Title of Rule and Other Identifying Information: WAC 246-282-005 Sanitary control of shellfish minimum performance standards and 246-282-016 Aquaculture, the department of health (department) is amending WAC 246-282-005 which references the 2015 version of the National Shellfish Sanitation Program (NSSP) Guide for the Control of Molluscan Shellfish (guide). The rule making is necessary to update the publication date of the NSSP guide adopted by reference in the rule from 2015 to the most recently adopted 2017 version. The department is also amending WAC 246-282-016 to remove an exemption from the requirements for hatchery operations because the 2017 NSSP guide no longer allows the exemption.

Purpose of the Proposal and Its Anticipated Effects, Including Any Changes in Existing Rules: The proposed amendments will update the reference to the NSSP guide to assure that the most current health and safety requirements are in rule as required by the statute. The United States Food and Drug Administration (FDA) requires all shellfish-producing states to follow the most current version of the NSSP guide in order to place molluscan shellfish into interstate commerce. The rule currently references the 2015 NSSP guide, leaving the current rules out of date. The proposed rule updates the reference to the 2017 version of the NSSP guide. The proposal also removes the exemption for persons conducting aquaculture activities for a hatchery operation or a hatchery only handling seed. This change is necessary to avoid inconsistency with the 2017 NSSP guide which removed the exemption from the 2017 version.

Reasons Supporting Proposal: FDA oversees a cooperative program between the shellfish-producing states and the shellfish industry for the production and processing of shellfish consistent with the NSSP guide. FDA evaluates each state's shellfish sanitation control program to ensure compliance with the NSSP guide. Therefore, an update of WAC 246-282-005 and 246-282-016 is needed so that Washington state remains compliant with the NSSP guide and the molluscan shellfish products from Washington can continue to be placed into interstate commerce.

A cost-benefit analysis is not required under RCW 34.05.328. The department did not complete a cost-benefit analysis under RCW 34.05.328. RCW 34.05.328 (5)(b)(iii) exempts rules that adopt or incorporate by reference without material change federal statutes or regulations, Washington state law, the rules of other Washington state agencies, or national consensus codes that generally establish industry standards.

Is exempt under RCW 19.85.061 because this rule making is being adopted solely to conform and/or comply with federal statute or regulations. Citation of the specific federal statute or regulation and description of the consequences to the state if the rule is not adopted: RCW 69.30.030(2) mandates the state board of health to consider the most recent version of the national shellfish sanitation program model ordinance, adopted by the interstate shellfish sanitation conference, when adopting rules. In order to remain compliant with FDA requirements to place molluscan shellfish into interstate commerce, the department must adopt rules that are at-least-as-stringent-as the most recent version of the NSSP guide. The proposed amendments are needed to remain compliant with the 2017 NSSP guide.

Is exempt under RCW 19.85.025(3) as the rules are adopting or incorporating by reference without material change federal statutes or regulations, Washington state statutes, rules of other Washington state agencies, shoreline master programs other than those programs governing shorelines of statewide significance, or, as referenced by Washington state law, national consensus codes that generally establish industry standards, if the material adopted or incorporated regulates the same subject matter and conduct as the adopting or incorporating rule.

(1) Any person engaged in a shellfish operation or possessing a commercial quantity of shellfish or any quantity of shellfish for sale for human consumption must comply with and is subject to:

(a) The requirements of the U.S. Food and Drug Administration National Shellfish Sanitation Program (NSSP), Guide for the Control of Molluscan Shellfish (((2015)))(2017) (copies available through the U.S. Food and Drug Administration, Shellfish Sanitation Branch, and the Washington state department of health, office of shellfish and water protection);

(b) The provisions of 21 Code of Federal Regulations (C.F.R.), Part 123 - Fish and Fishery Products, adopted December 18, 1995, by the United States Food and Drug Administration, regarding Hazard Analysis Critical Control Point (HACCP) plans (copies available through the U.S. Food and Drug Administration, Office of Seafood, and the Washington state department of health, office of food safety and shellfish programs); and

(2) If a requirement of the NSSP Model Ordinance or a provision of 21 C.F.R., Part 123, is inconsistent with a provision otherwise established under this chapter or other state law or rule, then the more stringent provision, as determined by the department, will apply.

Any person who conducts an aquaculture operation and is in possession of a commercial quantity of shellfish or any quantity of shellfish for sale for human consumption must meet all requirements of this chapter((, except such person is exempt from all requirements of this chapter for the purpose of conducting aquaculture activities limited to the following:

(1) A hatchery operation; or

(2) A nursery operation handling only seed that is obtained from a hatchery)).