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  • Earlier this week FDA published a draft guidance titled Establishing Sanitation Programs for Low-Moisture Ready-to-Eat Human Foods and Taking Corrective Actions Following a Pathogen Contamination Event.  (See publication notice at 90 Fed. Reg. 1052 (January 7, 2025)). Examples of low-moisture, ready-to-eat (LMRTE) foods include powdered infant formula, peanut butter, nut butters, powdered drink mixes, chocolate, medical foods in powdered and paste forms, processed tree nuts, milk powders, powdered spices, snack foods such as chips and crackers, granola bars, and dry cereal.
  • The draft guidance is intended to help manufacturers/processers of LMRTE human foods comply with 21 CFR part 117 (Current Good Manufacturing Practice (CGMP), Hazard Analysis, and Risk-Based Preventive Controls (HARPC) for Human Food) and, in the case of infant formula manufacturers, the requirements in 21 CFR part 106. In particular, the draft guidance provides FDA’s current thinking regarding:
    • Establishing and implementing a sanitation program and environmental monitoring program
    • Conducting root cause investigations following a pathogen contamination event
    • Applying a sanitizing treatment when remediating a pathogen contamination event
    • Taking steps to identify affected food; and
    • The limitations of relying solely on a product testing program to verify that pathogen contamination has been eliminated
  • The draft guidance includes a discussion of CGMPs necessary to control pathogens in LMRTE foods. Controlling water and maintaining a dry production site is a key feature of FDA’s recommended approach. The draft guidance notes that cleaning— removing residue from a food contact surface (FCS) — is distinct from sanitizing treatments (designed to kill pathogens) and that in dry processing conditions, cleaning and sanitizing is usually done sequentially. The draft guidance cautions that “material flush techniques,” which clean a FCS by pushing product or other materials (e.g., hot oil) through the FCS, are ineffective methods to kill pathogens.   
  • Among the points raised in its discussion of HARPC components applicable to a sanitation program, the draft guidance recommends the identification of Salmonella spp. as a hazard requiring a preventive control for products which are exposed to the environment before packaging and which are not treated. Similarly, the draft guidance recommends the identification of Cronobacter spp. as a hazard in the case of powdered infant formula products exposed to the environment before packaging that do not receive a kill step or other control measure.
  • In its discussion of preventive control step verification activities and root cause analysis, the draft guidance expresses a strong preference for identifying pathogens using whole genome sequencing (WGS) because of its much greater specificity and ability to discriminate between different pathogenic strains. Where WGS is not used, FDA recommends maintaining samples so that they can be characterized by WGS later if necessary (e.g., in a root cause investigation following a contamination event).
  • The draft guidance also indicates in several sections that finished product testing has limitations and should not be solely relied upon for verification of preventive controls or identifying affected food. Finished product testing will be particularly ineffective at identifying hazards which are present at low levels and which are unevenly distributed.
  • Comments to the draft guidance should be submitted by May 7, 2025. Keller and Heckman would be happy to assist in preparing comments.
  • On June 5, 2024, FDA announced preliminary findings from a nearly 5-year study of E. coli, including Shiga toxin-producing E. coli (STEC), and Salmonella pathogens in the Southwest agricultural region. The study was conducted in conjunction with a number of partners in the region and in the leafy green industry.  
  • These pathogens are a major cause of food-born illness in leafy greens and the study was launched following a major food-born illness outbreak in Yuma, Arizona which was linked to E. coli 0157:H7 (a STEC serotype). Over the course of the study (May 2019 – April 2024), more than 5000 samples were collected from a variety of potential environmental reservoirs, including water, soil, sediment, air, animal fecal material, and wildlife. Whole genome sequencing was performed on samples to determine their genetic relatedness and distribution.
  • The study found that positive results increased with proximity to concentrated animal feeding operations and the data suggests that air, dust, and wind play a role in pathogen transfer. However, birds and other wildlife do not appear to be a significant source of STEC.
  • Continued analysis of the data and its implications is planned and additional details will be presented at the International Association for Food Protection meeting on July 14-17, 2024.
  • In 2020 FDA established a collaborative partnership, i.e., “Statement of Intent” (SOI), with its Mexican counterparts (SENASICA and COFEPRIS) to improve the safety of food that is traded between the countries. The SOI expanded upon a 2014 SOI which had been limited to produce and minimally processed foods.
  • On March 31, 2023, FDA held a joint meeting with SENASICA and COFEPRIS to discuss the progress on food safety issues. Progress on identifying food contaminated with Cyclospora cayetanensis was particularly noteworthy and FDA shipped Cyclospora DNA sequences to SENASCIA and COFEPRIS and delivered a training on Chapter 19B of the Bacteriological Analytical Manual (BAM), which relates to FDA’s preferred methods for testing for Cyclospora cayetanensis.
  • Other accomplishments of the partnership can be found at the FDA webpage for the partnership where they are listed under one of the four content-specific working groups which worked on the issue: (1) the Strategic Priorities Work Group (focused on improving communication on important food safety issues), (2) the Laboratory Collaboration Work Group (focused on sharing lab data including whole genome sequencing, (3) the Outbreak Response Work Group (focused on enhancing effectiveness and timeliness of responses to food born illness outbreaks), and (4) the Food Safety Training Work group (focused on training to improve compliance with food safety requirements). 
  • We will continue to monitor and report on any developments in the partnership as well as other food safety issues.
  • FDA’s Center for Food Safety and Applied Nutrition (CFSAN) and Office of Food Policy and Response (OFPR) routinely publish a list of possible new topics for guidance documents or revisions to existing guidance documents that will be a priority during the next 12 months.  Guidance documents on the list are characterized as “Level 1,” meaning they involve FDA’s thoughts on significant new regulatory requirements or substantial changes to an earlier regulatory interpretation or policy, and complex scientific or highly controversial issues. 
  • On February 23, 2023, FDA released the list of draft and final guidance topics that are a priority for possible action before January 2024.  FDA’s 2023 list includes categories of food topics and items for prioritization as follows:
  • Allergens – following the addition of sesame to the list of major food allergens, effective January 1, 2023, as a result of the Food Allergy Safety, Treatment, Education, and Research (FASTER) Act of 2021, FDA may:
    • Finalize “Questions and Answers Regarding Food Allergens, Including the Food Allergen Labeling and Consumer Protection Act of 2004 (Edition 5),”released November 2022;
    • Finalize “Draft Guidance on Evaluating the Public Health Importance of Food Allergens Other Than the Major Food Allergens Listed in the Federal Food, Drug, and Cosmetic Act,” released April 2022;
    • Add additional draft guidance to the existing “Compliance Policy Guide Sec. 555.250 Major Food Allergen Labeling and Cross-contact;”
  • Dietary Supplements – FDA may:
    • Update the existing draft guidance, “New Dietary Ingredient (NDI) Notifications and Related Issues,” released October 2016, with new information on “NDI Notification and Timeframes;”
  • Food Additives – FDA may:
    • Issue draft guidance for industry on “Premarket Consultation on Cultured Animal Cell Foods,” following the November 16, 2022 completion of its first pre-market consultation for a human food made from cultured animal cells, discussed here. 
  • Food Safety – FDA may:
    • Issue draft guidance for industry on “Foods Derived from Plants Produced Using Genome Editing;”
    • Finalize industry guidance on “Inorganic Arsenic in Apple Juice: Action Level,” released July 2013;
    • Issue draft guidance for industry on “Detention Without Physical Examination (DWPE) of Fish and Fishery Products Due to the Appearance of Adulteration by Bacterial Pathogens, Unlawful Animal Drugs, Scombrotoxin (Histamine), or Decomposition – Evidence Recommended for Release of Goods Subject to DWPE and Removal of a Foreign Manufacturer’s Goods from DWPE;”
    • Finalize “Compliance Policy Guide Sec. 555.320 Listeria monocytogenes in Human Food,” released as draft guidance on February 2008;
  • Food Safety Modernization Act (FSMA) – FDA may:
    • Update its draft guidance on “Hazard Analysis and Risk-Based Preventive Controls for Human Food; Appendix 1: Potential Hazards for Foods and Processes” at Appendix 1: Potential Hazards for Foods and Processes, Chapter 11: Food Allergen Controls, Chapter 16: Validation of Process Controls, Chapter 17: Classifying Food as Ready-To-Eat or Not Ready- to-Eat, and Chapter 18: Acidified Foods; and
    • Finalize “Compliance with and Recommendations for Implementation of the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption for Sprout Operations,” released as draft guidance in January 2017.
  • Labeling – FDA may:
    • Finalize guidance for industry on “Labeling of Plant-Based Alternatives to Animal-Derived Foods,” released in draft in February 2023, as discussed here;
    • Issue draft guidance for industry on “Questions and Answers About Dietary Guidance Statements in Food Labeling.” 
    • Issue draft guidance for industry on “Use of Nutrient Content Claims for Added Sugars in the Labeling of Human Food Products,” following FDA’s September 28, 2022 announcement that it had issued a proposed rule for when foods can be labeled with the claim “healthy” that includes limits for added sugar, as discussed here. 
  • Other potential action items on FDA’s 2023 list are draft guidances for industry on “Insanitary Conditions at Tattoo Ink Manufacturing and Distribution Facilities” and “Preparation of Premarket Submission for Food Contact Substances (Chemistry Recommendations).” 
  • FDA’s plans to publish all draft and final guidance topics on the 2023 list of priorities before January 2024 are, of course, subject to change.  Public comments on the list, including suggestions for alternatives or recommendations on the topics FDA is considering, be submitted to www.regulations.gov in Docket FDA-2022-D-2088.  Please feel free to contact Keller and Heckman at fooddrug@khlaw.com for assistance providing FDA comments. 
  • On March 16, 2022, FDA announced its findings from a sampling assignment in which the Agency collected and tested processed avocado and guacamole from November 2017 to September 2019. The assignment tested for Salmonella spp. and Listeria monocytogenes, as part of FDA’s efforts to proactively ensure food safety.
  • FDA collected and tested 887 samples of domestic and imported processed avocado and guacamole. Salmonella spp. was found in 2 samples – neither of which had received high pressure processing (HPP) treatment, which is often used to neutralize harmful pathogens.  Listeria monocytogenes was detected in 15 samples, 8 of which had not received HPP treatment. When FDA encountered a pathogen in a sample, the Agency worked to remove all affected products from the market. The Agency also conducted whole genome sequencing on the positive samples but was unable to determine if they were associated with any known illnesses.
  • FDA’s sampling assignment confirmed that Salmonella spp. and Listeria monocytogenes may be present in processed avocados and guacamole. It also supported that HPP is effective at neutralizing pathogens. FDA will continue to sample processed avocado and guacamole for pathogens.
  • On January 31, the FDA’s Center for Food Safety and Applied Nutrition (CFSAN) and Office of Food Policy and Response (OFPR) released a list of draft and final guidance topics that are a priority to complete during the next 12 months. The list is an update on the guidance agenda that the agency published in June 2021 and includes many of the same documents including:
    • Evaluating the Public Health Importance of Food Allergens Other Than the Major Food Allergens Defined in the Federal Food, Drug, and Cosmetic Act; Draft Guidance for FDA Staff and Stakeholders;
    • Policy Regarding Certain New Dietary Ingredients and Dietary Supplements Subject to the Requirement for Pre-market Notifications; Draft Guidance for Industry;
    • Best Practices for Convening a GRAS Panel: Guidance for Industry;
    • Current Good Manufacturing Practice and Preventive Controls, Foreign Supplier Verification Programs, Intentional Adulteration, and/or Produce Safety Regulations: Enforcement Policy Regarding Certain Provisions; Guidance for Industry; and
    • Labeling of Plant-based Milk Alternatives; Draft Guidance for Industry
  • Notably, the FDA expects to publish many of these guidance documents by January 2023, which is a 6-month extension from the original expected publication date of June 2022.
  • The FDA added the following guidance topics to be published by January 2023:
    • Testing Methods for Asbestos in Cosmetic Products Containing Talc; Draft Guidance for Industry;
    • New Dietary Ingredient (NDI) Notifications and Related Issues:  NDI Notification Procedures and Timeframes; Guidance for Industry;
    • Premarket Consultation on Cultured Animal Cell Foods: Draft Guidance for Industry;
    • Foods Derived from Plants Produced Using Genome Editing; Draft Guidance for Industry; and
    • Labeling of Plant-Based Alternatives to Animal-Derived Foods; Draft Guidance for Industry
  • Public comments on the list, including suggestions for alternatives or recommendations on the topics FDA is considering, can be submitted to www.regulations.gov, using Docket ID: FDA-2021-N-0553. Please contact Keller and Heckman at fooddrug@khlaw.com for assistance providing FDA comments.
  • The United States Department of Agriculture’s (USDA) Food Safety and Inspection Service (FSIS) routinely monitors clusters of illnesses to determine if FSIS-regulated products may be the source of food-borne illnesses.  FSIS posts information on active outbreak investigations to a table on its website when there is compelling evidence that an FSIS-regulated product is the source.  The primary pathogens involved in FSIS outbreak investigations are Salmonella, Shiga toxin–producing Escherichia coli (STEC), Listeria monocytogenes (Lm), and Campylobacter.
  • In a November 19, 2021 Constituent Update, FSIS announced that it has posted on its website an after-action review report for the investigation of a 2018 multi-state outbreak of Lm illnesses associated with ready-to-eat (RTE), Asian-style pork patty products that resulted in 4 hospitalizations.  Whole genome sequencing (WGS) analysis of bacterial isolates from routine FSIS product and environmental samples indicated the historical presence of the outbreak strain at a single FSIS-regulated establishment.  The Investigation further revealed that the pork patty products were cooked using a process that was not validated to ensure all pieces were thoroughly cooked, and there was a history of Lm harborage and opportunities for contamination after cooking that were not considered by the establishment.
  • The Lm outbreak linked to pork patties was only the second reported multistate outbreak of listeriosis linked to a FSIS-regulated product since 2005.  Nevertheless, as noted in the investigation report, FSIS may consider an update of Directive 10240.4 (Verification Activities for the Lm Regulation and the RTE Sampling Program) to include additional instructions for inspection personnel when verifying if a product is exposed to the environment after undergoing a cooking step.
  •  Certain food establishments, referred to as dual jurisdiction establishments (DJEs), are under the jurisdiction of both the Food and Drug Administration (FDA) and the U.S. Department of Agriculture’s Food Safety Inspection Service (FSIS).  In January 2018, the FDA and FSIS announced a formal agreement, i.e., memorandum of understanding (MOU) 225-99-2001, to make the oversight of food more efficient and effective by bolstering coordination between the two Agencies.
  • In an August 6, 2021 Constituent Update, FSIS announced an updated agreement, MOU 225-20-2019, signed July 28, 2021, to further facilitate the exchange of information about DJEs.  DJEs under this MOU are limited to human food operations and exclude animal food operations, which are regulated by FDA.  The new MOU improves upon previous information exchange by:
    • Adding headquarters-level contacts for each agency to improve awareness of findings or emerging issues that may warrant more than local or regional coordination.
    • Updating the types of findings to be shared to reflect advances in understanding microbiological food hazards, including microbiological or other sampling findings in DJEs or products, which may provide information about sanitary conditions in those establishments or indicate serious adverse health consequence of products under either agency’s jurisdiction.  These results will include microbe characteristics (e.g., serotype, whole genome sequence, antimicrobial resistance profile, etc.) where applicable, and other information related to categorizing and tracking pathogens.
  • The new MOU 226-20-2019 supersedes the earlier MOU 225-99-2001 as well as MOU 225-14-0009, a formal agreement on the examination and inspection of Siluriformes fish and fish products, which was entered on April 30, 2014 following the handover of jurisdiction of Siluriformes species from FDA to USDA.