WSR 15-08-083 PERMANENT RULES STATE BOARD OF HEALTH [Filed March 31, 2015, 11:55 a.m., effective May 1, 2015] Effective Date of Rule: Thirty-one days after filing.
Purpose: WAC 246-282-006, the state board of health (board) revised the state Vibrio parahaemolyticus control plan rule to include more proactive measures to prevent illness and protect public health. This includes a combination of requirements based on environmental factors to determine the safety of shellfish prior to harvest and consumption. In addition, the board revised the rule for clarity and consistency with the National Shellfish Sanitation Program Model Ordinance.
Citation of Existing Rules Affected by this Order: Amending WAC 246-282-006.
Statutory Authority for Adoption: Chapter 69.30 RCW.
Adopted under notice filed as WSR 15-04-042 on January 28, 2015.
Changes Other than Editing from Proposed to Adopted Version: The board adopted clarifying changes to the proposed rule at the request of the regulated community. In addition to minor editing, the risk categories are based on a five-year average rather than a five-year trend; in regards to thermometers "calibrate" was changed to "verify;" and the rule directs the department of health to evaluate the effectiveness of the rule by November 2017.
A final cost-benefit analysis is available by contacting Laura Johnson, Department of Health, P.O. Box 47824, Olympia, WA 98504-7824, phone (360) 236-3333, fax (360) 236-2257, e-mail Laura.Johnson@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Number of Sections Adopted in Order to Comply with Federal Statute: New 0, Amended 0, Repealed 0; Federal Rules or Standards: New 0, Amended 1, Repealed 0; or Recently Enacted State Statutes: New 0, Amended 0, Repealed 0.
Number of Sections Adopted at Request of a Nongovernmental Entity: New 0, Amended 0, Repealed 0.
Number of Sections Adopted on the Agency's Own Initiative: New 0, Amended 1, Repealed 0.
Number of Sections Adopted in Order to Clarify, Streamline, or Reform Agency Procedures: New 0, Amended 1, Repealed 0.
Number of Sections Adopted Using Negotiated Rule Making: New 0, Amended 0, Repealed 0; Pilot Rule Making: New 0, Amended 0, Repealed 0; or Other Alternative Rule Making: New 0, Amended 1, Repealed 0.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: March 11, 2015.
Michelle A. Davis
Executive Director
AMENDATORY SECTION (Amending WSR 14-09-003, filed 4/3/14, effective 5/4/14)
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, temperature control, and transportation 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 the NSSP Model Ordinance and consist of:
(a) Time of harvest to temperature control 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 as the source of any Vibrio parahaemolyticus illness are also subject to the requirements of this section.
(3) The department may grant an annual exemption to the control plan for Puget Sound growing areas, including the Strait of Juan de Fuca, where there has been no epidemiologically associated Vibrio parahaemolyticus illness after review and approval of a written exemption request.
(a) The written exemption request must include the following information:
(i) Name of the growing area;
(ii) Description of the harvesting methods;
(iii) Description of the temperature control methods; and
(iv) Description of the transportation methods.
(b) The department shall review the exemption request within five business days of submittal.
(c) If approved, the licensed harvester or dealer shall comply with the department-approved exemption.
(d) The department-approved exemption expires October 1 of the calendar year for which it is approved. If the growing area is epidemiologically associated as the source of a Vibrio parahaemolyticus illness at any time after approval of the exemption, the department shall issue an order revoking the exemption.
(4) Time of harvest to temperature controls are:
Table 1
Puget Sound Growing Areas
(including the Strait of Juan de Fuca):
Table 2
Coastal Growing Areas:
(5) Licensed dealers and harvesters shall maintain harvest records showing the time of harvest and the time oysters are placed under temperature control to demonstrate compliance with the control plan. If ownership of oysters is transferred prior to the time that time of harvest to temperature control requirements must be met, the licensed dealer or harvester shall include in the harvest record date, time, and person or entity to whom the oysters were transferred. If the new owner is a licensed dealer, the dealer shall meet the time of harvest to temperature control requirements established in this section. The harvest times begin as follows:
(a) Intertidal (exposed) time of harvest begins after the first oysters to be harvested are exposed to the air by the receding tide.
(b) Submerged time of harvest begins 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.
(c) Temperature control is achieved when harvested oysters are placed in a controlled environment with an ambient temperature of 45°F (7.2°C) or less.
(6) All licensed harvesters and dealers in a growing area shall reduce the time of harvest to temperature control as defined in Table 1 or 2 of subsection (4) of this section by one hour if oysters from the growing area:
(a) Are epidemiologically associated as the probable source of two sporadic Vibrio parahaemolyticus illnesses; and
(b) Were harvested within thirty days of each other.
(7) A growing area shall be closed to harvest and shipment of oysters intended for raw consumption throughout the remainder of the control months for the calendar year when the following conditions are met:
(a) Oysters from the growing area are epidemiologically associated as the probable source of two additional sporadic Vibrio parahaemolyticus illnesses;
(b) Oysters from the growing area were harvested in compliance with the reduced time of harvest to temperature control provisions of subsection (6) of this section; and
(c) Oysters from the growing area were harvested within thirty days of the previous illnesses.
(8) If the two additional Vibrio parahaemolyticus illnesses specified in subsection (7) of this section 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 NSSP Model Ordinance to determine if the illnesses are the result of harvester or dealer practices or are linked to the growing area as the probable source. If the harvester or dealer practices are reasonably likely to have caused the illnesses:
(a) The harvester or dealer shall retake the training identified in subsection (12) of this section prior to renewal of their next year's license;
(b) The department may take disciplinary action against the harvester or dealer license; and
(c) The department will evaluate whether to associate the illnesses with the growing area.
(9)(a) The department may grant an exemption to closure identified in subsection (7) of this section if the licensed harvester or dealer can demonstrate in a written exemption request that an additional one hour reduction in the time of harvest to temperature control as identified in subsection (6) of this section can be successfully implemented. The written exemption request must include the following information:
(i) Name of the growing area;
(ii) Description of the harvesting methods;
(iii) Description of the temperature control methods; and
(iv) Description of the transportation methods.
(b) The department shall review the request within five business days of submittal.
(c) If approved, the licensed harvester or dealer shall comply with the requirements of the department-approved exemption throughout the remainder of the applicable control months for the particular growing area.
(10)(a) If the required time of harvest to temperature control period is not met, the licensed harvester or dealer shall either:
(i) Destroy the oysters; or
(ii) Remove all oysters from containers, disperse them within the original growing area, and allow a minimum of twenty-four hours for purging before reharvesting.
(b) If the required time of harvest to temperature control period is not met, the licensed harvester or dealer shall record the disposition of the oysters on the harvest record.
(11) In the event of a Vibrio parahaemolyticus illness outbreak where oysters from a growing area are epidemiologically associated as the source, the requirements as stated in the NSSP Model Ordinance shall apply.
(12) All licensed harvesters and dealers shall complete an initial department-approved training specific to the requirements of this section prior to harvesting or shipping oysters intended for raw consumption during the months of May through September. All licensed harvesters and dealers shall complete department-approved refresher training following any revision of this section considered significant under RCW 34.05.328. 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, and document the training for responsible employees in their operational records.
(13) Following completion of the training required in subsection (12) of this section:
(a) All licensed harvesters planning to harvest oysters intended for raw consumption from May through September shall develop a harvest plan that describes the harvest, temperature control, and transportation methods that meet the requirements of subsections (4) and (6) of this section. Licensed harvesters shall obtain department approval of the harvest plan prior to harvesting oysters for raw consumption.
(b) All licensed dealers planning to harvest oysters intended for raw consumption from May through September shall amend their Hazard Analysis Critical Control Point (HACCP) plans to define the harvest, temperature control, and transportation methods that meet the requirements of subsections (4) and (6) of this section. Licensed dealers shall obtain department approval of the amended HACCP plan prior to harvesting oysters for raw consumption.)) (1) This section establishes the Washington state Vibrio parahaemolyticus control plan (control plan) for the months of May 1st through September 30th (control months). The requirements of this section are an extension of the NSSP Model Ordinance.
(2) All harvesters and shellfish dealers harvesting or delivering oysters to a certified shucker packer for shucking or postharvest processing (PHP) during the control months must label the oysters with a harvest tag stating "For shucking by a certified dealer" or "For PHP by a certified dealer." Oysters harvested and tagged in compliance with this subsection are exempt from subsections (3) through (20) of this section.
(3) The following definitions apply throughout this section:
(a) "Single-source Vibrio parahaemolyticus case" or "case" means a laboratory-confirmed Vibrio parahaemolyticus-associated illness or illnesses with a common exposure that are reported to the department. The case must:
(i) Be associated with commercially harvested shellstock;
(ii) Not involve documented postharvest abuse; and
(iii) Be traced back to a single growing area.
(b) "Control months" means May 1st through September 30th.
(c) "Cool" or "cooling" means to:
(i) Adequately ice or place in a controlled environment with a temperature of 45°F (7.2°C) or less; and
(ii) Reach and maintain an internal oyster tissue temperature of 50°F (10°C) or less.
(d) "Harvest temperature" means the water temperature or internal oyster tissue temperature at the time of harvest. The harvester or shellfish dealer shall state whether they use water temperature or internal oyster tissue temperature for harvest temperature in their harvest plan.
(4) All harvesters and shellfish dealers harvesting oysters during the control months shall report the volume of oysters harvested. This information must be reported by month, oyster species, size class, and growing area for all control months. This information must be reported by December 31st each year. Harvesters and shellfish dealers that do not submit this information to the department may not harvest oysters during the control months during the next calendar year.
(5) Harvesters and shellfish dealers harvesting oysters during the control months shall complete, submit to the department, and keep on file a current Vibrio parahaemolyticus harvest plan. In order for the department to review the harvest plan prior to May 1st, the harvest plan must be submitted by March 1st each year unless no changes have been made to the existing harvest plan. Harvesters and shellfish dealers shall sign and date their harvest plan each year and make it available to the department upon request.
(6) The harvest plan must:
(a) Describe the harvest, temperature collection, cooling, and conveyance methods.
(b) Include an example of the harvest temperature record designed to meet the requirements in subsection (11) of this section.
(c) Identify if water temperature or internal oyster tissue temperature is used to meet the requirements in subsection (11) of this section and specifically how this measurement will be taken.
(7) The department shall review and either approve or deny the harvest plan within thirty days of receipt. If the department denies approval of the harvest plan, the department shall notify the applicant of the decision in writing stating the reasons for the denial and providing the opportunity to correct the deficiencies. Harvesters and shellfish dealers may not harvest oysters during the control months unless the department has approved the plan.
(8) Time of harvest to cooling requirements and harvest controls are based on a risk categorization of each growing area. The department shall assign each growing area a category of 1, 2, or 3 (where 1 corresponds to the least stringent and 3 the most stringent controls) based on the number of cases that occurred during the previous consecutive five-year period within the control months and were attributed to that growing area.
(9) The department shall categorize coastal growing areas in Willapa Bay and Grays Harbor as Category 1 for the first year of implementation attributing no illnesses to these areas for the years 2010 to 2014. For subsequent years, the department shall categorize coastal growing areas based on the criteria in subsection (8) of this section.
(10) The department shall complete risk categorization and publish a list of all growing areas by risk category no later than February 1st annually. The department shall use a rolling five-year average number of cases to calculate risk categories as follows:
(a) Category 1: An average of 0.2 or fewer cases attributed to the growing area over a five-year period.
(b) Category 2: An average of more than 0.2, but less than 1.0 cases attributed to the growing area over a five-year period.
(c) Category 3: An average of 1.0 or more cases attributed to the growing area over a five-year period.
(11) Time of harvest begins after the first oysters to be harvested are exposed to the air. Time of harvest to cooling requirements and harvest controls are as follows:
(a) Category 1:
(b) Category 2:
(c) Category 3:
(d) When a harvester or shellfish dealer places oysters in a container or conveyance, but does not remove them from the tide flat as part of their harvest and the harvest exceeds the time to cooling requirements in subsection (11) of this section, then the oysters in the container or conveyance must be covered by the tide for a minimum of four hours before harvest can be completed.
(12) Harvesters and shellfish dealers shall take the following measurements at the times specified below and record this information in a harvest temperature record for each harvest site for all harvests occurring within the control months. Harvesters and shellfish dealers shall take these measurements with a thermometer that is verified weekly using manufacturer specifications or with a method approved in a harvest plan. Thermometer verification must be documented and maintained with operational records. Harvesters and shellfish dealers shall record the following measurements and the date and time they were taken in the record, maintain the record for three years, and make the record available to the department upon request:
(a) Air temperature at time and location of harvest; and
(b) Harvest temperature at time and location of harvest. Harvesters and shellfish dealers using water temperature for harvest temperature shall take water temperature at depth of oysters unless another method is documented in their harvest plan.
(13) Harvesters and shellfish dealers shall initiate cooling as soon as practical from the time of harvest and within the time of harvest to cooling requirements for the growing area where the oysters were harvested to ensure that the maximum number of hours is not exceeded.
(14) If the required time of harvest to cooling requirements are not met after removal from the tide flat, the harvester or shellfish dealer shall dispose of the oysters using one of the methods below and record the disposition on the harvest record:
(a) Destroy the oysters;
(b) Place the oysters within the original growing area or another approved growing area and allow a minimum of fourteen days before reharvesting; or
(c) Deliver the oysters to a certified shucker packer for shucking or PHP and attach a harvest tag meeting the requirements in subsection (2) of this section.
(15) If ownership of oysters is transferred prior to the oysters being cooled in accordance with the time of harvest to cooling requirements, the harvester shall include in the harvest record required under WAC 246-282-080 the:
(a) Temperatures recorded under subsection (12) of this section;
(b) Date, time, and person or entity to whom the oysters were transferred; and
(c) Growing area risk category for the harvested product.
(d) The receiving shellfish dealer shall meet the time of harvest to cooling requirements for the original harvest time.
(16) Vibrio parahaemolyticus training requirements are as follows:
(a) Harvesters and shellfish dealers shall complete an initial department-approved training specific to the requirements of this section prior to harvesting or shipping oysters during the control months.
(b) Harvesters and shellfish dealers shall complete department-approved refresher training within one year following any revision of this rule considered significant under RCW 34.05.328 or at least every five years.
(c) Those responsible for the on-site management of harvest activities must be trained by either:
(i) Harvesters and shellfish dealers at their operation who completed the department-approved training; or
(ii) The department.
(d) Harvesters and shellfish dealers shall record those trained in their operational records.
(17) A harvester or shellfish dealer may request a waiver from specific requirements of this section. The request must:
(a) Be in writing;
(b) Identify the requirement requested to be waived;
(c) State the reason for the waiver; and
(d) Provide supporting information.
(18) The department may grant a waiver request if it:
(a) Is consistent with the applicable standards and the intent of this section; and
(b) Provides a comparable level of public health protection to the requirement being waived.
(19) If the department approves a waiver request, the department shall notify the requestor of the decision in writing.
(20) If the department denies a waiver request, the department shall notify the requestor of the decision in writing stating the reasons for the denial. The requestor shall comply with the provision that was the subject of the waiver request.
(21) The department shall review this section to evaluate the effectiveness of the rules and determine areas where revisions may be necessary by November 2017.
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