U. S. Food and Drug Administration
Center for Food Safety and Applied Nutrition
Office of Seafood
November 3, 2000


A more recent version of this document issued in November 2004. Below is an earlier version.

NATIONAL SHELLFISH SANITATION PROGRAM
MODEL ORDINANCE

III. LABORATORY

(Table of Contents)


Requirements for the Authority
[Note: The Authority must meet the requirements of this section even if the Authority does not formally adopt this chapter in regulation.]

@.01 Quality Assurance.

A. NSSP Conformance Required. All laboratory analyses shall be performed by a laboratory found to conform or provisionally conform by the FDA or FDA certified State Shellfish Laboratory Evaluation Officer (LEO) in accordance with the requirements established under the NSSP.

B. State Program Requirements. The Authority shall assure that all samples are collected, maintained, transported and analyzed in a manner that assures the validity of the analytical results. The Authority shall:

(1) Require laboratories to develop a written quality assurance plan that:
(a) Describes the organization and management structure of the laboratory;
(b) Describes the laboratory staff training program ensuring that all laboratory personnel are qualified, properly trained, and supervised;
(c) Describes all procedures and methods used to collect, maintain, transport and analyze samples;
(d) Describes quality control measures, their frequency and tolerance limits, for determining equipment performance;
(e) Requires maintenance of records of analytical performance, quality control results, and equipment maintenance and calibration;
(f) Provides a quality assessment program to demonstrate laboratory and analyst competence. At a minimum this program must include triennial onsite laboratory evaluations conducted by either FDA laboratory evaluation officers or FDA certified state laboratory evaluation officers, and annual internal laboratory audits. For microbiological laboratories, participation in the annual FDA sponsored proficiency test programs is also required; and
(g) Requires corrective action for any deficiencies found in the laboratory quality assurance program.
(2) Require laboratories to implement their quality assurance plan;
(3) Ensure that the laboratory has appropriate facilities and resources to effectively manage the workload;
(4) Require triennial or more frequent evaluations of all laboratories which conduct both microbial and marine biotoxin and analyses used to officially support the state shellfish program; and
(5) Require a laboratory to be re-evaluated when any major changes in personnel, workload, or facilities occur and when a laboratory is found in nonconformance.

C An FDA certified State Shellfish Laboratory Officer may evaluate laboratories in a different State under a memorandum of understanding agreement between the States and FDA. The agreement shall be consistent with NSSP requirements.

D Laboratory Evaluation.

(1) Laboratory Status. Continued acceptance of analytical data in support of the NSSP by the Authority from any operating laboratory is contingent upon the laboratory being found to conform or provisionally conform to NSSP requirements as determined in their most recent laboratory evaluation using the NSSP standardized laboratory evaluation criteria listed in Section IV Guidance Documents A. 12.
(a) Conforms. In order to achieve or maintain its conforms status, a laboratory shall meet the following requirements under the NSSP standardized laboratory evaluation criteria:
(i) No critical nonconformities have been identified;
(ii) Not more than 12 key nonconformities for microbiological or 4 for paralytic shellfish poisoning component have been identified;
(iii) Not more than 17 critical, key, and other nonconformities in total or 9 for paralytic shellfish poisoning component have been identified (not to exceed the critical and key criteria); and
(iv) No repeat key nonconformities have been identified in consecutive evaluations.
(b) Provisionally Conforms. In order to achieve provisionally conforming status, a laboratory shall meet the following requirements under the NSSP standardized microbiological laboratory evaluation criteria:
(i) Not more than 3 critical nonconformities for the microbiological or 1 for paralytical shellfish poisoning component have been identified;
(ii) Not more than 12 key nonconformities for the microbiological or 4 for paralytical shellfish poisoning component have been identified; and
(iii) Not more than one repeat Key nonconformity has been identified in consecutive evaluations.
(c) Nonconformance. When a laboratory exceeds the following criteria, the laboratory shall be determined to be in nonconformance:
(i) More than 3 critical nonconformities for the microbiological or 1 for paralytic shellfish poisoning component have been identified;
(ii) More than 12 key nonconformities for the microbiological or 4 for paralytic shellfish poisoning component have been identified; and
(iii) More than 17 critical, key, and other nonconformities for microbiological or 9 for paralytic shellfish poisoning component have been identified; or
(iv) One or more repeat critical or two or more key nonconformities have been identified in consecutive evaluations.

E. Time Limit on Laboratory Status.

(1) Conforming Status. A laboratory in conforming status may operate for up to 90 days during which the laboratory must be actively working on an FDA or FDA certified State Shellfish LEO approved action plan to maintain its conforming status. After this period, the laboratory shall be assigned a nonconforming status if all key deficiencies have not been successfully corrected.
(2) Provisionally Conforming Status. A laboratory in the provisionally conforming status may operate for up to 60 days during which the laboratory must be actively working on a FDA approved action plan that will bring the laboratory into the NSSP conforms status. After this period, the laboratory shall be assigned a status as:
(a) Conforms if all the critical and key nonconformities have been successfully corrected; or
(b) Nonconforming if any critical or key nonconformities have not been successfully corrected.
(3) Nonconformance. Upon determination of nonconforming status, data generated from the laboratory shall not be used in support of the NSSP. If the laboratory wishes to attain conforming status, the laboratory must immediately implement an FDA or FDA certified State Shellfish LEO approved action plan and has up to 30 days to demonstrate successful correction of all critical and key deficiencies. After this period, an onsite re-evaluation should be conducted. Upon re-evaluation, only a status of conforming shall allow data to be accepted in support of the NSSP.

F. Laboratory Services for Depuration Processors. For any laboratory providing services for the quality assurance program (e. g. water quality) including end product testing of any depuration processor, the Authority shall:

(1) Require the annual inspection of the laboratory in accordance with 01 and 02 of this Chapter.
(2) Require the laboratory to retain its records for a minimum of the previous two years.

@.02 Methods.

A. Microbiological. Methods, practices and procedures for the analyses of shellfish and shellfish growing or harvest waters shall be the methods required by the National Shellfish Sanitation Program.

B. Chemical and Physical.

(1) Methods for the analysis of shellfish and shellfish growing or harvest waters shall:
(a) Be the current AOAC or APHA method for all physical and chemical measurements; and
(b) Express results of all chemical and physical measurements in standard units, and not instrument readings.
(2) When an AOAC or APHA method is not available, EPA methods may be used.

C. Biotoxin. Methods for the analyses of shellfish and shellfish harvest waters shall be:

(1) The current AOAC and APHA methods used in bioassay for paralytic shellfish poisoning toxins; and
(2) The current APHA method used in bioassay for Gymnodinium breve toxins.

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