WSR 98-08-118

PROPOSED RULES

DEPARTMENT OF HEALTH

[Filed April 1, 1998, 11:56 a.m.]

Original Notice.

Preproposal statement of inquiry was filed as WSR 98-01-154

Title of Rule: WAC 246-282-990 Shellfish program certification fees

Purpose: The proposed rule creates "Harvester" as a new classification of commercial shellfish license with a fee of $250

Statutory Authority for Adoption: RCW 69.30.030 and 43.20B.020

Summary: The harvester classification is intended for very small commercial operations and will be exempt from federal HACCP regulations

Reasons Supporting Proposal: The proposal creates regulatory flexibility for the shellfish industry

Name of Agency Personnel Responsible for Drafting: Ned Therien, Airdustrial Center, Building 4, Tumwater, (360) 236-3326; Implementation and Enforcement: Jennifer Tebaldi, Airdustrial Center, Building 4, Tumwater, (360) 236-3325

Name of Proponent: Department of Health, governmental.

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

Explanation of Rule, its Purpose, and Anticipated Effects: Creates a new commercial shellfish license classification with an annual fee of $250. The harvester classification is proposed as a more limited classification. Harvesters will be required to follow the NSSP standards but will not be on the interstate shippers list. The classification is designed to include as harvesters those shellfish operations exempt from the new hazard analysis critical control point (HACCP) regulations that became effective December 18, 1997. The proposed rule creates a new option for very small shellfish operations that do not intend to ship interstate

Proposal Changes the Following Existing Rules: Adds a new commercial shellfish license category in addition to the existing shellstock shippers and shucker-packers

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

Small Business Economic Impact Statement

Significant Legislative Rule Analysis,

and Economic Impact Analysis

Background: The Office of Shellfish Programs of the Department of Health regulates commercial molluscan shellfish operations in Washington state. There are currently two main types of shellfish license distinguished by the types of activities allowed: Shellstock shippers and shucker-packers. Shellstock shippers grow, harvest, buy, or sell shellstock. Shucker-packers may shuck and pack shellfish in addition to the activities of a shellstock shipper. Some in the industry have requested another more limited regulatory class for small shellstock shippers.

Both shellstock shippers and shucker-packers are required to follow the national shellfish sanitation program (NSSP) guidelines, a national consensus code developed by the Interstate Shellfish Sanitation Conference (ISSC). This allows all Washington licensees to be placed on the interstate shippers list and allows their shellfish to be exported to all states and countries participating in the ISSC.

In December 1997 regulations of the Food and Drug Administration (FDA) regarding hazard analysis critical control point (HACCP) plans became effective. These new regulations require commercial shellfish operations that store or process shellfish to write and implement special food safety plans. This new requirement poses a large regulatory burden for many very small shellfish operations and has caused some confusion in the industry as to exactly who must implement a HACCP plan. A license category for small shellfish operations has been requested because the activities of small shellfish operations are within a much narrower scope than other shellstock shippers and, therefore, need less oversight.

In response to the industry requests for a new classification and for clarification of who must have a HACCP plan, the Office of Shellfish Programs proposes amending WAC 246-282-990 to include a harvester license category with an annual fee of $250. The harvester classification is proposed as a more limited class than the shellstock shipper class. Harvesters will be required to follow the NSSP standards but will not be on the interstate shippers list. The classification is designed to include as harvesters those shellfish operations exempt from the new federal HACCP regulations that became effective in December of 1997.

A. Clearly state in detail the general goals and specific objectives of the statute that the rule implements.

Establishing a harvester license with associated fee implements two separate statutes. The first is chapter 69.30 RCW, Sanitary control of shellfish, and the other is RCW 43.20B.020 Fees for service.

The department has authority to regulate commercial shellfish operations under the rules of the State Board of Health. Chapter 69.30 RCW, Sanitary control of shellfish, was enacted to protect the public health through the control of shellfish growing, harvesting and processing. RCW 69.30.005 Purpose, states, "Protection of the public health requires assurances that commercial shellfish are harvested only from approved growing areas and that processing of shellfish is conducted in a safe and sanitary manner." Further, RCW 69.30.030 Rules and regulations, directs the State Board of Health to "cause such investigations to be made as are necessary to determine reasonable requirements governing the sanitation of shellfish, shellfish growing areas, and shellfish plant facilities and operations, in order to protect public health and carry out the provisions of this chapter; and shall adopt such requirements as rules and regulations of the state board of health." This is the statute that authorizes the regulation of shellfish operations. The creation of license categories falls within this range of authority.

The second part of the new regulation sets and charges a fee for the created harvester class. The authority to charge fees comes from a statute separate from the general authority to regulate shellfish operations. RCW 43.20B.020 authorizes the department to charge fees to cover the entire cost of providing services. The intent is that people engaged in businesses that may pose a risk to the public health should bear the cost of regulating the activity.

B. Determine that the rule is needed to achieve the general goals and specific objectives stated under question A and analyze alternatives to rule making and the consequences of not adopting the rule.

The Office of Shellfish Programs has protected the public health adequately with the existing license classifications. The harvester class addition is not needed to address any public health risk. While the authority to regulate shellfish operations comes from chapter 69.30 RCW, it is not the basis for any need to create a new license.

In proposing the harvester class, the Department of Health is responding to industry requests. Also, the proposal will increase regulatory efficiency, flexibility and certainty, goals of the Administrative Procedure Act, chapter 34.05 RCW. Amending WAC 246-282-990 to establish a harvester classification will allow the department to implement chapter 69.30 RCW in a more efficient manner. Harvesters will require fewer regulatory resources because they will be limited in their activities. This will allow the department to focus resources on those operations engaged in activities that pose greater health risks. The industry benefits from a more flexible regulatory structure that gives them a wider range of options. In addition to flexibility, the industry will gain regulatory certainty because the creation of a harvester classification will clearly identify those shellfish operations which will have to comply with the federal HACCP regulations.

The fees assessed under RCW 40.20B.020 [43.20B.020] support a regulatory program with significant public health implications. The program activities include inspections, sanitary surveys, water quality testing, biotoxin testing, and technical assistance to the shellfish industry. The fees that will be charged to harvester operations will be less than those currently charged shellstock shippers. The fees are necessary to administer shellfish program activities.

Alternatives: No action - As mentioned before, if the department decides to take no action, there would probably be no public health consequences. Under this option, the Office of Shellfish Programs will evaluate individual operations at the time of a relicensing inspection to determine if the activities performed by that particular operation require a HACCP plan. Without a harvester classification, all commercial shellfish operations will be required by the new NSSP model ordinance to conduct at least part of the steps necessary to develop and implement a HACCP plan. Taking no action increases the burden on department staff and creates unnecessary regulatory uncertainty for the regulated community.

C. Determine that the probable benefits of the rule are greater than its probable costs.

In general, the benefits of a Department of Health rule are considered in terms of the increase in public health protection or the decrease in public health risk associated with the rule. Costs are generally expressed as the added expense to the regulated community to comply with the rule. However, the creation of a harvester license does not fit easily into this general formula.

Benefits: Because the purpose of this rule is not to address a public health problem, but rather to increase regulatory efficiency, there are no benefits to be described in terms of increased public health protection. The Office of Shellfish Programs will realize benefits from the harvester classification because without this classification, the activities of individual shellfish operations would have to be considered to determine the need for a HACCP plan. The Office of Shellfish Programs estimates that there are approximately 100 questionable operations that would need to be evaluated by the program and that each evaluation would take approximately one hour. This is work that will most likely be performed by a Public Health Advisor 1 at $19 an hour. By adopting this proposal the Office of Shellfish Programs could potentially save $1,900 in time spent evaluating individual shellfish operations.

100 operations x 1 hr. each x $19.00 = $1,900

A segment of the shellfish industry will also benefit from the regulatory certainty of knowing that they are not expected to have a HACCP plan.

Costs: There are no costs associated with adopting the harvester classification. There is no reduction in public health protection. Harvesters will not engage in the most hazardous shellfish processing activities, such as the storage and processing of shellfish, which the federal HACCP rule is intended to control. Since there is no reduction in public health protection and the actual cost of implementing this rule will be less to the department and to industry members, the Office of Shellfish Programs finds no costs associated with adopting the harvester class.

Economic Impact Analysis: Department - The Office of Shellfish Programs conducts a wide array of program activities including, water quality testing, sanitary surveys, biotoxin testing, inspections, and technical assistance. Overall, fee revenue recovers only about 8% of program activity costs. The table below shows the projected costs for the different activity areas compared to the fee support for the activity.

The Office of Shellfish Programs anticipates that the harvester classification will reduce the resources necessary to regulate small operations. Harvesters will require only one inspection per year, as opposed to up to four for the other classifications. The $250 fee will cover the majority of inspection and administrative costs of licensing the operations. However, it does not begin to cover the costs associated with monitoring growing areas or biotoxin testing.

The program estimates that approximately 100, about 1/3, of the current shellstock shipper licensees will qualify and choose to be classified as harvesters. These are operations currently paying $260 for a shellstock shipper's license. Therefore, each represents a $10 loss in revenue to the program. If the estimated 100 shellstock shippers become harvesters, there will be a reduction of about $1,000 a year in fees collected by the Office of Shellfish Programs.

Industry - $250 fee for license - This fee represents a $10 reduction in the cost currently paid by small shellfish operations. It is anticipated that the NSSP model ordinance will require all shellstock shippers to at least perform the first part of a HACCP determination. Harvesters will be exempt by definition.

D. Determine after considering alternative versions of the rule and the analysis required under questions B and C, that the rule being adopted is the least burdensome alternative for those required to comply.

The proposed harvester classification represents a new, less burdensome alternative, for small shellfish operations. Additionally, the decision to change classifications will be purely optional for shellfish operations. No one will be required to change classification. However, without this new license classification, small shellfish operations will continue to pay the higher fee of a shellstock shipper and will have the extra burden, at least initially, of a HACCP evaluation.

E. Determine that the rule does not require those to whom it applies to violate the requirements of another state or federal law.

The new classification is designed to better coordinate HACCP regulations and the NSSP standards. It does not require the violation of any other state or federal laws.

F. Determine that the rule does not impose more stringent performance requirements on private than on public entities unless required to do so by federal or state law.

The proposed new classification will not impose more stringent performance requirements on private than on public entities.

G. Determine that if the rule differs from any federal regulation or statute applicable to the same activity or subject matter and, if so determine that the difference is justified.

The proposed rule will not differ from other state or federal regulations.

H. Coordinate the rule, to the maximum extent practicable, with other federal, state, and local laws applicable the same activity or subject matter.

The Department of Health has been coordinating the harvester classification with both the FDA and the ISSC to ensure that the new classification is consistent with the HACCP regulations and the anticipated NSSP model ordinance.

Small Business Economic Impact Statement

Chapter 19.85 RCW, the Regulatory Fairness Act, requires agencies to consider the impact of administrative regulations on small businesses. The proposed rule amendment is a response to the requests of small shellfish operators for a new shellfish license category that recognizes their limited activities. The harvester class will be an option that mitigates current fees. No further analysis of the impact to small businesses is necessary.

A copy of the statement may be obtained by writing to Ned Therien, P.O. Box 47824, Olympia, WA 98504, phone (360) 236-3326, or FAX (360) 236-2257

RCW 34.05.328 applies to this rule adoption. The creation of a new license category is a significant rule under RCW 34.05.328. A significant analysis was prepared and can be obtained from Ned Therien, P.O. Box 47824, Olympia, WA 98504.

Hearing Location: Lacey Community Center, 6729 Pacific Avenue S.E., Lacey, WA, on May 6, 1998, at 9:00 a.m

Assistance for Persons with Disabilities: Contact Jan Jacobs-Diment by April 30, 1998, TDD (800) 833-6388

Submit Written Comments to: Ned Therien, P.O. Box 47824, Olympia, WA 98504, FAX (360) 236-2257, by May 6, 1998

Date of Intended Adoption: May 15, 1998

April 1, 1998

Bruce Miyahara

Secretary

OTS-1993.1

AMENDATORY SECTION (Amending WSR 97-12-031, filed 5/30/97, effective 6/30/97)

WAC 246-282-990  Shellfish program certification fees. (1) Annual certificate fees ((shall be)) are:

(2) Type of operations are defined as follows:

(a) "Shellstock shipper" shall mean shippers growing, harvesting, buying, or selling shellstock. Shellstock shippers are not authorized to shuck shellfish or to repack shucked shellfish.

(b) "Shucker-packer" shall mean shippers shucking and packing shellfish. A shucker-packer may act as a shellstock dealer.

(c) "Harvester" means a commercial shellfish operation with activities limited to harvesting shellstock, and shipping and selling it within Washington state to shellfish dealers licensed by the department. Harvesters do not shuck shellfish; repack shucked shellfish; repack shellstock; or store shellstock in any location other than the approved growing area where the shellstock was harvested.

(3) "Export certificate" means a certificate issued by the department to a licensed shucker-packer or shellstock shipper for use in the foreign export of a lot or shipment of shellfish. The fee for each export certificate shall be $10.

[Statutory Authority: RCW 43.203.020 [43.20B.020]. 97-12-031, § 246-282-990, filed 5/30/97, effective 6/30/97. Statutory Authority: RCW 43.20B.020 and 69.30.030. 96-16-073, § 246-282-990, filed 8/6/96, effective 10/1/96. Statutory Authority: RCW 43.70.040. 93-17-096 (Order 389), § 246-282-990, filed 8/17/93, effective 9/17/93; 91-02-049 (Order 121), recodified as § 246-282-990, filed 12/27/90, effective 1/31/91. Statutory Authority: RCW 43.20A.055. 85-12-029 (Order 2236), § 440-44-065, filed 5/31/85; 84-13-006 (Order 2109), § 440-44-065, filed 6/7/84; 83-15-021 (Order 1991), § 440-44-065, filed 7/14/83. Statutory Authority: 1982 c 201. 82-13-011 (Order 1825), § 440-44-065, filed 6/4/82.]

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