USDA Determination of Nonregulated Status for Bayer CropScience MON 95275 Genetically Engineered Maize
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The USDA Animal and Plant Health Inspection Service (APHIS) has officially determined that MON 95275 maize, a genetically engineered corn variety developed by Bayer CropScience, no longer requires regulatory oversight under federal biotechnology regulations. This corn variety was engineered to express two insecticidal proteins and produce a double-stranded RNA (dsRNA) transcript, providing protection against corn rootworm (coleopteran) pests, which are among the most destructive agricultural pests in the United States. The determination follows a thorough review process that included evaluation of Bayer CropScience's petition, available scientific data, a plant pest risk assessment, and public comments gathered during a prior notice period. APHIS concluded that MON 95275 does not present a plant pest risk and therefore does not warrant continued regulatory control under 7 CFR Part 340. With this nonregulated status determination, MON 95275 maize can now be commercially cultivated, sold, and distributed across the United States without the need for APHIS permits or notifications that are required for regulated genetically engineered organisms. This decision opens the pathway for full commercial deployment of this trait in corn agriculture.
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Key Changes
- MON 95275 maize is formally granted nonregulated status by USDA APHIS, removing it from oversight under 7 CFR Part 340
- Commercial cultivation, sale, and distribution of MON 95275 corn is now permitted nationwide without APHIS permits or notifications
- The variety expresses two insecticidal proteins plus a dsRNA transcript targeting coleopteran (corn rootworm) pests
+ 3 more changes with Pro
Obligations
What this law requires
Bayer CropScience must submit a petition for determination of nonregulated status to APHIS that includes evaluation data, scientific information, and plant pest risk assessment documentation
APHIS must conduct a plant pest risk assessment evaluating whether the genetically engineered organism presents a plant pest risk before making a nonregulated status determination
APHIS must publish notice announcing the availability of a petition for nonregulated status and draft plant pest risk assessment and provide a public comment period prior to making a final determination
Once nonregulated status is determined, MON 95275 maize may be commercially cultivated, sold, and distributed without requiring APHIS permits or notifications
APHIS must make available written determination and supporting documents to the public following a nonregulated status determination