tested for leakage or
contamination at intervals not to exceed six months or at alternative intervals
approved by the Agency, after evaluation of information specified by
641-subparagraphs 39.4(29)"I" (4) and
39.4(29)"l" (5) of these rules, an Agreement State, a
Licensing State, or the U.S. Nuclear Regulatory Commission.
c. Each sealed source that is designed to
emit alpha particles is tested for leakage or contamination at intervals not to
exceed three months or at alternative intervals approved by the Agency, after
evaluation of information specified by 641-subparagraphs
39.4(29)"l"(4) and 39.4(29)"l" (5) of these
rules, an Agreement State, a Licensing State, or the Nuclear Regulatory
Commission.
d. For each sealed
source that is required to be tested for leakage or contamination, at any other
time there is reason to suspect that the sealed source might have been damaged
or might be leaking, the licensee or registrant shall ensure that the sealed
source is tested for leakage or contamination before further use.
e. Tests for leakage for all sealed sources,
except brachytherapy sources manufactured to contain radium, shall be capable
of detecting the presence of 0.005 µCi (185 Bq) of radioactive material
on atest sample. Test samples shall be taken from the sealed source or from the
surfaces of the container in which the sealed source is stored or mounted on
which one might expect contamination to accumulate. For a sealed source
contained in a device, test samples are obtained when the source is in the
"off" position.
f.The test for
leakage for brachytherapy sources manufactured to contain radium shall be
capable of detecting an absolute leakage rate of 0.001 µCi (37 Bq) of
radon-222 in a 24-hour period when the collection efficiency for radon-222 and
its daughters has been determined with respect to collection method, volume and
time.
g. Tests for contamination
from radium daughters shall be taken on the interior surface of brachytherapy
source storage containers and shall be capable of detecting the presence of
0.005 µCi (185 Bq) of a radium daughter which has a half-life greater
than four days.
(2) A
licensee need not perform tests for leakage or contamination on the following
sealed sources:
a. Sealed sources containing
only radioactive material with a half-life of less than 30 days;
b. Sealed sources containing only radioactive
material as a gas;
c. Sealed
sources containing 100 µCi (3.7 MBq) or less of beta- or photon-emitting
material or 10 µCi (370 kBq) or less of alpha-emitting
material;
d. Sealed sources
containing only hydrogen-3;
e.
Seeds of iridium-192 encased in nylon ribbon; and
f. Sealed sources, except those used in
teletherapy and brachytherapy and those containing radium, which are stored,
not being used and identified as in storage. The licensee shall, however, test
each such sealed source for leakage or contamination and receive the test
results before any use or transfer unless it has been tested for leakage or
contamination within six months before the date of use or transfer.
(3) Tests for leakage or
contamination from sealed sources shall be performed by persons specifically
authorized by the agency, an Agreement State, a Licensing State, or the U.S.
Nuclear Regulatory Commission to perform such services.
(4) Test results shall be kept in units of
microcurie or becquerel and maintained for inspection by the agency.
(5) The following shall be considered
evidence that a sealed source is leaking:
a.
The presence of 0.005 µCi (185 Bq) or more of removable contamination on
any test sample.
b. Leakage of
0.001µCi (37 Bq) of radon-222 per 24 hours for brachytherapy sources
manufactured to contain radium.
c.
The presence of removable contamination resulting from the decay of 0.005
µCi (185 Bq) or more of radium.
(6) The licensee shall immediately withdraw a
leaking sealed source from use and shall take action to prevent the spread of
contamination. The leaking sealed source shall be repaired or disposed of in
accordance with this chapter.
(7)
Reports of test results for leaking or contaminated sealed sources shall be
made pursuant to40.102(136C).