Knowledge Center Guide
Please click on the link below to access more information.
Below are selected Guidance Documents; however, a variety of general resource and information documents can be found here on the FSIS website.
"Establishment Guidance for the Selection of a Commercial or Private Microbiological Testing Laboratory"
- Provides guidance to meat, poultry and processed egg establishment as it relates to selection and evaluation criteria for laboratories
- Discusses key quality assurance and control criteria needed to support the generation of reliable data and compiles this information in a succinct and user-friendly manner
- Includes a useful checklist to support laboratory assessments
- Issued April 2012 and electronically accessible here
"FSIS Guidance for Test Kit Manufacturers, Laboratories: Evaluating the Performance of Pathogen Test Kit Methods"
- Discusses the FSIS expectation that pathogen detection methods are "fit for use" and equivalent in performance to the corresponding FSIS method.
- The guidance document provides information on designing a robust validation study to assess performance and determine equivalence for the detection of foodborne pathogens in FSIS regulated commodities.
- The guidance is helpful for test kit manufacturers, laboratories and independent organizations with an interested in validating pathogen detection methods for specific pathogen targets and food types regulated by FSIS.
- Issued October 2010 and electronically accessible here.
Draft "FSIS Compliance Guideline – HACCP Systems Validation"
- This guidance provides useful information regarding initial process validation and ongoing verification.
- An overview on identifying key operational parameters and how to incorporate those into validation and verification
- Guidance on identifying scientific support documents and development of a scientific approach of validation and verification
- Issued April 2012 and electronically accessible here.
Additional Helpful USDA-FSIS Information and Resources
Federal Register Publications & Related Documents
- FSIS Federal Register Notices and related documents are searchable by year here.
- Notices and related documentation supporting food safety regulation are organized by issue date here.
- Regulatory Directives providing official communication to Agency personnel regarding their responsibilities and function are organized by subject area here.
Escherichia O157 & non-O157 STEC
- USDA-FSIS Microbiological Testing Program for Escherichia coli O157:H7 and non-O157 Shiga toxin-producing Escherichia coli (STEC). Data from June start date can be reviewed here.
Food Safety Research Priorities
- FSIS is not a funding agency, although the Agency has established key research priorities that will continue to be focus areas for promoting research. These priorities can be reviewed here.
FSIS Data Collection & Reports
- Surveillance data, sampling program information and scientific reports that the Agency uses to support food safety policy are accessible here.
Below are selected Guidance Documents; however, a series of Guidance Documents organized by issue year can be found on the FDA website here.
- Food Safety (Shell Eggs): Questions and Answers Regarding the Final Rule, Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation (August 2012) Accessible here.
- Food Safety (Shell Eggs): Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation (December 2011) Accessible here.
Salmonella in Human and Direct-Human-Contact Animal Foods (e.g. pet food)
- Food Safety: Testing for Salmonella Species in Human Foods and Direct-Human-Contact Animal Foods (March 2012) Accessible here.
Acidified Foods (e.g., salsa, marinades)
- Acidified and Low-Acid Canned Foods: Submitting Form FDA 2541 (Food Canning Establishment Registration) and Forms FDA 2541a and FDA 2541c (Food Process Filing Forms) to FDA in Electronic or Paper Format (July 2012) Accessible here.
- Acidified and Low-Acid Canned Foods: Draft Guidance: Acidified Foods (September 2010) Accessible here.