Food Industry Regulatory Update – June 18, 2021

In this Week’s Edition:

• FDA Updates Seafood HACCP Guidance
• NCBA Submits Petition on Country of Origin Labeling
• FSIS Posts New HACCP Models for Certain Categories of Products
• USDA Announces Additional Aid to Producers
• AMS Revises Standards for Lentils and Split Peas
• APHIS Delists Japan from Regions Free of Classical Swine Fever, Adds Thailand to List of Regions with African Horse Sickness
• Vilsack Speaks on Organic Livestock and Poultry Practices Rule
• FDA Issues Threshold of Regulation Exemption for Metal Carbides in Food Processing Equipment
• FSIS to Post Poultry Salmonella Testing Results
• FSIS to Host Virtual Open House at Midwest and Western Labs
• FSIS Updates Lists of Foreign Establishments Eligible to Export to U.S.
• FDA Import Alerts
• FDA Warning Letters

FDA Updates Seafood HACCP Guidance

FDA has determined specific chapters, appendices, and addenda of the guidance would be updated with the availability of new science. This update includes:

• Chapter 3: Potential Species-Related and Process-Related Hazards
• Chapter 11: Aquaculture Drugs
• Appendix 1: Forms
• Appendix 2: Product Flow Diagram – Example
• Appendix 3: Critical Control Point Decision Tree
• Appendix 5: FDA and EPA Safety Levels in Regulations and Guidance
• Appendix 8: Procedures for Safe and Sanitary Processing and Importing of Fish and Fishery Products
• Appendix 11: Approved Aquaculture Drugs
• Appendix 12: Unapproved Aquaculture Drugs
• Addendum 1: Fish and Fishery Products (21 CFR 123) and Control of Communicable Diseases (21 CFR 1240.60)
• Addendum 2: current Good Manufacturing Practices (cGMPs)

The modifications can be reviewed through the “Guidance to Industry: Fish and Fishery Products Hazards and Controls Guidance Fourth Edition – June 2021” section of the guidance document. The updated guidance supports and complements the FDA’s regulations for the safe and sanitary processing and importing of the fish and fishery products using hazard analysis and critical control point methods. Updates may be accessed through the Fish and Fishery Products Hazards and Controls Guidance Page.

NCBA Submits Petition on Country of Origin Labeling

The petition requests the U.S. Department of Agriculture (USDA) eliminate broadly applicable Product of USA labeling claims but continue to allow for more appropriately descriptive generic claims such as “Processed in the USA.” USDA will be accepting comments on the petition.

FSIS Posts New HACCP Models for Certain Categories of Products

Updated guides and models reflect changes in FSIS policy and lessons learned about implementing HACCP since its inception. The materials include updated scientific references and footnotes containing explanatory guidance and links to related sources of information. Consistent with the previous models, each model includes a product description, ingredients list, production flow diagram, hazard analysis and HACCP plan.

The revised Guideline for the Preparation of HACCP Plans leads an establishment through the process of developing a HACCP plan according to seven principles and provides links to additional reference materials. Templates are provided in the guide so the establishment can capture the product-specific information as demonstrated in the guide.

Additional models will be posted as they are revised. The following models were recently added:

• HACCP Model for Ready-to-Eat, Heat-Treated, Shelf-Stable (Beef Jerky)
• HACCP Model for Raw Ground Beef (Raw Non-Intact)
• HACCP Model for Bacon (Heat-Treated, Not Fully Cooked)
• HACCP Model for the New Swine Inspection System (pork slaughter)

USDA Announces Additional Aid to Producers

Details here.

AMS Revises Standards for Lentils and Split Peas

More information here:

• Lentils
• Split Peas

APHIS Delists Japan from Regions Free of Classical Swine Fever, Adds Thailand to List of Regions with African Horse Sickness

More information available here:

• Japan
• Thailand

Vilsack Speaks on Organic Livestock and Poultry Practices Here

The statement is available here.

FDA Issues Threshold of Regulation Exemption for Metal Carbides in Food Processing Equipment

FDA has issued a Threshold of Regulation (TOR) exemption for the use of metal carbides and metal carbide alloys as a component or ceramic coating in repeat-use applications such as parts in food processing equipment.

FSIS to Post Poultry Salmonella Testing Results

On June 21, 2021, FSIS will update the individual establishment Salmonella performance standard category information for raw poultry carcasses, raw chicken parts, and comminuted poultry products on the Salmonella Verification Testing Program Monthly Posting page. Additionally, FSIS will post the aggregate sampling results showing the number of establishments in categories 1, 2, or 3 for establishments producing young chicken or turkey carcasses, raw chicken parts, or not ready-to-eat (NRTE) comminuted poultry products at the location linked above.

FSIS to Host Virtual Open House at Midwest and Western Labs

FSIS plans to host a joint virtual open house at the Midwestern and Western Laboratories on August 2, 2021, from 11:30 a.m. – 4:00 p.m. ET. Topics have been specifically chosen based on recent feedback and frequent questions received by the FSIS laboratories.

Participants will learn:

• What happens to a sample from its delivery at an FSIS laboratory to reporting the sample results
• How FSIS Laboratories recently modernized Campylobacter screening tests to build efficiency into the method
• How FSIS Laboratories shortened the time-to-confirmation of bacterial pathogens using a MALDI-TOF proteomics approach

Participants must pre-register. The registration link for the open house will be announced in a future Constituent Update.

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

• Argentina
• Croatia

FDA Import Alerts

The latest FDA import alerts are available here and include pesticides, mycotoxins, illegal colors and L. monocytogenes in seafood.

FDA Warning Letters

The latest FDA warning letters are below:

Market of Choice, LLC

CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated/L. monocytogenes

Vape E’s Ltd

Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded

E-Vaperz Spring Hill Location LLC

Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded

Lincoln Vapor LLC

Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded

Please contact Erik Lieberman at elieberman@usfoodimports.com if you have questions or for additional information