YOUR SOURCE ON FOOD LITIGATION AND REGULATION

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.

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.

Reuters reports that California is considering adding processed meats (such as hot dogs, ham, and sausages) to its list of cancer-causing products. This comes after the World Health Organization (WHO) classified processed meats as carcinogenic to humans and advised people to moderate consumption of processed meat to reduce the risk of cancer. The WHO based its classification “on sufficient evidence from epidemiological studies that eating processed meat causes colorectal cancer.”

Under California’s Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65), the state is required to maintain a list of all substances known to cause cancer. Companies that sell products associated with these listed substances, either in combination with unlisted substances or alone, in California must provide “clear and reasonable” warnings on the label to inform consumers about the risk. Once a substance is listed, businesses are required to provide the warning within 20 months or otherwise must demonstrate that the anticipated exposure level will not pose a significant risk of cancer (stating “[n]othing in this article shall preclude a person from using evidence, standards, risk assessment methodologies, principles, assumptions or levels not described in this article to establish that a level of exposure to a listed chemical poses no significant risk.”).

However, if processed meats are included on the list, the meat industry can likely avoid the requirement of a Proposition 65 label on preemption grounds. The Federal Meat Inspection Act of 1906 (FMIA) contains a preemption provision that prohibits states from imposing labeling requirements “in addition to, or different from” the labeling required under FMIA. Pursuant to that provision, in American Meat Institute v. Whitney R. Leeman, a California appellate court concluded “that the FMIA expressly preempts [labeling] requirements imposed by Proposition 65 with respect to meat.” Although Leeman concerns fresh meat as opposed to processed meats, we expect preemption to extend to processed meats as well.

On June 10, the Agricultural Marketing Service (AMS), which administers the Shell Egg Surveillance Program (a mandatory inspection program for shell egs), published a proposed rule that would streamline the importation of table eggs, hatching eggs, and inedible liquid eggs. The proposed rule is intended to shorten the importation process by requiring that applications for inspection be submitted electronically.

This proposed rule conforms to Executive Order 13659, which aims to streamline the import/export process by using the International Trade Data System (ITDS). ITDS allows importers and exporters to complete a single electronic report that will distribute the appropriate data to relevant agencies. The goal of this streamlined process is to not only reduce cargo processing time, but also to increase the safety of the US public by identifying unsafe, dangerous, or prohibited cargo. Thus, AMS will integrate its system into ITDS to reduce processing time and increase safety by identifying restricted eggs that may contain dirty or cracked shells, leaking eggs, and eggs with interior meat or blood spots.

In a related measure, the USDA announced for the first time in a decade that it will allow imported pasteurized eggs from a European nation: The Netherlands. Prior to this announcement, only Canada was certified to export liquid, dried, and frozen eggs to the United States. The Netherlands was previously certified to export pasteurized egg products to the United States in 1987 but voluntarily stopped. In 2014, the Netherlands requested reinstatement. Subsequently, the USDA’s Food Safety and Inspection Service reassessed the laws, regulations, and inspection procedures in the Netherlands and conducted an on-site audit June 2–26, 2014. The review procedures confirmed that “The Netherlands’ processed egg products inspection system continues to be equivalent and to employ the necessary verification activities to result in safe product.” The final report on the Netherlands’ reinstatement can be found here.

Earlier this month, the U.S. District Court for the Central District of California agreed with a group of foie gras producers that California’s ban on the product’s sale was preempted by federal law, and the court overturned the ban that has been in place since July 1, 2012. The plaintiffs—foie gras producers from Canada and New York and a California restaurant owner—challenged the portion of California’s Health & Safety Code § 25982, which banned the sale of products made through gavage, the practice of feeding geese through an esophageal tube to fatten their livers.

On New Year’s Eve, the USDA’s (Department’s) Food Safety and Inspection Service (FSIS) released its final rule requiring meat and poultry processors to include added solutions in their product labeling.

FSIS issued the added solutions proposed rule on July 27, 2011, in response to petitions calling on the Department to address the notion that some product labels may not clearly and conspicuously identify that the raw meat or poultry products contain added solution.

The original petitions were driven by competitive disagreements within the poultry industry. More specifically, the petitioners originally asserted that some companies were marketing fresh chicken items extended with broth in a manner that confused such products with traditional single-ingredient products. Nevertheless, FSIS extended the scope of both the proposed and final rules to encompass the broader range of meat and poultry products within its jurisdiction. In doing so, FSIS chose to more formally codify a number of longstanding labeling precedents and guidance within this area.

The growing trend of retroactive recalls for already distributed food products calls into question commonly held beliefs about food safety. Americans expect that the foods they eat are safe, and, when a company becomes aware of a potential health hazard related to its food products, consumers expect that it will recall the products before people eat them. Consumers also expect that the USDA official mark of inspection on a meat or poultry product means the product is safe to eat because it has been certified by USDA’s Food Safety and Inspection Service (FSIS). In other words, the USDA seal is interpreted as a guarantee that the product is safe to eat because an FSIS inspector, who is continuously present in the facility, has verified the company’s compliance with regulations designed to protect the public health. What undermines this assumption, however, is a growing trend of retroactively recalling product after FSIS has inspected it and after the product has entered into commerce. This trend may confuse industry and consumers alike and creates uncertainty regarding the value for consumers of the USDA inspection seal.

Like the broader federal inspection program in which it is housed, the Food Safety and Inspection Service’s (FSIS’s) prior labeling approval system continues to evolve away from its history of extensive command and control. There is evidence now that, at least in some cases, the agency wants regulated companies themselves to clarify their label claims, rather than making those calls itself.

FSIS’s recent finalization and implementation of new rules for the so-called generic approval for labels is perhaps the agency’s final step in transitioning from a system that, some 30 years ago, essentially insisted on the review and approval of every single label and labeling change associated with all products within its inspection jurisdiction to a far more carefully targeted program. The final rule took effect on January 6, 2014.