Constituent Update - May 7, 2021
FSIS to Perform Clostridium perfringens Market Basket Survey
Starting in May 2021, FSIS will conduct a study to assess levels of C. perfringens in federally inspected ready-to-eat (RTE) meat and poultry products sold at retail locations. C. perfringens is a pathogen that can grow during improper cooling and hot holding of RTE products. The goal of the study is to determine the potential risk to consumers from large mass non-intact products (e.g., turkey breast or roast beef) that require an extended cooling time. The study will be performed in response to comments on the 2017 revised Appendix B guideline indicating that large mass non-intact products cannot be cooled quickly enough to meet the recommended cooling options.*
The samples will be collected at retail locations and analyzed by Food Emergency Response Network (FERN) laboratories. The results will be blinded and reported in aggregate on the FSIS website and in literature. FSIS does not expect to find samples with high levels of C. perfringens (>4-log10) due to previous studies reported in the literature as well as the lack of outbreaks associated with federally inspected RTE meat and poultry products. Regardless, enforcement actions will not be taken based on the study results. The study results will be used to assess whether changes are needed to the cooling recommendations in Appendix B for these products, or if a larger, more comprehensive baseline study is needed.
*The cooling options in Appendix B are designed to meet FSIS’ regulatory performance standards for a 1-log10 reduction in C. perfringens ((9 CFR 318.17(a)(2), 9 CFR 318.23(c)(1), 9 CFR 381.150(a)(2), and 9 CFR 381.150(b)).
Tips for Faster Label Approval Process
Labels are currently taking about 5-7 business days to evaluate.
TIP: Identifying all special statements and claims in the “Special Claims Information” section of the label application will help streamline the evaluation process.
FSIS continues to notice label applications submitted with incorrect or missing information in the “Special Claims Information” section. This section is Step 3 in the electronic Label Submission and Approval System (LSAS) process and Box 10 on the paper FSIS Form 7234-1. Providing all the correct information allows FSIS to quickly determine which area of expertise is needed to evaluate labels with special statements and claims.
For example, establishments should select the “Animal Production/Breed/Raising” box in LSAS for labels bearing claims related to animal raising practices, such as “grass fed” or “no antibiotics administered.” However, if the claim is not listed on the application form or if the establishment is unsure of which category a claim falls under, the establishment should select the “Other Claims” box and manually enter the claim into the text box, for example, “Gluten Free” or “Ingredients used are not bioengineered.” This information allows FSIS to assign the label to the staff officer best suited to evaluate that label, which helps streamline and speed up the label approval process.
The User Guide for Industry Users provides guidance on how to use LSAS. Page 107 specifically provides information on the tip cited above. The user guide can be accessed at: https://www.fsis.usda.gov/sites/default/files/import/LSAS-Industry-User-Guide-063015.pdf
Additional guidance on the types of claims that require FSIS approval as well as claims which may be approved generically may be found in the FSIS Guideline for Label Approval at:
FSIS will continue to provide updates regarding label turnaround time as well as suggestions to assist industry in streamlining label submissions in its Constituent Update.
Update to the FSIS Microbiology Laboratory Guidebook (MLG) Chapter 41, Campylobacter Isolation and Identification
The FSIS Office of Public Health Science (OPHS) announced plans to modernize its Campylobacter species microbiological testing method in an April 2, 2021 Constituent Update. The FSIS laboratory system evaluated commercially available rapid screening technologies for use in the high-throughput FSIS laboratory environment and decided to utilize the 3M™ Molecular Detection System (MDS) to perform rapid initial screens of regulatory samples for Campylobacter species. FSIS has revised the Microbiology Laboratory Guidebook (MLG) chapter “Isolation and Identification of Campylobacter jejuni/coli/lari from Poultry Rinse, Sponge and Raw Product Samples” and is publishing the updated chapter in a new user-friendly format.
FSIS will begin using the revised chapter to screen for Campylobacter species in regulatory samples received on or after June 7, 2021. Please refer to the “Notice of Change” page located at the beginning of the revised chapter for details of the changes that have been made throughout the document. Further, the FSIS laboratories will present details of the Campylobacter method modernization effort during their next public Open House in Summer 2021. Laboratory Open House details and registration instructions will be communicated in a future Constituent Update.
The FSIS MLG can be found at the following link:
FSIS Posts FY 2020 Sampling Summary
On May 5, 2021, FSIS posted the FY 2020 Sampling Summary Report to share retrospective FSIS sampling information with consumers and other stakeholders. The summary includes results from the domestic microbiological and chemical sampling projects for beef, pork, Siluriformes fish, poultry, and ready-to-eat products. In addition, the report includes import residue and microbiological sampling, whole genome sequencing information, National Antimicrobial Resistance Monitoring System (NARMS) sampling, and other sampling for special projects.
This Sampling Summary Report complements the annual FSIS Sampling Catalog, as part of the Agency’s continuing effort to enhance transparency and provide consumers and other stakeholders with reliable and timely information.
To view additional data and learn more about FSIS sampling, visit https://www.fsis.usda.gov/science-data/sampling-program.
Update on FSIS Quarterly Sampling Reports for Salmonella Serotype and Pulsed-field Gel Electrophoresis (PFGE) Information
On May 5, 2021, FSIS posted quarterly Salmonella serotype and PFGE data for Salmonella, Campylobacter, and Shiga toxin-producing Escherichia coli (STEC) isolates collected from FSIS product categories. This was later than the target release date of April 30, 2021.
This release includes serotype and PFGE from the first quarter of Fiscal Year 2016 through the fourth quarter of Fiscal Year 2020 (when applicable) and is available on the Microbiology web page. Quarterly sampling reports on PFGE extend through the end of FSIS’ transition to Whole Genome Sequencing. FSIS made this transition for Campylobacter beginning in November 2018 and finalized it for E. coli and Salmonella in April 2019.
The reports exclude data on pork projects from the first quarter of Fiscal Year 2016; however, these data will be included in the next report update in July 2021.
Export Requirements Update
The Library of Export Requirements has been updated for products for the following countries:
Complete information can be found at https://www.fsis.usda.gov/inspection/import-export/import-export-library.
FSIS notices and directives on public health and regulatory issues are available at https://www.fsis.usda.gov/policy/directives-notices. The following policy update was recently issued:
FSIS Notice 18-21 - Procedures for Work-Related Fatalities, Injury, and Illness Recordkeeping and Annual Reporting Requirements