WSR 02-14-050

PERMANENT RULES

DEPARTMENT OF HEALTH


[ Filed June 27, 2002, 8:32 a.m. ]

Date of Adoption: April 25 [26], 2002.

Purpose: The purpose of this rule revision is to increase clarity and usability with no material change using clear rule-writing techniques.

Citation of Existing Rules Affected by this Order: Repealing WAC 246-224-001 through 246-224-100 and 246-229-001 through 246-229-110.

Statutory Authority for Adoption: RCW 70.98.050 and [70.98.]080.

Adopted under notice filed as WSR 02-07-021 on March 11, 2002.

Changes Other than Editing from Proposed to Adopted Version: An exception, errantly removed in the proposed rule, was included in the rule prepared for adoption to be consistent with the original rule requirements.

Number of Sections Adopted in Order to Comply with Federal Statute: New 0, Amended 0, Repealed 0; Federal Rules or Standards: New 0, Amended 0, Repealed 0; or Recently Enacted State Statutes: New 0, Amended 0, Repealed 0.

Number of Sections Adopted at Request of a Nongovernmental Entity: New 0, Amended 0, Repealed 0.

Number of Sections Adopted on the Agency's Own Initiative: New 24, Amended 0, Repealed 0.

Number of Sections Adopted in Order to Clarify, Streamline, or Reform Agency Procedures: New 24, Amended 0, Repealed 0.

Number of Sections Adopted Using Negotiated Rule Making: New 0, Amended 0, Repealed 0; Pilot Rule Making: New 0, Amended 0, Repealed 0; or Other Alternative Rule Making: New 24, Amended 0, Repealed 0.
Effective Date of Rule: Thirty-one days after filing.

June 26, 2002

Mary C. Selecky

Secretary

OTS-5433.6

Chapter 246-224 WAC

RADIATION PROTECTION -- RADIATION MACHINE ASSEMBLY AND REGISTRATION


NEW SECTION
WAC 246-224-0001   Purpose.   The purpose of this chapter is to regulate sources of ionizing radiation as required by RCW 70.98.050 and 70.98.080. This chapter provides for the registration of all radiation machines installed, manufactured, tested, used, or located in Washington state.

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NEW SECTION
WAC 246-224-0010   Definitions.   "Agent" means a person, company, or dealer; which assembles, installs, repairs, sells, or leases x-ray machines.

"Department" means the department of health.

"Facility" means the location at which one or more radiation machines are installed, manufactured, tested, or used within one building, vehicle, or in one physical complex.

"FDA" means the United States Food and Drug Administration.

"Radiation" means, for the purposes of this chapter, ionizing radiation, including x-ray, electron beam, and other machine produced particulate radiation.

"Radiation machine" means, for purposes of this chapter, a device that, when operated, produces x-ray or electron radiation, in a prescribed manner, with defined characteristics, techniques, or parameters. It does not include devices with radioactive material as the only source of radiation.

"Registrant" means the owner or controller of the radiation machine who is responsible for the safe operation of the radiation machine.

"Registration" means providing required information and continuing contact with the department.

"Storage" means the status of a radiation machine that is approved by the department as being unable to produce radiation without substantial effort at set-up, reassembly, or reinstallation. For facilities with a radiation control authority, (e.g., radiation safety office) a locking or disabling procedure may serve to provide this status.

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NEW SECTION
WAC 246-224-0020   Who must register a radiation machine?   Any x-ray facility within Washington state must register with the department.

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NEW SECTION
WAC 246-224-0030   Are there any radiation machines within Washington state that do not have to be registered?   Machines do not need to be registered when:

(1) Electronic equipment (including television receivers) produces incidental x rays provided that the dose equivalent rate does not exceed 5 µSv/hr (0.5 mrem/hr) at 5 cm from any accessible equipment surface averaged over an area of 10 square centimeters;

(2) Radiation machines are in transit;

(3) Radiation machines are held for sale or lease by x-ray agents; or

(4) The department allows an exemption.

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NEW SECTION
WAC 246-224-0040   What if we have separate locations with radiation machines?   (1) Geographically separate facilities must register separately even if these separate facilities are under one administrative control (e.g., several satellite clinics operated by one health care institution).

(2) Each facility must designate a contact person.

(3) If machines are routinely moved between or among separate facilities, indicate this when registering.

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NEW SECTION
WAC 246-224-0050   When and how do I register?   (1) You must register with the department within fifteen calendar days of initial use. You may also register anytime before initial use.

(2) Registration is valid for one year from the department approval date.

(3) You must provide, at a minimum, the:

(a) Owner name;

(b) Profession and credential of user/registrant;

(c) Official contact person;

(d) Site address and phone number;

(e) Mailing address and phone number (if different from facility);

(f) Total number and type of radiation machines (tubes) at the facility;

(g) Installation date(s);

(h) Seller/installer name; and

(i) Name of former agent and address of former facility from which the machines were transferred or sold.

(4) Pay applicable registration fees according to WAC 246-254-053, Radiation machine facility registration fees.

(5) Submit registration information and applicable fees to:

Department of Health

Revenue Section

P.O. Box 1099

Olympia, WA 98507-1099

360-236-3230 or 1-800-299-XRAY


Note: For division of radiation protection information, visit the following website:
http://www.doh.wa.gov/ehp/rp/Default.htm.

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NEW SECTION
WAC 246-224-0060   Are there other requirements besides registration?   All registrants must:

(1) Follow applicable standards according to chapter 246-225 WAC, Radiation protection -- X-rays in the healing arts; chapter 246-227 WAC, Radiation protection -- Industrial x-ray; chapter 246-228 WAC, Radiation protection -- Analytical x-ray equipment; and chapter 246-229 WAC, Radiation protection -- Particle accelerators;

(2) Meet general radiation protection rules and standards according to chapter 246-220 WAC, Radiation protection -- General provisions; chapter 246-221 WAC, Radiation protection standards; chapter 246-222 WAC, Radiation protection -- Worker rights; and

(3) Pay applicable fees for radiation machine use according to WAC 246-254-053, Radiation machine facility registration fees.

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NEW SECTION
WAC 246-224-0070   When and how do I report changes to my registration?   (1) You must notify the department within thirty days of any change to your registration information.

(2) Submit registration changes to:

Department of Health

X-Ray Control Section

P.O. Box 47827

Olympia, WA 98504-7827

360-236-3230 or 1-800-299-XRAY

(3) You may notify the department of changes on the registration renewal notice if timely.

Note: For division of radiation protection information, visit the following website:
http://www.doh.wa.gov/ehp/rp/Default.htm.

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NEW SECTION
WAC 246-224-0080   When and how do I renew my registration?   (1) You must renew your registration annually.

(2) You must submit renewal information and the applicable registration fee as specified in WAC 246-254-053 at least thirty calendar days prior to your registration expiration date. The department provides notice of fees and current registration information ninety days prior to the registration expiration date, and anytime upon request.

(3) If registration is overdue, late fees apply according to WAC 246-254-053, Radiation machine facility registration fees.

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NEW SECTION
WAC 246-224-0090   What are my obligations if I close my facility or get rid of a machine?   (1) You must notify the department of the machine status within thirty days of closure or removal.

(2) If the machine is disposed of or transferred within Washington state, you must provide:

(a) The name and contact information of the recipient;

(b) The address of the recipient; and

(c) The date of the disposal or transfer.

(3) If the machine is to be placed in storage and retained, contact the department for approval.

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NEW SECTION
WAC 246-224-0100   What are the responsibilities of the x-ray agent?   (1) Within fifteen calendar days, any agent who sells, leases, transfers, lends, disposes of, assembles, repairs, replaces, or installs radiation machines or components in Washington state must notify the department of the:

(a) Recipient's name and facility address;

(b) Manufacturer, model, and serial number of each radiation machine master control; and

(c) Date of transfer of the radiation machine.

Note: An FDA form 2579 or equivalent may be used for this notification requirement.

(2) Any agent who installs x-ray systems, controls, or components must ensure that machines, accessories, or components (including exposure switch placement) meet the applicable requirements of chapter 246-225 WAC, Radiation protection -- X-rays in the healing arts; chapter 246-227 WAC, Radiation protection -- Industrial x-ray; chapter 246-228 WAC, Radiation protection -- Analytical x-ray equipment; and chapter 246-229 WAC, Radiation protection -- Particle accelerators.

(3) Agents shall not install or transfer a radiation machine if the registrant does not complete:

(a) A required plan review according to chapter 246-225 WAC, Radiation protection -- X-rays in the healing arts or chapter 246-227 WAC, Radiation protection -- Industrial radiography; or

(b) Shielding and/or required design construction.

(4) Agents must assemble certified x-ray systems according to 21 CFR, subchapter J so that manufacturer's specifications and intended performance designs are met.

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NEW SECTION
WAC 246-224-0110   What if I want to bring a radiation machine into Washington state for temporary use from out-of-state?   (1) Notify the department at least three business days prior to in-state use when bringing an x-ray machine into the state for any temporary use. The department may waive the time requirement upon hardship request by the owner. Notification to the department includes, at a minimum, the:

(a) Type of radiation machine;

(b) Nature, duration, and scope of use; and

(c) Exact location where the radiation machine is to be used.

(2) All machines and assemblies must comply with all applicable regulations.

(3) Any medical or dental use radiation (e.g., x-ray) machines within the state must register with the department according to WAC 246-224-0020.

(4) For radiation (e.g., x-ray) machines not intended for patient diagnosis and treatment, you must register the machine if it is used for more than sixty calendar days. Registration is waived for sixty or fewer calendar days per year.

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NEW SECTION
WAC 246-224-0120   What happens if I do not register my radiation machine?   You must pay a late fee plus registration fees due for the period of time the machine has been in operation and not registered according to WAC 246-254-053, Radiation machine facility registration fees.

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REPEALER

     The following sections of the Washington Administrative Code are repealed:
WAC 246-224-001 Purpose and scope.
WAC 246-224-010 Exemptions.
WAC 246-224-020 Application for registration of radiation machine facilities.
WAC 246-224-050 Renewal of registration.
WAC 246-224-060 Separate locations.
WAC 246-224-070 Report of changes.
WAC 246-224-090 Repair person, assembler, or installer obligation.
WAC 246-224-100 Out-of-state radiation machines.

OTS-5434.5


NEW SECTION
WAC 246-229-0001   Purpose.   The purpose of this chapter is to regulate certain sources of ionizing radiation as required by RCW 70.98.050 and 70.98.080. This chapter provides for the registration and use of all particle accelerators installed and/or used in Washington state.

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NEW SECTION
WAC 246-229-0010   Definitions.   "Department" means the department of health.

"High radiation area" means any area, accessible to individuals, in which radiation levels could result in an individual receiving a dose equivalent in excess of 1 mSv (100 mrem) in one hour at 30 centimeters from any source of radiation or from any surface that the radiation penetrates. For purposes of these regulations, rooms or areas in which diagnostic x-ray systems are used for healing arts purposes are not considered high radiation areas.

"Particle accelerator" means any machine capable of accelerating electrons, protons, deuterons, or other charged particles in a vacuum and of discharging the resultant particulate or other radiation into a medium at energies usually in excess of 1 MeV.

"Qualified expert" means an individual who has demonstrated to the satisfaction of the department that he or she is knowledgeable, trained, and/or experienced to measure ionizing radiation, evaluate safety techniques, and/or advise appropriately on matters of radiation protection. The department reserves the right to recognize qualifications in specific areas of radiation protection.

"Radiation machine" means any device capable of producing ionizing radiation except those devices with radioactive materials as the only source of radiation.

"Radiation safety committee" means a registrant-appointed committee of at least three members to evaluate and approve all proposals for research, diagnostic, and therapeutic use of a particle accelerator. Committee members should include, at a minimum, persons with expertise related to the intended use of the accelerator, and a person experienced in depth dose calculations and radiation safety.

"Radiation safety officer" means a knowledgeable and responsible person assigned by the registrant who provides radiation protection expertise to facilities and users of radiation machines.

"Radioactive material" means any material that emits radiation energy spontaneously. A machine that emits x-rays is not considered a radioactive material.

"Registrant" means an owner or controller of a radiation machine who is responsible for the safe operation of the radiation machine.

"Restricted area" means any area with limited access for the purposes of protecting individuals from undue risks of radiation exposure. A restricted area cannot be a residential area; a building may contain both restricted areas and residential areas.

"Unrestricted area" means any area freely available to the public, workers, or other persons; and where a person may receive less than 1 mSv (100 mrem) per year or be subject to any dose rate less than 20 µSv/hr (2 mrem/hr).

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NEW SECTION
WAC 246-229-0020   How do I get approval for particle accelerator installation and use?   (1) Anyone installing or using particle accelerators in Washington state must get department approval by registering with the department according to chapter 246-224 WAC, Radiation protection -- Radiation machine assembly and registration, prior to installation or use of the particle accelerator.

(2) A registrant must submit the following information:

(a) A membership list showing the establishment of a radiation safety committee;

(b) An identified radiation safety officer;

(c) A qualified expert's radiation shielding and safety plan review for approval according to chapter 246-225 WAC, Radiation protection -- X-rays in the healing arts; and

(d) Operating and emergency procedures.

(3) If the particle accelerator is intended for human use:

(a) The designated user must be a physician with training and experience in deep therapy techniques or in the use of particle accelerators to treat humans; and

(b) The registrant must appoint a radiation safety committee.

(4) To submit registration and questions, contact the department by phone or mail at:

Washington State Health Department

Division of Radiation Protection

Attn: X-Ray Registration

P.O. Box 47827

Olympia, WA 98504-7827

360-236-3230 or 1-800-299-XRAY

(5) A facility may not operate a particle accelerator:

(a) Without approval from the department; and

(b) If any applicable requirement in this chapter is not met.

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NEW SECTION
WAC 246-229-0030   What are the training requirements for particle accelerator use?   (1) The registrant must:

(a) Ensure training for operators to use the particle accelerator that meets the requirements of subsection (2) of this section; and

(b) Maintain training records that demonstrate compliance with the requirements of subsection (2) of this section for two years after the last employment or operation date for the operator.

(2) At a minimum, operators must:

(a) Demonstrate radiation safety expertise and other skills required by the facility training program;

(b) Understand applicable requirements and the registrant's operating and emergency procedures; and

(c) Demonstrate competence to use the particle accelerator, related equipment, and survey instruments, which are required by the operator's assignment.

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NEW SECTION
WAC 246-229-0040   Are there other requirements that apply to the use of particle accelerators?   (1) Registrants must meet the radiation standards of chapter 246-220 WAC, Radiation protection -- General provisions; chapter 246-221 WAC, Radiation protection standards; and chapter 246-222 WAC, Radiation protection -- Worker rights; for public, operator, and user protection.

(2) Depending on the installation, type of machine, and intended use, registrants may also need to meet:

(a) Industrial radiographic operations, chapters 246-243 and 246-227 WAC;

(b) X-ray in the healing arts, chapter 246-225 WAC; and

(c) Medical therapy, chapter 246-240 WAC.

(3) Registrants using particle accelerators to produce radioactive material must meet the requirements of chapter 246-232 WAC, Radioactive material -- Licensing applicability; and chapter 246-235 WAC, Radioactive materials -- Specific licenses.

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NEW SECTION
WAC 246-229-0050   Who is authorized to terminate a registrant's use of a particle accelerator?   The radiation safety committee, the radiation safety officer of the facility, and the department are authorized to terminate the particle accelerator operations at a facility if the action is determined necessary to protect health and minimize danger to public health and safety or property.

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NEW SECTION
WAC 246-229-0060   What are the minimum requirements for particle accelerator installation?   (1) Shielding and safety design. The installation must include:

(a) Primary and secondary radiation barriers to comply with the radiation protection standards of WAC 246-221-010 and 246-221-060.

(b) If necessary, a ventilation system designed to limit exposure to airborne radioactive materials as follows:

(i) For restricted areas, limits are specified in WAC 246-221-040;

(ii) For unrestricted areas, limits are specified in WAC 246-221-070; and/or

(iii) For unrestricted areas, the facility must prohibit releases, venting, or otherwise discharging airborne radioactive material which exceeds the limits of WAC 246-247-040 or 246-221-290 Appendix A - Table II, unless authorized in WAC 246-221-180 or 246-221-070(2). To calculate, concentrations may be averaged over a period not greater than one year. Every reasonable effort should be made to prohibit releases of radioactive material to unrestricted areas.

(2) Controls, instrumentation, and readouts. All controls, instrumentation, and readouts must be clearly identified and functional on the particle accelerator control console.

(3) Safety interlocks. All entrances into a target room or other high radiation area must have interlocks that shut down the machine if a door is opened (e.g., barrier penetrated) during irradiation.

(a) Manual reset. If the interlock engages (shuts the machine off), the machine must stay off until manually reset at the console.

(b) Independent function. Each safety interlock must function independently of any other safety interlocks.

(c) Failsafe. All safety interlocks must ensure that any defect or component failure in the interlock system prevents operation of the accelerator.

(4) Emergency power cutoff switch system. An identifiable "scram" button or emergency power cutoff switch which stops irradiation must exist in all high radiation areas. If the switch is engaged (shuts off the machine), the system must prohibit the accelerator from restarting until the switch in the room is reset and the main console restarted manually. Use of this system is limited to emergency situations.

(5) High radiation area warning devices. For areas designated as high radiation areas, the registrant must:

(a) Identify barriers (including temporary) for and pathways to high radiation areas according to WAC 246-221-120, Caution signs and labels.

(b) Except inside treatment rooms in facilities designed for human exposure, install easily observable warning lights at area entrances that activate when radiation is being produced.

(c) Except in facilities designed for human exposure, install an audible warning device which activates for fifteen seconds prior to accelerator use in all high radiation areas. Instruct all personnel in the area as to the signal's meaning.

(d) Except in facilities designed for human exposure, install continuous radiation detection monitoring equipment. The equipment must be electrically independent of the accelerator control and interlock systems and be calibrated every six months at a minimum. The equipment must provide:

(i) A remote and local readout; and

(ii) Visual and/or audible alarms at the control panel, entrances to high radiation areas, and other appropriate locations.

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NEW SECTION
WAC 246-229-0070   What are the minimum requirements for operating and emergency procedure documentation?   At a minimum, the procedures must include instruction on:

(1) Securing the accelerator to prevent unauthorized use.

(2) Operating the accelerator.

(3) Responding to an emergency involving the accelerator.

(4) Performing safety and warning device (including interlocks) checks at least every three months.

(5) Performing radiation surveys.

(6) Performing monitoring equipment calibration (if applicable).

(7) Recordkeeping and/or documentation.

(8) Bypassing safety interlocks.

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NEW SECTION
WAC 246-229-0080   What are the requirements for bypassing safety interlocks?   Bypassing a safety interlock or interlocks is allowed only if:

(1) Authorized by the radiation safety committee and/or radiation safety officer;

(2) Recorded in a permanent log and a notice posted at the accelerator control console; and

(3) The bypass procedure is terminated as soon as possible.

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NEW SECTION
WAC 246-229-0090   What are the minimum requirements for particle accelerator use?   The minimum requirements for the registrant to use a particle accelerator are to:

(1) Register the accelerator with the department;

(2) Submit plan review/shielding design to the department and receive written approval;

(3) Train operators and users;

(4) Complete a qualified expert's radiation protection survey of the room/area initially and after any changes in shielding, equipment, or occupancy of adjacent areas;

(5) Provide appropriate portable radiation monitoring equipment that is operable and tested daily, and calibrated every six months, or after any service/repair;

(6) Develop operating and emergency procedures and keep a copy of the current procedures at the accelerator control panel; and

(7) If applicable, provide the means and guidance to determine airborne particulate radioactivity present in areas of airborne hazards, and/or particulate radiation contamination (smear surveys) in target and other pertinent areas.

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NEW SECTION
WAC 246-229-0100   What are the recordkeeping requirements for particle accelerator use?  


Records Retention time
Operator training and qualifications Two years past last employment/operation
Safety and warning device checks Two years
Area radiation monitors Two years (if necessary)
Instrumentation tests Two years
Smear results Two years (if necessary)
Qualified expert radiation protection surveys Life of the accelerator
Electrical circuit diagrams Life of the accelerator
Permanent log of bypassing interlocks Life of the accelerator

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REPEALER

     The following sections of the Washington Administrative Code are repealed:
WAC 246-229-001 Purpose and scope.
WAC 246-229-020 General requirements for the issuance of a registration for particle accelerators.
WAC 246-229-030 Human use of particle accelerators.
WAC 246-229-050 Limitations.
WAC 246-229-060 Shielding and safety design requirements.
WAC 246-229-070 Particle accelerator controls and interlock systems.
WAC 246-229-080 Warning devices.
WAC 246-229-090 Operating procedures.
WAC 246-229-100 Radiation monitoring requirements.
WAC 246-229-110 Ventilation systems.

Washington State Code Reviser's Office