Wilson Sonsini Goodrich & Rosati

In response to concerns expressed by livestock groups and some in the biotechnology industry over the Food and Drug Administration's (FDA's) approval process for gene editing in animals, the Trump administration issued an executive order recently to address this matter. The executive order was titled, "Modernizing the Regulatory Framework for Agricultural Biotechnology Products," but if an informal subtitle had been included, it could have read: "The FDA should modify its regulatory framework for the gene editing approval process."


The federal system for evaluating products developed through modern biotechnology is guided by the Coordinated Framework for the Regulation of Biotechnology. Developed in 1986 and updated most recently in 2017, the coordinated framework clarifies regulatory roles with respect to agricultural biotechnology.

The Animal and Plant Health Inspection Service (APHIS) at the U.S. Department of Agriculture (USDA) regulates organisms and products that are known or suspected to be plant pests or to pose a plant pest risk, including those that have been altered or produced through genetic engineering. The Environmental Protection Agency (EPA) regulates pesticides that are produced through biotechnology. The FDA is responsible for ensuring the safety of all plant-derived food and feed, including those developed through genetic engineering.

In January 2018, an Interagency Task Force on Agriculture and Rural Prosperity, established by the Trump administration the year before, issued a set of recommendations for improving life in rural America. As part of this list, the task force recommended that additional steps be taken to further modernize the regulatory framework for agricultural biotechnology products to facilitate innovation and ensure coordination across regulatory agencies.

Based on the task force recommendation, the executive order directs the USDA, the EPA, and the FDA to identify and streamline relevant regulations and guidance documents within their respective jurisdictions to ensure that products of agricultural biotechnology are regulated based on the risks such products pose. Under the executive order, the agencies also are directed to "avoid arbitrary or unjustifiable distinctions across like products developed through different technologies" and exempt low-risk products from undue regulation.

It seems clear that the language in the executive order is directed at the FDA, specifically the agency's guidance for industry (GFI) on Regulation of Intentionally Altered Genomic DNA in Animals.

GFI #187

The debate over the gene editing approval process at FDA has been simmering for years. The FDA's GFI #187, first released in 2008, was updated in 2017 to confirm the agency's conclusion that intentional gene-editing would be subject to a mandatory new animal drug evaluation. This determination was made to the consternation of livestock groups and the biotechnology industry, which lamented that such a regulatory framework would be more burdensome and costly.

Livestock groups, particularly the National Pork Producers Council (NPPC), have argued that the FDA has jurisdiction over gene-editing in food-producing animals, despite the lack of any statutory requirements. They also contend that the FDA process would treat any gene-edited animal as an animal drug, and any livestock operation as a drug manufacturing facility, which ultimately would harm U.S. competitiveness in foreign markets.

The NPPC lauded the Executive Order in a press release declaring, "The United States is falling behind countries such as Canada, Brazil, and China that have established regulatory frameworks conducive to investment in the development of gene editing." The group added that they are hopeful that the executive order "breaks the FDA's current grip on gene editing" so a regulatory framework can be established at the USDA to ensure that American farmers realize its potential. The NPPC also complained in its statement that, through GFI #187, the FDA continues to advance a regulatory framework for gene edited livestock that counters the executive order.

Greater USDA Role in Gene Editing

APHIS has long been viewed by livestock groups and the biotechnology industry as the more appropriate federal agency to conduct oversight of gene editing in food-producing animals.

Perceived as being more responsive to industry concerns compared to their FDA counterparts, APHIS issued a statement in 2018 providing clarification that, under its biotechnology regulations, the agency does not regulate or have any plans to regulate plants gene-edited plants as long as they are not plant pests or developed using plant pests. A similar approach by the FDA for gene editing in food-producing animals would represent the best case scenario for livestock groups and the biotechnology industry.

Will FDA Slow-Walk Matters?

Whether the rank-and-file FDA personnel accede to the administration's position will be a situation worth monitoring as the executive order is implemented. Just as those at the USDA revere the 'mark of inspection' that gets affixed to labels of meat and poultry products, FDA scientists firmly believe in the sanctity of the agency's product approval process and resist any efforts that they feel would compromise that process.

It is conceivable that career FDA experts may use subtle administrative methods to delay any attempts to minimize the agency's oversight of gene editing in food-producing animals, and engage with public health allies in Congress for assistance. While the executive order imposes a six-month deadline for the relevant agencies to identify regulations that could be streamlined, there is an inconsistent record of these deadlines actually being met.