Bayer Crop Science’s MON 95379 corn has officially cleared USDA regulatory hurdles.
On Sept. 26, the U.S. Department of Agriculture’s Animal and Plant Health Inspection Service (APHIS) announced its determination that the insect-protected corn line no longer falls under its regulatory authority.
MON 95379 was developed using genetic engineering to resist damage from some of corn’s most notorious pests, including fall armyworm, sugarcane borer, and corn earworm. The corn produces two insecticidal proteins, Cry1B.868 and Cry1Da_7, which provide protection against lepidopteran pests, including populations already resistant to existing Bt technologies.
This decision follows a multi-year process that began when Bayer submitted a petition in 2020. APHIS made that petition available for public review and comment in early 2024, asking stakeholders to weigh in on potential environmental and economic impacts. After analyzing Bayer’s data, independent scientific evidence, and all submitted comments, APHIS concluded that MON 95379 is unlikely to pose a greater plant pest risk than nonmodified corn.
Although MON 95379 is not slated for U.S. commercialization, it will play a role in global seed development. Bayer intends to use the corn in small-scale nurseries for breeding, testing, and seed increases, with future commercialization targeted to South America. There, MON 95379 will be combined with other deregulated traits to build next-generation products with broader pest protection and herbicide tolerance.
A Shift in USDA Biotechnology Oversight
MON 95379 is one of the last biotech corn traits to move through USDA’s petition for nonregulated status process. In 2020, APHIS revised its biotechnology regulations and introduced the Regulatory Status Review (RSR) framework.
Under RSR, which became fully effective for all crops on Oct. 1, 2021, developers submit new traits for review without going through the older petition system. The updated process is intended to be more predictable and streamlined, focusing directly on whether a product could pose a plant pest risk.
Because Bayer’s MON 95379 petition was submitted in July 2020 — before the RSR system applied to corn — APHIS evaluated it under the legacy rules. That timing makes MON 95379 part of a transitional moment in how USDA handles biotech oversight.
