Food Industry Regulatory Update October 25, 2024

October 25, 2024

In This Week’s Edition:

FDA AAFCO Enforcement Policy
FSIS Revises Directive on Laboratory Sampling Program for Imported Meat, Poultry, and Egg Products
Updated Status Chart for FSIS Equivalence
FSIS Issues Public Health Alert for Ineligible Meat and Poultry Products Illegally Imported from Myanmar
FSIS Guidance on Foodborne Pathogen Test Kits Validated by Independent Organizations
FSIS Petitioned to Allow Small Establishments to Operate Under Custom, Retail and Small Business Exemptions Simultaneously
USDA Food Safety and Inspection Service Foreign Audit Report: Japan
EAPA Action: Notice of Determination as to Evasion for EAPA Case 7844 –Xanthan Gum from China
FDA Partners with Purdue University and Indiana Agricultural Stakeholders on Multi-year Environmental Microbiological Study to Enhance Food Safety
FDA CORE Outbreak Investigation Status Update
FSIS Updates Lists of Foreign Establishments Eligible to Export to U.S.
FDA Import Alerts
FDA Warning Letters

FDA AAFCO Enforcement Policy

FDA is announcing the availability of a final guidance for industry #293 entitled “FDA Enforcement Policy for AAFCO-Defined Animal Feed Ingredients.” This communicates FDA’s enforcement policy regarding ingredients listed in chapter six of the 2024 AAFCO Official Publication after the Agency’s memorandum of understanding with AAFCO expired on October 1, 2024.

FSIS Revises Directive on Laboratory Sampling Program for Imported Meat, Poultry, and Egg Products

This directive provides instructions to inspection program personnel (IPP) on the FSIS laboratory sampling and testing of imported meat, poultry, and egg products assigned by the Public Health Information System. FSIS is issuing a new version of this directive to incorporate all laboratory sampling instructions for imported meat, poultry, egg products, and Siluriformes fish, including instructions from expired FSIS notices for raw beef and Shiga toxin-producing Escherichia coli and Salmonella sampling, raw poultry Salmonella and Campylobacter sampling, and raw pork Salmonella sampling, and instructs IPP to use the cloth surface sampling method for imported fresh non-intact beef. This directive changes the packaging descriptions from intact to “product in the final package” and non-intact to “product not available in the final package,” so imported product packaging descriptions are consistent with domestic product packaging descriptions.

Updated Status Chart for FSIS Equivalence

This chart lists active equivalence requests received by FSIS regarding eligibility to export meat, poultry, or egg products to the United States. If FSIS has not received correspondence from a country regarding an equivalence request for one year, FSIS considers that request to be inactive. The chart has been updated October 23.

FSIS Issues Public Health Alert for Ineligible Meat and Poultry Products Illegally Imported from Myanmar

FSIS is issuing a public health alert for various meat and poultry products that were illegally imported from the Republic of the Union of Myanmar. FSIS is continuing to investigate how these products entered the country. See the products that are subject to the public health alert here.

FSIS Guidance on Foodborne Pathogen Test Kits Validated by Independent Organizations; Guidance

The guidance provides a list of test kits that have been validated for detection of relevant foodborne pathogens (i.e., Salmonella, Campylobacter, Listeria spp. including L. monocytogenes, E. coli O157:H7 and non-O157 STEC). It applies to official establishments and actions they may take when considering optional validated test kits for use to meet regulatory requirements for pathogen testing.

FSIS Petitioned to Allow Small Establishments to Operate Under Custom, Retail and Small Business Exemptions Simultaneously

The petition requests that FSIS change the Guidance for Determining Whether a Poultry Slaughter or Processing Operation is Exempt from Inspection Requirements of the Poultry Products Inspection Act to allow small and very small establishments to operate under the custom, small enterprise, and retail exemptions simultaneously if operations are conducted using sanitary methods and there is time and space between inspected and exempted operations.

USDA Food Safety and Inspection Service Foreign Audit Report: Japan

FSIS maintains a list of comprehensive audits of foreign country inspection systems to ensure compliance with certain regulatory requirements. Japan has been added to this list.

EAPA Action: Notice of Determination as to Evasion for EAPA Case 7844 –Xanthan Gum from China

CBP issued its Notice of Determination as to Evasion by Guy and O’Neill, Inc. in Enforce and Protect Act investigation 7844, examining the evasion of antidumping duty order A-570-985 on xanthan gum from the People’s Republic of China. Based on the record of the investigation, CBP found there was substantial evidence that the Importer entered covered merchandise from China that was transshipped through Israel.

FDA Partners with Purdue University and Indiana Agricultural Stakeholders on Multi-year Environmental Microbiological Study to Enhance Food Safety

FDA has launched a new study in partnership with Purdue University and members of the produce industry in Indiana to better understand the ecology of human pathogens in the environment of the Southwest Indiana agricultural region. Following multiple Salmonella outbreaks linked to this region, this multi-year study will focus on assessing risks related to how Salmonella is distributed and survives in the environment in Indiana in order to identify and implement practical and cost-effective mitigation strategies.

FDA CORE Outbreak Investigation Status Update

This week’s updates are:

A new outbreak of E. coli O157:H7 (ref #1270) has been added to the table and FDA has issued an advisory. A specific ingredient has not yet been confirmed as the source of the outbreak, but most sick people report eating McDonald’s Quarter Pounder burgers. Investigators are working to determine if the slivered onions or beef patties on Quarter Pounder burgers are the likely source of contamination.
• A new outbreak of Listeria monocytogenes (ref #1268) linked to a not yet identified product has been added to the table. FDA has initiated traceback and an onsite inspection.
• For the outbreak of Salmonella Thompson (ref #1262) linked to a not yet identified product, the case count has increased from 23 to 25 cases.
• For the outbreak of Cyclospora cayetanensis (ref #1245) in a not yet identified product, the outbreak has ended.
• For the outbreak of Cyclospora cayetanensis (ref #1237) in a not yet identified product, the outbreak has ended.

CORE Investigation Table

FSIS Updates Lists of Foreign Establishments Eligible to Export to U.S.

FDA Import Alerts

The latest FDA import alerts include foreign processors not in compliance with juice HACCP, human and animal food products from foreign suppliers who refused FDA inspection.