WSR 02-07-021

PROPOSED RULES

DEPARTMENT OF HEALTH


[ Filed March 11, 2002, 2:01 p.m. ]

Original Notice.

Preproposal statement of inquiry was filed as WSR 02-02-017 [02-02-016].

Title of Rule: Chapter 246-224 WAC, Radiation protection -- Machine assembly and registration and chapter 246-229 WAC, Radiation protection -- Particle accelerators.

Purpose: The purpose of this proposal is to increase clarity and usability using clear rule-writing techniques.

Other Identifying Information: These revisions are the result of a review conducted under EO 97-02, Regulatory Improvement.

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

Statute Being Implemented: RCW 70.98.050 and [70.98].080.

Summary: Chapter 246-224 WAC, regulates the registration, disposition, assembly, and installation of x-ray machines in Washington state; and chapter 246-229 WAC, regulates the installation and use of particle accelerators in Washington state.

Reasons Supporting Proposal: The Governor's Executive Order 97-02, Regulatory Improvement, supports this proposal for improving clarity and usability of Washington state rules.

Name of Agency Personnel Responsible for Drafting, Implementation and Enforcement: Mark Radonich, Seattle, (206) 281-6995.

Name of Proponent: Washington State Department of Health, governmental.

Rule is not necessitated by federal law, federal or state court decision.

Explanation of Rule, its Purpose, and Anticipated Effects: Chapter 246-224 WAC requires registration of x-ray machines and identifies the obligations of sellers, installers, and assemblers of x-ray equipment and services. Chapter 246-229 WAC regulates the installation and use of particle accelerators in order to provide protection to workers and the public.

The purpose of these chapters is to allow the department the ability to regulate ionizing radiation sources, as required by statute.

The anticipated effect of these revisions is to make the rules easier to read, understand, and use. The proposal is expected to greatly reduce the confusion caused by the obscure and outdated language used in the current rule. The department expects better compliance with the requirements of the rule with less technical assistance required to achieve compliance.

Proposal Changes the Following Existing Rules: This proposal eliminates obsolete reporting requirements, clarifies rule requirements for registrants and assemblers of x-ray machines.

No small business economic impact statement has been prepared under chapter 19.85 RCW. Chapter 19.85 RCW does not apply to this proposed rule because the revisions only clarify language without changing the effect and there are no increased costs as a result of these changes. On the contrary, costs of complying with this rule are expected to go down as a result of increased clarity and understanding of the requirements of the rule.

RCW 34.05.328 does not apply to this rule adoption. RCW 34.05.328 does not apply to this proposed rule because the revisions only clarify language without changing the effect.

Hearing Location: Department of Health, 20435 72nd Avenue South, Suite 200, Conference Room 2, Kent, WA 98032, on April 25, 2002, at 1:00 p.m.

Assistance for Persons with Disabilities: Contact Phyllis Hurtado by April 18, 2002, TDD (800) 833-6388, or (360) 236-3230.

Submit Written Comments to: Mark Radonich, Department of Health, Radiation Protection, P.O. Box 7827, Olympia, WA 98504, fax (360) 236-2255, by April 25, 2002.

Date of Intended Adoption: April 26, 2002.

Mary C. Selecky

Secretary

OTS-5433.3

Chapter 246-224 WAC

RADIATION PROTECTION -- X-RAY 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 x-ray 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.

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

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

"Storage" means the status of an x-ray machine that is unable to produce x-ray radiation without substantial effort at set-up, reassembly, or reinstallation.

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NEW SECTION
WAC 246-224-0020   Who must register an x-ray 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 x-ray machines within Washington state that do not have to be registered?   (1) Any electronic equipment producing incidental x rays does not need to be registered (including television receivers), 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) X-ray machines in transit or storage; and

(3) X-ray machines held for sale or lease by x-ray agents.

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NEW SECTION
WAC 246-224-0040   What if we have separate locations with x-ray machines?   (1) Geographically separate facilities must register and pay fees separately according to WAC 246-254-053, Radiation machine facility registration fees, 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) Registration information includes, 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 site);

(f) Total number and type of x-ray machines (tubes) at the site;

(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 x-ray machine 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 x-ray 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 registration change.

(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.

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 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, 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 placed in storage and retained, contact the department to suspend registration until the machine is reinstalled or returned to service.

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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 x-ray 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 an x-ray 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 x-ray 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 use or dental use x-ray machines within the state must register with the department according to WAC 246-224-0020.

(4) For 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 x-ray machine?   The registrant 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-5434.3


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 medical 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, physicians 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 -- X-ray machine assembly and registration, prior to installation or use of the particle accelerator.

(2) A registrant must submit the following information:

(a) A list of qualified operators and users;

(b) An identified radiation safety officer; and

(c) 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;

(b) The registrant must appoint a radiation safety committee; and

(c) The registrant must include 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.

(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) 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 assignment.

(2) The registrant must:

(a) Provide training for operators to use the particle accelerator that meets the requirements of subsection (1) of this section; and

(b) Maintain training records that demonstrate compliance with the requirements of subsection (1) of this section for two years after the last employment or operation date for the operator.

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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 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) Install easily observable warning lights at area entrances that activate when radiation is being produced.

(b) 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.

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

(d) Install continuous radiation detection monitoring equipment except in facilities designed for human exposure. 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 guidance 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) Intentionally bypassing safety interlocks.

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NEW SECTION
WAC 246-229-0080   What are the requirements for intentionally bypassing safety interlocks?   Bypassing a safety interlock or interlocks intentionally 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 servicing and/or repair of the particle accelerator, including 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