Biotechnology Guidance and Resources
On Dec. 2, 2024, the United States District Court for the Northern District of California, vacated the U.S. Department of Agriculture (USDA) final rule (7 CFR part 340) issued in May 2020 for organisms developed using genetic engineering. Regulatory Status Review responses, Confirmation Request responses, and active permits that USDA issued prior to Dec. 2, 2024, remain valid. APHIS is determining next steps and will provide additional guidance to stakeholders.
Key Resources
- Permit User Guide (5.84 MB)
- Guide for Submitting Confidential Business Information (492.34 KB)
- APHIS eFile Training Resources
Additional Guides
- DRAFT Guide for Submitting Permit Applications for Microorganisms (2.51 MB)
- Response to Comments (299.66 KB)
- Guide to Submitting Data for Reports and Notices in APHIS eFile (748.02 KB)
- Guidance for Submission of Planting/Environmental Release Reports and Reports of No Planting /Release Submitted Via Email or Mail (67.86 KB)
- Guidance for Submission of Field Test Reports submitted via e-mail or mail (64.53 KB)
- Guidance for Submission of Volunteer Monitoring Reports submitted via e-mail or mail (257.82 KB)
- BRS User’s Guide: General Document Preparation Guidelines for Submission to BRS (150.13 KB)
Additional Resources
- SOP Template for APHIS BRS Plant Permits (188.03 KB)
- SOP Template for APHIS BRS Modified Microbe Movement Permits (261.35 KB)
- Minimum Separation Distances to be used for Confined Field Tests of Certain Genetically Engineered Plants (107.72 KB)
- APHIS Recommendations for Best Management Practices for Authorized Field Trials of Regulated Herbicide-Resistant Crops (85.8 KB)
- List of Petunia Varieties (148.41 KB)
Download all BRS Permits and Notifications Data
- Download all BRS Permit and Notification data from APHIS eFile in csv file (1.62 MB)
- Download all BRS Permit and Notification data from ePermits in csv file (14.79 MB)
Paper Application
APHIS Form 2000 (67.52 KB)
Mail to: APHIS Biotechnology Regulatory Services, Permit Staff
4700 River Road, 6th Floor, Unit 91
Riverdale, MD 20737
- BRS Guide for Requesting a Confirmation of Exemption (1.28 MB)
- Guide for Submitting Confidential Business Information (492.34 KB)
- Guidance for Preparing Proposals to Exempt Plants with Additional Modifications from Regulation Pursuant to 7 CFR § 340.1(b)(4) (431.95 KB)
- Table of Confirmation Letters
- Plant-Trait-Mechanism of Action (MOA) Table
- Submit a Confirmation Request
- Submit a Question About Confirmations
Related Links
Final RSR Guide (548.41 KB)
- Response to Comments: RSR Guide (209.28 KB)
- Table of RSR Requests and APHIS Responses
- Guide for Submitting Confidential Business Information (492.34 KB)
- Contact us about submitting a Regulatory Status Review
Additional Resources
Learn about genetically engineered organisms, “GMOs” and how federal agencies work together to ensure GMOs are safe for people, animals, and the environment. View the new Feed Your Mind videos and fact sheets in English, Spanish, Simplified Chinese, and Navajo.
