WSR 26-09-069

NOTICE OF APPEAL

OFFICE OF THE GOVERNOR

[Filed April 14, 2026, 9:40 a.m.]

Pursuant to RCW 34.05.330(3), you are hereby notified for publication in the Washington State Register that:

On February 10, 2026, the Governor's Office received an appeal from William Osmunson, relating to the Washington State Board of Health's denial of a petition to amend or repeal WAC 246-290-220 (Drinking water materials and additives). The Governor denied the appeal on April 14, 2026.

DATE: April 14, 2026

Kristin Beneski

Chief Legal Counsel to the Governor

April 14, 2026

William Osmunson, DDS, MPH

Via email: billosmunson3@gmail.com

Re: APA Appeal - Washington Administrative Code (WAC) 246-290.

Dear Dr. Osmunson:

On February 10, 2026, the Governor's Office received the appeal you filed in response to the Washington State Board of Health's decision to deny your petition to amend WAC 246-290. Under RCW 34.05.330(3), an agency's denial of a petition to repeal or amend a rule may be appealed to the Governor. However, the Governor lacks jurisdiction under this statute to consider matters other than an appeal of the agency's denial of a petition, such as requests for clarification. See RCW 34.05.330(3).

On December 11, 2025, you petitioned the Board of Health to amend WAC 246-290 by adding the following sections:

"WAC 246-290-2XX - Manufacturer Safety Assurance for Disease-Prevention Additives

(a) This section is adopted under RCW 43.20.050 (2)(a), which requires the State Board of Health to assure safe and reliable drinking water for the people of Washington.

(b) The purpose of this section is to prevent the sale, distribution, or use of any substance intentionally added to public drinking water for the purpose of preventing, mitigating, or treating disease in humans unless the manufacturer or supplier has obtained applicable federal approval and demonstrated safety and efficacy for systemic exposure via drinking water, OR provides the Board of Health with the safety and efficacy randomized controlled studies to the Board and Department's satisfaction..

(c) This section places the primary burden of compliance on manufacturers, importers, and distributors, consistent with federal law, while maintaining oversight by the Board of Health and Department of Health.

(a) Disease-prevention additive (drug) means any chemical, compound, or preparation that is represented, labeled, marketed, or widely known to the public as intended to prevent, reduce, or treat disease in humans when ingested in drinking water, as defined by 21 U.S.C. § 321 (g)(1)(B).

(b) Manufacturer/Distributor means "drug manufacturer" and "drug wholesaler" as defined in RCW 69.70.010 and chapter 18.64 RCW, including any facility or entity (domestic or foreign) that manufactures, imports, or distributes disease-prevention additives for sale to Washington public water systems.

(c) Approval means authorization, New Drug Application (NDA/ANDA) approval, or other written determination of lawful marketing status by the U.S. Food and Drug Administration (FDA) under the FD&C Act, confirming safety and efficacy for systemic exposure in drinking water at the intended dose.

(d) Poison has the same meaning as in RCW 69.38.010.

(3) Prohibition on Unapproved Products

No Group A public water system may purchase, receive, or add any disease-prevention additive to a public drinking-water supply unless:

(a) The manufacturer or distributor has provided the Department of Health with:

(i) Proof of FDA approval or lawful marketing status for the intended disease-prevention use in drinking water; or

(ii) A sworn declaration under penalty of perjury that no such approval exists and that the product is not evaluated by FDA for safety and efficacy as an ingested drug;

(iii) Or, randomized controlled trials of both safety and efficacy; and

(b) The manufacturer or distributor accepts responsibility and liability for the additive, including contaminants, and for any harm arising from its use.

Manufacturers, importers, and distributors of disease-prevention additives shall:

(a) Submit to the Department of Health either:

(1) A copy of the FDA approval letter and NDA/ANDA number verifying lawful marketing status for the disease-prevention use; or

(2) A sworn declaration that no such approval exists, that the product is not FDA-evaluated as a drug for this use, and that any disease-prevention claims are made at the manufacturer's sole risk.

(3) Copies of randomized controlled trials of both safety and efficacy.

(b) Provide a Material Safety Data Sheet (MSDS) or Safety Data Sheet (SDS) and product label indicating chemical composition, batch assay, manufacturer identity (including country of origin), and intended use.

(c) Immediately notify the Department and all purchasers of any change in FDA approval status, formulation, source (including foreign supplier changes), or intended use.

(d) Provide proof of liability insurance adequate to cover harm to the public from ingestion of the additive and its contaminants.

(a) The Department shall maintain a public registry of disease-prevention additives, indicating for each product: manufacturer identity and country of origin; FDA approval status; and whether the product is unapproved and not evaluated for safety and efficacy.

(b) The Department shall notify all Group A public water systems annually of the registry and advise systems to purchase only from manufacturers with documented FDA approval or to disclose clearly to consumers when unapproved products are being used.

(c) If federal approval or jurisdiction is uncertain, the Department may request a legal opinion from the Attorney General and/or refer the matter to FDA for determination.

(a) Within 90 days of the effective date of this rule, each Group A system currently using a disease-prevention additive shall request from its supplier the documentation required under subsection (4).

(b) If proof of FDA approval or a sworn declaration is not received within 12 months, the system may not repurchase the additive until the manufacturer complies with this rule.

(c) The Department may issue notices of non-compliance and refer manufacturers or distributors to federal agencies for enforcement of drug laws as appropriate.

(a) Nothing in this section alters the authority of FDA or EPA under federal law.

(b) This rule ensures that state purchasing and use of human disease-prevention additives—other than substances used solely to treat and purify water under EPA authority—conform to the Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 321 (g)(1)(B); 21 U.S.C. § 355) and the state's duty to assure safe drinking water."

Petition at 1. These proposed subsections would regulate manufacturers, importers, and distributors of fluoride. The WAC chapter that is the subject of your appeal, Ch. 246.290 [246-290] WAC, defines basic regulatory requirements for Group A Public Water Systems.

The Board denied your petition on February 9, 2026. The Board's denial letter indicates that its members were provided with your petition and all supporting materials. Board Response at 1. At the Board meeting, Board staff provided background information about the petition's request. Board Response at 1. The Board states that RCW 43.20.050 authorizes the Board to adopt rules that apply to Group A Public Water Systems, but it does not regulate manufacturers of fluoride. Based on this limitation on its jurisdiction, the Board concluded that your request "is beyond the scope of their authority and referred to a previous letter sent to you on December 22, 2025 regarding a similar type of petition and describing this information." Board Response at 1.

On February 10, 2026, you appealed the denial to the Governor's office, requesting "executive review and clarification" of the Board's denial of your petition. Appeal Petition at 1. The appeal petition states that "[t]his request is not an appeal seeking reversal of the Board's decision, nor does it ask the Governor to substitute judgment for that of an independent board." Appeal Petition at 1. Instead, your submission asks the Governor to consider these questions: 1) "Which Washington State entity, if any, has responsibility for assuring the safety of substances intentionally added to public drinking water for disease prevention?"; 2) "May a state agency continue to permit or endorse such practices while disclaiming responsibility for safety determinations?"; 3) If the Board of Health lacks authority to adopt disclosure or procurement safeguards, which agency must act to prevent a regulatory void?"; and 4) Would an Attorney General opinion be appropriate to clarify jurisdiction, responsibility, and fiscal obligations under current law?" Appeal Petition at 2.

As noted above, RCW 34.05.330(3) provides for the Governor's review of agency denials of a petition to repeal or amend a rule; however, requests for clarification or consideration of questions outside the scope of the rule petition are outside the scope of this rule appeal process. Accordingly, the Governor does not have statutory authority to take action pursuant to RCW 34.05.330 in response to your request.

Sincerely,

Kristin Beneski

Chief Legal Counsel