BIOTECHNOLOGY REGULATORY SERVICES

BRS Annual 

Stakeholder Meeting

Jessica Mahalingappa 

Associate Deputy Administrator

Animal and Plant Health Inspection Service (APHIS)

Biotechnology Regulatory Services (BRS) 

December 8, 2022
BIOTECHNOLOGY REGULATORY SERVICES

Welcome and Introduction of 

Chief of Staff for Marketing and 

Regulatory Programs

Mike Watson

APHIS Associate Administrator
BIOTECHNOLOGY REGULATORY SERVICES

Agenda 

Overview 

Janice Strachan

Biotechnologist 

Plant Evaluation Branch,

Biotechnology Risk Analysis Programs
Biotechnology/Bioeconomy Executive Order

 Confirmation Requests

 Regulatory Status Review Process

 Q&A Session

 Break

 Permits Update

 Microbes Update

 Compliance Inspections Update

 International Engagement

 Q&A Session 

 Final Remarks and Adjournment

Agenda
BIOTECHNOLOGY REGULATORY SERVICES

Executive Order on the 

U.S. Bioeconomy

Anastasia Bodnar

Agricultural Biotechnology Advisor 

Biotechnology Coordinator for USDA

Acting Bioeconomy Coordinator for USDA
Executive Order on Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and 

Secure American Bioeconomy
Icons by Flaticon, figure adapted from Schmidt Futures

Products

(food, clothes, fuel, 

medicine, and more)

Intermediates

(chemicals, materials)

Biological or chemical

transformation

Starches, sugars

Waste products

 Bioeconomy: economic activity derived from the life sciences 

 Biotechnology: technology enabled by life sciences innovation

 Biomanufacturing: using biological systems to develop products

Terms in the Bioeconomy EO
USDA and the Bioeconomy EO

 Support the “National Biotechnology and Biomanufacturing Initiative”

“Invent it here, grow it here, make it here”

• Improve food security

• Strengthen supply chains 

• Reduce impacts of climate change

• Create jobs across America
EO Sec. 3. Biotechnology and 

Biomanufacturing for Societal Goals

 Report on biotechnology and biomanufacturing research and 

development in food and agriculture

• Improve sustainability, food quality, and nutrition

• Protect against pests and diseases

• Cultivate alternative food sources

 USDA is supporting reports on health, climate, supply chains, and 

cross-cutting research and development 
EO Sec. 5. Building a Vibrant Domestic 

Biomanufacturing Ecosystem

 Plan for U.S. biomass supply chains for domestic biomanufacturing 

and biobased product manufacturing

• Programs to encourage climate-smart production and use of 

domestic biomass 

• Advance food security, sustainability, and needs of underserved 

communities
EO Sec. 6. Biobased Products Procurement

Federal efforts to increase domestic production of biobased 

products

• Train federal purchasing staff

• Publish value of federal biobased product procurement

• Identify opportunities for new categories of biobased products

• Agencies strive to increase biobased product procurement by 2025
EO Sec. 8. Biotechnology Regulation 

Clarity and Efficiency

USDA, EPA, and FDA are co-leading efforts toward regulatory 

clarity and efficiency

• Identify areas of ambiguity, gaps, or uncertainties in the Coordinated 

Framework for Regulation of Biotechnology

• Provide plain-language information on roles, responsibilities & 

processes of each regulatory agency

• Identify regulations and guidance documents that can be created, 

updated, streamlined, or clarified
Additional EO Activities that USDA Supports

 Sec. 4 – “Data for the Bioeconomy Initiative” to identify data types and sources 

needed to advance bioeconomy-related R&D

 Sec. 7 – Plan for training and education; expanded career pathways into 

biotechnology and biomanufacturing

 Sec. 9 – “Biosafety and Biosecurity Innovation Initiative” to encourage best practices

 Sec. 10 – Plan to measure the bioeconomy; common federal bioeconomy lexicon

 Sec. 11 – Plan for securing the bioeconomy; assess and mitigate vulnerabilities of the 

bioeconomy 

 Sec. 12 – International engagement plan; working with foreign partners, 

organizations, and nongovernmental entities to grow the global bioeconomy
Seeking Stakeholder Insights

 Completed five White House-led industry listening sessions on food/ag, health, 

climate, supply chains, and cross-cutting research

 Expected two Requests for Information (RFIs) in December 2022

 Potential virtual public stakeholder listening sessions in January 2023

 Topics of interest include:

• Specific short- and long-term bold goals in food and agriculture that can be achieved 

with biotechnology and biomanufacturing

• How the federal government can work with public and private sectors to achieve 

these bold goals

• Successes and activities that accelerate bioeconomy innovation

• Challenges and opportunities to enhance innovation
Confirmation Requests

 Regulatory Status Review Process

 Q&A Session

 Break

 Permits Update

 Microbes Update

 Compliance Inspections Update

 International Engagement

 Q&A Session 

 Final Remarks and Adjournment

Agenda
BIOTECHNOLOGY REGULATORY SERVICES

Requests for 

Confirmation of 

Exemption from 

7 CFR part 340 Update

Michael Stulberg

Senior Biological Scientist

Biotechnology Risk Analysis Programs

Biotechnology Regulatory Services (BRS)
As of November 7, 2022

Exemption Requests Data

6

9 9

FY21 FY22 FY23

Confirmed

 Confirmation of Exemption 

Requests Confirmed

1

15

31

2

FY20 FY21 FY22 FY23

Confirmation of Exemption Requests 

Received
As of November 7, 2022

Exemptions

b1

54%

b2

13%

PTMOA

33%

 Types of Confirmed Exemption 

Requests

 Single genetic modification that:

• b1 – is a change resulting from cellular repair of a targeted DNA break in the 

absence of an externally provided repair 

template

• b2 – is a targeted single base pair substitution

• b3 – introduces a gene known to occur in the plant’s gene pool, or makes changes in 

the targeted sequence to correspond to a 

known allele of such a gene or to a known 

structural variation present in the gene 

pool

 Has the same plant-trait-mechanism of 

action combination that has previously 

undergone analysis by APHIS and 

determined not to be regulated under 7 

CFR part 340 (petition or RSR)

Exemptions to 7 CFR part 340
Academic

2

Large 

Companies

3

Small and Medium sized 

Enterprises

19

Exemption Data Institution Type

1

1

1

1

2

2

1

1

2

1

2

1

1

1

6

0 1 2 3 4 5 6 7

ALFALFA

APPLE

BANANA

BARLEY

BLACKBERRY

BRASSICA JUNCEA

CAMELINA SATIVA

CORN

COTTON

COYOTE TOBACCO

PETUNIA

POTATO

RICE

SORGHUM

SOYBEAN

CONFIRMED

 Variety of Plants Confirmed 

Exempt
BRS emails technical 

response

BRS sends 

confirmation response 

to sufficiently detailed 

request

Total days with BRS to 

get confirmation 

response letter

34 days 43 days 87 days

Average BRS 

Response Time

As of November 7, 2022
Reorganized the 

sections to better 

clarify what qualifies 

for exemption • Equivalent to 

conventional 

breeding category

• Same Plant-Trait-

Mechanism of 

Action category

On September 1, 2022, USDA-

APHIS published an updated 

Confirmation Request Guide
 Unintended retention of 

exogenous DNA inserted 

as part of the modification 

process

 Modifications to DNA 

sequences that are highly 

similar to the target 

sequence (e.g., sequences 

found in multigene 

families that have the 

same or highly similar 

sequences as the intended 

target, pseudogenes, or 

other conserved 

sequences)

Unintended Modifications
CR Table: 

https://www.aphis.usda.gov/a

phis/ourfocus/biotechnology/r

egulatoryprocesses/confirmations/respo

nses/cr-table

CR Guide: 

https://www.aphis.usda.gov/br

s/pdf/requesting-confirmationof-exemption.pdf

Submit a Confirmation of 

Exemption Request to: 

ConfirmationRequests@usda.g

ov

THANK YOU!
Regulatory Status Review Process

 Q&A Session

 Break

 Permits Update

 Microbes Update

 Compliance Inspections Update

 International Engagement

 Q&A Session 

 Final Remarks and Adjournment

Agenda
BIOTECHNOLOGY REGULATORY SERVICES

Regulatory Status 

Review Process Update

Suma Chakravarthy 

Branch Chief, Plant Evaluation Branch

Biotechnology Risk Analysis Programs

Subray Hegde

Director

Biotechnology Risk Analysis Programs

APHIS Biotechnology Regulatory Services
Regulatory Status Review (RSR)

the biological properties of the plant

the trait (or new characteristic)

the mechanism of action (or how the 

developer caused the new trait to occur)

RSR evaluates plant pest risk based on:
Regulatory Status Review Process (RSR)

Initial review problem formulation 

to identify whether there are 

plausible pathways to increased 

plant pest risk

Plant Pest Risk Assessment (PPRA) 

determines likelihood and 

consequence of any plausible 

pathways in the initial review
The RSR 

Process
Impact of Revised Regulations 

101

29

5

Completed Petitions

Major Biotech Other Companies Public

7

22

5

Regulatory Status Reviews (RSR)

Major Biotech Other Companies Public

19 Crops

1992-2020

20 Crops

2020-Present
RSR Requests 

41%

22%

5%

16%

13% 3%

Crop/Plant categories

Annual/ Row crop Vegetable/ Fruit

Ornamental Tree

Oilseed/ Cover crop Medicinal

72%

28%

Nature of modification 

Transgenes Genome edits
Completed RSRs

Infinite Enzymes 

Corn 

Enzyme for potential 

detoxification 

Agrivida Corn

Improved Digestion 

for Feed

Toolgen Potato

Reduced Browning

Simplot Potato

Improved Product 

Quality and Disease 

Resistance

Norfolk Tomato

Enhanced Nutrition

Technically complete to response in about 390 days 
• Plant species • Trait • Phenotype • Mechanism of 

Action 

Information 

about the 

modified plant

RSR Submission 

Requirements
Information specific to 

the modification

RSR Submission 

Requirements

Genotype of the modified plant  Sequence of the insert/edit • For edits: alignment to 

comparator sequence

 Publicly available reference 

numbers 

 Annotation and function 

description • Component type, 

name, genetic donor, 

function, and base pair 

location
34

Thank you!
Q&A Session

 Break

 Permits Update

 Microbes Update

 Compliance Inspections Update

 International Engagement

 Q&A Session 

 Final Remarks and Adjournment

Agenda
Q&A 
Break
Permits Update

 Microbes Update

 Compliance Inspections Update

 International Engagement

 Q&A Session 

 Final Remarks and Adjournment

Agenda
BIOTECHNOLOGY REGULATORY SERVICES

USDA APHIS BRS 

Permitting 

Update

Deshui Zhang

Branch Chief, Plants Branch

Biotechnology Risk Analysis Programs

Biotechnology Regulatory Services

December 8, 2022
 Update on permits

 APHIS eFile outlook in FY 2023

Overview
FY 2020: APHIS eFile, ePermits, and Legacy biotechnology 

regulations

FY 2021: Transition year, ePermits and Legacy biotechnology 

regulation phased out on April 4, 2021

FY 2022: First full year with APHIS eFile and Revised 

biotechnology regulations

Update on Authorizations – Context
Authorized 

Permits and 

Notifications

0

200

400

600

800

FY 2020 FY 2021 FY 2022

Permit Notification

758

506

261

340

454
Plants Microbes Arthropods

22

89

686

FY 2020

10

76

696

FY 2021

3

97

719

FY 2022

Authorizations – Organism Types
Authorized 

Constructs

14000

16000

18000

20000

FY 2020 FY 2021 FY 2022

19,329

17,467

21,670
Authorized 

Release 

Locations

0

1000

2000

3000

4000

5000

FY 2020 FY 2021 FY 2022

3,047

2,795

4,446
 Import or Interstate movement target timeframe: < 60 days (legacy), 45 days (revised).

 Release and IMR target timeframe: < 120 days (legacy or revised).

Permitting Update – Average Application Duration

Movement Type Import Interstate 

Movement Release

Interstate 

Movement 

and Release

FY 2020 (Legacy) 46 42 67 61

FY 2021 (Legacy) 42 37 66 79

FY 2021 (Revised) 45 43 39 72

FY 2022 (Revised) 43 41 65 84
Investing $1 M to maintain and 

enhance APHIS eFile for BRS 

permitting

 Bug fixes

 Functional enhancements

APHIS eFile Outlook - FY 2023

O&M Surge DSEP

APHIS eFile
Permitting Outlook - FY 2023: APHIS eFile 

CATEGORY Help Text Backlog & Reporting Planting Reports

OBJECTIVE • Increase support of 

application creation

• Clarify BRS 

expectations

• Address bugs and make 

system enhancements

• Improve reporting 

capacity in APHIS eFile

• Improve submission 

success of planting 

reports

RESULT • Draft and submit applications with less assistance 

from BRS staff

• Reduce back and forth discussion during internal 

BRS application processing

• Improve internal BRS processing times

• Independently submit 

and view planting 

reports without BRS 

intervention
THANK YOU!
Microbes Update

 Compliance Inspections Update

 International Engagement

 Q&A Session 

 Final Remarks and Adjournment

Agenda
BIOTECHNOLOGY REGULATORY SERVICES

Permit Requirements for 

Microbes Developed Using 

Genetic Engineering

Martha Malapi

Branch Chief, Plant Pest & Protectants

Biotechnology Risk Analysis Programs 

Biotechnology Regulatory Services

December 8, 2022
Meets the definition of a plant pest; or

Has received DNA from a plant pest, and the DNA 

is capable of producing an infectious agent, or 

encodes a compound, that causes plant disease; 

or

Used to control plant pests and could pose a 

plant pest risk

Modified Microbes
Exemptions from 

Permitting Requirements

Modified Disarmed 

Agrobacterium Species

 A permit for importation or 

interstate movement is not 

required for any disarmed 

Agrobacterium spp.

 Option to request a Letter of No 

Permit Required from BRS for 

importation.

Certain Microbial Pesticides

 A permit is not required for the 

movement or environmental 

release of any modified 

microorganism product that is (1) 

currently registered with the EPA as 

a microbial pesticide and that is (2) 

not a plant pest.
Trends in Permit Applications

0

10

20

30

40

50

60

70

80

90

100

FY20 FY21 FY22

Microbial Permits Issued 

0

10

20

30

40

50

60

70

FY20 FY21 FY22

Bacterial Permits Issued 
Clarity on Regulatory Requirements

House Appropriations Committee (2023 draft): Take measurable steps to establish a 

predictable and science-based regulatory pathway (scope of 340, 

outreach/engagement, scoping for regulatory status review process for microbes).

Executive Order 14081: Identify areas of ambiguity, gaps, or uncertainties in the 

Coordinated Framework; Improve the clarity of the regulatory processes and establish a 

plan for updating or streamlining regulations and guidance documents; and enhance 

the Unified Website for Biotechnology Regulation.

• The Future of Microbial Biotechnology Workshop, Organized by the Innovative 

Genomics Institute and USDA. February 2022.

• U.S. Regulatory Policy Workshop--Genome-Edited Microbial Products for Agricultural 

Use, Organized by CERSA and NC State University. September 2022. 
https://www.aphis.usda.gov/biotechnology/downloads/faq-modified-microbes.pdf

Commonly Asked 

Questions and 

Answers
https://www.aphis.usda.gov/biotechnology/downloads/faq-modified-microbes.pdf

Commonly Asked Questions and Answers

 Reviewed a total of ~ 700 

biotech queries

 152 queries (21%) were specific 

for modified microorganisms

 Most queries were for modified 

bacteria, followed by viruses and 

then fungi
 Microorganisms Regulated Under 7 CFR 

part 340

 Permit Applications for Modified 

Microorganisms

 Information to include

• About the modification to the microbe 

• For movement permits: SOPs for shipping; 

SOPs for containment

• For environmental releases: SOP to ensure 

that field trial is confined in time and space

• In-season activities

• Trial termination

• Post-season/post-trial

• In-season and post-trial monitoring

Synopsis

Guide Under Development
 Current under agency review

 Target posting for public review and 

comment: March 2023

 Target posting of the final version 

on APHIS website: September 2023

Guide Under Development
THANK YOU!
Compliance Inspections Update

 International Engagement

 Q&A Session 

 Final Remarks and Adjournment

Agenda
BIOTECHNOLOGY REGULATORY SERVICES

Compliance and 

Inspection Updates

Doug Grant

Director, Regulatory Operations Programs

Nathaniel Yates

Branch Chief, Compliance Evaluation and Enforcement Branch

APHIS Biotechnology Regulatory Services

December 8, 2022
Planting and inspection data

In-person and virtual inspections statistics

Compliance outcomes

Most common non-compliance issues

Projects in the coming year

Regulatory Operations Programs (ROP)

Statistics, Outcomes, and Projects
FY 2022 Unique Plantings

Total = 833
FY 2022 Conducted Inspections

Total = 663
FY BRS PPQ State

19 69% 25% 6%

20 95% 4% 1%

21 86% 11% 3%

22 83% 13% 4%

Percent of 

Inspections 

Conducted by 

Organization
Quarter New Cumulative

1 41 41

2 114 155

3 120 275

4 388 663

FY 2022 BRS 

Inspections by 

Quarter
 63% in-person inspections in FY 2022 (420 of 663 inspections):

• BRS: 313

• PPQ: 79

• States: 28

 Resumed after travel restrictions eased

 Certain trials (PMPIs, species with higher likelihood of persistence, trials with 

compliance issues) inspected at higher frequency

 Virtual and in-person inspections will continue in FY 2023

Resumption of In-Person Inspections
Compliance Rates

•FY 20 – 95%

•FY 21 – 98%

•FY 22 – 90% 

Notices sent in FY 22: 535

•Trial Compliant: 481

•Trial Non-compliant: 54

•Other outcomes: 2

Compliance Inspection Outcomes
Planting in unauthorized locations 

Not following Supplemental Permit 

Conditions 

Late Planting Reports 

No Planting Report 

No Report of No Planting 

Late Volunteer Monitoring Report

Common 

Compliance 

Challenges
Sharing Draft 

Guide for 

Submitting 

Reports

FY 2023 ROP 

Projects
THANK YOU!
International Engagement

 Q&A Session 

 Final Remarks and Adjournment

Agenda
BIOTECHNOLOGY REGULATORY SERVICES

International 

Collaboration

Jessica Mahalingappa

Associate Deputy Administrator

Animal and Plant Health Inspection Service 

Biotechnology Regulatory Services
International Strategy Main Goals

Provide assurance of the credibility of BRS’ regulations and 

regulatory processes internationally

Build capacity in other countries for regulating agricultural 

organisms developed using genetic engineering using risk-based 

approaches

1

2
FY2022 Successes

 Hosted or participated in over 

15 international engagements

 Collaborated with international 

organizations and trade 

agencies

 Advanced harmonization
 Expand engagement with international 

regulators

 Continue to provide technical assistance to 

trade agencies to safeguard trade and 

minimize disruptions

• Bioeconomy EO International outreach

 International harmonization efforts

• Organization for Economic Cooperation and 

Development

• Trilateral Technical Working Group

• Asia-Pacific Economic Cooperation

FY 2023 Plans
Q&A Session 

 Final Remarks and Adjournment

Agenda
Q&A 
THANK YOU!
Final Remarks and Adjournment

Agenda