Article 1. General Requirements
12VAC5-481-1170. Purpose.
Article 1
General Requirements
This part prescribes requirements for the issuance of licenses or registrations for the industrial use of sources of radiation and radiation safety requirements for persons using these sources of radiation in industrial radiography.
Statutory Authority
§ 32.1-229 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006.
12VAC5-481-1180. Scope.
The provisions and requirements of this part are in addition to, and not in substitution for, other requirements of these regulations. In particular, the general requirements and provisions of Parts I (12VAC5-481-10 et seq.); II (12VAC5-481-260 et seq.); III (12VAC5-481-380 et seq.); IV (12VAC5-481-600 et seq.); X (12VAC5-481-2250 et seq.) and XIII (12VAC5-481-2950 et seq.), of this chapter apply to applicants, licensees and registrants subject to this part. Parts III (12VAC5-481-380 et seq.) and XIII (12VAC5-481-2950 et seq.) of this chapter apply to licensing and transportation of radioactive material and Part II (12VAC5-481-260 et seq.) of this chapter applies to the registration of radiation machines. Except for sections that are applicable only to sealed radioactive sources, radiation machines and sealed radioactive sources are both covered by this part. This regulation does not apply to medical uses of sources of radiation that are addressed in Parts VII (12VAC5-481-1660 et seq.) and XV (12VAC5-481-3380 et seq.) of this chapter.
Statutory Authority
§ 32.1-229 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006.
12VAC5-481-1190. Exemptions.
A. Uses of certified and certifiable cabinet X-ray systems are exempt from the requirements of this part except for 12VAC5-481-1200 and the following:
1. For certified and certifiable cabinet X-ray systems, including those designed to allow admittance of individuals:
a. No registrant shall permit any individual to operate a cabinet X-ray system until the individual has received a copy of and instruction in the operating procedures for the unit. Records that demonstrate compliance with this subdivision shall be maintained for agency inspection until disposal is authorized by the agency.
b. Tests for proper operation of interlocks must be conducted and recorded at intervals not to exceed six months. Records of these tests shall be maintained for agency inspection until disposal is authorized by the agency.
c. The registrant shall perform an evaluation of the radiation dose limits to determine compliance with 12VAC5-481-720 and 21 CFR 1020.40, Cabinet X-ray Systems, at intervals not to exceed one year. Records of these evaluations shall be maintained for agency inspection for two years after the evaluation.
2. Certified cabinet X-ray systems shall be maintained in compliance with 21 CFR 1020.40, Cabinet X-ray Systems, and no modification shall be made to the system unless prior agency approval has been granted.
B. Industrial uses of hand-held light intensified imaging devices are exempt from the requirements of exceed 0.2 mSv (2 mrem) per hour. Devices that exceed this limit shall meet the applicable requirements of this part and the licensing or registration requirements of Part II (12VAC5-481-260 et seq.) or Part III (12VAC5-481-380 et seq.) of this chapter, as applicable.
Statutory Authority
§ 32.1-229 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.
12VAC5-481-1200. Licensing and registration requirements for industrial radiography operations.
A. The agency will approve an application for a specific license for the use of licensed material or a registration for use of radiation machines if the applicant meets the following requirements:
1. The applicant satisfies the general requirements specified in Part II (12VAC5-481-260 et seq.) for radiation machine facilities or Part III (12VAC5-481-380 et seq.) for radioactive material, as applicable, and any special requirements contained in this part;
2. The applicant submits an adequate program for training radiographers and radiographer's assistants that meets the requirements of 12VAC5-481-1320;
3. The applicant submits procedures for verifying and documenting the certification status of radiographers and for ensuring that the certification of individuals acting as radiographers remains valid;
4. The applicant submits written operating and emergency procedures as described in 12VAC5-481-1330;
5. The applicant submits a description of a program for inspections of the job performance of each radiographer and radiographer's assistant at intervals not to exceed six months as described in 12VAC5-481-1320 E;
6. The applicant submits a description of the applicant's overall organizational structure as it applies to the radiation safety responsibilities in industrial radiography, including specified delegation of authority and responsibility;
7. The applicant submits the qualifications of the individual(s) designated as the radiation safety officer as described in 12VAC5-481-1310 A 1;
8. If an applicant intends to perform leak testing of sealed sources or exposure devices containing depleted uranium (DU) shielding, the applicant must describe the procedures for performing the test. The description must include the:
a. Methods of collecting the samples;
b. Qualifications of the individual who analyzes the samples;
c. Instruments to be used; and
d. Methods of analyzing the samples;
9. If the applicant intends to perform calibrations of survey instruments and alarming ratemeters, the applicant must describe methods to be used and the experience of the person(s) who will perform the calibrations. All calibrations must be performed according to the procedures described and at the intervals prescribed in 12VAC5-481-1240 and 12VAC5-481-1350 G 4;
10. The applicant identifies and describes the location(s) of all field stations and permanent radiographic installations;
11. The applicant identifies the location(s) where all records required by this and other parts of these regulations will be maintained;
12. If a license application includes underwater radiography, a description of:
a. Radiation safety procedures and radiographer responsibilities unique to the performance of underwater radiography;
b. Radiographic equipment and radiation safety equipment unique to underwater radiography; and
c. Methods for gas-tight encapsulation of equipment; and
13. If an application includes offshore platform and/or lay-barge radiography, a description of:
a. Transport procedures for radioactive material to be used in industrial radiographic operations;
b. Storage facilities for radioactive material; and
c. Methods for restricting access to radiation areas.
B. A license or registration will be issued if the requirements of subsection A of this section, as applicable, are met.
Statutory Authority
§ 32.1-229 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.
12VAC5-481-1210. Performance requirements for industrial radiography equipment.
A. Equipment used in industrial radiographic operations must meet the following minimum criteria:
Each radiographic exposure device, source assembly or sealed source, and all associated equipment must meet the requirements specified in American National Standard Institute, N432‑1980 "Radiological Safety for the Design and Construction of Apparatus for Gamma Radiography," (published as NBS Handbook 136, issued January 1981). This publication may be purchased from the American National Standards Institute, Inc., 25 West 43rd Street, New York, NY 10036; telephone (212) 642‑4900.
B. In addition to the requirements specified in this section the following requirements apply to radiographic exposure devices, source changers, source assemblies and sealed sources:
1. The licensee shall ensure that each radiographic exposure device has attached to it a durable, legible, clearly visible label bearing the:
a. Chemical symbol and mass number of the radionuclide in the device;
b. Activity and the date on which this activity was last measured;
c. Model or product code and serial number of the sealed source;
d. Name of the manufacturer of the sealed source; and
e. Licensee's name, address, and telephone number.
2. Radiographic exposure devices intended for use as Type B packages must meet the applicable transportation requirements of Part XIII (12VAC5-481-2950 et seq.) of this chapter.
3. Modification of radiographic exposure devices, source changers, and source assemblies and associated equipment is prohibited, unless approved by the agency or other approval body.
C. In addition to the requirements specified in subsections A and B of this section, the following requirements apply to radiographic exposure devices, source assemblies, and associated equipment that allow the source to be moved out of the device for radiographic operations or to source changers:
1. The coupling between the source assembly and the control cable must be designed in such a manner that the source assembly will not become disconnected if cranked outside the guide tube. The coupling must be such that it cannot be unintentionally disconnected under normal and reasonably foreseeable abnormal conditions.
2. The device must automatically secure the source assembly when it is cranked back into the fully shielded position within the device. This securing system may only be released by means of a deliberate operation on the exposure device.
3. The outlet fittings, lock box, and drive cable fittings on each radiographic exposure device must be equipped with safety plugs or covers that must be installed during storage and transportation to protect the source assembly from water, mud, sand or other foreign matter.
4. Each sealed source or source assembly must have attached to it or engraved on it, a durable, legible, visible label with the words:
"DANGER—RADIOACTIVE."
The label may not interfere with the safe operation of the exposure device or associated equipment.
5. The guide tube must be able to withstand a crushing test that closely approximates the crushing forces that are likely to be encountered during use, and be able to withstand a kinking resistance test that closely approximates the kinking forces that are likely to be encountered during use.
6. Guide tubes must be used when moving the source out of the device.
7. An exposure head or similar device designed to prevent the source assembly from passing out of the end of the guide tube must be attached to the outermost end of the guide tube during industrial radiography operations.
8. The guide tube exposure head connection must be able to withstand the tensile test for control units specified in ANSI N432‑1980.
9. Source changers must provide a system for ensuring that the source will not be accidentally withdrawn from the changer when connecting or disconnecting the drive cable to or from a source assembly.
D. All radiographic exposure devices and associated equipment in use after January 10, 1996, must comply with the requirements of this section.
E. As an exception to subsection A of this section, equipment used in industrial radiographic operations need not comply with 8.9.2(c) of the Endurance Test in American National Standards Institute N432‑1980, if the prototype equipment has been tested using a torque value representative of the torque that an individual using the radiography equipment can reasonably exert on the lever or crankshaft of the drive mechanism.
Statutory Authority
§ 32.1-229 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 33, Issue 11, eff. February 22, 2017.
12VAC5-481-1220. Limits on external radiation levels from storage containers and source changers.
The maximum exposure rate limits for storage containers and source changers are 2 mSv (200 mrem) per hour at any exterior surface, and 0.1 mSv (10 mrem) per hour at one meter from any exterior surface with the sealed source in the shielded position.
Statutory Authority
§ 32.1-229 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.
12VAC5-481-1230. Locking of sources of radiation, storage containers and source changers.
A. Each radiographic exposure device must have a lock or outer locked container designed to prevent unauthorized or accidental removal of the sealed source from its shielded position. The exposure device and/or its container must be kept locked, and if a keyed-lock, with the key removed at all times, when not under the direct surveillance of a radiographer or a radiographer's assistant except at permanent radiographic installations as stated in 12VAC5-481-1370. In addition, during radiographic operations the sealed source assembly must be secured in the shielded position each time the source is returned to that position.
B. Each sealed source storage container and source changer must have a lock or outer locked container designed to prevent unauthorized or accidental removal of the sealed source from its shielded position. Storage containers and source changers must be kept locked, and if a keyed-lock, with the key removed at all times, when containing sealed sources except when under the direct surveillance of a radiographer or a radiographer's assistant.
C. The control panel of each radiation machine shall be equipped with a lock 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 or a radiographer's assistant.
Statutory Authority
§ 32.1-229 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.
12VAC5-481-1240. Radiation survey instruments.
A. The licensee or registrant shall keep sufficient calibrated and operable radiation survey instruments at each location where sources of radiation are present to make the radiation surveys required by this part and by Part IV (12VAC5-481-600 et seq.) of this chapter. Instrumentation required by this section must be capable of measuring a range from 0.02 mSv (2 mrem) per hour through 0.01 Sv (1 rem) per hour.
B. The licensee or registrant shall have each radiation survey instrument required under subsection A of this section calibrated:
1. At energies appropriate for use and at intervals not to exceed six months or after instrument servicing, except for battery changes;
2. 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 one decade; and for digital instruments, at three points between 0.02 and 10 mSv (2 and 1000 mrem) per hour; and
3. So that an accuracy within plus or minus 20% of the true radiation dose rate can be demonstrated at each point checked.
C. The licensee or registrant shall maintain records of the results of the instrument calibrations in accordance with 12VAC5-481-1410.
Statutory Authority
§ 32.1-229 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.
12VAC5-481-1250. Leak testing and replacement of sealed sources.
A. The replacement of any sealed source fastened to or contained in a radiographic exposure device and leak testing of any sealed source must be performed by persons authorized to do so by the agency, the NRC, or another agreement state.
B. The opening, repair, or modification of any sealed source must be performed by persons specifically authorized to do so by the agency, the NRC, or another agreement state.
C. Testing and recordkeeping requirements.
1. Each licensee who uses a sealed source shall have the source tested for leakage at intervals not to exceed six months. The leak testing of the source must be performed using a method approved by the agency, the NRC, or by another agreement state. The wipe sample should be taken from the nearest accessible point to the sealed source where contamination might accumulate. The wipe sample must be analyzed for radioactive contamination. The analysis must be capable of detecting the presence of 185 Bq (0.005 μCi) of radioactive material on the test sample and must be performed by a person specifically authorized by the agency, the NRC, or another agreement state to perform the analysis.
2. The licensee shall maintain records of the leak tests in accordance with 12VAC5-481-1420.
3. Unless a sealed source is accompanied by a certificate from the transferor that shows that it has been leak tested within six months before the transfer, it may not be used by the licensee until tested for leakage. Sealed sources that are in storage and not in use do not require leak testing, but must be tested before use or transfer to another person if the interval of storage exceeds six months.
D. Any test conducted pursuant to subsections B and C of this section that reveals the presence of 185 Bq (0.005 μCi) or more of removable radioactive material must be considered evidence that the sealed source is leaking. The licensee shall immediately withdraw the equipment involved from use and shall have it decontaminated and repaired or disposed of in accordance with agency regulations. A report must be filed with the agency within five days of any test with results that exceed the threshold in this paragraph, describing the equipment involved, the test results, and the corrective action taken.
E. Each exposure device using depleted uranium (DU) shielding and an "S" tube configuration must be tested for DU contamination at intervals not to exceed 12 months. The analysis must be capable of detecting the presence of 185 Bq (0.005 μCi) of radioactive material on the test sample and must be performed by a person specifically authorized by the agency, the NRC, or another agreement state to perform the analysis. Should such testing reveal the presence of DU contamination, the exposure device must be removed from use until an evaluation of the wear of the S-tube has been made. Should the evaluation reveal that the S-tube is worn through, the device may not be used again. DU shielded devices do not have to be tested for DU contamination while not in use and in storage. Before using or transferring such a device, however, the device must be tested for DU contamination, if the interval of storage exceeds 12 months. A record of the DU leak test must be made in accordance with 12VAC5-481-1420.
Statutory Authority
§ 32.1-229 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.
12VAC5-481-1260. Quarterly inventory.
A. Each licensee or registrant shall conduct a quarterly physical inventory to account for all sources of radiation, and for devices containing depleted uranium received and possessed under the license.
B. The licensee or registrant shall maintain records of the quarterly inventory in accordance with 12VAC5-481-1430.
Statutory Authority
§ 32.1-229 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006.
12VAC5-481-1270. Inspection and maintenance of radiation machines, radiographic exposure devices, transport and storage containers, associated equipment, source ....
A. The licensee or registrant shall perform visual and operability checks on survey meters, radiation machines, radiographic exposure devices, transport and storage containers, associated equipment and source changers before each day's use, or work shift, to ensure that:
1. The equipment is in good working condition;
2. The sources are adequately shielded; and
3. Required labeling is present.
B. Survey instrument operability must be performed using check sources or other appropriate means.
C. If equipment problems are found, the equipment must be removed from service until repaired.
D. Each licensee or registrant shall have written procedures for and perform inspection and routine maintenance of radiation machines, radiographic exposure devices, source changers, associated equipment, transport and storage containers, and survey instruments at intervals not to exceed three months or before the first use thereafter to ensure the proper functioning of components important to safety. If equipment problems are found, the equipment must be removed from service until repaired. Replacement components shall meet design requirements.
E. The licensee's inspection and maintenance program must include procedures to assure that Type B packages are shipped and maintained in accordance with the certificate of compliance or other approval.
F. Records of equipment problems and of any maintenance performed under this section must be made in accordance with 12VAC5-481-1450.
Statutory Authority
§ 32.1-229 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.
12VAC5-481-1280. Permanent radiographic installations.
A. Each entrance that is used for personnel access to the high radiation area in a permanent radiographic installation must have either:
1. An entrance control of the type described in 12VAC5-481-780 that causes the radiation level upon entry into the area to be reduced; or
2. Both conspicuous visible and audible warning signals to warn of the presence of radiation. The visible signal must be actuated by radiation whenever the source is exposed or the machine is energized. The audible signal must be actuated when an attempt is made to enter the installation while the source is exposed or the machine is energized.
B. The alarm system must be tested for proper operation with a radiation source each day before the installation is used for radiographic operations. The test must include a check of both the visible and audible signals. Entrance control devices that reduce the radiation level upon entry as designated in subdivision A 1 of this section must be tested monthly. If an entrance control device or an alarm is operating improperly, it must be immediately labeled as defective and repaired within seven calendar days. The facility may continue to be used during this seven-day period, provided the licensee or registrant implements the continuous surveillance requirements of 12VAC5-481-1370 and uses an alarming ratemeter. Test records for entrance controls and audible and visual alarms must be maintained in accordance with 12VAC5-481-1460.
Statutory Authority
§ 32.1-229 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006.
12VAC5-481-1290. Labeling, storage, and transportation.
A. Licensees may not use a source changer or a container to store radioactive material unless the source changer or the storage container has securely attached to it a durable, legible, and clearly visible label bearing the standard trefoil radiation caution symbol conventional colors, i.e., magenta, purple, or black on a yellow background, having a minimum diameter of 25 mm, and the wording:
CAUTION *
RADIOACTIVE MATERIAL
NOTIFY CIVIL AUTHORITIES (or "NAME OF COMPANY")
* ——or "DANGER"
B. Licensees may not transport radioactive material unless the material is packaged, and the package is labeled, marked, and accompanied with appropriate shipping papers in accordance with regulations set out in Part XIII (12VAC5-481-2950 et seq.) of this chapter.
C. Radiographic exposure devices, source changers, storage containers, and radiation machines, shall be physically secured to prevent tampering or removal by unauthorized personnel. The licensee shall store radioactive material in a manner that will minimize danger from explosion or fire.
D. Licensees shall lock and physically secure the transport package containing radioactive material in the transporting vehicle to prevent accidental loss, tampering, or unauthorized removal.
Statutory Authority
§ 32.1-229 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 32, Issue 24, eff. August 25, 2016.