1. A. The shellfish evaluation officer for the state of Louisiana shall be designated by letter by the Federal Department of Health and Human Services, Public Health Service, Food and Drug Administration, Center for Food Safety and Applied Nutrition, Office of Food Safety, Division of Seafood Safety, Shellfish Aquaculture and Policy Branch. Designation is based upon meeting the requirements of the NSSP Guide Guidance document.

   1. 1. The individual shall be administratively attached to a Louisiana Molluscan Shellfish Laboratory which has been found by the FDA to conform or provisionally conform with the National Shellfish Sanitation Program (NSSP).
   2. 2. The individual shall be an experienced analyst and should have supervisory experience.
   3. 3. If deemed necessary by an FDA laboratory evaluation officer, the individual shall conduct several laboratory evaluations jointly with FDA Shellfish and Aquaculture Policy Branch laboratory evaluation officers.
   4. 4. During a joint on-site evaluation with an FDA laboratory evaluation officer, the individual shall demonstrate competence in evaluating analysts' performance of the applicable shellfish laboratory test methods in the 4th edition of the APHA Recommended Procedures for the Examination of Sea Water and Shellfish and the Official Methods of Analysis of the Association of Official Analytical Chemists (A.O.A.C). The evaluation will be recorded on the FDA Evaluation Laboratory Checklist.
   5. 5. The individual shall submit a written report to all evaluations conducted to the FDA Division of Cooperative Programs, Shellfish Sanitation Branch with a copy to the appropriate FDA shellfish specialist. The report should consist of the FDA Shellfish Standard Laboratory Evaluation Form, a summary list of qualified analysts and a narrative discussion for each laboratory evaluated. The narrative discussions shall include the identity of the laboratory, the date of evaluation, name of evaluator, a precise and accurate description of the conditions which existed during the evaluation, including what recommendations were made to correct deviations necessary to bring the laboratory into substantial conformity with the requirements of NSSP as approved by the Louisiana State Shellfish Sanitation Program and appropriate information on personnel and procedures and conclusions.

2. B. The evaluation shall be valid for a period of three years and reevaluation will be held triennially. Satisfactory reevaluation is based on the individual satisfying the following criteria.

   1. 1. The individual shall continue to be administratively attached to a state central shellfish sanitation laboratory which has been found by FDA to be in conformity with the National Shellfish Sanitation Program (NSSP) requirements.
   2. 2. The individual shall demonstrate continued satisfactory competence in evaluating the shellfish laboratory test methods of analysts during a joint laboratory evaluation with an FDA laboratory evaluation officer.
   3. 3. The individual shall submit a written report of the joint laboratory evaluation to the FDA Shellfish and Aquaculture Policy Branch laboratory evaluation officers with a copy to the appropriate FDA shellfish specialist.
   4. 4. The individual shall have all state laboratory evaluations, quality control examinations, and reports
      up-to-date.
   5. 5. The individual shall receive continuing training, as necessary, in laboratory evaluations and analytical procedures.
3. C. Laboratory evaluation officers who fail to meet the recertification requirements shall lose their certification until it is demonstrated that all necessary requirements, including training are met.

Authority Note

AUTHORITY NOTE: Promulgated in accordance with R.S. 40:4.A.(1) , R.S. 40:5.A.(2)(3)(5)(7)(9)(15)(17)(19)(20) and R.S. 40:5.3.

Historical Note

HISTORICAL NOTE: Promulgated by the Department of Health and Hospitals, Office of Public Health, LR 28:1298 (June 2002), amended by the Department of Health, Office of Public Health, LR 48:1849 (July 2022), repromulgated LR 48:2137 (August 2022).