$15.9M

BUDGET

89

EMPLOYEES

Biotechnology

FY 2021 Highlights

WHERE 

WE WORK

• Riverdale, MD (APHIS Headquarters)

• Fort Collins, CO

• Raleigh, NC

www.aphis.usda.gov/biotechnology

Through the Biotechnology Regulatory Services (BRS) program, the U.S. Department of 

Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) protects against risks 

to U.S. plant health by overseeing the safe import, interstate movement, and environmental 

release/field testing of certain organisms developed using genetic engineering. APHIS coordinates 

these responsibilities along with the other Federal agencies as part of the Federal Coordinated 

Framework for the Regulation of Biotechnology.

Fully implemented USDA's revised biotechnology 

regulations, which streamline and modernize our 

system, providing over $8 million in annual cost 

savings

Completed 6 petitions for nonregulated status, 

bringing the total number of determinations to 135

Responded to 13 requests for confirmation that a 

plant met the criteria for exemption from regulation, 

resulting in 6 letters confirming exemption, issued 

in an average of 44 days from receiving a complete 

request

With APHIS’ Plant Protection and Quarantine (PPQ) 

and States, performed more than 700 inspections 

of authorized field trials involving organisms 

developed using genetic engineering, with a 98% 

rate of compliance 

Processed over 750 authorizations in 48 States for 

nearly 100 different species of organisms for the 

movement or field testing of organisms developed 

using genetic engineering

Fully implemented APHIS eFile, processing over 

300 authorizations in APHIS’ new online permitting 

system

Published an Advanced Notice of Proposed 

Rulemaking for regulatory oversight of certain 

animals developed using genetic engineering, 

receiving over 51,000 written comments and 

conducting 68 one-on-one outreach meetings

Delivered more than 20 presentations to 

international stakeholders representing 9 countries 

to offer technical information and build capacity 

abroad for regulating biotechnology

Managed 16 Freedom of Information Act (FOIA) 

requests and released over 184,000 pages of 

records under FOIA, upholding our commitment to 

the public and transparency about biotechnology 

regulatory activities

Provided over $74,000 in cooperative funding 

to universities and other partners for critical 

biotechnology work, including State inspections 

and protecting natural plant heritage

APHIS Biotechnology in Numbers

BRS-21-001 • Issued November 2021 USDA is an equal opportunity provider, employer, and lender.
FY21 Updates

Coming March 23, 2022

On April 5, 2021, the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) 

transitioned from ePermits to APHIS eFile. All applicants must 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. As of April 5, 2021, APHIS’ Biotechnology Regulatory Services (BRS) no longer accepts 

applications submitted in ePermits.

APHIS eFILE 

PROGRAM UPDATES 

Contact Us

efile.communica�ons@usda.gov

CREATE YOUR 

ACCOUNT TODAY

• Visit efile.aphis.usda.gov.

• Register with your eAuthentication account.

• Submit your first application!

• APHIS eFile fully released on April 5, 2021

• System aligned to updated 7 CFR part 340 

• BRS Permitting Assistant available to public

• Updated BRS application interface

• Enhanced PDF production

• Improved handling of large permit 

applications

The new APHIS eFile system allows 

applicants to submit APHIS form 

2000 electronically—permits for 

the importation, interstate 

movement, and environmental 

release of organisms developed 

through genetic engineering that are 

plant pests or that pose plausible 

plant pest risks.

Applicant Portal

Personalized Applicant Portal 

provides easy and quick navigation. 

Organization Accounts

Shared accounts enable team 

collaboration and management of 

applications. 

Previously Submitted Constructs

Add construct records from 

previous applications. 

Chatter

Communicate with APHIS reviewers 

online.

Permitting Assistant

Navigate revised 7 CFR part 340 

regulations.

Revising Applications

Correct submissions easily.

BIOTECHNOLOGY REGULATORY SERVICES

ABOUT APHIS eFILE 

APHIS eFILE FEATURES
BIOTECHNOLOGY REGULATORY SERVICES

APHIS eFILE 

*Bold indicates information required in the revised regulations 

Required Fields for Location Records

*Title, First Name, Last Name, Phone Number, and Email Address are minimally required for Location Agents

Interstate

Movement +

Movement Environmental Release Location

Environmental

Interstate

Destination Location

Import

Movement

Release

Release

Origin Location Origin + Destination Location

• Location Name

• Country

• State

• County

• Street Address

• City

• Zip Code

• Previously Inspected by APHIS

• At Least 1 Material Record

• At Least 1 Agent*

• Location Name

• Country

• State

• County

• Street Address

• City

• Zip Code

• Previously Inspected by APHIS

• At Least 1 Material Record

• At Least 1 Agent*

• Location Name

• Country

• State

• County

• Street Address

• City

• Zip Code

• Previously Inspected by APHIS

• At Least 1 Material Record

• At Least 1 Agent*

• Location Name

• Country

• State

• County

• Street Address

• City

• Zip Code

• Previously Inspected by APHIS

• At Least 1 Material Record

• At Least 1 Agent*

• Location Name

• Country

• State

• County

• Street Address

• City

• Zip Code

• Previously Inspected by APHIS

• At Least 1 Material Record

• At Least 1 Agent*

• Location Name

• Country

• State

• County

• Street Address

• City

• Zip Code

• Location Unique ID

• Number of Proposed Releases

• Number of Acres

• Critical Habitat Involved?

• Release Site History

• At Least 4 GPS Coordinate Sets

• At Least 1 Agent*

• Location Name

• Country

• State

• County

• Street Address

• City

• Zip Code

• Location Unique ID

• Number of Proposed Releases

• Number of Acres

• Critical Habitat Involved?

• Release Site History

• At Least 4 GPS Coordinate Sets

• At Least 1 Agent*

• Location Name

• Country

• State

• County

• Street Address

• City

• Zip Code

• At Least 1 Agent*

• Location Name

• Country

• State

• County

• Street Address

• City

• Zip Code

• At Least 1 Agent*

• Location Name

• Country

• City

• At Least 1 Agent*

BRS-21-002 • Issued November 2021 USDA is an equal opportunity provider, employer, and lender.