| (3) The record may also be stored in electronic media with the capability for producing legible, accurate, and complete records during the required retention period. (4) Records, such as letters, drawings, and specifications, shall include all pertinent information, such as stamps, initials, and signatures. (5) The registrant shall maintain adequate safeguards against tampering with and loss of records. (gg) Reports of stolen, lost, or missing radiation machines. (1) Each registrant shall report to the agency by telephone a stolen, lost, or missing radiation machine immediately after its occurrence becomes known to the registrant. (2) Each registrant required to make a report in accordance with paragraph (1) of this subsection shall, within 30 days after making the telephone report, make a written report to the agency that includes the following information: (A) a description of the radiation machine involved, including, the manufacturer, model and serial number; (B) a description of the circumstances under which the loss or theft occurred; (C) exposures of individuals to radiation, circumstances under which the exposures occurred, and the possible TEDE to persons in unrestricted areas; (D) actions that have been taken, or will be taken, to recover the radiation machine; and (E) procedures or measures that have been, or will be, adopted to ensure against a recurrence of the loss or theft of radiation machines. (3) Subsequent to filing the written report, the registrant shall also report additional substantive information on the loss or theft within 30 days after the registrant learns of such information. (4) The registrant shall prepare any report filed with the agency in accordance with this subsection so that names of individuals who may have received exposure to radiation are stated in a separate and detachable portion of the report. (hh) Notification of incidents. (1) Notwithstanding other requirements for notification, each registrant shall immediately report each event involving a radiation machine possessed by the registrant that may have caused or threatens to cause an individual, except a patient administered radiation for the purpose of medical diagnosis or therapy, to receive: (A) a TEDE of 25 rems (0.25 Sv) or more; (B) an LDE of 75 rems (0.75 Sv) or more; or (C) an SDE to the skin of the whole body or to the skin of the extremities of 250 rads (2.5 grays) or more. (2) Each registrant shall, within 24 hours of discovery of the event, report to the agency each event involving loss of control of a radiation machine possessed by the registrant that may have caused, or threatens to cause an individual to receive, in a period of 24 hours: (A) a TEDE exceeding 5 rems (0.05 Sv); (B) an LDE exceeding 15 rems (0.15 Sv); or (C) an SDE to the skin of the whole body or to the skin of the extremities exceeding 50 rems (0.5 Sv). (3) Registrants shall make the initial notification reports required by paragraphs (1) and (2) of this subsection by telephone to the agency and shall confirm the initial notification report within 24 hours by telegram, mailgram, or facsimile to the agency. (4) The registrant shall prepare each report filed with the agency in accordance with this section so that names of individuals who have received exposure to radiation are stated in a separate and detachable portion of the report. (ii) Reports of exposures and radiation levels exceeding the limits. (1) In addition to the notification required by subsection (hh) of this section, each registrant shall submit a written report within 30 days after learning of any of the following occurrences: (A) incidents for which notification is required by subsection (hh) of this section; (B) doses in excess of any of the following: (i) the occupational dose limits for adults in subsection (m)(1)(A) and (B) of this section; (ii) the occupational dose limits for a minor in subsection (m)(1)(C) of this section; (iii) the limits for an embryo/fetus of a declared pregnant woman in subsection (m)(1)(D) of this section; (iv) the limits for an individual member of the public in subsection (o) of this section; or (v) any applicable limit in the registration; (C) levels of radiation in: (i) a restricted area in excess of applicable limits in the certificate of registration; or (ii) an unrestricted area in excess of 10 times the applicable limit set forth in this section or in the registration, whether or not involving exposure of any individual in excess of the limits in subsection (o) of this section. (2) Each report required by paragraph (1) of this subsection shall describe the extent of exposure of individuals to radiation, including, as appropriate: (A) estimates of each individual's dose; (B) the levels of radiation involved; (C) the cause of the elevated exposures, dose rates; and (D) corrective steps taken or planned to ensure against a recurrence, including the schedule for achieving conformance with applicable limits, and associated registration conditions. (3) Each report filed in accordance with paragraph (1) of this subsection shall include for each individual exposed: the name, social security number, and date of birth. With respect to the limit for the embryo/fetus in subsection (m)(1)(D) of this section, 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. (4) All registrants who make reports in accordance with paragraph (1) of this subsection shall submit the report in writing to the agency. (jj) Notifications and reports to individuals. (1) Requirements for notification and reports to individuals of exposure to radiation are specified in §289.203 of this title (relating to Notices, Instructions and Reports to Workers; Inspections). (2) When a registrant is required in accordance with subsection (ii) of this section to report to the agency any exposure of an identified occupationally exposed individual, or an identified member of the public, to radiation, the registrant shall also notify the individual and provide a copy of the report submitted to the agency, to the individual. Such notice shall be transmitted at a time not later than the transmittal to the agency, and shall comply with the provisions of §289.203 of this title. (kk) Inspections. (1) The agency may enter public or private property at reasonable times to determine whether, in a matter under the agency's jurisdiction, there is compliance with the Act, the agency's rules, certificate of registration conditions, and orders issued by the agency. (2) Each registrant shall afford the agency, at all reasonable times, opportunity to inspect sources of radiation and the premises and facilities wherein such sources of radiation are used or stored. (3) Each registrant shall make available to the agency for inspection, upon reasonable notice, records made and maintained in accordance with this chapter. (4) Inspection of radiation machines and services. (A) Routine inspections by agency personnel will be made no more frequently than the intervals specified in subsection (ll)(2) of this section. Registrants having certificates of registration authorizing multiple uses will be inspected at the most frequent interval specified for the uses authorized. (B) Notwithstanding the inspection intervals specified in this section, the agency may inspect registrants more frequently due to: (i) the persistence or severity of violations found during an inspection; (ii) investigation of an incident or complaint concerning the facility; (iii) a request for an inspection by a worker(s) in accordance with §289.203 of this title; (iv) any change in a facility or equipment that might cause a significant increase in radiation output or hazard; or (v) a mutual agreement between the agency and registrant. (C) On-site routine inspections and remote inspections may be alternated as determined by the agency. (D) For remote inspection of radiation machines, each registrant shall respond to a request from the agency for a remote inspection by performing the following: (i) completing the remote inspection forms in accordance with the instructions included with the forms; and Cont'd... |
