WSR 11-17-104

PERMANENT RULES

DEPARTMENT OF HEALTH


[ Filed August 22, 2011, 3:31 p.m. , effective September 22, 2011 ]


Effective Date of Rule: Thirty-one days after filing.

Purpose: WAC 246-282-005 and 246-282-032, the purpose of this rule making is to adopt the 2009 National Shellfish Sanitation Program (NSSP) Guide for the Control of Molluscan Shellfish (guide), which all shellfish producing states are required to follow in order to place molluscan shellfish into interstate commerce. The proposed rule will also update the office name in WAC 246-282-005 (1)(a) and correct a subsection numbering error in WAC 246-282-032(4).

Citation of Existing Rules Affected by this Order: Amending WAC 246-282-005 and 246-282-032.

Statutory Authority for Adoption: RCW 69.30.030.

Adopted under notice filed as WSR 11-12-034 on May 25, 2011.

Number of Sections Adopted in Order to Comply with Federal Statute: New 0, Amended 0, Repealed 0; Federal Rules or Standards: New 0, Amended 1, Repealed 0; or Recently Enacted State Statutes: New 0, Amended 0, Repealed 0.

Number of Sections Adopted at Request of a Nongovernmental Entity: New 0, Amended 0, Repealed 0.

Number of Sections Adopted on the Agency's Own Initiative: New 0, Amended 1, Repealed 0.

Number of Sections Adopted in Order to Clarify, Streamline, or Reform Agency Procedures: New 0, Amended 0, Repealed 0.

Number of Sections Adopted Using Negotiated Rule Making: New 0, Amended 0, Repealed 0; Pilot Rule Making: New 0, Amended 0, Repealed 0; or Other Alternative Rule Making: New 0, Amended 2, Repealed 0.

Date Adopted: August 22, 2011.

Mary C. Selecky

Secretary

OTS-3967.1


AMENDATORY SECTION(Amending WSR 09-08-116, filed 3/31/09, effective 5/1/09)

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 ((2007)) 2009 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)) and water protection);

(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. 09-08-116, 246-282-005, filed 3/31/09, effective 5/1/09; 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.]


AMENDATORY SECTION(Amending WSR 01-04-054, filed 2/5/01, effective 3/8/01)

WAC 246-282-032   Relay permit.   (1) The department will issue a relay permit to a person to move shellfish from a harvest site in a growing area classified as "restricted" or "conditionally approved" in closed status meeting the criteria for "restricted" classification, if all of the following conditions are met.

(a) The person possesses a valid shellfish operation license.

(b) The person possesses a valid harvest site certificate listing both the initial harvest site and the grow-out site.

(c) The initial harvest site and grow-out site meet the requirements for relay specified in this chapter and the NSSP Model Ordinance.

(d) The person submits a completed written application and plan of operations approved by the department completely describing the procedures and conditions of the relay operation.

(e) The person conducts and documents a separate validation study approved by the department for each of the following periods of time when shellfish will be relayed:

(i) May 1 through October 31; and

(ii) November 1 through April 30.

(f) The person pays the department a relay permit application fee or renewal fee as required by this chapter.

(2) Each validation study for a relay permit must demonstrate that shellfish harvested from a specified initial site do not contain excessive levels of fecal coliform bacteria and when relayed to a specified grow-out site for a specified time period consistently purge themselves of bacteria to approved levels. Each validation study must meet all of the following conditions.

(a) It must document that the geometric mean fecal coliform bacteria level in a minimum of five 100-gram tissue samples, representative of shellfish of the same species in the entire initial harvest site, is equal to or less than 1300, with no sample having more than 2300.

(b) It must document that specified relay procedures, times, and environmental conditions reduce fecal coliform bacteria in a minimum of five 100-gram tissue samples, representative of the entire lot of shellfish relayed, to levels that are equal to or less than:

(i) 330, with no more than two samples having greater than 230; or

(ii) Ten percent greater than the geometric mean of a minimum of five 100-gram tissue samples representative of the same shellfish species grown continuously for a minimum of six months at the grow-out site.

(c) It must be repeated a minimum of once every twelve years for a continuing operation and whenever relay conditions change.

(d) All samples must be analyzed by an approved laboratory.

(3) A person operating under a relay permit must follow all procedures in the plan of operations approved by the department, including:

(a) Staking or marking the grow-out site to be easily identified by the person until the minimum relay period of time is passed;

(b) Considering the beginning of the minimum relay time period for a lot to be the moment that the last part of the lot is added to the grow-out site;

(c) Relaying shellfish to a designated grow-out site for a minimum of seven days, or longer period of time as approved by the department; and

(d) Keeping records for each relayed lot of shellfish that show a lot identification number; the species, location, date, and quantity moved from the initial harvest site; the grow-out location; and the date of first harvest of any of those shellfish from the grow-out site.

(4) For each lot of shellfish relayed to a site for a grow-out period of less than fourteen days, a person must:

(((i))) (a) Collect at least one sample from the shellfish lot at the initial harvest site and have it analyzed by an approved laboratory to demonstrate that the lot contains no more than 2300 fecal coliform bacteria per 100 grams of shellfish tissue; and

(((ii))) (b) Collect at least one sample from the shellfish lot at the grow-out site at the end of the relay period and have it analyzed by an approved laboratory to demonstrate that the lot contains fecal coliform bacteria within the maximum limits determined by a validation study, as described in subsection (2)(b) of this section, before releasing control of the shellfish lot.

(5) A person is exempt from any fees for an initial application and a validation study conducted by the department for a relay permit for the purpose of relaying shellfish from a growing area that the department downgraded from a classification of "approved" or "conditionally approved" to "restricted" within the previous twenty-four months.

(6) A person's relay permit expires on the same date as the person's shellfish operation license.

(7) A person is exempt from the provisions of subsection (1) (e) of this section for the purpose of relaying shellfish to an approved grow-out site for a minimum of six months.

(8) A person possessing a valid shellfish operation license may act as an agent for another person possessing a valid shellfish relay permit for the purpose of harvesting shellfish from the initial harvest site specified in the permit, provided that the agent conducting the harvest is:

(a) Documented in the permit;

(b) In possession of a copy of the permit at the time of harvest; and

(c) Conducting activities described in the written plan of operations approved by the department for the agent's shellfish operation.

[Statutory Authority: RCW 69.30.030 and 43.20.030. 01-04-054, 246-282-032, filed 2/5/01, effective 3/8/01.]

Washington State Code Reviser's Office