WSR 97-21-138

PROPOSED RULES

STATE BOARD OF HEALTH

[Filed October 22, 1997, 9:27 a.m.]

Original Notice.

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

Title of Rule: WAC 246-282-005 Minimum performance standards, minimum performance standards for licensed commercial shellfish operators.

Purpose: To adopt the federal Food and Drug Administration (FDA) hazard analysis critical control point (HACCP) regulations for seafood processors which are applicable to the shellfish industry. The rules are intended to prevent foodborne illness from contaminated molluscan shellfish through proper handling at every step in the shellfish growing/harvesting/processing cycle.

Statutory Authority for Adoption: RCW 69.30.030.

Summary: The Department of Health (DOH) proposes adopting the Food and Drug Administration's seafood hazard analysis critical control point (HACCP) regulations by reference into WAC 246-282-005.

Reasons Supporting Proposal: Department of Health adoption will ensure that commercial molluscan shellfish operations in the state will continue to be primarily inspected and regulated by DOH. This will avoid an overlap in federal/state regulatory authority and keep shellfish operations from being regularly inspected by both DOH and FDA.

Name of Agency Personnel Responsible for Drafting: Ned Therien, Building 4, Airdustrial Complex, Tumwater, (360) 664-4372; Implementation and Enforcement: Jennifer Tebaldi, Building 4, Airdustrial Complex, Tumwater, (360) 664-3257.

Name of Proponent: Department of Health, governmental.

Rule is necessary because of federal law, 21 CFR 123.3-123.28, 1240.3 and 1240.60.

Explanation of Rule, its Purpose, and Anticipated Effects: Molluscan shellfish pose a significant risk to public health if not properly handled at every step in the shellfish growing/harvesting/processing cycle to prevent contamination. The federal HACCP rules for seafood will require operations to evaluate their food processing procedures and monitor the steps to reduce potential hazards to consumers. Each shellfish operation which conducts processing (as defined by FDA) will be required to develop and implement a written HACCP plan. The HACCP principles have been employed by other segments of the food industry to reduce the risk of foodborne illness.

Proposal Changes the Following Existing Rules: The HACCP regulations are new requirements for the commercial shellfish industry. All other existing rules remain unchanged.

No small business economic impact statement has been prepared under chapter 19.85 RCW. This proposal adopts federal rules by reference into Washington Administrative Code (WAC) and is exempt from the requirement to prepare a small business economic impact statement.

RCW 34.05.328 does not apply to this rule adoption. This proposal adopts federal rules by reference into Washington Administrative Code (WAC) and is exempt from the analysis required by RCW 34.05.328.

Hearing Location: Doubletree Hotel, SeaTac, 18440 Pacific Highway South, Seattle, WA 98188, on December 10, 1997, at 9:30 a.m.

Assistance for Persons with Disabilities: Contact Ned Therien by December 3, 1997, TDD (800) 833-6388, or FAX (360) 586-4499.

Submit Written Comments to: Ned Therien, Office of Shellfish Programs, P.O. Box 47824, Olympia, WA 98504, FAX (360) 586-4499, by November.

Date of Intended Adoption: December 10, 1997.

October 20, 1997

Sylvia Beck

Executive Director

AMENDATORY SECTION (Amending WSR 96-18-096, filed 9/4/96, effective 10/5/96)

WAC 246-282-005 Minimum performance standards. (1) Every person engaged in a shellfish operation shall comply with and shall be subject to:

(a) The "satisfactory compliance" standards of the 1995 revision of the National Shellfish Sanitation Program (NSSP) Manual of Operations Part I and II, published by the United States Department of Health and Human Services, Public Health Service, Food and Drug Administration. Copies can be obtained through the U.S. Food and Drug Administration, Shellfish Sanitation Branch, and the Washington state department of health, office of shellfish programs.

(b) The provisions of 21 CFR, 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 can be obtained through the U.S. Food and Drug Administration, Office of Seafood, and the Washington state department of health, office of shellfish programs.

(c) All other provisions of this chapter.

(2) Where a "satisfactory compliance" provision is inconsistent with a provision otherwise established under this chapter or other state law or rule, the more stringent provision, as determined by the department, shall apply.