Biotechnology Regulatory Services 

Stakeholder Meeting 

November 18, 2021
Welcome

Alan Pearson

Assistant Deputy Administrator

Animal and Plant Health Inspection Service (APHIS)

Biotechnology Regulatory Services (BRS) 

November 18, 2021
Agenda

1. BRS Quick Recap of FY 

21 Focus for FY 22 

2. Biotechnology Risk 

Assessment Programs 

Update 

3. Compliance and 

Inspection Update

4. APHIS eFile Update 

5. Q&A

6. International 

Engagement 

7. Departmental Updates

8. Q&A

9. Closing Remarks

10. Break

11. APHIS eFile Breakout 

Session (Optional)
Deputy Administrator Update

Bernadette Juarez

Deputy Administrator

Animal and Plant Health Inspection Service (APHIS)

Biotechnology Regulatory Services (BRS) 

November 18, 2021
 Past

 Present

 Future

FY2021 Rapid Recap
 Addressing Climate Change via Climate Smart 

Agriculture and Forestry* 

 Advancing Racial Justice, Equity and 

Opportunity

 Creating More and Better Market 

Opportunities

 Tackling Food and Nutrition Insecurity 

 Making USDA a Great Place to Work for 

Everyone 

FY2022 USDA Priorities
 Safe return to offices

 Continued implementation of revised 

regulations

• Proposal to expand exemptions

• Litigation

 Biotechnology Quality Management System 

(BQMS) Update

 Animal biotechnology 

FY2022 BRS Priorities 
Biotechnology Risk Analysis 

Programs Update

Subray Hegde

Director, Biotechnology Risk Analysis Programs (BRAP)

Animal and Plant Health Inspection Service (APHIS)

Biotechnology Regulatory Services (BRS) 

November 18, 2021
FY21 Accomplishments

APHIS BRS made determinations on six 

petitions

• Monsanto insect (Lygus) protected cotton

• Westhoff orange-colored petunia

• Pioneer enhanced yield maize

• Pioneer SPTA (seed production technology for 

Africa) maize

• Agrivida phytase maize

• Okanagan non-browning apple 
Confirmation Requests

Received 24 requests 

Completed 13 total and confirmed 7 

(all posted to website)

11 remain in the queue
Authorizations

(October 1, 2020, through Sept 30, 2021 )

Processed 754 authorizations 

• 450 authorizations through ePermits 

• 304 authorizations in APHIS eFile
Regulatory Status Review (RSR) 

Guidance

Published Draft RSR Guidance for 

Review

September 28, 2021, webinar 

presentation to stakeholders on draft 

RSR guidance 

• 177 unique attendees and the recording 

of Q&A will be available soon on the 

APHIS website
Public Comments on the Draft RSR Guidance 

(Comment period closed on October 25, 2021)

 Number of unique comments: 9

• Requests for publication of the RSR risk evaluation 

model

• Suggestion for handling PIPs

• Concern that RSR is focused too broadly and will 

overregulate

• Concern that RSR is focused too narrowly and will miss 

risk

• Clarification about information/data requirement

• Concern regarding handling of CBI

• Clarification about NEPA analysis in RSR 
Update on Confirmation 

Request (CR) Process

Working to revise CR guidance

Updating CR FAQs

Tracking internal steps to monitor efficiency

• Currently averaging 45 days to send a decision 

after receiving a sufficiently detailed request
Guidance on Permits 

 Revising to reflect revised regulatory 

requirements and the capabilities of our new 

permitting system – APHIS eFile

Developing an optional template for Standard 

Operating Procedures (SOP)

• SOP replaces the design protocol requirement to guide 

developers with providing containment information, 

shipment, research, and field trial details
Supplemental Permit Conditions (SPCs) 

Updates

 Updated to align with the revised regulation and improve 

clarity, such as:

• Regulated article -> modified organism, regulated 

organism or regulated material

• References to renewals removed 

– “New authorization” used when appropriate for discussion of 

continuing a planted field trial

• Removed variance references to align with revised 

regulatory shipping requirements

• Responsible person(s) and their agents -> 

Permittee/Permit holder
SPC Updates

Report name changes:

• Planting Report -> Environmental Release 

Report

• Planting unique ID -> Environmental Release ID

• Field Test Report -> Final Environmental Release 

Report
FY22 Focus

Develop a guidance for microbial permits 

Continue reviewing pending petitions, CRs, 

and RSRs
Questions? Comments? 

Deshui Zhang (Permit and CR), 

deshui.zhang@usda.gov; 301-851-3913

Suma Chakravarthy (RSR), 

suma.chakravarthy@usda.gov; 301-851-3897

Martha Malapi-Wight (Microbial Permit), 

martha.m.wight@usda.gov; 301-851-3874

FY 2021 Compliance and 

Inspection Updates

Douglas Grant

Director, Regulatory Operations Programs (ROP)

Phil Mason

Chief, Western Compliance Assurance Branch

Biotechnology Regulatory Services (BRS)

Animal and Plant Health Inspection Service (APHIS)

November 18, 2021
FY 2021 ROP ConOps and Projects

 Carefully tracking authorizations in different 

permitting systems to ensure appropriate 

compliance oversight 

 Reduced hand-offs and time-in-process for 

compliance determinations to improve timeliness 

of any necessary corrective action 

 Engaged stakeholders to resolve issues and answer 

questions
FY 2021 ROP ConOps and Projects

 Continued virtual inspections during pandemic

• Known as Monitoring and Evaluation Interviews 

(MEIs)

• Document exchange of trial records and photos 

• Video conferencing technology for remote 

visualization

• Remote sensing to support trial site compliance 

analysis
Use of Remote Sensing and GIS

 Analyze geospatial data gathered from 

applicants and inspections

• Mapping GPS coordinates 

 Remote Sensing 

• Select best image dates to support 

compliance inspections

• Provides further context to assess 

observations from virtual 

inspections
FY 21 Conducted Inspections

Total = 708

32
% of Inspections 

Conducted By 

Organization

FY 19-21 

FY BRS PPQ State

19 68.5% 25.2% 6.3%

20 95.6% 3.9% 0.5%

21 86.4% 11.0% 2.6%
FY 21 BRS 

Inspections 

by Quarter 

Quarter New Cumulative

1 165 165

2 97 262

3 158 420

4 288 708
Resumption of In-Person Inspections

 In-Person Inspections in FY 21:

• 82 of 708 (11.6%)

– BRS: 42

– PPQ: 22

– States: 18

 Resumed in Q3 after travel restrictions eased

 Focused on higher risk trials (PMPIs, species with 

higher likelihood of persistence, trials with 

compliance issues)

 Will continue using both virtual and in-person 

inspections to evaluate compliance in FY 2022
Compliance Inspection Outcomes

Compliance Rates:

• FY 20 – 95%

• FY 21 – 98%

Notices sent in FY 21:

• Trial Compliant: 98.12%

• Trial Non-compliant: 1.72%

• Other outcomes: 0.16% 
Compliance Trends

Most Common Non-Compliances in FY 21:

• Late or missing reports (PPR/FTR): 45

• Failure to comply with Supplemental Permit 

Conditions: 17

• Failure to comply with Standard Permit 

Conditions: 6

• Release in areas or quantities not authorized: 8

• Failure to timely obtain or maintain 

authorization: 8

• Other: 32

• Total: 116
FY 2022 ROP Projects

Developing guide for submitting required 

reports and notices 

Integrate compliance database components 

into APHIS eFile

Update BRS Inspection Manual to align with 

new worksheets, SPCs, and revised 

regulations

GIS Dashboards to inform decision making 

31
Contact BRS ROP Team

BRSCompliance@usda.gov

Need support?

Questions?

Comments?

 Nate Yates, Compliance Evaluation and Enforcement Branch 

nathaniel.j.yates@usda.gov; 240-499-6542

 Christie Bertone, Eastern Compliance Assurance Branch, 

christie.a.bertone@usda.gov; 919-855-7622

 Phil Mason, Western Compliance Assurance Branch, 

phillip.a.mason@usda.gov; 970-390-9000

APHIS eFile Updates

Miranda Wanex 

Management Analyst 

Animal and Plant Health Inspection Service (APHIS)

Biotechnology Regulatory Services (BRS) 

November 18, 2021
FY2021 Updates

FY2022 Enhancements Overview

Breakout Session:

• BRS Permitting Assistant Demo

• FY2022 System Enhancements

• Upcoming Location Requirements

Agenda
On April 5, 2021, BRS transitioned all new 

applications to APHIS eFile system 

• ePermits remains open for compliance report 

submissions and accessing records

Applicant Guides to APHIS eFile are available:

• APHIS eFile: https://efile.aphis.usda.gov/

• Help > Training

FY2021 Updates
BRS implemented several system changes in 

accordance with revised 7 CFR part 340 

regulations:

• Notifications discontinued

• Terminology aligned 

• Required information adjusted

• Review process updated

FY2021 Updates
BRS Permitting Assistant released

• Interactive tool improves navigating revised 7 CFR 

part 340 regulations

• Displays whether a permit is required based on 

user input

• Indicates possible eligibility for Exemption or 

option for Regulatory Status Review

FY2021 Updates
Exciting updates to APHIS eFile system are 

coming:

• BRS application interface streamlined

• PDF generation improvements

• System improvements to process large data

Late March 2022!

FY2022 Enhancements Overview
Thank You!

APHIS eFile Homepage: 

https://efile.aphis.usda.gov/

BRS eFile Helpdesk:

BRS.eFile@usda.gov

USDA eAuthentication:

https://www.eauth.usda.gov/

International Collaboration

Jessica Mahalingappa

Associate Deputy Administrator

Animal and Plant Health Inspection Service (APHIS)

Biotechnology Regulatory Services (BRS) 

November 18, 2021
FY2021 Successes

 BRS hosted or participated in 

over 20 international 

engagements

 Collaborated with 

international organizations

 Bilaterals and trilaterals with 

Canada, Mexico, Korea, 

Spain, Portugal, UK, EU, and 

Brazil

 Developed an international 

strategy
International Strategy

Three main goals:

1. Provide assurance of the credibility of BRS’ 

regulations and regulatory processes 

internationally

2. Build capacity in other countries for regulating 

agricultural organisms developed using genetic 

engineering

3. Promote harmonization in risk-based 

approaches to agricultural biotechnology 

regulatory systems globally 
International Strategy

 Continue to engage with international regulators

 Continue to provide technical assistance to trade 

agencies to safeguard trade and minimize disruptions, 

as needed 

 Continue to participate in engagements through 

international organizations

• Organization for Economic Cooperation and Development 

(OECD)

• Inter-American Institute for Cooperation on Agriculture (IICA)

• Asia-Pacific Economic Cooperation (APEC)

• World Trade Organization (WTO)
International Strategy

 Continue to engage internationally through 

bilateral and trilateral meetings

• Canada/Mexico, Korea, and Japan

 Bolster international engagements by identifying 

additional economies to target for outreach 
Thank You!

Questions? 

Comments?

Feedback?

jessica.s.mahalingappa@usda.gov
Departmental Updates

Anastasia Bodnar 

USDA Biotechnology Coordinator

U.S. Department of Agriculture

November 18, 2021
 100,000 employees

 4,500 locations

 8 mission areas

 29 agencies and offices

Learn about USDA

U.S. Department of Agriculture
Biotechnology at USDA

Policy

Research

Regulation

Commercialization

Production

Labeling

Promotion

Trade

From innovation 

to table

Images from Freepik
Departmental Priorities in FY 2022

 Addressing Climate Change 

with Climate-Smart 

Agriculture and Forestry

 Advancing Racial Justice, 

Equity, and Opportunity

 Creating More and Better 

Market Opportunities

 Tackling Food and Nutrition 

Insecurity
Sustainable Aviation Fuel (SAF)

Grand Challenge

 Led by USDA, DOE, DOT

 Reduce cost, increase 

sustainability, expand 

production and use

 Meet 100% of U.S. aviation 

fuel demand by 2050

 USDA research in biomass 

feedstock genetics

Learn more about the government-wide Sustainable Aviation Fuels Grand Challenge
Coalition of Action for Sustainable 

Productivity Growth

 Initiated by the U.S. at the UN 

Food Systems Summit

 More efficient, productive, and 

sustainable agriculture and 

food systems

 80 partners, including 14 

countries

Learn about the Coalition for Sustainable Productivity Growth
Agriculture Innovation Mission 

(AIM) for Climate

 Joint initiative led by U.S. 

and UAE

 Climate-smart agricultural 

innovation

• Increase investment

• Enable technical 

discussions

• Establish cooperation

 Over 80 partners, 

including 34 countries

Learn about AIM for Climate
Facilitation of Trade

 Lead agency: Foreign 

Agricultural Service (FAS)

 APEC High Level Policy 

Dialogue on Agricultural 

Biotechnology 

 Topics for 2022:

• Resource sharing

• Communication efforts

• Policy and regulatory 

frameworks

Learn about APEC HLPDAB
Research and Collaboration

 Lead mission area: 

Research, Education, and 

Economics (REE)

 USDA Plant Breeding 

Stakeholder Meeting 

 Animal Biotechnology 

Workshops

 Ongoing research: 

Continuous flowering 

plants to feed astronauts Chris Dardick, USDA researcher, 

evaluates a continuous flowering plum 

plant. Image by Stephen Ausmus.
National Bioengineered Food 

Disclosure Standard 

 Lead agency: Agricultural Marketing 

Service (AMS)

 National standard for disclosing foods that are or 

may be bioengineered

 Mandatory compliance date is January 1, 2022

 Bioengineered foods are foods that:

• contain genetic material modified through rDNA 

techniques and 

• could not otherwise be developed with conventional 

breeding or found in nature

Learn about the National Bioengineered Food Disclosure Standard


Closing Remarks

Alan Pearson

Assistant Deputy Administrator

Animal and Plant Health Inspection Service (APHIS)

Biotechnology Regulatory Services (BRS) 

November 18, 2021
Break

Resuming in 5 minutes
62

APHIS eFile Breakout Session

Miranda Wanex 

Management Analyst 

Animal and Plant Health Inspection Service (APHIS)

Biotechnology Regulatory Services (BRS) 

November 18, 2021
BRS Permitting Assistant Demo

FY2022 System Enhancements

Upcoming Location Requirements

Breakout Agenda
BRS Permitting Assistant Demo
 Upcoming system update addresses:

• Improving large application submission

• PDF generation changes

• XML improvements

• Modernizing application and review interfaces

 Increased flexibility of application sizes and 

ease of use for all developers

FY2022 System Enhancements
 Improving large application submission

• Improved system response for applications with 

large numbers of constructs and locations

• Submit button moves application into submission 

queue

• Applicants receive success email once application is 

submitted and updates are completed

FY2022 System Enhancements
 PDF generation changes

• PDFs no longer generate in preview window

• Applicants click a button to initiate downloadable 

preview

- Time to generate varies depending on application size

• PDF outputs improved throughout application 

process

FY2022 System Enhancements
 XML improvements

• Upload area upgraded to modernized interface

• 10 MB upload limit increased to 20 MB

- Estimated: 20 million characters in XML

• Implement descending upload sorting

FY2022 System Enhancements
 Modernizing application and review interface

• Web application interface upgraded to match newer 

PPQ/VS look and feel

• Current functionality preserved with improvements

• More streamlined internal review interface and 

system improvements to process large data for 

faster application turnaround

FY2022 System Enhancements
 Project completion currently targeted for 

March 23, 2022

 Existing applicants involved in acceptance 

testing of new features

 Contact BRS.eFile@usda.gov to participate

FY2022 System Enhancements
 Updates coming to applicant resources to 

match new interface

 More applicant training provided - dates will 

be announced to existing applicants and 

through BRS stakeholder registry

FY2022 System Enhancements
 Additional fields required starting January 1, 2022

• Fields align with the revised 7 CFR part 340 

• Address fields required for most origins, all 

destinations, and all release locations

- Street Address 1 / <LocationAddressLine1>

- City / <LocationCity>

- Zip / <LocationPostalCode>

• Import permit origin locations require City 

• Provide northwest corner GPS coordinate if street 

address does not exist

Upcoming Location Requirements
 At least one Agent must be included with all 

locations, including origins

• The following Agent fields are required:

- Title / <Title>

- First Name / <FirstName>

- Last Name / <LastName>

- Phone / <DayTelephone>

- Email Address / <Email1>

 Applicants may request more time to adjust 

XML outputs

Upcoming Location Requirements