Current through Register No. 40, October 3, 2024
(a) Each licensee
and registrant shall perform, pursuant to instructions from DHHS/RHS, or shall
permit DHHS/RHS to perform, tests which will assist DHHS/RHS in determining the
licensee's or registrant's compliance with these rules, including tests of:
(1) Sources of radiation;
(2) Facilities where sources of radiation are
utilized or stored;
(3) Radiation
detection and monitoring instruments; and
(4) Other equipment and devices used in
connection with the utilization or storage of licensed or registered sources of
radiation.
(b) The
licensee in possession of any sealed source shall ensure that:
(1) Each sealed source, except as specified
in He-P 4001.05(c), 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 transferor indicating that the sealed source was tested
within 6 months before transfer to the licensee;
(2) Each sealed source that is not designed
to emit alpha particles is tested for leakage or contamination at intervals not
to exceed 12 months, except those as specified in He-P 4034.10 and He-P
4035.21;
(3) Each sealed source
that is designed to emit alpha particles is tested for leakage or contamination
at intervals not to exceed 3 months;
(4) Each sealed source that is required to be
tested for leakage or contamination, that might have been damaged or might be
leaking, is tested for leakage and contamination before further use;
(5) Tests for leakage for all sealed sources,
except brachytherapy sources manufactured to contain radium, are capable of
detecting the presence of 185 Bq (0.005 mCi) of radioactive material on a test
sample which is taken from the sealed source or taken from the surfaces of the
container in which the sealed source is stored or mounted and at the nearest
accessible point to the sealed source where contamination might accumulate, and
for a sealed source contained in a device, test samples are obtained when the
source is in the "off" position;
(6) Tests for leakage of sealed sources and
Brachytherapy sources and their associated requirements are specified in He-P
4035.21;
(7) Tests for
contamination from radium daughters are taken on the interior surface of
brachytherapy source storage containers and are capable of detecting the
presence of 185 Bq (0.005 ?Ci) of a radium daughter which has a half-life
greater than 4 days; and
(8) Tests
for leakage or contamination are performed using a leak test kit or method
approved by DHHS/RHS.
(c) A licensee shall not be required to
perform tests for leakage or contamination on the following sealed sources:
(1) Sealed sources containing only
radioactive material with a half-life of less than 30 days;
(2) Sealed sources containing only
radioactive material as a gas;
(3)
Sealed sources containing 3.7 MBq (100 mCi) or less of beta or photon-emitting
material or 370 kBq (10 µCi) or less of alpha-emitting
material;
(4) Sealed sources
containing only hydrogen-3;
(5)
Seeds of iridium-192 encased in nylon ribbon; and
(6) Sealed sources, except teletherapy and
brachytherapy sources, which are stored, not being used and identified as in
storage.
(d) The
licensee shall, however, test each such sealed source in He-P 4001.05(c)(6) for
leakage or contamination and receive the test results:
(1) At intervals no greater than 3 years;
and
(2) Before any use or transfer
unless the source has been tested for leakage or contamination within 6 months
before the date of use or transfer.
(e) Tests for leakage or contamination from
sealed sources shall be performed by persons specifically licensed by DHHS/RHS,
an agreement state, a licensing state, or the U.S. Nuclear Regulatory
Commission to perform such services.
(f) Test results shall be kept in units of
Becquerel or microcurie and maintained for inspection by DHHS/RHS for 5 years
from date of test.
(g) The
following shall be considered evidence that a sealed source is leaking:
(1) The presence of 185 Bq (0.005 µCi)
or more of removable contamination on any test sample;
(2) Leakage of 37 Bq (0.001 µCi) of
radon-222 per 24 hours for brachytherapy sources manufactured to contain
radium; or
(3) The presence of
removable contamination resulting from the decay of 185 Bq (0.005 µCi) or
more of radium.
(h) The
licensee shall immediately withdraw a leaking sealed source from use and shall
take action in accordance with He-P 4003.05(i) to prevent the spread of
contamination.
(i) If a sealed
source is leaking, the licensee shall:
(1)
Decontaminate the facility and source in accordance with He-P 4021.20, and
dispose of the leaking source in accordance with He-P 4023; or
(2) Decontaminate the facility and source in
accordance with He-P 4021.20, and have the source repaired by a person
specifically licensed to perform this service.
(j) Reports of test results for leaking or
contaminated sealed sources shall be made pursuant to He-P 4021.19.
#5903, eff 2-1-95; ss by #6827, eff 8-6-98; amd by #8488,
eff 11-18-05; amd by #8692, INTERIM, eff 7-27-06, EXPIRES: 2-2-07; ss by #8808,
eff 1-24-07
