U.S – The U.S. Department of Agriculture’s Food Safety and Inspection Service (USDA’s FSIS) has revised its rules on the accreditation of private laboratories to expand the scope of the accreditations offered by its voluntary Accredited Laboratory Program (ALP).
The final rule, “Changes to Accreditation of Non-Federal Analytical Testing Laboratories”, will now encompass testing of microbial indicator organisms, pathogen testing, and additional chemical residue testing.
The rule also reviews the statistical method that FSIS uses to evaluate ALP’s laboratory proficiency testing, as well as includes various updates that provide clarity and incorporate all sample types under the jurisdiction of FSIS.
Currently, participants in the ALP are accredited for the analysis of food chemistry (moisture, protein, fat, and salt), specific chemical residues, and classes of chemical residues.
ALP is a voluntary program through which FSIS accredits non-federal analytical laboratories to conduct analyses of official meat and poultry samples for food chemistry, specific chemical residues, classes of chemical residues, and now, specified microbiological organisms.
In response to the meat and poultry industries’ need for more rapid analytical results as food testing expanded, and because of limitations in FSIS laboratory capacity at the time of this need, these programs were established to accredit non-Federal laboratories for certain tests of both meat and poultry products.
ALP-accredited laboratories are monitored by FSIS to ensure that they are capable of producing reliable results, and are tested through the program’s Proficiency Testing (PT) program.
Monitoring is achieved by evaluating PT results for acceptable analytical performance and assessing quality assurance through on-site reviews of each laboratory’s management system and facility assets.
FSIS proposed changes to its ALP regulations on December 14, 2020 with a specific emphasis to change the statistical method it uses to evaluate laboratory PT sample results to the z score approach for those accreditations that are currently evaluated by Cumulative Summation (CUSUM).
It also proposed to accredit non-Federal laboratories for microbiological indicator organisms and pathogen testing, in response to industry interest.
This second change will allow ALP-accredited laboratories to support statistical process control testing. FSIS intends to announce additional criteria for submitting test results in a future Federal Register document.
The Department received seven comments from various sector stakeholders who were all in concurrence with the proposed change on the statistical method from CUSUM to z scores.
According to the new rules, a laboratory will be placed on probation for having two z scores that exceed the action level of | z| ≥ 3.0 for the same analyte or class of analytes within six consecutive PT events. Unacceptable z scores are greater than 3 and less than −3.
A laboratory may be placed on probation for having a persistent bias of an analyte or class of analytes compared to the accepted values of ALP PT samples.
The changes will become operative on October 24, 2022.