On June 11, 2019, President Trump issued an Executive Order that would require the Department of Agriculture, the Environmental Protection Agency, and the Food and Drug Administration—the three main agencies with regulatory authority over genetically-engineered (“GE”) plants and animals in the United States—to revise their regulations governing GE organisms. These changes follow closely on the heels of the Animal and Plant Health Inspection Service’s (“APHIS”) recent proposed regulations that would increase the number of genetically-engineered organisms that may be produced without undergoing APHIS review, and are likely of interest to biotechnology companies, agricultural organizations, and other entities interested in GE organisms.
The Executive Order directs the agencies to adopt a risk-based approach for regulating GE organisms, instructing the agencies to adopt regulatory approaches “that are proportionate responses to the risks such products pose,” while at the same time “ensur[ing] public confidence in the oversight of such products.” The Executive Order specifically requires that:
- The three agencies, within 180 days, identify regulations and guidance documents that “can be streamlined” to confirm to the risk-based approach described above, and then to move forward with streamlining those regulations and guidance documents. This is similar to the approach of a March 2017 Executive Order that called on agencies to review and report on any regulations and guidance that might impede the development of domestic energy resources;
- The three agencies exercise statutory authority “to exempt low-risk products of agricultural biotechnology from undue regulation”;
- The three agencies work together to establish a web-based platform containing consolidated information about governmental regulation of GE organisms;
- The three agencies review their regulations to remove barriers to development of plant products designed to have significant health, agricultural, or environmental benefits, with a focus on removing barriers that “impede small, private United States developers, the United States Government, and academic institutions from bringing innovative and safe genome-edited-specialty-crop-plant products to the marketplace,” and report to the Office of Management and Budget on their progress every 90 days;
- The three agencies and other government entities develop domestic and national outreach plans to engage stakeholders; and
- The United States Trade Representative within 120 days develop an “international strategy to remove unjustified trade barriers and expand markets for products of agricultural biotechnology.”
The recent APHIS proposed rule sheds some light on the approach suggested by the Executive Order, which would direct agencies to tailor their regulation of GM organisms to the agencies’ assessment of likely risk categories into which the particular organisms fall. The basic philosophy underlying APHIS’s proposal is that it need not regulate GE organisms “that are unlikely to pose a . . . risk.” 84 Fed. Reg. 26,514, 26,516 (June 6, 2019). Additional details on APHIS’s proposal can be found here.
One key question is whether risk factors can be identified ex ante that have a high likelihood of accurately identifying the risk profile posed by GM organisms, or at least identifying certain low-risk categories for which significant regulation may be unnecessary—an issue that the regulators have confronted at least since the original 1986 Coordinated Framework for Regulation of Biotechnology. Interested stakeholders will have opportunities to comment on proposed rule changes, with comments on the pending APHIS rule due by August 6, 2019. That rule in particular may be a harbinger of how the agencies as a whole modify their regulations of GE organisms, increasing the stakes of participating in that rulemaking process and any subsequent litigation.