FDA and Federal Partners Issue New Food Safety Analytics Strategic Plan

  • Created in 2011, The Interagency Food Safety Analytics Collaboration (IFSAC) is a partnership of three federal agencies—the Centers for Disease Control and Prevention (CDC), the U.S. Food and Drug Administration (FDA), and the Food Safety and Inspection Service of the United States Department of Agriculture (FSIS). IFSAC aims to enhance the coordination of federal food safety analytic efforts and address cross-cutting priorities for food safety data collection, analysis, and use.  In particular, IFSAC’s projects and studies seek to identify foods that are important sources of human illness and focuses its analytic efforts on four priority pathogens: Salmonella, Escherichia coli (E. coli) O157:H7, Listeria monocytogenes (Lm), and Campylobacter.  IFSAC’s success is tied, in large measure, to its work with key partners, including federal and state public health and regulatory agencies and industry stakeholders.
  • On March 24, 2017, FDA CDC, and FSIS issued a new Strategic Plan for 2017-2021 as part of IFSAC.  Under the new strategic plan, IFSAC intends to focus on continuing to improve estimates of the sources of foodborne illnesses and developing methods to estimate how these sources change over time. The three goals of the new strategic plan are: (1) to improve the use and quality of new and existing data sources; (2) to improve analytic methods and models; and (3) to enhance communication about IFSAC progress.  Key objectives outlined in the strategic plan to achieve these goals, include:
    • Enhance the collection and quality of relevant source data;
    • Enhance the use of existing regulatory and foodborne illness surveillance data;
    • Incorporate genomic data and other novel data sources;
    • Explore ways to address key gaps in data quality, methods and models;
    • Develop new analytic approaches and models to maximize use of existing data;
    • Expand the availability of technical and scientific expertise through collaboration with internal and external partners;
    • Enhance relationships and engagement with internal and external groups; and
    • Improve the synthesis, interpretation and dissemination of analytical findings for multiple audiences.
  • The new strategic plan highlights IFSAC’s intent to continue engaging with industry stakeholders on future work.

Senators Introduce Bipartisan Legislation to Protect American Agricultural Interests in Foreign Acquisitions

  • By way of background, foreign governments have recently made substantial investments in U.S. agriculture. Most notably, Smithfield’s sale to Chinese firm Shuangui, Syngenta’s acquisition by Chinese-government owned group ChemChina and Bayer’s proposed acquisition of Monsanto.  Transactions such as these are reviewed by the Committee on Foreign Investment in the United States (CFIUS), a panel of government officials tasked with reviewing proposed mergers and acquisitions of U.S. companies, including foreign entities seeking to purchase U.S. agricultural and food assets. CFIUS determines whether or not transactions initiated by foreign entities threaten to impair U.S. national security interests. Currently, CFIUS does not include permanent representation from the U.S. Department of Agriculture (USDA) or the U.S. Department of Health and Human Services (HHS).
  • On March 14, 2017, U.S. Senators Chuck Grassley (R-Iowa) and Debbie Stabenow (D-Mich.) introduced new bipartisan legislation to give senior USDA and HHS officials permanent representation on the CFIUS. The “Food Security is National Security Act of 2017” would also require that CFIUS consider new agriculture and food-related criteria when reviewing transactions that could result in control of a U.S. business by a foreign company.
  • In introducing the legislation, Sen. Stabenow noted: “Protecting the integrity, safety, and resiliency of America’s food system is core to our national security . . . As foreign entities continue their aggressive acquisitions of U.S. food and agriculture companies, it’s imperative that these transactions face additional scrutiny. This bill ensures that the U.S. has the appropriate tools and people in place to safeguard America’s food security, food safety, biosecurity, and the highly competitive U.S. farm sector as a whole.”
  • No companion legislation has been introduced in the U.S. House of Representatives to date, but there appears to be some appetite for doing so.  We will continue to monitor any developments on the proposed legislation.

Congresswoman Calls for Halting the Importation of Brazilian Meat

  • By way of background, Brazilian federal police raided several meat producers last Friday for allegedly doling out bribes to inspectors to certify meat that was either rotten or tainted with Salmonella. The raids uncovered that a small number of companies and inspectors have allegedly been using “carcinogenic acids” to mask rotten meat, switching out labels on expired meat to change the expiration dates, and deliberately approving shipments of meat products contaminated with Salmonella.  In response, a number of countries have halted the importation of Brazilian meat. So far, China, Chile, Japan, Mexico, Hong Kong, South Africa and the European Union have suspended Brazilian meat purchases, partially or completely.
  • Yesterday, Congresswoman Rosa DeLauro (CT) wrote to the USDA urging the Agency to cease the importation of Brazilian meat.
  • We will continue to monitor developments on this issue as they unfold.

Key Senator Urges Trump Administration to Scrap Reconsideration of COOL

  • As previously covered on this blog, mandatory country of origin labeling (COOL) rules for beef products have long been the subject of controversy and challenge, culminating in: (1) a World Trade Organization (WTO) ruling that the COOL requirements violate U.S. trade obligations to Canada and Mexico and (2) Congress repealing COOL as of December 21, 2015.  Against this backdrop, the Trump administration is gearing up to renegotiate the North American Free Trade Agreement (NAFTA) with COOL reportedly being a key element of a model trade agreement.
  • On March 14, 2017, speaking at the confirmation hearing of Robert Lighthizer to be U.S. Trade Representative, Senator Pat Roberts (R-Kan.), chairman of the Senate Agriculture Committee, warned against any reconsideration of country-of-origin labeling (COOL). Sen. Roberts explained, “We fixed the issue of COOL in 2015. We don’t need to go down that road again. We narrowly escaped about $4 billion … in retaliatory tariffs against the United States. I do not think we need a constantly changing list of key elements of a model trade agreement … what we need is a U.S. Trade Representative confirmed … and in place who will embark on a robust trade policy.”
  • It remains to be seen whether the new administration will seek to advance COOL as part of its apparently imminent renegotiation of NAFTA.

FDA May Simplify Produce Safety Rule’s Agricultural Water Standards

  • By way of background, the Produce Safety Rule under FDA’s Food Safety Modernization Act establishes two sets of criteria for microbial water quality based on the presence of generic coli, which can indicate the presence of fecal contamination. The first does not allow any detectable generic E. coli in agricultural water for certain uses, such as water used to wash hands and water used on food-contact surfaces. The second is for agricultural water that is applied directly to growing produce other than sprouts.
  • FDA has received feedback from stakeholder pointing out that some of these standards may be too complex to understand, translate and implement. As a result, the Agency announced on March 20, 2017, that it is considering how to simplify the water standards. FDA will work with stakeholders during this process. A copy of the announcement can be found here.
  • Previously, FDA clarified how it interprets the compliance dates for certain provisions related to agricultural water testing in the Produce Safety Rule in an August 24, 2016, Federal Register notice.

Slack Fill Settlement

  • “Slack fill” cases are on the rise across the U.S.  Slack fill is the empty space between products and their packaging. Companies can be challenged for including “nonfunctional slack fill” in product packaging under both the Federal Food Drug and Cosmetic Act (“FDCA”) and state unfair business practice statutes (particularly in California).  At the federal level, 21 C.F.R. §100.100 of FDA’s regulations provides that a food is “misbranded” if “its container is so made, formed or filled as to be misleading.”  Section 100.100(a) further provides that “a container that does not allow the consumer to fully view its contents shall be considered to be filled as to be misleading if it contains nonfunctional slack-fill.”
  • On October 9, 2015, a class-action lawsuit was filed against GNC Holdings Inc. (GNC) for allegedly deceptively packaging its Whey Protein products, including AMP Amplified Gold Whey Protein, AMP Amplified Wheybolic Extreme, and 100% Whey Protein products. The complaint alleged that the containers for these products were opaque and contained approximately 40% empty space in violation of the FDCA and California state consumer laws. (Gioia et al v. GNC Holdings, Inc., Case No. 15-cv-2273, S. D. CA.). In defending itself, GNC argued that “the products’ containers specifically stated the amount of product on the label . . . the labels contain the products’ net weight, serving size and the number of servings contained within each container. Thus, consumers are receiving the exact amount of product disclosed.” The plaintiffs countered that GNC’s arguments justifying the slack fill were inappropriate as they revolved around factual issues that should be resolved on a motion for summary judgment.
  • On March 17, 2017, GNC and the putative class of consumers agreed to end the slack fill lawsuit (subscription to Law 360 required).
  • Slack fill lawsuits are an increasing source of litigation exposure for marketers of FDA-regulated food and dietary supplement products. Given the duration of this case and the fact that the court did not dismiss the complaint per GNC’s request in earlier proceedings, this lawsuit demonstrates that marketers of FDA-regulated food and dietary supplement products should not assume that simply disclosing on a label the amount of product contained in a package will result in the quick dismissal of a slack fill suit.  Instead, consumer perception may be viewed as a fact-intensive inquiry requiring further discovery and summary judgment proceedings.  While settlement of such claims are certainly an option (and the path chosen here), manufacturers should seriously consider vigorous defenses against these claims given a number of favorable decisions to date.

FSIS Issues Updated Guidance Concerning Beef and Veal Slaughter Best Practices

  • As our readership is well aware, USDA’s Food Safety and Inspection Service (FSIS) regulates the production of meat, poultry, and egg products.  To help achieve its enumerated food safety goals, FSIS works with industry to develop and promote best practices at slaughter that may be used to prevent, eliminate, or reduce levels of potential microbiological contamination of the food products subject to its jurisdiction.
  • On March 3, 2017, FSIS released an updated Compliance Guideline for Minimizing the Risk of Shiga Toxin-producing Escherichia Coli (STEC) and Salmonella in Beef (including Veal) Slaughter Operations.  The guideline seeks to assist regulated establishments that slaughter beef (including veal) to:
    • Implement effective sanitary dressing procedures designed to prevent carcass contamination;
    • Implement effective decontamination and antimicrobial interventions;
    • Properly assess microbial testing results, including results for indicators of process control, at any point during slaughter; and
    • Use the results from the implementation of these components of the food safety systems to assess the effectiveness of the overall HACCP system.
  • FSIS will be accepting comments on this guideline through May 2, 2017.

Natural Challenge Stayed

Court places “natural” challenge on hold pending FDA action (subscription to Law 360 required)

  • As the food industry is well aware, lawsuits challenging “natural” claims continue to proliferate nationwide. Many challenges have focused on the presence or use of synthetic ingredients or processing aids in products positioned as “all-natural” or “100% natural.”
  • For example, Kraft Foods Group (Kraft Foods) has recently been embroiled in a “natural” class action lawsuit over claims that it falsely marketed its Shredded Fat Free Cheddar cheese as “natural” when it allegedly contains artificial ingredients.  Kraft Foods asked the court (the U.S. District Court for the District of Puerto Rico) to stay the case pending FDA guidance on “natural” (As previously covered on this blog, FDA has requested comments on the definition of “natural” to determine whether or how the FDA should define the term going forward).
  • On March 6, 2017, a Puerto Rico federal judge placed a hold on the false labeling suit explaining that the case is being stayed until the FDAprovides guidance on the use of the term “natural” on food products. In granting the stay, the judge pointed to three recent rulings in support of Kraft Foods’ argument that the case should be stayed pending the completion of the FDA’s rulemaking process concerning the definition of “natural”.  The three rulings are the Ninth Circuit’s 2016 decisions in Kane v. Chobani and Astiana v. Hain Celestial Group, as well as the Southern District of New York’s 2016 ruling in In re Kind LLC “Healthy & All Natural” Litigation.  See our previous blog coverage of the Kane v. Chobani case here.
  • Because any FDA action on “natural” claims may take several years, it remains to be seen just how long trial courts actually may be willing to wait and see.

More Calls for a National Food Safety Strategy

More Calls for a National Food Safety Strategy 

  • A month after four senators asked the Trump administration to implement the food safety recommendations in a General Accounting Office (GAO) report calling for a national food strategy (see our February 21, 2017 blog for more details), researchers at Vermont and Harvard law schools released the results of a collaborative project that also calls for a national food strategy. “Blueprint for a National Food Strategy” was produced by the Center for Agriculture and Food Systems (CAFS) at Vermont Law School and Harvard Law School Food Law and Policy Clinic (FLPC), with support form the W.K. Kellogg Foundation.
  • The report’s authors began by looking at national food strategies in other countries. These strategies include ones that simply aim to reduce the degree to which federal agencies, laws, and policies work at cross purposes, to ones that also seek to fulfill broader functions, such as: strengthening vital systems; addressing an overlooked policy area; and preventing or mitigating a national crisis.
  • “Blueprint for a National Food Strategy” is intended to provide a roadmap to develop a national food strategy and identifies four major principles to guide the process, namely: Coordination; Participation; Transparency and Accountability; and Durability. The report concludes by stating, “A national food strategy in the United States could provide a framework for more informed, effective, and coordinated law and policy-making at the federal level and throughout the country. While much of the conversation around a national food strategy will focus on the substance of such a strategy (the policy goals and priorities themselves), process is equally important.” It adds that the process “can ensure that a comprehensive national food strategy creates a structure to advance a more healthful, sustainable, equitable, and economically vital food system.”

FSIS Increases Beef Import Inspection From Certain Countries

  • By way of background, all meat and poultry food products are potentially subject to regulation by USDA’s Food Safety and Inspection Service (FSIS) upon import into the U.S.  Turning to raw beef, in particular, when FSIS has determined that a foreign country is “equivalent” to export raw beef, FSIS may assign an E. coli O157:H7 MT51 Type of Inspection (TOI) at an Increased Level of Reinspection (LOR) that is above the Normal LOR.  This targeted verification testing of shipments of raw beef products aims to verify that the foreign country’s raw beef products inspection system is adequately addressing these pathogens.
  • On March 13, 2017, USDA’s Food Safety and Inspection service issued a notice instructing its inspection program personnel (IPP) at official import inspection establishments to subject beef product from the following foreign countries to an “Increased Level of Reinspection” for purposes of an E. coli O157:H7 MT51 type of inspection (TOI): France, Ireland, and the Netherlands.
  • Additional information concerning the targeted, increased inspection of beef imports is available here.