Effective Date of Rule: Immediately.
Other Findings Required by Other Provisions of Law as Precondition to Adoption or Effectiveness of Rule: RCW 34.05.350 authorizes adoption of an emergency rule when necessary for the preservation of public health (see below justification).
Purpose: Creates a new section WAC 246-282-006, needed to implement a sampling protocol and control plan designed to detect and prevent illnesses associated with the bacteria vibrio parahaemolyticus (Vp) in shellfish. This plan is required for the summer months of 2007, when the presence of these bacteria is typically high and [the] shellfish consuming public are [is] at highest risk of potential illness.
Statutory Authority for Adoption: RCW 34.05.350, 69.30.030.
Under RCW 34.05.350 the agency for good cause finds that immediate adoption, amendment, or repeal of a rule is necessary for the preservation of the public health, safety, or general welfare, and that observing the time requirements of notice and opportunity to comment upon adoption of a permanent rule would be contrary to the public interest.
Reasons for this Finding: The department of health (DOH's) monitoring efforts in 2006 followed the existing national standard approved by the FDA. Despite this, there were [was] an unprecedented number of vibrio illnesses associated with Washington oysters in the summer of 2006. The emergency plan modifies the existing monitoring and control protocols to better identify the presence of high levels of Vp and help prevent vibriosis in humans.
The Washington state department of health (DOH) monitors for Vp in oysters. Vp is a naturally occurring bacteria found in shallow marine waters. Molluscan shellfish acquire Vp through filter feeding. Humans who consume raw or undercooked shellfish containing Vp can develop an intestinal disease called vibriosis. Both shucked shellfish and shellfish in the shell (shellstock) have been implicated in illnesses.
Vibriosis causes nausea, diarrhea, vomiting, abdominal cramps, headache, fever, and chills; hospitalization may be required in severe cases. The level of Vp required to cause illness is typically present only in warm summer months, when air and water temperatures are high.
The National Shellfish Sanitation Program (NSSP) model ordinance, a national guideline adopted by the International Shellfish Sanitation Conference (ISSC), approved by the United States Food and Drug Administration (FDA), and adopted by Washington state in chapter 246-282 WAC, requires specific monitoring and control protocols for Vp. Despite DOH's efforts, in 2006 there were [was] an unprecedented number of vibriosis illnesses in Washington state. There were one hundred thirteen reported cases involving Washington oysters. Although the Centers for Disease Control (CDC) have not yet reported final numbers, they have indicated that approximately three hundred cases associated with Pacific Northwest oysters were reported last year from across the United States. The actual number of cases in last year's outbreak is estimated to be much higher. CDC estimates that for every reported case, twenty cases go unreported. It is therefore likely that six thousand people became ill from Pacific Northwest oysters in the 2006 outbreak.
After the outbreak, DOH worked with FDA and the shellfish industry to analyze the information collected last year to determine the contributing factors in the outbreak. This analysis determined time-to-temperature control to be a major contributing factor to high levels of Vp. A consensus was reached that, to reduce the risk of Vp illnesses, a reduction in the amount of time harvested oysters were without temperature control was needed during the warmest months of the year.
Review of the historical data on vibrio illnesses in Washington showed that most of the illnesses occurred in the summer months, with the majority in July and August (see graph below). The illnesses were associated with oysters harvested in the following growing areas: Case Inlet, Eld Inlet, Grays Harbor, Hammersley Inlet, all of Hood Canal south of the Hood Canal Bridge, Mystery Bay, Oakland Bay, Samish Bay, Skookum Inlet, Totten Inlet, Westcott Bay, Willapa Bay (Bay Center and Nahcotta).
Through workshops, meetings, and teleconferences with ISSC, FDA, tribal representatives, shellfish growers, and other stakeholders, it has become apparent that modifications to the existing Vp control plan are needed to better protect shellfish consumers. The time required to modify the control plan through permanent rule making would extend beyond the upcoming 2007 summer season.
In order to better protect public health, the state board of health is adopting an emergency rule to implement a temporary revised Vp control plan for the summer months of 2007. DOH formulated a workgroup consisting of DOH staff, members of the shellfish industry, and representatives from the tribes and the FDA to assess and recommend changes to the existing control plan derived from the 2003 NSSP model ordinance. Recommendations put forward by the workgroup have been incorporated into the proposed temporary Vp control plan.
RCW 34.05.350 authorizes adoption of an emergency rule when it "…is necessary for the preservation of the public health, safety, or general welfare, and that observing the time requirements of notice and opportunity to comment upon adoption of a permanent rule would be contrary to the public interest." Observing the typical time requirements for notice and comment opportunity associated with standard rule making is not appropriate because it would extend beyond the upcoming 2007 summer season when the potential for a Vp illness outbreak is high. This rule is needed immediately so that a sampling protocol and control plan will be in place in time for the warm summer months of 2007 in order to protect shellfish consumers from Vp related illnesses.
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: June 1, 2007.
WAC 246-282-006 Washington state Vibrio parahaemolyticus control plan for June through September 2007. (1) The Washington state Vibrio parahaemolyticus control plan for June through September 2007, is also known as the control plan. This plan is designed to cover the harvest and shipment of oysters intended for raw consumption during the months of June through September. It does not apply to shucked oyster meats labeled "for cooking only." Growing areas subject to the requirements of this section are identified in subsection (9) of this section. The control plan consists of:
(a) A modification of Chapter VIII of the 2003 National Shellfish Sanitation Program Model Ordinance (NSSP), Requirements for Harvesters, .03 Shellfish Temperature, Control Option 2;
(b) More stringent time-to-temperature controls when one of three triggers is met: The month of the year, the presence of the pathogenic form of Vibrio parahaemolyticus, or a vibrio illness;
(c) A monitoring program; and
(d) A series of harvest method options that dealers may choose to further reduce risk of illness.
(2) The control plan allows for climatic differences between Puget Sound and coastal growing areas:
|Months of Control||Time-to-Temperature Control|
|June, July, August and September||Ten hours|
|Months of Control||Time-to-Temperature Control|
|June and September||Twenty-four hours|
|July and August||Ten hours|
(a) Intertidal (exposed) harvest - Time shall begin after the first oysters to be harvested are exposed to the air by the receding tide.
(b) Submerged (dredged) harvest - Time shall 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 filled previously which have been under water for a minimum of two hours for coastal areas and four hours for Puget Sound growing areas.
(4) The department shall require a monitoring program based on a biweekly sampling protocol, as defined in Chapter IV of the 2003 NSSP, section .03. If a thermo labile hemolysin level of 100 colony forming units per gram or greater is detected in a sample of oyster meats, the sampling frequency of the growing area shall be increased to weekly. The department, or designee of the department, shall collect samples using the following protocol:
(a) Samplers shall select oysters with the longest exposure to outside air temperature at the harvest site.
(b) Samplers shall record specific environmental data regarding the growing area conditions on the sample collection sheet and submit it with the sample to the department's public health laboratory. The following data will be recorded:
(i) Outside air temperature;
(ii) Surface water temperature; and
(iii) Internal temperature of one oyster.
(5) When the Vibrio parahaemolyticus monitoring program yields results showing a 0.03 most probable number (MPN) per 0.1 gram (detectable) or greater level of thermo direct hemolysin (tdh) in a growing area, another sample from that growing area shall be taken within four days. If the second sample also shows results of 0.03 MPN/0.1 gram (detectable) or greater level of tdh, the following time-to-temperature control and record requirements shall apply to that growing area:
|Time-to-Temperature Control||Records Required|
|Five hours||Time records|
(a) The department or designee of the department shall collect a sample as soon as possible as specified in subsection (4) of this section and test for Vibrio parahaemolyticus;
(b) Licensed harvesters and dealers in the implicated growing area shall immediately implement the time-to-temperature control and record requirements specified in subsection (5) of this section regardless of the time of year;
(c) The implicated growing area shall remain under the time-to-temperature control and record requirements specified in subsection (5) of this section until two successive samples taken no less than four days apart show no detectable tdh.
(7) In the event of a Vibrio parahaemolyticus-associated illness outbreak where oysters from a particular growing area are epidemiologically associated as the source, the requirements as stated in the 2003 NSSP, Chapter II, Risk Assessment and Risk Management, shall apply.
(8) Dealers who elect to further reduce their Vibrio parahaemolyticus risk exposure may employ a modification to their method(s) of harvest and incorporate it into their Hazard Analysis Critical Control Points (HACCP) plan, as defined in Chapter X of the 2003 NSSP, section .01, after consultation and approval by the department's shellfish program.
(9) This section applies to the following growing areas beginning June 2007 through September 2007:
(a) Case Inlet;
(b) Eld Inlet;
(c) Grays Harbor;
(d) Hammersley Inlet;
(e) All of Hood Canal south of the Hood Canal bridge, including all inlets and embayments;
(f) Mystery Bay;
(g) Oakland Bay;
(h) Samish Bay;
(i) Skookum Inlet;
(j) Totten Inlet;
(k) Westcott Bay;
(l) Willapa Bay (Bay Center); and
(m) Willapa Bay (Nahcotta).
(10) In the event an illness occurs from a growing area not listed in subsection (9) of this section, that growing area shall be added to the control plan and shall be subject to the requirements of this section.