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U.S. DEPARTMENT OF AGRICULTURE

 ANIMAL AND PLANT HEALTH INSPECTION SERVICE

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BIOTECHNOLOGY REGULATORY SERVICES

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STAKEHOLDER MEETING

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THURSDAY

DECEMBER 5, 2019

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The stakeholder meeting convened in

the Conference Room, 4700 River Road, Riverdale,

Maryland, at 1:00 p.m., Doug McKalip, Acting

Communications Branch Chief, presiding.

PRESENT

DOUG McKALIP, Acting Communications Branch Chief,

BRS

MAXINE BALL, Management Analyst,

BRS Communications Branch

FAN-LI CHOU, Ph.D., Biotechnology Coordinator,

USDA Office of the Chief Economist

DOUG GRANT, Ph.D., Branch Chief,

BRS Regulatory Operations Program

GREG IBACH, Under Secretary, USDA Marketing and 

Regulatory Programs

BERNADETTE JUAREZ, Deputy Administrator, BRS

IBRAHIM SHAQIR, Associate Deputy Administrator,

BRS

PUBLIC COMMENTERS

JANE DeMARCHI, American Seed Trade Association

RAY DOBERT, Bayer Crop Science

TIM EYRICH, Southern Gardens Citrus

JAYDEE HANSON, Center for Food Safety
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 C-O-N-T-E-N-T-S

Welcome

 Doug McKalip . . . . . . . . . . . . . . . . 3

Introduction

 Under Secretary Greg Ibach . . . . . . . . . 7

BRS Update

 Bernadette Juarez. . . . . . . . . . . . . .22

Overview of Administration Biotechnology

Activities

 Fan-Li Chou. . . . . . . . . . . . . . . . .40

Oversight Update

 Doug Grant . . . . . . . . . . . . . . . . .67

APHIS eFile Update

 Ibrahim Shaqir . . . . . . . . . . . . . . .91

Confidential Business Information Review

 Maxine Ball. . . . . . . . . . . . . . . . 100

Summary, Wrap-Up and Mingling

 Doug McKalip . . . . . . . . . . . . . . . 110

Adjourn. . . . . . . . . . . . . . . . . . . . . 113
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1:07 p.m.

MR. McKALIP: Okay. Good afternoon,

everyone, and welcome. And good morning to those

who are with us from the West Coast, and from the

Pacific Basin.

My name is Doug McKalip. Most of you

know me as Senior Policy Advisor at BRS. I'm also 

currently pinch hitting, and filling in as the 

Communications Branch Chief for BRS as well.

This is really the stakeholder meeting

of many new faces. And I mean that all around. We 

have a record number of folks registered, and

taking part in this stakeholder meeting.

We have nearly 200 folks that are

participating on the webinar. And we're hoping

that we are able to accommodate everyone who is

trying to sign up electronically. I know the

capacity it right around 200. So hopefully we're

going to be able to get everybody part of the

discussion.

22 This year we want to make sure we have
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1 a chance to have a good discussion, and dialogue,

2 and exchange between our speakers. We've

3 provided a much concise and condensed agenda than

4 maybe what you've been familiar with in years

5 past.

6 We want to hopefully hit on all of the

7 key biotechnology issues that are happening out

8 there, and provide you some updates on the BRS

9 side. And again, have a chance for questions and

10 answers.

11 One area that we won't be able to talk

12 about with you this afternoon is the rulemaking. 

13 As all of you know, I think, in this room and

14 online, we are currently in the process of

15 updating 7 CFR Part 340.

16 And the SECURE Rule is still under

17 development, the final rule, that is. So, we

18 won't be able to have a dialogue with you

19 specifically on contents of the rule. But again,

20 we hope to have a very developed dialogue on a

21 whole host of biotechnology issues.

22 For those of you who want to ask
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1 questions we've got a room mic here on a stand. 

2 WE also have a roving mic a few of the BRS staff

3 will be walking around with.

4 And for those of you participating by

5 webinar, just type your questions into the chat

6 box, and as appropriate we will read those

7 questions for the presenters, and give you a

8 chance to participate that way as well.

9 If you need restrooms they're just

10 outside the room. And there also is a

11 refreshment location nearby too. If we have time

12 we'll take a break. But if we have a very full

13 plethora of questions we may just work our way

14 straight through the agenda without stopping, as

15 appropriate.

16 So, I'm very excited to introduce our

17 first speaker. And I've talked to a lot of BRS

18 staff, and no one could remember the last time

19 that we have had the opportunity to have an Under

20 Secretary address our BRS stakeholder meeting.

21 But I'm really excited to introduce

22 Greg Ibach. He was sworn in as MRP Under
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1 Secretary in October of 2017. And the breadth of

2 programs and missions that he oversees is

3 incredibly large.

4 He has all the ag marketing service,

5 all of APHIS activities. Now a lot of the grain

6 packers and stockyards piece falls under his

7 purview, as well as some FSA programs

8 historically.

9 But you think about the gamut of all

10 the checkoff programs, and grading meat and eggs,

11 and the various pieces all of us are familiar

12 with the APHIS does. The organic program. It's

13 just a massive amount of array of programs.

14 But we've been very pleased to have

15 his unrelenting focus and attention on

16 biotechnology, even given the large scope of the

17 programs that he oversees.

18 He has been an incredible advocate,

19 and very closely involved in helping, and

20 pushing, and leading on biotechnology policy. I

21 know that we're all grateful for that.

22 So, with that, Under Secretary Ibach,
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1 we welcome you to the podium, and look forward to

2 your remarks.

3 UNDER SECRETARY IBACH: So, thank you

4 very much, Doug. And I think that part of, you

5 know, you spend a lot of time talking about all

6 the AMS stuff. But APHIS is equally as diverse

7 and challenging to watch over on a day to day

8 basis.

9 And Caleb Crosswhite is with me today. 

10 Caleb, I stole him from the House Ag Committee,

11 what, six months ago now, maybe, almost? And

12 maybe a little bit longer.

13 And it's been great to, you know, pay

14 backs are double. You know, he wrote a lot of

15 this crap now that he has to deal with. And so,

16 but it's good to have him, and the insight that

17 he had into the legislative side, and now working

18 with us on the implementation, the regulatory and

19 service side of things as well.

20 And, you know, I'm very thrilled to be

21 at MRP. And part of that is because of my past

22 experience as director of ag in Nebraska. I was
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1 a customer of most of the programs now that I'm

2 involved with USDA, as the vendor of those

3 programs.

4 And so, I think it gives me a unique,

5 I've been on both sides of the fence now. And it

6 gives me a unique approach to how I look at some

7 of these issues on the day to day basis.

8 But more importantly, I think, my, the

9 part that I think grounds me and draws me to the

10 biotechnology side of things, or the BRS issues

11 is the farmer in me.

12 And we still have an active farm and

13 ranch in central Nebraska. One of my sons is

14 home on a day to day basis watching over the

15 farm. The other one and his wife live in

16 Minneapolis, involved with agriculture as well.

17 And we have a daughter that lives in

18 Denver that works for the Colorado Farm Bureau as

19 a lobbyist. So, still a family very centered

20 around agriculture and production agriculture.

21 And so, anything that I do I think

22 helps augment those friends and neighbors back in
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1 our home town in Nebraska, as well as across the

2 United States, being more productive are things

3 that I'm really interested in.

4 You know, I think that one of the

5 things, as we talk about what BRS is really

6 focused on, and Bernadette will have an

7 opportunity to talk to you about in more of her

8 individual goals.

9 But, you know, biotechnology provides

10 the opportunity for us to be able to produce safe

11 and affordable food, for agriculture to be more

12 sustainable, for us to add quality to U.S. crops,

13 and for us to, as we're adding that quality, and

14 producing those larger amounts of food that are

15 required, it gives us a chance to be more

16 competitive, or remain competitive on the world

17 wide stage.

18 And so, that's what you developers in

19 the room are, that's your responsibility. And

20 that's your wheelhouse.

21 We also have a lot of BRS people

22 listening in, in the room here today, that are
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1 part of the other side of the equation, the

2 regulatory side.

3 But, and I also like to not

4 necessarily think of us as regulators and

5 innovators, but more as a team working together

6 to be able to bring both sides together and find

7 the solutions that are going to keep brining

8 innovation to farmers and ranchers across our

9 country.

10 And the, as we look at the road ahead

11 I think biotechnology is only going to grow in

12 prominence. We're going to see more innovation

13 coming to the table. We're going to see more

14 opportunities for Government and industry to work

15 together.

16 And so, I'm excited in building a team

17 and a framework here at USDA that allows

18 innovation to flow, and doesn't stifle

19 innovation. And encourages entrepreneurs, public

20 and private universities, as well as very large

21 multi-national companies to be part of bringing

22 that innovation to farmers and ranchers.
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1 And so, the other side of things that

2 I think is emerging is, we've had biotechnology

3 very prominent in the plant industry and the

4 plant world for a number of years.

5 We're now seeing more and more

6 innovation come to the table, and come to the

7 regulatory platform on the animal side of things. 

8 And some of the animal groups have called on USDA

9 to be more involved in that regulatory process.

10 And we're actively involved with

11 conversations to see what our role might be, what

12 FDA's role might be as we move forward, to be

13 able to make sure that animal biotechnology can

14 also make it to farms and ranches in a timely and

15 useful manner as well.

16 Doug mentioned the SECURE Rule that --

17 That's okay. I hear, I get feedback right away

18 on what I'm saying. But Doug mentioned that, and

19 that we're working on it.

20 This is the first time in I think

21 three decades that we're, I think we're going to

22 cross the finish line on updating plant
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1 biotechnology regulations.

2 That's going to give us the

3 opportunity not only to streamline our regulatory

4 process, based on science and risk. But it's

5 also going to give us the opportunity to do more

6 than streamline, to deregulate some things.

7 Biotechnology innovation that could be

8 accomplished through a traditional breeding

9 system, only cutting the timeline down through

10 some of the new technologies like CRISPR and

11 TALEN will give us the ability to maybe say, we

12 don't need to look at those if that's something

13 that could occur in nature.

14 It's also going to give us the

15 opportunity to say if we've already made the risk

16 base analysis, and decided that it's safe and

17 effective, we're not going to continue to require

18 companies to submit there. And we're excited

19 about being able to move forward there.

20 The initial, on the proposed rule the

21 comment period closed on August 6th. We had

22 about 6,100 comments, which I really, we expected
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1 a lot more, didn't we, Bernadette? We thought we

2 would have maybe hundreds of thousands. But, so

3 6,100 was a little bit of a surprise.

4 But I also think that maybe was a

5 result of the process that went through, in that

6 we conducted a very open process. We invited

7 lots of groups and organizations, both supporters

8 of biotechnology, as well as people that were a

9 little bit more skeptical about biotechnology and

10 deregulation, to the table ahead through the

11 process as we were formulating our ideas about

12 how we would write the proposed rule.

13 And so, I think a lot of the

14 discussion was had in a transparent way ahead of

15 writing that rule. And so, hopefully that

16 influenced some of the comments and feedback that

17 we got back.

18 I've referred to Bernadette Juarez a

19 couple of times. And I have to tell you how

20 excited we are to have Bernadette here as Deputy

21 Administrator to lead BRS.

22 I think Bernadette brings some great
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1 experiences with her past assignments here at

2 USDA. And we're just excited to have her and her

3 energy, and that background here. And like I

4 said, she's going to share a little bit more her

5 vision for the future with you here in just a

6 little while.

7 A couple of things, also we have some

8 other great presenters for you to listen to. We

9 have Dr. Fan-Li Chou is here. And she's going to

10 talk about the Executive Order that came out

11 earlier this spring, that we've worked on over

12 the summer to try to work together with EPA, FDA

13 and USDA to streamline the biotechnology

14 regulatory process overall.

15 We also have a unique coordinated base

16 that we're going to be releasing, where it's, you

17 can enter into that, and just access all three

18 agencies' regulatory process through one

19 platform. And so, we're excited about that as

20 well. And so, she'll share that a little bit

21 more with you.

22 I think the other thing that, as you
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1 talk about biotechnology, there's always the

2 issue about trade, and how biotechnology

3 interacts with trade.

4 Because we know that we live in an

5 environment here in the U.S. that is probably

6 more biotechnology friendly and progressive,

7 where other countries are more skeptical. And

8 we've seen times when biotechnology has actually

9 held up trade, or become a barrier to trade.

10 So, as we've been working on the

11 SECURE Rule in a new direction, as we've seen

12 CRISPR and TALEN emerge as promising new

13 technologies and gateways for the future, I

14 personally have spent some time working with the

15 Cartagena protocol countries, meeting with them.

16 I attended a conference in Columbia,

17 soon after the Secretary announced his vision for

18 how we were planning to handle gene editing as a

19 regulatory process.

20 I've also spent time in Japan to

21 communicate with the Asian countries. We know

22 Japan will be an important cog in that Asian
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1 regulatory wheel, that a lot of countries follow

2 Japan's lead, explaining to them what we, what

3 our vision is here in the U.S., and where we

4 think we're headed to be able to have a more

5 uniform approach internationally.

6 So, we know that if we get the western

7 hemisphere, where food is produced, unified, if

8 we get Asia, where the bulk of our customers are,

9 unified, I think we have a smoother road ahead on

10 the trade issues that sometimes are hurdles for

11 biotechnology to move forward.

12 With that I just want to thank all of

13 you for taking time, staff as well as industry,

14 to be here today.

15 I think one of the biggest things of

16 these stakeholder meetings, and the biggest

17 opportunities that they provide is that

18 opportunity for dialogue, and to listen to each

19 other, and hear each other in a more relaxed

20 fashion, than reading something in the newspaper,

21 or interacting over email. This way you can

22 actually have time to sit down and talk.
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1 Secretary Purdue, one of his first

2 stated goals when he came to USDA was for USDA to

3 be the most efficient, effective, and customer

4 friendly department in the Federal Government.

5 And I think that these stakeholder

6 meetings provide one of the greatest avenues for

7 us to really deliver on his expectation, is to

8 open the doors, have stakeholders come in, tell

9 us what you're thinking, tell us where we're

10 performing well, and where we're not performing

11 well.

12 And let's talk about how we can work

13 together, so that we meet those expectations you

14 have for efficiency and effectiveness, and good

15 customer service.

16 With that I would just wish you well. 

17 I guess I'm supposed to take a few questions. 

18 And Caleb is here to decide when they get too

19 hard, and I'm out of my zone of ability to

20 answer. And tell me it's, that my time's up. 

21 But with that, I would, if it's still

22 appropriate, Doug, I would take a few questions.
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1 MR. McKALIP: If you could use the

2 microphone there on the stand? And also, please

3 identify yourself and any affiliations, so we can

4 make sure that we capture that appropriately as

5 well. Thanks.

6 MR. HANSON: I'm Jaydee Hanson with

7 the Center for Food Safety, the nonprofit one. 

8 One of the things, one of the kinds of

9 biotechnology that you didn't discuss is

10 vaccines.

11 I've shared with some of your staff. 

12 But I think that the USDA is one of the bigger

13 vaccine deniers in the country, because we have

14 vaccines that can work with salmonella. We have

15 vaccines that work with other animal diseases

16 that aren't being required.

17 They're not all genetically

18 engineered. It would be good if APHIS, on your

19 website made clear how the different vaccines

20 were made. That's kind of a jumble the way it is

21 listed now.

22 But our friends at the Center for
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Science and Public Interest had petitioned the

USDA to declare some of the worst kinds of

salmonella to be adulterants. And your Secretary

Vilsack in the past didn't move on it.

It would be wonderful if you could

talk about how you would move on that. I saw

today that for swine flu, making progress on

vaccines. It doesn't kill people. It does kill

pigs fast.

So, what are you doing on the

pathogens that kill people? And how are we going

to use biotechnology to develop better vaccines

for those?

UNDER SECRETARY IBACH: Yes. So, I

think that's a great question. Also, some great

feedback, and some good challenges for us to take

a look at as well.

So, I think that not only what

biotechnology does, but what other vaccine

development procedures that are more traditional,

provides an opportunity for, is for us to try to

produce safer food that consumers are desiring. 
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1 And that we need to continue to try to serve

2 those needs out there.

3 That is, on the animal health side of

4 things, we are actually are, have asked for more

5 money. And there's some bills going through the

6 Congress right now that would enhance our budget

7 to be able to review vaccines for animal health,

8 and be able to work them through the system, and

9 make them available in a more timely basis.

10 That's a area that we've operated with

11 the same amount of staff and budget for over a

12 decade, with no enhancements. And we've seen the

13 growth in the expectations. And the products

14 that we're being asked to review grow by the

15 fold.

16 So, we are working together to try to

17 provide Congress technical assistance to make

18 sure we have the resources looking into the

19 future, to be able to meet your expectations, as

20 well as farmers' expectations, and ranchers'

21 expectations.

22 Any other questions? Well, if not,
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1 we'll have plenty of staff around here that you

2 can interact with to, I'm sure you have some

3 questions for individuals around the room, and

4 stuff.

5 Bernadette will be happy to answer

6 even harder questions than that one. And so,

7 thank you very much.

8 MR. McKALIP: Thank you again, Mr.

9 Ibach, for spending your valuable time with the

10 team here this afternoon. We really appreciate

11 you joining us. It's really enhanced our

12 meeting.

13 Our next speaker, Bernadette Juarez,

14 was appointed Deputy Administrator of BRS this

15 August, in August of 2019. Prior to this

16 appointment she served as Deputy Administrator

17 for Animal Care since 2016, where she led the

18 program's many employees in protecting and

19 ensuring the welfare of millions of animals

20 nationwide that are covered under the Animal

21 Welfare Act and Horse Protection Act.

22 She also worked on preparation for
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1 natural disasters and emergencies, and worked

2 with animal owners on those issues as well.

3 Ms. Juarez joined APHIS in 2009, and

4 first as an Investigative and Enforcement

5 Services Deputy Director, for five years. And

6 then as the Director of Animal Care, starting in

7 2013.

8 Before coming to APHIS Bernadette was

9 a trial attorney in USDA's Office of General

10 Counsel, from 2002 to 2009.

11 In 1999 she complete her bachelor's

12 degree from the University of New Mexico, and

13 went on to earn a juris doctor from American

14 University, Washington College of Law, in 2002.

15 I know all of the BRS staff are

16 excited to have her onboard. And we're looking

17 forward to her remarks, as I'm sure all the

18 stakeholders are, in her very first BRS

19 stakeholders meeting. So, please welcome

20 Bernadette to the podium.

21 MS. JUAREZ: Perfect. Good afternoon,

22 everyone. Wow, it's a really cool audience. 
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1 This is really great. So, thank you. Thanks for

2 spending the afternoon with me.

3 I just wanted to first off let you

4 know how excited I am to lead the incredible team

5 here at BRS. I have a team that has outstanding

6 scientific communication and inspection skills,

7 among many others. And I'm lucky to be part of

8 that.

9 I inherited this team from Dr. Firko,

10 who many of you know dedicated his career to

11 protecting plant health, and developing others,

12 really.

13 So now I want to tell you what my

14 vision is for BRS as we move forward together. I

15 want BRS and USDA's biotechnology program to be

16 the very best program in all of Federal

17 Government.

18 I want to lead a team that stay ahead

19 of the pace of innovation, and ahead of the needs

20 of American agriculture. I want a team that is

21 trusted, both domestically and internationally,

22 to make sound transparent decisions that enable
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1 policy alignment, and the productive use of

2 biotechnology around the world.

3 Achieving this vision really requires

4 a very delicate balance between two critical

5 functions, program efficiency and quality review. 

6 And in my view there is an inherent tension

7 between the two of those.

8 You want a thorough and careful

9 review. But given the pace and speed of

10 technology it must be efficient. This tension I

11 think is necessary to ensure that we minimize the

12 risks to plant health, while also maximizing the

13 use of innovation.

14 My role as the leader of BRS is to be

15 aware, and maintain balance of this tension. And

16 as I do that you'll see me do this in a couple of

17 ways.

18 The first thing that you'll see me do

19 is encourage engagement and communication across

20 the board, both with our regulated community

21 within our own organization, with our federal

22 partners, internationally, and of course with
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1 stakeholders who have an interest in plant

2 health.

3 A nice example of the type of

4 interaction that I'm looking for, recently has

5 been occurring in connection with our development

6 of an online permitting system.

7 We've engaged developers to assist us

8 with the development and testing of the system. 

9 And we've been able to make refinements that make

10 the system better for both of us.

11 And that's the exact type of

12 partnership that the Under Secretary was just

13 referencing when he said he wishes for us to not

14 just interact as regulator and developer, but

15 come together to find solutions that actually

16 make us both more productive in the work that we

17 do each day.

18 You'll also see me expanding my team

19 to make sure that they're able, and more able to

20 have the bandwidth to meet the balance that's

21 necessary between program efficiency and quality

22 review.
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1 Just recently BRS announced the

2 vacancy and hiring of 12 new positions to enable

3 the work that we do. These positions will enable

4 us to build the capacity that's necessary to

5 handle our current and future workload in an

6 efficient way.

7 In practice this means that we must be

8 thorough and careful in our decisions, and

9 efficient. And make them in a way that you can

10 come to understand in terms of expectation and

11 consistency.

12 In balancing between program

13 efficiency and quality review we have to work

14 together, and keep in contact and communication,

15 and interact with each other to make sure that

16 we're on the same page moving forward.

17 Often times you have concepts and

18 ideas that we may not turn to immediately, or be

19 aware of. And when we interact together we can

20 implement solutions that are helpful for

21 everybody.

22 I really appreciate the opportunity to
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1 lead this program, to step into a new space here

2 at USDA, a space that I think is a leading area

3 in agriculture.

4 I can't imagine agriculture without

5 biotechnology. And I quite frankly think that

6 it's one of the most special programs here at

7 USDA. So, thank you for the opportunity to lead

8 it.

9 I also appreciate the opportunity to

10 share my thoughts and my vision with you, so that

11 you know what to come to expect from me, and from

12 my team moving forward.

13 So, with that, knowing what's in the

14 future, I'll give a quick overview of what's just

15 happened in the past.

16 Okay. So, in Fiscal Year '19 we had

17 a few primary accomplishments. You heard the

18 Under Secretary say that we focused on issuing a

19 proposed rule involving the SECURE Rule,

20 reviewing 6,100 comments.

21 The rule remains under review within

22 the department. And the next public facing
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1 document that you'll see in connection with this

2 rule is the posting of an update on the

3 regsinfo.gov website, that indicates that it's

4 been accepted for review by the Office of

5 Management and Budget. So, stay tuned, and

6 refresh that page until you -- see that update.

7 We also, and I have to say that I

8 really enjoy working with rules. It's been

9 really great to step in and assist BRS to get

10 this to the finish line. We've made several

11 efforts to do that. And I hope to be the one to

12 get it across the line.

13 With respect to ePermits, I mentioned

14 to you the iterative process that we've engaged

15 with, with developers to start building our new

16 online permitting system.

17 The system is really important. 

18 Because in 2021 APHIS is going to be sunsetting

19 the existing ePermit system that you're familiar

20 with using.

21 So, BRS is really ahead of the game in

22 developing its online system, and integrating it
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with user testing in advance of having an all in

approach with that system.

And I'm really appreciate to the work

that our team at BRS has done, the developers,

and of course our contractor, Accenture.

We've also focused on making sure that

as a team in BRS we're working well together. 

And Dr. Firko was excellent in building a

community of great collaboration in BRS. I'm

lucky to be part of that now. And also ensuring

that we provide excellent customer service.

And when I think of customer service

I think of not only the service that we provide

to the regulated community, but the service that

we're able to provide internationally in

developing shared understanding of the uses of

biotechnology.

So, in 2019 we had 1,486

authorizations for regulated activity. We

authorized these activities at 3,283 sites. And

if you look at the phenotypic designations, there

are almost 25,000 types that were authorized for
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testing in 2019.

And I didn't have a chance to look at

what other countries are authorizing in terms of

field testing and phenotypic designations. But

I'm pretty sure that USDA is ahead of most

others.

We also completed three petitions for

deregulation. We have one for Texas A&M

involving low gossypol cotton, BASF, altered oil

profile and herbicide resistant canola, and

Verdeca has one too, involving soybean.

We have presently nine petitions

pending our review, and two requests for

extension that we look forward to completing.

The Am-I-Regulated process is a

process by which people can voluntarily ask

whether they are regulated or not under Part 340. 

You can see the statistics, that in 2017 we

responded to 14 of those, '18, 14, and in Fiscal

Year 2019 so far we've done 12, or we did 12.

We had a slight decrease in the number

that we completed because we had to divert some
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resources to other projects, like completing the

SECURE Rule.

And also, if you look at the last

statistic, we received 14 requests under the AmI-Regulated process since the mid-year. So,

there's a tiny bit of a rush to get those in the

door, perhaps in anticipation of switching to a

new regulatory framework.

We conducted over 600 inspections in

person, with partners from PPQ and our state

partners as well. A bulk of those inspections,

roughly 75 percent of them were actually

conducted by BRS staff.

We're really glad over the past

several years to be taking on an increasing

number of those inspections ourself, though we do

appreciate the additional bandwidth that PPQ and

our state partners provide.

We did also 53 inspections involving

virtual activities, where we're talking on the

phone to the developers, and exchanging

photographs that we can assess conditions.
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inspection staff, who will give you a rundown, an 

incredible rundown of information on inspections 

later. So, I won't spend much time here.

The Under Secretary also mentioned

that we're working to develop a website with our

federal partners, EPA and FDA. And USDA has the

good fortune of being the one to house that U.S.

biotechnology regulations.gov website, or

.usda.gov website.

We're very excited to see that launch,

which may actually occur later this week, or early 

next week.

This portal is designed to provide

folks with a one stop shop to reach all of the

information you may need to determine which

regulatory pathway, or pathways are necessary in

order for you to commercialize a product.

In addition, it will have a question

box that will allow for the submission of

questions that will be triaged by the three
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1 federal agencies, to ensure that you get the

2 response that you need.

3 We also did the soft launch of the

4 online permitting system. I've talked about this

5 a couple of times, how we've had developers

6 engaged in this process, and made refinements to

7 it.

8 Today you're going to hear an update

9 on this project. And we're encouraging

10 additional folks to begin to move over to this

11 new online permitting system.

12 If you've ever received a permit in

13 the past, or you're a permit applicant this is a

14 really great time to think about doing this,

15 because eventually everyone's going to be there.

16 And then we have the SECURE Rule. 

17 We've talked a lot about it. Unfortunately I

18 can't give you all the very good secrets that I

19 suspect is driving the large crown here today.

20 But I can say that everyone is very

21 supportive of seeing this move forward. It's

22 been long in the tooth, in terms of having an
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1 opportunity to update our regulatory framework.

2 We certainly look forward to launching

3 it. And we hope to see others align with USDA's

4 philosophy on overseeing biotechnology.

5 So, looking forward into 2020, our

6 number one goal will be seeing the SECURE Rule

7 through. Once you see it posted on the

8 regulations, reginfo.gov website, OMB has by

9 statute 90 days to review the rule. And they may

10 request an extension of an additional 30 days.

11 So, it could be at OMB for a while. 

12 We certainly hope that's not the case. But I

13 just wanted to provide you with some expectations

14 of timeframe, once you see that rule posted for

15 OMB review.

16 We'll also continue to make sure that

17 we have adequate staffing in the right places in

18 BRS. I mentioned to you that we have incredible

19 skills, and scientific and technical expertise in

20 BRS.

21 And I am so excited about expanding

22 and building that further, so that we can have
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the very best biotechnology team in all of

Federal Government.

And of course, I want to maintain the

close working relationship that I have with you

all, and that Dr. Firko has worked to first

establish. And I look forward to expanding.

And I'm glad to be here with you

today. I'll be around after the meeting. If you

have a chance, please come up and introduce

yourself, so I can get to know you. And when I

see your email or your telephone message, I'll

know who's writing or messaging me. That's it. 

Now, I get the questions.

MR. McKALIP: So, if folks have

question, either put your hand up, and Colleen

Wood can bring a roving microphone, or if you

want to go up to the mic stand, that would be

great.

Bernadette, we did have a question

submitted from the webinar from a researcher who

does agricultural research here in the U.S., but

works a lot with India.
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1 And they would like to know, as the

2 rules change, as we update our rule, what is your

3 vision for ensuring a common understanding on the

4 international community working with nations like

5 India, so that we understand each other's

6 requirements going forward?

7 MS. JUAREZ: Thank you for that

8 question. That's an area of particular focus and

9 emphasis for me. I worry about the differences

10 in requirements around the world, and look

11 forward to seeing greater alignment sometime in

12 the near future.

13 Until then we'll be spending plenty of

14 time with our trading partners, talking about the

15 content of the SECURE Rule, and the scientific

16 basis for the changes that we've made to the way

17 that we're evaluating biotechnology.

18 We also look forward to hosting

19 visitors who come to the United States. I'm

20 looking at Dave Heron, in the back right here. I

21 had the great fortune of sitting in with Dave on

22 a briefing with two Borlaug Fellows from Rwanda,
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1 who were looking to develop the biotech framework

2 in that country.

3 We'd love to be part of that. We'd

4 love to help countries who are contemplating

5 potential changes to their regulatory framework,

6 or establishing their framework.

7 I understand that India at one time

8 had a very active biotech program. There was

9 some stepping back for a while. And now India's

10 re-engaging. So, we look forward to working

11 closely with them. Yes.

12 MR. DOBERT: Hi. Ray Dobert with

13 Bayer Crop Science. So, Bernadette, you

14 mentioned that you have, you're looking to hire

15 about a dozen new staff persons. But you didn't

16 specifically mention what specific areas do you

17 think there's a need for additional staffing?

18 And what, so I don't know if there's

19 specific plans with those additional folks. But

20 what are the kind of areas that you're staffing

21 up in?

22 MS. JUAREZ: The 12 positions that I
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1 mentioned are all biological scientists that will

2 help with the evaluations for permits and

3 petitions, or other requests under the rule.

4 MR. McKALIP: Bernadette, we had

5 another question submitted on the webinar. This

6 one comes from Steve Davies with Agra-Pulse. And

7 he asked, to the extent you are able to share

8 what you believe the timing would be of issuance

9 of the final SECURE Rule? That might be a

10 question for Mr. Ibach, and/or Bernadette.

11 MS. JUAREZ: We are making wonderful

12 progress on the rule. And I don't wish to jinx

13 it by making any estimate as to its anticipated

14 publication. Although, I will say that I'd be

15 sorely disappointed if I didn't see it happen

16 relatively soon. Any other questions? Yes.

17 MS. DeMARCHI: Hi. Jane DeMarchi from

18 ASTA. In terms of outreach after the SECURE Rule

19 is finalized, there are going to be maybe some

20 other crops that are less used to coming to BRS

21 that -- Do you guys have plans to do some

22 outreach with additional crop sectors, and other
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1 crop developers?

2 MS. JUAREZ: Thanks for that question. 

3 We're still working out our implementation plan

4 for the SECURE Rule. And I see that outreach

5 will certainly be a strong component of that. We

6 did a lot of that in developing the initial

7 proposed rule.

8 So, we'll make sure to touch base with

9 folks who may be new to the regulatory framework,

10 or who may be coming through BRS's system for the

11 first time, and make sure that they have the

12 information they need to work with us. Did I

13 screw up? No? Is that it?

14 MR. McKALIP: Other questions from

15 folks in the room?

16 MS. JUAREZ: Okay. Well, thank you. 

17 Then, I'm finished.

18 MR. McKALIP: Thanks, Bernadette. 

19 We're excited to have Fan-Li Chou join us this

20 morning. I've been lucky enough to know Fan-Li

21 for a number of years, and worked with her, as

22 many of us in the room have in various
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1 capacities.

2 In her current position, which is

3 Biotechnology Coordinator for USDA, she really is

4 an ombudsman across the department in research in

5 the regulatory side and the communications side,

6 and the international trade piece as well. And

7 we're really lucky to have her in that role.

8 Dr. Chou has over ten years of

9 experience at USDA, including positions with FAS,

10 and as well with APHIS as well, here in this

11 building.

12 She has represented USDA in various

13 bilateral and multilateral negotiations,

14 including the Cartagena Protocol on Biosafety. 

15 She is a alumni of the AAAS Program, which I know

16 we've got a lot of those in the room here this

17 afternoon as well. So, please join me in

18 welcoming Fan-Li to the podium.

19 DR. CHOU: Hi, everyone. It's so

20 great to be back in this building. This building

21 has a very special place in my heart, because

22 this is where my career with USDA began as a AAAS
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1 Fellow, knowing absolutely nothing about USDA.

2 So, it's been such a great pleasure to

3 serve USDA here. And I want to thank the BRS

4 team for inviting me to just give you guys a

5 broad overview from a USDA perspective, and also

6 from a USG perspective what our priorities are

7 moving forward.

8 And as I was thinking about how to

9 talk about the Executive Order in a more exciting

10 way, rather than just reading about what we have

11 been asked to do, without any additional funding,

12 mind you, I thought about this a lot.

13 And I think a lot of what we are

14 working towards, I think what Bernadette's team

15 is working on, and what our FDA colleagues, and

16 everyone around here is working towards access

17 and choice.

18 And from this perspective, I mean, we

19 are here to provide access and choice to U.S.

20 farmers, to U.S. producers. And we want our

21 farmers to have the best available tools to do

22 what they need to do. And to have them have the
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1 ability to make that choice, of using what, the

2 tools that they need for the situations they have

3 at hand.

4 And we want this access and choice not

5 just to be available to U.S. farmers and

6 producers, but globally to other farmers and

7 producers.

8 But this access and choice is just not

9 limited to farmers and to producers. It also

10 needs to be centered towards the research

11 community.

12 And I think this is really important

13 for USDA. Because besides regulatory policy, and

14 trade policy, we have a tremendous amount of

15 research capacity.

16 So, we want our scientists to be able

17 to use these tools to develop new innovations

18 that our farmers can access. And we want this

19 access and choice available not just to our

20 scientific community, both public and private,

21 but globally as well.

22 So lastly, I want to talk about access
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1 from the consumer perspective, right. Not just

2 consumer at the supermarket, but consumer along

3 the value chain, your corn refineries, your seed

4 providers, your supermarket manufacturers.

5 Those producers, they need to have

6 choice and access as well. How do we provide the

7 variety of food that we are so used to in this

8 country? How do we expand that choice, maintain

9 that choice and access in the U.S., and expand

10 that access and choice globally?

11 So, with that kind of access and

12 choice as our two top kind of major goals in

13 mind, this is kind of how I think about the work

14 that we all do around here.

15 So, as many of you know, and Under

16 Secretary Ibach mentioned, in the summer of this

17 year a Executive Order came out of the White

18 House. And this was a lot of work, leading up to

19 this Executive Order being published.

20 And this Executive Order is actually

21 a continuation of a lot of the work that has been

22 done throughout the years. So, in 2017 we
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1 updated our coordinated framework. That has not

2 been updated for many years. We also put out a

3 national strategy on biotechnical regulatory

4 framework.

5 And this Executive Order kind of

6 carries on that progress of, what do we need to

7 do from a Government perspective, not just USDA,

8 but as a U.S. Government, to create that enabling

9 environment where our farmers, our producers, our

10 customers, our scientists, have that access and

11 choice, right?

12 So, you can read the Executive Order. 

13 But the way I read it there's two major

14 components. One component is regulatory reform.

15 As Bernadette says, we've been doing

16 this for 30 years. USDA, FDA, EPA, we've had a

17 great and efficient process in putting out, or

18 ensuring that we're delivering safe technological

19 tools to our farmers.

20 So, what have we learned in those 30

21 years? And how do we become more efficient in

22 providing that benefit? So, the regulatory
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1 reform part of the Executive Order is doing just

2 that. It's asking USDA, EPA, and FDA to look at

3 our guidances and our regulations, and see how

4 can we improve? How can we do better? How can

5 we be more efficient? How can we be more risk

6 proportionate in our approach? That's one

7 aspect.

8 It actually specifically calls out

9 genome edited plant products. And I think this

10 was, it's really important. Because as you look

11 at the research community, and the amount of

12 information, and amount of publication that's

13 coming out from there, you can see the great

14 potential that this tool can have across our

15 agricultural sector.

16 And not just for row crops, but across

17 a great variety of applications. And I think

18 that's where the excitement was. That's why the

19 Executive Order highlighted that specific sector,

20 right.

21 So, this is kind of the regulatory

22 reform. And the SECURE Rule is USDA's way of
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1 meeting that mandate under the Executive Order. 

2 It's very much aligned with that.

3 And we're a bit ahead of our sister

4 agencies, FDA and EPA. And they are also working

5 under this Executive Order to look at their

6 regulations and their guidance documents, to see

7 where they can make efficiency changes as, based

8 on science, and based on experience.

9 So, we're looking forward to see our

10 sister agencies kind of catch up with our

11 progress.

12 The other component of the Executive

13 Order that I want to talk about is this other,

14 the non-regulatory piece. This is more about,

15 you know, as regulators, as scientists we're very

16 confined in our work. We look at the assessment. 

17 We look at the risk. And we put out a product.

18 And whether people want that product

19 has so many different components, right. It's

20 not just about USDA, FDA saying it's safe. It's

21 about a lot of other things that I am not an

22 expert in, and slowly becoming more appreciative
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And so, the Executive Order is asking

us, and I think this is, our Secretary's also

asking us, is actually to be more, he would call

out there, to be more extroverted about

communicating our story about agriculture.

So, in that way, one, we want to

improve our communication with the regulated

community. And this is one way the USDA MRP, I

think Bernadette's team is leading developing

this single platform where anyone, mostly this is

aimed at the regulated community, can have one

point of access for all the regulatory

information, and to have one point of access to

ask a question.

And like many, many other, almost all

other countries, we have three separate agencies,

three separate doors that you may have to, or now

always walk through.

This can be quite daunting for folks

that do not have 200 regulatory folks like the

major companies to walk through. So, for us this
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1 is a mechanism for us to streamline that process.

2 That you can have one point of entry

3 to ask us questions. And we all can scramble

4 behind the scene and provide you with a

5 consistent and coordinated answer. So, that's

6 one way.

7 But the regulated community is just

8 one aspect. The Executive Order has tasked USDA

9 to lead in developing a domestic engagement

10 strategy.

11 And this is building on what FDA is

12 already doing with their Congressional issued

13 mandate. And this actually came with money. Our

14 mandate came with no money.

15 So, FDA has this initiative that FDA

16 funded, that, sorry, that Congress has funded, to

17 get out there and educate and outreach with the

18 community about how ag biotech is being used in

19 the food sector and the agricultural sector.

20 And USDA is part of that committee. 

21 So, what the Executive Order has asked us to do

22 is go beyond that. Go beyond just talking about
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1 how we have ensured food safety.

2 USDA is involved in ag biotech across

3 the board. How do we get it there and talk about

4 it? How do we ensure that our community, broader

5 community, the folks that pay taxes that fund

6 USDA research understand how we're using ag

7 biotechnology to solve agricultural problems, to

8 solve food nutrition problems, to solve animal

9 disease problems?

10 We've got to be more outgoing, to be

11 more extroverted in talking about that. So, I

12 have Paul here, who's been working with me from

13 the Office of Chief Scientist, putting together a

14 program.

15 But how do we use the resources we

16 have? How do we use our arboretum? How do we

17 use our connection with the land grant

18 universities to be more, to build our story, to

19 talk to, communicate about how agriculture

20 biotechnology has been used by USDA across the

21 board?

22 So, domestically it's important,
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1 right. We need the tools available to our

2 farmers. We need access and choice for our

3 consumers.

4 But internationally it's hugely

5 important, as some of the question folks have

6 asked. It's about trade. It's about the

7 international environment.

8 So, how do we go about creating an

9 international environment? The Executive Order

10 is asking State Department and USDA to develop a

11 outreach and communications strategy

12 internationally.

13 And this has multiple components. One

14 is to advocate, and I want to say advocate for

15 more consistent regulatory policy around not just

16 what I will call traditional biotech products,

17 but looking forward to the innovations that's

18 coming along. How do we have compatibility

19 globally, right?

20 This is good for trade. But it's also

21 good for research. As a research scientist,

22 moving product from country to country for your
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1 research collaboration, you need to have a

2 understanding of what the other country's

3 requirements are.

4 So, compatibility in that sense will

5 smooth research interactions as well. So, that

6 is very important. And I think it's really

7 important for us here in the U.S., and others who

8 have years of experience in safely deploying the

9 technology to really explain the safe history of

10 use that we've had.

11 And how do other countries like

12 Rwanda, that is standing up their regulatory

13 systems learn from that? Do they really have to

14 have, do things from the beginning? Can they

15 leapfrog us, really?

16 You know, they don't have to start

17 with a landline to get to the Smartphone. They

18 just go straight to the Smartphone. So, they can

19 just go straight to certain things that we have

20 already learned, right.

21 So, that's one component of the

22 international communication strategy. The other
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1 part is, how do we use our international

2 partners, our international organizations, to

3 refocus this conversation about innovation in

4 agriculture, and I want to say innovation writ

5 large, back to science based risk proportionate

6 decision making?

7 Some of these international

8 organizations, especially standard setting

9 organizations, is founded on scientifically

10 based, risk based decision making. So, how do we

11 re-bring that back into those communities?

12 And finally, the Executive Order is

13 tasking USTR, working with a lot of diverse

14 agencies here, to develop a trade strategy.

15 And this is for us to use all the

16 tools available to us that include our bilateral

17 relationships, our multilateral relationships,

18 our compliance and enforcement trade tools, to

19 ensure that our products are traded fairly and

20 equally in global marketplaces.

21 How do we protect our market share? 

22 Because this, at the end of the day it's very
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1 important to our farmers' access and choice.

2 So, all of these Executive Order

3 mandates, if you read them, all acme with an

4 actionable date. This is kind of special for all

5 the other Executive Orders I've worked on, where

6 they ask you to do a thing, but they don't give

7 you a really good deadline.

8 This one had very, very tight, and

9 very, very specific deadlines. So, the Executive

10 Order was published in June. All the deadlines

11 are going to end up right before Christmas.

12 So, for a lot of us, you know, we're

13 working hard getting through this. And it will

14 be a nice Christmas Present to the White House

15 when it's all done.

16 So, I just let you guys know that this

17 is all going to happen soon. So, keep your eyes

18 open. Stay tuned. There will be, I would expect

19 some announcements, if not from the White House,

20 then definitely from USDA about many of the

21 initiatives that USDA have been tasked with.

22 One with being the website. The other
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1 being our domestic engagement plans, and also out

2 international engagement plans. And so, I'll

3 take any questions.

4 MR. McKALIP: And if folks have

5 questions, please approach the microphone, or

6 motion, and Colleen Wood can bring you one.

7 Fan-Li, we did have a question come in

8 over the webinar from William Pilacinski. And

9 this deals with Codex Alimentarius, which as many

10 of you know has important bearing on food safety

11 requirements.

12 But he asked if in the context of what

13 you had to say, if you see any opportunities in

14 the near future to make any changes to Codex

15 guidelines?

16 DR. CHOU: So, the Codex, so, for

17 those of you that may not be aware, the Codex has

18 a compendium of guidelines and general principles

19 for food safety that's associated with either

20 plant, food derived from recombinant DNA plants, 

21 this is their terminology, or food derived from

22 recombinant DNA microorganisms, or food derived
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1 from recombinant DNA animals.

2 And these were hard negotiated

3 consensus documents. And they're good guidance

4 documents for, yes, for folks that need to do

5 this.

6 I think it would be very difficult to

7 renegotiate these things. I think that based on

8 experience that countries had using those

9 guidances as a guidepost of how to do this, there

10 are definitely ways to be more efficient, based

11 on our understanding.

12 For example, I think we have looked at

13 hundreds and hundreds, not just we from U.S.

14 Government, but around the world. Many, many

15 glyphosate resistant soybean food safety

16 assessments, you know. Do you we really need to

17 do another one?

18 I think that's a good question for the

19 food safety experts out there. Do we need to

20 look at, you know, another Bt corn? We've looked

21 at hundreds and hundreds of them.

22 And everybody has come to the same
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1 conclusion. It's just inefficient use of your

2 regulatory resources. But those can be handled

3 without reopening the Codex guidelines. Sir.

4 MR. EYRICH: Yes. Tim Eyrich,

5 Southern Gardens Citrus. Can you unpack a little

6 bit more on this domestic engagement --

7 DR. CHOU: Sure.

8 MR. EYRICH: -- initiative? Your

9 words are outreach on how biotech is used. 

10 That's a confusing message to the consumer

11 anyways.

12 DR. CHOU: Right.

13 MR. EYRICH: If you're involved in it,

14 to try to figure out what your strategy is going

15 to be, it's highly confusing. So, how are you,

16 are you going to work with industry across this? 

17 Are you going to have industry participating on a

18 unified message on how biotech's used? Again,

19 can you, from a small company, we just don't have

20 the resources --

21 DR. CHOU: Right.

22 MR. EYRICH: -- to market like others. 
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1 So, can you unpack a little bit more about that?

2 DR. CHOU: Sure. I think for us too

3 is, there's lots of already private sector

4 communication on this. There's lots of, you

5 know, Governmental organization involved in this

6 space.

7 And for us it's thinking about what

8 value does the U.S. Government, or USDA have in

9 this space? You know, we can all get out there

10 and say the same thing. Does that add any value?

11 And I think where USDA add value is

12 not to talk about biotechnology in isolation. I

13 don't think that works really well, coming from

14 someone who is not from a agricultural

15 background.

16 Like, you can't start the conversation

17 with like, this is biotechnology, and this is how

18 it's used. It's about how it's using context

19 updates. And USDA uses them in many different

20 ways.

21 I think it's very important for us to

22 get out there and say how are scientists using
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1 this. How are we, is citrus important to you in

2 Florida, right?

3 We don't, is plum pox resistant trees

4 important to you in California? Is papaya

5 important to you in Hawaii? Is potato important

6 you to in Idaho? And how does technology help

7 solve some of the problems that are important to

8 you?

9 As a mother, as a suburban person, I

10 want to have strawberries in the middle of

11 November that taste like strawberries. How does

12 technology help me with that?

13 If you're curious about how we're

14 going to get to Mars, how does biotechnology get

15 us there? How is USDA working with NASA on those

16 problems?

17 So, things that people don't

18 traditionally associate with biotech, how do you

19 bring those stories to the forefront, so people

20 actually have a context, and you're not just

21 talking in isolation about a technology?

22 And in that way I think USDA is in a
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1 very special place. Because we have special

2 partnerships. But also, I think it's really, as

3 part of our domestic strategy we really want to

4 use the state ag resources, the universities.

5 So, how do you have that conversation

6 in your community? Because your conversation in

7 your community is going to be very different from

8 the conversation in my community.

9 My community at Bethesda, Maryland is

10 interested in buying, you know, good nutritious

11 food for my children that I feel safe about. And

12 we don't know anything, really about farms.

13 If you're in Idaho do you have

14 different conversations? And how, and what's

15 important to you? What are the questions?

16 So, from USDA we're thinking about how

17 to build tools, working with our state partners,

18 working with our university partners, working

19 with our private sector commodity partners, to

20 figure out how to have conversations around, what

21 is important in that community?

22 How do we build tools so people can
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1 take that toolbox to have that communication in

2 their community about how ag biotech, or

3 innovation in general is useful in the

4 agricultural space? All right. That was

5 relatively easy. Oh no, Ray.

6 MR. DOBERT: Ray Dobert, Bayer Crop

7 Science, so no one has mentioned something that's

8 going to be pretty impactful in about two years

9 from now. It'll be the implementation of the 

10 Bioengineered Food Disclosure Act.

11 DR. CHOU: Yes.

12 MR. DOBERT: And in terms of

13 communicating, because obviously that would be

14 one way that the public will get information with

15 regard to what foods do and do not contain

16 bioengineered ingredients.

17 Is anything that you're considering,

18 with regard to this outreach and this engagement

19 exercise, at all mindful of the fact that there

20 is this overarching disclosure provisions that

21 will be implemented on less than two years, or

22 about two years?
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1 DR. CHOU: Right. So this is all

2 under Under Secretary Ibach. And he should have

3 left -- 

4 (Laughter.)

5 DR. CHOU: -- so we can ask him. I

6 think, as Bernadette has mentioned, we're going

7 to have this unified web platform for the

8 regulators. Or how do you approach the

9 regulation information at a one-stop-shop?

10 USDA would have all this different

11 pieces about biotech. And how do people find out

12 that information? So we do actually have a

13 usda.gov/biotech planning page at the Secretary, 

14 at the Departmental level. And we are revamping

15 that. Because that is ancient.

16 And we're trying to figure out how to

17 streamline consumer access to information that

18 USDA has about biotechnology's use writ large. 

19 And that would be our disclosure standard, even

20 our organic program, all of these touches there.

21 So want to have a place where we can

22 streamline access to this information and have a
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1 place that people can have a wholesome or

2 fulsome, a holistic conversation about this,

3 right. Sir?

4 UNDER SECRETARY IBACH: So AMS was the

5 agency that actually worked on the bioengineered

6 food disclosure regulations. And they were

7 really kind of the model that we used when we set

8 out to start working on the proposed SECURE Rule. 

9 Because we spent a lot of time doing the same

10 thing as we wrote those regulations. We opened

11 the doors, we had lots of people come in, we had

12 lots of conversations. Arthur Neil led that

13 charge for us on the AMS side and did an

14 excellent job.

15 And there's another example of where

16 we anticipated that whatever we came out with

17 would be controversial. And at the end of the

18 day, because of the transparent process we went

19 through, we really had a surprising embrace of

20 that final rule when it came out.

21 You're going to start seeing it. It

22 ramps up, it phases in over this year and into
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1 next year. And so you're going to start seeing

2 some of those logos or the sign show up on food

3 products.

4 And we're prepared to try to address,

5 if necessary, questions that consumers have. But

6 it also provides an opportunity for food

7 companies to really, you know, kind of self8 provide that educational process as well.

9 And, you know, I'm somewhat

10 anticipating that that issue, the consumers had

11 their opportunity, they were interested in it. 

12 They know there's a solution out there that

13 provides the transparency forum.

14 I don't think we're going to see a lot

15 of new renewed interest. The consumer groups

16 that were interested in that accomplished their

17 goal, have that transparency out there, and I

18 think that we've kind of gotten over that

19 interest level.

20 MR. McKALIP: Under Secretary Ibach,

21 while we have you up there, we had a question

22 come in on the webinar for you. And they're
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1 looking for advice on balancing messages. 

2 Because you talk to a lot of farmers, you talk to

3 a lot of consumers from all backgrounds.

4 They're interested in any thoughts on

5 how you can balance messages, or dealing with

6 producers, and productivity with technological

7 innovations, with what's happening on the

8 regulatory front in trade, and how you kind of

9 balance those messages for various audiences when

10 you're meeting with them.

11 UNDER SECRETARY IBACH: I think the

12 key is to approach the audience trying to

13 understand what their questions are, or their

14 understanding gap is, and to try to have that

15 conversation in that context.

16 I think no matter who you're talking

17 to, there's the challenge of making what's

18 unfamiliar to them familiar. And whether it's

19 out in a foreign country trying to talk about

20 American agriculture, and why you should be

21 comfortable buying food from our family farm and

22 ranchers, 90 percent of our farmers and ranchers
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1 are family farms and ranches.

2 And communicating that understanding

3 that we are not America factory farms or

4 industrial agriculture, to talking to a consumer

5 about why they should be comfortable with the

6 regulatory processes we have in place to assure

7 that the food that meets their table is going to

8 be safe, and wholesome, and most importantly

9 affordable as well, and so I think that's the

10 challenge that we face, is trying to shape those

11 messages that the family is talking about to be

12 able to make what's unfamiliar to that audience

13 familiar and make them comfortable with it. 

14 Okay, thank you very much.

15 (Applause.)

16 MR. McKALIP: Thank you again, Under

17 Secretary Ibach, for spending your time with us

18 here this afternoon. And thank you, Fan-Li, for

19 your remarks and being willing to answer

20 questions as well.

21 We're going to switch gears now. 

22 We're sort of at the half-time point of the
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1 stakeholder meeting. You've heard a lot of the

2 global issues happening at the administration

3 level, at the departmental level, sort of an

4 overview on policy.

5 We're going to shift gears not to talk

6 a little bit in specifics about specific BRS

7 oversight work over the course of FY 2018 and '19

8 and looking ahead to 2020, as well.

9 I think last year at our stakeholder

10 meeting we didn't necessarily dig into some 2018

11 data. So we're going to make sure that we bring

12 you up to date on the oversight and compliance

13 information.

14 So we'll have Doug Grant come up to

15 the podium. Doug is the chief of our BRS Western

16 Compliance Assurance Branch. He's located in

17 Fort Collins, Colorado, normally. Although he's

18 willing to come in here to provide the update.

19 Doug has a Ph.D. in plant ecology from

20 Colorado State University. He grew up in Ohio

21 and then moved to Colorado when he went to

22 college. And he joined APHIS in 2005 and worked
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1 in our crops research laboratory at ARS from 1999

2 to 2005. Doug Grant.

3 (Applause.)

4 DR. GRANT: Thanks, everybody, for 

5 coming today. And thank you for having me here. 

6 I appreciate the opportunity to share some data

7 with you for our compliance and inspection

8 program and the regulatory operations program of

9 BRS. 

10 I also want to say thank you to some

11 folks that helped me with some of the data and

12 maps for the slides. So thanks, Heather Brown,

13 Deshui Zhang, and Meghan Dexter. I appreciate

14 it.

15 So looking, for the last couple of

16 years we've had, you know, quite a few field

17 trials, but the numbers have been sort of coming

18 down. so I'm going to provide, some FY '18 and

19 FY '19 data. And we'll also look at some trends.

20 We had about 4,500 release sites that

21 were authorized in FY '18, and then it dropped

22 down to about 3,300 release sites authorized in
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1 FY '19. And you can see the number of phenotypic 

2 designation crop-trait combinations up there as

3 well which is a very high number. A lot of field

4 trials that we see out there have a lot of

5 different combinations that are planted.

6 So looking at the number of release

7 authorizations going back 30 years or so, you can

8 see that we sort of hit a peak there in the early

9 2000s with almost 12,000, I'm sorry, 1,200

10 authorizations in that year. And then we've come

11 down gradually over time. And over the last

12 half-dozen years or so, we've had between 350 and

13 550 or so authorizations.

14 Now, in terms of the number of field

15 release sites, that number has a little bit of a

16 different trend, where we actually saw a peak

17 about five or six years ago where we had, you

18 know, a lot more authorized sites than we

19 currently have. So we reached a peak of about

20 11,000. And now we're down to about 3,300 in FY

21 '19.

22 So for those of us in the Regulatory
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1 Operations Program, you know, the Biotechnology

2 Risk Analysis Program has to look at all of those

3 different authorizations and all of those

4 different release sites.

5 In the Regulatory Operations Program,

6 we're really looking at what actually was

7 planted. So we're focusing on the sites that

8 ended up being planted, not just everything that

9 was authorized.

10 And so what do we do to decide what to

11 inspect? There's a lot of stuff out there. And

12 we first and foremost rely on the data that we

13 get from you, all right, the data in the

14 application to tell us exactly what's being put 

15 out there, but then the data that comes through

16 in the planting reports.

17 And so we take that information that

18 we get from you, we put it into spreadsheets and

19 databases. We put it into geographic information

20 systems. And then we use that information, and

21 also looking at compliance history or other

22 issues, to determine which one should we sort of
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1 prioritize for inspection.

2 And, you know, some of the species

3 that Fan-Li just mentioned are some of the types

4 of species that we see out there. It's not just

5 corn and soybeans. It's also camelina, cotton,

6 canola, strawberries, grapes, walnuts. There's

7 poplars, pineapples, potatoes. So it's a really

8 broad range in terms of the number of species

9 that we actually authorize each year. So we have

10 got to make some decisions about what to inspect.

11 So for those lower risk

12 authorizations, you know, primarily

13 notifications, what we're looking at is sort of a

14 random selection of what's been planted. And we

15 also want to try to get good geographic

16 distribution in terms of where those inspections

17 are occurring.

18 With the higher risk authorizations,

19 we have a standard policy that we're going to

20 inspect at least once in each state where there's

21 release each year, at a minimum. With perennial

22 trials like poplars, switchgrass, alfalfa, things
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1 like that, we want to look at those every single

2 year.

3 And then we also still continue to

4 have a few pharmaceutical, plant-made

5 pharmaceutical or industrial trials. And in

6 those, we look at those multiple times every

7 site, every year.

8 So what do we do when we decide we're

9 going to inspect somebody, most of our

10 inspections are scheduled inspections. We'll

11 contact you ahead of time, tell you which site we

12 want to look at, and then we'll make a plan when

13 it works with your schedule to meet you out

14 there.

15 We do do some of our inspections as

16 unannounced. And those could also be thought of

17 as same-day inspections. So we'll contact you in

18 the morning and say we'd like to meet you out

19 there this afternoon and take a look at your

20 trial site.

21 We've also been moving towards, and

22 Bernadette mentioned this, some virtual
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1 inspections. And another name that we have for

2 those are MEIs or monitoring and evaluation

3 interviews. And that basically consists of a

4 phone interview and some document exchange

5 through email looking at some photos of the site. 

6 And those generally occur with trials that have

7 already been harvested.

8 So a lot of those types of inspections

9 are occurring during the, you know, winter months

10 rather than during the growing season. And we do

11 want to place an emphasis on species that have

12 some sort of heightened concern, whether that be

13 perennials or other things that might have a

14 higher likelihood to persist in the environment. 

15 Now, looking at the compliance rates,

16 you know, generally we see really good compliance

17 with the inspections that we do. And in FY '18,

18 the rate of compliance was 92 percent. And in FY

19 '19, the rate of compliance was 97 percent.

20 Now, those are based on the things

21 that we've actually inspected. There are also

22 other compliance issues that come up. And I'll
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1 talk a little bit about those later on. So now

2 looking at a map of where are these authorized

3 sites, and where do we conduct our inspections, I

4 wanted to provide some visuals for you so you can

5 see kind of the distribution across the US.

6 And basically, this is showing

7 anything that was valid in FY '18. The next

8 slide shows anything that was valid in FY '19. 

9 So that might mean it was only valid for three

10 days at the beginning of the fiscal year, or the

11 entire fiscal year, or three days at the end of

12 the fiscal year. That's why you see these

13 numbers are about twice as high as the number of

14 sites that we authorize each year.

15 But there are big concentrations in

16 certain areas. In the Midwest, places like

17 Nebraska, Kansas, Iowa, Illinois, we see a lot of

18 corn and soybeans. In the winter nursery

19 locations like Hawaii and Puerto Rico, they've

20 got field trials going on year-round.

21 And then there are places like

22 California where you have anything you can think
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1 of being grown out there from, you know,

2 strawberries, to walnuts, to corn, to wheat. 

3 We've got citrus in the southeast, you know,

4 we've got poplars in the northwest. So things

5 vary depending on where you are in the country. 

6 And then this is looking at FY '19, so

7 a similar number of valid release sites, about

8 7,800. But then of those, which ones were

9 actually planted? So in FY '18, you can see the

10 concentration is also similar to where they're

11 authorized. So we have pretty high

12 concentrations in the Midwest, also on the

13 coasts, and then in the winter nursery locations

14 in Hawaii and Puerto Rico.

15 And of those 1,300 unique plants at

16 locations, some of which have multiple plantings

17 at the location through the year, we inspected

18 700, we did 706 inspections. So we're inspecting

19 a little bit more than half of the sites that are

20 planted out there in the US. And, you know, we

21 concentrate in those areas where there are more

22 plantings, like Hawaii, Puerto Rico, Illinois,
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1 Iowa, California.

2 In FY '19, the numbers came down a

3 little bit, so we had about 1,100 plantings, I'm

4 sorry, sites, unique sites across the United

5 States. And we did 636 inspections, so slightly

6 more than half of the sites out there we inspect.

7 And some of the numbers are different

8 depending on the state. So if you have a state

9 where you have some pharmaceutical industrial

10 trials, there may be more inspections than there

11 actually were plantings, because we're going out

12 there multiple times, or places where there are

13 perennials, or things like that.

14 So this is just to try to give you an

15 overall idea of where things are generally being

16 planted across the United States that we have to

17 inspect.

18 Now, who does those inspections? They

19 are primarily done by employees of Biotechnology

20 Regulatory Services. But that hasn't always been

21 the case. Going back a half-dozen years, we have

22 been partnering with APHIS plant protection and
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1 quarantine for a long time.

2 They've been conducting inspections of

3 biotech crops since before there was a thing

4 called BRS, which BRS just came into being in

5 2002. So some of the people who work on my team

6 have actually been doing inspections going back

7 to, you know, the late '90s.

8 So we used to have them do the vast

9 majority of the inspections going back to FY '14. 

10 PPQ did about 85 percent of the inspections. We

11 also have partnerships with a bunch of states,

12 and their state departments of agriculture will

13 actually conduct inspections on behalf of

14 Biotechnology Regulatory Services. And so

15 through that agreement, they are providing

16 oversight in a lot of those locations.

17 And as we've built our own inspection

18 workforce, those numbers have been rising and

19 have sort of leveled off the last three fiscal

20 years where BRS employees are doing about 70

21 percent of those inspections. PPQ employees are

22 doing about 25 percent, and the states are doing
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1 between 5 and 10 percent of the inspections each

2 year.

3 So of those inspections, we already

4 talked about the total inspection numbers, what

5 about the unannounced? Well, we're doing about

6 10 percent of the inspections that are conducted

7 by BRS employees as unannounced each year. And,

8 you know, almost ironically, we had 43 in FY '18

9 and FY '19. And I double-checked the slide,

10 because I thought maybe I messed up the data. 

11 In terms of virtual inspections, those

12 are the things that we're doing over the phone,

13 the monitoring and evaluation interviews. And

14 most of our inspections occur in season. And so

15 the vast majority really occur in Q3 and Q4 of

16 the fiscal year, because that's the primary

17 growing season in the Continental US.

18 So more than half of our inspections

19 are done in Q4, and a large number in Q3. But

20 those virtual inspections tend to happen in Q1

21 and Q2. And we've been sort of increasing the

22 number of virtual inspections we've been doing
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1 the last of years since we piloted it.

2 All right, what about reports and

3 notices? We have been meeting with different

4 members of the regulating community, and we've

5 gotten some feedback. We changed some

6 supplemental permit conditions, and they're kind

7 of going, what's the deal with these changes? 

8 Why are you asking for these additional types of

9 reports and notices?

10 And we've always required certain

11 reports and notices, and we've added requirements

12 for a couple of different ones such as storage

13 reports. But we have planting reports which tell

14 us when the material goes in the ground. And

15 then after the material is harvested, we have

16 volunteer monitoring reports. After the trial

17 has been completed, and all of the data has been

18 collected, we have field test data reports.

19 And, you know, we are really

20 interested in your feedback to hear what we can

21 do better into modifying and tweaking those

22 supplemental permit conditions to try to make
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1 them better so that they work for everyone.

2 We had an OIG audit back in 2015, and

3 one of the things that they told us was they

4 basically wanted us to be able to track the fate

5 of all the regulated material. And so it's like

6 the, you know, slogan that they use in real

7 estate, location, location, location. They want

8 to know where it is from the time that it was

9 taken out of the lab, or out of the greenhouse,

10 and put into the field, to the time that it's

11 devitalized and disposed of.

12 So that's why we're asking you for

13 those reports. We're trying to make sure that we

14 have a good idea of where the material ends up

15 after everything is said and done. And it's

16 really important to us that you please try to get

17 those reports submitted to us in a timely manner

18 as indicated in the supplemental permit

19 conditions.

20 And we know it's a lot of work, and we

21 appreciate that work. And we're willing to work

22 with you if things come up. You know, we
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1 understand that not everything happens like

2 clockwork all the time.

3 So most of those can be sent

4 electronically, some of them you can still send

5 hard copy. You can also send them to our BRS

6 compliance inbox via email. But, you know, right

7 now, everything should work through ePermits. 

8 And we're working on making it so that all of

9 that stuff will work in eFile as well.

10 So speaking of eFile, we've been

11 working really hard in the Regulatory Operations

12 Program on the I&C, the Inspection and Compliance

13 workflow within eFile, and working with Accenture

14 and really trying to make that happen.

15 We've also had several other smaller

16 projects that are sort of going on in the

17 background in FY '19. So I'd like to point out a

18 couple of those that you might be interested in.

19 APHIS has been making a big push to

20 work on what is called the GIS portal which is

21 basically mapping that's done in the cloud. So

22 all of that GIS data, instead of existing on
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1 someone's hard drive, or on a remote drive, is

2 existing in the cloud. And that's all of the

3 information that we get from you when you submit

4 an application about where your trials will be

5 located. All that geospatial data goes into the

6 mapping.

7 And then we also do mapping with all

8 the information that we collect during

9 inspections. And so BRS has been doing a really

10 great job being part of this APHIS-wide effort.

11 And everything that is involved is

12 secure, so I just want to reassure you. When you

13 submit your data to us, and we put it in the

14 portal, it's completely secure, it's all FedRAMP

15 authorized, or approved, or whatever the right

16 term is for that. But basically, we can't use

17 any software or anything in USDA that's not

18 approved at the federal level.

19 We also were partnering with ESRI,

20 through the use of the GIS portal, to create a

21 mobile app to collect data. So basically, other

22 parts of APHIS are using this already. PPQ and
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1 VS use the collector app when they go out and do

2 surveys, and check traps, and things like that.

3 And we started beta testing that the

4 past growing season where you could basically

5 just take your phone or your iPad out into the

6 field. You could collect coordinates, enter

7 other information, and then it will be uploaded

8 and synched directly to the porta.

9 And this is really cool for us to try

10 to make our processes more efficient. And also,

11 in the not too distant future hopefully, this

12 will be integrated so that portal will work

13 directly with eFile. So we're excited about

14 that.

15 Another thing that we continually work

16 on is trying to make sure that we are reminding

17 folks about notifying us when there happens to be

18 some sort of an incident. And incidents might be

19 discovered through different paths. It's not

20 necessarily just during an inspection.

21 It could be a self-report where you

22 realize that confinement was lost on a field
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1 trial. It could be through a third party report. 

2 It could be somebody reports it to the state

3 department of agriculture, and then they come and

4 notify APHIS.

5 So if you have an incident of some

6 kind, in particular part of our regulations say

7 that if you have an accidental or unauthorized

8 release, if material end up being planted in a

9 field that was not authorized or, you know,

10 accidentally released in the environment for some

11 other reason, you need to notify us. And you can

12 do that sending an email to the BRS compliance

13 inbox. And there's also a BRS compliance

14 hotline, and that is checked every day to see if

15 we have any reports of incidents.

16 And we did have one incident in FY '19

17 that I'd like to talk a little bit more about. 

18 As some of you are probably aware, we had an

19 incident where some regulated herbicide-tolerant

20 wheat ended up appearing in a field in the

21 Pacific Northwest. And it wasn't a fallow field.

22 This isn't the field, this is just a
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1 picture of wheat stubble. But it is important

2 for us. Because one of the things that Mr. Ibach

3 said was, you know, we want to protect and

4 facilitate trade, and most of the wheat that is

5 grown in the Pacific Northwest is exported to

6 markets in Asia. And they have a very low

7 tolerance for anything that's genetically

8 engineered. And we've never deregulated any

9 genetically engineered wheat.

10 So when we were notified about this,

11 we took swift action to get out there to the

12 field to collect samples, to identify the

13 material, and to delimit the area that was

14 affected, and also to make sure that this

15 material was not ending up in commerce.

16 So in terms of just sort of the

17 summary of the wheat incident, we received a

18 report that some wheat had survived the

19 glyphosate treatment in a fallow field in

20 Washington. And that report came into us in late

21 May. And we were out there working in the field

22 also, you know, had folks from APHIS, PPQ out
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1 there working in the field all the way through

2 the month of June through early July.

3 And we had excellent communication,

4 which was really the key to success in terms of

5 figuring out the extent of the incident and

6 making sure that things did not enter commerce. 

7 But not only did we have really good cooperation

8 from the developer and the grower, but we also

9 had really good communication and cooperation

10 with the Washington State Department of

11 Agriculture.

12 We got mitigation plans in place in

13 terms of how to handle the site going forward,

14 and got a compliance agreement in place with the

15 grower. There was really no evidence in all the

16 places that we looked, and we did look hard in

17 the state of Washington, also looked hard at the

18 seed sources in terms of that foundation seed,

19 the certified seed, the seed that's planted by

20 wheat farmers.

21 We didn't find any evidence that

22 there's any genetically engineered wheat in those
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1 materials that are planted in the field or that

2 ended up entering commerce in any of the

3 shipments or anywhere in that pathway.

4 So most recently, we also collaborated

5 with Washington State University to develop some

6 best management practices, guidance for wheat

7 growers. And, you know, we'll continue to be

8 paying very close attention and trying to keep

9 our fingers crossed and hope, through those best

10 management practices, that we don't have future

11 incidents like that.

12 So with that, I'll be happy to take

13 some questions. And thank you.

14 MR. McKALIP: Doug, we had a question

15 come in on the webinar dealing specifically with

16 the Midwest. And if you could share with the

17 folks, according to weather, if their particular

18 concerns on regulatory oversight in any of your

19 experiences there from this past year, that you

20 think the group would benefit from?

21 DR. GRANT: Well, we did have, you

22 know, the severe flooding events that occurred in
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1 the Midwest this year. We had some other weather

2 events, you know, such as hurricanes that

3 impacted other parts of the country.

4 In terms of those flooding events that

5 occurred and impacted a lot of farmers, we look

6 very carefully, and we do send out reminders to

7 folks who have regulated plantings in those

8 locations that are impacted during a severe

9 weather event. And it was sort of lucky that we

10 found that none of the locations where there were

11 regulated trials had actually been impacted by

12 those floods in Nebraska and other parts of the

13 Midwest.

14 So we've got a lot of corn and soybean

15 trials in those areas, and other types of trials

16 as well. But I don't think we've had any, you

17 know, major compliance issues in the Midwest in

18 the last couple of years.

19 MR. McKALIP: Another question from

20 Genna Jenkins with Ventria. She asks about PMPIs

21 or plant made pharmaceuticals and industrials,

22 and if you have any kind of rough estimate in 
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1 your region of what level of business, or what

2 percentage of your business and oversight work

3 would be PMPI-related?

4 DR. GRANT: I, you know, don't know. 

5 I could guess at it, but it'd be a really rough

6 guess. It'd be a fairly small percentage. We

7 don't really have that many PMPI types of trials

8 going on.

9 But those that we do have, we make

10 sure to look at every site and work with those

11 developers to make sure that everything is

12 isolated away from any commercial material. But

13 it is a rather small percentage of the overall

14 number of sites that we see planted.

15 MR. McKALIP: That's good for an

16 eyeball guestimate. We can follow-up with maybe

17 some data from your branch as well as the Eastern

18 Compliance Branch.

19 DR. GRANT: Yes. We'd have to crunch

20 some numbers.

21 MR. McKALIP: Okay. Another question

22 comes from DTN Progressive Farmer. Emily
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1 Unglesbee asks a question you may or may not be

2 able to respond to, but she wanted to know if

3 there was any determination on how the GE wheat

4 got into the field there.

5 DR. GRANT: You know, we have had very

6 little success in the area of trying to find a

7 particular smoking gun when it's related to our

8 various GE wheat incidents. And so we don't know

9 exactly how it ended up there.

10 We do believe it's isolated to one

11 grower's field in Washington State. But no,

12 that's not something that we have an exact answer

13 to. And we've looked. And we've tried, but we

14 really don't know exactly how it ended up there.

15 MR. McKALIP: But as you described,

16 your major focus of resources is then dealing

17 with the follow-up in doing those steps

18 appropriately.

19 DR. GRANT: Right, making sure we have

20 good mitigation plans in place to make sure that

21 doesn't persist.

22 MR. McKALIP: Okay. Questions from
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1 folks in the room, either wave your hand or step

2 up to the mic for Doug.

3 Okay, I don't think we have any more

4 questions come in over the line, but Doug will be

5 available throughout the afternoon if folks want

6 to grab him and ask additional questions as well.

7 DR. GRANT: Thank you.

8 (Applause.)

9 MR. McKALIP: As you know, a major

10 initiative for BRS this year was the successful

11 pilot launch of eFile. And I'm going to invite

12 Ibrahim Shaqir to come up and provide us with an

13 overview of where we currently stand.

14 Ibrahim is no stranger to all the

15 folks in the room and on the call. He serves as

16 our Associate Deputy Administrator, focuses on

17 many areas. One in particular is international

18 biotechnology.

19 He represents APHIS, many departmental

20 working groups, and across the federal government

21 as well, providing international technical

22 assistance on standards for biotech and providing
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1 his expertise to countries around the world in

2 biotechnology.

3 Prior to joining us, Ibrahim was the

4 Director of International Research over at ARS. 

5 In 2012, he was selected as in residency with the

6 U.S. Institute for Peace as well. He's an alumni

7 of the University of Maryland, has a B.S. degree

8 as well from the University of Rutgers, and is a

9 graduate of the Harvard Kennedy School, Senior

10 Executive Fellows Program. And we're looking

11 forward to having Ibrahim's update on eFile. 

12 Ibrahim?

13 (Applause.) 

14 MR. SHAQIR: Well, thank you very

15 much, Doug. That's a very generous introduction. 

16 Well, eFile you've heard a lot about it. 

17 Bernadette is so passionate about it, I feel I

18 don't have to present. But nonetheless ---

19 (Laughter.)

20 MR. SHAQIR: -- we are lucky in that

21 regard. We have a great team. Bernadette, from

22 her previous experience with Animal Care, she was
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1

2

3

4

5

6

7

8

9

10

11

12

13

14

15

16

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18

19

20

21

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also thoroughly engaged in and involved in the

whole process from the Animal Care side. And

when she joined us, also she devoted the same

passion about it.

We reported to you, you know, the

great progress we're making. But behind that, we

have a great team that's working to support this

important system of the permitting system of

APHIS.

Miranda Wanex, probably you've heard,

many of you, she's been leading this for us from

the BRS side. And we have a great team here in

BRS that collaborates closely with the developer,

Accenture, but also all the support. And anytime

we need added funding, of course, the Office of

Administrator. And Dr. Mike Watson is here, our

Associate Administrator. We thank you for coming.

And so in brief, I just would like to

provide you with a quick update about eFile. Last 

year, we shared with you a demo of how eFile
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1 will look like. And we devoted, I believe, an

2 entire afternoon specifically for that. And we

3 promise that we will continue to engage you. And

4 we were able to basically continue that dialogue

5 with you, developers, throughout the process.

6 But back in July, on July 23rd, we

7 were ready to go and pilot eFile. And we invited

8 selected developers to participate, and not only

9 participate but also provide us with valuable

10 feedback that can help us in the process.

11 As a result, we have received about 76

12 comments and important feedback from developers. 

13 We were able address, and create, establish some

14 kind of enhancement about almost 31 of them. And

15 that's tremendous progress, I believe.

16 So you can see that we value your

17 feedback and input. Even though we are in pilot,

18 we are truly committed to providing you with an

19 excellent alternative to ePermit, to our current

20 permitting system. And with eFile, as we

21 transition and move forward, we want to provide

22 you with a fantastic system that we all can be
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1 proud of, okay.

2 So we will continue to engage, and we

3 will continue to work on our system, and we will

4 open it up. And I will mention that later on you

5 have a flyer we attached to the agenda that we'd

6 like you to take with you.

7 And from that, we just provide you

8 with added information and who basically will be

9 a good developer, customer to take advantage of

10 that. Anyone who already previously submitted an

11 application for an authorization for a permit

12 will qualify to be part of the pilot.

13 The next, basically the step now, we

14 are opening up to larger developers. And we hope

15 to give you much more substantial update summer

16 of 2020.

17 I just want to give you a quick

18 example of the certain, how the collaboration,

19 close collaboration with developers helped us in

20 the process.

21 There was an issue with the previously

22 submitted construct where developers could not
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1 take advantage of that with eFile, because we had

2 an issue with XML. And because we were able to

3 communicate that early on in the process, we were

4 able to devote resources, human capital

5 resources, as well as financial resources, to

6 address this important issue.

7 And we created some kind of a tiger

8 team, as we refer to it, with an important and

9 appropriate surge to address this very issue. 

10 And we have good news that I think, I'm not going

11 to commit tomorrow, but by early, as soon as

12 possible, it will be ready for, basically for

13 developers to take advantage of it.

14 Miranda, is there any -- do you have

15 a specific date when?

16 MS. WANEX: No date just yet.

17 MR. SHAQIR: Not yet, okay. And so

18 we're excited that we will be able to share with

19 you sooner than later on how this, when will be

20 available to you. And that, again, wouldn't have

21 been possible without the continuous dialogue

22 with you.
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1 So we open it up for all of you,

2 again, people who already have, we issued a

3 permit for you in the past. You were able to

4 join us and take advantage of this important and

5 really exciting system that we have in place.

6 And you cannot, if you want a multi7 year permit, you will have, I think it will be

8 important for you to come to eFile, okay. And we

9 shared with you the organizational access feature

10 that we, it's only unique to eFile.

11 We demo'd that last year, where a

12 company, a developer can provide one

13 administrator key to provide access to multi14 users in the company to access that and provide

15 either part of the permitting process or the

16 compliance aspect. And so again, that's

17 basically the feature that we are excited about. 

18 And I'm sure you will be happy to be part of

19 that.

20 The exciting other XML compliance is

21 for reporting, and we hope this will be ready as

22 soon as possible for the compliance aspect. And
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1 I believe the planting reporting will be first,

2 and then the other reporting will be available to

3 you as well.

4 So we invite you to please communicate

5 with us. And now we're moving forward. Even

6 though we're in a pilot stage, we will continue

7 to modify and enhance so we have a great system

8 that we all can be proud of. With that, thank

9 you very much. And I look forward to if you have

10 any questions. 

11 Excellent, you're all happy with

12 eFile.

13 (Laughter.)

14 (Applause.)

15 MR. McKALIP: Thank you very much,

16 Ibrahim. This brings us to the final item on our

17 agenda but by no means the least important. 

18 Maybe in many cases for the regulating community

19 here in the room this afternoon, it could be one

20 of the most important pieces.

21 We wanted to have a chance for Maxine

22 Ball to come up and talk through some of the
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1 administrative pieces that go along in terms of

2 requirements with documents submitted to BRS. 

3 And we've had a couple instances within even just

4 the past couple of weeks where we have had to

5 return a document, either because of lack of

6 signature or other technicalities.

7 Obviously, it's not something we like

8 doing, we don't feel good about it. And clearly,

9 for the regulating community, it's a good use of

10 your time and resources either. So we would love

11 to avoid these if possible. I'm sure you would

12 too. So that's what this agenda item is all

13 about.

14 Now, many of you, as you work through

15 the petition process under the current

16 regulation, are familiar with whether the

17 document is technically complete. This step

18 we're going to talk about in this final agenda

19 item is actually making sure whether the document

20 is administratively complete.

21 And that's important, because you

22 can't get to that technical analysis and
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1 evaluation if you haven't already passed the

2 basic requirements in making sure that your

3 document has all the administrative pieces

4 completed before that stage.

5 So I'm going to invite Maxine Ball to

6 come up. Maxine started with the federal

7 government in 2012. She actually worked in the

8 APHIS Investigative and Enforcement Services

9 Branch initially while she was working on her

10 master's degree.

11 And four months before she graduated,

12 BRS was able to recruit her over and get her as

13 an analyst for BRS. Her major responsibilities

14 within BRS are analyzing the FOIA requests that

15 come in. She assists in records management for

16 BRS, and she works on processing incoming

17 permits, and petitions, and notifications.

18 So she sees a lot of these things, so

19 she knows a few things about these. So, Maxine,

20 welcome you to come up and talk about the

21 administrative requirements.

22 (Applause.)
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1 MS. BALL: Thank you, Doug, and thank

2 all of you for this opportunity to talk with you

3 about the procedures and formatting for

4 petitions.

5 As Doug mentioned, there are some

6 things that we have been seeing. And we just

7 want to make sure that we're providing everything

8 that we can to ensure that your petitions are

9 being reviewed and getting them over to the

10 technological side so that your petitions can be

11 expedited and issued.

12 So I'm kind of new at this, and I'm

13 going to see if this works. Okay, all right. I

14 think I've got it.

15 So what we will cover today, we'll be

16 looking at when you're submitting your petitions,

17 the number of copies you should be sending, the

18 structure and the formatting of them,

19 certification statements and the importance of

20 signatures, the completeness of the package or

21 what we call administratively complete, how to

22 mark your CBI information, and then guidelines.
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1 There will be actually a couple of

2 examples, and it should be also in your packet of

3 examples of each of the, whether your petition is

4 a CBI copy, it's your CBI-deleted copy, and then

5 also the no-CBI.

6 So first of all, the number of copies

7 to send. So when submitting petitions, send two

8 copies of the petition, and that's going to go to

9 my team leader who is Cindy Eck. Cindy is our

10 BRS Document Control Officer.

11 This means if you have a petition with

12 confidential business information, which we name

13 CBI, you should send us two copies of the CBI

14 version and then two copies of the CBI-deleted

15 version.

16 If there is no CBI information that's

17 claimed in your document, then you would just

18 send the two copies with a statement, no-CBI. 

19 And the same is true if you're sending an amended

20 petition as well as extensions.

21 Our regulations under 7 C.F.R.

22 340.6(b) require the petition to be structured in
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1 a certain way. On the cover of the page, you

2 need to date the petition and provide the

3 following statement and a signature. The

4 undersigned submits this petition under 7 C.F.R.

5 340.6 to request that the administrator makes a

6 determination that the article should not be

7 regulated under 7 C.F.R. Part 340.

8 Our regulations were written before

9 the time of electronic signatures, so the intent

10 was to require a wet signature.

11 Okay, so that's right there. That's

12 why that's highlighted. This I one of the main

13 things that we have been seeing, is to make sure,

14 and we wanted to highlight that the signature is

15 there.

16 So following the required submission

17 statement and signature, you need to provide a

18 statement of grounds. And that just basically

19 means that you need to provide an explanation as

20 to why the organism should not be regulated under

21 7 C.F.R. 340.6.

22 On the certification statement and
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1 signature required, so below the statement of

2 grounds our regulations require the following

3 certification statement. The undersigned

4 certifies that, to the best and belief of the

5 undersigned, this petition includes all

6 information and views on which to base a

7 determination, and that it includes relevant data

8 and information known to the petitioner which are

9 unfavorable to the petition.

10 Below the certification, you need to

11 provide another signature, so there's actually

12 two signatures that are required on the

13 petitions, the individual petitioner's name, a

14 mailing address, and telephone number.

15 Again, these are all items that are

16 spelled out in the regulations, and we will

17 kindly ask you to provide an email even though

18 it's not mandatory or required. But email

19 addresses were not around as widely used at the

20 time the current regulations were under 340.

21 So additionally, our regulations also

22 state that if there is any known unfavorable
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1 information to a petition it should be made

2 known. And if there is no unfavorable

3 information, we just ask that you put none, just

4 add none, that clause. 

5 So again, I want to highlight petition

6 requires two signatures on the first page and

7 also on the certification page.

8 Administratively complete, so in order

9 for us, BRS, to make a determination of

10 regulatory status, we must see that you have

11 provided at least the items that are required in

12 our regulations. And a complete list of all

13 items required to submit a petition can be found

14 in Paragraph (c) of 7 CFR 340.6.

15 Our regulations say you will need to

16 include copies of scientific literature, copies

17 of unpublished studies, when available to you,

18 and data from tests performed upon which BRS can

19 base a determination that the organism no longer

20 needs to be regulated under 7 CFR 304.6. So any

21 cited literature that you use in the petition, it

22 should be submitted along with the petition
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1 package.

2 And so now we get down to really the

3 nitty gritty. And this is where lots of

4 sometimes confusion as to how to actually format

5 the CBI in your document. 

6 So if you are providing us a petition

7 that contains confidential business information,

8 again CBI, you must also provide us a CBI-deleted

9 version of that same petition. Our regulations

10 require that, if portions of the petition contain

11 trade secret or confidential business

12 information, each page of the petition containing

13 CBI information should be marked CBI-copy and

14 marked on each page where CBI is cited. And I'll

15 show you that in a moment.

16 Each page of the petition where CBI

17 information was deleted should be marked

18 CBI-deleted and marked on each page where the CBI

19 was deleted. If a petition does not contain CBI,

20 the first page of both copies shall be marked no21 CBI. Or sometimes we just see it spelled out, no

22 confidential business information.
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1 Okay, so here we go. all right, so

2 this is a copy of the CBI-copy. And each page of

3 the petition containing CBI must have CBI marked

4 in the upper right-hand corner.

5 Okay, well if you look in your

6 package, if everyone will look in their package

7 while she's working to try to get that back up. 

8 And you should be looking at the copy that says

9 CBI-copy. So if you have your copy, you can see,

10 in the upper right-hand side of the document, it

11 says CBI-copy right where there is the little

12 yellow arrow. Does everybody see that?

13 Oh, okay. Oh, there it goes. Okay,

14 so right there, CBI-copy, in that upper right15 hand corner. And a lot of times this right here

16 is actually missing. And it will cause a

17 deficiency and would have to go back. 

18 Also, so that's the CBI-copy, and then

19 for all the information that you are claiming to

20 be CBI --- okay, so all the information that you

21 are claiming as CBI, it has to be CBI in the

22 right margin identifying the information in
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1 brackets --- I just can't really see it.

2 Okay, so your information is bracketed

3 here. Can you make that bigger, is there any way

4 to make that bigger? No? Okay. All right, so

5 it's a bracket here and there should be an open

6 bracket right here, okay.

7 So right here is the information that

8 you claim as CBI, CBI in the right margin, and

9 then the closed brackets for CBI here. So every

10 place that you are actually marking as CBI with

11 those brackets, you should be making sure that

12 that information, you have an open bracket, and

13 you have a closed bracket, and then the CBI in

14 the right margin.

15 Okay, the second one is your CBI16 deleted copy which also each page must contain,

17 in that same upper right-hand margin, CBI18 deleted, mark up in the upper right-hand corner.

19 And then on the CBI-deleted version,

20 you replace blank spaces. For that information

21 that you're claiming as CBI, it should be

22 redacted or just white space in between the open
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1 bracket and the closed bracket.

2 The CBI-deleted version should be

3 identical to the CBI version except the

4 difference being, again, blank spaces between the

5 brackets and then also CBI-deleted copy at the

6 top, and then CBI-deleted for every instance

7 where you have information that has been

8 redacted.

9 The CBI-deleted version must be

10 paginated identically to the CBI-copy as well. 

11 The CBI-deleted version should be made directly

12 from the same document. You find that's going to

13 be the most easily to keep your pages in order as

14 well as your brackets lining up from the CBI15 copy.

16 We ask that you do not insert

17 additional text, transitions, paraphrasing, or

18 generic substitutions into the spaces where you

19 have redacted the information.

20 One thing also to remember on your

21 published references, if they appear in your CBI22 copy, make sure that also the reference list is
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1 in the CBI-deleted copy as well.

2 And then lastly, each page of a

3 petition that does not contain any CBI, then no

4 CBI should be marked also in that same upper

5 right-hand corner. So those are the things that 

6 we're actually looking for when we first get the

7 document to start to analyze them and review

8 them.

9 We're looking for the formatting, and

10 that is what helps move the petition through the

11 process quickly when all of the documents are

12 formatted properly and we can, as I said, just

13 move the petition on.

14 So this concludes my reminders. And

15 our final recommendation is to contact us

16 directly before you submit it. And as we said,

17 customer service is important to us. And so we

18 want to be able available to answer any questions

19 that you may have.

20 If you have difficulty in trying to

21 format the petition, we can go over that

22 information with you before you submit it. And
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1 that way, when we get it, it will expedite moving

2 it through the process.

3 So on this slide, this is where you

4 can do, if you have any follow-up questions to

5 what I've presented today, you can reach out to

6 us, again, Cynthia Eck, who is the document

7 control officer of BRS, along with myself, a

8 management analyst, and my colleague, Helena

9 Johnson. And I thank you for your time.

10 (Applause.)

11 MR. McKALIP: Thanks so much, Maxine. 

12 And our goal with that module was not to talk too

13 much on the bureaucrat side, but our key really

14 for BRS is we want to streamline, provide

15 efficient service, provide timely service. We

16 just want to make sure that we get past a couple

17 hurdles that have to be surmounted to get you to

18 the right part of the implementation process.

19 So with that, that brings us, really,

20 to the close of our agenda for this afternoon. 

21 As you heard Bernadette mention, many of us will

22 be around and want to have a chance to visit with
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1 you. If you haven't introduced yourself, please

2 do so.

3 All of our presenters, Doug Grant,

4 Ibrahim Shaquir, Maxine, are available to answer

5 questions and help you with any technical details

6 that maybe we weren't able to cover in the actual

7 presentations or in the Q&A portion.

8 I also wanted to mention, you know,

9 in the theme of new faces, there are many new

10 faces in BRS leadership who are here in the room

11 who either weren't in the exact same position at

12 this time last year. And it's a good chance to

13 maybe catch up with folks and to know who they

14 are.

15 Dr. Alan Pearson, if you'd stand up? 

16 Alan is in the role that many of you were

17 familiar with previously, Sid Abel, our associate

18 deputy administrator. Mary, are you still in the

19 room? Mary Fleming, our chief of staff, is here.

20 Many folks are in positions this December that

21 maybe they weren't in that exact role last year,

22 even if you know who they are. So this is a good
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1 chance just to connect with folks.

2 Again, if you have questions that we

3 weren't able to answer, many of the BRS team are

4 here. And we really do welcome your questions

5 and your feedback to help us as well.

6 Most importantly, Bernadette actually

7 sponsored the coffee in the back of the room, so

8 please grab some refreshments and make sure that

9 we take advantage of her generosity in providing

10 refreshments for the room.

11 So any members of the BRS team have

12 any closing messages that I might have missed or

13 any items that we need to make sure that we

14 cover?

15 Dr. Watson, we're happy you're here

16 too, hopefully you can stick around for a few

17 minutes too.

18 So with that, and for the folks on the

19 webinar, we appreciate your participation as

20 well. We had a few items that I think we're

21 going to follow-up with in writing. The slide

22 decks can all be downloaded from the same site
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1 where the webinar is located. So all those

2 materials are available.

3 If you are interested in signing up

4 for being a participant with us on eFile, the

5 paper copies are on all the tables, but there

6 also is an electronic means of signing up. And

7 we have sign-up sheets here on this front table

8 as well. So if you haven't signed up to work

9 with us on eFile and are interested, we would

10 love to have your participation and your help on

11 that effort.

12 So with that, thank you so much for

13 being part of the discussion. And please, we

14 hope that you will hang around and spend some

15 time with us more this afternoon. Thank you very

16 much.

17 (Applause.)

18 (Whereupon, the above-entitled matter

19 went off the record at 3:09 p.m.) 

20

21

22
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A

A&M 30:8

AAAS 40:15,22

Abel 111:17

ability 12:11 17:19 42:1

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9:10 10:6 11:13 12:19

16:4 20:7,8,19 25:9

25:19,19 29:15 38:7

42:16 65:12 79:4 89:2

93:4,13 95:2,4,18

96:3 99:12 109:18

111:6 112:3

above-entitled 113:18

absolutely 41:1

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accepted 28:4

access 14:17 41:16,19

42:4,8,18,19,22 43:6

43:9,10,11 44:10

47:13,14 50:2 53:1

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accidentally 83:10

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accomplished 12:8

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27:17

Achieving 24:3

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Act 21:21,21 60:10

Acting 1:11,13

action 84:11

actionable 53:4

active 8:12 37:8

actively 11:10

activities 2:7 6:5 29:20

31:20

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actual 111:6

add 9:12 57:10,11

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additional 31:17 33:10

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108:17

additionally 103:21

address 5:20 63:4

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Adjourn 2:21

administration 2:6 66:2

administrative 98:1

99:3,21

administratively 98:20

100:21 104:8

administrator 1:18,18

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92:16,17 96:13 102:5

111:18

adulterants 19:3

advance 29:1

advantage 94:9 95:1,13

96:4 112:9

advice 64:1

Advisor 3:8

advocate 6:18 50:14,14

affiliations 18:3

affordable 9:11 65:9

afternoon 3:3 4:12

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110:20 113:15

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45:15 48:19 49:7

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agriculture 1:1 8:16,20

8:20 9:11 23:20 27:3

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64:20 65:4 76:12 83:3

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ahead 10:10 13:10,14

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alfalfa 70:22

align 34:3

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alignment 24:1 36:11

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allow 32:21

allows 10:17

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alternative 93:19

alumni 40:15 91:6

am- 31:4

am-I-regulated 30:15

amended 101:19

America 65:3

American 1:20 22:13

23:20 64:20

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amounts 9:14

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analysis 12:16 69:2

98:22

analyst 1:14 99:13

110:8

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animal 1:2 11:7,8,13

18:15 20:3,7 21:17,20

22:2,6 49:8 91:22

92:2

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announced 15:17 26:1

announcements 53:19

answer 17:20 21:5 48:5

65:19 89:12 109:18

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anticipating 63:10

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arrow 106:12

ARS 67:1 91:4

Arthur 62:12

article 102:6

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Asian 15:21,22

asked 20:4,14 38:7

41:11 48:21 50:6

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asking 45:2 47:2,4

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assessments 55:16

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assists 99:15

associate 1:18 58:18

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Association 1:20

Assurance 66:16

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attached 94:5

attended 15:16

attention 6:15 86:8

attorney 22:9

audience 22:22 64:12

65:12

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audit 79:2

augment 8:22

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authorization 94:11

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68:7,10,13 69:3 70:12

70:18

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67:21,22 68:18 69:9

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authorizing 30:3

available 20:9 41:21

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90:5 95:20 97:2

104:17 109:18 111:4

113:2

avenues 17:6

avoid 98:11

aware 24:15 26:19

54:17 83:18

B

B.S 91:7

bachelor's 22:11

back 8:22 13:17 36:20

37:9 40:20 52:5,11

68:7 75:21 76:6,9

79:2 93:6 106:7,17

112:7

background 14:3 57:15

80:17

backgrounds 64:3

backs 7:14

balance 24:4,15 25:20

64:5,9

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base 12:16 14:15 39:8

103:6 104:19

based 12:4 46:7,8 52:5

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basic 99:2

basically 72:3 73:6 79:4

80:21 81:16,21 82:4

93:4 94:8,13 95:12

96:17 102:18

Basin 3:6

basis 7:8 8:7,14 20:9

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Bayer 1:21 37:13 60:6

bearing 54:10

becoming 46:22

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beginning 51:14 73:10

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22:8,20 35:19 37:13

38:4,10 39:18 44:15

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110:21 112:6

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better 19:12 25:10 45:4

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beyond 48:22,22

big 73:15 80:19

bigger 18:12 107:3,4

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60:16 62:5

biological 38:1

Biosafety 40:14

biotech 37:1,8 48:18

49:2 50:16 56:9 58:18

60:2 61:11 76:3 90:22

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biotechnical 44:3

biotechnology 1:4,15

2:6 4:7,21 6:16,20

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14:13 15:1,2,6,8

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108:1,1

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broad 41:5 70:8

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13:21 21:14 22:15,18

23:5,14,15 24:14 26:1

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104:9,18 110:7,14

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build 26:4 49:18 59:17

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42:15

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92:2

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careful 24:8 26:8

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cause 106:16

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101:16 105:5,8,13,14

105:16,18,19,21

106:3,3,20,21,21

107:8,8,9,10,13,21

108:3 109:3,4

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108:21

CBI-copy 105:13 106:2

106:9,11,14,18

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105:8,18 107:19

108:2,5,6,9,11 109:1

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central 8:13

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78:10 94:18 102:1

certainly 34:2,12 39:5

certification 100:19

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choice 41:17,19 42:1,4

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43:12 44:11 50:2 53:1

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39:19 40:8,19 54:16

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56:3

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collaboration 29:9 51:1

94:18,19

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66:21

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29:14 36:4 42:11,20

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66:12,16 67:7 69:21

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80:6,12 83:12,13

85:14 87:17 88:18

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concentrate 74:21

concentration 74:10

concentrations 73:15

74:12

concepts 26:17

concern 72:12

concerns 86:18

concise 4:3

concludes 109:14

conclusion 56:1

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conditions 31:22 78:6

78:22 79:19

conduct 73:3 76:13

conducted 13:6 31:9,13

77:6

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conference 1:11 15:16

confidential 2:15

101:12 105:7,11,22

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confinement 82:22

confusing 56:10,15

confusion 105:4

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48:16

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connect 112:1

connection 25:5 28:1

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consensus 55:3

considering 60:17

consistency 26:11

consistent 48:5 50:15

consists 72:3

construct 94:22

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56:10 61:17 63:15

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63:5,10 64:3

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109:15

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105:19 107:16 109:3

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106:3

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content 36:15

contents 4:19

context 54:12 57:18

58:20 64:15

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continually 82:15

continuation 43:21

continue 12:17 20:1

34:16 71:3 86:7 93:3

93:4 94:2,3 97:6

continuous 95:21

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convened 1:10

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57:16 59:5,6,8 62:2

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Coordinator 1:15 40:3

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101:13,14,18 104:16

104:16 105:20 113:5

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106:2,8,9 107:16

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16:1 30:3 37:4 47:17

51:11 55:8 91:1

country 10:9 18:13 37:2

43:8 50:22,22 64:19

74:5 87:3

country's 51:2

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24:16 33:5 67:15

78:12 80:18 87:18

98:3,4 101:1 110:16

course 24:22 29:5 35:3

66:7 92:15

cover 100:15 102:1

111:6 112:14

covered 21:20

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create 44:8 81:20 93:13

created 95:7

creating 50:8

CRISPR 12:10 15:12

critical 24:4

crop 1:21 37:13 38:22

39:1 60:6

crop-trait 68:2
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crossed 86:9

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data 66:11 67:6,11,19

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date 53:4 66:12 95:15

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day 7:7,7 8:7,7,14,14

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days 34:9,10 73:10,11

deadline 53:7

deadlines 53:9,10

deal 7:15 78:7

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decade 20:12

decades 11:21

December 1:8 111:20

decide 17:18 69:10

71:8

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decision 52:6,10

decisions 23:22 26:8

70:10

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declare 19:2

decrease 30:21

dedicated 23:10

deficiency 106:17

definitely 53:20 55:10

degree 22:12 91:7

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107:16,18

delicate 24:4

delimit 84:13

deliver 17:7

delivering 44:18

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demo'd 96:11

deniers 18:13

Denver 8:18

department 1:1 17:4

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40:5,5 62:13 92:2,12

100:10 106:10 110:13

sides 8:5 10:6

sign 3:18 63:2

sign-up 113:7

signature 98:6 102:3,10

102:14,17 103:1,11

signatures 100:20

102:9 103:12 104:6

signed 113:8
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signing 113:3,6

similar 74:7,10

single 47:11 71:1

Sir 56:3 62:3

sister 46:3,10

sit 16:22

site 71:7,11,20 72:5

85:13 88:10 112:22

sites 29:20 67:20,22

68:15,18 69:4,7 73:3

73:14 74:7,19 75:4,4

75:6 88:14

sitting 36:21

situations 42:2

six 7:11 68:17

skeptical 13:9 15:7

skills 23:6 34:19

slide 73:8 77:9 110:3

112:21

slides 67:12

slight 30:21

slightly 75:5

slogan 79:6

slowly 46:22

small 56:19 88:6,13

smaller 80:15

Smartphone 51:17,18

smoking 89:7

smooth 51:5

smoother 16:9

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software 81:17

solution 63:12

solutions 10:7 25:15

26:20

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somebody 71:9 83:2

someone's 81:1

somewhat 63:9

sons 8:13

soon 15:17 38:16 53:17

95:11 96:22

sooner 95:19

sorely 38:15

sorry 48:16 68:9 75:4

sort 65:22 66:3 67:17

68:8 69:22 70:13

72:12 76:19 77:21

80:16 82:18 84:16

87:9

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60:4 107:22

spaces 107:20 108:4,18

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species 70:2,4,8 72:11

specific 37:16,19 45:19

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specifically 4:19 37:16

45:8 86:15 93:2

specifics 66:6

speed 24:9

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spend 7:5 32:4 113:14

spending 21:9 23:2

36:13 65:17

spent 15:14,20 62:9

sponsored 112:7

spreadsheets 69:18

spring 14:11

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20:11 21:1 22:15

31:13 32:2 37:15

111:19

staffing 34:17 37:17,20

stage 9:17 97:6 99:4

stakeholder 1:6,10 3:11

3:14 5:20 16:16 17:5

66:1,9

stakeholders 17:8

22:18,19 25:1

stand 5:1 18:2 35:17

90:13 111:15

standard 52:8 61:19

70:19

standards 90:22

standing 51:12

start 28:15 51:16 57:16

62:8,21 63:1 109:7

started 82:3 99:6

starting 22:6

state 31:10,18 50:10

59:4,17 66:20 70:20

75:8,8 76:12 83:2

85:10,17 86:5 89:11

103:22

stated 17:2

statement 101:18 102:3

102:17,18,22 103:1,3

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states 9:2 36:19 75:5

75:16 76:11,22

statistic 31:4

statistics 30:18

status 104:10

statute 34:9

stay 23:18 28:5 53:18

step 27:1 28:9 90:1

94:13 98:17

stepping 37:9

steps 89:17

Steve 38:6

stick 112:16

stifle 10:18

stockyards 6:6

stole 7:10

stop 32:16

stopping 5:14

storage 78:12

stories 58:19

story 47:6 49:18

straight 5:14 51:18,19

stranger 90:14

strategy 44:3 48:10

50:11 51:22 52:14

56:14 59:3

strawberries 58:10,11

70:6 74:2

streamline 12:3,6 14:13

48:1 61:17,22 110:14

strong 39:5

structure 100:18

structured 101:22

stubble 84:1

studies 104:17

stuff 7:6 21:4 69:11

80:9

submission 32:21

102:16

submit 12:18 81:3,13

104:13 109:16,22

submits 102:4

submitted 35:20 38:5

79:17 94:10,22 98:2

104:22

submitting 100:16

101:7

substantial 94:15

substitutions 108:18

suburban 58:9

success 85:4 89:6

successful 90:10

summary 2:18 84:17

summer 14:12 43:16

94:15

sunsetting 28:18

supermarket 43:2,4

supplemental 78:6,22

79:18

support 92:7,14

supporters 13:7

supportive 33:21

supposed 17:17

surge 95:9

surmounted 110:17

surprise 13:3

surprising 62:19

surveys 82:2

survived 84:18

suspect 33:19

sustainable 9:12

swift 84:11

swine 19:7

switch 65:21

switchgrass 70:22

switching 31:7

sworn 5:22

synched 82:8

system 12:9 20:8 25:6

25:8,10 28:16,17,19

28:22 29:2 33:4,11

39:10 92:8,8 93:20,22

94:3 96:5 97:7

systems 51:13 69:20

T

table 10:13 11:6 13:10

65:7 113:7

tables 113:5

taken 79:9

TALEN 12:11 15:12

talk 4:11 9:5,7 14:10

15:1 16:22 17:12 19:6

41:9 42:22 46:13 49:3

49:19 57:12 64:2,2,19

66:5 73:1 83:17 97:22

98:18 99:20 100:2

110:12

talked 5:17 33:4,17

77:4

talking 7:5 31:20 36:14

48:22 49:11 58:21

64:16 65:4,11

tasked 48:8 53:21

tasking 52:13

taste 58:11

taxes 49:5

team 10:5,16 21:10

23:4,5,9,18,20 25:18

27:12 29:4,7 35:1

41:4,14 47:10 76:5

91:21 92:7,12 95:8

101:9 112:3,11

technical 20:17 34:19

90:21 98:22 111:5

technicalities 98:6

technically 98:17

technological 44:18

64:6 100:10

technologies 12:10

15:13

technology 24:10 51:9
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58:6,12,21

telephone 35:11 103:14

tell 13:19 17:8,9,20

23:13 69:14 71:11

78:13

ten 40:8

tend 77:20

tension 24:6,10,15

term 81:16

terminology 54:21

terms 26:10 30:3 33:22

38:18 60:12 68:14

70:8,16 77:11 84:16

85:4,13,18 87:4 98:1

test 78:18

testing 25:8 29:1 30:1,4

82:3

tests 104:18

Texas 30:8

text 108:17

thank 7:3 16:12 21:7,8

23:1 27:7 36:7 39:16

41:3 65:14,16,18 67:5

67:10 86:13 90:7

91:14 92:17 97:8,15

100:1,1 110:9 113:12

113:15

thanks 18:5 23:1 39:2

39:18 67:4,12 110:11

theme 111:9

things 7:19 8:10 9:2,5

11:1,7 12:6 14:7

16:15 18:8 20:4 46:21

51:14,19 55:7 58:17

70:22 72:13,20 74:4

75:13,15 77:12 79:3

79:22 82:2 84:2 85:6

99:18,19 100:6

102:13 109:5

third 83:1

thorough 24:8 26:8

thoroughly 92:1

thought 13:1 41:12

71:16 77:10

thoughts 27:10 64:4

thousands 13:2

three 11:21 14:17 30:7

32:22 47:17,18 73:9

73:11 76:19

thrilled 7:20

THURSDAY 1:8

tiger 95:7

tight 53:8

Tim 1:21 56:4

time's 17:20

timeframe 34:14

timeline 12:9

timely 11:14 20:9 79:17

110:15

times 13:19 15:8 26:17

33:5 71:6 75:12

106:15

timing 38:8

tiny 31:6

today 7:9 9:22 16:14

19:7 33:8,19 35:8

67:5 100:15 110:5

told 79:3

tolerance 84:7

tomorrow 95:11

tool 45:14

toolbox 60:1

tools 41:21 42:2,17

44:19 50:1 52:16,18

59:17,22

tooth 33:22

top 43:12 108:6

total 77:4

touch 39:8

touches 61:20

town 9:1

track 79:4

trade 1:20 15:2,3,9,9

16:10 40:6 42:14 50:6

50:20 52:14,18 64:8

84:4 105:11

traded 52:19

trading 36:14

traditional 12:8 19:20

50:16

traditionally 58:18

transition 93:21

transitions 108:17

transparency 63:13,17

transparent 13:14

23:22 62:18

traps 82:2

treatment 84:19

trees 58:3

tremendous 42:14

93:15

trend 68:16

trends 67:19

triaged 32:22

trial 22:9 71:20 78:16

83:1

trials 67:17 68:4 70:22

71:5 72:6 73:20 75:10

81:4 87:11,15,15 88:7

tried 89:13

true 101:19

truly 93:18

trusted 23:21

try 14:12 19:21 20:1,16

56:14 63:4 64:14

70:15 75:14 78:22

79:16 82:9 106:7

trying 3:18 61:16 64:12

64:19 65:10 79:13

80:14 82:16 86:8 89:6

109:20

tuned 28:5 53:18

turn 26:18

tweaking 78:21

twice 73:13

two 24:4,7 30:13 36:22

43:12 44:13 60:8,21

60:22 101:7,13,14,18

103:12 104:6

type 5:5 25:3,11

types 29:22 70:3 72:8

78:8 87:15 88:7

U

U.S 1:1 9:12 15:5 16:3

32:9 35:21 41:19,20

42:5 43:9 44:8 51:7

55:13 57:8 91:6

unannounced 71:16

77:5,7

unauthorized 83:7

undersigned 102:4

103:3,5

understand 26:10 36:5

37:7 49:6 64:13 80:1

understanding 29:16

36:3 51:2 55:11 64:14

65:2

unfamiliar 64:18 65:12

unfavorable 103:9,22

104:2

Unfortunately 33:17

Unglesbee 89:1

unified 16:7,9 56:18

61:7

uniform 16:5

unique 8:4,6 14:15

74:15 75:4 96:10

United 9:2 36:19 75:4

75:16

universities 10:20

49:18 59:4

university 22:12,14

59:18 66:20 86:5 91:7

91:8

unpack 56:5 57:1

unpublished 104:17

unrelenting 6:15

update 2:5,9,12 28:2,6

33:8 34:1 36:2 66:18

91:11 92:21 94:15

updated 44:1,2

updates 4:8 57:19

updating 4:15 11:22

uploaded 82:7

upper 106:4,10,14

107:17,18 109:4

USDA 1:15,17 8:2 10:17

11:8 14:2,13 17:2,2

18:12 19:2 27:2,7

30:5 32:8 40:3,9,12

40:22 41:1,3,5 42:13

44:7,16 45:2 46:20

47:9 48:8,20 49:2,6

49:20 50:10 53:20,21

57:8,11,19 58:15,22

59:16 61:10,18 81:17

USDA's 22:9 23:15 34:3

45:22

usda.gov 32:11

usda.gov/biotech

61:13

use 18:1 19:12 24:1,13

42:17 49:15,16,17

51:10 52:1,15 56:1

59:4 61:18 69:20 79:6

81:16,20 82:1 98:9

104:21

useful 11:15 60:3

user 29:1

users 96:14

uses 29:16 57:19

USG 41:6

USTR 52:13

V

vacancy 26:2

vaccine 18:13 19:19

vaccines 18:10,14,15

18:19 19:8,12 20:7

valid 73:7,8,9 74:7

valuable 21:9 93:9

value 43:3 57:8,10,11

93:16

variety 43:7 45:17

various 6:11 39:22

40:12 64:9 89:8

vary 74:5

vast 76:8 77:15

vendor 8:2

Ventria 87:20

Verdeca 30:11

version 101:14,15

105:9 107:19 108:2,3

108:9,11

view 24:6

views 103:6

Vilsak 19:4

virtual 31:20 71:22

77:11,20,22

vision 14:5 15:17 16:3

23:14 24:3 27:10 36:3
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visit 110:22

visitors 36:19

visuals 73:4

voluntarily 30:16

volunteer 78:16

VS 82:1

W

walk 47:19,22

walking 5:3

walnuts 70:6 74:2

Wanex 92:10 95:16

wanted 23:3 34:13 73:4

79:4 89:2 97:21

102:14 111:8

Washington 22:14

84:20 85:10,17 86:5

89:11

wasn't 83:21

watch 7:7

watching 8:14

Watson 92:16 112:15

wave 90:1

way 5:8,13 13:14 16:21

18:20 26:6,9 36:16

41:10 44:13 45:22

47:7,9 48:6 58:22

60:14 85:1 102:1

107:3 110:1

ways 24:17 55:10 57:20

weather 86:17 87:1,9

web 61:7

webinar 3:16 5:5 35:20

38:5 54:8 63:22 86:15

112:19 113:1

website 18:19 28:3 32:7

32:10,11 34:8 53:22

week 32:13,14

weeks 98:4

welcome 2:2 3:4 7:1

22:19 99:20 112:4

welcoming 40:18

welfare 21:19,21

went 13:5 22:13 62:18

66:21 113:19

weren't 111:6,11,21

112:3

West 3:5

western 16:6 66:15

wet 102:10

wheat 74:2 83:20 84:1,4

84:9,17,18 85:20,22

86:6 89:3,8

wheel 16:1

wheelhouse 9:20

white 43:17 53:14,19

107:22

wholesome 62:1 65:8

wide 9:17

widely 103:19

wife 8:15

William 54:8

willing 65:19 66:18

79:21

winter 72:9 73:18 74:13

wish 17:16 38:12

wishes 25:13

wonderful 19:5 38:11

Wood 35:16 54:6

words 56:9

work 5:13 10:14 14:12

17:12 18:14,15 20:8

25:16 26:3,13 29:3

39:12 43:13,18,21

46:16 56:16 66:7 76:5

79:1,20,21,21 80:7,9

80:20 82:12,15 88:2

88:10 94:3 98:14

113:8

worked 14:11 21:22

22:1 35:5 39:21 53:5

62:5 66:22 99:7

workflow 80:13

workforce 76:18

working 7:17 10:5

11:19 15:10,14 20:16

28:8 29:7 32:7 35:4

36:4 37:10 39:3 41:14

41:15,16 46:4 49:12

52:13 53:13 58:15

59:17,18,18 62:8 80:8

80:11,13 84:21 85:1

90:20 92:7 99:9 106:7

workload 26:5

works 8:18 35:22 57:13

71:13 99:16 100:13

world 9:16 11:4 24:2

36:10 55:14 91:1

worry 36:9

worst 19:2

wouldn't 95:20

Wow 22:22

Wrap-Up 2:18

writ 52:4 61:18

write 13:12

writing 13:15 35:12

112:21

written 102:8

wrote 7:14 62:10

X

XML 95:2 96:20

Y

year 3:22 27:16 30:20

43:17 62:22 63:1 66:9

68:10 70:9,21 71:2,7

73:10,11,12,14 74:17

77:2,7,16 86:19 87:1

90:10 92:22 96:7,11

111:12,21

year-round 73:20

years 4:4 11:4 22:5

31:15 39:21 40:8

43:22 44:2,16,21 51:8

60:8,21,22 67:16 68:7

68:12,17 75:21 76:20

78:1 87:18

yellow 106:12

Z

Zhang 67:13

zone 17:19

0

1

1,100 75:3

1,200 68:9

1,300 74:15

1,486 29:18

1:00 1:11

1:07 3:2

10 77:1,6

100 2:16

11,000 68:20

110 2:19

113 2:21

12 26:2 30:20,20 37:22

12,000 68:9

14 30:19,19 31:4 76:9

18 30:19 67:18,21 72:17

73:7 74:9 77:8

19 27:16 66:7 67:19

68:1,21 72:19 73:8

74:6 75:2 77:9 80:17

83:16

1999 22:11 67:1

2

200 3:15,19 47:21

2000s 68:9

2002 22:10,14 76:5

2005 66:22 67:2

2009 22:3,10

2012 91:5 99:7

2013 22:7

2015 79:2

2016 21:17

2017 6:1 30:18 43:22

2018 66:7,10

2019 1:8 21:15 29:18

30:1,20

2020 34:5 66:8 94:16

2021 28:18

22 2:5

23rd 93:6

25 76:22

25,000 29:22

283 29:20

3

3 2:2 29:20

3,300 67:22 68:20

3:09 113:19

30 34:10 44:16,20 68:7

304.6 104:20

31 93:14

340 4:15 30:17 102:7

103:20

340.6 102:5,21 104:14

340.6(b) 101:22

350 68:12

4

4,500 67:20

40 2:7

43 77:8

4700 1:11

5

5 1:8 77:1

53 31:19

550 68:13

6

6,100 12:22 13:3 27:20

600 31:9

636 75:5

67 2:10

6th 12:21

7

7 2:4 4:15 101:21 102:4

102:7,21 104:14,20

7,800 74:8

70 76:20

700 74:18

706 74:18

75 31:12

76 93:11

8

85 76:10

9

90 34:9 64:22

90s 76:7

91 2:13

92 72:18

97 72:19
NEAL R. GROSS

COURT REPORTERS AND TRANSCRIBERS 

1323 RHODE ISLAND AVE., N.W. 

(202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com 

C E R T I F I C A T E

This is to certify that the foregoing transcript 

In the matter of: 

Before: 

Date: 

Place: 

was duly recorded and accurately transcribed under 

my direction; further, that said transcript is a 

true and accurate record of the proceedings. 

 

 ----------------------- Court Reporter 

128

Biotechnology Regulatory Services

USDA/APHIS

12-05-19

Riverdale, MD