Section 641.45.2. Radiation safety requirements for the use of radiation machines in industrial radiography.

         45.2(1) Locking of sources of radiation. The control panel of each radiation machine shall be equipped with a locking device that will prevent the unauthorized use of an X-ray system or the accidental production of radiation. The radiation machine shall be kept locked and the key removed at all times except when under the direct visual surveillance of a radiographer.

         45.2(2) Permanent storage precautions. Radiation machines shall be secured while in storage to prevent tampering or removal by unauthorized individuals.

         45.2(3) Requirements for radiation machines used in industrial radiographic operations.

            a.               Equipment used in industrial radiographic operations involving radiation machines manufactured after January 1, 1992, shall be certified at the time of manufacture to meet the criteria set forth by ANSI N537-1976.

            b.               The registrant’s name and city or town where the main business office is located shall be prominently displayed with a durable, clearly visible label(s) on all vehicles used to transport radiation machines for temporary job site use.

         45.2(4) Operating and emergency procedures.

            a.               The registrant’s operating and emergency procedures shall include instructions in at least the following:

             (1)             Operation and safety instruction on the radiation machine(s) to be used;

             (2)             Methods and occasions for conducting radiation surveys;

             (3)             Methods for controlling access to radiographic areas;

             (4)             Methods and occasions for locking and securing sources of radiation;

             (5)             Personnel monitoring and the use of personnel monitoring equipment, including steps that must be taken immediately by radiography personnel in the event a pocket dosimeter is found to be off-scale;

             (6)             Minimizing exposure of individuals in the event of an accident;

             (7)             The procedure for notifying proper personnel in the event of an accident;

             (8)             Maintenance of records; and

             (9)             Inspection and maintenance of radiation machines.

            b.               Each registrant shall provide, as a minimum, two radiographic personnel when radiation machines are used for any industrial radiography conducted other than at a permanent radiographic installation (shielded room, bay, or bunker). If one of the personnel is a radiographer’s assistant, the other shall be a radiographer trainer authorized by the certificate of registration.

            c.               No individual other than a radiographer or a radiographer’s assistant who is under the direct supervision of a radiographer trainer shall manipulate controls or operate equipment used in industrial radiographic operations.

            d.               Rescinded IAB 4/8/98, effective 7/1/98.

         45.2(5) Radiation surveys and survey records.

            a.               No radiographic operation shall be conducted unless calibrated and operable radiation survey instrumentation, as described in 45.1(5), is available and used at each site where radiographic exposures are made.

            b.               A physical radiation survey shall be made after each radiographic exposure using radiation machines to determine that the machine is “off.”

            c.               All potential radiation areas where industrial radiographic operations are to be performed shall be posted in accordance with 45.1(15), based on calculated dose rates, before industrial radiographic operations begin. An area survey shall be performed during the first radiographic exposure to confirm that 45.1(15) requirements have been met and that unrestricted areas do not have radiation levels in excess of the limits specified in 641—subrule 40.26(1).

            d.               Records shall be kept of the surveys required by 45.2(5)“b” and “c.” Such records shall be maintained for inspection by the agency for two years after completion of the survey. If the survey was used to determine an individual’s exposure, however, the records of the survey shall be maintained until the agency authorizes their disposition.

         45.2(6) Special requirements and exemptions for enclosed radiography.

            a.               Systems for enclosed radiography, including shielded-room radiography and cabinet radiography, designed to allow admittance of individuals shall:

             (1)             Comply with all applicable requirements of this chapter and 641—subrule 40.26(1). If such a system is a certified cabinet X-ray system, it shall comply with all applicable requirements of this chapter and 21 CFR 1020.40.

             (2)             Be evaluated at intervals not to exceed one year to ensure compliance with the applicable requirements as specified in 641—subrule 40.26(1). Records of these evaluations shall be maintained for inspection by the agency for a period of three years after the evaluation.

            b.               Certified and certifiable cabinet X-ray systems are exempt from the requirements of this chapter except that:

             (1)             Operating personnel must be provided with individual monitoring devices in accordance with the appropriate provisions of 641—40.37(136C).

             (2)             No registrant shall permit any individual to operate a cabinet X-ray system until such individual has received a copy of and instruction in the operating procedures for the unit and has demonstrated competence in its use. Records which demonstrate compliance with this subparagraph shall be maintained for inspection by the agency until disposition is authorized by the agency.

             (3)             Tests for proper operation of interlocks used to control entry to the high radiation area or alarm systems, where applicable, shall be conducted and recorded every three months. Records of these tests shall be maintained for agency inspection until disposal is authorized by the agency.

             (4)             The registrant shall perform an evaluation, at intervals not to exceed one year, to determine conformance with 641—subrule 40.26(1). If such a system is a certified cabinet X-ray system, it shall be evaluated at intervals not to exceed one year to determine conformance with 21 CFR 1020.40. Records of these evaluations shall be maintained for inspection by the agency for a period of two years after the evaluation.

            c.               Certified cabinet X-ray systems shall be maintained in compliance with 21 CFR 1020.40 unless prior approval has been granted by the agency pursuant to 641—38.3(136C).

         45.2(7) Registration for industrial radiographic operations.

            a.               Radiation machines used in industrial radiographic operations shall be registered in accordance with 641—Chapter 39.

            b.               In addition to the registration requirements in 641—Chapter 39, an application for a certificate of registration shall include the following information:

             (1)             A schedule or description of the program for training radiographic personnel which specifies:

            1.      Initial training,

            2.      Periodic training,

            3.      On-the-job training, and

            4.      Methods to be used by the registrant to determine the knowledge, understanding, and ability of radiographic personnel to comply with agency rules, registration requirements, and the operating and emergency procedures of the applicant.

             (2)             Written operating and emergency procedures, including all items listed in Appendix D.

             (3)             A description of the internal inspection system or other management control to ensure that radiographic personnel follow registration provisions, rules of the agency, and the applicant’s operating and emergency procedures.

             (4)             A list of permanent radiographic installations and descriptions of permanent storage and use locations.

             (5)             A description of the organization of the industrial radiographic program, including delegations of authority and responsibility for operation of the radiation safety program.

            c.               A certificate of registration will be issued if the requirements of 641—Chapter 39 and this subrule are met.