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UNITED STATES DEPARTMENT OF AGRICULTURE (USDA)

ANIMAL AND PLANT HEALTH INSPECTION SERVICE 

(APHIS)

+ + + + +

BIOTECHNOLOGY REGULATORY SERVICES (BRS)

+ + + + +

STAKEHOLDER MEETING

+ + + + +

WEDNESDAY

NOVEMBER 7, 2018

+ + + + +

The Meeting convened in the Oklahoma

City Memorial Conference Center, 4700 River Road, 

Riverdale, Maryland, at 10:00 a.m., Dick George, 

BRS Communications Branch Chief, presiding.

PRESENT

DICK GEORGE, BRS Communications Branch Chief

SID ABEL, Assistant Deputy Administrator for BRS

BILL DOLEY, BRS Government Relations Specialist

MIKE FIRKO, APHIS Deputy Administrator for BRS

SALLY McCAMMON, BRS Scientific Investigator

IBRAHIM SHAQIR, APHIS Associate Deputy

Administrator for BRS

PAUL SPENCER, Director, New Technologies and 

Production Methods Division, USDA FAS
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CONTENTS

Welcome ....................................... 3

Reflections on FY18 and a Look

Forward to FY19 ............................... 7

International Engagement & Outreach .......... 37

International Strategy for Plant Breeding

Innovation ................................... 46

APHIS BRS Biotechnology Research and

Scientific Engagement ........................ 72

Am I Regulated?- Implementation

of Process Improvements ...................... 92

Agricultural Biotechnology Education and

Outreach Initiative .......................... 99

APHIS eFile Demonstration & Discussion ...... 118

Adjourn ..................................... 178
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1 P-R-O-C-E-E-D-I-N-G-S

2 (10:02 a.m.)

3 MR. GEORGE: Good morning, everybody. 

4 I'm Dick George, Communications Branch Chief here 

5 at the Biotechnology Regulatory Services. We're 

6 very glad that you're joining us today for our 

7 2018 Stakeholders Meeting.

8 Those of you who attend our meetings 

9 every year may recall that last year we tried to 

10 liven things up a bit by adding music during the 

11 breaks. Last year we featured the music of John 

12 Philip Sousa: big, energetic march music. That 

13 worked okay, so we figured to do it again but 

14 maybe change it up with somebody else. But who? 

15 So, let me tell you a quick story.

16 I used to work at a Fortune 100 energy 

17 company. And like most places, we'd talk about 

18 other people we work with. Maybe you guys have 

19 done this yourselves. And this one guy I worked 

20 with, his name was Kevin, he had his own unique 

21 rating scale. He would judge people, and 

22 especially leadership, on whether they had any 
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1 Elvis. That was his criteria.

2 We'd say, Hey, Kevin, what do you 

3 think of so-and-so?

4 He'd shake his head dismissively and 

5 say, No Elvis. Or he'd give a thumbs up and say, 

6 Elvis.

7 We were amused by this apparently 

8 arbitrary rating, but it turns out it really 

9 meant something to Kevin, and we all got it after 

10 a while. High Elvises were the people who were 

11 totally engaged in their work and passionate 

12 about it, people who cared about getting it 

13 right, people who really knew what they were 

14 doing.

15 So, of course, Elvis Presley came to 

16 mind for this meeting because all of our speakers 

17 today rate very highly on that Elvis scale. So, 

18 we will play some music today to give the 

19 proceedings a little spark, especially to end the 

20 breaks. When you hear Elvis, it means we're 

21 ready to get back to work.

22 Some housekeeping details. Please 
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1 set your cell phones on vibrate or turn them off. 

2 We have coffee and water in the back. Down the 

3 hall, out this door to the right and then a first 

4 left is our little café if you'd like a different 

5 beverage or something to eat during the break.

6 In your package of handouts is a list 

7 of local lunch eateries. Many of them will 

8 deliver to this building, and pretty quickly, 

9 too.

10 As usual, we are webcasting our 

11 meeting and we don't want to forget our out-of12 sight attendees. And by the way, those of you 

13 that are online, the handouts that we are giving 

14 out here today in the room are also now on our 

15 website.

16 I'll ask all of you here today to wait 

17 until we either get a microphone to you, or if 

18 it's closer for you to walk to one of our 

19 microphones, please do so before you make a 

20 comment or ask a question so that our webinar 

21 audience can hear. And please identify yourself 

22 and your organization, if you represent one, 
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1 before you speak, whether you're here in person 

2 or via the web.

3 We have a court reporter who will 

4 produce a complete transcript of this meeting. 

5 And that transcript will be posted to our website 

6 within a few weeks. That's why we need you to, 

7 please, always wait for a microphone before you 

8 speak, or walk to the nearest one, and identify 

9 yourself. And spell your name, especially if 

10 it's anything unusual, so our transcript will 

11 have it right.

12 Please hold your questions until each 

13 speaker has completed their presentation. 

14 We've allowed time for questions at the end of 

15 each segment.

16 Those of you online, on the telephone 

17 keypad press 1 and then 0. This will alert our 

18 moderator that you would like to speak, and we 

19 will un-mute you and invite you to ask a question. 

20 So, again, for online attendees to ask a question 

21 just press 1 and then 0 on your telephone keypad.

22 If you prefer, you can ask a question 
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1 or make a comment via the web. On your screen 

2 type your comment or question in the comment box 

3 and hit "enter." We'll have someone monitoring 

4 this, and they'll get your question or comment to 

5 us.

6 So let's get started. At this time, 

7 to take a look at the year just past and the year 

8 to come I'd like to introduce our APHIS Deputy 

9 Administrator for BRS and a guy, I might add, 

10 with a lot of Elvis, Mike Firko.

11 MR. FIRKO: Thank you. And thanks to 

12 everybody who joined us here today. We currently 

13 have 60 people who have joined us on the webinar. 

14 If you see this little blue sticker over there, 

15 Robin will be keep updating that. And based on 

16 my days of estimating insect populations in the 

17 field, we have about 60 people in here I would 

18 say.

19 (Laughter.)

20 MR. FIRKO: Sixty-three? Okay, that 

21 was pretty close.

22 Okay. Can we advance to the next 
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1 slide? Can you do it manually?

2 Good. You turned it off.

3 So, for the first nine slides or so 

4 I'm going to be talking about things that we 

5 accomplished during 2018. It was a very 

6 interesting year, very productive. We had good 

7 results in several areas.

8 I always show you this one every year: 

9 number of release authorizations. Down a little 

10 bit from last year.

11 Number of release sites, actually 

12 about the same.

13 And then the number of unique 

14 Phenotypic Designations, now different from the 

15 first two numbers this is for all activities, 

16 meaning it includes imports, interstate 

17 movements, and release authorizations.

18 Now, I should note that this number is 

19 substantially lower than last year. Because I 

20 had a question. Those of you who were here last 

21 year may remember it. I had a question last year 

22 about whether that number, 14,856 -- it was in 
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1 the 40 thousands last year -- did we account for 

2 redundancy across years, and across permits, and 

3 across states? And my answer was I'm not sure, 

4 but we'll look into that.

5 So, we looked into it and sure enough 

6 there were some things that were getting counted 

7 twice. So, 14,856 is the number of unique plant 

8 trait mechanism of action combinations that we 

9 revised during 2018 as we were considering 

10 authorizations for field releases, importation, 

11 and interstate movement.

12 So, in this year we completed two 

13 deregulation petitions. The first one was the 

14 Bayer dual herbicide. And of course all this 

15 information and all of the associated documents 

16 are available on our web pages.

17 You'll see here that we accomplished 

18 this in 332 days. Our published time frame is 

19 395 days. So about 11 months instead of 13 

20 months. So, we substantially beat our target for 

21 how long it would take us to complete this 

22 petition for deregulation.
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1 The second one was from Nuseed America 

2 for an improved omega-3 canola. This was a Path 

3 2, meaning we had an extra Federal Register 

4 notice with a public comment period. So, because 

5 it's a Path 2 the target is 463 days. We beat 

6 this one by quite a bit, about 100 days.

7 I'm cheating a little bit here because 

8 we've done another one since the end of fiscal 

9 year '18, so it counts for fiscal year '19, but 

10 I couldn't help but point out that we did this 

11 one in 362 days instead of 463. So we're, we're 

12 really cranking on these things. We're getting 

13 them done even more quickly than we thought 

14 possible.

15 Am I Regulated? That we get. And, 

16 of course, in the quote there is the typical 

17 translation of what this program, the Am I 

18 Regulated Program, is all about. Showing you 

19 statistics for the last three years we're doing, 

20 they're coming in at about a consistent 

21 frequency. We are answering them in about a 

22 consistent frequency. And again cheating a 
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1 little bit, we've already done two in October. 

2 Those will count for fiscal '19.

3 We currently have five inquiries under 

4 review. All of them have been received since 

5 July. So we're also answering these Am I 

6 Regulated? requests very quickly.

7 Now, this is a subset of the Am I 

8 Regulated? requests. These are requests involving 

9 Site Directed Nucleases. I showed you this slide 

10 last year, slightly modified from last year. And 

11 the numbers are, therefore, updated.

12 It shows the frequency of 

13 Meganucleases, Zinc Finger, TALEN, and CRISPR, 

14 how many of each of those we've gotten. You see 

15 that the only two Site Directed Nuclease Am I 

16 Regulated? pending are both CRISPR.

17 Now, every one of these responses has 

18 been not regulated. Our answer to them has been 

19 "not regulated," including our first SDN 2/3.

20 Now, why do I call that a 2/3? Well, 

21 there's a lot of reasons. One is that I think 

22 it's fair to say that there's no consensus on the 
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1 line between 2 and 3. We, based on most of the 

2 literature and the papers on this, we would 

3 probably call this a 3 because it is a complete 

4 allele replacement. Templates involved a 

5 thousand base pairs or more.

6 The requester thought of this as a 

7 SDN-2 because it was cisgenic. Not sure what 

8 that has to do with the criteria that I've heard, 

9 but it points to maybe it doesn't matter. 

10 There's SDN-1's without a template, and then 

11 there's SDN-2's and 3's with a template.

12 But one of the points I want to make 

13 here is in terms of our decision making, which is 

14 about plant pests and weeds, it doesn't matter. 

15 We don't have any legislation that tells us that 

16 we need to look at SDN. We don't have any 

17 legislation about biotech in particular. Our 

18 legislation is about plant pests and weeds. So 

19 that's what our decisions are about.

20 I also talked to you last year a 

21 little bit about the permit application we had 

22 received for fairly expansive -- every county in 
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1 Florida -- release of a genetically engineered 

2 Citrus Tristeza Virus of biologic control of 

3 Citrus Greening Disease. As most of you probably 

4 know, Citrus Greening is a really terrible 

5 disease of citrus in Florida. The poor folks in 

6 Florida have also been getting hammered by 

7 hurricanes off and on over the last few years, 

8 but this particular disease has been devastating.

9 This year we published a draft 

10 Environmental Impact Statement that was prepared 

11 in support of us issuing a permit for release in 

12 every county in Florida, up to the discretion of 

13 the permit holder, of this genetically engineered 

14 Citrus Tristeza Virus to control Citrus Greening 

15 Disease. We had a whopping 51 comments -- not a 

16 lot in other words.

17 Now, I'll talk about this more in a 

18 few minutes. But since we published the draft 

19 EIS and draft Pest Risk Assessment there was a 

20 paper published that we'll need to think about.

21 So, regarding our, the work that we do 

22 with our partners in the coordinated framework, 
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1 EPA and FDA, we did a lot of work on a Horizon 

2 Scanning System. This comes to a large degree 

3 from a National Academy of Sciences study. The 

4 title of that study is "Preparing for Future 

5 Products of Biotechnology." And they made a 

6 recommendation about creating a Horizon Scanning 

7 System.

8 Now, you're going to get many more 

9 details from Sally McCammon when she gives her 

10 talk in a little while, but we're very pleased 

11 with this work. The three agencies are working 

12 together very well on this. And we think folks 

13 will like what we're doing here.

14 Now, I added this as my last little 

15 bullet here because that's a heck of a URL. 

16 Sally will show it again. This will be available 

17 when the slides are made available. But you can 

18 go, you can go in and look at this system now and 

19 see what's on there. More details on this system 

20 to follow.

21 Another USDA-EPA-FDA collaboration 

22 has to do with the Biotechnology Unified Web 
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1 Portal. And as you might guess from the title, 

2 this is a single point of entry for regulatory 

3 information about the United States' regulatory 

4 program. This will have a dot gov URL. We have 

5 had a lot of discussions with EPA and FDA about 

6 hosting this as a dot gov URL. In other words, 

7 it's not a USDA URL, it's not a FDA URL, it's not 

8 a EPA URL.

9 And, of course, one of the major 

10 efforts here is to make this user friendly for 

11 any aspect of biotech regulation in the United 

12 States. Fortunately, since we're building from 

13 scratch we can use modern approaches to these 

14 tools. And as is of interest to this 

15 administration, we are thinking very careful 

16 about how this might be helpful for small 

17 developers, which is where we get most of the 

18 questions about what does it mean to be in 

19 compliance with the U.S. regulatory system, and 

20 how do I do that?

21 Again, this is also partly a result of 

22 the National Academy's recommendation. And this 
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1 talks a little bit about what that system will 

2 look like.

3 This launch is anticipated in the 

4 future. I suspect that there will also be a beta 

5 version available. We'll see how the development 

6 goes. It will have a variety of pages.

7 At some point things will get shunted 

8 to one of the three agencies because we in the 

9 USDA don't speak for FDA or EPA. They don't 

10 speak for us. But the idea is to make a system 

11 where you can get direct information about all of 

12 those programs. Some of the stuff that we're 

13 still working on is to what degree will 

14 particular agencies take responsibility to 

15 provide answers with the agencies working 

16 together in the background. Some of those 

17 details are still being worked out, but the idea 

18 is to make this as user friendly as possible to 

19 get folks the answers they're looking for.

20 So, we're going to have a whole 

21 afternoon session on APHIS eFile. I talked about 

22 this in previous years. This is the replacement 
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1 for our current APHIS ePermits system, electronic 

2 permitting system. I think I told you that we 

3 tried to be careful and called this APHIS eFile 

4 because the IRS already got the name eFile. So 

5 we had to be careful about that.

6 Some of the things that we're thinking 

7 very carefully about is what is the transition 

8 going to look like from ePermits to eFile? 

9 That's one of the key things that you'll hear 

10 about this afternoon if you're registered for

11 that session this afternoon. There will be 

12 plenty of detail about exactly what that will 

13 look like.

14 You know, our goal in moving to a new 

15 system is many-fold. We have many goals. One 

16 is that our current ePermit system is built on an 

17 older platform. It was released in 2006. We 

18 started working on it about 2001. It's well over 

19 15 years old in technology. There are newer 

20 tools out there. Dealing with mobile devices is 

21 much different these days. Users expect a much 

22 different type of user interface. We're very 
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1 excited that new tools will be available not only 

2 for us, because both of these systems to a large 

3 degree are a workflow manager for us.

4 We come in in the morning, we boot up 

5 the system, and there are work assignments, 

6 things that we do. We get the assignments out 

7 of the system. Behind the scenes documents are 

8 being shunted from biotechnologist branch chiefs 

9 back to biotechnologists. So there's a lot of 

10 movement behind the scenes.

11 I've always thought of ePermit as a 

12 workflow manager. But, of course, for external 

13 stakeholders it is a way to come in and apply for 

14 a permit electronically and to get your permit 

15 electronically.

16 So we understand that transitioning 

17 from ePermit to a new system is going to be 

18 traumatic for all of us. We have change 

19 management programs that we're doing internally. 

20 And you will hear this afternoon about some of 

21 the change management we're doing from an 

22 external point. In fact, our session this 
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1 afternoon is part of our change management.

2 Of course, as you know, we're also 

3 thinking real hard about changing our 

4 regulations. So, for about three years now we've 

5 been asking ourselves what does our system need 

6 to do under a new set of regulations? Because, 

7 frankly, it's being built right now for the 

8 regulations that we have right now. There will 

9 be some changes.

10 As I've been saying the last couple 

11 years, we anticipate not using notifications in 

12 the future. Notifications are the biggest type 

13 of input that we get. Now, that's a throughput 

14 issue, not necessarily something completely 

15 different. But we are, we're also building a 

16 permitting system now as well as a notification 

17 system. So if we're using only permits in the 

18 future, we'll have that built already.

19 The number of changes that we need to 

20 make to the system once the new regulations are 

21 in place are actually fairly minimal. So, that's 

22 very good news. We started work on what we call 
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1 a concept of operations two-and-a-half years ago, 

2 and we've been tracking that as we go. You'll 

3 hear much more about APHIS eFile this afternoon.

4 So, 340. The timing on this is a 

5 little interesting. I'm trying to remember. I 

6 think this 340 proposed rule that was published 

7 in January of 2017, I think that was withdrawn 

8 right before the last stakeholder meeting. Is 

9 that right? Fiscal '18, so in fiscal '18 that 

10 was one of our accomplishments.

11 And, of course, the reason that this 

12 rule was withdrawn is we received a lot of very 

13 disparate comments. And we felt it was necessary 

14 to start over, get more input from external 

15 stakeholders, get more input from states and do 

16 more outreach with foreign governments, do more 

17 outreach with EPA and FDA. And, of course, we've 

18 been very busy at that. And you'll be hearing 

19 more about that.

20 But withdrawing that proposed rule set 

21 the stage for a new level of engagement which we 

22 could not do as long as we were in open 
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1 rulemaking. And we've done quite a bit of 

2 outreach on that since then.

3 This year we published a notice of 

4 intent to conduct a programmatic Environmental 

5 Impact Statement. So that's the little "p," 

6 programmatic, and that's because it relates to 

7 the biotech program. Wow, another whopping 35 

8 comments on that. I guess people aren't

9 particularly interested in biotech anymore. I 

10 don't know.

11 And we have been preparing a new 

12 proposed rule, a new programmatic Environmental 

13 Impact Statement, and a Regulatory Impact 

14 Analysis, sometimes known as the Economic 

15 Analysis. And those are the things that we'll 

16 be going public with.

17 So, looking forward to 2019: 340, 340, 

18 340.

19 This is our number one strategic 

20 initiative. I think last year I said that our 

21 regulations were 30 years old. Now they're 31 

22 years old. The fundamental basis of those 
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1 regulations has not changed in 31 years. It's 

2 long overdue. It's very difficult to do anything 

3 with biotech regulations. I'm very confident 

4 that we're going to be able to do something now 

5 though.

6 So, our plan for 2019 is to publish a

7 new proposed rule. It would be great if we could 

8 accomplish that in the first calendar quarter of 

9 2019. That's our intent. We'll be publishing 

10 the draft Programmatic Impact Statement at about 

11 the same time. I think in 2017 that was done 

12 within a week of each other. That's partly 

13 because EPA is involved in publishing the 

14 Environmental Impact Statement, and the proposed 

15 rule - USDA has the lead on that, so getting them 

16 published on the same day is a little difficult.

17 The Draft Regulatory Impact Analysis 

18 will also be published at about the same time.

19 And at the end of my talk I'll have 

20 more to say about 340.

21 So, we currently have five petitions 

22 for non-regulated status. Our good old standby 
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1 ArborGen Freeze Tolerant Eucalyptus from 2011. 

2 We sent a request to Fish and Wildlife Service 

3 about three years ago for consultation. We have 

4 not yet gotten an answer about whether or not 

5 they will entertain consultation.

6 We have the Verdeca Increased Yield 

7 Soybean, the draft Plant Pest Risk Assessment and 

8 Environmental Assessment are in preparation. 

9 Those should be published for comment soon.

10 We have a canola product from BASF. 

11 Same thing, the draft EPRA and EA are in 

12 preparation. You should be seeing those in the 

13 Federal Register for comment pretty soon.

14 There we go. And we have two 

15 petitions that we have received quite recently. 

16 And those, the petitions themselves will be 

17 published soon. We are working with the 

18 petitioners now on the completeness of those

19 petitions. And we typically do not announce 

20 those petitions until, or identify those 

21 petitions until they've been published in the 

22 Federal Register for comment. But we're at very 
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1 early stages. Just received. And you should 

2 see those petitions in the Federal Register soon.

3 So, back to the genetically engineered 

4 Citrus Tristeza Virus. It is our intent early 

5 in calendar 2019 to issue that statewide permit 

6 for release of genetically engineered Citrus 

7 Tristeza Virus. And, of course, when I say 

8 release what I mean is grafting budwood onto 

9 existing trees or roots. This is not like a 

10 spray or anything like that, it's a grafting 

11 process.

12 I mentioned in a previous slide that 

13 there was a new paper published about, about 

14 these issues. It was a transmission of Citrus 

15 Tristeza Virus by the insect vectors. And it's 

16 pretty new. We just became aware of it several 

17 weeks ago.

18 Because of some language that we had 

19 in our draft EIS and the draft Pest Risk 

20 Assessment we're looking at these new data to 

21 decide what, if anything, we need to do in 

22 response to these new data. And we'll have a 
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1 better idea about what impact that will have on 

2 going forward. But like I said, we don't 

3 anticipate this really delaying things.

4 I spoke with the permit applicant this 

5 morning, and we're completely in line with their, 

6 the timing of their business model. And that's 

7 important to me because my commitment to them and 

8 to the citrus industry was that we will not delay 

9 you. When you're ready with this important tool 

10 to combat citrus greening, we will be ready with 

11 the permit for you. And we're still in line to 

12 be able to do that.

13 So, you'll hear more about 340 

14 outreach, but this is a sampling of the sorts of 

15 engagements that we've done in the past. Mostly 

16 in the past -- June, July, August, September, 

17 October -- six months about, we have traveled, I 

18 traveled personally to I think three 

19 universities. And there were multiple 

20 universities at each of those.

21 Doug McKalip, Ibrahim Shaqir, Sid 

22 Abel, a variety of people have visited, have gone 
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1 out to universities and met with them. And we 

2 reached face-to-face 17 universities in that 

3 route, in that way. And, of course, we chose 

4 these universities because of their involvement 

5 in plant development and biotechnology in the 

6 crop arena.

7 We met with a variety of non8 governmental organizations and thought leaders, 

9 -- there's one in the audience here, I think --

10 small and large biotechnology companies, industry 

11 groups, commodity groups, grain trade value 

12 chain, tribes.

13 We do have some additional tribal 

14 engagements that are scheduled for about a week, 

15 week-and-a-half, state Departments of 

16 Agriculture, of course, our federal partners, 

17 other USDA agencies. And we have talked about 

18 our conceptual framework with at least 50 

19 countries in a variety of different venues.

20 I will say that with very few 

21 exceptions our conceptual framework has been 

22 received very gladly.
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1 So, this is my last slide. You have 

2 in your handout package a statement from 

3 Secretary Perdue about plant breeding innovation, 

4 and a companion document that has as its first 

5 name "Details." Let me see if I can see where 

6 this is. I guess it's about the fourth or fifth 

7 page in. Yeah.

8 So, the first of these two documents 

9 is the press release. And the second one is 

10 "Details on USDA Plant Breeding Innovations." 

11 Probably most of you are familiar with this 

12 already. You can take it with you and read it 

13 at your leisure. Basically what this document 

14 says is that we're familiar with plant breeding 

15 innovations. We've been regulating in this space 

16 for quite a while. And over the years, 30 years 

17 of experience regulating products of 

18 biotechnology, we have learned a lot about where 

19 risk comes from.

20 And there are four categories of 

21 modifications that we don't intend -- we don't 

22 now and we don't intend in the future to regulate. 
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1 And they are deletions, single-based pair 

2 substitutions, cisgenic changes, or what we call 

3 complete Null Segregants.

4 Now, this is where I segue into the 

5 next document, because what this statement also 

6 says in the details is that we do not currently 

7 regulate these things unless a plant pest was 

8 used in making this genetically engineered plant. 

9 That caveat would go away under our conceptual 

10 framework.

11 So, what I mean by that is we 

12 currently have three plant pest triggers in our 

13 current regulations: if a plant pest was used as 

14 a vector; if a plant pest donated genes; or if 

15 the organism that was genetically engineered is 

16 a plant pest itself.

17 We plan on losing 1.95 of those. So 

18 let me explain what I mean by that. Completely 

19 dropping the vector. There's never been any 

20 evidence in almost four decades that using 

21 agrobacterium tumefaciens to vector genetic 

22 material into a plant causes that plant to become 
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1 a bacterium or makes it into a plant pest of some 

2 kind. So we would like to drop that. And that's 

3 what we'll be proposing.

4 One part that we are keeping in full 

5 is if you genetically engineered a plant pest. 

6 That's the basis of our authority. That is our 

7 authority, plant pest authority. So, how we 

8 regulate genetically engineered plant pests, we 

9 don't really see that changing very much.

10 Now, the .95, that's the part about if 

11 a plant pest donated genes let's say to a plant, 

12 so the likelihood of that making a difference in 

13 terms of plant pest risk is exceedingly small. 

14 As a 4-decade risk assessor I don't believe in 

15 zero risk. But the likelihood of using plant 

16 pest DNA in a genetically engineered plant, the 

17 likelihood of that creating a plant pest risk is 

18 very remote, but it cannot be completely 

19 discounted, so that's the .05.

20 Oh, I do need to click. Now, one more 

21 click.

22 So, now let's move to the flow chart 
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1 which is I think the next document. Looks like 

2 this. Now, this is what all of us have been 

3 doing in all of those engagements that I showed 

4 you a couple of slides ago. We typically do 

5 these in two or three hours.

6 I have I think two minutes, Dick, so 

7 I'm going to go through this really quickly. But 

8 we'll be here over lunch. We'll be here this 

9 afternoon over the eFile thing. You can ask any 

10 of us questions about this. So, let me very 

11 quickly go through this.

12 Each of these boxes has in the upper 

13 lefthand corner a little number, it's a little 

14 tiny number, small font -- sorry about that, I 

15 might have to get my reading glasses out. So one 

16 of the reasons I started with the secretary's 

17 statement, at Box 1, the orange box in the middle 

18 top of this flowchart is about that.

19 So, if your genetically engineered 

20 plant -- and I should take a moment to say this 

21 chart is about plants, plants only, this is not 

22 about plant pests, plants only -- so, if your 
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1 genetically engineered plant fits into one of 

2 those categories described in the secretary's 

3 statement on plant breeding innovation, "yes" 

4 from Box 1 takes you to Box 4, the green on the 

5 left. Then the answer is that's not regulated.

6 Deletions, single-based pair 

7 substitutions, those happen all of the time. 

8 Every time there's a meiotic event, those things 

9 happen.

10 Cisgenic, if we're talking about 

11 sexually compatible species, those things happen 

12 all the time. You know, we would like to back 

13 away from regulating things that could happen 

14 naturally in nature or through traditional plant 

15 breeding.

16 The complete null segregant piece is 

17 if you use plant pests but then you remove all of 

18 the plant pest material, we don't see us having 

19 a nexus to regulate that.

20 If the answer is you have a 

21 genetically engineered plant and it is not one of 

22 those four categories, then formally ask the 
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1 question, ”Is the plant genetically engineered?” 

2 And the regulations will have a definition of 

3 that, similar to what -- to the definition we had 

4 in the 2017 proposed rule but not exactly the 

5 same.

6 If the answer is no, it's not 

7 genetically engineered, you're not regulated.

8 Down to Box 3. If it is genetically 

9 engineered, then the question is, “Is this 

10 something that we have looked at before?” If the 

11 answer is yes, we don't want to go through the 

12 same thing again. It's not regulated.

13 And, of course, this list -- we've 

14 been calling it the Box 3 list -- will be 

15 available on our web pages, and it will list all 

16 of the plant trait mechanism of action 

17 combinations that we've already rendered a 

18 decision on.

19 Now, notice the horizontal light blue 

20 line through the middle of the document. Above 

21 that line says "developer actions," below the 

22 line says "agency actions." Above that line 
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1 APHIS doesn't necessarily need to be involved.

2 Now, if a developer meets Box 1 or Box 

3 3 and they would like a letter from us saying, 

4 no, you really are not regulated, you really 

5 aren't, we'll write you that letter. That's the 

6 box for it.

7 But if you don't meet any of those 

8 criteria, then you go down and you may be subject 

9 to regulation, we have to make that 

10 determination.

11 Now, Box 7 and Box 6 are a little bit 

12 different because Box 5 is new in our thinking 

13 compared with the 2017 proposed rule. We were

14 hopeful that we could make decisions about 

15 whether or not something was regulated before we 

16 actually started regulating things, by making a 

17 jurisdictional analysis. Do we have any 

18 authority to be regulating this? That proposed 

19 rule got blasted. People wanted permits.

20 And we've been hearing over the last 

21 year from many, mostly large companies, that no, 

22 we want permits. We're always going to go to Box 
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1 7.

2 We're like, Well, okay. You want to 

3 be regulated; we can do that.

4 What we're hearing from mostly small 

5 companies and universities, they're going right 

6 to Box 6. They want an answer ahead of time: Is 

7 the thing that I made subject to regulations or 

8 not? We will be very happy to accommodate those 

9 requests. Similar to an Am I Regulated? Not 

10 the same as the Am I Regulated passage, but a 

11 similar idea.

12 Before you have been subject to any 

13 regulation, before you've had a permit for field 

14 trials, you can call and ask us: Is it subject to 

15 the regulations or not? We'll be happy to give 

16 that answer. We think we can do those very 

17 quickly.

18 And the things that we'll be looking 

19 at in that analysis are going to be the same 

20 things we look at now in our Plant Pest Risk 

21 Assessments. Is it a plant pest? Does it create 

22 plant pest risks? Are there indirect plant pest 
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1 risks? Is it a weed? Does it exacerbate 

2 weediness? Are there sexually compatible weedy 

3 relatives?

4 So, those are all the questions that 

5 we'll be asking. The authority that we 

6 anticipated employing in 340 going forward is the 

7 plant pest authority. If and when -- and I hope 

8 this doesn't happen -- we encounter a genetically 

9 engineered plant that we think raises serious 

10 weed concerns, there's regulations about noxious 

11 weeds that can be brought to bear for those.

12 Now, notice there's a loop from Box 7 

13 back to Box 6. If someone believes that there 

14 are new data that would lead us to a different 

15 conclusion, or if they're done having a permit 

16 and would like to not have to get a permit 

17 anymore, they can go from Box 7 into a 

18 jurisdictional analysis. Maybe there's been one 

19 done before, maybe there hasn't.

20 Now, as we complete these Box 6 

21 analyses, those answers will feed into Box 3. 

22 But every time we make a decision about a crop 
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1 trait mechanism of action combination that will 

2 get added to the Box 3 list, it will be on our 

3 webpage about things you don't need to ask us 

4 about anymore.

5 And I know you've all heard me say 

6 this before, but we are so done doing glyphosate 

7 resisting corn and soy, but we keep getting 

8 petitions for those, so we just have to go through 

9 the same thing. We want to stop doing those 

10 things. We've made those decisions already.

11 So, once you clear Box 6, if the 

12 answer is no, you're not regulated, that will be 

13 made public. The developer can get an 

14 affirmation letter and you're cleared with the 

15 USDA biotech regulations.

16 Now, one or two little notes. Notice 

17 that Box 3 and my emphasis on crop trait mechanism 

18 of action -- and I'll say a little bit about that 

19 -- that's moving away from the event by event 

20 regulation, to regulation by what is the thing 

21 you made? And is the thing that you made a plant 

22 pest? Does it represent plant pest risks? Or 
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1 is it a weed?

2 So it's a different approach based on 

3 risk.

4 How far over time am I?

5 MR. GEORGE: About 10 minutes.

6 MR. FIRKO: About 10 minutes, okay.

7 We're going to have questions later?

8 MR. GEORGE: Yes.

9 MR. FIRKO: Yes. Thank you.

10 MR. GEORGE: Well, thank you, Mike. 

11 Mike will be available for the breaks and also at 

12 lunch if people want to follow up with some other 

13 questions.

14 So, next I want to introduce a person 

15 here not only on the domestic front but also 

16 internationally, APHIS Associate Deputy 

17 Administrator Ibrahim Shaqir, who heads up our 

18 BRS International Group, here to tell us about 

19 it. Ibrahim.

20 MR. SHAQIR: Thank you very much, 

21 Dick, for the introduction.

22 Mike, great presentation.
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1 And now I need to figure this out. 

2 Okay.

3 All right. So, I welcome everyone to 

4 our stakeholder meeting. I want to welcome you 

5 all. And I want to also acknowledge our 

6 international partners here and visitors from 

7 China and Czech Republic and EU. So, I'm sure 

8 there are other international representation 

9 countries, so we welcome you all.

10 So, I gave a general presentation last 

11 year about our international engagement and 

12 outreach. And I thought just to give you a quick 

13 reminder of what we do. And then I will be 

14 followed by a great colleague and friend who will 

15 be expanding on the international activities and 

16 implications concerning trade and updates on 

17 that. Paul Spencer is here, so a great 

18 presentation. So it's going to be a quick 

19 overview of what we do and why we do it.

20 So, what we do is really complement 

21 our international -- our biotechnology regulatory 

22 approach to doing things. And we, we cannot 
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1 operate in a vacuum. So, we have certain 

2 mechanisms to conduct our international outreach 

3 and also within government.

4 So, why do we do it? To protect the 

5 plant health, support international trade, and 

6 training and outreach. Protecting plant health 

7 through ensuring that plant health is safe, what 

8 comes into the country and also what goes out, to 

9 basically ensure that the products, basic 

10 products are safe and there are no international 

11 implications.

12 Supporting international trade, we do 

13 that through several mechanisms: with 

14 coordinating with colleagues, with FAS, CONAG 

15 service, cooperation with other agencies, USTR, 

16 Department of States, and also international 

17 partners.

18 The training and outreach, there's 

19 many several ways that we do that. But I will 

20 expand on that further.

21 So, these are some of the 2018 

22 activities. We engage with the foreign 
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1 governments where we either visited several 

2 countries or have them come and visit us here in 

3 the U.S.

4 We've had several, well, several 

5 bilateral meetings, but there are some that are 

6 standing meetings, that these are annual 

7 meetings, and bilateral working groups as well.

8 We have ongoing global collaboration, 

9 again through either global platforms or 

10 international engagement through international, 

11 where we attend international meetings and talk 

12 about our regulatory systems.

13 And with all of that we do support 

14 international trade and commerce.

15 So, we've had several visitors from 

16 really various countries, from over nine 

17 countries this year with some 87 -- 86 visitors. 

18 And they basically have different backgrounds. 

19 There were presentations from different 

20 countries; from different sort of sectors within 

21 government; government officials; scientists; 

22 importers of seed, grain. And also have had 
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1 journalists that come and visit us from several 

2 countries who will basically talk about, you 

3 know, and understand genetically engineered 

4 organisms or regulatory systems and visit with us 

5 and visit with other important entities that deal 

6 with genetically engineered organisms.

7 There are several also kind of 

8 capacity building in partnership with 

9 universities. There is on with Michigan State 

10 University, University of Missouri-Columbia. 

11 And we've had now for the past two years National 

12 Defense University. And we've had also 

13 engagement with China Agricultural University.

14 The Michigan State and Missouri are 

15 with their regulators, scientists from various 

16 countries, from Asia, Africa, Europe, and South 

17 America, Central America that come in and 

18 basically have a full course on biotechnology and 

19 regulation.

20 So we receive many questions about --

21 from these visitors. I've had this question, a 

22 question about do Americans eat food derived from 
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1 genetically engineered crops? And they believe 

2 that much of what's really produced we export. 

3 Okay? So, and I think this is an important --

4 my EU friend is laughing at me, but that's okay.

5 So, of course, the question, of course 

6 Americans do eat genetically engineered product.

7 How do APHIS, EPA, and FDA coordinate? 

8 And I think this is an important question. And 

9 it's important for many of these regulators to 

10 understand how we operate and how we maintain our 

11 regulatory lanes, and coordinate so to ensure any 

12 biotech crop products are safe. And so that's 

13 an important question. And that's why we include 

14 at any of our meetings where we have visitors, 

15 our colleagues from FDA and EPA.

16 What resources are needed for to 

17 implement a system like ours? And so that's, you 

18 know, for many of these -- some countries they 

19 don't have a really formalized system in place 

20 for regulation. And so they come in and hear 

21 about what we do. And I think that's important 

22 that we share.
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1 And what is your regulatory approach 

2 for new plant breeding innovation technique? 

3 That's really for the past years now we have been 

4 asked this question. And we have been sharing 

5 with them our experience, and particularly on the 

6 Am I Regulated? process and how we make the 

7 determination on how to regulate or not to 

8 regulate genetically engineered crops where 

9 genome editing techniques were used.

10 And the last one about co-existence 

11 with ag production, we basically talk about 

12 collaborate work with dealing with that.

13 So, I mentioned the bilateral 

14 meetings. We have a standing meeting with China. 

15 Well, this is the trilateral meeting with Canada 

16 and Mexico. We meet annually. We talk about --

17 we identify a theme to basically dig deep into 

18 and share information.

19 The last time we met we talked about 

20 our basically regulatory updates, but also we 

21 talked about the chestnut blight resistant trees 

22 that is genetically engineered. And we do have 
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1 also a kind of quarterly discussions as well as 

2 we organize scientific webinars. The last one 

3 we've had was about two weeks ago, and we talked 

4 about synthetic biology.

5 The meeting with, bilateral meeting 

6 with China is a standing annual meeting in 

7 partnership with our sister agency, Foreign Ag 

8 Service. Paul Spencer was there. And each year 

9 we basically share our, we share our updates. 

10 And then we identify a theme that's of mutual 

11 interest. And this also, our Chinese colleagues 

12 asked to learn about how we are dealing with 

13 citrus greening, really an important disease also 

14 for China. And they want to learn about the type 

15 of things we're doing in dealing with this 

16 important challenge.

17 The other one, this is my one of the 

18 slides before last. This is what we do in 

19 support of harmonizing, harmonizing the thinking 

20 around genetically engineered products. And 

21 we've had some issues of great importance in the 

22 U.S. but also for our international partners, 
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1 trading partners.

2 So, Sally McCammon, who you will be 

3 hearing from her later on, she chairs the Group 

4 on Environment. And that group came up with 

5 several documents, biology documents on weeds, 

6 even salmon documents as well. And there is an 

7 apple document. And she's doing a great job in 

8 that regard.

9 So, Sally chairs that group. The Food 

10 and Feed Working Group is shared by FDA.

11 So, at the last June 2018 meeting also 

12 we've had stock of an important issue of great 

13 interest internationally on genome editing. And 

14 OECD is very much interested in really finding a

15 way to harmonize the thinking and the regulatory 

16 approach to genome-edited crops, not only crops 

17 but also animals.

18 And, so, the three topic areas that we 

19 talked on the animal and plant applications of 

20 genome editing: risk and safety considerations; 

21 and regulatory aspects.

22 Excellent discussion. Very fruitful. 
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1 But obviously showed the divide, and which I'm 

2 sure Paul will touch on some of that in his talk. 

3 So the other follow-up with that will be taking 

4 place. And I think there would be a report 

5 coming out soon on that.

6 So this is my quick update. And thank 

7 you. And I will be happy to answer questions 

8 later.

9 MR. GEORGE: Okay, thank you. Thank 

10 you, Ibrahim.

11 So, as you can see, there's a lot 

12 going on internationally at BRS, but we're 

13 certainly not the only ones. USDA's Foreign 

14 Agricultural Service, FAS, keeps its finger on 

15 the pulse of biotechnology regulation on a global 

16 level. And with some recent developments that's 

17 a pretty big job.

18 Here to tell us about it is the 

19 Director of the FAS New Technologies and 

20 Production Methods Division, Paul Spencer.

21 MR. SPENCER: Well, good morning. 

22 I'm here to talk a little bit about the 
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1 department's international policy engagement on 

2 precision breeding. But before I do that let me 

3 give you a little bit of background on our agency 

4 to give you context organizationally from how 

5 we're engaging.

6 So, FAS, Foreign Agricultural 

7 Service, is the international arm of the 

8 Department of Agriculture. And we represent the 

9 full range of interests of U.S. agriculture 

10 overseas, from farmers, ranchers, and also our 

11 food processing industry. We have 93 offices 

12 with staff, and we're covering over 170 countries 

13 globally. Usually we're co-located with a U.S. 

14 embassy or a U.S. consulate.

15 And our overseas staff help us do a 

16 lot of different tasks:

17 They help market U.S. agricultural 

18 products through trade shows and other marketing 

19 activities;

20 They provide commodity reporting. We 

21 contribute to the department's global picture of 

22 production supply and demand for major 
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1 commodities;

2 And then also we provide policy 

3 information and policy advocacy for -- in support 

4 of U.S. agriculture.

5 And as part of this work it's 

6 important to mention that we maintain a global 

7 information network that provides public 

8 reporting on all sorts of issues. This is called 

9 the Global Agricultural Information Network, or 

10 GAIN. And within this system we require an 

11 annual report from most of our overseas offices 

12 on agricultural biotechnology policies, 

13 production, and marketing.

14 So, this is kind of a long-winded way 

15 of saying that we have a unique source of 

16 information globally from our offices about 

17 agricultural policy. And it's from these public 

18 reports and from our interaction with other 

19 governments that a lot of my presentation today 

20 is drawn.

21 So, you might wonder why a trade 

22 agency would be so interested in the introduction 
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1 of a new set of technologies like genome editing 

2 and precision breeding. Well, there's some 

3 direct trade-related reasons:

4 Because exports are such an important 

5 part of U.S. agricultural income, if our 

6 production technology is not approved in a major 

7 foreign market it could lead to trade disruption. 

8 You can actually have vessels turned around. It 

9 could lead to the product being withheld from the 

10 market by the developer. Or it could be rejected 

11 by farmers or other elements of the value chain, 

12 which is grains traders.

13 But I think an even broader reason is 

14 that we want U.S. farmers to remain competitive 

15 globally. And this means having choice. Our 

16 farmers really do need to have choice when it 

17 comes to production technologies.

18 And if you look at genome editing 

19 technologies broadly, they really are of 

20 strategic importance. They can be applied to 

21 plants, they can be applied to fungus, they can 

22 be applied to animals, microbes, even insects. 
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1 And the long-term challenge is to make sure that 

2 the foreign markets remain open and foreign 

3 regulatory systems remain open to the 

4 technologies our farmers choose to use.

5 Our approach, and the best way we 

6 believe to handle potential disconnect between 

7 U.S. innovation and foreign market acceptance is 

8 to engage foreign governments early and often. 

9 And we do this in the context of an interagency 

10 process, and we work very closely with Food and 

11 Drug Administration, the Environmental 

12 Protection Agency, the Office of U.S. Trade 

13 Representative, our State Department. And we 

14 always engage with science and international 

15 rules-based principles in mind, especially with 

16 the World Trade Organization.

17 So, we're seeking, broadly, we're 

18 seeking regulatory compatibility, meaning that if 

19 countries can have similar approaches, 

20 implemented at similar times, then this will 

21 facilitate both innovation and choice.

22 So, the government's fiscal year began 
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1 on October 1st. And that provides us a good 

2 breaking point to kind of look backward and look 

3 forward. And if you look at, if you look at FY 

4 2018, it's been a really busy year on 

5 international engagement with precision 

6 breeding, on genome editing. In early fiscal 

7 year 2018 we drew on these 93 overseas offices 

8 and created a complete assessment of the 

9 regulatory approaches that governments around the 

10 world are taking to genome editing. Many of them 

11 don't have an approach, but we do keep a 

12 spreadsheet that shows where each government is 

13 falling currently.

14 And subsequently we worked within the 

15 department to draft an international engagement 

16 strategy around genome editing. And we also 

17 defined the main policy risk. The main policy 

18 risk, you know, last year, as it is now I believe, 

19 is the potential for genome edited crops to be 

20 indiscriminately regulated as GMOs, as 

21 genetically modified organisms. And if this is 

22 adopted by our major trading partners, this will 
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1 unnecessarily subject a whole new class of 

2 production technology to restrictive and 

3 potentially trade-distorting regulations.

4 And there would be a lot of results of 

5 this if this happened. One result would be the 

6 likely exclusion of products developed by small 

7 companies and public research institutions. The 

8 regulatory bar for GMOs is just too high for them.

9 And if they are, if these technologies 

10 are regulated broadly as GMOs, only a handful of 

11 multinational companies would have the technical 

12 expertise, the funding, and the global regulatory 

13 affairs footprint to complete multi-country 

14 approval. Minor crops, and crops that are often 

15 -- that could be improved subsistence crops in 

16 developing countries would also be excluded if 

17 there is too much of a regulatory burden, simply 

18 because the seed sales for these crops don't 

19 justify the high regulatory costs associated with 

20 GMOs.

21 So, clear domestic policies on the 

22 regulation of genome edited plants are an 
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1 integral part of USDA's international engagement 

2 plan. And we also believe that having a clear 

3 domestic policy enhances the overall U.S. 

4 leadership on this issue.

5 And as was mentioned, on March 28th, 

6 and it's in your packet there, Secretary Perdue 

7 put out his statement on plant breeding 

8 innovation. And Mike's already gone through the 

9 details of that, but it really has provided us a 

10 solid basis from which to work as we engage with 

11 other governments.

12 And essential to our strategy, as I 

13 mentioned earlier, has been cooperating with 

14 other governments. And immediately following 

15 the secretary's March statement we followed with 

16 a USDA-funded genome editing workshop in Colombia 

17 that included regulators from 18 countries, and 

18 including USDA crops regulator, and Mike's boss, 

19 Undersecretary Greg Ibach. He gave the keynote 

20 address at that event.

21 And then, as I mentioned, that had 18 

22 different countries in it, and provided a real 
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1 kickoff point for our international engagement on 

2 this issue. Subsequently, my boss, 

3 Undersecretary Ted McKinney, who deals with 

4 international affairs for the department, has 

5 raised this issue on each one of his visits to 15 

6 different countries in fiscal year 2018.

7 So, USDA is also coordinating with 

8 partner countries for activities in the Cartagena 

9 Protocol on Biosafety, of which there's a big set 

10 of meetings in a couple of weeks in Sharm El11 Sheikh, Egypt. And, as Ibrahim mentioned, we 

12 also worked in the OECD.

13 And then also there is a lot of work 

14 that is being done every year in APEC that is 

15 funded by the Asia-Pacific Economic Cooperation 

16 group that's funded by USDA. And Dr. Chao also 

17 participated in those activities in fiscal year 

18 '18.

19 And then, as mentioned, Ibrahim also 

20 covered some of the bilateral engagements we 

21 have. We have with China the Biotech Working 

22 Group; the U.S.-Canada-Mexico Trilateral Biotech 
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1 Working Group; and also scheduled visits by 

2 Japanese regulators. So we've had a pretty good 

3 state of engagement in FY '18.

4 So, this map will show some of the 

5 global regulatory status that we're aware of for 

6 genome editing. And there's a lot more data 

7 behind this map. And we do keep an ongoing 

8 running spreadsheet of regulatory approaches that 

9 we're aware of. And we're happy to share that

10 with anyone in the room.

11 But let me just talk a little bit. 

12 The good news is that a number of countries have 

13 adopted policies that appear to innovate, to 

14 support innovation in trade in genome-edited 

15 products. Argentina was the first country to 

16 publish a policy on breeding technique. And 

17 under Argentine approach, consultations are 

18 required, and the products will be regulated 

19 depending on whether or not foreign DNA is 

20 introduced. And decisions are made usually 

21 within 60 days.

22 Now, interestingly, a decision not to 
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1 regulate by the Argentine Government is not made 

2 public. So that has implications for grain trade 

3 and competitiveness from my perspective.

4 Well, let me go on. Brazil and Chile 

5 have a functionally similar system to Argentina. 

6 And I think if you're going to generalize about 

7 South America, I think you can say that they are 

8 setting up an innovation and science-based system 

9 that will help their competitiveness.

10 Canada, as you see on the screen 

11 there, they regulate based on product, using an 

12 existing novel foods regulation. They regulate 

13 based on whether or not the end product is 

14 identified as novel, not on the process that was 

15 used to create it.

16 For Australia, Australia uses its 

17 Office of the Genome Technology Regulator. It

18 has proposed to regulate genome-edited products 

19 where template DNA is involved, but not regulate 

20 products with small random changes such as 

21 deletions.

22 And also I'd mentioned two, that 
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1 China, Japan, and Korea don't really have 

2 specific rules in place yet. We believe China -

3 - and you can ask our Chinese representatives 

4 here -- but China is operating under a draft 

5 proposed policy. And that hasn't really come out 

6 publicly yet.

7 Japan is developing, and we believe 

8 that they will publish something before the 

9 beginning of their fiscal year in April of 2019.

10 I think, though, the big news for this 

11 year is what is the European Union policy and the 

12 direction that they're taking. In July, the 

13 European Union Court of Justice decision said 

14 that newer mutagenesis techniques should be 

15 regulated as GMOs.

16 And so I want to talk about this a 

17 little bit more in detail. So, we view the EU 

18 decision as a major setback for the potential 

19 benefits that can be received from agricultural 

20 genome editing technologies broadly.

21 On July 25th, the European Court of 

22 Justice found that organisms produced from newer 
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1 mutagenesis techniques using CRISPR, TALEN, et 

2 cetera, are subject to their Directive on 

3 Genetically Modified Organisms. So, what this 

4 means is that the same risk assessments, the same 

5 monitoring, the same labeling, the same 

6 traceability laws currently applied to 

7 genetically engineered products will apply to 

8 gene-edited products imported into the EU.

9 Now, there's more to it than that. 

10 But we're primarily concerned with the trade 

11 elements of this.

12 Now, the implications of this is that 

13 the European Union's global policy influence 

14 could pose a threat to U.S. agriculture's ability 

15 to adopt and benefit from these genome editing 

16 tools. The ECJ decision emboldens the anti17 technology groups. And that's already prevalent 

18 in EU member states such as France.

19 And in the broadest sense it's 

20 negatively impacting global agricultural 

21 innovation and food security. It potentially 

22 takes a whole set of tools off the table.
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1 So, more narrowly, as new restrictions 

2 and regulatory regulations are developed and 

3 implemented, the ruling expands the potential for 

4 trade conflict between the EU and the United 

5 States as well.

6 So, in response, on July 2th USDA 

7 Secretary Perdue issued a statement on the 

8 European Court of Justice case. And I'll just 

9 say I'll quote him here.

10 He says, "The global regulatory 

11 treatment of genome-edited agricultural products 

12 has strategic innovation and trade implications 

13 for U.S. agriculture. For this reason, USDA has 

14 clear science- and risk-based policies that 

15 enable needed innovation, while continuing to 

16 ensure these products are safe. In light of the 

17 ECJ ruling, USDA will re-double its efforts to 

18 work with partners globally towards science- and 

19 risk-based regulatory approaches."

20 So, looking ahead to fiscal year '19 

21 which we're just starting right now, our overall 

22 objectives will remain similar. But we have to 
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1 take into account the European policy changes 

2 that are coming as a result of the ECJ ruling. 

3 Specifically, the EU Commission will be looking 

4 how to implement the ECJ ruling.

5 But our international policy 

6 engagement will still seek to maintain and expand 

7 U.S. agricultural exports; shape the global 

8 policy environment in a way that preserves 

9 American agriculture's freedom to innovate; 

10 continue to build an active, multi-year global 

11 coalition of countries in support of science12 based and risk-proportional regulations; and also 

13 to, frankly, limit the policy influence that the 

14 ECJ judgment has.

15 And we'll also be partnering with the 

16 private sector to build a communication capacity. 

17 One of the things that we'll be exploring more in 

18 this fiscal year is how to use U.S. farmers more 

19 effectively as international communicators. We 

20 actually have farmers who are making money 

21 growing genome-edited crops. And we think that 

22 that's something that we can share with the world 
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1 as part of our messaging.

2 And let me talk for a moment about a 

3 recent success that we had in the international 

4 policy arena, in fact last week. So, as I 

5 mentioned, the United States has a long history 

6 of cooperating with an informal coalition to 

7 advance trade policy positions related to the use 

8 of new technologies in agriculture. And since 

9 May, following the secretary's statement we've 

10 been part of a loose coalition of countries 

11 working on an international statement on 

12 agricultural applications of Precision 

13 biotechnology.

14 And that, that actually, that 

15 statement is included in your packet.

16 So, Argentina, with our strong 

17 support, led in drafting of this statement and 

18 introduced it to the World Trade Organization's 

19 Sanitary and Phytosanitary Committee meeting last 

20 Thursday in Geneva. And these principles, the 

21 principles in this statement rearticulate the 

22 commitment that all WTO members have already 
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1 agreed to, to develop science-based and non2 distorted trade policies with regard to 

3 agriculture.

4 Now, the statement is non-binding, and 

5 it reiterates some high level principles 

6 regarding the science-based treatment of 

7 precision biotechnology. We like this statement 

8 because it's very positive. You know, it's a way 

9 to get countries to support enabling science10 based regulations, but also shows that there's a 

11 broad international support for agricultural 

12 innovation, despite what the ECJ ruling says.

13 And so far we have 13 countries, so 

14 far 13 countries have indicated their support for 

15 this statement, including Argentina, Australia, 

16 Brazil, Canada, the Dominican Republic, Honduras, 

17 Paraguay, of course the United States, Uruguay, 

18 and a few others. The countries have the ability 

19 to show their support for the statement up until 

20 around the 15th in the WTO committee. And we 

21 expect more countries to do so.

22 So, let me just conclude by 
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1 reiterating a couple of points. We still see the 

2 biggest policy threat to genome editing 

3 technologies in agriculture as the broad 

4 conflating of genome-edited technologies with 

5 GMOs in the regulatory space.

6 There are also, just want to remind 

7 everyone, we think there's strong trade linkages 

8 between technology adoption and, you know, 

9 between trade and technology adoption and, for 

10 this reason, we need a lot more regulatory 

11 compatibility internationally. And we're 

12 working hard towards that.

13 I also have a little bit of optimism. 

14 I think we're, you know, a number of countries 

15 are off to a good start. EU will remain a 

16 challenge, but I'm still optimistic that we can 

17 be able to draw on these technologies in support 

18 of agriculture.

19 And, finally, USDA is actively 

20 advocating internationally on behalf of U.S. 

21 agriculture for these, for these products.

22 Thank you.
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1 MR. GEORGE: So, we're scheduled to 

2 go for a break. But I think we should pause for 

3 a moment and ask if there's questions for any of 

4 our speakers so far today, Mike or Ibrahim or 

5 Paul, including online. If you're online and 

6 you'd like to make a comment or ask a question, 

7 press 1 and then 0 on your keypad and we'll open 

8 your mike.

9 OPERATOR: This conference is now in 

10 question answer mode. To alert the speaker that 

11 you have a question, press 1 then 0.

12 MR. GEORGE: Any questions?

13 So, we'll also have an opportunity 

14 right before lunch to take a few questions also. 

15 But if you have questions, also these folks will 

16 be available, obviously, during the break and 

17 lunchtime also if you have a question.

18 So, it looks like we have a question 

19 online, so.

20 MS. WANEX: One of the most common 

21 questions we've gotten so far is whether or not 

22 the slides are available for download. We're 
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1 actually going to give everybody who's speaking 

2 an opportunity to run through their slides during 

3 this meeting, so they'll be available online 

4 afterwards.

5 Other than that, we have a question 

6 for Mike.

7 Does APHIS still have a group 

8 evaluating genetically engineered insects?

9 Is there a group evaluating 

10 genetically engineered insect pathogens? For 

11 example, new insect-associated viruses are being 

12 identified frequently thanks to sequencing 

13 technology.

14 MR. FIRKO: So, in our biotechnology 

15 risk analysis programs we have two branches. One 

16 of those two branches is the pest branch. And 

17 in that group we have plant pathologists, 

18 entomologists, and a variety of other scientific 

19 expertise.

20 And to the extent that we encounter 

21 those as part of our biotechnology program, 

22 absolutely. We do whatever analyses are done for 
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1 risk assessment or risk management or decision 

2 making.

3 So, yes, we have a group dedicated to 

4 those efforts.

5 MS. WANEX: We had a question during 

6 Ibrahim's presentation.

7 The word "coexistence" seems to have 

8 different meanings in different contexts. Does 

9 the speaker interpret a conflict between pro10 biotech versus organic/natural? Or is this a 

11 foreign relations context or a combination?

12 MR. SHAQIR: I think the intent was 

13 to basically when we look at these coexisting 

14 functions from not the regulatory aspect, and 

15 that's basically what our approach to that.

16 MS. WANEX: This question was typed 

17 in during when we opened it up for questions for 

18 all three speakers. So I'm not 100 percent sure 

19 which one should answer. I'm just going to leave 

20 it up to you guys.

21 Many kinds of genome editing had 

22 significant off-target effects. The U.S. and 
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1 other countries should require full genome 

2 sequences to look for off-target effects.

3 It's not so much a question but it was 

4 written while we asked for questions, so I was 

5 wondering if anybody wanted to answer that?

6 MR. FIRKO: So, under our current 

7 regulations, if we were to receive a petition for 

8 non-regulated status we would look at those. We 

9 always look at those.

10 Under our future regulations if the 

11 product is something that could be produced 

12 through traditional breeding techniques they 

13 would not need to come in. And the risk would 

14 be the same as if that product had been bred 

15 traditionally.

16 If it is not something we've made a 

17 decision on and it came into us for a Box 6 

18 analysis, absolutely we would be looking at those 

19 things.

20 MR. TERZI: My name is Lorenzo Terzi. 

21 I'm the Minister Counselor for Food Safety and 

22 Health for the European Union.
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1 I would like to thank today for this 

2 opportunity to be here. We tried to take the 

3 opportunity to be active partners as possible on 

4 the evolution. And I have a comment and a 

5 question.

6 So, the comment is that of course we 

7 are aware about the implications of our court 

8 ruling. But, you know, regardless of our taking 

9 a position, we have to abide the ruling of the 

10 court. And we have one similarity now, as the 

11 court is the supreme entity institution 

12 interpreting the new law. And we have to respect 

13 the ruling.

14 We are aware about the challenges. We 

15 are, again, of this administration it's unlikely 

16 that the internal debate within the commission 

17 will lead to anything before 2019, the year of 

18 the elections of the European Parliament. And 

19 then once the new commission, the new parliament 

20 will be in place, the debate will be reopened.

21 So, unfortunately, we have to wait 

22 till time of couple of years to have an evolution 
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1 within the EU on this file.

2 The question is, regarding the trades 

3 which are already cultivated and harvested, we 

4 had a meeting last week, USTR and commission, in 

5 the frame of the Executive Working Group. And 

6 USTR informed us that there are already a couple 

7 of events. We were already aware that this was 

8 the case.

9 So I have a question. What are the 

10 real commercial trades which are on the market at 

11 present? We've been told about the soybean, 

12 about the rapeseed. But if you could be more 

13 precise of what is really of commercial value 

14 currently on the U.S. field ready to be traded 

15 and eventually exported?

16 MR. SPENCER: Well, thank you for the 

17 question. This is a question we've gotten from 

18 a number of our trading partners.

19 You know, we are keeping an eye on the 

20 marketability of our products overseas. And, you 

21 know, we talked to the companies that we're aware 

22 of who are developing the technologies. And by 
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1 and large they're produced -- they're value-added 

2 products, so they have an incentive to keep them 

3 in a closed loop production. And so we're not 

4 really aware of any products that are in open 

5 production that would be mixed with the general 

6 commodities.

7 You'd have to talk to the individual 

8 country -- companies that are producing those to 

9 get much more detail on it.

10 MR. GEORGE: Thank you.

11 One more question, Miranda?

12 MS. WANEX: I'm trying to understand 

13 this question.

14 It's the dilution of DNA sequence size 

15 through genome editing question one. If you 

16 could clarify that question online, I'm sure that 

17 may help us.

18 MR. GEORGE: We'll give you an 

19 opportunity to do that. And if you get a little 

20 clarity of that, we'll take a break and we will 

21 come back and we can try to -- Oops, go on.

22 MS. WANEX: We still have one more 
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1 question. I'm sorry.

2 APHIS agreed with the USDA Inspector 

3 General in 2011 that you would develop 

4 regulations for GE effect on animals but you 

5 still have not done this. Why not?

6 MR. GEORGE: And the microphone is 

7 being passed to Mike Gregoire.

8 MR. GREGOIRE: It's not for lack of 

9 trying, let me say that. We've made two runs 

10 with that. It is updating the rule, and the 

11 third time's a charm. So, we are still mindful 

12 of the IG recommendations, and it's our intent to 

13 fulfill the commitment we made to update the 

14 regulation.

15 MR. GEORGE: Thank you, Mike.

16 So, with that I'm going to sort of, 

17 we'll pause for 10 minutes. Let's come -- tell 

18 you what, let's come back at 11:30, which is about 

19 8 minutes from now. And then we'll go from 

20 there.

21 Thanks, everybody.

22 (Whereupon, the above-entitled matter 
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1 went off the record at 11:23 a.m. and resumed at 

2 11:32 a.m.)

3 MR. GEORGE: Okay folks, we're going 

4 to get going. Our next speaker, and I see her 

5 approaching the podium now. Our next speaker is 

6 BRS Scientific Advisor, Sally McCammon, who will 

7 -- we'll take our seats please -- who will talk 

8 about our activities regarding the important area 

9 of biotech research and our engagement with the 

10 scientific community. Thanks, Sally.

11 (Off-microphone comments.)

12 MS. MCCAMMON: Good morning and thank 

13 you for visiting us out in Riverdale. I think 

14 there's a mansion that's an old plantation that's 

15 associated with this, but we've only been there 

16 once I think.

17 Anyway -- with Riverdale, Maryland. 

18 Anyway my name is Sally McCammon, I'm a science 

19 advisor in the Office of the Deputy 

20 Administrator, along with Neil Hoffman. Who is 

21 also a science advisor. And that just gives you 

22 an idea of the emphasis that we place on science.
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1 I'm going to try to give you a bit of 

2 an overview of the kinds, our processes for 

3 getting the scientific research that we need. 

4 Identifying it, as well as the variety of 

5 engagement that undertake.

6 Oops, hum, well, that's Paul.

7 (Off-microphone comments.)

8 MS. MCCAMMON: Okay, basically I'm 

9 going to go over a little bit of the context. 

10 The latest policies that we've been handed. How 

11 we identify our research priorities, and the 

12 variety of different engagements that we have.

13 Okay, the context is as always, it's 

14 the law. It codifies our protection goals and 

15 what we're charged with doing, which is basically 

16 protect against pest and diseases. We've tested 

17 pesticides in general, we don't do pesticides, 

18 EPA does them.

19 But that's done by Congress and the 

20 Executive Branch provides regulations to 

21 implement the law. The science for us is 

22 critical. It provides the data and information 
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1 for us to do what we need to do, evaluate and 

2 manage those risks. And this also feeds into 

3 policies, the use of risk assessment and 

4 decisions and management.

5 All right, last year most recently, 

6 and this was done after the modernization of the 

7 Coordinated Framework Initiative, President 

8 Trump asked Secretary Perdue to put together a 

9 Task Force on Agriculture and Rural Prosperity. 

10 He pulled together 22 agencies, offices et 

11 cetera, across the government. And by October 

12 of last year, he had come out with the report of 

13 the Task Force on Agriculture and Rural 

14 Prosperity. There were over 100 

15 recommendations, and five major Calls to Action.

16 And one of those Calls to Action was 

17 Harnessing Technological Innovation. And one of 

18 the major components of that was to Streamline 

19 Science-based Regulatory Policy for Biotech. 

20 And this involves coordination across the federal 

21 government, coordination in interagency actions, 

22 particularly to focus on making the regulatory 
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1 system clear and available for the small and mid2 sized innovators, and protect consumers.

3 And the third component was to 

4 Expedite Commercialization of Biotech Products. 

5 So to make sure we're science-based, but to keep 

6 moving.

7 So, annually APHIS and BRS internally 

8 gets together to review and go over our research, 

9 and update our research priorities. I think, I 

10 was trying to guess how many scientists, PhDs 

11 that we have on our staff including our Deputy 

12 Administrator, Mike Firko. And I think it's 

13 probably 40 or so. So there's a lot of interest 

14 in the science.

15 And under -- these are just general 

16 categories of our most recent interests, a 

17 variety of aspects that have to do with 

18 weediness, genetic attributes et cetera, gene 

19 drives, comparison of sources of genomic 

20 variation, frequency and types of variation 

21 between genetically engineered plants and other 

22 kinds of plants, RNAi interference, a comparison 
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1 of potential unintended affects between 

2 traditional plant varieties and genetically 

3 engineered varieties.

4 Our primary vehicles for working on 

5 these priorities are USDA's National Institutes 

6 of Food and Agriculture, and the Agricultural 

7 Research Service. The NIFA implements the 

8 Biotechnology Risk Assessment Research Grants 

9 Program, that they will implement, they manage 

10 it, excuse me.

11 And yearly they come out with a 

12 request for applications, usually in December. 

13 And that request for applications is crafted and 

14 updated by an interagency process including 

15 APHIS, BRS, EPA, FDA, ARS, and NIFA.

16 Besides the request for applications, 

17 we work with -- we have reviewers that 

18 participate on the panel that reviews the 

19 applications. And we have an internal government 

20 workshop yearly with some of the principle 

21 investigators that have developed the information 

22 that we -- that have developed the research that 
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1 we use. Shane Ball is the primary person we work 

2 with over in NIFA.

3 There are five major areas that have 

4 to be covered in this request for application, 

5 and these are all elaborated by the research 

6 agencies. And the elaborations change from year 

7 to year in the RFA.

8 The management practices to minimize 

9 environmental risk of GE organisms, methods to 

10 monitor and understand the dispersal of 

11 organisms, gene transfer to domesticated and wild 

12 relatives, environmental impacts of GE relative 

13 to non-GE organisms in the context of production 

14 systems. And then there is, lucky for us, 

15 there's other research topics.

16 Okay, how is this authorized and 

17 funded? In the 2002 Farm Bill the grant program 

18 was initiated to provide necessary funding for 

19 environmental and risk assessment research 

20 concerning the introduction of genetically 

21 engineered animals, plants, and microorganisms 

22 into the environment.
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1 It also later was updated to authorize 

2 appropriations that come from the biotech outlays 

3 for research in USDA. And that is two percent 

4 of those outlays, which is one of the reasons 

5 that ARS is very interested in this program too. 

6 Because most of those research outlays go to the 

7 Agricultural Research Service.

8 So, last year for the 2018 RFA, 35 

9 proposals were submitted to BRARG and with awards 

10 of 5.4 million, and made for nine research 

11 proposals, and one conference.

12 We do also work with the Agricultural 

13 Research Service directly. Particularly for 

14 their -- they have five year strategic plans for 

15 each of their national programs. And National 

16 Program 301 covers Plant Genetic Resources, 

17 Genomics and Genetic Improvement.

18 And we are part of the stakeholder 

19 group that comes in when each of those five year 

20 plans are organized and put together. There's, 

21 under the Crop Biotechnology Risk Assessment 

22 component of this plan, there's a component that 
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1 deals with unintended effects of biotech 

2 improvements on crop plants, agricultural 

3 production, and the environment.

4 APHIS and ARS have recently upped the 

5 ante on their coordination and collaboration 

6 together. APHIS has internally put together a 

7 Science Committee at the administrator level in 

8 2016.

9 And they've been working to make sure 

10 that we're coordinated at all different levels 

11 from staff up to top management, to leadership 

12 with the same counterparts in ARS in order to 

13 enhance our cross agency communication in a 

14 variety of ways, to identify innovative solutions 

15 to prepare or prevent major problems particular 

16 to pests and diseases. And to be prepared to for 

17 emergencies and for responding to dynamic 

18 critical research needs.

19 So, and this is across APHIS. It's 

20 not just BRS, but we're also a part of this. And 

21 I think Ibrahim is the BRS representative to this 

22 APHIS committee.
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1 Another major -- to shift gears a 

2 little bit, we also have relied a lot on the 

3 National Academy of Sciences Engineering and 

4 Mathematics reports.

5 One of the critical ones that came out 

6 recently is preparing for future products of 

7 biotechnology. And this was the third component 

8 of the Modernization of the Coordination 

9 Framework effort that was undertaken by the White 

10 House Office of Science and Technology Policy 

11 between 2015 and 2017.

12 And the Academies were commissioned to 

13 do this report so that we could -- the regulatory 

14 agencies hopefully could continue to prepare for 

15 what's coming. And not just keep hanging onto 

16 past approaches and past conceptual frameworks.

17 Another, but there are a variety of 

18 reports the Academies do, whether or not we 

19 specifically support them financially. One on 

20 gene drives came out in 2016. But since the 

21 beginning, since 1987 when our regulation was 

22 finalized, we've been working with the Academies. 
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1 And I'm not sure if you can see that on here.

2 Introduction of, well anyway, I can't 

3 read that --

4 (Off-microphone comment.)

5 MS. MCCAMMON: Why I need new glasses. 

6 And my name is not Priscilla, Priscilla Presley, 

7 sorry. Darn it.

8 Okay, well I just -- anyway but the 

9 Academies came out with key issues of dealing 

10 with genetically engineering organisms in the 

11 environment. And that was a critical paper that 

12 provided the assumptions that have been almost 

13 used globally around the world.

14 In that they stated that when you're 

15 looking at the interaction of a genetically 

16 engineered plant in the environment, you look at 

17 the interaction of the crop, the trade, and the 

18 environment. That those are the critical 

19 components that you look at.

20 That -- the our DNA -- traits 

21 introduced using recombinant DNA do not provide 

22 unique risks. Or do not introduce unique risks 
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1 that need to be evaluated. And a couple of other 

2 critical assumptions that we still use today.

3 Currently, we are working with the 

4 Academies on a new report, the Potential for 

5 Biotechnology to Address Forest Health. I think 

6 Mike brought up earlier that we're looking 

7 towards having a Chestnut blight petitioned 

8 sometime in the future.

9 And that forest health and how we deal 

10 with these particular issues is going to be 

11 critical. These are not necessarily -- the 

12 thinking with forest health is not going to be 

13 same as we're going to have with the traditional 

14 crop plants in agricultural settings.

15 So, this study was funded between a 

16 variety of agencies in USDA, as well as EPA. We 

17 hope that this will become publically available 

18 next month. And it should be presented at the 

19 American Association for the Advancement of 

20 Sciences meeting here in the District of Columbia 

21 in Washington.

22 One of the outgrowths -- oh, not too 
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1 bad, five minutes -- one of the outgrowths of the 

2 future products of biotechnology's report that 

3 came out from the Academies was they recommended 

4 that we continue Horizon Scanning exercise. And 

5 Sid Abel has been the major point person on that 

6 for our agency to get -- we set up a cooperative 

7 agreement with the Environmental Law Institute to 

8 carry on this exercise.

9 They are an NGO. They're not a 

10 government agency. But the intent is to design 

11 and develop a Horizon Scanning system for the 

12 future biotechnology products, consistent with 

13 the NASEM report.

14 And I think Mike mentioned this 

15 report. And right now it's under testing. But 

16 you can see the prototype on the link that's both 

17 in Mike's talk as well as right here. So, we 

18 intended to at least have an idea of what's coming 

19 down the pipe.

20 Another organization that we've 

21 worked continuously, particularly Susan Koehler 

22 of our staff, is the Weed Science Society of 
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1 America. We've helped fund two major reports 

2 that came out in 2012 that have to do with 

3 herbicide resistance management and 

4 understanding the impact of herbicide resistant 

5 crops on the environment.

6 Now one of the major reasons we've 

7 gotten into this is many times we as regulators 

8 are called upon to solve problems that really 

9 regulatory approaches are not the best way to 

10 solve the problems. So we've tried to engage 

11 with the appropriate scientific communities to 

12 help us engage with all the stakeholders involved 

13 in solving some of these problems.

14 Currently we're working on another 

15 grant, and working with the Weed Science Society 

16 of America to come up with strategies for dealing 

17 with herbicide resistance issues with all the 

18 stakeholders. And Ms. Susan Koehler is part of 

19 the Herbicide Resistance Education Committee 

20 which is managing this particular initiative.

21 I'll give a couple of more examples of 

22 our engagement. I think Ibrahim brought up the 
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1 OECD, the Organization for Economic Cooperation 

2 and Development and the two technical groups that 

3 work on biotechnology risk assessment and 

4 regulation.

5 And the variety of documents, biology, 

6 trade, and composition documents that are 

7 initiated and developed by the actual countries 

8 and their scientific communities. So you can 

9 have a global scientific community working on any 

10 one of these documents that we try to identify 

11 and provide the basic information that regulators 

12 need for doing their assessments.

13 We've done emerging issues, 

14 particularly one in the last several years was 

15 low level presence of unauthorized plant material 

16 in imports. Particularly seeds and grains that, 

17 well obviously seeds are intended for the 

18 environment but grains can fall off the truck or 

19 whatever.

20 We've also had a variety of workshops 

21 and conferences on new plant breeding techniques, 

22 genome editing that Ibrahim mentioned and next 
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1 generation sequencing.

2 Also this year NIFA funded, has been 

3 funding these Specialty Crop Regulatory 

4 Assistance workshops. I think we had one in 

5 2011, one in 2016, and most recently this year. 

6 It's intended to really bring the innovators, 

7 both from companies and academics together with 

8 the regulatory agencies for two days of 

9 uninterrupted access to each other.

10 So, and they let us know what they're 

11 thinking about in a way which helps us to identify 

12 what we need to do to help them. And they can 

13 see us as humans, not just as a monolithic agency 

14 logo.

15 And to put together relationships that 

16 can help them be cost effective and plan and 

17 design their research in the most effective and 

18 efficient way.

19 One of the outcomes of a previous 

20 workshop was that we, APHIS put together guidance 

21 for new users into the petition process, which 

22 gives recommendations of how you can interact 
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1 with all three agencies in a way that's 

2 beneficial to you.

3 This is my last slide, just we have a 

4 variety of other informal ways that we bring in 

5 science and interact. We have a journal club 

6 which our staff gives presentations on new 

7 papers.

8 We have four American Association for 

9 the Advancement of Science fellows that we 

10 currently have. We have Smriti, Tracy, Holly, 

11 and Kayla. And they're sitting in the back of 

12 the room kind of taking it all in.

13 And they have, they come on board with 

14 the newest training, the newest understanding of 

15 the science, the hands-on-science and we're very 

16 grateful to have those folks.

17 We have onsite presentations as 

18 scientists come in, and they call up and say, oh 

19 I'm in town. We say, oh good, you want to come 

20 over and give a talk?

21 Mike also mentioned outreach on 340 in 

22 which we visited a variety of academic 
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1 institutions as kind of a hub. To bring in 

2 stakeholders from surrounding institutions to 

3 discuss some of the scientific issues that the 

4 scientific community is dealing with. As well 

5 as to give us an understanding of what kinds of

6 questions or concerns we need to be thinking 

7 about.

8 And Ibrahim also brought up that we 

9 have webinars with Canada and Mexico to kind of 

10 -- if we're putting on a presentation why not 

11 share it with your counterparts and other 

12 regulatory components of other countries?

13 So, there you go. This is the Tree 

14 of Knowledge circa 1490. Thank you.

15 MR. GEORGE: Thank you, Sally. 

16 Before you go, any questions for Sally? So the 

17 way we're going to do this is, we have two more 

18 speakers and we're going to take questions at the 

19 end of each of each of their segments, the 

20 questions for them. And then before we pause for 

21 lunch if there are other questions for any of our 

22 speakers, we'll take a few minutes to take those 
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1 questions.

2 So are there any questions for Sally? 

3 We have one online.

4 MS. WANEX: We have one on line. I 

5 was kind of thinking this is maybe better for 

6 Sid, but it was asked during Sally, so I'll give 

7 it a shot. For enhanced preparedness and 

8 prevention responses to potential incidents, will 

9 the USDA, DOI, FEMA, ESF11 also be updated with 

10 new findings and proposals as part of the USDA 

11 APHIS framework revisions initiative?

12 MR. GEORGE: I don't have an answer 

13 to that.

14 MS. MCCAMMON: If I understand the 

15 question correctly, the USDA is thinking about 

16 revising their 340 regulations. Are we 

17 coordinating and apprising other agencies across 

18 the U.S government about those regulations? Is 

19 that -- and we are.

20 We have discussed with a variety of 

21 agencies. Maybe not all of the federal 

22 government agencies, but our regulation is only 
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1 under our authorities in our agency. We don't 

2 have a regulation that is developed to respond to 

3 other authorities.

4 MS. WANEX: Thank you.

5 MS. MCCAMMON: Did you want to try?

6 MR. GEORGE: No that's it.

7 MS. MCCAMMON: Okay.

8 MS. WANEX: And to the individual on 

9 line who is asking about their question that was 

10 given right before the break. Any questions for 

11 the former panel, is we're going to make sure 

12 that we read before we go to lunch. Right now, 

13 we wanted to focus on questions for Sally. 

14 Unless you want me to read that question to Sally.

15 MR. GEORGE: I think we'll move on, 

16 okay thanks.

17 MS. WANEX: She wants you to answer 

18 it.

19 MR. GEORGE: Oh, okay.

20 MS. MCCAMMON: I'm good at making up 

21 --

22 MS. WANEX: Okay, double stranded 
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1 RNA, RNAi technologies have been generally 

2 classified as not GMO. Now it appears there is 

3 a movement to classify all dsRNA whether tested 

4 or functional in any way as a pesticide that must 

5 be handled with pesticide applicator 

6 certification. Does this make any sense?

7 MS. MCCAMMON: There are two 

8 components of the RNAis that I know -- this is 

9 more related to EPA regulations -- there's 

10 topically implied RNA, RNAis and there are, or 

11 RNAs. And then there are those that are 

12 incorporated into the genome. And in both cases, 

13 I think those are EPA questions as they relate to 

14 pesticides.

15 MR. GEORGE: Thank you, Sally.

16 So about six years ago we created our, 

17 "Am I Regulated?" process. Last year government 

18 relations specialist, Bill Doley was here to tell 

19 us about plans to make that process better. And 

20 he's back this year to tell us about the changes 

21 that have already been implemented. Bill.

22 MR. DOLEY: Thank you, Dick. Good 
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1 morning everyone -- what have we got for slides 

2 here? Oh, here we go.

3 As Dick mentioned, I reported on this 

4 last year. We did a business process improvement 

5 project in 2017 to make some improvements to our, 

6 "Am I Regulated?", process. And last year I told 

7 you about what our plans were. And this year, 

8 it's what we've implemented and what we've 

9 completed. And if some of this looks familiar 

10 it's because some of it is. Because I'm using a 

11 few of the same slides before I get to the new 

12 stuff.

13 And this one here, benefits of AIR 

14 process, somebody reworded it nicely so it's 

15 better than before. But really the bottom line 

16 is here, we don't want to spend resources 

17 regulating things that aren't regulated articles. 

18 It's not a good use of our resources and I would 

19 go out on a limb and say you'd probably agree. 

20 You don't want your things regulated if they 

21 don't need to be.

22 So the process has to do with the 
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1 definition of a regulated article. And because 

2 the definitions will be complicated, it's not 

3 always that easy to self-determine if you're a 

4 regulated article or not. So you can write us a 

5 letter. And we have instructions on our website 

6 about what we want to see in the letter, so we 

7 can respond and analyze your question 

8 appropriately.

9 Since we started this in 2011, so it's 

10 been seven years, we've answered 70 of these 

11 inquiries. And I'm going to guess based on 

12 Mike's presentation that last year this slide 

13 said 56, because we did 14 over the last year, 

14 something like that. And a lot of these relate 

15 to new plant breeding techniques. And of most 

16 interest really is the genome editing. So we've 

17 had a lot on where people have created products 

18 using site-directed nucleases.

19 You can't see that too well, but if 

20 you go to the website you can look at all of the 

21 inquiries and responses. So after we complete 

22 them, we post them on the website. So all 70 are 
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1 up there. And you can't really see too well, but 

2 right here it says description. And that's a big 

3 field there, and what I'm going to mention in the 

4 end is we have some ideas to improve that 

5 presentation.

6 So the analysis is basically a legal 

7 analysis of whether, what you describe meets the 

8 definition of regulated article. So there's two 

9 main components. Is it altered or produced 

10 through genetic engineering? And is the donor, 

11 vector or recipient a plant pest?

12 And of the 70 that we've looked at, 

13 three have been regulated articles. Bad news for 

14 those people, they were hoping otherwise. The 

15 31 at the top, where it says no plant pest 

16 components, most of those are genetically 

17 engineered plants that were made with biolistics. 

18 But there was no plant pest component in the 

19 donor. And the vector was biolistic, so it's not 

20 there either. So most of those are actually 

21 genetically engineered plants.

22 And when you get to the second 
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1 category, the site-directed nucleases. This is 

2 where in most cases, you're making a genetically 

3 engineered plant. And then after you stop it, 

4 you have something that only contains a deletion. 

5 And then it's not regulated because there's no 

6 plant pest components incorporated. And you 

7 could argue about whether those are genetically 

8 engineered or not.

9 So now we're into the business process 

10 improvement project. We had three main goals. 

11 We wanted to make our responses more predictable 

12 in time frame. And to have less variance around 

13 those times. And to make the responses 

14 consistent from a technical and policy 

15 standpoint.

16 And I was just thinking today that 

17 number three could actually work against number 

18 one. And that's one of the things we've been 

19 doing is trying not to implement things that slow 

20 it down, to get number three accomplished.

21 So we have three things I'm going to 

22 tell you about that we improved. First, we redid 
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1 our Standard Operating Procedure to take into 

2 account places in the process where we, where 

3 things that slowed us down, to get past those 

4 things and move them along faster.

5 Also there was a bunch of checklists and 

6 other documents associated with the SOP to help 

7 the process be consistent. The Triage Review 

8 Committee was something we implemented to work on 

9 that third bullet about technical and policy 

10 consistency.

11 So we have a group of, oh, five people 

12 who look at these increases as soon as they come 

13 in and try to flag significant issues so we can 

14 be on top of them right at the beginning instead 

15 of having them bite us at the end of the process.

16 And the third thing we implemented --

17 that was two, let me go back here. Oh, those we 

18 implemented right after the stakeholder meeting 

19 last year. So those have been in place for a 

20 year.

21 And then this third one here is 

22 something we just got out last month, or two 
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1 months ago. But we updated our guidance for 

2 developers.

3 And this had two main purposes because 

4 we've had a lot of delays with the confidential 

5 business information aspects of the increase not 

6 being formatted properly. Or we didn't get all 

7 the copies. We have to have the CBI, and the CBI 

8 deleted on the justification.

9 Sometimes that holds us up for up to 

10 a month in the beginning. So we've tried to make 

11 that more clear and actually we redid our CBI 

12 instructions too. So those are hopefully easier 

13 to follow.

14 And then we also want to reduce delays 

15 due to requests for additional information. So 

16 we try to make real clear what the information we 

17 need in that guidance so that we can complete the 

18 analysis without having to come back and ask for 

19 more.

20 So we have a little bit of data. When 

21 we did the BPI, we had BPI data. So it was data 

22 that we looked at going into the project. So we 
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1 had 24, "Am I Regulated?" that took about eight 

2 months each to complete. And now we have what 

3 we call the control phase in the BPI process, the 

4 generic process, the last step is called control. 

5 Where you, basically you're supposed to be 

6 looking at whether your improvements are working.

7 And so we haven't actually completed 

8 all our improvements. So this control phase 

9 should get better after we implement more things. 

10 But you can see there we've basically cut the 

11 time in half from eight months down to three and 

12 a half in the ones that we've completed since.

13 And the last improvement we have in 

14 mind is to improve the website display. That one 

15 column called, description, we intend to divide 

16 it into all these columns, species, 

17 transformation method, genetic alteration, 

18 phenotype. And that would allow you to sort or 

19 allow people to get more information about these. 

20 And to zero in on the ones they want to look at.

21 And right now, we don't always provide 

22 all that in the -- you can't search for all those 
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1 things. You'd have to go in one at a time to 

2 figure out what some of those things are. And 

3 hopefully that will be up soon and you'll like it 

4 better. And that's all for me.

5 MR. GEORGE: All right, thank you, 

6 Bill. That's a very brisk pace. We're almost 

7 back on time even, just a little behind. Any 

8 questions for Bill?

9 (No audible response.)

10 MR. GEORGE: No? Questions on line, 

11 no. Okay, we'll move on. USDA has been working 

12 with FDA and EPA on the Agricultural 

13 Biotechnology Education and Outreach Initiative, 

14 a lot of syllables there. Our own Assistant 

15 Deputy Administrator, Sid Abel, has been a member 

16 of the Steering Committee and is here to fill us 

17 in. Sid.

18 MR. ABEL: Thank you, Dick. Good 

19 morning everyone. All right, let's get started.

20 So this time last year we, our 

21 colleagues at FDA opened up their session with 

22 supplying information to everyone that we had 
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1 begun this initiative to provide information to 

2 consumers on biotechnology and the products 

3 thereof, in a way that would be understandable to 

4 them, scientifically based, unbiased type 

5 information.

6 That was an offshoot of a 2017 

7 Congressional appropriation of about $3 and 1/2 

8 million, or $3 million. And then again in 2018 

9 they were granted another $1.5 million. The 

10 total of $4 and 1/2 million to build this 

11 initiative.

12 They are working with us and USDA and 

13 FDA to provide this information to the public. 

14 The tentative timeline is to produce a final 

15 product in the way, in the terms of some type of 

16 material. I'll get to that a little bit more 

17 later on, by the end of this fiscal year, in the 

18 fall of 2019.

19 So in addition, FDA has built some web 

20 pages for people who are interested in this 

21 project, to go there and see the progress of the 

22 work that's being done by the three agencies.
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1 So in establishing this initiative, 

2 FDA created a Steering Committee that's put into 

3 place to kind of give guidance to the project, 

4 make decisions on the project, review materials, 

5 and those kinds of activities.

6 And underneath the Steering 

7 Committee, there's four workgroups. And these 

8 workgroups are the ones that are actually doing 

9 the work to build the products that will be part 

10 of this initiative.

11 One of the workgroups that we have in 

12 there would be a workgroup like, the External 

13 Input Workgroup. There's also a Consumer 

14 Research group as well. There's the Education 

15 Outreach group itself, which is actually building 

16 the material for us. And then there's a 

17 Stakeholder Update group that provides 

18 information to the stakeholders on these updates, 

19 answer inquiries, and things like that.

20 In addition to those things, we have 

21 about 60 people in total, maybe a little bit more 

22 than that, because I added more people from USDA 
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1 to this group that are actually working on this 

2 initiative. So, we've got a pretty large cadre 

3 of people that are working on this.

4 The project is built around building 

5 some form to the research, around the area of 

6 consumer attitudes toward biotechnology. What 

7 they respond to? What they know about 

8 biotechnology? Where they get their information 

9 from on biotechnology? And we're using this 

10 information to guide us in how we're going to 

11 prepare material that would be useful to them.

12 So we've done this through a number of 

13 ways. We've done this through a series of 

14 literature reviews, which are being conducted by 

15 a contractor. We've held some, what we call 

16 audience listening analyses, I'll get to that in 

17 just a second.

18 We've done some social listening 

19 groups as well. We've done some focus groups, 

20 which I'll give you some more details on in just 

21 a few minutes. And all this is geared toward 

22 obtaining the latest information on consumer 
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1 messaging.

2 So the public listening sessions, back 

3 in November of last year, we started off along 

4 with opening up the docket for comments from the 

5 public. Two listening sessions, one in North 

6 Carolina, the other one in California to get 

7 information from the public on the kind of 

8 information that would be useful to them in 

9 learning more about the products of biotechnology 

10 and how biotechnology affects them.

11 Whoops, I lost a slide here, guys. 

12 Okay, I'm going to jump. We'll come back to that 

13 slide I was just on because that's the closing 

14 slide. Got them out of order.

15 So, I want to kind of just stop here 

16 just for a couple of minutes. The docket, we got 

17 about 600 comments, and we've analyzed those 

18 comments. We had the listening sessions. We 

19 gathered that information, and you know, we've 

20 analyzed that information. And using all that 

21 information, we decided to hold a couple of focus 

22 groups.
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1 First one was back earlier this year, 

2 February-March, and the one we just completed was 

3 in August and September. The first listening 

4 group we kind of gauged the consumer's 

5 perceptions, motivations, beliefs, feelings, 

6 attitudes towards biotechnology.

7 And then using that information in 

8 another focus group, we built materials and then 

9 shared that material with these consumers to test 

10 their response to the materials and themes that 

11 we built.

12 And we've centered those two themes 

13 around knowledge and empowerment. And then we 

14 added some taglines to that as well. So it says, 

15 Feed Your Mind, it's rather hard to see on the 

16 slide that's up there. But there's a little 

17 tagline on the bottom that says, Feed Your Mind. 

18 And then there's another one about, you know, 

19 Know Your Food.

20 The tagline for, Feed Your Mind, was 

21 one that resonated very well with the public. 

22 And it was information that, you know, that they 
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1 thought if they needed they can go to, to get, by 

2 the fact that we have these presentations.

3 These focus groups were made up of a 

4 wide variety of people. We had various age 

5 groups, educational levels, demographics in terms 

6 of race, in terms of ethnic background. We 

7 stratified these groups in a way that we can get 

8 information that would be useful in building 

9 these various materials. And then as you can 

10 see, we put together some things, some slides to 

11 get the response from those.

12 Some of the things we heard from the 

13 public during the course of these focus groups is 

14 that they didn't know the basic facts about --

15 and I'm going use the word GMO from this point on 

16 because they, that word resonates with them 

17 better than GE, bio-engineered, and other terms 

18 are used to represent genetically engineered 

19 products.

20 But they just didn't know the basic 

21 facts about genetically modified organisms. But 

22 they wanted to know. So we knew we had an 
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1 opportunity there. Didn't know the facts, but 

2 they wanted to know those facts.

3 They had general negative feelings 

4 about GMOs, but they couldn't say why. They just 

5 had generally negative feelings about that. They 

6 felt that GMOs contributed to health problems, 

7 obesity, allergies, cancer, other ailments. But 

8 again, they didn't have the facts that would link 

9 those things together. More often times, 

10 confused GMOs with things like hormones, 

11 pesticides, antibiotics, obesity other things 

12 like that.

13 And then they were ultimately very 

14 skeptical about information from the FDA, other 

15 government agencies, and very skeptical about the 

16 overuse of the word safety. Every time they had 

17 conversations, or they read materials from 

18 government agencies, it always had a heavy focus 

19 on safety.

20 So with this information in hand, and 

21 the outputs from these two focus groups, we 

22 decided, we came to some conclusions about some 
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1 opportunities we had in terms of building this 

2 material.

3 And the first and foremost is that 

4 food is very personal. And so we felt, you know, 

5 we decided we needed to use the human angle that 

6 was value based to that consumer, to put together 

7 these materials.

8 Consumers make many decisions on 

9 health, wellness, and especially nutrition. And 

10 they want their answers about this information to 

11 be very brief. We got that out of these focus 

12 sessions. And they wanted to connect what was 

13 important to them.

14 So we decided that maybe the approach 

15 of using storytelling may be helpful. And the 

16 storytelling, not from the perspective so much of 

17 a federal regulator, but from say, an academic 

18 who they trusted very well. Or from a farmer, 

19 or from a nutritionist, or from a physician. 

20 Those kinds of people providing storytelling to 

21 the consumer resonated well with them.

22 And if we were going to use the word 
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1 safety, we wanted the word safety to be used in 

2 the broader context, not in and of itself. We 

3 also decided it was very important for us to 

4 address head-on the issues of pesticides, 

5 hormones, additives, and other things, rather 

6 than letting that stay in the background 

7 unaddressed by the federal government.

8 And so in sum, we wanted the message 

9 -- it needed to be upbeat, it needed to be 

10 positive, it needed to resonate with those 

11 consumers.

12 And so these materials that you see up 

13 on the screen here were just the things we shared 

14 with the consumers. We got their feedback. 

15 We're going to go back using all this 

16 information. We'll modify these pictures. Have 

17 it more connection with a person and the food.

18 And then again, later on in this year, 

19 probably sometime this fiscal year, we're going 

20 to do another set of focus groups to get those 

21 final responses to the material we get out.

22 So let me go back to this frame so 
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1 that you know what the next steps are. So we're 

2 going to use this, so called "formative research 

3 and guidance" from the Steering Committee to 

4 develop these final educational materials.

5 The materials will take the form of 

6 videos. They make take the form of fact sheets, 

7 story boards, or storytelling, and some various 

8 types of infographics. We're going to use every, 

9 at least to the extent we can, every possible 

10 media to be able to share this information with 

11 the consumer.

12 We also understand that consumers want 

13 basic quick answers to things. So we're looking 

14 at maybe a 101 level type information to the 

15 consumer. If they want to know more about a 

16 particular product technology issue, or a 

17 product, they can then go to what we would call

18 a 201 level and get more information out of it.

19 And the last thing I want to just 

20 mention real quickly is that, you know, there's 

21 the Bioengineered Food Disclosure Law that's in 

22 the process. The whole initiative will be 
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1 updated relative to the outcome of that final 

2 rule once it's been published.

3 And so we've got a lot more work to 

4 do, and again the tentative initial launch will 

5 be sometime in the fall of 2019, once all these 

6 materials are finalized.

7 And let me go back. And so I 

8 mentioned the webpage -- there we go. So the 

9 webpage is up for USDA. You can go to USDA's 

10 webpage, there's Google in there for the, for 

11 this initiative. And it should bring up their 

12 page and you'll be able to read what we're going 

13 in terms of the initiative. So that's the update 

14 of this.

15 I think by the next year there will be 

16 a lot more information provided to you at the 

17 Stakeholder Meeting. The perspective is 

18 hopefully by then we'll get everything done. 

19 We'll see. With that I'll take any questions, 

20 Dick for this group. And then we'll turn it over 

21 to questions for all of the speakers.

22 MS. WANEX: We have a question on 
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1 line. Which social engineering venues are 

2 targeted?

3 MR. ABEL: Okay. That, we haven't 

4 made a final decision on those venues. And I 

5 think by venues you mean things like, YouTube's 

6 type venues. If that's the case, what you mean 

7 by venues there's a good chance that we would use 

8 those kind of techniques. But there will 

9 certainly be web-based.

10 MS. WANEX: They asked, Reddit.

11 MR. ABEL: Reddit?

12 MS. WANEX: Reddit.

13 MR. ABEL: It's certainly an 

14 opportunity to use that. I'm a little bit 

15 familiar with it, not that much familiar with but 

16 it's certainly something we'll take into 

17 consideration.

18 (Off-microphone comments.)

19 MR. GEORGE: Okay, so I will invite 

20 questions for any of our speakers. Before we go 

21 for lunch, I think there were some, might have 

22 been some questions we didn't get to. If anybody 
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1 has questions for any of our speakers? So far, 

2 we'd be willing to take them now.

3 I will mention that for those of you 

4 in the room, our speakers will be around during 

5 lunchtime if you wanted to ask your question 

6 personally, get a one-on-one answer, but -- no?

7 MS. WANEX: We've had two questions 

8 that have been waiting since we breaked. I 

9 wanted to go ahead and make sure that we got to 

10 them.

11 The first question is, is there any 

12 limit on deleted DNA sequence size for genome 

13 editing?

14 MR. FIRKO: No.

15 MS. WANEX: Nope, and the next 

16 question is addressed specifically to Dr. Firko. 

17 It says, I would like to read the new study on 

18 Citrus Tristeza Virus Transmission. Can you 

19 provide a citation? Thank you.

20 MR. FIRKO: If you provide us with a 

21 mailing address, email address whatever, we'll 

22 make sure you get that.
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1 MS. WANEX: Type that into the box. 

2 I can make sure that we get you a copy of that 

3 document.

4 We've had a couple more questions come 

5 in. It looks like some folks are still typing 

6 them out, so if you want to switch to the in the 

7 room questions for a few minutes, we can come 

8 back and make sure that everything here gets 

9 addressed.

10 MR. GEORGE: Other questions in the 

11 room?

12 MS. WANEX: You're welcome to raise 

13 your hand, or come up to the microphone.

14 MR. GEORGE: I think we have one in 

15 the back.

16 MR. GIDDINGS: My name is Val 

17 Giddings. I'm with the Information Technology 

18 and Innovation Foundation. I have a question for 

19 Sid about the outreach education, and outreach 

20 plans that are being developed.

21 It seemed that most of what you were 

22 thinking about as to materials to be shared in 
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1 these outreach efforts, you know, it was written 

2 documents that could be posted and shared on the 

3 web, things like that?

4 Have you contemplated more active 

5 engagement such as, Ask Me Anythings, on Reddit? 

6 Or you know, engaging in pushing some material 

7 out by social media, like Twitter and Facebook?

8 I think those are the places where the 

9 disinformation coefficient is highest. And so 

10 arguably those are the places in which the 

11 opportunities for getting return on the 

12 investment that Congress has made in this 

13 outreach, would be highest.

14 So I'm curious as to, you know, what 

15 thoughts you might have along those lines?

16 MR. ABEL: Excellent question and 

17 good timing actually. We are in the process of 

18 looking into what we will call amplifiers of our 

19 information. Those people that we would use to 

20 push this information out, for us.

21 So, go to -- we have mentioned here 

22 like using perhaps information that we can share 
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1 with STEM schools, or STEM teachers to push 

2 information to students at the youngest age 

3 possible.

4 And one of the things we've been 

5 looking into, these storytellers that we would 

6 get to, or recruit to provide information on 

7 biotechnology and the products thereof. We're 

8 using them as well to push information out.

9 So yes, that's one of the things 

10 that's in consideration like now, is what will be 

11 the material that we'll actually create? Whether 

12 they're in hard copy or on the web? And then of 

13 course YouTube and things like that we'd also be 

14 considering, yes.

15 MR. GEORGE: Thank you. Take it?

16 MS. WANEX: Anyone else in the room?

17 MR. GEORGE: Anyone else in the room? 

18 No, so we're going to online.

19 MS. WANEX: Currently are grants only 

20 available to non-profit and government agencies?

21 MR. GEORGE: Sally, I think that one 

22 is for you.
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1 MS. MCCAMMON: That's a good 

2 question.

3 MR. GEORGE: You need a mic.

4 MS. MCCAMMON: Sorry, I don't know the 

5 exact answer to that. It's a good question. I 

6 think you can look up on the NIFA website just 

7 with the Biotechnology Risk Assessment Grant 

8 Program. And it'll give you last RFA, which will 

9 have all the context and background on that, as 

10 to who can apply and who can't.

11 My sense is, you know, non-profits. 

12 I don't know about for-profit entities, but the 

13 information is available. I basically just 

14 focused on the actual substance of what's in 

15 them, the RFA. But there's a lot of other 

16 language that can give you the who can apply and 

17 when you need to apply.

18 MR. GEORGE: Thanks Sally.

19 MS. WANEX: Next we have a comment for 

20 Sid, and related to Margaret's question. Those 

21 methods that you mentioned, the videos, the 

22 interactives, have all been effective in my 
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1 opinion in DoD website updates for better viewer 

2 interaction.

3 It's -- I think this is more of a 

4 comment. The methods that you mentioned, the 

5 videos, the interactives, have all been effective 

6 in my opinion in BOD website updates for better 

7 viewer interaction.

8 MR. GEORGE: Thank you.

9 (Off-microphone comments.)

10 MR. ABEL: Sounds more like a 

11 statement than it does -- sounds more like a 

12 statement. And we would agree with that. Yes, 

13 those are effective ways of communicating.

14 MS. WANEX: The FDA includes 

15 pesticide residues in the family diet survey 

16 every year. Can the FDA change the study to 

17 include pesticide residues from eating GMO 

18 products?

19 MR. ABEL: I'm not sure that I can 

20 answer that question completely. But I can say 

21 that the foods that are included in the FDA or 

22 USDA's food survey that they conduct are 
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1 irrespective of whether or not they're 

2 genetically engineered, or sourced from 

3 genetically engineered materials.

4 It's very possible that many of the 

5 foods that they're actually doing surveys on and 

6 collecting these residue data, do include 

7 products that are sourced from genetically 

8 engineered products.

9 MS. WANEX: That's it for the 

10 questions we've gotten on line.

11 MR. GEORGE: Other questions in the 

12 room?

13 (No audible response.)

14 MR. GEORGE: Okay, so we're going to 

15 break for lunch. I'm going to make a quick plug 

16 for the afternoon session on eFile. It's 

17 something you've been hearing about for a while 

18 and it's going to be within 2019. So we'll give 

19 you a little sneak peek how that's going to work. 

20 So we hope you stick around for that.

21 And when we convened, there's 

22 information in your handouts about local eateries 
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1 and some of which will deliver. So please take 

2 advantage of that. And Elvis will call you back 

3 at 1:30. Thank so much.

4 (Whereupon, the above-entitled matter 

5 went off the record at 12:23 p.m. and resumed at 

6 1:31 p.m.)

7 MR. GEORGE: So as you all know for 

8 the past couple of years we've been working on a 

9 replacement for ePermits, our electronic 

10 permitting system. That system is APHIS eFile.

11 Here to tell you about it is our APHIS 

12 eFile team, and they will be running this 

13 afternoon's session, starting with the Chief of 

14 our APHIS MRP Digital Support Offices, Laura 

15 Lewandowski. Laura.

16 MS. LEWANDOWSKI: Good afternoon. 

17 Thank you very much. I appreciate the 

18 introduction. My name is Laura Lewandowski. 

19 And I work in MRP IT, which is part of APHIS. 

20 And I work for the Digital Services support 

21 office. And our office is responsible for the 

22 implementation of APHIS eFile.
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1 So today our main focus of this 

2 session is to provide a demo for you. But before 

3 we do that, we're going to take a few minutes 

4 just to talk a little bit, to give you a little 

5 bit of context, a little bit of history, maybe 

6 answer some questions about why we're making this 

7 change in the first place.

8 So for this session, we're going to 

9 talk a little bit, like I said, about why we're 

10 making the change. So we're going to tell you 

11 about what's going on inside of APHIS and then 

12 beyond APHIS through the Department USDA so that 

13 you can understand what some of the drivers are 

14 in making this change.

15 We're going to go through the demo and 

16 run through and show you what an actual 

17 application is going to look like. My first 

18 caution is that the application and the solution 

19 is not completely finished. We are in the middle 

20 of the implementation.

21 So we're going to show you the 

22 functionality that has been built now. But know 
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1 that in three months' time or so there's going to 

2 be additional functionality. So this is the 

3 first peek.

4 And we're going to continue our 

5 communication on how this implementation is going 

6 and continue to talk to you about what the 

7 improvements are that you're going to be able to 

8 see.

9 And then we're going to have Q&A after 

10 the demo. And then to close out talking about 

11 preparing and forwarding an APHIS eFile.

12 So to talk about modernizing IT in our 

13 mission area, I will start by saying that it's 

14 been a real vision for Secretary Perdue to 

15 modernize IT systems to have your USDA in line 

16 with what you expect to see in industry. But 

17 also, you know, and probably even more 

18 importantly, so that people who are stakeholders 

19 of USDA can expect a similar look and feel, not 

20 feel like they are off, you know, going from one 

21 silo to another silo. So making sure that we're 

22 doing this in a well-planned and consolidated 
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1 effort.

2 To talk to you a little bit more about 

3 that, I want to introduce Mark Davidson. Mark 

4 Davidson is the Deputy Administrator for MRPBS, 

5 which is Marketing and Regulatory Programs 

6 Business Services.

7 MRPBS is in charge of our mission 

8 area, not just APHIS, but marketing and 

9 regulatory programs, which includes APHIS, which 

10 includes AMS and the former GIPSA.

11 And Mark, before becoming MRPBS Deputy 

12 Administrator, has a history of being a champion 

13 for eFile. Mark came to us from Veterinary 

14 Services. So he's a Doctor of Veterinary 

15 Medicine, and he was a steering committee member 

16 on the VS side of the eFile implementation.

17 So we're very fortunate to have Mark 

18 as Deputy Administrator overseeing this project 

19 and all of the experience that he brings from his 

20 earlier days as an eFile champion.

21 And so without further ado, I want to 

22 introduce Mark Davidson.
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1 MR. DAVIDSON: Thanks, Laura, and 

2 good afternoon, everyone. We appreciate you 

3 staying and joining us for the demo today.

4 I want to talk a little bit about, you 

5 know, why we're modernizing APHIS permitting. 

6 And if we can go to the next slide. Oh, I've got 

7 the clicker. Oops. There we go so.

8 So one of the things as we're moving 

9 forward, you know, we've been on the ePermits 

10 platform for about 15 years. And it served all 

11 of us very well and has been a good mechanism for 

12 us to handle all of our permitting issues in 

13 APHIS.

14 However, as we start to move forward, 

15 we need to look at all of our legacy system. And 

16 ePermits is built on an outdated technology, 

17 ColdFusion. And as we move into these older 

18 systems that very heavily rely on custom coding, 

19 we experience increased maintenance costs.

20 And we have some of the lack of the 

21 flexibility of where we want to go as we modernize 

22 our business solutions and scale up across all of 
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1 the APHIS and AMS platforms in using different 

2 things.

3 Right now there's a really good 

4 opportunity as we're working to embrace digital 

5 transformation in the federal government. And 

6 Doug will talk with you all in a little bit, but 

7 USDA is a leader on that forefront in partnering 

8 with the White House and the General Service 

9 Administration.

10 I think another important thing is 

11 that permitting is the first part of what we're 

12 building on this platform. And we're looking to 

13 a lot of our different functions, including 

14 certifications, registrations, licenses to build 

15 off of this platform and be able to support just 

16 one platform within APHIS.

17 So what are we hoping to accomplish 

18 through our steps here? And we're looking 

19 towards implementation in the spring of 2019 with 

20 the APHIS eFile BRS release.

21 Now BRS won't be the first component 

22 out. We're already doing live dog permitting 
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1 with our animal care units. We also have started 

2 with registration renewals with animal care.

3 So we're doing some work right now 

4 utilizing the eFile system. But BRS will be our 

5 next and one of our bigger, more complex pathways 

6 that we're addressing as we go forward.

7 And there's three really important 

8 areas. First, we want to have an improved 

9 customer experience. That's for you all and also 

10 for all of our staff that is using eFile. We 

11 want to take advantage of some of the newer more 

12 flexible intuitive user interfaces, things you 

13 would experience as you're doing your banking and 

14 other types of internet transactions that I'm 

15 sure all of you do every day in your life.

16 We're hoping to use this to improve 

17 our business workflows and reduce our submission 

18 times, give us some more collaboration tools 

19 within the system and have an increased system 

20 reliability.

21 And some of the ways we're going to 

22 get there is through a more sustainable IT path. 
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1 We're using the Salesforce platform, and it's a 

2 platform being used not only within APHIS but 

3 also strongly within the Department, USDA.

4 We're trying wherever we can to use 

5 the more off-the-shelf functionality out of the 

6 software. And this gets it where it's easier to 

7 maintain your code updates and all of that. We 

8 rely on the vendors to help us update and move 

9 forward with this.

10 As we bring together all of the 

11 information with APHIS, we've got a data 

12 management plan with it. And this modern 

13 infrastructure helps us from our deployment time 

14 frames, our cybersecurity and the enterprise 

15 approach within the marketing and regulatory 

16 programs.

17 And it all ties into how we work and 

18 we support the OneUSDA initiatives around 

19 technology. And as I mentioned USDA is embracing 

20 Salesforce in a number of platforms. And we'll 

21 use this for the system enterprise for our 

22 overall CARPOL project. I mentioned 
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1 certification, registration, those types of 

2 things.

3 So as we do this, we'll build it into 

4 other legacy systems as we replace and modernize 

5 those. And so as our customers are stakeholders, 

6 there will be a more common field across all of 

7 our platforms as you move forward.

8 And so I want to thank you again for 

9 joining us. And I want to thank the team for all 

10 of their work to get us to this point. I think 

11 you'll see some very exciting things today. And 

12 there's quite a bit of work to get us to the 

13 spring of '19 yet but thank you.

14 And I want to introduce Doug Nash. 

15 Doug is our Assistant Chief Information Officer 

16 for all of marketing and regulatory programs.

17 Doug just joined us from the 

18 Agriculture and Marketing Service. We just 

19 underwent a consolidation of all of our 

20 information technology into MRPBS.

21 And Doug brings a wealth of experience 

22 from not only the Department, but also Forest 
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1 Service and AMS to here in APHIS. And Doug is 

2 going to talk about our broader modernization 

3 efforts.

4 MR. NASH: Thank you, Mark. Good 

5 afternoon. It's great to be here talking with 

6 you. And I appreciate the opportunity to share 

7 what's going on with the modernization of 

8 ePermitting, eFile and BRS services.

9 The work that APHIS is doing to 

10 modernize the ePermitting system is not being 

11 done in a vacuum as Mark mentioned. Our new 

12 Secretary, Secretary Perdue, has really put a big 

13 focus on making USDA one of the best managed 

14 federal departments. And he recognizes that to 

15 do that is to modernize information technology.

16 You are probably pretty familiar with 

17 USDA in the sense it's a fairly decentralized 

18 agency in terms of missions and also the IT and 

19 how that was managed and developed was very 

20 similar.

21 And so what the Secretary with his IT 

22 modernization initiative has done is he's really 
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1 taken a step back and asked us all to look at how 

2 do our stakeholders, like you, how does the 

3 public look at the systems that we provide in the 

4 USDA so that when you go to each agency it doesn't 

5 look like a completely different agency, a 

6 different experience, a different technology and 

7 all of that.

8 He talks a lot about using the Amazon 

9 metaphor, the Amazon experience, where you get a 

10 consistent high quality 21st Century digital 

11 experience. And so that's what we are part in 

12 APHIS and ultimately with the BRS ePermitting 

13 modernization is to build a modern technology 

14 platform that takes advantage of all of the good 

15 work and the capabilities you had with 

16 ePermitting but also brings in a lot of new 21st 

17 Century features that you didn't have.

18 And so just to provide you some 

19 broader context, as we are doing this 

20 modernization across the Department, we're 

21 approaching IT modernization through five 

22 different focus areas.
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1 And the first is around IT 

2 infrastructure optimization. So this is where 

3 we're taking all of our old applications, what we 

4 call on-premise data centers, and we're moving 

5 them to the commercial cloud.

6 Why that would be of interest and 

7 importance to you is it will make APHIS and how 

8 we provide services more agile, more efficient in 

9 how we can build, deliver and support IT services 

10 plus it ultimately will help drive costs down for 

11 IT services.

12 We are using cloud. Cloud allows us 

13 take advantage of commodity IT and also just 

14 allows us to do things more efficiently and 

15 quickly.

16 Another big focus of the Secretary's 

17 IT modernization is around the customer 

18 experience. So rather than USDA employees alone 

19 trying to anticipate what you're looking for in 

20 services, digital services you get from USDA from 

21 APHIS, USDA is actually doing pretty broad 

22 comprehensive stakeholder engagement sessions to 
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1 find out what you like, what you don't like, using 

2 industry best practices and then building that 

3 into our digital modernization.

4 And then we're also building better 

5 capabilities for data analytics so that you'll be 

6 able to access data more easily. It won't be a 

7 stovepipe and difficult to access, but you can 

8 use it in much more creative ways and useful ways. 

9 And then finally improving our contact centers 

10 and how we provide support and reach out to 

11 customers.

12 We're on a fairly aggressive time 

13 frame to implement these IT modernization 

14 initiatives. We started last year. Many of 

15 these are going to be significantly -- well, they 

16 are all started and many of them are going to be 

17 finished by the end of 2019. So it's pretty 

18 quick.

19 And certainly we look forward to 

20 releasing the BRS ePermitting capabilities in the 

21 spring. So that's coming fairly quickly in large 

22 part because of some of the technologies that 
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1 we're using and also all of the engagement from 

2 our subject matter experts and our stakeholders.

3 So we look forward now to giving you 

4 the actual demo so we can get away from just kind 

5 of this high level discussion. You can actually 

6 see precisely what improvements have been made, 

7 how that looks. And then we really look forward 

8 to your comments and feedback.

9 So I'd like to introduce Monica Galli, 

10 BRS Senior Regulatory Specialist and then Ashok 

11 Anant, who is our eFile product owner.

12 MS. GALLI: Good afternoon. I'm 

13 Monica Galli, Senior Regulatory Specialist for 

14 BRS Compliance Evaluation, Enforcement Branch. 

15 And over the last two years, I've served as the 

16 project manager for the BRS portion of APHIS 

17 eFile. And my APHIS colleague is Ashok Anant.

18 MR. ANANT: Hi. Good evening, 

19 everyone. Good afternoon, everyone. My name is 

20 Ashok Anant. I am the eFile product owner 

21 responsible for ensuring the new system meets the 

22 business and functional requirements for the BRS 
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1 permitting.

2 I want to introduce Mahvash Taqi, 

3 Business Analyst. Mahvash and their team has 

4 been working with us for the past several months 

5 trying to elaborate these requirements and get 

6 them implemented into the system.

7 Today Mahvash will navigate the system 

8 while me and Monica talk about some of the 

9 features in the new system. I can only do one 

10 thing well at a time.

11 So I am excited to give you all --

12 MS. GALLI: Oh, just bear with us for 

13 a minute. It's going to take a second for the 

14 remote users to see the switch between the 

15 presentation and APHIS eFile.

16 MR. ANANT: Are you guys ready? 

17 Thank you. Today I'm excited to give you all a 

18 preview of our new eFile system. The new 

19 permitting system as you've heard is cloud based 

20 and is built on the Salesforce platform, widely 

21 adapted across the federal sector.

22 The cloud-based application has many 
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1 advantages for us, scalability, better 

2 performance and more availability.

3 The delivery of this cloud-based 

4 system puts APHIS in the forefront of the IT 

5 modernization effort across the federal 

6 government. Before I get into the demonstration, 

7 I want to reiterate that what you are about to 

8 see is work in progress and many of the features 

9 are still being developed and refined.

10 MS. GALLI: So as Mahvash logs in to 

11 get us started, come fly away with me to eFile 

12 land where Ashok and I will be playing the part 

13 as an experienced applicant today. We're going 

14 to be applying for an import permit for 

15 genetically engineered corn being imported from 

16 Peru to Riverdale, Maryland.

17 We're going to be using web entry to 

18 apply today, but XML upload is also an option. 

19 So buckle up and please hold your questions until 

20 the end of the demo. Ashok, take it away.

21 MR. ANANT: Thanks, Monica. Similar 

22 to the current ePermits system, access to the new 
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1 system requires Level II e-authentication. What 

2 you are seeing currently on the screen is a 

3 landing page once a user logs into the system 

4 with Level II access.

5 Before I create a new application 

6 here, I wanted to go over some of the key screen 

7 elements on this page. What you are looking at 

8 is the applications tab. The applications tab 

9 shows the application page where it lists all 

10 your current or active applications. As you can 

11 see, there are many applications this user has 

12 submitted.

13 If you have a large number of 

14 applications like this, you will be able to 

15 configure the system to allow whatever number of 

16 applications that you would like to view.

17 With each of these applications, if 

18 you see across the column, there is a status 

19 field. The status field shows if your 

20 application is still open, submitted or 

21 withdrawn. Columns are also sortable if you 

22 could see up, if you want to look at application 
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1 type, with new applications, you can sort those 

2 columns.

3 There is also the search feature on 

4 the right side. If you know your application 

5 number and you directly want to get into it and 

6 work on it, you can type in the number and get 

7 directly into your application.

8 On the top of the screen, you see four 

9 tabs: dashboard, contacts, applications and 

10 authorization. The dashboard has not been fully 

11 developed, but this will be the landing page once 

12 it's developed.

13 Once developed the dashboard will 

14 provide you a quick snapshot of status of 

15 applications, authorizations and permits in a 

16 visual format.

17 Please note we haven't fully developed 

18 so you're not able to see anything. But it 

19 should be a more graphical view once it's 

20 developed. You'll be able to see the number of 

21 open applications, the number of authorizations 

22 that have been issued, et cetera.
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1 The contacts tab. The contacts tab 

2 is where the user can update his profile 

3 information. Sometimes you want to change your 

4 phone number or put a different email address, 

5 you will go here and update your personal 

6 information.

7 And finally, I wanted to talk about 

8 the authorizations tab. The authorizations tab 

9 is where you can find the disposition or status 

10 of your submitted application, whether a permit 

11 or notification for an application has been 

12 issued or acknowledged.

13 If you notice, every application has 

14 an equally valid authorization number. And BRS 

15 will eventually issue a permit or notification. 

16 The layout of this page, if you observe it, is 

17 very similar to the one you saw earlier, the 

18 applications page.

19 You have the number of entries where 

20 if there are a large number of authorizations, 

21 you can control how many you want to see on a 

22 page. In this page, you also have a few other 
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1 columns on the top, decision type, decision 

2 status, permit number, exit draft.

3 If you want to sort those columns, you 

4 can click on that and you can see a permit number, 

5 that's an issued permit for that authorization.

6 So with that said, now I'm going to 

7 take you through the process of creating an 

8 actual application. In eFile before you proceed 

9 to create an application, the user is prompted to 

10 answer a series of questions similar to Turbo 

11 Tax. These questions are similar to what you do 

12 in ePermits today.

13 Based on the user's responses, the 

14 system automatically determines if the user is 

15 required to apply for a standard permit or a 

16 notification or if a permit is required at all in 

17 some cases. In this instant, as we click 

18 through, based on the user's responses, the 

19 standard permit is required.

20 Now, let us proceed with creating the 

21 actual application and putting in the contents. 

22 If you look at the top column, there are several 
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1 columns. This is called a chevron view. If you 

2 look at the top, you see the application data, 

3 related articles, constructs, location, SOP,

4 attachments and line item review.

5 We have made filling out the 

6 applications very easy for the user by breaking 

7 it down into different logical sections.

8 If you look at the top, we also 

9 provide instructional text throughout the 

10 applications and to make it easier for you to get 

11 some instructions on how to fill out the 

12 application.

13 We first start by asking CBI 

14 information. This will ensure we collect any 

15 additional data required in the application as 

16 appropriate. Also in some areas of the 

17 application, as you just noticed in CBI, the 

18 application will only allow certain types of 

19 characters.

20 Based on the notification of permit

21 that was required in this, the related active 

22 duty section appears below, and it will have the 
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1 necessary fields to be filled out based on 

2 whether a permit or notification is required.

3 With that said, there are a few more 

4 sections, and I will turn it over to Monica to 

5 present them to you. MS. GALLI: Thank you. 

6 Now we'll navigate to the regulated article's 

7 page. Instead of manual text and tree fields, I 

8 use a lookup feature to search through a list of 

9 regulated articles.

10 Today I'm adding maize commonly known 

11 as corn to my import permit. I use the search 

12 box to search either by the scientific name or 

13 common name and then select the appropriate 

14 regulated article. You see that it automatically 

15 populated the regulated article text field with 

16 the scientific name.

17 If I didn't see the regulated article 

18 I was looking for, I would simply email BRS so 

19 that the regulated article could be added to the 

20 system.

21 So once I click save, I was taken back 

22 to the regulated article table where I can 
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1 confirm that I've added the correct regulated 

2 article.

3 Now I can proceed to the constructs 

4 stage. The constructs page has a new feature 

5 that I love and I think everyone else will like, 

6 too. APHIS eFile has previously submitted 

7 constructs.

8 This feature allows me to search and 

9 re-add constructs that I previously submitted on 

10 other corn applications. This feature is so 

11 great because it cuts down on the amount of manual 

12 text entry I have to do.

13 Each previously submitted construct 

14 is associated to a given regulated article. So 

15 I have corn previously submitted constructs and 

16 avocado previously submitted constructs 

17 associated with my eFile account because in eFile 

18 land I'm also conducting trials on non-browning 

19 avocados.

20 Another bonus is that I don't have to 

21 worry about data security. Only my account can 

22 see my previously submitted constructs. Like 
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1 regulated articles, constructs also appear in a 

2 table format as I add them to the application.

3 I'm going to search -- I'm going to 

4 use the search function to locate a construct 

5 that I submitted in my last application. I'll 

6 click the magnifying glass to review the 

7 phenotypic and genotypic details so that I can 

8 make sure that I'm adding the proper previously 

9 submitted construct. It looks good.

10 So we'll select the checkbox and click 

11 add selected. I'm taken back to the construct 

12 landing page where I can see that my previously 

13 submitted construct was added.

14 Now we'll go ahead and add a new 

15 construct to this application. I'll add the 

16 construct name and associate it with a regulated 

17 article.

18 Next, I'll select the mode of 

19 transformation from a drop down list. I make 

20 sure to click the claim as CBI box since this a 

21 drop down list and brackets are not accepted in 

22 this field.
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1 Once I click save, I am given the 

2 chance to add the phenotypes and genotypes. So 

3 I'll click add phenotypes, select the phenotype 

4 category and input a phenotypic description and 

5 click save. For this construct we'll go ahead 

6 and add an extra phenotype.

7 Next I use the add genotype button to 

8 add my genotype details, including the genotype 

9 category, construct component name, construct 

10 component, the description of the component and 

11 the details similar to the experience now with 

12 ePermits.

13 Now that I have completed my 

14 construct, I will navigate back to the construct 

15 landing page to verify I have added all of the 

16 constructs needed for this application. So 

17 they're all displayed on this table in the 

18 construct landing page. So far so good.

19 Next I'll move on to the next section 

20 of the application, locations. In this section, 

21 I'll enter both an origin location and a 

22 destination location since this is an import 
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1 permit.

2 In this case, the material is being 

3 imported from the U.S. Embassy in Peru. To 

4 select a foreign country, I use a lookup table to 

5 select Peru as the country of origin. Once I hit 

6 save, the option to add location contacts 

7 appears.

8 Today we're going to skip adding the 

9 contacts for the origin and move into adding --

10 navigate back to the location landing page to add 

11 our destination location.

12 Since the destination location is 

13 APHIS here in Riverdale, Maryland, I will also 

14 use additional lookups to provide the state and 

15 country information. I will also indicate 

16 whether the location has been inspected by APHIS 

17 in the past.

18 Now I will describe the material that 

19 will arrive at this location, including the 

20 quantity, unit of measure and material type. And 

21 then I want to claim my information as 

22 confidential business information so I click the 
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1 checkbox for CBI.

2 Now I'll add a location contact for 

3 this location. The contact is my boss, Secretary 

4 Sonny Perdue. Better make sure that I use 

5 brackets and checkboxes to claim all of Secretary 

6 Perdue's contact information as CBI. I 

7 definitely want to make sure that his information 

8 is protected.

9 Once I save, I can confirm that all 

10 the information for this location is correct. 

11 Everything looks good.

12 The next section is SOPs and 

13 attachments are pretty straightforward. So 

14 we're not going to cover those today. Instead, 

15 we're going to jump ahead to line item review.

16 I see that each section of the 

17 application is visible, making it easy to review 

18 the information that I've entered into my 

19 application so far before submitting.

20 Now we're going to jump to the 

21 application review page after certifying that all 

22 of the information submitted is correct and true 
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1 and follows BRS' regulation.

2 The application review page again 

3 requires you to certify that all your information 

4 follows APHIS regulation. And then you're able 

5 to submit your application.

6 In the future, eFile will have

7 validations in place to prevent me from 

8 submitting an incomplete application. But with 

9 the magic of eFile land, we were able to 

10 successfully submit this application today.

11 That's all we're ready to show you 

12 today. But hopefully everything you've seen so

13 far gives you a sense of what's coming with eFile. 

14 Now Ashok will talk about other exciting eFile 

15 features that will be available at Go-Live and 

16 then we will take your questions.

17 MR. ANANT: Thank you, Monica. If 

18 you could switch back to the presentation? Thank 

19 you. All right. Thank you, Monica. In 

20 addition to what you saw in this review, there 

21 was going to be additional functionality you can 

22 expect when you first log into eFile after it is 
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1 released.

2 As I mentioned earlier, applications 

3 dashboards will be available and fully 

4 functional. Application cloning will be 

5 available. And we mentioned renewals, self6 reporting and XML uploads. These are all going 

7 to be part of the first release, but you didn't 

8 get to see that today. We are still --

9 development is in progress.

10 MS. GALLI: Well, the next slide is 

11 questions. So if anyone has any questions, we 

12 can go ahead and get that started.

13 MR. ANANT: Thank you.

14 MR. WEEKS: I'm Michael Weeks, BASF. 

15 I'm excited to see the retention of previously 

16 submitted constructs for ease of use in the 

17 future. If accounts are transferred between 

18 applicants then organizations, is there a 

19 possibility that they also transfer using 

20 previously submitted constructs within the 

21 system?

22 MS. GALLI: I'll have to look into 
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1 that. But there is a concept we didn't talk 

2 about today that has been introduced to all the 

3 stakeholders before called organizational 

4 applicant where you'll be able to actually manage 

5 multiple applications who all work for the same 

6 company. And those will actually be able to 

7 share previously submitted constructs across the 

8 applications. So I think that might get to the 

9 business need.

10 MR. WEEKS: Yes. That's excellent. 

11 Similar question, will locations and contacts 

12 also have retention in the system similar to 

13 constructs?

14 MS. GALLI: Locations will not. 

15 Contacts will and the article, supplier and 

16 developer may function that way to retain that 

17 information.

18 MR. BOTTOMS: Jeff Bottoms with 

19 Syngenta. A couple of questions. I just want 

20 to confirm that your application cloning is 

21 copying that application?

22 MS. GALLI: Correct.
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1 MR. BOTTOMS: Good, awesome. Thank 

2 you. The other question that I have.

3 MS. GALLI: Copying and also allowing 

4 editing, yes.

5 MR. BOTTOMS: Perfect. Thank you. 

6 The other part, I noticed there were a couple 

7 different ways to designate CBI. Could you 

8 address why there's the inconsistency and why 

9 certain fields have the checkboxes versus certain 

10 fields you actually manually enter the brackets?

11 MS. GALLI: Yes. So today in 

12 ePermits you use brackets to signify confidential 

13 business information. In eFile, certain fields 

14 are formatted to either be a phone number or an 

15 email address or you select them by a drop down 

16 list, so in those type of fields you cannot 

17 physically use checkboxes -- or, I'm sorry, 

18 brackets. So we've introduced the checkboxes for 

19 those fields to be able to claim CBI. Any other 

20 free data entry field you will still signify CBI 

21 using brackets.

22 So when you review your PDF, you will 
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1 see the checkboxes format that data in brackets 

2 also.

3 MR. BOTTOM: Great. Thank you. One 

4 last question for me, you noted that if you don't 

5 have an article in your drop down list, to contact 

6 the USDA to add it. Do you have any estimation 

7 on the timelines to get that added?

8 MS. GALLI: No, not at this point we 

9 don't. But we're coming up with a process now. 

10 And on the last page of your handout is kind of 

11 an overview for this afternoon. And there's an 

12 email address on that. So if you have any other 

13 additional questions or anything, you can start 

14 using that email address right away to get in 

15 contact with us about eFile.

16 MR. MUNDELL: Scott Mundell, Corteva 

17 Agriscience. So first I want to applaud the 

18 modernization and --

19 MS. GALLI: Thank you.

20 MR. MUNDELL: -- moving on and making 

21 things better for all of us. One question 

22 specifically about using cloud that I have 
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1 relative to protection of federally protected 

2 information under CBI. Can you describe a little 

3 bit how you're working in regard to security in 

4 this area?

5 MS. GALLI: Wait a minute. Okay.

6 MR. NASH: It's a great question. 

7 And security is always the first thing that comes 

8 up when we start talking about commercial cloud 

9 and those kinds of commodity services.

10 And we have to use -- within the 

11 federal government we have to use cloud services 

12 that are certified by GSA basically. FedRAMP is 

13 our techy term for it. But that's kind of the 

14 first level is we have to use federally certified 

15 cloud systems.

16 And then on top of that, we do 

17 analysis of the kinds of data that gets stored in 

18 the cloud in this particular system and how it's 

19 used. And then we also have to do a specific 

20 what we call re-certification for the 

21 application.

22 So we kind of do it in multiple layers 
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1 to make sure that all the data is protected. So 

2 we take it very, very seriously.

3 MS. WANEX: We have a number of 

4 questions online. Does anyone else in the room 

5 have any questions before we go to that?

6 MR. MUNDELL: Scott Mundell with 

7 Corteva again. Thank you for returning the mic. 

8 So you noted that there would be a role -- that 

9 there would be an organizational oversight. I 

10 suspect a number of us in large organizations 

11 have a group and they might like to all see each 

12 other's stuff.

13 So can more than one individual be set 

14 up at that organizational level? So say you had 

15 four employees all working in the same space, 

16 they would have cross-visibility on what's been 

17 put into the system?

18 MS. GALLI: Let me make sure I 

19 understand your question right. Within the same 

20 organization or even across organizations?

21 MR. MUNDELL: Within the same 

22 organization.
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1 MS. GALLI: Within the same 

2 organization, yes, that's correct.

3 MR. MUNDELL: Fantastic. And when 

4 might the schema templates for the system be 

5 available? Or if you're going to get that later, 

6 please feel free to put me on ice.

7 MS. GALLI: We don't have an exact 

8 date of when the schema templates will be 

9 available. We're working to minimize the changes 

10 that will be needed on the new schema.

11 MR. MUNDELL: Okay.

12 MS. GALLI: I suspect we'll have a 

13 template available at least a month before Go14 Live and then later on I'm talking about the 

15 transition period and I think that may answer 

16 your question.

17 MR. MUNDELL: Okay. Thank you very 

18 much.

19 MS. WANEX: Okay. The first question 

20 online that we had is where is the downloadable 

21 file with the handouts? It's in the box to the 

22 right-hand side of the screen in the webinar.
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1 The next one is there any provision to 

2 see previous permit numbers for renewal permits?

3 MS. GALLI: So if you are going to 

4 renew a permit, renewals have to happen in the 

5 system the original permit was issued in. So if 

6 you are going to come in with a renewal into 

7 eFile, it would be processed as a new permit the 

8 first time it came into the system.

9 MS. WANEX: I think the question might 

10 have been more about if the first permit was in 

11 eFile would you be able to see the trail from 

12 where you started to where you ended up with 

13 renewals?

14 MS. GALLI: Yes. So when you renew a 

15 permit in eFile, the experience will be very 

16 similar to renewing a permit in ePermits.

17 MS. WANEX: The next question, 

18 notifications issued during the transition to 

19 eFile will be converted to permits automatically 

20 or will they need to be reapplied?

21 MS. GALLI: So nothing will be 

22 converted. If you apply for a permit or a 
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1 notification in ePermits, it will live out its 

2 life in ePermits. So, yes, if you need a renewal 

3 or a permit or notification the next year, any 

4 payment through eFile, it would be a new permit 

5 number, a new system.

6 MS. WANEX: Since there is no 

7 provision for a user to add a regulated item, 

8 they have to email BRS, how long do you expect 

9 the response time to be to add the item once you 

10 email BRS?

11 MS. GALLI: We're still working on 

12 what that process would be, but the delay should 

13 not be too long.

14 MS. WANEX: Will there be an unknown 

15 choice for inspection history questions?

16 MS. GALLI: Yes, that is something 

17 we're working on adding. The question of has the 

18 destination been inspected by APHIS before will 

19 probably be updated. It will definitely be 

20 updated before Go-Live and may not even be 

21 required.

22 MS. WANEX: Will preparers have 
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1 access to all of the constructs associated with 

2 the permit of these accounts?

3 MS. GALLI: We're still working 

4 through how the preparers will access the system 

5 and interact with it and what data they will have 

6 -- will be available to them after it's actually 

7 submitted. So I don't have a full answer for you 

8 at this time.

9 MS. WANEX: Will we still be issued 

10 USDA ID numbers?

11 MS. GALLI: I'm not really sure what 

12 the USDA ID number is.

13 MS. WANEX: The format that everybody 

14 is used to the numbers being in.

15 MS. GALLI: Oh, of our permit 

16 notification numbers now. No. Unfortunately 

17 our permit and notification number format will 

18 change.

19 Right now it is the year Julian day or 

20 the calendar and then it's 101 for the first 

21 notification that comes in that day or 102, 103. 

22 Unfortunately, we are going to lose that format 
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1 and we're going to a standard format that will be 

2 used all across APHIS.

3 MS. WANEX: If one simply wants to 

4 extend the permit period, how do you do the 

5 amendment?

6 MS. GALLI: An amendment never 

7 extends the expiration date of a permit. The 

8 only way to extend the expiration date of a permit 

9 or notification is to apply for a new 

10 notification or permit.

11 MS. WANEX: Will eFile have a message 

12 box feature for communication with 

13 biotechnologists and condition acceptance?

14 MS. GALLI: Yes, it will have a 

15 message box. And that's an exciting feature that 

16 we will display to you through webinars and other 

17 training materials as a way to communicate back 

18 and forth with the biotechnologists and have 

19 communications retained in the system.

20 MS. WANEX: Will eFile have a way to 

21 add a location as an origin destination and 

22 release location at one time or will they have to 
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1 be entered three different times?

2 MS. GALLI: Unfortunately, no. But 

3 we do have a new type of location, which is an 

4 origin/destination. So you will only have to 

5 enter it twice instead of three times. So not 

6 everything you want, but at least it's an 

7 improvement.

8 MS. WANEX: Will reporting, 

9 planting/field tests be done in eFile or in 

10 another system?

11 MS. GALLI: All self-reporting will 

12 be done in a system that the permit or 

13 notification originated in. And we'll talk more 

14 about that in the coming slide.

15 MS. WANEX: Somebody was clarifying 

16 their question from earlier, I believe, it was 

17 about the renewal. He said if you have Permit 1 

18 which is renewed to Permit 2 and then renewed to 

19 Permit 3, will there be a trail in Permit 3 that 

20 has the other permits listed?

21 MS. GALLI: Yes. In eFile there 

22 would be a trail if all those permits were issued 
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1 through eFile.

2 MS. WANEX: Will our existing user ID 

3 and security levels transfer from ePermits to 

4 eFile?

5 MS. GALLI: So I'm assuming you are 

6 talking about the eOffice authentication ID? 

7 Yes, it will transfer.

8 MS. WANEX: If a new file is very 

9 similar to an existing permit, can you reuse the 

10 existing file to avoid entering all information 

11 all over again?

12 MS. GALLI: The schema file? I'm 

13 assuming?

14 MS. WANEX: I believe this might be a 

15 question related to cloning.

16 MS. GALLI: So you can go into an 

17 application, and it will copy it. You will have 

18 to still upload new SOPs and attachments.

19 MS. WANEX: For MRP IT, PPQ has also 

20 heard that ePermits was going away. Do you know 

21 if PPQ will be moving towards eFile? Will a 

22 similar presentation and demo be offered to PPQ 
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1 stakeholders?

2 MR. ANANT: Yes. It will happen in 

3 the future. We don't have any definite dates, 

4 but we have multiple releases planned. And we 

5 will get to PPQ and we have some more to add to 

6 that.

7 MS. LEWANDOWSKI: I also wanted to add 

8 that ePermits will not go away as long as we still 

9 have a need for it. So any decommissioning of 

10 ePermits while it may be in a planning stage, 

11 it's not going to go away until we know that eFile 

12 is up and running and handling permits that 

13 ePermits is currently being utilized for.

14 MS. WANEX: After transition to 

15 eFile, will applicants still be able to access 

16 applications that were done in ePermits? I think 

17 you might have just answered that.

18 MS. GALLI: Yes. As Laura said, 

19 ePermits isn't going away. You'll still be able 

20 to access. You might not be able to apply for 

21 new permits, but you will be able to access those 

22 records.
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1 MS. WANEX: Has the USDA considered 

2 creating a similar portal for submitting export 

3 applications for health certificates, for 

4 example, the VS 16-4 form?

5 MS. GALLI: Yes. Eventually eFile 

6 will be built out to handle all of APHIS' 

7 permitting and licensing requirements. So a 

8 similar system is in the plans for that type of 

9 work.

10 MS. WANEX: Will applicants be able 

11 to initiate a message to the biotechnologists in 

12 the message box? Currently the applicant can 

13 only reply to messages initiated by the 

14 biotechnologist.

15 MS. GALLI: Chris, do you know for 

16 sure?

17 MR. HOLBY: I would say --

18 MS. GALLI: I'll have to look into 

19 that question. I'm not exactly sure of that 

20 functionality if that exists without the biotech 

21 first initiating the conversation.

22 MR. HOLBY: Yes, I would say the same.
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1 MS. GALLI: Yes.

2 MS. WANEX: Will inspection letters 

3 be in eFile similar to how they are available in 

4 ePermits?

5 MS. GALLI: Yes.

6 MS. WANEX: We have some more 

7 questions being typed. Are there any additional 

8 questions in the room?

9 MR. MUNDELL: So what steps -- you 

10 showed a process there and currently there's an 

11 initiation process in ePermits. And then you get 

12 to the point where you reach the XML upload stage.

13 MS. GALLI: Yes.

14 MR. MUNDELL: Will that be 

15 essentially in the same spot in the process or 

16 will it move to earlier or later? Do you have 

17 any information on that?

18 MS. GALLI: Yes, so when we went to 

19 the question, we clicked a tab kind of up in the 

20 corner and there was, like, four different 

21 choices, and she chose one that took us to the 

22 question. There will be an XML upload right 
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1 there. So you'll just select and start the 

2 process for XML uploads that way.

3 MS. WIETZKI: Christine Wietzki with 

4 Betaseed. I was just curious. After filling 

5 out the application, will we still have the 

6 ability to generate a PDF to view that 

7 application?

8 MS. WANEX: Yes, you will. And if 

9 you're filling out a CBI application, you can 

10 generate both the CBI version and CBI deleted 

11 version of the PDF.

12 MS. WANEX: Online, please make sure 

13 you type your question in the chat box. I see 

14 somebody pressed 01. I'm going to take their 

15 question. Hi, there. You can speak at any time 

16 if you have a question.

17 MS. GALLI: So if you're interested 

18 in giving input of what you'd like to see in the 

19 system, we will be conducting user acceptance 

20 testing the week after Thanksgiving.

21 So go ahead and email the email on 

22 your handout. And then I'll be soliciting from 
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1 some of you who have helped test in the past also 

2 to see if you're still interested in 

3 participating and available.

4 MS. WANEX: To the individual that had 

5 a question, you should be able to talk. Please 

6 stay in the chat box because we're not hearing 

7 you. I definitely hear somebody talking. Well, 

8 we're not hearing anything in the room so I'm 

9 just going to read the next question. At any 

10 time you should still be able to talk.

11 Will the applicants be able to see the 

12 status of submitted applications in eFile?

13 MS. GALLI: Yes, you will be able to 

14 see the status of all of your applications in 

15 eFile.

16 MS. WANEX: If the applicant already 

17 knows that the material is regulated, is there a 

18 way to bypass the "am I regulated" questions?

19 MS. GALLI: Unfortunately no. There 

20 is no way to bypass the "am I regulated" questions 

21 unless you were to clone a previous application 

22 that you used in -- or you have already gone 
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1 through the questions to get to the correct 

2 outcome.

3 MS. WANEX: We have some more typing. 

4 Thank you, everyone, so much for your questions. 

5 It's been a really helpful discussion for us.

6 MS. GALLI: Yes. We definitely want 

7 to hear your feedback.

8 MR. BOTTOMS: Jeff Bottoms, Syngenta. 

9 Has there been any explanation of given more 

10 descriptive statuses for the applications once 

11 they're submitted? Currently, the permit is just 

12 ending but you don't know --

13 MS. GALLI: Where it is in the 

14 process?

15 MR. BOTTOMS: Exactly.

16 MS. GALLI: That is a possibility. 

17 We haven't really explored that very much, but 

18 yes. Okay. Thank you. We will definitely 

19 write that down.

20 MS. WANEX: We have another question. 

21 I think one we already answered. Will current 

22 access be migrated from ePermits to eFile 
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1 automatically?

2 MS. GALLI: Yes. You will use your 

3 eAuthentication logins for both systems. And it 

4 will be the same login.

5 MS. WANEX: And if CBI boxes aren't 

6 checked, who has visibility to the CBI?

7 MS. GALLI: Well, you would as the 

8 applicant and then BRS would. But the main 

9 reason that you claim information as CBI is in 

10 case that information becomes FOIA'd because the 

11 public can ask for it. So anybody that could 

12 potentially FOIA that information would be able 

13 to see information that you did not CBI protect.

14 MS. WANEX: Will there be a way to add 

15 supplemental documents to a submitted application 

16 without it having to be kicked back?

17 MS. GALLI: Supplemental documents --

18 but once it's submitted, I don't believe so. 

19 There will be a reports and notices section 

20 though so we could probably have the documents 

21 there after it's issued.

22 MS. WANEX: Do we need to write a new 
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1 XML upload program to mesh with the eFile system?

2 MS. GALLI: Yes. You will probably 

3 have to make small changes, but we're trying to 

4 minimize the amount of changes.

5 MS. WANEX: Last chance for anybody 

6 in the room if you have any extra questions. I 

7 see a hand.

8 MR. MUNDELL: Scott Mundell for 

9 Corteva Agrisciences. More of a comment. The 

10 sooner you can get us the schemas for all of this, 

11 the faster we can transition and we can be out of 

12 ePermits.

13 MS. GALLI: Yes.

14 MS. WANEX: I think you might find 

15 some useful information on that topic. One more 

16 question, will this system be ready to go for 

17 field crops by next March?

18 MS. GALLI: The Go-Live date is 

19 planned for spring of 2019. We're not ready to 

20 release the exact date or announce the exact 

21 date. So March falls in the spring. There's a 

22 possibility, but I'm not exactly sure.
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1 MS. WANEX: Thank you, everyone, for 

2 the questions. We'll have another opportunity 

3 to ask more questions. You're always welcome to 

4 type them into the box.

5 MS. GALLI: Okay. So we'll move on 

6 to preparing for APHIS eFile. So let's talk 

7 about the transition from ePermits to eFile. The 

8 dates and timeframes that I mentioned are 

9 estimates only and are subject to change. eFile 

10 will go live, meaning it will be available to 

11 apply for permits and notifications in the spring 

12 2019.

13 The transition between ePermits and 

14 eFile will occur in three stages. Each stage is 

15 expected to last approximately three months. Now 

16 let's explore how different business needs will 

17 transition.

18 First, we'll talk about reporting 

19 requirements. And what we mean by reporting 

20 requirements are the required self-reports such 

21 as planting reports, field test reports, 

22 volunteer monitoring reports and any other types 
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1 of reports that you're required to submit for 

2 permits and notification.

3 For issued permits and acknowledged 

4 notifications, permittees will submit their 

5 required reports in the system that issued the 

6 permit or notification. So anything issued out 

7 of ePermits, you will submit your self-reports in 

8 ePermits. Anything issued out of eFile, you will 

9 submit your self-report in eFile. And self10 reports can be submitted both via web entry or 

11 XML upload.

12 Now new permit applications, so this 

13 is the diagram that you have in your handout on 

14 the last page. To minimize the total transition 

15 time between the system, BRS has already stopped 

16 accepting applications for multiple year permits.

17 So today you can apply for a one year 

18 permit or a one year notification in ePermits 

19 using web entry or XML upload.

20 At Go-Live you will be able to apply 

21 for one year permits, multiple year permits and 

22 one year notifications using XML upload or web 
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1 entry.

2 During stage one, both web entry and 

3 XML upload will still be available in ePermits. 

4 During stage two, only XML upload will be 

5 accepted in ePermits. Web entry applications 

6 will have to be submitted in eFile.

7 I encourage everyone to use eFile as 

8 soon as possible. But we have the stages for 

9 those of us that are reluctant to change or to 

10 get our XML schemas in order.

11 Beginning in Stage three, BRS will no 

12 longer accept applications in ePermits and all 

13 applications will need to be filed in eFile. And 

14 you'll be able to file those either using web 

15 entry or XML upload.

16 So the next business need would be for 

17 renewal permits. And only permits can be 

18 renewed. Notifications cannot. And you can 

19 only renew a permit via web entry. And that will 

20 change with eFile.

21 BRS will no longer accept permit and 

22 renewal applications in ePermits at the end of 
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1 stage one. And to reiterate, any renewal request 

2 submitted through ePermits will only be granted 

3 for one year. To get a multiyear permit, all 

4 applications must be submitted in eFile.

5 And the final business case is for 

6 amendment request applications. In both 

7 systems, we only issue amendments for permits. 

8 Notifications are not eligible to be amended.

9 BRS will accept amendment requests for 

10 permits in the system that issued the original 

11 permit. So if your original permit is from 

12 ePermits, you would need to request in ePermits. 

13 And if your original permit was issued in eFile, 

14 you would make your amendment request through 

15 eFile.

16 And as a reminder, no change can be 

17 made to the expiration date of the permit. Once 

18 you renew it, the expiration date stays the same 

19 as the original permit. I'm sorry, once you 

20 amend the permit not renew it.

21 Now I'll turn the mic over to Ashok to 

22 talk about what we can expect to see in the long-
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1 term from APHIS eFile.

2 MR. ANANT: Thank you, Monica. Like 

3 with any product, we will continue to enhance the 

4 product and provide more features. You know, I 

5 have my iPhone, which is 6S. I started with 3S.

6 So we hope to do more releases. You 

7 know, we haven't decided the time frame of these 

8 releases. But some of the features, like, you 

9 know, more robust organizational applicant 

10 feature. Of course, we will continue to get 

11 usability feedbacks from you and others and roll 

12 these out as we do future releases.

13 And I think there was a question about 

14 plant production and quarantine permitting. So 

15 we are also planning towards getting the PPQ 

16 permitting into eFile. We don't have a date yet 

17 for that. Similar to that, Veterinary Services 

18 permitting will also roll into eFile in the 

19 future in 2019 or 2020 maybe.

20 So in addition to permitting, we are 

21 also looking into a one stop shop where 

22 certifications, accreditations, registrations 
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1 and other licensing can all be part of this eFile 

2 system. In fact, in animal care, annual 

3 reporting is already live. They have already 

4 gone to the next letter of ours, and they are in 

5 eFile.

6 So expect continual releases after the 

7 first BRS release, and we will tell you what where 

8 those new releases are going.

9 So in terms of getting up to speed 

10 with APHIS eFile, as you look at the system, we 

11 don't expect it to be very difficult to learn 

12 this interface. But we are going to definitely 

13 make sure you have the necessary support 

14 resources.

15 We will have webinars, which will be 

16 recorded and available any time you want to go to 

17 it. We will have FAQs. And we will have user 

18 guides to support this process of learning the 

19 new system. And one more opportunity for 

20 questions.

21 MR. WEEKS: Michael Weeks, BASF. The 

22 organizational applicant is something we've been 
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1 chasing after for years. And now that I'm 

2 thinking about it, I'm just curious, what the 

3 measures will be when someone becomes 

4 eAuthenticated and claims an organization to 

5 verify they do belong to that organization from 

6 the perspective that once they're in they would 

7 have access to everything else that was submitted 

8 within that organization. Does that make sense?

9 MS. GALLI: What we're imagining is 

10 that the organization will be able to designate 

11 their own system administrator, which will be 

12 able to control who in the organization shares 

13 information with each other. Chris, do you have 

14 anything else to add on how that functionality 

15 might exactly play out?

16 MR. HOLBY: I think that's right. I 

17 mean, I imagine it being a pretty direct to BRS 

18 conversation on who is that person and then that 

19 person then is kind of the gatekeeper. Yes.

20 MR. ANANT: Any questions online?

21 MR. MUNDELL: Scott Mundell, Corteva 

22 Agrisciences. So the current ePermits system 
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1 does have some system limitations on the size of 

2 the XML file that we can upload. And that 

3 creates extra workload for you, as an 

4 organization and for us. Do you anticipate file 

5 size upload limitations with this system?

6 MR. HOLBY: I understand there's a 

7 current page limit XML, and there's no page limit 

8 on the new uploads. We expect the system to 

9 support up to 500 constructs. So that's how 

10 we're measuring the size of the application.

11 MS. WANEX: The next couple of 

12 questions online. Will scanned blue and white 

13 import label history be in the file?

14 MS. LEWANDOWSKI: So any import that 

15 is issued in eFile you would use eFile to get 

16 your blue and white import labels from. The 

17 history from blue and white labels issued for 

18 import permits through ePermits, you would 

19 continue to get that label history out of the 

20 ePermits system.

21 MS. WANEX: How can we make sure we 

22 know when this system is live, when training 
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1 occurs, et cetera?

2 MS. GALLI: Don't worry. We will 

3 publicize and let you all know when the system is 

4 live and ready to use. We will let you know loud 

5 and clear.

6 MS. LEWANDOWSKI: Yes. That's 

7 absolutely right, Monica, and I just wanted to 

8 emphasize that this is really one of the very 

9 first of, I hope, several exchanges.

10 We are working on an entire change 

11 management plan to assist not only the applicants 

12 in their use of the system, but also to 

13 communicate with stakeholders, communicate 

14 throughout internally as well.

15 So this is -- you know, you're here at 

16 the very beginning, seeing the sneak peek. 

17 You're seeing the application even without all 

18 the functionality. And I know that there are 

19 questions about schemas. And so as we are 

20 developing more and more, we will be providing 

21 more and more detail.

22 And another point I wanted to make 
NEAL R. GROSS

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1 kind of related to that is that we are using an 

2 agile methodology. So we are building the system 

3 and releasing and then building again rather than 

4 the old waterfall methodology where you build the 

5 whole thing before you show any of it.

6 So as we go, we will be communicating 

7 what's new and as we get closer to dates we will 

8 communicate those as well.

9 MR. MUNDELL: Scott Mundell, Corteva 

10 Agrisciences. One of my team back home actually 

11 texted me this one. So one thing to keep aware 

12 of in terms of your user authenticity, that being 

13 in the fall here, November/December, that's also 

14 the time that our teams inside our organizations 

15 are busy writing the applications that you all 

16 receive and review typically in December, January 

17 and February.

18 So if you could stretch that user 

19 acceptance testing out a little bit into January 

20 or February as well that also might help us 

21 communicate with you more effectively. Thank 

22 you.
NEAL R. GROSS

COURT REPORTERS AND TRANSCRIBERS

1323 RHODE ISLAND AVE., N.W.

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

1 MS. LEWANDOWSKI: Yes. That's a 

2 really good point. And thank you for that 

3 feedback. We're taking that.

4 And one thing I want to emphasize is 

5 that the user acceptance testing for November is 

6 actually for what we're referring to as pass one, 

7 which is a portion of the implementation. We'll 

8 have another user acceptance testing round as we 

9 get closer to the actual release. So we'll have 

10 several opportunities.

11 MS. GALLI: Any last questions in the 

12 room? Seeing none, thank you, everyone. Thank 

13 you for joining us. And we look forward to 

14 informing you more about eFile as it develops.

15 (Whereupon, the above-entitled matter 

16 went off the record at 2:44 p.m.)

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