§ 439.10 - Criteria for obtaining accreditation.

§ 439.10 Criteria for obtaining accreditation.

(a) Analytical laboratories may be accredited for the analyses of food chemistry foodborne indicator and pathogen analytes, as defined in § 439.1 of this part, or a specific specified chemical residue or a class of chemical residues, in raw or processed meat, poultry, and egg products. Analytical laboratories also may be accredited for the analyses of food chemistry components in raw or processed meat and poultry products.

(b) Accreditation will be given granted only if the applying laboratory successfully satisfies the requirements presented below. For food chemistry accreditation, the requirements must be satisfied for all four analytes.

(c) This accreditation authorizes official FSIS acceptance of the analytical test results provided by these laboratories on official samples.

(d)

FSIS requirements that are stated in this part.

(c) To obtain FSIS accreditation, an analytical laboratory must:

(1) Be supervised by a person holding, at a minimum, a bachelor's degree in biology, chemistry, microbiology, food science, food technology, or a related field.

(i) For food chemistry accreditation, the supervisor must also have one year

's

of experience in food chemistry analysis, or equivalent qualifications

, as determined by the Administrator

.

(ii) For chemical residue accreditation, either the supervisor or the analyst assigned to analyze the sample must also have three years

'

of experience determining analytes at or below part per million levels, or equivalent qualifications

, as determined by the Administrator

.

(iii) For indicator organisms or pathogen accreditation, either the supervisor or the analyst assigned to analyze the sample must also have three years of experience in foodborne pathogen analyses or equivalent qualifications.

(2) Demonstrate

an ability

the capability to achieve quality assurance levels that are within acceptable limits

for systemic laboratory difference, variability, and individual large deviations,

as determined by evaluation that is consistent with ISO 13528 for the analysis of initial accreditation proficiency testing samples, in the analyte category for which accreditation is sought

, using analytical procedures designated by the FSIS ALP as being acceptable. An applying laboratory will successfully demonstrate these capabilities for:

(i) Food chemistry if its results from a 36 check sample accreditation study each satisfy the criteria presented in paragraph (e) of this section.

(ii) Chemical residues if its analytical results for each specific chemical residue provided in a check sample accreditation study containing a minimum of 14 check samples satisfy the criteria presented in paragraph (e) of this section, including criteria for QA and QC recovery and for residue identification. In addition, if the laboratory is requesting accreditation for the analysis of chlorinated hydrocarbons, all analytical results for the residue class must collectively satisfy the criteria. [Conformance to criteria in paragraph (e) of this section will only be determined when six or more analytical results with associated comparison means at or above the logarithm of the minimum proficiency level are available.]

(3) Round all check sample statistical computations to the nearest tenth, except where otherwise noted.

(4) Complete a second set of the requisite number of check

. FSIS and some Association of Official Analytical Collaboration (AOAC) International analytical test procedures are acceptable for use in this program. FSIS procedures may be found on the U.S. Department of Agriculture (USDA) FSIS website at www.fsis.usda.gov. AOAC procedures may be found on the AOAC website at www.aoac.org.

(3) Complete a second set of proficiency testing samples if the results of the first set of

check samples do not meet the criteria for obtaining accreditation

proficiency testing samples are unsuccessful.

(i) The second set of

check

proficiency testing samples will be provided within 30 days following the date of receipt by FSIS of a request from the applying laboratory. The second set of

food chemistry check

proficiency testing samples will be analyzed only for

only

the analyte(s) or analyte classes for which unacceptable initial results had been obtained by the laboratory.

(ii) If the results of the second set of

check samples do not meet the criteria for obtaining accreditation

proficiency testing samples are unsuccessful, the laboratory may

reapply

request a third set of proficiency testing samples after a 60-day waiting period, commencing from the date of

refusal of accreditation

notification by FSIS

. At that time, a new application, all fees, and all documentation of corrective action required for accreditation must be submitted. (5

of unsuccessful results. The third set of proficiency testing samples will be analyzed only for the analyte(s) or analyte classes for which unacceptable initial results had been obtained by the laboratory.

(iii) If the laboratory is unsuccessful for the third set and still wishes to pursue accreditation, the ALP will require a new application and an application fee if the initial accreditation process is not completed within eleven months. Documentation of corrective action(s) related to the previous unsuccessful accreditation attempt must be submitted to and accepted by the ALP.

(4) Allow inspection of the laboratory facility and pertinent documents by FSIS officials prior to the determination of granting accredited status.

(

6

5) Pay the accreditation fee by the date required.

(e) Quality assurance levels -

(1) Systematic laboratory difference: The absolute value of the average standardized difference must not exceed the following:

(i) For food chemistry, 0.73 minus the product of 0.17 and the standard deviation of the standardized differences; and

(ii) For chemical residues, 1.67 (2.00 if there are less than 12 analytical results) minus the product of 0.29 and the standard deviation of the standardized differences.

(2) Variability: The estimated standard deviation of the standardized difference must not exceed the following:

(i) For food chemistry, 1.15; and

(ii) For chemical residues, a computed limit that is a function of the number of analytical results used in the computation of the standard deviation, and of the amount of variability.

(3) Individual large deviations: One hundred times the average of the large deviation measures of the individual samples must be less than 5.0. A result will have a large deviation measure equal to zero when the absolute value of the result's standardized difference, (d), is less than 2.5 and otherwise a measure equal to 1-(2.5/d).

(4) For residue analyses, the following additional quality assurance requirements must be met.

(i) QA recovery: The average of the QA recoveries of the individual check sample analytical results must lie within ranges established by FSIS.

(ii) QC recovery: All QC recoveries must lie within ranges established by FSIS. Supporting documentation must be made available to FSIS upon request.

(iii) Correct identification: There must be correct identification of all chemical residues in all samples.