WSR 08-08-087

PROPOSED RULES

STATE BOARD OF HEALTH


[ Filed April 1, 2008, 3:11 p.m. ]

Original Notice.

Preproposal statement of inquiry was filed as WSR 07-21-143.

Title of Rule and Other Identifying Information: WAC 246-282-006 Vibrio parahaemolyticus control plan.

Hearing Location(s): Rosario Resort, 1400 Rosario Road, Eastsound, WA 98245, on May 14, 2008, at 11:30 a.m.

Date of Intended Adoption: May 14, 2008.

Submit Written Comments to: Jessie DeLoach, Department of Health, 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 May 14, 2008.

Assistance for Persons with Disabilities: Contact Jan Jacobs by May 7, 2008, TTY (800) 833-6388 or 711.

Purpose of the Proposal and Its Anticipated Effects, Including Any Changes in Existing Rules: The purpose of the proposal 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.

Reasons Supporting Proposal: In 2006 there was an unprecedented number of vibriosis cases involving Washington shellfish. The state board of health adopted modifications to the existing Vibrio parahaemolyticus control plan as an emergency measure for the summer months of 2007 to better protect shellfish consumers from vibriosis. The permanent rule is needed to establish ongoing state-specific control measures.

Statutory Authority for Adoption: Chapter 69.30 RCW.

Statute Being Implemented: Chapter 69.30 RCW.

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

Name of Proponent: State board of health, governmental.

Name of Agency Personnel Responsible for Drafting, Implementation and Enforcement: Jessie DeLoach, 111 Israel Road S.E., Tumwater, WA, (360) 236-3302.

A small business economic impact statement has been prepared under chapter 19.85 RCW.

Small Business Economic Impact Statement

Brief Description of the Rule: The Vibrio parahaemolyticus control plan outlined in the proposed Washington state board of health rule is intended to reduce the risk to the public of acquiring vibriosis from the consumption of raw and undercooked oysters. The rule is designed to do this by establishing shorter time-to-temperature controls during the months of most concern (May through September) in growing areas most likely to be associated with vibriosis. This rule also establishes additional time-to-temperature controls and potential growing area closure requirements in response to sporadic cases of vibriosis.

The proposed rule also imposes requirements for records that reflect the time of harvest, in addition to the date and the time the product is placed under temperature control. This record requirement is necessary to verify appropriate handling that limits pathogen growth in oysters intended for raw consumption.

In order for this rule to be properly implemented and practiced by the commercial oyster growers in Washington state, a training requirement for all who intend to commercially harvest raw oysters for human consumption is established by the proposed rule.

Finally, this rule requires changes in the hazard analysis critical control point (HACCP) plans of licensed dealers. The HACCP plan is a food safety process control system that establishes a requirement for licensed harvesters to have a written Vibrio parahaemolyticus control plan and checklist to document compliance with the handling and record-keeping requirements of this rule.

Small Business Economic Impact Statement (SBEIS) Requirement: Yes, an SBEIS is required for this rule.

Industries Affected by the Rule: The shellfish fishing industry, North American Industry Classification System Code (NAICS Code) 114112, is the only industry affected by this rule.

Costs of Complying with the Rule: The largest 10% of shellfish dealers consists of some shucker packer companies, some shellstock shipper companies, and one harvester company. They all share the same characteristic, regardless of license category, and that is that they all have multiple crews working either a very large farm or several to many farms throughout Washington's estuarine waters. The small companies on the other hand typically have one or two employees or just the owner doing the harvesting. The largest companies have from three to eight crews harvesting oysters each tide; each team leader maintains the harvest records for that team.

The costs of compliance for the proposed rule are associated with time-to-temperature control including effects on tribal harvest. There is no quantifiable cost attributed to sporadic illness response, record keeping, training, or modification of HACCP plans and creation of harvest checklists.

Time-to-Temperature Control: The department of health (DOH) assumes that companies will likely choose from two options to comply with the time-to-temperature requirements of the proposed rule: Reduce harvest times to only those identified in the control plan for the geographic location and month of year, or submerge oysters for storage and later retrieval. The department further assumes that 50% of the approximately two hundred licensed companies will choose to reduce harvest times and 50% will choose to use submerged harvest techniques. Under this assumption, the compliance costs for the proposed requirements are the opportunity costs of the hours that harvesting is not conducted beyond the specified time-to-temperature control. The costs estimated below are based on annual Puget Sound harvest figures for oysters. Willapa and Grays Harbor would see reduced harvest opportunities with a reduced time-to-temperature control from twelve to ten hours for July and August only. However, by basing the calculation of costs on annual production rates for the more productive growing areas in Puget Sound, the reduced harvest opportunity for Willapa and Grays Harbor are adequately addressed. Although time-to-temperature control for May is reduced from thirty-six hours to twelve hours, there are no costs calculated for this change. The department assumes that dealers are meeting this harvest time currently in preparation for warmer weather months.

For those companies that elect to store oysters submerged for later retrieval as provided for in the proposed rule, the harvest curtailment would not apply. However, this method could probably only be employed by about half of the two hundred companies identified above because of equipment requirements and location considerations. This means approximately one hundred companies would be able to continue harvesting at normal capacity May through September with no lost revenue.

For those companies who elect to harvest within the time-to-temperature controls specified in the proposed rule, the department assumes available harvest time would be reduced in Puget Sound from twelve hours to five hours during the months of June and September, and from twelve hours to four hours in July and August. Assuming twenty-eight days of harvest for each of these months, the result is a decrease in hours available for harvest of three hundred ninety-two hours total during June and September, and four hundred forty-eight hours during July and August. Natural tidal cycles limit the amount of time harvesting can occur.

Harvesting can only occur during daylight hours and low tides. Because the low tide for a twenty-four hour cycle intermittently occurs during the night when harvesting cannot be done, this analysis does not assume a direct reduction in harvest opportunity from twelve hours for all four months of control. (Based on the hours calculated above, direct reductions would be 58% in June and September, and 67% in July and August.) Instead, harvest opportunity reductions are calculated based on projected tide cycles for 2008 taking into account the time of day for each low tide. This equates to a 29% reduction in available harvest time for June and September, and a 33% reduction in available harvest time for July and August. Because tide cycles change yearly, these changes will vary from year to year.

The department assumes that 65% of the 31,000,000 pounds of shellfish harvested annually in Washington is oysters harvested from Puget Sound, including those intended for raw consumption (approximately 20,150,000 pounds). The department also assumes equal distribution of harvested oysters across the twelve months (1,679,167 pounds monthly). The total volume of oysters normally harvested during June through September (6,716,668) equates to a retail value of $4,365,834.00 (6,716,668 divided by five pounds per dozen, multiplied by $3.25 per dozen). This averages to $1,091,459.00 per month.

Applying the 29% reduction in available harvest time for June and September results in an estimated reduced income of $316,523.00 ($1,091,459.00 multiplied by .50 of companies, multiplied by two months, multiplied by 0.29). Applying the 33% reduction in available harvest time for July and August results in an estimated reduced income of $360,181.00 ($1,091,459.00 multiplied by .50 of companies, multiplied by two months, multiplied by 0.33). The total estimated annual reduction is $676,704.00.

Based on the assumptions identified above, the total estimated cost of compliance for the proposed time-to-temperature control is $676,704.00. However, actual costs are expected to be different due to the following factors: Additional costs for wages associated with transporting oysters after being submerged, reduced costs associated with oysters that don't meet time-to-temperature control that are sold under a "for cook only" label, reduced costs associated with the practice of icing oysters to achieve temperature control while continuing to harvest during the entire low tide, and reduced costs associated with the fact that there is not a strict one-to-one relationship between available harvest time and income because such factors as weather are being discounted. With these variables, the department assumes the cost estimated in this analysis for reduced time-to-temperature control requirements is overestimated.

There are harvesters for whom the proposed time-to-temperature control would impose a unique cost. Tribal harvesters, whose growing areas are often remote and difficult to access, might have to forego harvest in some instances with a resulting loss in revenue of $110.00 to $220.00 per harvest ($2.20 per dozen oysters harvested, multiplied by a typical daily harvest of fifty to one hundred dozen oysters per harvester). There are fourteen tribes that harvest oysters in Washington state with approximately twelve harvesters per tribe for a total of one hundred sixty-eight harvesters. A second concern of tribal harvesters is the lack of security at some of their growing areas, which are also public beaches or state parks. If they were forced to submerge their days' harvest of oysters prior to delivering them to the buyer, they could lose some to all of their oysters to theft which, again, would amount to $110.00 to $220.00 per harvest for each harvester. The estimated cost of this requirement is based on the percentage of licensed companies that did not harvest oysters for raw consumption in 2007: 10%. The estimated cost of this requirement to tribal harvesters ranges from $31,790.00 ($110.00 multiplied by seventeen harvesters multiplied by seventeen weeks) to $63,580.00 ($220.00 multiplied by seventeen harvesters multiplied by seventeen weeks).

The estimated range of cost associated with reduced time-to-temperature control, including costs for tribal harvesters, is from $679,883.00 to $740,284.00.

Disproportionate Impact on Small Businesses: To calculate the impact of the proposed regulations for small businesses, the department assumes that the size of a business is determined by number of employees. Of the two hundred companies affected by this rule, three are considered large with approximately fifty employees each for a total of one hundred fifty employees for large businesses, and one hundred ninety-seven are considered small businesses with an average of two employees each for a total of three hundred ninety-four.

The department has determined that this rule does not impose a disproportionate impact on small businesses compared to large businesses.

Time-to-Temperature Control: The total estimated annual reduction of income associated with this requirement is at most $740,284.00. Of the oysters produced in Washington state, approximately 67% are produced by large businesses and approximately 33% are from small businesses. Thus, the loss to large and small business is apportioned according to these percentages. This equates to a loss for large businesses of $495,990.00 equaling $3,307.00 per employee. For small business, the total cost is $244,294.00 equaling $620.00 per employee. This indicates that there is no disproportionate impact to small businesses on a per employee basis.

Mitigation Measures: Because the department has determined that the rule does not impose a disproportionate impact on small businesses, no mitigation measures are necessary.

Small Business Involvement in Rule Development: DOH staff worked closely with industry and interested constituents such as the Northwest Indian Fisheries Commission, Point No-Point Treaty Council, the United States Food and Drug Administration, individual tribes, and the Pacific Coast Shellfish Growers Association, to minimize the burden of this rule. The office of shellfish and water protection had five meetings with a Vibrio Advisory Group selected from among the interested parties listed above. Of the dozen members of the Vibrio Advisory Group that represented oyster harvester[s] and dealers, one represented Washington's largest dealer and the remainder represented companies with fewer than fifty employees.

Jobs Created or Lost as a Result of the Rule: The proposed rule is likely to result in temporary unemployment as a result of harvest area closures for oysters intended for raw consumption due to sporadic cases of Vibrio parahaemolyticus-associated illness. This job loss is temporary during the summer months when the risk of Vibrio is greatest. Once the summer has ended and the increased risk of Vibrio has passed, employees are rehired. The largest companies, the thirty-five that make up the top 10%, have historically kept as many people employed as possible, assigning them to farmwork on the shellfish beds and postponed repair, maintenance, and construction tasks around the company's physical facilities. However, temporary unemployment will remain a hazard of employment in the oyster industry.

A copy of the statement may be obtained by contacting Jessie DeLoach, Department of Health, P.O. Box 47824, Olympia, WA 98504, phone (360) 236-3302, fax (360) 236-2257, e-mail jessie.deloach@doh.wa.gov.

A cost-benefit analysis is required under RCW 34.05.328. A preliminary cost-benefit analysis may be obtained by contacting Jessie DeLoach, Department of Health, P.O. Box 47824, Olympia, WA 98504, phone (360) 236-3302, fax (360) 236-2257, e-mail jessie.deloach@doh.wa.gov.

March 31, 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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Washington State Code Reviser's Office