WSR 09-04-097

PROPOSED RULES

DEPARTMENT OF HEALTH


[ Filed February 4, 2009, 10:21 a.m. ]

Original Notice.

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

Title of Rule and Other Identifying Information: WAC 246-282-005 Sanitary control of shellfish -- Minimum performance standards.

Hearing Location(s): Department of Health, Point Plaza East, Rooms 152 and 153, 310 Israel Road S.E., Tumwater, WA, on March 11, 2009, at 2:00 p.m.

Date of Intended Adoption: March 11, 2009.

Submit Written Comments to: Jan Jacobs, Office of Shellfish and Water Protection, P.O. Box 47824, Olympia, WA 98504-7824, web site http://www3.doh.wa.gov/policyreview/, fax (360) 236-2257, by March 4, 2009.

Assistance for Persons with Disabilities: Contact Jan Jacobs by March 3, 2009, TTY (800) 833-6388 or 711.

Purpose of the Proposal and Its Anticipated Effects, Including Any Changes in Existing Rules: Currently, WAC 246-282-005 references the United States Food and Drug Administration (FDA) 2005 NSSP guide, which all shellfish-producing states are required to follow in order to place molluscan shellfish into interstate commerce. The FDA has now adopted a 2007 version of the NSSP guide, leaving the current rules out of date. This rule making will amend the section to update the reference to the current code. The document below summarizes differences between the 2005 and 2007 version of the NSSP guide.

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

Statutory Authority for Adoption: RCW 69.30.030.

Statute Being Implemented: RCW 69.30.030.

Rule is not necessitated by federal law, federal or state court decision.

Name of Proponent: Department of health, governmental.

Name of Agency Personnel Responsible for Drafting: Jan Jacobs, 111 Israel Road S.E., Tumwater, WA, (360) 236-3316; Implementation and Enforcement: Maryanne Guichard, 111 Israel Road S.E., Tumwater, WA, (360) 236-3391.

No small business economic impact statement has been prepared under chapter 19.85 RCW. Under RCW 19.85.025(3) and 19.85.061, this proposed rule is exempt from the requirements of chapter 19.85 RCW because it adopts national consensus codes without material change. By federal rule/statute (list C.F.R./U.S.C. citation), the FDA requires shellfish-producing states to follow the NSSP guide in order to place molluscan shellfish into interstate commerce.

A cost-benefit analysis is not required under RCW 34.05.328. Under RCW 34.05.328 (5)(b)(viii), this proposed rule is exempt from the requirements of RCW 34.05.328 because it adopts a national consensus code without material change. By federal rule/statute (list C.F.R./U.S.C. citation), the FDA requires shellfish-producing states to follow the NSSP guide in order to place molluscan shellfish into interstate commerce.

February 4, 2009

Craig McLaughlin

Executive Director

State Board of Health

OTS-2108.1


AMENDATORY SECTION(Amending WSR 07-20-014, filed 9/20/07, effective 10/21/07)

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 ((2005)) 2007 National Shellfish Sanitation Program (NSSP) Guide for the Control of Molluscan Shellfish, published by the United States Department of Health and Human Services, Public Health Service, Food and Drug Administration (copies available through the U.S. Food and Drug Administration, Shellfish Sanitation Branch, and the Washington state department of health, office of food safety and shellfish programs);

(b) The provisions of 21 Code of Federal Regulations (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 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 Guide for the Control of Molluscan Shellfish or a provision of 21 CFR, 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.

[Statutory Authority: RCW 69.30.030. 07-20-014, 246-282-005, filed 9/20/07, effective 10/21/07; 06-01-055, 246-282-005, filed 12/16/05, effective 1/16/06. Statutory Authority: RCW 69.30.030 and 43.20.030. 01-04-054, 246-282-005, filed 2/5/01, effective 3/8/01. Statutory Authority: RCW 69.30.030. 98-18-066, 246-282-005, filed 8/31/98, effective 10/1/98; 98-03-096, 246-282-005, filed 1/21/98, effective 2/21/98; 96-18-096, 246-282-005, filed 9/4/96, effective 10/5/96; 94-23-026, 246-282-005, filed 11/8/94, effective 12/9/94.]

Washington State Code Reviser's Office