(d) Very high radiation areas.
(1) Each very high radiation area shall be
conspicuously posted with a sign or signs bearing the radiation caution symbol
and the following words:
GRAVE DANGER VERY HIGH RADIATION AREA
(2) Each registrant or licensee shall
institute measures to ensure that an individual is not able to gain
unauthorized or inadvertent access to an area in which radiation levels could
be encountered at five Gy (500 rad) or more in one hour at one meter from a
source of radiation or any surface through which the radiation penetrates. This
area is called a very high radiation area.
(A) Paragraph (d)(2) shall not apply to rooms
or areas in which diagnostic X-ray systems are the only source of radiation, or
to non-self-shielded irradiators.
(B) The registrant or licensee shall not be
required to control entrance or access to rooms or other areas containing
sources of radiation capable of producing a very high radiation area, as
described in this regulation, if the registrant or licensee has met all the
specific requirements for access and control specified in part 7 for industrial
radiography, part 5 for X-rays in the healing arts, and part 9 for particle
accelerators.
(3)
Control of access to very high radiation areas; irradiators.
(A) Paragraph (d)(3) shall apply to licensees
or registrants with sources of radiation in non-self-shielded irradiators and
shall not apply to sources of radiation used in teletherapy, in industrial
radiography, or 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 a high level of
radiation in an area that is accessible to any individual.
(B) Each area in which there could exist
radiation levels in excess of five Gy (500 rad) in one hour at one meter from a
source of radiation that is used to irradiate materials shall be equipped with
entry control devices that perform the following:
(i) Function automatically to prevent any
individual from inadvertently entering a very high radiation area;
(ii) 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
(iii) prevent operation of the source of
radiation if the source 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.
(C)
Additional control devices shall be provided so that, upon failure of the entry
control devices to function as required in this regulation, both of the
following will occur:
(i) The radiation level
within the area, from the source of radiation, is reduced below the level 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.
(ii) Conspicuous visible and audible alarm
signals are generated to make an individual attempting to enter the area aware
of the hazard and at least one other authorized individual who is physically
present, familiar with the activity, and prepared to render or summon
assistance aware of the failure of the entry control devices.
(D) The licensee or registrant
shall provide control devices so that, upon the failure or removal of physical
radiation barriers other than the sealed sources shielded storage container,
both of the following will occur:
(i) The
radiation level from the source of radiation is reduced below the level 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.
(ii) Conspicuous visible and audible alarm
signals are generated to make potentially affected individuals aware of the
hazard and to make the licensee, 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.
(E) If the shield for stored sealed sources
is a liquid, the licensee or registrant shall provide the means to monitor the
integrity of the shield and to automatically signal the loss of adequate
shielding.
(F) Physical radiation
barriers that comprise permanent structural components, including walls, that
have no credible probability of failure or removal in ordinary circumstances
shall not be required to meet the requirements of paragraphs (d)(3)(D) and (E).
(G) Each area shall be equipped
with devices that 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, which shall be installed in the area and
which shall prevent the source of radiation from being put into operation.
(H) Each area shall be controlled
by the use of any administrative procedures and devices necessary to ensure
that the area is cleared of personnel before each use of the source of
radiation.
(I) Each area shall be
checked by a measurement of the radiation 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 is below the level 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.
(J) The entry control devices required in
paragraph (d)(3) shall be tested for proper functioning.
(i) Testing shall be conducted before initial
operation with the source of radiation on any day, unless operations were
continued uninterrupted from the previous day.
(ii) Testing shall be conducted before
resuming operation of the source of radiation after any unintentional
interruption.
(iii) The licensee
or registrant shall submit and adhere to a schedule for periodic tests of the
entry control and warning systems.
(K) 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 the control devices
are functioning properly.
(L)
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 those devices and administrative procedures necessary to
physically protect and warn against inadvertent entry by any individual through
these portals. Exit portals for irradiated materials shall be equipped to
detect and signal the presence of any loose radioactive material that is
carried toward such an exit and automatically to prevent any loose radioactive
material from being carried out of the area.
(4) Licensees, registrants, or applicants for
licenses or registrations for sources of radiation subject to paragraph (d)(3)
that will be used in a variety of positions or in locations including open
fields or forests that make it impracticable to comply with certain
requirements of this regulation, including those for the automatic control of
radiation levels, may apply to the department for approval of alternative
safety measures. Alternative safety measures that are at least equivalent to
those specified in paragraph (d)(3) shall be provided. At least one of the
alternative measures shall include 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 such sources of
radiation are used.