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  1. Agreement to Establish Partnership

    This agreement applies to molluscan shellfish, which are also covered under the National Shellfish Sanitation Program, a cooperative, Federal/State/industry program, as well as to fresh and saltwater fin fish, crustaceans, other forms of aquatic life (including, but not limited to, alligator, frog, aquatic turtle, jellyfish, sea cucumber, and sea urchin, and the roe of such animals) other than birds and mammals, and to other mollusks, where such animal life is intended for human consumption. (optional replacement for required language paragraph)

  2. Partnership Purpose and Goals

    1. The anticipated outcomes of the partnership are:
      • To provide enhanced protection to consumers of fish and fishery products by securing industry compliance with the Seafood HACCP Regulation, the Current Good Manufacturing Practices Regulation, other applicable regulations and standards, and the provisions of the National Shellfish Sanitation Program; (optional replacement for required language bullet)
      • To secure this compliance through adequate and credible inspectional coverage of the fish and fishery products processing industry in the State of (name of State) through a combined Federal/State inspection frequency of HACCP-based inspections of at least once per year for non-molluscan shellfish processors (i.e. a minimum frequency of once per year, with the actual inspection frequency being risk-based) and combined Federal/State inspection frequencies consistent with the inspection frequencies specified by the National Shellfish Sanitation Program for the various classes of molluscan shellfish processors; (optional replacement for required language bullet)
      • To foster uniform, consistent Federal/State application of the Seafood HACCP Regulation, the Current Good Manufacturing Practices Regulation, other applicable regulations and standards, and the provisions of the National Shellfish Sanitation Program to the benefit of consumers and the fish and fishery products processing industry; (optional replacement for required language bullet)
  3. Program Areas and Activities for Partnership

    1. Program areas for partnership include:
      • Inspections of fish and fishery product processors to ensure conformance with the requirements of the Seafood HACCP Regulation, the Current Good Manufacturing Practices Regulation, other applicable regulations, and the provisions of the National Shellfish Sanitation Program; (optional replacement for first required language bullet)
  4. Responsibilities
    1. Joint:
      • Each party will include their establishment inventories of fish and fishery product processors in an on-line data base (either inclusive or exclusive of bivalve molluscan shellfish processors) to produce a combined list. (optional replacement for required language bullet)
      • Each party will ensure that its inspection personnel (inspection personnel may include analysts involved in team inspections) that are involved in work under this agreement are adequately trained (i.e. introductory regulatory training [e.g. evidence development, interviewing technique], the principles of HACCP and the requirements of the Seafood HACCP Regulation [e.g. the Alliance HACCP course, or equivalent], the performance of a HACCP inspection [e.g. the Regulator HACCP course], and bivalve, molluscan shellfish plant inspection standardization). In addition, each party will strive to provide training in food science and microbiology (e.g. the FDA Food Microbiological Control course, or equivalent) to their inspection personnel (inspection personnel may include analysts involved in team inspections) that are involved in work under this agreement. (optional replacement for required language bullet)

        Note: FDA is in the process of developing a certification process for FDA investigators and analysts performing seafood inspections, and an equivalent process for state inspectors. When such a system is developed, it would be appropriate to include it as a requirement at this point in the agreement.

      • The combined efforts of FDA and (name of State agency) will result in the inspection of all non-molluscan shellfish fish and fishery product processors in the state of (name of State) at least annually and all classes of molluscan shellfish processors at frequencies specified by the National Shellfish Sanitation Program, in a manner consistent with the terms of this agreement. (optional replacement for required language bullet)

        Note: this is a general statement of intent. More specific inspectional commitments are contained in the FDA and State responsibilities sections. Federal/State work planning may result in a dividing of the inventory between the agencies or, simply, inclusion of some or all State inspections in the national data base. Some States are obligated to inspect all registered establishments as a condition of registration.

      • FDA and (name of State agency) will jointly perform a minimum of 5% of the non-molluscan shellfish inspections covered by this agreement. FDA and (name of State agency) will jointly perform all of the molluscan shellfish inspections specified in the appropriate FDA Compliance Program. The joint inspections will serve training, technology and information exchange, and verification functions. (optional replacement for required language bullet)
      • For each inspection that is covered by this agreement, the inspector will complete, at a minimum:
      • the Seafood HACCP Inspection Report;
      • the Computer Generated Cover Sheet or similar document that contains, at a minimum: the voluntary corrections taken by the processor; and, the final classification of the inspection by the agency for each of the products inspected and for both compliance with the Seafood HACCP Regulation and other applicable regulations (i.e. separate classification for each);
      • an FDA-483 or similar document that lists the specific violations noted during the inspection; and,
      • for molluscan shellfish inspections, the National Shellfish Sanitation Program Standardized Shellfish Processing Plant Inspection Form.

        (optional replacement for required language bullet)

      • FDA and (name of State agency) will coordinate anticipated publicity relative to regulatory actions taken against fish and fishery products. (optional additional bullet)

        Note: In order to reduce the possibility for inconsistent publicity between FDA and the states, it is advisable to include this bullet in the agreement.

    2. FDA:
      • FDA will maintain a combined establishment inventory of fish and fishery product processors, including their central file numbers, and provide on-line access to it to (name of State agency). (optional replacement for required language bullet)
      • FDA will provide standardization training for FDA and (name of State) bivalve, molluscan shellfish inspection personnel (inspection personnel may include analysts involved in team inspections), as needed. (optional additional bullet)
      • FDA will provide training for FDA and (name of State agency) personnel on product coding, classification of inspections, and completion of the relevant documents, as needed. (optional additional bullet)
      • FDA will commission State inspection personnel under section 702(a) of the FD&C Act as necessary to facilitate their carrying out of functions under this agreement. (optional additional bullet)

        Note: this will be germane at least where a State has not adopted as its own the FDA Seafood HACCP Regulation. Commissioning under these circumstances would be necessary to ensure access to HACCP plan and records that are required under the FDA regulation.

      • FDA will conduct at least (enter the appropriate number of non-molluscan shellfish inspections that are to be performed by FDA under the terms of the agreement, but in no case less than 10% of the fish and fishery products processors in the state) inspections of non-molluscan shellfish fish and fishery product processors consistent with the terms of this agreement (exclusive of joint inspections). Additionally, FDA will cover molluscan shellfish processing during inspections of multiple product processors. (optional replacement for required language bullet)
      • FDA will provide analytical and regulatory follow-up support to (name of state agency), as requested. (optional additional bullet)
      • FDA will initiate all enforcement actions relating to deficiencies in processors' HACCP systems, as revealed through inspections conducted pursuant to this agreement. Note: this is germane where a State has not adopted the FDA Seafood HACCP Regulation as its own but is conducting HACCP-based inspections under partnership with FDA and reporting the results to FDA.
    3. (name of state agency):
      • (name of State agency) will develop and implement inspection procedures that are equivalent to those delineated in the Regulator HACCP course, the Domestic Fish and Fishery Products Inspection Program (for non-molluscan shellfish inspections), the Investigations Operations Manual (for non-molluscan shellfish inspections), and the National Shellfish Sanitation Program (for molluscan shellfish inspections).
  5. Planned Resources
    1. Funding
      • Training - costs of attendance for FDA and (name of State agency) fish and fishery product inspection personnel (inspection personnel may include analysts involved in team inspections) at introductory regulatory training (e.g. evidence development, interviewing technique), food science and microbiology (e.g. the FDA Food Microbiological Control course, or equivalent), the principles of HACCP and the requirements of the Seafood HACCP Regulation (e.g. the Alliance HACCP course, or equivalent), the performance of a HACCP inspection (e.g. the Regulator HACCP course), molluscan shellfish plant inspection standardization, product coding, classification of inspections, and completion of the relevant documents will be funded as follows:

        (describe funding as agreed to by FDA and the State) (replacement for required language bullet)

        Note: include only the relevant training programs.

    2. Personnel:
      • Training -
      • FDA and (name of State agency) will provide inspection personnel (inspection personnel may include analysts involved in team inspections) to receive training as follows:
        (list the number of FDA and State inspection personnel that will receive training in introductory regulatory issues [e.g. evidence development, interviewing technique], food science and microbiology [e.g. the FDA Food Microbiological Control course, or equivalent], the principles of HACCP and the requirements of the Seafood HACCP Regulation [e.g. the Alliance HACCP course, or equivalent], the performance of a HACCP inspection [e.g. the Regulator HACCP course], molluscan shellfish plant inspection standardization, product coding, classification of inspections, and completion of the relevant documents.)
      • FDA will provide (appropriate number of facilitators) facilitator(s) for the Regulator HACCP course, as needed.
      • (list the number of FDA and State trainers for the standardization course)
      • FDA will provide (appropriate number of trainers) trainer(s) for training in product coding, classification of inspections, and completion of the relevant documents. (replacement for required language bullet)
      • Sample Analysis - FDA will provide (describe the location and number of analysts or FTEs that will be responsible for analyzing the samples collected under this agreement) analysts (or FTEs) for analyzing regulatory follow-up samples collected as needed under this agreement. (optional additional bullet)