Two contrasting regulatory decisions by authorities in the United States and Mexico highlight the continued progress toward, and challenges to, the development of science and evidence based regulatory policies applicable to genetically engineered foods. In the United States, the U.S. Department of Agriculture (USDA) announced the issuance of the Record of Decision as the final action completing the National Environmental Policy Act (NEPA) process associated with the 2020 amendments to the 7 C.F.R. Part 340 regulations that govern the interstate movement of certain genetically engineered organisms. The Part 340 amendments updated USDA’s regulations applicable to genetically engineered organisms that are subject to USDA’s regulatory purview to better reflect current scientific understanding of the risks posed by such organisms. Meanwhile, moving in a completely opposite direction, the Government of Mexico continues to lurch toward an effective prohibition on imports of some genetically engineered corn in accordance with a December 31, 2020 decree. The decree and possible consequent actions are based on assumptions and conclusions that are completely at odds with scientific evidence regarding genetically engineered foods.

Addressing the Government of Mexico decree first, it requires the relevant authorities to (1) “revoke and refrain from granting permits” for the release of “genetically modified corn seeds” into the environment; and (2) “revoke and refrain from granting authorizations” for the use of “genetically modified corn grain in the diet of Mexican women and men,” with a deadline for full elimination of genetically engineered corn in human diets by January 31, 2024. How this decree will ultimately be implemented remains to be seen, but the prohibition on the use of genetically engineered corn in “the diet of Mexican women and men” could have significant impacts for U.S. farmers as Mexico is a major destination for exports of U.S. corn. The key question is whether this will be interpreted as applying only to corn that is used for direct consumption by humans and not to corn that is used as feed for livestock and poultry production.  

While a large number of GE corn events have been approved in Mexico, at present, because of judicial injunction, there is no economically significant cultivation of GE corn in Mexico. The December 31 decree appears to be intended to make this official government policy (to the unfortunate detriment to Mexican farmers and the Mexican environment). Moreover, the ban on the use of genetically engineered corn for human consumption likely will result in a prohibition on imports of genetically engineered corn for human food use. What remains unclear is whether the import ban is intended to apply to corn imported for animal feed also, or, if the intent is for a situation similar to that in the EU, where imports of genetically engineered foods for human consumption are essentially nil, while a substantial amount of genetically engineered animal feed is imported to support meat production. If, in fact, imports of genetically engineered corn to Mexico for animal feed are not halted, then some of the negative impacts to U.S. growers may be ameliorated (the bulk of U.S. corn exports to Mexico are for animal feed). Nonetheless, formalizing the ban on planting seeds of genetically engineered corn means that Mexican growers will suffer the adverse consequences of losing access to the most technologically advanced seeds. We will continue to follow this developing situation.

With regard to the USDA issuance of the final Record of Decision associated with the 2020 Part 340 amendments, this action closes out the administrative process for USDA’s updating of its regulations applicable to GE organisms that are regulated under its Plant Protection Act authorities. (Wiley discussed USDA’s Part 340 amendments previously in a Wiley Alert that we published when USDA promulgated the final rule in May 2020 - in addition, as part of the Wiley Biotech Briefings Series, I will discuss how the revised Part 340 regulations in conjunction with EPA’s soon to be amended PIPs regulations constitute a good start to a more coordinated approach to the regulation of advanced agricultural biotech in the United States).

Among the Coordinated Framework agencies, FDA and USDA must comply with NEPA requirements when taking actions relevant to genetically engineered organisms that may be released into the environment. (Moreover, as Wiley has recently discussed, such regulatory actions may implicate the Endangered Species Act also.) NEPA requires Federal agencies to systematically address potential environmental impacts that may result from administrative actions. To meet this obligation, Federal agencies must prepare detailed assessments of the potential environmental impacts of Federal actions that may significantly affect the environment. USDA prepared a draft Environmental Impact Statement (referred to as a Programmatic EIS or PEIS) for its proposed Part 340 amendments and included it for public comment as part of the docket for the proposed rule. USDA prepared a final PEIS to accompany its final rule and, consistent with EPA’s regulations, submitted the final PEIS to EPA for review. EPA released USDA’s final PEIS for public comment (In short, rulemaking actions that are subject to the APA and NEPA must comply with both. While USDA met its APA obligations when the final Part 340 amendments rule was promulgated in May 2020, the NEPA process was still ongoing). With the issuance of the final Record of Decision USDA has now completed its NEPA obligations for the Part 340 amendments. USDA’s issuance of the Record of Decision and completion of the NEPA process for this rulemaking is timely in that the effective date of Sections 340.4 and 340.5, the primary regulatory provisions of the Part 340 amendments, is April 5, 2021.

These actions demonstrate the ongoing fluid and wide-ranging regulatory environment applicable to genetically engineered crops in the United States and elsewhere. As noted above, future regulatory actions related to genetically engineered foods are anticipated by the EPA, as well as FDA.

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