About Biotechnology Regulatory Services

Last Modified: July 17, 2024

APHIS' Biotechnology Regulatory Services uses a science-and risk-based system to ensure organisms developed using genetic engineering don't pose a plant pest risk. These organisms include genetically modified plants, insects, and microbes. We set regulatory requirements for these products and oversee their safe importation, interstate movement, and environmental release.

BRS coordinates work across two main areas: Risk Analysis Programs conducted at APHIS Headquarters in Riverdale, MD, and Regulatory Operations Programs with offices in Fort Collins, CO, and Raleigh, NC. We also have several units that support all of BRS' work, including our science advisors and Communications; Intergovernmental Operations; Policy, Program, and International Collaboration; and Resource Management Services branches.

BRS At-a-Glance

Here's a snapshot of our accomplishments in 2023 (13.95 MB).

  • Issued 15 Regulatory Status Review (RSR) decisions to developers, informing them that their modified plants were not subject to regulation and could be safely grown. By adopting a science-based and risk-proportionate framework for reviewing products, we reduced processing times by 37 percent and completed roughly three times the number of product reviews compared to the legacy review process.
  • Responded to 40 requests for confirmation that a plant met the criteria for exemption from regulation, within an average of 51 days from receiving the requests, including products involving grain, oilseed, fruit, vegetable, and cover crops. Eighty six percent of these products replicated modifications achievable through conventional breeding and 95 percent were developed by small- to medium-sized enterprises and public institutions.
  • Issued 784 authorizations across 45 States and territories for the movement or field testing of organisms developed using genetic engineering.
  • With State agricultural officials, performed more than 700 inspections of authorized field trials involving organisms developed using genetic engineering.
  • Delivered more than 10 presentations to international stakeholders representing 40 countries to offer technical information and build capacity abroad for regulating biotechnology.
  • Contributed to the critical international guide for the products of biotechnology released by the Organization of Economic Cooperation and Development (OECD). Regulatory colleagues in OECD member countries finalized the document after more than 15 years of development, protecting the environment and enabling trade and use of these products.

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