| (a) Purpose. This section contains requirements for
the issuance of a license authorizing the use of sealed sources containing
radioactive material used in irradiating objects or materials using
gamma radiation. This section also contains radiation safety requirements
for operating irradiators.
(b) Scope.
(1) In addition to the requirements of this section,
all licensees, unless otherwise specified, are subject to the requirements
of:
(A) §289.201 of this chapter (relating to General
Provisions for Radioactive Material);
(B) §289.202 of this chapter (relating to Standards
for Protection Against Radiation from Radioactive Materials);
(C) §289.203 of this chapter (relating to Notices,
Instructions, and Reports to Workers; Inspections);
(D) §289.204 of this chapter (relating to Fees
for Certificates of Registration, Radioactive Material Licenses, Emergency
Planning and Implementation, and Other Regulatory Services);
(E) §289.205 of this chapter (relating to Hearing
and Enforcement Procedures);
(F) §289.252 of this subchapter (relating to Licensing
of Radioactive Material); and
(G) §289.257 of this subchapter (relating to Packaging
and Transportation of Radioactive Material).
(2) Nothing in this section relieves the licensee from
complying with other applicable federal, state, and local regulations
governing the siting, zoning, land use, and building code requirements
for industrial facilities.
(3) The requirements in this section apply to panoramic
irradiators having either dry or wet storage of radioactive sealed
sources and to underwater irradiators in which both the source and
the product being irradiated are under water. Irradiators whose dose
rates are greater than 500 rads (5 grays) per hour at 1 meter (m)
from the radioactive sealed sources in air or in water, as applicable
for the irradiator type, are covered by this section.
(4) The requirements in this section do not apply to
self-contained, dry-source-storage irradiators (those in which both
the source and the area subject to irradiation are contained within
a device and are not accessible by personnel), medical radiology or
teletherapy, radiography (the irradiation of materials for non-destructive
testing purposes), gauging, or open-field (agricultural) irradiations.
(c) Definitions. The following words and terms when
used in this section have the following meanings unless the context
clearly indicates otherwise.
(1) Annually--At intervals not greater than 390 days.
(2) Doubly encapsulated sealed source--A sealed source
in which the radioactive material is sealed within a capsule and that
capsule is sealed within another capsule.
(3) Category I self-contained, dry-source irradiator--An
irradiator in which the sealed source is completely contained in a
dry container constructed of solid materials and shielded at all times,
and in which human access to the sealed source and the volume undergoing
irradiation is not physically possible in its designed configuration.
(4) Irradiator--A facility using radioactive sealed
sources for the irradiation of objects or materials and in which radiation
dose rates are greater than 500 rads (5 grays) per hour exist at 1
m from the sealed radioactive sources in air or water, as applicable
for the irradiator type, but does not include irradiators in which
both the sealed source and the area subject to irradiation are contained
within a device and not accessible to personnel.
(5) Irradiator operator--An individual who successfully
completed the training and testing described in subsection (s) of
this section and is authorized by the terms of the license to operate
the irradiator without the presence of a supervisor who completed
the requirements of subsection (s)(1) - (3) of this section.
(6) Onsite--A physical presence within the building
housing the irradiator or on property controlled by the licensee contiguous
with the building housing the irradiator.
(7) Panoramic dry-source-storage irradiator--An irradiator
in which the irradiations occur in air in areas potentially accessible
to personnel and in which the sources are stored in shields made of
solid materials. The term includes beam-type dry-source-storage irradiators
in which only a narrow beam of radiation is produced for performing
irradiations.
(8) Panoramic irradiator--An irradiator in which the
irradiations are done in air in areas potentially accessible to personnel.
The term includes beam-type irradiators.
(9) Panoramic wet-source-storage irradiator--An irradiator
in which the irradiations occur in air in areas potentially accessible
to personnel and in which the sources are stored under water in a
storage pool.
(10) Pool irradiator--Any irradiator in which the sources
are stored or used in a pool of water, including panoramic wet-source-storage
irradiators and underwater irradiators.
(11) Product conveyor system--A system for moving the
product to be irradiated to, from, and within the area where irradiation
takes place.
(12) Radiation room--A shielded room in which irradiations
take place. Underwater irradiators do not have radiation rooms.
(13) Seismic area--Any area where the probability of
horizontal acceleration in rock of more than 0.3 times the acceleration
of gravity in 250 years is greater than 10 percent, as designated
by the United States Geological Survey.
(14) Underwater irradiator--An irradiator in which
the sources always remain shielded under water and humans do not have
access to the sealed sources or the space subject to irradiation without
entering the pool.
(d) Application for a specific license. Applications
for specific licenses must be filed as specified in §289.252(d)
of this subchapter.
(e) Specific licenses for irradiators.
(1) The department approves an application for a specific
license for the use of licensed material in an irradiator if the applicant
meets the requirements contained in this section.
(2) The applicant must satisfy the general requirements
specified in §289.252 of this subchapter and the requirements
contained in this section.
(3) The application must describe the training provided
to irradiator operators including:
(A) classroom training;
(B) on-the-job or simulator training;
(C) safety reviews;
(D) means employed by the applicant to test each operator's
understanding of the department's rules and licensing requirements
and the irradiator operating, safety, and emergency procedures; and
(E) minimum training and experience of personnel providing
training.
(4) The application must include a copy of the written
operating, safety, and emergency procedures as outlined in subsection
(t) of this section describing the radiation safety aspects of the
procedures.
(5) The application must describe the organizational
structure for managing the irradiator, specifically the radiation
safety responsibilities and authorities of the radiation safety officer
(RSO) and those management personnel having radiation safety responsibilities
or authorities. In particular, the application must specify who, within
the management structure, has the authority to stop unsafe operations.
The application must also describe the training and experience required
for the position of RSO.
(6) The application must include a description of the
access control systems required by subsection (i) of this section,
the radiation monitors required by subsection (l) of this section,
the method of detecting leaking sources required by subsection (w)
of this section, including the sensitivity of the method, and a diagram
of the facility showing the locations of all required interlocks and
radiation monitors.
(7) If the applicant intends to perform and analyze
leak tests of dry-source-storage sealed sources, the applicant must
establish procedures for leak testing and submit a description of
these procedures to the department. The description must include at
least:
(A) the instruments to be used;
(B) the methods of performing the analysis; and
(C) the pertinent experience of the individual analyzing
the samples.
(8) If licensee personnel are to load or unload sources,
the applicant must describe the qualifications and training of the
personnel and the procedures used. If the applicant intends to contract
for source loading or unloading at its facility, the loading or unloading
must be done by a person specifically authorized by the department,
the United States Nuclear Regulatory Commission (NRC), or an agreement
state to load or unload irradiator sources.
Cont'd... |
