Current through Register Vol. 50, No. 12, December 20, 2024
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. 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. The
individual shall be an experienced analyst and should have supervisory
experience.
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.
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. 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.
BThe 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. 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.
2The 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. 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.
4The individual shall have all state
laboratory evaluations, quality control examinations, and reports up-to-date.
5The individual shall receive
continuing training, as necessary, in laboratory evaluations and analytical
procedures.
CLaboratory
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:
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.
