Current through Register Vol. 30, No. 38, September 20, 2024
A. This Section
applies to licensees or registrants with sources of radiation in
non-self-shielded irradiators. This Section does not apply to sources of
radiation that are used in teletherapy, industrial radiography, or completely
self-shielded irradiators in which the source of radiation is both stored and
operated within the same shielding radiation barrier and, in the designed
configuration of the irradiator, is always physically inaccessible to any
individual and cannot create high levels of radiation in an area that is
accessible to any individual.
B. A
licensee or registrant shall ensure that each area in which radiation levels
may exceed 5 Gy (500 rad) in one hour at 1 meter from a source that is used to
irradiate materials meets the following requirements:
1. Each entrance or access point shall be
equipped with entry control devices that:
a.
Function automatically to prevent any individual from inadvertently entering a
very high radiation area;
b. Permit
deliberate entry into the area only after a control device is actuated that
causes the radiation level within the area, from the source of radiation, to be
reduced below that at which it would be possible for an individual to receive a
deep-dose equivalent in excess of 1 mSv (0.1 rem) in one hour; and
c. Prevent operation of the source of
radiation if it would produce radiation levels in the area that could result in
a deep-dose equivalent to an individual in excess of 1 mSv (0.1 rem) in one
hour.
2. If the control
devices required in subsection (B)(1) fail to function, additional control
devices shall be provided so that:
a. The
radiation level within the area, from the source of radiation, is reduced below
that at which it would be possible for an individual to receive a deep-dose
equivalent in excess of 1 mSv (0.1 rem) in one hour; and
b. Conspicuous visible and audible alarm
signals are generated so that an individual entering the area is aware of the
hazard. The individual who enters the very-high radiation area after an alarm
signals shall be familiar with the process and equipment. Before entering, the
individual shall ensure that a second individual is present and aware of the
first person's actions.
3. The licensee or registrant shall provide
control devices so that, upon failure or removal of physical radiation barriers
other than the sealed source's shielded storage container:
a. The radiation level from the source of
radiation is reduced below that at which it would be possible for an individual
to receive a deep-dose equivalent in excess of 1 mSv (0.1 rem) in one hour,
and
b. Conspicuous visible and
audible alarm signals are generated so that potentially affected individuals
are aware of the hazard. Potentially affected individuals shall notify the
licensee or registrant of the failure or removal of the physical
barriers.
4. When the
shield for stored sealed sources is a liquid, the licensee or registrant shall
provide means to monitor the integrity of the shield and to signal,
automatically, loss of adequate shielding.
5. Physical radiation barriers that comprise
permanent structural components, such as walls, that have no credible
probability of failure or removal in ordinary circumstances need not meet the
requirements of subsections (B)(3) and (4).
6. The licensee or registrant shall equip
each area with devices that will automatically generate conspicuous visible and
audible alarm signals to alert personnel in the area before the source of
radiation can be put into operation and in time for any individual in the area
to operate a clearly identified control device, installed in the area, and
which can prevent the source of radiation from being put into
operation.
7. The licensee or
registrant shall control each area by use of administrative procedures and
devices necessary to ensure that the area is cleared of personnel before each
use of the source of radiation.
8.
The licensee or registrant shall check each area by radiation measurement to
ensure that, before the first individual's entry into the area after any use of
the source of radiation, the radiation level from the source of radiation in
the area will not expose an individual to a deep-dose equivalent in excess of 1
millisievert (0.1 rem) in one hour.
9. The licensee or registrant shall test the
entry control devices required in subsection (B)(1) for proper functioning and
keep records according to
R9-7-421.
a. Testing shall be conducted before initial
operation with the source of radiation on any day, unless operations were
continued uninterrupted from the previous day;
b. Testing shall be conducted before
resumption of operation of the source of radiation after any unintentional
interruption;
c. The licensee or
registrant shall submit to the Department a schedule of testing; and
d. The licensee or registrant shall include
in the schedule a listing of the periodic testing that will be
followed.
10. The
licensee or registrant shall not conduct operations, other than those necessary
to place the source of radiation in a safe condition or effect repairs on
controls, unless control devices are functioning properly.
11. The licensee or registrant shall control
entry and exit portals that are used in transporting materials to and from the
irradiation area, and that are not intended for use by personnel, with devices
and administrative procedures necessary to physically protect and warn against
inadvertent entry by an individual through one of the portals. Exit portals for
irradiated materials shall be equipped to detect and signal the presence of any
uncontained radioactive material that is carried toward an exit and
automatically prevent contained radioactive material from being carried out of
the area.
C. A licensee,
registrant, or applicant seeking a license or registration for a source of
radiation within the purview of subsection (B) that will be used in a variety
of positions or in locations, such as open fields or forests, that make it
impractical to comply with certain requirements of subsection (B) may apply to
the Department for approval of alternative safety measures. Alternative safety
measures shall provide personnel protection at least equivalent to that
specified in subsection (B). At least one of the alternative measures shall be
an entry-preventing interlock control, based on a measurement of the radiation
that ensures the absence of high radiation levels before an individual can gain
access to the area where the sources of radiation are used.
D. A licensee or registrant shall provide the
entry control devices required by subsections (B) and (C) in such a way that no
individual will be prevented from leaving the area.
E. Records.
1. Each licensee or registrant shall maintain
records of tests made according to subsection (B)(9) on entry control devices
for very-high radiation areas. These records shall include the date and results
of each test of function.
2. The
licensee or registrant shall retain the records for three years from the date
the record is made.
