Current through Register Vol. 46, No. 12, March 20, 2024
(a) Reports of
stolen, lost, or missing licensed or registered sources of radiation.
(1) Telephone reports. Each licensee or
registrant shall report to the department by telephone as follows:
(i) Immediately after its occurrence becomes
known to the licensee or registrant, stolen, lost, or missing licensed
radioactive material in an aggregate quantity equal to or greater than 1,000
times the quantity specified in Appendix 16-A, Table 9, infra, under such
circumstances that it appears to the licensee or registrant that an exposure
could result to individuals in unrestricted areas; or
(ii) Within 30 days after its occurrence
becomes known to the licensee, lost, stolen, or missing licensed radioactive
material in an aggregate quantity greater than 10 times the quantity specified
in Appendix 16-A, Table 9, infra, that is still missing.
(iii) Immediately after its occurrence
becomes known to the registrant, a stolen, lost, or missing radiation
equipment.
(iv) Immediately after
the discovery of an event that prevents immediate protective action necessary
to avoid exposures to radiation or radioactive materials which could exceed the
regulatory limits, or releases of radioactive material which could exceed
regulatory limits; due to an event such as an explosion, or toxic gas
release.
(2) Written
reports. Each licensee or registrant required to make a report pursuant to this
subdivision shall, within 30 days after making the telephone report, make a
written report to the department setting forth the following information:
(i) a description of the licensed or
registered source of radiation involved, including, for radioactive material,
the kind, quantity, and chemical and physical form; and, for radiation
equipment, the manufacturer, model and serial number, type and maximum energy
of radiation emitted;
(ii) a
description of the circumstances under which the loss or theft occurred;
and
(iii) a statement of
disposition, or probable disposition, of the licensed or registered source of
radiation involved; and
(iv)
exposures of individuals to radiation, circumstances under which the exposures
occurred, and the possible total effective dose equivalent to persons in
unrestricted areas; and
(v) actions
that have been taken, or will be taken, to recover the source of radiation;
and
(vi) procedures or measures
that have been, or will be, adopted to ensure against a recurrence of the loss
or theft of licensed or registered sources of radiation.
(3) After filing the written report, the
licensee or registrant shall also report any additional substantive information
on the loss or theft within 30 days after the discovery of such
information.
(4) The names of
individuals who may have received exposure to radiation must be stated only in
a separate and detachable portion of the report.
(b) Notification of incidents.
(1) Immediate notification. Notwithstanding
other requirements for notification, each licensee or registrant shall
immediately report each event involving a source of radiation possessed by the
licensee or registrant that may have caused or threatens to cause any of the
following conditions:
(i) An individual to
receive:
(a) a total effective dose
equivalent of 0.25 Sv (25 rem) or more; or
(b) an eye dose equivalent of 0.75 Sv (75
rem) or more; or
(c) a shallow dose
equivalent to the skin or extremities of 2.5 Gy (250 rad) or more; or
(ii) The release of radioactive
material, inside or outside of a restricted area, so that, had an individual
been present for 24 hours, the individual could have received an intake five
times the occupational ALI. This provision does not apply to locations where
personnel are not normally stationed during routine operations, such as
hot-cells or process enclosures.
(2) Twenty-four hour notification. Each
licensee or registrant shall, within 24 hours of discovery of the event, report
each event involving loss of control of a licensed or registered source of
radiation possessed by the licensee or registrant that may have caused, or
threatens to cause, any of the following conditions:
(i) An individual to receive, in a period of
24 hours:
(a) a total effective dose
equivalent exceeding 0.05 Sv (5 rem); or
(b) an eye dose equivalent exceeding 0.15 Sv
(15 rem); or
(c) a shallow dose
equivalent to the skin or extremities exceeding 0.5 Sv (50 rem); or
(ii) The release of radioactive
material, inside or outside of a restricted area, so that, had an individual
been present for 24 hours, the individual could have received an intake in
excess of one occupational ALI. This provision does not apply to locations
where personnel are not normally stationed during routine operations, such as
hot-cells or process enclosures.
(3) The licensee or registrant shall prepare
each report filed with the department pursuant to this subdivision so that
names of individuals who have received exposure to sources of radiation are
stated in a separate and detachable portion of the report.
(4) Licensees or registrants shall make the
reports required by paragraphs (1) and (2) of this subdivision by telephone,
telegram, mailgram, or facsimile to the department.
(5) The provisions of this subdivision do not
apply to doses that result from planned special exposures, provided such doses
are within the limits for planned special exposures, and are reported pursuant
to subdivision (d) of this section.
(c) Reports of exposures, radiation levels,
and concentrations of radioactive material exceeding the limits.
(1) Reportable events. In addition to the
notification required by subdivision (b) of this section, each licensee or
registrant shall submit a written report within 30 days after learning of any
of the following occurrences:
(i) incidents
for which notification is required by subdivision (b) of this
section;
(ii) doses in excess of
any of the following:
(a) the occupational
dose limits for adults in section
16.6(a)
of this Part;
(b) the occupational
dose limits for a minor in section
16.6(g)
of this Part;
(c) the limits for an
embryo/fetus of a declared pregnant woman in section
16.6(h)
of this Part;
(d) the limits for an
individual member of the public in section
16.7(a)
of this Part;
(e) any applicable
limit in the license or registration; or
(iii) levels of radiation or concentrations
of radioactive material in:
(a) a restricted
area in excess of applicable limits in the license or registration;
(b) an unrestricted area in excess of 10
times the applicable limit set forth in this Part or in the license or
registration, whether or not involving exposure of any individual in excess of
the limits in section
16.7(a)
of this Part.
(2) Contents of reports.
(i) Each report required by this subdivision
shall describe the extent of exposure of individuals to radiation and
radioactive material, including, as appropriate:
(a) estimates of each individual's dose;
and
(b) the levels of radiation and
concentrations of radioactive material involved; and
(c) the cause of the elevated exposures, dose
rates, or concentrations; and
(d)
corrective steps taken or planned to ensure against a recurrence, including the
schedule for achieving conformance with applicable limits, generally applicable
environmental standards, and associated license or registration
conditions.
(ii) Each
report filed pursuant to paragraph (1) of this subdivision shall include for
each individual exposed: the name, social security account number, and date of
birth. With respect to the limit for the embryo/fetus in section
16.6(h)
of this Part, the identifiers should be those of the declared pregnant woman.
The report shall be prepared so that this information is stated in a separate
and detachable portion of the report.
(3) All licensees or registrants who make
reports pursuant to this subdivision shall submit the report in writing to the
department.
(d) Reports
of planned special exposures. The licensees or registrant shall submit a
written report to the department within 30 days following any planned special
exposure conducted in accordance with section
16.6(f)
of this Part, informing the department that a planned special exposure was
conducted and indicating the date the planned special exposure was conducted
and indicating the date the planned special exposure occurred and the
information required by section
16.14(e)
of this Part.
(e) Notifications and
reports to individuals.
(1) Requirements for
notification and reports to individuals of exposure to radiation or radioactive
material are specified in section
16.13
of this Part.
(2) When a licensee
or registrant is required pursuant to subdivision (c) of this section to report
to the department any exposure of an individual to radiation or radioactive
material, the licensee or registrant shall also notify the individual. Such
notice shall be transmitted at a time not later than the transmittal to the
department, and shall comply with the provisions of section
16.13
of this Part.
(f)
Reports of leaking or contaminated sealed sources. If a sealed source is
determined to be leaking or contaminated, a report shall be filed within five
days with the department describing the equipment involved, the test results
and the corrective action taken.
(g) Each professional practitioner who treats
or diagnoses any suspected radiation illness shall report in writing to the
department within seven days after such treatment or diagnoses, the fact
thereof and the full name, address and age of the individual. Included in this
reporting requirement are patients who have developed clinical symptoms as a
result of contact with radioactive (gold) jewelry.