Time Is Running Out for Meaningful EPA Reforms on Agricultural Biotech
Nearly four months ago, on June 11, President Trump signed an Executive Order (EO) to modernize the regulatory framework for agricultural biotechnology products. The EO directs the USDA Secretary, the EPA Administrator, and the FDA Commissioner to take specific actions to facilitate science-based, timely, efficient, and transparent oversight of agricultural biotech products.
Importantly, by December 8, 2019, USDA, EPA, and FDA must (1) identify relevant regulations and guidance documents that can be streamlined and (2) take steps “appropriate and necessary” to accomplish such streamlining. The EO also requires USDA, EPA, and FDA to “take steps to update its regulations and guidance, as necessary and appropriate, to remove undue 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.”
To date, EPA has not taken any public action to implement the EO. At this point, the agency will likely issue or propose less-than-ideal guidance on agricultural biotech – representing a significant missed opportunity for both EPA and the biotech industry. With the proper advocacy, clear focus, and right arguments, however, this outcome is not inevitable.
For example, in the past few decades, EPA has applied a questionable interpretation of FIFRA’s definition of a pesticide to assert authority over genetically engineered plants that do not actually exhibit any pesticidal traits. By determining that these plants are regulated under FIFRA, EPA has effectively prevented many of them from entering the marketplace, largely due to the registration and data requirements that come with being labeled a pesticide.
Industry would need to submit a well-reasoned, comprehensive petition for rulemaking to convince EPA and its leadership to reevaluate its past interpretation and decide that it had overreached when interpreting FIFRA’s definition of a pesticide. This agency skepticism should not discourage the biotech industry from seeking a concrete, realistic deregulatory action such as the reinterpretation of what constitutes a pesticide. The industry might not get everything it wants, but it can get something it needs.
The EO represents a pivotal moment for the agricultural biotech industry – one that could facilitate the growth of genetic engineering or impede this technological innovation for the foreseeable future. Time is running out, and once EPA proposes its expected guidance in response to the EO, it may be too late.