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2	U.S. ENVIRONMENTAL PROTECTION AGENCY

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4	PESTICIDE PROGRAM DIALOGUE COMMITTEE MEETING

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8	Thursday, May 13, 2021

9	11:00a.m.

10	DAY TWO

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PESTICIDE PROGRAM DIALOGUE COMMITTEE ROSTER

May 2021

NAME	AFFILIATION

User/Grower Groups/ Farmer Representatives

Amy Asmus

Jim Fredericks

Mark Johnson

Patrick Johnson
Dominic LaJoie
Lauren Lurkins
Tim Lust
Gary Prescher

Caleb Ragland
Damon Reabe

Tim Tucker

John Wise

Weed Science Society of
America

National Pest Management
Association

Golf Course Superintendents
Association of America
National Cotton Council
National Potato Council
Illinois Farm Bureau
National Sorghum Producers
National Corn Growers
Association

National Soybean Association
National Agricultural
Aviation Association
American Beekeeping
Federation

American Honey Producers

Association

IR-4 Project

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NAME	AFFILIATION

Environmental/ Public Interest/ Animal Welfare Groups
Lori Ann Burd	Center for Biological

Diversity

Gina Hilton	PETA Science Consortium

David Shaw	Mississippi State University

Christina Stucker-Gassi Northwest Center for

Alternatives to Pesticides
Edward Wakem	American Veterinary Medical

Association

Farmworker Representatives

Iris Figueroa	Farmworker Justice

Amy Liebman	Migrant Clinicians Network

Mily Trevino-Sauceda	Alianza Nacional de

Campesinas, Inc.

Public Health Representatives

Joseph Grzywacz

Aaron Lloyd

Daniel Markowski

Department of Family and
Child Sciences Florida State
University

Lee County Mosquito Control
District

Vector Disease Control
International

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NAME	AFFILIATION

Chemical and Biopesticides Industry/Trade
Associations

Manojit Basu
Steven Bennett

Gary Halvorson

Komal Jain

Karen Reardon

Charlotte Sanson
Nina Wilson

CropLife America
Household and Commercial
Products Association
Council of Producers and
Distributors of
Agrotechnology
Center for Biocide
Chemistries

American Chemistry Council
RISE, Responsible Industry
for a Sound Environment
ADAMA

Biological Products Industry
Alliance

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NAME	AFFILIATION

State/Local/Tribal Government

Ruben Arroyo

Carol Black

Jasmine Brown

Liza Fleeson Trossbach

Federal Agencies
Walter Alarcon

Douglas Burkett

Ed Messina (Chairl

Sheryl Kunickis

Riverside County
Department of Agriculture
and Measurements Standards
American Association of
Pesticide Safety Educators
Tribal Pesticide Program
Council

Association of American
Pesticide Control Officials

National Institute for
Occupational Safety and
Health Centers for Disease
Control and Prevention
Armed Forces Pest Management
Board

Office of Pesticide Programs
Environmental Protection
Agency

Office of Pest Management
Policy

US Department of Agriculture

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NAME

AFFILIATION

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Charlotte Liang

Center for Food Safety and

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Applied Nutrition

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US Food and Drug

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Administration

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Cathy Tortorici

Endangered Species Act

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Interagency Cooperation
Division

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Atmospheric Agency

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1

PROCEEDINGS

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DAY TWO - MAY 13, 2 021
MR. MESSINA: Why don't we throw up the

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4	agenda so folks can see it and I can make sure we're

5	looking at the right one.

7	emerging pathogens, Komal Jain, Taj ah Blackburn, from

8	11:00 to noon. Then we have our pesticide resistance

9	management workgroup update with David Shaw, Bill

10	Chism, Alan Reynolds. And then we have the PPDC

11	member presentations on stakeholder interests. We're

12	going to hear from Charlotte Sanson and Mano Basu

13	from ADAMA and CropLife.

14	We'll have our lunch break, and then 2:00

15	p.m. promptly for about 15 minutes, we'll hear from

16	Michal Freedhoff -- I'll do a brief introduction of

17	her -- who's the current principal deputy assistant

18	administrator for the Office of Chemical Safety and

19	Pollution Prevention.

20	2:15 to 3:00, we'll have another

21	stakeholder presentation. We have the ongoing FIFRA

22	ESA consultation work from Cathy Tortorici from NOAA,

23	and then ESA consultations and species protections

24	from Lori Anne Burd from the Center of Biological

25	Diversity. We'll take some questions and comments

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So we've got welcome. We've got the

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Committee Meeting

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1	from members for that time frame. Then we'll close

2	it out with what do we expect at the next meeting,

3	kind of really hear from you on topics you'd like to

4	hear, any deliverables or to-dos, takeaway actions

5	that we need to work on, and we can have Shannon

6	maybe review her list as well. And then we'll have

7	time for public comments and then we'll adjourn at

8	4:00.

9	So I would say, you know, make sure if

10	you're wanting to speak at the public comment

11	session, you provide your email and send in your

12	name, and we'll add you to the list and then we'll go

13	through it at 3:30. So welcome your input. And with

14	that, I think we're probably ready to begin.

15	MR. ANNINOS: Excellent, Ed. Thank you

16	very much. And, again, great day yesterday. We have

17	another one in store for you today. We were able to

18	stay on schedule very well yesterday, so I don't

19	think we ever felt rushed, which means that Shannon
2 0	and her team and the workgroup members did a great

21	job of kind of designing the agenda and you all did a

22	great job using that chat window yesterday to get

23	your questions posed kind of in order of precedence.
2 4	So thank you.

25	We're not going to go into details on the

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1	instructions again. You all have got the hang of it.

2	Obviously, if anybody on the call, members of the

3	public, no matter who you are, if you need

4	assistance, you can email Shannon Jewell. It's

5	Jewell.Shannon@EPA.gov, or you can select host from

6	the drop-down list in the chat window and that will

7	put you in touch with Sarah Chadwick who's providing

8	the support -- the platform support today.

9	A reminder that this is an unusual

10	opportunity for the PPDC members to all be together

11	at once and to provide inputs and feedback to the

12	workgroup presentation, so please take advantage of

13	that. And then for those that are not members of the

14	working groups or PPDC, you may find that you don't

15	have access to the chat window. You can open the

16	chat window and you can read what's happening, but

17	you have read-only rights, so to speak. You won't be

18	able to insert your comments into the chat window.

19	And just another final reminder because

20	there was some confusion yesterday on this, and that

21	was if you want to make sure your chats are being

22	seen, then you would go to the drop-down list at the

23	bottom -- near the bottom of the chat window.

24	There's a to, T-0, colon and then a drop-down list.

25	Scroll down almost to the bottom of that list past

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1	everybody's name and select everyone, the word

2	"everyone." And then that will be the default

3	whenever you -- whenever you put a chat in the

4	window, you know that everybody's going to see it.

5	So I think we're ready to get started and

6	we're ready to move to the first working group

7	meeting -- I mean, presentation today. Sorry that we

8	took a few of your minutes for this intro piece.

9	So I'm going to bring Komal Jain and Tajah

10	Blackburn, the co-chairs of the emerging pathogens

11	workgroup, to step up now. And I think that the

12	presenter role is going to go to Tajah, unless that's

13	been -- unless that's changed. So hopefully, you

14	have access now and can run the slides.

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1	EMERGING PATHOGENS WORKGROUP UPDATE

2	MS. JAIN: Thank you, Paul. Let's give

3	Taj ah a second to get the presentation up. There it

4	is.

5	Taj ah, are you ready?

6	DR. BLACKBURN: Let's do it.

7	MS. JAIN: Okay. So good morning,

8	everyone. I'm going to kick us off. My name is

9	Komal Jain. I am the executive director of the

10	Center for Biocide Chemistries and co-chair the

11	emerging pathogens workgroup with the esteemed Dr.

12	Taj ah Blackburn. For those that do not know Taj ah,

13	she is the current senior scientist in the Product

14	Science Branch in the Antimicrobials Division of EPA

15	and she holds a PhD in microbiology -- sorry,

16	microbiology and infectious diseases.

17	So we are really pleased to be here with

18	you today. This is a really unique and challenging

19	time in history as we combat SARS-CoV-2 and the

20	disease, COVID-19. So this is a time that demands

21	leadership and thoughtfulness and care, and we are

22	pleased to chair a workgroup on this issue and work

23	with so many colleagues to try to assess the

24	situation and better prepare our communities and the

25	EPA if we should be faced with something like this

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1	again.

2	So our agenda for this morning is to review

3	with you our membership and, you know, who, in fact,

4	is serving on the workgroup with us, our objectives,

5	the three charge questions and outcomes that we have

6	addressed thus far, and our next steps for the

7	remaining period of time that this workgroup is going

8	to be chartered. And then we will take questions. I

9	will note that we are going to try to take a pause as

10	we go through each one of our charge questions. So

11	anything that is top of mind for you can be addressed

12	along the way. But then, again, there will be time

13	built out at the end to address questions.

14	Next slide.

15	All right. So apologies, I know that this

16	is a difficult slide to read, but you do have copies

17	of it. So as you can see, we are a large workgroup.

18	We have 22 members and our members represent a real

19	mix of constituents. We have federal regulators. We

20	have registrants. We have formulators. We have

21	members of academia and science and legal experts, as

22	well as members of the end use community.

23	Specifically, we have representation from the health

24	care industry, the air transport industry and ground

25	transport.

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1

We have solicited members. Taj ah and I

2	have worked hard to round out this group. And I will

3	say that I think where we could still use feedback

4	and where I would say this group is open is if there

5	are folks in the end-user community that would still

6	have some availability to commit time to us, we would

7	welcome you into the group.

8	So to date, we've answered three questions.

9	The analysis has been thorough and our goal is to

10	ultimately provide EPA with recommendations on how to

11	be even better prepared for any future pandemic or

12	emergencies. And I'll get to that idea of

13	emergencies in just a moment. So through these

14	recommendations, we hope to include recommended

15	processes and recommendations on how to accomplish

16	the goals.

17	So you'll see on the slide we have

18	objectives. This group -- workgroup was formed based

19	on a proposal submitted by my organization, the

20	Centers for Biocide Chemistries, because we thought

21	there was so much to be learned as we make our way

22	through the response to COVID. And so I want to just

23	thank my fellow PPDC members and EPA for supporting

24	this effort.

25	And, again, as proposed by the CBC and

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1	ultimately accepted by this group, we have three

2	objectives. And that is, one, to assess EPA's COVID-

3	19 response and stakeholder experiences with the

4	emerging viral pathogens guidance for antimicrobials;

5	second, assess the user experience with antimicrobial

6	disinfection products registered by the EPA for

7	infection control; and provide recommendations to for

8	policy improvements and identify education gaps.

9	So in keeping with those objectives, I will

10	turn this over to Taj ah and she will run through our

11	first charge question.

12	DR. BLACKBURN: Thanks, Komal. More

13	importantly, thank you for providing the dynamics of

14	the working group, our meetings, highlighting the

15	depth of knowledge in the group, the cross-sectional

16	experience of the membership and, most importantly,

17	their dedication to get and gather substantive

18	information for the agency.

19	Let's spend some time navigating through

20	the current outcomes of our discussion. In the next

21	six months, we do plan to revisit our responses to

22	further enhance the products and deliverables through

23	a couple of mechanisms, prioritization of the answers

24	that have been documented and then develop a process

25	for implementation of those high-priority items.

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1 What I like to say, from concept to completion.

2

As Komal mentioned, I will pause after each

3	charge question and associated information for

4	comments, questions, and suggestions from the larger

5	body.

7	strengths and weaknesses of EPA's first use of the

8	emerging viral pathogens policy during the COVID-19

9	pandemic? As you can imagine, this was a very

10	concentrated experience field question to unpack that

11	required a plan for dissection early in the process

12	to really get to the nuts and bolts of the response.

13	The EVP guidance document was triggered for the first

14	time in January 2020, following a long span of review

15	and reevaluation that was initiated back in 2006 and

16	finalized in 2016.

17	The responses that are highlighted on this

18	slide focus on the identify weaknesses to further

19	assist the agency with clarification of the document

20	and defining items that were really unclear doing

21	this additional implementation process. We

22	approached this question by developing buckets and

23	then sub-buckets working from the center of the
2 4	document and unpacking as we moved towards the
25	perimeter.

6

So charge question number one, what are the

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1

The larger buckets represent the main

2	topics in the emerging viral pathogens guidance

3	document, and these topics being background and

4	purpose -- let's see if I can use the arrow pointer

5	-- background and purpose; viral subgroup

6	classification; product eligibility; and outbreak

7	criteria.

8	The sub-buckets were regenerated based on

9	the relevant topics associated with the buckets or

10	those main topics. The sub-buckets further expanded

11	the background and purpose section, for an example,

12	to communications, trigger, labeling, and hierarchy.

13	For those topics, the following gaps and weaknesses

14	were identified. Communications were limited during

15	the activation phase with the evolving criteria for

16	List N products. There were contradictions with

17	labeling and List N instructions.

18	The trigger timing was unclear and could be

19	enhanced through a public announcement that may

20	minimize confusion. The required label language was

21	thought to be lengthy and prescriptive with limited

22	options for additional language. The pathogen list

23	was difficult to understand. And, lastly, only a few

24	options existed for List N products. So those were

25	the weaknesses associated with the background and

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1	purpose section.

2	So let's move to the viral subgroup

3	classification or this List N that you hear me speak

4	about. The members conveyed that the EVP guidance

5	does not direct publication of a list. So this List

6	N isn't explicitly stated in the EVP guidance or any

7	list has to be generated as a function of products

8	that are against a targeted pathogen. The List N

9	could be more user-friendly for products that are

10	difficult to locate.

11	Another weakness was that List N did not

12	include trade names or ABNs, or alternate brand

13	names, and these were not included, and they were

14	rather included under one registration number.

15	Another weakness was the sub-distributor products

16	were not included on List N. Members conveyed the

17	List N products contradicted EVP language for many

18	products and that, lastly, List N was created without

19	any visibility to the registrant community.

20	For the product eligibility criteria in

21	this section, with the sub-buckets of efficacy

22	claims, labeling, CSF, a confidential statement form

23	-- a formula, registered formulations and use sites,
2 4	the members conveyed that the EVP guidance lacked

25	information regarding active ingredient requirements,

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1	that the SARS-2 protocol was an overkill and it was

2	too cumbersome to maneuver. Some members conveyed

3	that the guidance lacked temporary amendments for

4	emerging situations and the guidance lacked

5	flexibility for application methods beyond typical

6	applications that expanded to electrostatic sprayers.

7	Members also felt that the guidance lacked

8	information concerning concentrations, contact times

9	and use sites. Members conveyed that the document

10	lacked sensitivities for supply chain constraints and

11	new supplier -- changes to existing supplier

12	information had to go through agency review, which

13	may have delayed product registration.

14	For the outbreak criteria, identified in

15	this yellow section, weaknesses were not identified,

16	but two questions were raised regarding whether the

17	EVP should be applied equally for animal-related

18	outbreaks, such as the African swine flu fever, and

19	whether the agency was concerned about pathogen

20	cross-species transmission or interspecies

21	transmission or, as a layman's term, jump -- as an

22	organism jump species.

23	Some of the strengths, though not

24	explicitly spelled out on this slide, were that

25	preloaded labels did make labeling straightforward

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1	and that sharing of information with global partners

2	through a blessed List N was and still continues to

3	be a valuable tool.

4	So let's just briefly recap the terms EVP,

5	List N, and put some context and definition around

6	those -- those terms for the larger PPDC membership.

7	For context, let's briefly revisit EVP guidance, or

8	formally termed, the process for making claims

9	against emerging viral pathogens not on EPA-

10	registered disinfectant labels.

11	In 2016, as I mentioned, EPA finalized the

12	guidance for making claims against emerging viral

13	pathogens that are not on EPA-registered disinfectant

14	labels. The finalization of the guidance was

15	followed by a 30-day public comment period with a

16	response to comment document. So that's the EVP

17	guidance in a nutshell.

18	As previously mentioned, the EVP was

19	activated for the first time in January 2020. In

20	March of the same year, EPA began announcing that it

21	would begin to expedite products eligible for

22	emerging viral pathogen claims using the disinfectant

23	hierarchy as outlined in the EVP guidance. Also

24	around this time, in March, List N was posted and

25	accessible. In May 2020, EPA expanded its expedited

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1	review program to include new products and amendments

2	to existing product labels that required the review

3	of new efficacy data.

4	So what is this List N and why is it termed

5	List N? List N includes disinfectants for use

6	against SARS-CoV-2. As I mentioned, List N was

7	posted on March 55, 2020. The initial list contained

8	90 products and has grown to approximately 550

9	products. 377 of those products, about 68 percent,

10	are supported by EVP guidance. It is of important

11	note that, as of two weeks ago, the list had 23.5

12	million views.

13	So why is it called List N? Well, it's

14	List N because it represents the next available

15	alphabet in the growing list of products targeted

16	against specific pathogens.

17	So that's a lot of information to digest.

18	I will take a brief pause here for questions/comments

19	before we transition to charge question number two.
2 0	MR. ANNINOS: Thank you, Taj ah. Thanks,

21	Komal. We're changing things up a little bit as you

22	can tell. In the other presentations, we waited for

23	everybody to get through their entire deck and then

24	it was open to the PPDC and other workgroup members

25	for comments. This is an opportunity now to pause,

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1	as Taj ah has just indicated, and to get some

2	feedback, some direct feedback and thoughts from the

3	committee, the full committee, on this particular

4	charge question. And then we'll move on to the next

5	charge question. And then at the end, hopefully,

6	we'll have a few extra minutes so that -- in case

7	there's general comments about the whole topic.

8	So let's just open it up. I think you

9	remember the protocol here. You'll go to the chat

10	window. As matter of fact, you should probably just

11	keep the chat window open all day long on the right-

12	hand side of your screen, and just enter your name

13	here if you want to make a -- ask a question or make

14	a comment. Or if you're feeling bold, just blurt

15	something out and suddenly we'll be able to see you

16	and respond to your question.

17	And I'm not worried about dead air because

18	it's just -- as Tajah just said, it's a lot to

19	absorb. Hopefully, you had a chance to look at --

20	some of you had a chance to look at this deck

21	beforehand, but this is a great chance to provide

22	some feedback or to get some clarifying questions to

23	the team.

24	MS. JAIN: So Paul, if I could

2 5	jump in, something for our members to think about and

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1	that we would love feedback on is particularly List

2	N. Many of you probably are users of List N and have

3	tried to access it, applied it in your businesses or

4	shared it with your community. You know, we would

5	appreciate feedback on the utility of that document

6	and how you could see it being improved.

7	So, Paul, maybe we'll just let that linger

8	with folks and we can move on.

9	MR. ANNINOS: Yep. Absolutely, absolutely.

10	We can definitely continue. And for the folks --

11	everybody else, be thinking about the questions and

12	the comments you'd like to make in the next segment

13	or at the end of the entire deck.

14	So let's go ahead and continue. Yep.

15	DR. BLACKBURN: Okay. So Komal?

16	MS. JAIN: Okay. So the next charge

17	question that the group addressed is, what, if any,

18	documents, policies, guidances, for example, PR-

19	Notice 98-10 and the EVP, should have increased

20	flexibilities to respond to supply chain challenges

21	during a pandemic or other emergency and what

22	revisions should be made?

23	So first thing to note here is that we

24	decided to broaden our ask of ourselves to more than

25	just a situation of an emerging pathogen. We really

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1	wanted to see, you know, what EPA documents need

2	greater flexibilities to address other emergencies.

3	So when I say other emergencies, things that, you

4	know, could be considered is geo-specific challenges,

5	for example, Brexit or shutdowns that occurred like

6	in Texas or China, Texas being weather-related, China

7	being other emergency type situations, facilities

8	that had to close down.

9	And then when that emergency is declared,

10	the question is when should it be declared? For

11	example, prior to a pathogen arriving on U.S. soil,

12	African swine fever virus or Ebola, you know, do we

13	want to be able to be more proactive to allow users

14	to stock up on current product in advance of arrival

15	to U.S. borders?

16	And, you know, what circumstances might we

17	want to consider? Is it quantitative or is it

18	qualitative? You know, consideration of human or

19	animal morbidity or mortality, economic impact,

20	endangerment to species? So we are working to help

21	define what is, in fact, that emergency situation and

22	trying to identify what it is that would trigger

23	classification of the emergency.

24	Next, we identified the targeted documents

25	within EPA's library that are applicable to these

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1	situations to see what possibly could be needing

2	revision. So the documents that we have, at least

3	initially or immediately identified, include the EVP,

4	which you've just heard a great deal about from

5	Tajah, PR-Notice 98-10. And for those of you that

6	are in the antimicrobial space, you'll know that

7	there is a series of temporary amendments that came

8	into play after COVID or SARS-CoV-2 was declared, all

9	to address the supply chain issues. And there is a

10	petition in place to see whether some of those

11	temporary amendments that are currently in play can

12	be formally adopted. So one of the things we want to

13	do is look at PR-Notice 98-10 in its current version,

14	but also its temporary amendments.

15	We also want to look at the label review

16	manual and the registration review manual, test

17	guidelines, you know, 158w regulations, and then

18	provisions for importation and international supply

19	chains.

20	Next question -- next slide, Tajah.

21	So as I've already gone through, we feel it

22	is an important exercise not to be so narrowly

23	focused on just a situation of another pandemic. We

24	want to consider other possible emergency situations.

25	Something that was suggested to me this morning that

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1	should be part of our definition of emergency

2	possibly is when there's cyber attacks or ransomware,

3	all that can have crippling effects on supply chains.

5	know, we're looking to see how registrants of

6	antimicrobial pesticides can make changes to their

7	suppliers in a more streamlined process than is

8	currently in place. Should it be just a notice?

9	Should it be via a self-certification?

10	We're also considering whether or not we

11	can take advantage of work that is done on a more

12	global scale. We have sister jurisdictions that are

13	faced with some of the same questions that we are in

14	the U.S. Can EPA rely on the work of the agencies in

15	the EU and those member countries, Asia? You know,

16	if it's not total reciprocity, can it be a work-

17	sharing environment such that some of the hard work

18	is done and the reviews are shared and then EPA goes

19	through its own analysis and makes its own

20	determination?

21	Another solution is, can, you know,

22	chemistries and formulations be changed for these

23	products, again, based on the self-certification

24	process versus amendments and a thorough review by

25	the agency.

4

And then when we think about solutions, you

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1

I should be clear, though, that, in no way

2	are we talking about sacrificing the efficacy or the

3	safety of these products. We're really just looking

4	to see how we can streamline the paperwork exercises

6	antimicrobial pesticide products, but there are other

7	products that go beyond disinfectants that have been

8	critical in the response to COVID. So under this

9	charge question, should we be looking at other

10	pesticides, because we do want to at least keep it

11	narrow to OPP matters, but, you know, is it beyond

12	disinfectants and, you know, is it beyond surface

13	contamination and surface transmission?

14	So those are, again, some in -- some of our

15	pending questions that we do hope to better answer.

16	So I think that is it for the work that

17	we've done thus far on charge question two.

18	Something that maybe Taj ah and I haven't pointed out

19	yet is by no means do we -- do the two of us or the

20	workgroup members feel like any of these charge

21	questions and responses have come to closure. I

22	think this is going to be an evolving process,

23	particularly as we work towards the final report to

24	EPA.

25	So again, we're soliciting feedback from

5

And then, lastly, I keep on saying

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1	you and from others that we can reach out to because

2	we really want our final report and our guidance to

3	the agency to be as comprehensive as possible.

4	So with that, let me take a pause and see

5	if there is any feedback.

6	MR. ANNINOS: Thank you, Komal. And,

7	folks, we're taking a pause again. This is a chance

8	to weigh in on charge question two and some of the

9	recommendations that this team has -- is considering.

10	MS. JAIN: I will also invite we have two

11	members of our workgroup that are on the line with

12	us, and I'll invite to Alex Cook or Elaine Black to

13	chime in if you feel like we've missed anything or

14	I've missed anything on charge question two. And

15	then we have other PPDC members that serve on this

16	workgroup, and I believe they can also unmute

17	themselves and chime in.

18	MR. ANNINOS: Absolutely. The mic is open.

19	MS. BLACK: This is Elaine. I'll just say

20	you've covered everything very well. Thanks, Komal.

21	MS. JAIN: Thanks, Elaine.

22	MR. WISE: This is John Wise. I have a
2 3	comment.

2 4	MS. JAIN: Yes.

25	MR. WISE: I was thinking about your

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1	question about how the work you've done might relate

2	to pesticide use and/or I'm thinking agricultural

3	pest management, and it did strike me that there is a

4	hydrogen peroxide product called Jet-Ag that's being

5	used in specialty crops and it doesn't have direct

6	lethal effects on the target pest, but it eliminates

7	some of the yeast and other necessary foods for

8	Drosophila flies and, thus, is useful in the field to

9	be sprayed like a pesticide. So that's one that has

10	some relationship to the work you folks are working

11	on.

12	And the other thing that comes to my mind

13	is post-harvest, many fruits and vegetables, once

14	they're in a sorting or processing plant, go through

15	a series of washing steps that, in some cases,

16	include some kind of sterilant or agent that is

17	disinfecting fruit.

18	So those areas have some tangent

19	relationship to the work you're doing. So I just

20	wanted to share that as a source of information.

21	MS. JAIN: Thank you. That's very helpful.

22	I appreciate it. And I've taken notes.

2 3	DR. BLACKBURN: Yes, and thanks, John, for

24	that. I think that's critically important to

25	feedback. And so that charge question number one,

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1	where possibly expanding that EVP guidance to other

2	use sites, other applications, you know, and just

3	kind of looking at this thing comprehensively so

4	that we can -- you know, we can think of all these

5	other industries -- and that's going to lead me to

6	charge question number three -- but all these other

7	industries that may be impacted while we're operating

8	in our silo, just the importance of expanding that to

9	these other entities. So thanks so much for sharing

10	that.

11	MR. WISE: You're welcome.

12	MS. BLACK: I want to just build on that.

13	This is Elaine. Yeah, we saw lots of kind of knock-

14	on effects of high demand for certain ingredients

15	that went into disinfectants that were on the List N.

16	But that, you know, once we saw stresses on that

17	supply chain, other products that were not considered

18	definitely kind of felt the pain, and we saw it in,

19	you know, rising prices and other issues and

20	availability of ingredients.

21	So, yeah, thanks, John. I think those

22	products, in particular, are very important. We know

23	that just the -- you know, like for the food supply,

24	we have to -- for all of these emergencies, we have

25	to consider all the things that we need when we're in

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1 an emergency. So thank you.

2

DR. BLACKBURN: And then, too, I think it's

3	important that as Komal mentioned, we're expanding

4	that to beyond a pandemic, but considering

5	emergencies as well. And then what we're going to do

6	-- and what I'm going to mention as it relates to

7	charge question number three -- is we're going to go

8	back and try to define what an emergency is and make

9	that a quantitative type of approach so that, you

10	know, if it's impacting multiple industries, if it's

11	impacting the supply chain, that could feed into the

12	emergency and then may trigger some of these

13	documents and policies so that these items can be

14	addressed in a timely fashion and products can still

15	be made available. So thanks very much for that

16	insight Elaine as well.

17	So charge question number three, as we seek

18	to wrap this up and have further discussion, is, what

19	education is needed during a pandemic or other

20	emergency for the public end-users and other

21	regulating authority? Again, this is a very, very

22	weighted question. We're still unpacking it and

23	really trying to get to, again, the nuts and bolts to

24	get this question addressed.

25	So we utilize a bucket approach, again, but

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1	across time as well. We analyze across multiple

2	industries and sectors to include ground

3	transportation, airlines, the cruise industry,

4	government facilities, office buildings,

5	entertainment venues, the food service from

6	agriculture through process to retail, restaurants

7	and bars as well, healthcare, and schools across the

8	time periods of pre-pandemic/emergency, during the

9	pandemic and emergency, and then finally post-

10	pandemic and emergency.

11	Again, we're going to have additional

12	discussions around defining what those emergencies

13	are, so be assured that it's going to be a

14	quantitative type of approach that's -- you know,

15	it's not a gray area, if you will. It's really clear

16	as to when an emergency is triggered. But as it

17	relates to the industry's outline on this slide, I

18	tried to not include a whole lot of information, but

19	focus on those industries that provide unique,

20	isolated challenges and gaps and potentially

21	conflicting messaging with their respective

22	industries.

23	To some of these -- these isolated

24	challenges include compatibility concerns, conflicts

25	with sister agency regulations provided maybe by DOT

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1	or FAA -- and/or FAA for materials incompatibility

2	and corrosivity testing, challenges with

3	international regulations for vessels that travel

4	into the international spaces. So we first have to

5	identify those nuances, if you will, against all of

6	those industries and those sectors, so then we can

7	better understand what those educational gaps are.

8	So just still kind of high level as we're

9	working through this question, significant

10	educational gaps during the pre-pandemic or during a

11	pandemic or emergency phase were identified and we

12	felt that there was a need for consistent and

13	centralized messaging from our government partners

14	and even on the state level, but including the trade

15	associations as well, to bridge those gaps as it

16	relates to education and training. And this can be

17	accomplished through informational webinars, to

18	address and mitigate conflicting messaging with

19	ongoing dialogues to address and convey changes and

20	updates through a timely and centralized matter.

21	As it relates to materials compatibility,

22	concerns require awareness across EPA's landscape to

23	better understand these issues and the potential

24	limitations of the FAA list, of compatible products

25	for use on airplanes and DOT's challenges and even

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1	the impact on the food service sector as it relates

2	to compatibility as well.

3	Another gap across all industries was how

4	do we manage these high-touch surfaces? And how does

5	that translate into proper use of the products via

6	what the label is stating and translating that, like

7	I say, from prose to practice. How do you take that

8	word -- take those words on a label and make those

9	mean something when they're actually being used?

10	So post-pandemic/emergency and ongoing

11	through a pandemic, and I was thinking about the

12	different phases of a pandemic, but the working group

13	highlighted that surveys, high wash -- hot washes may

14	prove useful in gathering lessons learned and

15	understanding lessons and best practices from past

16	maybe isolated contained outbreaks on a large or

17	small scale. And what brings -- what comes to mind

18	is maybe the cruise ship industry and how they manage

19	outbreaks on their vessels or maybe an outbreak

20	within a health care suite in the hospital.

21	So in closing, as it relates to our charge

22	questions, one of the members provided this context

23	that really kind of frames these educational gaps in

24	our exercises in answering these charge questions, in

25	that these educational gaps and challenges seem to be

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1	getting to this idea, and I like this, of competing

2	commitments or competing priorities, where one set of

3	rules of best practices is at odds with another.

4	And working through this space to better understand

5	the individual gaps and the collective processes for

6	it is what we're challenged to do in this space and

7	for the next six months.

8	So I'll pause there for any questions and

9	clarification.

10	MS. JAIN: I'll just chime in to say, in

11	many ways, I think this is one of the harder charge

12	questions that the workgroup is faced with. Look, we

13	know education is needed. We know that it can be

14	improved. But when we think about how to accomplish

15	that, it's really challenging because we're talking

16	about anyone and everyone. So that means, you know,

17	how we approach our communications can be -- might

18	need to be really technical and might need to be

19	really basic. It should be bilingual. What type of

20	platform should we use? Does everybody have access

21	to the platforms that we want to use and how we go

22	about crafting the proper messaging that can be

23	easily understood by our targeted audiences. So I

24	really do believe this is the hardest one and

25	probably the one that we're going to spend the

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1 greatest amount of time trying to unpack.

2

And, again, as all of you on the phone are

3	users of disinfectant products, hopefully, you have

4	guidance or thoughts that you can share with us.

6	much. We do have some time here, so let's just --

7	oh, I see, you have more slides. I'm sorry, I

8	thought that was the last slide. So go ahead. I'll

9	let you finish up the deck and then we'll open it up

10	to insights, comments, questions from the larger

11	group.

12	MS. JAIN: Sounds great. So I think we've

13	really said this repeatedly, but for the next six

14	months we really hope to go back to the three charge

15	questions that we've already identified and

16	prioritize our responses, and we really do want to

17	rank in order of priority what some of those

18	solutions are and provide specific processes or

19	guidance to the EPA or others that should be, you

20	know, a part of the solution to work our way to a

21	better situation in in the future.

22	So we do have these three charge questions.

23	We feel like they're pretty comprehensive. And while

24	we have toyed with additional questions, we feel like

25	the ones that we've identified thus far get wrapped

5

MR. ANNINOS: Taj ah, Komal, thank you very

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1	up in our original three. So this last bullet here

2	is we are open to addressing additional charge

3	questions if we feel like they haven't already been

4	covered. So again, this is another area where we

5	invite feedback. If you think this group has missed

6	something thus far, there is an area that really

7	should be addressed that hasn't been, then there's

8	time in the next six months for us to dig in.

9	So with that, I will say on behalf of Tajah

10	and our workgroup members, thanks for giving us time

11	today to explain what we've been doing thus far, and

12	we'll open it up to questions.

13	MR. ANNINOS: Mily Trevino-Sauceda has a

14	question. So, Mily, go ahead and unmute yourself and

15	join us.

16	MS. TREVINO-SAUCEDA: Yes, I'm leaving my

17	screen off because I'm having problems with my

18	internet. Yesterday, I just got cut off and for

19	whatever reason I could not get back, too much wind.

20	I'm in another place right now, but nonetheless.

21	Can we go back to the prior slide that you

22	used, please?

23	MS. JAIN: This one?

24	MS. TREVINO-SAUCEDA: No, the other one

25	before.

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2

4

3

1

MS.	JAIN: Charge question three?

MS.	TREVINO-SAUCEDA: Yes, please, yeah.

MS.	JAIN: Okay.

MS.	TREVINO-SAUCEDA: Okay. So because of

5	what -- I remember that when we were presenting

6	yesterday and we were talking about any -- and this

7	goes for any group or any community, any whatsoever

8	and this also goes for any kind of industry. It is

9	whatever the -- whatever is -- following, you know,

10	the questions and it's talking about education with

11	-- about pandemic and other any other kind of

12	emergency, in terms of get prepared whatsoever.

13	Are we also thinking, you know, what, you

14	know, mainstream end uses, cultural competency, all

15	these other -- all these other areas of how people

16	will understand the messages or the education that

17	would be provided so that people get the message

18	based on how they really, you know, would understand

19	it. Am I making sense in terms of my question?

20	MS. JAIN: Maybe I can take a stab at it.

21	I think what you're trying to say is that as we

22	develop education material and communications, we

23	really need to do so with the lens of the receiving

24	audience and make sure that --

25	MS. TREVINO-SAUCEDA: Yes.

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1

MS. JAIN:

in fact, we're talking their

2 talk. Right?

3

MS. TREVINO-SAUCEDA: Yes, yes.

MS. JAIN: So if we're trying to reach out

4

5	to a largely Spanish-speaking population, have we

6	taken effort to, one, develop material in Spanish;

7	two, are we shying away from vocabulary that they

8	might not be familiar with because it's so colloquial

9	to English speakers, things like that. Do I have

10	that? Have I captured it?

11	MS. TREVINO-SAUCEDA: Yes, yes. And I

12	would just think about -- because this is -- you're

13	doing it to a wider audience -- audiences and this

14	would be multiple languages and multicultural,

15	whatsoever. I mean, it just -- I'm not saying, you

16	know, that this group would be providing everything,

17	all the details, but it would help if that is taken

18	into our account, especially because we're talking

19	about -- you're talking about education using

20	materials, you know, and whatsoever with anything

21	that -- that's going to be used to get to the

22	audiences.

23	MS. JAIN: I think you make a really good

24	point. And, certainly, as we provide recommendations

25	to the educators -- and when I say that, you know, I

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1	think that's going to be a shared responsibility as

2	Tajah mentioned. It's not just the Government; it's

3	industry, you know, those that produce the products

4	that would be responsive to a pandemic or an

5	emergency. The onus is also on the trade

6	associations, you know. And perhaps we can partner

7	with academia, so -- but that has to be part of our

8	recommendation. I absolutely agree.

9	Tajah, any --

10	MS. TREVINO-SAUCEDA: Yeah, and just yeah,

11	I'm sorry. I just want to add in terms of -- based

12	on your response and looking at, you know, your --

13	there's a large gap many more times in terms of how

14	government, either agencies and community and even

15	community organizations have, based on terminologies,

16	even in English, based on terminologies, based on

17	anything, there's a lot more times that people will

18	not understand what you're talking about or -- and

19	will -- I mean, we're talking about communicating and

20	it -- we have found in our 30-plus years of

21	organizing with just farmworker women, we just --

22	it's -- there's more details to look at than just

23	thinking that everybody will understand because we

24	think we're talking the same language. Even if it's

25	the same language, that's where I'm getting at.

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1

And this is why we call it the -- working

2	within the cultural context of those audiences. It's

3	not just, oh, she's a Latina or she's an Asian or --

4	no, it's looking at wider -- so it's not black and

5	white. It's not English/Spanish. It's not -- you

6	know, it's a little bit more than that to be

7	efficient, yes.

8	DR. BLACKBURN: I really agree about the

9	cultural sensitivities, and I know, as an officer,

10	when we get dropped into certain places, that's some

11	of the first training that we go through is better

12	understanding the population that we're going to work

13	with and what we do and how it impacts that. So I

14	think -- I thank you for raising that salient point

15	and we will take note of that as we move through our

16	recommendations. Thank you so much.

17	MR. ANNINOS: Absolutely, thank you.

18	And thank you, Mily.

19	Liza Fleeson Trossbach has also requested a

20	moment for a question or a comment. Go ahead, Liza.

21	You can unmute yourself.

2 2	MS. FLEESON TROSSBACH: Thank you. Can you

23	hear me?

2 4	MR. ANNINOS: Yep.

25	MS. FLEESON TROSSBACH: Okay. Fantastic.

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1	I appreciate the presentation. Obviously, with SARS-

2	CoV-2, this is near and dear to all of us. And just

3	a somewhat related comment, throughout this, as

4	pesticide regulatory officials, we obviously are

5	directly involved with the use of pesticides, and

6	then also with the registration process, particularly

7	for those products that are trying to be approved

8	under an emergency exemption, one of the challenges

9	that we had as pesticide regulators, and I think some

10	of those registrants had, was understanding what the

11	data requirements are going to be for this. You

12	know, we have a new pathogen, we have a new

13	situation.

14	And there were quite a few states that had

15	emergency exemptions that were submitted, but there

16	was a lack of information or it wasn't really clear

17	necessarily what the data requirements would be for

18	registrants on some of those processes for quite

19	long. And so I think as part of this education, it

20	should really include educating the registrants and

21	the peptide regulators about how you meet these

22	during an emerging pathogen. I don't know what might

23	be next, but certainly we'd like to be prepared.

24	And I think there needs to be a little --

25	maybe a quicker response or an ability to get some of

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1	that information out. You know, maybe there's a way

2	that there can be kind of a baseline of information

3	and then maybe there are things that could be

4	specific to certain pathogens. I don't really know.

5	That's not my area of expertise, but I think there

6	were some -- potentially some pesticides that could

7	potentially have helped at least a certain -- during

8	certain periods that perhaps couldn't get to market

9	soon enough or couldn't get through the approval

10	process. So just a little bit about that to let

11	regulators help registrants and vice versa.

12	So thank you.

13	MS. JAIN: That is really helpful, Liza.

14	Thank you. And I know that's also responsive to

15	challenges that AD specifically faced. There were a

16	lot of new registrants that entered the market and,

17	you know, to AD's credit, they spent a lot of time

18	walking these newcomers through the regulatory

19	process. And it would be nice if there was some go-

20	to material that could at least provide that baseline

21	that you referenced. So yes, we will add that to the

22	list.

23	Taj ah, anything you want to add?

2 4	DR. BLACKBURN: No, nothing on that point.

25	I mean, even though I work with a lot of the Section

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1	18 data, we did see -- the standard, of course, is a

2	little different for the Section 3 data, but I can

3	understand some of the frustration that may have been

4	experienced as it relates to that. So it's noted.

5	Thank you.

6	MR. ANNINOS: And, Liza, this is Paul. I

7	apologize for mispronouncing your name when I

8	introduced you. I have a staff member with the same

9	spelling of your name and she goes by Lisa and so I

10	-- it was like an automatic mispronunciation of your

11	name. So I apologize.

12	And the floor is still open. We have a few

13	minutes left, two or three, four minutes left. If

14	anybody has a final thought, comment, question,

15	insight, advice for this hard-working working group.

16	And hearing none, I can turn the floor back

17	to you, Komal or Tasha or any member of your working

18	group, if you have any -- if you all have any final

19	thoughts or comments.

20	DR. BLACKBURN: I would just like to say if

21	things come up and you have additional questions,

22	comments and suggestions, please send those to

23	Shannon and she will get those to us, and we will

24	definitely add them to our list of things to consider

25	as we work through the rest of our six months in

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1	answering questions and prioritizing and developing

2	new processes forward. So that's all I have.

3	Komal?

4	MS. JAIN: I just echo that we welcome the

5	feedback and, again, for those that are on the

6	workgroup with us and you're listening in, we thank

7	you for all your hard work. So hopefully more to

8	come, I guess, with the next PPDC meeting.

9	Paul, I'm going to turn it over to you.

10	MR. ANNINOS: Okay, all right. Very good.

11	Well, listen, thank you very much. Excellent

12	presentation. Really appreciate the feedback that we

13	did get and, obviously, people know they can contact

14	you offline with anything that relates to your

15	objectives and charge questions and even the work

16	over the next several months. So thank you very

17	much. Great job to all of you.

18	I think with that we're -- even though

19	we're kind of three minutes early, I think we should

20	move into the next part of our agenda, and for that,

21	we're talking about pesticide resistance management.

22	The co-chairs for this workgroup are David Shaw from

23	Mississippi State University and both Bill Chism and

24	Alan Reynolds from EPA as the government co-chairs.

25	And so I'm actually not sure who we're handing this

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1	off to first. I think Alan might be the one kicking

2	it off. I could be wrong, but let's try that.

3	MR. REYNOLDS: You're correct, Paul. It's

4	going to be me to get the presentation started.

5	MR. ANNINOS: Great.

6	MR. REYNOLDS: So if it's okay with you,

7	I'll just go ahead and dive right into it then.

8	MR. ANNINOS: Yeah, that's -- absolutely,

9	you know, you're up.

10	MR. REYNOLDS: Okay. Terrific.

11

12

13

14

15

16

17

18

19

20

21

22

23

24

25

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1

PESTICIDE RESISTANCE MANAGEMENT WORKGROUP UPDATE

2

MR. REYNOLDS: Okay. So along with my co-

3	chairs, Drs. Bill Chism and David Shaw, I'm going to

4	be presenting our interim progress report on our

5	resistance management workgroup. And just some quick

6	intros, I'm -- both Bill and myself are in EPA's

7	Office of Pesticide Programs. I'm a lead biologist

8	in the Biopesticides and Pollution Prevention

9	Division. Bill is a senior scientist in our

10	Biological and Economic Analysis Division. And Dr.

11	Shaw is a distinguished Professor of Weed Science and

12	Provost at Mississippi State University.

13	Okay, so just to recap our workgroup goal,

14	what we're looking at is we're looking to develop

15	recommendations to EPA on how the agency can assist

16	stakeholders, addressing the challenges of

17	conventional pesticide resistance. And just a

18	reminder that what we'll be talking about today,

19	we're not going to be talking about final

20	recommendations. This is really a progress report

21	and we'll be going through the topics of discussion

22	that we've been focusing on so far over the past few
2 3	months.

24	Okay, so for our group, we have four charge

25	questions. And I'm just going to read through these

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1	really quickly to recap. So the first question is,

2	are there current EPA policies that positively or

3	negatively affect conventional pesticide resistance

4	management and what policies could be reworked to

5	more positively address resistance management?

6	The second charge question is, are there

7	current industry programs that positively or

8	negatively affect conventional pesticide resistance

9	management and would EPA have a role in those

10	programs and what might that be to positively

11	influence industry?

12	The third question is, are there incentives

13	for registrants or pesticide users that could be

14	considered related to conventional pesticide

15	regulation that might positively affect resistance

16	management and are there other ways in which the

17	agency can work with stakeholders, for instance,

18	growers, commodity groups and academics, to

19	cooperatively address resistance management?

20	And then, finally, the fourth question is,

21	are there elements from EPA's current Bt PIP

22	resistance management program that could be used in

23	conventional pesticide resistance management?

24	So given the broad depth and breadth of

25	these charge questions, we felt it would be better to

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1	create breakout groups within our workgroup to

2	individually address each one of these charge

3	questions. And on the next slide, I'll show how

4	we've done that.

6	roster, and first, I'll just point out that like the

7	emerging pathogens workgroup, we are also a very big

8	group. And it's a terrific group to work with. We

9	have very diverse stakeholder viewpoints represented,

10	including industry pesticide developers. We've got

11	grower groups, independent growers. We've got

12	academia as well as government and regulatory. So

13	for each of our groups, we've identified a organizer

14	to help moderate the discussions, and also in each

15	group, there's also an EPA representative.

16	So what we'll be doing is, for the next

17	part of the presentation, we'll be going through each

18	group. Each group will be presenting what they've

19	been talking about, what their progress has been to

20	date, as well as identifying some of the questions we

21	have and some of the opportunities for input from the

22	larger PPDC group.

23	So for Group 1, we're going to have Bill

24	Chism from EPA is going to give that update. From

25	Group 2, it will be Caydee Savinelli, will give the

5

So on this slide, we've got our workgroup

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1	update there. From Group 3, it will be Amy Asmus.

2	And then it will circle back to me for the Group 4

3	update.

5	shout out to our PPDC program support folks, Shannon

6	Jewell and Carla Theriault. Without their

7	assistance, this workgroup would not have gone very

8	far at all. They've been just absolutely invaluable

9	to helping us make this work.

10	And so with that, I'm going to turn the

11	next part of the presentation over to Bill Chism to

12	go through our workgroup 1 -- or our breakout group 1

13	progress.

14	DR. CHISM: [Audio issue] EPA policies that

15	positively or negatively affect conventional

16	pesticide resistance management?

17	Next slide.

18	And I want to just reiterate what Alan

19	said, these aren't really recommendations at this

20	point. These are just some of the areas of

21	discussion that we've had so far. So we've talked

22	about establishing a federal interagency workgroup on

23	resistance management. There's a lot of federal

24	agencies that have a potential role in resistance

25	management. Regulations clearly can help or hinder

4

Before we dive in, I also want to give a

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1	resistance management. And there's also cross-

2	country movement of weed seeds, insects, pathogens.

3	So there's lots of agencies that interact on this

4	topic.

6	resistance management meeting, and with the

7	recommendations that stakeholders, both public and

8	private, be involved, have a yearly meeting to

9	coordinate and discuss resistance management plans

10	across disciplines, and specifically we've been

11	thinking in terms of insects, plant pathogens and

12	weed so far.

13	Establish a grant program to support

14	community-based programs. There's a lot of research

15	that suggests community-based programs are much more

16	effective. And then think about some sort of

17	reporting incentives, getting people to report early

18	signs of resistance. There's those first key years

19	when we hear about resistance are really important.

20	So see if we could develop incentives for researchers

21	users and suppliers to reward people who report

22	suspected resistance or reveal lack of performance

23	patterns very early on.

24	Also, develop tools and regional centers,

25	through the universities or IPM centers for rapid

5

We've also discussed having a yearly

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1 identification of resistance.

2

Next slide.

3

Educational topics: Consider updating

4	training modules from -- and provide them from OPP on

5	resistance management, provide those training modules

6	to states for applicator training. The Weed Science

7	Society has a series of educational trainings that

8	would be a good framework to consider for starting to

9	provide resistance management training for NRCS

10	staff. Provide mode of action training. OPP should

11	consider having a training requirement for resistance

12	management as part of pesticide licensing. And the

13	training should obviously include retailers and

14	distributors because if they are [audio issue] then

15	they're not able to help when their -- when their

16	part of the role is called.

17	There's conflicting impacts of some of our

18	current policies. We need to consider balancing off-

19	target movement and weed resistance. Off-target

20	movement guidelines, for example, buffers, can have a

21	negative effect on weed management, and the

22	Endangered Species Act may have indirect effects on

23	resistance management. We should consider leveraging

24	the reduced risk status for faster registration of

25	pesticide for resistance management and also create

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1	an incentive to develop tank mixes for resistance

2	management.

5	wanted to point out, we will come back at the end for

6	all these questions, but I wanted to read through our

7	section first, and we will be coming back to these at

8	the end for your input. So did we miss any policies

9	or topics? Do you have any suggestions on incentives

10	to raise awareness and actions to help on resistance

11	management?

12	And with that, I'd like to turn it over to

13	Caydee Savinelli for the second question.

14	MS. SAVINELLI: So thank you, Bill. Can

15	you hear me okay? Good, excellent, thank you.

16	So just as a reminder, I was the organizer

17	for the breakout group 2 and this shows the question

18	that we're dealing with. And we had a number of

19	clarifying questions for the EPA as we went through

20	this. And the other comment I want to make is, as I

21	go through the various slides, you'll start seeing

22	some overlap because each group has kind of worked in

23	isolation. So there's some overlap between a lot of

24	our recommendations. So that's actually a good

25	thing.

3

Next slide.

4

We have a series of questions -- and I just

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1

So in this slide, the few things I wanted

2	to point out is really about industry. What is

3	industry? What's a program? Because I was

4	originally thinking it was just resistance

5	management, but I'll show you that it's actually

6	more. And then also, you know, elaborate on some of

7	the roles that EPA can have.

8	Next slide.

9	So the first area of discussion, you know,

10	when we were first talking about it, industry was

11	viewed as just the registrants, but between our group

12	and some other input from the other groups, when we

13	were having trouble getting into our rooms, we really

14	came up with an extensive list. And you can see

15	there's commodity groups, community-based,

16	government, can't forget government, NOGs,

17	professional societies, such as like the RAC, the

18	resistance action committees, registrants, and

19	retailers. And so this is the list that we've come

20	up with so far. It's a pretty comprehensive list and

21	it definitely goes beyond just to registrants.

22	Next slide, please.

23	And to me, this is probably one of the most

24	important slides I'm going to show you. And the way

25	I view just all of this is really the farmers, the

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1	golf course managers, the mosquito control operators,

2	everybody, they're really talking about managing the

3	pests. I mean, they think of resistance management

4	as part of it, but you're not saying I will use this

5	product because of resistance management. That could

6	be part of it, but they're really trying to control

7	the pests. And what I believe is that the pest

8	management programs will use the same tools as

9	resistance management. How they deploy that may be

10	different, but I think it's something important to

11	remember.

12	And then really the outcome is to manage

13	the pest while minimizing resistance. So that's kind

14	of what farmers and others are looking for. It's

15	just a pest is eliminated or controlled. And that's

16	a good thing.

17	And the other thing that I think that's

18	going to be developed in our group and across our

19	groups, there's really multiple tools. We have

20	tended in all of our groups to really focus on the

21	pesticides, but I think we need to really think about

22	others tools in the toolbox because that will

23	certainly help with resistance management.

24	I just want to give a couple of examples.

25	Certainly, when you think about mechanical control,

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1	so when you're thinking about mosquitos and you have

2	pots with saucers underneath and it collects water,

3	it's probably a good idea to empty that out for the

4	mosquito control. And then a cultural control is

5	really about, there's this fly, it's called Hessian

6	fly, and it attacks wheat, and there's these Hessian-

7	fly-free, wheat-planting dates, in other words, you

8	plant it after the fly is a problem. So there's a

9	lot of other tools that can be used in the toolbox.

10	Next slide, please.

11	And, as I mentioned, though, there will be

12	some overlap. So certainly, education is probably

13	foremost in underpinning a lot of the things that we

14	do and it's not just one group that educates, there's

15	lots of different groups that educate. I think Bill

16	mentioned fast track registrations. Certainly, that

17	would help if there's a new active ingredient that

18	could actually control some of these resistance

19	pests.

20	I think there's some opportunities with EPA

21	to participate in either consortiums that are looking

22	at pest management and resistance management. I'm

23	part of the Insecticide Resistance Action Committee,

24	and we typically annually meet with BE just to talk

25	about what's happening in the insect world and

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1	(inaudible) and I think just kind of get a handle on

2	what's going on. So I think that's important.

4	pesticide safety -- sorry, that was my cat -- the

5	pesticide safety education programs. And, finally, I

6	just said work with the federal governments and

7	agencies. There's probably so many I can't even

8	count on one hand. But, certainly, I think that's

9	another area that could be considered in these

10	recommendations.

11	Next slide.

12	So that was just sort of a highlight of

13	sort of the three key areas, but some of the other

14	things that we've been having some discussions but

15	haven't really necessarily gotten into it very much

16	is what programs are being used. And a lot of times

17	when we talk about programs, they differ by what

18	you're trying to control. So controlling mosquitoes

19	is a lot different than, let's say, controlling

20	weeds. And we always have to keep that in the back

21	of our mind when we're making recommendations.

22	Some of the behavior considerations are

23	important. And we have an economist who also, you

24	know, thinks about social recommendations. So that's
2 5	important.

3

Promoting programs, and then also the

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1	Economic motivation, a lot of times some of

2	what we're recommending is really long term versus

3	short term. And so there's -- you know, there's some

4	tradeoffs there.

5	Risk versus reward, a lot of people are

6	very risk averse. So there's a reward with that. So

7	that's something else we're going to delve into.

8	And, finally, you know, it's all good to

9	have all of these things, but if you can't engage and

10	get commitment from the stakeholders or the people

11	that are using products or growing crops or managing

12	golf courses, et cetera, then all the work that we've

13	done is for naught.

14	And the last -- next slide and this is my

15	last slide.

16	So really these are the questions to the

17	PPDC, and as Bill mentioned, we're going to be taking

18	questions at the end of the session, but I wanted to

19	put these out to everybody just to see them. So with

20	regards to industry types, have we missed any as we

21	go through this extensive list? With regards to

22	programs, are there other areas regarding EPA's role

23	in pest management?

24	And then also, you know, some other

25	considerations, as I mentioned, social behavior, that

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1 type of thing.

2

So that is all that I have and I would like

3 to turn it over to Amy Asmus.

4

MS. ASMUS: Hello. Hopefully, you can hear

5 me. I was having some voice issues earlier.

6

Breakout group number 3, we had a very,

7	very broad ask. So we've taken our question and kind

8	of broken it down into two different questions, and

9	one is to consider incentives for registrants or

10	pesticide users that could be considered related to

11	conventional pesticide regulation that might

12	positively affect resistance management. The second

13	half is, are there other ways in which the agency, in

14	this case EPA, can work with their stakeholders to

15	cooperatively address resistance management?

16	Like the others, I'd like to say we're just

17	in the exploratory stage of our task and our comments

18	today are a brainstorming session. They are not

19	weighted comments at this time to pros, cons, and

20	their ability to be implemented. Right now, it's

21	just a thought process.

22	So if you go to the next stage, I'd kind of

23	like you -- to walk you through the thought process

24	that our group took as we addressed these questions.

25	So next slide, please.

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1

So the first thing we looked at is the

2	target audience for our incentive. The charge

3	question asked us to look at registrants or pesticide

4	users. We will eventually look at both, but for this

5	time being, we have focused less on the registrants

6	for incentives and more on the end pesticide users,

7	which would include retailers, consultants,

8	applicators, producers, landowners, municipalities.

9	And we also want to look at -- I live in a world of

10	annual row crops. We also need to make sure that

11	we're looking at some of the perennial crops and

12	maybe some of the pesticides used to control pests in

13	municipalities, tribals, and other areas and try not

14	to get just focused on the annual row crops.

15	So one thing I would like to point out as

16	we look at the users is the bullet point that says

17	some users may need additional incentives to overcome

18	the hurdles to implementation of those practices.

19	And how do we segment the users to address those

20	hurdles? Because not all incentives will apply to

21	all end-users and so it's going to be really

22	important for us to segment those users. And how do

23	we structure those incentives not to penalize the

24	good actors while encouraging the bad actors in this

25	space?

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2

1

Next slide, please.

So we tried to identify some of the hurdles

3	to adoption. We took some of these from the

4	expertise of my group, and I have a really great

5	group that brings a lot of different perspectives.

6	We also took some of this from listing sessions that

7	the Weed Science Society had held across the U.S. So

8	some of the hurdles that we identified, our growers

9	may not implement best management practices until

10	resistance is in their area or field.

11	There are economic thresholds that cost --

12	the added cost of resistance management best

13	management practices may be a hurdle to some growers

14	to implementing that. There's issues affecting

15	efficacy of the products. And so one of the things

16	we want to make sure we don't jump to is not every

17	time a weed doesn't die, can we contribute that to

18	resistance? We have to look at some of the other

19	issues with the efficacy and how do we address those

20	as well?

21	There's social factors, what's acceptable

22	if I'm spraying next to a school, I really want to

23	time that out while there's no children in the

24	school, which may then affect the efficacy of that

25	application, may apply a reduced rate because maybe

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1	the plant is not growing or the pest is not present

2	or active at that time when the spraying is socially

3	acceptable, and that can have effects on resistance.

4	We also have conflicting messages from

5	trusted advisors. Trusted advisors may include

6	people like landlords or the banker that controls

7	your operating loan, and that gets us back to the

8	economic issues. So there may be priorities of some

9	of your trusted advisor partners that have

10	conflicting messages.

11	And also we looked at if we use label

12	language exclusively, that does not reach all

13	audiences and really doesn't touch on the integrated

14	pest management aspect of resistance management.

15	Next slide, please.

16	So we tried to figure out what we needed to

17	address some of these hurdles. Education has been

18	talked about in every group so far. So that's a

19	biggie. Incentives to address the hurdles to

20	adoption, so we need to look at each of those hurdles

21	and see if there are incentives and then to take it a

22	step further and see if EPA has control over those

23	incentives or we need to move to some of their

24	stakeholders, to provide those incentives.

25	And that leads to the next one, which is

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1	the realization that the EPA can't do this alone.

2	Integrated pest management, including nonchemical

3	practices, must be included in education and

4	resistance management plans. And a community of

5	stakeholders would more completely influence all

6	pesticide users.

7	So this will take us to the next slide,

8	please, which is, are there ways or are there

9	incentives that the EPA can do, or work with their

10	stakeholders to do, to cooperatively address

11	resistance. So we looked at -- a lot of you have

12	heard the terminology carrots, which is an incentive;

13	sticks, which is some of our sticks are very big

14	hammers and we don't want to go there, or are we

15	throwing carrot sticks, which would be incentives

16	that are backed by regulations.

17	So again, education is one of our big

18	things. It would be a carrot definitely to

19	incentivize more knowledge and better implementation

20	of best management practices. We can look at what

21	are the long-term economic benefits of good pest

22	control. So there may be some short-term economic

23	difficulties, but education around the long-term

24	benefits of resistance management. How do we reach

25	that decision-maker? How do we include those people

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1	that are private or commercial applicators and the

2	trainings that they are required to take? Can we

3	include resistance management?

4	And then how do we link education with

5	information gathering as well? If we educate these

6	growers as to what to look for, retailers,

7	applicators how do we get some feedback on their in-

8	field practices? And we can use that to fuel further

9	education.

10	Again, we talked about a points program for

11	participation in those practices. That's kind of a

12	carrot stick, this is what we'd like you to do.

13	We'll incentivize you to do them. USDA has some

14	models for that we'll be looking at. We can

15	incentivize stakeholder community involvement. How

16	do we get communities to come together around

17	resistance management and address it in their

18	cropping systems and their local environmental and

19	social aspects around resistance management?

20	What are the role of industry marketing

21	programs? We're looking at how do you make it a

22	mandatory enforceable part of the label. This is a

23	big stick. Our group would favor more incentives

24	than support heavy regulation, but it's on this list

25	to consider. Pest commissioners to control

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1	uncontrolled pests. Again, that's a very big stick

2	at the state and local level. And mandatory

3	reporting and mapping of target resistance issues.

4	We'd like this accessible to all stakeholders who are

5	involved in creating resistance management plans and

6	carrying those plans out, but we do have a lot of

7	conversation to have around suspected resistance

8	versus proven resistance.

9	Next slide, please.

10	So these are some of our questions that we

11	can talk about at the end. It's our conclusion that

12	registrants have internal incentives to steward their

13	products for resistance management and should not

14	need external incentives. That's a question.

15	Have we identified the hurdles to adoption

16	of resistance management? Are there other categories

17	that we need to address in resistance management? In

18	our discussions of carrots/sticks and carrot sticks,

19	are there are other types of incentives we should

20	explore that we haven't yet? And do you have any

21	other considerations you'd like us to look at as we

22	move forward with our charge?

23	Thank you. I will turn it back to Alan for
2 4	Group 4.

2 5	MR. REYNOLDS: Thanks, Amy.

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1

So for breakout group 4, we were tasked

2	with looking at EPA's current Bt PIP resistance

3	management program and determining whether there are

4	any elements from that program that could be used for

5	a conventional pesticide resistance management

6	strategy.

7	So the first thing we did is we really

8	drilled into the core elements of the current PIP

9	resistance management strategy. And so that really

10	consists of, you know, different mitigation

11	strategies for PIPs. So it's primarily been the use

12	of non-PIPs refuges, IPM stewardship, best management

13	practices, acreage limitations in some cases. There

14	have also been crop destruct measures for -- in other

15	scenarios.

16	Also, our resistance monitoring and

17	scouting is a very important part of the PIP

18	strategy. And then the remedial action plan, if we

19	actually do find a resistance developing to PIPs.

20	Grower education, another critical aspect of the

21	resistance management strategy. And then the

22	respective roles and responsibilities of the

23	registrants and EPA as far as overseeing the

24	resistance management program.

25	So so far in our group discussions, we

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1	really have drilled down primarily into the

2	mitigation and the resistance monitoring aspects.

3	We've had some discussions on remedial action, grower

4	education, but those have been relatively preliminary

5	and we're going to be following those up with that

6	more detailed discussion in the next months.

7	Okay. So what have we talked about so far?

8	So in terms of mitigation, the first thing we really

9	looked at were some of the PIP-specific mitigation

10	measures, particularly refuges or acreage

11	limitations. Crop destruct-type scenarios are really

12	not going to be adaptable to most conventional

13	pesticides. So instead, we've really focused on the

14	IPM stewardship aspect and is that something that we

15	could really work on and develop for conventional

16	pesticides.

17	So that's led to some general questions and

18	the challenges that we've identified. So first, in

19	terms of an overall goal, should we be looking at IPM

20	stewardship as a measure to be taken proactively to

21	prevent resistance, or is this something that we

22	should really be focusing on when we see cases of

23	resistance in the field to deal with those cases in a

24	more reactive manner.

25	There are some challenges. So who would be

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1	responsible for implementing a a stewardship program?

2	You know, as we've -- as some of the other groups

3	have talked about, you know, the EPA has authority

4	over the product registrations and the product label.

5	But as far as the registrant goes, you know, there

6	may not be a direct link from the registrant right to

7	the user of that product given the distribution

8	network can be quite complicated. That's a little

9	different than the scenario we have in PIPs where

10	there's an actual contractual relationship between

11	the registrant and that grower, which can be

12	leveraged to implement resistance management.

13	Another challenge, you know, we've been --

14	particularly for PIPs, one of the things we've been

15	criticized is that the resistance management strategy

16	is more or less a "one size fits all" approach,

17	particularly at the federal level, and has really not

18	been able to account for regional differences or

19	regional distinctions as far as (inaudible)

20	resistance. And so thinking about how we would look

21	at conventional pesticides, is that something that we

22	could look at? Can we make a program flexible enough

23	that we can respond on a more regional or local

24	level?

25	So also in terms of mitigation, we've been

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1	talking about the role of product labeling and

2	particularly the role of growers, so where do growers

3	get their information and how do they make decisions?

4	So, you know, can a product label actually influence

5	a grower's behavior. And how would we modify that

6	label to accomplish those goals?

7	You know, how do growers play into this?

8	Where are they getting their information? You know,

9	where are they -- what would be impactful ways to

10	interact with growers? We talked about grower

11	meetings that can be conducted by registrants or the

12	role of extension personnel. And, of course, social

13	media in this day and age has a critical role in

14	reaching users. So all of those aspects could play

15	into how we use stewardship and how we implement a

16	stewardship type program.

17	This leads to the question, you know, how

18	can we make pesticide users into good stewards,

19	particularly when most growers already consider

20	themselves good stewards? So, you know, convincing

21	folks to actually implement sound resistance

22	management strategies in addition to measures they

23	may already be taking.

24	One of the interesting things we've talked

25	about is a certification type program to incentivize

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1	stewardship. There are examples of that that we

2	talked about. One is a water quality program that

3	was developed in Illinois, the STAR program, that

4	awards points for growers who adopt certain measures

5	to deal with nutrient and soil loss. And they could

6	get those points and work towards a certification.

7	So we thought about, is there something similar that

8	we think about for resistance management? You know,

9	users who are adopting good practices, can they be --

10	essentially get points for -- to show that they've

11	employed these good practices?

12	Pivoting to resistance monitoring and

13	scouting, so for the PIPs, EPA has historically

14	employed two strategies. The first is a more

15	proactive measure in which the registrants will go

16	out and actively sample for -- sample target pests

17	and then conduct bioassays in high selection pressure

18	areas, trying to more actively look for shifts in

19	susceptibility before you would see field level

20	effects.

21	The second component has been to

22	investigate cases where we have had field damage in

23	PIP fields where you would have the unexpected pest

24	pressure or pest damage, and conducting

25	investigations to see if those are actually resistant

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1	insects. That, of course, is more of a reactive

2	approach. So our group has been deliberating, you

3	know, which of those approaches would make sense for

4	conventional pesticides.

6	challenges when we think about resistance monitoring,

7	the first being, you know, who's responsible for

8	doing it. On the PIP side, there's an industry

9	group, ABSTC, that essentially conducts some of the

10	resistance monitoring activities. So they have been

11	able to essentially pool resources between different

12	registrants, so they conduct one monitoring effort.

13	But would that really be feasible for other types of

14	pesticides, particularly when you have a lot of

15	different companies registering similar chemistries?

16	The question of resources is a huge one.

17	You know, resistance monitoring is -- it is resource

18	heavy, so who would be doing the work, who would be

19	managing the populations that are collected, doing

20	the testing, those types of activities? And, of

21	course, there's a huge financial investment there.

22	So who's paying for that?

23	In terms of damage investigations, can they

24	be standardized or would each company kind of be on

25	their own to conduct their own type of investigation

5

Of course, there are questions and

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1	and then their own follow-up based on that? So

2	there's a lot of questions that need to be answered

3	there.

4	So our discussions have led to a number of

5	overarching questions, and these -- so a lot of these

6	questions have cut across our breakout groups. So we

7	do have some common themes here. So a first basic

8	question we've been asking is, should we be

9	conducting resistant management for all different

10	types of pesticide chemistries? For the Bt PIPs, it

11	was the PPDC back in the 1990s that actually

12	established a public grid criteria for Bt, and that

13	was due to the lack of human and environmental risks

14	and, you know, the very favorable safety profile of

15	Bt being in the public interest and public good and,

16	you know, the need to maintain that. You know, is

17	that true for all chemistries, though?

18	Of course, our breakout group, and I think

19	some of the other breakout groups, have been largely

20	ag-centric in our discussions, but that leaves out

21	other pesticides and other pesticide type uses,

22	things like vector management or, you know,

23	structural pesticides, residential use pesticides.

24	You know, should they be considered?

25	The question of voluntary versus mandatory,

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1	you know, should the program be voluntary? That

2	might be easier to implement, but what kind of

3	adherence would we get to that? You know, that might

4	depend on a number of socioeconomic factors.

5	If the program is mandatory, who's going to

6	enforce it? You know, it could be EPA via pesticide

7	labeling. You know, we've talked about that. But

8	certainly overly complicated or complex labels could

9	be a burden for the user and could lessen the

10	likelihood that they'll actually comply with those

11	measures.

12	And then the question as to what role EPA

13	should have and what level of oversight. With the

14	PIPs, we've had a very prescriptive program in place,

15	so they're at a very high level of oversight. But

16	should that be the case for -- you know, for other

17	types of pesticides.

18	Okay. So those are our breakout questions.

19	And so at this point, I'm going to just give a very

20	quick update on what we conceive to be our next steps

21	in the process here before we pivot to the overall

22	question and answer and discussion period. So as far

23	as our next steps, after this meeting today, we'll

24	reconvene our full workgroup. That will be next

25	week.

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1	We'll be asking ourselves based on the

2	input we get today, do we need to make any course

3	corrections, you know, in terms of the general

4	direction of our discussions? Is there anything else

5	we need to consider, any other topics? Should we

6	tweak the charge questions in any way to, you know,

7	to better focus our discussions?

8	We, of course, are planning to continue our

9	breakout group discussions. You know, we'll be

10	ongoing with those and then the strategy or the plan

11	is going to be to make recommendations to the full

12	group in the September time frame with the goal of

13	creating a final workgroup report and full

14	recommendations to the PPDC at the October meeting.

15	Okay. And so with that, I think we can

16	pivot to the Q&A/discussion portion of the hour here.

17	And I'm going to turn to our session moderator, Paul,

18	as to how he would like to have this work. So I've

19	got the breakout group questions up here and I don't

20	know if you want to just go through them one by one

21	or just open it up for a larger discussion.

22	MR. ANNINOS: Thank you very much, Alan.

23	Thanks to this whole team. Really well done

24	presentation. And I really liked that as you moved

25	through these breakout groups, you had very specific

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1	requests to the PPDC, we need your feedback, we need

2	your input on these very specific topics. And,

3	again, it's a lot to absorb in a 30-minute

4	presentation. We do have a fair amount of time now

5	to just get into conversations.

6	I'm assuming that this slide and the next

7	one are the -- there must be a breakout group 3 and

8	4, also. For those of you -- I think we have a link

9	in the chat that takes you to all the presentations

10	for yesterday and today. If you go open that link

11	and then select the pesticide resistance management

12	presentation, you can, yourself, go through and have

13	those questions in front of you. But we -- I'm going

14	to suggest that we open it up. If someone has a

15	response -- there we go, Sarah just posted. Sorry,

16	Shannon -- Shannon and Sarah just both posted the

17	links in the chat if you wanted to have those kind of

18	front and center for you.

19	I'm going to suggest we kind of open it up

20	broadly. If someone has an insight or a comment or a

21	question that pertains to a specific breakout group,

22	they can say that. But I think we should open it up

23	broadly for any kind of comments, insights,

24	questions, clarifying questions for your team. A

25	really fantastic job. So let's pause and we will

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1 wait to hear from folks.

2

And Damon Reabe has a comment. So, Damon,

3 go ahead and unmute yourself and join us.

4

MR. REABE: Hey, thank you, Paul. I really

5	appreciate this presentation, a lot of great

6	information. On behalf of the National Aerial

7	Applicators Association, I'm formally requesting that

8	that -- the aerial applicators in the United States

9	are very much okay with more complex label language

10	for the purposes of better risk assessments. You

11	know, right now, the -- and the EPA has worked very

12	closely with the National Ag Aviation Association,

13	but -- and continues to do so, but we welcome the

14	idea of more prescriptive label language as it

15	regards to aerial applications so that risk

16	assessment that is based on worst case scenario is

17	based upon best management practice. And I think

18	what that will do is better risk assessment outcomes.

19	And then the additional benefit to that

20	will be reducing the size of buffer zones, which in-

21	field buffer zones are, in fact, the place where the

22	resistance is born. And we can work towards making

23	these wind-directional. Currently, buffer zones

24	typically, on most pesticide labels, are not wind-

25	directional. So we're leaving a buffer in a place

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1	where the pesticide can't drift to on the up-wind

2	side. And then on the downwind side, we're getting

3	partial rate applications performed there, which

4	accelerates the resistance to pesticides. And we

5	don't have the ability after the wind has switched to

6	go back and re-treat that area to prevent that

7	resistance development.

8	The other final thing I'd like to mention

9	is our state regulatory officials -- Liza's here and

10	she can comment on this -- right now, a lot of state

11	enforcement policy is when there is a drift

12	allegation, the investigation is based on foliar

13	resident testing as far as what the offsite drift was

14	and that is driven primarily by the science -- the

15	science of being able to find the product itself and

16	is not weighted in any way as to what that amount --

17	if that amount of product is, in fact, actually

18	harmful.

19	So I think the EPA could work really

20	closely with state lead agencies on sharing what

21	actually is an amount of offsite deposition that, in

22	fact, is in no way harmful. And so that would then

23	allow applicators to, again, get more of that field

24	actually treated at the intended use rate.

25	Thank you for all the hard work on this

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1	subject.

2

MR. REYNOLDS: Thank you very much. Great

3	comments to consider. Absolutely. And something we

4	should -- you know, as we think about pesticide

5	labels, you know, over a huge range of products,

6	different types of chemistries, there's a lot to

7	think about there. So very good -- great insights.

8	Thanks a lot.

9	MR. REABE: I mean, it's a call out to the

10	registrants as well because obviously the EPA is

11	doing risk assessments based upon what the

12	registrants submit. So, you know, I'm addressing the

13	EPA, but, of course, obviously our registrant

14	community as well.

15	MR. ANNINOS: Thank you very much, Damon.

16	Very, very thoughtful comments. I'm sure the

17	workgroup appreciates that.

18	We have a line forming for you all. This

19	is great. So we're going to hear from the four

20	people in line right now. You can kind of follow

21	along with me in chat window. First, we'll hear from

22	John Wise and then Cathy Tortorici and then there's
2 3	two more beyond that.

24	So, John, you're up.

25	MR. WISE: Okay, thank you. I have just a

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1	short suggestion in relation to Caydee's presentation

2	of the breakout group. And her question was, are

3	there other industry types that should be considered?

4	And I thought about food processors of, at a minimum,

5	of fruits and vegetables that are becoming more

6	prescriptive to growers on what their past management

7	programs should be and what MRLs they accept for

8	their products as they're being sold around the

9	globe. And I think about Nestle Gerber and other

10	packers, processors.

11	So it's just a thought to be considered

12	that's an industry type. That's all I had.

13	MR. ANNINOS: Great. Thank you, John.

14	Thanks very much.

15	MR. SAVINELLI: I just wanted to thank

16	John. It was good to see you. Thanks.

17	MR. ANNINOS: All right. Thank you,

18	Caydee. So Cathy Tortorici from NOAA Office of

19	Protected Resources at Fisheries.

20	MS. TORTORICI: I just — thank you. I

21	just have a quick question. Early on in the

22	presentations, you made mention of the ESA having

23	some kind of an indirect influence or effect on what

24	you all were doing or thinking about. I'm not

25	phrasing this correctly. I should have written down

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1	the bullet. But I think you know what I'm referring

2	to and I'm hoping you can go into a little bit more

3	detail on what you were thinking of when you said

4	that. Thanks.

6	Chism. One example might be because of endangered

7	species, we have a larger buffer area between the

8	treated area. So an area in which pesticides cannot

9	be applied, so that potentially leaves a large area

10	for pests to accumulate in and potentially

11	accumulate, survive and thrive in. So is that

12	helpful?

13	MS. TORTORICI: That is helpful and maybe

14	we should talk more about those sort of items that

15	you might be thinking of indirect effects because

16	that would be interesting to have that conversation

17	with you all, because we would -- I think that's

18	important. If you have concerns along those lines,

19	we should know that. Thank you.

2 0	MR. ANNINOS: Very good. Thank you very

21	much, Cathy.

22	Thanks, Bill, for your response as well.

23	We're going to move now to Liza, Liza

24	Trossbach, and then followed by Mark Johnson.

25	Liza, go ahead.

5

DR. CHISM: Yeah, thank you. This is Bill

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1

MS. FLEESON TROSSBACH: Thank you very

2	much. Again, another great presentation as all of

3	them have been over the last two days. A lot of

4	great information and discussion. I just wanted to

5	kind of mention from a pesticide regulatory

6	official's standpoint -- and we certainly believe

7	that an educated community is a compliant community.

8	And so we're always very happy to participate in

9	training. We absolutely believe in training. I

10	would just caution or just bring up that there have

11	been -- there seems to be a move towards requiring

12	additional training for the use of certain products

13	and we've seen that as pesticide regulatory officials

14	and end-users and registrants.

15	And while -- again, while we appreciate

16	training, you know, all states have a pesticide

17	certification program that determines the minimum

18	competencies of applicators. They go through annual

19	training. They are certified or recertified. And to

20	add additional training for specific product uses or

21	to put something on top of that can be burdensome.

22	And, again, I do think it's important, but I also

23	think that, you know, all of us, as pesticide

24	regulatory officials and end-users, the pesticide

25	application begins with the label. And there's been

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1	mentioned about labels being complicated, and they

2	are, but pesticides are complicated.

3	And just because a pesticide provides a lot

4	of information doesn't mean it can't be -- you know,

5	that the language can't be clear and we can make it

6	clear how it needs to be applied. And I think if

7	there are use requirements or use directions that can

8	help facilitate a reduction in resistance or can

9	further resistance management, then they should be on

10	the label.

11	The label is the law. We preach it all the

12	time. The EPA preaches it all the time. That's

13	where users go to when they're making their product

14	selections. And so I would really encourage, to the

15	extent possible, in addition to continuing to educate

16	and perhaps be able to incentivize users, is really

17	that those requirements -- I mean, they should be

18	requirements and I think that they should be on the

19	pesticides label.

20	And just real quick to Damon's comments

21	about, you know, enforcing the proper use and drift.

22	Damon is correct. You know, I would say, in general

23	-- I mean, there may be some limited exceptions --

24	but, in general, in drift cases, pesticide regulatory

25	officials are looking for absence or presence of a

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1	pesticide residue. There are no harm standards.

2	It's been discussed over the years. There's been a

3	lot of conversations about that, but currently it is

4	presence or absence.

5	So thank you very much.

6	MR. ANNINOS: Thank you, Liza. Thanks. I

7	don't know if the workgroup wanted to respond to any

8	of that, but that's really good feedback and input

9	for the team.

10	MR. REYNOLDS: Yeah, I would just say

11	thanks for those comments. They're very helpful. I

12	really appreciate it. Good points.

13	MR. ANNINOS: Thank you, thank you.

14	Mark Johnson is up and then followed by

15	Nina Wilson.

16	MR. M. JOHNSON: Yeah, I want to say great

17	work. I think the work of the policies is pretty

18	comprehensive. Thank you. And as the other breakout

19	groups were, too.

20	I'd like to make a couple of points, you

21	know, and as far as in light as a professional

22	industry, in applications, the label is the law. We

23	fully support that. Before things boil down to the

24	label, though, I want to address a couple of things.

25	You know, we rely upon the resistance action

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1	committees for both herbicides, insecticides, and the

2	information that comes out of that with the

3	researchers that are involved there as, you know, the

4	researchers provide a lot of education to the

5	extension agencies and to -- especially through the

6	state level, and turf grass programs in golf

7	specifically are continuing professional education

8	and professional applicator points. Right?

9	So the education venues exist. What's

10	missing perhaps is a lot of research that's necessary

11	in specific crops, and there are a few in the turf

12	grass industry that are doing research related to

13	weeds, insects, et cetera, and then the whole

14	fungicide aspect. You know, in industry, we do

15	provide best management practices for pesticide

16	selection. We're strong in IPM. We're strong in

17	providing that education on IPM and setting that

18	stage. And, also, pesticide selection is stepping up

19	some in resistance management.

20	It's important that these university

21	programs are supported. So if you want to think

22	about incentives, we might be able to incentivize

23	golf course superintendents through our association,

24	but what's probably going to be more important is

25	making sure that the resistance management topics are

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1	adequate and presented at the education, that not

2	only our members take, but everyone in the turf grass

3	professional aspect, right?

4	And so I would encourage you, as you think

5	about those incentives, think about the existing

6	venues to educate professionals applying pesticides,

7	herbicides and fungicides, right, in the outdoor

8	landscape setting, you may be better suited to ensure

9	that resistance is addressed in those education

10	venues with incentives. I'm not saying no to

11	incentives. We'd certainly take a look at how we

12	could participate with that as an organization and

13	would encourage you to do that.

14	I will post a link to everyone for where

15	our BNPs are located. They do the conversations on

16	buffer strips and, you know, pollinators alone and

17	making that selection. This is a very deep important

18	project not only to water quality, habitat, wildlife,

19	it's across the board and it's the future of ensuring

20	sustainable businesses.

21	So we want to make sure when we make policy

22	recommendations to be represented in the label that

23	you do address everyone and the application of those

24	pesticides in, like, turf and the approaches as you

25	do so well now. And, second, you know, the regional

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1	aspect that was brought up is critical. It's going

2	to be critical for the growing season, the species

3	that are available, right? If you build it, they

4	will come, right? And you know what I mean by they

5	will come, the disease, the insects, and they're

6	going to be pertinent to those regions, warm season

7	versus cool season to be very specific to you.

8	And across the 50 states and what we deal

9	with with the 50 states, we do want to adhere to the

10	label. It is the law. It's what we train. It's

11	what we preach. We need the resources in order to

12	ensure that we minimize resistance out there. And

13	the stage is set to do that, we just need to be able

14	to do it effectively while not closing the door when

15	there's no alternative products.

16	So thank you for the time and for the

17	comments. Congratulations on great work. Keep

18	ramping it up and we're here to support you. Thank

19	you.

2 0	MR. ANNINOS: Thanks very much, Mark. I

21	think those are also very, very helpful comments for

22	the workgroup going forward. So thank you.

23	Also, so Nina is up, Nina Wilson, followed

24	by Charlotte Sanson.

25	So, Nina, you're up, if you can unmute

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1	yourself.

2

MS. WILSON: Hi. Hey, Alan, how are you?

3	Thanks very much for those presentations. They were

4	great.

6	missed it. I was trying to listen for it, but what

7	interaction have you had with the HRAC, IRAC, you

8	know, the FAC, these people -- you know, the

9	resistance management groups that have been

10	categorizing the families and that I think we're

11	using on our labels? Because they've been thinking

12	about this for a long time. And I think as well as

13	if we're going to be using them to annotate or

14	identify different products and families, that we

15	just make sure we use the same language whenever

16	we're talking about our labeling and whether or not

17	we're talking about any education.

18	Because I know, like, when gallon -- when

19	we try to do resistance management, we tend to -- we

20	try to use the same language because it gets very

21	confusing when people start branching out. So I

22	didn't know whether or not they're a part of it or

23	that we had reached out to them or incorporated them

24	in any thinking about the training.

25	DR. CHISM: Alan, shall I take this?

5

I wanted to make one -- and I may have

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1

MR. REYNOLDS: I was going to suggest just

2 that, Bill. Thanks.

3

DR. CHISM: Okay. Nina, that's an

4	excellent point. In my workgroup, we have -- I

5	believe he's the chair of a HRAC and, in general we

6	meet with the different RACs -- well, in the past

7	before the pandemic, we used to meet with RACs about

8	once a year, the HRAC and IRAC, and then we would

9	have conversations with FRAC. So we do meet with

10	them on a regular basis and they are represented here

11	in our meeting, in our workgroup.

12	MS. WILSON: Great, thank you.

13	MR. ANNINOS: Excellent, Nina.

14	Thank you very much for your comments,

15	Bill. Thanks for your response.

16	Charlotte Sanson is up.

17	And, Charlotte, you might be on mute or

18	unmuting yourself at the moment.

19	MS. SANSON: Well, maybe it's better if I

20	take my headset off, that might be the problem.

21	MR. ANNINOS: Oh, there you go. You're

22	loud and clear right now.

23	MS. SANSON: Yeah. Sorry about that. So,

24	yeah, there is so much information packed into here.

25	It's a very complex topic. I see there are questions

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1	directed to registrants, which are good questions.

2	And I think it probably would be helpful for us

3	registrants to take this offline. On the spot, it's

4	a little challenging to provide some direct feedback.

5	I see there are some registrants obviously in the

6	breakout groups. So it's just a comment. We'll get

7	back. Thank you.

8	MR. REYNOLDS: Thanks, Charlotte.

9	MR. ANNINOS: Thanks, Charlotte.

10	MR. REYNOLDS: Yeah, and I would just say

11	to -- you know, to anybody, please feel free to, you

12	know, after this meeting to email us any additional

13	suggestions or input that you might have or

14	questions. Certainly, you can direct those to

15	Shannon Jewell or myself or my co-chairs. And we'd

16	certainly be happy to entertain further discussion.

17	MR. ANNINOS: Thanks, Alan. I think that

18	goes for all the workgroups. Obviously, this two-day

19	meeting is like an event in time, but time is going

20	to move on past today and I know these workgroups

21	have a lot of work to do between now and October. So

22	your feedback to them, one on one, one on multiple,

23	however you want to provide it, I know they're

24	anxious to get it. So thanks.

25	We have a few minutes left in this segment

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1	if -- let me just pause for a moment just to see if

2	anybody else from PPDC, the other workgroup members,

3	anybody that's participating that wants to pose a

4	question, make a comment, et cetera. So let's just

5	see.

6	You had a lot of engagement on this -- so

7	oh, did someone say something? I'm sorry. I might

8	have cut someone off. Maybe not.

9	So we've had a lot of engagement on the

10	topic, so you got some really good feedback here

11	real-time. And not surprising, you had a really good

12	set of trigger questions that you were, like, really

13	anxious to hear feedback on. So I think you got some

14	of that today.

15	And any other -- again, any other last-

16	minute comments or even members, the co-chairs, our

17	presenters today, you know, Alan, Bill, David, Amy,

18	Caydee, any last or final words you'd like to --

19	MR. BURKETT: Yeah. Hi. Can you hear me?

20	For some reason, my chat doesn't seem to be working.

21	MR. ANNINOS: Oh, okay, yeah.

22	MR. BURKETT: This is Doug Burkett from the

23	Department of Defense. And I have a question for the

24	various working groups. I did see in the membership

25	list that you do have some members that are involved

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1	in public health, insecticides and resistance, I

2	think Janet McAllister there from the CDC and maybe

3	some others.

5	terms of -- and maybe this is way outside the scope

6	of this particular group, but, you know, periodically

7	in Defense, we're always kind of asking whether or

8	not there's a standardized or a preferred list of

9	places you can go to for the best methods for using

10	insecticide resistance testing, as an example,

11	whether it's molecular testing for KDR or whether

12	it's bioassays or for various forms of resistance, if

13	there's any kind of standards or [audio issue] that

14	outline the preferred bioassay methods for

15	determining resistance for various pests that are out

16	there, particularly in the public health career field

17	but others as well.

18	MS. SAVINELLI: I'd like to answer the

19	question. It's okay, Paul. So this is Caydee

20	Savinelli and I'm -- you know, I represent -- I work

21	for Syngenta. They pay my salary, but I also

22	represent the Insecticide Resistance Action

23	Committee. And you can go into the Insecticide

24	Resistance Action Committee and find standards for

25	testing. And we definitely recommend it because it's

4

But I have a question for the group in

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1	a lot easier to compare across studies. And this is

2	publicly available. You don't have to be a member of

3	IRAC. And I can talk to Janet McAllister because

4	she's on the subgroup to just make sure that she has

5	the right information.

6	MR. ANNINOS: Thank you, Caydee. That's

7	helpful. And also Dan Markowski has chimed in to say

8	he might be able to comment on this as well.

9	MR. MARKOWSKI: Yes, this is Dan Markowski.

10	I'm with VDCI. I've worked with Janet quite a bit.

11	And probably the easiest and most standard tool for

12	testing in the public health field, mosquitoes in

13	general, is the CDC bottle bioassay. It's a fairly

14	simple tool. They actually have free kits that they

15	send out to most of the mosquito control districts,

16	if requested, and have standardized the testing of

17	mosquitoes for resistance. So that's probably the

18	most standard and simple.

19	There are other assays you can do.

20	Certainly, if anyone wants to contact her she'll tell

21	you all about that. But the CDC bottle bioassay is a

22	pretty standard and simple tool to use. Thank you.

23	MR. ANNINOS: There you go, Doug, you ask a

24	question and you get two really great responses right

25	on the spot.

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1	MR. BURKETT: Awesome. The PPDC is

2	working, yeah. Thank you very much. That was pretty

3	useful. So the Insecticide Resistance Action Committee,
their

4	website you say has some recommended insect

5	resistance or pesticide resistance testing protocols

6	there. I'll have to check that out. So thank you so

7	much for your feedback. Appreciate it.

8	MR. ANNINOS: Well, thank you for your

9	question, Doug.

10	And Dan and Caydee, thanks for providing

11	some help to Doug right here in the midst of things.

12	So that's great.

13	We're about out of time and, again, I've

14	just got to -- I got to thank, you know, Alan, Bill,

15	David, Amy, and Caydee for your presentations today.

16	Really well done. I hope you got some good feedback

17	that you can put to action over the next few weeks

18	and months. And, again, that's an open-ended --

19	that's an open-ended ask, right, for all the

20	workgroups. So thank you all very much.

21	Any final words by any of you?

22	MR. REYNOLDS: I'd just like to thank the

23	PPDC group. We really appreciate your feedback and

24	input today. It's invaluable for us and we look

25	forward to working with you over the next few months.

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1

MR. CHISM: Yes, thank you very

2 much.

3

MR. ANNINOS: Thanks. Thanks, everybody.

4	And so with that, what we can do is we can move to

5	the next segment of the agenda. And so yesterday we

6	had the first of four segments, what we're calling

7	the PPDC member presentations on stakeholder

8	interests. So now we're on the second of the four,

9	information and perspectives on the crop protection

10	industry, and Charlotte Sanson and Mano Basu are our

11	co-presenters here today.

12	And so we'll go ahead -- I think this is a

13	15 or 20-minute segment. Actually, my notes are a

14	little bit fuzzy on that. We have until 1:20 Eastern

15	time for this segment. Is that right, Shannon?

16	MS. JEWELL: That's right. Yep.

17	MR. ANNINOS: Okay, very good. Very good.

18	So let me turn it over -- I think Mano is getting the

19	presenter role, so maybe that is happening as we

20	speak. And whoever's going to take it away, go

21	ahead.

22

23

24

25

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1	PPDC MEMBER PRESENTATION ON STAKEHOLDER INTERESTS

2	INFORMATION AND PERSPECTIVE ON THE CROP PROTECTION

3	INDUSTRY

4	MR. BASU: Thank you very much, Paul.

5	Yeah, I have the presenter role now. Shannon --

6	sorry, Charlotte was going to start on this

7	presentation. So, Charlotte, please say next and I

8	will move the slides.

9	MS. SANSON: Okay, sounds good. Thanks,

10	Mano.

11	And thank you for the opportunity for this

12	presentation.

13	So, okay, next.

14	I'm going to share a brief overview of the

15	product development process for a conventional active

16	ingredient and describe the underlying robust process

17	that ensures the associated scientific integrity.

18	And then Mano will share the strategic priorities of

19	our trade association, CropLife America.

20	Okay, next slide.

21	So this slide of -- I could speak to this

22	slide all day, but I'll try and condense it here.

23	This is a high level illustration of the typical

24	timeline and investment relative to a registrant's

25	path to obtain registration of a new conventional

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1	active ingredient, be it a fungicide, a herbicides,

2	insecticide or plant growth regulator. A company

3	will initially screen thousands of potential

4	compounds at the discovery phase before selecting the

5	one that has the best market potential and chance of

6	success going through the regulatory development

7	process.

8	So it all starts with biological screening

9	in the lab, in the field, while toxicology screening

10	is done and a business case is developed. And as you

11	can see, there are several processes that can occur

12	in parallel. When things are looking favorable, by

13	the end of year three and upon approval of the

14	business case by company management, the required

15	regulatory studies are initiated. Some cases are

16	already started. But that process can typically take

17	about three years and sometimes even up to four years

18	to complete. And, of course, that depends on the

19	complexity of the molecule, the target uses, the

20	formulations, et cetera, with an overall cost for all

21	these activities that can run more than $250 million,

22	over a period that can take up to 11 years from

23	discovery to market.

24	So during the development phase, the

25	company usually plans pre-submission meetings with

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1	EPA and also with PMRA in the event the review is

2	planned to be a joint review between U.S. and Canada,

3	and this is to inform the agency of the intention to

4	register the product and then also an opportunity to

5	obtain guidance or feedback on the study strategies.

6	So the application to register the active ingredient

7	and the associated end use products is submitted to

8	OPP after the data package is complete. And this can

9	contain over 200 individual study reports. And, of

10	course, that's quite an overwhelming job at both

11	ends. But then the PRIA timeline is designated at 24

12	months. I think we've noticed an average of about 33

13	to 34 months in terms of EPA review.

14	If a company's applied for reduced risk

15	status or goes through review as a reduced risk

16	candidate, the PRIA timeline is 18 months, and that's

17	as an incentive, and PRIA 4 also established a

18	reduced fee for a reduced risk chemical, as you can

19	see. So this slide is sort of simplified, but it

20	encompasses the whole process.

21	Okay. So next slide.

22	So from a registrant's perspective, there

23	are key expectations at the foundation of a sound

24	regulatory process, and this is what I would consider

25	priority areas. We rely on scientific integrity both

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1	on our part, as well as the agencies, for sound

2	decisions. The studies that a company conducts and

3	submits to EPA in support of a product's registration

4	are done under strict conditions, and that's in

5	accordance with good laboratory practice or GLP.

6	This ensures such things as data integrity, quality,

7	and reproducibility, and I'll speak to those further

8	in a minute.

9	We rely on consistency of EPA reviews and

10	interpretation of supporting data and the companion

11	product labels. And we know that predictability for

12	when to expect a PRIA decision does not guarantee

13	registration will happen by that date. However, with

14	a business that is so seasonal-driven as ours is,

15	it's critically important that surprises are

16	minimized and unexpected issues are addressed along

17	the way.

18	And then the one thing that we've all

19	experienced internally, especially in the past year,

20	is the value of efficient processes, which are

21	critically important to maintain timelines and help

22	ensure that predictability. And I'm encouraged that

23	at the OPP end, a lean initiative is underway as

24	presented by Ed during the previous PPDC, and look

25	forward with the expectation when the registration

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1 division will begin to employ that.

2

Next slide.

3

So as everyone knows FIFRA regulation of

4	pesticides is data driven and the PPDC panel members

5	were well educated on this topic as well as the

6	associated risk assessment and evaluation process by

7	the OPP teams during our onboarding session. So I

8	don't intend to repeat any of that, just except to

9	emphasize the GLP, or good laboratory practice,

10	aspect of data generated in support of a product's

11	registration.

12	So next slide.

13	So in the previous version of this week's

14	PPDC agenda, we noticed that there was originally a

15	presentation planned OECA that was going to discuss

16	the topic of the GLP inspection process, which

17	hopefully we'll still get to here at a future

18	meeting. So maybe in preparation for that, we

19	thought we would take the opportunity to provide a

20	very high-level overview of GLP and describe what it

21	is for those who may not be familiar and the efforts

22	that registrants put into ensuring compliance. And

23	so GLP is a quality system of controls for research

24	laboratories and organizations, and in the end, EPA

25	should be able to reconstruct a study in its

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1	entirety.

2

Adherence to GLP ensures uniformity,

3	consistency, reliability, reproducibility, quality,

4	and data integrity. And you can find more about GLP

5	requirements and the compliance standards in 40 CFR

6	Part 160. It is all spelled out in there in great

7	detail.

8	So next slide.

9	So the main elements of GLP include

10	organization and personnel and companies who generate

11	their own data have their own QA staff who serve to

12	make certain that GLP procedures are being followed.

13	They'll audit a study that's in process and ensure

14	the integrity of the study's final report. They also

15	will audit CROs with whom the company might outsource

16	a study to ensure that the lab is adhering to GLP

17	because the sponsor company is ultimately

18	responsible.

19	Roles for others involved in the study are

20	also defined and GLP also addresses, as shown here,

21	the test facilities, equipment, how the test

22	facilities should operate, which is using SOPs, the

23	test substances, study protocols, as well as study

24	reports and records.

25	So next slide.

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1

So I'm only going to discuss a couple of

2	those areas and primarily the study protocol and the

3	record-keeping requirements. So within the company

4	and in coordination with the CRO if a study is

5	outsourced, a study protocol is created and agreed by

6	all parties involved and signed off. And at that

7	point, any changes to the study protocol must be

8	fully documented.

9	Okay. Next slide.

10	There's also strict record-keeping

11	requirements that apply to SOPs detailing how a

12	specific task is done, by whom, et cetera. Persons

13	who perform these duties are required to sign off on

14	the SOP to certify they understand the procedures as

15	written.

16	Okay, next slide.

17	And record-keeping is intended to provide

18	the Government with a fully auditable study record,

19	allowing them to reconstruct the study according --

20	that's done according to GLP, and the raw data that

21	has to do with GLP are maintained for long periods of

22	time. Companies typically maintain these records for

23	as long as the product is registered and usually for

24	a period of five additional years after that.

25	So okay, next slide.

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1

So there is an audit component.

2	Independent audits are done to ensure study integrity

3	and, typically, study auditors are employed by the

4	same organization as the laboratory staff, but

5	they're removed from participating in the study

6	itself. So one of the things an auditor does is to

7	ensure the raw data matches that which is reported

8	and that calculations are correct and so on.

9	And then EPA's Office of Enforcement and

10	Compliance and Assurance, or OECA, they'll do public

11	or, excuse me, periodic audits of studies and

12	facilities.

13	So next slide.

14	So here's an example of a GLP statement

15	that's required for inclusion in every study report

16	that's submitted in support of a registration action.

17	As you can see, it's signed by the study director,

18	the study sponsor, the person who submits the study

19	itself. If a report is submitted and the information

20	contained was not done according to GLP, that needs

21	to be stated and explained here. And an example

22	would be maybe a waiver rationale where there's no

23	data generated, but the information is relevant and

24	important for consideration by reviewers. And a

25	separate quality assurance page is also included that

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1 is signed by the QA personnel.

2

So in the end, the process is very robust,

3	it's taken seriously by all parties involved to

4	ensure the scientific integrity. And I hope this

5	provides some useful insights into GLP compliance and

6	helps inform GLP members in advance of a future

7	presentation by EPA on the GLP inspection process.

8	So now I will turn it over to Mano who will

9	discuss CLA's strategic priorities. Thanks.

10	MR. BASU: Thank you very much, Charlotte.

11	And my presentation is just before a very

12	timely lunch break for those on the East Coast, so

13	I'11 be quick.

14	Again, as Charlotte mentioned, CropLife

15	America, we are a trade association representing

16	manufacturers, formulators, distributors of

17	pesticides and plant science solutions for ag and

18	pest management in the U.S.

19	From an organization point of view, we have

20	identified three strategic imperatives, priorities

21	for us, one around environmental sustainability,

22	industry perception, and regulatory integrity. For

23	today's presentation, what I'm going to do is focus

24	on two of our priorities, one around environmental

25	sustainability and some of the work we are doing on

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1 regulatory integrity.

2

So what the industry is looking into is

3	continually improve our environmental outcomes

4	through voluntary conservation measures and

5	innovative technologies. There's a lot of innovation

6	that is going on within our industry. You heard some

7	of the innovative technology, emerging technologies

8	that are coming out on the application side

9	yesterday, but there's also work on the chemistry

10	side that our members are doing on almost a daily

11	basis.

12	As we were thinking about agricultural

13	sustainability and how do we define sustainability

14	for ourselves, we started this journey where we said,

15	let's see what's the best way for defining

16	sustainability for us as an industry. We were aware

17	of the United Nations' sustainable development goals

18	that were out there. The staff conducted a series of

19	interviews from members, NGOs, other associations,

20	the food industry, people on the Hill to see what are

21	those -- out of the 17 UN SDGs, what are the ones

22	which are relevant to our industry?

23	What we did, based on the effort, is

24	identify three UN SDGs, one around innovation and

25	agricultural productivity, the second on

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1	biodiversity, and the third on climate change. As

2	part of our ag sustainability work, once we have

3	defined what sustainability means, what are the focus

4	areas we have that we will be working on in the next

5	five years? We were looking for engagement. So

6	what we are looking into is outreach to academics

7	where research is going on on agriculture

8	productivity, biodiversity, climate change. We are

9	engaging with a few environmental NGOs -- we would

10	like to engage with more -- and conservation

11	organizations where we are having discussions.

12	Finally, the goal is, from a communication

13	perspective, talk about pesticides and

14	sustainability, talk about what our members are

15	doing, the amount of work that they are doing around

16	sustainability, develop some of the fact sheets on

17	greenhouse gas emissions, habitat restored, some of

18	the soil health productivity work. Our research plan

19	is to focus on life cycle analysis and do some

20	monitoring and reporting on ag sustainability

21	overall.

22	Thinking specifically on defining

23	sustainability and what does it mean from a

24	biodiversity perspective, we then started looking

25	into specific metrics or indicators that would help

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1	us understand how biodiversity is being improved,

2

3	looking specifically into improving soil health and

4	resiliency, reducing topsoil erosion -- we know

5	topsoil erosion is a major issue -- cover crop,

6	reduce stale agronomic practices, reduce topsoil

7	erosion, how our products help in reduction of

8	topsoil erosion. Contributing to soil health is

9	something we are going to look into. Improving

10	pollinator health and then, again, promoting

11	conservation. There's a lot of effort going on

12	within our member companies. How do we bring those

13	efforts and share that with the audience.

14	MR. BASU: From a climate change

15	perspective, focusing again on lowering greenhouse

16	gases, whether it's through cutting fuel consumption

17	because of few tractor runs that need to happen with

18	a cover crop or reduced-till practices and in

19	promoting reduced-till practices in itself.

20	Moving on to the innovation and

21	productivity, looking into newer chemistries. You

22	heard about robotics and precision ag yesterday,

23	looking into decreasing yield and also focusing on

24	enhancing farmer education on the use of these tools.

25	Just to give you some example of some of

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1	the conservation work our member companies have done,

2	and these are just a few examples, there are several

3	examples out there, last year, Corteva Agriscience

4	announced a two-year agreement to support efforts of

5	the Nature Conservancy, and this work was around

6	growing more sustainability while protecting water

7	quality.

8	Another example was pollinator health, and

9	since 2011 Bayer Bee Care Program has supported more

10	than 30 collaborative projects, addressing local and

11	regional threats and opportunities facing

12	pollinators.

13	Finally, another example on rescuing

14	farmland, and this is Syngenta's Good Growth Plan

15	Program, where the company benefitted about 2 6.7

16	million acres of farmland on the brink of

17	degradation, roughly the size of Tennessee.

18	So you can imagine these conservation

19	programs, these programs our members are supporting,

20	has a huge impact on environmental sustainability.

21	And what we are looking into is how can we promote

22	these efforts and how can we advocate for -- on these

23	efforts.

24	The second issue I want to talk about

25	briefly here is around regulator integrity. Again,

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1	we are committed to a transparent and reliable

2	federal risk-based pesticide regulatory process. And

3	within that, the one area I want to focus today is on

4	the endangered species evaluation. Talking

5	specifically on the endangered species, ESA FIFRA, we

6	at CLA have submitted several comments on the

7	challenges that we see with the biological evaluation

8	process. There are lots of conservative assumptions

9	that are being made.

10	In the BE, we have submitted extensive

11	comments whether it be on the revised methods or the

12	BE's -- some (inaudible) have come in. We are aware

13	of challenges with limited expertise. On the

14	services side, a lack of transparency with the whole

15	handoff process, a 12,000-page document being handed

16	off to the services. Errors with the modeling,

17	issues with the legal standard, the limited

18	collaboration and the BE workload that's going to be

19	there in the next few years.

20	This is not, again, the full list of

21	problems we have identified, but you could boil all

22	these problems down into three issues, one around

23	inefficient process, the second around opaque

24	communication, again that huge technical complex

25	document being passed over to services, and the lack

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1	of resources within services who are doing all the

2	work that is coming their way in the next few years.

4	challenges? I mean, we know -- we are aware of the

5	registration delays, litigation and farmers' access

6	to key tools, maybe in the middle of the growing

7	season or just before the growing season. These are

8	real concerns and issues. But, most importantly, the

9	current process does not provide any benefit to

10	species. So what we propose and what we are looking

11	at from a CLA strategy -- industry strategy

12	perspective is how can we benefit species and at the

13	same time ensure legal certainty.

14	Working around efficiency, as I said, there

15	are challenges with efficiency. Working on

16	resources, what are the resource allocation that

17	needs to happen? And, finally, stakeholder

18	engagement, we truly believe that more stakeholder

19	engagement needs to happen between the federal

20	family, the registrant, NGOs, grower groups, and

21	everyone who is involved in the process.

22	Finally, from the presentation on ESA, some

23	key takeaways, what we support and we request is more

24	collaboration between the federal family, EPA

25	services, USDA, the stakeholder engagement around

3

So what happens because of these

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1	federal family, registrants, farmers. Better

2	communication within the federal family. Explaining

3	the limited purpose of the biological evaluation in

4	non-tech -- for the non-technical audience. There's

5	a lot of details in those. And the biological

6	evaluation is not the end of the risk assessment

7	process. There is the bio (inaudible). There is the

8	whole registration process. So how can the agency

9	help explain the limited purpose of the biological

10	evaluation?

11	Explain avoidance and minimization aspects

12	of pesticide registration, these are key. There's so

13	much of avoidance and minimization as part of the

14	label registration that happens, and there is no

15	recognition for those avoidance and minimization.

16	Finally, around improving efficiency, we

17	know the risk assessment, it's a continuous

18	improvement process and there are challenges that we

19	have identified with the risk assessment. Those

20	issues with the risk assessment need to be fixed.

21	And the second part of improving efficiency is on

22	leveraging existing and seeking additional resources

23	for conservation of listed species.

24	We know, I mean, last year Congress

25	appropriated about $8 billion towards ag

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1	conservation. How can we utilize some of those funds

2	towards benefitting the species? What are the

3	additional requirements from a funding perspective

4	that we can consider for benefitting the species? At

5	the end of the day, we are looking at benefit to the

6	species and the legal certainty.

7	Paul, back to you. I saw the reminder.

8	Thank you.

9	MR. ANNINOS: No problem at all, Mano. No

10	problem at all. And thank you. Thank you,

11	Charlotte. Thank you, Mano, for these great

12	presentations. Maybe we have time for one question,

13	just to see if there's anybody that has a burning

14	question for -- or a comment for either or both of

15	you on your presentations. I don't see anything in

16	the chat window, but I'll just make it open for one

17	person.

18	(No response.)

19	MR. ANNINOS: Hearing none, I think I just

20	wanted to thank you very much for the presentations.

21	We're ready to move to the lunch break. I see that

22	Ed has come on the screen there. I didn't know if

23	you had anything you wanted to add before we broke

24	for lunch, Ed.

25	MR. MESSINA: No, just thanks for the great

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1	presentations today, the great discussions. We

2	really appreciate it. And be back promptly at 2:00,

3	where we'll hear from Michal Freedhoff.

4	MR. ANNINOS: Exactly, exactly. So I would

5	suggest people just stay connected to the Webex.

6	They just go -- maybe just turn off your video, turn

7	off your audio, set a reminder on your calendar on

8	your phone to ping you at 1:55 p.m. Eastern time.

9	Log in a little bit early so we can get started right

10	at 2:00 Eastern time. Okay?

11	Thank you very much. Enjoy your lunch.

12	Take a break.

13	(Lunch break.)

14

15

16

17

18

19

20

21

22

23

24

25

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1

WELCOME FROM PRINCIPAL DEPUTY ASSISTANT

2 ADMINISTRATOR

3

MR. MESSINA: So welcome, Michal. Thank

4	you so much for joining the PPDC meeting that we've

5	been having for the last couple of days.

7	she is currently the Principal Deputy Assistant

8	Administrator for Chemical Safety and Pollution

9	Prevention, which is the office that sits above the

10	Office of Pesticide Programs. So she is my boss.

11	And she's been here for a couple of months and I've

12	gotten a chance to know her a little bit and it's

13	very obvious to anyone who meets her that she's

14	incredibly smart, shows great judgment, and is

15	extremely willing to listen to the career scientists

16	and the professionals at EPA. So it's really been a

17	delight to work with her for the past couple of

18	months.

19	But my introduction here really pales in

20	comparison to the reception that Michal had yesterday

21	at her hearing. I'm going to call it, quote,

22	unquote, "hearing." It was almost like a homecoming.

23	President Biden recently nominated Michal to be the

24	Assistant Administrator for the Office of Chemical

25	Safety and Pollution Prevention. And as I mentioned

6

So for those of you who don't know Michal

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1	yesterday, her confirmation hearing was yesterday,

2	which is why we're hearing from her today.

4	at that hearing were that Michal was referred to as a

5	brilliant scientist. Senator Inhofe, in his own

6	words, said that it was basically the only thing that

7	Senator Markey and he agreed upon was Michal's

8	qualifications. She was credited for making Senator

9	Markey sing on the Senate floor, a song about TSCA

10	and chemicals. She's received numerous endorsements

11	from various organizations, including multiple past

12	administrators and assistant administrators.

13	And then, lastly, near and dear to my

14	heart, when she was asked sort of a final question,

15	which was was there any question that she wished she

16	had been asked but wasn't, she chose to highlight the

17	great work of OPP in response to COVID as something

18	that she wanted to talk about. And so that was

19	really great to see her continuing to be a

20	cheerleader for the office that she is representing.

21	So it's safe to say she did a pretty good

22	job yesterday visiting with the committee, for which

23	she has obviously -- which obviously has assessed her

24	abilities quite well. And it's where she worked in

25	the past. So it's great when your colleagues and

3

And some of the things that were mentioned

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1 your boss sing your praises at the hearing.

2

So please join me in welcoming Michal to

3	talk to us at the PPDC and thank her for her time

4	today. With that, over to Michal.

6	was really nice. And I promise everybody there will

7	be no singing. Like for the whole four years if I'm

8	lucky enough to be here, there will be no singing.

10	work we do to partner with EPA and other stakeholders

11	to develop practical and protective approaches for

12	pesticide regulatory policy implementation. And, you

13	know, I really first wanted to say that I appreciate

14	your flexibility on scheduling and I was kind of busy

15	yesterday morning, as Ed let you know, and I'm very

16	glad I was able to join you this afternoon.

17	So I'd like to just share briefly some of

18	the priorities that I see our office addressing over

19	the coming year. And let me start by saying that I

20	want you all to know how important it is to me that

21	EPA prosper a meaningful and cooperative relationship

22	with our stakeholders. And, you know, coming to EPA

23	after spending more than two decades in Congress,

24	most recently with the Senate Environment and Public

25	Works Committee, I really did develop a tremendous

5

DR. FREEDHOFF: Thanks so much, Ed. That

9

So thanks to all of you on the PPDC for the

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1	respect for the role that all stakeholders play in

2	moving environmental and health policies forward, and

3	even more importantly than that, making sure that

4	they're robust and long-lasting. And I think that

5	when you can find consensus in as many places as

6	possible, that's when we end up with the most

7	durable and lasting policies, outcomes, and

8	solutions.

9	I also know that in many, if not most,

10	cases, you know the issues you're concerned about

11	better than we do because you're the ones who see

12	firsthand how EPA's policies play out in the real

13	world. So I know and value the importance of the

14	collaboration that regulators at EPA must have [audio

15	issue].

16	So the first step towards effective

17	environmental protection is ensuring the integrity of

18	our science because our actions are really only as

19	effective as the [audio issue]. And as you know,

20	President Biden has issued executive orders and

21	direction to review all Trump-era environment rules.

22	And that will ensure that what we do is protected and

23	will restore scientific integrity to EPA's decision-

24	making process.

25	Political interference with the work of

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1	scientists and blocking the communication and

2	critical information to the American people was

3	unfortunately a bit too commonplace in the last

4	administration, even though I just want to say a

5	great deal of a fantastic science and work did happen

6	in the last four years as well.

7	But one high-profile example of a time when

8	science wasn't really the driver of our policy was

9	when OCSPP's previous senior leadership interfered

10	with the 2018 Dicamba decision by discounting

11	(inaudible) facts assessments of Dicamba's risks and

12	benefits. And that probably contributed to a court

13	vacating EPA's 2018 Dicamba pesticide registrations.

14	And the court found that EPA failed to even consider

15	reports of damage to millions of acres of crops, for

16	example, to non-Dicamba resistant varieties of

17	soybeans, along with damage to high-value crops like

18	peaches and tomatoes, which affected many farmers.

19	And, in addition, there were other reports of damage

20	From Dicamba to residential gardens and ornamental

21	plantings.

22	And so the political interference that the

23	2018 decision had and the court's subsequent decision

24	to throw it out impacted all of growers' ability to

25	(inaudible) product. And it also contributed to an

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1	aversion in the trust that the public has in the

2	agency.

3	When EPA says that a pesticide can be used

4	safely, it's in everyone's interests that the people

5	believe that what we're saying is grounded in the

6	science and the law. And it's also in the industry's
interest

7	because if the public has confidence in

8	the safety of the product industry makes that's good

9	for industry, too. And, right now, I don't think the

10	agency's trusted in the way that it needs to be.

11	Unlike 2018, the 2020 decision on Dicamba

12	does reflect the insight of EPA scientists. EPA

13	stands behind that decision.

14	More generally, I want to affirm my

15	commitment to scientific integrity, communication,

16	trust and transparency in EPA's decision-making

17	process. And I want to know that OCSPP is home to

18	world class scientists and I will ensure their voices

19	will guide our decisions during this administration.

20	So part of our commitment to sound science

21	involves keeping pace with scientific investments and

22	adjusting our regulatory approaches when necessary to

23	align with those advancements. And in recent years,

24	our agency has made strides towards reducing the use

25	of laboratory animals in testing -- in pesticide

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1	testing. Some of the briefings that I've had on that

2	have been really, really exciting.

4	evaluating new technologies in molecular, cellular,

5	and computational sciences to reduce and replace more

6	traditional methods of toxicity testing in risk

7	assessment, and OPP is also modernizing data used in

8	risk assessment. And the transition from relying

9	primarily on laboratory animal studies to non-animal

10	approaches is being done in a transparent and

11	scientifically robust way (inaudible). We're working

12	collaboratively with stakeholder groups, including

13	animal welfare groups, states, academic and industry

14	scientists to ensure that new methods made agency

15	needs to protect human health and the environment.

16	We're also encouraging and implementing

17	novel effective ways to minimize pesticide drift.

18	Spray draft is routinely evaluated in the

19	registration review process using peer review

20	risk assessment (inaudible). And I'm sure you all

21	know there's multiple ways to reduce spray drift,

22	including changes in nozzle selection, hooded

23	sprayers, choice of application method and

24	application rate changes. And we're also supporting

25	precision agriculture approaches that better manage

3

Our pesticide program is developing and

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1	the use of pesticides and application processes, like

2	GPA guidance and (inaudible) which can turn sprayers

3	on and off as appropriate. We need to help growers

4	use pesticides efficiently and better ensure

5	chemicals stay within (inaudible).

6	As a country, we're also facing the crisis

7	of a rapidly changing climate. We know many of our

8	stakeholders are already grappling with climate-

9	related challenges, like changing weather patterns

10	and increasing temperatures, changes in insect and

11	pest behavior, more frequent and extreme

12	precipitation and drought, all of which can

13	dramatically alter plant growth patterns.

14	Within hours of taking office, President

15	Biden issued an executive order that made clear his

16	commitment to tackling climate change in the ways

17	this administration [audio issue].

18	Looking through an expanded lens for OCSPP,

19	we're thinking creatively of ways to manage some of

20	the effects of climate change, like further

21	leveraging integrated pest management, or IPM. We

22	want to build IPM capacities and evaluate the

23	feasibility of new innovative IPM approaches and

24	methodologies that will combat pesticide resistance,

25	reduce risk, and protect the environment. In some

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1	instances, the flexibility of using IPM as an

2	alternative to conventional pesticides will also

3	reduce the impact to climate change.

5	cover crops to grow can keep moisture and nutrients

6	in the ground and that will lower greenhouse gases.

7	And pesticide use itself, particularly the use of

8	fumigants, can be a contributor of climate change.

9	So it's important to ensure that we're using these

10	chemicals just when and where they're needed. A

11	significant percentage of the world's food supply is

12	lost annually to pests and climate change has rapidly

13	introduced new pests. So improving pest management

14	with a focus on integrated sustainable practices is a

15	way to ensure (inaudible) security while decreasing

16	greenhouse gas emissions.

17	And decreased pesticides are also

18	Often an outcome when IPM practices are

19	implemented. Less pesticide use and reduced use of

20	the equipment needed for those applications would

21	also reduce greenhouse gas emissions, furthering the

22	fight against climate change.

23	In addition, in January, EPA renewed its

24	commitment to working with the agricultural community

25	as a partner in the pesticide environmental

4

There's a couple of examples. Allowing

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1	stewardship program. We're reinstating the PESP

2	grants for projects that explore innovative

3	solutions, that promote adoption of IPM, furthering

4	the agency's role of providing a healthier

5	environment for all Americans. We expect a call for

6	submissions sometime in the next few weeks, so we

7	need to be on the lookout for that.

8	The President has also directed EPA and

9	other agencies to advance equity for all Americans,

10	including people of color and others who've been

11	historically underserved, marginalized, and adversely

12	impacted by persistent poverty and equality

13	(inaudible). And this also includes some of our

14	nation's farmworkers, their families, and residents

15	of agricultural communities, all of whom would

16	benefit most from our national pesticide safety

17	training, education, and outreach efforts.

18	As a part of our commitment to farmworker

19	protection, we're continuing our important work with

20	the Association of Farmworker Opportunity Programs,

21	or AFOP, toward our common goal of protecting our

22	farmworkers and their families. Starting this year

23	through 2025, AFOP will receive up to $500,000

24	annually through our National Farmworker Training

25	Grants Program to conduct training across the

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1	country. They'll provide occupational health and

2	pesticides safety training to migrant and seasonal

3	farmworkers in more than 25 states with a network of

4	over 200 (inaudible) and we know this will have a big

5	impact because through our previous cooperative

6	agreement with AFOP, the program trained 184,000

7	farmworkers and 40,000 children.

8	We're also committed to upholding

9	farmworker protections through the historic 2015

10	Agricultural Worker Protection Standard, which

11	improved protections against pesticide poisoning and

12	injuries for more than 2 million workers.

13	Now, I mentioned that I brought up COVID

14	and the agency's response to that in my hearing

15	yesterday and I really had hoped to get a question on

16	that and was really very happy to have the

17	opportunity to talk about it, because EPA really

18	played an important role in the nation's response to

19	(inaudible). Since the declaration of the public

20	health emergency, EPA worked aggressively to ensure

21	that Americans are aware of the facts as to surface

22	disinfectant products that would be used effectively

23	against the virus.

24	And in OCSPP, we expedited the review

25	process for products eligible for emerging viral

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1	pathogen claims (inaudible) requiring the review of

2	new data. We expedited applications to add

3	directions for use with electrostatic sprayers to

4	products intended to kill SARS-CoV-2. We created

5	flexibilities for manufacturers by temporarily

6	allowing registrants to notify EPA of certain

7	formulation and manufacturing facility changes and

8	immediately released the product for sale without

9	first waiting for EPA approval. We provided

10	flexibility for the annual worker protection training

11	requirements, pesticide applicator certifications,

12	and to address respiratory equipment shortages.

13	And over the course of the past year, we

14	also learn a lot more about COVID-19, how it spreads

15	and the role contaminated surfaces play in the

16	transmission process. And the more we learned, the

17	more we were able to adjust our decisions, actions,

18	and requirements to make some of these changes

19	accordingly.

20	So recent information from the CDC notes

21	that the risk of being infested with COVID-19 by

22	touching contaminated services is actually pretty low

23	and that airborne transmission is a much higher risk.

24	So given the release of that new information, we've

25	updated our disinfectant policy to align with new CDC

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1	science.

2	And two weeks ago, we announced the agency

3	was no longer prioritizing public health emergency

4	requests for new products that address surface

5	transmission of SARS-CoV-2. And, instead, we're

6	going to shift our resources to the evaluation of

7	innovative and novel products, like those that kill

8	airborne SARS-CoV-2. And, in addition, in light of

9	the hundreds -- I think we're up to 550 -- of EPA

10	registered surface disinfectants, we won't be

11	expediting new product registrations and other

12	actions for products intended to kill SARS-CoV-2 on

13	surfaces. We'll just continue to review them using

14	standard registration process (inaudible). Working

15	with our counterparts at CDC and other federal and

16	state agencies, we ensure our guidance continues to

17	reflect the most up-to-date findings.

18	In closing, I'd just like to to reiterate

19	our commitment to returning to our core mission of

20	protecting human health and the environment, which

21	starts with effective cooperation with our

22	stakeholders. It's an exciting time at EPA. We're

23	moving ahead with fresh ideas and a renewed

24	commitment to our mission, science, and transparency.

25	We'll be taking on the climate crisis and deliver
environmental(inaudible)

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1	justice.

2

I'm looking forward to your advice and

3	input over the rest of this meeting on important

4	topics that PPDC (inaudible) minimizing pesticide

5	resistance, how to bring new agricultural

6	technologies to the market, and how we can enhance

7	existing policies to better respond to challenges

8	from viral pathogens. It's all very important work.

9	And I thank you all again for your time and service.

10	And I'll turn it back to Ed so you can

11	resume with this meeting. Thanks again.

12	MR. MESSINA: Thank you so much for joining

13	us, Michal.

14	All right. So we are -- I know your

15	schedule is tight and I know Michal has got to run,

16	so it was great to have her. So I appreciate her

17	stopping in.

18	So now we're going to go on and hear about

19	the Endangered Species Act. We've got some great

20	presenters on this topic. Obviously, a topic of

21	great interest to the agency and the public and we've

22	heard some initial information from industry and

23	we're going to hear from the Government and then also

24	hear from NOGs on this topic.

25	So with that, I'll kick it over to you,

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1	Paul.

2	MR. ANNINOS: Thank you. Thanks a lot, Ed.

3	And for those of you that want a chance to see Dr.

4	Freedhoff's testimony yesterday, it's all online.

5	And I have a chance to peek into that today, this

6	morning before this meeting, really great comments

7	that she made in front of the Congressional members

8	and a great ambassador of EPA and, of course, very

9	focused on the mission of OCSPP.

10	So we're going to move now, but before I

11	introduce Cathy, I think Charlotte Samson wanted to

12	-- I'm not sure if it was like correcting a statement

13	or maybe expanding on a statement from earlier in the

14	day.

15	So, Charlotte, let me just hand it to you

16	for just a minute to do that.

17	MS. SANSON: Yeah, thank you. Thank you so

18	much, Paul. This will be really quick.

19	During my talk, I had referenced Ed's

20	presentation from the last PPDC where he described

21	OPP's Lean initiative. And I just wanted to make a

22	correction in something I had said. And I meant to

23	say that we understand that the Registration Division

24	is already putting Lean into practice and we know

25	that they'll be implementing some -- a Salesforce

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1	that is intended to replace legacy tracking systems.

2	And we expect this will greatly contribute to

3	efficiencies once it's implemented following the

4	pilot that is being done with the Antimicrobial

5	Division and BPPD. So I just wanted to be sure that I

6	was clear on what I had said there with regard to

7	efficiency.

8	So thank you, Paul. I appreciate it.

9	MR. ANNINOS: You bet, you bet, Charlotte.

10	No problem at all. Thank you.

11	MR. MESSINA: Thank you, Charlotte.

12	MR. ANNINOS: Okay.

13	MR. MESSINA: Yeah. At some point, when we

14	deploy the Salesforce instance in the Registration

15	Division, we'll definitely come to this group and

16	talk to you about what that looks like, maybe even do

17	a demo. It's a pilot right now for BPPD and the

18	Antimicrobials Division. And I have presented on

19	that topic. I'm happy to put that on maybe as a

20	future deliverable for us to talk about at the PPDC.

21	It might be good timing in the fall.

22	MR. ANNINOS: Perfect, perfect.

23	So we've heard two stakeholder interest

24	presentations so far. Now we're going to hear, back-

25	to-back, numbers 3 and 4 of 4. So both topics are

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1	ESA related. Cathy Tortorici from the Office Of

2	Protected Resources, focused on endangered species at

3	NOAA fisheries. And so we're very happy to have her

4	with us today.

5	And I'm assuming by now you've been handed

6	the -- oh, actually, I think Sarah Chadwick may be

7	actually running the slides.

8	MS. TORTORICI: Yes, that's correct.

9	MR. ANNINOS: So all you have to do is give

10	her a verbal cue and she'll know when to move to the

11	next slide.

12	So, Cathy, you're up. And then -- you're

13	up at this point. So good.

14

15

16

17

18

19

20

21

22

23

24

25

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1

2	PPDC MEMBER PRESENTATIONS ON STAKEHOLDER INTERESTS

5	much. It's great to be here, and I want to spend the

6	next few minutes just giving everybody some updates

7	on what we've been doing from the ESA-FIFRA

8	consultation standpoint. And I'm presenting some

9	information not only from the Fisheries Service, but

10	also from Fish and Wildlife and EPA as well. So it's

11	kind of a round-up of where we are right now.

12	So let's take it away. Next slide, please.

13	So you've been -- you've heard about the

14	ESA already in this meeting, and just to orient folks

15	who may not be aware in terms of the Endangered

16	Species Act, it's really a -- it's a law that's based

17	on species conservation in terms of protecting

18	species and the environments in which they live.

19	Ed had brought up this issue earlier in the

20	meeting about Section 7(a)(2). This is what we call

21	interagency consultation and this is where the

22	Fisheries Service and also the Fish and Wildlife

23	Service, because we share responsibility to implement

24	this act, are working with federal agencies to ensure

25	that the federal agency -- and you can see the text

3

ON-GOING FIFRA-ESA CONSULTATION WORK

4

MS. TORTORICI: Thank you. Thank you so

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1	there -- their actions are not resulting in adversely

2	affecting species or resulting in destruction or

3	adverse modification of what we call critical

4	habitat. And so we've been working with EPA on this

5	for a number of years, many years. So this is not

6	new to us, not new to EPA in the work that we're

7	doing here.

8	Mano brought up the biological evaluation,

9	and just quickly in terms of the process, I'll speak

10	generically now, but when an action agency, like EPA,

11	comes to us and they're asking for consultation on a

12	particular action, they prepare a document called a

13	biological evaluation that basically summarizes what

14	is the action that they're going to give to us,

15	either NMFS or Fish and Wildlife to consult on, and

16	that document also describes what they believe the

17	effects of their action are to the ESA-listed species

18	that are within the action area of the project.

19	And then if we believe that there's going

20	to be some level of take associated with this action,

21	we're preparing what we call a biological opinion.

22	And in this case, it's about how pesticides could or

23	could not jeopardize, threaten endangered species or

24	destroy or modify critical habitat. So that's the

25	mini, mini version of the process that we've been

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1 engaged in for years on this particular topic.

2

3

Next slide please.

So I think Ed might have mentioned this,

4	EPA recently released, in March 2020, a revised

5	method document for the way that they're conducting

6	the analytical assessments around the development of

7	their biological evaluations. Okay? This is

8	important because it really sets the stage for what's

9	in those documents that then we, as the Fisheries

10	Service or Fish and Wildlife Service, are going to

11	react to in terms of the development of the

12	biological opinion. We certainly consider everything

13	that's in that biological evaluation when we're

14	making determinations. We may also include

15	additional information that we've determined to be

16	best available science.

17	So we're bringing that all together in the

18	biological opinion, but the core of it is with the

19	biological evaluation, and this revised methods

20	document is the core of what EPA is using to develop

21	their documents.

22	Next slide, please.

23	So EPA has been working on biological

24	evaluations using this revised method for the

25	chemicals, carbaryl and methomyl, atrazine, simazine,

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1	propazine and glyphosate, and there's a website that

2	Ed mentioned as well, and here's the link to it and I

3	invite you to go to that website because I think that

4	it has a lot of really good information to help

5	understand the process of what we're trying to

6	accomplish, at least from the EPA side, with the

7	consultation process.

8	Next slide.

9	So we have a schedule for biological

10	evaluation development that EPA has put together.

11	We've actually completed some of this, which is great

12	news for the first two sets of chemicals. The final

13	BE for atrazine, simazine, propazine and glyphosate

14	is going to be ready in November. We've already done

15	good work on carbaryl and methomyl. And the rest of

16	those chemicals you can see when the draft BEs are

17	coming and when the final BEs are coming and those

18	graph BEs are out -- you know, they will be put out

19	for public review on the EPA docket so that

20	stakeholders will have the opportunity to provide

21	review and comment of those documents.

22	Next slide.

23	So the Fish and Wildlife Service just

24	recently released for public comment and review a

25	draft biological opinion related to malathion. This

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1	has been a long time coming in terms of the Fish and

2	Wildlife Service working to prepare this document.

3	It's a complicated document. And so the document is

4	out for public review. The comment period ends in

5	June. And you can see also the docket number and the

6	docket, at www.regulations.gov.

7	If you are interested in spending time

8	reviewing this document, I would encourage you to do

9	it because -- I will say the following, we have a

10	unique relationship with EPA on this issue of draft

11	documents or draft biological opinions. It is not

12	normally the process of, at least the Fisheries

13	Service, to release documents at a draft stage for

14	public review and comment. This process has really

15	been envisioned as an interagency conversation

16	between, for example, the Fisheries Service and the

17	action agency in terms of what is going on with the

18	proposed action, and sometimes applicants are brought

19	in on a case-by-case basis.

20	What we have with the EPA, ESA, FIFRA

21	services process is really quite different about

22	putting draft documents like this out for public

23	review and getting feedback on those. So if you're

24	interested, I would invite you to take advantage of

25	what is being offered in terms of the opportunity to

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1 provide review and comment.

2

3

Next slide, please.

So what did Fish and Wildlife say about

4	malathion? They said that of the species they looked

5	at, and they looked at many species, that 78 of those

6	listed species could be jeopardized and there were 23

7	critical habitats that could be adversely modified.

9	interesting, is rather than presenting defined

10	reasonable and proven alternatives, which are

11	approaches to relieve the jeopardy, the BiOp has

12	included categories of different types of techniques

13	or ways that you can then adapt or adopt into an RPA

14	alternative, and then also it's going to include

15	reasonable and prudent measures to help minimize

16	incidental take. And then that it's Fish and

17	Wildlife Service's intention to work with EPA and the

18	appropriate registrants to craft those final

19	reasonable and prudent alternatives.

20	Next slide, please.

21	So we have two biological opinions that we

22	recently put out for public review, and that comment

23	period closed in April of 2021. And you can see the

24	chemicals there. We analyzed the impacts not

25	nationally -- the malathion BiOp was a national

8

And what the document does, which is

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1	biological opinion. These particular biological

2	opinions, for the way that they were set up from

3	court orders, et cetera, really only covered 26

4	listed species, and those are salmon and steelhead in

5	Washington, Oregon, and California.

6	So we put those documents out for public

7	review. We got a lot of really good feedback on

8	those. The common period is closed on that. And now

9	we're projecting to complete those opinions in 2021.

10	And what I want to say -- next slide,

11	please -- is that we ended up with a no jeopardy

12	conclusion for the species that were involved and we

13	worked very closely on these two opinions with

14	stakeholders, meaning the registrants, as well as

15	EPA, to help craft those reasonable and prudent

16	measures in terms and conditions, which is also a

17	normal part of the EPA process with other federal

18	agencies, not just this one.

19	And what we have in terms of RPAs -- RPMs

20	and terms and conditions is that -- I call it a pick

21	list. There are a variety of different risk

22	reduction measures from a list of alternatives that

23	the grower can choose from to end up in a certain

24	place that's going to avoid and reduce the risk to

25	listed species. And you can see some of the examples

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1	there in terms of filter strips, riparian buffers, et

2	cetera.

5	chlorpyrifos, diazinon and malathion back in 2017,

6	and that was a jeopardy conclusion biological opinion

7	for a number of species. And so as a result of a

8	request from EPA, with new information that they felt

9	they had, they reinitiated consultation in 2019 on

10	that biological opinion. We've been working with EPA

11	and the registrants in terms of providing --

12	reviewing additional data that they've given us, and

13	we hope to complete that process per a court order

14	settlement in June of 2022.

15	And I'm saying court order in a couple of

16	places because I think some of you know, but maybe

17	not all of you know, that a lot of this is very

18	litigation-driven in terms of due dates for these

19	various documents. So there's a certain amount of

20	contents under pressure, so to speak, in terms of

21	reviewing and completing documents within a certain

22	time frame because many of the due dates are court-

23	ordered-driven due dates.

24	I've also included on the slide the EPA

25	website that you can go to to find out additional

4

3

Next slide, please.

So we also issued a biological opinion on

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1	information about reducing exposure to nontarget

2	plants and animals, where they focus on listed

3	species because as part of this re-initiation effort

4	and also part of implementing the biological opinion

5	while this is going on, EPA developed a website with

6	this information. And I would also invite you to go

7	to that website and take a look at what they're doing

8	regarding these issues.

9	Next slide.

10	So I'm going to close with the following --

11	a couple following statements. You know, Mano

12	mentioned about maybe some difficulties or challenges

13	with the consultation process. I think Ed brought

14	that up as well in terms of maybe there are some

15	challenges going on. I don't disagree with that.

16	This is a very complicated process.

17	The consultations that we're preparing are

18	probably some of the most technically complicated

19	consultations that the Fisheries Service does across

20	the country. And with that comes a lot of back and

21	forth and a lot of information sharing, agreeing,

22	disagreeing, you know, talking it through about how

23	to do this in a way that's not only efficient but

24	protective in terms of species conservation and also

25	fulfills the mandates under FIFRA and ESA.

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1

And we're really committed to enhancing --

2	looking where we can to improve this consultation

3	process because just like anything, it can always be

4	made better. We can always be in a process of

5	continuous improvement as I like to say.

7	considering are, you know, where can you have

8	protections for listed species and move them earlier

9	into the consultation process, so that rather than

10	them coming later, they're included within the

11	proposed action. And in doing so, then that becomes

12	part of the consideration of what we're actually

13	consulting on in terms of looking at effects and

14	levels of effects. And this is not new to the

15	consultation process. This is something that we

16	would like to talk more about in terms of maybe

17	emphasizing it in this consultation process.

18	The other thing that we're thinking about

19	is the following, we need to look at all species,

20	especially when we're doing a national consultation,

21	right? We're looking at all of the listed species

22	under our purview in terms of the analyses that we're

23	doing in our biological opinions. But how can we

24	maybe think about especially sensitive species and

25	how we're doing that analysis and the way that we're

6

And so a couple of the ideas that we're

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1	doing that compared to other species that might not

2	be as sensitive.

4	prioritization scheme, et cetera, et cetera. It

5	doesn't mean that we're not going to analyze all the

6	species or do a full-throated analysis, but where are

7	the places where we can really home in on a chemical

8	basis and think about those essentially especially

9	sensitive species and what we might be doing with

10	those?

11	With that, that is the end of my

12	presentation and thank you for the opportunity to

13	speak and I'd be happy to take any comments or

14	questions that you have later. Thanks.

15	MR. ANNINOS: Thanks very much, Cathy. And

16	I think given the time and the fact that the next

17	segment starts around 3:00, I'm going to turn this

18	immediately over to Lori Anne.

19	Hi, Lori Anne. And you can unmute yourself

20	and you can take it from here.

21	MS. BURD: Can someone advance to the next

22	slide, please?

23	Good afternoon, everyone. So we've spent a

24	lot of time here talking about the Endangered Species

25	Act, but you'll notice a few things never really come

3

This is sort of thinking about what is a

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1	up in the conversation. The first is, what's at

2	stake? And the second is, how do we actually

3	implement protections to stop extinction? Because,

4	ultimately, the ESA is not about the process. The

5	ESA is not about working hard. The ESA is not about

6	stakeholder extinction. The ESA is about stopping

7	extinction and the stakes could not be higher.

8	I hate to say this again. I've said this

9	at many meetings, but extinction is forever. And

10	after years and years of hard work, we still don't

11	have ESA consultations that have been completed and

12	implemented on the ground. We don't have measures to

13	benefit our most imperiled plants and animals, even

14	the most narrow endemics or the most sensitive

15	species. And I'm really glad that Cathy brought that

16	up, the need to look at a path forward for them. So

17	I'm going to talk about what's at stake and I'm going

18	to talk about a path forward.

19	The American bald eagle is a great

20	conservation success story. The symbol of our

21	nation, bald eagles almost went extinct. One of the

22	key factors driving them towards extinction was DDT.

23	Action was taken to stop that extinction. DDT was

24	banned. Bald eagles were listed under the Endangered

25	Species Act. EPA was created in response to all

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1	this.

2	Fast forward a few decades, bald eagles are

3	once again imperiled by pesticides. A new study that

4	just came out has shown that 82 percent of bald

5	eagles have anticoagulant rodenticides in their

6	blood, 82 percent. Poisoning and death by

7	anticoagulant rodenticides is an awful, awful way to

8	go, and that's the fate that we are giving to bald

9	eagles.

10	And this is the results of our choices.

11	This is the result of the actions of this office.

12	This office plays a significant role in driving our

13	current heartbreaking extinction crisis. What are

14	casually called off-target impacts around these parts

15	are not a de minimis issue. I'll say it again. The

16	actions taken by these people in this office play a

17	major role in driving extinction. And we've too long

18	pretended that this is a side issue to deal with.

19	Study after study shows this is not true. We have to

20	face this fact.

21	Next slide.

22	It's not just bald eagles. It's countless

23	species that are being impacted by pesticides. A new

24	study released just a few weeks ago found 55.8

25	percent of Florida manatees sampled have glyphosate

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1	in their plasma, 55.8. The level of glyphosate

2	exposure in these manatees is enough to cause both

3	kidney and liver damage. This is not an

4	insignificant off-target impact. This is not

5	something to look at with endless refinements. This

6	is real harm, real suffering to real endangered

7	species right now.

8	Next slide, please.

9	The insect apocalypse is here. Study after

10	study shows the populations of insects, birds,

11	amphibians, and mammals are decreasing. For many of

12	them, pesticides play a significant role in their

13	population level declines. I'm going to highlight

14	insects in my presentation because, of course, a

15	significant portion of crop protection efforts target

16	insects.

17	Next slide, please.

18	Monarch butterflies. Monarch butterflies

19	are right now on a freefall towards extinction. In

20	the upper left corner, you can see blue is the total

21	number of monarchs we have; green is the increasing

22	glyphosate use that corresponds with the time of

23	their population level decline. You can see about

2 4	the same amount of corn and soy has been grown, but

25	the big thing that has changed is the widespread

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1	adoption of RoundUp Ready or glyphosate-tolerant

2	crops.

4	milkweed. A few decades ago milkweed was considered

5	a pesky weed. Now, people are desperately planting

6	milkweed in their gardens. I won't even tell you all

7	what I just paid for a packet of native milkweed

8	seeds for my garden. But all of our gardens planted

9	can't be enough to replace the milkweed that has been

10	destroyed in the Heartland.

11	The amazing migration of monarchs could end

12	right now. We have more Starbucks locations in

13	California than Western monarchs, 1,900 Western

14	monarchs total. Of course, there are other factors

15	impacting monarchs. I will not say that, you know,

16	pesticides are the only thing impacting them, but

17	they play a significant role.

18	Next slide, please.

19	Monarchs aren't the only insects we're

20	tracking. As many of you know, populations of native

21	pollinators are in severe decline nationwide, not all

22	of them, but many of them. A few months ago, we

23	petitioned the U.S. Fish and Wildlife service to list

24	the American bumblebee as endangered. It was once

25	found in 47 of the lower 48 States, every state

3

Glyphosate is really good at killing

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1	except Washington. It's now experienced an 89

2	percent population level decline. And pesticides are

3	playing a major role in this.

4	And, you know, often we talk about how

5	pesticides are getting more sophisticated, more

6	targeted, we have all these new technologies, but the

7	fact of the matter is that study after study shows

8	that U.S. agriculture is getting more toxic.

9	Next slide, please.

10	On Monday, the U.S. Fish and Wildlife

11	Service took a big step in proceeding with our 2020

12	petition to list the Suckley's Cuckoo bumblebee, an

13	amazing bumblebee. It issued a 90-day finding, the

14	first step towards being listed.

15	If you look at this map, you'll see that

16	this bee has basically disappeared from all areas

17	with heavy pesticide use, and the blue -- the green

18	dots, I'm sorry, are the dots that show where it

19	remains. The yellow dots or historic occurrences,

20	not many left.

21	So next slide, please.

22	The Endangered Species Act is both a legal

23	and a moral imperative. I show this picture of

24	Aleutian geese because they're an amazing ESA success

25	story, and there are so many of them. The Endangered

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1	Species Act is 99 percent effective at stopping

2	extinction, but we have to actually implement it for

3	it to work. And success stories cannot happen when

4	agencies do not carry out their duties under the ESA.

5	And the ESA asks for more than hard work; the ESA

6	asks for completion of consultations and their

7	implementation. The ESA doesn't ask for refinements

8	or multi-led stakeholder processes. The ESA asks

9	agencies to use the best available science.

10	I also included this picture of geese

11	because the actual use -- the chase for actual use

12	data of the past four years has been a wild goose

13	chase. Career staff in OPP have long considered

14	actual use data in their ESA consultation processes.

15	It's a very small part of the data that's required in

16	this process. It's a very incomplete subset. Any of

17	you look who look at the malathion BiOp will read the

18	part where they talk about how they reached out to

19	all the states and most states didn't get back to

20	them, and even the ones that did didn't get back to

21	them after that. The data just doesn't exist.

22	But, luckily, that's not what the ESA asks

23	for. The ESA asks for data -- asks for consultation

24	to happen on the agency action, not some

25	extrapolation of how the action might play out but

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1 what the agency authorized.

2

This all has been a huge distraction, this

3	actual use data and the 2017 Bernhardt intervention

4	that axed the almost completed biological opinions on

5	malathion, diazinon and chlorpyrifos, and has really

6	set this work back. The time lost is sad. The

7	wheels spun are sad. But the real issue is that this

8	has precluded actual progress and it's species that

9	bear the brunt of the suffering. Zero on-the-ground

10	protections have been implemented, even after

11	biological opinions, draft or final, have shown

12	jeopardy.

13	There's no real work plan. EPA has taken

14	no proactive steps on consultation without

15	litigation. None. There's no plan for moving

16	forward. There's just adhering to the deadlines that

17	are coming down.

18	So I'll say, you know, we can continue

19	litigating, we can continue bringing cases, or we can

20	find a path forward that makes sense and gets species

21	the protections they need to dodge extinction.

22	Next slide, please.

23	I think one myth that is successfully

24	circulated around these parts is that ESA

25	consultation is extraordinarily hard. And I will

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1	acknowledge that pesticide consultations, nationwide

2	consultations are not the easiest consultations by a

3	long shot. However, consultations happen every

4	single day. Between 2008 and 2015, there were almost

5	-- there were over 88,000 consultations. None of

6	them stopped projects. However, they did result in

7	important conservation measures. And that's not

8	what's happening here.

9	Every other agency routinely consults on

10	their actions. They don't have to be sued every

11	single time. There's no other agency that has

12	consistently flouted the law like this. I'll just

13	say complying with the ESA is like paying taxes.

14	It's something everyone has to do. You might not

15	like it, but you've got to do it. You can't just opt

16	out of taxes or ESA compliance. We are, after all, a

17	nation of laws.

18	Next slide, please.

19	I recognize we're running low on time, so

20	this is just a slide that shows some admissions of

21	noncompliance. It's not an open question. EPA is

22	not even pretending even to the court that it is

23	complying with the ESA aside from instances where

24	litigation deadlines are set -- or work deadlines are

25	set by litigation. And there has been no attempt to

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1	explain how OPP will achieve compliance with the

2	mandates of ESA.

5	minutes, because this isn't just a backlog issue,

6	this is an issue of OPP making an affirmative

7	decision to ignore the ESA every single day. For

8	example, just in January, it approved the use of

9	Aldicarb for Florida citrus. This decision affects a

10	small number of species, a very small number of

11	species, and many of them are narrow endemics.

12	Consulting on this decision would have been

13	relatively simple. It would have been an opportunity

14	for OPP to demonstrate a willingness to consult to

15	get started, to find a path forward where it does not

16	continue to add to the backlog. But, once again, it

17	affirmatively chose to violate the ESA.

18	And you'll hear a lot from OPP about how

19	they're not consulting on new decisions because

20	they're working on getting these new pesticides

21	online that will replace the bad old ones, but I'm

22	not sure how that logic actually would apply to

23	something like Aldicarb. And Florida also didn't buy

24	it. Florida said because OPP failed to comply with

25	federal law, under their state law, they could not

4

3

Next slide, please.

I want to talk about Aldicarb for a few

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1	abide by that decision and will not allow Aldicarb to

2	be used for the uses that EPA authorized.

6	good indication of what a path forward might look

7	like. And it's simple. It's really extraordinarily

8	simple, because at the end of the day, all we're

9	looking for is common sense actions to protect our

10	nation's most vulnerable species, and by extension,

11	many of our most vulnerable people.

12	The path forward that atrazine shows could

13	happen provides certainty. It reduces workload. And

14	what does it involve? It involves registrants

15	proactively working with the agency to modify labels

16	to minimize the effects on endangered species. The

17	picture of the bird here is an ^i'iwi. It's a

18	Hawaiian species that now is not going to have to

19	have endangered species consultation completed on it

20	because atrazine will no longer be used in Hawaii per

21	in agreement with the registrant and OPP. These are

22	the kinds of common sense actions that provide a way

23	forward that doesn't continue to have us mired in

24	litigation and endless delay.

25	I'm asking registrants to get proactive.

3

Next slide, please. And this is my final

4 one.

5

Atrazine I think really provides us with a

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1	If you want certainty, then sit down and figure out a

2	path to certainty that reduces the scope of pesticide

3	use in endangered species habitat. Once you do that,

4	the process will be faster. The expert agencies can

5	do their jobs. EPA can implement the consultations.

6	Species can get protections. We can stop suing.

7	Everyone is happy.

8	And in the meantime, we ask OPP to get

9	serious about on-the-ground protections, especially

10	for the most sensitive species, especially for the

11	narrow endemics. These actions will protect

12	communities and they'll stop extinction. Endangered

13	species are the canary in the coal mine. When we

14	protect them, we protect everyone.

15	So, you know, in closing, I'll say we're

16	not going away. The attempts to exempt pesticides

17	from the ESA in the last Farm Bill failed. We ask

18	you to set a schedule. We ask you to set an

19	ambitious schedule. Categorize it as you like. You

20	know we will sit down with you and work with you. If

21	you want to do all the neonics at once, insecticides

22	at once, broad spectrum herbicides, whatever it is,

23	set a schedule, come up with a plan, stick with it.

24	Enough refinements, enough process. We

25	want to see protections implemented. We want to see

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1	20 consultations completed and implemented each year

2	while you get the hang of this process and get a grip

3	on what catching up with the backlog is going to look

4	like. We will support you. We hope industry will

5	support you as well. This era of lawlessness and

6	endless delay has to end and we have to get serious

7	about ending this office's role in driving

8	extinctions and finding a path forward to spare

9	species this terrible fate.

10	Thank you.

11	MR. ANNINOS: Thank you very much, Lori

12	Anne.

13	I see we have about five or six minutes

14	before the next segment. Let's take some questions,

15	comments from the audience. They could be for either

16	Lori Anne or Cathy.

17	MR. MESSINA: Yeah, please don't be shy

18	about this important issue. And thank you to our

19	presenters for those presentations.

20	Surely someone must have a comment.

21	MR. ANNINOS: So it looks like Mano would

22	like to chime in. Mano, you're up.

2 3	MR. BASU: Thank you very much, Paul.

24	Again, a great presentation from Cathy and

25	Lori Anne. I just want to reiterate what I mentioned

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1	in my presentation, that we, as industry, are willing

2	to sit and have conversation on moving the process

3	forward and looking for a path forward on the

4	extremely important, complex ESA-FIFRA issue, where,

5	you know, as I mentioned in my presentation, at the

6	end of the day, it's what are we doing to benefit the

7	species. Let's focus on the benefit of species and

8	the legal certainties. Again, any future opportunity

9	that may exist for all of us to come together, sit

10	down and explore opportunities, we are looking

11	forward to those opportunities.

12	Thank you.

13	MR. ANNINOS: Thank you, Mano.

14	The mic is open, folks.

15	MR. MESSINA: About maybe examples of good

16	mitigation, I think Lori Anne had an easy one that's

17	right on the slide here and thanks for highlighting

18	that one, Lori Anne. Are there other examples or

19	things the agency should consider with regard to

20	early mitigation that could be some quick wins that

21	folks want to suggest or talk about?

22	MR. ANNINOS: Mano, did you -- it looks

23	like you popped up again. Let's go.

2 4	MR. BASU: Yes, I did. Thanks, Paul. Not

25	necessarily around mitigation, but one comment that

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1	we have made through our public comments to the BEs,

2	as well as the revised method, we have suggested the

3	extremely complex tools that have been used for the

4	BEs, the MAGtool and the plant assessment tool, tools

5	like these should be reviewed by a scientific

6	advisory panel as a normal practice. So I just want

7	to reiterate that at the PPDC here. Thank you.

8	MR. MESSINA: Thanks, Mano.

9	Who's going to be brave to talk about this

10	topic? Come on, this is like the topic we need to

11	talk about, right? So let's hear some talk.

12	MR. ANNINOS: Joe Grzywacz, go ahead. You

13	might want to go off mute. Take yourself off mute.

14	We still don't hear you, Joe. Maybe -- Sarah, is Joe

15	on mute?

16	MS. CHADWICK: No, he is unmuted, so we

17	should be able to hear him. I would just recommend

18	to make sure that your mic isn't off on your

19	computer.

20	MR. MESSINA: And, Joe, are you dialed in

21	by your phone or is it possible you're double muted

22	on the phone? Give me a thumbs up. Are you dialed

23	in from the computer? Give me a thumbs up if you're

24	dialed in by computer. Okay. He's on by computer,
2 5	yeah. So...

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1

MR. ANNINOS: Okay. Well, while Joe is

2	figuring that out, Jasmine has popped into the chat.

3	So Jasmine Brown and then we'll come back to Joe.

5	path forward, not just for atrazine, but its

6	breakdown products are sometimes more toxic than the

7	parent compound and so that should be a

8	consideration. Simazine, triazine, and atrazine seem

9	to all have same effects. And this is something I'll

10	bring back to the Tribal Pesticide Program Council

11	for discussion and then, hopefully, they can provide

12	their collective comments back to the group.

13	MR. ANNINOS: Excellent. Thanks, Jasmine.

14	And, Joe, how about now, can you say

15	something and see if we hear you?

16	MR. GRZYWACZ: Can you hear me now?

17	MR. ANNINOS: You bet.

18	MR. MESSINA: Yes, we can hear you now.

19	MR. GRZYWACZ: All right. Sorry about

20	that. And I have to admit, I am totally dumb about

21	all of this stuff. So this question is probably not

22	wisely raised and it may throw oil on fire, but I'm

23	really compelled by Lori Anne's presentation. And it

24	seems as though part of the presentation is sort of

25	the notion of all the litigation that's at play. And

4

MS. BROWN: I just wanted to add that a

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1	so one of the questions that I have is clearly doing

2	away with litigation would be a nice thing, but

3	that's a hard thing to do.

5	what are the different points of view on why the

6	litigation is coming? Because it seems as though

7	industry is happy to play, but yet, you know, who is

8	rendering or who is putting forward the litigation,

9	which groups is it coming from and how is that

10	bogging down the system I guess, is my question.

11	MS. BURD: Ed, do you want to answer that

12	or do you want me to?

13	MR. MESSINA: It's such a great question.

14	Why don't you take a stab? And it's sort of a 30-

15	year history, that you've asked that great question

16	and maybe Lori Anne can talk and then I can fill in

17	some of the gaps. But, please, yeah, Lori Anne, that

18	would be great.

19	MS. BURD: So there has been zero USA

20	compliance except for with litigation. It's the only

21	thing that's gotten any action under the ESA. So

22	we'd be happy not to bring it if there was ESA

23	compliance. But without it, endangered species would

24	be completely ignored. And there is nothing on the

25	schedule that has not been because of litigation.

4

So what is the source -- why -- you know,

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1	And, again, you know, I'll reiterate, we're happy to

2	talk about a schedule any time so we don't have to

3	continue bringing litigation.

5	about the challenges, right? Because you want to

6	talk about sort of past administrations on both sides

7	of the aisle have struggled with this issue, ESA, and

8	this is a 30-year, sort of how do you show that a --

9	let's take an herbicide, for example, that is

10	designed to kill plants won't land on an endangered

11	plant. That's sort of the scientific questions that

12	we're trying to answer in the thousands of pages that

13	are written about that, right?

14	And there's a number of mitigation and

15	approaches you can take. And now we're talking about

16	thousands of species, we're talking about plants and

17	animals and insects, right? So now we have an

18	insecticide that is designed to kill things. It's

19	not an insecticide if it's not killing things. I

20	mean, that doesn't work. So how do you then do that

21	scientific review? That's been the struggle for the

22	last 30 years with multiple administrations.

23	Go ahead, Joe.

24	MR. GRZYWACZ: I'm sorry, but, I mean,

25	again, now we're in a space where I actually know

4

MR. MESSINA: Yeah, so I think I'll talk

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1	something about it and that is this is not unlike the

2	challenges of those of us who do public health

3	research with humans, you know, are kind of grappling

4	with the same question. And it usually comes down to

5	which hegemonic science really has the advantage.

6	You know, is it the basic biology or chemistry or

7	whatever else it is? And what models are those sort

8	of set up upon and the assumptions that we're willing

9	to make or not make?

10	So it seems as though that's the issue at

11	play and it's a matter of not being able to come to

12	consensus on, well, which one is the right one or

13	should there even be a right one.

14	MR. MESSINA: Well, and then so take your

15	point and extrapolate it. It's even developing those

16	methodologies and having scientific consensus around

17	those methodologies for this area where these two

18	things sort of got mashed together, right? And it's

19	an important legal obligation for the agency to

20	satisfy, Endangered Species Act, because as Lori Anne

21	points out, once you're extinct, you're extinct. So

22	we want to make sure we're not contributing to that

23	and we're meeting our ESA obligation.

24	I'll say, you know, I'm hopeful. You know,

25	the fact that we put this on the agenda and the fact

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1	that we've invited Lori Anne, we've invited

2	government, we've invited industry to talk about

3	these issues. This is going to take a collaborative

4	effort. We can keep litigating around it, but that

5	is -- I think everyone's in agreement, that's not

6	going to help solve the problem. And we're not doing

7	a -- we're doing a disservice to those species that

8	need us to focus on this.

9	So I think, you know, going into the next

10	session, which is sort of next steps, we will start

11	seeing some things would come out from the agency on

12	this. There is a willingness to work with industry

13	and the NGOs on this topic, to develop a plan going

14	forward. And let's try to [audio issue] and keep

15	talking about this and maybe that's one of the new

16	workgroups we form for PPDC, right, which is a

17	workgroup that deals with ESA. So it's an important

18	topic.

19	MR. ANNINOS: If you'll note, Gina Hilton

20	has put -- entered something in the chat, a link to

21	EPA cross-species toxicity assessment that might be

22	of interest to folks.

23	MR. MESSINA: Thanks, Gina.

24	MR. ANNINOS: Lori Anne, you put some

25	stakes in the ground in your presentation. No doubt

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1	about it. And you've had a chance to hear Joe's

2	question and Ed's remarks. Anything you'd like to

3	respond with?

4	MS. BURD: Yeah, thank you. I'll just note

5	that the ESA doesn't ask for perfect science. It

6	asks for the best available science. And endless

7	refinements towards perfection are not getting us

8	anywhere. And so we submitted a notice of intent to

9	sue over the revised methods. You'll notice we

10	haven't sued yet because what we want is action and

11	implementation. Obviously, that action still exists,

12	but, again, like, this pursuit of perfection is

13	getting in the way of anything. And so, you know,

14	more stakeholder process, more conversation, I don't

15	think is the solution. I think the solution is a

16	work plan going forward.

17	And, like I said, you know, atrazine shows

18	us that we can eliminate a lot of species from

19	consideration by taking some common sense measures to

20	take them out of play. And I think that there needs

21	to be a lot more consideration of that, because at

22	the end of the day all consultation will result in,

23	you know, it's not going to bring the whole house

24	down, all consultation will result in are some common

25	sense measures, some increased buffers, maybe some

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1	areas where a pesticides can't get used where there's

2	a very narrow endemic, really, you know, steps that

3	protect species and that's it.

5	following what the ESA says, which is consulting on

6	the action, not every possible way the action might

7	play out or has played out, following the best

8	available science that we already have in front of

9	us, rather than continuing to look for more, that's

10	how we find a path forward that will protect species

11	and provide certainty.

12	MS. TORTORICI: So, Paul, I would like to

13	make one comment, which is, you know, I believe that

14	those opinions that we just released, for example,

15	the ones that we just completed in April and now

16	we're putting out in June, are achieving the concept

17	of what we're talking about here in terms of reaching

18	a level of species conservation that makes sense,

19	allowing for flexibility on the part of growers to be

20	able to manage the process that they are going to be

21	using to implement that work, the kind of items that

22	Lori has on this slide about a path forward.

23	These are the kind of conversations that we

24	need to be engaging further in, not only EPA but also

25	with the registrants, because some of this might

4

So getting to that point is the goal and

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1	involve label changes. And so that's the kind of

2	conversation that we're hoping to have with EPA and

3	registrants about not only mitigation measures,

4	conservation measures, but also appropriate label

5	changes that can be brought forward into the process.

6	And then at the end of the day, what you're

7	consulting on is already have a level of protection,

8	because those items have been already built into the

9	action on which we're looking at.

10	And so I think part of the litigation issue

11	has been, yeah, it's like we don't all agree on the

12	science, whoever's suing us, there's a process, we

13	don't all agree on that either. But I think that

14	we're making progress in certain areas. And it's

15	really not about trying to get to a perfect thing.

16	It's about trying to continue to get to a practical

17	workable thing that makes sense in terms of

18	implementing on-the-ground protections to conserve

19	species, and we really are trying hard to do that.
2 0	MR. ANNINOS: Thank you, Cathy.

21	And with Ed's permission -- and I know we

22	originally had a one-hour block for this topic and

23	then we had to kind of shift that a little bit with

24	Dr. Freedhoff joining us after lunch, so what I'm --

25	Lauren -- sorry, how come I'm thinking -- yeah,

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1	Lauren Lurkins and Mano had a couple of comments. Do

2	we have -- can we go ahead and take those?

3	MR. MESSINA: Yes, please.

4	MR. ANNINOS: And then we can close this

5	out.

6	MR. MESSINA: Yeah, I'm not going to cut

7	this conversation short.

8	MR. ANNINOS: Okay, thank you.

9	Go ahead. Lauren, go ahead and go off --

10	Lauren Lurkins, go ahead and go off of mute, followed

11	by Mano.

12	There you are.

13	DR. KUNICKIS: I've not figured out how to

14	get off of mute.

15	MR. ANNINOS: Oh, we can hear you.

16	MR. MESSINA: Sheryl, we can hear you,

17	Sheryl, Dr. Kunickis.

18	DR. KUNICKIS: Oh, did you call me?

19	MR. ANNINOS: Oh, no, no, no.

20	DR. KUNICKIS: Or did you call Lauren?

21	MR. MESSINA: We called Lauren.

22	MR. ANNINOS: Lauren Lurkins. Is Lauren

23	Lurkins in the house?

24	(No response.)

2 5	MR. ANNINOS: Probably on mute or having

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1 trouble unmuting.

2

Let's move to Mano and then maybe, Sarah,

3 you could help Lauren get unmuted.

4

MR. BASU: And I just want to check since

5	Dr. Kunickis is on the line, if she had a comment or

6	not, given Dr. Kunickis' involvement with the ESA

7	process for such a long time.

9 a different computer today, and I don't have any way

10	to raise my hand. So that's why I'm kind of waving.

11	So thank you very much, if you don't mind.

13	acknowledge that over the 11 years I've been working

14	working with -- working with your staff has been

15	incredible. They're very dedicated to making sure

16	that the work they do is very thorough, very well

17	done, and they are credible scientists.

18	The other thing I want to note, too, is

19	that many of us working in this space over the years

20	have looked at the recovery plans on the species, and

21	it's very interesting to note -- and I've talked

22	about this in a previous public meeting and we have

23	noted that pesticides are not generally even listed

24	as one of the stressors for some of the endangered or

25	listed species. As a matter of fact, what we've

8

DR. KUNICKIS: Actually, I did, and I'm on

12

This is mainly for Ed. Ed, I just want to

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1	learned, and we're very much aware of, is that the

2	fact -- and I think every -- Lori Anne and Cathy

3	would agree that the fragmentation of habitat is a

4	huge effort.

6	trying to work on taking care of the species -- and I

7	assure you that I am not aware of anybody who isn't

8	interested in doing that -- that we really should put

9	our efforts toward improving habitat in the areas

10	where species need to be or that they need to thrive.

11	I don't know what problem it is we're trying to solve

12	with going after and spending millions and millions

13	of dollars and hours working on the issue of

14	pesticides and not getting anywhere, where those

15	dollars could be invested on habitat improvements.

16	And then there was one other thing I wanted

17	to mention, also, the question that you asked about

18	measures that that could be done or mitigations that

19	could be done. It's absolutely essential that

20	America's farmers have to be included in looking at

21	what those mitigations are. We've been really

22	challenged with some of what we've seen. What works

23	in the EU does not work for farmers in America. Our

24	farming systems are so very different.

2 5	And so I would hope that everybody would

5

So I would think often that if we're truly

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1	look and make sure that farmers, representatives for

2	growers, are included in any mitigations that are put

3	forward or required to be implemented.

4	That's all I have to say. Thank you for

5	the time. Thanks, Mano, for seeing my hand up.

6	MR. ANNINOS: Thank you, Sheryl.

7	And, Mano, go ahead. We're still working

8	with Lauren on how to release her voice.

9	MR. BASU: Thanks, Paul. And I'll make it

10	quick.

11	Again, it's great to see so many

12	questions/comments coming up. I mean, this is an

13	issue there -- you know, everyone has had challenges

14	with resolving this, making progress. A great

15	presentation from Lori Anne, suggestion on the path

16	forward. Cathy as well. You know, the question is,

17	how could we continue with the discussion on

18	prioritization? How do we start the conversation?

19	I mean, certainly, we have to bring all

20	stakeholders and that's what I mean when, from my

21	presentation, I said broader stakeholder engagement,

22	federal family, growers, registrants, NGOs,

23	mitigation bank, conservation groups and who

24	(inaudible), and how can all of these folks come

25	together focusing on conserving the species,

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1	protecting the species. Because, you know, none of

2	us want extinction of a species. So the focus should

3	certainly be on the species here. Thanks once again,

4	Paul.

5	MR. ANNINOS: Thank you, Mano. Thanks very

6	much.

7	Lauren, let's try you once more, then we're

8	going to go to Iris.

9	MR. ANNINOS: Okay, I think what Lauren's

10	going to try to do now is maybe get her comment or

11	question into the chat window.

12	In the meantime, Iris, you have the mic.

13	MS. FIGUEROA: Thanks. And I'm really

14	heartened to hear that it seems like this is an area

15	where there might be space for collaboration.

16	Admittedly, endangered species is not my area of

17	expertise, but to Sheryl's earlier comment, I think

18	from Lori's presentation and other presentations,

19	it's clear pesticides are not the only factor, but,

20	of course, we're having this meeting under the

21	auspices of OPP. So I think it's absolutely relevant

22	and important and a concern for this group. Whatever

23	those other factors may be, this agency and this

24	office doesn't have authority over many of those

25	other factors.

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1	So we need to really be focused on making

2	sure that the responsibility and the ability and the

3	capacity that we do have within the auspices of OPP

4	and of EPA are really maximized to be able to

5	mitigate some of that damage, again, even though it

6	might not be the sole cause of the damage that is

7	what's within our purview.

8	MR. ANNINOS: Thank you, Iris. Thanks for

9	that comment.

10	Let me give Lauren one more shot of this.

11	We're trying to troubleshoot it behind the scenes,

12	but we are having trouble with that. So let me just

13	pause and see if Lauren is there.

14	Well, here we go. What she's done is she's

15	put her thoughts or a comment into the chat box. Let

16	me read it, if that would help.

17	I would like to offer the perspective of

18	someone who works alongside growers in the middle of

19	the country. FIFRA is complicated. ESA is

20	complicated. Farmers are a bit perplexed by the

21	intersection of the two and particularly the court

22	challenges. At the end of the day, the pesticide

23	products are needed in ag, even as we look to address

24	climate change.

25	Lauren, thanks for contributing that. She

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1	goes on to say, there's also a significant amount of

2	species conservation that occurs due to the action by

3	farmers on their private lands.

4	MS. TORTORICI: So, Paul, maybe Ed wants to

5	say something about this as well but I don't agree --

6	I don't disagree with what Lauren is saying. I mean,

7	part of the dilemma that we're struggling with here

8	is trying to integrate two pieces of legislation that

9	weren't necessarily lined up, per se, when they were

10	developed. Do you know what I mean? So that

11	integration of those two things is simply complex.

12	And, yes, I can certainly appreciate that,

13	you know, from the grower perspective, this might

14	this might look like just a -- I don't even know what

15	it would look like, you know. And so that's why

16	we're trying to figure out ways, not only to

17	understand through EPA, for example, and USDA through

18	Sheryl, you know, what are growers thinking about all

19	of this, but try to pull that information into how

20	we're talking about implementing our work in a way to

21	make it implementable, right? So that it's easier to

22	implement on the ground and then you're going to get

23	the result that you want, because people understand
2 4	it and can embrace it and implement it in a way that
25	makes sense for them.

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1

So there is a role in terms of bringing in

2	individuals like that and groups like that to get

3	that practical approach in the same way that we work,

4	for example, in the Fisheries Service with the

5	fishing industry, right? As we're regulating them on

6	commercial fishing, so we're not doing that in a

7	vacuum, there are fishery management councils that we

8	work with and we work very closely with them in terms

9	of implementation of regulations. So it's an

10	analogous kind of activity that we're trying to do

11	here with all the bumps and the warts and trying to

12	make progress as we move along.

13	But I want to say thank you, Lauren, for

14	that comment because it's right in the bailiwick of

15	what we need to be thinking about to balance out the

16	species conservation aspect with the implementability

17	aspect.

18	MR. ANNINOS: Great point, Cathy,

19	especially this analogy with the fishing industry.

20	It's a harvesting-related industry. There's economic

21	value associated with the take of commercial fish and

22	recreational fishing for that matter.

23	MS. TORTORICI: Yes.

24	MR. ANNINOS: And so constant balance

25	between the economic considerations and the species

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1 protection consideration. So great point.

2

And so we've got to -- boy, I tell you, we

3	definitely didn't reserve enough time on the agenda

4	for this. We got everybody all energized here at the

5	end of the day. I did notice the Jasmine Brown

6	popped into the chat.

9	comment. So we have sampled for atrazine and while a

10	farmer may follow a label and do the application

11	perfectly legally, during rain, we see spikes of it

12	in wells and drinking water. And in our streams,

13	when there's a storm, so there's a lot of rain -- a

14	rain event, we'll see spikes of it. And so these

15	products are very easily displaced from the site of

16	application downstream.

17	And then in drier climates, if we're

18	thinking ahead for climate change -- and just for any

19	registrants on the call, drier areas, there's higher

20	pesticide carryover in drier areas, because there's

21	just not the soil microbes, insects, and rain and

22	things to start breaking those down. Same as Alaska.

23	They have higher persistence because of their cold

24	weather and snow pack. So there's different

25	persistence and different things happening regionally

8

7

Jasmine, a brief comment from you.

MS. BROWN: Yeah, I just wanted to briefly

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1	and just to keep that in mind.

2	The buffers are great. We don't allow

3	picloram or atrazine in any wetlands, period. But,

4	like I said, even if they applied to up to 15 feet

5	away, doesn't mean that's actually protective on the

6	ground for that species. Chances are it will still

7	be displaced in the environment 15 feet away. I'm

8	not saying taking off the market. I'm just saying

9	consider that when you're thinking of how you're

10	going to mitigate it. Thank you.

11	MR. ANNINOS: Thank you very much, Jasmine.

12	So I think one thing I wanted to ask maybe

13	Shannon and Carla, we've got quite a little bit of a

14	conversation going in the chat window. Maybe we

15	could -- I don't think the chat windows are preserved

16	in the recordings. I could be wrong about that, but

17	maybe just grab this chat, copy it and paste it

18	somewhere so -- just in case a workgroup does emerge

19	on this topic, which sounds like there might be some

20	energy behind that based on a question I see from

21	Mano in the latest entry in the chat window. And

22	maybe this also leads into the next segment when we

23	talk about next steps, moving forward, et cetera.

24	Maybe this topic is part of that.

25	But what I think we'll do is because I

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1	think if we just left it open, we could probably

2	stick around for another hour or two talking about

3	this topic. And so I want to suggest unless there is

4	an objection, which is perfectly legit, I'm going to

5	maybe ask Ed if it makes sense for us to move to the

6	next segment of the agenda now and --

7	MR. MESSINA: Yeah, I'll close this out

8	with a couple of comments --

9	MR. ANNINOS: Okay.

10	MR. MESSINA: -- and then we'll move to the

11	next session.

12	And so certainly, you can see why we put

13	this on the agenda. I agree with Sheryl's, Dr.

14	Kunickis', views that the scientists at EPA that are

15	working on this issue are just some of the smartest

16	minds we have in the world. They are dedicated.

17	They've done some incredible work these last couple

18	of years, considering these issues, and they deserve

19	our credit and respect. And so I could not agree

20	with Sheryl more on that issue.

21	I think grower concerns really need to be

22	taken into account in terms of the implementability

23	of mitigation. I know and I've met a number of

24	growers who have ESA pollinator gardens and

25	pollinator strips and areas where they've set aside

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1	to protect species where they need to. So we need to

2	definitely consult with the growers on any aspect of

3	this.

5	stakeholders, which is why I think this is a great

6	venue for us to have this conversation. But there's

7	probably going to be a need for other venues as the

8	agency puts out more policies around this. And I

9	think I -- and hopefully this came through -- I think

10	one of -- rather than, you know, more workgroups and

11	more conversation and -- you know, I'm not implying

12	that that's all we need to do. I think the

13	conversation around what are some early mitigation

14	that we can put in place while we continue to refine

15	the science, which we need to, and while we continue

16	to refine the procedures here is an important aspect

17	of this as well.

18	I think we need to try to find some quick

19	wins here and focus on what we're trying to protect,

20	which is the endangered species, while also

21	preserving tools for growers who desperately need

22	these tools to provide safe food for the citizens of

23	this great country. So it's been a great topic,

24	multiple perspectives that need to be taken into

25	account, and so I appreciate everyone for taking

4

As Mano mentioned, there's multiple

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1	their time to listen to this and also to our speakers

2	for taking the time to prepare remarks and provide

3	your important perspectives on this.

4	So with that, I think we will move on to

5	sort of next steps. I know we've captured aspects of

6	things that we'd like to move forward, but I really

7	wanted to -- a couple of things, to remind folks for

8	the PPDC next meeting, we'll have a similar format.

9	We're going to have the workgroups present. Maybe it

10	will be shorter, but it will be this is what -- the

11	work product that was developed by the workgroup.

12	Suggest that it go to the full PPDC where the full

13	PPDC will recommend yea or nay as to whether those

14	work products should be moved to EPA for

15	consideration, representing the full PPDC consensus

16	on any products that are going to go forward to EPA

17	for consideration on the various workgroups that

18	you've heard from today. So that's going to be one

19	of the main objectives for the next meeting.

20	The other thing is there are certainly some

21	new topics that came up today that we can sort of

22	highlight and talk about whether we add to the next

23	agenda. I think, you know, for example, on the

24	emerging technologies workgroup, we heard that

25	possibly a future topic is hearing from the non-ag

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1	space for emerging technologies. And so maybe if

2	somebody wanted to take the baton to volunteer to

3	take that on and present or find some speakers that

4	could present on those non-ag technologies, we could

5	make that a potential agenda topic.

6	I think we're automatically going to put

7	ESA on just as a topic and then our -- so to the

8	group, are there any tasks, deliverables that you

9	heard, and topics for the next meeting that we want

10	to put on the agenda? And so with that, Shannon's

11	going to take some notes. Feel free to just type it

12	in the chat, too, and we can copy and paste that chat

13	into the document and sort of collect where we want

14	to go moving forward.

15	So with that, I'll stop talking and let

16	others sort of chime in.

17	MR. ANNINOS: I can sense the wheels

18	turning so feel free to keep thinking about this.

19	It's a chance to help shape the agenda for the

20	next --

21	MR. MESSINA: Yes, I think non-ag would

22	include specialty crops. Yes. Sorry. Non-ag is not

23	the best term to use for that. So we could say non-

24	ag and specialty crops. And, Mark, if you're

25	volunteering to present, feel free to indicate in the

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1	comments.

2	All right. So we have from now until the

3	fall. I know there's more topics that folks want to

4	talk about. I don't want to be the only one to

5	suggest them. Maybe there's a presentation from the

6	worker community on what it's like to be -- you know,

7	the challenges that are in the field. Maybe it's a

8	grower who wants to provide information on the

9	challenges for how to comply with labels. Maybe it's

10	a state organization that wants to present on some of

11	the issues on the enforceability of language in the

12	labels.

13	There's lots of expertise out there that I,

14	hopefully, would encourage you to discuss. How does

15	EPA interface with RNAI technology. So I think --

16	let's add a session on biotechnology. I think that

17	we heard from BPIA today, but I think maybe -- I

18	think we could do a presentation on some new

19	activities for biotechnology. That might be a good

20	time in the fall.

21	MR. ANNINOS: Ruben, I see you're lighting
2 2	up.

23	MR. ARROYO: Yeah, Ed, I just wanted to

24	mention, you know, when we talk about label changes

25	and languages, you know, as far as an enforcement

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1	agency, you know, we run into a lot of Spanish-

2	speaking people and, yeah, that would be great. Or I

3	think Mily had maybe mentioned it before about, you

4	know, having our manufacturers or registrants having

5	a link to having it translated in another language.

6	The only question that comes up to me as an

7	enforcement person is the enforcement end of it. So

8	we can have all the label changes we want, it's just,

9	you know, in some states I know there's one state

10	agent or a few for -- that actually do the

11	enforcement versus California where we have close to

12	3- to 400 inspectors out in the field doing pesticide

13	use enforcement. And so that's the big challenge I

14	see in some of these states and districts is who's

15	enforcing it. And, you know, we can make all the

16	label changes we want, but it's the enforcement end

17	of it that we have to deal with.

18	And granted, like I said, California, yeah,

19	you can make the changes and it will happen the next

20	day once we see it on the label, but how do we know

21	who's enforcing it in these other states? And what's

22	the, I guess, the goal and how do we get that

23	outreach out to those enforcement agencies and the

24	state agencies? And how do we know if it's being

25	effective or not, I guess? Because I don't know

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1	about the other states; I just know about California.

2	And maybe you can shed some light as to if

3	we make label changes, how does that occur in the

4	other states, as far as the enforcement end of it.

5	MR. MESSINA: Yeah, and I see Liza chiming

6	in. So maybe there's an AAPCO presentation in the

7	works, Liza. That might be helpful to refresh.

8	MS. FLEESON TROSSBACH: Sure, Ed. I mean,

9	I'm certainly happy to provide that information. I

10	mean, I can speak to it now, but I can certainly

11	provide a broader presentation to the group about the

12	regulatory activities in states and territories.

13	MR. MESSINA: Yeah, why don't we put that

14	on for the fall agenda as a topic for consideration.

15	MS. FLESSON TROSSBACH: Okay.

16	MR. ARROYO: And, Ed, I'd be more than

17	happy to help in giving, you know, at least the

18	California perspective and what we see in our

19	enforcement end of it, along with the California

20	Department of Pesticide Regulation.

21	MR. MESSINA: That would be phenomenal.

22	Thank you, Ruben.

23	MS. BROWN: And, Liza, I'd be happy to give

24	you the updates for the tribes and territories

25	enforcement actions.

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1

MS. FLEESON TROSSBACH: Fantastic. Happy

2 to help there, Jasmine.

3

MR. MESSINA: Shannon, I think another

4	topic we -- I mentioned, just seeing if the group is

5	interested, if there were maybe just 30 minutes on

6	the technological improvements that the agency was

7	trying to undertake in-house to address the

8	registration workflow and workload issues. I had a

9	couple of slides just on the workload issue, but we

10	could expand a little bit on that and maybe even do a

11	demo of the tool if folks are interested. You could

12	say yea or nay in the chat if you don't mind.

13	Okay. Well, I think this was a good start.

14	I want to be sensitive to the fact that we preserved

15	this time for public comments and allow folks to

16	provide that. And we can kind of wrap this up. Any

17	closing comments from anybody? And certainly feel

18	free -- GLP inspection update from OPP. Okay, great,

19	we'll add that and see if our OECA friends are

20	interested in providing an update on that. I think

21	we had had them potentially -- they weren't ready to

22	speak at this session, but I think in the fall, we'll

23	get them geared up and we can have a GLP inspection

24	update from OECA. Yep, thank you, Charlotte.

25	So why don't we close this out. Keep your

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1	ideas coming in the chat and then Shannon will record

2	them and -- risk communication, yep. Thanks. We

3	definitely -- we're going to try to get Casey Buell

4	to present in the fall.

5	And then, of course, as part of the normal

6	procedure we'll send out to this group the list of

7	topics and then have the group decide sort of what

8	are the best issues for the agency to hear about

9	collectively.

10	So with that, we'11 open it up for the

11	public comment period, Paul.

12	MR. ANNINOS: Great. Thank you, Ed, and

13	thank you, everybody. That was a rapid fire set of

14	fodder for the next meeting. So that's excellent.

15	Great job.

16	So we're now prepared to, in this segment

17	of the agenda, which is our final segment -- and

18	after this segment, I certainly will ask Ed to come

19	back and, you know, close out the day or the two days

20	really. But we're in the process now of kind of

21	receiving comments from the public. Earlier today, I

22	checked in with Sarah, with Sarah Chadwick, and she

23	indicated that we had five individuals that had --

24	that are on our list, so to speak, for speaking

25	today.

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1	So just a couple of things. One, I just

2	want to confirm verbally with Sarah while we're

3	online here, is that still the number, Sarah, about

4	five people?

5	MS. CHADWICK: Yes. Last time I checked,

6	there were about five of our preregistered speakers

7	on.

8	MR. ANNINOS: Okay. So if we give each of

9	those people, let's say, three minutes -- three or

10	four minutes apiece that still leaves a little bit of

11	time for anybody that wants to provide "last-minute"

12	public comments. So with no objections, I think

13	that, Sarah, I'd like you to just kind of walk

14	through the instructions for the public comment

15	period. We'll then throw the slide up that shows the

16	five names and then we'll work our way through that

17	list.

18	MS. CHADWICK: Great. Thanks, Paul. So as

19	Paul mentioned, everyone will have three minutes to

20	speak and provide their public comment. I'll give

21	kind of a warning slide when you have about 30

22	seconds left and then once your time is up.

23	We'll start with the names of those who

24	have preregistered to speak and, as Paul said, we'll

25	be showing those on the next slide in a moment. And

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1	we'll be going in alphabetical order by first name.

2	And then if there's additional time, at the end,

3	we'll open the public comment period to those who

4	have not preregistered. And you can identify your

5	interest to speak in two ways. One is by sending a

6	chat message to the host or Sarah Chadwick, and you

7	can use the chat box to do that and let us know that

8	you're interested in making a comment, or you can

9	email Shannon Jewell, and her email address is there

10	on this slide. And if you're interested in speaking,

11	you can also email her and she'll let us know. So I

12	think that covers all the instructions.

13	So I'll pass it back to you, Paul.

14	MR. ANNINOS: Thank you, Sarah.

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1

2

PUBLIC COMMENT PERIOD

3

MR. ANNINOS: And these are the folks that

4	are preregistered, and I'm not sure if you can -- if

5	you can help me. Yesterday, I went down the list and

6	we didn't -- we went pretty far down the list before

7	I got to somebody that was ready to speak. So we can

8	do that again. And we'll just make sure that we get

9	everybody a chance.

10	So Abdeljalil Mekkaaoui (phonetic), are you

11	present and want to speak?

12	(No response.)

13	MS. CHADWICK: I don't see him in the

14	meeting. The first person on our list that I see is

15	Laura Campbell.

16	MR. ANNINOS: Okay.

17	MS. CHADWICK: So I can go ahead and unmute

18	you and you can provide your comment.

19	MS. CAMPBELL: Thank you very much. I

20	appreciate the chance to be able to comment on this

21	process and I also appreciate the commentary and the

22	dialogue that's been going on, especially this

23	afternoon as we've been kind of talking about how to

24	move forward with combining Endangered Species Act

25	regulations with FIFRA pesticide labels and how do

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1 you review registrations.

2

I think Lauren Lurkins said it very well,

3	that, you know, farmers really want clear guidance,

4	and I think we also want a process that we can look

5	back to to say, okay, this isn't just based on

6	estimations, it's not models, it's not something that

7	someone could interpret differently, you know. That

8	we want to be able to look back at evidence and

9	results and know that if we're going to require

10	someone to do something that it's for a reason and

11	not just, you know, because we're taking a

12	precautionary principle to it, you know, but that

13	there's science behind the decisions that we make.

14	So I really -- I have been glad to see that

15	this is a topic that the group wants to continue to

16	work on and wants to continue to have more

17	discussions about to figure out how do we get to that

18	place where these two statutes that don't really fit

19	together very well can hopefully find a process to

20	make not only label restrictions but also the

21	registration review process a little bit more

22	straightforward and a little bit better for farmers

23	trying to use them out in the field. Thanks.

2 4	MR. ANNINOS: Thank you very much, Laura.

25	Sarah, is Olga speaking today?

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1	MS. CHADWICK: I do not see Olga on our

2	list.

3	MR. ANNINOS: Okay. How about —

4	MS. CHADWICK: I also — Ray is on the

5	line, however, he indicated that he will not be

6	making a comment today. Therefore, the next person

7	on our list is Sydney Morgan. Sydney, I'll go ahead

8	and unmute you and you can make a comment.

9	And it looks like Sydney actually just

10	signed off. So I will move down the list to Todd.

11	Todd, you're unmuted, so you may make your

12	comment.

13	MR. SCHOLZ: Well, good -- for me, it's

14	afternoon, I guess it's afternoon for you, too.

15	Thank you for giving me the opportunity to comment.

16	I really learned a lot attending this two-

17	day session. I appreciate all the presentations.

18	They were great. And I just want to remind everybody

19	that, you know, as we use pesticides, there is an

20	economic disincentive to use too much or to use it

21	incorrectly. And so I'm really excited about the

22	upcoming technologies that are available to my

23	producers. And the other thing I -- to be able to be

24	more targeted and be able to only spray where we need

25	to spray.

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1

The other comment that I'd like to say is,

2	you know, one of my farmers reminded me that

3	sustainability isn't just about the environment, it's

4	also about him. So part of what we're trying to do

5	here is keep farmers sustainable. And so sometimes

6	pesticides are necessary, they're needed tools to be

7	able to to do that. And so we appreciate your work

8	and I really appreciate the presentations and the

9	earnestness of everybody involved. Thanks.

10	MR. ANNINOS: Thank you very much. Thank

11	you very much. Mr. Morton.

12	MR. SCHOLZ: I'm Mr. Schultz.

13	MR. ANNINOS: Sorry, Mr. Schultz. Sorry

14	about that. I thought we were -- okay, I messed up.

15	I'm very sorry.

16	MR. SCHULTZ: It's okay. You've done a

17	great job, Paul.

18	MR. ANNINOS: Okay. I'm finishing on a low

19	note, I guess. I'm sorry about that. All right, Mr.

20	Schultz, thank you.

21	Sarah?

22	MS. CHADWICK: We also have William Jordan

23	in the meeting, so I will go ahead and unmute you and
2 4	you can make your comment.

2 5	MR. JORDAN: Thank you for the opportunity

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Committee Meeting

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1	to comment again. I'll be speaking on behalf of the

2	Environmental Protection Network about the ESA path

3	forward.

4	I want to say that I think Lori Anne Burd

5	nailed the problem that's facing EPA and all of the

6	rest of the stakeholders, and that is that pesticides

7	may be harming endangered species and there has

8	simply been, over the last 30 years, no effective way

9	of identifying those problems and putting in place

10	measures to protect the species. And that is

11	something that really has to change.

12	For the first time, although I worked on

13	this for 30 years and really made no progress, I'm

14	encouraged. And I'm encouraged because I've heard

15	today interest on the part of the pesticide

16	registrant community, on the part of NGOs, on the

17	part of agriculture, on the part of EPA and the

18	services to get together and figure out a new way.

19	And I think that new way has to start with setting

20	priorities.

21	Currently priorities are based on

22	litigation and that is, at best, a very poor way of

23	doing it. There should be, I think, a better

24	scientifically based way of setting priorities. And

25	I want to suggest that there are three elements that

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1	should be considered in this. First of all, what

2	chemicals do you look at? You probably want to focus

3	on the chemicals that pose the biggest risk because

4	of their inherent toxicity and their widespread use.

5	Second, you want to focus on the species that are

6	probably at biggest risk, the ones that are most

7	sensitive, the ones that have the least -- the

8	poorest chances of survival. And third, and this is

9	a new idea that I understand from both things that

10	Cathy Tortorici and Lori Anne Burd said, you want to

11	focus on the risks that are the biggest.

12	One of the problems that has affected the

13	scope of the biological evaluations is that EPA is

14	chasing after not only direct effects, but also

15	indirect effects that vastly complicates the analysis

16	and means more and more work needs to be done. If

17	you zero in on direct effects, using information that

18	EPA already has you will identify, I think, the most

19	risky chemicals to the most sensitive species,

20	certainly obvious things, as Ed Messina said, like an

21	insecticide that's used in the areas where endangered

22	insects are found and that in turn, I think, can lead

23	to the kind of ideas that Cathy Tortorici was talking

24	about for identifying protective measures earlier in

25	the process.

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1	I want to end by one more note on this kind

2	of approach. This is a fairly big approach and I'm

3	not sure everybody will agree. That's why everybody

4	needs to talk about this and work through this and

5	exchange ideas. So some sort of collaborative

6	process, I would say that based on my experience, the

7	FIFRA 88, the FQPA amendments and the PRIA amendments

8	all were successful because of that collaborative

9	process, but all of them were mediated through

10	external stakeholder collaborative processes. And

11	that's probably what's needed here. A PPDC

12	workgroup, for all that I respect the PPDC process,

13	seems to me to be not the right kind of vehicle for

14	that. And so I encourage people to pursue a

15	collaborative mediated public dialogue kind of

16	process that involves a broad range of stakeholders.

17	Last thing I want to talk about is the

18	point raised by Mr. Arroyo and Ms. Trossbach, and

19	that has to do with compliance. I think one of the

20	assumptions that EPA makes about its label changes is

21	that people will comply. And EPA should know, from

22	its experience with resistance management's programs,

23	as well as state reports on enforcement activities,

24	is that not everybody does. And I think EPA lacks

25	information, critical information about the extent of

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1	compliance. And so understanding the effectiveness

2	of enforcement programs and then bringing that

3	information back to the risk assessment process will

4	be essential to understanding whether the measures

5	that EPA decides are necessary to address pesticide

6	risks are actually going to be effective. Thank you.

7	MR. ANNINOS: Jordan, thank you very much.

8	That's the entire list we have in front of

9	us, but I should pause just in case, Shannon, if

10	you've gotten any emails or, Sarah, if you've gotten

11	any private messages from anybody else who would like

12	to speak.

13	MS. CHADWICK: I have not received anything

14	in the chat so far.

15	MS. JEWELL: No, not for me, Paul. Sydney

16	Morton did email me just to say that he had no

17	comment, but wanted to say that he was really

18	appreciative of the presentations today.

19	MR. ANNINOS: Okay, very good.

2 0	MS. JEWELL: She. I think Sydney was a

21	female.

22	MR. ANNINOS: Okay, got it. Thank you.

23	All right. So, Ed, before I hand it over

24	to you to close out, I just wanted to thank you and

25	your office, of course, for sponsoring the PPDC,

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1	sponsoring this two-day meeting and all the

2	transparency of the work performed by the committee,

3	by the workgroup members, by your professional staff,

4	et cetera. So thank you very much for that.

5	And a special thanks, of course, to Shannon

6	and Clara behind the scenes for their kind of expert

7	work in designing not only a realistic agenda, but an

8	engaging agenda.

9	And thank you Sarah Chadwick for a great

10	job kind of managing this engagement platform for the

11	meeting today.

12	And to all the workgroup co-chairs and

13	their leadership in making these days very

14	productive.

15	So thanks to everybody. And I'll turn it

16	over to Ed for a final closeout.

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CLOSEOUT/REMARKS

2

MR. MESSINA: Well, thanks, and back at

3	you, Paul for the thank yous coming your way for

4	facilitating. I think it was a really a great

5	addition to have you and your team here. Shannon and

6	Carla, for all the technological wonders you've done.

7	I know COVID sometimes feels like one endless Zoom

8	meeting or, you know, teleconference meeting and, you

9	know, kudos to you guys, for everyone on this call

10	for hanging on for two days while we did have a great

11	discussion. So the technology worked and held up in

12	many cases and I think that's a testament to the

13	great behind-the-scenes work that's been going on.

14	So I want to thank each and every PPDC

15	member for attending. I want to really thank the

16	workgroup leads. I know how much work goes into

17	that, watching Mano manage that group for me, who's

18	been doing a lot of work there on the emerging

19	technology group, and there's lots of folks who are

20	pitching in. So thank you for really being a sort of

21	contributing member to those groups and particularly

22	to the heads of those.

23	Members of the public, all the different

24	stakeholder communities that came here today to

25	discuss and debate these important issues, your

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1	engagement here will really help EPA make sound

2	decisions in the future and help us tackle some of

3	the toughest issues that we have to. And I so really

4	appreciate you hanging on here for the whole

5	presentation and in both days.

6	Looking forward to doing this at some point

7	in person where we can not have to do the virtual

8	hands going across the screen to clap for everyone.

9	But thanks again, everyone. And hopefully have a

10	safe and healthy summer and we will see you guys in

11	the fall. So thanks. Take care.

12	(Day 2 adjourned.)

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