- As previously covered on this blog, on January 19, 2017, the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) published a proposed rule to update its regulations regarding the importation, interstate movement, and environmental release of certain genetically engineered (GE) organisms in response to advances in genetic engineering and the Agency’s understanding of the plant pest and noxious weed risk posed by genetically engineered organisms. These requirements have not been comprehensively revised since they were established in 1987.
- On November 7, 2017, APHIS published a notice in the Federal Register (82 Fed. Reg. 51582) announcing its withdrawal of the January 19th proposed rule. In withdrawing the proposed rule, APHIS cited stakeholder feedback critical of the proposed revisions. As previously covered on our blog this summer, in comments submitted to APHIS, industry stakeholders applauded the Agency’s proposed rule as underscoring the need to promote innovation in biotechnology and for proposing to ease regulation of gene-edited products. But at the same time, industry called out a number of proposed revisions as improperly expanding USDA’s review process in certain respects which could effectively hamstring developers before they can even begin testing products.
- In its November 7th withdrawal of the proposed rule, APHIS stated that it is committed to exploring “a full range of policy alternatives” and that the Agency will “re-engage with stakeholders to determine the most effective, science-based approach for regulating the products of modern biotechnology while protecting plant health.” Now that APHIS has decided to go back to the drawing board, industry has an opportunity to work with APHIS to develop revised requirements to facilitate a regulatory framework that promotes innovation in biotechnology.
FDA issued a proposed rule to address the application of “gluten-free” labeling requirements to fermented and hydrolyzed foods and foods that contain fermented and hydrolyzed ingredients. The underlying issue is that uncertainty prevails in interpreting the results of current test methods for detecting gluten in such foods.
On February 12, FDA announced its intent to extend the comment period for this proposed rule. Although the comment period technically closes on February 16, FDA will be reopening it to extend the timeframe for an additional 60 days (to be counted from the date that a notice reopening the comment period appears in the Federal Register).
The proposed rule would affect the labeling of foods and ingredients such as yogurt, hydrolyzed soy protein, distilled vinegar, and FDA-regulated beers (i.e., beers that are not made from malted barley and hops). The rule also could affect beers regulated by the Alcohol and Tobacco Tax and Trade Bureau (TTB), as TTB has indicated that it may revise its own gluten claim policy once FDA has issued a final rule or other guidance. Interested stakeholders are invited to submit comments via Regulations.gov (Docket Number FDA-2014-N-1021).
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As the agriculture and food industries head into the new year, a number of important cases and regulatory issues that have the potential to dramatically affect the industry are front and center. Below, an overview of the status of several of the key cases and issues that related industries should keep an eye on during 2016.
Waters of the United States
On October 9, 2015, following an earlier ruling by the U.S. District Court for the District of North Dakota, the United States Circuit Court for the Sixth Circuit issued a nationwide stay of the so-called “Waters of the United States” or “WOTUS” rule. The stay halted implementation of the WOTUS rule, pending resolution of jurisdictional issues that were the subject of oral argument on December 8, 2015. Those jurisdictional issues are focused on whether the Sixth Circuit is the proper venue to hear challenges to the rule. A ruling is expected in 2016.
A number of district court cases across the country also remain pending, and the District of North Dakota’s earlier injunction against implementation of the WOTUS rule in 13 states, including Missouri, remains in place.
Vermont Act 120
On October 8, 2015, the U.S. Circuit Court of Appeals for the Second Circuit heard oral argument of an appeal filed by the Grocery Manufacturers Association and other plaintiffs seeking review of the U.S. District Court for the District of Vermont’s denial of their Motion for Preliminary Injunction on April 27, 2015. The motion sought a preliminary injunction enjoining implementation of Vermont Act 120, passed on May 8, 2014, with an effective date of July 1, 2016. Act 120 would, among numerous provisions, mandate new labeling requirements on the part of manufacturers and other food processors for any food that is “produced with genetic engineering,” “partially produced with genetic engineering,” or “may be produced with genetic engineering.” Violators of Act 120 are subject to civil penalties of up to $1,000 per day, per product.
A decision is expected in the first two quarters of 2016 in advance of the July 1, 2016, effective date of the law.
Federal Activity Regarding GMOs and the Safe and Accurate Food Labeling Act
The U.S. House of Representatives passed the Safe & Accurate Food Labeling Act (SAFL) on July 23, 2015. The SAFL Act would, among other things, serve to pre-empt any state laws governing labeling of GMO-containing food products, including Vermont’s Act 120 due to become effective on July 1, 2016. Despite pressure on the U.S. Senate to address the SAFL Act and pass a companion or similar bill before the end of 2015, efforts to include any such bill or related provisions in the year-end omnibus spending bill were unsuccessful. Senate Agricultural Committee Group leaders, including Sen. Debbie Stabenow, D-Mich., have pledged to make the issue a top priority in January 2016, and many expect Sen. John Hoeven, R-N.D., to play a role in trying to secure passage of a bipartisan bill.
Food Safety Modernization Act Roll-Out
The Food Safety Modernization Act (FSMA) was signed into law on January 4, 2011, and represents the most comprehensive overhaul of the U.S. food safety regulatory scheme since the passage of the Food, Drug and Cosmetic Act in 1938. For nearly five years, the U.S. Food and Drug Administration (FDA) has been developing the seven final rules that implement FSMA. Each final rule impacts a different fundamental area of the U.S. food system.
In September and November 2015, the FDA issued the first five of the seven final rules: (1) Preventive Controls for Human Food; (2) Preventive Controls for Animal Food; (3) Foreign Supplier Verification Program; (4) Standards for Produce Safety; and (5) Accredited Third-Party Certification. The issuance of these rules initiates the countdown for the relevant compliance deadlines for covered entities.
It is anticipated that the final two FSMA rules regarding Sanitary Transportation and Intentional Adulteration will be issued on March 31, 2016. The Sanitary Transportation final rule will establish criteria for the sanitary transportation of food, including criteria targeted at shipping conditions and practices, employee training, and record keeping. The Intentional Adulteration final rule will require domestic and foreign food processing facilities to address vulnerabilities in their operations to prevent acts on the food supply intended to cause large-scale public harm. In 2016, the FDA will also be working with certain alliance groups to further develop FSMA compliance and enforcement guidance.
FDA Menu Labeling Requirements
Section 4205 of the Affordable Care Act charges the FDA with establishing labeling requirements for certain retail food establishments and vending machines. On December 1, 2014, the FDA issued two rules requiring calorie information to be listed on menus and menu boards at retail food establishments if they are a part of a chain of twenty or more locations operating under the same name and offering for sale substantially the same restaurant-type food items.
In July 2015, the FDA announced that the compliance deadline for the menu labeling rule was being extended by one year. All covered establishments (e.g., restaurants, grocery stores, and gas station convenience stores) now have until December 1, 2016, to identify calorie count and other information on their menus and menu boards as required by the FDA menu labeling rules.
In our February 12, 2014 post, entitled “Consumer Class Actions Trending From Attacking ‘All Natural’ to ‘Raw,’” we addressed whether claims challenging consumer product advertising as “all natural” were preempted in the absence of specific guidance from the FDA and the mixed results the argument has produced. In Ault v. J.M. Smucker Co. et al., 2014 WL 1998235 (S.D.N.Y. May 15, 2014), the Court denied a motion to dismiss based on preemption and primary jurisdiction where the plaintiff alleged that it was deceived into purchasing Smucker’s Crisco oil by “all natural” advertising where the product contained genetically modified organisms, or GMOs, because the FDA has not addressed the use of the term “all natural” in this context.
Smuckers argued that FDA policies regarding the use of the term “natural” preempt state law false advertising claims based on this language, even if those policies are informal. However, the Court found, “no federal specifications exist here.” Id. at *3. And “[e]ven if an informal FDA definition does exist, the term ‘natural’ ‘may be used in numerous contexts and may convey different meanings depending on that context” [citation,] [and] “that is one of the reasons the FDA has never adopted a formal definition.” Id. (citing Pelayo v. Nestle USA, Inc.,<“> No. CV 13–5213, 2013 WL 5764644, at *5 (C.D.Cal. Oct. 25, 2013)). In addition, “the FDA has declined to consider the specific issue here: whether and under what circumstances food products containing ingredients produced using genetically engineered ingredients may or may not be labeled ‘natural.’” Id. (citation and some internal quotation marks omitted). “As a result,” the Court found, “any general, informal FDA guidance is not controlling.” Id. (citing In re Frito–Lay N. Am., Inc. All Natural Litig., No. 12–md–2413,2013 WL 4647512, at *10 (E.D.N.Y. Aug. 29, 2013)).
The Court also rejected Smucker’s argument that the FDA’s decision not to impose a labeling requirement for foods with GMOs supports preemption, stating, “[i]n effect, Defendant interprets the FDA’s lack of action as approval for Defendant’s use of the phrase ‘All Natural’ to describe foods containing GMO [but] [i]n reality, the FDA has stayed silent because it ‘operates in a world of limited resources’ where it ‘must prioritize which issues to address.’” Id. (citation omitted.)
In addition, the Court found Smucker’s primary jurisdiction argument unavailing: “three federal district judges previously referred the question of whether foods containing GMOs may be labeled ‘natural’ to the FDA under the primary jurisdiction doctrine [and on] January 6, 2014, the FDA responded and explicitly declined to make such a determination.” Id. at *4 (citing January 6, 2014 FDA Letter). “The FDA’s refusal to consider the question demonstrates that ‘resort to the agency at this time would be unavailing,’ [citation] and therefore weighs against applying the primary jurisdiction doctrine.” Id.
This case signals that, until the FDA acts, preemption and primary jurisdiction arguments against “all natural” advertising of products with GMOs may be more and more challenging.