YOUR SOURCE ON FOOD LITIGATION AND REGULATION

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.

See the chart >>

Law clerk Angela M. Silva contributed to this post.

The designation of the food industry as critical infrastructure in the context of the coronavirus (COVID-19) pandemic has led to necessary and sensible efforts to realign the federal regulatory landscape to facilitate this essential activity, without compromising the public interest.

From the perspective of FDA regulated companies, this has essentially involved a changed environment, where the agency has announced its willingness to step back, physically and otherwise, from many routine inspections and the enforcement of various pending labeling requirements. However, the meat, poultry, egg product, and catfish industries, overseen by USDA’s Food Safety and Inspection Service (FSIS), confront a different reality because statutory requirements of carcass-by-carcass and continuous inspections dictate daily interaction, often in close quarters, between the inspector and the inspected.

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).

As referenced earlier in this space, the Food Safety and Inspection Service (FSIS) hosted a public meeting on Whole Genome Sequencing (WGS) issues late in October (see meeting agenda). It provided a range of helpful information on the implications of the rapid and ongoing adoption of such technology by FSIS and other actors in the public health community at both federal and state levels. Also, in the nature of such events, it generated questions, particularly with regard to some of the core legal issues that surround WGS adoption.

On September 22, 2017, the Food Safety and Inspection Service (FSIS) announced its intention to host a public meeting in October to discuss overall federal food safety agency practices as well as plans for collecting and analyzing whole genome sequence (WGS) data of bacteria isolated from official samples, including the state of the science and other issues surrounding use of this technology. Additionally, at the October public meeting, FSIS intends to discuss the agency’s recent experience in using WGS as well as its intention to expand its use in the future.

Last week FSIS’s Revised Nutrition Facts Panel proposed rule was placed on the list of “inactive” regulations, indicating that the rule is no longer a priority and will be reconsidered at an unspecified time in the future.[1] This notice comes after FDA announced last month that it would be postponing the compliance date for its Nutrition and Supplement Facts Label rule and Serving Size rule from July 2018 to an undetermined implementation date.[2]

On December 1, the US Department of Agriculture's (USDA’s) Food Safety and Inspection Service (FSIS) issued a proposed rule to amend the nutrition labeling regulations for meat and poultry products (Proposed Rule). The revisions in the Proposed Rule are meant to parallel, to the extent possible, the US Food and Drug Administration’s (FDA’s) two similar final rules concerning nutrition fact labels (Nutrition Labeling Rules).1

Some notable similarities between provisions in the Proposed Rule and FDA’s Nutrition Labeling Rules include, but are not limited to, the following:

  • Updating the list of nutrients required or permitted to be declared (e.g., no longer requiring declaration of Vitamins A and C but requiring declarations for Vitamins D and Potassium) and updating Dietary Reference Values (DRVs) and Reference Daily Intakes (RDIs) that are based on current dietary recommendations2
  • Requiring the declaration of trans fat in the Nutrition Facts label
  • Requiring the declaration of added sugars
  • Establishing a new definition of “dietary fiber”
  • Modifying the nutritional labeling format for certain nutrition information (e.g., calories, serving size, and servings per container) prominence, and changing the order of the “Serving Size” and “Servings Per Container” declarations
  • Requiring mandatory dual-column labeling on certain packages of meat and poultry products (i.e., products that contain 200–300% of the applicable reference amounts customarily consumed (RACC))
  • Amending the requirements for foods represented or purported to be specifically for children under the age of four years, and pregnant and lactating women

On November 2, the Food Safety and Inspection Service (FSIS or the Agency) released its Fiscal Year (FY) 2017–2021 Strategic Plan,1 which provides a framework for FSIS to address continual challenges with inspection modernization and articulates FSIS’s goals for meeting its public health mission over the next four years.

FSIS strongly asserts that it has successfully implemented the 2011–2016 Strategic Plan with the collaborative assistance of industry, Agency employees, and the public. The FSIS Constituent Update indicates that these efforts have culminated in the Agency’s system of food safety inspection continuing to be one of the most reliable and well-documented in the world.2