Biotechnology Regulatory Services

Annual Stakeholder Meeting

November 7, 2018

Meeting Begins At 10:00 AM EST
BRS Reflections on FY18

A Look Forward to FY19

BRS Stakeholder Meeting, November 07, 2018

Michael Firko, Ph.D

APHIS Deputy Administrator

Biotechnology Regulatory Services
Next 9 Slides

FY 18 Primary BRS 

Accomplishments & Progress
Number of 

Release 

Authorizations

Number of 

Release

Sites

Number of unique

Phenotypic Designations 

(crop-trait combination, 

all activities)

387 4,553 14,856

Authorized Activities with

Regulated Articles, FY18
Two deregulation petitions completed

• Bayer dual herbicide resistant cotton

 332 days (Path I target 395 days)

• Nuseed Americas Inc. improved omega-3 canola

 370 days (Path II target, 463 days)

Plus one already completed this FY 

• Texas A&M ultralow gossypol cotton

 362 days (Path II target, 463 days)

Petitions for Deregulation
“Does my GE organism meet the definition of 

a regulated article under 7 CFR part 340?”

– FY 16: 13

– FY 17: 14

– FY 18: 14 (plus 2 answered so far in FY 19)

Inquiries under review: 5 (all received since July)

Am I Regulated ?

6
SDN Am I Regulated Requests (2011-2018)

Site Directed

Nuclease

Number of

Inquires

Number

Pending

Number of 

Responses *

Meganuclease 4 0 4

Zinc Finger 1 0 1

TALEN 9 0 9

CRISPR 11 2 9

TOTAL 25 2 23

* All Responses = Not Regulated. This year: our first SDN 2/3
Published dEIS & dPRA

• 51 comments

• New paper on transmission

Permit Application: Genetically Engineered 

Citrus Tristeza Virus (CTV) for Biological 

Control of Citrus Greening Disease
Horizon Scanning System

• NAS recommendation (“Preparing for Future Products of Biotechnology”)

• Details will be provided by Sally McCammon at 11:20

• Beta release available at https://www.futurebioengineeredproducts.org

USDA / EPA / FDA
Biotechnology Unified Web Portal

• Single point of entry for regulatory information on products of 

biotechnology

• Goal – modern, user-friendly tool for assisting developers, especially 

small developers, navigate the regulatory system

• NAS recommendation

• Set of global pages describing the regulatory system with links to more 

details hosted by EPA, FDA and USDA

• Query tools for questions from one or more of the three regulatory 

agencies

• Launch anticipated in near future

USDA / EPA / FDA
• Afternoon session

• Transition ePermits  APHIS eFile

• Relationship between change in system and 

change in regulations

APHIS eFile
• Withdrew Proposed Rule (PR) for revisions to 340

• Published Notice of Intent (NOI) for programmatic 

Environmental Impact Statement (pEIS)

• 35 comments

• Preparing new PR, draft pEIS, Regulatory Impact 

Analysis (RIA)

340 (7 CFR part 340) 
340, 340, 340

Our No. 1 Strategic Initiative

• Publish:

– Proposed Rule

– Draft pEIS

– Draft RIA

– More to say about 340 as my final topic today

Looking Forward to 2019

13
Current Petitions for Non-Regulated status: 5

1. ArborGen Freeze Tolerant Eucalyptus

• Pending FWS decision on whether to enter consultation

2. Verdecca Increased Yield Soybean

• Draft PPRA and EA in preparation

3. BASF Canola

• Draft PPRA and EA in preparation

4-5. Two petitions received recently 

• Completeness reviews underway

Looking Forward to 2019

14
Issue Permit for Florida-wide release of GE 

CTV as a Biological Control Agent of Citrus 

Greening Disease

Looking Forward to 2019

15
• 17 Universities

• NGOs & Thought Leaders

• Small & Large Biotechnology Developers

• Industry Groups

• Commodity Groups

• Grain Trade, Value Chain

• Tribes

• State Departments of Agriculture

• EPA, FDA, USTR, other USDA Agencies

• 50+ Countries

340 Outreach

16
• Starts with Secretary Perdue’s 

statement on Plant Breeding Innovation

• Flow Chart 

340 Conceptual Framework

17

International Outreach

November 7, 2018 

Ibrahim Shaqir 

Associate Deputy Administrator for International and Emerging Issues

USDA APHIS Biotechnology Regulatory Services
Approach to International Collaboration

Protect Plant 

Health Support 

International 

Trade

Training and 

Outreach
• Foreign Government Capacity Building

• Bilateral and Trilateral Working Groups

• Global Collaboration

• Support for International Trade

2018 BRS International Activities 
Visitors to Washington, DC

(FY2018 total visitors = 86 from 9 different countries)

Diverse visitors:

• Parliamentarians and local legislators

• Government regulatory officials

• Scientists

• Importers of seed, grain, etc.

• Journalists
International Courses and Meetings 

(163 participants from 26 countries)

Workshops, courses, and meetings:

• Michigan State University

• University of Missouri-Columbia

• National Defense University

• China Agricultural University
Frequent Questions

• Do Americans eat food derived from GE crops?

• How do APHIS, EPA, and FDA coordinate roles?

• What resources are needed to implement a system?

• What is your regulatory approach for new plant 

breeding techniques (e.g., gene editing)?

• What is government’s role in co-existence in ag 

production?
Topics:

• Approvals, Consultations, etc.

• Seminars (e.g., Synthetic 

Biology)

• International Organizations

• Chestnut blight resistant trees

Biotechnology Trilateral Technical Working Group
USA – China Technical Working Group (2018)

• Citrus Greening - UF Indian River 

Research and Education Center, 

Fort Pierce, FL

• Regulatory updates

• Public outreach and education

• Regulatory approaches for plant 

breeding innovations
New Breeding Innovation and Genome Editing in OECD

OECD Technical Biotechnology Working Groups 

o Food/Feed (US FDA chairs)

o Environment (APHIS-BRS chairs)

o Biology consensus documents, etc.

o http://www.oecd.org/science/biotrack/

Organisation for Economic Co-operation and Development
Conference on Genome Editing Applications in Agriculture: 

Implications for Health, Environment and Regulation

June 28-29, 2018 

• Ken Ash, Director of the Trade and Agriculture Directorate: 

policies must be “fit-for-purpose” and international 

cooperation can mitigate problems before they arise.

• Three topic areas with speakers and a panel discussion 

1. Animal and plant applications

2. Risk and safety considerations

3. Regulatory aspects
Questions?

BRS International Outreach
United States

Department of

Agriculture

Foreign

Agricultural

Service

International Policy Engagement -

Precision Breeding

Paul Spencer

Paul.Spencer@fas.usda.gov

Director

New Technologies and Production Methods Division 

Foreign Agricultural Service USDA
United States

Department of

Agriculture

Foreign

Agricultural

Service

FAS Worldwide

U.S. Officer + Local Staff

Local Staff Only

Covered Regionally

96 Offices (Posts)

Covering 170 countries
United States

Department of

Agriculture

Foreign

Agricultural

Service

Trade and Innovation Linkages

• Innovation = U.S. Competitive Advantage

• Foreign market ‘signals’ are influential 

• Foreign Acceptance Requires U.S. 

Government Advocacy

• Seeking Regulatory Compatibility 
United States

Department of

Agriculture

Foreign

Agricultural

Service

International Engagement

FY 2018 USDA Efforts

• Collected data on country policies

• Defined main policy risk

• Started engagement based on: 

• Secretary’s March Policy statement on 

Plant Breeding Innovation

• Multilateral cooperation
United States

Department of

Agriculture

Foreign

Agricultural

Service

Global Regulatory Status

Countries with regulatory 

policy with exclusions

Countries with pending policies, 

regulations, or legal rulings

Countries with GMO only 

policy with no exclusions

Argentina, Brazil, Chile, Colombia: 

Case by case approaches; foreign DNA 

insertions generally regulated as GMO

Canada: Not regulated 

unless product identified as 

novel Europe: European Court of Justice 

ruling genome editing techniques 

must be regulated as GMOs

Norway: Proposed; foreign DNA insertion 

regulated; case-by-case tiered approach –

notification, expedited, standard review

Australia: Under review; possibly 

regulated whenever when templates 

involved; case-by-case review

Israel: Foreign DNA 

insertions regulated

China, Korea: Issue 

still being debated; 

no formal guidance

Philippines, Japan: Under 

consideration; Foreign DNA insertions 

likely to be regulated as GMO

United States: developing 

new rule; for plants – USDA 

‘Am I Regulated?’ letters, 

March 28 Statement; 

FDA & EPA under review
United States

Department of

Agriculture

Foreign

Agricultural

Service

Court of European Justice (ECJ) Decision 

What it says

• Genome editing is 

subject to the GMO 

directive

• Member states may 

regulate conventional 

mutagenesis products

• [the European 

Commission is 

studying how to 

implement ruling]

Implications

• Emboldens antitechnology groups

• Negatively impacts 

global agricultural 

innovation and food 

security

• Expands potential 

for trade conflict 

between EU and its 

trading partners

USDA response

• Secretary Perdue 

statement, July 27th

• “Global regulatory 

treatment... has 

strategic innovation 

and trade implications 

for U.S. agriculture”

• Redouble efforts to 

work with partners 

globally
United States

Department of

Agriculture

Foreign

Agricultural

Service

Looking Ahead

FY 2019 USDA International Approach

• Continue building coalitions 

• Limit influence of European Court of 

Justice decision 

• Develop communication themes
United States

Department of

Agriculture

Foreign

Agricultural

Service

Recent International Engagement

International Statement on Agricultural 

Applications of Precision Biotechnology 
United States

Department of

Agriculture

Foreign

Agricultural

Service

Conclusions

• Conflating genome editing with ‘GMO’ 

remains the biggest policy challenge

• Strong trade linkages = need for regulatory 

compatibility

• Many countries off to a good start (but EU a 

challenge)

• USDA is advocating internationally 
APHIS-BRS

Biotechnology Research and

Scientific Engagement 

November 7, 2018

Sally McCammon

Science Advisor

Biotechnology Regulatory Services
Presentation Outline

 Context

 Policy

 USDA-APHIS-BRS Research 

Priorities

 USDA-NIFA and USDA-ARS

 NASEM

 Partnering 

 Engagement

 Informal
The Law

– Codifies protection goals 

• Protect against pests and diseases, weeds, pesticides, etc.

• Regulations implement

Science

– Data and information

– Most aspects of evaluation and management

Policies- use of risk assessment and 

decisions, management

Context

Science

Law

Policy

Politics

Values
Policy

TASK FORCE ON AGRICULTURE AND RURAL 

PROSPERITY

Call to Action #4: Harnessing 

Technological Innovation

Stream-lined, science-based Regulatory Policy 

for Biotechnology

 Coordinate Federal regulation of biotech products

 Coordinate Interagency action through the Office of 

Science and Technology Policy

 Small and mid-sized innovators

 Protect consumers

 Expedite Commercialization of Biotech Products
APHIS-BRS Research Priorities

ANNUALLY IN AUGUST

Weediness

Gene Drives

Comparison of sources of 

genomic variation

RNAi

Comparison of 

potential unintended 

effects 
USDA NIFA and ARS

National Institutes of Food and 

Agriculture

Biotechnology Risk Assessment 

Research Grants (BRARG)

 REQUEST FOR APPLICATIONS

 December 21, 2017

 APHIS-BRS, EPA, FDA, ARS, NIFA

 REVIEWER PANEL

 WORKSHOP May 22, 2018
REQUEST FOR APPLICATIONS: 

ADDRESS ONE OF THE FOLLOWING

 Management Practices to Minimize 

Environmental Risk 

 Methods to Monitor and Understand the 

Dispersal

 Gene Transfer to Domesticated and Wild 

Relatives

 Environmental Impacts of GE relative to Non-GE 

Organisms in the Context of Production Systems

 Other Research Topics
2002 FARM BILL (Section 7210)

GRANT PROGRAM:

 provide the necessary funding for 

environmental assessment research 

concerning the introduction of genetically 

engineered animals, plants, and 

microorganisms into the environment.

AUTHORIZATION OF 

APPROPRIATIONS.— 2) WITHHOLDINGS FROM BIOTECHNOLOGY OUTLAYS for research on 

biotechnology, at least 2 percent for research on biotechnology risk 

assessment.
BRARG

In 2018, thirty-five (35) proposals 

were submitted to the BRARG 

program with awards of $5.4 M 

made for nine research and 

one conference proposals. 
Agriculture Research Service

https://www.ars.usda.gov/ARSUserFiles/np301/NP%20301%20Action%2

0Plan%202018-2022%20FINAL.pdf

Action Plan: National Program 

301: Plant Genetic Resources, 

Genomics & Genetic 

Improvement

2018-2022

Crop biotechnology risk assessment...

Identify and reduce unintended 

effects of biotechnological 

improvement on crop plants, 

agricultural production, and the 

environment 
APHIS SCIENCE COMMITTEE

APHIS-ARS Science Symposium

August, 2018

 Enhancing cross-agency communication for addressing 

scientific problems and engaging with policy-makers and 

stakeholders

 Identifying innovative solutions and technologies for enhanced 

preparedness and prevention

 Best practices in preparing for and preventing potential 

emergencies and for responding to dynamic critical research 

needs
NASEM Authoritative Scientific 

Reports

2016

1987

2017
The Potential for Biotechnology to 

Address Forest Health

 NASEM

 Interagency funded study

 December - publically available 

 International Union of Forest Research 

Organizations Workshop August 2018

 AAAS meeting in DC on Presidents’ Day 

weekend (Feb 16-18, 2019)

http://dels.nas.edu/Study-In-Progress/Potential-Biotechnology-Address/DELSBANR-16-0
Horizon Scanning System

Follow up to March 2017 NASEM report

September 2017, APHIS cooperative agreement 

Environmental Law Institute (ELI) 

– design and development of a horizon scanning system for 

future biotechnology products consistent with the NASEM 

report. 

Alpha version for review and comment

Complete Beta testing of the website with a select group 

https://www.futurebioengineeredproducts.org

PARTNERING
Weed Science Society of America

WSSA and Interagency Engagement

Weed Science 60(sp1):1-1. 2012 

https://doi.org/10.1614/WS-D-12-10001.1

Introduction to the Special Issue of Weed 

Science on Herbicide Resistance Management

Weed Science 60(sp1):2-30. 2012 

https://doi.org/10.1614/WS-D-11-00206.1

Herbicide Resistance: Toward an 

Understanding of Resistance Development and 

the Impact of Herbicide-Resistant Crops
Weed Science Society of America

• WSSA Herbicide Resistance Education Committee and 

USDA OPMP and EPA

• 2018 grant-Actions to further address herbicide 

resistance. 

• planning team meetings on Oct 16 at the EPA and on Oct 

25-28 in Guelph. 

• Two open access articles --HR regional Listening Sessions in 

Weed Technology Vol. 32(4) 

(https://www.cambridge.org/core/

journals/weed-technology ) 

• National forum to include additional 

agencies and stakeholders
Engagement

Organization for Economic Cooperation and 

Development (OECD) 

Technical Working Groups and Biotechnology 

Risk Assessment

-Biology, trait and composition documents

-Emerging Issues-e.g. LLP

-Workshops and Conferences on New Plant Breeding 

Techniques, Genome Editing Applications in 

Agriculture and 

Next Generation Sequencing
2018 'Nuts and Bolts of Biotech Regulations’ Workshop 

(October 3-5, 2018) 

Small and large companies, academics, and other 

potential developers

USDA-APHIS, FDA, and EPA 

Case studies

– American Chestnut

– Golden Rice

– Hypo-allergenic peanut

facilitating technological innovation of safe crops

Guidance for New Users to the Petition Process

Specialty Crops Regulatory Assistance
Informal

BRS Science Journal Club

4 AAAS Fellows

On Sight Presentations

Outreach on 340 

Webinars – Canada and 

Mexico
Tree of Knowledge circa 1490

Thank You!
USDA-APHIS-BRS 

Am I Regulated (AIR) Process:

Implementations of Business Process 

Improvements

November 07, 2018

Bill Doley, BRS Government Relations Specialist
Reduces the frequency of organisms that 

are not regulated articles from entering the 

regulatory system. 

Benefits of the AIR Process
The Am I Regulated (AIR) Process

 A developer who would like agency analysis 

and confirmation that their GE organism does 

not meet the definition of a regulated article 

is encouraged to send a letter of inquiry to 

USDA-APHIS-BRS.

 Instructions for voluntarily submitting “Am I 

Regulated?” inquiries can be found on the BRS 

website.
The Am I Regulated (AIR) Process

 After BRS responds to the inquiry, both the 

inquiry and the response are posted on the 

BRS website.

 Since July 2011, BRS has responded to 70 

“Am I Regulated?” inquiries.

 Some of these inquiries and responses 

relate to the so-called new plant breeding 

techniques (NPBTs).
Posted AIR Inquiry / Response Sets – Screenshot

www.aphis.usda.gov/aphis/ourfocus/biotechnology/am-i-regulated
 Does the GE organism meet the definition of

a regulated article?

1. Is it altered or produced through 

genetic engineering?

AND

2. Is the donor, vector or recipient a plant 

pest?

AIR Legal Analysis
AIR Responses by Category

1 = Some SDN inquiries utilized plant pest components as donor, a plant pest 

vector (Agrobacterium) and/or a plant pest vector agent (TALEN).

2 = The organism is a regulated article; however, these requests relate to the 

movement of non-viable plant parts.

AIR Responses AIR Category

31 No Plant Pest Components

25 Site Directed Nucleases (SDN) 1

6 Null Segregants

3 Nonviable Material 2

1 Not an Organism

1 Not Genetically Engineered

3 Regulated Article

70 Total
Purpose of the AIR BPI Project:

 Make response times more predictable for 

developers.

 Reduce the variance in response times.

 Ensure our responses are more consistent 

from a technical and policy standpoint. 

The AIR Business Process Improvement (BPI) Project
Revised Standard Operating Procedures (Nov 2017)

 New templates and checklists for various steps in 

the AIR process.

AIR Triage Review Committee (Nov 2017)

 Small team to identify any new 

scientific or policy issues early in 

the AIR process.

FY 2018 Improvements to the AIR Process (1) 
Improved Guidance for Developers (Sept 2018)

 Reduction in delays due to Confidential Business 

Information (CBI) issues.

 Reduction in delays due to requests for additional 

information.

FY 2018 Improvements to the AIR Process (2) 
Improved AIR Response Time 

Data Set Timeframe Sample Response Time

Size (months)

Control Phase Jun 2017 - Aug 2018 N=11 Mean 3.5

STD 1.5

BPI Data 2014 - 2016 N=24 Mean 7.9

STD 4.4
Improved AIR Website (Nov/Dec 2018)

 New columns will allow searches by species, 

transformation method, genetic alteration and 

phenotype.

FY 2019 Improvements to the AIR Process

72

Agricultural Biotechnology

Education and Outreach Initiative

Update of Activities

November 7, 2018

www.fda.gov
73

Appropriations Language

A total of $4.5 million has been appropriated for this initiative

P.L. 115-31, Consolidated Appropriations Act, 2017

• "Provided further, That of the total amount made available under 

this heading, $3,000,000 shall be used by the Commissioner of Food 

and Drugs, in coordination with the Secretary of Agriculture, for 

consumer outreach and education regarding agricultural 

biotechnology and biotechnology derived food products and animal 

feed, including through publication and distribution of science-based 

educational information on the environmental, nutritional, food 

safety, economic, and humanitarian impacts of such biotechnology, 

food products, and feed:..."

www.fda.gov
74

Agencies involved

• FDA has established an interagency Steering 

Committee, which includes experts from FDA, 

USDA and EPA.

• The Steering Committee helps guide decisions 

on the Initiative.

www.fda.gov
75

Formative Research

We are conducting formative research to inform 

and guide the formulation of effective 

communication concepts and materials. 

• Literature review

• Public comments

• Audience analysis

• Social listening

• Focus groups 

www.fda.gov
76

Public Listening Sessions

• Public meetings were held Nov. 7 and 14, 2017, in 

Charlotte, NC, and San Francisco, CA, respectively. 

• Comments in person and through docket

– Commenters included consumers, advocacy 

groups, farmers, academia and industry.

www.fda.gov
77

Next Steps

• Develop draft educational materials

• Test draft materials in another wave of focus groups

• Revise educational materials and conduct evaluation of 

materials

• Finalize materials and implement the initiative

• Tentative initiative launch date: Fall 2019

www.fda.gov
78

Knowledge Empowerment
79

Initiative Webpage

• FDA has created a webpage (Agricultural 

Biotechnology Education and Outreach 

Initiative) under the “Resources for You” 

section of FDA’s website where stakeholders 

can keep abreast of the initiative. 

• We plan to update this page as the initiative 

proceeds. 

www.fda.gov
80

Questions?
United States Department of Agriculture

APHIS eFile:

“A Sneak Peek”

BRS Stakeholder Meeting

November 7, 2018 1
United States Department of Agriculture

Welcome

Laura Lewandowski, Chief, Digital Services Support Office – MRP IT

2
United States Department of Agriculture

Agenda

Modernizing APHIS Permitting

Learn Why APHIS is Transitioning Permitting Systems

APHIS eFile Demo

A Preview of the APHIS eFile Customer Portal and BRS Applications

Demo Q&A

Question and Answer Session Following the Demonstration

Preparing for APHIS eFile

Learn How APHIS Will Transition From ePermits to APHIS eFile

3
United States Department of Agriculture

Modernizing APHIS 

Permitting

Mark Davidson, DVM, Deputy Administrator – MRPBS 

Doug Nash, Assistant Deputy Administrator – MRPBS 

4
United States Department of Agriculture

Where We’re Coming From: ePermits

Why does ePermits have to go away?

• Built on Outdated technology (Cold Fusion)

• Increased Maintenance Costs

• Lack of Flexibility

• Scalability Issues

• Embrace Digital Transformation in Federal Government 

5
United States Department of Agriculture

Newer, More Flexible and 

Intuitive User Interface

Reduced Submission Times

Improved Collaboration

Increased System Reliability

IMPROVED CUSTOMER 

EXPERIENCE

Easier to Maintain and 

Update

Better Data Management

Modern Infrastructure

SUSTAINABLE IT PATH

System Architecture for 

Enterprise (APHIS 

CARPOL)

USDA Embracing 

Salesforce

SUPPORTING ONEUSDA

Where We’re Going in Spring 2019: APHIS eFile

BRS Release

6
United States Department of Agriculture

The Journey: 

APHIS Modernization Initiative

USDA is the “Lighthouse” or Pilot Agency for the New Centers of Excellence (CoE) 

Approach to IT Modernization

Five Centers of Excellence Addressed by APHIS eFile

IT Infrastructure Optimization

Cloud Adoption

Customer Experience

Data Analytics

Contact Centers

7
United States Department of Agriculture

APHIS eFile Demo

Monica Galli, Senior Regulatory Specialist, Biotechnology Regulatory Service

Ashok Anant, eFile Product Owner, Digital Services Support Office – MRP IT

Mahvash Taqi, Business Analyst, Accenture Federal Services

8
United States Department of Agriculture

#1: Navigation #2: New Application #3: Application Details 

and CBI

#4: Regulated Articles 

and Constructs

#5: Locations #6: Application Review 

Page

BRS Applicant Experience

9
United States Department of Agriculture

Full Scope of the BRS Initial Release for APHIS 

eFile

At BRS Go-Live, APHIS eFile will also include:

• Applicant Dashboards

• Application Cloning

• Amendments & Renewals

• Self-Reports

• XML Uploads

10
United States Department of Agriculture

Demo Q&A

Monica Galli, Senior Regulatory Specialist, Biotechnology Regulatory Services

Ashok Anant, eFile Product Owner, Digital Services Support Office – MRP IT

Chris Holby, Project Manager, Accenture Federal Services

11
United States Department of Agriculture

Preparing for APHIS 

eFile

Monica Galli, Senior Regulatory Specialist, Biotechnology Regulatory Services

Ashok Anant, eFile Product Owner, Digital Services Support Office – MRP IT

12
United States Department of Agriculture

BRS ePermits Transition Plan

BRS is developing guidance to minimize confusion and disruption during the 

transition from ePermits to APHIS eFile, which will occur in three stages. BRS 

will inform BRS applicants of movement between stages. The following slides 

illustrate guidance for each stage.

What you use ePermits for today will in part determine how you’ll use APHIS 

eFile later.

– Self-Reporting

– New Permit Applications

• Single and Multi-Year Permits 

• Web and XML applications

– Permit Renewals

– Permit Amendments

13
United States Department of Agriculture

Today Stage 1 Stage 2 Stage 3

Submit Self-Report

Submit Self-Report

APHIS eFile 

Go-Live

ePermits

APHIS eFile

Web Planting, Volunteer Monitoring, or Field Test Report 

XML Planting, Volunteer Monitoring, or Field Test Report Upload

Web Planting, Volunteer Monitoring, or Field Test Report 

XML Planting, Volunteer Monitoring, or Field Test Report Upload

ePermits Transition Plan for BRS Permit 

Holders – Reporting Requirements

BRS will accept selfreports on a permit in 

the system that the 

permit was 

originally issued

14
United States Department of Agriculture

ePermits Transition Plan for BRS 

Applicants – New Permit Applications

Today Stage 1 Stage 2 Stage 3

Single Year Permits

Single Year Permits

APHIS eFile 

Go-Live

ePermits

APHIS eFile

Web Applications Accepted

XML Applications Accepted

Web Applications Accepted

XML Applications Accepted

Multi-Year Permits

Web Applications Accepted

XML Applications Accepted

BRS will no longer issue 

any new permits in 

ePermits at stage 3 and 

APHIS eFile will be 

the only way to 

submit all new permit 

applications

15
United States Department of Agriculture

ePermits Transition Plan for BRS Permit 

Holders – Permit Renewal Applications

Today Stage 1 Stage 2 Stage 3

Single Year Permits

Single Year Permits

APHIS eFile 

Go-Live

ePermits

APHIS eFile

Web Interface for Application to Renew Permit

Multi-Year Permits

Web Interface for Application to Renew Permit

BRS strongly 

recommends that

applicants submit 

new permit 

requests in APHIS 

eFile rather than 

permit renewals in 

ePermits

Renew Permit created via Web Application

16
United States Department of Agriculture

ePermits Transition Plan for BRS Permit 

Holders – Amended Permit Applications

Today Stage 1 Stage 2 Stage 3

Amend Active Permit

Amend Active Permit

APHIS eFile 

Go-Live

ePermits

APHIS eFile

Web Interface for Application to Amend Permit

Web Interface for Application to Amend Permit

BRS will accept permit 

amendment requests in 

the system that the 

permit was 

originally issued

17
United States Department of Agriculture

Scope of Future Releases for 

APHIS eFile

How will APHIS eFile grow to meet APHIS’ needs?

• Organizational Applicant

• Usability enhancements based on your feedback

• PPQ Permitting Release

• VS Permitting Release

• Building to meet APHIS’ other customer-facing functions over time:

o Certifications

o Accreditations 

o Registration (AC Annual Reporting is live)

o Other Licensing 18
United States Department of Agriculture

Getting Up to Speed with APHIS eFile

What resources will be available to help applicants learn the new 

system?

User guides

Webinars

FAQs

19
United States Department of Agriculture

Preparing for APHIS 

eFile Q&A

Monica Galli, Senior Regulatory Specialist, Biotechnology Regulatory Services

Ashok Anant, eFile Product Owner, Digital Services Support Office – MRP IT

Chris Holby, Project Manager, Accenture Federal Services

20
United States Department of Agriculture

THANK YOU!

Questions? Reach out to us at eFile.Communications@aphis.usda.gov

21