Tag: GMO

Grocery Manufacturers of America (GMA) and Vermont Agree to Drop GMO Lawsuit

GMO LawsuitThe food industry, led by the Grocery Manufacturers of America (GMA), and Vermont have agreed to dismiss a federal lawsuit that challenged a state law requiring the labeling of certain foods made with genetically modified organisms.

Vermont’s labeling requirements for genetically modified (GM) foods have been preempted by the recent enactment of federal GM labeling legislation which establishes a “National Bioengineered Food Disclosure Standard” and calls for the U.S. Department of Agriculture (USDA) to “establish a national mandatory bioengineered food disclosure standard”.  On August 11, 2016, Vermont’s Attorney General (AG) issued a formal memo stating that the AG’s office will no longer enforce the state’s requirements.  Still pending on appeal to the 2nd U.S. Circuit Court of Appeals in New York, however, was a federal court case filed by food industry groups against the state of Vermont challenging the state GMO labeling law.

Earlier this week, the parties to the lawsuit agreed the suit was no longer warranted because a new federal law preempted the Vermont law that took effect July 1, 2016.

The dismissal of the legal challenge to Vermont’s GMO labeling law represents the formal conclusion of a particularly controversial chapter in the GM labeling debate that involved sparring over the potential development of a patchwork of conflicting labeling requirements across the 50 states.  With the conclusion of the Vermont GMO labeling law saga, industry can now work with USDA to develop uniform federal regulation for labeling GMO foods.

ARTICLE BY Food and Drug Law at Keller and Heckman of Keller and Heckman LLP
© 2016 Keller and Heckman LLP

Lawsuit Challenges FDA Approval of Genetically Engineered Salmon

BullmonLast November, we posted that the Food and Drug Administration (FDA) had approved a genetically engineered (GE) salmon: AquaBounty Techonologies’ AquAdvantage Salmon. This approval marked the first time that the FDA authorized selling a genetically engineered animal for human consumption.

Immediate backlash followed the FDA’s November 19, 2015 announcement from environmental and consumer advocacy groups. On March 31, 2016, environmental and food safety groups, as well as fisherman trade associations, sued the FDA and related agencies in federal court in California. The suit seeks to reverse the FDA’s approval of the fish for human consumption.

The complaint alleges that the FDA failed in its statutory duty to take a “hard look” at how GE salmon will impact the environment. The plaintiffs warn that the FDA did not appreciate the risk that the farmed salmon would inevitably escape, “interbreed with wild endangered salmon, compete with them for food and space, or pass on infectious disease . . . .”

The plaintiffs also take aim at the FDA’s authority to regulate GE animals under the Federal Food, Drug, and Cosmetic Act (FFDCA), arguing that, back in 1938, Congress did not expect the FDA to regulate genetically engineered animals for human consumption: “GE animals present enormously different risks and impacts than drugs, requiring different expertise, analyses, and regulation than were contemplated when Congress enacted the FFDCA.”

Whether additional lawsuits will follow this one remains to be seen. In our November post, we predicted that consumers could sue to challenge the labeling of the GE fish. Although the FDA initially determined that AquaBounty would not need to label its salmon as GE, a provision in December’s 2016 Omnibus Appropriations Bill required the FDA to ban GE salmon imports until it published labeling guidelines for the fish. In February, the FDA issued that ban and announced its plans to establish labeling guidelines.

Even if AquaBounty puts FDA-approved labeling on its product, consumers still may sue under failure to warn and related legal theories. The food industry has had some success defending state law food labeling claims based on federal preemption. But the federal Nutrition Labeling and Education Act exempts claims based on the adequacy of safety warnings unless the FDA has actually considered a risk and determined that no warning is necessary. So, the key question in any consumer personal injury suit involving GE salmon likely will be whether the FDA considered the risk of the alleged harm in implementing its new labeling guidelines.

Article By Amy M. Rubenstein & Katia Asche of Schiff Hardin LLP

© 2016 Schiff Hardin LLP

EPA OIG Will Evaluate EPA’s Management of Resistance Issues Related to Herbicide Tolerant GE Crops

EPAOn March 25, 2016, the U.S. Environmental Protection Agency’s (EPA) Office of Inspector General (OIG) sent a memorandum to Jim Jones, Assistant Administrator, Office of Chemical Safety and Pollution Prevention (OCSPP), announcing that it plans to begin preliminary research to assess EPA’s management and oversight of resistance issues related to herbicide tolerant genetically engineered (GE) crops.  OIG states that its review will include the Office of Pesticide Programs (OPP), as well as other applicable headquarters and regional offices.  OIG’s objectives are to determine:

  1. What processes and practices, including alternatives, EPA has provided to delay herbicide resistance;

  2. What steps EPA has taken to determine and validate the accurate risk to human health and the environment for approved pesticides to be used to combat herbicide resistant weeds; and

  3. Whether EPA independently collects and assesses data on, and mitigates actual occurrences of, herbicide resistance in the field.

OIG states that the anticipated benefit of the project “is a greater understanding of herbicide resistance[,] which will lead to an enhancement of EPA’s herbicide resistance management and oversight.”

Commentary

Pesticide resistance is not a new issue and is one that EPA has affirmatively addressed when granting registrations for new products, GE or not, for some time.  In fact, that newer chemistries often have a more niche mode of action to reduce potential toxicity concerns has led some observers to speculate that greater resistance is one potential trade-off for the development of less toxic materials.

This “investigation” may appear to some to be a response to concerns raised by critics of GE crops generally and to a recent EPA decision to approve Enlist Duo herbicide, a new formulation of 2,4,D- and glyphosate designed to address the problem of weed resistance to glyphosate-tolerant crops.  Glyphosate tolerant crops were first approved some years ago, and their use was so broadly and readily adopted that issues have arisen with regard to potential resistance to some weed species.  EPA is currently expected to approve another GE strain, Dicamba-tolerant crops, to control glyphosate tolerant weeds.

To critics of GE crops, using more herbicides to control problems caused by what they claim is overuse of another herbicide is evidence of a troubling “pesticide treadmill,” which they believe should not have been allowed to occur in the first place.  Rebutting this criticism, others assert that resistance is a problem for all pesticides, not only genetically modified ones, and that with sufficient controls, resistance can be delayed, if not avoided.  Registrants point out that it is very much in their self-interest to take steps to avoid resistance to their products — once that occurs, the market viability of the product is significantly reduced.

ARTICLE BY Lisa M. Campbell, James V. Aidala & Carla N. Hutton of Bergeson & Campbell, P.C.
©2016 Bergeson & Campbell, P.C.

California Court Curbs Chipotle GMO Case

Chipotle dodges non-GM class action lawsuit…for now.

Sign is seen at a Chipotle Mexican Grill restaurant in San Francisco, California
A sign is seen at a Chipotle Mexican Grill restaurant in San Francisco, California July 21, 2015. REUTERS/Robert Galbraith

  • In 2015, Chipotle Mexican Grill launched a nationwide advertising campaign premised on the chain’s pledge to serve food made only with non-genetically modified (GM) ingredients.  However, the company continued to serve meat and dairy products from animals that consume GM crops, as well as beverages with GM ingredients (e.g., sodas with corn syrup from GM corn).  A class action lawsuit was filed against Chipotle in the “Food Court” (Northern District of California), based on allegations that the chain’s non-GM advertising campaign violates California consumer protection, false advertising, and unfair competition laws.

  • On February 5, the lawsuit was dismissed.  The judge found that the plaintiff had failed to specify that she purchased food in the “GM” categories (i.e., meat, dairy, or soft drinks) and thus failed to connect economic injury to the allegedly deceptive claims.  In the dismissal order, the judge also questioned the plaintiff’s allegations that a reasonable consumer would interpret Chipotle’s non-GM ingredient claims to extend to meat and dairy products derived from animals that never consumed any GM ingredients.

  • Although the plaintiff in this case may file an amended complaint in the future, the dismissal suggests that the court may be looking for additional support for the notion that reasonable consumers hold the same strict interpretation of non-GM claims.  Even Vermont’s GM labeling requirements provide exemptions for animal products derived from animals that consumed GM crops, which suggests that it might be an uphill battle to establish that such products should themselves be considered “GM.”

Article By Food & Drug at Keller and Heckman LLP
© 2016 Keller and Heckman LLP

Agriculture, Food, and Health Issues to Watch for 2016

Label Food Organic.jpgAs 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.

Article By Laura A. Bentele, Scott K.G. Kozak & Jonathan D. Valentino of Armstrong Teasdale
© Copyright 2016 Armstrong Teasdale LLP. All rights reserved

Vermont GMO Battle Continues in Second Circuit

The Second Circuit Court of Appeals is currently in the midst of an interlocutory appeal by the Grocery Manufacturer’s Association (“GMA”) and others of the District Court of Vermont’s denial of a request for a preliminary injunction against Vermont’s “Right to Know” Act.

The Act, passed by the Vermont legislature on May 8, 2014, and effective July 1, 2016, has the stated goal of establishing a system to allow for informed decisions by consumers with respect to the potential health effects of “genetically engineered foods,” commonly referred to as “GMOs.”  The Act applies to products entirely or partially produced with genetic engineering, with a focus on raw agricultural commodities and covered processed foods.  Labels on covered food products must either state that they are “produced with genetic engineering” or “may be produced with genetic engineering.”  Limited exceptions are made for foods derived entirely from animals, restaurant foods, alcoholic beverages and foods that have been independently verified to have “minimal” GMO content.  Penalties under the Act include $1,000.00 per day, per product, fines for food manufacturers.

The GMA filed its initial Complaint with the District Court in June 2014, and sought a preliminary injunction in September 2014.  U.S. District Judge Christina Reiss refused to enjoin the law in a ruling issued on April 27, 2015, which was promptly appealed to the Second Circuit.  Oral argument in the appeal took place on October 8, 2015.

The crux of the issue before the Second Circuit is the proper standard for evaluating GMA’s position that the Act violates the First Amendment by imposing a burden on speech by, inter alia, food manufacturers, based upon the content of that speech.  In reaching her decision to deny the preliminary injunction, Judge Reiss applied the less-stringent First Amendment analysis set forth in Zauderer v. Office of Disciplinary Counsel,  471 U.S. 626 (1985).  Given what the appellants term the “controversial” information/disclosures mandated by the Act, they argue the U.S. Supreme Court’s decision in Central Hudson Gas & Electric Corp. v. Public Service Commission of New York, 447 U.S. 557 (1980) and its stricter level of scrutiny applies.  Appellants further rely on Second Circuit precedent, arguing that the case of Int’l Dairy Foods Ass’n v. Amestoy, 92 F.3d 67 (2d Cir. 1996), bars the state legislature from enacting a law that “trammel[s] manufacturer’s free speech rights to appease “consumer curiosity” and was ignored by the District Court.  The State of Vermont continues to argue that the District Court’s reliance on Zauderer and its less-stringent “rational basis” test was proper, in that the Act merely serves to provide consumers with “factual information.”

The Second Circuit panel reviewing the case addressed the issue of ripeness during oral argument, and remains, given the impact of the Act as the first of its kind to have a set effective date, at the forefront of debate over the regulation of GMO food and food products.  The Second Circuit’s decision bears watching, as the costs to industry resulting from enactment of the Act and the potential domino effect of similar acts being passed by other state legislatures could be significant and will require extensive advanced planning to ensure compliance.

The Second Circuit case is Grocery Manufacturers Association, et al. v. Sorrell, Case No. 15-1504.  The District Court case is Case No. 5:14-cv-117 and the Court’s order denying the preliminary injunction is Document #95.  A link to a .pdf copy of the Order is provided immediately here.

Article By Scott K.G. Kozak of Armstrong Teasdale

© Copyright 2015 Armstrong Teasdale LLP. All rights reserved

More GMO Woes: Another Corn Exporter Sues Syngenta for its Failure to Isolate its GMO Corn

Mintz Levin Law Firm

Last month, Archer Daniels Midland Co. (“ADM”) joined a slew of corn exporters and other stakeholders who have sued Syngenta based on allegations that China rejected these exporters’ products because Syngenta’s genetically modified corn seed, which contains a trait that China has not yet approved for import, was not kept separate from the plaintiffs’ products.

Corn Thrasher

Syngenta’s corn seed contains MIR 162, a patented genetically modified (“GMO”) trait that may protect corn crops from insect damage.  This corn is also known as “Viptera corn.”  The ADM suit against Syngenta, which was filed in Louisiana state court on November 19, alleges that Syngenta was negligent in marketing its GMO corn.

The complaint explains that although Syngenta told the U.S. Department of Agriculture that it would put into place programs to keep the GMO corn separate from other strains so that it would not end up on ships headed for countries that have not yet approved the import of foods containing MIR 162. Syngenta has not implemented any such programs.

One major issue stemming from Syngenta’s alleged failure to isolate GMO corn is that MIR 162 has not been approved in all major export markets, including China, the world’s second-largest consumer of corn behind the United States.  Therefore, when the Syngenta seed is mixed with other corn seed during shipment, as corn in the United States is “commoditized,” or mixed together, during export, the entire lot is rejected when it reaches China because MIR 162 has not yet been approved for import.  Over the past year, China has rejected over one million tons of U.S. corn and corn products because they contained MIR 162.

ADM, which alleges “substantial economic losses and damages” due to these rejections, joins over one hundred farmers and corn exporters who have filed lawsuits against Syngenta for damages stemming from Syngenta’s failure to segregate its GMO corn seed.  For example, corn exporters Cargill Inc. and Trans Coastal Supply recently sued Syngenta for damages suffered due to China’s rejection of their corn shipments.

Additionally, groups of Midwestern farmers filed proposed class actions in Nebraska and Illinois federal courts in October 2014, in which they accused Syngenta of continuing to market and sell seeds containing MIR 162 and misleading farmers into planting this GMO corn alongside the rest of their corn crops.  In response to these prior suits, Syngenta has continually stated that these cases have no merit.  For example, in a recent conference call with analysts, Syngenta’s CFO stated that the company believes that it has complied with all laws, rules, and regulations in all of the countries in which it sells its GMO corn.

As we’ve explored in past posts, GMO foods continue to be controversial in the United States.  The ADM case is just one example of how the development and use of GMO foods in the United States can have far-reaching effects that extend beyond American consumers and legislation and into international trade.  Stay tuned for updates regarding Syngenta’s response to the ADM complaint.

ARTICLE BY

Michelle Gillette
Dominique L. Windberg
OF
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.

“The Good Wife” Defends Genetically Modified Organisms (GMOs)

Schwegman Lundberg Woessner

Last Sunday’s episode of “The Good Wife” featured a Christian mediation between a farmer (Robert Joy) sued by a Pioneer-like company, represented by the actor Richard Thomas, for saving GMO corn seed for replanting. The facts were a mash-up of J.E.M. Ag Supply v. Pioneer Hi-Bred., 534 U.S. 124 (2001), and Monsanto Canada v. Schmeiser, 1 S.C.R. 902 (2004). In the former case, JEM was selling Pioneer’s hybrid seed that had been “saved” by farmers from a previous crop of the seed, in violation of the shrink wrap-type license on the original Pioneer seed they had purchased at JEM. In Monsanto-Canada, a farmer saved and replanted glyphosate-resistant canola seed from a field he claimed was contaminated by “GMO” pollen from neighboring fields.

In J.E.M. Ag Supply, the only defense mounted by J.E.M. was that utility patents should not be issued on plants and, fortunately, the Supreme Court disagreed, in a decision that includes both plants made by conventional breeding techniques and transgenic modifications. In Monsanto Canada, the farmer was found to have infringed Pioneer’s patents.

In the “Good Wife” episode, the farmer was accused of saving seed in violation of the agribusiness’ patents. He argued that his field had been contaminated by “seed” blown from neighboring GMO fields, but Florick Agos presented an expert witness who “testified” that such blow-over would only “contaminate” about 6% of a non-GMO crop per year. The farmer and the agribusinessman were friends and after the farmer admitted he had replanted the transgenic canola, they settled the dispute with the farmer agreeing to pay some small amount of damages, as I recall.

The major issue for patent attorneys working in the ag biotech area (and for agribusiness itself) is the public perception –despite decisions upholding the patentability of plants in the U.S. or of the transgene or the transformed plant cell in Canada—that it is wrong to patent living organisms. At the end of the “Good Wife” mediation scene, one of the parties – the preacher? – exclaims that he is shocked that plants can be patented. J.E.M. was one of the last Supreme Court decisions that expanded the scope of patent rights. The Canadian Supreme Court was divided in ruling for Monsanto. As succinctly summarized by the majority:

“Inventions in the field of agriculture may give rise to concerns not raised in other fields—moral concerns about whether it is right to manipulate genes in order to obtain better weed control or higher yields. It is open to Parliament to consider these concerns and amend the Patent Action should it find them persuasive.”

© 2014 Schwegman, Lundberg & Woessner, P.A. All Rights Reserved.
ARTICLE BY

Warren Woessner
OF
Schwegman, Lundberg & Woessner, P.A.