U.S. ENVIRONMENTAL PROTECTION AGENCY

PRESENTATION OF THE APPROACH

TO REEVALUATE ATRAZINE

U.S. EPA

One Potomac Yard, South Building

2777 South Crystal Drive

Arlington, Virginia 22202

NOVEMBER 3, 2009

9:03 A.M.THE APPROACH TO REEVALUATE ATRAZINE 11/03/09 CCR#16343 -1 2

1

2 PRESENTATION OF THE APPROACH

3 TO REEVALUATE ATRAZINE

4 OPEN MEETING

5 November 3, 2009

6 MR. BAILEY: Good morning, everyone. My

7 name is Joe Bailey, and I'll be serving as the

8 Designated Federal Official for this FIFRA Scient ific

9 Advisory Panel meeting.

10 The topic for this meeting is

11 presentation of the approach to reevaluate atraz ine. I

12 might add that this is an informational meeting to

13 present the plan for reevaluation in 2010.

14 As the Designated Federal Official, I

15 serve as a liaison between the Agency and the pu blic

16 and the panel to ensure that all FACA requiremen ts are

17 met.

18 Dr. Heeringa, sitting next to me, will

19 be serving as the chair for this meeting, and th e panel

20 only provides independent, scientific peer revie w and

21 advice...and advice to the Agency on pesticide i ssues.

22 The panel only provides advice and recommendatio ns, and

23 EPA does all the regulatory and decision making and

24 implementation authority associated with pestici de

25 issues.THE APPROACH TO REEVALUATE ATRAZINE 11/03/09 CCR#16 343-1 3

1 This meeting does provide an opportunity

2 for public comment. I think it's projected to beg in

3 about 9:30 this morning. I have a number of peopl e who

4 have requested to make comments ahead of time, an d if

5 there's anyone else in the audience that wishes t o make

6 public comments, please let me or anybody else on the

7 SAP staff here know, and if you do walk up and re quest

8 to comment this morning, we'll have to limit your time

9 to five minutes or...or fewer.

10 We have a public docket associated with

11 the meeting as well. A number of comments have b een

12 submitted to that. It is accessible to the publi c,

13 and...and the presentations and any other materi al that

14 is brought forward during this meeting will be p laced

15 in that docket and available to the public withi n a few

16 days as well.

17 After the meeting is over, we will

18 prepare a meeting minutes or report, and that al so will

19 be available on the web site and...and in the pu blic

20 docket.

21 And I think at this point, I will turn

22 the meeting to the chair, Dr. Heeringa.

23 DR. HEERINGA: Thank you very much, Joe.

24 And as Joe mentioned, I'd like to welc...welcome all of

25 you to this administrative meeting of the FIFRA ScienceTHE APPROACH TO REEVALUATE ATRAZINE 11/03/09 CCR#16 343-1 4

1 Advisory Panel with the subject and a briefing on the

2 presentation of the approach to reevaluate atrazi ne.

3 Before we begin, I'd like to have the

4 members of the permanent FIFRA Science Advisory P anel

5 introduce themselves and begin with Dan Schlenk.

6 DR. SCHLENK: Good morning. My name is

7 Dan Schlenk. I'm a professor of aquatic ecotoxico logy

8 at the University of California at Riverside in t he

9 Department of Environmental Sciences. My areas of

10 expertise are primarily mechanisms of action, me rging

11 contaminants, and pesticides in aquatic organism s.

12 DR. HEERINGA: And I am Steve Heeringa,

13 the chair, currently, of the FIFRA Science Advis ory

14 Panel. I'm a research scientist and professor at the

15 University of Michigan. I'm an applied statistic ian by

16 training.

17 DR. POPE: Good morning. I'm Cary Pope.

18 I'm a professor of toxicology at Oklahoma State

19 University Center for Veterinary Health Sciences . I'm

20 a neurotoxicologist, and my primary interest is in

21 toxicity of pesticides.

22 DR. PORTIER: Good morning. I'm Ken

23 Portier, Director of Statistics at the American Cancer

24 Society national home office in Atlanta. I'm an

25 applied biostatistician with 30 years of experie nce inTHE APPROACH TO REEVALUATE ATRAZINE 11/03/09 CCR#16 343-1 5

1 agriculture and public health.

2 DR. CHAMBERS: I'm Jan Chambers. I'm a

3 professor at the College of Veterinary Medicine a t

4 Mississippi State University. I'm a pesticide

5 toxicologist with emphasis on neurotoxicology and

6 metabolism.

7 DR. BUCHER: I'm John Bucher. I'm the

8 associate director of the National Toxicology Pro gram

9 in Research Triangle Park at NIEHS. I have a gene ral

10 interest in all kinds of issues related to toxic ology

11 and...and carcinogenesis.

12 DR. HEERINGA: Thank you very much,

13 members of the panel, and I think at this point, with

14 those introductions, that we're ready to begin, and I'd

15 like to turn first to Steve Bradbury who is depu ty

16 director of the Office of Pesticide Programs in the

17 EPA. Good morning, Steve.

18 DR. BRADBURY: Thank you, Dr. Heeringa,

19 and I'd like to welcome the panel to today's mee ting

20 and also thank Joe Bailey and the staff of the O ffice

21 of Science Coordination and Policy for helping t o

22 organize the meeting today.

23 I'd also like to introduce some of the

24 colleagues with me today before I just give a br ief

25 little background to today's meeting. Dr. Tina L evineTHE APPROACH TO REEVALUATE ATRAZINE 11/03/09 CCR#16 343-1 6

1 will be speaking after...after I finish my commen ts as

2 the director of our Health...Health Effects Divis ion.

3 Next to her is Don Brady who's the

4 director of our Environmental Fate and Effects

5 Division. Elaine Francis, Dr. Elaine Francis from

6 Office of Research and Development is the nationa l

7 program director for ORD's pesticides and toxics

8 research. And Dr. Ed Ohanian, to my left, is the

9 director of the Health and Ecological Criteria Di vision

10 in the Office of Water.

11 As we'll be discussing briefly this

12 morning, the science review plan that will be

13 undertaken during 2010 includes close collaborat ion

14 with our colleagues in the Office of Research an d

15 Development and the Office of Water, so I wanted to

16 make sure they were here with us today as...as w e go

17 forward and outline what we'll be doing over the course

18 of the next year or so.

19 Tina...when...when Dr. Levine gives her

20 comments, she'll introduce the members of our te am or

21 our team leaders who will be taking the point in ...in

22 going through the...the peer review process over the

23 next year or so.

24 As Joe indicated, today's meeting is an

25 informational meeting. It's a meeting where we'r e...weTHE APPROACH TO REEVALUATE ATRAZINE 11/03/09 CCR#16 343-1 7

1 want to share with you in words to complement wha t's in

2 text with the paper that you all received about a month

3 ago which is describing the...the science review plan

4 over the course of the next year. So, the purpose of

5 today's meeting isn't to get into the scientific issues

6 associated with the upcoming peer review but to p rovide

7 some context to the peer review and discuss, broa dly,

8 sort of the scope of each of the three peer revie ws

9 that we'll be having during the course of the

10 coming...coming year.

11 What I'd like to do is just spend a few

12 minutes providing a little context on...on atraz ine and

13 its regulatory history. We'll touch on some of t he

14 previous Science Advisory Panel reviews that we' ve had,

15 and then I'll turn it...turn it over to Dr. Levi ne who

16 can go into a little bit more detail on the cont ext

17 of...of the upcoming year.

18 Atrazine was first registered, actually,

19 by USDA back in 1958 as a herbicide, a broad spe ctrum

20 herbicide. It's used both at plant and post-plan t,

21 and, currently, it's primarily used in corn, sor ghum

22 production, sugarcane and, to some degree, in tu rf,

23 especially in the southeast.

24 In the early '80s, in 1983, EPA issued a

25 registration standard which was some of the earl yTHE APPROACH TO REEVALUATE ATRAZINE 11/03/09 CCR#16 343-1 8

1 phrases associated with the registration process and

2 the re-registration process, and at that time, th e

3 Agency indicated that it wanted to keep track of the

4 potential of cancer, carcinogenicity of atrazine, and

5 also indicated the importance of groundwater and

6 surface water protection with the use of atrazine

. 7 Throughout the 1990s, there were a

8 series of voluntary adjustments to the label or t o the

9 use practices of atrazine, and these primarily fo cused

10 on risk reduction measures to ensure minimal exp osure

11 to surface water and groundwater, particularly i n the

12 context of drinking water sources.

13 And associated during the time frame of

14 the 1990s, there were rate reductions, setbacks from

15 wells, setbacks from stream banks and...and wate r

16 bodies. Also at that time, the compound received a

17 restricted use classification for just about all of its

18 uses, and in large part, that was involving the need to

19 try to keep the product from getting into the wa ter due

20 to runoff.

21 In 1994, the Agency initiated a special

22 review for not only atrazine but the other triaz ine

23 herbicides, and the focus of that special review was

24 around the potential for atrazine to cause cance r as

25 well as the importance of minimizing exposure ofTHE APPROACH TO REEVALUATE ATRAZINE 11/03/09 CCR#16 343-1 9

1 atrazine to groundwater and surface water.

2 As we move from the '90s into the early

3 2000s, there were two SAPs that were held, one in 2000

4 and one in 2003. Essentially, the outcome of thos e

5 Science Advisory Panel reviews was that atrazine was

6 not likely to be carcinogenic in humans, and so, the

7 concern about carcinogenicity was researched and

8 studied during the '80s, during the '90s, leading to

9 the SAP recommendations in 2000 and 2003 looking at

10 prostate cancer, but sort of reaching the conclu sion

11 that it was not likely that atrazine was carcino genic

12 in humans.

13 In January of...of 2003, the Agency

14 issued an IRED, an Interim Re-registration Eligi bility

15 Decision which culminated much of the science th at had

16 been developing over the last ten years. In that

17 decision, we re-registered the product and incor porated

18 some of the additional mitigations that I've des cribed

19 before in terms of protecting groundwater and su rface

20 water, also some additional protections for work ers as

21 well. And at that time, we also...the Agency als o

22 established a drinking water monitoring program to

23 ensure the concentrations of atrazine in drinkin g water

24 source waters as well as finished water did not reach

25 our levels of concern.THE APPROACH TO REEVALUATE ATRAZINE 11/03/09 CCR#16 343-1 10

1 In October of 2003, we issued a revised

2 IRED or Interim Re-registration Eligibility Decis ion

3 which included a memorandum of agreement with the

4 registrants to sort of memorialize the monitoring

5 programs for drinking water. It also established a

6 monitoring program associated with ecological sys tems,

7 in particular, assessing whether or not atrazine was

8 reaching levels of concern in terms of protecting

9 aquatic communities. Also, that IRED in October o f

10 2003 summarized where we were in terms of lookin g at

11 the potential effects of atrazine on amphibian g onadal

12 development as well.

13 In 2006, the Agency issued a triazine

14 cumulative risk assessment, and so, the atrazine

15 Interim Re-registration Eligibility Decision bec ame a

16 Registration Eligibility Decision, because the

17 cumulative assessment had been completed for the

18 triazine herbicides.

19 Right now, atrazine is scheduled to

20 initiate registration review in...in 2013.

21 Now, through all this time frame of the

22 '80s and '90s into...into where we are today, as you

23 all know, if not directly at least from your

24 colleagues, your predecessors on the Science Adv isory

25 Panel, we spent a lot of time going through a nu mber ofTHE APPROACH TO REEVALUATE ATRAZINE 11/03/09 CCR#16 343-1 11

1 issues with the Science Advisory Panel to help gu ide us

2 in...in interpreting the science and...and, ultim ately,

3 to inform our decisions, and let me just do a qui ck

4 snapshot on some of those previous SAPs.

5 I mentioned the...the efforts to better

6 understand the potential of atrazine to cause can cer

7 and what some of its mechanisms and mode of actio n may

8 be. There were peer reviews in 1998 as well as 20 00

9 that led us to the conclusion, with your advice a nd

10 counsel, that the neuroendocrine mechanisms of a ction

11 likely associated with atrazine with the cancer

12 observed in rodents is probably not...is likely not to

13 be operable in humans. However, the neuroendocri ne

14 mode of action was an important mechanism for us to

15 focus on in terms of our risk assessment in huma n

16 health protection.

17 So, we went through that 2000 SAP, the

18 conclusion that atrazine's mechanism of action w as

19 likely associated with the neuroendocrine mechan ism of

20 action. The cancer observed in rodents probably was

21 not likely relevant in humans because of the

22 differences in the biological models but focusin g on

23 that neuroendocrine mechanism of action as initi ating

24 events as being the focus of...of the risk asses sment

25 which was the focus, then, of that IRED in 2003.THE APPROACH TO REEVALUATE ATRAZINE 11/03/09 CCR#16 343-1 12

1 In 2002, we also had a Science Advisory

2 Panel looking at the cancer issue in, for example , 3 prostate cancer, looking at a study in a manufact uring

4 plant where atrazine was manufactured to determin e

5 whether or not there was an association between

6 prostate cancer and atrazine exposure. The conclu sion

7 of that SAP in followup work was that it was not likely

8 that atrazine was associated with the prostate ca ncer

9 for the workers in that plant. However, the Agenc y

10 continues to monitor the literature in terms of

11 atrazine's potential cancer effects which I'll t ouch

12 upon in a little bit.

13 In addition to the...the reviews

14 regarding human health, we also through the 2000 s met

15 with you four times to discuss atrazine's potent ial

16 role in terms of ecological effects and risk, an d there

17 were two Science Advisory Panels discussing...ex ploring

18 the potential of atrazine to cause gonadal

19 developmental effects in amphibians.

20 In 2003, we had an SAP that looked at

21 literature that had been published at the time a nd

22 proposed that the literature established a stron g

23 hypothesis that atrazine may be able to cause am phibian

24 gonadal development effects, and we proposed a r esearch

25 or a study design to you to follow up on thatTHE APPROACH TO REEVALUATE ATRAZINE 11/03/09 CCR#16 343-1 13

1 hypothesis, and we sort of worked through that.

2 And then, with your advice on that study

3 protocol, asked the registrant, required the regi strant

4 to do that study protocol and then came back in 2 007

5 with the results from that study as well as other

6 literature that had been published in the open

7 literature since that time and concluded from tha t peer

8 review that at least up to 100 ppb atrazine, we w eren't

9 seeing effects on gonadal development. But again,

10 focusing on ongoing research as it gets publishe d in

11 the literature since 2007.

12 We also spent some time, two SAPS, one

13 in 2007 and one just this last spring, looking a t the

14 effects of atrazine on aquatic communities, in

15 particular, getting feedback on how to interpret

16 effects of atrazine on aquatic communities and h ow to

17 integrate that with the monitoring program to he lp

18 elucidate where there may be vulnerable watershe ds in

19 terms of...of atrazine exposure.

20 Given sort of where we are in the state

21 of the science, our focus for 2010 is to focus o n the

22 human health effects as our...as our area of emp hasis

23 as we go into 2010, and we'll revisit some of th e

24 ecological effects after we get through the...th e human

25 health effect risk assessments.THE APPROACH TO REEVALUATE ATRAZINE 11/03/09 CCR#16 343-1 14

1 So, what will be...if I could have the

2 next slide forwarded please...what our white pape r

3 describes is a series of...of three peer reviews

4 over...over 2010. We'll just wait a second and se e if

5 this slide will come up. There you go...so there will

6 be a series of three Science Advisory Panel meeti ngs,

7 one in February 2010, one in April of 2010, and o ne in

8 September of 2010.

9 As we put forth our science...our review

10 plan, we wanted to take advantage of...of SAPs t hat we

11 already had scheduled. As you know, in February 2010,

12 we already had a Science Advisory Panel meeting

13 scheduled on the issue of how to incorporate

14 epidemiological studies with experimental studie s and

15 how to develop those lines of evidence and integ rate

16 those lines of evidence.

17 And what we've done is added a case

18 study to that February SAP which will look at so me

19 recent epidemiological studies associated with a trazine

20 and get some advice not only on those studies bu t also,

21 more broadly, methodological insights into how t o

22 integrate different kinds of epidemiological stu dy

23 designs as well as, more broadly, how to integra te

24 epidemiological studies with experimental studie s.

25 So, in a sense a building block as weTHE APPROACH TO REEVALUATE ATRAZINE 11/03/09 CCR#16 343-1 15

1 move throughout...through the year. That panel me eting

2 will also include some discussion around the

3 agricultural health study and how to take a look at

4 different ways of estimating exposure in differen t

5 kinds of epidemiological studies and how to integ rate

6 some of that information.

7 In April 2010, we'll focus on

8 experimental studies, both in vitro and in vivo

9 studies, and review the previous risk assessment,

10 review any new information that's come out since that

11 time, and take a look at some of the critical as pects

12 of hazard identification, dose response relation ships,

13 as Tina will describe in a bit more detail.

14 We'll also take a look at how our

15 toxicological interpretation influences sampling

16 designs in terms of monitoring drinking water so urces

17 to ensure the frequency of sampling matches the

18 dosimetry that we're elucidating through the

19 toxicological studies.

20 So, that's a new review that wasn't

21 scheduled previously.

22 The September 2010 SAP, again, will

23 build on an SAP that was already scheduled. As I

24 mentioned before, we continue to look at the pot ential

25 of atrazine to cause cancer. As I said, we'veTHE APPROACH TO REEVALUATE ATRAZINE 11/03/09 CCR#16 343-1 16

1 determined that atrazine is not likely a human

2 carcinogen.

3 However, we wanted to keep track of

4 epidemiological studies as they progress and,

5 particularly, the ag health study which has two o r

6 three studies that we anticipate being published this

7 spring or summer which will be very important to take a

8 look at the cancer issue.

9 So, in 2010, we'll not only take a look

10 at the ag health study; we'll look at other epi studies

11 in terms of cancer, non-cancer, integrate that w ith the

12 animal or the experimental toxicology studies, a nd try

13 to bring it all together in September, 2010.

14 In closing, before I turn it over to

15 Tina, I just want to indicate that as we approac h this

16 peer review process, we'll be taking advantage o f

17 Agency guidance in terms of how we do risk asses sments,

18 in terms of the NAS.

19 And the risk assessment paradigm, using

20 our risk characterization handbook in terms of e nsuring

21 transparency and clarity, consistency, reasonabl eness

22 in how we interpret our assumptions and integrat e the

23 data and also be taking a look at the National A cademy

24 report on 21st century toxicology, the importanc e of

25 toxicity pathways, and how to interpret the info rmationTHE APPROACH TO REEVALUATE ATRAZINE 11/03/09 CCR#16 343-1 17

1 that will be before us.

2 So, with that, unless there are any

3 clarifying questions, I'll turn it over to Dr. Le vine

4 now.

5 DR. HEERINGA: Thank you, Dr. Bradbury.

6 Dr. Levine?

7 DR. LEVINE: Thank you. I would also

8 like to thank the panel for all the time and effo rt you

9 bring to bear on our risk assessments, and your i nput

10 is critical to ensuring that our risk assessment s are

11 transparent and are based on strong science.

12 And I would like to introduce at least

13 the shell of the team. There's going to be a lot of

14 people in HED working on this over the next year . I

15 would like to introduce the...the leads for the

16 project. First, Dr. Anna Lowit who's to the left of

17 Steve Bradbury is going to be the overall lead f or the

18 three SAPS, and she also has the lead on the Feb ruary

19 meeting.

20 And next to her is Dr. Elizabeth Mendez

21 who is taking the lead for the April meeting tha t's

22 going to look at the laboratory data.

23 And to the left of Ed Ohanian is soon24 to-be Dr. Carol Christiansen who's finishing her Ph.D.

25 in epidemiology and is going to take the lead on theTHE APPROACH TO REEVALUATE ATRAZINE 11/03/09 CCR#16 343-1 18

1 September meeting.

2 So, this is going to be...these are

3 going to be our principal players, but there are going

4 to be a lot of people going through a lot of stud ies

5 and working through the issues.

6 And I...a lot of this I think Steve has

7 touched upon and I will be brief, but as Steve sa id, we

8 signed the...the atrazine RED in 2003, and we use d the

9 best available science at the time to support the RED,

10 and we used well accepted and publicly vetted Ag ency

11 guidance in the way we approached it and also ha d three

12 SAPS on the human health side, the one in 1998 t hat

13 looked at the mammary gland tumors in rats, the one in

14 2000 that looked at the neuroendocrine mode of a ction,

15 and the 2003 SAP on epidemiology of prostate can cer.

16 We based our...our science on a mode of

17 action approach as the foundation for our dose r esponse

18 and extrapolation from animals to humans and amo ng

19 humans, and the 2000 SAP supported this approach , and,

20 basically, we believe that atrazine works via a

21 neuroendocrine mode of action which ultimately l eads to

22 the various toxic effects that are seen in the a nimal

23 data.

24 And as our point of departure, we used

25 attenuation of the pre-ovulatory luteinizing hor moneTHE APPROACH TO REEVALUATE ATRAZINE 11/03/09 CCR#16 343-1 19

1 surge as a biomarker of disruption of hypothalami c

2 function, and that's what we are basing...based o ur

3 risk assessments of various scenarios on.

4 In this year-long review, we'll be

5 looking at a thorough, objective review of new sc ience

6 and integrating it into the existing science that we

7 based our 2003 RED on.

8 We'll be placing emphasis on evaluating

9 mode of action and action pathways to toxicity, b ecause

10 we believe that understanding how a chemical wor ks in

11 the body will help us better interpret dose resp onse

12 data, life stage susceptibility, and the factors that

13 lead to susceptibility, and also that mode of ac tion

14 provides a strong science for explicitly conside ring

15 human relevance, the relevance of animal data to ...to

16 human health effects.

17 We'll be reconsidering all aspects of

18 the hazard assessment, specifically, the critica l

19 effects used to extrapolate risk, the points of

20 departure used for the margin of exposure calcul ation

21 and the relevant durations of exposure, and, fin ally,

22 the...the life stage susceptibility and what imp acts

23 the statutory requirement for the 10x factor to protect

24 infants and children unless we have strong scien ce

25 that, data that allows us to change that..THE APPROACH TO REEVALUATE ATRAZINE 11/03/09 CCR#16 343-1 20

1 And as Steve mentioned, we're doing this

2 through three SAPs, and so the rest of this talk is to

3 basically try to provide a little bit more detail on

4 the three SAPs.

5 Again, the February meeting has...has

6 always been on the schedule, and it really has a

7 broader purpose than just atrazine, but some of t he

8 atrazine data fits very well into the broad purpo se of

9 the February meeting.

10 We had planned to do this meeting for a

11 while, because especially with all of the data c oming

12 out of the Ag Health Study which is a rather maj or

13 prospective study of 90,000 certified pesticide

14 applicators from North Carolina and Iowa, that's a

15 collaboration between NCI and NIHS and EPA, both the

16 pesticide program and the ORD scientists, we've been

17 getting information and we're getting regular up dates

18 on various outcomes of the epidemiological prosp ective

19 study, and we realized that we needed to develop a

20 framework for incorporating this data...these da ta into

21 our risk assessments.

22 So, what we plan to do in February is

23 develop a white paper framework based upon...bui lding

24 on the human relevancy framework that the Agency

25 already has, and...and that was a big part of wh at weTHE APPROACH TO REEVALUATE ATRAZINE 11/03/09 CCR#16 343-1 21

1 were planning to do in February, and we wanted to

2 basically vet this framework with some case studi es.

3 And our framework is going to use, you know, weig ht of

4 evidence approach and best available information for

5 humans and animals, and will again, as I said,

6 emphasize mode of action and toxicity pathways, a nd

7 it's quite consistent with guidance that's alread y out

8 there that maybe doesn't specifically address a l ittle

9 of the epidemiology data that may be coming down the

10 pike.

11 And we also wanted to take advantage

12 of...of increases of incident data. We've been b eefing

13 up our ability to analyze the data that we have

14 from...from our 6A2 incident reporting and also from

15 poison control center data, and so, we wanted to use

16 this SAP to try and evaluate that, too.

17 So, we're going to have three case

18 studies, and the first case study will be the at razine19 related case study, a review of several recent

20 epidemiology studies that have been fairly well

21 publicized and have come to our attention. And m ost of

22 these, I think, are in the category of

23 hypothesized...hypothesis generating, some, a lo t of

24 them are ecologic, and we will be soliciting com ments

25 from the panel on ways to consider these types o fTHE APPROACH TO REEVALUATE ATRAZINE 11/03/09 CCR#16 343-1 22

1 studies in risk assessment.

2 And then, the second case study is going

3 to involve the Ag Health, but it's not...it's goi ng to

4 be actually the exposure part of the Ag Health. W e're

5 going to be...we're in the early stages of perfor ming a

6 side by side comparison of the exposure assessmen t

7 approaches used in the Ag Health study to those t hat

8 OPP routinely uses. And the second component of t he

9 exposure assessment case study involved evaluatin g co10 exposure to multiple pesticides.

11 The third case study will involve a

12 retrospective analysis of reported human inciden ts from

13 exposure to an organophosphate pesticide that

14 historically has been used in residential settin gs.

15 It's important for the panel and the

16 public to keep in mind that although the Februar y SAP

17 will explicitly involve consideration of some at razine

18 epidemiologic studies, there really is a broader intent

19 for this meeting.

20 The second SAP in 2010 is planned for

21 April and will focus on experimental laboratory

22 studies, from both in vitro and in vivo situatio ns, and

23 we will discuss our preliminary considerations f or the

24 updated hazard identification and dose response

25 characterization. And as I will discuss in a fewTHE APPROACH TO REEVALUATE ATRAZINE 11/03/09 CCR#16 343-1 23

1 minutes, we will also be discussing...and, actual ly,

2 Steve mentioned it... that we'll also discuss som e of

3 the drinking water monitoring issues.

4 We will be performing a comprehensive

5 literature review of studies related to human hea lth

6 for atrazine. The April meeting will focus on our

7 preliminary evaluation of these studies.

8 As I noticed...I noted a few minutes

9 ago, we're going to emphasize mode of action as a

10 starting point for thinking about the dose respo nse and

11 life stage susceptibility, and we will also cons ider

12 those studies used in the 2003 assessment as wel l as

13 more recent studies investigating a variety of

14 hypotheses. For example, we have identified new

15 studies on mammary gland development, neurotoxic ity,

16 endocrine disruption, immunotoxicity, and studie s on

17 atrazine metabolites that we will be considering

. 18 In April, we will be soliciting comments

19 on our preliminary review of the updated critica l

20 effects and our preliminary evaluation of dose

21 response. And one of the key areas of interest i n the

22 new analysis will be evaluating life stage effec ts and

23 considering the factors that lead to life stage

24 susceptibility as we think about the science tha t

25 informs the FQPA 10x factor.THE APPROACH TO REEVALUATE ATRAZINE 11/03/09 CCR#16 343-1 24

1 As Steve told you a few minutes ago, the

2 temporality of the critical effect is an importan t

3 aspect of this risk assessment. This is because

4 monitoring frequency for community water systems should

5 be related to toxic effects being used to develop the

6 human health risk assessment.

7 In light of this, we'll be putting a lot

8 of focus during our analysis on considering

9 developmental windows of susceptibility, time cou rse of

10 toxicokinetic and toxicodynamic factors.

11 Drinking water exposure is the major

12 pathway by which people are exposed in the Unite d

13 States to atrazine. Temporal window is relevant for

14 toxicity endpoints that inform the exposure asse ssment.

15 Specifically, in a case where acute effects are of

16 greatest concern, monitoring must be done more

17 frequently to ensure that the peaks are detected and

18 also if chronic effects, like cancer, are of gre atest

19 concern, then monitoring can be done less freque ntly.

20 For the September meeting, the Agency

21 will solicit comments from the SAP on three area s,

22 epidemia out...epidemiological studies on cancer and

23 non-cancer effects, experimental studies/laborat ory

24 studies on cancer and non-cancer effects, and pu lling

25 it all together, the integrated weight of eviden ce,THE APPROACH TO REEVALUATE ATRAZINE 11/03/09 CCR#16 343-1 25

1 hazard dose response and exposure assessment and

2 characterization.

3 The epidemiology studies, we expect to

4 have new studies from the Ag Health study. It's

5 expected, I think, in the spring, and there will be

6 other scientific reports, and there also will be the

7 epidemiology studies that we first raise in Febru ary,

8 in the February meeting next...that's coming up e arly

9 next year, and other scientific reports.

10 We will discuss a weight of evidence

11 approach in February which involves using the be st

12 available science from humans and animals, and w e plan

13 to apply this approach at the September meeting.

14 Specifically, we will integrate all of the infor mation

15 in February and April along with additional

16 epidemiology studies and do a new hazard

17 characterization for atrazine.

18 In the event that new studies come out

19 between April and September from in vitro or in vivo

20 studies, we'll also include these. And at the

21 September meeting, we'll provide our proposals f or

22 updated points of departure and FQPA safety fact ors.

23 We will also update our thoughts on

24 sampling frequency considerations based on the A pril

25 SAP and if there are any potential revisions inTHE APPROACH TO REEVALUATE ATRAZINE 11/03/09 CCR#16 343-1 26

1 sampling design options, or if any changes in the

2 atrazine risk assessment are proposed, those will be

3 discussed at the September meeting.

4 And in light of the new science and the

5 feedback we get from the panel, the Agency will

6 determine if the risk assessment for atrazine sho uld be

7 revised and whether the drinking water monitoring

8 frequency requirements should be changed.

9 So, again, here is the summary slide

10 that Steve gave you at the end of his talk. At t he

11 February meeting, we're incorporating the epidem iology

12 study and human health incident data and risk

13 assessment. We're also going to be doing some st uff

14 on...work on exposure assessments in epidemiolog y and

15 comparing them to other...other ways in which we assess

16 exposure, and we're going to do a case study usi ng

17 recent atrazine hypothesis generating epidemiolo gy

18 studies.

19 In April will be the preliminary

20 evaluation of in vitro and in vivo lab studies,

21 preliminary identification of critical effects a nd dose

22 response assessment and some discussion of the

23 frequency of atrazine monitoring in drinking wat er

24 sources.

25 And in September, we will focus on theTHE APPROACH TO REEVALUATE ATRAZINE 11/03/09 CCR#16 343-1 27

1 epidemiology studies for cancer and non-cancer,

2 integrate everything into a weight of evidence an d

3 hazard characterization, and, again, revisit the

4 frequency of atrazine monitoring in drinking wate r

5 sources.

6 And with that, I thank the panel for

7 their time and attention.

8 DR. HEERINGA: Thank you very much, Dr.

9 Levine.

10 Just an opportunity for quick questions

11 of clarification from the...the panel members fo r

12 either Steve Bradbury or Tina Levine?

13 (No response.)

14 DR. HEERINGA: With that, I think we'll

15 have an opportunity after the period of public c omment,

16 too. They will be here. Are we ready to move on then?

17 At this point in our meeting, then, I

18 believe we're ready to move on to the period of public

19 comment. I just want...

20 OFF THE RECORD

21 (WHEREUPON, there was a pause in the proceedings.)

22 DR. HEERINGA: Okay, let's return to the

23 proceedings of our meetings. For anyone who has joined

24 us through the teleconference line to...as a com panion

25 to the webcast, welcome to this morning's inform ationalTHE APPROACH TO REEVALUATE ATRAZINE 11/03/09 CCR#16 343-1 28

1 meeting of the FIFRA Science Advisory Panel on th e

2 presentation of the approach to reevaluate atrazi ne.

3 We are at the point in the morning

4 meeting where we have an opportunity for public

5 comment, and we have eight parties that have regi stered

6 with Joe Bailey to present public comment, but be fore

7 we begin those, I would like to draw your attenti on

8 also to the docket for this meeting in which ther e

9 are...I won't try to count it but approximately e ight

10 double-spaced pages of registered docket comment s from

11 various parties who have submitted public commen t,

12 written form public comment and supporting mater ials

13 for this meeting.

14 This morning, though, we're going to

15 hear from eight public commenters representing v arious

16 groups and various interests, and they will be c alled

17 up to present in order that they were registered with

18 Joe Bailey, and I'd like to begin with Scott Sla ughter

19 of the Center for Regulatory Effectiveness. So, Scott,

20 are you here?

21 It could be possible to use any one of

22 these microphones on the side.

23 MR. SLAUGHTER: That works. I'm Scott

24 Slaughter, and I'm here commenting on behalf of the

25 Center for Regulatory Effectiveness. We have thr eeTHE APPROACH TO REEVALUATE ATRAZINE 11/03/09 CCR#16 343-1 29

1 comments at this point.

2 First, any alleged endocrine effects

3 from atrazine should be reviewed and assessed by the

4 endocrine disruptor screening program, not these SAPs,

5 not any other process within EPA.

6 Second, these SAPs are not motivated by

7 science. They are politically motivated.

8 Third, the EPA political appointees need

9 to defend the SAPs and the EPA staff who've worke d on

10 atrazine in the past from the personal attacks o n their

11 competency that have been waged by various NGOs, blogs,

12 and media and individuals.

13 The first point is that any alleged

14 endocrine effects from atrazine should be review ed and

15 assessed in EDSP, not in EPA's proposed SAPs and not in

16 some other context at EPA. EPA has already send out

17 EDSP test orders for atrazine.

18 EPA told the EDSP SAP that the EDSP

19 process would identify any endocrine effects by

20 pesticides, including atrazine. If so, then

21 additional review of endocrine effects by these SAPs or

22 by any other parts of EPA would be an unnecessar y and

23 duplicative waste of resources.

24 If what EPA told the EDSP staff is not

25 correct, then EPA should withdraw and rethink it s EDSPTHE APPROACH TO REEVALUATE ATRAZINE 11/03/09 CCR#16 343-1 30

1 test orders for atrazine, because they do not do what

2 EPA said they would do.

3 A second point is that EPA's new

4 proposed SAPs have nothing to do with new science

. 5 They're all about politics. Atrazine had a clean

6 review from EPA as of July, '09 on the EPA web si te.

7 Then, the NRDC published a propaganda piece about

8 atrazine. A dying newspaper, the New York Times, then

9 ran an unbalanced opinion piece based on the prop aganda

10 piece by NRDC. And, according to the Huffington Post,

11 Senator Boxer then ordered EPA to go after atraz ine,

12 and EPA followed orders.

13 These SAPs are bad politics, and they're

14 a colossal waste of scientific time. EPA hasn't even

15 given this SAP any SAP charges. Consequently, we

16 suggest that the SAP consider making its own cha rges

17 and tell EPA not to propose any further atrazine SAPs

18 until and unless the Agency can justify them on the

19 basis of EPA-reviewed data that meet Agency qual ity

20 standards, including the Information Quality Act

21 predissemination review standards.

22 Our third and last point is that various

23 blogs, NGOs, and individuals have attacked the

24 competence and integrity of EPA career staff tha t have

25 worked on atrazine in the past. Some of their at tacksTHE APPROACH TO REEVALUATE ATRAZINE 11/03/09 CCR#16 343-1 31

1 have been directly at named EPA individuals and v iolate

2 all civilized standards of professional debate.

3 Because EPA's assessment and regulation

4 of atrazine has always been based on review by SA P

5 scientists, these attacks also challenge the comp etence

6 and integrity of the seven SAPs who have reviewed

7 atrazine over the last 15 years under four

8 administrations, including President Clinton's

9 Democratic administration.

10 We ask the current EPA political

11 appointees to publicly state their competent...t heir

12 confidence in the competence and integrity of th e EPA

13 career staff and the SAP scientists who have rev iewed

14 and regulated atrazine in the past. This public

15 statement of support is necessary to protect Age ncy

16 staff and scientists who are being bullied and t o

17 demonstrate that science and civil discourse are still

18 the rule at EPA.

19 Thank you.

20 DR. HEERINGA: Thank you very much, Mr.

21 Slaughter.

22 At this point, we have a second public

23 comment presentation which, in agreement and

24 prearrangement with Joe Bailey, the Designated F ederal

25 Official, will run a little longer. This is aTHE APPROACH TO REEVALUATE ATRAZINE 11/03/09 CCR#16 343-1 32

1 presentation by Syngenta Crop Protection and incl udes

2 Janice McFarland, Dr. Janice McFarland, Dr. Peter

3 Hurdle, and Dr. Charles Breckenridge.

4 And if they would like to come forward,

5 and why don't we use these chairs here on the sid e? I

6 believe there is a presentation set of slides for the

7 panel members that should be in your packet. Dr.

8 McFarland will take the lead.

9 DR. MCFARLAND: Thank you, Mr. Chairman,

10 for the opportunity to be here today and to the panel

11 and also to EPA.

12 We look forward to...I'm Janice...I'm

13 Dr. Janice McFarland, and my background is that I

14 started with our company 23 years ago as a metab olism

15 chemist doing guideline studies for...for...in t he

16 environmental animal and plant metabolism, guide line

17 studies under EPA.

18 I then in 1994 was the manager of the

19 atrazine, triazine special review at the initiat ion of

20 that...at the initiation of that review and then stayed

21 involved in the science regulatory process for t he

22 triazines since that time. I'm currently...and s ince

23 2000 have been the head of regulatory affairs fo r

24 Syngenta for the U.S. and Canada and Mexico.

25 Syngenta, for a little background forTHE APPROACH TO REEVALUATE ATRAZINE 11/03/09 CCR#16 343-1 33

1 those who don't know the company, is a world lead er in

2 the discovery and development, registration and

3 stewardship of agricultural tools. We currently

4 steward approximately 75 different fungicides,

5 herbicides, and insecticides. Atrazine we have be en

6 the principal steward of for the past 51 years an d have

7 greatly appreciated the thorough and comprehensiv e

8 scientific reviews of that product.

9 I'm happy to be here today with two of

10 our top leading scientists and all who have many , many

11 years of experience on the atrazine safety profi les.

12 They are Dr....to my far left, Dr. Charles

13 Breckenridge. He's a senior research fellow with

14 Syngenta, and he has been the leading mammalian

15 toxicologist and the lead scientist on the mode of

16 action of atrazine.

17 I also have Dr. Peter Hurdle with us.

18 He is Syngenta's head of product safety for the U.S.,

19 Canada, and Mexico and has been the lead environ mental

20 exposure and monitoring and characterization sci entist.

21 We're all happy to be here today.

22 We'd like to thank the SAP for...I'd

23 like to thank the SAPs for all the contributions on the

24 work and review of atrazine over the last 20 yea rs as

25 well as the extensive work of the Agency scienti stsTHE APPROACH TO REEVALUATE ATRAZINE 11/03/09 CCR#16 343-1 34

1 who, throughout that process, there's been an

2 advancement of not only basic research but the

3 understanding of safety testing for both atrazine and

4 for all products.

5 The thorough review that's been well

6 documented in the white paper has been going on f or

7 some...for 20 years. It's an unprecedented state of

8 the art science data base, and as Dr. Breckenridg e will

9 share with you, the regulatory endpoints are

10 conservative and very protective.

11 Independent reviews, you often don't

12 hear about the other regulatory authorities arou nd the

13 world have also confirmed atrazine's safety in r ecent

14 years, and I'll go over that a little bit, but t he

15 process in the U.S. EPA has been very transparen t, and

16 since 2000 alone, there have been opportunities for

17 more than 16 public comment periods. And as many of

18 you know and have been involved with, there have been

19 six SAPs alone since 2007 since the re-registrat ion.

20 This time line we don't need to go into,

21 because Dr. Bradbury and also Dr. Levine discuss ed

22 various aspects of it. This is a time line just

23 documenting all the different work since 2000, t he key

24 milestones and key regulatory milestones with th e U.S.

25 EPA, and if you go back, it was in the, as theyTHE APPROACH TO REEVALUATE ATRAZINE 11/03/09 CCR#16 343-1 35

1 mentioned prior, it was '88 when the re-registrat ion

2 started.

3 An SAP was held in '88. In '88, also

4 health advisory limits were established by the Of fice

5 of Water, and the NCL was promulgated for the wat er

6 standard for...was promulgated by EPA's Office of Water

7 in 1991. The special review started in 1994.

8 There are some public comment periods

9 that people don't realize have happened that...th at

10 really add to the transparency of the last 20 ye ar

11 review.

12 For instance, if you look at that '02

13 time frame and you see the public technical brie fing on

14 atrazine, prior to that, in '01 when EPA complet ed

15 their preliminary health reviews and the prelimi nary

16 science...environmental science reviews, those a re put

17 out for people to review and there are 60-day pu blic

18 comments. So, throughout this time line, there's

19 extensive opportunity for transparent public com ment

20 and information exchange.

21 Around the world, there has been a

22 systematic review. So not only by U.S. EPA, but a

23 systematic comprehensive review by different reg ulatory

24 authorities, and in this time...this particular graph

25 is focused on the cancer decisions for theTHE APPROACH TO REEVALUATE ATRAZINE 11/03/09 CCR#16 343-1 36

1 International Agency on Research in Cancer. Looke d at

2 atrazine in 1999.

3 Different regulatory bodies to look at

4 the registration, the registerability of atrazine and

5 the cancer classification began with the European

6 Union. The United Kingdom was the science rapport eur,

7 and...and they looked at atrazine thoroughly in b oth

8 '96, 2000, and then again in 2003.

9 The U.S. EPA, we all know here.

10 Canada...Canada just completed their review of

11 atrazine, and they came out with documents in 20 03,

12 '04, and then '07. And Australia came out with

13 documents and reports and conclusions of reviews in '04

14 and '08.

15 If you look at the World Health

16 Organization, the last column there, the World H ealth

17 Organization and the United Nations Food and Ag

18 organizations...that's a joint meeting for pesti cide

19 residues...was held in 2007.

20 For all of these different

21 regulatory...regulatory authority reviews and

22 decisions, they determined that it was non- geno toxic,

23 atrazine was not genotoxic, that its mode of act ion was

24 not relevant to humans, and gave the cancer

25 classification as not likely to cause cancer in theTHE APPROACH TO REEVALUATE ATRAZINE 11/03/09 CCR#16 343-1 37

1 language of the different regulatory, that the

2 different regulatory authorities use. Either not

3 classifiable or not likely to cause cancer.

4 If you...when the reviews are extensive

5 of many different studies. This is one just from the

6 World Health Organization. It documents that the

7 reviews are comprehensive, that the mode of actio n is

8 well understood, that epidemiology research was

9 reviewed and looked at, that atrazine is non10 development...developmental toxicant or and...an d it

11 does not cause harm to fetuses, infants, and chi ldren.

12 Other quotes just from some of these

13 reviews, often because atrazine is not registere d in

14 Europe, people erroneously conclude that that wa s due

15 to science or health reviews, and that...that is not

16 true. The science and health assessments conduct ed by

17 European Union authorities, with the United King dom

18 being their science rapporteur and France also h eld

19 their own review, all determined that atrazine c ould be

20 safely used. And so, the quote from France, they don't

21 represent a public health. The United Kingdom, t hat

22 atrazine can be used without harm to animal heal th or

23 the environment.

24 And then, the most recent regulatory

25 authority review around the world outsi...since theTHE APPROACH TO REEVALUATE ATRAZINE 11/03/09 CCR#16 343-1 38

1 cumulative risk assessment conducted by EPA in 20 06 was

2 done by the Australian regulatory authorities and

3 determined that atrazine was not...not carcinogen ic and

4 also did not have developmental effects and could be

5 safely used as a weed control tool.

6 With that as a backdrop, I'm going to

7 turn over the...turn over the presentation to Dr.

8 Breckenridge who is going to give a brief overvie w of

9 the human safety assessment of...of atrazine.

10 DR. BRECKENRIDGE: Thank you, Janice.

11 My name is Charles Breckenridge. I'm a senior re search

12 fellow with Syngenta. I have been involved with the

13 atrazine safety profile and exposure characteriz ation

14 for more than 22 years now.

15 We at Syngenta were the first ones to

16 discover that atrazine caused mammary tumors in 1986,

17 and since that time, we have been working with a group

18 of outside researchers to assist us to understan d the

19 processes associated with the cancer response in

20 animals and, subsequently, other...other effects that

21 we have proposed as the mode of action underlyin g that

22 tumor response.

23 Some of my colleagues that are not here

24 with me today and who have contributed substanti ally to

25 the development of knowledge on atrazine include theTHE APPROACH TO REEVALUATE ATRAZINE 11/03/09 CCR#16 343-1 39

1 head of our endocrinology team, Dr. James Simpkin s.

2 He's from the University of North Texas, and you all

3 have probably met him at earlier SAPs.

4 Dr. Robert Handa who's at...now at the

5 University of Arizona, previously at Colorado Sta te

6 University, has continued to work on the mode of action

7 relative to the effects on GnRH neurons. Dr. Russ

8 Holvey from the University of California Davis is

9 working with us today, currently on mammary gland

10 development studies.

11 Evan Simpson is an aromatase expert from

12 Prince Henry Institute in Australia, is working with us

13 on stereogenic factor 1 and the postulate that a trazine

14 regulates that factor and is responsible for aro matase

15 expression. Jack Mandel, who's served with us on a

16 number of epidemiology SAPs, particularly, the

17 prostate cancer SAP, and has also done a critica l case

18 control study at our production facility relativ e to

19 prostate cancer.

20 Jim Slinberg is an expert in weight of

21 evidence characterization now at the University of

22 North Carolina, Chapel Hill, has also been worki ng with

23 us over the years, and undoubtedly, you will hea r from

24 all of these gentlemen as we move forward with.. .with

25 new data as it pertains to questions that are ra ised byTHE APPROACH TO REEVALUATE ATRAZINE 11/03/09 CCR#16 343-1 40

1 the EPA and the published literature.

2 For today, we intend to...to not take

3 our standard approach of presenting data and reas oned

4 logic and reaching conclusions. Rather, we intend to

5 sort of summarize in a captioned way what has bee n

6 known as we've gone through the development of

7 knowledge on the atrazine hazard profile, exposur e

8 characterization and risk.

9 So, that is not the way we will operate

10 in subsequent SAPs. We will present data. We wil l

11 reason through logic, and we will reach scientif ic

12 conclusions, and, hopefully, you'll concur with our

13 interpretation of our own data and other data, b ut for

14 today, we're just going to summarize in a nutshe ll what

15 we believe to be true based on more than 22 year s of

16 research on atrazine.

17 And I should say, just as a...a

18 first...they don't seem to be advancing...okay.. .so

19 that we will give just a brief description of th e

20 comprehensive database that exists, the safety p rofiles

21 that have been characterized, the safety standar ds that

22 EPA has endeavored to set based on the effects t hat

23 have been observed with atrazine in animal model s, and

24 the perspective of exposure relative to those sa fety

25 standards, especially as it pertains to exposure viaTHE APPROACH TO REEVALUATE ATRAZINE 11/03/09 CCR#16 343-1 41

1 drinking water.

2 This slide represents a...a picture

3 of...of our database within the company, and each of

4 these is not necessarily a single study, but it

5 represents a project, and it comprises areas of s tudy,

6 including herbicidal properties, physicochemical

7 properties, environmental fate transport, environ mental

8 effects, toxicity, mode of action, metabolism,

9 kinetics, dynamics, risk assessment methodologies . So,

10 that over the course of...of near 50 years, many

11 studies have been conducted, and some of those h ave

12 been brought forward and have shown to be greatl y

13 critical for this risk characterization for atra zine.

14 Other people have, obviously, developed

15 an interest in atrazine as well. In the public d omain,

16 we keep track of published...any new published s tudies

17 as, apparently, others do, and we note that ther e is an

18 exponential growth in publications. We do pay

19 attention to that literature, and to the extent that we

20 see a study has implications that are critical f or the

21 human safety, we endeavor to investigate those s tudies

22 and perhaps even try to replicate them and under stand

23 what they're telling us.

24 These are in vitro, in vivo, mode of

25 action across the whole spectrum, and that's bas icallyTHE APPROACH TO REEVALUATE ATRAZINE 11/03/09 CCR#16 343-1 42

1 our strategy of continuing to keep updated on wha t is

2 happening in the literature relative to atrazine and

3 whether or not the concepts that are developing i n the

4 literature that are at odds with the regulatory

5 standards are our own perception of...of what atr azine

6 does.

7 Now, in regard to regulatory standards,

8 obviously, Syngenta and other registrants are obl igated

9 to provide specific high-quality studies that are well

10 documented in terms of standards of excellence, and our

11 database on atrazine has repeatedly grown and be en

12 updated as new concepts and new protocols have b een

13 developed and new approaches have been taken. In the

14 areas of mutagenicity, we have within our own da tabase

15 and within the published literature, there are m ore

16 than 50 studies.

17 When I speak of atrazine, I speak of

18 atrazine in the mono and dealkylated metabolites as

19 well as hydroxyatrazine, because effectively, EP A

20 reached a conclusion which we concur with that a trazine

21 should belong to a common mode of action group w ith the

22 chlorotriazines, and so, when you speak of atraz ine,

23 you should speak of the chloro metabolites. We d id

24 lifetime studies on hydroxy metabolite as well w hich

25 happens to be a...a major plant metabolite, and weTHE APPROACH TO REEVALUATE ATRAZINE 11/03/09 CCR#16 343-1 43

1 demonstrated that it, in fact, had a different mo de of

2 action distinct from the chlorotriazines.

3 So, in the course of studies that we've

4 done, we've done full databases or part databases on

5 the metabolites and as well as the parent. We've done

6 mode of action studies in parent and we've done c ross7 over studies to metabolites so we can appreciate, in

8 fact, where the toxicity might be coming from.

9 You should be aware that for a human

10 that is exposed to atrazine, atrazine's half-lif e in

11 the body is very short. It actually gets convert ed

12 very quickly to the dealkylated metabolites and

13 conjugated metabolites so that, in fact, the iss ue

14 isn't atrazine. It's...it's the biotransformatio n

15 products in the body, and we've been involved in that,

16 in those investigations.

17 Overall mode of action work on the

18 cancers led us to the first question, is it

19 carcino...is it a mutagen, and the answer seems to be

20 resoundingly clear that it is not, and that is p retty

21 well, from our viewpoint, no matter how many add itional

22 studies might or might not get published, is off the

23 table as a serious consideration for its mode of

24 action.

25 We have studied whether atrazineTHE APPROACH TO REEVALUATE ATRAZINE 11/03/09 CCR#16 343-1 44

1 directly mimics estrogen, androgen, or the thyroi d

2 hormone. EPA's own research lab has been very muc h

3 involved with this work. There are now more than 40

4 published studies on whether atrazine has estroge nic or

5 anti-estrogenic properties, and in 2008, Aldridge , 6 et.al. reviewed those studies and wrote up a...a weight

7 of evidence on that. The conclusions are that atr azine

8 does not operate as a direct hormone mimic in any of

9 these vectors, and these are the principal target s for

10 the endocrine disruption screening.

11 I think in 1994 when we first began this

12 work, we kind of predated the concern for endocr ine

13 disruption. It turns out that atrazine had a mod e of

14 action relating to the endocrine system. We disc overed

15 that and today, I think, we're hearing a lot mor e

16 interest in potential chemicals to do with effec ts on

17 the endocrine system.

18 As has been stated, the cancer mode of

19 action has been well characterized. We've been

20 involved with that research over the years. So h as

21 critical labs in EPA's ORD. And from these studi es

22 have been developed the critical no effect level s that

23 currently set the standard of exposure to atrazi ne, and

24 this is based on the suppression of luteinizing hormone

25 which was mentioned as a surrogate for the endoc rineTHE APPROACH TO REEVALUATE ATRAZINE 11/03/09 CCR#16 343-1 45

1 effects of atrazine.

2 Just so briefly we can say what

3 that...that comprises is that atrazine seems to

4 modulate the GnRH neurons which are a small set o f

5 neurons located in the preoptic area in the

6 hypothalamic region of the brain. They are pulse

7 generators that lead to pulsatile release of GnRH which

8 travels to the pituitary and causes LH and FSH ac tually

9 to be released.

10 These have effects on the gonads,

11 especially in females, to...to lead to ovulatory events

12 and, in males, to regulate testosterone levels. And

13 these processes play a critical role during onse t of

14 puberty in the sense that GnRH pulse generator p lays a

15 role in puberty onset as well as regulating

16 reproductive function in the adult animal.

17 So, the LH suppression that we see with

18 atrazine at high doses is actually a decent surr ogate

19 for its effects on the endocrine system. We've b een

20 working with Dr. Handa for a number of years to try to

21 understand precisely how and where atrazine oper ates on

22 the GnRH system, and you'll hear more about that

23 research in...in subsequent meetings.

24 (W(WHEREUPON, there was a pause in the proceedings.)

25 DR. BRECKENRIDGE: So, the LH endpointsTHE APPROACH TO REEVALUATE ATRAZINE 11/03/09 CCR#16 343-1 46

1 that EPA utilized for short and long-term duratio n

2 exposures in their 2006 chlortriazine cumulative risk

3 assessment, I will focus on two of them. The firs t one

4 is the...for covering 90-day exposures and exposu res

5 that extend throughout a lifetime. This is based on an

6 LH effect, that is, LH LH suppression in the Spra gue7 Daly rat at 6 months of age or at 6 months of dos ing, I

8 should say, and this represents a no effect level , a

9 1.8 milligrams per kg with 1000-fold uncertainty

10 factor, including a 10x FQPA factor leads to a

11 reference dose of 0.0018 mg/kg, and that is the basis

12 for what we believe would be an acceptable stand ard for

13 setting the...the chronic exposure to atrazine i n

14 drinking water. We'll come to what the current

15 standard is in a minute.

16 The second endpoint that was selected

17 was 6.25 mg/kg no effect level from a study by T ammy

18 Stoker in the ORD, a group in Research Triangle Park.

19 She was studying a surrogate for LH suppression. She

20 was looking at preputial separation in males, th at is,

21 the onset of sexual maturation in males which is

22 dependent on testosterone and, in turn, dependen t on LH

23 release. She established a no effect level in th is

24 study, and this was about a 20 or 30-day study.

25 We have taken the liberty of plottingTHE APPROACH TO REEVALUATE ATRAZINE 11/03/09 CCR#16 343-1 47

1 the various studies available in the literature t hat we

2 could find on the Sprague-Daly rat in terms of du ration

3 of dosing and effect on LH. So, these NOELs are

4 actually LH no effect levels in animals at differ ent

5 durations of treatment. So that Ralph Cooper has done

6 a study in 2000 where he dosed animals for either 1

7 day, 3 days, or 21 days.

8 The no effect level for effects on the

9 LH system at 1 and 3 days was 300 mg/kg. We have

10 recently, through collaborators in Dr. Handa's l ab,

11 published a study with Fidori that the no effect level

12 for, I believe it was, a 4 or 5-day treatment wa s

13 around about 100. Cooper at 21 days showed it wa s less

14 than 100. Our own study, Morrisette in 1996...I think

15 that was a 28-day study, Stoker's around about 2 1 days,

16 at 6.25 mg/kg, and as I stated, the Stoker study

17 actually sets the short-term reference dose for

18 atrazine in regard to the LH effect.

19 And, finally, the long-term LH effect.

20 Now, you may think that this actually

21 represents continuous effects of atrazine treatm ent on

22 this LH system, but, in fact, it actually simply might

23 reflect that the neuroendocrine system is very r obust

24 in the young adult animal, and as Sprague-Daly r ats age

25 endocrinologically, it becomes progressively dam aged asTHE APPROACH TO REEVALUATE ATRAZINE 11/03/09 CCR#16 343-1 48

1 a result of continuous estrogen exposure.

2 It actually damages the arcuate nucleus

3 and its regulatory process so that, in fact, this might

4 simply reflect age-dependent deterioration of a c ontrol

5 mechanism in the brain, and one would need a spec ial

6 set of studies to...to illustrate that point.

7 So, the aspect of the young being more

8 sensitive in regard to this effect, it does not s eem to

9 be supported by existing data where the actual ag ed,

10 endocrinologically aged animal has the lowest no effect

11 levels, whereas the young animals tend to have l ess of

12 a response.

13 Nevertheless, we come to finally taking

14 those endpoints and establishing standards for d rinking

15 water, and the Agency has expressed concern abou t have

16 we been able to properly characterize the freque ncy or

17 the...the spikiness of atrazine exposure in drin king

18 water. So, the postulate would be that somehow d uring

19 a runoff event in agricultural season, we would miss a

20 critical peak if we hadn't had very frequent

21 monitoring.

22 But put that in the context of the

23 actual no effect levels in single day NOELs and we

24 derive DW LOC, you can see that, in fact, in the short

25 term, the animal tolerates the...the dose much b etter.THE APPROACH TO REEVALUATE ATRAZINE 11/03/09 CCR#16 343-1 49

1 So that single-day developmental NOEL, the Agency

2 actually didn't use LH. They used a developmental NOEL

3 from a rapporteur ecology study which is 13 days of

4 treatment. That NOEL is 10 mg/kg.

5 The Stoker study for 30 days at 6.25,

6 and the MCL was set in 1991 based on a chronic do g

7 study where, in fact, that no effect level has be en

8 outdated to a...a higher level. That MCL, basical ly,

9 has been in need of updating for...for more than 25

10 years.

11 Today, under the TCT cumulative risk

12 assessment, EPA reached a viewpoint that 1.8 mg/ kg is

13 the no effect level of record for the most sensi tive

14 species in strength, and if you take that into a child,

15 a child's body weight and water intake, you get a

16 standard of 12.5 ppb considered to be safe in dr inking

17 water for lifetime exposure.

18 Those limits are brought forward to you

19 today so that you can see them in the context of the

20 subsequent presentation by Dr. Hurdle who will

21 characterize the presence and amount of atrazine in

22 drinking water over the course of many years of

23 monitoring. So, with that, I'll turn the lectern over

24 to Dr. Hurdle unless there's any questions. Dr.

25 Hurdle?THE APPROACH TO REEVALUATE ATRAZINE 11/03/09 CCR#16 343-1 50

1 DR. HEERINGA: I think we'll wait. Thank

2 you, Dr. Breckenridge. Dr. Hurdle?

3 DR. HURDLE: My name is Peter Hurdle. I

4 thank the panel for the opportunity to comment, a nd

5 without much ado, I would like to jump into the n ext

6 slide which is entitled comprehensive drinking wa ter

7 exposure assessment.

8 And very much like the presentation that

9 Dr. Breckenridge gave about the number of studies that

10 have been conducted, I have to say that drinking water

11 exposure has been characterized by a huge number of

12 research teams which include our own internal Sy ngenta

13 research efforts, and we'll be speaking about th at in a

14 couple of minutes but also includes a huge body of data

15 that has been generated under the Safe Drinking Water

16 Act by the states, by universities, by academia, and by

17 other research organizations.

18 So, what I will try to show you in the

19 next couple of minutes is the comprehensiveness of the

20 monitoring database, that impact exists and has been

21 generated over the last 20-plus years. The...our

22 ability to fully define the exposure protocols

23 that...that consumers are potentially exposed to , we

24 will actually show you that the current drinking water

25 exposure levels demonstrate that we do achieve a largeTHE APPROACH TO REEVALUATE ATRAZINE 11/03/09 CCR#16 343-1 51

1 margin of...of safety, and we will also show you that

2 the stewardship measures that have been undertake n over

3 the last 15 years since the mid '90s, the label c hange,

4 the setbacks and other mitigation language

5 effectively...have been quite effective in reduci ng

6 environmental concentrations in both well and fin ished

7 water.

8 So, if you...if you look at databases

9 for drinking water exposure, data are generated, first

10 and foremost, are the state drinking water monit oring

11 programs which are community water systems that ensure

12 quality control in their drinking water supplies to

13 their consumers. You have about 51,000 community water

14 systems in the...in the United States. About 40, 000 of

15 them are community systems and groundwater.

16 If you look at the actual analytical

17 record that has been generated since '93, to dat e,

18 there are about 212,000 samples analyzed in thos e

19 programs. These are all finished drinking water, and

20 the bottom line is that detects in groundwater s ystems

21 are extremely infrequent. Less than 1 percent of the

22 system has a detect of atrazine, and if you find it,

23 it's very low. The resulting, resulting margins of

24 exposure greatly exceed 20,000.

25 The margin of exposure would be here.THE APPROACH TO REEVALUATE ATRAZINE 11/03/09 CCR#16 343-1 52

1 The actual maximum concentration people might be

2 exposed to in a day or chronically as compared to the

3 no effect level that was established for the

4 appropriate time period.

5 Which leaves us about 11,000 systems on

6 surface water that do provide drinking water to, in the

7 United States. Again, all these 11,000 systems we re

8 candidates for drinking water monitoring under th e Safe

9 Drinking Water Act, and they do sample finished w ater.

10 They typically take quarterly samples, so four s amples

11 per year, sometimes less, and most of the system s that

12 are in areas of potential high atrazine exposure have a

13 record of about 16 years of data, because they

14 initiated the sampling program in 1993 and it's still

15 active today.

16 So, this is the...the state database.

17 The state database is supplemented by two high

18 intensity sampling monitoring programs. The firs t one

19 was voluntarily initiated by Syngenta in 1993 an d

20 continued until February, 2003. It included the most

21 vulnerable community water systems that were pro ducing

22 surface water and supplying it as drinking water , 23 mainly in water systems in the Midwest and in th e

24 South. We had up to 120 community water systems in

25 that program.THE APPROACH TO REEVALUATE ATRAZINE 11/03/09 CCR#16 343-1 53

1 It was a high sampling intensity

2 program. It took between 40 and 60 samples per ye ar in

3 both raw and finished water which enabled us to f ully

4 characterize exposure protocols in the raw waters as

5 well as in the finished water supply to consumers

. 6 This program was replaced in spring of

7 2003 by the atrazine monitoring program which was a

8 condition of the MOA Dr. Bradbury referred to ear lier,

9 and we have now a formal entry criteria for syste ms

10 joining the monitoring program which was more

11 conservative. Any system that had a single excee dance

12 of 2.6 ppb total for triazines. AMP also looks f or

13 metabolites which is about the equivalent of 1.6 ppb

14 atrazine joins the system.

15 And so, that program then included up to

16 151 community water systems in intensive monitor ing.

17 Took about 64 to 70 samples per year in both raw and

18 finished water, mainly weekly and also some bi-w eekly

19 sampling during Q3 and Q4 and Q1. So, in a nutsh ell,

20 if we look at surface water systems which are th e ones

21 with potential exposure to atrazine, we have a s ubset,

22 a small percentage, of the high...most highly ex posed

23 systems in the U.S. under a high frequency, cont inuous

24 monitoring program.

25 Systems will stay in the program for aTHE APPROACH TO REEVALUATE ATRAZINE 11/03/09 CCR#16 343-1 54

1 minimum of five years period.

2 So, what did we get from those programs?

3 I summarize quickly the Safe Drinking Water Act

4 monitoring program time record 1993 to '08. We ha ve

5 data for 47,000 community water systems. That's b oth

6 ground and finished water. We have 212,000 sample s in

7 groundwater. We have 68 samples in finished surfa ce

8 water.

9 This data set is complemented by

10 Syngenta's intensive monitoring data which inclu ded up

11 to 151 vulnerable community water systems in a y ear.

12 It looks into raw and finished. Both programs

13 generated 64,000 finished surface water analyses in the

14 most highly exposed systems.

15 Now, in a nutshell, if we look at the

16 finished water samples, none of the more than 34 0,000

17 data we have on record from finished drinking wa ter

18 exceeded 100 ppb ever. By that, they didn't exce ed the

19 209 ppb that Dr. Breckenridge mentioned earlier for

20 short-term exposure as DW LOC. They did also not

21 exceed the 298 ppb DW LOC that was published by EPA in

22 their 2003 IRED.

23 If you look at it chronically, no

24 community water systems in the AMP program which

25 includes the most vulnerable systems with a very highTHE APPROACH TO REEVALUATE ATRAZINE 11/03/09 CCR#16 343-1 55

1 sampling frequency has exceeded 3 pb as an annual

2 average in finished water since 2006.

3 So, we strongly believe that drinking

4 water supply is safe.

5 Now, if we look at effectiveness of

6 label changes and mitigation, what I'm giving you here

7 is a view on the most vulnerable systems, surface water

8 with high intense monitoring, so this is very pre cise

9 data, and what we see here is the overall average of

10 atrazine concentrations between 1994 and 2008. T he

11 years between '94 and 2002 are the voluntary mon itoring

12 program, and then we have the AMP which includes a few

13 more systems.

14 So, what we see, that overall in those

15 most vulnerable systems, finished water concentr ations

16 were at about 1.5 ppb in the mid '90s, and they

17 consistently declined and have reached a level o f about

18 0.5 ppb in finished drinking water by 2008.

19 If we look at well water in those same

20 systems...we also took well water samples, high

21 frequency...we see a very similar trend. We see a high

22 level in the early '90s in well water which does not

23 quite reach 3 ppb on average, and we see a consi stent

24 decline to levels just below 1 ppb.

25 So, both in raw and in surface water, asTHE APPROACH TO REEVALUATE ATRAZINE 11/03/09 CCR#16 343-1 56

1 a total average in those systems that are the mos t

2 highly exposed in the U.S., we have had a 60 to 7 0

3 percent decline in concentrations in well water a s well

4 as in...as in finished water.

5 Peaks have been quite a bit of

6 discussion and hype recently, and we do believe t hat we

7 actually have a second program in place that give s us a

8 good view on what peak concentrations could poten tially

9 be and how peaks could be characterized. This is the

10 eco monitoring program that I'm referring to. Dr

. 11 Bradbury mentioned it as well as one of the cond itions

12 of the memorandum of agreement.

13 This is not drinking water. I am giving

14 you here a little snapshot result. You might hav e seen

15 this slide already. So, these are 45 watersheds in

16 highly vulnerable settings, ecologically very

17 vulnerable and with high atrazine use volume. We look

18 in second and third order headwater streams, so these

19 are not drinking water water bodies, but they mi ght

20 feed into some.

21 That program was initiated in 2004 and

22 is still active today. We have over 10,000 sampl es

23 analyzed. And the program was set up to focus on the

24 run-off seas, and we run it for about four to fi ve

25 month right after the atrazine application seaso n, soTHE APPROACH TO REEVALUATE ATRAZINE 11/03/09 CCR#16 343-1 57

1 we have a very good profile and characterization of

2 potential exposure peaks.

3 This program has generated 190 site

4 seasons of well resolved concentration time profi les

5 for atrazine. Again, this is not drinking water, but

6 the data, sampling data, we believe, can be used to

7 serve as a worst case surrogate to describe peaks

. 8 What do we see in those programs? Let

9 me quickly talk about the eco monitoring program which

10 is in the left upperhand box. We have about 10,0 00

11 data points. We have had a sampling schedule in 2004

12 and 2006, four days, grab samples. This was

13 supplemented at about 25 percent of the sites wi th

14 autosamples which were event driven.

15 And then, in 2007, we changed the

16 program in order to be able to better describe p eak

17 concentration profiles to a daily sampling progr am.

18 So, 2008, '07, 2008, 2009 generates data...daily

19 samples, very tight time resolution.

20 This data set is, again, supplemented by

21 a huge database that is available and has been

22 generated over the last 40 years in surface wate r

23 bodies. These are mainly studies that both were done

24 under the USGS's monitoring program and other US GS

25 programs. Heidelberg College has done a substant ialTHE APPROACH TO REEVALUATE ATRAZINE 11/03/09 CCR#16 343-1 58

1 body of work.

2 Most of these programs were sampled on,

3 the ones you see were sampled on characterizing r unoff

4 events. So, what did we see in those almost 120,0 00

5 environmental samples over the last 20 years?

6 We see that we have the peaks well

7 characterized. We have a large body of data that is

8 available for analysis, and we have never seen an

9 exceedance of the 298 ppb drinking water level of

10 concern in any of those environmental monitoring

11 programs.

12 So, let me quickly talk about the

13 concentration frames. You have seen this slide b efore.

14 This is the overall average concentrations in th e

15 high...most highly exposed systems that grew in the

16 voluntary monitoring program and the atrazine

17 monitoring program.

18 If you analyze those data a little bit

19 more thoroughly as statisticians would do and ta ke

20 only those community water systems that have a

21 continuous record of at least nine years and rep orted

22 both programs, you do get a highly significant

23 statistical trend that shows you that concentrat ions in

24 those systems have been declining between 1994 a nd

25 2006, and they have been declining more for syst emsTHE APPROACH TO REEVALUATE ATRAZINE 11/03/09 CCR#16 343-1 59

1 that were more highly exposed in 1994 than for a group

2 that never exceeded an MCL of 3 ppb in 1994 and l ater.

3 Overall, the numbers are quite the same.

4 We see a decline of about 60 percent to 70 percen t in

5 '06 relative to the baseline that we have in the mid

6 '90s, and this was achieved without reducing the use

7 volume of atrazine in those areas where these sys tems

8 are located. So, the line at the top of the graph is

9 the actual use volume of atrazine in those years.

10 Now, what that...what does that mean in

11 terms of margins of exposure and...and human saf ety?

12 What I, you know, give you here on this slide is an

13 attempt to describe the worst case margin of exp osure

14 resulting from a single day exposure based on th e data

15 we have generated. So, you have the single day n o 16 effect level of 10 mg/kg/day which EPA used to d efine

17 short-term exposure drinking water level of conc ern

18 with a safety factor of 1000. You get...and the

19 appropriate body weight and intake numbers. You get a

20 concentration of 298 ppb.

21 What you have on the bottom right-hand

22 of the graph is the probability of this situatio n of

23 all samples that was generated in the AMP and BM P

24 finished drinking water monitoring program. So, this

25 is the full distribution of all the data, single dayTHE APPROACH TO REEVALUATE ATRAZINE 11/03/09 CCR#16 343-1 60

1 values that were measured in those programs in fi nished

2 water.

3 And if you do a margin of exposure

4 calculation to be a single day no effect level, t he

5 resulting margin of exposure is in excess of 10,0 00 at

6 the 99.9 percentile. If you do the same exercise for

7 chronic and, just for simplicity's sake, I took t he

8 median here and compare it to the chronic no effe ct

9 level of 1.8 mg/kg/day and the safety factor of 1 000

10 which leads you if you want to reference those, if you

11 look at the actual exposure resulting in the

12 most...resulting from the most vulnerable system s,

13 we're talking a margin of exposure as in excess of

14 200,000.

15 Please keep in mind these are the most

16 vulnerable systems where you see exposure in dri nking

17 water.

18 So, in summary, we have a huge

19 monitoring database. We have about 340,000 finis hed

20 drinking water samples and 60,000 samples in gro und

21 water. We have 118,000 environmental water sampl es.

22 We have broad geographic and temporal coverage i n that

23 data set. We have high sampling frequency in a

24 significant number of data sets which is focused on

25 monitoring locations. You have well characterize dTHE APPROACH TO REEVALUATE ATRAZINE 11/03/09 CCR#16 343-1 61

1 peaks in runoff events based on daily sampling.

2 And if you take those data and put them

3 into context of current no effect levels, all tho se

4 data indicate that we have large margins of expos ure

5 which are in excess of 10,000. What we also see i s

6 that the label changes actually did have an effec t. We

7 had significant reduction in environmental

8 concentrations. This is not only our own data. Al so,

9 USGS and state monitoring studies show that.

10 And with that, I hand it back to Dr.

11 McFarland.

12 DR. HEERINGA: Thank you, Dr. Hurdle.

13 DR. MCFARLAND: The concerns about the

14 process for this SAP are documented in our writt en

15 comments that went into the docket, but as...but we

16 know that it's an unusual situation for both the SAP to

17 be in as well as us, because normally, we're pro viding

18 basic research, data information that is actuall y

19 addressing charge questions or specific reviews of

20 scientific assessments, and in this case, we...w e

21 strongly feel that the new information that has been

22 sparked by the attacks of the anti-atrazine grou p and

23 also in the press do not justify opening a

24 comprehensive re-review of atrazine.

25 But we are...we do remain confident andTHE APPROACH TO REEVALUATE ATRAZINE 11/03/09 CCR#16 343-1 62

1 will be really working hard, committed to fully a nd

2 openly to contribute in the scientific process th at lie

3 ahead. We do ask that EPA be accountable for the

4 scientific integrity of the pro...the regulatory

5 review, and we appreciate and thank the SAP to he lp

6 ensure that...that it goes through a scientifical ly

7 rigorous process.

8 We have an unparalleled commitment to

9 advancing the research in the safety assessments and

10 stewardship of atrazine, and the past comprehens ive

11 reviews, we're appreciative of all of the effort s that

12 went into those. It is an unprecedented data set on

13 all levels of...of toxicology, risk assessment,

14 exposure, and...and health assessments.

15 The regulatory endpoints, as you saw

16 from both Dr. Breckenridge and Dr. Hurdle, are

17 conservative and protective. They're...we are... we

18 feel very fortunate and blessed, actually, to be part

19 of such a transparent, open review process that has

20 gone on for this product, and we also appreciate all

21 the work from the past SAPs.

22 People, as I mentioned, often forget

23 that the favorable registration decisions or saf ety

24 assessments were...were not...not concluded only by EPA

25 but by regulatory authorities around the world, and weTHE APPROACH TO REEVALUATE ATRAZINE 11/03/09 CCR#16 343-1 63

1 look forward to...to contributing science through out

2 the next part of this process, and are happy to

3 entertain any questions from the panel now or if there

4 are other questions after other public commenters

.

5 DR. HEERINGA: Quick opportunity for

6 panel members to ask questions of clarification o f the

7 Syngenta representatives. Dr. Bucher?

8 DR. BUCHER: John Bucher. Just out of

9 curiosity, the specific technical part of water

10 disinfection that would reduce atrazine levels,

11 what...what can you tell me about that?

12 DR. HEERINGA: Dr. Hurdle?

13 DR. HURDLE: Well, as you probably could

14 glean from the slides, there is an effect of wat er

15 processing. As you process a lot of raw water to

16 finished water, you see reduced levels in those

17 finished water sources.

18 Therefore, I have...however, I have to

19 point out so that there is an effect of water

20 processing, water processing technologies do red uce

21 atrazine levels. However, one of the remarkable points

22 is if you look at the MCL which is the current s tandard

23 that even the most exposed systems, on average, you do

24 see that in all those sources, an average of far below

25 that...that...that MCL to date which was wholly aTHE APPROACH TO REEVALUATE ATRAZINE 11/03/09 CCR#16 343-1 64

1 consequence of, you know, all the label changes t hat

2 have been in the last 15 years.

3 DR. BUCHER: Thank you, but that wasn't

4 exactly quite what I was asking. The aspect of th e

5 drinking water disinfection byproduct or the

6 disinfection process that reduces atrazine levels , do

7 you know what that, technically, what that might be?

8 DR. HEERINGA: Dr. Breckenridge?

9 DR. BRECKENRIDGE: I don't believe I

10 could comment on the effect of disinfection bypr oducts

11 modulating atrazine concentration. We know that the

12 carbon filtration systems will modulate atrazine

13 concentrations, if that's what you're getting at , but

14 disinfection byproducts and their presence reall y

15 don't...

16 DR. BUCHER: No, I'm sorry, I misspoke.

17 I have that on my mind, because we deal with tha t all

18 the time.

19 DR. HEERINGA: Dr. Hurdle?

20 DR. HURDLE: Well, I have just one add

21 on to it. While we do know the hydrology stabili ty

22 under different pH conditions of atrazine, but.. .you

23 know, and that's evident, so, there is data avai lable

24 that, you know, might instruct to that, but I'm not

25 prepared to, you know, answer that question righ t away.THE APPROACH TO REEVALUATE ATRAZINE 11/03/09 CCR#16 343-1 65

1 DR. HEERINGA: Dr. Portier.

2 DR. PORTIER: You talked a lot about

3 community water systems. Has there been any

4 measurement of...of well water, non-community wat er

5 systems, residential wells in rural areas where t here

6 would be vulnerability?

7 DR. HURDLE: We have, in fact, done a

8 pretty comprehensive rural well monitoring study in '92

9 to '94. We sampled about 1505 rural wells, if I'm

10 correct, recall that correctly. We analyzed the well

11 water for both atrazine and atrazine metabolites , and

12 that data are available and have been related by EPA,

13 so they're part of the atrazine database.

14 We did some resampling campaigns in 2000

15 and then again in 2007 to look at the most vulne rable

16 wells and that could confirm exactly the same tr end

17 that you have seen here with the surface water s ystems.

18 Levels have been declining significantly and

19 consistently.

20 DR. HEERINGA: Okay, I'd like to move

21 on, but I'd like to also thank Syngenta represen tatives

22 for their presentation. Thank you.

23 Our next scheduled public commenter is

24 Dr. Jennifer Sass who is representing the Nation al

25 Resources Defense Council. Jennifer, are you her e?THE APPROACH TO REEVALUATE ATRAZINE 11/03/09 CCR#16 343-1 66

1 Jennifer...Dr. Sass, are you here?

2 (No response.)

3 DR. HEERINGA: Not seeing Dr. Sass, we

4 will move on to Dr. Joel Nelson who is representi ng

5 California Citrus Mutual. Dr. Nelson? Take this c hair

6 where the mike's lit up there, if you want.

7 MR. NELSON: Well, thank you, ladies and

8 gentlemen for this opportunity to participate in

9 another SAP. For the record, I'm not a Ph.D., not a

10 doctor. I'm not a lawyer, either, so I think I'm in

11 pretty good shape.

12 My name is Joel Nelson. I'm president

13 of California Citrus Mutual which is a citrus

14 producers' trade association from California.

15 Now, you're probably wondering why I'm

16 here, and last night or yesterday afternoon as I was

17 flying into Washington, I was wondering the same thing.

18 Been here, done that on several occasions, in my

19 particular case, about four times relative to at razine.

20 But our industry is a user of simazine, a deriva tive of

21 atrazine. And as goes atrazine, so goes simazine , and

22 we know that.

23 So, a number of years ago...and our

24 chairman will be testifying shortly...agricultur e

25 across the country formed an entity called the T riazineTHE APPROACH TO REEVALUATE ATRAZINE 11/03/09 CCR#16 343-1 67

1 Network, and we became part of the steering commi ttee,

2 and we began working with colleagues across the c ountry

3 on this particular issue, because we felt we had a

4 responsibility, a responsibility to address the

5 concerns, the legitimate concerns associated with

6 herbicide use in agriculture.

7 For our industry, the citrus industry,

8 we are weed free. We have to be. Our fruit stores on

9 the tree. It constitutes a problem when weeds are

10 pervasive in a grove. Creates a home for invasiv e

11 pests, but just as importantly if not more so, w e keep

12 our groves warm without weeds by running water a nd wind

13 machines. Weeds will make a grove colder by 3 to 4

14 degrees, according to scientific studies at the

15 University of California.

16 So, it's in our best interests to keep

17 our groves weed free. We don't till. Warmth is a

18 serious, serious issue for us in the months of N ovember

19 15th through, roughly, March 1st.

20 So, simazine has become an important

21 product for our arsenal and our growers, 38...35 00

22 producers, 285,000 acres, $1.8 billion worth of

23 product. We're the number one citrus producing s tate

24 in the nation. We got that way because of diseas e in

25 Florida. They've lost their value. Ours continue s toTHE APPROACH TO REEVALUATE ATRAZINE 11/03/09 CCR#16 343-1 68

1 increase, and we're proud of it.

2 But as I flew back here again, ladies

3 and gentlemen, I wondered, why are we here again? And

4 I was struck by the similarity of the occurrence in

5 reading the documents from EPA. I was around when

6 Fenton Communications started the Alar situation in

7 public relations.

8 I was around when we had an adverse

9 kneejerk effect with that public relations fiasco . It

10 took a long time for the public relations indust ry to

11 recover their credibility as a result of that, a nd

12 there were a lot of chastened individuals as a r esult

13 of that entire episode.

14 And I was around and went and saw Straw

15 Dogs with Al...Al Pacino, and I remember what ha ppened

16 in that particular movie.

17 Well, ladies and gentlemen, as I read

18 the documentation creating this effort, knowing that we

19 have gone through this so many times and we're

20 scheduled to go through it again under a normal

21 process, why are we here again?

22 Well, we're here because government

23 asked us to participate once again in a science

24 advisory committee. So, all I say to you now is that

25 the citrus industry from California, Citrus Mutu al willTHE APPROACH TO REEVALUATE ATRAZINE 11/03/09 CCR#16 343-1 69

1 participate where appropriate.

2 I will admit I don't understand three3 fourths of what you just...three-fourths of what you

4 just heard. I'm a policy person. I can read

5 conclusions. I have read your conclusions at EPA.

6 Atrazine is safe. I have read your conclusions fo r 14

7 years. Atrazine, when used according to the label

8 restrictions, is safe. I've read it relative to w ater.

9 I've read it relative to carcinogens.

10 I've read it over and over and over

11 again, and I'll wait for a conclusion, and I'll

12 participate in a process, because that's what th is is

13 all about. It's another process. Let's be honest

14 about it.

15 So, we have an obligation to

16 participate, but on behalf of the citrus industr y in

17 California, you know we will be here. Again, whe n

18 appropriate, call upon our industry, but please, don't

19 ever address me as Doctor, because I can't wear that

20 hat.

21 Thank you very much.

22 DR. HEERINGA: Thank you, Mr. Nelson.

23 Somebody felt you earned it, but we'll track the m down.

24 Our next public commenter is Gary

25 Marshall who is here today representing Missouri CornTHE APPROACH TO REEVALUATE ATRAZINE 11/03/09 CCR#16 343-1 70

1 Growers Association. Gary?

2 MR. MARSHALL: Thank you, Mr. Chairman.

3 It is, I guess, good to be back here again. Seems like

4 I was just here a couple of months ago, maybe thr ee

5 months ago, whenever it was, in June.

6 Again, my name is Gary Marshall, and I'm

7 the CEO for the Missouri Corn Growers Association , and

8 I also serve as chairman of a group that we have in

9 Missouri called the Environmental Resources Coali tion,

10 ERC.

11 Environmental Resources Coalition

12 is...is a group that we helped put together alon g with

13 several government entities, including our Depar tment

14 of Natural Resources, the University of Missouri , a

15 number of farmers in the State of Missouri, the farmers

16 that I represent. And we used, over the years, s ome of

17 EPA's 319 dollars to help address some of the ar eas of

18 concern that we're talking about today, and talk ing

19 about it again today, I must say.

20 You know, we have about 15,000 growers

21 in the State of Missouri and over 300,000 farmer s

22 nationwide who utilize atrazine as a product.

23 And...and I realize this is more about the scien ce, but

24 there's also the user community out there which I

25 represent.THE APPROACH TO REEVALUATE ATRAZINE 11/03/09 CCR#16 343-1 71

1 In Missouri, we use it on over...between

2 3 and 3.5 million acres, because the product work s.

3 It's better than anything else that we have acces s to

4 today. Combining atrazine with other herbicides a llows

5 us to minimize weeds which compete for the nutrie nts

6 and the water in our soils.

7 Beyond that, I have about 15 years'

8 worth of experience in utilizing atrazine. In a

9 previous life, we spread probably in excess of 20 0,000

10 acres over a 6 to 8-year period as a commercial

11 applicator. So, I've utilized atrazine. I've uti lized

12 other products that are out there. I know what i t

13 does, and I know that it works.

14 And the farmers in Missouri tell us that

15 it does work. It continues to work. In fact, in the

16 last survey that we had, about $60...or $20 per acre, 17 $60 million worth of savings by utilizing atrazi ne

18 instead of switching to another product that doe sn't

19 work as well and that has a higher cost.

20 So, bottom line, it's right and

21 appropriate for us to engage in this process. An d

22 we've submitted comments previous to this, and I 'm not

23 going to read those comments, but, you know, Hal loween

24 was just a few days ago, and it almost feels lik e

25 Halloween again. Here we are again one more time

.THE APPROACH TO REEVALUATE ATRAZINE 11/03/09 CCR#16 343-1 72

1 It...it's scary, because I'd like to know when is

2 enough enough.

3 You know, I've worked with scientists

4 back in our state, and sometimes, 98 percent is g ood,

5 and sometimes, 99 percent, and sometimes, I think here

6 we're talking about 99.89, 99.92 percent. When is

7 enough enough? We've got thousands of studies now , over

8 6000 studies, I think, reams of paper. I think th e

9 agreement is out there.

10 In fact, let me read just a quote to you

11 that...that we found in EPA's own web site, and that

12 is, the Agency has found that there is a reasona ble

13 certainty that no harm will result to the genera l U.S.

14 population, infants, children, or other major

15 identifiable subgroups of consumers from aggrega te

16 exposure from food, drinking water, and non17 occupational sources to cumulative residues of a trazine

18 and the other chlorinated triazine pesticides.

19 Now, that's what we go on. We trust the

20 EPA. There's a process here that we've been invo lved

21 with for a number of years. As...as Joel just

22 mentioned, I'm going up, I think, on 14 years wi th the

23 triazine network as a steering committee member, 13 or

24 14 years. I think it's been around for 15 years. And,

25 again, I would say, when is enough enough?THE APPROACH TO REEVALUATE ATRAZINE 11/03/09 CCR#16 343-1 73

1 We think that the science is there.

2 We've seen it. We've looked at some of the new sc ience

3 that's out there. We don't believe that it tells us

4 that we need to be looking again at more science.

5 So, I guess my comments would be that

6 there's nothing new. This is kind of unprecedente d. I

7 think it's being driven by some folks out there t hat

8 are anti-farming. They're anti-agriculture, and i f

9 that's true, you own it. If it is an activist age nda

10 that is to ban all pesticides, well, we're going to be

11 here. Just like Joel, we're going to be here. We 're

12 going to fight that.

13 We're going to use our connections

14 wherever we have them to...to get our point acro ss,

15 because, again, we believe that the credibility of the

16 EPA is at risk whenever we go back and we review , 17 again, based on some...some new science that's o ut

18 there that hasn't went through the same review p rocess

19 as the other science has that we've talked about over

20 the last 12 to 14 years.

21 So, we look for the EPA to be non22 biased, and...and we hope that the science, in t he end,

23 dictates the process. If the science dictates it , 24 we're good to go. If it's politics, we're good t o

25 fight.THE APPROACH TO REEVALUATE ATRAZINE 11/03/09 CCR#16 343-1 74

1 Thank you.

2 DR. HEERINGA: Thank you, Mr. Marshall.

3 I believe that Dr. Sass has arrived, and given he r

4 earlier priority on the list, I call on her one m ore

5 time. Jennifer Sass, Jennifer, are you here?

6 SPEAKER: She's here, maybe outside.

7 DR. HEERINGA: Okay. Maybe she just

8 stepped...let's...I'm going to move on, then, to Mr.

9 Jerry White who is representing the Kansas Corn G rowers

10 Association and Kansas Grain and Sorghum Produce rs

11 Association.

12 Mr. White? I believe we have heard you

13 before, too. Welcome back.

14 MR. WHITE: Yes, it's good to be back

15 again.

16 DR. HEERINGA: Next up, Jennifer. Mr.

17 White, please, and then we'll go to Dr. Sass. Ye s.

18 MR. WHITE: Mr. Chairman and members of

19 the committee, I guess it's good to be back agai n. My

20 name is Jerry White. I'm the executive director for

21 Kansas Corn and Grain Sorghum associations and s erve as

22 chairman of the triazine network.

23 The network did submit comments into

24 the...into the docket, and so, I certainly won't go

25 through all of...all of those, but to echo the c ommentsTHE APPROACH TO REEVALUATE ATRAZINE 11/03/09 CCR#16 343-1 75

1 that were made earlier by Mr. Nelson and Mr. Mars hall,

2 we certainly are concerned that not only does it appear

3 but I think in some of the not...been documented and

4 reported that the SAP...it's not just the three t hat

5 we're talking about in 2010 but also, according t o a

6 stakeholder conference call that several of us we re on,

7 there are additional SAPs, at least one additiona l SAP

8 beyond September, 2010 that are scheduled in rega rds to

9 atrazine.

10 And...and, certainly, we understand the

11 process, that as new science comes out, new repo rts

12 come out, that the Agency has a responsibility a nd

13 obligation to review the new stuff that comes ou t and

14 determine if it...or not it warrants a further r eview

15 by their Science Advisory Panel, and we understa nd and

16 appreciate that.

17 What we're not sure in this case is how

18 we bypass some of that, what I call more formal

19 internal review by Agency staff and, instead, ha ve gone

20 to a peer review by the New York Times. It seems

21 hardly appropriate. The Agency itself, the assis tant

22 administrator, has indicated that...that the med ia

23 reports are quite a bit of the driver for this.

24 Quite frankly, I'm confused about an SAP

25 topic that's considered a kick-off meeting. It'sTHE APPROACH TO REEVALUATE ATRAZINE 11/03/09 CCR#16 343-1 76

1 almost like it's a United Way campaign or, or som ething

2 like that. It's...it's unusual, and at least from my

3 standpoint, which probably doesn't go back as far

4 as...as many of you, but this is SAP number six f or me.

5 So, it's not exactly a new experience.

6 You know, the agricultural community has

7 participated for 15 years on this subject, will

8 continue to participate. We do think the Agency a nd

9 the SAP has done a...a tremendous job in the past

. 10 We've not always liked the positions taken.

11 The positions asserted by the Agency

12 have not always been supported by the SAP, you k now, I

13 take you back to a previous administration and t he

14 issue of cancer. The...the presentations by the EPA at

15 the time, widely reported again in the media the day

16 before the SAP really began substantive discussi ons,

17 suggested that, in fact, atrazine should be a

18 carcinogen.

19 At the end of the process, it was not,

20 but let's face it, the media had already had the ir

21 field day, and they did not go back and readdres s it in

22 the same substance that they did report the init ial

23 presentations from EPA.

24 So, we've been there. We've seen the

25 process work. We think we'll continue to see theTHE APPROACH TO REEVALUATE ATRAZINE 11/03/09 CCR#16 343-1 77

1 process work, and...and we'll be back, but we...w e do

2 point out that there are some very unusual things that

3 seem to be going on.

4 We can appreciate that, but the sanctity

5 of the science that's been a part of this review,

6 it...it's...some of the most concerning things th at I

7 guess I've observed is a reference to things like the

8 Bush EPA. And I'm just going to come straight out and

9 say it.

10 In my mind, some of the most substantial

11 science that occurred did not occur during the B ush

12 EPA, if you want to call it that. The cancer iss ue was

13 number one with a bullet when the special review was

14 initiated, and, quite frankly, the body of scien ce

15 under that was done under the Clinton EPA, if we want

16 to use those targets, and, in fact, the most

17 substantial statement, I think, on public safety

18 probably came out and on the review in total in July of

19 this year by the Obama EPA.

20 So, it's a science that has carried the

21 day through many administrations, and...and we

22 certainly expect that to occur in the future, an d I

23 guess we'll look forward to seeing you again.

24 I'm...I'm a little disappointed. I thought maybe I was

25 going to be able to get a chance to hear his com mentsTHE APPROACH TO REEVALUATE ATRAZINE 11/03/09 CCR#16 343-1 78

1 some more, but I guess I should pass on that.

2 DR. HEERINGA: Thank you very much, Mr.

3 White.

4 Just a note for myself as chair that

5 this morning's meeting is a public meeting which is a

6 public meeting of an annual update that the SAP, the

7 permanent members you see here, receive from the EPA.

8 And, generally, it is a...a general coverage of t he

9 topics that we expect to come down the pike in th e next

10 year and two years.

11 It is a little unusual that it's focused

12 on one topic, but the fact that it's public, I t hink,

13 in my view, reflects the EPA's interest in makin g this

14 initial presentation which would, again, just be an

15 administrative discussion with...with the perman ent

16 panel about upcoming things, to make that inform ation

17 open and available to the public.

18 At this point, Dr. Sass, we have your

19 public comment.

20 DR. SASS: Thank you. I'm glad to be

21 here, and I'm sorry that I was late. I will be h ere

22 for the rest of the day. So, I will be looking f orward

23 to hearing your thoughts as well as the public

24 commenters.

25 My name is Jennifer Sass, and I'm withTHE APPROACH TO REEVALUATE ATRAZINE 11/03/09 CCR#16 343-1 79

1 the Natural Resources Defense Council which is an

2 environmental non-profit, and I'm based here in

3 Washington, D.C., and I'm a senior scientist in t he

4 health program. My comments were submitted to the

5 docket about a week ago or whenever they were. As

6 well, I brought 30 copies in with Dr. Bailey to b e

7 distributed. So, hopefully, you know, you, at lea st,

8 can access them at some point if you so desire.

9 So, I'm going to touch on some of the

10 points in the comments. First of all, we're very

11 pleased that the EPA and the scientific advisory panel

12 will be taking a look at the atrazine issue for a

13 number of reasons that are based on some new

14 information that's come in, first of all, some o f the

15 monitoring, both water, ecological water monitor ing as

16 well as drinking or tap water monitoring informa tion

17 and some new science that's come out in the last few

18 years.

19 As well, this science that was

20 previously available to SAPs in earlier determin ations

21 is still very relevant, of course. There's no st atute

22 of limitations on the truth, and in this case, I think

23 that the science has been increasing, making a s tronger

24 argument supporting the concern that atrazine in our

25 waterways, both drinking water and particularly in theTHE APPROACH TO REEVALUATE ATRAZINE 11/03/09 CCR#16 343-1 80

1 wat...in open and surface water systems is a conc ern

2 for wildlife.

3 So, first of all, at NRDC, we analyzed

4 the drinking water and the ecological water monit oring

5 data, and we have a report that's available, and I've

6 also provided a summary in my comments.

7 Some of the main points are that the

8 water monitoring from the watersheds, the surface

9 water, showed that all 40 watersheds that were te sted

10 had detectable levels of atrazine, and this supp orts

11 USGS water monitoring also that found widespread

12 atrazine contamination in surface water. 25 of t he

13 watersheds that were looked at had average

14 concentrations above 1 ppb which is the concentr ation

15 at which primary production of aquatic, non-vasc ular

16 plants such as algae is reduced. So, one would e xpect

17 or predict that there might be harm to the ecosy stem

18 because of that.

19 Nine of the monitored watersheds, which

20 is 22 percent of the total, had at least one sam ple

21 showing atrazine levels above 50 ppb. This...thi s

22 isn't an average, but it's a spike or one sample above

23 50 ppb, and four watersheds, representing 10 per cent of

24 the total, had peak maximum concentrations that

25 exceeded 100 ppb.THE APPROACH TO REEVALUATE ATRAZINE 11/03/09 CCR#16 343-1 81

1 So, this is a concern for us for aquatic

2 wildlife as well as aquatic plants that provide o xygen

3 and nutrients to the wildlife in the water.

4 One...at one place, the annual average

5 concentration, that is, an average over the entir e

6 year, was 7.5 ppb. This is surface water at Littl e

7 Pidgeon Creek in Indiana. And the maximum

8 concentration in that location was 237.5 ppb. Tha t was

9 detected in May of '05.

10 We also looked at the drinking water

11 monitoring data, and it also revealed some distu rbingly

12 high spikes or short-term peaks. More than 90 pe rcent

13 of the samples taken in the 139 water systems ha d

14 measurable levels of atrazine over both sampling years.

15 That was '03 and '04. And three water systems ha d

16 running annual averages for atrazine in the fini shed or

17 tap water that exceeded the 3 ppb drinking water

18 standard.

19 54 of the water systems, representing 39

20 percent, had a one-time peak atrazine concentrat ion

21 that was above 3, and the highest peak in one of the

22 systems was 36...39.69 in Evansville.

23 So, the...the peaks are a real concern

24 to us because of potential effects on wildlife e ven

25 during those short-term exposures which might be daysTHE APPROACH TO REEVALUATE ATRAZINE 11/03/09 CCR#16 343-1 82

1 or weeks long. They don't actually...they aren't

2 actually considered as peaks, per se, in the regu latory

3 system for drinking water, and that doesn't fall under

4 the Office of Pesticides' jurisdiction in any cas e.

5 And there's some new science as well

6 that's worth taking a look at. In 2009, there was a

7 number of studies published, and I want to just t ouch

8 on some highlights from a...a meta analysis that was

9 published by Drs. Rohrer and McCoy. Atrazine in t hat

10 study...and that was a study on a wildlife speci es,

11 frogs...found that atrazine reduced size at or n ear

12 metamorphosis in 19 of the 19 studies that were looked

13 at in the meta analysis. Responses were non-mono tonic,

14 meaning that sometimes metamorphosis was delayed , and

15 sometimes it was accelerated.

16 Atrazine reduced anti-predator behavior

17 in six out of seven studies that were looked at, and

18 atrazine is associated with impaired immune func tion in

19 35 of 42 endpoints. There was an increased rate of

20 infection in 13 of 16 endpoints. And atrazine al tered

21 gonadal development in eight out of ten studies that

22 were examined. It impaired gonad function by alt ering

23 spermatogenesis in two of the two studies that w ere

24 looked at and altered sex hormone concentrations in six

25 out of seven studies that were examined.THE APPROACH TO REEVALUATE ATRAZINE 11/03/09 CCR#16 343-1 83

1 So...I'm not going to go through the

2 strengths and weaknesses of meta analyses except to say

3 that it raises some points that I think are worth

4 taking a deeper look at in terms of the potential

5 effects for atrazine on wildlife species, even in

6 spikes or short-term durations.

7 There are some other significant studies

8 that were published in 2009. One study, by Laws,

9 et.al., found that even a single dose of atrazine ...it

10 was 200 mg/kg given to male oyster rats...caused a

11 measurable increase in steroid hormone release w ithin

12 15 minutes after dosing, so a rapid response to a

13 short-term spike.

14 In another study, a different study,

15 published in 2009, rats that were fed atrazine

16 contaminated feed for one or two weeks had a dos e17 dependent reduction in sperm number and impaired daily

18 sperm production. And in another study published in

19 2009, rats that were fed atrazine contaminated f eed for

20 25 days had a dose-dependent reduction in steroi d

21 production in the leydig cells of the testes.

22 Finally, in another 2009 study, rats

23 that were treated for five months with atrazine- laced

24 drinking water at 330 or 300 ppb, which were wit hin the

25 range of the spikes or peaks that we're seeing i n theTHE APPROACH TO REEVALUATE ATRAZINE 11/03/09 CCR#16 343-1 84

1 monitoring program, had associated insulin resist ance

2 leading to obesity. I think that one's very

3 interesting, because it's so directly relevant be cause

4 it was atrazine-laced drinking water was the dosi ng

5 method, and the dose was just in the ranges of wh at we

6 see in the monitoring program.

7 So, we are very pleased that EPA and the

8 SAP is willing to take the time to look at this i ssue

9 again. We have some recommendations for your

10 scientific advisory panel as you put them togeth er.

11 First of all, to gain assurances that

12 EPA will provide all the published peer reviewed

13 studies of relevant data, including but not limi ted to

14 the animal bioassays, in vitro data, human

15 epidemiology, incident data, and ecological

16 epidemiology, that the questions and...the charg e

17 questions and the data provided to you should be broad

18 so that your decision, your determination and yo ur

19 conclusions can be based on...on a broad sweep o f the

20 literature.

21 We recommend that SAP get assurances

22 from EPA that it will...its review will not be l imited

23 to only studies published since the last review, given

24 that previous SAP reviews did not do comprehensi ve

25 literature reviews. They were...the charge quest ionsTHE APPROACH TO REEVALUATE ATRAZINE 11/03/09 CCR#16 343-1 85

1 were more limited in those ones.

2 And we recommend that the SAP get

3 assurances that the cancer and non-cancer review will

4 include both human and animal data from published peer

5 reviewed studies, including but not limited to th e

6 animal bioassays, in vitro studies, occupational

7 epidemiology, and ecological epidemiology.

8 All data endpoints...all...sorry...all

9 endpoints relevant to cancer, including endocrine

10 endpoints, should be considered in order to help the

11 SAP make a determination that considers the full sweep

12 of the data.

13 Thank you very much for your time to do

14 this.

15 DR. HEERINGA: Thank you very much, Dr.

16 Sass.

17 We'd like to move on to our next public

18 commenter. We have three more this morning, and then

19 we'll take a break. It's a little different form at.

20 We've gone a little longer than we typically do, but we

21 want to try to get through this period of public

22 comment.

23 At this point, I'd like to ask Rob

24 Schneider who is with the National Corn Growers

25 Association. Mr. Schneider?THE APPROACH TO REEVALUATE ATRAZINE 11/03/09 CCR#16 343-1 86

1 The remaining discussants in order, just

2 so you can prepare, would be Alex Avery and then Wayne

3 McAllister.

4 MR. SCHNEIDER: Good morning. It's good

5 to be with you all today again. My name is Rob

6 Schneider, director of public policy with the Nat ional

7 Corn Growers Association, providing comment on be half

8 of NCGA which represents more than 36,000 members in 48

9 states, 47 affiliated state organizations, and mo re

10 than 300,000 corn farmers who contribute to stat e

11 checkoff programs across the country.

12 NCGA's members strongly support the

13 continued use of atrazine as an agronomic necess ity on

14 about two-thirds of all U.S. corn. U.S. farmers rely

15 on atrazine for cost-effective broad-leaf weed c ontrol.

16 First of all, NCGA is disappointed with

17 EPA's decision to not extend the recent comment period

18 on the atrazine reevaluation approach. According to

19 the Agency, atrazine is one of the most widely u sed

20 agricultural pesticides in the U.S., with approx imately

21 7...70 million pounds of active ingredient appli ed

22 domestically per year.

23 The chemical has been safely used in the

24 U.S. since 1958, yet the Agency provided only 15 days

25 for interested parties to submit written comment s. IfTHE APPROACH TO REEVALUATE ATRAZINE 11/03/09 CCR#16 343-1 87

1 EPA was interested in adhering to principles of

2 transparency and sound science, it would have giv en

3 adequate time for the public to review relevant

4 materials and provide input.

5 In addition, the timing of this proposal

6 in the midst of harvest made it particularly diff icult

7 for corn growers to meet the abbreviated deadline for

8 comment submission. EPA's current course of actio n

9 would suggest that it is prejudging the safety of

10 atrazine, holding this meeting and determining t he

11 Agency's course of action within six business da ys of

12 the close of the condensed comment period.

13 This week's meeting comes on the heels

14 of almost continuous EPA review of atrazine over the

15 past 10 years. The scientific advisory panels co nvened

16 in 2000 and 2003, 2007, and 2009. There were

17 additional studies already scheduled for 2010 be fore

18 this current comprehensive review was announced last

19 month.

20 During EPA's recent special review of

21 atrazine, more than 6000 studies were considered in

22 determining that atrazine's registration can be safely

23 maintained. Perhaps what is most alarming is the

24 precedent that is being established by the Agenc y's

25 current action.THE APPROACH TO REEVALUATE ATRAZINE 11/03/09 CCR#16 343-1 88

1 Before convening a scientific advisory

2 panel, EPA would typically review any new applica ble

3 data or information, weigh its scientific integri ty and

4 regulatory significance, and determine the necess ity of

5 a new SAP.

6 This...there is no evidence that EPA has

7 thoroughly evaluated any new underlying studies b efore

8 proceeding with this particular panel. In fact, t he

9 Agency is attempting to review a host of issues i n the

10 next 12 months that previously took more than a decade

11 to consider.

12 This creates a false sense of urgency

13 and causes our members to question the motivatio n

14 behind this process.

15 Our growers have always been committed

16 to leaving our environment in better shape than we

17 found it. Stewardship measures ensure that atraz ine is

18 used in accordance with the label and applied in a

19 judicious and cost-efficient manner.

20 At the same time, NCGA believes that 50

21 years of safe use and extensive monitoring data support

22 atrazine's continued registration in the U.S. In

23 short, we are simply asking the EPA to stand by its own

24 science.

25 NCGA and myself would like to thank youTHE APPROACH TO REEVALUATE ATRAZINE 11/03/09 CCR#16 343-1 89

1 for the opportunity to comment here this morning.

2 DR. HEERINGA: Thank you very much, Mr.

3 Schneider.

4 For our next public comments, I would

5 like to call up Alex Avery of the Hudson Institut e

6 where he is director of research.

7 MR. AVERY: Thank you for allowing us

8 to...to be here and to comment. I've been in this

9 arena for more than 15 years. I cut my teeth on t he

10 infamous Alar scare...scandal, really...that was

11 perpetrated by the perpetrators of this current

12 scandal. And I'm going to call a spade a spade t oday.

13 The announcement of this review a scant

14 three months after the conclusions that were ann ounced

15 from the last decades-long review does not stron gly

16 suggest that this process is being entirely moti vated

17 by politics. It gives us a virtual high definiti on

18 video of the politicization of the regulatory pr ocess.

19 It should be noted, as others have, that

20 there was another review scheduled for next fall

. 21 There is not a shred of science that's been pres ented

22 to suggest that a new, urgent, full evaluation i s

23 warranted or necessary, but the politics sure... sure do

24 suggest urgency.

25 We all know if the Democrats lose theTHE APPROACH TO REEVALUATE ATRAZINE 11/03/09 CCR#16 343-1 90

1 next presidential election in 2012 that they will also

2 lose the reins on the political machine with whic h to

3 ban atrazine on political grounds. Hence, a new

4 scientific review of atrazine must start immediat ely if

5 the Agency and its, more importantly, its politic al

6 directors are to have a fig leaf of science with which

7 to hide their politically motivated ban or severe

8 restrictions of atrazine.

9 And as the EPA is well aware, a ban or

10 severe restriction on atrazine will mean higher food

11 costs, more soil erosion, less sustainable farmi ng, and

12 more environmental degradation and damage. It wi ll

13 mean putting more of our farming eggs in fewer b askets,

14 and with the inevitable return of bedbugs to our major

15 cities, we've learned the hard way, just recentl y, how

16 needlessly restricting the tools that we have to fight

17 the scourges of Mother Nature hamstrings our eff orts.

18 The world's population is continuing to

19 grow, and world food demand is set to at least d ouble

20 over the next 40 years. We need every single too l we

21 have and then some just to keep our heads above the

22 rising tide of agricultural demand.

23 Atrazine is a critical tool in that

24 process. It's also a critical tool in protecting the

25 environment and keeping our agricultural systemTHE APPROACH TO REEVALUATE ATRAZINE 11/03/09 CCR#16 343-1 91

1 sustainable. Atrazine and other herbicides are

2 integral.

3 They're at the heart of the no plow, no

4 tillage farming revolution that has caused soil e rosion

5 to drop precipitously, thankfully so. Research by the

6 USDA at Beltsville has demonstrated conclusively that

7 no tillage farming suffers less than 20 percent o f the

8 soil loss that organic and old-style conventional

9 chillage, tillage plowing methods suffer.

10 And atrazine is a critical tool in that

11 process. It helps us to combat resistance to oth er

12 weed killers, maintain high...higher soil organi c

13 matter contents which is something that EPA is

14 supposedly in favor of when it comes to climate change,

15 and it protects our rivers and streams from

16 sediment...sediment pollution which is also a ma jor

17 concern of the EPA under normal circumstances.

18 The witch hunt against atrazine has been

19 perpetrated for more than a decade by the Natura l

20 Resources Defense Council, and they will not tak e no

21 for an answer. And they realize that they don't need

22 sound science or any good scientific evidence to

23 justify a ban on atrazine. All they know...they know

24 full well that, based on the Alar scandal, that all

25 they need is innuendo. All they need is the sugg estionTHE APPROACH TO REEVALUATE ATRAZINE 11/03/09 CCR#16 343-1 92

1 and enough concocted public fear.

2 And, hence, suggestions today from

3 the...the one who came before me that atrazine is now

4 responsible for the obesity epidemic in the Unite d

5 States.

6 So, back in the 21st century, the

7 Natural Resources Defense Council was trying to d o to

8 atrazine what they did to Alar. Make no mistake, the

9 NRDC and the political operators running the EPA today

10 will go back to the scientific wishing well unti l they

11 create enough innuendo and fear to cover a polit ically

12 motivated, ideological effort to ban or severely

13 restrict atrazine.

14 We are watching. We will fight it. We

15 are not going away.

16 Thank you.

17 DR. HEERINGA: Thank you, Mr. Avery.

18 And now, not Wayne McAllister but Ray McAllister from

19 Croplife America.

20 MR. MCALLISTER: Thank you. I apologize

21 for not having copies of my comments, but I'll m ake

22 those available through the Agency.

23 Croplife America is a trade association

24 which represents the common interests of manufac turers,

25 formulators, and distributors of virtually all t heTHE APPROACH TO REEVALUATE ATRAZINE 11/03/09 CCR#16 343-1 93

1 active ingredients used in crop protection produc ts in

2 the United States. We're commenting today because of

3 our concern about the Agency initiating a...a rev iew of

4 a compound that has been reviewed almost continuo usly

5 for more than 20 years, and the Agency has put a great

6 deal of effort into this already.

7 In the course of making regulatory

8 evaluations and decisions on individual products, the

9 potential exists to set new policies and alter ex isting

10 ones which will affect subsequent decisions acro ss the

11 board. That's our concern about the initiation o f this

12 review today which does not appear to be entirel y

13 motivated by science-based principles. We are no t

14 aware of any basis in...in real fact or law to r eopen

15 the long series of Agency decisions which are ba sed on

16 years of data on record and many years of the Ag ency

17 analysis.

18 We're concerned that this...this

19 decision for a new year-long review has been tak en

20 rather hastily and is based on un...unsubstantia ted

21 media...media reporting and reports of an activi st

22 organization over alleged human health effects a nd

23 concerns and criticisms of EPA's regulatory over sight.

24 The Agency announces as much in its public docke t.

25 The Agency is well aware of theTHE APPROACH TO REEVALUATE ATRAZINE 11/03/09 CCR#16 343-1 94

1 importance of basing its rulings on sound science and a

2 transparent progress, allowing adequate time for public

3 participation. That is their statutory obligation , to

4 adhere to these principles and frequently re..res tate

5 them in their communications regarding such actio ns

6 and...and activities of the Agency.

7 Yet, this year-long review of atrazine

8 involves a compound which has been in use for 50 years.

9 It's been under a number of different types of re views,

10 many of them or some of them only recently concl uded.

11 The Administrative Procedures Act

12 requires notice and comment on actions by Federa l

13 agencies for a number of reasons. Public partici pation

14 and fairness to affected parties is a principal reason.

15 It ensures that the agency will have before it t he

16 facts and information relevant to a particular

17 administrative problem, and it allows an agency to

18 reconsider and sometimes change its proposals ba sed on

19 the comments of affected persons.

20 It doesn't specify a minimum comment

21 period, but even providing 30 days to comment fo r

22 the...from the publication of a Notice in the Fe deral

23 Register might not be an adequate period of time to

24 respond to proposals that are complex or based o n

25 significant scientific and technical data.THE APPROACH TO REEVALUATE ATRAZINE 11/03/09 CCR#16 343-1 95

1 In this case, the compressed time

2 schedule between publication of the notice of the

3 meeting on October 7th and the call for public

4 comments, a little more than two weeks later, for a

5 meeting even just two weeks after that precluded

6 considered and thoughtful comments on the review of the

7 proposal by the public.

8 This compressed schedule also

9 affected...gives the impression that EPA has prej udged

10 the critical aspects of the year-long review of this

11 compound and leaves no time for reasoned comment

12 development by commenters, much less review of s uch

13 comments by the EPA and adequate time for you, t he SAP,

14 to...to review and make appropriate recommendati ons to

15 the Agency.

16 Under these circumstances, are we, as

17 regulated entities and the regulated community, to

18 conclude that EPA is establishing a new paradigm to

19 take groundless and unsub...unsubstantiated info rmation

20 from the press and from activist organizations t o start

21 a new review of a compound? NRDC cites studies t hat

22 have been reviewed numerous times and discounted by the

23 experienced EPA scientists due to defects, flaws , or

24 lack of quality in those studies.

25 We're concerned that this is a...this isTHE APPROACH TO REEVALUATE ATRAZINE 11/03/09 CCR#16 343-1 96

1 a divergence from the science-based process under FIFRA

2 FQPA. EPA has done special reviews of triazines t hat

3 took place over 12 years, concluded just 3 years ago.

4 It has planned a registration review of atrazine to

5 begin in just a few years from now. So, dropping

6 another comprehensive year-long review in the mid st of

7 these other reviews in progress or recently concl uded

8 or on the schedule appears to be politically moti vated,

9 and we're concerned that this sets a precedent fo r

10 other...other products in the marketplace where a

11 review may be unjustified.

12 Thank you.

13 DR. HEERINGA: Thank you, Mr.

14 McAllister.

15 A note to the presenters here during the

16 public comment period. If you have a written ver sion

17 of your comments, including the version that you used

18 to read from, and have not provided it for the d ocket,

19 I would encourage you to do that, to provide it to

20 ...to Joe Bailey who is the Designated Federal O fficial

21 for this meeting.

22 At this point in time, I'd like to draw

23 the period of public comment to a close and call for a

24 15-minute break at which time our meeting will

25 reconvene, and we will have an opportunity, as w e wouldTHE APPROACH TO REEVALUATE ATRAZINE 11/03/09 CCR#16 343-1 97

1 typically in our permanent panel administrative

2 meeting, to address some questions to the scienti fic

3 and administrative staff of the EPA.

4 So, let's all rejoin here about...oh,

5 let's say 11:25, and we'll continue until about t he

6 noon hour.

7 (WHEREUPON, a brief recess was taken.)

8 DR. HEERINGA: Okay, welcome back,

9 everybody, to the second half of our...our mornin g

10 session, our morning meeting in which the panel is

11 hearing from the EPA and from public commenters on the

12 topic of the presentation of the approach to ree valuate

13 atrazine.

14 At this point in time, we have on the

15 agenda a period of time for the...the panel to d iscuss

16 the material that we've heard this morning and t o maybe

17 ask questions of Dr. Bradbury and Dr. Levine, Dr

. 18 Lowit, and others on the staff who will be worki ng on

19 this particular effort.

20 I would like, if we could, to bring out

21 the slide number 1 from Dr. Bradbury's presentat ion

22 which is the...the columns are the three monthly

23 meetings, and the rows are sort of a summary of content

24 in each of those three meetings if we could.

25 And while that's...while that's comingTHE APPROACH TO REEVALUATE ATRAZINE 11/03/09 CCR#16 343-1 98

1 up, I guess I'd like to open up to my fellow pane l

2 members the floor to ask questions based on, agai n, the

3 presentations this morning on the nature of this

4 initiative. Does anyone want to take a leap? Dr.

5 Portier?

6 DR. PORTIER: So, thinking about

7 these...these upcoming meetings and, in particula r,

8 looking at the February meeting, we had a...we ha d a

9 meeting last year where we looked at the three

10 epidemiology studies from California. I don't kn ow if

11 you remember that meeting. Was it last year or

12 year...late year before last? It was last year, early

13 last year.

14 The community health work...the

15 bystander exposure in epidemiology, but I just r emember

16 that panel and remember having a lot of discussi on. I

17 think it's going to be of importance for the pan el to

18 kind of see the questions for that meeting a lit tle bit

19 early so we can really understand what you're tr ying to

20 get at in those questions.

21 It's been my experience on the panel

22 that every time epidemiology studies come up, th ere's a

23 lot of discussion and a lot of confusion. We spe nd a

24 lot of time trying to understand the value of th ose

25 studies, and sometimes, they're underpowered orTHE APPROACH TO REEVALUATE ATRAZINE 11/03/09 CCR#16 343-1 99

1 undersized, and then we're trying to figure out w hat

2 are we really getting out of these...out of the

3 studies.

4 And then, I guess, the second thing is

5 if...if what we're going to be looking at is the

6 agricultural workers study design, if you're goin g to

7 be asking the panel to look at that design, to

8 anticipate what we might be getting from that, it would

9 be nice to be able to see those design parameters

. 10 We...we were talking at the break about

11 things like at this point, they should know roug hly

12 what their...their data collection rates look li ke,

13 missing data, what kind of things it characteriz ed,

14 what kind of...what...what they actually measure d, so

15 we can be looking at those parameters and

16 anticipating...I don't know if February's linked to

17 September. In September, I'm thinking we're look ing at

18 the results of those studies. Right? Of whatever 's

19 published out of that study over the spring and the

20 summer.

21 But if we're looking at kind of the

22 value of epidemiology, we're going to need to

23 understand up front what that...what was...what went

24 into that particular study.

25 DR. HEERINGA: Dr. Chambers?THE APPROACH TO REEVALUATE ATRAZINE 11/03/09 CCR#16 343-1 100

1 DR. CHAMBERS: With respect to the

2 February study, it sounds like incorporating epi

3 studies and human health incident data into risk

4 assessment is a very important generic topic, and I

5 assume that was what was on the table for Februar y,

6 anyway. I guess my question would be, is the atra zine

7 data set really relevant to those particular ques tions,

8 or are we going to get bogged down on just the

9 individual atrazine data set? Because the generic

10 questions, I think, might be broader than just t he

11 individual studies and...

12 DR. LEVINE: Well, actually, in my

13 remarks, I think I tried to stress that we don't want

14 that session to get bogged down to...into just b eing

15 about atrazine, but...but we always envisioned

16 this...this, the February session to have some c ase

17 study examples.

18 And...and, in actuality, we had thought

19 that they would be more of the data out of the A g

20 Health study that we could use, but that wasn't

21 happening which is part of the reason it seems t o get

22 postponed and postponed, and since there were a number

23 of different designs, designs that are different from

24 the Ag Health study that were...were...have been cited

25 in the media about atrazine risk and there areTHE APPROACH TO REEVALUATE ATRAZINE 11/03/09 CCR#16 343-1 101

1 other...probably other studies, too, we thought t hey

2 would make good case studies. And, in addition, w e

3 have some incident case studies, and we'd always

4 planned to do it that way.

5 So, it's really going to be one of the

6 illustrations, but it's going to be about the mor e

7 generic issue.

8 DR. LOWIT: And, Dr. Chambers, the only

9 thing I would add to that...Anna Lowit. The only thing

10 I would add to that is...is that the atrazine st udies

11 that we'll talk about are not, although they're unique

12 to atrazine, those questions are not unique to

13 atrazine, and there's not a unique situation whe re

14 studies are published in the open literature tha t, on a

15 pesticide chemical.

16 There's...questions always arise of how

17 to incorporate that into our risk characterizati on.

18 So, we share a concern of having atrazine not ov erwhelm

19 that meeting and to focus on the broader intent, but I

20 think the answer to your question is simply yes, the

21 questions that we'll ask about those studies fit very

22 well in that meeting, I think.

23 DR. HEERINGA: Dr. Bucher?

24 DR. BUCHER: John Bucher. I think the

25 same kinds of comments could be made about theTHE APPROACH TO REEVALUATE ATRAZINE 11/03/09 CCR#16 343-1 102

1 references that you made, Dr. Bradbury, to the

2 toxicology in the 21st century with respect to th e

3 ToxCast program that...the generation of data fro m in

4 vitro assays and how that's used in risk assessme nt,

5 and I'm...I'm not...I don't know exactly...in my own

6 mind, I'm not sure exactly how mature that, the

7 appreciation of all that information is going to be

8 with respect to also inserting the atrazine issue s in

9 that regard.

10 So, I...I guess I just had some of the

11 same concerns with that, that were just expresse d.

12 DR. BRADBURY: With regard to...if I

13 could read a little bit more into your question with

14 regard, especially, to the April SAP, what we wa nt to

15 ensure that, consistent with Agency guidance on using

16 best available information and developing of lin es of

17 evidence and weight of evidence to try to charac terize

18 the risk as best we can, think about the uncerta inty

19 either qualitatively or quantitatively.

20 We want to ensure that we're taking

21 advantage of any in vitro information in the cou rse of

22 the data quality review of that data to see to w hat

23 extent it can help inform us as to the mechanism s of

24 action, mode of action of atrazine and how is th at

25 information concurrent with other experimentalTHE APPROACH TO REEVALUATE ATRAZINE 11/03/09 CCR#16 343-1 103

1 toxicology information we review in April to see can we

2 put together a coherent picture, maybe update the

3 picture or maybe it's a new picture, in terms of what

4 do we know about the mechanisms of action, toxici ty

5 pathways associated with atrazine and/or its

6 metabolites and how does that lead to adverse out comes,

7 which we feel is an important part of doing a ris k

8 assessment today.

9 And we'll continue to advance that...the

10 ability to try to integrate that information, to use

11 toxicity pathways, mode of action to help inform dose

12 response relationships, to help inform what may be

13 similar or dissimilar across species and underst and

14 aspects of...of exposure considerations in terms of

15 characterizing the risk.

16 So, that...April will be atrazine, but I

17 think it's fair to say we'll not only advance

18 our...and...and update our understanding of atra zine,

19 but we'll probably get some other insights that can be

20 more broadly applicable to integrating diverse s ets of

21 information together, especially as these go fro m April

22 to...to September where experimental studies are being

23 integrated with epidemiology studies.

24 If I could just comment a little bit on

25 the earlier question about February/September, t heTHE APPROACH TO REEVALUATE ATRAZINE 11/03/09 CCR#16 343-1 104

1 epidemiology studies, to...to reinforce what Dr. Levine

2 was saying, our goal all along in February was to have

3 a risk assessment to look at approaches for inclu ding

4 incident data, as appropriate, as well as epidemi ology

5 studies, as appropriate, based on data quality an d

6 designs, all those issues, into a robust risk

7 characterization and integrating this information

. 8 February, in a sense, is a building

9 block step as we move forward. And so, atrazine

10 provides us some opportunity to explore some

11 epidemiology designs as well as get some insight s on

12 some specific studies. I'm not an epidemiologist . I

13 mean, I don't wear that hat, but my colleagues a re

14 explaining to me that there's a spectrum of desi gn

15 types from ecologic studies to retrospective cas e

16 studies to prospective studies, and what we want to

17 look at in February, in particular, are ecologic

18 designs and retrospective designs and get some s ense as

19 to how you interpret that kind of information al ong

20 with other kinds of information.

21 As we move to September, we'll be

22 looking at the Ag Health study which is a prospe ctive

23 study which is a different design. We'll ultimat ely

24 get some advice from you on how do we integrate these

25 different kinds of epidemiology studies, designs orTHE APPROACH TO REEVALUATE ATRAZINE 11/03/09 CCR#16 343-1 105

1 strengths and limitations in the context of the a nimal

2 or experimental toxicology data that we'll also h ave

3 available.

4 DR. HEERINGA: Steve Heeringa. I'd like

5 to introduce just a few comments of my own and... and

6 these are my own views here and don't necessarily

7 reflect those of the complete panel.

8 In the over...over a decade that I've

9 been involved in the process with the ad hoc pane ls as

10 a person who sat and provided advice or serving on the

11 permanent panel, this is a little out of the ord inary,

12 but I...certainly, it's not my position right no w to

13 question your judgment or the motivation on this

. 14 We are an advisory panel and here to

15 serve you objectively to help interpret science, and I

16 think I certainly have worked with you long enou gh and

17 have enough confidence to know that when you com e to

18 us, it's for a purpose to seek out scientific re view on

19 new information.

20 That said, this is going to be a very

21 busy year, and these are going to be very demand ing

22 reviews not only for the permanent panel but als o for

23 the ad hoc members. And you know that the ad hoc

24 members play a key role in these reviews. And it 's

25 going to be essential in this process, as it goe sTHE APPROACH TO REEVALUATE ATRAZINE 11/03/09 CCR#16 343-1 106

1 forward...it's...it has some pretty broad aims, a nd I

2 think, scientifically, as I say, we're prepared t o help

3 you evaluate those aims, and that's what we're go ing to

4 do.

5 But it does mean that data sources,

6 materials, background materials should be ready e arly

7 in this process for review. The amount of data

8 alone...if I think about even the April meeting w ith

9 the sort of reassessment and look at the experime ntal

10 toxicology studies could easily overwhelm review ers,

11 and I want to make sure that, as we go through t his

12 process as a panel, to be fair to you and to be fair to

13 us, that we, in fact, have time to prepare.

14 And looking ahead to September with the

15 Agricultural Health study...I have some knowledg e of

16 this because of participations in the meeting, b ut I

17 don't know anything about the design.

18 Maybe it's a simple trip to the...to the

19 web to learn some of that information, but I wou ld

20 say...ask of you in terms of your working with t he

21 permanent panel and also with the ad hoc panels that

22 are formed that as soon as you have data and

23 documentation that you can provide to us, it wou ld be

24 important for us to receive this even in advance of

25 receiving the charge questions.THE APPROACH TO REEVALUATE ATRAZINE 11/03/09 CCR#16 343-1 107

1 Because while the charge questions will

2 help focus our scientific response to your concer ns and

3 your issues, I think it's very important in this very

4 data intensive set of reviews for us to be able t o

5 become directly familiar with most of these infor mation

6 sources.

7 And...and we can communicate on that,

8 too, but I just want to emphasize that, again, wh at

9 you've presented here in terms of a scientific re view,

10 and we anticipate your request of us as an advis ory

11 panel on that science as we move ahead, please h elp us

12 be prepared to do this. And we'll keep a close e ye,

13 too, because we want to make sure that there is

14 adequate time for these reviews and for consider ation

15 of all of the information.

16 Additional comments? Dr. Chambers?

17 DR. CHAMBERS: As just a followup to

18 Steve's remarks, then, if...if the data really c an't be

19 compiled in a well organized and well analyzed m anner

20 in time for those particular meetings, you've pu t

21 meetings off before when they haven't been prepa red,

22 and maybe you should put those off, because we r eally

23 do absolutely, the same thing Steve said, we abs olutely

24 need enough time to look at the materials.

25 DR. HEERINGA: Any other comments orTHE APPROACH TO REEVALUATE ATRAZINE 11/03/09 CCR#16 343-1 108

1 information? Steve?

2 DR. BRADBURY: Seeing if any of my

3 colleagues had any followup questions. I want to take

4 the opportunity to maybe clarify a few things and a

5 little bit of feedback and, you know, move on.

6 First of all, I want to thank you all

7 for spending the time with us this morning on an

8 informational session just to share with you wher e we

9 are, where our vision is in terms of taking a loo k at

10 the science around atrazine.

11 As we mentioned before many times,

12 administrative sessions are not public sessions, but we

13 felt it was very important for this particular t opic,

14 as we look forward to the 2010 season, that we h ave a

15 transparent session, we have an open meeting so people

16 could provide some of their initial thoughts and

17 clearly as we move forward through these three p eer

18 reviews.

19 And I certainly appreciate the timing

20 and the need to get information in the docket as we

21 form the charge questions.

22 But I just want to reaffirm that the

23 process we use for each of these three SAPs will be

24 like the process we typically use where informat ion is

25 put in the docket, there's opportunity for the p ublicTHE APPROACH TO REEVALUATE ATRAZINE 11/03/09 CCR#16 343-1 109

1 to provide nominations to our colleagues and the

2 designated official, federal officials, to vet a robust

3 panel as well as the opportunity for people to lo ok at

4 the materials going into the docket and provide t heir

5 insights on the information as well as their view s

6 on...on the charge questions as they're formulate d as

7 well as to offer you other issues that they think , the

8 public thinks, are important to...to focus on.

9 And so, I just want to reassure the

10 public as well as the panel that we will be usin g that

11 same process that we've always done in terms of

12 transparency and openness to get information. An d,

13 clearly, we will have a number of people working very

14 hard to provide information as soon as we can, a nd

15 we'll be working with Laura Bailey and others to ensure

16 we have a good process in doing that, in getting

17 information to you ahead of time.

18 And clearly, we value the input that

19 you're going to be providing over the coming 12 months

20 or so as we take a look at these issues.

21 The last comment I wanted to make was

22 just to make it really clear again that when we come to

23 the Science Advisory Panel it's to get advice on

24 important scientific issues, and, clearly, scien tific

25 issues are the foundation for any and all of ourTHE APPROACH TO REEVALUATE ATRAZINE 11/03/09 CCR#16 343-1 110

1 regulatory decisions, and we don't make regulator y

2 decisions without having a good understanding of the

3 science.

4 And so, coming to you is an important

5 step in evaluating this compound and ensuring tha t we

6 have the most current and accurate insights as to how

7 to interpret the risk characterization of atrazin e.

8 And it's clearly our process consistent with

9 Administrator Jackson's process of very strong sc ience,

10 the rule of law and transparency in how we make

11 decisions, and the Science Advisory Panel lookin g, the

12 scientists in OBT and ORD and Office of Water is an

13 important foundation to...to how we take a look at this

14 chemical and...and just to reassure everyone tha t the

15 first step is making sure we're current with the

16 science, we understand the science well and have

17 the...the advice and input from this panel to he lp

18 guide us in thinking about the science and that' s the

19 step that we're at right now.

20 So, I just want to close by thanking you

21 all for spending time with us this morning and.. .and

22 into the future, and we're very conscious of the

23 aggressive schedule and the need to provide info rmation

24 in a timely manner.

25 Thank you.THE APPROACH TO REEVALUATE ATRAZINE 11/03/09 CCR#16 343-1 111

1 DR. HEERINGA: Well, the lights dimmed

2 because there was no activity. There was thought

3 process going on, but I...apparently, it dropped to a

4 certain level and it cut the juice.

5 So, Dr. Bradbury, if I could, just one

6 more question. With regard to the epidemiology

7 studies, the non-cancer that we'll consider in Fe bruary

8 and the cancer that we'll consider in...in Septem ber,

9 are you aware of current work? Have you seen draf t

10 manuscripts on studies on ag health that motivat e those

11 agenda items? Or is it just the anticipation of the

12 data release itself, the final data cleaning at a

13 certain stage opens this up for reanalysis and

14 publication?

15 DR. BRADBURY: With regard to the...the

16 cancer effects in epidemiology, I mentioned in m y

17 opening remarks some of the regulatory process t hat

18 atrazine is, is in. And atrazine is still in spe cial

19 reviews. The special review for atrazine hasn't been

20 closed.

21 And the special review for atrazine and

22 its primary focus was the extent to which atrazi ne

23 could be a carcinogen and the potential carcinog enicity

24 of atrazine. So, throughout our...our regulatory game

25 plan time line for atrazine which includes closi ng theTHE APPROACH TO REEVALUATE ATRAZINE 11/03/09 CCR#16 343-1 112

1 special review, before we can close the special r eview,

2 we needed to take a final look at atrazine and it s

3 potential for carcinogenicity.

4 And consistent with the 2003 IRED, it

5 indicated that the Ag Health study that was ongoi ng,

6 getting started at the time, and the forecasting for

7 when the last atrazine studies would be completed would

8 be roughly in this time frame.

9 So, that 2010 SAP was always scheduled

10 to deal with the Ag Health study and the cancer studies

11 within the Ag Health study as that last critical step

12 of the science to then determine if we can close the

13 special review for atrazine which had this remai ning

14 step in it.

15 Our colleagues in ORD and R&D and our

16 individuals here in OBT with Carol, are working closely

17 with colleagues in the National Cancer Institute and

18 NIEHS, and it's our understanding that those fin al, I

19 think it's two or three studies should be gettin g

20 completed in the spring time frame, hence that's why we

21 had scheduled September.

22 With regard to the other epidemiology

23 studies, right now, we're focusing on studies th at have

24 been published in the peer reviewed journals. To the

25 extent the Ag Health studies are looking at non- cancerTHE APPROACH TO REEVALUATE ATRAZINE 11/03/09 CCR#16 343-1 113

1 issues and they're coming to bear at the time, we

2 would...we would fold those in as well.

3 So, our primary focus for Ag Health

4 study was largely cancer, the last science step t o

5 determine if we can close the special review for

6 atrazine. The other studies is more consistent wi th

7 our holistic look at...at atrazine, epidemiology

8 studies have been published since 2003 on non-can cer.

9 We want to take a look at those. See how the diff erent

10 designs should be considered.

11 Again, we will be focusing on

12 information that's been published in the peer re view

13 literature. To the extent something hasn't been

14 published in the peer review literature, by defi nition,

15 it's very difficult for us to review that. To th e

16 extent, I suppose if an individual or a research group

17 wanted to submit their studies to the docket bef ore

18 they submit it into a journal, we would certainl y take

19 a look at them.

20 DR. HEERINGA: Thank you very much. Any

21 other questions?

22 (No response.)

23 DR. HEERINGA: Well, at this point, I

24 guess I'd like to turn the morning's proceedings over

25 to Joe Bailey to see if there's any finalTHE APPROACH TO REEVALUATE ATRAZINE 11/03/09 CCR#16 343-1 114

1 administrative notes, and then we'll wrap up.

2 I'd just remind everybody that the FIFRA

3 SAP will reconvene...it's a larger group this

4 afternoon...to address the topic of nanosilver, a nd

5 that meeting will be chaired by Gary Pope, my col league

6 this afternoon, so we hope to see many of you bac k here

7 for that this afternoon.

8 Joe?

9 MR. BAILEY: Thank you, Dr. Heeringa.

10 One note. Security has come forward and

11 said there is a Toyota Forerunner on lower level 2 with

12 the interior lights on, so if it's yours...it ha s

13 Maryland plates. If it's yours, you might want t o

14 check it, or you will have to stay here for the rest of

15 the meeting. If you weren't planning to.

16 And in closing, I just want to thank

17 everyone for attending and express my appreciati on to

18 EPA staff and to the public commenters for their

19 presentations. And I want to thank the panel and Dr.

20 Heeringa for being here.

21 Thanks.

22 DR. HEERINGA: Yes, thank you, everyone,

23 and we appreciate all of the participation, to t he EPA

24 scientific staff for their initial presentations and

25 for bringing us to an open and public, transpare ntTHE APPROACH TO REEVALUATE ATRAZINE 11/03/09 CCR#16 343-1 115

1 discussion and for all of the public commenters f or

2 their input, and we look forward to seeing everyo ne

3 over the course of the next year on this topic.

4 (WHEREUPON, the Meeting was adjourned at 11:55 a. m.)

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25THE APPROACH TO REEVALUATE ATRAZINE 11/03/09 CCR#16 343-1 116

1 CAPTION

2 The foregoing matter was taken on the date, and a t the

3 time and place set out on the Title page hereof.

4 It was requested that the matter be taken by the

5 reporter and that the same be reduced to typewrit ten

6 form.

7 Further, as relates to depositions, it was agreed by

8 and between counsel and the parties that the read ing

9 and signing of the transcript, be and the same is

10 hereby waived.

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25THE APPROACH TO REEVALUATE ATRAZINE 11/03/09 CCR#16 343-1 117

1 CERTIFICATE OF REPORTER

2 COMMONWEALTH OF VIRGINIA

3 AT LARGE:

4 I do hereby certify that the witness in the foreg oing

5 transcript was taken on the date, and at the time and

6 place set out on the Title page hereof by me afte r

7 first being duly sworn to testify the truth, the whole

8 truth, and nothing but the truth; and that the sa id

9 matter was recorded stenographically and mechanic ally

10 by me and then reduced to typewritten form under my

11 direction, and constitutes a true record of the

12 transcript as taken, all to the best of my skill and

13 ability.

14 I further certify that the inspection, reading a nd

15 signing of said deposition were waived by counse l for

16 the respective parties and by the witness.

17 I certify that I am not a relative or employee o f

18 either counsel, and that I am in no way interest ed

19 financially, directly or indirectly, in this act ion.

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24 MARK REIF, COURT REPORTER / NOTARY

25 SUBMITTED ON NOVEMBER 3, 2009THE APPROACH TO REEVALUATE ATRAZINE 11/03/09 CCR#16 343-1 118 $ $1.8 67:22 $20 71:16 $60 71:17 $60...or 71:16

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A

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61:18 62:18 82:2 99:14 100:12 actually...they 82:1

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90:5 92:22 93:3 93:5 93:15 93:16 93:24 93:25 94:6 94:15 94:17 95:15 102:15 Agency's 87:11 87:24 agenda 73:9 97:15 111:11 aggregate 72:15 aggressive 110:23

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Anna 17:16

announced 87:18 89:14

announcementTHE APPROACH TO REEVALUATE ATRAZINE 11/03/09 CCR#16 343-1 123

89:13

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be...these 18:2

be...we're 22:5THE APPROACH TO REEVALUATE ATRAZINE 11/03/09 CCR#16 343-1 126

bear 17:9 113:1

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Beltsville 91:6

best 18:9 21:4 25:11 67:16 102:16 102:18

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biased 73:22

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Boxer 30:11 Bradbury 5:15 5:18 17:5 17:17 27:12 34:21 53:8 56:11 97:17 102:1 102:12 108:2 111:5 111:15 Bradbury's 97:21 Brady 6:3

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Bucher 5:7 5:7 63:7 63:8 63:8 64:3 64:16 101:23 101:24 101:24THE APPROACH TO REEVALUATE ATRAZINE 11/03/09 CCR#16 343-1 127

build 15:23 building 14:25 104:8

bullet 77:13

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Canada 32:24 33:19

Canada...Canada 36:10

cancer 4:23 8:4 8:24 9:10 11:6 11:11 11:20 12:2 12:3 12:6 12:8 12:11 15:25 16:8 16:11 18:15 24:18 24:22 24:24 27:1 35:25 36:1 36:5 36:24 36:25 37:3 38:19 39:17 39:19 44:18 76:14 77:12 85:3 85:9 111:8 111:16 112:10 112:17 113:4

cancers 43:18

candidates 52:8 captioned 40:5

carbon 64:12

carcino...is 43:19 carcinogen 16:2 76:18 111:23 carcinogenesis 5:11 carcinogenic 9:6 9:11 38:3 carcinogenicity 8:4 9:7 111:23 112:3 carcinogens 69:9

career 30:24 31:13

Carol 17:24 112:16

Carolina 20:14 39:22

carried 77:20 Cary 4:17

case 14:17 21:2 21:17 21:18 21:19 22:2 22:9 22:11 24:15 26:16 39:17 57:7 59:13 61:20 66:19 75:17 79:22 82:4 95:1 100:16 101:2 101:3 104:15 category 21:22

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caused 38:16 91:4

causes 45:8 88:13

cells 83:21

center 4:19 21:15 28:19 28:25 century 16:24 92:6 102:2

CEO 70:7

certain 111:4 111:13 certainly 74:24 75:2 75:10 77:22 105:16 108:19 113:18 certainty 72:13

certified 20:13

chair 2:19 3:22 4:13 66:5 78:4

chaired 114:5

chairman 32:9 66:24 70:2THE APPROACH TO REEVALUATE ATRAZINE 11/03/09 CCR#16 343-1 128

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chairs 32:5 challenge 31:5

Chambers 5:2 5:2 99:25 100:1 101:8 107:16 107:17

chance 77:25 change 19:25 51:3 91:14 94:18 changed 26:8 57:15 changes 26:1 55:6 61:6 64:1 Chapel 39:22

characterization 16:20 22:25 25:2 25:17 27:3 33:20 38:13 39:21 40:8 41:13 57:1 101:17 104:7 110:7

characterize 48:16 49:21 53:4 102:17

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chastened 68:12

check 114:14

checkoff 86:11

chemical 19:10 86:23 101:15 110:14

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chemist 32:15

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child's 49:15 chillage 91:9

chlorinated 72:18

chloro 42:23

chlorotriazines 42:22 43:2

chlortriazine 46:2

Christiansen 17:24

chronic 24:18 46:13 49:6 60:7 60:8 chronically 52:2 54:23

circumstances 91:17 95:16

cited 100:24

cites 95:21

cities 90:15

citrus 66:5 66:13 66:13 67:7 67:23 68:25 68:25 69:16

civil 31:17

civilized 31:2

clarification 27:11 63:6 clarify 108:4 clarifying 17:3 clarity 16:21

classifiable 37:3

classification 8:17 36:5 36:25

clean 30:5 cleaning 111:12

clear 43:20 109:22 clearly 108:17 109:13 109:18 109:24 110:8

climate 91:14

Clinton 77:15

Clinton's 31:8

close 6:13 87:12 96:23 107:12 110:20 112:1 112:12 113:5

closed 111:20 closely 112:16 closing 16:14 111:25 114:16

co 22:9

Coalition 70:9THE APPROACH TO REEVALUATE ATRAZINE 11/03/09 CCR#16 343-1 129

70:11

coherent 103:2

colder 67:13

collaboration 6:13 20:15

collaborators 47:10 colleague 114:5 colleagues 5:24 6:14 10:24 38:23 67:2 104:13 108:3 109:1 112:15 112:17

collection 99:12 College 5:3 57:25

Colorado 39:5

colossal 30:14

column 36:16

columns 97:22

combat 91:11 Combining 71:4

comes 75:11 75:13 87:13 91:14 coming 20:11 21:9 25:8 43:8 97:25 109:19 110:4 113:1 coming...coming 7:10

comment 3:2 3:8 27:15 27:19 28:5 28:6 28:11 28:12 31:23 34:17 35:8 35:19 50:4 64:10 78:19 85:22 86:7 86:17 87:8 87:12 89:1 89:8 94:12 94:20 94:21 95:11 96:16 96:23 103:24 109:21

commenter 65:23 69:24 85:18

commenters 28:15 63:4 78:24 95:12 97:11 114:18 115:1 commenting 28:24 93:2

comments 3:4 3:6 3:11 6:1 6:20 21:24 23:18 24:21 28:10 29:1 35:18 61:15 71:22 71:23 73:5 74:23 74:25 77:25 79:4 79:10 80:6 86:25 89:4 92:21 94:19 95:4 95:6 95:13 96:17 101:25 105:5 107:16 107:25

commercial 71:10

commitment 62:8

committed 62:1 88:15

committee 67:1 68:24 72:23 74:19

common 42:21 92:24

communicate 107:7 communications 68:6 94:5

communities 10:9 13:14 13:16 community 24:4 51:11 51:13 51:15 52:21 52:24 53:16 54:5 54:11 54:24 58:20 65:3 70:24 76:6 95:17 98:14 companion 27:24

company 32:14 33:1 41:3

compare 60:8 compared 52:2 comparing 26:15 comparison 22:6 compete 71:5 competence 30:24 31:5 31:12 competency 29:11 competent...their 31:11 compiled 107:19 complement 7:1 complemented 54:9 complete 105:7 completed 10:17 35:14 36:10 112:7 112:20 complex 94:24 component 22:8 compound 8:16 93:4 94:8THE APPROACH TO REEVALUATE ATRAZINE 11/03/09 CCR#16 343-1 130

95:11 95:21 110:5 comprehensive 23:4 33:7 35:23 37:7 40:20 50:6 61:24 62:10 65:8 84:24 87:18 96:6 comprehensiveness 50:19 compressed 95:1 95:8 comprises 41:5 45:3

concentration 52:1 57:4 57:17 58:13 59:20 64:11 80:14 81:5 81:8 81:20

concentrations 9:23 51:6 55:10 55:15 56:3 56:8 58:14 58:23 61:8 64:13 80:14 80:24 82:24 concepts 42:3 42:12

concern 9:7 9:25 10:8 24:16 24:19 44:12 48:15 58:10 59:17 70:18 79:24 80:1 81:1 81:23 91:17 93:3 93:11 101:18

concerned 75:2 93:18 95:25 96:9 concerning 77:6

concerns 61:13 67:5 67:5 93:23 102:11 107:2

conclude 37:14 95:18

concluded 13:7 62:24 94:10 96:3 96:7

conclusion 9:10 11:9 11:18 12:6 42:20 69:11

conclusions 36:13 40:4 40:12 44:7 69:5 69:5 69:6 84:19 89:14 conclusively 91:6

concocted 92:1

concur 40:12 42:20

concurrent 102:25

condensed 87:12

condition 53:8

conditions 56:11 64:22

conducted 37:16 38:1 41:11 50:10

conference 75:6

confidence 31:12 105:17

confident 61:25

confirm 65:16

confirmed 34:13 confused 75:24

confusion 98:23 conjugated 43:13

connections 73:13

conscious 110:22

consequence 64:1 Consequently 30:15

conservative 34:10 53:11 62:17

consider 21:25 23:11 30:16 88:11 111:7 111:8

consideration 22:17 43:23 107:14

considerations 22:23 25:24 103:14

considered 49:16 75:25 82:2 85:10 87:21 95:6 113:10 considering 19:14 23:17 23:23 24:8

considers 85:11 consistency 16:21

consistent 21:7 55:23 102:15 110:8 112:4 113:6 consistently 55:17 65:19THE APPROACH TO REEVALUATE ATRAZINE 11/03/09 CCR#16 343-1 131

constitutes 67:9

consumers 50:23 51:13 53:5 72:15

contaminants 4:11

contaminated 83:16 83:19

contamination 80:12

content 97:23

contents 91:13

context 7:7 7:12 7:16 8:12 29:16 48:22 49:19 61:3 105:1

continue 15:24 76:8 76:25 97:5 103:9

continued 39:6 52:20 86:13 88:22

continues 12:10 67:25 71:15 continuing 42:1 90:18

continuous 47:21 48:1 53:23 58:21 87:14 continuously 93:4

contribute 62:2 86:10

contributed 38:24 contributing 63:1

contributions 33:23

control 21:15 38:5 39:18 48:4 51:12 86:15

convened 87:15 convening 88:1

conventional 91:8

converted 43:11 Cooper 47:5 47:13

Coordination 5:21 copies 79:6 92:21

corn 7:21 69:25 70:7 74:9 74:21 85:24 86:7 86:10 86:14 87:7

correct 29:25 65:10 correctly 65:10

cost 71:19

cost-effective 86:15

cost-efficient 88:19

costs 90:11

Council 65:25 79:1 91:20 92:7

counsel 11:10

count 28:9 country 66:25 67:2 86:11 couple 50:14 50:19 70:4

course 6:17 7:4 7:9 24:9 41:10 43:3 49:22 79:21 87:8 87:11 93:7 102:21 115:3

cover 92:11

coverage 60:22 78:8 covering 46:4

create 92:11

creates 67:10 88:12 creating 68:18 credibility 68:11 73:15

Creek 81:7

criteria 6:9 53:9

critical 15:11 17:10 19:18 23:19 24:2 26:21 39:17 41:13 41:20 44:21 44:22 45:13 48:20 90:23 90:24 91:10 95:10 112:11

criticisms 93:23

crop 32:1 93:1 Croplife 92:19 92:23

cross 43:6

culminated 9:15

cumulative 10:14 10:17 38:1 46:2 49:11 72:17 curiosity 63:9

current 31:10 46:14 50:24 61:3 63:22 87:8 87:18THE APPROACH TO REEVALUATE ATRAZINE 11/03/09 CCR#16 343-1 132

87:25 89:11 110:6 110:15 111:9 currently 4:13 7:21 33:3 39:9 44:23 currently...and 32:22

cut 89:9 111:4

D D.C 79:3 daily 57:17 61:1 83:17 Daly 46:7 damage 90:12 damaged 47:25 damages 48:2

Dan 4:5 4:7

data 16:23 17:22 18:23 19:12 19:15 19:25 20:8 20:11 20:20 21:9 21:12 21:13 21:15 26:12 30:19 34:8 39:25 40:3 40:10 40:13 40:13 48:9 50:14 51:9 52:13 54:5 54:9 54:10 54:17 55:9 57:6 57:6 57:11 57:20 58:7 58:18 59:14 59:25 60:23 60:24 61:2 61:4 61:8 61:18 62:12 64:23 65:12 80:5 81:11 84:13 84:14 84:15 84:17 85:4 85:8 85:12 88:3 88:21 93:16 94:25 99:12 99:13 100:3 100:7 100:9 100:19 102:3 102:22 102:22 104:4 104:5 105:2 106:5 106:7 106:22 107:4 107:18 111:12 111:12 data...daily 57:18

data...these 20:20

database 40:20 41:3 42:11 42:14 50:20 52:16 52:17 57:21 60:19 65:13

databases 43:4 43:4 51:8

date 51:17 63:25

Davis 39:8 day 47:7 48:23 52:2 59:14 59:15 59:25 60:4 76:15 76:21 77:21 78:22 days 3:16 47:7 47:7 47:9 47:13 47:15 49:3 49:5 57:12 71:24 81:25 83:20 86:24 87:11 94:21

deadline 87:7

deal 64:17 93:6 112:10 dealkylated 42:18 43:12

debate 31:2

decade 88:10 91:19 105:8 decades-long 89:15

decent 45:18

decision 2:23 9:15 9:17 10:2 10:15 10:16 84:18 86:17 93:19

decisions 11:3 35:25 36:22 62:23 93:8 93:10 93:15 110:1 110:2 110:11

decline 55:24 56:3 59:4

declined 55:17 declining 58:24 58:25 65:18 deeper 83:4

defects 95:23

defend 29:9

Defense 65:25 79:1 91:20 92:7

define 50:22 59:16THE APPROACH TO REEVALUATE ATRAZINE 11/03/09 CCR#16 343-1 133

definition 89:17 113:14 degradation 90:12 degree 7:22 degrees 67:14 delayed 82:14

demand 90:19 90:22 demanding 105:21

Democratic 31:9

Democrats 89:25

demonstrate 31:17 50:25

demonstrated 43:1 91:6 Department 4:9 70:13 departure 18:24 19:20 25:22 dependent 46:22 46:22 83:17 deputy 5:15

derivative 66:20

derive 48:24

describe 15:13 57:7 57:16 59:13

described 9:18

describes 14:3 describing 7:3 description 40:19 design 12:25 26:1 99:6 99:7 99:9 104:14 104:23 106:17 designated 2:8 2:14 31:24 96:20 109:2 designs 14:23 15:16 100:23 100:23 104:6 104:11 104:18 104:18 104:25 113:10

desire 79:8

detail 7:16 15:13 20:3

detect 51:22

detectable 80:10

detected 24:17 81:9

detects 51:20

deterioration 48:4

determination 84:18 85:11

determinations 79:20

determine 12:4 26:6 75:14 88:4 112:12 113:5

determined 16:1 36:22 37:19 38:3 determining 87:10 87:22 develop 14:15 20:19 20:23 24:5 developed 41:14 42:13 44:22 developing 9:16 42:3 102:16 development 6:6 6:15 10:12 12:24 13:9 23:15 33:2 38:25 39:10 40:6 82:21 95:12 development... developmental 37:10 developmental 12:19 24:9 38:4 49:1 49:2

dictates 73:23 73:23

differences 11:22

different 14:22 15:4 15:4 33:4 34:23 35:23 36:3 36:20 37:1 37:2 37:5 43:1 47:4 64:22 83:14 85:19 94:9 100:23 100:23 104:23 104:25 113:9

difficult 87:6 113:15

dimmed 111:1

direct 44:8 directly 10:23 31:1 44:1 84:3 107:5

director 4:23 5:8 5:16 6:2 6:4 6:7 6:9 74:20 86:6 89:6

directors 90:6THE APPROACH TO REEVALUATE ATRAZINE 11/03/09 CCR#16 343-1 134

disappointed 77:24 86:16

discounted 95:22

discourse 31:17

discover 38:16

discovered 44:14 discovery 33:2

discuss 7:7 12:15 22:23 22:25 23:2 25:10 97:15

discussants 86:1

discussed 26:3 34:21 discussing 6:11 discussing... and 23:1 discussing... exploring 12:17

discussion 15:2 26:22 56:6 78:15 98:16 98:23 115:1

discussions 76:16

disease 67:24

disinfection 63:10 64:5 64:6 64:10 64:14 disruption 19:1 23:16 44:10 44:13 disruptor 29:4

dissimilar 103:13

distinct 43:2

distributed 79:7 distribution 59:25

distributors 92:25 disturbingly 81:11 divergence 96:1

diverse 103:20

Division 6:2 6:5 6:9

docket 3:10 3:15 3:20 28:8 28:10 61:15 74:24 79:5 93:24 96:18 108:20 108:25 109:4 113:17

doctor 66:10 69:19

documentation 68:18 106:23

documented 34:6 42:10 61:14 75:3 documenting 34:23

documents 36:11 36:13 37:6 68:5 dog 49:6 Dogs 68:15

dollars 70:17

domain 41:15 domestically 86:22

Don 6:3

done 14:17 24:16 24:19 38:2 39:17 43:4 43:4 43:5 43:6 47:5 57:23 57:25 65:7 66:18 76:9 77:15 96:2 109:11

dose 15:12 18:17 19:11 22:24 23:10 23:20 25:1 26:21 46:11 47:17 48:25 83:9 83:16 84:5 103:11

dosed 47:6 dose-dependent 83:20

doses 45:18 dosimetry 15:18 dosing 46:7 47:3 83:12 84:4

double 90:19 double-spaced 28:10

Dr 2:18 3:22 3:23 4:6 4:12 4:17 4:22 5:2 5:7 5:12 5:18 5:18 5:25 6:5 6:8 6:19 7:15 17:3 17:5 17:5 17:6 17:7 17:16 17:20 17:24 27:8 27:8 27:14 27:22 31:20 32:2 32:2 32:3 32:7 32:9 32:13 33:12 33:17 34:8 34:21 34:21 38:7 38:10 39:1 39:4 39:7THE APPROACH TO REEVALUATE ATRAZINE 11/03/09 CCR#16 343-1 135

45:20 45:25 47:10 49:20 49:24 49:24 50:1 50:2 50:2 50:3 50:9 53:8 54:19 56:10 61:10 61:12 61:12 61:13 62:16 62:16 63:5 63:7 63:8 63:12 63:12 63:13 64:3 64:8 64:8 64:9 64:16 64:19 64:19 64:20 65:1 65:1 65:2 65:7 65:20 65:24 66:3 66:3 66:4 66:5 69:22 74:2 74:3 74:7 74:16 74:17 78:2 78:18 78:20 79:6 85:15 85:15 89:2 92:17 96:13 97:8 97:17 97:17 97:17 97:21 98:4 98:6 99:25 99:25 100:1 100:12 101:8 101:8 101:23 101:23 101:24 102:1 102:12 104:1 105:4 107:16 107:17 107:25 108:2 111:1 111:5 111:15 113:20 113:23 114:9 114:19 114:22

Dr....to 33:12

draft 111:9 draw 28:7 96:22 drinking 8:12 9:22 9:23 10:5 15:16 23:3 24:11 26:7 26:23 27:4 41:1 46:14 48:14 48:17 49:16 49:22 50:6 50:10 50:15 50:24 51:9 51:10 51:12 51:19 52:6 52:8 52:9 52:22 54:3 54:17 55:3 55:18 56:13 56:19 57:5 58:9 59:17 59:24 60:16 60:20 64:5 72:16 79:16 79:25 80:4 81:10 81:17 82:3 83:24 84:4

driven 57:14 73:7

driver 75:23 drop 91:5 dropped 111:3 dropping 96:5

Drs 82:9

due 8:19 37:14 95:23 duplicative 29:23

duration 46:1 47:2

durations 19:21 47:5 83:6 during 3:14 6:13 7:9 8:13 9:8 9:8 24:8 45:13 48:18 53:19 77:11 81:25 87:20 96:15

DW 48:24 54:20 54:21 dying 30:8 dynamics 41:9

E earlier 39:3 53:8 54:19 74:4 75:1 79:20 103:25 early 7:24 7:25 9:2 22:5 25:8 55:22 98:12 98:19 106:6

earned 69:23 easily 106:10

echo 74:25

eco 56:10 57:9 ecologic 21:24 104:15 104:17 ecological 6:9 10:6 12:16 13:24 79:15 80:4 84:15 85:7 ecologically 56:16 ecology 49:3 ecosystem 80:17 ecotoxicology 4:7

Ed 6:8 17:23

EDSP 29:15THE APPROACH TO REEVALUATE ATRAZINE 11/03/09 CCR#16 343-1 136

29:17 29:18 29:18 29:24 29:25

effect 13:25 24:2 44:22 46:6 46:8 46:17 46:23 47:3 47:4 47:8 47:11 47:18 47:19 48:8 48:10 48:23 49:7 49:13 52:3 59:16 60:4 60:8 61:3 61:6 63:14 63:19 64:10 68:9

effective 51:5 effectively 42:19 effectively... have 51:5

effectiveness 28:19 28:25 55:5

effects 6:2 6:4 10:11 12:11 12:16 12:19 12:24 13:9 13:14 13:16 13:22 13:24 18:22 19:16 19:19 23:20 23:22 24:5 24:15 24:18 24:23 24:24 26:21 29:2 29:14 29:19 29:21 38:4 38:20 39:7 40:22 41:8 44:16 45:1 45:10 45:19 47:8 47:21 81:24 83:5 93:22 111:16

effort 17:8 68:18 92:12 93:6 97:19

efforts 11:5 50:13 62:11 90:17

eggs 90:13 eight 28:5 28:9 28:15 82:21

either 27:12 37:2 47:6 66:10 102:19

Elaine 6:5 6:5

election 90:1 Eligibility 9:14 10:2 10:15 10:16

Elizabeth 17:20

else 3:5 3:6 71:3

elucidate 13:18 elucidating 15:18 emphasis 5:5 13:22 19:8 emphasize 21:6 23:9 107:8

enabled 53:3

encourage 96:19

endeavor 41:21

endeavored 40:22

endocrine 23:16 29:2 29:4 29:14 29:19 29:21 44:10 44:12 44:14 44:17 44:25 45:19 85:9 endocrinologicall y 47:25 48:10 endocrinology 39:1 endpoint 46:16 endpoints 24:14 34:9 45:25 48:14 62:15 82:19 82:20 85:9 85:10 endpoints... all...sorry... all 85:8

engage 71:21

ensure 2:16 8:10 9:23 15:17 24:17 51:11 62:6 88:17 102:15 102:20 109:15

ensures 94:15 ensuring 16:20 17:10 110:5

entertain 63:3

entire 68:13 81:5 entirely 89:16 93:12

entities 70:13 95:17

entitled 50:6 entity 66:25 entry 53:9

environment 37:23 88:16 90:25

environmental 4:9 6:4 32:16 33:19 41:7 41:7 51:6 58:5THE APPROACH TO REEVALUATE ATRAZINE 11/03/09 CCR#16 343-1 137

58:10 60:21 61:7 70:9 70:11 79:2 90:12

envisioned 100:15

EPA 2:23 5:17 7:24 20:15 29:5 29:8 29:9 29:16 29:16 29:18 29:22 29:24 29:25 30:2 30:6 30:6 30:11 30:12 30:14 30:17 30:24 31:1 31:10 31:12 31:18 32:11 32:17 34:15 34:25 35:14 35:22 36:9 38:1 40:1 40:22 42:19 46:1 49:12 54:21 59:16 62:3 62:24 65:12 68:5 69:5 72:20 73:16 73:21 76:14 76:23 77:8 77:12 77:15 77:19 78:7 79:11 84:7 84:12 84:22 87:1 87:14 88:2 88:6 88:23 90:9 91:13 91:17 92:9 95:9 95:13 95:18 95:23 96:2 97:3 97:11 114:18 114:23

EPA-reviewed 30:19

EPA's 29:15 30:3 31:3 35:6 44:2 44:21 70:17 72:11 78:13 86:17 87:8 87:20 93:23 epi 16:10 100:2 epidemia 24:22 epidemic 92:4 epidemiologic 22:18 epidemiological 14:14 14:19 14:22 14:24 15:5 16:4 20:18 epidemiologist 104:12 epidemiology 17:25 18:15 21:9 21:20 25:3 25:7 25:16 26:11 26:14 26:17 27:1 37:8 39:16 84:15 84:16 85:7 85:7 98:10 98:15 98:22 99:22 103:23 104:1 104:4 104:11 104:25 111:6 111:16 112:22 113:7 episode 68:13 equivalent 53:13

ERC 70:10

erosion 90:11 91:4 erroneously 37:14 especially 7:23 20:11 40:25 45:11 102:14 103:21

essential 105:25 Essentially 9:4

established 9:22 10:5 12:22 35:4 46:23 52:3 87:24 establishing 48:14 95:18 estimating 15:4 estrogen 44:1 48:1 estrogenic 44:4

et.al 44:6 83:9 Europe 37:14 European 36:5 37:17

evaluate 21:16 106:3

evaluated 88:7 evaluating 19:8 22:9 23:22 110:5

evaluation 23:7 23:20 26:20 89:22

evaluations 93:8

Evan 39:11

Evansville 81:22

event 25:18 48:19 57:14

events 11:24 45:11 58:4 61:1 everybody 97:9THE APPROACH TO REEVALUATE ATRAZINE 11/03/09 CCR#16 343-1 138

114:2

everyone 2:6 110:14 114:17 114:22 115:2 everything 27:2

evidence 14:15 14:16 21:4 24:25 25:10 27:2 39:21 44:7 88:6 91:22 102:17 102:17

evident 64:23 exactly 64:4 65:16 76:5 102:6 exactly...in 102:5

examined 82:22 82:25 example 12:2 23:14 examples 100:17

exceed 51:24 54:18 54:21

exceedance 53:11 58:9

exceeded 54:18 55:1 59:2 80:25 81:17

excellence 42:10 except 83:2

excess 60:5 60:13 existing 19:6 48:9 93:9

exists 40:20 50:20 93:9 expect 25:3 77:22 78:9 80:16 expected 25:5 experience 4:25 33:11 71:8 76:5 98:21 experienced 95:23 experimental 14:14 14:24 15:8 16:12 22:21 24:23 102:25 103:22 105:2 106:9 expert 39:11 39:20 expertise 4:10 explaining 104:14 explicitly 19:14 22:17 explore 104:10 exponential 41:18 exposed 24:12 43:10 50:23 52:2 53:22 54:14 56:2 58:15 59:1 63:23

exposure 8:10 8:25 12:6 33:20 38:13 40:7 40:24 40:25 44:23 46:13 48:1 48:17 49:17 50:7 50:11 50:22 50:25 51:9 51:24 51:25 52:12 53:4 53:21 54:20 57:2 59:11 59:13 59:14 59:17 60:3 60:5 60:11 60:13 60:16 61:4 62:14 72:16 98:15 103:14

exposures 46:2 46:4 46:4 81:25

express 114:17 expressed 48:15 102:11 expression 39:15

extend 46:5 86:17

extensive 33:25 35:19 37:4 88:21

extent 41:19 102:23 111:22 112:25 113:13 113:16 extrapolate 19:19 extrapolation 18:18 extremely 51:21

eye 107:12

61:5 71:9 13:19 15:4 19:20

exchange 35:20

executive 74:20

exercise 60:6 19:21 22:4 22:6 22:9 22:10 22:13 24:11 24:14 25:1 26:14 26:16 F FACA 2:16

face 76:20 facility 39:18THE APPROACH TO REEVALUATE ATRAZINE 11/03/09 CCR#16 343-1 139

fact 43:1 43:8 43:13 47:22 48:3 48:24 49:7 65:7 71:15 72:10 76:17 77:16 78:12 88:8 93:14 106:13

factor 19:23 23:25 39:13 39:14 46:10 46:10 59:18 60:9

factors 19:12 23:23 24:10 25:22

facts 94:16

fair 103:17 106:12 106:12 fairly 21:20

fairness 94:14

fall 82:3 89:20

false 88:12

familiar 107:5

farmers 70:15 70:15 70:21 71:14 86:10 86:14 farming 90:11 90:13 91:4 91:7

fate 6:4 41:7

favor 91:14

favorable 62:23

fear 92:1 92:11 February 14:7 14:11 14:18 17:18 20:5 20:9 20:22 21:1 22:16 25:7 25:8 25:11 25:15 26:11 52:20 98:8 100:2 100:5 100:16 104:2 104:8 104:17 111:7 February/ September 103:25 February's 99:16

fed 83:15 83:19

federal 2:8 2:14 31:24 94:12 94:22 96:20 109:2

feed 56:20 83:16 83:19

feedback 13:15 26:5 108:5

feel 61:21 62:18 103:7

feels 71:24

fellow 33:13 38:12 98:1

felt 67:3 69:23 108:13

females 45:11

Fenton 68:6

fetuses 37:11

fewer 3:9 90:13

fiasco 68:9

Fidori 47:11

field 76:21

FIFRA 2:8 3:25 4:4 4:13 28:1 96:1 114:2 fig 90:6 fight 73:12 73:25 90:16 92:14 figure 99:1

filtration 64:12

final 111:12 112:2 112:18 113:25 finally 19:21 47:19 48:13 83:22

finish 6:1

finished 9:24 51:6 51:19 52:9 53:3 53:5 53:18 54:6 54:7 54:12 54:13 54:16 54:17 55:2 55:15 55:18 56:4 59:24 60:1 60:19 63:16 63:17 81:16 finishing 17:24

first 5:15 7:18 17:16 21:18 25:7 29:2 29:13 38:15 43:18 44:11 46:3 51:9 52:18 79:10 79:14 80:3 84:11 86:16 108:6 110:15 first...they 40:18

fit 101:21

fits 20:8THE APPROACH TO REEVALUATE ATRAZINE 11/03/09 CCR#16 343-1 140

five 3:9 54:1 56:24 83:23

flaws 95:23

flew 68:2

floor 98:2

Florida 67:25 flying 66:17

focus 8:23 11:15 11:24 11:25 13:21 13:21 15:7 22:21 23:6 24:8 26:25 46:3 56:23 101:19 107:2 109:8 111:22 113:3

focused 8:9 35:25 60:24 78:11 focusing 11:22 13:10 112:23 113:11

fold 113:2

folks 73:7 followup 12:7 107:17 108:3

food 36:17 72:16 90:10 90:19

for...for 49:9

for...for...in 32:15

for...I'd 33:22

for...was 35:6 forecasting 112:6

foremost 51:10 Forerunner 114:11 forget 62:22

form 28:12 108:21

formal 53:9 75:18

format 85:19

formed 66:25 106:22

formulated 109:6

formulators 92:25

forth 14:9

fortunate 62:18

forward 3:14 6:17 32:4 32:12 39:24 41:12 49:18 63:1 77:23 78:22 104:9 108:14 108:17 114:10 115:2

forward... it's...it 106:1

forwarded 14:2

foundation 18:17 109:25 110:13

fourths 69:3 FQPA 23:25 25:22 46:10 96:2

frame 8:13 10:21 35:13 112:8 112:20

frames 58:13

framework 20:20 20:23 20:24 21:2 21:3

France 37:18 37:20

Francis 6:5 6:5 frankly 75:24 77:14

free 67:8 67:17 frequency 15:17 24:4 25:24 26:8 26:23 27:4 48:16 53:23 55:1 60:23 frequency...we 55:21 frequent 48:20 frequently 24:17 24:19 94:4 frogs...found 82:11

from...from 21:14

front 99:23

fruit 67:8

FSH 45:8

full 43:4 59:25 85:11 89:22 91:24 fully 50:22 53:3 62:1

function 19:2 45:16 82:18 82:22 fungicides 33:4

future 77:22 110:22

G gain 84:11THE APPROACH TO REEVALUATE ATRAZINE 11/03/09 CCR#16 343-1 141

game 111:24 Gary 69:24 70:1 70:6 114:5 general 5:9 72:13 78:8 generally 78:8 generated 50:15 50:21 51:9 51:17 54:13 57:3 57:22 59:15 59:23 generates 57:18 generating 21:23 26:17 generation 102:3 generator 45:14 generators 45:7 generic 100:4 100:9 101:7 genotoxic 36:22 36:23 gentlemen 39:24 66:8 68:3 68:17 geographic 60:22 get...and 59:18 gets 13:10 43:11 getting 8:19 13:15 20:17 20:17 64:13 99:2 99:8 109:16 112:6 112:19 given 13:20 30:15 74:3 83:10 84:23 87:2 gives 6:19 56:7 89:17 giving 55:6 56:13 glad 78:20 gland 18:13 23:15 39:9 glean 63:14

GnRH 39:7 45:4 45:7 45:14 45:22

go...so 14:5 goal 104:2 gonad 82:22 gonadal 10:11 12:18 12:24 13:9 82:21 gonads 45:10

gone 40:6 62:20 68:19 75:19 85:20 government 68:22 70:13 grab 57:12

Grain 74:10 74:21 graph 35:24 59:8 59:22 great 93:5 greatest 24:16 24:18 greatly 33:7 41:12 51:24

grew 58:15 ground 54:6 60:20 groundless 95:19 grounds 90:3 groundwater 8:5 8:11 9:1 9:19 51:15 51:20 54:7

group 38:17 42:21 46:18 59:1 61:22 70:8 70:12 113:16 114:3

groups 28:16

grove 67:10 67:13

groves 67:12 67:17

grow 90:19

growers 67:21 70:1 70:7 70:20 74:9 85:24 86:7 87:7 88:15

grown 42:11 growth 41:18

guess 70:3 73:5 74:19 77:7 77:23 78:1 98:1 99:4 100:6 102:10 113:24 guidance 16:17 18:11 21:7 102:15 guide 11:1 110:18 guideline 32:15 32:16

H half 97:9

half-life 43:10

Halloween 71:23 71:25 hamstrings 90:17

hand 61:10THE APPROACH TO REEVALUATE ATRAZINE 11/03/09 CCR#16 343-1 142

Handa 39:4 45:20

Handa's 47:10

handbook 16:20 happened 35:9 68:15 happens 42:25 happy 33:9 33:21 63:2

hard 62:1 90:15 109:14 hardly 75:21

harm 37:11 37:22 72:13 80:17

harvest 87:6

has...has 20:5 hastily 93:20

hat 69:20 104:13

have...however 63:18

haven't 107:21 having 7:9 92:21 98:16 101:18 110:2

hazard 15:12 19:18 22:24 25:1 25:16 27:3 40:7

head 32:23 33:18 39:1

heads 90:21

headwater 56:18

health 4:19 5:1 6:9 11:16 12:14 13:22 13:25 15:3 16:5 16:10 18:12 19:16 20:12 22:3 22:4 22:7 23:5 24:6 25:4 26:12 35:4 35:15 36:15 36:16 37:6 37:15 37:16 37:21 37:22 62:14 79:4 93:22 98:14 100:3 100:20 100:24 104:22 106:15 111:10 112:5 112:10 112:11 112:25 113:3

Health...Health 6:2

hear 28:15 34:12 39:23 45:22 77:25

heard 69:4 74:12 97:16 hearing 44:15 78:23 97:11

heart 91:3

HED 17:14

heels 87:13 Heeringa 2:18 3:22 3:23 4:12 4:12 5:12 5:18 17:5 27:8 27:14 27:22 31:20 50:1 61:12 63:5 63:12 64:8 64:19 65:1 65:20 66:3 69:22 74:2 74:7 74:16 78:2 85:15 89:2 92:17 96:13 97:8 99:25 101:23 105:4 105:4 107:25 111:1 113:20 113:23 114:9 114:20 114:22 Heidelberg 57:25

held 9:3 35:3 36:19 37:18 help 11:1 13:17 19:11 62:5 70:17 85:10 102:23 103:11 103:12 105:15 106:2 107:2 107:11 110:17 helped 70:12 helping 5:21 helps 91:11

hence 90:3 92:2 112:20 Henry 39:12

herbicidal 41:6

herbicide 7:19 7:20 67:6

herbicides 8:23 10:18 33:5 71:4 91:1

He's 33:13 39:2

hide 90:7 high 45:18 52:12 52:17 53:1 53:23 54:25 55:8 55:20 55:21 56:17 60:23 81:12 89:17THE APPROACH TO REEVALUATE ATRAZINE 11/03/09 CCR#16 343-1 143

high...higher 91:12 high...most 53:22 58:15 higher 49:8 71:19 90:10 highest 81:21 highlights 82:8 highly 53:22 54:14 56:2 56:16 58:15 58:22 59:1 high-quality 42:9

Hill 39:22 historically 22:14 history 7:13

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home 4:24 67:10

honest 69:13 hope 73:22 114:6 hopefully 40:12 79:7

hormone 18:25 44:2 44:8 44:24 82:24 83:11

host 88:9

hour 97:6

Hudson 89:5 Huffington 30:10 huge 50:11 50:14 57:21 60:18

human 11:15 12:14 13:22 13:24 16:1 18:12 19:15 19:16 20:24 22:12 23:5 24:6 26:12 38:9 41:21 43:9 59:11 84:14 85:4 93:22 100:3

humans 9:6 9:12 11:13 11:21 18:18 18:19 21:5 25:12 36:24

hunt 91:18

Hurdle 32:3 33:17 49:20 49:24 49:25 50:2 50:3 50:3 61:12 62:16 63:12 63:13 64:19 64:20 65:7 hydrology 64:21 hydroxy 42:24 hydroxyatrazine 42:19 hype 56:6 hypothalamic 19:1 45:6 hypotheses 23:14 hypothesis 12:23 13:1 26:17 hypothesized... hypothesis 21:23 I I...a 18:6 I...apparently 111:3 I...certainly 105:12

I...I 102:10

I'd 3:24 4:3 5:14 5:19 5:23 7:11 28:18 65:20 65:21 72:1 85:23 96:22 98:1 105:4 113:24 114:2

identifiable 72:15

identification 15:12 22:24 26:21

identified 23:14 identify 29:19 ideological 92:12

if...if 99:5 107:18

I'll 2:7 7:15 12:11 17:3 34:14 49:23 69:11 69:11 92:21

illustrate 48:6

illustrations 101:6

I'm 4:7 4:14 4:15 4:17 4:18 4:19 4:22 4:24 5:2 5:2 5:4 5:7 5:7 28:23 28:24 32:22 33:9THE APPROACH TO REEVALUATE ATRAZINE 11/03/09 CCR#16 343-1 144

38:6 38:11 55:6 56:10 64:16 64:24 65:9 66:9 66:10 66:10 66:12 66:15 69:4 70:6 71:22 72:22 74:20 75:24 77:8 78:20 78:21 78:25 79:2 79:3 79:9 89:12 99:17 102:6 104:12

I'm...I'm 77:24 102:5 immediately 90:4

immune 82:18 immunotoxicity 23:16 impact 50:20 impacts 19:22 impaired 82:18 82:22 83:17 implementation 2:24 implications 41:20 importance 8:5 8:25 16:24 94:1 98:17 important 11:14 16:7 22:15 24:2 67:20 100:4 103:7 106:24 107:3 108:13 109:8 109:24 110:4 110:13 importantly 67:11 90:5 impression 95:9

in...as 56:4

in...in 6:21 10:20 11:2 45:23 93:14 111:8

incident 21:12 21:14 26:12 84:15 100:3 101:3 104:4

incidents 22:12

include 15:2 25:20 38:25 50:12 85:4

included 10:3 52:20 53:15 54:10

includes 6:13 32:1 50:14 54:25 55:12 111:25 including 29:20 30:20 31:8 41:6 46:10 70:13 84:13 85:5 85:9 96:17 104:3 incorporate 14:13 101:17 incorporated 9:17 incorporating 20:20 26:11 100:2

increase 68:1 83:11

increased 82:19

increases 21:12 increasing 79:23 independent 2:20 34:11

Indiana 81:7

indicate 16:15 61:4

indicated 6:24 8:3 8:5 75:22 112:5

individual 93:8 100:9 100:11 113:16

individuals 29:12 30:23 31:1 68:12 112:16 industry 66:20 67:7 67:7 68:10 68:25 69:16 69:18

inevitable 90:14

infamous 89:10

infants 19:24 37:11 72:14

infection 82:20

influences 15:15

inform 11:3 24:14 102:23 103:11 103:12

information 15:6 15:10 16:25 20:17 21:4 25:14 30:20 35:20 61:18 61:21 78:16 79:14 79:16 88:3 94:16 95:19 102:7 102:16 102:21 102:25 103:1THE APPROACH TO REEVALUATE ATRAZINE 11/03/09 CCR#16 343-1 145

103:10 103:21 104:7 104:19 104:20 105:19 106:19 107:5 107:15 108:1 108:20 108:24 109:5 109:12 109:14 109:17 110:23 113:12

informational 2:12 6:25 27:25 108:8

informs 23:25 infrequent 51:21 ingredient 86:21 ingredients 93:1

initial 76:22 78:14 108:16 114:24

initiate 10:20

initiated 8:21 52:14 52:19 56:21 77:14 initiating 11:23 93:3

initiation 32:19 32:20 93:11

initiative 98:4

innuendo 91:25 92:11 input 17:9 87:4 109:18 110:17 115:2

insecticides 33:5 inserting 102:8 insights 14:21 103:19 104:11 109:5 110:6

instance 35:12

instead 71:18 75:19

Institute 39:12 89:5 112:17

instruct 64:24

insulin 84:1

intake 49:15 59:19 integral 91:2 integrate 13:17 14:15 14:22 14:23 15:5 16:11 16:22 25:14 27:2 103:10 104:24 integrated 24:25 103:23 integrating 19:6 103:20 104:7 integrity 30:24 31:6 31:12 62:4 88:3

intend 40:2 40:4

intense 55:8 intensity 52:18 53:1

intensive 53:16 54:10 107:4

intent 22:18 101:19

interest 4:20 5:10 23:21 41:15 44:16 78:13

interested 86:25 87:1 interesting 84:3

interests 28:16 67:16 92:24

Interim 9:14 10:2 10:15

interior 114:12

internal 50:12 75:19

International 36:1 interpret 13:15 16:22 16:25 19:11 104:19 105:15 110:7 interpretation 15:15 40:13 interpreting 11:2

into...into 10:22

introduce 4:5 5:23 6:20 17:12 17:15 105:5

introductions 5:14

invasive 67:10 investigate 41:21 investigating 23:13 investigations 43:16

involve 22:3 22:11 22:17THE APPROACH TO REEVALUATE ATRAZINE 11/03/09 CCR#16 343-1 146

involved 22:9 32:21 34:18 38:12 43:15 44:3 44:20 72:20 105:9

involves 25:11 94:8 involving 8:18

Iowa 20:14

IRED 9:14 10:2 10:9 11:25 54:22 112:4

is...is 70:12 101:10

isn't 7:5 43:14 80:22

issue 12:2 14:13 16:8 43:13 67:3 67:18 76:14 77:12 79:12 84:8 101:7

issued 7:24 9:14 10:1 10:13

issues 2:21 2:25 5:10 7:5 11:1 18:5 23:3 88:9 102:8 104:6 107:3 109:7 109:20 109:24 109:25 113:1

It...it's 72:1

it...it's...

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it...turn 7:15

items 111:11 it's 3:2 6:25 7:20 7:21 21:7 22:3 22:15 25:4 34:7 51:23 52:14 61:16 67:16 69:13 71:3 71:20 72:24 73:7 73:24 74:14 74:19 75:25 76:1 76:5 77:20 78:11 78:12 80:22 84:3 85:19 86:4 90:24 94:9 98:17 98:21 101:5 101:6 103:3 103:17 105:12 105:18 105:24 106:18 107:3 109:23 110:8 112:18 112:19 113:15 114:12 114:13

It's...it's 43:14 76:2

I've 9:18 69:8 69:9 69:10 71:11 71:11 72:3 77:7 80:5 89:8 105:8

J Jack 39:15

Jackson's 110:9

James 39:1

Jan 5:2

Janice 32:2 32:2 32:13 38:10

Janice...I'm 32:12 January 9:13

Jennifer 65:24 65:25 74:5 74:5 74:16 78:25

Jennifer...Dr 66:1 Jerry 74:9 74:20

Jim 39:20 job 76:9

Joe 2:7 3:23 3:24 5:20 6:24 28:6 28:18 31:24 96:20 113:25 114:8

Joel 66:4 66:12 72:21 73:11

John 5:7 63:8 101:24 joined 27:23 joining 53:10 joins 53:14 joint 36:18 journal 113:18 journals 112:24 judgment 105:13 judicious 88:19 juice 111:4 July 30:6 77:18 jump 50:5

June 70:5 jurisdiction 82:4just...threefourths 69:3 justify 30:18THE APPROACH TO REEVALUATE ATRAZINE 11/03/09 CCR#16 343-1 147

61:23 91:23

K Kansas 74:9 74:10 74:21

Ken 4:22 key 23:21 34:23 34:24 105:24 kg 46:9

kick-off 75:25

killers 91:12

kinds 5:10 14:22 15:5 101:25 104:20 104:25

kinetics 41:9 Kingdom 36:6 37:17 37:21 kneejerk 68:9 know...they 91:23 knowledge 38:25 40:7 106:15

known 40:6

L lab 26:20 44:2 47:10

label 8:8 51:3 55:6 61:6 64:1 69:7 88:18 laboratory 17:22 22:21

labs 44:21

lack 95:24

ladies 66:7 68:2 68:17 language 37:1 51:4 large 8:18 50:25 58:7 61:4 largely 113:4 larger 114:3

last 9:16 13:13 30:22 31:7 33:24 35:10 36:16 50:21 51:3 57:22 58:5 64:2 66:16 71:16 73:20 79:17 84:23 87:18 89:15 98:9 98:11 98:12 98:12 98:13 109:21 112:7 112:11 113:4

late 78:21

later 59:2 95:4

Laura 109:15

law 93:14 110:10

Laws 83:8 lawyer 66:10

lead 17:17 17:18 17:21 17:25 19:13 23:23 32:8 33:15 33:19 45:7 45:11 103:6

leader 33:1

leaders 6:21 leading 9:8 33:10 33:14 84:2 leads 17:15 18:21 46:10 60:10

leaf 90:6 leap 98:4

learn 106:19

learned 90:15

least 10:23 13:8 17:12 58:21 75:7 76:2 79:7 80:20 90:19

leaves 52:5 95:11 leaving 88:16

lectern 49:23

led 11:9 43:18 legitimate 67:5

less 24:19 47:13 48:11 51:21 52:11 90:11 91:7 95:12

let's 27:22 69:13 76:20 97:4 97:5

level 46:8 46:17 46:23 47:8 47:11 49:7 49:8 49:13 52:3 55:17 55:22 58:9 59:16 59:17 60:4 60:9 111:4 114:11

levels 9:25 10:8 44:22 45:12 47:4 48:11 48:23 50:25 55:24 61:3 62:13 63:10 63:16 63:21 64:6 65:18 80:10THE APPROACH TO REEVALUATE ATRAZINE 11/03/09 CCR#16 343-1 148

80:21 81:14

Levine 5:25 6:19 7:15 17:3 17:6 17:7 27:9 27:12 34:21 97:17 100:12 104:1 leydig 83:21

LH 45:8 45:17 45:25 46:6 46:6 46:6 46:19 46:22 47:3 47:4 47:9 47:18 47:19 47:22 49:2

liaison 2:15 liberty 46:25

lie 62:2

life 19:12 19:22 23:11 23:22 23:23 71:9

lifetime 42:24 46:5 49:17 light 24:7 26:4 lights 111:1 114:12 likely 9:6 9:11 11:11 11:12 11:19 11:21 12:7 16:1 36:25 37:3

limit 3:8

limitations 79:22 105:1

limited 84:13 84:22 85:1 85:5

limits 35:4 49:18 line 27:24 34:20 34:22 35:18 51:20 59:8 71:20 111:25

lines 14:15 14:16 102:16

linked 99:16

list 74:4

lit 66:6

literature 12:10 12:21 12:22 13:6 13:7 13:11 23:5 40:1 41:19 42:2 42:4 42:15 47:1 84:20 84:25 101:14 113:13 113:14

little 5:25 7:12 7:16 12:12 20:3 21:8 31:25 32:25 34:14 56:14 58:18 77:24 78:11 81:6 85:19 85:20 95:4 98:18 102:13 103:24 105:11 108:5

LOC 48:24 54:20 54:21

located 45:5 59:8

location 81:8

locations 60:25 logic 40:4 40:11 long 68:10 82:1 93:15 105:16 longer 31:25 85:20 long-term 46:1 47:19

lose 89:25 90:2

loss 91:8

lost 67:25

lot 10:25 17:13 18:4 18:4 18:6 21:23 24:7 44:15 63:15 65:2 68:12 98:16 98:23 98:23 98:24

low 51:23

lower 114:11

lowest 48:10

Lowit 17:16 97:18 101:8 101:9 luteinizing 18:25 44:24

M machine 90:2

machines 67:13

main 80:7 mainly 52:23 53:18 57:23

maintain 91:12

maintained 87:23 major 20:12 24:11 42:25 72:14 90:14 91:16

male 83:10

males 45:12 46:20 46:21THE APPROACH TO REEVALUATE ATRAZINE 11/03/09 CCR#16 343-1 149

mammalian 33:14

mammary 18:13 23:15 38:16 39:9

manager 32:18

Mandel 39:15

manner 88:19 107:19 110:24

manufactured 12:4

manufacturers 92:24 manufacturing 12:3 manuscripts 111:10

March 67:19 margin 19:20 51:1 51:25 59:13 60:3 60:5 60:13 margins 51:23 59:11 61:4 marketplace 96:10

Marshall 69:25 70:2 70:6 74:2 75:1 Maryland 114:13

matches 15:17

material 3:13 97:16

materials 28:12 87:4 106:6 106:6 107:24 109:4

matter 43:21 91:13

maturation 46:21 mature 102:6

maximum 52:1 80:24 81:7

may 11:7 12:23 13:18 21:9 47:20 81:9 96:11 103:12 maybe 21:8 70:4 74:6 74:7 77:24 97:16 103:2 103:3 106:18 107:22 108:4

McAllister 86:3 92:18 92:18 92:20 96:14 McCoy 82:9

McFarland 32:2 32:2 32:8 32:9 32:13 61:11 61:13

MCL 49:6 49:8 59:2 63:22 63:25

mean 59:10 90:10 90:13 104:13 106:5 meaning 82:14

measurable 81:14 83:11

measured 60:1 99:14

measurement 65:4

measures 8:10 51:2 88:17

mechanism 11:14 11:18 11:19 11:23 48:5

mechanisms 4:10 11:7 11:10 102:23 103:4

media 29:12 75:22 76:15 76:20 100:25

media...media 93:21

median 60:8

Medicine 5:3

meet 30:19 87:7 meeting 2:4 2:9 2:10 2:12 2:19 3:1 3:11 3:14 3:17 3:18 3:22 3:25 5:19 5:22 5:25 6:24 6:25 6:25 7:5 14:12 15:1 17:19 17:21 18:1 20:5 20:9 20:10 22:19 23:6 24:20 25:8 25:13 25:21 26:3 26:11 27:17 28:1 28:4 28:8 28:13 36:18 75:25 78:5 78:5 78:6 87:10 87:13 95:3 95:5 96:21 96:24 97:2 97:10 98:8 98:9 98:11 98:18 101:19 101:22 106:8 106:16 108:15 114:5 114:15 115:4 meetings 14:6THE APPROACH TO REEVALUATE ATRAZINE 11/03/09 CCR#16 343-1 150

27:23 45:23 97:23 97:24 98:7 107:20 107:21

member 72:23

members 4:4 5:13 6:20 27:11 32:7 63:6 74:18 78:7 86:8 86:12 88:13 98:2 105:23 105:24

memorandum 10:3 56:12

memorialize 10:4

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mentioned 3:24 11:5 15:24 20:1 23:2 35:1 44:25 54:19 56:11 62:22 72:22 108:11 111:16 merging 4:10

met 2:17 12:14 39:3

meta 82:8 82:13 83:2

metabolism 5:6 32:14 32:16 41:8

metabolite 42:24 42:25

metabolites 23:17 42:18 42:23 43:5 43:7 43:12 43:13 53:13 65:11 103:6 metamorphosis 82:12 82:14

method 84:5 methodological 14:21 methodologies 41:9

methods 91:9

Mexico 32:24 33:19 mg/kg 46:11 46:17 47:9 47:16 49:4 49:12 83:10 mg/kg/day 59:16 60:9 Michigan 4:15 microphones 28:22

mid 51:3 55:16 59:5

midst 87:6 96:6

Midwest 52:23

mike's 66:6

milestones 34:24 34:24 milligrams 46:9

million 71:2 71:17 86:21

mimic 44:8

mimics 44:1

mind 22:16 60:15 64:17 77:10 102:6

minimal 8:10

minimize 71:5 minimizing 8:25 minimum 54:1 94:20

minute 46:15

minutes 3:9 3:18 7:12 23:1 23:8 24:1 50:14 50:19 83:12

miss 48:19 missing 99:13 Mississippi 5:4

Missouri 69:25 70:7 70:9 70:14 70:15 70:21 71:1 71:14 misspoke 64:16

mistake 92:8 mitigation 51:4 55:6 mitigations 9:18

MOA 53:8

mode 11:7 11:14 18:14 18:16 18:21 19:9 19:13 21:6 23:9 33:15 36:23 37:7 38:21 39:6 41:8 41:24 42:21 43:1 43:6 43:17 43:23 44:13 44:18 102:24 103:11

models 11:22 40:23

modulate 45:4 64:12THE APPROACH TO REEVALUATE ATRAZINE 11/03/09 CCR#16 343-1 151

modulating 64:11

monitor 12:10

monitored 80:19 monitoring 9:22 10:4 10:6 13:17 15:16 23:3 24:4 24:16 24:19 26:7 26:23 27:4 33:20 48:21 49:23 50:20 51:10 52:8 52:18 53:7 53:10 53:16 53:24 54:4 54:10 55:8 55:11 56:10 57:9 57:24 58:10 58:16 58:17 59:24 60:19 60:25 61:9 65:8 79:15 79:15 79:16 80:4 80:8 80:11 81:11 84:1 84:6 88:21

mono 42:18

month 7:2 56:25 87:19 monthly 97:22

months 46:7 46:7 67:18 70:4 70:5 83:23 88:10 89:14 109:19 morning 2:6 3:3 3:8 4:6 4:17 4:22 5:17 6:12 28:3 28:14 85:18 86:4 89:1 97:9 97:10 97:16 98:3 108:7 110:21 morning's 27:25 78:5 113:24

Morrisette 47:14

most... resulting 60:12

Mother 90:17

motivate 111:10

motivated 29:6 29:7 89:16 90:7 92:12 93:13 96:8

motivation 88:13 105:13

move 9:2 15:1 27:16 27:18 39:24 65:20 66:4 74:8 85:17 104:9 104:21 107:11 108:5 108:17

movie 68:16 multiple 22:10 mutagen 43:19 mutagenicity 42:14

Mutual 66:5 66:13 68:25 myself 78:4 88:25

N nanosilver 114:4

NAS 16:18

nation 67:24

national 4:24 5:8 6:6 16:23 65:24 85:24 86:6 112:17 Nations 36:17

nationwide 70:22

Natural 70:14 79:1 91:19 92:7

nature 90:17 98:3

NCGA 86:8 86:16 88:20 88:25

NCGA's 86:12

NCI 20:15

NCL 35:5 necessarily 41:4 105:6

necessary 31:15 89:23 necessity 86:13 88:4 needlessly 90:16

Nelson 66:4 66:5 66:7 66:12 69:22 75:1

network 67:1 72:23 74:22 74:23

neuroendocrine 11:10 11:13 11:19 11:23 18:14 18:21 47:23

neurons 39:7 45:4 45:5 neurotoxicity 23:15 neurotoxicologist 4:20 neurotoxicologyTHE APPROACH TO REEVALUATE ATRAZINE 11/03/09 CCR#16 343-1 152

5:5

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newspaper 30:8

next...that's 25:8

NGOs 29:11 30:23

nice 99:9

NIEHS 5:9 112:18 night 66:16

NIHS 20:15

nine 58:21 80:19

NOEL 49:1 49:2 49:4

NOELs 47:3 48:23

nominations 109:1

non 36:22 37:9 72:16 73:21

non-cancer 16:11 24:23 24:24 27:1 85:3 111:7 112:25 113:8 non-community 65:4

none 54:16

non-monotonic 82:13 non-profit 79:2

non-vascular 80:15

noon 97:6

normal 68:20 91:17 normally 61:17

North 20:14 39:2 39:22

not...been 75:3

not...I 102:5

not...is 11:12

not...it's 22:3

not...not 38:3 62:24

note 41:17 78:4 96:15 114:10

noted 23:8 89:19

notes 114:1 nothing 30:4 73:6

notice 94:12 94:22 95:2

noticed...I 23:8

November 2:5 67:18

NRDC 30:7 30:10 80:3 92:9 95:21

nucleus 48:2

numerous 95:22

nutrients 71:5 81:3

nutshell 40:14 53:19 54:15

O Obama 77:19 obesity 84:2 92:4 objective 19:5 objectively 105:15 obligated 42:8 obligation 69:15 75:13 94:3

OBT 110:12 112:16 obviously 41:14 42:8

occasions 66:18 occupational 72:17 85:6

occur 77:11 77:22

occurred 77:11

occurrence 68:4

October 10:1 10:9 95:3

odds 42:4

of...all 74:25

of...of 7:17 9:13 11:24 13:19 14:3 14:10 21:12 38:9 41:3 41:10 42:5 51:1 62:13 65:4 103:14

of...what... what 99:14

offer 109:7

office 4:24 5:16 5:20 6:6 6:10 6:14 6:15 35:4 35:6 82:4 110:12

official 2:8 2:14 31:25 96:20 109:2

officials 109:2THE APPROACH TO REEVALUATE ATRAZINE 11/03/09 CCR#16 343-1 153

Ohanian 6:8 17:23 Okay 27:22 65:20 74:7 97:8

Oklahoma 4:18 old-style 91:8

on...on 7:12 84:19 109:6

on...work 26:14

One...at 81:4

ones 38:15 53:20 58:3 85:1 93:10

one's 84:2

one-time 81:20 ongoing 13:10 112:5

onset 45:13 45:15 46:21

open 2:4 13:6 62:19 78:17 80:1 98:1 101:14 108:15 114:25 opening 61:23 111:17 openly 62:2

openness 109:12

opens 111:13 operable 11:13 operate 40:9 44:8 operates 45:21 operators 92:9 opinion 30:9

OPP 22:8 opportunities 34:16 opportunity 3:1 27:10 27:15 28:4 32:10 35:19 50:4 63:5 66:8 89:1 96:25 104:10 108:4 108:25 109:3 options 26:1

or...or 3:9

ORD 20:16 44:21 46:18 110:12 112:15

order 28:17 56:18 57:16 85:10 86:1

ordered 30:11

orders 29:17 30:1 30:12 ordinary 105:11

ORD's 6:7 organic 91:8 91:12 organisms 4:11 organization 36:16 36:17 37:6 93:22 organizations 50:17 86:9 95:20 organizations... that's 36:18 organize 5:22 organized 107:19 organophosphate 22:13

other...other 26:15 38:20 96:10

other... probably 101:1

others 41:17 89:19 97:18 109:15

our...and...and 103:18

our...as 13:22

our...our 18:16 97:9 111:24

Ours 67:25

out... epidemiological 24:22

outcome 9:4

outcomes 20:18 103:6

outdated 49:8

outline 6:17

outsi...since 37:25

outside 38:18 74:6

over...between 71:1

over...over 14:4 105:8

overall 17:17 43:17 55:9 55:14 58:14 59:3 oversight 93:23

overview 38:8

overwhelmTHE APPROACH TO REEVALUATE ATRAZINE 11/03/09 CCR#16 343-1 154

101:18 106:10 ovulatory 45:11

oxygen 81:2 oyster 83:10

P Pacino 68:15 packet 32:7

pages 28:10 panel 2:9 2:16 2:19 2:22 4:1 4:4 4:14 5:13 5:19 7:14 9:5 10:25 11:1 12:2 14:6 14:12 15:1 17:8 21:25 22:15 26:5 27:6 27:11 28:1 32:7 32:10 50:4 63:3 63:6 75:15 78:16 79:11 84:10 88:2 88:8 97:1 97:10 97:15 98:1 98:16 98:17 98:21 99:7 105:7 105:11 105:14 105:22 106:12 106:21 107:11 109:3 109:10 109:23 110:11 110:17 114:19 panels 12:17 87:15 105:9 106:21

paper 7:2 14:2 20:23 34:6 72:8 paradigm 16:19 95:18 parameters 99:9 99:15 parent 43:5 43:6

Park 5:9 46:18 participate 66:8 68:23 69:1 69:12 69:16 76:8 participated 76:7 participation 94:3 94:13 114:23 participations 106:16 particular 10:7 13:15 35:24 66:19 67:3 68:16 88:8 94:16 97:19 98:7 99:24 100:7 104:17 107:20 108:13 particularly 8:11 16:5 39:16 79:25 87:6 parties 28:5 28:11 86:25 94:14

pass 78:1 past 29:10 30:25 31:14 33:6 62:10 62:21 76:9 87:15 pathway 24:12 pathways 16:25 19:9 21:6 103:5 103:11

pause 27:21 45:24

pay 41:18 pb 55:1 peak 48:20 56:8 57:16 80:24 81:20 81:21 peaks 24:17 56:5 56:9 57:2 57:7 58:6 61:1 81:12 81:23 82:2 83:25

peer 2:20 6:22 7:6 7:7 7:8 11:8 13:7 14:3 16:16 75:20 84:12 85:4 108:17 112:24 113:12 113:14 people 3:3 17:14 18:4 24:12 35:9 35:17 37:14 41:14 52:1 62:22 108:15 109:3 109:13

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performing 22:5 23:4 perhaps 41:22 87:23 period 27:15 27:18 52:4 54:1 71:10 85:21 86:17 87:12 94:21 94:23 96:16 96:23 97:15 periods 34:17 35:8 permanent 4:4 78:7 78:15 97:1 105:11 105:22 106:21 perpetrated 89:11 91:19 perpetrators 89:11

person 69:4 105:10 personal 29:10

persons 94:19 perspective 40:24 pertains 39:25 40:25 pervasive 67:10 pesticide 2:21 2:24 5:4 5:16 20:13 20:16 22:13 36:18 101:15 pesticides 4:11 4:21 6:7 22:10 29:20 72:18 73:10 82:4 86:20 pests 67:11

Peter 32:2 33:17 50:3 pH 64:22

Ph.D 17:24 66:9 phrases 8:1 physicochemical 41:6 picture 41:2 103:2 103:3 103:3 Pidgeon 81:7 piece 30:7 30:9 30:10 pike 21:10 78:9 pituitary 45:8 placed 3:14 placing 19:8 plan 2:13 6:12 7:3 14:10 20:22 25:12 111:25 planned 20:10 22:20 96:4 101:4 planning 21:1 114:15 plant 7:20 12:4 12:9 32:16 42:25 plants 80:16 81:2 plates 114:13 play 45:13 105:24 players 18:3 plays 45:14 please 3:6 60:15 69:18 74:17 107:11 please...what 14:2 pleased 79:11 84:7 plotting 46:25 plow 91:3 plowing 91:9 point 3:21 5:13 6:21 18:24 23:10 27:17 28:3 29:1 29:13 30:3 30:22 31:22 48:6 63:19 73:14 77:2 78:18 79:8 85:23 96:22 97:14 99:11 113:23 points 19:19 25:22 57:11 63:21 79:10 80:7 83:3 poison 21:15 policies 93:9 policy 5:21 69:4 86:6 political 29:8 31:10 90:2 90:3 90:5 92:9 politically 29:7 90:7 92:11 96:8 politicization 89:18 politics 30:5THE APPROACH TO REEVALUATE ATRAZINE 11/03/09 CCR#16 343-1 156

30:13 73:24 89:17 89:23 pollution 91:16 Pope 4:17 4:17 114:5 population 72:14 90:18

Portier 4:22 4:23 65:1 65:2 98:5 98:6 position 105:12 positions 76:10 76:11 possible 28:21

Post 30:10 post-plant 7:20 postponed 100:22 100:22 postulate 39:13 48:18 potential 8:4 8:24 10:11 11:6 12:11 12:15 12:18 15:24 25:25 44:16 52:12 53:21 57:2 81:24 83:4 93:9 111:23 112:3 potentially 50:23 56:8 pounds 86:21 ppb 13:8 49:16 53:12 53:13 54:18 54:19 54:21 55:16 55:18 55:23 55:24 58:9 59:2 59:20 80:14 80:21 80:23 80:25 81:6 81:8 81:17 83:24 practices 8:9 prearrangement 31:24 precedent 87:24 96:9 precipitously 91:5 precise 55:8 precisely 45:21 precluded 95:5 predated 44:12 predecessors 10:24 predict 80:17 predissemination 30:21 prejudged 95:9 prejudging 87:9 preliminary 22:23 23:7 23:19 23:20 26:19 26:21 35:15 35:15 preoptic 45:5 pre-ovulatory 18:25

prepare 3:18 86:2 106:13 prepared 64:25 106:2 107:12 107:21 preputial 46:20

presence 49:21 64:14 present 2:13 28:6 28:17 40:10 presentation 2:2 2:11 4:2 28:2 31:23 32:1 32:6 38:7 49:20 50:8 65:22 78:14 97:12 97:21 presentations 3:13 76:14 76:23 98:3 114:19 114:24 presented 89:21 107:9 presenters 96:15 presenting 40:3 president 31:8 66:12 presidential 90:1

press 61:23 95:20 pretty 43:20 65:8 66:11 106:1 previous 7:14 11:4 15:9 71:9 71:22 76:13 84:24 previously 15:21 39:5 79:20 88:10 primarily 4:10 7:21 8:9THE APPROACH TO REEVALUATE ATRAZINE 11/03/09 CCR#16 343-1 157

primary 4:20 80:15 111:22 113:3

Prince 39:12 principal 18:3 33:6 44:9 94:14 principles 87:1 93:13 94:4 prior 35:1 35:14 priority 74:4 pro...the 62:4 probability 59:22 probably 11:12 11:20 39:3 63:13 66:15 71:9 76:3 77:18 103:19 problem 67:9 94:17

Procedures 94:11 proceeding 88:8 proceedings 27:21 27:23 45:24 113:24

process 6:22 8:1 8:2 16:16 29:5 29:19 32:21 34:1 34:15 48:3 61:14 62:2 62:7 62:19 63:2 63:15 64:6 68:21 69:12 69:13 71:21 72:20 73:18 73:23 75:11 76:19 76:25 77:1 88:14 89:16 89:18 90:24 91:11 96:1 105:9 105:25 106:7 106:12 108:23 108:24 109:11 109:16 110:8 110:9 111:3 111:17

processes 38:19 45:13 processing 63:15 63:20 63:20 producers 66:14 67:22 74:10 producing 52:21 67:23 product 8:19 9:17 33:8 33:18 62:20 67:21 67:23 70:22 71:2 71:18 production 7:22 39:18 80:15 83:18 83:21 products 34:4 43:15 71:12 93:1 93:8 96:10 professional 31:2 professor 4:7 4:14 4:18 5:3 profile 38:13 40:7 57:1 profiles 33:11 40:20 57:4 57:17

program 5:8 6:7 9:22 10:6 13:17 20:16 29:4 52:14 52:25 53:2 53:6 53:7 53:10 53:15 53:24 53:25 54:4 54:24 55:12 56:7 56:10 56:21 56:23 57:3 57:9 57:16 57:17 57:24 58:16 58:17 59:24 79:4 84:1 84:6 102:3

programs 5:16 10:5 51:11 51:19 52:18 54:2 54:12 57:8 57:25 58:2 58:11 58:22 60:1 86:11

progress 16:4 94:2 96:7 progressively 47:25 project 17:16 41:5 projected 3:2 promulgated 35:5 35:6 propaganda 30:7 30:9 properly 48:16 properties 41:6 41:7 44:5 proposal 87:5 95:7 proposals 25:21 94:18 94:24

propose 30:17 proposed 12:22 12:24 26:2 29:15THE APPROACH TO REEVALUATE ATRAZINE 11/03/09 CCR#16 343-1 158

30:4 38:21 prospective 20:13 20:18 104:16 104:22 prostate 9:10 12:3 12:6 12:8 18:15 39:17 39:19 protect 19:23 31:15 protecting 9:19 10:8 90:24 protection 8:6 11:16 32:1 93:1 protections 9:20 protective 34:10 62:17 protects 91:15 protocol 13:3 13:4 protocols 42:12 50:22 53:4 proud 68:1 provide 3:1 7:6 20:3 25:21 42:9 52:6 81:2 84:12 87:4 96:19 106:23 108:16 109:1 109:4 109:14 110:23 provided 80:6 84:17 86:24 96:18 105:10 provides 2:20 2:22 19:14 104:10 providing 7:12 61:17 86:7 94:21 109:19 puberty 45:14 45:15 public 2:15 3:2 3:6 3:10 3:12 3:15 3:19 5:1 22:16 27:15 27:18 28:4 28:6 28:11 28:12 28:15 31:14 31:22 34:17 35:8 35:13 35:17 35:19 37:21 41:15 63:4 65:23 68:7 68:9 68:10 69:24 77:17 78:5 78:6 78:12 78:17 78:19 78:23 85:17 85:21 86:6 87:3 89:4 92:1 93:24 94:2 94:13 95:3 95:7 96:16 96:23 97:11 108:12 108:25 109:8 109:10 114:18 114:25 115:1 publication 94:22 95:2 111:14 publications 41:18 publicized 21:21 publicly 18:10 31:11 published 12:21 13:6 13:10 16:6 30:7 40:1 41:16 42:15 43:22 44:4 47:11 54:21 82:7 82:9 83:8 83:15 83:18 84:12 84:23 85:4 99:19 101:14 112:24 113:8 113:12 113:14 published...any 41:16 pulling 24:24 pulsatile 45:7 pulse 45:6 45:14

purpose 7:4 20:7 20:8 105:18 putting 24:7 90:13

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105:13 111:6 questions 17:3 27:10 39:25 49:24 61:19 63:3 63:4 63:6 84:16 84:17 84:25 97:2 97:17 98:2 98:18 98:20 100:7 100:10 101:12 101:21 106:25 107:1 108:3 108:21 109:6 113:21 quick 11:3 27:10 63:5 quickly 43:12 54:3 57:9 58:12 quite 21:7 51:5 55:23 56:5 59:3 64:4 75:23 75:24 77:14 quote 37:20 72:10 quotes 37:12

R R&D 112:15

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ranges 84:5 rapid 83:12 rapporteur 36:6 37:18 49:3

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rates 99:12

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rats 18:13 47:24 83:15 83:19 83:22

rats...caused 83:10

raw 53:3 53:4 53:17 54:12 55:25 63:15 Ray 92:18

re..restate 94:4

reach 9:24 40:11 55:23

reached 42:20 49:12 55:17 reaching 9:10 10:8 40:4

readdress 76:21 reading 68:5 ready 5:14 27:16 27:18 106:6

reaffirm 108:22

real 81:23 93:14

realize 35:9 70:23 91:21

realized 20:19 really 20:6 22:18 35:10 62:1 64:14 76:16 98:19 99:2 100:7 101:5 107:18 107:22 109:22 really...that 89:10

reams 72:8 reanalysis 111:13

reason 40:11 94:14 100:21

reasonable 72:12

reasonableness 16:21

reasoned 40:3 95:11

reasons 79:13 94:13

reassessment 106:9

reassure 109:9 110:14

recall 65:10

receive 78:7 106:24

received 7:2 8:16 receiving 106:25

recent 14:19 21:19 23:13 26:17 34:13 37:24 86:17 87:20 recently 47:10 56:6 90:15 94:10 96:7

recess 97:7

recommend 84:21THE APPROACH TO REEVALUATE ATRAZINE 11/03/09 CCR#16 343-1 160

85:2

recommendations 2:22 9:9 84:9 95:14

reconsider 94:18 reconsidering 19:17

reconvene 96:25

reconvene... it's 114:3

record 27:20 49:13 51:17 52:13 54:4 54:17 58:21 66:9 93:16

recover 68:11

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reduce 63:10 63:20

reduced 63:16 80:16 82:11 82:16

reduces 64:6 reducing 51:5 59:6

reduction 8:10 61:7 83:17 83:20

reductions 8:14

reevaluate 2:3 2:11 4:2 28:2 97:12

reevaluation 2:13 86:18

reference 46:11 47:17 60:10 77:7 references 102:1

referred 53:8 referring 56:10

reflect 47:23 48:4 105:7

reflects 78:13 regard 42:7 47:18 48:8 102:9 102:12 102:14 111:6 111:15 112:22 regarding 12:14 94:5 regards 75:8 region 45:6 Register 94:23 registerability 36:4 registered 7:18 28:5 28:10 28:17 37:13 registrant 13:3 13:3 registrants 10:4 42:8 registration 7:25 8:1 10:16 10:20 33:2 36:4 62:23 87:22 88:22 96:4 regular 20:17 regulate 45:12 regulated 31:14 95:17 95:17 regulates 39:14 regulating 45:15 regulation 31:3 regulatory 2:23 7:13 28:19 28:25 32:21 32:23 34:9 34:12 34:24 35:23 36:3 37:1 37:2 37:24 38:2 42:4 42:7 48:3 62:4 62:15 62:25 82:2 88:4 89:18 93:7 93:23 110:1 110:1 111:17 111:24 regulatory... regulatory 36:21

reinforce 104:1

reins 90:2 rejoin 97:4

related 5:10 21:19 23:5 24:5 65:12 relating 44:14

relations 68:7 68:9 68:10 relationships 15:12 103:12

relative 39:7 39:18 40:24 42:2 59:5 66:19 69:8 69:9

release 45:7 46:23 83:11 111:12

released 45:9

relevance 19:15THE APPROACH TO REEVALUATE ATRAZINE 11/03/09 CCR#16 343-1 161

19:15 relevancy 20:24

relevant 11:21 19:21 24:13 36:24 79:21 84:3 84:13 85:9 87:3 94:16 100:7 rely 86:14

remain 61:25 remaining 86:1 112:13

remarkable 63:21

remarks 100:13 107:18 111:17

remember 68:15 98:11 98:15 98:16

remind 114:2

reopen 93:14 repeatedly 42:11 replaced 53:6 replicate 41:22 report 3:18 16:24 76:22 80:5 reported 22:12 58:21 75:4 76:15 reporting 21:14 93:21 reports 25:6 25:9 36:13 75:11 75:23 93:21 represent 37:21 70:16 70:25 representatives 63:7 65:21 representing 28:15 65:24 66:4 69:25 74:9 80:23 81:19 represents 41:2 41:5 46:8 47:21 86:8 92:24 reproductive 45:16 request 3:7 107:10 requested 3:4 required 13:3 requirement 19:23 requirements 2:16 26:8 requires 94:12 re-registered 9:17 re-registration 8:2 9:14 10:2 10:15 34:19 35:1

re-review 61:24 resampling 65:14

research 4:14 5:9 6:6 6:8 6:14 12:24 13:10 33:13 34:2 36:1 37:8 38:11 40:16 44:2 44:20 45:23 46:18 50:12 50:13 50:17 61:18 62:9 89:6 91:5 113:16

researched 9:7 researchers 38:18

residential 22:14 65:5

residues 72:17

residues...was 36:19

resistance 84:1 91:11

resolution 57:19

resolved 57:4 resoundingly 43:20

resources 29:23 65:25 70:9 70:11 70:14 79:1 91:20 92:7 respect 100:1 102:2 102:8 respond 94:24

response 15:12 18:17 19:11 22:24 23:10 23:21 25:1 26:22 27:13 38:19 38:22 48:12 66:2 83:12 103:12 107:2 113:22 Responses 82:13 responsibility 67:4 67:4 75:12 responsible 39:14 92:4

rest 20:2 78:22 114:14

restrict 92:13THE APPROACH TO REEVALUATE ATRAZINE 11/03/09 CCR#16 343-1 162

restricted 8:17 restricting 90:16

restriction 90:10

restrictions 69:8 90:8

result 48:1 56:14 68:11 68:12 72:13 resulting 51:23 51:23 59:14 60:5 60:11

results 13:5 99:18

rethink 29:25 retrospective 22:12 104:15 104:18

return 27:22 90:14

revealed 81:11

review 2:20 6:12 6:22 7:3 7:6 7:7 8:22 8:23 10:20 13:8 14:9 15:9 15:10 15:20 16:16 19:4 19:5 21:19 23:5 23:19 29:21 30:6 30:21 31:4 32:19 32:20 33:24 34:5 35:7 35:11 35:17 35:22 35:23 36:10 37:19 37:25 62:5 62:19 73:16 73:18 75:13 75:14 75:19 75:20 77:5 77:13 77:18 84:22 84:23 85:3 87:3 87:14 87:18 87:20 88:2 88:9 89:13 89:15 89:20 90:4 93:3 93:12 93:19 94:7 95:6 95:10 95:12 95:14 95:21 96:4 96:6 96:11 102:22 103:1 105:18 106:7 107:9 111:19 111:21 112:1 112:1 112:13 113:5 113:12 113:14 113:15

reviewed 29:3 29:14 31:6 31:13 37:9 44:6 84:12 85:5 93:4 95:22 112:24

reviewers 106:10

reviews 7:8 7:14 9:5 11:8 12:13 14:3 33:8 34:11 35:15 35:16 36:13 36:21 37:4 37:7 37:13 37:15 61:19 62:11 84:24 84:25 94:9 96:2 96:7 105:22 105:24 107:4 107:14 108:18 111:19

revised 10:1 26:7 revisions 25:25

revisit 13:23 27:3

revolution 91:4 right-hand 59:21 rigorous 62:7 rising 90:22

risk 8:10 10:14 11:15 11:24 12:16 13:25 15:9 16:17 16:19 16:20 17:9 17:10 19:3 19:19 20:21 22:1 24:3 24:6 26:2 26:6 26:12 38:1 40:8 41:9 41:13 46:2 49:11 62:13 73:16 100:3 100:25 101:17 102:4 102:18 103:7 103:15 104:3 104:6 110:7

rivers 91:15

Riverside 4:8

Rob 85:23 86:5

Robert 39:4

robust 47:23 104:6 109:2

rodents 11:12 11:20

Rohrer 82:9

role 12:16 45:13 45:15 105:24THE APPROACH TO REEVALUATE ATRAZINE 11/03/09 CCR#16 343-1 163

roughly 67:19 99:11 112:8 routinely 22:8

rows 97:23

rule 31:18 110:10 rulings 94:1

run 31:25 56:24 running 67:12 81:16 92:9

runoff 8:20 48:19 58:3 61:1

run-off 56:24

rural 65:5 65:8 65:9

Russ 39:7

S safe 49:16 50:15 52:8 54:3 55:4 69:6 69:8 88:21 safely 37:20 38:5 86:23 87:22 safety 25:22 33:11 33:18 34:3 34:13 38:9 38:13 40:20 40:21 40:24 41:21 51:1 59:11 59:18 60:9 62:9 62:23 77:17 87:9

sake 60:7 sample 52:9 80:20 80:22 sampled 58:2 58:3 65:9 samples 51:18 52:10 52:10 53:2 53:17 54:6 54:7 54:16 55:20 56:22 57:12 57:19 58:5 59:23 60:20 60:20 60:21 81:13 sampling 15:15 15:17 25:24 26:1 52:14 52:18 53:1 53:19 55:1 57:6 57:11 57:17 60:23 61:1 81:14 sanctity 77:4

SAP 3:7 9:9 11:17 12:7 12:20 14:18 15:22 15:23 18:15 18:19 21:16 22:16 22:20 24:21 25:25 29:18 30:15 30:15 30:16 31:4 31:13 33:22 35:3 39:17 61:14 61:16 62:5 66:9 75:7 75:24 76:4 76:9 76:12 76:16 78:6 84:8 84:21 84:24 85:2 85:11 88:5 95:13 102:14 112:9 114:3

SAP...it's 75:4

SAPs 9:3 11:4 13:12 14:10 17:18 18:12 20:2 20:4 29:4 29:6 29:9 29:15 29:21 30:4 30:13 30:17 31:6 33:23 34:19 39:3 39:16 40:10 62:21 75:7 79:20 108:23

Sass 65:24 66:1 66:3 74:3 74:5 74:17 78:18 78:20 78:25 85:16

sat 105:10 savings 71:17

saw 62:15 68:14 say...ask 106:20

scandal 89:12 91:24

scant 89:13

scare...scandal 89:10

scary 72:1

scenarios 19:3

schedule 20:6 57:11 95:2 95:8 96:8 110:23

scheduled 10:19 14:11 14:13 15:21 15:23 65:23 68:20 75:8 87:17 89:20 112:9 112:21

Schlenk 4:5 4:6 4:7

Schneider 85:24 85:25 86:4 86:6 89:3

science 3:25THE APPROACH TO REEVALUATE ATRAZINE 11/03/09 CCR#16 343-1 164

4:4 4:13 5:21 6:12 7:3 7:14 9:5 9:15 10:24 11:1 11:2 12:1 12:17 13:21 14:6 14:12 17:11 18:9 18:16 19:5 19:6 19:14 19:24 23:24 25:12 26:4 28:1 29:7 30:4 31:17 32:21 34:8 35:16 36:6 37:15 37:16 37:18 63:1 68:23 70:23 73:1 73:2 73:4 73:17 73:19 73:22 73:23 75:11 75:15 77:5 77:11 77:14 77:20 79:17 79:19 79:23 82:5 87:2 88:24 89:21 90:6 91:22 94:1 105:15 107:11 108:10 109:23 110:3 110:9 110:11 110:16 110:16 110:18 112:12 113:4

science... environmental 35:16

science...our 14:9

science-based 93:13 96:1

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scientific 2:8 2:20 7:5 25:6 25:9 30:14 33:8 40:11 61:20 62:2 62:4 67:14 79:11 84:10 87:15 88:1 88:3 90:4 91:22 92:10 94:25 97:2 105:18 107:2 107:9 109:24 109:24 114:24 scientifically 62:6 106:2

scientist 4:14 33:15 33:20 79:3

scientists 20:16 31:5 31:13 31:16 33:10 33:25 72:3 95:23 110:12

scope 7:8

Scott 28:18 28:19 28:23

scourges 90:17 screening 29:4 44:10

se 82:2

seas 56:24

season 48:19 56:25 108:14

seasons 57:4

second 14:4 22:2 22:8 22:20 29:6 30:3 31:22 46:16 56:7 56:18 97:9 99:4 Security 114:10

sediment... sediment 91:16 seeing 13:9 66:3 77:23 83:25 108:2 115:2

seek 105:18

seem 40:18 48:8 77:3

seems 43:19 45:3 70:3 75:20 100:21

seen 18:22 56:14 58:8 58:13 65:17 73:2 76:24 111:9

selected 46:16

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