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Tuesday, February 11, 2014
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GM and GE Foods Decoded: Federal Regulation and the (expired) Monsanto Rider

By Guest Author, Avana Andrade, Yale F&ES '15

Images of innocent tomatoes pierced by a needle, biohazard signs next to corn fields, or some mixed animal-fruit or animal-human species circulate in the popular media. These images reflect widespread public concern about the implications of GMOs for future agriculture production and for human health. The popular debate about genetically modified organisms or GMOs is, as one could expect, polarized and often lacking a nuanced understanding of what GMOs are, and how the US federal government handles the manipulation of genetic material. As the journalist Nathanael Johnson reminds us, the topic of GMOs is immediately charged because they are symbols: for proponents, GMOs represent the human ability to end hunger and poverty through technological advances, while for opponents, GMOs embody all that is evil about corporate control in the country’s food systems.

Beneath the hype, however, lies an issue that many Americans are overlooking or do not care to observe. In her talk, “The [In]significance of the Monsanto Rider to the Farm Bill”on January 28, Professor Beyranevand argued that while much attention was paid to the Monsanto Rider – which would have allowed farmers to keep using biotech seeds even if they were under court review –its inclusion in the Farm Bill would not have substantively changed the current regulatory regime or mitigated the perceived threat of GMOs. In order to more fully convey the weight of Beyranevand’s claim, this blog is devoted to contextualizing the GMO debate and providing a glimpse into why superficial attacks on GMOs can be so misleading.

To be clear, the term GMO makes a broad reference to plants that have undergone traditional hybridization techniques, a practice that humankind has been engaged in for many years, as well as those that have been genetically engineered (GE). Genetically engineered organisms, more specifically, garner far greater public attention. With GE organisms, scientists add foreign genes from an unrelated plant or animal to the chosen crop’s genetic structure to alter key traits, such as growing rate, taste, or resistance to pests.

American citizens have expressed great concern about the effect of GE food crops and, in particular, the main company that produces bioengineered seeds, Monsanto. Recently, protestors gathered outside a shareholder meeting at Monsanto headquarters in St. Louis, Missouri, decrying the company’s “corporate greed” and its “mutant seeds.” Similarly, the 2013 film GMO OMG, poses the question, “is this the end of real food?” The filmmakers express not only grave concern with the corporate control over the world’s food supply but air widespread worry about the uncertainty surrounding the potential or unknown human health impacts of GE products.

Although much of the debate revolves around labeling regulation, concerned groups such as the Non GMO Project, endeavor to raise awareness about what genetically modified foods are, which food sources may contain GE ingredients, and potential health risks associated with them. Other groups point to observed or unforeseen ecological impacts of GMOs such as the inadvertent creation of increasingly resistant pests, the elimination of wild and rare plant species (i.e. permanent loss of biodiversity), and collateral impacts to beneficial organisms. Another criticism levied against Monsanto, is the unequal distribution of profits associated with their sale and the subsequent corporate ownership of genetic material in the farmers’ fields. In other words, the issue is a socio-economic and ethical one too. Collectively, skeptical organizations doubt whether the purported benefits of GMO and GE crops (greater productivity, less insecticide needed etc.) are worth the potential ecological harm they represent. While some citizens wonder if the debate matters at all, concerned local leaders and politicians, as in Hawaii, face serious backlash from their own constituents for remotely entertaining the idea of permitting GMO crops or considering their benefits.

However, for the lay person not tuned into the debate, news reports state that the Food and Drug administration regulates GMO and GE foods “the same as any other foods,” a statement intended to convey trust in existing federal regulation. For some, including Professor Beyranevand, this is the problem.

While public debates continue about labeling and potential health impacts of GE foods, little public attention is paid to the limitations of the existing systemto adequately regulate bioengineered seeds and crops. The coordination between federal agencies, overlapping jurisdiction, and potentially inadequate statutory authority are among the more prominent points of criticism of the existing federal regulatory framework.

Federal regulation of biotechnology is executed through the Environmental Protection Agency (EPA), the Food and Drug Administration (FDA), and the US Department of Agriculture, and depends on the stage of the seed, crop, or final product in the market. The EPA regulates biopesticides (pesticides derived from animals, plants, bacteria, or minerals), some of which are not necessary genetically engineered or toxic. For example, one common household item that is classified as a biopesticide is canola oil. The EPA regulates and defines the conditions under which canola oil, and other plant-based oils, can be used to control agricultural pests. Nevertheless, the EPA controls pesticides through two federal laws, the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Federal Food, Drug, and Cosmetics Act (FFDCA). In order for a pesticide, including biopesticides, to be marketed in the US, the EPA is required to determine whether the substance does not pose “unreasonable risk of harm to human health or the environment.” In accordance with this FIFRA requirement, the EPA requires the submission of data that describes a pesticide’s chemical composition, assesses the long-term fate of the substance in the environment, and analyzes its toxicity and effect on human and environmental health.

The EPA divides biopesticides into three main categories, microbial pesticides, plant pesticides, and biochemical pesticides. Microbial pesticides are microorganisms such as bacterium, fungus or virus, and are used to target a variety of agricultural pests. Different kinds of fungi, for example, can control certain weeds and insects. Plant pesticides are those generated within a plant as a result of added genes. The gene for a commonly used pesticidal protein, Bt, for example, can be inserted into a plant’s genetic material and effectively eliminate pests that attempt to consume the plant. The EPA regulates the protein and its enabling genes, but not the plant. Biochemical pesticides are “naturally occurring substances” such as insect sex pheromones or a scented plant extract, both of which alter a potential pest’s behavior.

The FDA presides over GM crops that human and/or animals consume and manages them according to their “substantial equivalence” (their essential “sameness”) in comparison to non-GM plants. The FDA regulates the inclusion of GE plants into human and animal food sources through a voluntary consultation process with GE plant developers. These consultationsinvolve a developer entering into discussion about the safety, nutritional, and regulatory issues associated with a GE food item. The developer submits summaries of scientific analyses of its product, which the FDA evaluates and determines whether unresolved problems persist, or if all safety and regulatory facets are adequately addressed, thereby granting or denying permission to enter the US food market. An “unresolved issue” in these proceedings might entail the reduced concentration of important nutrients, new allergens, or the presence of an unapproved additive. In general, foods that contain corn, soybean and/or cotton oil are foods which likely contain genetically engineered plant ingredients, which the FDA tracks and controls, but for which currently does not require labeling.

The USDA regulates GE crops through the Animal and Plant Health Inspection Services (APHIS) according to the Plant Protection Act of 2000. The USDA regulates GM plants under a permit or notification process. For simple field testing, the USDA requires a notification process, typically a formality, which involves a company giving APHIS notice of the trial while consenting to follow USDA rules. For crops that produce pharmaceutical or industrial chemicals, the USDA requires a more extensive permit process, along with field trials and an environmental assessment or an environmental impact statement. Once a company can commercialize a crop and produce sellable seed for farmers, it then petitions APHIS for “deregulated status” and submits comprehensive risk-assessment data. Monsanto, for example, continuously develops new GE corn and wheat seeds, among many other crops. In order to market these seeds to farmers, the company must first demonstrate to the USDA that these crops do not pose significant threats to human or environmental health. The USDA system, however, does not guarantee in-depth environmental impact statements; its confinement measures for field tests may not reliably prevent migration of GM crop genes, and understaffing can lead to self-regulation on behalf of the private biotechnology companies.

A 2003 PEW Initiative on Food and Biotechnology report, Post-Market Oversight of Biotech Foods, calls attention to similar systemic issues within the USDA. The report highlights APHIS’ powerlessness in imposing conditions on the use or environmental impact of a GM crop after deregulation. The PEW report also cites a 2002 National Resource Council publication, Environmental Effects of Transgenic Plants, which focuses on problems associated with the notification, permit, and deregulation processes, also citing the need for more robust post-commercialization and environmental testing. The National Resource Council report grounds its assessment in the “inherent scientific difficulty and uncertainty of predicting system ecological effects on the basis of field trials that are necessarily small relative to the commercial scale.”

The issue of genetic containment has caught media attention in recent events, which may lead to more calls for greater federal oversight. In Oregon, for example, a strain of Monsanto’s GM wheat mysteriously found its way into the field of a farmer who had not purchased or intentionally planted the product. The investigation linking the “rogue” seeds to Monsanto’s research site hasn’t produced a plausible answer, but it brings to light the difficulty inherent in tightly controlling the global distribution of GM or GE seeds.

Professor Beyranevand argues that even if the Monsanto Rider had made its way into the final Farm Bill, it would not have substantively changed the way the federal government regulates GM and GE seeds, crops, and products. Public skepticism about GMOs is, perhaps, warranted given the surreptitious inclusion of the Monsanto Rider. However, in focusing on this facet of the bill, the public may be missing an opportunity to address fundamental issues in how the American government ensures food that is beneficial for its citizens and the environment.

A link to the recording of Professor Beyranevand’s talk can be found here: https://vimeo.com/86143076.

For further reading:

GMO and GE Defined

World Health Organization: 20 Questions on Genetically Modified Foods

Farm Bill and the Monsanto Rider

Monsanto Rider’ in Farm Bill Allows Planting of Genetically Modified Crops without Environmental Impact Studies

‘Monsanto’ Rider Ridiculed by Both Sides, But Is it as Bad as it Looks

Federal GMO Regulation

Federation of American Scientists: US Regulation of Genetically Modified Crops

Council on Foreign Relations: The Regulation of GMOs in Europe and the United States 

PEW Trusts Report: Post-Market Oversight of Biotech Foods

Berkeley Technology Law: Issues in the Regulation of Bioengineered Food

Cornell University: The Role of Government in the Labeling of GM Food      

FDA Regulation and Consultation Procedures

Avana Andrade is a first year Master of Environmental Management candidate at the Yale School of Forestry and Environmental Studies. She earned her B.A. in International Studies and Western European History at Colorado State University in 2010. Before returning to school, she worked as a public historian and backcountry ranger with the Student Conservation Association and the National Park Service in both Northern Arizona and Southern Utah. Her work has focused on the history of grazing and cultural resource management in Glen Canyon National Recreation Area and Canyonlands National Park. Work and recreation on the Colorado Plateau motivates her primary interest in grad school, environmental conflict mediation. Avana is a Colorado native and an avid backpacker and gardener.

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