Regulate new GE techniques? U.S. (never) vs. EU (yes)

Iowa Corn Planting

A U.S. farmer loads GE corn seed into a planter. Photo by Chris Palmquist

New agricultural technologies present new challenges for assessing risks and tailoring risk management measures for those technologies. However, governments, particularly those that have invested taxpayer money to develop the technologies, may not adapt to meet those challenges. The U.S. and EU are taking very different approaches to that task.

In previous articles, IATP has summarized the subordination of science offices to trade functions in the Trump administration’s reorganization of the U.S. Department of Agriculture to serve its agribusiness “customers,” in the words of Secretary Sonny Perdue. IATP has also reported on how the Obama administration attempted to export to Europe and elsewhere its deregulatory practices for foods and agricultural products derived from new genetic engineering (GE) techniques.

In 2018, USDA has further served its agribusiness “customers” by marginalizing risks of the new techniques reported in the scientific literature to expedite commercial authorizations as the agency begins again to revise a 20-year old rule to deregulate GE food products. In contrast, a July 25th ruling by the European Court of Justice (ECJ) on the regulation of those products will enable European Union member states to regulate both the import and planting of GE food and agricultural products. In September 2016, IATP, as a member of the Transatlantic Consumer Dialogue, urged the European Commission to regulate and label those products under EU law.

But implementation of the ECJ ruling in EU member states will face stiff opposition from agribusiness, from university GE plant researchers hoping to commercialize their patents of GE products and from U.S. government agencies. For example, Professor Johnathan Napier, who is conducting field trials of CRISPR edited plants in the United Kingdom, said of the ECJ ruling, “This is a very disappointing outcome, and one that will hinder European innovation, impact and scientific advance. The classification of genome-edited organisms as falling under the GMO directive could slam the door shut on this revolutionary technology.” This message and others like it are part of an industry campaign whose ultimate objective is no pre-market safety assessment, post-market monitoring or labeling of foods derived from genome editing techniques, according to a May report by Corporate Europe Observatory.

IATP responded on July 30, 2018, to a USDA Notice of Intent to Draft a Programmatic Environmental Impact Statement (EIS) for genetically modified organisms. An EIS is required under the National Environmental Policy Act (NEPA) for government rules that affect the natural and human environment. Normally, an EIS is written after a rule is proposed to enable decision-making about a final rule’s implementation. But the Trump administration's USDA has not proposed a such rule.

In November 2017, USDA withdrew, to the applause of the Biotechnology Innovation Organization (BIO), the Obama administration’s proposed rule that described options for regulating and deregulating genetically engineered plants, including those developed with genome editing techniques such as CRISPR Cas9. USDA Secretary Sonny Perdue, BIO’s Governor of the Year in 2009, has already signaled the orientation of any future Proposed Rule on GE plants in his “Statement on Plant Breeding Innovation” of March 28: “Under its biotechnology regulations, USDA does not regulate or have any plans to regulate plants that could otherwise have been developed through traditional breeding techniques as long as they are not plant pests or developed using plant pests.” Unlike plants developed with transgenes, gene-edited plants do not use plant pests in their development. Therefore, USDA will not regulate them.

Nevertheless, numerous scientific articles show that gene-editing techniques result in hundreds of unintended (off-target) mutations, some of which pose risks, such as weakened resistance to plant disease, elevated production of toxins and deficient nutritional content. Indeed, crops of greatest commercial interest to industry, such as corn and wheat, have the most complex genomes and the highest percentage of off-target effects, about 70 percent in the case of corn. IATP recommended nine categories of information that USDA should include in the programmatic EIS and require GE plants developers to provide USDA in their applications to commercialize new plant varieties.

To ignore the risks of gene-editing plants in the EIS, to fast-track their commercialization, would be another instance of the Trump administration’s War on Science. If the USDA again evades the requirement of the Plant Protection Act to regulate to prevent “indirect injury” resulting from plant breeding, e.g. by GE plants engineered to resist proprietary pesticides, that evasion will help increase the well-documented adverse environmental impacts from growing GE crops as they are designed to be used.

But USDA appears to be fast tracking the EIS drafting process, allowing only thirty days for comment on the Notice. IATP noted that the never finalized 2007 draft EIS for GMOs had a six-month consultation period, including a comment period, public meetings and a survey of scientists about potential risks of GE plants.

USDA and the biotech industry are determined to export gene-edited grains and horticulture products, including those not approved for consumption in the importing country, through so-called Low-Level Presence (LLP) of GMOs provisions in the Trans-Pacific Partnership Agreement, and (following U.S. withdrawal from the TPP), almost certainly in the revised North American Free Trade Agreement (NAFTA). Those provisions would require governments to negotiate quantitative thresholds of GE grains and oilseeds, e.g. five percent or ten percent of the volume of a corn shipment, that would be legal to import even if unapproved in the importing country. LLP agreements would also concern grain sampling, detection and analysis methods for genome edited agricultural products. IATP believes that USDA’s lightly staffed Grain Inspection Service has neither the legal authority, nor adequate technical capacity to stop export shipments that violate whatever LLP terms are finalized in NAFTA 2.0.

The USDA and biotech industry are determined to facilitate exports of gene-edited grains, oilseeds and horticulture products and to avoid regulating those products relative to the risks characteristic of off-target effects. They now have to figure out how to circumvent the July 25 ECJ ruling that requires genome edited food and agriculture products to be regulated under the 2001 EU law governing GMOs. According to the ruling, “organisms obtained by means of techniques/methods of mutagenesis which have not conventionally been used in a number of applications and do not have a long safety record come within the scope of Directive 2001/18 and are, therefore, subject to the obligations arising from that directive,” (paragraph 77). (Directives are EU wide legislation to be adapted in member state law.) European Union law requires a long and well-documented demonstration of safe use of GMOs, whereas the U.S. deregulates new GMOs based on whether they are developed with the use of a plant pest.

The Court ruling responded to a lawsuit by the Conféderation Paysanne (a French farmers’ union) and eight other organizations against the French Ministry of Agriculture, for allowing the U.S. biotech firm Cibus to circumvent EU law by importing and allowing the planting herbicide-resistant rape seed. The ruling requires implementation by the French government and European Union member states. The ruling further states, “The precautionary principle has been taken into account in the drafting of this Directive and must be taken into account when implementing it,” (paragraph 3.8).

The United States does not recognize the precautionary principle in international law and denies GMO commercialization applications only when the GE product developer has not provided USDA or the Food and Drug Administration with requested information. As noted in IATP’s EIS comment letter, the Obama administration’s proposed rule on GMOs stated that as of 2017, about 30,000 petitions to commercialize had been authorized, while 1,500 had been denied. (Authorization entails an agency review of applicant selected and submitted documentation, but not a formal risk assessment.)

BIO and its European affiliates predictably decried the ruling as an impediment to European innovation and trade. Secretary Perdue’s response was determined to find a way to export gene-edited products to EU member states, notwithstanding the ruling: “Unfortunately, this week’s ECJ ruling . . .  narrowly considers newer genome editing methods to be within the scope of the European Union’s regressive and outdated regulations governing genetically modified organisms. We encourage the European Union to seek input from the scientific and agricultural communities, as well as its trading partners, in determining the appropriate implementation of the ruling.” IATP interprets this statement to indicate that the United States will seek input for the EU member states to implement the ruling in a way that will facilitate trade and render the ECJ ruling irrelevant.

European NGOs did not wait to use the EJC ruling with their governments. The British NGOs Gene Watch and GM Freeze wrote to the Secretary of Environment, Food and Rural Affairs on July 25 to inform him that the legal basis for allowing a genome edited plant field trial in the United Kingdom was now based on false legal reasoning. They demanded an immediate stop to the field trial.

The United Kingdom must present a proposal to leave the European Union by March 29, 2019. According to the terms of the Brexit “divorce,” the United Kingdom may decide it can ignore the EJC rulings as part of a UK-US trade deal and choose not export its genome-edited food and agriculture products to the soon-to-be 27 European Union member states. But other member states will not have so straightforward a basis to circumvent the ruling.

USDA will have the support of the European Commission, as both seek to weaken and circumvent the implementation of the ECJ ruling in the member states. As IATP wrote in January, in 2017 the European Commission refused to allow the European Network of GMO Laboratories, an official and specialized source of advice to the Commission, to carry out a study of the new GE techniques to advise the Commission. Instead, the Commission will depend for its scientific advice on industry studies and the scientific opinions of the European Food Safety Authority, about half of whose consulting experts have a financial conflict of interest, according to Corporate Europe Observatory.

This erosion of independent and specialized scientific advice may not be on par with USDA’s rejection of the advice of the National Research Council in 2002 to use GE modification as a regulatory trigger or the Trump administration’s replacement of independent scientists with industry scientists on the advisory committee to the Environmental Protection Agency and other agencies. But it does signal a political preference by the European Commission to prize industry innovation and commerce over rigorous risk assessment of new GE products. Risk assessment agencies in EU member states will now be charged to advise member state risk managers of risks specific to genome editing of agricultural plants under the terms of the July 25th ECJ ruling. The U.S. State Department, the Office of the U.S. Trade Representative and, of course, USDA, will continue to lobby the EU to import both its GE edited products and its deregulatory practices, the ECJ ruling be damned.