BIOTECHNOLOGY REGULATORY SERVICES

Biotechnology 

Regulatory Services (BRS) 

Annual Stakeholder Meeting

November 15, 2023
BIOTECHNOLOGY REGULATORY SERVICES

Welcome

Doug Grant

Director, Regulatory Operations 

Programs
BIOTECHNOLOGY REGULATORY SERVICES

Opening Remarks

Jenny Lester Moffitt

Under Secretary of Agriculture for 

Marketing and Regulatory Programs
BIOTECHNOLOGY REGULATORY SERVICES

Some Good News

Bernadette Juarez

BRS Deputy Administrator
The BRS Top 5

The BRS

Top 5

1

2

75% + Small-Medium

Size Enterprises 

78% Cost Savings

3 300%+ Increase 

in Responses

4 100% Consensus

5 80% + In-Person
BIOTECHNOLOGY REGULATORY SERVICES

BRS Workforce 

Update 

Alia Shabazz

Branch Chief

BRS Resource Management Services
BRS Workforce Profile 

 Employee Strength: 83 as of October 1, 2023

 Mission Critical Occupations: Biological Scientists, 

52; Administration & Program Management, 13

 Mission Support Occupations: 8 occupations, 18

 Veterans: 7.22%

 Retirement Eligibility: 17 employees are currently 

eligible to retire and 30 are eligible to retire within 

5 years.
BRS Workforce Forecast

Biotechnology Risk Analysis Programs

Recruit staff with advanced knowledge of microbes and 

trees 

Regulatory Operations Programs

Recruit staff with advanced technical skills and experience 

using GIS & Satellite imagery

Policy, Program, and International Collaboration Branch 

Recruit policy analysts with international knowledge and 

ability to review and interpret regulations and statutes
Organizational Chart
New Staff: BRAP

Alina Davis, Biological Scientist, Plant Evaluation Branch 

• Ph.D. in Biology from the University of Cincinnati

• Postdoctoral research in Texas and Wisconsin in 

invasive ecology

Ariel Heminger, Biological Scientist, Plants and Microbe 

Branch

Ph.D. from Virginia Tech in microbial ecology and 

M.S. in Entomology

Studied biological control agents and invasion biology 
New Staff: BRAP

Jaclyn Motyka Corbin, Biological Scientist, Plants Branch

Ph.D. in Biology: Ecology, Evolution and Conservation 

emphasis from Northern Arizona University

Worked for the US Geological Survey and the US Forest 

Service

Zachary Schultzhaus, Biological Scientist, Plants and 

Microbes Branch

Ph.D. in Plant Pathology and Microbiology from 

Texas A&M University

Worked for the Federal Select Agent Program
New Staff: ROP

Ann Gobei-Bacaylan, Student Intern, Eastern Compliance 

Assurance Branch

• Undergrad student at the University of California 

majoring in ecology and evolutionary biology

• Worked with various sea life

Phuong Thanh Le, Biological Scientist, Western 

Compliance Assurance Branch

• B.S. in biology from UC Davis

• Worked as Agricultural & Standard Inspector for 

Tulare County Agriculture 

Jolene Prochazka, Biological Scientist, Eastern 

Compliance Assurance Branch

• B.S. in cell and molecular biology and M.S. in 

integrated biological sciences from University of Minn

• Worked for PPQ as a Plant Health Specialist
New Staff: ROP

Cindy Stuefer Powell, Biological Scientist, Western 

Compliance Assurance Branch

• B.S. and M.S. in Botany

• Managed various scientific laboratories at the 

University of Nebraska 

Moises Vega, Biological Scientist, Eastern Compliance 

Assurance Branch

• B.S. in Agriculture from the University of Puerto Rico

• Served in the U.S. Navy and worked with APHIS PPQ

Ashley Fehn, Biological Scientist, Compliance Evaluation 

and Enforcement Branch

• M.S. in Environmental Management from George 

Mason University

• Worked for 13 years in the environmental industry
New Staff: PPIC

Lakshmanan (Lak) Ramamoorthi, Science Advisor, Policy 

Program and International Collaboration

• Ph.D. in Food Science and Microbiology from the 

University of Strathclyde, Glasgow, UK

• Started at USDA with Agricultural Marketing Service, 

Bioengineered Food Disclosure program

Joseph Tangredi, Program Specialist, Policy Program and 

International Collaboration

• B.S. in Biology from the University of Nevada Las 

Vegas and a graduate of the University of San Diego 

School of Law

• Practiced law for 9 years and has been a FOIA analyst 

with various agencies of USDA since 2009
New Staff: RMS

David Richardson, Program Assistant, 

Resource Management Services Branch

• A.A. degree in Business Administration and will earn 

a B.S. in Business Administration in December 2023 

from the University of Maryland

• Previous government experience at the US Postal 

Service
Promotions

Laura Andrako, Branch Chief, Eastern Compliance 

Assurance Branch, Regulatory Operations

• M.S. in Plant Pathology from North Carolina State, 

and B.A. in Environmental Studies from Warren 

Wilson College

• Has worked in BRS compliance evaluation since 2015

Suma Chakravarthy, Senior Scientific Advisor, Office of 

the Deputy Administrator

• Ph.D. from Delhi University in India and has several 

years of research experience at Boyce Thompson 

Institute and Cornell University

• Served as a Branch Chief, Biotechnology Risk Analysis 

Programs
Promotions

Samantha Greer, Biological Scientist, Eastern 

Compliance Assurance Branch, Regulatory Operations 

Program

• B.S. in Biological Sciences from North Carolina State

• Started with as an intern with APHIS’ Animal Care 

Program and with BRS since 2011 

Michael Stulberg, Branch Chief, Plants and Insects 

Branch, Biotechnology Risk Analysis Programs

• Ph.D. and M.S. in Molecular Biology from Yale 

University and B.S. in Molecular Biology from 

Kenyon College

• Has worked for USDA since 2012 at USDA’s 

Agricultural Research Service, APHIS’ PPQ, and at 

BRS as a Senior Biological Scientist
Thank you!

18
BIOTECHNOLOGY REGULATORY SERVICES

Update on EO 14081

“Advancing 

Biotechnology and 

Biomanufacturing 

Innovation”

Alan Pearson

BRS Assistant Deputy Administrator
Section 1: 

Statement of 

Policy

“Clarify and 

streamline 

regulations in service 

of a science-and-risk 

based, predictable, 

efficient, and 

transparent system to 

support the safe use 

of products of 

biotechnology.”
Section 8: Biotechnology Regulation

Identify ambiguities, gaps, or uncertainties in the Coordinated 

Framework

Provide plain-language information regarding roles, 

responsibilities, and processes on the Unified Website

Provide a plan with processes and timelines to implement 

regulatory reform

Enable developers to submit inquiries about a particular product 

and promptly receive a single, coordinated response

Provide an annual progress update
Request for Information

Four Overlapping Themes

Regulatory 

Clarity

Regulatory 

Resources

 88 distinct public 

comments submitted

 Sign-on letter with 

6083 signatories

Regulatory 

Coordination Listening Sessions

• USG Jan 12: 281 attendees, 16 

commenters

• BIO Jan 26: 18 commenters

• ASTA Jan 28: 11 commenters

• BPIA Jan 31: 7 commenters

Regulatory 

Reform
Regulatory Clarity

• Increase regulatory clarity and assistance

All Agencies

• Clarity regarding Regulatory Status Reviews 

(RSRs)

• Clarity regarding microbes

BRS
Regulatory Coordination

Align definitions, 

exemptions, data 

and information 

requirements, & 

review timelines

01

Clarify 

jurisdiction and 

harmonize 

approaches for 

microbes

02

Reduce 

duplicative 

oversight

03

Establish 

interagency 

coordination 

mechanism

04
Regulatory Reform

All Agencies

Update regulatory 

frameworks to account 

for genome editing and 

minimize regulation of 

genome edited products

Streamline regulations 

and processes, and 

reduce regulatory 

burdens and duplicative 

regulation

Provide more thorough 

and continuing oversight 

for biotechnology 

products based on the 

entire lifecycle of the 

production process
APHIS Regulatory Reform

Expand exemptions 

Meet regulatory timeframes and reduce regulatory burdens

Streamline procedures and information requirements for 

interstate movement permits

Establish a regulatory off-ramp for modified microbes

Include noxious weed provisions in USDA biotechnology 

regulations
Regulatory Resources

 Appropriately fund, staff, and train employees to 

ensure timely and consistent reviews 

 Develop streamlined, consistent, science-based 

permit templates and review processes to ensure 

reviewers treat similar requests in a similar manner 

and maintain consistency
Positive Feedback

 USDA’s revised 

regulations are “a major 

advance” and “a positive 

step towards risk 

proportionate 

regulations” for which 

“USDA APHIS needs to be 

commended.” 

 The regulatory agencies 

“are doing things that are 

very positive... One of 

these strengths is the 

quality of the scientific 

reviewers and the fact 

that the agencies 

encourage informal pre- submission discussions 

and consultations with 

researchers and 

developers.”
Thank you!

29
BIOTECHNOLOGY REGULATORY SERVICES

Proposal to Add 

Modifications that 

Qualify for Exemption 

from Regulation Under 

7 CFR part 340

Neil E. Hoffman

BRS Science Advisor 
Keeping Pace With Advances 

in Science and Technology 

APHIS may exempt plants with additional 

modifications achievable through 

conventional breeding

Proposals will be based on scientific 

evidence demonstrating that the 

proposed modification(s) could be 

achieved through conventional breeding
Scientific 

Rationale for 

Exemptions:

Treat Similar 

Products in a 

Similar Way

Genetic engineering, in and of 

itself, does not introduce plant 

pest risk

Conventional breeding has a 

history of safe use related to 

plant pest risk

Exempt plants with certain 

modifications achievable 

through conventional breeding
Current Exemptions

A change resulting from cellular repair of a targeted DNA break in the 

absence of an externally provided repair template (b1);

A targeted single base pair substitution (b2); or

Introduction of a gene known to occur in the plant’s gene pool, or a 

change in a targeted sequence to correspond to a known allele of such a 

gene or to a known structural variation present in the gene pool (b3).
New Notice

Introduces new 

modifications 

related to

- Loss of function (LOF) modifications

- Polyploid plants 

- Multiple edits

- Successive edits 

Builds on 

Notice 

published in 

July 2021 that 

sought to

- Clarify the meaning of “single modification” 

- Allow use of an external template to make a 

deletion
Loss of Function on All Alleles (AM1)

 Would exempt certain plants with loss of function mutations 

in the same gene across all chromosomes, regardless of how 

the mutation is generated

 Would apply to modifications without the insertion of 

exogenous DNA in:

• A diploid or autopolyploid plant with any combination of loss of 

function modifications in one to all alleles of a single genetic locus, 

or 

• An allopolyploid plant with any combination of loss of function 

modifications in one or both alleles of a single genetic locus on up 

to four pairs of homoeologous chromosomes
Loss of Function on All Alleles Modifications 

Need Not be Identical (AM1)

Allows identical or non-identical 

changes on a pair of 

chromosomes if the outcome is 

loss of function
Loss of Function on All Alleles 

of a Single Genetic Locus (AM1)

2 sets chromosomes 

diploid 2N

8 sets of chromosomes 

Allo-octaploid 8N

Homoeologous c-somes

4 sets chromosomes 

autotetraploid 4N

Homologous c-somes

*

*

*

*

*

*

*

*

*

*

*

*

*

*
Single Contiguous Deletion of 

Any Size (AM2)

 Would apply to diploids and autopolyploids plants but 

not allopolyploids plants

 Would allow a deletion at the same location on two or 

more homologous chromosomes

 The modification must be a single contiguous deletion 

of any size, resulting from cellular repair of one or two 

targeted DNA breaks on a single chromosome or at the 

same location(s) on two or more homologous 

chromosomes, without insertion of DNA, or with 

insertion of DNA in the absence of a repair template
Deletions of Any Size 

Achieved by Two Breaks (AM2)

Diploids Autopolyploids
Extends (b)(2) and (b)(3) Exemptions 

to Autopolyploids (AM3)

 For all alleles of a genetic locus on the homologous 

chromosomes of autopolyploid

• Would allow a targeted single base pair substitution 

(b)(2)

• Would allow the introduction a gene known to occur in 

the plant’s gene pool or make changes in a targeted 

sequence to correspond to a known allele (b)(3) 
Extends Exemption that Allows a Single 

Base Pair Substitution (AM3)

Diploids Autopolyploids

*

* *

*

*

*
Extends Exemption that Allows the 

Introduction of an Allele in Gene Pool (AM3)

Diploids Autopolyploids

Current allele

Allele in gene pool
Allows Up To Four Modifications (AM4)

 Would apply to diploids and autopolyploids plants, and to 

allopolyploids plants with some limitation

 Modifications could be made simultaneously or sequentially

 Each modification must individually qualify for exemption

 Each modification must be made at a different genetic locus

 Allopolyploids could:

• Contain up to four loss of function modifications in homologous 

alleles; or

• Contain up to four (b)(2) or (b)(3) modifications in a single allele
Allows Up To Four Modifications (AM4) 

2 sets 

chromosomes 

diploid 2N

8 sets of 

chromosomes 

Allo-octaploid 8N

4 sets 

chromosomes 

autotetraploid 4N

*

*

*

* *

*

* * *

*

*

* *

*

*

*

*

*

*

*

*

*

*

*

*

*

*

*

*

*

LOF

Nt 

substitution

Allele 

replacement

LOF
Successive Modifications (AM5)

 Would apply to plants that have completed the 

voluntary confirmation process

 The plant that is the subject of the confirmation 

response must be produced, grown, and 

observed consistent with breeding methods 

appropriate for the species

 If the above criteria are met, the plant could be 

modified using the exemptions available for under 

340.1(b), including any additional modifications that 

may be finalized through the ongoing notice process
Successive Modifications (AM5)

2 sets chromosomes

diploid 2N

8 sets of chromosomes 

Allo-octaploid 8N

4 sets chromosomes 

autotetraploid 4N

*

*

*

* *

*

* * *

*

*

* *

*

*

*

*

*

*

*

*

*

*

*

*

*

*

*

*

*

LOF Nt 

substitution

Allele

replacement

LOF

Make up to 4 modifications that qualify for exemption under 

340.1(b)

Confirmation Request-Exempt Status + Plant/Grow/Observe

For a modified plant confirmed as exempt, additional four 

modifications can be made under 340.1(b) exemptions
Thank you!

47
Break Time

48
BIOTECHNOLOGY REGULATORY SERVICES

Update on the 

Permitting Process

Subray Hegde

Director, BRS Biotechnology Risk 

Analysis Programs
Permitting: Looking 

Back and Forward

 FY2023 Permitting at a Glance

 Flexibilities for Permitting

 Tips for Efficient Permit Processing

 FY2024 Permitting Business Process Improvement 

Project 
FY2023 Permitting at a Glance

Permit Types

296

337

151

0

100

200

300

400

500

600

700

800

Release/IMR

Interstate Movement

Import

1%

12%

87%

Insects Microbes Plants
FY2023 Permitting at a Glance

Average Processing Time (Days)

From Technical 

Completeness

From 

Submission

Import or Interstate Movement 31 50

Release or Interstate Movement and Release 47 87

90% of authorizations were processed within the target 

timeframe based on technically complete to issuance
Flexibilities: 

Permit 

Applications

In Place: 

Multi-year interstate 

movement/import permits for 

plant species and modified 

microbes

Completely updated 

instructional and help text in 

the application User 

Interface (UI)
Flexibilities: Permit Applications

In Place: 

Updated Job Aid for Permit Application

Voluntary Standard Operating Procedures Template

Revised Draft Guide for Submitting Permit Applications for 

Microorganisms

• Posted a second draft version to indicate applicants can submit a 

multiyear (2-3 years) permit application 

• Applicant can submit permit applications for the importation and 

interstate movement of bacteria and fungi at the genus level

• BRS plans to publish a plant pest list in the FY24-25
Flexibilities: 

Permit 

Applications

Multi-year release permit for 

annual plant species

Multiple points of origin and/or 

destinations for import permits

Under Review:

Coming Soon:
Flexibilities: 

Permit 

Applications

Updated Permit User’s Guide

Updated Application and 

Authorization Detail Pages

Updated Instructional Text for 

Sharing Accounts

Coming Soon:
Tips for Efficient Permit Processing

Take advantage of pre-consultation meetings

Only submit a permit application that contains complete 

information 

Monitor your inbox for communications from BRS

Respond quickly if action is required before BRS can continue to 

evaluate your permit application

Consult the APHIS eFile Job Aid and Permit User’s Guide

Consult the voluntary SOP template, as necessary

Provide additional information to help BRS review permits, 

e.g., linked permits
FY2024 Permitting 

Business Process Improvement Project

OBJECTIVE

Reestablish a riskbased and familiaritybased approach for 

reviewing crop-trait 

combinations in the 

permit applications

GOAL

Restore track-record 

of predicable and 

timely issuance of 

permits and 

confidence in BRS’ 

permitting process

APPROACH

Identify opportunities 

to promote consistent 

reviews, address 

inefficiencies, 

implement process 

changes, and 

measure progress 

bi-monthly
FY2024 Permitting 

Business Process 

Improvement 

Project

• Standardized supplemental permit 

conditions for importation/interstate 

movement for plants

• Dedicated staff for permit reviews

Completed Steps

• Document current process

• Measure process steps and identify 

bottlenecks

• Reestablish risk-based and familiarity-based 

categories of organism-trait combinations for 

permit reviews

• Set objective criteria for a technically 

complete permit application

• Improve communications with applicants to 

expedite response to technical deficiencies

Next Steps 
For More Information

APHIS BRS 

https://www.aphis.usdourfocus/

biotechnology

Revised Regulations

www.ecfr.gov/current/title7/subtitle-B/chapter-III/part340?toc=1

Permit User’s Guide

www.aphis.usda.gov/biotechnol

ogy/downloads/permit_guidanc

e.pdf

APHIS eFile

BRS Permitting Assistant 

(usda.gov)
Thank you!

61
BIOTECHNOLOGY REGULATORY SERVICES

Regulatory 

Off-Ramps for Plants

Michael Stulberg

Branch Chief, BRS Biotechnology 

Risk Analysis Programs

Suma Chakravarthy

BRS Science Advisor
Main Pathways to Safely Commercialize

Agricultural Biotechnology Products 

Confirmation Request 

Process

Plants that meet the 

criteria for exemption from 

regulation.

Regulatory Status Review 

Process

Non-exempt plants that 

may nevertheless be 

unlikely to pose an 

increased plant pest risk.

How Are These Processes Performing?
Facilitating Growth in the Bioeconomy

REVISED REGULATIONS 

FY23 COMPLETED 

CONFIRMATION REQUESTS

Major 

Biotech

5% Public

2%

Small to medium 

size enterprise

93%

REVISED REGULATIONS 

FY23 COMPLETED 

REGULATORY STATUS REVIEWS

Major 

Biotech

7%

Public

13%

Small to medium 

size enterprise 

80%

LEGACY REGULATIONS 

COMPLETED PETITIONS

Major Biotech

75%

Public 4%

Small and medium 

size enterprise 

21%

As of Oct 1, 2023
Timely Responses to Increased Number of 

Confirmation of Exemption Requests (CRs) in FY23

40 Timely Responses in FY23

6

9

40

0

5

10

15

20

25

30

35

40

45

FY21 FY22 FY23

Confirmed

CRs Mostly Equivalent to 

Conventional Breeding in FY23

Modifications Achievable 

Through Breeding

86%

Previously 

Reviewed 

Modifications

14%
FY23 

Confirmation 

of Exemption 

Responses

12 Crop 

Varieties 

1 Tomato 1 Potato 1 Apple 1 Sorghum

1 Cotton 1 Citrus 2 Brassica 

Juncea 2 Corn

3 Rice 8 Pennycress 9 Soybean 10 Blackberry
Regulatory Status Review Process

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 to plant pest risk 

identified in the initial review
FY23 

Completed 

Regulatory 

Status 

Reviews

15 Crop 

Varieties

Ohalo Genetics 

Potato Altered 

Nutrition

Simplot Potato 

Improved Product 

Quality & Disease 

Resistance

Infinite Enzymes Corn 

Enzyme for Potential 

Detoxification 

Zeakal Soybean

Increased Oil and 

Protein 

Suntory Flowers 

Limited 

Chrysanthemum 

Altered Flower Color

Moolec Science 

Safflower

Altered Seed Oil 

Profile

Inner Plant Soybean

Fluorescent Reporter

Inner Plant Soybean

Fluorescent Reporter

Inner Plant Tomato

Fluorescent Reporter

Donald Danforth Teff 

Reduced Lodging

Bayer Corn Reduced 

Lodging

University of 

California Davis 

Walnut altered for 

disease resistance 

Light Bio Petunia 

Altered Appearance

G.T. Research Hemp 

with Altered 

Cannabinoid Profile

Ohalo Genetics 

Potato with Altered 

Tuber Sugar Profile

Transgene Genome Edited

Diverse plants and traits not seen in the legacy regulations
FY23 RSR 

Actions 

Completed 21 Initial Reviews in FY23 relative to 3 

in FY2022. Ongoing work for 2 RSRs in Step 2.

Nearly 20% were completed within the regulatory 

timeframes.

Dedicated staff for RSRs and Senior Advisor 

Support.

Creation of new Plants and Insects Branch.

Developing IT platform for RSR management.

By gaining experience, BRS has reduced handoffs 

and made other process refinements.

Obtained approval to pilot test A.I. to scan 

literature for writing documents.
A Snapshot of Pending Requests 

Genome 

Edited 

Transgene 47%

45%

Transgene 

+ Genome 

Edited

8%

RSR REQUESTS

Annual/Row 

crop

42%

Oilseed/Cover crop

23%

Tree

19%

Vegetable/Fruit

16%

PLANTS

As of October 26, 2023
Addressing 

the Pending 

RSRs

• Completion

• Percentage of on-time completion

• Cross-training staff members in 

the RSR review process

Goals for FY24

• Continue implementing efficiency 

gains realized in FY2023

• Forming a team to collect and 

implement process improvement 

ideas to gain efficiency

Evaluation of RSR Process
Suggestions for Developers

Plant-MOA Information

• For plants we are not familiar 

with, can also submit publicly 

available data related to the 

plant’s biology

• Can submit more information 

regarding MOAs that cite 

publicly available data

Tips for Avoiding 

Returned Initial 

Submissions

• Include/annotate all inserted 

nucleotide sequence, including 

spacer sequence 

• Avoid drawing conclusions 

about the plant pest risk of the 

modified plant and

• Do not include non-publicly 

available data outside what is 

required
Thank you!

73
BIOTECHNOLOGY REGULATORY SERVICES

Compliance and 

Inspection Updates

Laura Andrako

Branch Chief, BRS Eastern Compliance 

Assurance Branch
Regulatory Operations Programs (ROP)

Statistics, Outcomes, and Projects

 APHIS eFile upgrades and other improvements

 Inspection data

 Compliance outcomes

 Overview of noncompliance

 New projects
APHIS eFile Upgrades

Stakeholder APHIS eFile Users

• Improved Reporting Experience

- Improved XML uploads, tables

- Ability to create, upload, larger reports

• Ability to delete supporting documents before 

submission

• Centralized method to check compliance status 

before issuing new permits
Other FY 2023 BRS Improvements

Draft Guide for Submitting Data for Reports and Notices in 

APHIS eFile (available for public comments through 

Dec. 11, 2023)

Onboarding and training of four new BRS inspectors

Proactive compliance assistance – 17 engagements
FY 2023 Conducted 711 Inspections 
In-Person Inspections

In FY 2023, 80% of inspections were in-person (571 of 711)

BRS

461

PPQ

86*

State 

Partners

24*

*all PPQ and State inspections were in-person
Compliance Inspection Outcomes

Notices sent in FY 2023 

Compliant 

591

Notice of 

Noncompliance

119

Pending 

Outcomes 

1
Noncompliance 

Documented

During 

Inspection

Approximately 140 Noncompliances

Records (82)

Persistence (15)

Separation (11)

Unauthorized Release (11)

Other (8)

Confinement (8)

Equipment Cleaning (5)
Records

Equipment 

Cleaning 

Records (56)

Volunteer 

Monitoring 

Records (9)

In-season 

Monitoring (6)

Multiple 

Types (5)

Shipping 

Records (3)

Plant 

Reports (3)
Equipment Cleaning Records

• Early and clear notice for new information 

requirements in supplemental permit conditions 

• Proactively monitor inspection trends and 

communicate across inspectorate 

What we can improve

• Recovery/disposition of material

• Complete list of equipment used and cleaned

What you can improve
Records Review

Records help verify what has been done so far

Planting information (acreage, location, constructs), 

shipping information

Separation, confinement

Equipment cleaning

Preventing persistence after trial termination
FY24 ROP 

Projects

Address Public Comments on Draft Guide 

for Reports and Notices

• Publish Final Guide

Business Process Improvement (BPI)

• Re-evaluate risk-based inspection selection process 

based on experience and familiarity

• Streamlining internal inspection procedures

• Update enforcement strategy

Data-driven Proactive Compliance 

Assistance
Thank you!
BIOTECHNOLOGY REGULATORY SERVICES

Exploring Regulatory Off-Ramps 

for Modified Microbes

Chessa Huff-Woodard

Branch Chief

BRS Policy, Program, and International 

Collaboration
Exploring Regulatory Off-Ramps: 

Modified Microbes

Continue to address stakeholder feedback 

Begin developing a contemplated 

framework that enables commercialization 

of modified microbes
Stakeholder Engagement: Microbes

24 

Mar

• Publish a Request for Information 

24 

July

• Review and Analyze Comments

24 

Sep

• Develop Contemplated Regulatory Framework

• Address actionable non-regulatory solutions, in 

coordination with PPQ and EPA under the EO
Thank you!

90
BIOTECHNOLOGY REGULATORY SERVICES

International 

Engagement

Jessica Mahalingappa

BRS Associate Deputy Administrator
ARGENTINA BRAZIL BANGLADESH PHILIPPINES

Bilateral Engagements
Support for Foreign Affairs Agencies

JAPAN TAIWAN KOREA COLOMBIA
Multi-Lateral Engagement

Tri-lateral 

Technical 

Working Group

Inter-American 

Institute for

Cooperation 

in Agriculture

Asia-Pacific 

Economic 

Cooperation
Thank you!
BIOTECHNOLOGY REGULATORY SERVICES

Questions & Answers
BIOTECHNOLOGY REGULATORY SERVICES

Final Remarks

Bernadette Juarez

BRS Deputy Administrator
Thank you for 

joining us 

today!

98