Vermont enacted the first state law that requires the manufacturers of food products with genetically engineered (GE) ingredients to label their food products accordingly. Its Act 120 became law on July 1, 2016. However, for decades, there has been an ongoing battle at the federal level over whether a national labeling scheme should be enacted (the term GMO/genetically modified organism is also used). (See earlier posts for more background). So, after the Vermont bill became effective, there was a flurry of activity in Congress again to address the issue of a federal labeling scheme for GE food products. (The FDA has not required labels on food products with GE ingredients, in a policy that dates back to 1992). The Senate recently passed a bill, S. 764, that would mandate a particular federal labeling scheme for GE ingredients, and would also preempt any state labeling laws. The federal bill uses the term "bioengineering" to describe the products covered by the law:
[F]ood - (A) that contains genetic material that has been modified through in vitro recombinant [DNA] techniques; and (B) for which the modification could not otherwise be obtained through conventional breeding or found in nature.
There is an explicit statement of the preemption achieved by this legislation:
No State or a political subdivision of a State may directly or indirectly establish under any authority or continue in effect as to any food or seed in interstate commerce any requirement relating to the labeling of whether a food (including food served in a restaurant or similar establishment) or seed is genetically engineered (which shall include such other similar terms as determined by the Secretary of Agriculture) or was developed or produced using genetic engineering, including any requirement for claims that a food or seed is or contains an ingredient that was developed or produced using genetic engineering.
This last provision is aimed at the recent Vermont law, as well as other initiatives in Connecticut, Maine and Alaska. Since its enactment in 2014, the Vermont law had already impacted the food and restaurant industries, with some major players declaring that they would provide labels in anticipation of the law (see here). It was apparent that the Vermont law had immediate national impact, as food manufacturers faced compliance with the statute or avoidance of Vermont’s market (practically unworkable). Now, the House of Representatives has passed a version of the recent Senate bill, and it goes to President Obama for signing; it appears that he will sign it. The clear effect of the federal bill is to preempt the long-sought state labeling laws. However, does this bill actually require a label? The bill departs from other labeling proposals over the years (state and federal) in that it contains no explicit requirement to provide a “GMO” or other GE-related name on the main label of the product. The actual labeling scheme in the new federal law is quite elastic, describing the format of the labeling as follows:
[T]he form of a food disclosure under this section be a text, symbol, or electronic or digital link.
Thus, a consumer could use a smartphone to read a QR code, or utilize a provided link to access information, or read whatever disclosure material the manufacturer has chosen to provide. The forms of the notification could be arguably obscure, and indirect. In other words, at least so far, there will be no uniformity of disclosure. Already, there are allegations that the bill is discriminatory in that it will make it harder for some consumers to pursue the informational references; access to digitally formatted information is not universal. The USDA has two years to make the law operational, and may refine the labeling formats in that period, subject to public input.
The National Academies of Sciences, Engineering and Medicine (NAS) have released a report on the safety and impact of genetically engineered (GE) crops: Genetically Engineered Crops: Experiences and Prospects. This was an extensive evaluation by a committee comprised of academic experts to consider health and/or environmental effects of GE crops (note that the term "genetically modified organism/GMO" is used widely as well). As the authors described the scope of the report:
The committee examined almost 900 research and other publications on the development, use, and effects of genetically engineered characteristics in maize (corn), soybean, and cotton, which account for almost all commercial GE crops to date.
Here is a summary conclusion from the report:
[T]he study committee found no substantiated evidence of a difference in risks to human health between current commercially available genetically engineered (GE) crops and conventionally bred crops, nor did it find conclusive cause-and-effect evidence of environmental problems from the GE crops.
The committee noted that the majority of GE crops in commercial use are engineered to carry just a few additional genetic traits:
The committee used evidence accumulated over the past two decades to assess purported negative effects and purported benefits of current commercial GE crops. Since the 1980s, biologists have used genetic engineering to produce particular characteristics in plants such as longer shelf life for fruit, higher vitamin content, and resistance to diseases. However, the only genetically engineered characteristics that have been put into widespread commercial use are those that allow a crop to withstand the application of a herbicide or to be toxic to insect pests.
The fact that only two characteristics have been widely used is one of the reasons the committee avoided sweeping, generalized statements about the benefits and risks of GE crops. Claims about the effects of existing GE crops often assume that those effects would apply to the genetic engineering process generally, but different characteristics are likely to have different effects. A genetically engineered characteristic that alters the nutritional content of a crop, for example, is unlikely to have the same environmental or economic effects as a characteristic for herbicide resistance.
There is a reiteration of the basic U.S. regulatory paradigm, which focuses on the nature of a GE product, rather than a process-based approach:
All technologies for improving plant genetics – whether GE or conventional -- can change foods in ways that could raise safety issues, the committee’s report notes. It is the product and not the process that should be regulated, the new report says, a point that has also been made in previous Academies reports.
In determining whether a new plant variety should be subject to safety testing, regulators should focus on the extent to which the novel characteristics of the plant variety (both intended and unintended) are likely to pose a risk to human health or the environment, the extent of uncertainty about the severity of potential harm, and the potential for human exposure – regardless of whether the plant was developed using genetic-engineering or conventional-breeding processes. ” –omics” technologies will be critical in enabling these regulatory approaches.
The United States’ current policy on new plant varieties is in theory a “product” based policy, but USDA and EPA determine which plants to regulate at least partially based on the process by which they are developed. But a process-based approach is becoming less and less technically defensible as the old approaches to genetic engineering become less novel and as emerging processes — such as genome editing and synthetic biology — fail to fit current regulatory categories of genetic engineering.
On the contentious issue of labeling food derived from GE crops (see here), the committee did not find a compelling scientific basis to require labeling, but noted that there are other considerations:
[T]he issue involves social and economic choices that go beyond technical assessments of health or environmental safety; ultimately, it involves value choices that technical assessments alone cannot answer.
The report therefore endorses the existing product-based framework, but coupled with a nuanced determination of what products should receive enhanced oversight. Critically, the report notes a fact which is not widely appreciated, which is that GE crops largely contain only two added traits: insect or herbicide resistance. Both of these characteristics serve agronomic ends, in contrast to alteration of product attributes, such as nutritional enhancement. As a result, the NAS committee notes that other GE traits could be introduced and require specific regulatory focus. This could be especially true when the goal of a GE alteration is a deliberate change in food composition. Finally, and not insignificantly, the committee finds that GE crops, on balance, have not led to increased yields, and notes the development of resistance in both insects and weeds. These latter conclusions will feature prominently as the cost/benefit calculus for the use of GE crops continues to be debated.
The federal regulation of biotechnology products is grounded in a design that was first announced in 1986 as the Coordinated Framework (CF) for the Regulation of Biotechnology, later updated in 1992. Those documents have largely shaped the the federal regulatory regime for biotechnology. A key concept in this original framework was that products produced through genetic engineering (or recombinant DNA) techniques would not receive special oversight because of the processes used to produce them. Instead, a risk-based approach was instituted that focused on the characteristics of actual products, not underlying production techniques. In 2015, the White House, through its Office of Science and Technology (OSTP), announced that it would launch an overhaul of the 1992 policy. In the memorandum, the OSTP provided a definition of “biotechnology products” to be included in the review:
For the purpose of this memo, “biotechnology products” refers to products developed through genetic engineering or the targeted or in vitro manipulation of genetic information of organisms, including plants, animals, and microbes. It also covers some of the products produced by such plants, animals, and microbes or their derived products as determined by existing statutes and regulations. Products such as human drugs and medical devices are not the focus of the activities described in this memorandum.
Since the 1980’s, the existing coordinated framework has divided the primary regulation of biotechnology products among three agencies: the U.S. Environmental Protection Agency (EPA), the U.S. Department of Agriculture (USDA), and the U.S. Food and Drug Administration (FDA). The OSTP is involved in a more general role as overseer of the regulatory design, rather than as a formal regulatory body. In the memorandum sent to the heads of the EPA, FDA and USDA, the OSTP alludes to the regulatory overlap, redundancy and confusion that has arisen with the multi-agency design:
Each of the Federal regulatory agencies with jurisdiction over the products of biotechnology has developed regulations and guidance documents to implement its authority under existing laws, resulting in a complex system for assessing and managing health and environmental risks of the products of biotechnology. While the current regulatory system for the products of biotechnology effectively protects health and the environment, in some cases unnecessary costs and burdens associated with uncertainty about agency jurisdiction, lack of predictability of time frames for review, and other processes have arisen.
As part of the modernization initiative, the Administration held 3 meetings organized by the relevant agencies to receive feedback on the proposed overhaul. Two documents were issued that are helpful to understanding the current climate that is precipitating calls for redesign: a table of current agency responsibilities, and a series of case studies illustrating how a singular GE product can be subject to multi-agency review. Pursuant to the OSTP charge, a committee formed by the National Academy of Sciences, Medicine and Engineering was commissioned to conduct a formal study, “Future Biotechnology Products and Opportunities to Enhance Capabilities of the Biotechnology Regulatory System.” This committee has set the following objectives:
Describe the major advances and the potential new types of biotechnology products likely to emerge over the next 5-10 years.
Describe the existing risk analysis system for biotechnology products including, but perhaps not limited to, risk analyses developed and used by EPA, USDA, and FDA, and describe each agency’s authorities as they pertain to the products of biotechnology.
Determine whether potential future products could pose different types of risks relative to existing products and organisms. Where appropriate, identify areas in which the risks or lack of risks relating to the products of biotechnology are well understood.
Indicate what scientific capabilities, tools, and expertise may be useful to the regulatory agencies to support oversight of potential future products of biotechnology.
The first public meeting of the NAS committee will be held on April 18, 2016. The agenda for the meeting is posted here.
This week, a coalition of environmental, food safety and consumer groups has filed suit against the FDA for its 2015 approval of a genetically engineered (GE) salmon product in 2015 (following several decades of review). The product is AquaAdvantage, made by Aqua Bounty, Inc. This is the first transgenic animal to be approved by the FDA for food consumption. To produce the GE salmon, Atlantic salmon is engineered to contain the growth hormone gene from Pacific Chinook salmon, which causes the fish to grow in less time; the gene is placed under the control of a promoter from ocean pout, which causes elevated expression of the hormone. The fish are to be only sterile females. The production plans submitted to the FDA describe the preparation of the GE fish eggs in Canada, and the actual production of the fish in Panama (with eventual location in the U.S. as well). Following the approval, Alaska Sen. Lisa Murkowski, an opponent of the FDA's actions (see here), inserted a legislative provision into the 2015 omnibus spending bill, requiring the FDA to develop a labeling scheme for the GE salmon before they enter the market. As a result of that maneuver, the FDA is in the process of complying with that mandate, and the GE salmon is not yet commercially available.
In their press release, the plaintiffs assert several grounds on which the agency’s action does not comply with existing federal law:
The lawsuit challenges FDA’s claim that it has authority to approve and regulate GE animals as “animal drugs” under the 1938 Federal Food, Drug, and Cosmetic Act. Those provisions were meant to ensure the safety of veterinary drugs administered to treat disease in livestock and were not intended to address entirely new GE animals that can pass along their altered genes to the next generation. The approval of the GE salmon opens the door to other genetically engineered fish and shellfish, as well as chickens, cows, sheep, goats, rabbits and pigs that are reportedly in development.
The lawsuit also highlights FDA’s failure to protect the environment and consult wildlife agencies in its review process, as required by federal law. U.S. Atlantic salmon, and many populations of Pacific salmon, are protected by the Endangered Species Act and in danger of extinction. Salmon is a keystone species and unique runs have been treasured by residents for thousands of years. Diverse salmon runs today sustain thousands of American fishing families, and are highly valued in domestic markets as a healthy, domestic, “green” food.
The lawsuit was filed in the Northern District of California. The suit could directly test the applicability of the FDA's determination that the insertion of new genetic material amounts to a kind of "veterinary drug" and thus applications for approval of food from GE animals require a new drug application under the Federal Food, Drug, and Cosmetic Act. According to the FDA:
FDA regulates GE animals under the new animal drug provisions of the law, and the agency must approve them before they are allowed on the market. Food and animal feed from GE animals will undergo FDA review before the food or feed can be marketed. The Federal Food, Drug, and Cosmetic Act defines a drug as "an article (other than food) intended to affect the structure or any function of the body of man or other animals." Therefore, the rDNA construct intended to change the structure or function of the body of the GE animal is a drug.
The suit also challenges the legitimacy of the FDA's determination that the GE salmon posed no environmental risk, based on an Environmental Assessment; the plaintiffs argue that the FDA is required to perform the more rigorous Environemntal Impact Statement (EIS). The food and restaurant industries had earlier indicated some resistance to selling the GE salmon; Red Lobster and Costco have already announced that the product will not be carried.
Vermont is on track to implement the nation’s first law requiring the labeling of foods with genetically engineered (GE) ingredients, whether raw or processed. (The term "genetically modified organism" (GMO) is often seen in discussions as well). The state’s Act 120, passed in 2014, was enacted to advance several objectives related to “public health and food safety, environmental impacts” and avoidance of “consumer confusion and deception.” The law states:
[F]ood offered for sale by a retailer after July 1, 2016 shall be labeled as produced entirely or in part from genetic engineering if it is a product:
(1) offered for retail sale in Vermont; and
(2) entirely or partially produced with genetic engineering.
The law further describes the labeling:
[I]n the case of any processed food that contains a product or products of genetic engineering, the manufacturer shall label the package in which the processed food is offered for sale with the words: “partially produced with genetic engineering;" “may be produced with genetic engineering;" or “produced with genetic engineering.”
In the two years since its passage, there have been several efforts in Congress to enact a federal law that would reassert federal jurisdiction over the labeling issue and preempt any state labeling laws. The House considered bills in 2015, and the Senate just this month considered its own version. Although a House bill passed, the attempts to establish a federal counterweight to state labeling efforts failed as a similar bill was defeated in the Senate. Efforts to mandate the labeling of GE food products at the national level have consistently failed in Congress, and the FDA has resisted all calls for a national mandate on labeling. Now, as Vermont’s law will take effect on July 1, 2016, preparations for compliance are evident on a number of fronts. The Attorney General has issued a memorandum detailing its enforcement strategy which states:
Our Office expects that most GE foods on Vermont grocery store shelves will be properly labeled by July 1, 2016. Out of recognition that some food products have longer shelf lives, CP (Consumer Protection Rule) 121 creates a six-month “safe harbor” for foods distributed before July 1, 2016, and offered for retail sale through December 31, 2016. During this six-month period, unless there is evidence that a manufacturer distributed a mislabeled product after July 1, 2016, we will not bring an enforcement action or seek fines for those products.
Beyond these developments in Vermont, Connecticut and Maine have also passed mandatory GE labeling laws; however, their implementation will only be triggered when a number of states join the effort (see here). On the commercial front, with the Vermont mandate looming, major food manufacturers are releasing plans to add labeling labeling regarding the “genetically engineered” attributes of their food products. General Mills issued a statement:
As the discussions continue in Washington, one thing is very clear: Vermont state law requires us to start labeling certain grocery store food packages that contain GMO ingredients or face significant fines. We can’t label our products for only one state without significantly driving up costs for our consumers and we simply will not do that. The result: consumers all over the U.S. will soon begin seeing words legislated by the state of Vermont on the labels of many of their favorite General Mills products.
Other major companies following suit include Kellogg’s, ConAgra Foods, and Campbell’s Foods. In a departure from other manufacturers, Campbell’s has called for a federally mandated labeling system to systematize labeling, and the company formally withdrew from food industry efforts to oppose GE food labeling laws and initiatives. The effect of the Vermont law is now being realized across the food industry; however, a lawsuit filed against Vermont's law by the Grocery Manufacturers Association (GMA) is still working through the federal courts: the trial judge denied summary judgment and a preliminary injunction for GMA; an appeal of the district court's injunction ruling is on appeal at the Second Circuit.
The FDA has issued an approval for the marketing of genetically engineered (GE) Atlantic salmon, capping a long regulatory review (see here). The product, AquaAdvantage, made by Aqua Bounty, Inc., has been under agency review for years. This Atlantic salmon has been genetically engineered to add the growth hormone gene from the Chinook salmon, which causes the fish to reach market weight in about half the time. The FDA regulates GE animals under the new animal drug provisions of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) because recombinant DNA introduced into an animal is treated as a drug. From the FDA statement:
Based on a comprehensive analysis of the scientific evidence, the FDA determined that AquAdvantage Salmon meets the statutory requirements for safety and effectiveness under the Federal Food, Drug, and Cosmetic Act. Among the requirements the sponsor had to meet are that food from the fish is safe to eat; the rDNA construct (the piece of DNA that makes the salmon grow faster) is safe for the fish itself; and the AquAdvantage Salmon meets the sponsor’s claim about faster growth. In addition, the FDA determined that food from AquAdvantage Salmon is as safe to eat and as nutritious as food from other non-GE Atlantic salmon and that there are no biologically relevant differences in the nutritional profile of AquAdvantage Salmon compared to that of other farm-raised Atlantic salmon.
The AquAdvantage Salmon may be raised only in land-based, contained hatchery tanks in two specific facilities in Canada and Panama. The approval does not allow AquAdvantage Salmon to be bred or raised in the United States. In fact, under this approval, no other facilities or locations, in the United States or elsewhere, are authorized for breeding or raising AquAdvantage Salmon that are intended for marketing as food to U.S. consumers. As required by the National Environmental Policy Act, the FDA completed an environmental assessment to determine whether approval of the application would result in significant effects on the quality of the human environment in the United States. The FDA has determined that the approval of the AquAdvantage Salmon application would not have a significant environmental impact because of the multiple and redundant measures being taken to contain the fish and prevent their escape and establishment in the environment.
The agency will not require the GE salmon to be labeled:
Based on our assessments of food derived from the AquAdvantage Salmon, we have determined that the term “Atlantic salmon” is the appropriate common or usual name for such food within the meaning of section 403(i) of the FD&C Act because AquAdvantage Salmon meets FDA’s regulatory standard for Atlantic salmon (Ref. 10) and the composition and basic nature of food from AquAdvantage Salmon does not significantly differ from its non-GE counterpart—non-GE farm-raised Atlantic salmon. In addition, we have determined that food derived from AquAdvantage Salmon is as safe and nutritious as food from other farm-raised Atlantic salmon. For these reasons, we have concluded that there is no material difference between food derived from AquAdvantage Salmon and food derived from other non-GE, farm-raised Atlantic salmon that is required to be disclosed in the labeling of food derived from AquAdvantage Salmon under the relevant provisions of the FD&C Act, as explained above. See 21 U.S.C. 321(n) & 343(a).
Senator Lisa Murkowski (R-AK) has been an outspoken opponent of FDA approval of the GE salmon (in line with general statewide opposition), and has been attempting to pass legislation requiring the labeling of the GE salmon if the agency approval cannot be overturned:
The FDA has said there will be draft guidance on voluntary labeling indicating whether food has or has not been derived from GE Atlantic salmon. So, basically, if you want to put a label on that says this is a fake fish, a fake salmon, you can go ahead, but you don't have to. It is only voluntary. That is not good enough for this mom. That is not good enough for most who care about what their families are eating. So we are going to continue to press for mandatory labeling if the FDA is going to approve--wrongheadedly, in my mind--this genetically engineered fake fish for human consumption. They darn well better agree that labeling will be required because I am not going to eat it.
Public sentiment against approval of the GE salmon was well-registered with the FDA; over 1.5 million public comments were posted against agency approval; the agency decision not to require labeling has generated more opposition and the FDA's safety evaluation has been challenged as cursory. The marketplace could well determine whether GE salmon actually becomes part of the American food supply; many retailers and restaurants are on record stating that they will not sell the product. Upcoming developments to watch will be the ongoing pressure to require labeling (as well as the Senate prospects for the federal anti-GE labeling bill discussed here earlier). Furthermore, the fate of future GE seafood products (about 35, by one count) that come before the FDA remains uncertain. Lastly, a lawsuit has been filed in Canada opposing the AquaBounty production of the GE salmon eggs in Canada as a potential environmental threat to wild salmon stocks.
As genetic engineering emerged from laboratories in the 1970’s into the biotechnology industry in the 1980’s, the possibility of government regulation arose, with a central question of whether a drug, for example, produced by genetic engineering rather than conventional chemical synthesis, required a distinct regulatory response. In another version of that same question: did a genetically modified plant require a distinct biotechnology regulatory treatment or could the plant fit into established oversight routes for plants produced through convention breeding techniques? In its most generic form, the debate that began in the 1980's wrestled with whether biotechnology processes produce inherently distinct products that demanded novel regulatory responses. According to the Coordinated Framework for the Regulation of Biotechnology announced by White House Office of Science and Technology Policy (OSTP) in 1986, the answer was generally no; a product or an engineered organism could be evaluated by the traditional agencies and laws that already existed to identify and manage risk. The
coordinated framework thus divided the primary regulation of
biotechnology products among three agencies – the Department of
Agriculture’s Animal and Plant Health Inspection Service (APHIS), the Environmental Protection Agency (EPA), and the Food and Drug
Administration (FDA). That scheme was updated in 1992, and that document continued to be the last word in regulatory design. Now the White House OSTP has announced that it will initiate a modernization of the 1992 policy. In a just-published memorandum to the three federal agencies, the OSTP first provides a definition of “biotechnology products” that will be the targets of the review:
For the purpose of this memo, “biotechnology products” refers to products developed through genetic engineering or the targeted or in vitro manipulation of genetic information of organisms, including plants, animals, and microbes. It also covers some of the products produced by such plants, animals, and microbes or their derived products as determined by existing statutes and regulations. Products such as human drugs and medical devices are not the focus of the activities described in this memo.
In a briefing document on its blog, the OSTP has described the process ahead:
The goal of the effort is to ensure public confidence in the regulatory system and improve the transparency, predictability, coordination, and, ultimately, efficiency of the biotechnology regulatory system. Here is a bit more detail about the effort’s three components:
First, the Administration will update the Coordinated Framework, after public input, by clarifying the current roles and responsibilities of the EPA, USDA, and FDA in the regulatory process. This update will help clarify which biotechnology product areas are within the authority and responsibility of each agency and outline how the agencies work together to regulate products that may fall under the authorities of multiple agencies.
Second, the Administration will develop a long-term strategy, after public input, to ensure that the Federal regulatory system is well-equipped to assess efficiently any risks associated with the future products of biotechnology. This will include performing periodic horizon-scanning of new biotech products, coordinating support for the science that informs regulatory activities, developing tools to assist small businesses as they navigate the regulatory system, and creating user-friendly digital tools for presenting the agencies’ authorities, practices, and basis for decision-making.
Third, the Administration will commission an outside, independent analysis of the future landscape of the products of biotechnology. The Administration has already asked the National Academies of Sciences, Engineering, and Medicine to conduct such an analysis.
A modernized jurisdictional design could address some overlap between the responsible agencies, while also considering newer technologies and their placement into the scheme. For example, new organisms or products from the more recent field of synthetic biology might not fit the traditional category of “genetically engineered” which contemplated a small number of discrete and planned changes into an existing organism. A recent study from the Venter Institute on the regulatory challenges raised by synthetic biology endorsed the basic earlier principle that a product should be evaluated for its own discrete risk profile even when produced through synthetic biology; however, the study notes that specific jurisdictional boundaries between the three federal agencies and specific legal authorities need to be updated to account for an expanding portfolio of genetic engineering modalities that will produce even more novel organisms than the first wave of genetic engineering.
Today, the full House of Representatives passed H.R. 1599, the Safe and Accurate Food Labeling Act, by a vote of 275-150. The bill would amend the Federal Food, Drug, and Cosmetic Act regarding the FDA’s interaction with genetically engineered (GE) food products (often called genetically modified organisms, i.e., GMOs). The general purpose of the bill is to establish that GMO regulation should be managed at the federal level only. The bill was written to counter the most common form of state regulation of GMOs, namely, the state laws that mandate the labeling of GMO-derived food products. This includes the Vermont Act 120, scheduled to take effect in 2016, and the Maine and Connecticut laws which are conditional labeling mandates that are only triggered upon the passage of similar laws by neighboring states (see here). The bill contains an express preemption:
(b) Prohibitions against mandatory labeling of food developed using genetic engineering.—No State or political subdivision of a State may directly or indirectly establish under any authority or continue in effect as to any covered product (as defined in section 291 of the Agricultural Marketing Act of 1946, as added by section 201 of this Act) in interstate commerce, any requirement for the labeling of a covered product indicating the product as having been produced from, containing, or consisting of a genetically engineered plant, including any requirements for claims that a covered product is or contains an ingredient that was produced from, contains, or consists of a genetically engineered plant unless the State (or a political subdivision thereof) establishes either of the following programs for the regulation of such claims...
The use and management of GMO crops and derived foods continues to be of great interest at the state legislative level. Here is the official summary of H.R. 1599:
This bill amends the Federal Food, Drug, and Cosmetic Act to require the developer of a bioengineered organism intended as food to submit a premarket biotechnology notification to the Food and Drug Administration (FDA). A “bioengineered organism” (commonly called a “genetically modified organism” or “GMO”) is a plant or part of a plant that has been modified through recombinant DNA techniques in a way that could not be obtained using conventional breeding techniques.
The premarket notification must include the developer’s determination that food from, containing, or consisting of the GMO (GMO food) is as safe as a comparable non-GMO food. For the GMO to be sold as food, the FDA must not object to the developer’s determination. If the FDA determines that there is a material difference between a GMO food and a comparable non-GMO food, the FDA can specify labeling that informs consumers of the difference.
A food label can only claim that a food is non-GMO if the ingredients are subject to certain supply chain process controls. No food label can suggest that non-GMO foods are safer than GMO foods. A food can be labeled as non-GMO even if it is produced with a GMO processing aid or enzyme or derived from animals fed GMO feed or given GMO drugs.
The FDA must allow, but not require, GMO food to be labeled as GMO.
The FDA must regulate the use of “natural” on food labels.
This bill amends the Agricultural Marketing Act of 1946 to require the Agricultural Marketing Service to establish a program to certify non-GMO food.
This bill preempts state and local restrictions on GMOs or GMO food and labeling requirements for GMOs, GMO food, non-GMO food, or “natural” food.
H.R. 1599 now goes to the Senate, which is not expected to take it up before September. Supporters of the bill are interested in preempting the wave of state attempts and successes at imposing mandatory labeling of GMO-derived foods and believe that Congress can finally shut down mandatory labeling through express preemption of state efforts. Supporters of mandatory GMO food labeling, knowing that the FDA has refused to impose a federal GMO labeling requirement for years, believe that state efforts constitute legitimate responses to consumer interest in GMO food labeling (most surveys note overwhelming support for labeling in the U.S). Although the conflict over product labeling has received the most attention, the bill has other particulars that define a more robust federal regulatory role – allowing the use of the term “natural” when food has GMO-derived content, specifying an acceptable pathway for manufacturers to claim “non-GMO”, and a possibly more general authority to regulate the use of GMO crops – for example, could planting bans on planting GMO crops that are enacted at a county level (see here) also be extinguished as the bill “preempts state and local restrictions on GMOs?” However, after several decades of state-based GMO labeling battles, H.R. 1599 appears to deliver a kind of nuclear option to these efforts, generally relying on a preemption analysis under the Supremacy Clause of the U.S. Constitution to nullify state laws. The state law battles have occurred because of the FDA's refusal to mandate the labeling of GMO food. One counter-measure that still remains at the federal level is an ongoing effort to require the FDA to impose a mandatory GMO labeling scheme at the federal level - see S.511, the Genetically Engineered Food Right-to-Know Act - but this bill has no chance, given the political realities manifest by the passage of H.R. 1599.
Federal legislation has been introduced to impose a national scheme on the labeling of genetically engineered (GE) foods. The Safe and Accurate Food Labeling Act of 2015 (H.R. 1599) was reintroduced following a recent hearing on the subject in the House Agriculture Committee. This proposed bill continues an ongoing oscillation between state and federal initiatives on the labeling of GE food. H.R. 1599 would amend Section 403 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 343) (FFDCA) to classify a food as misbranded if:
[I]t bears labeling (indicating that bioengineering was or was not used in the production of the food) in violation of section 425.
Misbranded foods are prohibited by the FFDCA. The proposed bill would preempt state labeling laws regarding GE food. To date, several states have passed mandatory GE labeling foods. The proposed anti-labeling law introduced in the House would preempt the food labeling laws passed by Vermont, Connecticut and Maine. Also at the federal level and in opposition, bills to mandate nationwide labeling of GE foods have been introduced for many years, none of them getting very far. However, the Genetically Engineered Food Right to Know Act (H.R. 913) has also been reintroduced in this session of Congress; this bill would amend Section 403 of the FFDCA to declare that a food is “misbranded” if:
[I]t is a food that has been genetically engineered or contains 1 or more genetically engineered ingredients, unless the ingredients label clearly states that the food has been genetically engineered or identifies any genetically engineered ingredients, as applicable.
Legislators in Maine have proposed delinking that state’s labeling law from the need to wait for other regional neighbors to follow suit. As it stands, Maine’s law cannot take effect until 4 other Northeastern states pass labeling laws. As state laws go, Vermont is on track to be the first state to require labeling when its law goes into effect in 2016. Legislative activity over mandatory labeling of GE food has occurred in more than half the states. In another aspect of the labeling debate, Agriculture Secretary Tom Vilsack has proposed that labeling information could be delivered by a smartphone app, making it available to consumers on a discretionary basis, without imposing direct labels on food products. That proposal has not satisfied critics, who view do not view that approach as an equitable substitute for mandatory labeling. The upshot of all this activity is that both federal laws, in opposition to each other, are still very unlikely to pass. At the state level, Vermont is on track to an active law in 2016, and we are likely to see some state pro-labeling ballot initiatives again in the 2016 election, similar to what occurred in 2014.
The 2014 midterm elections contained a number of state ballot measures on policy issues involving biotechnology. Not surprisingly, the issue of whether foods containing genetically engineered ingredients should be labeled appeared on two state ballots. In Oregon, Measure 92 was apparently narrowly defeated (50% to 49%) (Oregon had also rejected a similar ballot measure in 2002). However, the narrowness of the vote has now resulted in this week's order of a recount. With respect to Colorado's proposed labeling measure, the vote was not so close: Proposition 105 was defeated 65%-34%. These defeats mean that the current status of state labeling measures is that Vermont has fully passed a labeling law that takes effect in 2016; Connecticut and Maine have also passed labeling laws but their implementation is conditionally linked to a trigger where neighboring states passing similar measures (which has not yet occurred). A second issue with implications for biotechnology on the ballots this month was the issue of fetal personhood: two such initiatives on the ballots in North Dakota and Colorado would have declared personhood to begin at the moment of conception; these and similar measures have been crafted by anti-choice groups in order to elevate the constitutional status of the unborn and effectively criminalize abortion as a result. However, conception-triggered personhood also has implications for the field of human embryonic stem cell (hESC) research: the use of such cells requires their removal from an early-stage embryo, and under a fetal personhood statute, effectively becomes a criminal act against a legally-declared person. As a result, these initiatives have also threatened hESC research. The measures in North Dakota and Colorado were both rejected (by almost identical margins of 65% to 35%). To date, all fetal personhood ballot measures in the states have failed. A third issue on the November ballots was agricultural, relating to the presence of genetically engineered crops: several county-wide ballot measures that would ban the planting and cultivation of genetically engineered crops (on the ballots as "genetically modified organisms") were passed in Humboldt County, California and Maui County, Hawaii. Lastly, a bond measure in Maine to authorize funding
"to discover genetic solutions for cancer and the diseases of aging" passed overwhelmingly. The 2014 elections continued the ongoing attention to GMO labeling and fetal personhood initiatives as the most contentious state-based legislative battles affecting biotechnology.
An update on the efforts to enact state laws that mandate the labeling of genetically engineered (GE) foods: at present, Connecticut and Maine have enacted conditional GE food labeling laws, which are not to take effect until a requisite number of neighboring states also pass such laws; effectively, these laws are dormant right now. In contrast, Vermont passed a GE food labeling law, Act 120, in April of this year, with its mandates to take effect in July, 2016. Vermont did not follow the conditional model set by the other states, and supporters of the law expected litigation to follow. Since the enactment of this law, Vermont has been sued by the Grocery Manufacturer’s Association and other trade groups, which filed their complaint in June. The complaint alleges a violation of the First Amendment, arguing that the manufacturers will be subject to a form of compelled speech, and as such, this amounts to an impermissible content-based regulation that is unconstitutional. Even accounting for the sometimes more deferential review of speech-related laws that target commercial entities (see 1980 Central Hudson v Public Service Commission), the plaintiffs assert that the state even fails to muster a “substantial government interest,” noting the failure of an earlier Vermont labeling law on dairy products produced from BGH-few animals to pass constitutional scrutiny in International Dairy Foods Association v. Amestoy (2nd. Cir. 1996) (one of the plaintiffs in this current litigation, the International Dairy Foods Association, had challenged the earlier law as well). The complaint against the Vermont GE law further alleges a Fifth Amendment defect pertaining to the vagueness of some terms in the statute, as well as a dormant Commerce Clause violation in view of the extraterritorial effects of the Vermont law on companies based outside Vermont who would be required to “establish Vermont-specific distribution channels.” As this litigation unfolds, efforts continue to mandate GE food labeling in other states. Active legislative efforts are underway in Pennsylvania, New Jersey, Illinois, Massachusetts and New Hampshire. Lastly, voter-initiated ballot measures to mandate GE food labeling will appear this fall in Colorado and Oregon (earlier initiatives in Washington (2013) and California (2012) failed by narrow margins). All of these state efforts arise in the absence of (and official resistance to) any federal scheme for mandatory labeling of GE foods; the FDA imposes no such requirement but does allow voluntary labeling.
Two counties in Oregon recently passed bans on the planting of genetically engineered (GE) crops; the Jackson and Josephine County measures passed handily. The Jackson County ordinance:
It is a county violation for any person or entity to propagate, cultivate, raise or grow genetically engineered plants in Jackson County.
These efforts began in Jackson County where proponents of the ban (local farmers) gathered enough signatures in 2013 to put a local GE ban on the ballot in the spring of 2014. That effort stirred opposition from seed companies and other parties, which reacted by pushing for a legislative fix to preempt such local agricultural governance. The result is that both of these newly-enacted county bans exist against the backdrop of a recently enacted state law that prohibits local counties from interfering with agricultural choice:
A local government may not enact or enforce a local law or measure, including but not limited to an ordinance, regulation, control area or quarantine, to inhibit or prevent the production or use of agricultural seed, flower seed, nursery seed or vegetable seed or products of agricultural seed, flower seed, nursery seed or vegetable seed.
The Oregon county measures are in line with other counties around the country that have enacted such bans (e.g., in Washington, Hawaii, California). In Oregon and the other states with such bans, the rationales advanced for the ban on GE crops include the avoidance of genetic contamination of non-GE crops by neighboring GE crops (e.g., pollen drift). (Several years ago, an apparent genetic contamination of the wheat crop in eastern Oregon elevated concerns about other potential instances of genetic contamination). A further motivation for a GE ban arises from the nature of the engineering itself – these crops are generally engineered for herbicide resistance (Monsanto's Roundup Ready technology) – meaning that the crops can withstand widespread application of these weed-killers. As a result, heavy use of potentially dangerous herbicides is encouraged by the planting of these GE crops, and proponents of such a ban point to the potential environmental and health complications from widespread use of the herbicide. The Oregon counties also have significant numbers of organic farming operations which could face exposure to GE materials or herbicides, scenarios that conflict with established principles of organic farming.
An apparent clash between the new county ordinances (at least for Josephine County) and the state’s new preemption statute looms, lodged against a backdrop of the significant home rule environment for localities that is found in Oregon; Jackson County was granted a waiver from the state law because the ballot initiative had been established before the law was passed. A similar legal showdown could emerge in Hawaii, which has passed a state preemption statute following the enactment of local GE crop bans. The shifting legal landscape between assertions of local governance and reactive preemption is also occurring with respect to state mandates for the labeling of GE food and pending federal preemption efforts to nullify such laws (see earlier post here). In a further sign of Oregon's attention to the legal issues raised by GE crops and GE food, a citizens' effort is underway to get a mandatory GE food labeling law on the ballot for November, 2014.
The Vermont legislature has passed what could be the nation’s first state law requiring the labeling of foods with genetically engineered (GE) ingredients (at the federal level, the FDA does not mandate the labeling of GE-derived foods). The Vermont Senate has now cleared H. 112, which sets labeling standards for raw agricultural commodities and processed food that contain genetically engineered ingredients. In the last several years, a mechanism has emerged for states who want to implement labeling in concert with other states - they passed conditional labeling requirements for foods with GE ingredients that would only take effect if other states were adopting the same standards. Most notably, in 2013, Connecticut and Maine took this approach (see earlier post) and as of now, their laws have not taken effect as they await the required trigger conditions. The new Vermont law also adopts a similar conditional trigger, if that were to accrue before July 1, 2015, but if not – the Vermont law will go into effect on that date, whether other states do so or not. So Vermont is prepared to go it alone. Already, advocates of labeling in Vermont are anticipating the legal consequences of the law, sketching out responses to likely constitutional challenges – on First Amendment grounds (compelled speech) and the dormant Commerce Clause (improper state overreach into a federal sphere of action). Vermont has already experienced a defeat over a labeling law enacted in 1994 that required the labeling of dairy products from cows that were treated with recombinant bovine somatotropin (“rBST”); dairy farmers challenged the law under the First Amendment. In that case, the trial court had characterized the state motivation for the law:
The State does not claim that health or safety concerns prompted the passage of the Vermont Labeling Law. Instead, it bases its justification for mandatory labeling not otherwise required by the FDA on strong consumer interest and the public's "right to know" whether a particular dairy product contains milk produced by cows given rBST.
The 2nd Circuit ruled for the farmers, noting the government’s asserted interest in in satisfying the consumers’ right to know was “insufficient” to justify the speech-related injury claimed by the farmers:
[W]e hold that consumer curiosity alone is not a strong enough state interest to sustain the compulsion of even an accurate, factual statement in a commercial context (citations omitted).
With that characterization in mind, the new Vermont labeling law includes the following statement of objectives:
Because both the FDA and the U.S. Congress do not require the labeling of food produced with genetic engineering, the State should require food produced with genetic engineering to be labeled as such in order to serve the interests of the State, notwithstanding limited exceptions, to prevent inadvertent consumer deception, prevent potential risks to human health, promote food safety, protect cultural and religious practices, protect the environment, and promote economic development.
This clause explicitly expands the state rationale to include matters of health and safety, likely elevating the significance of the government interests at stake, and refuting any charge that the state is only satisfying consumer curiosity, a seemingly trivial government interest to the courts that doomed the 1994 dairy labeling law. There is a flurry of state labeling efforts now underway - there are 33 new GE food labeling bills pending in 19 states, as well as an Oregon ballot initiative on the November 2014 ballot. At the federal level, opponents of mandatory labeling of GE food have introduced a federal bill, H.R. 4432, that would override any state legislation that would amend the Federal Food, Drug, and Cosmetic Act to declare that any labeling with respect to "bioengineering" would constitute “misbranding” and thus violate the federal statute. This bill would explicitly override state labeling laws:
No State or political subdivision of a State may directly or indirectly establish under any authority or continue in effect as to any food in interstate commerce any requirement for the labeling of a food by virtue of its having been developed using bioengineering, including any requirements for claims that a food is or contains an ingredient that was developed using bioengineering.
This bill competes with the previously-introduced H.R. 1699, a federal bill that would mandate nationwide GE food labeling. Both federal bills are unlikely to pass, leaving the state patchwork of labeling efforts and mandates in place.
The movement to place a referendum on the ballot in Colorado this year that would authorize the labeling of foods with genetically engineered (GE) ingredients has survived a legal challenge by opponents. Initiative 48 has been submitted by Right to Know Colorado GMO, which must now collect 86,105 signatures needed for the measure to appear on the 2014 Colorado ballot. A challenge to the proposed referendum was filed by an association of retail grocers, alleging that the measure was “misleading.” That petition recited various misleading aspects of the ballot measure, including this allegation:
The titles do not inform voters that the essence of the Proposed Initiative is that the failure to label genetically modified food is treated as "misbranding" of food.
In an order issued by the Colorado Supreme Court, the court affirmed an earlier decision of the Title Board, which characterized the initiative in its brief to the court:
The meat of the initiative is not misbranding. It is the creation of new labeling responsibilities to inform consumers.
If Right to Know Colorado can submit enough signatures for the ballot, it will appear later this year. In general, state-level developments in the labeling of genetically engineered food or ingredients emerge through direct legislative enactments (see here) or by ballot measures (see here). Many state-level legislative attempts to require GE labeling have failed (such as this effort in Colorado last year), so the direct ballot route becomes an alternative. That, however, is no guarantee of electoral success (a mandatory GE food labeling referendum, Proposition 37, appeared on the California 2012 ballot, and was defeated). In fact, defeat of that referendum has swung the pendulum back to a direct legislative effort in California this year (supporters note that “SB 1381 is a simpler, clearer version of Prop. 37).”
Connecticut and Maine have become the first states to pass laws mandating the labeling of foods with genetically engineered (GE) ingredients (Maine law; Connecticut law). The laws, however, are conditional in that they will not take effect until a critical mass of similar laws is enacted by other states; thus, they remain pending in actual effect. The battles over the labeling of GE food have continued for years, with efforts at state and national levels (see here and here). Maine will mandate the phrase “Produced with Genetic Engineering" and the Maine law contains this synopsis:
This bill requires disclosure of genetic engineering at the point of retail sale of food and seed stock and provides that food or seed stock for which the disclosure is not made is considered to be misbranded and subject to the sanctions for misbranding. The bill provides that food or seed stock may not be labeled as natural if it has been genetically engineered. The bill exempts products produced without knowledge that the products, or items used in their production, were genetically engineered; animal products derived from an animal that was not genetically engineered but was fed genetically engineered food; and products with only a minimum content produced by genetic engineering. The bill also provides that the disclosure requirements do not apply to restaurants, alcoholic beverages or medical food.
The Maine law embeds the following trigger: it “goes into effect when five other states, or any state, or states with a total population of 20 million people, enact labeling requirements for genetically modified (GM) foods.” The Connecticut law dictates labeling “in the case of such food for retail sale contained in a package, with the clear and conspicuous words: "Produced with Genetic Engineering." Here is a similar trigger in Connecticut, activating the law in a year where the following conditions occur:
(1) Four states, not including this state, enact a mandatory labeling law for genetically-engineered foods that is consistent with the provisions of this subsection, provided one such state borders Connecticut; and (2) the aggregate population of such states located in the northeast region of the United States that have enacted a mandatory labeling law for genetically-engineered foods that is consistent with this subsection exceed twenty million based on 2010 census figures.
The northeast region defined in the Connecticut law consists of Maine, Vermont, New Hampshire, Massachusetts, Rhode Island, New York, New Jersey and Pennsylvania. It could be argued that the approach of Maine and Connecticut to a GE food labeling law – not with immediate effect, but conditional on other political developments – can recruit support from hesitant politicians because it remains aspirational. That might encourage other states to follow suit. At the federal level, the Genetically Engineered Food Right-to-Know Act, has been introduced to mandate a federal scheme for GE food labeling; such bills have been introduced for years in Congress. Prospects for federal legislation, however, remain dim.
Yesterday, the Supreme Court issued its opinion in Bowman v. Monsanto, a patent infringement case that tested how the doctrine of patent exhaustion applies to self-replicating patented inventions such as genetically engineered (GE) seeds. The patented invention is the Monsanto Roundup Ready soybean, which contain a gene that encodes EPSPS, a glyphosate-tolerant enzyme. The genetically modified plants express the enzyme and thus exhibit resistance to the herbicide glyphosate– specifically, to the application of the Monsanto glyphosate product, sold as Roundup. A license restriction accompanies the sale of the Roundup Ready seeds, and it prohibits the use of second-generation seeds in later plantings. Farmer Vernon Bowman was accused of patent infringement by buying GE commodity seed from a grain elevator (not directly from Monsanto) which he then used for replanting (replication); Monsanto characterized his activities as an unauthorized use of a patented invention because it involved the “making” of a patented article. The doctrine of patent exhaustion operates to limit the control that an inventor holds over the life of a lawfully sold patented article – the first sale of a patented invention is authorized, and that act exhausts the control that the patent holder retains over subsequent uses of the article (absent some valid conditional sale agreement that accompanies the sale). Did that doctrine extend to a claim that a later sale of originally-patented GE seed to Bowman and his use in planting became an act of patent infringement because the seed replicates and he “made” an infringing article? In 2011, the Federal Circuit ruled that Bowman’s planting of the GE seed he purchased became an act of patent infringement, rejecting an interpretation of the exhaustion doctrine that would recognize the special attributes of seeds, which embody the property of replication and “manufacture” of an originally-patented invention (see earlier post). Did the company’s patent rights extend to this later series of events, or did they exhaust upon the first sale of the patented seed? Although one can freely “use” a product after patent exhaustion, does that authorize a use that results in the creation of a new copy of the patented article, which is generally viewed as an act of patent infringement? In the unanimous opinion authored by Justice Kagan, the Supreme Court said no:
Reproducing a patented article no doubt “uses” it after a fashion. But as already explained, we have always drawn the boundaries of the exhaustion doctrine to exclude that activity, so that the patentee retains an undiminished right to prohibit others from making the thing his patent protects.
What does not exhaust is the ability of patent holder to enforce one of the rights of exclusion, that is, the ability to prevent unauthorized replication of a patented invention. No exception applied here to GE seeds in this scenario, despite Bowman's invocation of self-replication by the product itself. Justice Kagan did note, however, that the decision was limited to this set of facts:
Our holding today is limited—addressing the situation before us, rather than every one involving a self-replicating product. We recognize that such inventions are becoming ever more prevalent, complex, and diverse. In another case, the article’s self-replication might occur outside the purchaser’s control. Or it might be a necessary but incidental step in using the item for another purpose.
This restraint from the Court at least references analogous scenarios in computer software, where use of a lawfully obtained program often requires the making of a copy on a host computer; Congress has address this with an amendment to copyright law (17 U.S.C. 117) that immunizes users from copyright infringement in such circumstances. There is some pushback in Congress with respect to patented seeds and the restrictions that accompany their sale; H.R.19, the Seed Availability and Competition Act of 2013 was introduced this year and it authorizes second generation plantings of patented seeds, effectively establishing a compulsory license, but setting a royalty mechanism for payments to the patent holder. This is unlikely to garner significant support in Congress, but it indicates that there are legislative approaches that can theoretically modulate patent rights for certain technologies, if the political will exists to do so.
At state and federal levels, Alaska continues to display its opposition to the introduction of a genetically engineered (GE) food product - specifically, to the potential entry of GE salmon into the U.S. marketplace (see here). To date, the product, AquAdvantage salmon, made by AquaBounty Technologies (ABT) has not received market approval from the FDA. To produce the GE salmon, Atlantic salmon is engineered to contain the growth hormone gene from Pacific Chinook salmon, which causes the fish to grow in less time; the gene is placed under the control of a promoter from ocean pout, which causes elevated expression of the hormone. According to ABT, the addition of the growth hormone gene “provides the fish with the potential to grow to market size in half the time of conventional salmon.” At the end of 2012, pursuant to the National Environmental Policy Act (NEPA), the FDA released a draft Environmental Assessment (EA) in support of its Finding of No Significant Impact (FONSI) for AquAdvantage salmon. The FONSI determination, if prevailing, means that the FDA will not be required to prepare the more rigorous environmental impact statement (EIS) for GE salmon; this determination has been criticized by consumer advocates. The FDA has extended the period for public comments on the draft EA until April 26, 2013. Both state and federal legislators from Alaska have been active in opposing the introduction of the fish, voicing concerns about potential mating between the GE salmon and the native Alaska salmon, with the potential for irreversible genetic contamination of the wild-type stock. According to ABT, the selected fish would be female and sterile and could not breed with the wild salmon. But assuming less than 100% ability to properly screen and control the stocks, even a minute number of GE fish that could breed into the wild population could initiate the genetic contamination of the wild-type stock. The Alaska legislature has now passed a bipartisan resolution opposing the introduction of the GE salmon:
Opposing the United States Food and Drug Administration's preliminary finding relating to genetically engineered salmon; urging further examination of genetically engineered salmon; opposing AquaBounty's petition to produce genetically engineered salmon; and proposing, if AquaBounty's petition is approved, that its product should be labeled as "genetically modified.”
The regulatory paradigm for the review of the ABT salmon is that the added gene is reviewed as a veterinary drug: "the rDNA construct in the resulting GE animal is thus a regulated article that meets the drug definition" - hence the oversight by the FDA's Center for Veterinary Medicine (CVM). In 2010, an earlier CVM report stated that there were no significant safety or environmental issues raised by the ABT salmon. A food additive petition was filed at the FDA by food safety advocates in 2012, requesting that the addition of the growth hormone gene to the fish trigger a food additive review, bringing the GE salmon under the purview of a more conventional food safety review process. In addition, current FDA policy will not require the GE salmon to be labeled (nor any other GE food). Several supermarket chains have announced that they will not carry the GE salmon product. Just last month, Sen. Mark Begich (D-AK) succeeded in introducing an amendment to the continuing resolution passed in March (temporary budget agreement) that would establish a reserve fund for the labeling of GE fish. Begich also introduced two bills in the Senate; a prohibition on approval of GE salmon (the bill cites “escapement”) and, if GE salmon is approved, a requirement for food labeling (that would a first at the federal level). Regarding the strength of the opposition in Alaska, there is no comparable statewide cohesion to date targeting a specific GE food product. More generally, future litigation is likely to challenge both the FDA’s regulatory paradigm for GE salmon as well as the merits of the FONSI determination for the food product by the agency.
