Current through Register Vol. 50, No. 9, September 20, 2024
A. The laboratory
and laboratory analysts are required to receive a satisfactory evaluation
during an on-site visit by the shellfish evaluation officer for the state of
Louisiana or FDA laboratory evaluation officer in order to be certified.
1. The purpose of the evaluation will be to
assure the uniform application of standard procedures and methods in the
sampling and analytical examination of shellfish growing waters and to
determine and assure the adequacy of facilities, equipment and personnel to
perform analytical testing necessary to meet the requirements recommended by
the National Shellfish Sanitation Program and found to be acceptable by the
Louisiana Molluscan Shellfish Program, administered by the Department of
Health, Office of Public Health. Evaluation is not an endorsement of the
laboratory facility, its staff the operation as this implies continuing
guarantee of performance.
2. A
satisfactory rating is achieved by demonstration during an on-site evaluation
that the laboratory and laboratory personnel are found to conform or
conditionally conform with all requirements as listed in the Shellfish
Laboratory Evaluation Check Lists provided 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, Shellfish
Aquaculture and Policy Branch. A satisfactory rating indicates that FDA
recognizes that the laboratory complies with recommended procedures and
capabilities and that the analytical results produced by the laboratory are in
support of the Louisiana Shellfish Sanitation Program and are acceptable to
FDA.
3. No reference shall be made
in any advertising or sales promotion which would indicate or imply that the
Louisiana state shellfish evaluation officer or FDA laboratory evaluation
officer evaluated this laboratory or approves, endorses or recommends any
proprietary materials, services, or publications mentioned herein or which has
as its purpose and intent to cause directly or indirectly the advertised
materials or services to be used or purchased because of the
evaluation.
B. An
applicable, currently dated (i.e., the last satisfactory on-site evaluation
shall be documented to have been held within the prior three year period)
satisfactory FDA Shellfish Standard Laboratory Evaluation Form and narrative
report submitted by the appropriate laboratory evaluation officer to the FDA
Division of Cooperative Programs, Shellfish Sanitation Branch with a copy to
the appropriate FDA shellfish specialist and the public health laboratory
director shall be on file or available upon request.
1. Said narrative report shall include the
identity of the laboratory, the date of evaluation, name of evaluator,
information on personnel and procedures and conclusions and shall precisely and
accurately describe the conditions which existed during the evaluation,
including what recommendations were made to correct deficiencies and proposed
timetable for any corrective action necessary to bring the laboratory into
substantial conformity with the requirements of NSSP as approved by the
Louisiana State Shellfish Sanitation Program.
2. If any deficiencies or recommendations
were noted in the narrative report, the laboratory shall demonstrate that the
stated deficiencies and/or recommendations have been satisfactorily corrected
or addressed within the proposed timetable and that the laboratory is
substantially in compliance with the requirements of NSSP as approved by the
Louisiana state Sanitation Program.
3. Failure to be found to conform or
provisionally conform during the on-site evaluation by the appropriate
Laboratory Evaluation Officer and/or failure to correct or address deficiencies
or recommendations as noted in the narrative report within the stated timetable
shall result in loss of satisfactory evaluation.
C. As samples are available, the laboratory
shall periodically participate in a split-sample program to test laboratory
proficiency and shall receive a grade of satisfactory.
1. Refusal to participate and/or repeated
failure to receive a satisfactory grade shall result in loss of satisfactory
evaluation.
D. The
laboratory shall maintain a list of qualified analysts who have received a
satisfactory rating as a result of the evaluation procedures and who are
consequently approved to conduct analysis in the laboratory.
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.
