WSR 14-21-060 EMERGENCY RULES STATE BOARD OF HEALTH [Filed October 9, 2014, 8:00 a.m., effective October 9, 2014, 8:00 a.m.] Effective Date of Rule: Immediately upon filing.
Purpose: WAC 246-282-005, amending the rule to reference the 2013 version of the National Shellfish Sanitation Program (NSSP) Guide. The United States Food and Drug Administration (FDA) requires all shellfish-producing states to follow the most current version of the NSSP, Guide for the Control of Molluscan Shellfish in order to place molluscan shellfish into interstate commerce. The rule currently references the 2011 NSSP Guide, leaving the current rules out-of-date.
Citation of Existing Rules Affected by this Order: Amending WAC 246-282-005 Sanitary control of shellfish—Minimum performance standards.
Statutory Authority for Adoption: RCW 69.30.030.
Under RCW 34.05.350 the agency for good cause finds that immediate adoption, amendment, or repeal of a rule is necessary for the preservation of the public health, safety, or general welfare, and that observing the time requirements of notice and opportunity to comment upon adoption of a permanent rule would be contrary to the public interest.
Reasons for this Finding: The Administrative Procedure Act, RCW 34.05.350, allows the department to adopt an emergency rule as follows:
(1) If an agency for good cause finds:
(a) That immediate adoption, amendment, or repeal of a rule is necessary for the preservation of the public health, safety, or general welfare, and that observing the time requirements of notice and opportunity to comment upon adoption of a permanent rule would be contrary to the public interest;
(b) That state or federal law or federal rule or a federal deadline for state receipt of federal funds requires immediate adoption of a rule; or
(c) In order to implement the requirements or reductions in appropriations enacted in any budget for fiscal years 2009, 2010, 2011, 2012, or 2013 which necessitates the need for the immediate adoption, amendment, or repeal of a rule, and that observing the time requirements of notice and opportunity to comment upon adoption of a permanent rule would be contrary to the fiscal needs or requirements of the agency.
The agency may dispense with those requirements and adopt, amend, or repeal the rule on an emergency basis. The agency's finding and a concise statement of the reasons for its finding shall be incorporated in the order for adoption of the emergency rule or amendment filed with the office of the code reviser under RCW 34.05.380 and with the rules review committee.
The FDA published the 2013 NSSP Guide on September 30, 2014. This guide includes license requirements for growing, harvesting, processing, and shipping molluscan shellfish in a way that is safe for human consumption. The FDA requires states to regulate these activities consistent with the NSSP Guide in order for licensees to place molluscan shellfish into interstate commerce.
The state must ensure that our requirements immediately align with the 2013 NSSP Guide in order to protect public health and prevent disease, and for FDA to allow interstate commerce of molluscan shellfish from Washington state. The short time frame between the publication of the 2013 version of the NSSP by the FDA and the required implementation of the NSSP requirements by the state does not allow use of the regular rule-making process. Therefore, an emergency rule is necessary in order for the state to remain consistent with the requirements of the FDA.
Number of Sections Adopted in Order to Comply with Federal Statute: New 0, Amended 0, Repealed 0; Federal Rules or Standards: New 0, Amended 1, Repealed 0; or Recently Enacted State Statutes: New 0, Amended 0, Repealed 0.
Number of Sections Adopted at Request of a Nongovernmental Entity: New 0, Amended 0, Repealed 0.
Number of Sections Adopted on the Agency's Own Initiative: New 0, Amended 0, Repealed 0.
Number of Sections Adopted in Order to Clarify, Streamline, or Reform Agency Procedures: New 0, Amended 0, Repealed 0.
Number of Sections Adopted Using Negotiated Rule Making: New 0, Amended 0, Repealed 0; Pilot Rule Making: New 0, Amended 0, Repealed 0; or Other Alternative Rule Making: New 0, Amended 1, Repealed 0.
Date Adopted: October 8, 2014.
Michelle A. Davis
Executive Director
AMENDATORY SECTION (Amending WSR 14-09-003, filed 4/3/14, effective 5/4/14)
WAC 246-282-005 Minimum performance standards.
(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 (((2011)) 2013) (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
(c) All other provisions of this chapter.
(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.
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