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- (i) Not more than 3 critical nonconformities for the microbiological or 2 for paralytic shellfish poisoning component have been identified;
(ii) Not more than 12 key nonconformities for the microbiological or 5 for paralytic 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 2 for paralytic shellfish poisoning component have been identified;
(ii) More than 12 key nonconformities for the microbiological or 5 for paralytic shellfish poisoning component have been identified;
(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.
(1) Methods for the analysis of shellfish and shellfish growing or harvest waters shall: