Biotechnology Regulatory Services 

Stakeholder Meeting Agenda

Check-in begins at 12:30 pm

Welcome Doug McKalip

Acting Communications Branch Chief

Introduction Greg Ibach

Under Secretary, USDA Marketing 

and Regulatory Programs

BRS Update

Overview of BRS activities for FY 2019, and a look ahead to 

FY 2020 priorities and status of the SECURE Rule

Bernadette Juarez

BRS Deputy Administrator

Overview of Administration Biotechnology Activities 

Status update on implementation of Executive Order

13874, highlights of biotechnology education and outreach 

efforts, and a summary of current trade topics impacting 

innovation

Fan-Li Chou

Biotechnology Coordinator, 

USDA Office of the Chief Economist

Oversight Update

Status update on FY19 compliance activities, including 

wheat incident response

Doug Grant

Branch Chief, 

BRS Regulatory Operations Program

APHIS eFile Update

Status update on the APHIS eFile pilot and next steps

Ibrahim Shaqir

Management Analyst

Confidential Business Information Review

Review on how to submit CBI 

Maxine Ball

Management Analyst

Summary, Wrap-Up, and Mingling Doug McKalip

Acting Communication Branch Chief
$19M

BUDGET

82

EMPLOYEES

Biotechnology

Provided $870,000 in cooperative funding 

to universities and other partners for critical 

biotechnology work, including State inspections, 

risk assessments, and protecting natural 

plant heritage

With APHIS Plant Protection and Quarantine and 

States, conducted more than 600 safety inspections 

of authorized GE field trials to protect other crops 

Completed 53 virtual inspections of GE field trials

Held 3 meetings or workshops for our stakeholders 

and regulated community to share information and 

guidance helping them understand how to follow 

our regulatory processes

Completed 3 petitions for deregulation within 

time targets, bringing the cumulative number of 

deregulated products to 132

2019 Highlights

Delivered presentations to over 100 visitors 

representing 12 countries to offer technical 

information and build capacity abroad for regulating 

biotechnology

Processed 1,486 permits and notifications for the 

import, interstate movement, or environmental 

release of regulated GE products 

Authorized 10,027 locations and 3,283 sites in 

51 U.S. States and territories for the movement 

or field testing of GE products

Converted 670,000 pages of notification and permit 

records from paper to electronic versions, allowing 

faster response to requests for FOIA (Freedom of 

Information Act) and administrative records

Through the Biotechnology Regulatory Services 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 genetically engineered (GE) organisms. APHIS coordinates 

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

Coordinated Framework for the Regulation of Biotechnology. 

WHERE 

WE WORK

•Riverdale, MD (APHIS Headquarters)

•Fort Collins, CO

•Raleigh, NC

www.aphis.usda.gov/biotechnology

ANIMAL AND PLANT HEALTH INSPECTION SERVICE

APHIS 21-05-004 • Issued November 2019 USDA is an equal opportunity provider, employer, and lender.
APHIS eFile Update

The BRS eFile team continues to prioritize user experience as it updates and improves the eFile 

system based on real-world feedback. Input from pilot participants has led to improvements in the XML 

schema and previously submitted constructs. As the pilot expands at the end of 2019 and into 2020, BRS 

and the regulated community will continue to collaborate to create a better online permitting experience. 

EFILE PROGRAM UPDATES

JOIN THE EXPANDED EFILE PILOT!

STAKEHOLDERS OFTEN ASK:

Pilot Applicants...

• Can request multi-year permits

• Use the new organizational access feature

• Provide input so that BRS can improve the 

system

Where can I access 

application data from eFile?

› The BRS Permits’ Check 

Status page on 

aphis.usda.gov1

Who can apply to join the 

expanded pilot?

› Any applicants that have 

received at least one permit 

from BRS in ePermits

When will BRS fully switch 

to eFile?

› BRS will provide an 

updated full-release 

timeline in early Summer 

2020

76 Feedback items 

received 7 Applications’ data 

available on BRS 

website 1

4 Notifications 

acknowledged 1 Permit pending

eFile by the numbers...

For additional assistance, please email BRS at eFile.Communications@usda.gov. 

BRS Stakeholder Meeting

December 5, 2019

Join the eFile Pilot Today!

1. Request a PDF application from 

efile.communications@usda.gov

2. Complete the application then email it to 

efile.communications@usda.gov

1 https://www.aphis.usda.gov/aphis/ourfocus/biotechnology/permits-notifications-petitions/sa_permits/ct_status
CBI Copy

Your Email

Bernadette Juarez 

APHIS Deputy Administrator 

Biotechnology Regulatory Services 

4700 River Rd, Unit 98 Riverdale, 

MD 20737

Contains Confidential Business Information

Dear Ms. Juarez,

The following example document demonstrates proper formatting and composition of submissions 

containing Confidential Business Information (CBI) to Biotechnology Regulatory Services. Arranging 

content in this way ensures clarity and protection for an institution’s CBI data.

This sentence gives background on the purpose of the communication without disclosing novel 

business methods, practices, or data. This sentence names and describes specific genotypes, phenotypes, 

donor organisms, gene names, gene descriptions and transformation methods to provide BRS with 

context needed for a decision or response. Square brackets should surround the CBI data to denote its 

sensitivity.

Publically available information is not eligible to be claimed as CBI. However, [trade secrets and 

information that is commercially valuable] may be claimed with the proper justification. This 

justification letter should be submitted along with the request, and should detail each category of 

information that was claimed, without revealing the data itself. A CBI deleted copy of the document 

should also be provided along with the submission.

For example, if [Gene ABC] is CBI and used in transformation of the organism, [Gene ABC] 

should be surrounded by brackets and not visible anywhere in the CBI deleted copy of the document. In 

the justification document, a submitter may describe why disclosure of genomic information is 

competitively or financially harmful without revealing the actual information that was enclosed in square 

brackets.

For proper formatting of CBI Deleted or No CBI materials, please see the following pages.

CBI 

CBI

CBI, CBI

Sincerely,

Your Name 

Your Title 

Your Address 

Your Phone

Please provide contact information 

for BRS to use in a response. This 

cannot be claimed as CBI. 

Each page 

should 

denote 

that the 

document 

contains 

CBI 
Your Email

CBI Deleted Copy

Bernadette Juarez

APHIS Deputy Administrator 

Biotechnology Regulatory Services 

4700 River Rd, Unit 98 Riverdale, 

MD 20737

Confidential Business Information Deleted

Dear Ms. Juarez,

The following example document demonstrates proper formatting and composition of CBI Deleted 

documents that must be included with CBI submissions to Biotechnology Regulatory Services. This 

document should be identical to the confidential copy, but have all CBI replaced with blank space.

This sentence gives background on the purpose of the communication without disclosing novel 

business methods, practices, or data. This sentence names and describes specific genotypes, phenotypes, 

donor organisms, gene names, gene descriptions and transformation methods to provide BRS with 

context needed for a decision or response. Square brackets should surround the CBI data to denote its 

sensitivity.

Publically available information is not eligible to be claimed as CBI. However, [

] may be claimed with the proper justification. This 

justification letter should be submitted along with the request, and should detail each category of 

information that was claimed, without revealing the data itself. A CBI deleted copy of the document 

should also be provided along with the submission.

For example, if [ ] is CBI and used in transformation of theorganism, [ ]

should be surrounded by brackets and not visible anywhere in the CBI deleted copy of the document. In 

the justification document, a submitter may describe why disclosure of genomic information is 

competitively or financially harmful without revealing the actual information that was enclosed in square 

brackets.

For proper formatting of CBI documents, please see the previous page. A No CBI example follows.

CBI-Deleted 

CBI-Deleted

CBI-Deleted, 

CBI-Deleted

Sincerely,

Your Name 

Your Title 

Your Address

Your Phone

Contact information may not be 

claimed as CBI, but is often 

protected by FOIA as Personally 

Identifiable Information. 

Each page 

should 

denote 

that the 

copy is 

CBIDeleted 
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