WSR 08-04-081

PROPOSED RULES

DEPARTMENT OF HEALTH


[ Filed February 4, 2008, 11:00 p.m. ]

Original Notice.

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

Title of Rule and Other Identifying Information: Chapter 246-224 WAC, Radiation protection -- Radiation machine assembly and registration, WAC 246-224-0010 Definitions, 246-224-0040 What if we have separate locations with radiation machines?, 246-224-0050 When and how do I register?, 246-224-0070 When and how do I report changes to my registration?, 246-224-0080 When and how do I renew my registration?, and 246-224-0090 What are my obligations if I close my facility or get rid of a machine?

Hearing Location(s): Department of Health, Town Center 3, Room 224, 243 Israel Road S.E., Tumwater, WA 98501, on March 11, 2008, at 2:00 p.m.

Date of Intended Adoption: March 12, 2008.

Submit Written Comments to: Ellen G. Haars, Ph.D., X-ray Program, P.O. Box 47827, Olympia, WA 98504-7827, ellen.haars@doh.wa.gov, web site http://www3.doh.wa.gov/policyreview/, fax (360) 236-2266, by March 11, 2008.

Assistance for Persons with Disabilities: Contact Sharon Grundhoffer by March 1, 2008, TTY (800) 833-6388 or 711.

Purpose of the Proposal and Its Anticipated Effects, Including Any Changes in Existing Rules: Chapter 246-224 WAC informs registrants on how to apply for an X-ray registration and pay registration and renewal fees through the department of licensing (DOL). Amendments are needed for clarity and consistency with chapter 246-254 WAC, Radiation protection -- Fees.

Reasons Supporting Proposal: Previously, chapter 246-254 WAC, Radiation protection -- Fees, was revised in order to participate in DOL's master license service (MLS) and to comply with the governor's enterprise business portal initiative and RCW 19.02.050. Revisions are now needed in chapter 246-224 WAC to inform registrants on how to apply for their X-ray registration and pay registration and renewal fees through DOL.

Statutory Authority for Adoption: RCW 19.02.050, 43.20B.020, 43.70.110, 70.98.050, 70.98.080.

Statute Being Implemented: RCW 19.02.050, 43.20B.020, 43.70.110, 70.98.050, 70.98.080.

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

Name of Proponent: Washington state department of health, governmental.

Name of Agency Personnel Responsible for Drafting: Terry Frazee, 111 Israel Road S.E., Tumwater, WA 98501, (360) 236-3213; Implementation and Enforcement: Ellen G. Haars, Ph.D., 111 Israel Road S.E., Tumwater, WA 98501, (360) 236-3231.

No small business economic impact statement has been prepared under chapter 19.85 RCW. A small business economic impact statement (SBEIS) was not prepared. Under RCW 19.85.025(3) and 34.05.310 (4)(g)(ii), an SBEIS is not required for proposed rules that adopt, amend, or repeal a filing or related process requirement for applying to an agency for a license or permit.

A cost-benefit analysis is not required under RCW 34.05.328. The agency did not complete a cost-benefit analysis under RCW 34.05.328. RCW 34.05.328 (5)(b)(iv) exempts rules that only correct typographical errors, make address or name changes or clarify the language of a rule without changing its effect.

February 4, 2008

Mary C. Selecky

Secretary

OTS-1248.2


AMENDATORY SECTION(Amending WSR 02-14-050, filed 6/27/02, effective 7/28/02)

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

"Application" means, for the purpose of this chapter, the master business application and appropriate addenda used by the master license service of the department of licensing (DOL).

"Department" means the department of health.

"DOL" means the department of licensing.

"Facility" means ((the location)) all buildings, structures, and operations on one contiguous site or identified by one physical location address designation 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.

"MLS" means the department of licensing's master license service.

"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 by any person possessing a radiation machine in accordance with regulations adopted by 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.

[Statutory Authority: RCW 70.98.050 and [70.98.]080. 02-14-050, 246-224-0010, filed 6/27/02, effective 7/28/02.]


AMENDATORY SECTION(Amending WSR 02-14-050, filed 6/27/02, effective 7/28/02)

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)) notify DOL prior to the machine being moved, or notify the department at the time shielding plans are submitted for review.

[Statutory Authority: RCW 70.98.050 and [70.98.]080. 02-14-050, 246-224-0040, filed 6/27/02, effective 7/28/02.]


AMENDATORY SECTION(Amending WSR 02-14-050, filed 6/27/02, effective 7/28/02)

WAC 246-224-0050   When and how do I register?   (1) You must register with the department ((within)) through submission of a master business license application and appropriate addendum used by MLS no later than fifteen calendar days of initial use unless shielding plans review is required. ((You may also register anytime before initial use.))

(2) Facilities requiring shielding plan review must register with DOL and submit plans to the department for review prior to construction or installation of radiation machines according to WAC 246-225-030, General requirements -- Plan review.

(3) Registration is valid for one year from the department approval date, or any other date as may be determined through partnership with MLS.

(((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)) MLS in accordance with their instructions.


Note: For ((division of radiation protection)) DOL information, visit the following web site:
((http://www.doh.wa.gov/ehp/rp/Default.htm.)) http://www.dol.wa.gov/business/xray.htm.

[Statutory Authority: RCW 70.98.050 and [70.98.]080. 02-14-050, 246-224-0050, filed 6/27/02, effective 7/28/02.]


AMENDATORY SECTION(Amending WSR 02-14-050, filed 6/27/02, effective 7/28/02)

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

(2) Submit registration changes to:


Department of ((Health)) Licensing

((X-Ray Control Section)) Master License Service

P.O. Box ((47827)) 49034

Olympia, WA 98504-((7827))9034

((360-236-3230 or 1-800-299-XRAY)) 360-664-1400 or fax 360-570-7875


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

Note: For ((division)) office of radiation protection information, visit the following web site:
http://www.doh.wa.gov/ehp/rp/Default.htm.
For department of licensing information, visit the following web site:
http://www.dol.wa.gov/business/xray.htm.

[Statutory Authority: RCW 70.98.050 and [70.98.]080. 02-14-050, 246-224-0070, filed 6/27/02, effective 7/28/02.]


AMENDATORY SECTION(Amending WSR 02-14-050, filed 6/27/02, effective 7/28/02)

WAC 246-224-0080   When and how do I renew my registration?   (1) You ((must renew your registration annually)) will receive registration renewal notices from DOL.

(2) You must submit renewal information and the applicable ((registration)) fees to DOL 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)) by MLS.

(3) If ((registration is overdue, late fees apply according to WAC 246-254-053, Radiation machine facility registration fees)) you do not receive a renewal notice, contact DOL.

[Statutory Authority: RCW 70.98.050 and [70.98.]080. 02-14-050, 246-224-0080, filed 6/27/02, effective 7/28/02.]


AMENDATORY SECTION(Amending WSR 02-14-050, filed 6/27/02, effective 7/28/02)

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 or DOL 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 the department the following:

(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.

[Statutory Authority: RCW 70.98.050 and [70.98.]080. 02-14-050, 246-224-0090, filed 6/27/02, effective 7/28/02.]

Washington State Code Reviser's Office