Safety Code 34. Radiation Protection and Safety for Industrial X-Ray Equipment

2. Management of Radiation Protection and Safety: Relevant Parties and Responsibilities

Mitigation of radiation risks associated with the use of industrial x-ray equipment requires the collective action of various stakeholders: the regulatory authority, the equipment manufacturers, equipment owners, equipment operators, equipment servicing personnel, organizations carrying out industrial radiography, clients responsible for hiring such organizations, and the public. The stakeholders' responsibilities and functions are indicated below.

2.1 Regulatory Authority

The primary functions of the regulatory authority (Health Canada) are: to develop standards and provide guidance; to verify, ensure and enforce compliance with the standards and safety requirements; and to conduct evaluations of industrial x-ray equipment and of organizations carrying out radiography. In accord with its health protection mandate, the regulatory authority has the powers to enforce compliance with this Safety Code, to make or authorize measurements that would facilitate evaluation for compliance with the requirements of this Safety Code or to require an operating organization or facility to modify or correct any procedure, practice, system or component to ensure safety. It can issue directives prohibiting use of industrial x-ray equipment, depending on the hazards and risks presented by deviations of procedures or by safety violations, and can annul the confirmation of registration.

2.2 Industrial X- ray Equipment Owner

Only products that are compliant with the RED Act ⁽⁹⁾ shall be procured. The owner of industrial x-ray equipment is ultimately responsible for the radiation safety of that equipment, and for ensuring that it is used in accordance with all legislation and regulations, including conformance with other safety standards (e.g., electrical, explosive) that might be applicable for the safe use of the equipment in the intended workplace. This responsibility requires a strong commitment to safety by the owner of the industrial x-ray equipment, demonstrated by the establishment and use of a radiation safety program.

The owner shall appoint a Radiation Safety Officer (RSO) to oversee and implement the radiation safety program at each facility in which industrial radiography is carried out, and shall provide adequate financial and physical resources for the incumbent duties and actions. A facility-designated RSO, by appointment to the position, is empowered to undertake necessary supervision of radiation protection activities, stop unsafe practices, implement safety directives and enforce prohibitions issued by the regulatory authority pursuant to this Safety Code. An RSO shall be a certified industrial radiographer at the NDT Level 1, or higher, as described in Section 2.2.1.12. of this Safety Code.

The owner of industrial x-ray equipment that is to be operated in a facility under federal jurisdiction shall ensure that the equipment is duly registered as described in Section 3.2 of this Safety Code and that there is a valid confirmation of registration before the equipment is used. A federal facility that operates industrial x-ray equipment without a valid confirmation of registration is in contravention of legislation ⁽⁵⁾ .

2.2.1 Radiation Safety Officer

Prior to procurement of industrial x-ray equipment, the RSO must receive written confirmation from the equipment manufacturer or its authorized marketing agent that the product complies with the RED Act (refer to Section 4.1 of this Safety Code). The onus is on the equipment manufacturer to show proof of or demonstrate regulatory compliance. Only products that are compliant with the RED Act shall be procured. The RSO must ensure that (i) the industrial x-ray equipment and the facility(ies) in which it will be in use meet all applicable radiation safety and regulatory requirements in this Safety Code, including conformance with other applicable standards (e.g., electrical, explosive); and (ii) industrial radiography is performed in accordance with safety procedures consistent with those of the practice. In a case for which noncompliance is identified after the equipment has left the manufacturer's premises, guidance to ensure regulatory compliance of the equipment is given in Section 2.4 of this Safety Code.

The specific and incumbent actions required of an RSO are:

1. To register all industrial x-ray equipment with the regulatory authority and obtain a valid confirmation of registration which must be posted conspicuously at that facility. For equipment installed inside a permanent installation or stored in a designated key-locked room, the wall beside the main access door to the inside of such a structure would suffice for posting the confirmation of registration. Where a facility has portable industrial x-ray equipment for use off site, the industrial radiographer tasked with operating the equipment at the off-site location shall have appropriate documentation attesting that the equipment is duly registered. Non-registered equipment shall not be used.
2. To prepare or review all safety, ALARA and radiation accident or overexposure response procedures and submit them to the regulatory authority for review.
3. To ensure that all protective and safety equipment and materials required in the safety, ALARA, and radiation accident or overexposure response procedures are available.
4. To ensure that a program of regular maintenance is in place for all industrial x-ray equipment used at the facility.
5. To provide written notification to the regulatory authority of industrial x-ray equipment that does not comply with the requirements of Section 3.1 of this Safety Code in the event that noncompliance was identified after the equipment has been installed or in use, and clearly detail the item(s) of noncompliance.
6. To ensure that the proposed design plans for a new permanent installation or for modifications of an existing permanent installation are reviewed by the regulatory authority, before any construction or modification begins.
7. To consult and liaise with the appropriate personnel responsible for the construction of new permanent installations or of modifications to existing installations in order to ensure compliance with regulatory requirements and incorporation of recommendations of the regulatory authority.
8. To arrange for on-site evaluations associated with the pre-commissioning tests of permanent installations.
9. To identify the controlled and supervised areas at the facility.
10. To acquire a calibrated and operable survey meter at each facility where industrial x-ray equipment is in use. Such meters shall be calibrated by a national calibration ionizing radiation laboratory (e.g., National Research Council, Ottawa, Canada; NIST, USA) or, a laboratory that has been accredited by a national laboratory to perform such calibrations. Calibrations shall be done at several photon energies to cover the range of photon energies, generated by the x-ray equipment that will be in use. Calibration frequency is once a year or after the meter has bee n serviced or repaired. Records of the results of survey meter calibrations shall be kept at the facility. Each facility shall have a back up radiation protection survey meter that is also calibrated and functional as indicated in this subsection.
11. To undertake reviews and modifications, as necessary, of operational procedures relevant to protection and safety to ensure radiation exposure to industrial radiographers is ALARA and public dose limits (in Appendix II, Tables 1 and 2 of this Safety Code) are not exceeded.
12. To ensure that any person operating industrial x-ray equipment for industrial radiography purposes is an industrial radiographer, with certification at the NDT Level 1, or higher, in accordance with the requirements of the Canadian General Standards Board ⁽¹⁰⁾ . Persons operating industrial x-ray equipment specifically for police and security radiography must be certified at Level I or higher in accordance with the Canadian General Standards Board requirements ⁽¹¹⁾ .
13. To ensure that individuals operating electron beam welders and other users receive radiation safety education as outlined in Section 4.3 of this Safety Code.
14. To ensure that both industrial radiographers and other users have received practical training on the proper use of the specific x-ray equipment and of the survey meter(s) present at the facility, and have received instruction on the operational, ALARA,and safety procedures applicable to the facility.
15. To conduct quarterly reviews of the industrial radiographer's signed and dated log reflecting periodic safety checks done on the industrial x-ray equipment and its safety-related components, and on the safety accessories comprising the permanent installation as described in Section 3.3.1. of this Safety Code.
16. To make decisions on reassignment of duties for declared or confirmed pregnant industrial radiographers to ensure that the pregnancy dose limit is not exceeded for the duration of the pregnancy, and on the need for special restrictions to limit exposure of female employees in the work area. (Consultation with the regulatory authority is suggested.)
17. To arrange for training, where applicable, and briefing of industrial radiographers, other users and allied personnel on radiation safety issues or procedures, and maintain appropriate record keeping of training material and a roster of trained personnel.
18. To supervise safety procedures for industrial radiography at temporary job sites or delegate such tasks to a safety officer or an equivalent alternative as described in Section 3.3.2.3. of this Safety Code.
19. To ensure that individuals training for industrial radiographer certification are supervised by an appropriately certified industrial radiographer, and are subject to all protection, safety and dose monitoring procedures commensurate with those applicable to an industrial radiographer.
20. To develop and maintain a system of personnel monitoring that includes periodic reviews of personnel monitoring data, investigation of inconsistencies, implementation of remedial actions in a timely manner, and retention of all such documents and records.
21. To ensure that there are available sufficient passive dosimeters for the industrial radiographers, other users and allied personnel as applicable, and that passive personnel dosimeters assigned to an individual are not shared by others.
22. To acquire personnel dosimetry records from industrial radiographers who are engaged in service contractual agreements with multiple employers, then assess and ensure that their annual permissible occupational dose limit has not been exceeded, prior to undertaking the industrial radiography work at hand.
23. To investigate radiation accidents or abnormal exposures or suspected exposures to personnel and file an appropriate report with the regulatory authority within 5 calendar days of the incident.
24. To ensure that individuals accidentally exposed to ionizing radiation receive proper medical attention.
25. To ensure that service personnel are qualified and authorized by the industrial x-ray equipment manufacturer to service the equipment, and have read and understood all radiation safety procedures applicable to the facility, before they can proceed with the impending servicing tasks.
26. To ensure that persons proximal to industrial radiography work sites are briefed on the radiography work being done, the potential hazards and radiations risks, the applicable regulations, the safety procedures that will be followed, the duration of the work, and are provided with contact information on the RSO to whom ionizing radiation-related issues or concerns may be directed. (This action is perceived as promoting a positive safety culture in the workplace.)
27. To initiate revisions of safety procedures and ensure that the facility is in compliance with the requirements of this Safety Code for as long as the facility uses, owns or stores industrial x-ray equipment.
28. To ensure that the industrial x-ray equipment is returned to the manufacturer for disposal or, if the manufacturer is no longer in business, is delivered to a company specifically contracted by the equipment owner to undertake the actions indicated in Section 4.8 of this Safety Code in order to ensure safe disposal.

2.3 Certified Industrial Radiographer

A certified industrial radiographer is an individual meeting the requirements as described in Section 2.2.1.12. of this Safety Code. The individual has a responsibility to carry out the radiography work in accordance with instructions and defined operating and safety procedures to ensure his or her protection and that of others. It is therefore imperative that there be strict adherence of the safety instructions, procedures and precautions provided in the operating manual of the specific industrial x-ray equipment to be used. The individual shall adopt an overall safety philosophy when doing industrial radiography and, in this context, exercise vigilance with respect to the interlocks, alarms, warning indicators and signs. A certified industrial radiographer shall:

1. carry on his or her person appropriate proof of identification and certification as an industrial radiographer whenever radiography is being conducted;
2. provide the facility RSO with appropriate evidence affirming identification, certification and training;
3. provide the facility RSO with a record of any radiation exposure history, especially if the industrial radiographer has been or is engaged in service contractual agreements with multiple employers at any time;
4. ensure that his or her annual permissible occupational equivalent dose limit (20 mSv, refer to Appendix II, Table 1 of this Safety Code) has not been exceeded, prior to undertaking industrial radiography at a facility;
5. receive safety instructions and training specific to the industrial x-ray equipment and survey meter(s) to be used at the permanent installation or temporary job site, and confirm with the facility RSO that this action has been taken;
6. keep radiation exposure to himself or herself and others ALARA, and use one of the facility's functional and calibrated survey meter to ensure radiation levels are within dose limits that would not present an undue risk to any person;
7. wear (i) a personnel radiation dosimeter (passive dosimeter) supplied by a dosimetry service provider ^{(12, 13)} which is approved by the Canadian Nuclear Safety Commission (CNSC) in accordance with CNSC regulations ⁽¹⁴⁾ , and (ii) an electronic alarm dosimeter (active dosimeter) which shall emit an audible signal when the equivalent dose rate reaches or exceeds 5 mSv/h or where the total equivalent dose reaches or exceeds 2 mSv;
8. not wear another individual's passive radiation dosimeter;
9. perform preliminary checks on all safety devices (interlocks, warning lights, timers, shields, survey meters, personnel alarm dosimeters, etc.) for proper functioning and resolve any inadequacies identified, before undertaking industrial radiography, and maintain an appropriately signed and dated log of such checks;
10. check the inside of a permanent installation or controlled area to confirm that no person is present before initiating the generation of x-radiation;
11. follow all protection and safety rules, including procedures established for the pending radiography work at the facility;
12. notify the facility RSO of any known or suspected abnormal radiation exposure to any person, and maintain a record of such notification;
13. supervise, as delegated by the owner of the industrial x-ray equipment in collaboration with the facility RSO, any individual in training for industrial radiographer certification;
14. exercise vigilance and check, at least once a month,: (i) the x-ray tube and cables for visible damage and wear, and (ii) the warning labels and signs on the control console and radiation source assembly, including the exposure factors on the control console for legibility;
15. not use any defective industrial x-ray equipment or survey meters or radiation dosimeters or shielding; and
16. where applicable, when industrial radiography work is to be carried out at a client's facility which is off site from the facility in which the industrial radiographer is registered, brief the client as described in Section 2.5 of this Safety Code.

Due consideration shall be given to female industrial radiographers of reproductive capacity. Female industrial radiographers, whether certified or in training, who are confirmed or declared pregnant shall discuss with the facility RSO their potential occupational doses and radiation hazards for the remainder of the pregnancy. (Should private or sensitive information about the radiographer's pregnancy be divulged in the discussion, such information shall be treated in a confidential manner.) Having been made knowledgeable of the potential occupational doses and radiation hazards associated with the work, should the pregnant industrial radiographer choose to continue radiography work, personnel monitoring shall be implemented on a monthly basis and the badge readings shall be promptly reviewed by the facility RSO to ensure that the pregnancy dose limit (in Appendix II, Table 1 of this Safety Code) is not exceeded. Records of these actions shall be properly documented and retained by the facility RSO. No pregnant industrial radiographer shall be re-assigned to other duties simply on the basis of information that the individual is pregnant.

2.4 Manufacturer of Industrial X- ray Equipment

Manufacturers of industrial x-ray equipment shall acknowledge that such equipment is federally regulated in Canada (refer to Section 3.1 of this Safety Code). It is the manufacturers' responsibility to ensure that their products comply with the RED Act ⁽⁹⁾ before they are imported, leased or sold in Canada. To facilitate demonstration of product compliance, manufacturers of industrial x-ray equipment or their marketing agents shall:

1. provide written notification to the regulatory authority, Health Canada, of the particular product intended for commerce in Canada;
2. include with that written notification: a copy of the promotional literature, technical specifications, including installation, operational, safety, maintenance and disposal instructions in respect of that particular product, if these materials have not been previously submitted to the regulatory authority; and
3. provide supportive evidence that the particular product conforms with the requirements as specified in Section 3.1 of this Safety Code.

The regulatory authority may evaluate the product and provide a response to the manufacturer accordingly. (Evaluation and responses may take place 4-6 weeks following receipt of all required documentation and supportive evidence from the manufacturer.) The importation, lease or sale of industrial x-ray equipment that does not conform with the REDAct is unlawful. Any violation of the REDAct is a criminal offence.

In a case for which noncompliance is revealed after procurement or installation of the industrial x-ray equipment, the equipment manufacturer and the importer, upon written or verbal notification of the noncompliance by the regulatory authority or by the equipment owner, shall take the necessary actions to bring the equipment into compliance within 30 days from the date of noncompliance notifica tion. In such situations, the equipment owner is further advised to cease using the equipment until the noncompliance issues are resolved to the satisfaction of the regulatory authority. The manufacturer is solely responsible for providing training on the servicing, safety and radiation protection specific to the industrial x-ray equipment, and for issuing appropriately written authorizations to individuals so trained to carry out servicing.

2.4.1 Service Personnel

Personnel responsible for servicing industrial x-ray equipment in a facility or other workplace shall:

1. provide proof to the facility RSO or workplace manager, as applicable, that they have received service training specific to the industrial x-ray equipment that is to be serviced;
2. provide written evidence to the facility RSO or workplace manager, as applicable, that they are authorized by the industrial x-ray equipment manufacturer to service the industrial x-ray equipment;
3. follow all safety rules, including ALARA and accident response procedures established at the facility;
4. wear personnel monitoring devices as specified in Section 2.3.7. of this Safety Code;
5. acknowledge that, for the application of this Safety Code, 'radiation worker' dose limits apply;
6. ensure that their annual permissible occupational dose limits of 20 mSv (Appendix II, Table 1 of this Safety Code) is not exceeded; and
7. specify any unsafe conditions that could arise during operation of the industrial x-ray equipment in a written, signed and dated report which shall be submitted to the facility RSO or workplace manager as applicable.

2.5 Clients Hiring Organizations or Individuals to Perform Industrial Radiography

Before any radiography services are undertaken at a client's facility, the client shall be briefed on the industrial radiography, the potential risks and hazards that are intrinsic to the work, the safety procedures that will be followed for the client's specific work required, applicable regulations, and proof of radiography personnel certification and training. This briefing shall be done by the certified industrial radiographer hired or authorized to perform the radiographic services at the client's premises, before any such services are carried out.

The client shall acknowledge that contractual conditions must not hinder the operating organization or individuals from performing the radiographic work safely, that is, regulatory and safety requirements take precedence in industrial radiography. The client must ensure that industrial radiography is conducted in a safe manner to minimize the risk of ionizing radiation exposure to the operators and others on site. The client shall, therefore, designate a safety officer to ensure that all safety procedures are being adhered to at the facility. Where different industrial radiography jobs on site are required, the issuance of work permits in conjunction with client supervision is necessary to reduce the likelihood of radiation accidents or abnormal exposures. Based on the foregoing, the client in conjunction with the radiography service provider shall prepare and retain a document (e.g., a checklist) which incorporates appropriate signatures and dates in order to demonstrate that the client was briefed on the safety issues relevant to the job, and is satisfied that appropriate safety actions were taken at the work site. Acopy of all documents so prepared shall be kept on file at the radiographer's facility and at the client's premises where the radiography was carried out.

2.6 Unauthorized Individuals in Industrial Radiography Areas

Unauthorized individuals, other workers and staff in an organization or facility, and members of the general public, who might be in areas where industrial radiography is being carried out must adhere to all safety warnings, instructions and notices posted in such areas, and apply "common sense thinking and action" for their own protection and safety. An individual who violates this 'standard of care' and incurs harm is deemed to have acted voluntarily in a negligent manner.