Current through Register No. 40, October 3, 2024
(a) This section shall apply to licensees or
registrants with sources of radiation in non-self-shielded
irradiators.
(b) This section shall
not apply to sources of radiation that are used:
(1) In teletherapy;
(2) In industrial radiography; or
(3) In 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.
(c) Each
area in which there may exist radiation levels in excess of 5 Gy (500 rad) in
one hour at one meter from a source of radiation that is used to irradiate
materials shall meet the following requirements:
(1) Each entrance or access point shall be
equipped with entry control devices which shall:
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
one 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 one mSv (0.1 rem) in one
hour;
(2) Upon failure
of the entry control devices to function as required by
He-P
4022.06(c) (1) , additional control
devices shall be provided so that:
a. The
radiation level within the area, from the source of radiation, shall be reduced
below that at which it would be possible for an individual to receive a deep
dose equivalent in excess of one mSv (0.1 rem) in one hour; and
b. Conspicuous visible and audible alarm
signals shall be generated to make:
1. An
individual attempting to enter the area aware of the hazard; and
2. At least one other authorized individual,
who is physically present, familiar with the activity, prepared to render or
summon assistance, and is aware of the failure of the entry control
devices;
(3)
Upon failure or removal of physical radiation barriers other than a sealed
source's shielded storage container, the licensee or registrant shall provide
control devices so that:
a. The radiation
level from the source of radiation shall be reduced below that at which it
would be possible for an individual to receive a deep dose equivalent in excess
of one mSv (0.1 rem) in one hour; and
b. Conspicuous visible and audible alarm
signals shall be generated to make:
1.
Potentially affected individuals aware of the hazard; and
2. The licensee or registrant or at least one
other individual, who is familiar with the activity and prepared to render or
summon assistance, aware of the failure or removal of the physical
barrier;
(4)
When a 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 shall not need to
meet the requirements of
He-P
4022.06(c) (3) and (4) ;
(6) Each area shall be equipped with devices
that automatically generate conspicuous visible and audible alarm signals to:
a. Alert personnel in the area before the
source of radiation can be put into operation; and
b. Allow time for any individual in the area
to operate a clearly identified control device, which:
1. Shall be installed in the area;
and
2. Shall prevent the source of
radiation from being put into operation when the control device is
actuated;
(7)
Each area shall be controlled by use of such administrative procedures and such
devices as are necessary to ensure that the area is cleared of personnel prior
to each use of the source of radiation;
(8) Each area shall be checked by a radiation
measurement prior to the first individual's entry into the area and after any
use of the source of radiation to ensure that the radiation level from the
source of radiation in the area is below that at which it would be possible for
an individual to receive a deep dose equivalent in excess of one mSv (0.1 rem)
in one hour;
(9) The entry control
devices required in He-P 4022.05(c) (1)
shall be tested for proper functioning:
a. Prior to initial operation with the source
of radiation on any day, unless operations were continued uninterrupted from
the previous day; and
b. Prior to
resumption of operation of the source of radiation after any unintentional
interruption;
(10) The
licensee or registrant shall adhere to and submit to DHHS/RHS a schedule for
periodic tests of the entry control and warning systems;
(11) The licensee or registrant shall not
conduct operations, other than those necessary to place the source of radiation
in safe condition or to effect repairs on controls, unless control devices are
functioning properly;
(12) Entry
and exit portals that are used in transporting materials to and from the
irradiation area, and that are not intended for use by individuals, shall be
controlled by such devices and administrative procedures as are necessary to
physically protect and warn against inadvertent entry by any individual through
these portals; and
(13) Exit
portals for irradiated materials shall be equipped to detect and automatically
signal the presence of any loose radioactive material that is carried toward
such an exit to prevent loose radioactive material from being carried out of
the area.
(d) Licensees,
registrants, or applicants for licenses or registrations for sources of
radiation within the purview of
He-P
4022.06(c) which will be used in a
variety of positions or in locations that make it impracticable to comply with
certain requirements of
He-P
4022.06(c) may apply to DHHS/RHS for
approval of alternative safety measures.
(e) Alternative safety measures shall:
(1) Provide personnel protection at least
equivalent to those specified in
He-P
4022.06(c) ; and
(2) Have at least one of the alternative
measures to include an entry-preventing inter-lock 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 such sources of
radiation are used.
(f)
The entry control devices required by
He-P
4022.06(c) and (d) shall not prevent
an individual from leaving the area.
#5903, eff 2-1-95; ss by #6827, eff 8-6-98; ss by #8692,
INTERIM, eff 7-27-06, EXPIRES: 2-2-07; ss by #8808, eff
1-24-07