WSR 99-01-095

PROPOSED RULES

DEPARTMENT OF HEALTH

[Filed December 17, 1998, 9:57 a.m.]



Original Notice.

Exempt from preproposal statement of inquiry under RCW 34.05.310(4).

Title of Rule: Clarification of instructions to workers, notifications and reports to individuals, and update of industrial radiography equipment requirements.

Purpose: To amend several sections to bring radiation protection regulations into conformance with the United States Nuclear Regulatory Commission rules on instructions to workers, notifications and reports to individuals, and equipment performance requirements for industrial radiography. A housekeeping change is made to consolidate related requirements into a single section.

Statutory Authority for Adoption: RCW 70.98.050.

Statute Being Implemented: RCW 70.98.050.

Summary: The proposed rule clarifies who is required to receive notifications and reports (WAC 246-221-280), clarifies when an individual is required to receive instruction as a worker (WAC 246-222-030), and updates and consolidates the requirements for equipment used in industrial radiography (WAC 246-243-040 and 246-243-090).

Name of Agency Personnel Responsible for Drafting, Implementation and Enforcement: Terry C. Frazee, Tumwater, (360) 236-3221.

Name of Proponent: Division of Radiation Protection, Department of Health, governmental.

Rule is necessary because of federal law, 60 FR 36038, 10 CFR Part 34 RIN 3150.

Explanation of Rule, its Purpose, and Anticipated Effects: This rule clarifies that both workers and members of the public are required to receive notifications and reports when exposed to radiation or radioactive material; clarifies when an individual is to be considered a worker for purposes of providing appropriate radiation instruction; and corrects a flaw in required performance test criteria for equipment used in industrial radiography in order to be consistent with the federal rules governing the same areas. These changes are required for compatibility with the United States Nuclear Regulatory Commission. The anticipated effect of these changes is to bring our radioactive materials licensees into conformance with national standards.

Proposal Changes the Following Existing Rules: WAC 246-221-280 is amended to clarify that both workers and members of the public are required to receive notifications and reports when exposed to radiation or radioactive material exceeding the limits specified in WAC 246-221-260; WAC 246-222-030 is amended to clarify that the licensee or registrant shall take into consideration normal and abnormal situations involving exposure to sources of radiation which can reasonably be expected to occur during the life of a facility when determining which individuals shall receive instructions appropriate to radiation workers; WAC 246-243-040 is amended to be compatible with the equivalent federal regulation and consolidate all equipment performance requirements within a single section; and WAC 246-243-090 is amended to move current equipment requirements from this section to WAC 246-243-040 and delete outdated requirements.

No small business economic impact statement has been prepared under chapter 19.85 RCW. This rule conforms to a federal rule change for which a "Regulatory Flexibility Certification" was prepared stating that the "rule will not have a significant economic impact upon a substantial number of small entities."

Section 201, chapter 403, Laws of 1995, does not apply to this rule adoption. This rule adopts federal regulations without material change. This rule, exclusive of housekeeping measures, is for conformance with the United States Nuclear Regulatory Commission regulations and is mandatory under our agreement state status with the federal government.

Hearing Location: Department of Health, Division of Radiation Protection, New Market Industrial Campus, Building 5, Tumwater, Washington, on January 27, 1999, at 10:00.

Assistance for Persons with Disabilities: Contact Terry Frazee by January 26, 1999, TDD (800) 833-6388 or fax (360) 236-2255.

Submit Written Comments to: Terry Frazee, fax (360) 236-3221, by January 27, 1999.

Date of Intended Adoption: February 3, 1999.

December 16, 1998

Kristine Van Gorkom

Deputy Secretary

OTS-2454.1

AMENDATORY SECTION (Amending Order 184, filed 7/24/91, effective 8/24/91)



WAC 246-221-280  Notifications and reports to individuals. (1) Requirements for notification and reports to individuals of exposure to radiation or radioactive material are specified in WAC 246-222-040.

(2) When a licensee or registrant is required pursuant to WAC 246-221-260 to report to the department any exposure of an identified occupationally exposed individual, or an identified member of the public, or dosimetry device assigned to any individual to radiation from any source, the licensee or registrant shall also notify the individual. Such notice shall be transmitted at a time not later than the transmittal to the department, and shall comply with the provisions of WAC 246-222-040(1).



[Statutory Authority: RCW 70.98.050 and 70.98.080. 91-15-112 (Order 184), 246-221-280, filed 7/24/91, effective 8/24/91. Statutory Authority: RCW 43.70.040. 91-02-049 (Order 121), recodified as 246-221-280, filed 12/27/90, effective 1/31/91. Statutory Authority: RCW 70.98.080. 87-01-031 (Order 2450), 402-24-215, filed 12/11/86; Order 1095, 402-24-215, filed 2/6/76.]

OTS-2455.1

AMENDATORY SECTION (Amending WSR 94-01-073, filed 12/9/93, effective 1/9/94)



WAC 246-222-030  Instructions to workers. (1) All individuals likely to receive in a year an occupational dose in excess of 1 mSv (100 mrem):

(a) Shall be kept informed of the storage, transfer, or use of sources of radiation in the licensee's or registrant's facility;

(b) Shall be instructed in the health protection considerations for the individual and potential offspring associated with exposure to radiation or radioactive material, in precautions or procedures to minimize exposure, and in the purposes and functions of protective devices employed;

(c) Shall be instructed in, and instructed to observe, to the extent within the worker's control, the applicable provisions of these regulations, department form RHF-3 "Notice to employees," and license conditions for the protection of personnel from exposures to radiation or radioactive material;

(d) Shall be instructed that any worker or representative of workers who believes that a violation of the regulations, license conditions, or unnecessary exposure to radiation exists or occurred, may request an inspection by the department by oral or written notification. The notification shall set forth specific grounds for the complaint. Any such notification to the department is confidential;

(e) Shall be instructed of their right to notify the department if the individual suspects improper actions by a licensee/registrant, or conditions which may lead to a violation of these regulations, the license/registration, or unnecessary exposure to radiation or radioactive materials;

(f) Shall be instructed that employment discrimination by a licensee/registrant against an employee because of actions described in this chapter is prohibited;

(g) Shall be instructed as to their responsibility to report promptly to the licensee or registrant any condition which may constitute, lead to, or cause a violation of the act, these regulations, and licenses or unnecessary exposure to radiation or radioactive material;

(h) Shall be instructed in the appropriate response to warnings made in the event of any unusual occurrence or malfunction that may involve exposure to radiation or radioactive material; and

(i) Shall be advised as to the radiation exposure reports which workers shall be furnished pursuant to WAC 246-222-040.

(2) Records of these instructions described in subsection (1) of this section for all individuals working in, or frequenting any portion of, a restricted area shall be maintained for inspection by the department until further notice. These records shall include a copy of this section, or all the information contained in this section, along with a dated verification signature by the employee stating that the individual has received an explanation of the instructions contained in this section.

(3) In determining those individuals subject to the requirements of subsection (1) of this section, licensees and registrants shall take into consideration assigned activities during normal and abnormal situations involving exposure to sources of radiation which can reasonably be expected to occur during the life of a licensed or registered facility. The extent of these instructions shall be commensurate with potential radiological health protection considerations present in the workplace.



[Statutory Authority: RCW 70.98.050. 94-01-073, 246-222-030, filed 12/9/93, effective 1/9/94. Statutory Authority: RCW 70.98.050 and 70.98.080. 91-15-112 (Order 184), 246-222-030, filed 7/24/91, effective 8/24/91. Statutory Authority: RCW 43.70.040. 91-02-049 (Order 121), recodified as 246-222-030, filed 12/27/90, effective 1/31/91. Statutory Authority: RCW 70.98.080. 83-19-050 (Order 2026), 402-48-030, filed 9/16/83. Statutory Authority: RCW 70.98.050. 81-01-011 (Order 1570), 402-48-030, filed 12/8/80; Order 1084, 402-48-030, filed 1/14/76.]

OTS-2453.2

AMENDATORY SECTION (Amending WSR 94-01-073, filed 12/9/93, effective 1/9/94)



WAC 246-243-040  Equipment ((control)) performance requirements. (((1))) Equipment used in industrial radiography operations must meet the following minimum criteria((, the following requirements apply to radiographic exposure devices and associated equipment that allow the source to be moved out of the device for routine operation)):

(1)(a) Each radiographic exposure device, source assembly or sealed source, and all associated equipment must meet the requirements specified in American National Standards Institute, N432-1980 "Radiological Safety for the Design and Construction of Apparatus for Gamma Radiography," (published as NBS Handbook 136, issued January 1981). Copies of the document are available for inspection at the Department of Health, Division of Radiation Protection, Olympia, Washington.

(b) Engineering analysis may be submitted by an applicant or licensee to demonstrate the applicability of previously performed testing on similar individual radiography equipment components. Upon review, the department may find this an acceptable alternative to actual testing of the component pursuant to the above referenced standard.

(c) Notwithstanding (a) of this subsection, 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 realistically exert on the lever or crankshaft of the drive mechanism.

(2) In addition to the requirements specified in subsection (1) of this section, the following requirements apply to radiographic exposure devices, source changers, source assemblies and sealed sources.

(a) The licensee shall ensure that each radiographic exposure device has attached to it a durable, legible, clearly visible label bearing the:

(i) Chemical symbol and mass number of the radionuclide in the device;

(ii) Activity and the date on which this activity was last measured;

(iii) Model (or product code) and serial number of the sealed source;

(iv) Manufacturer's identity of the sealed source; and

(v) Licensee's name, address, and telephone number.

(b) Radiographic exposure devices intended for use as Type B transport containers must meet the applicable requirements of 10 CFR Part 71.

(c) Modification of radiographic exposure devices, source changers, and source assemblies and associated equipment is prohibited, unless the design of any replacement component, including source holder, source assembly, controls or guide tubes would not compromise the design safety features of the system.

(3) In addition to the requirements specified in subsections (1) and (2) 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.

(a) 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 can not be unintentionally disconnected under normal and reasonably foreseeable abnormal conditions.

(b) The device must automatically secure the source assembly when it is cranked back into the fully shielded position within the device. The securing system may only be released by means of a deliberate operation on the exposure device.

(c) The outlet fittings, lock box, and drive cable fitting on each radiographic exposure device must be equipped with safety plugs or covers which must be installed during storage and transportation to protect the source assembly from water, mud, sand, or other foreign matter.

(d)(i) 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."

(ii) The label may not interfere with the safe operation of the exposure device or associated equipment.

(e) The guide tube must ((have passed the crushing tests for the control tube as specified in ANSI N432 and)) 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 likely to be encountered during use.

(((e))) (f) Guide tubes ((or exposure heads connected directly to the device)) must be used when moving the source out of the device.

(((f))) (g) An exposure head or similar device designed to ((protect)) 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 radiographic operations.

(h) The guide tube exposure head connection must be able to withstand the tensile test for control units specified in ANSI N432-1980.

(((g))) (i) Source changers must provide a system for ((assuring)) 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.

(((h) All newly manufactured radiographic exposure devices and associated equipment acquired by licenses after January 1, 1995, must comply with the requirements of this section.))

(((i))) (4) All radiographic exposure devices and associated equipment in use after January 1, 1998, must comply with the requirements of this section.

(((2) Limits on levels of radiation for radiographic exposure devices and storage containers:

(a) Radiographic exposure devices measuring less than four inches from the sealed source storage position to any exterior surface of the device shall have no radiation level in excess of fifty milliroentgens per hour (50mR/hr) at six inches from any exterior surface of the device.

(b) Radiographic exposure devices measuring a minimum of four inches from the sealed source storage position to any exterior surface of the device, and all storage containers for sealed sources or outer containers for radiographic exposure devices, shall have no radiation level in excess of two hundred milliroentgens per hour (200mR/hr) at any exterior surface, and ten milliroentgens per hour (10mR/hr) at one meter from any exterior surface.

(c) The radiation levels specified are with the sealed source in the shielded (i.e., "off") position.)) (5) The maximum exposure rate limits for storage containers and source changers with the sealed source in the shielded position are:

(a) 2 millisieverts (200 millirem) per hour at any exterior surface; and

(b) 0.1 millisieverts (10 millirem) per hour at one meter from any exterior surface.



[Statutory Authority: RCW 70.98.050. 94-01-073, 246-243-040, filed 12/9/93, effective 1/9/94. Statutory Authority: RCW 43.70.040. 91-02-049 (Order 121), recodified as 246-243-040, filed 12/27/90, effective 1/31/91. Statutory Authority: RCW 70.98.050. 81-01-011 (Order 1570), 402-36-030, filed 12/8/80; Order 1084, 402-36-030, filed 1/14/76; Order 1, 402-36-030, filed 1/8/69; Rules (part), filed 10/26/66.]



AMENDATORY SECTION (Amending WSR 94-01-073, filed 12/9/93, effective 1/9/94)



WAC 246-243-090  Leak testing, repair, tagging, opening, modification, and replacement of sealed sources. (1) The replacement of any sealed source fastened to or contained in a radiographic exposure device and leak testing, repair, tagging, opening, or any other modification of any sealed source shall be performed only by persons specifically authorized to do so by the department, the United States Nuclear Regulatory Commission, or any agreement state.

(2) Each sealed source shall be tested for leakage at intervals not to exceed six months. In the absence of a certificate from a transferor that a test has been made within the six-month period prior to the transfer, the sealed source shall not be put into use until tested and results obtained.

(3) The leak test shall be capable of detecting the presence of 185 becquerels (0.005 microcurie) of removable contamination on the sealed source. An acceptable leak test for sealed sources in the possession of a radiography licensee would be to test at the nearest accessible point to the sealed source storage position, or other appropriate measuring point, by a procedure specifically approved in a license condition. Records of leak test results shall be kept in units of microcuries and maintained for inspection by the department for three years after the leak test is performed.

(4) Any test conducted pursuant to subsections (2) and (3) of this section which reveals the presence of 185 becquerels (0.005 microcurie) or more of removable radioactive material shall be considered evidence that the sealed source is leaking. The licensee shall immediately withdraw the equipment involved from use and shall cause it to be decontaminated and repaired or to be disposed in accordance with regulations of the department. Within five days after obtaining results of the test, the licensee shall file a report with the department describing the involved equipment, the test results, and the corrective action taken.

(((5) A sealed source which is not fastened to or contained in a radiographic exposure device shall have permanently attached to it a durable tag at least one inch square bearing the prescribed radiation caution symbol in conventional colors magenta or purple on a yellow background, and at least the instructions: "Danger - Radioactive Material - Do not handle - Notify civil authorities if found."

(6) Each radiographic exposure device shall have permanently and conspicuously attached to it a durable label at least two inches square bearing the prescribed radiation caution symbol in conventional colors (magenta or purple on a yellow background), and at a minimum the instructions, "Danger - Radioactive Material - Do not handle - Notify civil authorities if found."

(7) Each radiographic exposure device must have attached to it by the user, a durable, legible, clearly visible label bearing the following:

(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 number and serial number of the sealed source;

(d) Manufacturer of the sealed source; and

(e) Licensee's name, address, and telephone number.))



[Statutory Authority: RCW 70.98.050. 94-01-073, 246-243-090, filed 12/9/93, effective 1/9/94. Statutory Authority: RCW 70.98.050 and 70.98.080. 91-15-112 (Order 184), 246-243-090, filed 7/24/91, effective 8/24/91. Statutory Authority: RCW 43.70.040. 91-02-049 (Order 121), recodified as 246-243-090, filed 12/27/90, effective 1/31/91. Statutory Authority: RCW 70.98.080. 87-01-031 (Order 2450), 402-36-070, filed 12/11/86; 83-19-050 (Order 2026), 402-36-070, filed 9/16/83. Statutory Authority: RCW 70.98.050. 81-01-011 (Order 1570), 402-36-070, filed 12/8/80; Order 1084, 402-36-070, filed 1/14/76; Order 1, 402-36-070, filed 1/8/69; Rules (part), filed 10/26/66.]

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