Omnibus bill does not include federal GM labeling fix.

  • For months, the food industry has been hopeful that Congress would act to develop a legislative solution to establish federal regulatory control over the labeling of genetically modified (GM) foods.  The industry-supported bill would block inconsistent state requirements, such as the mandatory GM labeling law set to take effect in Vermont in 2016.  Although the House passed a GM labeling bill in July that would preempt Vermont’s law (and similar state laws), the Senate did not introduce a companion bill.  The Grocery Manufacturers Association (GMA) pushed hard for a GM labeling rider to be added to the omnibus bill that must pass to ensured continued government funding.
  • The omnibus bill has been released and does not include a GM labeling solution.  GMA issued a press release expressing frustration over Congress’s failure to reach agreement on GM legislation this year despite the existence of bipartisan support for the industry-supported bill.  Although GMA remains hopeful about revisiting GM labeling legislation in January, time is running out for food companies to implement their compliance strategies in advance of the July 1, 2016 effective date for Vermont’s GM labeling requirements.
  • Although a GM labeling fix was omitted from the omnibus bill, notable inclusions in the bill are:
    • (1) a provision to repeal country of origin labeling (COOL) requirements in an effort to avoid over $1 billion in retaliatory tariffs recently authorized by the World Trade Organization (WTO) for Canada and Mexico;
    • (2) provisions that would (i) give schools greater flexibility in the implementation of nutrition standards aimed at increasing whole grain consumption and (ii) prevent further reductions in the sodium content of school lunches until the latest scientific evidence establishes that the reduction is beneficial for children;
    • (3) a provision that would block the sale of genetically engineered salmon until FDA publishes labeling guidelines to inform consumers of the product’s GM content;
    • (4) a ban on horse slaughter in the United States;
    • (5) a provision to block the release or implementation of any portion of the Dietary Guidelines for Americans not based on “significant scientific agreement” or not focused on nutritional and dietary information;
    • (6) an extension of FDA’s implementation or enforcement of menu labeling requirements until one year after final guidance is published; and
    • (7) a clarification that partially hydrogenated oils (PHOs) remain lawfully marketable until the June 18, 2018 compliance date specified in FDA’s formal order revoking the GRAS status of PHOs.  Presumably, this latter provision is intended to limit industry liability related to the continued presence of PHOs in the food supply until the compliance date.

USDA issues final rule imposing new recordkeeping requirements on beef producers to improve traceability.

  • The U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) regulates the safety of meat products in the United States.  In recent years, FSIS has struggled with limits on its ability to trace the source of foodborne illness outbreaks involving ground beef.  For example, a 2011 outbreak of Salmonella in the northeastern states was difficult to trace because retail stores had mixed and ground cuts of beef from various sources and had not kept records of suppliers on file.  In response to that outbreak, FDA published a proposed rule in 2014 to require official establishments and retail stores to maintain records related to suppliers and source materials.
  • FSIS now has issued a pre-publication version of a final rule to amend recordkeeping requirements for official establishments and retail stores that grind raw beef products for sale in commerce.  Specifically, all such establishments must maintain the following records:  (1) the establishment numbers of establishments supplying material used to prepare each lot of raw ground beef product; (2) all supplier lot numbers and production dates; (3) the names of the supplied materials, including beef components and any materials carried over from one production lot to the next; (4) the date and time each lot of raw ground beef product is produced; and (5) the date and time when grinding equipment and other related food-contact surfaces are cleaned and sanitized.  These requirements also apply to raw beef products ground at the request of an individual customer when new source materials are used.  Records must be retained for one year after the date of the recorded grinding activity.
  • FSIS believes the final rule will provide a significant improvement in traceback capabilities that will facilitate recall efforts, stop outbreaks, and prevent additional foodborne illnesses.  Establishments will have 180 days after publication in the Federal Register to comply with the new recordkeeping requirements.

USDA issues revised guidelines for poultry processors to control Salmonella and Campylobacter in raw products.

  • The U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) regulates the production of meat products, poultry products, and egg products.
  • FSIS has released revised poultry processing guidelines intended to help poultry establishments prevent Salmonella and Campylobacter contamination of raw products.  The new guidelines provide science-based recommendations for pre-harvest (on farm) interventions, sanitary dressing procedures, further processing practices, antimicrobial interventions, and other management practices.
  • The revised guidance is part of FSIS’s broader “Salmonella Action Plan,” and the Agency’s goal is a 25% reduction in Salmonella illnesses linked to meat and poultry products by 2020.

EFSA publishes new online warehouse for data on chemical contaminants and food consumption.

  • The European Food Safety Authority (EFSA) is responsible for providing scientific advice and performing food risk assessments in the European Union.  EFSA has long had access to significant quantities of data on chemical contaminants and food consumption, but did not have a unified or systematic approach to making these data available for public use.
  • EFSA now has created a new online warehouse that contains available statistics for different countries on the prevalence of food and feed contaminants, as well as food consumption data for different age groups.  The database is available to the public and is intended to make information access user-friendly.
  • EFSA’s database launch is part of a broader website redesign, which is intended to make information easier to find and to increase overall transparency related to EFSA’s work.  In the future, EFSA plans to expand the database to include information related to zoonotic microorganisms in the food supply, antibiotic resistance, and pesticide and chemical hazards in food and feed.

Sales of antibiotics for food animals increased by 23% between 2009 and 2014.

  • As previously covered on this blog, the use of antibiotics to promote growth or feed efficiency in food-producing animals has been the subject of significant scrutiny.  FDA has taken action in this area by requesting voluntary industry efforts to reduce antibiotic use, by proposing to expand data collection in this area, and by issuing a final rule requiring veterinary supervision of antibiotic use in food-producing animals.  California recently became the first state in the U.S. to ban the routine use of antibiotics in livestock.  Major food suppliers and restaurants also have committed to eliminating antibiotics from their supply chains.
  • FDA has now released a report showing that sales of medically important antibiotics used in food-producing animals in the United States increased by 23% between 2009 and 2014.  Tetracycline sales represented the largest volume of domestic sales during this time frame.
  • The data that FDA reported indicate sales information, which may not directly correlate with the use of these drugs.  Early media reports suggest that not all interested stakeholders grasp this distinction, and these data may serve as fodder for criticism that drug use is increasing in spite of recent multi-faceted efforts to curb the routine administration of antibiotics in livestock rearing.

FDA approves transgenic chicken, but not for consumption.

  • FDA has the authority to approve genetically modified (GM) animals as “new animal drugs.”  In 2009, FDA approved a GM goat — the ATryn Goat — that produces a therapeutic biologic in its milk.  In November 2015, FDA approved its first-ever GM animal intended for direct human consumption — the AquAdvantage Salmon.
  • On December 8, 2015, FDA approved the Kanuma Chicken — a GM chicken designed to produce a therapeutic biologic in its egg whites.  As was the case with the ATryn goat, the Kanuma Chicken received approvals from two FDA centers.  The Center for Biologics Evaluation and Research (CBER) approved the human biologic based on its safety and efficacy, and the Center for Veterinary Medicine (CVM) approved the rDNA construct in the chickens that produce the biologic.  In its review of the GM chicken application, CVM had to assess the safety of the GM technology — including its safety to the animals and a review of the rDNA construct and its stability in the chicken genome over multiple generations.  CVM also had to conduct an environmental impact assessment related to the approval of the chickens, in which the Agency determined that the approval does not cause any significant impact on the environment because the animals are raised in highly secure indoor facilities.
  • Regulatory actions of this nature highlight the complexity of the FDA review that may be required for certain innovative products.  The chicken approval represents only the third time that FDA has approved a transgenic animal via its new animal drug authority, with two approvals coming in 2015 alone.  We have yet to see whether the rate of such approvals will increase in the future.  In any event, the existing approvals help to set precedents for future innovators who seek to consider the marketing and regulatory possibilities related to the application of GM technology to animals.

Federal legislation proposed to curb food waste.

  • As previously covered on this blog, food waste is a major issue in the United States.  Government estimates indicate that Americans waste between 30 and 40% of the overall food supply on an annual basis.
  • Congresswoman Chellie Pingree (D-Maine) has introduced a bill that proposes a sweeping and multi-faceted reform to America’s approach to food waste.  The “Food Recovery Act of 2015” (H.R. 4184) seeks to create tax incentives and provide grants to promote the diversion of food to food banks and the composting of inedible food scraps (e.g., banana peels, eggshells).  The law also would standardize date marking on foods such that label dates would be immediately preceded by the words, “Best if Used By” (or “Expires on,” in the case of ready-to-eat foods at high risk of microbial contamination if not consumed by a certain date) and followed by the statement, “Manufacturer’s Suggestion Only.”  This modification is intended to clarify that the date marking on most foods (with the exception of infant formula) is just the manufacturer’s suggestion and does not mean the food is unsafe to consume after that date.  The bill contains provisions intended to promote food waste reduction strategies specific to farms, the retail and restaurant sectors, schools and public institutions, and state governments.
  • Although the bill likely will garner ideological support, it remains to be seen whether legislation this comprehensive — and which necessarily poses administrative and implementation challenges — will gain traction.

WTO authorizes Canada and Mexico to impose over $1 billion in retaliatory tariffs on U.S. products related to country of origin labeling dispute.

  • As previously covered on this blog, the U.S. has been dealing with the aftermath of a World Trade Organization (WTO) ruling that mandatory country of origin labeling (COOL) requirements unfairly discriminate against meat imports.  After the ruling, Congress made attempts to repeal the COOL requirements, while Canada and Mexico sought authorization from the WTO to impose $3 billion in retaliatory tariffs on the U.S.
  • On December 7, 2015, a WTO panel decided that Canada and Mexico collectively could impose over $1 billion in retaliatory tariffs related to COOL.  The decision is not subject to appeal.
  • To avoid the authorized trade sanctions, the U.S. may either take immediate action to repeal the COOL requirements or broker a diplomatic trade resolution directly with the Canadian and Mexican governments.  U.S. industry trade associations are calling for a repeal of the COOL requirements as soon as possible, and reports indicate that a COOL fix could appear in proposed legislation as early as this week.

California Supreme Court ruling opens door to “organic” labeling challenges. 

  • The U.S. Department of Agriculture (USDA) regulates organic production in the United States under the Organic Foods Production Act of 1990 (OFPA).  USDA’s National Organic Program (NOP) has promulgated a series of regulations that define the criteria for organic production, labeling, and certification.  Thus — unlike in the “natural” claim arena — organic claims are subject to a robust federal regulatory regime.  Still, federal organic regulations have not deterred class action lawsuits in state courts where plaintiffs sought to challenge alleged abuses of the use of the term “organic” on product labels.  In one such case, a California consumer challenged the truthfulness of organic labeling where a herb producer allegedly commingled its organic products with conventional products prior to sale.  Both a state district court and an appeals court dismissed the suit on preemption grounds, and many have awaited the high court’s decision in this matter.
  • On December 3, 2015, the California Supreme Court overturned the appellate court’s decision and found that federal law does not preempt state law “organic” labeling challenges that involve intentional commingling or fraudulent substitution of conventional for organic produce.  Quesada v. Herb Thyme Farms Inc., case number S216305.  In a unanimous opinion, the seven justices first rejected the district court’s holding that OFPA expressly preempted state law labeling challenges, finding that the Act’s preemption clause effectively federalizes the organic standards and the certification process, but not state consumer protection lawsuits that seek to hold producers accountable for deceptive or fraudulent organic labeling.  Next, the justices rejected the appellate court’s holding that OFPA impliedly preempted state law labeling challenges, finding state consumer fraud actions to be consistent with OFPA’s goals of “reassuring consumers and enabling fair competition.”  The Court found no evidence that Congress intended remedial exclusivity for enforcement mechanisms under OFPA.
  • The California Supreme Court’s ruling paves an easier road to the courthouse for plaintiffs’ class action lawsuits seeking to challenge “organic” claims in the future.  Although the substance of the ruling may not surprise many stakeholders, it nevertheless strikes a definitive blow to a potential defense in such suits.

Citizen Petition requests that FDA update its definition of “healthy.”

  • FDA has established qualifying criteria for foods to bear the claim that they are “healthy” (including related terms) (21 CFR 101.65(d)).  Among other factors, a “healthy” food generally must contain 3 grams or less of total fat per serving and 1 gram or less of saturated fat per serving.  (Fish and meat are required to contain 5 grams or less of total fat per serving and 2 grams or less of saturated fat per serving).
  • Snack bar producer, Kind, LLC has filed a Citizen Petition requesting that FDA revise and update its definition of the term, “healthy.”  The Citizen Petition argues that FDA’s “healthy” definition — which has remained the same since 1994 — is outdated and fails to take into account present-day scientific understanding about the health benefits of many nutrient-dense foods.  Under the current regulations, foods must meet the “low fat” and “low saturated fat” criteria regardless of their nutrient density, resulting in a framework under which fat-free pudding and sugary cereal may bear the term “healthy” while nuts, avocados, olives, and salmon may not.  The Citizen Petition urges FDA to amend the regulations to give food producers more flexibility to use the term “healthy” by excluding the total fat or saturated fat content contributed to a product by fruits, vegetables, nuts, seeds, legumes, whole grains, and seafood provided that these components are “used in their whole form or have been processed in such a way that did not materially degrade their nutritional value.”  The Citizen Petition also argues more broadly that food producers should be able to make label claims that are consistent with federal dietary recommendations and current scientific evidence.
  • The Citizen Petition is likely to garner support from many diverse stakeholders, ranging from food producers who seek greater claim flexibility to nutrition experts who agree that scientific understanding of the role of fat in the diet has evolved over the past two decades.  It is not clear whether and how quickly FDA will act on this Citizen Petition, but Kind’s request fits within the continued public discussion about healthy dietary practices, particularly as we await the upcoming release of the 2015 Dietary Guidelines for Americans and FDA’s forthcoming revisions to the nutrition labeling and serving size regulations.