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
On October 5, the US Department of Agriculture’s (USDA’s or the Agency’s) Food Safety and Inspection Service (FSIS) released an updated version of its Labeling Guideline on Documentation Needed to Substantiate Animal Raising Claims for Label Submission (the Guidance).1 All labels with special claims, including animal-raising claims, must be submitted to FSIS prior to being used on a product under 9 CFR 412.1(c)(3). Examples of animal-raising claims include “grass-fed,” “raised without antibiotics,” and “free-range.”
Adopting a practice with the potential for considerable long-term significance, USDA’s Food Safety and Inspection Service (FSIS) recently announced that it will soon begin sharing more food safety data regarding slaughter and processing facilities on www.data.gov.1
FSIS inspects meat, poultry, and processed-egg-product establishments to ensure that the food produced therein is safe, wholesome, and properly labeled. Its inspections generate a large volume of data that is mainly made public in aggregated and/or summary format or through requests for data pursuant to the Freedom of Information Act (FOIA). Citing several motivating factors (including the policies of the Obama administration and the Office of Management and Budget that have called for increased data sharing and greater transparency), FSIS began exploring in 2010 how to share establishment-specific data with the public. That effort resulted in FSIS’s Establishment-Specific Data Release Plan,2 published on July 11, which details the framework for release of the safety data that FSIS collects.
The food industry has become a fertile ground for class-action lawsuits over the last few years and shows no signs of slowing down. New cases are decided daily. There are several factors that drive this trend and that are likely to propel forward new cases in the coming years. As a detailed review of some of the cases in this area reveals, these factors make it probable that litigation in this area is likely to continue, even if not at the same rate that it has over the last couple of years.
In the white paper titled “Appetite for Litigation: Why Plaintiffs’ Lawyers Hunger for Food-Labeling Lawsuits,” partner Tom Sullivan provides an overview of federal statutes and regulations, outlines the different types of cases, summarizes the recent court trends and defenses to food-labeling litigation, and forecasts the emerging trends in the industry.
In late October, the Food and Drug Administration (FDA), Centers for Disease Control and Prevention (CDC), along with state and local officials investigated an outbreak of E. coli infections linked to food served at a major fast-casual restaurant chain. Much of the underlying information documenting the outbreak has been derived from an advanced laboratory technique called “whole genome sequencing” (WGS). This is a fairly new instrument in the CDC toolbox. WGS reveals the complete DNA make-up of an organism, thereby enabling health officials to better understand variations both within and between potentially pathogenic species. Such information can then be compared with clinical isolates from sick patients, and, if they match, there may be a reliable link established between the illness and the pathogen. This new technique has the potential to define the scope of a foodborne illness outbreak more quickly and ideally will help to prevent additional cases. Traditionally, this analysis has been done via a process known as pulse-field gel electrophoresis (PFGE). But PFGE has a shortcoming in that it is unable to differentiate between related species of organisms, which can be critical when health officials are trying to delineate the specific source of the outbreak, and want to know whether to recall a product or not.
