These Regulatory Updates are brought to you by Michael Best & Friedrich. 

This Regulatory Update includes information from February 1-16, 2021. Please contact Paul Benson, Taylor Fritsch, or Leah Ziemba for additional information on regulatory issues that may affect your business.

For access to articles and resources from our Premium Member law firm, Michael Best & Friedrich, to help navigate this challenging time, please follow these hyperlinks to Michael Best’s COVID-19 Resource Center and CARES Act Relief Resource Center.

FDA UPDATES

• FDA Launches Phase 2 of Artificial Intelligence Imported Seafood Pilot Program MUST READ
• FDA Publishes Materials from Food Traceability Public Meetings MUST READ
• FDA Resumes Microbiological Surveillance Sampling of Fresh Herbs
• FDA Launches New Sampling Plan for Romaine Grown in Yuma, Arizona

USDA UPDATES

• USDA Publishes Study on Campylobacter Contamination of Raw Chicken MUST READ
• USDA Seeks Comments on Petition for Rule Regarding Enforceable Poultry Standards for Salmonella and Campylobacter

OTHER DEVELOPMENTS

• U.S. House Oversight Committee Report Finds Major Baby Foods Contain Toxic Heavy Metals MUST READ
• Future Meat Technologies Vastly Reduces Price of Producing Cell-Based Chicken

UPCOMING MEETINGS & CONFERENCES

• February 18 – 19, 2021: Virtual Agricultural Outlook Forum (AOF), USDA’s largest annual meeting, on “Building on Innovation: A Pathway to Resilience.” Program to be announced in early December 2020. Register here and read about this year’s program here.
• March 9 – 12, 2021: Consumer Food Safety Education (CFSE) Virtual Conference, hosted by the Partnership for Food Safety Education. Register here.
• View slide decks from past USDA-FSIS meetings and presentations here. 

FDA UPDATES

FDA Launches Phase 2 of Artificial Intelligence Imported Seafood Pilot Program
February 8:  FDA moved into the second phase of its Artificial Intelligence (AI) Imported Seafood Pilot program, which will run from February 1, 2021 through July 31, 2021. This pilot program “is designed to enhance and improve the agency’s ability to quickly and efficiently identify imported seafood products that may pose a threat to public health,” according to FDA’s Constituent Update.

In 2019, FDA launched the first phase of the pilot to assess the use of Machine Learning (ML) in targeting violative seafood shipments. In late August 2020, the agency provided promising updates about that first phase and claimed that ML had “real potential to be a tool that expedites the clearance of lower risk seafood shipments, and identifies those that are higher risk.”

The pilot taps into two FDA initiatives: the New Era of Smarter Food Safety and the Technology Modernization Action Plan (TMAP). Data collected from the program “will be studied and used to evaluate the utility of AI in support of import targeting, which may ultimately help implement an AI model to target high-risk seafood products.”

Read FDA’s Constituent Update here. Read about FDA’s updates on Phase 1 of the pilot program in our September 2020 (Part 1) Regulatory Update here. Read about the New Era of Smarter Food Safety here and the TMAP here.

FDA Publishes Materials from Food Traceability Public Meetings
February 12:  Between November 6 and December 2, 2020, FDA held three virtual one-day public meetings to discuss its recently released Food Traceability Proposed Rule (“Requirements for Additional Traceability Records for Certain Foods,” 85 Fed. Reg. 59984). This proposed rule would establish additional food traceability recordkeeping requirements for manufacturers of foods on a proposed “Food Traceability List” (FTL). The agency released the recordings of and various event materials for each public meeting, including meeting agendas, speaker/panelist biographies, and meeting transcripts.

Read FDA’s Constituent Update and access the meeting materials here. Visit the webpage for the proposed rule here. Read about the proposed rule in our September 2020 (Part 2) Regulatory Update here.

FDA Resumes Microbiological Surveillance Sampling of Fresh Herbs
February 5:  FDA announced that it had resumed its fresh herbs sampling for Salmonella, Shiga-toxin producing E. coli (STEC), E. coli O157:H7, and Cyclospora cayetanensis as of January 12, 2021. The agency began collecting and testing cilantro, parsley, and basil, in addition to processed avocado and guacamole, in October 2017, but it paused its fresh herbs sampling in Spring 2020 due to the COVID-19 pandemic.

FDA will resume collecting imported cilantro and parsley samples shortly and anticipates completing the assignment in Spring 2021.  The agency also announced that it concluded its sampling of processed avocado and guacamole at the close of fiscal year (FY) 2019. Publication of a final report on the agency’s analysis is forthcoming.

Read FDA’s Constituent Update here. Read about FDA’s fresh herbs, processed avocado, and guacamole sampling here.

FDA Launches New Sampling Plan for Romaine Grown in Yuma, Arizona
February 5:  FDA launched an assignment to collect and test romaine lettuce samples from commercial coolers in the Yuma County, Arizona growing region for Shiga toxin-producing Escherichia coli (STEC) and Salmonella spp. The new sampling plan is part of the agency’s “ongoing surveillance efforts  following the spring 2018 multistate E. coli O157:H7 outbreak of foodborne illness linked to romaine lettuce from the Yuma agricultural region,” according to its Constituent Update.

FDA plans to collect and test approximately 500 romaine lettuce samples from February 2021 through the end of Yuma’s romaine harvest season, focusing on “commercial cooler and cold storage facilities where field heat is removed from harvested romaine and where product is cold stored before processing and shipment.”

This new assignment supports the goals of FDA’s 2020 Leafy Greens STEC Action Plan, which delineates the agency’s plans to advance work on prevention, response, and addressing knowledge gaps regarding the safety of leafy greens. It also “adds to other work underway in collaboration with stakeholders in the Yuma agricultural region…including a multi-year study to assess the environmental factors that impact the presence of foodborne pathogens in this region.”

Read FDA’s Constituent Update here. Read about the Leafy Green STEC Action Plan in our March 2020 Regulatory Update here.

USDA UPDATES

USDA Publishes Study on Campylobacter Contamination of Raw Chicken
USDA-FSIS recently published a study assessing Campylobacter contamination rates on raw chicken over the last 25 years and comparing those rates to human campylobacteriosis incidence using CDC data (“A Comparative History of Campylobacter Contamination on Chicken and Campylobacteriosis Cases in the United States: 1994-2018,” International Journal of Food Microbiology Volume 342).

According to USDA’s Constituent Update, the study found “substantial reductions in contamination have occurred during this period…[and] a downward trend in campylobacteriosis during the late 1990s and early 2000s that mirrored a decline in contaminated chicken around the same time period.” These findings “support the relationship between pathogen contamination in raw poultry and the occurrence of foodborne illness.”

Read USDA’s Constituent Update here and the study here.

USDA Seeks Comments on Petition for Rule Regarding Enforceable Poultry Standards for Salmonella and Campylobacter
February 5:  USDA is seeking comments on a January 2021 petition by the Center for Science in the Public Interest to initiate rulemaking that would “(1) Create enforceable poultry finished product standards for Salmonella types of the greatest public health concern and Campylobacter and (2) Require establishments to identify and control food safety risks within their supply chains,” according to USDA’s Constituent Update. The Center for Science in the Public Interest contended that its requested performance standards could “reduce, with an aim to ultimately eliminate, Salmonella types of the greatest public health concern from raw poultry, while continuing to target reductions in Salmonella and Campylobacter overall.”

Submit comments on the petition to the Federal eRulemaking Portal here by April 6, 2021.  

Read USDA’s Constituent Update here.  

OTHER DEVELOPMENTS

U.S. House Oversight Committee Report Finds Major Baby Foods Contain Toxic Heavy Metals
February 4:  The House of Representatives Committee on Oversight and Reform’s Subcommittee on Economic and Consumer Policy released a report revealing that top “commercial baby foods are tainted with significant levels of toxic heavy metals, including arsenic, lead, cadmium, and mercury.”

In November 2019, after receiving reports of high levels of toxic heavy metals in baby food, the Subcommittee requested internal documents and test results from seven of the largest baby food manufacturers in the U.S.: Nurture Inc., Beech-Nut Nutrition Co., Hain Celestial Group Inc., Gerber, Campbell Soup Co., Walmart Inc. and Sprout Foods, Inc. While Nurture, Beech-Nut, Hain, and Gerber responded to these requests, Walmart, Campbell, and Sprout Organic Foods “refused to cooperate with the Subcommittee’s investigation.” The test results from the four companies that responded demonstrated dangerous levels of heavy metals that were well above FDA’s maximum allowable levels, with arsenic present in some baby foods up to 91 times the allowable level and lead present up to 177 times that level.  Meanwhile, independent testing showed high levels of heavy metals in the baby foods of the three companies that did not respond.

In response to these results, the Subcommittee made the following recommendations: (1) FDA-mandated testing of baby food not just for their ingredients but also for toxic heavy metals; (2) FDA-mandated reporting of toxic heavy metal levels on food labels; (3) the voluntary phase-out of toxic ingredients; (4) FDA standards for the maximum permitted levels of toxic heavy metals in baby foods; and (5) “parental vigilance,” fostered by the implementation of the previous four recommendations.

The report condemned the Trump administration’s federal regulators for their alleged complicity in the report’s concerning findings, stating: “Baby food manufacturers hold a special position of public trust. Consumers believe that they would not sell products that are unsafe. Consumers also believe that the federal government would not knowingly permit the sale of unsafe baby food. As this staff report reveals, baby food manufacturers and the Trump administration’s federal regulators have broken the faith.”

Read the Oversight Committee report here (PDF).

Future Meat Technologies Vastly Reduces Price of Producing Cell-Based Chicken
In an exciting installment for the nascent cell-based (lab-grown) meat industry, Israel-based Future Meat Technologies announced that it had reduced the price of producing a cell-based chicken breast to $7.50 – a far cry from the $325,000 production of the world’s first cell-based hamburger in 2013.

According to Megan Poinski of Food Dive, Future Meat Technologies Founder and Chief Science Officer Yaakov Nahmias believes that “[g]etting the price of cell-based meat down to where consumers can afford it is central to developing it as a food item and to building the foundation of the industry.” Future Meat Technologies blended cell-based chicken with some plant proteins to produce its $7.50 chicken breast in order to get the cost down, but Nahmias claimed that the chicken breast has “the look, texture, smell and taste of conventional chicken.”

Alongside its announcement about the lower cost of a cell-based chicken breast, Future Meat Technologies announced $26.75 million in new funding, with participation from such existing investors as Tyson Foods and Archer Daniels Midland and such new investors as  German dairy producer Müller Group and the U.S.-based foodservice products maker Rich Products Corp. Though the only cell-based meat provider with product currently on the market is Eat Just, which sells cultured chicken in Singapore at the price of S$23 (about $17.29 USD), this influx of funding for Future Meat Technologies is promising. The next significant hurdle for the company, as for all cell-based meat producers, will be attaining regulatory approval for its products.