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Biotechnology Permits

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APHIS regulates the importation, interstate movement, or environmental release

(i.e., outdoor field trials) of certain organisms developed using genetic engineering

(including plants, insects, and microbes) that may pose a plant pest risk. Permit

applications, which are carefully reviewed by APHIS regulatory scientists, provide

details about the nature of the organism and the conditions that will be used to

prevent the spread and establishment of the organism in the environment. A permit
may include additional conditions to help prevent unauthorized release into the

environment.

Permits Guidance and Resources

BRS Permit User's Guide (2.18 MB)

Table of Biotechnology Release Permits and Legacy Notifications

Table of Biotechnology Movement Permits and Legacy Notifications

Guide for Submitting Confidential Business Information (492.34 KB)

APHIS eFile Training Resources

Additional Guidance

DRAFT Guide to Submitting Data for Reports and Notices in APHIS eFile (290.08

KB)

DRAFT Guide for Submitting Permit Applications for Microorganisms (290.08 KB)

Response to Comments (299.66 KB)

Q&As on Working with Modified Microorganisms

Minimum Separation Distances to be used for Confined Field Tests of Certain

Genetically Engineered Plants (107.72 KB)

BRS User’s Guide: General Document Preparation Guidelines for Submission to

BRS (150.13 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)

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)

Additional Resources and Data

Table of Pharmaceuticals and Industrial Permits

Learn More About Legacy Notifications

Download all BRS Permits and Notifications Data
Download all BRS Permit and Notification data from ePermits in csv file (14.79

MB)

Download all BRS Permit and Notification data from APHIS eFile in csv file

(979.38 KB)

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

Regulatory Exemptions

Under the revised regulations, certain categories of modified plants are exempt from

the regulations because they could otherwise have been developed through

conventional breeding techniques and thus are unlikely to pose an increased plant

pest risk compared to conventionally bred plants. These exemptions apply only to

plants because the long history of plant breeding provides us extensive experience

in safely managing associated plant pest risks. In addition, plants that have a planttrait-mechanism of action combination that is the same as in a plant that has been

determined by APHIS to be unlikely to pose a plant pest risk and therefore to be not

regulated are exempt from the regulations

Developers can request a confirmation from APHIS that a modified plant qualifies for

an exemption and is not subject to the regulations in 7 CFR part 340. This

confirmation process replaces the preexisting “Am I Regulated?” (AIR) process.

Previous AIR responses indicating nonregulated status of organisms are still

considered valid exemptions from the new regulation for the particular requestor

and specific plant(s).

Learn More About Regulatory Exemptions and Confirmations

Learn More About the Revised Regulations

Learn More About the Revised Regulations

Letter of No Permit Required
A permit is not required for the importation of interstate movement of most

disarmed Agrobacterium strains or most Drosophila melanogaster developed using

genetic engineering. In these instances, APHIS provides a “Letter of No Permit

Required” to facilitate importation these organisms. Please refer to the guidance

below for information on how to submit your request.

Letter of No Permit Required Submission Guide (172.88 KB)

Submit a Request for a "Letter of No Permit Required"

Apply Online

On April 5, 2021, APHIS transitioned from ePermits to APHIS eFile. All applicants are

required to use APHIS eFile to apply for permits for organisms developed using

genetic engineering. Any applications submitted in the retired ePermits system

through April 4, 2021, will complete processing in ePermits. Compliance reports

related to these applications must also be submitted in ePermits. BRS will reject any

applications submitted in ePermits on or after April 5, 2021.

Apply Online

Learn More About APHIS eFile