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) has issued a report on gene drive technology, Gene Drive Research in Non-Human Organisms: Recommendations for Responsible Conduct. A gene drive is a method by which specific genetic mutations (or alleles) are preferentially inherited, and over time, the effect is to eliminate other competing alleles. This has population-wide consequences for an organism, and can permanently alter (or reduce) the genetic diversity of a species. The phenomenon of a gene drive occurs in nature, and has been observed in many organisms:
In nature, certain genes ‘drive’ themselves through populations by increasing the odds that they will be inherited.
Now, however, advances in gene-editing technology have facilitated the development of deliberately engineered gene drives. From the report summary:
A wide variety of gene drives occur in nature. Researchers have been studying these natural mechanisms throughout the 20th century but, until the advent of CRISPR/Casfor gene editing, have not been able to develop a gene drive. Since early 2015, laboratory scientists have published four proofs-of-concept showing that a CRISPR/Cas9-based gene drive could spread a targeted gene through nearly 100% of a population of yeast, fruit flies, or mosquitos.
In other words, use of gene drive technology can impose a specific genetic allele (variant) on a population and eliminate all other forms of the gene. Effectively, the population is now homozygous for the preferred variant. That is both the attraction and the concern regarding the use of this technique. Genetic traits could be eliminated, and at its most extreme, whole populations could be "driven" out of existence. It is simple to imagine particular uses of the technology that would eliminate undesirable traits in a target population, such as the ability of mosquitos to spread malaria, or very currently, the ability of the Aedes aegypti mosquito to transmit the Zika virus. The report summarizes possible applications and the requirement for a deliberative approach to use of the technique:
Gene-drive modified organisms hold promise for addressing difficult-to-solve challenges, such as the eradication of insect-borne infectious diseases and the conservation of threatened and endangered species. However, proof-of-concept in a few laboratory studies to date is not sufficient to support a decision to release gene-drive modified organisms into the environment. The potential for gene drives to cause irreversible effects on organisms and ecosystems calls for a robust method to assess risks. A phased approach to testing, engagement of stakeholders and publics, and clarified regulatory over-sight can facilitate a precautionary, step-by-step approach to research on gene drives without hindering the development of new knowledge.
The report did not recommend a moratorium on research, despite noting the potential for adverse consequences. Instead, it endorsed continued research on the technology with some limited field evaluations:
Although there is insufficient evidence available at this time to support the release of gene-drive modified organisms into the environment, the likely benefits of gene drives for basic and applied research are significant and justify proceeding with laboratory research and highly-controlled field trials.
The current regulatory landscape for gene drive applications is summarized:
In the United States, regulation of gene-drive modified organisms will most likely fall under the Coordinated Framework for the Regulation of Biotechnology, which includes the U.S. Food and Drug Administration, the U.S. Department of Agriculture, and the U.S. Environmental Protection Agency. However, the diversity of potential gene-drive modified organisms and contexts in which they might be used reveals a number of regulatory overlaps and gaps. The U.S. government will need to clarify the assignment of regulatory responsibilities for field releases of gene-drive modified organisms, including the roles of relevant agencies.
At the present time, the patchwork structure for biotechnology regulation is currently under formal review by the Obama administration (see earlier post for more background). In general, as the new products of genetic engineering have been developed over the years, they encounter oversight from any one (or more) of three agencies: the FDA, EPA, or USDA. As the regulatory framework is redesigned, we could expect that various applications of gene drive technology will face an approval process customized to the particular goal and purpose of the technology. The report states:
It is important to note that a one-size-fits-all approach to governance is not likely to be appropriate. Each phase of research activity—from developing a research plan to post-release surveillance—raises different levels of concern depending on the organism being modified and the type of gene drive being developed.
The NAS report has received criticism from opponents of field testing, who noted that precise control of such experiments is not possible, and wider, possiblly uncontrolled spread of altered organisms could occur. Other criticisms suggest that the scope of the report is too limited, and does not adequately address possible dual-use concerns (malevolent uses of the technology). The report has some conceptual overlap with efforts of the World Health Organization (WHO) has previously released a guidance framework for how to introduce genetically engineered mosquitoes that are reproductively disabled, thus reducing the population of a malaria vector. In summary, the NAS panel has cautiously endorsed further gene drive research in the U.S., and contemplates eventual field trials of engineered organisms.
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.
Genetic alteration since the beginning of the biotechnology age has largely relied on the introduction of new genetic material into an organism to create a genetically engineered (GE) bacterium, plant or animal (also known as a genetically modified organism, GMO). Regulatory schemes reflected that dominant paradigm. Now, however, the use of gene-editing technology for genetic manipulation in plants can result in genetically altered plants that bypass the regulatory requirements for the introduction of standard GE plants into the marketplace. The traditional genetic engineering of crops employed the introduction of foreign genetic material into the crop; such gene transfer generally triggered formal review of the altered product because of the phenotype conveyed by the introduced gene(s), or because of the use of a vector that had plant pest characteristics. A GE plant product would trigger review if the newly introduced trait posed environmental or other safety-related risks. The review was conducted by the Animal and Plant Health Inspection Service (APHIS) of the USDA, pursuant to its statutory authority under the Plant Protection Act of 2000. (Depending on the product, additional oversight by the FDA or EPA could be required). Today, genetic alteration has moved beyond simple gene transfer into more precise techniques for changing the genome of an organism. Now, in a regulatory first, APHIS has made a determination that a white button mushroom altered by CRISPR/Cas9 gene editing technology to exhibit reduced browning is an “unregulated article” that will not require the kind of formal review usually applied to traditionally genetically engineered products containing foreign DNA:
APHIS does not consider CRISPR/Cas9-edited white button mushrooms as described in your October 30, 2015 letter to be regulated.
Here, CRISPR/Cas9 gene editing technology was used to introduce a small deletion in a polyphenol oxidase gene in the mushroom, with the result that the altered enzyme cannot produce the browning that shortens shelf life. The final product has no foreign DNA and no plant pest characteristics. This decision by APHIS follows earlier determinations that have resulted in at least 10 genetically altered products being approved without requiring a formal review. These products have been produced with, e.g., techniques that did not rely on the introduction of new genetic material using any plant pest vector, or non-CRISPR gene editing technologies. This shift in regulation highlights how modern genetic alteration writ large encompasses multiple technologies, some of which fall into an existing regulatory mandate, and some of which do not. The central theme of biotechnology regulation to date has been to focus on the product, not the process. As far back as the introduction of the federal Coordinated Framework for Regulation of Biotechnology in 1986, the prevailing scheme ensured that genetically engineered products would not be singled out for heightened review simply because of the way they were produced. The product was the focus; more precisely, the actual phenotypes of the GE plants or insects were evaluated to identify traits that required additional oversight. The traditional dichotomy between product-based or process-based paradigms for regulation biotechnology products has been criticized as a poor fit for the realities of the biotech marketplace. Evidence for an evolution of the regulatory scheme has been provided by the Obama administration’s announcement of a deliberative process to overhaul and modernize the regulation of biotech products, with the recruitment of the FDA, EPA, and USDA in the process (see earlier post). This regulatory renewal will no doubt eliminate a strict focus on gene transfer as the only genetic technology producing altered organisms, and strive to broaden the definition of the field of genetic alteration to reflect new realities, such as CRISPR and other gene-editing technologies. Then the calculus of risk/benefit analysis will need to be applied, in the context of emerging genetic technologies where risk profiles are not yet established.
In the ongoing outbreak of Zika virus infection across parts of North and South America, there are several developments which signal increasing concern over the exact impact and geographic reach of the virus (the first death in the U.S. linked to the virus has been reported). At least 55 countries report Zika outbreaks, according to the World Health Organization. The virus is spread by mosquitos, specifically the Aedes aegypti. In the U.S., 426 cases of Zika-infected individuals have been reported. Although a course of infection may be mild and easily resolved in most individuals, Zika has become a high-profile infectious disease because viral infection in pregnant women has been linked to an increased risk of microcephaly in offspring. There are suspicions that more developmental risks to the child of an infected mother may exist, possibly unknown and only seen as development unfolds. In general, the mosquito thrives in warm and tropical climates, but seasonal weather patterns can shift the field of exposure. NASA scientists and other colleagues have published an Aedes aegypti risk map of the U.S., showing that a wide swath of the eastern U.S. is potentially susceptible to mosquito (and thus virus) spread, especially in the upcoming summer of 2016; the potential spread goes north as far as New York City. A commercially available test for detection of the Zika virus received an Emergency Use Authorization (EUA) from the FDA (the Quest Diagnostics Zika RT-PCR test). A current legislative battle over possible increased funding for public health responses to Zika reached a stalemate before Congress adjourned. One bill calls for $1.6 billion in supplemental funding for dedicated Zika virus research and public health capabilities, but is encountering Republican opposition. Some of the political infighting over a federal response to the Zika outbreak recalls earlier conflicts during the Ebola virus crisis. However, the Zika virus is already in the U.S., cases are officially documented, and the upcoming summer portends more infections, not less. The 2016 Summer Olympics in Brazil this summer have already caused concern among attending athletes; the current understanding of transmission suggests that Zika virus cases in the U.S. are largely explained by travel to countries with high risk of infection; that fact will also impact the Olympics participation. No effective treatment or vaccine for the Zika virus is yet developed; increased NIH funding would certainly allow research to expand. Another target for intervention is to reduce the Aedes aegypti mosquito population; already, a British biotechnology has produced a genetically engineered (GE) mosquito that is reproductively crippled and is hoping to conduct trials in the U.S. An upcoming post will examine that option in more detail.
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.
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.
A federal judge in Oregon has rejected an initial challenge to the ban on the planting of genetically engineered/modified (GMO) crops in Jackson County, Oregon. Jackson County Ordinance 635 was a ballot initiative put to a vote in May, 2014 and it passed by a 2-1 margin. In Schultz Family Farms, LLC v. Jackson County, (D. Ore. 2015) a group of local alfalfa farmers challenged the ban, due to go into effect later this year, citing Oregon’s Right to Farm Act. Right to farm laws have generally insulated existing farming activities from later-enacted prohibitions that would declare farming activities to be a nuisance or trespass. The plaintiffs claimed that they would be required to remove about 300 acres of herbicide-resistant “Roundup Ready” alfalfa in order to comply with the ordinance. The plaintiffs also claimed that the ordinance was prohibited by a recently enacted state law, Senate Bill 863 (the Seed Bill), that preempted any local bans on the planting of GMO crops. However, in the ruling, the judge stated:
It is clear from the text and context of the Seed Bill that the Oregon legislature meant to preempt counties and other local governments from enacting laws banning the use of GE seeds so that the GMO issue could be addressed on a state-wide, uniform basis.In other words, the Seed Bill preempts laws precisely like the Ordinance. However, it is equally clear that the legislature meant to carve out a specific exception authorizing Jackson County Ordinance 635.
Thus, the judge denied summary judgment for the farmers, finding that the challenged ban had specifically survived the statewide prohibition on local ordinance banning the planting of GMO crops, and Jackson County can continue with enforcement of the ordinance. The judge agreed, however, that Oregon now has a statewide preemption against any other similar ordinances. The order notes that Ordinance 635 contemplates possible interference with farming activities because of the planting of GMO crops, thus inadvertently aligning with the purpose of the more traditional right to farm laws:
Section 2 of the Ordinance states the "findings" and gives the primary purposes of the Ordinance, one of which is to protect local farmers from "significant economic harm to organic farmers and to other farmers who choose to grow non-genetically engineered crops" that can be caused by "genetic drift" from GE crops.
There are a few other jurisdictions with bans on the cultivation of GMO crops. Several California counties have bans in place, including Marin, Santa Cruz, Mendocino, Trinity, and Humboldt. Last year, a federal judge in Hawaii ruled that an ordinance banning cultivation of GMO crops in Kauai County was preempted by state law. Efforts continue to enact GMO crops bans in some jurisdictions; however, just last month, a ballot initiative banning GMO cultivation in Benton County, Oregon, was defeated by an over 2-1 margin. It is possible that the plaintiffs could pursue a regulatory taking challenge now to Ordinance 635, if they can demonstrate loss of all economic value of their property (Lucas v. South Carolina Coastal Council) or meet the demanding requirements of a balancing test derived from Penn Central Transportation Co. v. New York City. However, for now, this ruling is significant for its determination that a ban on GMO planting can coexist with a right to farm statute.
