As the public health emergency caused by the coronavirus (COVID-19) continuously evolves, the US Department of Agriculture Food Safety Inspection Service (FSIS) and the Food and Drug Administration (FDA) are actively releasing new, and updating existing, policy statements and temporary guidance providing flexibility on certain regulatory requirements during the pendency of the COVID-19 pandemic. FDA recently issued a final guidance providing the Accredited Third-Party Certification Program some flexibility. FSIS recently extended its policies for the labeling of products intended for food products going to retail through the end of July.
Law clerk Angela Silva contributed to this post.
The US Department of Agriculture Food Safety Inspection Service (FSIS) and US Food and Drug Administration (FDA) have released policy statements and temporary guidance providing flexibility on certain regulatory requirements during the pendency of the coronavirus (COVID-19) pandemic.
FSIS is exercising enforcement discretion for the labeling of products intended for food products going to retail. The scope of FDA’s enforcement discretion is broader, allowing flexibility with respect to both labeling and audits.
We’ve created the attached chart describing the modified requirement under each policy statement or guidance. It also includes the standard requirement for a point of reference.
We hope this will serve as a convenient resource, and we will provide additional amendments as future circumstances warrant.
Law clerk Angela M. Silva contributed to this post.
The USDA’s Food Safety and Inspection Service (FSIS) updated two labeling guidelines involving animal raising claims in December. Labeling Guideline on Documentation Needed to Substantiate Animal Raising Claims (Animal-Raising Claims Guideline) discusses the current requirements for substantiating a variety of animal-raising claims (e.g., Raised without Antibiotics, Grass Fed, Raised Without the Use of Hormones). Labeling Guideline on Statements That Bioengineered or Genetically-Modified Ingredients or Animal Feed Were Not Used in Meat, Poultry, or Egg Products (Animal Ingredient/Feed Claims Guideline) specifically focuses on claims that state bioengineered or genetically modified ingredients or feed were not fed to animals being raised for human consumption (i.e., negative claims).
Marler Clark LLP filed a petition on behalf of several individuals and consumer groups on January 19, asking USDA’s Food Safety and Inspection Service (FSIS) to issue an interpretive rule declaring 31 salmonella strains as per se adulterants in meat and poultry products. These strains, which the petition refers to as the “Salmonella Outbreak Serotypes,” include four antibiotic-resistant strains—Salmonella hadar, heidelberg, newport, and typhimurium—as well as Salmonella dublin, enteritidis, and infantis. The petition seeks expedited review of its request on the grounds that these strains have been shown to be linked to foodborne illness outbreaks and/or product recalls and, as such, constitute an imminent threat to public health.
According to the petition, declaring these 31 strains as adulterants would promote the goals of the Federal Meat Inspection Act (FMIA) and the Poultry Products Inspection Act to protect public health by encouraging the meat and poultry industry to implement more effective safeguards and oversight measures. The petition relies heavily on its interpretation of precedent established following the 1993 Escherichia coli, when USDA declared Escherichia coli O157:H7 a per se adulterant in raw ground beef through interpretive rulemaking.
Whole genome sequencing (WGS) has become the technology of choice for FDA, the Centers for Disease Control and Prevention (CDC), and the USDA Food Safety and Inspection Service (FSIS) to help protect consumers from foodborne illness. It can reveal the complete DNA makeup of an organism, thus enabling the differentiation between organisms with a precision that other technologies do not allow. Agencies can use WGS to determine what illnesses are part of an outbreak or narrow down the specific ingredient in a multi-ingredient food responsible for an outbreak; identify the geographic areas from where a contaminated ingredient may have originated; differentiate sources of contamination, even within the same outbreak; and link illnesses to a processing facility even before the food product vector has been identified. See, e.g., FDA, Examples of How FDA Has Used Whole Genome Sequencing of Foodborne Pathogens For Regulatory Purposes (WGS Examples).
The US Department of Agriculture (USDA) issued a Notice of Availability and Request for Public Comment on a new guideline addressing multi-component food kits that contain meat or poultry items (Meal Kit Guideline). The Meal Kit Guideline provides industry with information on how to label a multi-component food kit that contains meat or poultry and whether it would need to be prepared under FSIS inspection.
The major takeaways include the following:
FDA released a consumer update stating that it supports industry’s effort to toss expiration dating terms on foods, such as “use before,” “sell by,” and “expires on,” for the more neutral date phrase “best if used by.”
Recent scientific advancements have revolutionized the way food and agricultural products are being grown, sold, and regulated. These advancements raise new regulatory issues and create unique challenges for companies in the industry. A rapidly growing population, combined with tremendous attention from investors, means animal cell-culture derived products are poised for entry into the global marketplace within 5 to 10 years.
FDA partner Bob Hibbert explored this topic in a webinar titled “Opportunities in Food and Agricultural Tech” as part of the 2019 Morgan Lewis Technology May-rathon. The Technology May-rathon, now in its ninth year, is a series of tailored webinars and in-person events designed to share tech-related current issues, trends, and developments.
As promised and on time, the US Food and Drug Administration (FDA) and the US Department of Agriculture (USDA) issued an agreement on March 7 describing in some detail the division of responsibility between the two agencies over the emerging and much-talked-about category of human food produced using cell culture technology derived from cell lines of USDA-amenable species of meat and poultry. The document contains no real surprises and, as is often the case with such materials, tends to raise as many questions as it answers. Nonetheless, it provides the clearest delineation to date on the particulars of just how the safety, suitability, and marketing of such products is to be overseen by the two agencies.
With a focus upon the emerging cell-cultured meat industry, there has been considerable recent discussion about the significance of jurisdictional differences at the federal level between the US Department of Agriculture and the US Food and Drug Administration. But what now appear to be moving on a parallel track are various recently enacted laws or proposed legislation at the state level designed to impose new labeling requirements and/or restrictions for meat-alternative products, both cell- and plant-based, generally designed to restrict access to traditional terminology such as “ground beef” on such products' labels.