Biotechnology Regulatory Services 

Stakeholder Meeting 

December 5, 2019
Welcome

Doug McKalip

Senior Advisor 

Biotechnology Regulatory Services
Introduction

Greg Ibach

Under Secretary

USDA Marketing and Regulatory Programs
BRS Summary of FY19

A Look Ahead to FY20

Bernadette Juarez

APHIS Deputy Administrator

Biotechnology Regulatory Services
• SECURE Rule

• ePermits eFile Pilot

• Teamwork & ensuring excellent level of 

customer service

FY 19 Primary BRS 

Accomplishments & Progress
Number of 

Authorizations

Number of 

Sites

Number of

Phenotypic Designations 

(crop-trait combination, 

all activities)

1,486 3,283 24,906

Authorized Activities with

Regulated Articles, FY19
Three deregulation petitions completed (Path II)

• Texas A&M low gossypol Cotton

• BASF altered oil profile and herbicide 

resistant Canola

• Verdeca increased yield and glufosinate 

resistant Soybean

Petitions for Deregulation (FY19)
Currently:

10 Petitions in various stages

2 Extension requests

Petitions for Deregulation (FY20)
“Does my GE organism meet the definition of a regulated article 

under 7 CFR part 340?”

• FY 17: 14

• FY 18: 14

• FY 19: 12

• Inquiries under review: 17

• 14 received after 3/31/19 (11 of these after 8/1/19) 

Am I Regulated? 
• With PPQ and States, conducted more 

than 600 safety inspections of authorized 

GE field trials 

• Completed 53 virtual inspections of GE 

field trials

Inspections

10
Biotechnology Unified Web Portal

• Outlined in Executive Order 13874

• Provides capability to query agencies

• Goal: User-friendly tool to navigate the 

regulatory system

• Detailed pages hosted by EPA, FDA and USDA

• Launch anticipated as early as next week

USDA / EPA / FDA
• Soft launch - July 23, 2019

• Transition ePermits  APHIS eFile

• Pilot Program

• Relationship between change in system 

and change in regulations

APHIS eFile
• June 2019 published new proposed rule –

SECURE (Sustainable, Ecological, Consistent, 

Uniform, Responsible, and Efficient)

• Comment period closed August 2019

• Received more than 6,100 comments

SECURE Rule (7 CFR part 340) 
• SECURE - Our No. 1 Strategic Initiative

• Ensuring appropriate staffing resources

• Maintaining excellent customer service

• Close working relations/communications

Looking Forward to 2020

14


Overview of Administration 

Biotechnology Activities

Fan-Li Chou

Biotechnology Coordinator 

USDA Office of the Chief Economist


Regulatory Operations Program 

(ROP) Update

Douglas Grant, Ph.D.

Chief, Western Compliance Assurance Branch

Biotechnology Regulatory Services (ROP)
Release Authorizations Issued in FY18

Number of 

Release 

Authorizations

Number of 

Release Sites 

(authorized, not necessarily 

planted)

Number of 

Phenotypic 

Designations

(crop-trait combos)

382 4,481 32,628
Release Authorizations Issued in FY19

Number of 

Release 

Authorizations

Number of 

Release Sites 

(authorized, not necessarily 

planted)

Number of 

Phenotypic 

Designations

(crop-trait combos)

335 3,283 19,320
Release Authorizations

23

0

200

400

600

800

1000

1200

1400
Authorized Field Release Sites

24

0

2000

4000

6000

8000

10000

12000

19911992199319941995199619971998199920002001200220032004200520062007200820092010201120122013201420152016201720182019
Inspection Selection and Execution

 Compile Post-Planting Report (PPR) data 

• Used to select planted sites (plantings) for inspection 

• Database and GIS

• Consider compliance history

 Lower risk authorizations

• Selected randomly 

• Geographically dispersed

 Higher risk authorizations

• Inspected at least once in each state of release

• Perennials inspected at least once per year

• Pharmaceutical-industrial (PMPI) inspected multiple times 

per year

25
Inspection Execution and Compliance

 Most field inspections are scheduled

• Some are unannounced 

• Some are virtual

 Emphasis placed on species with heightened concern 

(such as perennials)

 Compliance Rates:

• FY18 – 92%

• FY19 – 97%

26
FY18 Valid Release Sites

Total 7,884

27
FY19 Valid Release Sites

Total 7,723

28
29

FY18 Unique Locations Planted

Total 1,315
FY18 Conducted Inspections

Total 706

30

56
31

FY19 Unique Locations Planted

Total 1,131
FY19 Conducted Inspections

Total 636

32
33

Percentage of Inspections Conducted in 

FY14-19

BRS PPQ State

FY14 6.6% 85.4% 8%

FY15 43% 50.7% 6.3%

FY16 56.2% 36.8% 7%

FY17 65% 28% 7%

FY18 69.1% 23.7% 7.2%

FY19 68.8% 25.1% 6.1%
Inspection Numbers

34

Total Inspections Virtual Unannounced

FY18 706 27 43

FY19 636 53 43
Records and Reports

35
ROP FY19 Projects 

36
APHIS GIS Portal – Mapping in the Cloud

 Portal allows BRS to analyze geospatial 

data provided by applicants and obtained 

from inspections

• Map GPS coordinates 

 Part of an APHIS-wide effort to advance 

mapping capabilities within a data-secure

cloud space 

• FedRAMP authorized 

 Mobile Data Collection – *testing*

• App for data collection, during inspections

• Geospatial data synced directly to Portal
Incident Notification 

 Incident may be discovered 

• During inspection

• Third-party report

• Self report

 Compliance inbox: BRSCompliance@usda.gov

 Compliance hotline: (301) 851-3935

 Standard Permit Conditions - 7 CFR 340.4(f):

(10) APHIS shall be notified within the time periods and manner 

specified below, in the event of the following occurrences: 

(i) Orally notified immediately upon discovery and notify in 

writing within 24 hours in the event of any accidental or 

unauthorized release of the regulated article; 38
39
2019 GE Wheat Incident Summary

 APHIS BRS received a report of wheat that survived 

glyphosate treatment in a fallow field in WA

• Incident response late May through early July

 Good cooperation and communication throughout 

the incident with the grower, developer, and WA 

State authorities

 Mitigation plans and compliance agreement

 No evidence that any GE wheat entered commerce, 

trade markets remained open

 Recently BRS collaborated with WSU to develop 

Best Management Practices (BMPs) guidance


United States Department of Agriculture

APHIS eFile Update

BRS Stakeholder Meeting

December 5, 2019

43

Ibrahim Shaqir
United States Department of Agriculture

44

Pieces of 

applicant

feedback 76 received

System 

enhancements 31 completed

Applicant involvement during the pilot has led to tangible 

improvements to APHIS eFile that otherwise would have 

been impossible
United States Department of Agriculture

45

The APHIS eFile Pilot will continue to be the 

avenue where BRS and its stakeholders 

collaborate to develop the best online 

experience 

An update on the full release timeline will be 

shared in early Summer 2020
United States Department of Agriculture

46

A group of BRS employees and pilot applicants met to tackle a challenge identified 

during the pilot: 

...the Previously Submitted Construct feature would not work for applicants

Through their collaboration and close communication, a solution was identified and will go live 

in the coming days!

Collaboration Case Study for Success: 

BRS & Applicant “Previously Submitted Construct Tiger Team”
United States Department of Agriculture

47

Pilot applicants may 

continue to use ePermits for 

all Permit and Notification 

Applications

Join the Expanded eFile Pilot!

Pilot applicants...

Can apply for multi-year permits

Provide input to enhance the system 

Use the new Organizational Access feature

Email us to get involved! efile.communications@usda.gov
United States Department of Agriculture

48

• Exclusive to APHIS eFile

• Allows companies to organize and 

manage their employees’ access 

within the system

XML Compliance Reporting 

APHIS eFile Highlights

Organizational Access
United States Department of Agriculture

THANK YOU!

Questions? Reach out to us at 

eFile.Communications@usda.gov

49

BRS Pilot Applicants

For an incredible job navigating a new system and 

providing helpful feedback! 

BRS Stakeholders

For patience and participation on this journey!
United States Department of Agriculture

Procedures & Formatting 

for Submitting Petitions

Under 7 CFR 340.6

Maxine Ball

Management Analyst 

BRS Communications
United States Department of Agriculture

What We Will Cover Today

 Number of Copies

 Structure and Formatting

 Certification Statement and Signatures

 Completeness of Package

 Marking for CBI

 Guidelines - CBI, CBI-Deleted and No-CBI Deleted Petition 

Versions 
United States Department of Agriculture

Number of Copies to Send

Send (2) two copies of a petition to:

Ms. Cynthia A. Eck

Document Control Officer

Animal and Plant Health Inspection Service, 

Biotechnology Regulatory Services

4700 River Road, Unit 146, 

Riverdale, Maryland 20737-1237
United States Department of Agriculture

Structure & Formatting Fall Under Our Regulations

Structure as follows:

Each petition submission shall be dated.

On the cover page provide the following statement AND a signature:

The undersigned submits this petition under 7 CFR 340.6 to request that the 

Administrator, make a determination that the article should not be regulated 

under 7 CFR part 340. 

(Signature) 

Provide a Statement of Grounds: 

A person must present a full statement explaining the factual grounds why the 

organism should not be regulated under 7 CFR part 340. 
United States Department of Agriculture

Certification Statement & 

Signature Required 

Certification 

The undersigned certifies, that to the best knowledge and belief of the 

undersigned, this petition includes all information and views on which to base 

a determination, and that it includes relevant data and information known to 

the petitioner which are unfavorable to the petition. 

(Signature) 

(Name of Petitioner) 

(Mailing Address) 

(Telephone Number)
United States Department of Agriculture

Administratively Complete?

Is the Petition package complete?

The petitioner shall include copies of scientific literature, copies 

of unpublished studies, when available, and data from tests 

performed upon which to base a determination. 

A complete list of all items required to submit a petition, can be 

found in paragraph (c) of 7 CFR 340.6. 
United States Department of Agriculture

Marking for CBI

Justifying and Marking a Petition for Confidential Business Information:

 If portions of the petition contain trade secret or confidential business information 

(CBI):

– Each page of the petition should be marked “CBI Copy.” 

– Each page of the petition where CBI information was deleted should be 

marked “CBI Deleted” AND marked on each page where the CBI was deleted: 

“CBI Deleted.” 

– If a petition does not contain CBI, the first page of both copies shall be marked: 

“No CBI.” 
United States Department of Agriculture

Use the 

following 

Guidelines to 

prepare CBI 

versions of 

the Petition:
United States Department of Agriculture

Use the 

following 

Guidelines to 

prepare the 

CBI-Deleted 

versions of 

the Petition:
United States Department of Agriculture

Use the 

following 

Guidelines to 

prepare No-CBI 

versions of the 

Petition:
United States Department of Agriculture

Follow Up Questions

BRS Document Control Officer:

Cindy Eck

Cynthia.A.Eck@usda.gov (301) 851-3892

BRS Document Management Analysts:

Maxine Ball Maxine.Ball@usda.gov

Helana Johnson Helana.D.Johnson@usda.gov