[28 Pa.B. 881]
[Continued from previous Web Page] § 224.458. Training for use of brachytherapy sources.
Except as provided in § 224.463 (relating to training for experienced authorized users), the licensee shall require the authorized user of a brachytherapy source listed in § 224.301 (relating to use of sources for brachytherapy) to be a physician who meets one of the following requirements:
(1) Is certified in one of the following:
(i) Radiology or therapeutic radiology or radiation oncology by the American Board of Radiology.
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§ 224.460. Training for use of sealed sources for diagnosis.
Except as provided in § 224.463 (relating to training for experienced authorized users), the licensee shall require the authorized user of a sealed source in a device listed in § 224.351 (relating to use of sealed sources for diagnosis) to be a physician, dentist or podiatrist who meets one of the following requirements:
(1) Is certified in one of the following:
(i) Radiology, diagnostic radiology or therapeutic radiology or radiation oncology by the American Board of Radiology.
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(iv) Nuclear Medicine by the Royal College of Physicians and Surgeons of Canada.
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§ 224.461. Training for teletherapy.
Except as provided in § 224.463 (relating to training for experienced authorized users), the licensee shall require the authorized user of a sealed source listed in § 224.401 (relating to use of a sealed source in a teletherapy unit) in a teletherapy unit to be a physician who meets one of the following requirements:
(1) Is certified in one of the following:
(i) Radiology or therapeutic radiology or radiation oncology by the American Board of Radiology.
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§ 224.462. Training for teletherapy physicist.
The licensee shall require the teletherapy physicist to be an individual who meets one of the following requirements:
* * * * *
(3) Is certified by the American Board of Medical Physics in radiation oncology.
§ 224.465. Recentness of training.
The training and experience specified in this chapter shall have been obtained within the [5] 7 years preceding the date of application or the individual shall have had related continuing education and experience since the required training and experience was completed.
§ 224.466. Training for an authorized nuclear pharmacist.
(a) The licensee shall require the authorized nuclear pharmacist to be a pharmacist who meets one of the following requirements:
(1) Has current board certification as a nuclear pharmacist by the Board of Pharmaceutical Specialties.
(2) Has completed 700 hours in structured educational program consisting of both of the following:
(i) Didactic training in the following areas:
(A) Radiation physics and instrumentation.
(B) Radiation protection.
(C) Mathematics pertaining to the use and measurement of radioactivity.
(D) Chemistry of byproduct material for medical use.
(E) Radiation biology.
(ii) Supervised experience in a nuclear pharmacy involving the following:
(A) Shipping, receiving and performing related surveys.
(B) Using and performing checks for proper operation of dose calibrators, survey meters, and, if appropriate, instruments used to measure alpha- or beta-emitting radionuclides.
(C) Calculating, assaying and safely preparing dosages for patients or human research subjects.
(D) Using administrative controls to avoid mistakes in the administration of byproduct material.
(E) Using procedures to prevent or minimize contamination and using proper decontamination procedures.
(b) A pharmacist meeting the requirements of subsection (a)(2) shall obtain written certification, signed by a preceptor authorized nuclear pharmacist, that the above training has been satisfactorily completed and that the pharmacist has achieved a level of competency sufficient to independently operate a nuclear pharmacy.
§ 224.467. Training for experienced nuclear pharmacists.
A licensee may apply for and must receive a license amendment identifying an experienced nuclear pharmacist as an authorized nuclear pharmacist before it allows this individual to work as an authorized nuclear pharmacist. A pharmacist who has completed a structured educational program as specified in § 224.466(a)(2) (relating to training for an authorized nuclear pharmacist) before ______(Editor's Note: The blank refers to the effective date of adoption of this proposal), and who is working in a nuclear pharmacy would qualify as an experienced nuclear pharmacist. An experienced nuclear pharmacist need not comply with §§ 224.465 and 224.466(b) (relating to recentness of training) to qualify as an authorized nuclear pharmacist.
[Subchapter K. ENFORCEMENT] (RESERVED) § 224.501. [Resolution of conflicting requirements during transition period] (Reserved).
[If this chapter conflicts with the licensee's radiation safety program as identified in its license, and if that license was approved by the Department before June 20, 1992 and has not been renewed since June 20, 1992, the requirements in the license apply. However, if that licensee exercises its privilege to make minor changes in its radiation safety procedures that are not potentially important to safety under § 224.58 (relating to radiation safety program changes), the portion changed shall comply with this chapter. At the time of license renewal and thereafter, this chapter applies.]
CHAPTER 225. RADIATION SAFETY REQUIREMENTS FOR INDUSTRIAL USES AND RADIOGRAPHIC OPERATIONS
GENERAL PROVISIONS § 225.1. Purpose and scope.
(a) This chapter establishes radiation safety requirements for persons utilizing radiation sources for industrial [radiography] uses and radiographic operations. Licensees and registrants who use radiation sources for industrial [radiography] uses and radiographic operations shall comply with this chapter. The requirements of this chapter are in addition to and not a substitution for other applicable requirements of this article. This chapter does not apply to medical diagnosis or therapy.
(b) Persons who use particle accelerators to perform radiographic operations shall also comply with Chapter 228 (relating to particle accelerators).
§ 225.2. Definitions.
The following words and terms, when used in this chapter, have the following meanings, unless the context clearly indicates otherwise:
Annual refresher safety training--A review conducted or provided by the licensee or registrant for its employes on radiation safety aspects of industrial radiography. The review may include, as appropriate, the results of internal inspections, new procedures or equipment, new or revised regulations, accidents or errors that have been observed, and should also provide opportunities for employes to ask safety questions.
Associated equipment--Equipment used in conjunction with a radiographic exposure device to make radiographic exposures when the equipment drives, guides or comes into contact with the source.
Cabinet X-ray system--An X-ray system with the X-ray tube installed in an enclosed, interlocked cabinet, designed to exclude personnel from its interior during operation. The term includes X-ray ststems designed primarily for the inspection of baggage or packages. The term does not include an X-ray tube used within a shielded part of a building or X-ray equipment which may temporarily or occasionally incorporate portable shielding.
* * * * *
Certifying entity--An independent certifying organization meeting the requirements of § 225.102 (relating to requirements for an independent certifying organization) or an agreement state which meets the same requirements as § 225.102.
Collimator--A radiation shield made of lead, tungsten or other heavy metal which is placed on the end of a guide tube or directly onto a radiographic exposure device to restrict the size and shape of the radiation beam when the sealed source is moved into position to make a radiographic exposure.
Control cable--The cable which is connected to the source assembly and used to drive the source to and from the exposure location. The term may be also referred to as the drive cable.
Control drive mechanism--The device that enables the source assembly to be moved to and from the exposure device.
Crank-out device--The cable, protective sheath and handcrank used to move the sealed source from the shielded to the unshielded position to make an industrial radiographic exposure.
Exposure head--A device that locates the gamma radiography sealed source in the selected working position. An exposure head is also known as a source stop.
Guide tube (projection sheath)--A flexible or rigid tube (that is, ''J''-tube) for guiding the source assembly and the attached control cable from the exposure device to the exposure head. The guide tube may also include the connections necessary for attachment to the exposure device and to the exposure head.
Individual's certification--Written approval received from a certifying entity stating that an individual has satisfactorily met certain established radiation safety, testing and experience criteria.
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Lock-out survey--A radiation survey performed to determine that a sealed source is in its shielded position.
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Personal supervision--The provision of guidance and instruction to a radiographer's assistant by a radiographer who is:
(i) Physically present at the site.
(ii) In visual contact with the radiographer's assistant while the assistant is using radiation sources.
(iii) In proximity so that immediate assistance can be given if required.
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Radiographer--An individual who performs, or [provides personal supervision of,] who, while in attendance at the site where the radiation source is being used, personally supervises industrial radiographic operations and who is responsible to the licensee or registrant for assuring compliance with this part and the conditions of the license or registration.
Radiographer's assistant--An individual who, under the personal supervision of a radiographer, uses radiographic exposure devices, radiation sources, related handling tools or radiation survey instruments in industrial radiography.
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Radiographic operations--All activities associated with the presence of radiation sources in a radiographic exposure device or in a radiation-producing machine during use of the device or machine or transport (except when being transported by common carrier or contract transport), to include surveys to confirm the adequacy of boundaries, setting up equipment and any activity inside restricted area boundaries.
S-tube--A tube through which the radioactive source travels when inside a radiographic exposure device.
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Source assembly--A component to which the sealed source is affixed or in which the sealed source is contained. The source assembly includes the sealed source.
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Storage facility--A location, area or vehicle which is used to store, transport or secure a radiographic exposure device, a storage container, or a sealed source when it is not in use, and which is locked or has a physical barrier to prevent accidental or inadvertent exposure, tampering with or unauthorized removal of the device, container or source.
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Temporary job site--A location where industrial radiography is performed for 180 days or less during any consecutive 12-months other than the location listed in a specific license or registration.
Transport container--A package that is designed and constructed to provide radiation safety and security when a sealed source is transported and which meets applicable provisions of Chapter 230 (relating to packaging and transportation of radioactive material).
§ 225.10. Application for a specific license or registration.
(a) A person who intends to use sealed sources in industrial uses or radiographic operations shall file an application in accordance with §§ 217.51 and 217.65 (relating to filing application for specific license; and specific licenses for the use of sealed sources in industrial radiography).
(b) A person who intends to use X-ray machines for industrial radiography shall have a program for training personnel, written operating and emergency procedures, an internal review system, and an organizational structure which includes specified delegations of authority and responsibility for operation of the program. This program shall be approved by the Department before commencing industrial radiography.
[SEALED SOURCE REQUIREMENTS] GENERAL PROVISIONS § 225.11. [Storage position radiation level limits.] Reciprocity.
[(a) Radiographic exposure devices that have the sealed source storage position located less than 4 inches (10 centimeters) from an exterior surface of the device shall have radiation levels not exceeding 50 milliroentgens (12.9 µC/kg) per hour at 6 inches (15 centimeters) from an exterior surface of the device when the sealed source is in the shielded-- off--position.
(b) Radiographic exposure devices that have the sealed source storage position located more than 4 inches (10 centimeters) from an exterior surface of the device, and storage containers for sealed sources or outer containers for radiography exposure devices, shall have radiation levels not exceeding 200 milliroentgens (51.6 µC/kg) per hour and not exceeding 10 milliroentgens (2.58 µC/kg) per hour at 1 meter from an exterior surface when the sealed source is in the shielded--off--position.]
Out-of-State users of sealed source radiographic exposure devices or X-ray machines shall meet the requirements of § 216.7 or 217.121 (relating to out-of-state radiation producing machines; and reciprocity of licenses of by-product, source, and special nuclear materials in quantities not sufficient to form a critical mass), as appropriate.
§ 225.12. [Radiation source locks] Prohibitions.
[(a) A radiation source shall be kept in a lockable radiographic exposure device or in a lockable source changer to prevent unauthorized removal of, or accidental exposure from, the radiation source. The radiographic exposure device, source changer and storage container shall be kept locked when containing a radiation source except when under the direct surveillance of a radiographer or radiographer's assistant, or as may be otherwise authorized under § 225.52 (relating to security).
(b) Radiographic exposure devices, source changers and storage containers, prior to being moved from one location to another and also prior to being secured at a given location shall be locked and surveyed to assure that the sealed source is in the shielded position.]
Human use of the radiation sources covered by this chapter is not permitted.
(Editor's Note: Sections 225.13--225.18, 225.21--225.23, 225.31--225.33 and 225.41--225.44 are proposed to be deleted. The current versions of these sections appear at pps. 225-6--225-17, Pennsylvania Code serial pps. (203960)--(203971)).
§§ 225.13--225.18. (Reserved).
[RADIATION-PRODUCING MACHINE REQUIREMENTS] §§ 225.21--225.23. (Reserved).
[RADIATION SURVEY INSTRUMENTS AND LOGS] §§ 225.31--225.23. (Reserved).
[OPERATOR'S PERSONAL SAFETY REQUIREMENTS] §§ 225.41--225.44. (Reserved).
[PRECAUTIONARY PROCEDURES] GENERAL ADMINISTRATIVE REQUIREMENTS § 225.51. [Permanent radiographic installation] Duties of personnel.
[Permanent radiographic installations having high radiation area entrance controls of the types described in §§ 219.91 and 219.154 (relating to control of access to high radiation areas; and posting of high radiation areas) shall also meet the following requirements.
(1) Each entrance that is used for personnel access to the high radiation area in a permanent radiographic installation shall have visible and audible warning signals to warn of the presence of radiation. The visible signal shall be activated by radiation whenever the source is exposed. The audible signal shall be actuated when an attempt is made to enter the installation while the source is exposed.
(2) The control device or alarm system shall be tested for proper operation at the beginning of each day of use.]
(a) The radiation safety officer (RSO) shall be an individual who shall ensure that radiation safety activities are being performed in accordance with approved procedures and requirements in the daily operation of the licensee's or registrant's program, and in compliance with Department requirements, and who has the authority to suspend or terminate operations which are not being conducted in accordance with license or registration conditions.
(b) The radiographer shall be an individual who performs or who is in attendance at a site where a source is being used, who personally supervises radiographic operations, and who is responsible to the licensee or registrant for ensuring compliance with this article and conditions of a license or registration.
(c) The radiographer's assistant shall be an individual who, under the personal supervision of a radiographer, uses radiographic exposure devices, sealed sources or X-ray machines, related handling tools or radiation survey instrumentation.
(d) The radiography trainee is an individual who is in the process of becoming a radiographer's assistant or a radiographer, in accordance with a licensee's or registrant's procedures. The trainee is not permitted to operate radiographic exposure devices, sealed sources or X-ray machines, or radiation survey instrumentation.
§ 225.71. Training of personnel.
A licensee or registrant may not allow an individual to act as a radiographer or assistant radiographer unless that individual meets the requirements of § 225.72 (relating to training and testing), appropriate license or registration requirements, and operating and emergency procedures.
§ 225.72. Training and testing.
(a) The licensee or registrant may not permit an individual to act as a radiographer until that individual:
(1) Has been instructed in the subjects outlined in Appendix A (relating to subjects to be covered during instruction of radiographs).
(2) Is certified through a radiographer's certification program by a certifying entity in accordance with the criteria specified in §§ 225.102 and 225.103 (relating to requirements for an independent certifying organization; and requirements for certification programs). An independent organization that would like to be recognized as a certifying entity shall submit its request to the Department. The licensee or registrant may allow an individual who has not met the certification requirements to act as a radiographer, so long as the individual has received the training required under this subchapter. This allowance expires _____(Editor's Note: The blank refers to a date 2 years after the effective date of adoption of this proposal).
(3) Has received copies of this chapter, Chapters 219, 220 and 230. A copy of the license or certificate of registration issued to the licensee or registrant and copies of the licensee's or registrant's operating and emergency procedures.
(4) Has been instructed in the use of the licensee's or registrant's sources of radiation, radiographic exposure devices, radiation-producing machines, related handling tools, radiation survey instruments, regulations, and operating and emergency procedures.
(5) Has demonstrated, to the satisfaction of the licensee or registrant, competency and understanding of the information as evidenced by having successfully completed a written test and a field examination.
(b) The licensee or registrant may not permit an individual to act as a radiographer's assistant until that individual:
(1) Has received copies of, and instruction in, the licensee's or registrant's operating and emergency procedures.
(2) Has been instructed in the use, and has demonstrated, to the satisfaction of the licensee or registrant, that when the individual is under the direct personal supervision of the radiographer, the individual is competent in the use of sources of radiation, radiographic exposure devices, related handling tools and radiation survey instruments that will be used.
(3) Has demonstrated, to the satisfaction of the licensee or registrant, an understanding of the information as evidenced by having successfully completed a written or oral test and a field examination on the subjects relevant to being an assistant radiographer.
(c) Records of the training required under subsections (a) and (b), including copies of written tests, dates of oral tests and field examinations, shall be maintained for inspection by the Department for 5 years following termination of employment by the individual or until the radioactive material license or certificate of registration is terminated.
§ 225.73. Audits and safety reviews of radiographers and radiographers' assistants.
(a) The licensee or registrant shall provide safety reviews for radiographers and radiographer's assistants at least once during each calendar year.
(b) The licensee or registrant shall conduct an annual inspection program for the job performance of each radiographer and radiographer's assistant to ensure that this title, license or certificate of registration requirements and the licensee's or registrant's operating and emergency procedures are followed. This audit program shall:
(1) Include observation of the performance of each radiographer and radiographer's assistant during an actual radiographic operation at intervals not to exceed 1-calendar year.
(2) Provide that, if a radiographer or radiographer's assistant has not participated in a radiographic operation for more than 6 months since the last inspection, the individual's performance shall be observed and recorded when the individual next participates in a radiographic operation.
(c) The licensee or registrant shall maintain records of the training required in subsections (a) and (b) to include certification documents, written and field examinations, annual safety reviews and annual audits of job performance. These records shall be maintained by the licensee or registrant for inspection by the Department for 5 years following termination of employment by the individual or until the radioactive material license or certificate of registration is terminated.
§ 225.74. Reporting requirements.
(a) In addition to the reporting requirements in Chapter 219 (relating to standards for protection against radiation), each licensee or registrant shall provide to the Department, within 30 days of its occurrence, a written report on the following incidents involving radiographic equipment used for industrial radiography:
(1) Unintentional disconnection of the source assembly from the control cable.
(2) Inability to retract or secure a sealed source to its fully shielded position.
(3) Failure of a component critical to the safe operation of a radiographic exposure device to perform its intended function properly.
(4) Inability to terminate irradiation with an X-ray machine.
(5) Failure of an interlock in shielded room radiography.
(b) The licensee or registrant shall include the following information in each report submitted under subsection (a):
(1) A description of the equipment problem.
(2) The cause of the incident, if known or determined.
(3) The manufacturer and model number of the equipment involved.
(4) The place, time and date of the incident.
(5) The action taken to reestablish normal operations.
(6) The corrective action taken or planned to prevent reoccurrence.
(7) The names and qualifications of personnel involved.
(c) Reports of overexposures, required under § 219.222 (relating to notification of incidents) or of excessive exposures, required under § 219.223 (relating to reports of exposures, radiation levels and concentrations of radioactive material exceeding the limits) which involve the failure of safety components of radiography equipment shall also include the information specified under subsection (b).
GENERAL TECHNICAL REQUIREMENTS § 225.101. Certification of personnel.
Radiographers and assistant radiographers shall meet the examination criteria in the license application and procedures defined in the license application.
§ 225.102. Requirements for an independent certifying organization.
An independent certifying organization shall meet the following conditions:
(1) Be an organization such as a society or association, whose members participate in, or have an interest in, the fields of industrial radiography or nondestructive testing.
(2) Make its membership available to the general public Nationwide that is not restricted because of race, color, religion, sex, age, national origin or disability.
(3) Have a certification program open to nonmembers.
(4) Be an incorporated, Nationally-recognized organization, that is involved in setting National standards of practice within its fields of expertise.
(5) Have an adequate, full-time staff, a viable system of financing its operations, and a policy- and decisionmaking review board.
(6) Have a set of written organizational bylaws and policies that provide adequate assurances of lack of conflict or interest and a system of monitoring and enforcing those bylaws and policies.
(7) Have a committee, whose members can carry out their responsibilities impartially, to review and improve the certification guidelines and procedures, and to advise the organization's staff in implementing the certification program.
(8) Have a committee, whose members can carry out their responsibilities impartially, to review complaints against certified individuals and to determine appropriate sanctions.
(9) Have written procedures describing all aspects of its certification program, maintain records of the current status of each individual's certification and the administration of its certification program.
(10) Have procedures to ensure that certified individuals are provided due process with respect to the administration of its certification program, including the process of becoming certified, and any sanctions imposed against certified individuals.
(11) Have procedures for proctoring examinations, including qualifications for proctors. These procedures shall ensure that the individuals proctoring each examination are not employed by the same company or corporation or a wholly-owned subsidiary of the company or corporation as any of the examinees.
(12) Exchange information about certified individuals with the Department, other independent certifying organizations, the NRC or agreement states.
(13) Allow periodic review of its certification program and its related records.
(14) Provide a description to the Department of its procedures for choosing examination sites and for providing an appropriate examination environment.
§ 225.103. Requirements for certification programs.
Certification programs shall meet the following conditions:
(1) Require that individuals meet the following:
(i) Receive training in the topics in Appendix A (relating to subjects to be covered during the instruction of radiographers).
(ii) Complete satisfactorily a written examination covering the topics in Appendix A.
(2) Require applicants for certification to provide documentation that demonstrates that the applicant has met the following:
(i) Received training in the topics in Appendix A.
(ii) Completed satisfactorily a minimum period of on-the-job training.
(iii) Received verification by an agreement state or NRC licensee that the applicant has demonstrated the capability of independently working as a radiographer.
(3) Include procedures to ensure that all examination questions are protected from disclosure.
(4) Include procedures for denying an application, revoking, suspending and reinstating a certificate.
(5) Provide a certification period of not less than 3 years nor more than 5 years.
(6) Include procedures for renewing the certifications and, if the procedures allow renewals without examination, require evidence of recent active, full-time employment and annual refresher training.
(7) Include procedures whereby an individual's certification may be revoked, suspended or restricted for willful or significant failure to comply with his employer's operating and emergency procedures, or the Department's, the NRC's or an agreement state's regulations.
(8) Provide for automatic suspension of an individual's certification, based on the Department's, NRC's or an agreement state's action prohibiting the individual from acting as a radiographer.
(9) Provide the sanctions imposed against the certified individuals that are at least as severe as any action taken by the Department, NRC or an agreement state.
(10) Provide a timely response to inquiries, by telephone, letter or electronic means, from members of the public, about an individual's certification status.
§ 225.104. Requirements for written examinations.
Examinations shall meet the following conditions:
(1) Be designed to test an individual's knowledge and understanding of the topics listed in Appendix A (relating to subjects to be covered during the instruction of radiographers) or equivalent NRC or agreement state requirements.
(2) Be written in a multiple-choice format.
(3) Have test items drawn from a question bank containing psychometrically valid questions based on the material in Appendix A.
§ 225.105. Permanent radiographic installation.
(a) Permanent radiographic installations having high radiation area entrance controls of the types described in §§ 219.91 and 219.154 (relating to control of access to high radiation areas; and posting of high radiation areas) shall also meet the following requirements:
(1) Each entrance that is used for personnel access to the high radiation area in a permanent radiographic installation shall have both visible and audible warning signals to warn of the presence of radiation. The visible signal shall be activated by radiation whenever the source is exposed or when the X-ray tube is energized. The audible signal shall be actuated when an attempt is made to enter the installation while the source is exposed or the X-ray tube is energized.
(2) The entrance control device or alarm system shall be tested for proper function prior to beginning operations on each day of use.
(3) The radiographic exposure system may not be used if an entrance control device or alarm system is not operating properly. If an entrance control device or alarm system is not functioning properly, it shall be removed from service and repaired or replaced immediately. If no replacement is available, the facility may continue to be used so long as the licensee or registrant implements the continuous surveillance of §§ 225.52 and 225.53 (relating to security; and posting) and, if the permanent radiographic installation uses sealed sources, § 225.261 (relating to radiographic operations, security and posting) and uses an alarming ratemeter. Before the entrance control device or alarm system is returned to service, the radiation safety officer or an individual designated by the radiation safety officer shall validate the repair.
(b) Records of the tests performed under subsection (a) shall be maintained for inspection by the Department for 5 years.
§ 225.106. Operating requirements.
(a) When radiography is performed at a location other than a permanent radiographic installation, a minimum of two radiographic personnel shall be present to operate the radiographic exposure device. At least one of the radiographic personnel shall be a certified radiographer. The other individual may be either a certified radiographer or a radiographer's assistant.
(b) Collimators shall be used in industrial radiographic systems that use crank-out devices except when physically impossible.
(c) Other than a radiographer, or a radiographer's assistant who is under the personal supervision of a radiographer, an individual may not manipulate the controls or operate the equipment used in industrial radiographic operations.
(d) At each job site, the following shall be supplied by the licensee or registrant:
(1) The appropriate barrier ropes and warning signs.
(2) At least one operable, calibrated radiation survey instrument.
(3) A current whole body individual monitoring device (''film badge'' or ''TLD'') for each worker.
(4) An operable, calibrated pocket ionization chamber (that is, ''pocket dosimeter'') with a range of zero to 51.6 µC/kg (200 milliroentgen) for each worker.
(5) An operable, calibrated alarm rate meter for each worker who performs industrial radiography with a sealed source.
(e) An industrial radiographic operation may not be performed if any of the items in subsection (d) are not available at the job site or is inoperable.
§ 225.107. Records required at temporary job sites.
Each licensee or registrant using a source of radiation at a temporary job site shall maintain and have available at that job site, for inspection by the Department, the following records or documents:
(1) The radioactive materials license, certificate of registration or equivalent document and personnel certifications.
(2) Operating and emergency procedures.
(3) Relevant regulations of the Department.
(4) Survey records required under this chapter for the period of operation at the site.
(5) Daily pocket ionization chamber records for the period of operation at the site.
(6) If sealed sources are used at the site, daily alarm rate meter records for the period of operation at the site.
(7) Both the latest radiation survey meter calibration records and sealed source leakage or contamination test records for specific devices in use at the site. Acceptable records include tags or labels that are affixed to the device or survey meter and decay charts showing leakage or contamination test results for the sources that have been manufactured within the last 6 months.
§ 225.108. Operating and emergency procedures.
The licensee's or registrant's operating and emergency procedures shall include instruction in at least the following:
(1) Handling and use of sources of radiation to be employed so that no individual is likely to be exposed to radiation in excess of the limits established in Chapter 219 (relating to standards for protection against radiation).
(2) Methods and occasions for conducting the radiation surveys.
(3) Methods for controlling access to areas where radiographic operations are being conducted.
(4) Methods and occasions for locking and securing sources of radiation.
(5) Personnel monitoring and the use of individual monitoring devices, including steps that are to be taken immediately by radiographic personnel if of an ionization chamber (that is, ''pocket dosimeter'') is found to be off-scale.
(6) Transportation to field locations, including packing of sources of radiation in the vehicle, placarding of the vehicle if necessary, and control of sources of radiation during transport.
(7) Methods and procedures for minimizing exposure of individuals in the event of an accident, including procedures to follow in the event of a disconnect accident, a transportation accident or the loss of a sealed source.
(8) The procedure for notifying proper personnel in the event of an accident or loss of a sealed source.
(9) Maintenance of records required by the Department.
(10) The inspection and maintenance of radiographic exposure devices, source changers, storage containers, transportation containers, source guide tubes, crank-out devices and radiation-producing machines.
RADIATION SURVEY INSTRUMENT AND PERSONNEL MONITORING REQUIREMENTS § 225.151. Radiation survey instruments.
(a) A licensee or registrant shall maintain sufficient calibrated and operable radiation survey instruments to make physical radiation surveys as required by this chapter and Chapter 219 (relating to standards for the protection against radiation).
(b) A radiographic operation may not be conducted unless calibrated and operable radiation survey instrumentation is available and used at each site where radiographic exposures and radiation-producing machines are used.
(c) Immediately prior to use, a radiation survey instrument shall be checked to ensure that it is operating properly by bringing it near a source of radiation and observing its response. Instruments that fail to respond may not be used.
§ 225.152. Radiation survey instrument calibration requirements.
(a) In addition to the requirements of § 225.151 (relating to radiation survey instruments), instruments required by this chapter shall be capable of measuring 0.516 µC/kg (2 mR) per hour through 258 µC/kg (1 R) per hour.
(b) Each radiation instrument shall be calibrated:
(1) At energies appropriate for use.
(2) At intervals not to exceed one of the following:
(i) For radioactive materials, 6 months.
(ii) For radiation-producing machines, 6 months.
(3) After each instrument servicing, other than battery replacement.
(4) So that accuracy within +20% can be demonstrated.
(5) For linear scale instruments, at two points located approximately one-third and two-thirds of full scale on each scale; for logarithmic scale instruments, at mid-range of each decade, and at two points of at least 1 decade; and for digital instruments, at three points between 0.516 µC/kg (2 mR) and 258 µC/kg (1 R) per hour.
(6) By a person authorized by the Department, the NRC or an agreement state.
(c) Records of calibration shall be maintained for 5 years after the calibration date for inspection by the Department.
§ 225.153. Personnel monitoring control.
(a) A licensee or registrant may not permit an individual to act as a radiographer or as a radiographer's assistant, unless, at all times during radiographic operations, each individual wears a combination of direct-reading pocket dosimeter, an operating alarm ratemeter and either a film badge or a thermoluminescent dosimeter (TLD). The individual shall wear the personnel monitors on the trunk of the body. Registrants are exempted from requiring the use of alarm rate meters. Each film badge or TLD shall be assigned to and worn by only one individual.
(b) Film badges shall be replaced at intervals not to exceed 1 month and thermoluminescent dosimeters (TLDs) shall be replaced at intervals not to exceed 3 months.
(c) The use of pocket dosimeters is subject to the following requirements:
(1) Pocket dosimeters shall have a range of 0 to 51.6 µC/kg (200 mR) and shall be recharged at least daily or at the start of each work shift. Electronic personal dosimeters may only be used in place of ion-chamber pocket dosimeters.
(2) Pocket dosimeters shall be read and exposures recorded at least at the beginning and end of each worker's shift involving the use of a source of radiation.
(3) Pocket dosimeters shall be checked for correct response to radiation at periods not to exceed 1 year, and acceptable dosimeters shall read within +30% of the true radiation exposure. Records of pocket dosimeter calibration shall be maintained for inspection by the Department for 5 years.
(4) If an individual's pocket dosimeter is discharged beyond its range (that is, ''off-scale''), industrial radiographic operations by that individual shall cease immediately and the individual's film badge or TLD shall be sent immediately for processing. The individual may not use sources of radiation until the individual's radiation dose has been determined.
(d) Reports received from film badge or TLD processors and workers with daily pocket dosimeter readings shall be kept for inspection by the Department until the radioactive materials license or certificate of registration is terminated or until the Department authorizes their disposition, in writing, following a determination by the Department that the records contain inaccurate personnel monitoring information.
§ 225.154. Personal alarm rate meters.
(a) In addition to other requirements of this subsection, each individual performing radiography with sealed sources shall wear and use an operable and functioning alarm rate meter. Each alarm rate meter shall:
(1) Be checked prior to use at the start of each shift to ensure that the alarm functions properly (sounds).
(2) Be set to give an alarm signal at a preset dose rate of 5 millisievert (500 millirem) per hour or less.
(3) Require special means to change the preset alarm function.
(4) Be checked for proper response to radiation at intervals not to exceed 1 year. The alarm rate shall alarm within +20% of the true radiation dose rate. Records of alarm rate meter calibration shall be maintained for inspection by the Department for 5 years.
(b) The alarm rate meter shall be used in addition to, and not as substitute for, the portable radiation survey instrument required by this chapter. The alarm rate meter is intended to provide additional assurance that the radiation exposure levels are within regulatory limits.
RADIATION PRODUCING MACHINE REQUIREMENTS § 225.201. Cabinet X-ray systems.
(a) It shall be impossible to energize a cabinet X-ray system unless all openings are securely closed and the openings meet the requirements of § 219.31 (relating to occupational dose limits for adults). Each access door to the cabinet shall have an interlock that terminates the exposure whenever the door is opened. The enclosure shall be shielded so that every location on the exterior meets the conditions for an unrestricted area.
(b) A registrant may not permit an individual to operate a cabinet X-ray system until the individual has received a copy of, and instruction in, the operating procedures for the system and has demonstrated an understanding of the operating procedures and competency in the use of the cabinet X-ray system.
(c) The registrant shall evaluate the cabinet X-ray system to assure compliance with § 219.31 (relating to occupational dose limits for adults) and with 21 CFR 1020.40 (relating to cabinet X-ray systems) if the system is a certified cabinet X-ray system. The records of these evaluations shall be maintained for inspection by the Department for 5 years after evaluation.
(d) The registrant shall test the on-off switch, the unit interlocks and safety devices at intervals not exceeding 1 year, and make repairs as necessary. Records of these tests shall be maintained for inspection by the Department for 5 years.
(e) Cabinet X-ray systems are exempt from all other provisions of this chapter.
§ 225.202. Shielded room X-ray machine radiography.
(a) A room used for shielded room radiography shall be shielded so that every location on the exterior meets conditions for an unrestricted area and the only access to the room is through openings which are interlocked so that the radiation source will not operate unless all openings are securely closed and meet the requirements of § 219.91 (relating to control of access to high radiation areas).
(b) A registrant may not permit an individual to operate a radiation-producing machine for shielded room radiography until the individual has received a copy of, and instruction in, the operating procedures for the unit and has demonstrated an understanding of the operating procedures and competency in the use of the unit.
(c) The registrant shall provide personnel monitoring equipment to every individual who operates, positions material for irradiation or performs maintenance on a radiation-producing machine for shielded room radiography.
(d) The operator shall conduct a physical radiation survey to determine that the radiation machine X-ray tube is de-energized prior to each entry into the radiographic exposure area.
(e) Shielded room radiography using radiation-producing machines shall be exempt from §§ 225.251--225.262 (relating to sealed source requirements).
§ 225.203. Field site radiography.
(a) The operator shall conduct a physical radiation survey to determine that the radiation machine X-ray tube is de-energized prior to each entry into the radiographic exposure area. Survey results and records of the boundary location shall be maintained and kept available for inspection by the Department for 5 years.
(b) Mobile or portable radiation-producing machines shall be physically secured to prevent tampering or removal by unauthorized personnel.
(c) Other radiography using radiation-producing machines shall be exempt from §§ 225.251--225.262 (relating to sealed source requirements).
§ 225.204. Surveys and survey records.
(a) A survey with a calibrated radiation survey instrument shall be made after each radiographic exposure to determine that the radiation-producing machine X-ray tube is de-energized.
(b) Records of the surveys required by subsection (a) shall be maintained for inspection by the Department for 5 years. If the survey has been used to determine an individual's exposure, the records of the survey shall be maintained until the Department authorizes their disposition.
§ 225.205. Utilization logs.
A registrant shall maintain current logs, which shall be kept available for inspection by the Department for 5 years from the date of the event, showing for each radiation-producing machine, the following applicable information:
(1) The identity (name and signature) of the operator to whom the radiation-producing machine is assigned.
(2) The model and serial number of the radiation-producing machine.
(3) The location and date of use.
(4) The technique factors (tube kilovoltage, tube current, exposure time) used for each radiographic exposure.
§ 225.206. Bomb detection or baggage/package X-Ray systems.
(a) This section applies to X-ray systems that produce an image which may be used to screen packages for the presence of explosive devices or components, weapons, or other contraband or prohibited items. This section does not apply to cabinet X-ray systems designed and used primarily for the inspection of baggage or packages at airports. X-ray systems used for bomb detection or baggage/package screening are exempt from §§ 225.251--225.262 (relating to sealed source requirements).
(b) An X-ray system used for explosives or weapons detection may not be used on human beings or animals. X-ray systems whose purpose is the irradiation of human beings for medical diagnosis are covered under Chapter 221 (relating to X-rays in the healing arts). X-ray systems that irradiate animals for diagnosis or therapy are covered under Chapter 223 (relating to veterinary medicine).
(c) Training shall be as follows:
(1) A registrant shall provide training and safety rules to each individual who operates the radiation-producing machines or equipment under his control, including restrictions of the operating technique required for the safe operation of the particular apparatus, and require that the operator demonstrate familiarity with these rules.
(2) An individual may not operate these X-ray systems unless the individual has received training in, and received a copy of, the operating instructions for the unit and the operating and emergency procedures relevant to the use of these systems. The operator shall demonstrate, to the satisfaction of the registrant, competency in the safe use of this equipment.
(d) Radiographic equipment shall conform to the following:
(1) The leakage radiation from the source assembly measured at a distance of 1 meter in any direction from the source may not exceed 25.8 µC/kg (100 mR) in 1 hour when the X-ray tube is operated at its leakage technique factors. Compliance shall be determined by measurements averaged over an area of 100 square centimeters with no linear dimension greater than 20 centimeters.
(2) Portable X-ray systems shall be equipped with collimators which are capable of restricting the useful beam to the area of interest. Collimators shall provide the same degree of protection required in paragraph (1).
(3) A means shall be provided to terminate the exposure after a preset time or exposure or a preset product of exposure time and tube current.
(4) The X-ray control shall have a dead-man type exposure switch.
(5) X-ray controls shall indicate the technique factors (that is, kilovoltage, tube current and exposure time or the product of tube current and exposure time).
(6) The X-ray machine shall be labeled with a readily discernible sign bearing the radiation symbol and the words, ''Caution Radiation--This equipment produces radiation when energized'' or words containing a similar warning, near any switch that energizes the X-ray tube.
(7) For fixed radiographic equipment, an easily visible warning light shall be located adjacent to the X-ray tube and labeled with the words ''X-ray on'' or words containing a similar warning. This light shall be illuminated only when the X-ray tube is energized or only when the shutter is open.
(e) Fluoroscopic equipment shall be as follows:
(1) Leakage radiation from the source assembly measured at a distance of 1 meter in any direction from the source may not exceed 25.8 µC/kg (100 mR) in 1 hour when the X-ray tube is operated at its leakage technique factors. Compliance shall be determined by measurements averaged over an area of 100 square centimeters with no linear dimension greater than 20 centimeters.
(2) The X-ray machine shall be labeled with a readily discernible sign bearing the radiation symbol and the words, ''Caution Radiation--This equipment produces radiation when energized'' or words containing a similar warning, near any switch that energizes the X-ray tube.
(3) To the extent practicable, the X-ray system (X-ray tube, imaging system and the object being irradiated) shall be completely enclosed so that every location on the exterior meets conditions for an unrestricted area and the only access to the room or enclosure is through openings which are interlocked so that the radiation source will not operate unless all openings are securely closed and meet the requirements of § 219.91 (relating to control of access to high radiation areas).
(4) The equipment shall be so constructed that, under conditions of normal use, the entire cross-section of the useful beam shall be attenuated by a primary protective barrier permanently incorporated into the equipment.
(5) The X-ray control shall have a dead-man type exposure switch. Activation of the X-ray beam shall be possible only by continuous pressure on the exposure switch.
(6) The X-ray machine shall be labeled with a readily discernible sign bearing the radiation symbol and the words, ''Caution Radiation--This equipment produces radiation when energized'' or words containing a similar warning, near any switch that energizes the X-ray tube.
(7) An easily visible warning light shall be located adjacent to the X-ray tube or on the outside of the enclosure and be labeled with the words ''X-ray on'' or words containing a similar warning. This light shall be illuminated only when the X-ray tube is energized or only when the shutter is open.
(f) Portable X-ray radiographic equipment operating procedures are as follows:
(1) To the extent practicable, portable X-ray tube heads shall be supported by a stand.
(2) To the extent practicable, supporting or positioning devices for the film shall be used for radiation exposures.
(3) Individuals, other than those whose presence is necessary to conduct the X-ray procedure, shall be located at least 5 meters away from the X-ray tube and the object being irradiated during exposures.
(4) An individual may not be regularly employed to support the film or object during radiation exposures.
(g) Fixed radiographic equipment operating procedures are as follows:
(1) A registrant shall test the safety and warning devices, including interlocks, at intervals not to exceed 12 months. Records of these tests shall be maintained for inspection by the Department for 5 years after the test has been conducted.
(2) A safety or warning device which is found not to be functioning properly shall be repaired as necessary.
§ 225.207. X-ray calibration systems.
(a) This section applies to registrants who regularly, or for commercial purposes, calibrate equipment used to measure the output of radiation for medical diagnosis and therapy, or for radiation survey meters and similar instrumentation. X-ray systems used for calibration purposes are exempt from §§ 225.251--225.262 (relating to sealed source requirements).
(b) A room or enclosure used for calibration shall be shielded so that every location on the exterior meets conditions for an unrestricted area and the only access to the room or enclosure is through openings which are interlocked so that the radiation source will not operate unless all openings are securely closed and meet the requirements of § 219.91 (relating to control of access to high radiation areas).
(c) A registrant may not permit an individual to operate a radiation-producing machine for shielded room radiography until the individual has received a copy of, an instruction in, the operating procedures for the unit and has demonstrated an understanding of the operating procedures and competency in the use of the unit.
(d) The operator shall conduct a physical radiation survey to determine that the radiation machine X-ray tube is de-energized prior to each entry into the radiographic exposure area.
(e) As an alternative to the radiation survey requirement of subsection (d), the registrant may use an independent radiation monitoring system that displays the radiation intensity or displays when radiation levels have returned to their pre-irradiation levels.
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