YOUR SOURCE ON FOOD LITIGATION AND REGULATION

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.

Morgan Lewis partners recently published an article in the Institute of Food Technologist’s Food Technology magazine on the future of obesity-related litigation. The article discusses how companies can maximize their insurance assets, use federal regulations proactively, and refocus compliance programs to improve their position against possible lawsuits. Read the full article here.

New regulations for poultry inspection from the USDA’s Food Safety and Inspection Service (FSIS) may end its long, acrimonious struggle to modernize the existing status quo. Given the competing interests surrounding the initiative, compromise was inevitable—and compromise is precisely what everyone got. As previously proposed, the rule would have mandated universal changes in the inspection system. The proposed rule directed all poultry slaughterers to initially examine and screen birds for cosmetic and other nonsafety-related defects—traditionally the role of USDA inspectors—and maintained the core government responsibility to identify problems associated with animal disease and other forms of product contamination. This system has been in effect—and successful—on a voluntary basis for more than a decade within the context of so-called pilot programs.

The Food Safety and Inspection Service (FSIS) recently proposed a rule that, if adopted, will require both processing establishments and retail facilities that grind raw beef products to maintain records in a newly prescribed format. That format will delineate source materials and the identity of suppliers as well as any carryover from one production lot to the next. Our FDA Practice discussed the details and implications of the rule, which was proposed in July, in a Food Industry LawFlash.

The proposed rule represents a significant new recordkeeping requirement at the retail/grocery level and should be examined closely by such businesses. Submitted comments to FSIS detailing potential recordkeeping burdens and logistical concerns will be important to ensure that the proposal balances practical considerations with the intended food-safety goals.