NAFTA 2.0: New genetic engineering techniques and agricultural trade

Industry demands to the Trump administration for the renegotiation of the North American Free Trade Agreement (NAFTA) require that NAFTA 2.0 “do no harm” to U.S. exports, including agribusiness exports. But U.S. agribusinesses don’t just hope to increase market access for their products; they intend to force other governments to accept genetically engineered (GE) agricultural exports that have not been risk assessed in the importing country. According to several sources, including the Wilson Center, a U.S. government funded research institution, the NAFTA 2.0 chapter which likely would define the terms for agricultural biotechnology trade, is agreed upon. If so, the U.S. will have locked in the terms to ‘export’ its largely voluntary and industry-dominated GE product and labeling regime.

What are the likely terms of GE agriculture in NAFTA 2.0?

U.S. draft trade negotiation documents are available only to security cleared advisers to the U.S. Trade Representative, to Members of Congress, and to cleared congressional staff. As a result, the best proxy for what is in NAFTA 2.0 is to read industry demands for NAFTA 2.0 and for the agreed and published text of the Trans-Pacific Partnership (TPP) Agreement. A TPP market access provision requires governments to negotiate so-called “Low Level Presence” (LLP) agreements on unapproved genetically modified organisms (GMOs) in grain, oilseeds and produce exports. LLPs set threshold levels for detection of unapproved GMOs, and agree on detection methods to be used. The Global Alliance for Ag Biotech Trade demanded that LLPs be “predictable, efficient and achievable by the industry and governments.” However, the U.S. Department of Agriculture’s Grain Inspection Service had four staffers in its international affairs division and four in its biotechnology lab for all domestic and international testing in December 2017. With so few staff, it is unlikely that the U.S. will be able to enforce whatever LLP agreement is negotiated. 

The American Farm Bureau Federation, as a member of the U.S. Biotech Crops Alliance, has requested that USTR negotiate a NAFTA 2.0 agricultural biotechnology chapter, including “a mutual recognition agreement on the safety determination of biotech crops intended for food and feed.” Mutual Recognition Agreements (MRAs) require importing governments to accept the risk assessment and risk management rules and practices of exporting governments as providing equivalent protection in human, animal and plant health. The USTR did not include an MRA requirement in the TPP and is unlikely to do so in NAFTA 2.0. However, NAFTA 2.0, following WTO and TPP precedents, will require governments to negotiate ‘equivalence’ agreements in food safety, animal health and plant health, which are a less comprehensive and efficient method for expediting GE product trade than the inclusion of a MRA.

The U.S. regulates GE agriculture, doesn’t it?

In 2017, the Obama administration released a 74-page update to the 1992 Coordinated Framework for the Regulation of Biotechnology. The Coordinated Framework describes the bureaucratic division of labor among federal agencies, chiefly the Food and Drug Administration (FDA), the U.S. Department of Agriculture (USDA) and the Environmental Protection Agency (EPA), and the legal authorities for regulating GE agricultural and food products. There is little information about regulatory process. The Coordinated Framework states, in footnote 79, “FDA has a voluntary food safety and regulatory consultation process for human and/or animal foods derived from genetically engineered plant varieties to be used in the food supply and recommends that developers of such products partake in the consultation process early in the development process.” In practice, the biotech industry self-regulates, not only in United States, but in major GE crop exporters, such as Argentina.

This voluntary approach to regulation allows the commercial applicant to determine what information about the GE product it wishes to present to the agency. The TPP stipulates that risk assessments shall be performed not based on publicly available studies and data, but based on “reasonably available” information, allowing companies to determine what studies shall be classified as Confidential Business Information. Such a provision is very likely to be included in NAFTA 2.0.

U.S. agencies do not “approve” GE products in the sense that the products are risk assessed based on peer-reviewed and publicly available science. For example, a March 11, 2016 FDA letter to Monsanto states that according to the company’s understanding of the data it presented voluntarily to FDA, “genetically engineered MON 87419 corn does not raise issues that would require premarket review nor approval by FDA.” This letter allows Monsanto to sell its GE corn without a risk assessment based approval by FDA.

What potential problems with GE products are the FDA and other U.S. agencies ignoring?

Testbiotech, a German NGO, compiled a sample list of unregulated U.S. agricultural products derived from new GE techniques. The products include wheat, potatoes, waxy corn, wheat, rice, white mushrooms and maize. However, the new GE techniques result in hundreds of unintended mutations, some beneficial, some neutral and some harmful. Scientists have characterized risks corresponding to those mutations. These risks include increases in plant toxins; deficiencies in proteins important for nutrition and plant disease defense; increases in allergens; increases in a plant’s invasive capacity; disruptions of genetic expression, which may “silence” a gene for generations with beneficial, neutral or harmful effects; and positional changes in genes that impact ecology without being evident in the GE derived product.

There is a strong presumption in the coordinated framework that the risks of GE products should not be assessed in terms of the process that produced the product: “The risk posed by the introduction of the biotechnology product and should not turn on the fact that it was created or has been altered by a particular process,” (p. 7). The policy that risk assessment can only be performed on the final traded product, and not on the production process, allows FDA and USDA to ignore most environmental and food safety risks of GE techniques. Or in the bureaucratic euphemisms of the FDA letter to Monsanto, the product presents no “issues” that would require a pre-market safety determination.

What is the state of GE commercialization and labeling rules in the Trump administration? What are the consequences of the anti-regulatory agenda for NAFTA 2.0?

In November 2017, USDA announced, to the applause of industry, it was withdrawing a rule proposed by the Obama administration to revise procedures to commercialize GE products. As a result, products derived from new GE techniques will be marketed based on a 20-year old USDA rule. USDA’s proposed GE labeling rule ignored a USDA internal study that concluded the rule’s proposed method for informing consumers, a QR code, would discriminate against the 100 million U.S. consumers who do not have a smart phone or the wi-fi access to enable reading of the code. If the rule is finalized by the July 29 deadline mandated by Congress, its legality will be challenged in court. The Trump administration’s war on science and subordination of scientific agencies to trade and commercial interests, e.g. in USDA, may backfire in NAFTA 2.0. The lack of mandatory U.S. risk assessment, regulation and informative labeling of GE products may result in market rejection as the risks of more scientifically complex products emerge.