PREPROPOSAL STATEMENT OF INQUIRY
Subject of Possible Rule Making: Repeal of the Washington red raspberry grades and standards, chapter 16-143 WAC.
Statutes Authorizing the Agency to Adopt Rules on this Subject: Chapters 69.04 and 15.17 RCW.
Reasons Why Rules on this Subject may be Needed and What They Might Accomplish: The director is proposing to repeal the Washington red raspberry grades and standards.
The Washington red raspberry grades and standards were adopted in May 2000. As a result of issues raised after the adoption of the rules, the director then extended the effective date of the rules until June 1, 2001. The director also determined that additional rules are necessary to address how red raspberries harvested outside of Washington can meet the Washington No. 1 processing grade standards and be deemed equivalent when the grades and standards go into effect.
On January 19, 2001, the Federal Food and Drug Administration issued final rules at 212 C.F.R., Part 120 - Hazard Analysis and Critical Control Point (HACCP) Systems. These federal rules will become effective January 22, 2002, or after depending on whether a business is small or very small. These rules require processors to implement a HACCP system that complies with the requirements established in the federal rules for the purpose of ensuring the safety of juice beverages. The department is consulting with the federal Food and Drug Administration to determine whether purees of fruits and vegetables used in products other than juice or beverages are covered by the requirements. At this point, FDA has not been able to provide a definitive answer.
Whether or not puree is included in the HACCP rules impacts the possible scope of the department's red raspberry grades and standards as well as any equivalency rules. At a minimum the HACCP requirements impact red raspberries used for juice. The determination of whether puree is included or excluded also impacts the nature and scope of the small business economic impact statement (SBEIS) that must be prepared. Without that determination, an adequate and accurate SBEIS cannot be prepared. As a result of the delay, the department will not be able to adopt equivalency rules in time to be effective June 1, 2001, when the red raspberry grades and standards will become effective.
In addition, following the adoption of the grades and standards rules, a petition was filed with the Joint Administrative Rules Review Committee (JARRC) contesting the small business economic impact statement (SBEIS) filed with the red raspberry grades and standards. The department delayed initiating the additional rule-making process on developing the equivalency rules until a determination was made on the adequacy of the SBEIS. A public hearing was held in Bellingham on January 18, 2001, to accept industry testimony on that subject and a report was prepared for JARRC. We have not received a final response from JARRC on its review. Finalization of that review may present additional issues that must be considered in the rule-making process.
The director is therefore proposing to repeal the present rules until such time as FDA can provide definitive guidance on the scope of the HACCP rules, the agency grades and standards can be modified as appropriate, and the equivalency rules can be incorporated with the grades and standards.
Other Federal and State Agencies that Regulate this Subject and the Process Coordinating the Rule with These Agencies: Relevant are the Federal Food and Drug Administration final rules at 21 C.F.R., Part 120 - Hazard Analysis and Critical Control Point (HACCP) Systems issued on January 19, 2001. We are in contact with FDA to clarify the scope of the federal rules. Also see above.
Process for Developing New Rule: The department will seek comments from the Red Raspberry Commission, growers and processors.
Interested parties can participate in the decision to adopt the new rule and formulation of the proposed rule before publication by submitting written comments to Linda Condon, Food Safety and Animal Health Division, Washington State Department of Agriculture, P.O. Box 42560, Olympia, WA 98504-2560, fax (360) 902-2087, e-mail email@example.com.
April 4, 2001