White House announces planned revision of federal GMO regulatory standards.

  • For decades, the United States government has regulated genetically modified organisms (GMOs) under a regulatory framework called the “Coordinated Framework for the Regulation of Biotechnology” (Coordinated Framework).  The Coordinated Framework explains the different roles played by the three major agencies involved in the regulation of GMOs:
    • The Food and Drug Administration (FDA) regulates GMOs under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and ensures the safety and proper labeling of GMO-derived foods and feed.
    • The Environmental Protection Agency (EPA) regulates plant-incorporated protectants (PIPs) — a type of pesticide that is bioengineered into crops — under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and sets tolerance limits or exemptions from tolerance for pesticide residues on or in food and animal feed.  EPA also regulates certain biological control organisms under the Toxic Control Substances Act (TSCA).
    • The U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) regulates GMOs under the Plant Pest Act.  APHIS reviews GM crops to determine whether they meet the definition of a “plant pest” and may pose risks to domestic agriculture.
  • The White House recently announced that FDA, EPA, and USDA will update the Coordinated Framework to reflect advances in science and technology that have occurred since the framework was last revised in 1992.  In a memorandum to the heads of the responsible agencies, the White House indicated that the existing GMO regulatory framework has created “unnecessary costs and burdens associated with uncertainty about agency jurisdiction, lack of predictability of timeframes for review, and other processes….”  The White House urged the Agencies to update and modernize their rules to continue to protect the public health while facilitating innovation in a transparent manner.
  • GMO regulation continues to be a topic of heated discussion and legislative/regulatory activity among federal, state, and local regulatory officials, as well as stakeholders in the agricultural industry and the consumer safety sphere.  The White House’s memo classifies the “development of an updated [Coordinated Framework]” as a “one-year objective,” although the actual implementation time frame remains to be seen.  It will be interesting to see whether and how a potentially comprehensive (and long-overdue) update to the Coordinated Framework will influence national regulatory policy with respect to the safety and labeling of GMOs and GMO-derived food and feed products in the future.

FDA releases supplement to 2013 Food Code.

  • Published by FDA, the Food Code serves as a model for retail and food service regulations nationwide.  FDA urges state, local, tribal, and territorial regulatory bodies to adopt the latest version of the Food Code.  Although the Food Code initially was published every two years, FDA now publishes a full version every four years.  During the interim period between full editions, FDA may publish Food Code Supplements to update, modify, or clarify provisions as needed.  The most recent full edition of the Food Code is the 2013 version.
  • On July 2, 2015, FDA issued the Supplement to the 2013 Food Code, which modifies the Food Code to:
    • Expand the duties of the Person in Charge in a food establishment to include overseeing the routine monitoring of food temperatures during hot and cold holding.
    • Expand and clarify the type of information that should be included when a Hazard Analysis and Critical Control Point Plan is required by a regulatory authority.
    • Emphasize that cleaning and sanitizing agents should be provided and available for use during all hours of operation.
    • Clarify the difference between Typhoid Fever and nontyphoidal Salmonellosis with regard to the reporting of illness and the exclusion and restriction of ill food employees.
    • Suggest that regulatory authorities ensure that inspection staff has access to the necessary training and continuing education.
  • Particularly as state and local authorities may adopt the modified Food Code requirements as laws or regulations in the near future, it is beneficial for food service and food retail providers across the country to stay up-to-date on the latest developments in this area.

USDA to permit beef imports from Argentina and Brazil.

  • The U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) is tasked with protecting the United States from animal and plant pests that could threaten the domestic agricultural market and the food supply.  Regulations in 9 CFR Part 94 prohibit or restrict the import of certain animals/animal products into the United States to prevent the introduction and spread of various diseases that may pose health threats to ruminants and swine.
  • On June 29, 2015, APHIS announced amendments to its regulations to permit the importation of fresh (chilled or frozen) beef from regions of Northern Argentina and certain Brazilian states under specific conditions intended to mitigate the risk of food-and-mouth disease.
  • Some stakeholders are concerned that the regulatory change will put the country at risk of exposure to foot-and-mouth disease.  Representative Rosa DeLauro (D-Connecticut) sharply criticized the change as an example of trade concerns trumping food safety.  As Congress currently sits poised to repeal mandatory country-of-origin labeling requirements for meat products to alleviate trade concerns, APHIS’ rule amendment adds to recent activities that highlight the tensions between regulating the domestic meat market and remaining adequately open to foreign trade where appropriate standards are met.

Federal judge strikes down Maui County’s GM crop ban.

  • As recently covered on this blog, various counties in Hawaii and Oregon have enacted bans on the cultivation of genetically modified (GM) crops.  Those jurisdictions have been facing legal and practical hurdles related to enforcement of the GM restrictions.
  • On June 30, 2015, a Hawaii federal judge ruled that Maui County’s ban on the cultivation of GM crops is preempted by federal and state laws, and is thus invalid.  In ruling in favor of the plaintiffs — which included Monsanto Co. and Agrigenetics, Inc. a unit of Dow Chemical Co. — the judge found the county ban to conflict with the U.S. Department of Agriculture’s (USDA) 1987 regulation permitting cultivation of GM crops under certain circumstances, rendering it preempted by the federal Plant Protection Act.
  • Although the current decision is likely to be appealed, it highlights the continuing challenges that localities face in attempting to enact and implement GM restrictions, ranging from cultivation bans to affirmative labeling requirements on products containing GM constituents.  Unless and until the federal government takes action in this area, the result is likely to be a growing patchwork of attempted restrictions, enforcement hurdles, and legal challenges.

JECFA concludes use of carrageenan in infant formula “not of concern.”

  • Carrageenan is a seaweed-derived ingredient used widely in the food industry to perform gelling, thickening, and stabilizing functions.  Although many long-term studies support the safety of carrageenan consumption, concerns have been raised in recent years regarding its potential to cause gastrointestinal inflammation.
  • At its June 2015 meeting in Geneva, the Joint FAO/WHO Expert Committee on Food Additives (JECFA) concluded that the use of carrageenan in infant formula is “not of concern” at levels of up to 1,000 mg per liter.  JECFA’s report references new studies that “allay the earlier concerns that carrageenan, which is unlikely to be absorbed, may have a direct effect on the immature gut.”
  • Although carrageenan lawfully may be used in infant formula in the United States, such use is not permitted in the EU.  In light of the new data and JECFA’s conclusive opinion on this subject, it remains to be seen whether the European Food Safety Authority (EFSA) will revisit its prior evaluation.

Consumer Goods Forum members aim to cut food waste in half by 2025.

  • Food waste is a continuing problem, with the United Nations’ Food and Agriculture Organization (FAO) estimating that 1/3 of food produced worldwide is either wasted or lost along the supply chain.
  • The Consumer Goods Forum (CGF) — which includes more than 400 major manufacturers and retailers (e.g., Nestle, Unilever) — has openly committed to halving food waste over the next 10 years.  The CGF has created a toolkit to assist members with achieving this goal.
  • Although battles over companies’ “natural,” “organic,” or “GM” profiles surely will continue to wage in the marketplace, initiatives like this remind us of the potential market value of sustainability too.

Senate still has not passed bill to repeal COOL requirements.

  • As previously covered on this blog, the U.S. House of Representatives recently passed a bill to repeal country of origin labeling (COOL) requirements for meat products.  The COOL requirements have long been mired in controversy, culminating in a World Trade Organization (WTO) ruling that the COOL requirements violate U.S. trade obligations to Canada and Mexico.  Unless the COOL requirements are repealed, the WTO may authorize retaliatory tariffs from Canada and Mexico.
  • On June 25, 2015 — two weeks after the House passed a bill to repeal COOL — the Senate Agriculture Committee held a hearing to discuss the COOL requirements.  Five of the six testifying witnesses supported the immediate repeal of COOL, and Chairman Pat Roberts (R-Kansas) cited letters from Canadian and Mexican government officials, indicating both governments’ plans to seek retaliation absent repeal.
  • The Senate appears to be contemplating a voluntary COOL program for beef and pork, for which there may already be some support.  In the meantime, however, stakeholders anxiously await the Senate’s vote to repeal the existing mandatory COOL requirements before the U.S. suffers any retaliatory impact.

New York City’s Department of Consumer Affairs accuses Whole Foods of “routinely” overpricing food sold by weight.

  • On June 24, 2015, New York City’s Department of Consumer Affairs (DCA) announced that an investigation into prices of prepackaged food at Whole Foods Markets in the city uncovered “systemic” overcharging for pre-packaged foods.  DCA tested packages of 80 different types of foods, including meats, dairy, nuts, and baked goods, and found all of the products were mislabeled as to weight.
  • According to the NYC DCA, 89% of the packages tested do not meet the federal standards established by the Department of Commerce and administered by the FDA and the U.S. Department of Agriculture for the maximum amount that an individual package can deviate from the stated weight.  As reflected in U.S. Food and Drug Administration guidance, FDA may take action against products where the average actual net weight is at little as one percent less than the declared net weight.
  • NYC’s penalty for falsely labeling a product is up to $950 for the first infraction and $1,700 for others thereafter; according to DCA, Whole Foods “potentially committed thousands of violations in its nine New York City locations.”  In 2012, Whole Foods face similar allegations from city attorneys of Santa Monica, San Diego, and Los Angeles, and ultimately agreed to pay an $800,000 fine.  These incidents serve as a powerful reminder to manufacturers, distributors, and retailers of the importance of implementing robust compliance measures to guard against short filling.

House of Representatives appears close to passing the 21st Century Cures Act.

  • On May 21, 2015, the House Energy & Commerce Committee voted unanimously to to advance the 21st Century Cures Act (H.R. 6), a bill that its sponsors say would help accelerate the discovery, development, and delivery of life-saving and life-improving drugs and devices.
  • As detailed in the committee’s press release, the legislation would remove barriers to sharing heath data generated in research and clinical settings; strengthen FDA’s ability to incorporate patients’ perspectives in the drug development and approval process; advance personalized medicine by promoting tools such as biomarkers; modernize clinical trials to produce results faster and at less cost; remove regulatory uncertainty with regard to medical apps, provide new incentives for the development of drugs for rare diseases; create a coordinating mechanism to facilitate connections between scientific discovery, drug and device development, approval, and delivery to patients; and create an “Innovation Fund” that would provide $2 billion per year for five years to fund these initiatives.
  • Under the leadership of Reps. Pitts (R-PA) and Upton (R-MI), the legislation has attracted the support of more than 140 members of Congress, as well as a number of industry stakeholders and patient advocacy groups, but the likelihood of its enactment depends, in large part, on how quickly the bill is advanced; as election season approaches, support for and interest in such bipartisan efforts is expected to erode.  Committee and leadership staff expect the bill will come to the floor following the House’s Independence Day recess; in the interim, staff are racing to adjust the bill’s cost offsets to ensure its passage; the Congressional Budget Office’s estimate, released June 23, 2015, puts the cost at $872 million.

EWG and other consumer groups signal alarm over progress of federal GM bill.

  • As covered previously on this blog, on March 25, 2015, Reps. Mike Pompeo (R-KS) and G. Butterfield (D-NC) reintroduced the Safe and Accurate Food Labeling Act of 2015, which would prohibit states from mandating the labeling of GM foods.  The bill also would create a voluntary certification process for companies that want to claim that their products are “GM-free.”   On June 10, 2015, Pompeo and Butterfield circulated a revised discussion draft.
  • On June 18, 2015, the House Subcommittee on Health held a meeting to discuss the role biotechnology plays on the nation’s farms, food supply, and economy and heard from industry and legal experts regarding the impact of state-specific labeling regulations on interstate commerce and consumers.
  • Following the hearing, a number of consumer groups, including the Environmental Working Group (EWG), the Organic Consumers Association, and the National Sustainable Agriculture Coalition, raised alarm over the progress of the proposed legislation, which they have dubbed the DARK (Deny Americans the Right to Know) Act.  The draft legislation, while heralded by many stakeholders as critical to putting a stop to a patchwork of state-based GM labeling requirements, is likely to continue to raise concerns from consumer groups.