Title of Rule and Other Identifying Information: Chapter 246-315 WAC, Dental laboratories, the department of health is creating a new chapter to establish registration, regulation, and fees for dental laboratories as required by HB 1177 (chapter 68, Laws of 2019).

Hearing Location(s): On October 28, 2020, at 1:00 p.m. In response to the coronavirus disease 2019 (COVID-19) public health emergency, the department of health (DOH) will not provide a physical location for this hearing to promote social distancing and the safety of the citizens of Washington state. A virtual public hearing, without a physical meeting space will be held instead.

To access the meeting: Please join meeting from your computer, tablet or smartphone: https://global.gotomeeting.com/join/246294429. You can also dial in using your phone: United States: +1 (872) 240-3212. Access Code: 246-294-429.

Submit Written Comments to: Bruce Bronoske, Jr., Washington State Department of Health, P.O. Box 47852, Olympia, WA 98504, email https://fortress.wa.gov/doh/policyreview, fax 360-236-4901, bruce.bronoske@doh.wa.gov, by October 28, 2020.

Assistance for Persons with Disabilities: Contact Bruce Bronoske, Jr., phone 360-236-4843, fax 360-236-4901, TTY 771 [711], email bruce.bronoske@doh.wa.gov, by October 21, 2020.

Purpose of the Proposal and Its Anticipated Effects, Including Any Changes in Existing Rules: DOH (department) proposes new rules to implement HB 1177. This bill created a dental laboratory registration within the department. The bill establishes minimum standards for dental laboratories, and instructs the department to register and assign registration numbers for dental laboratory registrations, and establish fees.

The department will maintain a registration database for dental laboratories and is proposing rules that establish standards for denial of a registration and disciplinary action. The proposed rules also establish fees for registration. The proposed rules restate the requirements in the statute for background and continuity, and provide clarity as needed.

Reasons Supporting Proposal: The statute and proposed new rules will increase public safety by establishing minimum registration requirements for dental laboratories including fees. The proposed rules also clarify material disclosure requirements by mandating that the disclosures be provided in writing to the prescribing dentist. The goal of HB 1177 is to protect the safety of Washington residents, and the department proposes to achieve that goal through the establishment of this rule.

A cost-benefit analysis is required under RCW 34.05.328. A preliminary cost-benefit analysis may be obtained by contacting Bruce Bronoske, Jr., P.O. Box 47852, Olympia, WA 98504, phone 360-236-4843, fax 360-236-4901, TTY 711, email bruce.bronoske@doh.wa.gov.

Is exempt under RCW 19.85.025(3) as the rules only correct typographical errors, make address or name changes, or clarify language of a rule without changing its effect; rule content is explicitly and specifically dictated by statute; and rules set or adjust fees under the authority of RCW 19.02.075 or that set or adjust fees or rates pursuant to legislative standards, including fees set or adjusted under the authority of RCW 19.80.045.

The proposed rule does not impose more-than-minor costs on businesses. Following is a summary of the agency's analysis showing how costs were calculated. The proposed rules do not impose costs on businesses.

The definitions in this section apply throughout the chapter unless the context clearly requires otherwise.

(1) "Department" means the Washington state department of health.

(2) "Responsible person" means an owner or employee who meets the requirements listed in RCW 70.352.050 (1) and (2).

(3) "Supervising dentist" means an individual licensed to practice dentistry pursuant to chapter 18.32 RCW, and who has personally authorized the procedures to be performed.

As of January 31, 2021, each dental laboratory operating, doing business, or intending to operate or do business in this state must possess a current registration issued by the department, unless exempt under RCW 70.352.020(3) or 70.352.900.

An applicant for a dental laboratory registration shall submit to the department the following:

(1) An application on forms provided by the department;

(2) A verification that the dental laboratory meets the requirements listed in RCW 70.352.050;

(3) An acknowledgment by the responsible person or supervising dentist who is licensed in this state attesting that the dental laboratory will provide written material disclosure to the prescribing dentist that contains the information required in RCW 70.352.030 (1)(e);

(4) An acknowledgment by the responsible person or supervising dentist who is licensed in this state attesting that the dental laboratory will disclose in writing to the prescribing dentist the point of origin of the manufacture of each prescribed restoration as required in RCW 70.352.030 (1)(f); and

(5) The fee required under WAC 246-315-990.

(1) Under RCW 70.352.070 and chapter 34.05 RCW the department may deny a registration to any applicant who does not comply with the requirements or standards listed in chapter 70.352 RCW or the rules adopted in this chapter.

(2) Pursuant to chapter 34.05 RCW, the department may impose conditions, suspend or revoke the registration of any dental laboratory which fails or refuses to comply with the requirements of chapter 70.352 RCW or the rules adopted in this chapter.

Dental laboratory registration fees, renewal requirements and renewal cycle.

(1) Registration must be renewed annually prior to July 31st of each year as provided in RCW 70.352.060.

(2) The department will renew the dental laboratory registration when the responsible person or supervising dentist submits:

(a) A completed renewal form, provided by the department;

(b) The designated renewal fee; and

(c) A signed attestation verifying that the dental laboratory continues to meet the registration requirements listed in RCW 70.352.030 and 70.352.050(3).

(3) The following nonrefundable fees will be charged:

Title of Fee	Fee
Application	$250.00
Renewal	250.00
Late renewal penalty	125.00
Expired registration reissuance	125.00
Registration verification	25.00
Duplicate registration	15.00