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Biotechnology Meeting Archive

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Below is a list of past biotechnology meetings that APHIS has led or led in

coordination with other organizations.

2023 BRS Stakeholder Meeting

On November 15, 2023, Biotechnology Regulatory Services (BRS) held its annual

Stakeholder Meeting to provide highlights from fiscal year 2023, key updates and

plans for fiscal year 2024, including regulatory exemptions, permitting, regulatory

status reviews, and our international efforts.

View Agenda  (62.59 KB)

View Data Snapshot Handout (684.03 KB)

View Presentation (7.11 MB)

View Transcript (330.95 KB)

Watch the Meeting

2022 BRS Stakeholder Meeting

On December 8, 2022, Biotechnology Regulatory Services (BRS) held its annual

Stakeholder Meeting on virtually and onsite. BRS provided updates on the
implementation of the revised biotechnology regulations, including the new

Regulatory Status Review and Confirmation Request processes. They also shared

other fiscal year (FY) 2022 activities, including permitting, questions and answers for

microbes, and international efforts, and priorities for FY 2023.

Agenda (129.29 KB)

2022 eFile Update Handout (143 KB)

Presentation (3.31 MB)

Questions and Answers (chat box questions we were not able to get to during

the meeting) (191.83 KB)

Transcript (318.56 KB)

Presentation

APHIS eFile Training Webinar

On March 29 - April 7, 2022, APHIS' Biotechnology Regulatory Services held a series

of webinar trainings on the APHIS eFile system to show BRS applicants how to use

the updated permit application functionality in APHIS eFile, which was released on

March 28, 2022. Two training topics were available, including Submitting Permit

Applications in APHIS eFile and Post Submission Activities.

Training Resources

2021 BRS Stakeholder Meeting

On Thursday, November 18, 2021 BRS held its annual stakeholder meeting to share

information on the U.S. Department of Agriculture’s Animal and Plant Health

Inspection Service’s (APHIS) revised biotechnology regulations, the new electronic

permitting system—APHIS eFile, a review of fiscal year 2021, and discussion of our

FY 2022 priorities that support protecting plant health through the regulation of

organisms developed using genetic engineering. BRS also held an optional session

on APHIS eFile that will included a demo of APHIS eFile's Permitting Assistant, an

overview of enhancements coming in 2022, and location requirements.

Agenda (88.9 KB)

Presentation (1.49 MB)

Handouts (889.55 KB)
Stakeholder Meeting Transcript (270.03 KB)

Stakeholder Meeting Presentation

Regulatory Status Review Guide Webinar

On Tuesday, September 28, 2021, BRS held a webinar to provide an overview of the

draft Regulatory Status Review (RSR) Guide and an opportunity for stakeholders to

provide feedback and ask questions.

Draft RSR Guide  (548.41 KB)

RSR Webinar Presentation (442.57 KB)

RSR webinar Q&As (160.28 KB)

RSR webinar

APHIS eFile Training Webinar 

On April 5 through April 12, 2021, APHIS hosted a series of webinar trainings on our

new APHIS eFile system. These trainings were designed to support applicants’

transition to APHIS eFile. Four training topics were available, including an

Introduction to APHIS eFile, Submitting Permit Applications, Post Submission

Activities, and Compliance. Learn more about APHIS eFile.

2020 BRS Stakeholder Meeting

On Wednesday, December 9, 2020 BRS held its annual stakeholder meeting. The

meeting is open to all, and is held annually to foster transparency and engagement

in the BRS program. BRS provided information on our ongoing efforts to implement

the new Sustainable, Ecological, Consistent, Uniform, Responsible, Efficient

(SECURE) biotechnology regulations; a look back at FY 2020 and look ahead to our

FY 2021 priorities that support protecting plant health through the regulation of

organisms developed using genetic engineering.

Agenda (80.95 KB)

2020 BRS Numbers Handout (313.6 KB)

2020 APHIS eFile Update Handout (587.9 KB)

2020 Stakeholder Meeting Presentation (751.94 KB)

2020 Stakeholder Meeting Transcript (322.25 KB)
Confirmation Process Meetings

On June 24 and August 5, 2020, APHIS hosted technical webinars to assist

developers with submitting requests to confirm that plants meet established criteria

for regulatory exemption. APHIS reviewed the confirmation of exemption process

and provided stakeholders the opportunity to ask questions. 

Learn more about Confirmations

Confirmations Webinar Presentation (140.22 KB)

2019 BRS Stakeholder Meeting

On December 5, 2019, USDA APHIS' Biotechnology Regulatory Services (BRS) held

its annual Stakeholder Meeting. The meeting is open to all, and is held annually to

foster transparency and engagement in the BRS program. BRS provided information

on past year activities and a look forward to FY 2020; including updates on the

proposed 340 SECURE rule for biotechnology regulations, eFile, and compliance,

regulatory, and policy activities. BRS also introduced our new Deputy Administrator,

Bernadette Juarez.

Agenda and Handouts (1.06 MB)

Presentation (4.22 MB)

Transcript (292.06 KB)

BRS BQMS Foundations Workshop

On September 30, 2019, APHIS' Biotechnology Regulatory Services held a

Biotechnology Quality Management Support (BQMS) Program webinar as part of its

BQMS Foundations Workshop series. The workshop familiarized participants with the

BQMS tools to enhance compliance with current biotechnology regulations at 7 CFR

part 340 regarding the import, interstate movement, and environmental release of

regulated GE organisms.

2018 BRS Stakeholder Meeting 

On November 7, 2018, BRS held its annual Stakeholder Meeting.  BRS hosted two

sessions; the morning session provided information on current BRS activities,
including information on modern biotechnology techniques and the afternoon

session consisted of a demonstration of our new APHIS eFile permitting system that

will replace our current ePermits system in 2019.  

Handouts (558.21 KB)

Presentation (6.87 MB)

Transcript  (477.18 KB)

BQMS and Volunteer Monitoring Information

Webinar

On Thursday September 20, 2018, APHIS’ Biotechnology Quality Management

Support (BQMS) program hosted a webinar on monitoring for volunteers as part of

its “Building Upward” webinar series.  The webinar provided details and supporting

examples on the relationship between volunteer monitoring activities and

compliance with APHIS’ biotechnology regulations. 

BQMS and Confidential Business Information

Webinar

On March 29, 2018 APHIS’ Biotechnology Quality Management Support Program

hosted an interactive webinar to enhance understanding of Confidential Business

Information (CBI).  APHIS' BRS provided a brief overview of the BQMS Program and

described the fundamentals of claiming CBI when submitting documents such as

permit applications, petitions for non-regulated status, notifications, and “Am I

Regulated?” inquiries.

Presentation (1.28 MB)

Updates to Supplemental Permit Conditions

Webinar

On March 8, 2018, USDA APHIS Biotechnology Regulatory Services held a webinar to

familiarize participants with changes to standard supplemental conditions for

permits authorized under the biotechnology regulations at 7 CFR part 340 regarding
the import, interstate movement, and environmental release of regulated GE

organisms. The changes are part of efforts to ensure clear, consistent, and

enforceable requirements in authorized biotechnology permits that protect the

ability of American agricultural producers to prosper.

Supplemental Permit Conditions Update Overview (138.12 KB)

Presentation (519.27 KB)