WSR 08-11-051

PERMANENT RULES

STATE BOARD OF HEALTH


[ Filed May 15, 2008, 3:21 p.m. , effective May 19, 2008 ]


     Effective Date of Rule: May 19, 2008.

     Other Findings Required by Other Provisions of Law as Precondition to Adoption or Effectiveness of Rule: RCW 34.05.380 (3)(c) "The earlier effective date is necessary because of imminent peril to the public health, safety, or welfare."

     Purpose: The purpose of this rule is to protect public health by establishing a state-specific control plan to reduce the incidence of Vibrio parahaemolyticus-associated illness (vibriosis). The control plan consists of time-to-temperature controls, training, illness response, record-keeping requirements, and modified hazard analysis critical control point plans.

     Statutory Authority for Adoption: Chapter 69.30 RCW.

      Adopted under notice filed as WSR 08-08-087 on April 1, 2008.

     A final cost-benefit analysis is available by contacting Jessie DeLoach, Office of Shellfish and Water Protection, P.O. Box 47824, Olympia, WA 98504-7824, phone (360) 236-3302, fax (360) 236-2257, e-mail jessie.deloach@doh.wa.gov.

     Number of Sections Adopted in Order to Comply with Federal Statute: New 0, Amended 0, Repealed 0; Federal Rules or Standards: New 0, Amended 0, Repealed 0; or Recently Enacted State Statutes: New 0, Amended 0, Repealed 0.

     Number of Sections Adopted at Request of a Nongovernmental Entity: New 0, Amended 0, Repealed 0.

     Number of Sections Adopted on the Agency's Own Initiative: New 1, Amended 0, Repealed 0.

     Number of Sections Adopted in Order to Clarify, Streamline, or Reform Agency Procedures: New 0, Amended 0, Repealed 0.

     Number of Sections Adopted Using Negotiated Rule Making: New 0, Amended 0, Repealed 0;      Pilot Rule Making: New 0, Amended 0, Repealed 0; or Other Alternative Rule Making: New 1, Amended 0, Repealed 0.

     Date Adopted: May 14, 2008.

Craig McLaughlin

Executive Director

OTS-9693.6


NEW SECTION
WAC 246-282-006   Washington state Vibrio parahaemolyticus control plan.   (1) The Washington state Vibrio parahaemolyticus control plan, also known as the control plan, establishes harvest and transport requirements for oysters intended for raw consumption during the months of May through September. This section does not apply to shucked oyster meats labeled "for cooking only." The requirements of this section are in addition to Chapter VIII of the 2005 National Shellfish Sanitation Program Model Ordinance (NSSP), Requirements for Harvesters, .03 Shellfish Temperature, Control Option 2; and consists of:

     (a) Time-to-temperature controls based on the growing area and month of the year;

     (b) Harvest record requirements;

     (c) Vibrio illness response requirements;

     (d) Training requirements; and

     (e) Hazard Analysis Critical Control Point (HACCP) plan and harvest checklist requirements.

     (2) All Puget Sound growing areas, including the Strait of Juan de Fuca, are subject to the requirements of this section. Growing areas in Grays Harbor and Willapa Bay where oysters have been epidemiologically associated (linked) as the source of any Vibrio parahaemolyticus-associated illness are also subject to the requirements of this section.

     (3) The department may grant an exemption to the control plan for Puget Sound growing areas, including the Strait of Juan de Fuca, where there has been no epidemiologically associated (linked) Vibrio parahaemolyticus-associated illness if the licensed harvester or dealer can demonstrate safe and effective harvest and transportation methods, as developed in a written agreement.

     (4) Time-to-temperature controls are:


Table 1
Puget Sound Growing Areas
(including the Strait of Juan de Fuca):

Months of Control Time-to-Temperature Control
May Twelve hours
June and September Five hours
July and August Four hours

Table 2
Coastal Growing Areas:

Months of Control Time-to-Temperature Control
July and August Ten hours

     (5) Licensed dealers and harvesters shall maintain harvest records showing the time of harvest to assure compliance with the control plan. The harvest times begin as follows:

     (a) Intertidal (exposed) harvest - Time must begin after the first oysters to be harvested are exposed to the air by the receding tide.

     (b) Submerged harvest - Time must begin after the first oysters harvested are exposed to the air and have been placed onto a conveyance, such as a barge or boat. Submerged harvest includes dredge harvesting or retrieval of harvest tubs, bags, baskets, or other containers of oysters previously filled which have been under water for a minimum of one hour for coastal areas and four hours for Puget Sound growing areas.

     (6) In the event of two sporadic Vibrio parahaemolyticus-associated illnesses within thirty days where oysters from a single growing area are epidemiologically associated (linked) as the source, all licensed harvesters and dealers in the implicated growing area shall reduce the time-to-temperature control by one hour. The implicated growing area shall remain under the reduced time-to-temperature control throughout the control months for that area as defined in Table 1 or 2 of subsection (4) of this section.

     (7) In the event of two additional sporadic Vibrio parahaemolyticus-associated illnesses within thirty days under the one hour reduced time-to-temperature control where oysters from a single growing area are epidemiologically associated (linked) as the source, the growing area shall be closed to harvest and shipment of oysters intended for raw consumption throughout the control months as defined in Table 1 or 2 of subsection (4) of this section. If the two additional Vibrio parahaemolyticus-associated illnesses are attributed to the same licensed harvester or dealer as the first two illnesses, the department shall conduct an investigation in accordance with the requirements as stated in the 2005 NSSP, Chapter II, Risk Assessment and Risk Management, to determine if the illnesses resulted from dealer practices or the growing area.

     (8) An exemption to closure identified in subsection (7) of this section may be granted if the licensed harvester or dealer can demonstrate to the department, as developed in a written agreement, that an additional one hour reduction in time-to-temperature controls can be successfully implemented. If approved, the licensed harvester or dealer shall remain under the reduced time-to-temperature control throughout the control months for that area as defined in Table 1 or 2 of subsection (4) of this section.

     (9) If the required time-to-temperature control period is not met, the licensed harvester or dealer shall either:

     (a) Destroy the oysters; or

     (b) Remove all oysters from containers, disperse them within the original growing area, and allow a minimum of twenty-four hours for purging before reharvesting.

     (10) In the event of a Vibrio parahaemolyticus-associated illness outbreak where oysters from a particular growing area are epidemiologically associated (linked) as the source, the requirements as stated in the 2005 NSSP, Chapter II, Risk Assessment and Risk Management, shall apply.

     (11) All licensed harvesters and dealers shall complete department-approved training specific to the control plan prior to harvesting or shipping oysters intended for raw consumption during the months of May through September. Licensed harvesters and dealers who complete the training shall provide the training to those responsible for the on-site management of harvest activities for their operation.

     (12) Following completion of the training required in subsection (11) of this section, all licensed harvesters intending to harvest oysters intended for raw consumption from May through September shall develop a harvest plan and checklist that defines the harvest protocols that will be employed to assure oysters are placed under temperature control as defined in Table 1 or 2 of subsection (4) of this section, and subsection (6) of this section. Licensed dealers (other than harvesters) shall amend their Hazard Analysis Critical Control Point (HACCP) plans to define what harvest protocols will be employed to assure oysters are placed under temperature control as defined in Table 1 or 2 of subsection (4) of this section, and subsection (6) of this section.

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