U.S. ENVIRONMENTAL PROTECTION AGENCY

 TESTING OF CERTAIN HIGH PRODUCTION

 VOLUME CHEMICALS;

 SECOND GROUP OF CHEMICALS,

 ORAL COMMENTS ON A PROPOSED REGULATION

 MEETING AND PUBLIC COMMENTS

 1201 CONSTITUTION AVENUE, NW

 HEARING ROOM 1153 EPA EAST

 WASHINGTON, D.C. 20460

 MARCH 31, 2009

 8:05 A.M.
US EPA MEETING 03/31/09 CCR#16194-1 2

1 U. S. ENVIRONMENTAL PROTECTION AGENCY

2 TESTING OF CERTAIN HIGH PRODUCTION VOLUME CHEMICALS:

3 SECOND GROUP OF CHEMICALS, ORAL COMMENTS ON A PROPOSED

4 REGULATION

5 March 31, 2009

6 DR. WILLIS: All right, good morning,

7 everyone and welcome, thanks for coming to offer

8 comments on the proposed Rule to require testing for

9 certain endpoints on high production volume chemicals.

10 I'd like to start by introducing the EPA staff who are

11 going to be here so that those of you providing

12 comments know actually exactly who you're providing

13 comments to other than the Agency.

14 My name is Jim Willis, I am Director of

15 Chemical Control Division.

16 DR. SHAFFER: My name is John Shaffer,

17 I'm the co-manager of this whole discussion.

18 DR. HALL: My name is Franklin Hall,

19 I'm a chemical engineer in the Economics Exposure

20 Technology Division and I work on the exposure and

21 release elements of these chemicals.

22 DR. GABARDELLA: Paul Gabardella, I'm

23 the co-manager of this high production volume rule,

24 proposed rule and will be seeing this project through

25 to the final stages.
US EPA MEETING 03/31/09 CCR#16194-1 3

1 DR. VANRODEN: I'm Victoria VanRoden,

2 also with EPA.

3 DR. CAMPANELLA: There is a sign up

4 sheet, I want to make sure everyone is signed up, I'd

5 like your name, phone number, email or address where

6 you can be contacted, basically that's it, it's our

7 intention is that the Court Reporter here, our

8 intention is to have a transcript of this and the

9 inclusion of hard copy where necessary to that will all

10 be included in the docket, to the public docket and

11 will be used in the final Rulemaking.

12 DR. WILLIS: All right. This meeting was

13 really triggered by our publication of a Proposed HPV

14 II Rule in July of last year, July 4th of last year.

15 The time period for that rule was proposed on October

16 22nd. During that comment period we provided the

17 opportunity for interested parties to present oral

18 comments.

19 And in response to that we received two

20 requests for oral comments, those requests came from

21 People for the Ethical Treatment of Animals and the

22 Chlorinated Paraffins Industry Association so that

23 triggered the need for this public meeting, and as I

24 think all of you know we published in the Federal

25 Register a Notice for this meeting on March 16th of
US EPA MEETING 03/31/09 CCR#16194-1 4

1 this year.

2 And in response to that we got two

3 further requests to make oral comments from the

4 Physicians Committee for Responsible Medicine and from

5 ARISE, in New Jersey. We also got notice that six or so

6 other individuals plan to attend the meeting although I

7 think if you do your mass balance, they may not have

8 all shown up today.

9 So what I would like to do is take us

10 through those four in the order that they expressed

11 interest and then I'd like to also recall once again

12 Paul Campanella's point that there will be a verbatim

13 transcript of this.

14 Nevertheless, we would like those

15 providing comments to leave their, a brief written

16 statement or a copy of their comments if you would be

17 so kind. So let me then invite the People For The

18 Ethical Treatment of Animals to provide comments.

19 (WHEREUPON, there was a pause in the proceeding.)

20 MR. KENNEDY: I apologize in advance for

21 my voice. My name is Mark Kennedy and I am Associate

22 General Counsel for the Physicians Committee for

23 Responsible Medicine (PCRM).

24 I make these comments on behalf of both

25 PCRM and People for the Ethical Treatment of Animals in
US EPA MEETING 03/31/09 CCR#16194-1 5

1 support of the written comment jointly submitted by

2 PETA, PCRM, the Alternatives Research Development

3 Foundation, and the American Anti-Vivisection Society.

4 We oppose as improper the issuance of this proposed

5 rule because we believe that EPA has not made two of

6 the findings required under TSCA.

7 First EPA has not found that existing

8 data are insufficient to reasonably determine or

9 predict the effects of exposure to the 19 chemicals

10 covered by the proposed rule. It therefore follows

11 that EPA also could not have found that testing is

12 necessary to develop such data. EPA's decision to

13 issue a test rule without first making these findings

14 will result in unnecessary duplication of testing,

15 needless expenditure of resources, and a substantial

16 and unacceptable increase in the number of animals

17 subjected to testing.

18 Section 4 of the Toxic Substances

19 Control Act require EPA to issue a test rule requiring

20 companies to test certain chemicals that they

21 manufacture when EPA has made the following four Track

22 B findings:

23 1. the chemicals are produced in

24 substantial quantities,

25 2. there is or may be substantial human
US EPA MEETING 03/31/09 CCR#16194-1 6

1 exposure to the chemicals.

2 3. existing data are insufficient to

3 determine or predict their health and environmental

4 effects and

5 4. testing is necessary to develop such

6 data. In its notice of proposed rulemaking EPA based

7 its finding of data insufficiency solely upon data

8 available from the voluntary HPV Challenge Program, the

9 sources outlined in section 3.1 of the OECD guidelines,

10 and the EPA's HPV Information System.

11 However, EPA did not use its reporting

12 authority under TSCA Section 8 to collect from

13 manufacturers and processors all known data regarding

14 the 19 chemicals covered by the proposed rule.

15 Therefore, EPA cannot validly make a finding regarding

16 insufficiency of data.

17 Because the HPV Challenge Program is

18 discussed at length in the notice and elsewhere, I will

19 not describe it in detail here. The crucial

20 characteristic of the program is that it is voluntary.

21 The only participants in the program are those who

22 choose to provide data, and their participation is

23 limited to the extent to which they are interested in

24 sharing that data.

25 As such there is no guarantee that
US EPA MEETING 03/31/09 CCR#16194-1 7

1 companies participating in that program have provided

2 all existing data within their possession. Further it

3 goes without saying that the voluntary HPV Challenge

4 Program does not include information possessed by

5 chemical companies that choose not to participate.

6 Therefore the HPV Challenge Program and other voluntary

7 collection programs fail to collect existing data. EPA

8 is well aware of the shortcomings of the HPV Challenge

9 Program.

10 On page 43317 of the notice, EPA states

11 that, quote, "U.S. data needs which remain unmet in the

12 voluntary international efforts may be addressed

13 through TSCA section 4 rulings. This proposed rule

14 addresses the unmet data needs of 19 chemicals." EPA

15 later states on the following page its intent to,

16 quote, "use rulemaking under TCSA to help fill data

17 gaps not addressed as part of the voluntary HPV

18 Challenge Program."

19 Section 8 of TSCA provides a statutory

20 procedure by which EPA could overcome the shortcomings

21 of volunteer data collection programs. Section 8

22 empowers EPA to require chemical manufacturers,

23 processors, and distributors to provide any necessary

24 reports or information needed to evaluate HPV

25 chemicals.
US EPA MEETING 03/31/09 CCR#16194-1 8

1 Specifically Section 8(d) allows EPA to

2 mandate reporting by companies, I'm sorry, 8(a), and

3 Section 8(d) allows EPA to compel companies to produce

4 any existing health or safety reports to which they

5 have access. For reasons not explained in the notice

6 EPA has chosen not to use its statutory powers to

7 gather data on the 19 chemicals covered by the proposed

8 rule.

9 Instead EPA, quote, "strongly encourages

10 the submission of", end quote, additional relevant

11 studies and says that it will, quote, "take such

12 measures as are necessary to avoid unnecessary testing

13 in the final rule", end quote.

14 If EPA truly wants to collect data from

15 chemical companies, it makes little sense for it to

16 require companies to test for the data anew when it can

17 simply require them to provide all existing data

18 already in their possession. There are significant

19 reasons why companies may not have voluntarily provided

20 data relevant to the chemicals at issue.

21 First companies that did such testing in

22 the past but do not currently sell or distribute large

23 amounts of these chemicals have no incentive to now

24 produce such data. Further, these companies may have

25 substantial incentives not to produce data
US EPA MEETING 03/31/09 CCR#16194-1 9

1 voluntarily..

2 For example, if the data were

3 proprietary and done at a company's expense, there may

4 be some reluctance to share this data for free. More

5 significantly, if the data could be interpreted as

6 showing potential toxicity to humans, there might be

7 significant liability concerns about providing data

8 that might be used in another courtroom, another

9 setting, such as a courtroom, to attempt to show that

10 the company was selling a chemical without appropriate

11 warnings about possible toxic effects.

12 Because it failed to collect existing

13 data, EPA cannot make a valid finding of data

14 insufficiency. Moreover EPA's fourth finding, that

15 testing is necessary for these 19 chemicals consists of

16 just two paragraphs in the notice and is based entirely

17 on its prior invalid finding regarding insufficiency.

18 Because it can't confirm that it has reviewed all

19 existing data, EPA cannot validly find that further

20 testing is necessary.

21 In PCRM v. Johnson, a 2006 case, a

22 federal circuit court discussed the factors required of

23 findings under Track B of TSCA Section 4. First the

24 court noted that EPA must make, quote, "critical

25 science based conclusions", end quote. Here EPA cannot
US EPA MEETING 03/31/09 CCR#16194-1 10

1 claim to have made a critical science based conclusion

2 regarding data insufficiency if it has not first

3 reviewed all existing scientific data.

4 The court also found the use of an,

5 quote, "analytical process for gathering and assessing

6 data to make the necessary determinations for all HPV

7 chemicals", end quote.

8 Here however, EPA has not used its

9 authority to gather and assess data on the chemicals

10 covered by the proposed rule. Next the court focused

11 on whether EPA, quote, "used its own procedures for

12 making the B findings", end quote. Again, here EPA has

13 not used its statutory procedure, TSCA Section 8, for

14 making such findings.

15 Interestingly, in the Johnson case EPA

16 argued that general statements do not constitute

17 factual findings because general statements are neither

18 scientific nor accurate. Yet it seems to have taken

19 the opposite approach here. It is well established that

20 administrative agencies have no power to act beyond the

21 authority conferred upon them by Congress.

22 EPA cannot issue a test rule under TSCA

23 Section 4 without first making certain findings

24 regarding existing data. But EPA cannot make such

25 findings without first using its authority under TSCA
US EPA MEETING 03/31/09 CCR#16194-1 11

1 Section 8 to require manufacturers, processors, and

2 distributors to provide existing data already in their

3 possession. EPA has not done the latter, as such, it

4 cannot do the former.

5 DR. WILLIS: All right. Thank you very

6 much, and next on my list is the Chlorinated Paraffins

7 Industry Association. Can everybody see that okay?

8 Thoughts? Don't write that down, it's how you hack

9 into the system later, right? Yeah, I will, I'm about

10 to pull up a presentation.

11 Andrew Jaques on the list there.

12 Somewhere in here, there we go.

13 DR. JAQUES: Thanks for your patience,

14 I'm sorry, I think my loading of these slides probably

15 is going to take more than this brief testimony will,

16 but my name is Andrew Jaques and I'm with the

17 Chlorinated Paraffins Industry Association. I didn't

18 bring a written copy of what I'm going to say today, I

19 will leave a copy of the slides with you, Jim, and what

20 we say here is identical to the written comments we

21 submitted last fall essentially.

22 CPIA represents producers and users of

23 chlorinated paraffins including the sole producer of

24 the chloro alkene C-12 to C-24 that was included in

25 this test rule. CPIA has been active for many years in
US EPA MEETING 03/31/09 CCR#16194-1 12

1 addressing health and safety and environmental issues

2 related to chlorinated paraffins, including working

3 with EPA Canada, OECD member states, conducting

4 research and sponsoring various international health

5 and environmental activities.

6 I'm just going to talk very briefly

7 about chlorinated hydrocarbon chemistry because I think

8 it's germane to the main point that we want to make in

9 our comments here. Chlorinated paraffins are straight

10 chain hydrocarbons that are generally in the range of

11 C10 to C30 with a typical chlorine content of about

12 thirty to seventy percent, that's by weight so it's

13 not.

14 If there's ten carbons, then there would

15 necessarily be somewhere between six and ten or so

16 chlorines that will get attached to those and those are

17 grouped into three classes of products. Short chain,

18 medium chain and long chain with the carbon ranges that

19 you see here, ten to thirteen for the short, fourteen

20 to seventeen for the medium, and eighteen to thirty for

21 the long chain.

22 The carbon range of these starting

23 hydrocarbon feedstock is really what dictates the

24 carbon range of the finished chlorinated paraffin

25 product and the hydrocarbon feedstocks are reacted with
US EPA MEETING 03/31/09 CCR#16194-1 13

1 chlorine to produce the chlorinated paraffin and the

2 degree of chlorination is essentially what's controlled

3 in that reaction and that can produce different

4 finished characteristics of the final product. Just

5 briefly talking about the difference between alkane and

6 alkenes, the top one is an alkene, there's essentially

7 a decene, one decene for the whole thing, and the

8 bottom is just decane so that would be the simplest of

9 the C10.

10 Once you chlorinate those, this

11 particular example just has five chlorines that have

12 been added onto the chain, you eliminate essentially

13 most of the distinction between the alkane and the

14 alkene starting material, and we anticipate that the

15 studies show that the chlorine will substitute

16 favorably on the side of the double bond such that we

17 don't believe the double bond is remaining after the

18 chlorination occurs.

19 And this is the same conclusion that EPA

20 came to in the 1994 TRI expansion rule which they

21 state, "EPA believes that chlorination of paraffins and

22 a-olefins result in products that do not differ

23 significantly structurally, physically or

24 toxicologically. In terms of the work that's been done

25 so far on the chlorinated paraffins for the HPV and
US EPA MEETING 03/31/09 CCR#16194-1 14

1 OECD SIDS programs, CPI actually sponsored this

2 particular CAS number that's in the test rule in '99

3 when the original rule, I'm sorry, the original

4 voluntary program came out.

5 There was already efforts underway in

6 Europe on chlorinated paraffins primarily led by the UK

7 through...so activities were shifted to the OECD SIDS

8 program, the short and medium chain assessments have

9 already been completed through the OECD SIDS.

10 The long chain is still underway, UK

11 just finished their environmental risk assessment and

12 we're in the process of working with them to finish the

13 final OECD SIDS materials for that category. Once all

14 that's done we anticipate that the medium and long

15 chain will cover this CAS number that's subject to the

16 test rule.

17 While the carbon number range in the CAS

18 number definition is C-12 to 24, the predominant mass

19 is actually about eighty five percent is in the long

20 chain and so that particular category which as I've

21 said is in the process of being finished, we think is

22 going to be particularly germane to this CAS number and

23 the UK assessments.

24 And I think maybe this is one of the

25 reasons why this ended up in the particular test rule
US EPA MEETING 03/31/09 CCR#16194-1 15

1 used CAS numbers that were common in the EU that didn't

2 include, well, one of them did mention this CAS number

3 although I don't think that was clear in the OECD SIDS

4 information.

5 So, we will work to clarify that. Though

6 in terms of just proposed next steps, and this is

7 really the conclusion of what I want to propose to the

8 agency, we'd like to see the proposed testing on

9 these...this CAS number dropped, we feel that the work

10 that's being done on the chlorinated paraffins

11 categories will adequately cover the OECD SIDS

12 endpoints that have been identified for this CAS

13 number.

14 The CPIA is continuing to work with the

15 UK authorities and the other OECD member states to get

16 the final SIDS category completed for CPs and we

17 anticipate that once all that's competed we will

18 prepare and submit to the Agency as part of the HPV

19 program a final assessment on this CAS number that uses

20 the data from the MCCPs and the LCCPs categories.

21 Thank you very much, and thank you to the EPA for

22 having this hearing.

23 (WHEREUPON, there was a pause in the proceeding.)

24 DR. MANUPPELLO: I brought some

25 handouts with my slides, going through the data we
US EPA MEETING 03/31/09 CCR#16194-1 16

1 found and references for them. My name is Joseph

2 Manuppello, I'm with the People for the Ethical

3 Treatment of Animals. I'd like to thank the EPA for

4 this opportunity to comment on the second HPV test

5 rule.

6 While EPA has taken the lead in

7 commissioning the NRC to develop their toxicity testing

8 in the 21st century report and also in issuing their

9 own strategic plan just last week, we're very concerned

10 that this test rule will add another ten thousand

11 animals to the hundred thousand that have already been

12 killed in the HPV program In so doing, EPA has ignored

13 their own laudable goal expressed in their strategic

14 plan.

15 I lost my first page of notes so I don't

16 know the exact words but basically this is to go from

17 toxicity testing based on whole animal systems to a

18 more in vitro high throughput method using human cells

19 so in addition to ignoring that, EPA has also ignored

20 its first principle that was enumerated in the 1999

21 guidance issued to HPV program participants about

22 animal welfare principles and this advises HPV chemical

23 sponsors to conduct a thoughtful qualitative analysis

24 rather than to use a rote checklist approach.

25 It also makes clear that participants
US EPA MEETING 03/31/09 CCR#16194-1 17

1 may conclude that there is sufficient data, given the

2 totality of what is known about a chemical, including

3 human experience, that certain endpoints need not be

4 tested.

5 While the Agency specifically agreed to

6 incorporate these animal welfare principles into any

7 subsequent test rules, even a cursory review of

8 existing toxicity data and human experience with the

9 chemicals included in this test rule demonstrates that

10 in many cases, the required tests would add no useful

11 information to what is already known. I need to take a

12 little break, is there any chance I could get some

13 water? I'm just not going to make it through.

14 Thanks a lot. I'll get going. I'll

15 begin by addressing these test requirements

16 individually and present relevant existing data that

17 we've located or obtained and the references for this

18 data are in your handout. I'll go on to describe

19 several approaches for reducing the number of animals

20 killed in mammalian and fish acute toxicity and

21 developmental toxicity testing.

22 And I'll conclude with general comments

23 about the test rule stressing the need to allow an

24 opportunity for public comments after any additional

25 existing data is made available.
US EPA MEETING 03/31/09 CCR#16194-1 18

1 Noting that this would also allow any

2 justifications for in vivo genetic toxicity testing or

3 separate repeated dose and reproduction developmental

4 toxicity testing to be made prior to conducting that

5 testing instead of after the fact, so it would allow

6 for the inclusion of chemical category and SAR

7 approaches. I'd like to begin with sorbic acid since it

8 appears to be a special case.

9 We find it especially surprising that

10 the Agency would require testing for sorbic acid, a

11 naturally occurring fatty acid that has been safely

12 used as a preservative and antimicrobial agent in

13 foods, cosmetics and personal care products since the

14 1960s. The proposed test rule would require a

15 reproduction/developmental toxicity screening test that

16 would kill approximately 675 animals.

17 Even more confusing is the fact that

18 this requirement was included in the Agency's first

19 proposed test rule for HPV chemicals but dropped in the

20 final rule and there is no indication as to why it has

21 been included again in this second proposal.

22 Regarding the first test rule, the

23 Ashland Distribution Company or ADC, asked that

24 consideration be given to the results of studies it

25 submitted which indicated a low level of risk to
US EPA MEETING 03/31/09 CCR#16194-1 19

1 reproduction from sorbic acid exposure before

2 conducting another test merely to achieve consistency

3 with current guidelines.

4 The references are included in your

5 handout. The EPA agreed, finding that there was no

6 evidence in the multi-generation reproduction studies

7 to suggest that sorbic acid is a reproductive toxicant

8 and also that there was no evidence in a teratological

9 study conducted by the Food and Drug Research Labs to

10 suggest that sorbic acid is a developmental toxicant.

11 In the final rule the Agency stated clearly that it is

12 not requiring the reproduction/developmental toxicity

13 screening test of sorbic acid in this final rule.

14 We ask why this opinion has changed or

15 whether this requirement has been included again as the

16 result of some oversight. In addition to the studies

17 previously submitted by the ADC, we obtained a report

18 of a three generation reproduction study in rats from

19 the Eastman Chemical Company that was conducted by

20 Bio/Dynamics, Inc. for the Monsanto Company.

21 The authors reported that evaluation of

22 mating, pregnancy and fertility indices; litter

23 survival, offspring viability at parturition, offspring

24 survival, weight and sex distribution data and gross

25 postmortem observation data of offspring did not
US EPA MEETING 03/31/09 CCR#16194-1 20

1 indicate any adverse effects attributable to sorbic

2 acid administration through three successive

3 generations

4 These results are similar to those

5 previously cited by the ADC. Of relevance to humans,

6 Walker observed in a 1990 review that sorbic acid is a

7 naturally occurring fatty acid similar in structure to

8 linoleic and oleic acids and that it is metabolized in

9 mammals as a normal short chain fatty acid similar to

10 hexanoic acid. Guidelines by the International

11 Programme on Chemical Safety suggest that a more

12 limited range of tests might be acceptable for

13 substances which are converted to normal body

14 metabolites.

15 The FDA lists sorbic acid as generally

16 recognized as safe or GRAS as a preservative for direct

17 addition to food. In addition the European Commission

18 Cosmetics Directive has approved the use of sorbic acid

19 without restrictions or warning labels at levels up to

20 0.6 percent. GRAS substances generally have extensive

21 databases demonstrating their lack of toxicity.

22 In its 1999 letter EPA recommends that

23 participants should specifically consider whether the

24 information available makes it unnecessary to proceed

25 with further testing involving animals and whether any
US EPA MEETING 03/31/09 CCR#16194-1 21

1 additional information obtained would be useful or

2 relevant for GRAS substances.

3 Considering the history of this test

4 requirement, existing data, weight of evidence and GRAS

5 status, it is imperative that EPA reconsider its

6 testing requirements for sorbic acid in the proposed

7 test rule. Moving on to oxalic acid, having recently

8 passed a kidney stone, oxalic acid is something I've

9 had intense personal experience with.

10 Oxalic acid, supposed to pause for

11 laughter there, oxalic acid is listed as requiring a

12 reproduction/developmental toxicity screening test and

13 possibility a fish acute toxicity test. Thanks so

14 much. Uh-oh.

15 That'll do. So oxalic acid is listed as

16 requiring a reproduction/developmental toxicity

17 screening test and possibly a fish acute toxicity test.

18 It seems incomprehensible that additional animal

19 testing would be required for this extremely well

20 characterized toxin. Oxalic acid occurs naturally in

21 foods and its toxicity has been studied extensively as

22 a metabolite of ethylene glycol.

23 The American Conference of Governmental

24 Industrial Hygienists regards oxalic acid as a strong

25 poison and observes that as little as 5 grams have
US EPA MEETING 03/31/09 CCR#16194-1 22

1 proved fatal when taken internally. Specific data on

2 reproductive and developmental endpoints are numerous.

3 A search of the National Library of Medicine's

4 Developmental and Reproductive Toxicology or DART

5 database returned 23 results.

6 The National Toxicology Program

7 concluded in its Reproduction and Fertility Assessment

8 in CD -1 mice that oxalic acid is a reproductive

9 toxicant even at concentrations that cause few other

10 somatic effects. The NTP reported that at 0.2 percent

11 oxalic acid, the number of litters per pair was reduced

12 by 5 percent , the number of live pups per litter was

13 reduced by 20 percent and the weight of the surviving

14 pups was reduced by nearly 4 percent.

15 Also the percentage of abnormal sperm

16 forms doubled. In their subchronic rat study Goldman et

17 al reported that vaginal smears indicated the existence

18 of prolonged diestrus, persistent vaginal

19 cornification, dense compact ovarian and interstitial

20 tissue with small cells, absence of adipose tissue and

21 depressed follicular development.

22 They also noted that luteal cells

23 contained dark, condensed and shrunken nuclei and that

24 testes tissue appeared compact with seminiferous

25 tubules of small diameter containing immature
US EPA MEETING 03/31/09 CCR#16194-1 23

1 Sertolicells and spermatogonia with an absence of

2 mitoses.

3 In their study of the effects of

4 ethylene glycol and its metabolites on the development

5 of rat embryos, Klug et al. reported that 1-3

6 millimolar oxalic acid was embryotoxic.

7 In addition to the approximately 675

8 rats that would be killed in a reproductive and

9 developmental toxicity screen, a fish acute toxicity

10 test would likely kill another 120 fish. A search of

11 the ECOTOX database returns four results including a

12 study in bluegills reporting an LC50 of 24 mg/L.

13 The Agency must review these existing

14 data before requiring duplicative studies for this

15 substance. Sulfated and oxidized derivatives of castor

16 oil are listed as each requiring a mammalian acute

17 toxicity test, a combined repeated dose with

18 reproduction/developmental toxicity screen and possibly

19 a fish acute toxicity test.

20 These tests would kill approximately

21 1,350 - 1,600 animals. The castor oil derivatives share

22 a long history of safe use. Castor oil is a natural

23 vegetable oil obtained from the castor bean that is

24 used in pharmaceuticals, food and other industries.

25 The FDA lists castor oil as GRAS for
US EPA MEETING 03/31/09 CCR#16194-1 24

1 over the counter use as a laxative. An extensive 2007

2 safety review of castor oil and its derivatives by the

3 Cosmetic Ingredient Review Expert Panel concluded that

4 these ingredients are safe and that the safety test

5 data on castor oil is broadly applicable to the entire

6 group evaluated.

7 Sulfated castor oil, also known as

8 Turkey red oil, completely disperses in water and, as a

9 result is widely used in cosmetic and personal care

10 products as well as in lubricants and softeners. It is

11 listed by Health Canada as a substance not requiring

12 further work for human health.

13 A 1980 (sic) study reports a mean LC50

14 of 2.2 mg/ L for sulfated castor oil in medaka, which

15 is a aquatic toxicity report. Oxidized castor oil is

16 produced by bubbling air through castor oil at elevated

17 temperatures which causes oxidative polymerization to

18 occur at the double bonds of the fatty acids.

19 In its comments, Vertellus Specialties,

20 Incorporated summarized, among other data, an octanol21 water partition coefficient log value estimated to be

22 17.97 and an LD 50 value for oxidized castor oil of

23 greater than 5 grams per kilogram body weight in rats.

24 Vertellus notes that aquatic toxicity tests would be

25 problematic given the lack of water solubility of
US EPA MEETING 03/31/09 CCR#16194-1 25

1 oxidized castor oil and expects no effects at

2 saturation.

3 In any case, considering the log Kow

4 value, chronic toxicity testing in Daphnia would be

5 indicated instead of acute toxicity testing in fish.

6 With regard to mammalian toxicity testing, Vertellus

7 observes that given that the oxidation of castor oil

8 results in a polymerized fatty acid triglyceride

9 product, oxidized castor oil should be less

10 bioavailable than the castor oil starting material,

11 which itself is recognized as nontoxic as reported by

12 the NTP, and Vertellus challenges the value of

13 subjecting this chemical to mammalian toxicity

14 endpoints.

15 Given the wealth of human experience

16 with castor oil and its derivatives, it is

17 inconceivable that animal tests would be required.

18 Considering existing data and weight of evidence EPA

19 must consider (sic) its testing requirement for these

20 chemicals.

21 Penta-erythritol tetra-nitrate or PETN,

22 a highly sensitive explosive, is listed as requiring a

23 fish acute toxicity test. A search of the ECOTOX

24 database returns a U.S.Army study reporting acute

25 toxicity for fathead minnows and bluegills that
US EPA MEETING 03/31/09 CCR#16194-1 26

1 classifies the chemical as not acutely toxic.

2 In addition Dyno Nobel, Incorporated has

3 submitted the results of testing under the first test

4 rule and reports results from water solubility tests

5 suggesting that PETN dissolves very slowly in water to

6 reach a relatively low water solubility limit. Attempts

7 to determine the rate at which PETN degrades in

8 naturally occurring water samples failed to reach

9 solubility limits of PETN determined from previous

10 experiments with pure water.

11 This suggests that breakdown exceeds the

12 rate of solubility. As a result Dyno Nobel concludes

13 that since PETN degrades more rapidly than it

14 dissolves, there is no logical justification for

15 completing any additional aquatic toxicity tests.

16 Dyno Nobel also notes that PETN has not

17 been detected in any environmental water sample to its

18 knowledge. Pyromellitic Dianhydride is listed as

19 requiring a fish acute toxicity test, a mammalian acute

20 toxicity test, and repeated dose toxicity with

21 reproduction and developmental screen.

22 The acid anhydrides have been the

23 subjects of extensive human exposure and case studies

24 with the most common adverse health effects reported

25 being pulmonary edema, immune sensitization and
US EPA MEETING 03/31/09 CCR#16194-1 27

1 irritation of mucous membranes and skin.

2 In addition oral LD50 values of 2.25 to

3 3.5 grams per kilogram body weight have been reported

4 in rats, 2.3 to 2.65 grams per kilogram body weight in

5 mice and 1.6 grams per kilogram body weight in guinea

6 pigs as well as lowest lethal inhalation dose of 150

7 milligrams per cubic meter in rats No embryotoxicity

8 was observed in rats given oral doses of 44 and 220

9 mg/kg body weight.

10 In rats exposed to the oral dose of 44

11 mg/kg body weight, a weak effect on gonad morphology

12 was observed. E. I. Dupont de Nemours and Company

13 submitted comments that included summaries of

14 additional in house data.

15 These include results from an inhalation

16 toxicity study reporting an Approximate Lethal

17 Concentration or ALC of 3 mg/L in rats and from an

18 acute oral toxicity study reporting an ALD of 5,000

19 milligrams per kilogram in rats.

20 In addition Dupont argues that

21 trimellitic anhydride or TMA is an appropriate analog

22 for PMDA, and reports a No Observed Effects

23 Concentration of 896 milligrams per liter in fish, 792

24 milligrams per liter in invertebrates and 739

25 milligrams per liter in algae.
US EPA MEETING 03/31/09 CCR#16194-1 28

1 Further Dupont understands that PMDA has

2 been preregistered under REACH and expects that a SIEF

3 consortia will be organized to share data on this

4 chemical. At a minimum, rather than risk duplicating

5 animal studies, EPA should await the results from this

6 SIEF before establishing requirements for this chemical

7 in its final rule.

8 This chemical, also known as Ionox 220,

9 is listed as possibly requiring a fish acute toxicity

10 test. It is included in comments submitted by

11 Albemarle Corporation in which Albemarle notes that it

12 previously reported to EPA an octanol water partition

13 coefficient log value grater than 6.5.

14 In addition a study conducted by Shell

15 Oil Company reports a value of 7.4 Since these values

16 are greater than 4.2, the aquatic toxicity endpoint

17 should be filled by a chronic test on Daphnia. Also the

18 report submitted by Shell Oil includes data on acute

19 toxicity to steelhead trout and chronic toxicity to

20 fathead minnows.

21 There may also be data available from

22 Exxon Mobil as their MSDS for 10W-30 motor oil states

23 that this chemical is not expected to be harmful to

24 aquatic organisms based on available data. Diethyl25 phosphoro-chloro-thioate or DECTP is listed as
US EPA MEETING 03/31/09 CCR#16194-1 29

1 requiring a fish acute toxicity test and a

2 reproduction/developmental toxicity test.

3 In its submitted comments Albemarle

4 Corporation reports that its production of this

5 chemical ceased subsequent to the 2006 IUR and that no

6 future production of this chemical is anticipated. As a

7 result Albemarle suggests that the Agency's findings of

8 substantial production and human exposure should be

9 reevaluated.

10 In the event that additional production

11 of DECTP exists, we note that in 1981 Chemical Hazard

12 Information Profile Draft Report for DECTP by the EPA's

13 Office of Toxic Substances lists median lethal doses

14 ranging from 810 mg/kg body weight in guinea pigs to

15 1340 mg/kg body weight in rats.

16 The study upon which this was apparently

17 based, an investigation of the toxicological

18 characteristics of thiophosphoric acid esters by

19 Kukatov, also reports an LD 50 of 910 milligrams per

20 kilogram in mice.

21 The EPA report notes structural

22 similarities with dimethyl-chloro-thio- phosphate and

23 we urge the Agency to consider any existing data on

24 this chemical as a possible analog. Sodium gluco25 heptonate is listed as requiring a mammalian acute
US EPA MEETING 03/31/09 CCR#16194-1 30

1 toxicity test, a combined repeated dose with

2 reproduction/developmental toxicity screen and possibly

3 a fish acute toxicity test.

4 The FDA's Priority based Assessment of

5 Food Additives or PAFA database lists sodium

6 glucopheptonate as a secondary direct food additive

7 permitted in food for human consumption and as an

8 indirect food additive.

9 Further, the PAFA database includes that

10 or indicates that fully up to date toxicology

11 information has been sought. As noted previously with

12 regard to GRAS substances, EPA has recommended that

13 consideration be given as to whether information

14 already available makes it unnecessary to proceed with

15 further testing involving animals and whether any

16 additional information obtained would be useful or

17 relevant.

18 It seems likely that the FDA has

19 toxicology information that addresses at least some of

20 the endpoints sought in this test rule and we urge the

21 Agency to investigate whether this is the case. C. I.

22 Leuco Sulphur Black 1 is listed as requiring a

23 mammalian acute toxicity test and possibly a fish acute

24 toxicity test.

25 A European Chemicals Bureau, IUCLID
US EPA MEETING 03/31/09 CCR#16194-1 31

1 Dataset, summarizes data from 1986 studies of acute

2 toxicity in mammals and fish conducted for Sandoz

3 Products. These report an LD50 of greater than 2 grams

4 per kilogram body weight in rats and an LC50 of 401

5 milligrams per liter in salmon trout.

6 Again the Agency must review these

7 studies and reconsider its requirements for this

8 chemical. Diethyltoluenediamine or DETDA is listed as

9 requiring a fish acute toxicity test and a combined

10 repeated dose with developmental screen, repeated dose

11 with reproduction/developmental screen. We note that an

12 MSDS from Bayer MaterialScience reports an LC 50 value

13 of 194 mg/l in goldfish.

14 The EPA lists Albemarle Corporation as a

15 tentative ICCA sponsor for this chemical. Albemarle

16 submitted written comments on DETDA including an ECOSAR

17 estimated 96 hour fish LC 50 of 37.9 milligrams per

18 liter.

19 Albemarle also notes that DETDA has been

20 tested in multiple repeated dose studies including two

21 year carcinogenicity tests by several exposure routes.

22 Neither the male nor female reproductive tracts were

23 identified as target organs in these studies which

24 Albemarle has previously forwarded to the EPA.

25 Albemarle also includes occupational
US EPA MEETING 03/31/09 CCR#16194-1 32

1 exposure data and handling recommendations and

2 concludes that additional testing for reproductive

3 endpoints is not indicated.

4 Just a few more. Hydrocarbons, C

5 greater than 4 is listed as requiring a mammalian acute

6 toxicity test, a combined repeated dose with

7 reproduction/ developmental toxicity screen and

8 possibly a fish acute toxicity test.

9 Aquatic toxicity data for this mixture

10 would be expected to fall within a narrow range of

11 values regardless of chemical class or carbon number

12 because the toxic mode of action for neutral organic

13 hydrocarbons is known to be non-polar narcosis.

14 As thoroughly discussed in The American

15 Petroleum Institute's test plan for the Gasoline

16 Category, this mechanism of short term toxicity for

17 these chemicals is disruption of biological membrane

18 function, and any differences between toxicities can be

19 explained by differences between the target tissue

20 partitioning behaviors of the individual constituents.

21 The existing fish toxicity database for

22 hydrophobic neutral chemicals supports a critical body

23 residue, the internal concentration that causes

24 mortality, of between 2 and 8 millimole per kilogram

25 body weight for fish.
US EPA MEETING 03/31/09 CCR#16194-1 33

1 Also given a compositional analysis of a

2 mixture of hydrocarbons, the acute toxicity can be

3 calculated and toxicity QSARS may be used to provide

4 LL50 estimates for hydrocarbons where acute toxicity

5 data are not available, since these are well

6 established for hydrocarbons.

7 We urge the Agency to consider such an

8 approach for this mixture. For acetaldehyde I'd like to

9 summarize comments submitted by the Acetaldehyde

10 Working Group or AWG of the Vinyl Acetate Council.

11 These were extensive comments.

12 AWG notes first that acetaldehyde was

13 originally designated as being sponsored in another

14 program and considering that the International Agency

15 for Research on Cancer, IARC, and the international, or

16 the IPCS as already mentioned are evaluating

17 acetaldehyde.

18 It was not recognized that acetaldehyde

19 was in fact an orphan chemical. Acetaldehyde has been

20 reviewed numerous times by regulatory agencies

21 including the EPA, the IPCS, and IARC and it has been

22 labeled as GRAS for use as a flavor additive and

23 adjuvant.

24 AWG observes that the Agency's exposure

25 findings presented for acetaldehyde do not recognize
US EPA MEETING 03/31/09 CCR#16194-1 34

1 that acetaldehyde is a normal human metabolite and that

2 endogenously produced acetaldehyde levels are likely to

3 be higher than those from exogenous sources.

4 As previously noted for sorbic acid,

5 guidelines by the IPCS suggest that a more limited

6 range of tests might be acceptable for normal body

7 metabolites. AWG also notes that acetaldehyde exposure

8 from industrial sources is limited by regulatory

9 controls already in place. It may also be a closed

10 system intermediate as defined by the OECD/SIDS

11 guidelines and as such reproductive toxicity data

12 should not be required.

13 AWG evaluated the Agency's findings for

14 human exposure by looking at actual concentrations of

15 acetaldehyde from environmental monitoring and computer

16 (sic) product modeling and then comparing these levels

17 to human biomonitoring data.

18 It was found that exposure from

19 environmental sources appears to be significantly less

20 than from acetaldehyde naturally produced in the body.

21 AWG also observes that there is already a significant

22 toxicology data base for acetaldehyde.

23 AWG reviewed the available data and

24 provided robust summaries for several unpublished

25 studies as well as a specially commissioned review of
US EPA MEETING 03/31/09 CCR#16194-1 35

1 developmental and reproductive toxicity data. The in

2 vivo developmental and reproductive toxicity data

3 indicate no significant developmental or reproductive

4 organ effects from oral or inhalation exposure to

5 acetaldehyde.

6 Due to its strong irritation to mucous

7 membranes, acetaldehyde exposure by inhalation is

8 unlikely to result in sufficiently high maternal blood

9 concentrations to result in an adverse effect on

10 developing embryos.

11 Also a 1997 expert panel review of

12 acetaldehyde by Toxicology Excellence for Risk

13 Assessment concluded that systemic toxicity, including

14 any effects on a fetus, are not likely to be of concern

15 following inhalation exposure because its exposure is

16 likely to be limited by respiratory tract and ocular

17 irritation.

18 AWG also notes that a new IUCLID dossier

19 for acetaldehyde will be developed under REACH by

20 December 2010. This should address the EPA's data

21 requirements. A new reproduction/developmental toxicity

22 screening test will not add any new information to the

23 data set already available on acetaldehyde.

24 AWG concludes, and we agree, that to

25 require an additional screening level toxicity study on
US EPA MEETING 03/31/09 CCR#16194-1 36

1 acetaldehyde would be inconsistent with EPA's stated

2 goal to maximize the use of existing and scientifically

3 adequate data to minimize further testing.

4 Moving on from the specific chemicals,

5 I'm at the end of my slides, as a general observation

6 about the test that would be required under this

7 proposed rule, we note that basic information on

8 physical/chemical properties and environmental fate are

9 apparently lacking for many of these chemicals.

10 For example, the test rule would require

11 testing for all physical/chemical endpoints for five

12 chemicals or groups, while testing for one to four of

13 these endpoints would be required for another five

14 chemicals.

15 It is senseless to conduct health

16 effects in ecotoxicity testing until such basic

17 information is known, since in some cases a chemical's

18 physical/chemical and environmental fate properties

19 will preclude the need for further testing.

20 This is the backbone of an intelligent

21 testing strategy such as the OSIRIS initiative,

22 Optimized Strategies for Risk Assessment of Industrial

23 Chemicals through Integration of Non-Test and Test

24 information, the goal of which is to significantly

25 increase the use of non-testing information to
US EPA MEETING 03/31/09 CCR#16194-1 37

1 regulatory decision making under REACH and thus to

2 minimize the need for animal testing.

3 At this point, I'd like to outline a

4 number of approaches for reducing the number of animals

5 killed in toxicity testing, beginning with mammalian

6 acute toxicity testing. The acute toxicity test

7 inflicts suffering so extreme that by design many of

8 the animals who are exposed to the test chemicals are

9 poisoned to death.

10 Under the proposed rule, mammalian

11 toxicity testing would be required for seven chemicals.

12 Alternative approaches exist that either refine

13 existing methods, allowing more information to be

14 obtained from them, or replace acute toxicity testing

15 with non- animal methods.

16 Last year, for example, the

17 International Council on Harmonization proposed

18 removing the acute toxicity testing requirement from

19 its guidelines in favor of obtaining this data from

20 available repeated dose studies.

21 This followed the report of a coalition

22 of European pharmaceutical companies that regulatory

23 decisions are almost never based on the results of

24 acute toxicity tests. ECVAM, the European Center for

25 the Validation of Alternative Methods, reported that it
US EPA MEETING 03/31/09 CCR#16194-1 38

1 was able to correctly classify a majority of chemicals

2 using this approach.

3 Another approach for chemicals tested by

4 the inhalation route of exposure is based on the

5 observation that a chemical's water solubility and

6 vapor pressure represent the effective dose to which

7 fish or mammals would be exposed, respectively. As a

8 result, acute mammalian inhalation toxicity can be

9 predicted using available acute fish toxicity data and

10 vice versa.

11 The International QSAR Foundation has

12 preliminary data showing very good correlations, and is

13 using this concept to build a QSAR model. These

14 approaches are examples of the kind of thoughtful

15 toxicology that the Agency and chemical manufacturers

16 should be applying to the testing of HPV chemicals.

17 Also recent efforts to validate the in

18 vitro 3T3 Neutral Red Uptake or NRU cytotoxicity assay

19 as a replacement for the in vivo acute toxicity test

20 indicate that it correctly discriminates non-toxic

21 chemicals -- those with an LD 50 greater than 2 grams

22 per kilogram body weight from more toxic ones and shows

23 a good correlation with mammalian LD 50 data at both

24 extremes of the toxicity spectrum.

25 This suggests using the 3T3 NRU assay as
US EPA MEETING 03/31/09 CCR#16194-1 39

1 a first tier, particularly for those substances that

2 are already suspected to be at the extremes of

3 toxicity. If the in vitro predictions corroborate the

4 expectations from preliminary evidence, then no

5 additional animal testing need be conducted for such

6 substances. This would result in an immediate reduction

7 in the number of animals used.

8 We urge the Agency to reconsider

9 allowing this approach, particularly for pyromellitic

10 dianhydride, CI Leuco Sulphur Black 1 and the castor

11 oil derivatives since at least preliminary data exist

12 indicating that these chemicals are nontoxic.

13 The same is likely true of sodium

14 glucoheptonate which is permitted as a food additive by

15 the FDA. In addition ECVAM is currently conducting a

16 definitive validation study of the 3T3 NRU assay, the

17 results of which are expected later this year.

18 At a minimum the Agency should await the

19 results of this validation effort before finalizing

20 acute toxicity requirements for these chemicals. Moving

21 on to aquatic toxicity testing, based on the OECD's

22 Test Guideline 203, each fish acute toxicity test will

23 kill approximately 120 animals.

24 Under the proposed rule, fish toxicity

25 testing would be required for as many as twelve
US EPA MEETING 03/31/09 CCR#16194-1 40

1 chemicals. As a general observation fish toxicity

2 testing is intended to predict the potential for

3 economic loss and ecological damage resulting from fish

4 death on a large scale.

5 If a chemical is toxic to the food on

6 which fish subsist, fish populations would be affected

7 even without direct toxicity to fish. As a result,

8 toxicity to aquatic plants and invertebrates should

9 generally be characterized prior to consideration of

10 acute toxicity testing on fish.

11 In addition in silico and in vitro

12 methods exist that can replace in vivo fish testing and

13 another alternative approach can greatly reduce the

14 number of fish killed.

15 The Agency's guidance document entitled

16 The Use of Structure-Activity Relationship in the High

17 Production Volume Chemicals Challenges Program notes

18 that if a QSAR model is available, then it may be used

19 and identifies ECOSAR as an available model to estimate

20 aquatic toxicity.

21 Toxicity screening of HPV chemicals is

22 an ideal application of such QSAR tools and the Agency

23 and chemical sponsors should make every effort to use

24 them.

25 An in vitro approach to fish toxicity
US EPA MEETING 03/31/09 CCR#16194-1 41

1 testing is the validated DarT test which uses

2 fertilized zebrafish eggs as a replacement for living

3 fish. Since the eggs do not hatch, the DarT test is a

4 non-animal test method.

5 Following a 48 hour exposure assessed

6 endpoints are comparable to lethality in vivo. These

7 include incomplete gastrulation and somite development,

8 absence of a heartbeat and coagulation of eggs.

9 The reliability and relevance of this

10 test have been confirmed through an international multi

11 laboratory validation study coordinated by the German

12 Environmental Protection Agency.

13 Predictions of acute toxicity from the

14 DarT test correlated very well with in vivo reference

15 data. This in vitro test has been accepted in Germany

16 as a replacement for the use of fish in the assessment

17 of wastewater effluent and has since been nominated for

18 development into an OECD test guideline.

19 It is clearly suitable for immediate use

20 as a replacement for the use of fish in providing

21 screening level hazard data. If a fish acute toxicity

22 test is still perceived to be required, the fish acute

23 threshold or step down test can reduce the number of

24 fish killed by 50 to 70 percent.

25 Since fish are less sensitive than algae
US EPA MEETING 03/31/09 CCR#16194-1 42

1 or Daphnia in acute aquatic toxicity tests roughly 85

2 percent of the time, an upper threshold concentration

3 or UTC is set at the lowest EC 50 value observed in the

4 algae and Daphnia tests. An acute toxicity is carried

5 out at the UTC with five fish each in the test and

6 control groups.

7 If no toxicity is observed, no further

8 tests are carried out and the LC 50 is reported as

9 greater than the UTC value. If toxicity is observed, a

10 second test is performed at a step down concentration

11 using a dilution factor of 3.2 which is based on a

12 semi-logarithmic concentration series.

13 The testing continues to lower

14 concentrations until no toxicity is observed. The LC50

15 value is obtained using all of the test data by

16 applying the binomial method of interpolation. An

17 additional refinement can be obtained by terminating

18 the test after 24 hours of exposure if lethality or

19 serious morbidity are observed in two out of the five

20 fish.

21 When no replacement for the acute fish

22 toxicity test is perceived to be applicable, we

23 strongly urge the use of this new testing strategy.

24 With regard to developmental toxicity testing, we note

25 that an embryonic stem cell test or EST has been
US EPA MEETING 03/31/09 CCR#16194-1 43

1 validated by ECVAM as a test for embryotoxicity, a

2 critical developmental toxicity endpoint.

3 The test uses rodent derived stem cells

4 which survive in culture indefinitely and are capable

5 of differentiation. Embryoxtoxicity is determined by

6 the concentration of the test chemical required to

7 inhibit differentiation by 50 percent, together with

8 growth inhibition by 50 percent relative to controls.

9 This method is suited for immediate use

10 at the screening level and would reduce the number of

11 animals killed since chemicals that test positive for

12 embryoxtoxicity in the EST could be classified as

13 probable developmental toxicants without further

14 testing.

15 I'd like to say a few words about in

16 vitro genetic toxicity testing and combined repeated

17 dose reproduction/developmental toxicity testing that

18 will lead to some general comments about this test

19 rule. The proposed rule states that persons who would

20 be required to conduct testing for chromosomal damage

21 are encouraged to use in vitro genetic toxicity

22 testing.

23 It seems to us that a rule must

24 stipulate the Agency's requirements not just encourage

25 actions by regulated entities. Further, a subject
US EPA MEETING 03/31/09 CCR#16194-1 44

1 person who uses one of the in vivo methods instead of

2 the in vitro method would be required to submit to EPA

3 a rationale for conducting that alternative test in the

4 final study report.

5 Similarly a person who uses separate

6 repeated dose and reproduction/ developmental toxicity

7 tests instead of the combined protocol would be

8 required to submit to EPA a rationale for conducting

9 these alternative tests in the final study reports. If

10 a company's rationale is flawed, there will have been

11 no opportunity to spare animals from these tests.

12 We call upon the Agency to amend the

13 proposed rule to mandate the use of internationally

14 accepted in vitro genetic toxicity screening tests and

15 the combined protocol.

16 In addition, companies proposing to use

17 in vivo genetic toxicity testing or separate repeated

18 dose and reproduction/developmental toxicity tests

19 should be required to submit a compelling justification

20 for an exemption prior to the testing being conducted,

21 and opportunity for public comment should be made

22 available prior to the Agency's final decision.

23 In response to similar comments on the

24 first proposed test rule, the Agency noted that it

25 anticipates that test sponsors will generally choose to
US EPA MEETING 03/31/09 CCR#16194-1 45

1 conduct the less costly and less resource intensive in

2 vitro and combined tests unless there are sound

3 scientific reasons not to do so.

4 In our retrospective analysis of all

5 test plans submitted to the HPV Challenge Program,

6 however, we found that 21 percent of in vivo

7 chromosomal aberration tests originally proposed were

8 subsequently replaced by the in vitro test in revised

9 test plans.

10 This saved the lives of more than 500

11 animals. Likewise, 35 percent of individual repeated

12 dose reproduction and developmental toxicity tests were

13 subsequently replaced by the combined protocol and this

14 saved the lives of more than 16,000 animals.

15 In many cases these revisions resulted

16 at least in part from the involvement of animal

17 protection organizations. The Agency suggests that

18 publication of study plans in order to provide an

19 opportunity for public comment on the inclusion of any

20 alternative tests could cause a significant delay in

21 the initiation of testing.

22 Considering that the Agency took more

23 than four years just to respond to public comments on

24 the first proposed test rule and more than five years

25 to publish a final rule, a 120 day public comment
US EPA MEETING 03/31/09 CCR#16194-1 46

1 period seems hardly significant. The Agency's sudden

2 concern for efficiency is not an acceptable reason for

3 allowing test sponsors to justify the use of in vivo

4 methods after the fact.

5 Another reason for the publication of

6 study plans along with an opportunity for public

7 comment would be to allow the evaluation of existing

8 data that is not yet publicly available.

9 In its response to comments on the first

10 test rule, the Agency claimed that its "designation in

11 the proposed test rule of the tests and test methods to

12 be required for each chemical is in essence the test

13 plan for each chemical."

14 Elsewhere in its response, however, the

15 Agency agreed that publicly available data bases do not

16 provide access to all existing data on particular

17 chemicals and stated its hope that the test rule would

18 "cause manufacturers to release any in house testing

19 results and other existing data of which they are

20 aware."

21 If it is in part the purpose of the

22 proposed test rule to make this data available during

23 the public comment period or after, how is the public

24 to comment on their adequacy and whether or not

25 additional testing is called for?
US EPA MEETING 03/31/09 CCR#16194-1 47

1 The Agency must allow for public comment

2 after any in-house testing results or other existing

3 data are made available in a test plan as part of this

4 proposed rule. This would also provide test sponsors

5 with the opportunity to consider the use of categories

6 or analogs and SAR analyses.

7 Notably these approaches have once again

8 been excluded from the current proposal, although

9 comments suggesting procedures for their inclusion were

10 received in response to the first test rule from

11 diverse organizations including the Synthetic Organic

12 Chemical Manufacturers Association, the American

13 Chemistry Council, and several animal protection

14 organizations.

15 The Agency states that these approaches

16 would require "time consuming and intensive procedural

17 steps such as multi-phase rulemaking without a

18 corresponding benefit."

19 However, throughout the HPV Challenge

20 Program, category and SAR approaches have resulted in

21 considerable benefit by reducing testing required and

22 consequently the number of animals killed in that

23 testing.

24 In our retrospective analysis we show

25 that nearly a third of all test plans submitted to the
US EPA MEETING 03/31/09 CCR#16194-1 48

1 HPV Challenge Program in which animal tests were

2 proposed were for categories of chemicals. These

3 opportunities for read-across from already

4 characterized category members are likely to have

5 spared the lives of tens of thousands of animals.

6 Likewise, ECOSAR data was used to fulfill the fish

7 acute toxicity endpoint in approximately 10 percent of

8 these test plans.

9 In conclusion, the Agency has once again

10 failed to consider the totality of what is known about

11 each chemical, including human experience, before

12 concluding that all endpoints need to be tested. The

13 inclusion of such familiar substances as acetaldehyde,

14 sorbic acid, oxalic acid and castor oil derivatives is

15 evidence that this primary principle has been grossly

16 ignored.

17 Also the Agency must allow for public

18 comment after any in-house testing results or other

19 existing data are made available in a test plan as a

20 result of this proposal. We also urge the Agency to

21 take this opportunity to reconsider the alternatives to

22 mammalian acute toxicity testing, fish acute testing,

23 toxicity testing and developmental toxicity testing

24 detailed earlier.

25 Finally, and most urgently, the Agency
US EPA MEETING 03/31/09 CCR#16194-1 49

1 must thoroughly evaluate the existing data we have

2 cited for many of the chemicals included in this

3 proposed test rule. We appeal to the Agency and to

4 chemical companies themselves to carefully evaluate all

5 available data to avoid conducting duplicative animal

6 tests. Thank you.

7 DR. WILLIS: Thank you, next on my list

8 is ARISE from New Jersey..

9 MR. CHAIFETZ: Good morning, my name is

10 Stuart Chaifetz, I'm program director for ARISE. On

11 February 14th, 2008 the National Institutes of Health

12 and the Environmental Protection Agency held a press

13 conference announcing a new collaborative effort to use

14 state of the art technology to test for chemical

15 toxicity These pioneering procedures, which include

16 using robotics and human cell cultures have brought us

17 to the dawn of a new era in scientific experimentation

18 and toxicity safety testing.

19 The EPA rules we are here today to

20 discuss, however, drag us back into the darkness for

21 exposing animals to lethal doses of chemicals is not a

22 thing of the 21st Century. Toxicity testing using

23 animals is, quote, "clearly quite expensive, it is time

24 consuming, it uses animals in large numbers and it

25 doesn't always predict which chemicals would be harmful
US EPA MEETING 03/31/09 CCR#16194-1 50

1 to humans.

2 These are the words of Dr. Francis

3 Collins, the then Director of the National Human Genome

4 Research Institute, speaking at the NIH/EPA

5 teleconference on the 14th of last year. Dr. Collins

6 continued, quote. "There are differences between

7 species.

8 We are not rats and we are not even

9 other primates," end quote. Speaking directly to the

10 point of the NIH/EPA joint venture that would act as a

11 replacement for animal testing, Dr. Collins said,

12 quote, "And so the desire here is to try to see if we

13 could do better."

14 Samuel Wilson, former director of the

15 NIH National Institute of Environmental Health

16 Sciences, was also at the NIH/EPA press conference and

17 he echoed Dr. Collins' statements. As quoted in

18 Scientific American, February 15th, 2008 Wilson said,

19 quote, " this sort of high throughput testing will

20 enable researchers to generate more data relevant to

21 humans and at the same time reduce the amount of animal

22 experimentation."

23 The cross species extrapolation from

24 animals to humans is "not always as precise as it

25 should be," Wilson said. This collaboration is a
US EPA MEETING 03/31/09 CCR#16194-1 51

1 milestone because it gives us the ability to apply a

2 new generation of approaches to determining toxicities.

3 Robert Kavlock, Director of the National Center for

4 Computational Toxicology at EPA was quoted in the same

5 article and joined his colleagues in expressing the

6 inherent flaws with animal toxicity testing by saying,

7 quote,:"that it is also expensive, inefficient and is

8 not always an accurate indicator of how a substance

9 will affect humans."

10 The NIH/EPA are not alone in seeking a

11 more advantageous method to test for toxicity. Another

12 ground breaking technological advancement are called

13 "biochips", the MetaChip (Metabolizing Enzyme

14 Toxicology Assay Chip) and the DataChip, (Data Analysis

15 Toxicology Assay Chip), which were created by

16 researchers at Rensselaer Polytechnic Institute, the

17 University of California at Berkeley and Solidus

18 Biosciences, Inc.

19 Both chips are glass slides with the

20 MetaChip containing human enzymes while the DataChip

21 contains cell cultures.

22 As was reported in the National

23 Institute of Environmental Health Sciences News of

24 March 2008: Quote, "When the two slides are

25 sandwiched together and incubated, they mimic the
US EPA MEETING 03/31/09 CCR#16194-1 52

1 body's reactions to compounds.

2 If the cells stop growing, appear sick

3 or die, it's an indication that a toxin is present".

4 End quote. The headline for the story on biochips in

5 Scientific American, December 21st, 2007 read, quote,

6 "Biochips promise to deliver better drug and chemical

7 testing, cutting costs and nixing the need for most

8 animal testing." Dr. Collins set the correct ethical

9 and scientific tone when he said that the desire is to,

10 quote, "do better", yet the rules we are discussing

11 today fail this. They do not do better.

12 These animal tests will be expensive.

13 They will take a great deal of time. They will destroy

14 the lives of thousands of animals, and they will not

15 produce the best hazard assessments for human health

16 and the environment.

17 In science, we must always press

18 forward, pushing the frontiers of our knowledge and our

19 ethics to new heights, topping each crowning moment

20 with the race to the next summit.

21 With so much technology within our

22 grasp, is it not better to apply this superior

23 technology to the testing of HPV chemicals rather than

24 waste so much time, money and life? Our argument, in

25 its most direct and uncomplicated expression, is that
US EPA MEETING 03/31/09 CCR#16194-1 53

1 we do it better. Thank you very much.

2 DR. CAMPANELLA: I think that brings us

3 to a close the comment period.

4 Are there any other comments from the

5 audience that anybody wants to make?

6 If not I want to thank you all for

7 coming, I think I've heard some interesting and very

8 useful analysis today. I thought the, I thought the, a

9 lot of the points made by Mr. Manuppello were very good

10 and will cause us to consider very seriously what he

11 said as we go forward to develop a final rule.

12 We're going to revisit a lot of these

13 points and incorporate them into our thinking. I think

14 it's useful for us to hear these comments and I don't

15 mean the written ones, but also the oral ones because I

16 think they add a new dimension to the analysis that we

17 have to do to make wise decisions about these

18 chemicals.

19 So I thank you all for coming, I know it

20 was a good opportunity for you to come, also it was a,

21 sort of a burden to come and present, but we appreciate

22 that and so I thank you again.

23 We will be producing a transcript of the

24 meeting, which will be entered into the public docket

25 and that will available for your perusal whenever. I
US EPA MEETING 03/31/09 CCR#16194-1 54

1 think you'll probably have, I'm not sure what the

2 delivery date of that would be, do you have any, any

3 idea when that would be ready?

4 COURT REPORTER: Seven to ten days.

5 DR. CAMPANELLA: Seven to ten days.

6 Okay, thank you then we'll conclude this.

7 (WHEREUPON, the PUBLIC MEETING was concluded at

8 9:19 a.m.)

9

10

11

12

13

14

15

16

17

18

19

20

21

22

23

24

25
US EPA MEETING 03/31/09 CCR#16194-1 55

1 CAPTION

2 The foregoing matter was taken on the date, and at 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 typewritten

6 form.

7 Further, as relates to depositions, it was agreed by

8 and between counsel and the parties that the reading

9 and signing of the transcript, be and the same is

10 hereby waived.

11

12

13

14

15

16

17

18

19

20

21

22

23

24

25
US EPA MEETING 03/31/09 CCR#16194-1 56

1 CERTIFICATE OF REPORTER

2 COMMONWEALTH OF VIRGINIA

3 AT LARGE:

4 I do hereby certify that the witness in the foregoing

5 transcript was taken on the date, and at the time and

6 place set out on the Title page hereof by me after

7 first being duly sworn to testify the truth, the whole

8 truth, and nothing but the truth; and that the said

9 matter was recorded stenographically and mechanically

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 and

15 signing of said deposition were waived by counsel for

16 the respective parties and by the witness.

17 I certify that I am not a relative or employee of

18 either counsel, and that I am in no way interested

19 financially, directly or indirectly, in this action.

20

21

22

23

24 CHARLES DAVID HOFFMAN, COURT REPORTER / NOTARY

25 SUBMITTED ON MARCH 31, 2009
US EPA MEETING 03/31/09 CCR#16194-1 57

0

0.2 22:10

0.6 20:20

1

1 5:23 22:8 30:22

39:10

1,350 23:21

1,600 23:21

1.6 27:5

10 48:7

10W-30 28:22

120 23:10 39:23

45:25

1-3 23:5

1340 29:15

14th 49:11 50:5

150 27:6

15th 50:18

16,000 45:14

16th 3:25

17.97 24:22

19 5:9 6:14

7:14 8:7 9:15

194 31:13

1960s 18:14

1980 24:13

1981 29:11

1986 31:1

1990 20:6

1994 13:20

1997 35:11

1999 16:20 20:22

2

2 5:25 31:3 32:24

38:21

2.2 24:14

2.25 27:2

2.3 27:4

2.65 27:4

20 22:13

2006 9:21 29:5

2007 24:1 52:5

2008 49:11

50:18 51:24

2009 2:5

2010 35:20

203 39:22

21 45:6

21st 16:8 49:22

52:5

220 27:8 28:8

22nd 3:16

23 22:5

24 14:18 23:12

42:18

3

3 6:2 27:17

3.1 6:9

3.2 42:11

3.5 27:3

31 2:5

35 45:11

37.9 31:17

3T3 38:18 38:25

39:16

4

4 5:18 6:5 7:13

9:23 10:23 22:14

32:5

4.2 28:16

401 31:4

43317 7:10

44 27:8 27:10

48 41:5

4th 3:14

5

5 21:25 22:12

24:23

5,000 27:18

50 24:22 29:19

31:12 31:17

38:21 38:23

41:24 42:3

42:8 43:7 43:8

500 45:10

6

6.5 28:13

675 18:16 23:7

7

7.4 28:15

70 41:24

739 27:24

792 27:23
US EPA MEETING 03/31/09 CCR#16194-1 58

8

8 6:12 7:19

7:21 10:13

11:1 32:24

8(a 8:2

8(d 8:1 8:3

810 29:14

85 42:1

896 27:23

9

9:19 54:8

910 29:19

96 31:17

99 14:2

A

a.m 54:8

aberration 45:7

ability 51:1

able 38:1

abnormal 22:15

absence 22:20

23:1 41:8

acceptable

20:12 34:6 46:2

accepted 41:15

44:14

access 8:5 46:16

accurate 10:18

51:8

acetaldehyde 33:8

33:9 33:12 33:17

33:18 33:19

33:25 34:1

34:2 34:7

34:15 34:20

34:22 35:5

35:7 35:12 35:19

35:23 36:1 48:13

Acetate 33:10

achieve 19:2

acid 18:7 18:10

18:11 19:1

19:7 19:10 19:13

20:2 20:6 20:7

20:9 20:10 20:15

20:18 21:6

21:7 21:8

21:10 21:11

21:15 21:20

21:24 22:8 22:11

23:6 25:8

26:22 29:18 34:4

48:14 48:14

acids 20:8 24:18

act 5:19 10:20

50:10

action 32:12

actions 43:25

active 11:25

activities 12:5

14:7

actual 34:14

actually 2:12

14:1 14:19

acute 17:20 21:13

21:17 23:9 23:16

23:19 25:5 25:23

25:24 26:19

26:19 27:18 28:9

28:18 29:1 29:25

30:3 30:23 30:23

31:1 31:9 32:5

32:8 33:2 33:4

37:6 37:6

37:14 37:18

37:24 38:8

38:9 38:19 39:20

39:22 40:10

41:13 41:21

41:22 42:1

42:4 42:21

48:7 48:22 48:22

acutely 26:1

ADC 18:23 19:17

20:5

add 16:10 17:10

35:22 53:16

added 13:12

addition 16:19

19:16 20:17

20:17 23:7

26:2 27:2

27:20 28:14

39:15 40:11

44:16

additional 8:10

17:24 21:1 21:18

26:15 27:14

29:10 30:16 32:2

35:25 39:5 42:17

46:25

additive 30:6

30:8 33:22 39:14

Additives 30:5

address 3:5 35:20

addressed 7:12

7:17

addresses 7:14
US EPA MEETING 03/31/09 CCR#16194-1 59

30:19

addressing 12:1

17:15

adequacy 46:24

adequate 36:3

adequately 15:11

adipose 22:20

adjuvant 33:23

administration

20:2

administrative

10:20

advance 4:20

advancement 51:12

advantageous

51:11

adverse 20:1

26:24 35:9

advises 16:22

affect 51:9

affected 40:6

agencies 10:20

33:20

agency 2:1 2:13

15:8 15:18

17:5 18:10 19:11

23:13 29:23

30:21 31:6

33:7 33:14 38:15

39:8 39:18 40:22

41:12 44:12

44:24 45:17

45:22 46:10

46:15 47:1 47:15

48:9 48:17 48:20

48:25 49:3 49:12

Agency's 18:18

29:7 33:24 34:13

40:15 43:24

44:22 46:1

agent 18:12

agreed 17:5

19:5 46:15

air 24:16

al 22:17 23:5

Albemarle 28:11

28:11 29:3

29:7 31:14 31:15

31:19 31:24

31:25

ALC 27:17

ALD 27:18

algae 27:25 41:25

42:4

alkane 13:5 13:13

alkene 11:24 13:6

13:14

alkenes 13:6

allow 17:23

18:1 18:5 46:7

47:1 48:17

allowing 37:13

39:9 46:3

allows 8:1 8:3

alone 51:10

already 8:18 11:2

14:5 14:9

16:11 17:11

30:14 33:16 34:9

34:21 35:23 39:2

48:3

alternative 37:12

37:25 40:13 44:3

44:9 45:20

alternatives

5:2 48:21

am 2:14 4:21

amend 44:12

American 5:3

21:23 32:14

47:12 50:18 52:5

among 24:20

amount 50:21

amounts 8:23

analog 27:21

29:24

analogs 47:6

analyses 47:6

analysis 16:23

33:1 45:4

47:24 51:14 53:8

53:16

analytical 10:5

Andrew 11:11

11:16

anew 8:16

anhydride 27:21

anhydrides 26:22

animal 16:17

16:22 17:6 21:18

25:17 28:5

37:2 37:15

39:5 45:16 47:13

48:1 49:5

50:11 50:21 51:6
US EPA MEETING 03/31/09 CCR#16194-1 60

52:8 52:12

animals 3:21 4:18

4:25 5:16 16:3

16:11 17:19

18:16 20:25

23:21 30:15 37:4

37:8 39:7

39:23 43:11

44:11 45:11

45:14 47:22 48:5

49:21 49:23

49:24 50:24

52:14

announcing 49:13

anticipate

13:14 14:14

15:17

anticipated 29:6

anticipates 44:25

antimicrobial

18:12

AntiVivisection 5:3

anybody 53:5

a-olefins 13:22

apologize 4:20

apparently

29:16 36:9

appeal 49:3

appear 52:2

appeared 22:24

appears 18:8

34:19

applicable 24:5

42:22

application 40:22

apply 51:1 52:22

applying 38:16

42:16

appreciate 53:21

approach 10:19

16:24 33:8

38:2 38:3 39:9

40:13 40:25

approaches

17:19 18:7

37:4 37:12 38:14

47:7 47:15 47:20

51:2

appropriate

9:10 27:21

approved 20:18

Approximate 27:16

approximately

18:16 23:7 23:20

39:23 48:7

aquatic 24:15

24:24 26:15

28:16 28:24 32:9

39:21 40:8 40:20

42:1

argued 10:16

argues 27:20

argument 52:24

ARISE 4:5 49:8

49:10

art 49:14

article 51:5

Ashland 18:23

assay 38:18 38:25

39:16 51:14

51:15

assess 10:9

assessed 41:5

assessing 10:5

assessment

14:11 15:19 22:7

30:4 35:13 36:22

41:16

assessments

14:8 14:23 52:15

Associate 4:21

Association

3:22 11:7

11:17 47:12

attached 12:16

attempt 9:9

Attempts 26:6

attend 4:6

attributable 20:1

audience 53:5

authorities 15:15

authority 6:12

10:9 10:21 10:25

authors 19:21

available 6:8

17:25 20:24

28:21 28:24

30:14 33:5 34:23

35:23 37:20 38:9

40:18 40:19

44:22 46:8 46:15

46:22 47:3 48:19

49:5 53:25

avoid 8:12 49:5
US EPA MEETING 03/31/09 CCR#16194-1 61

await 28:5 39:18

aware 7:8 46:20

AWG 33:10 33:12

33:24 34:7 34:13

34:21 34:23

35:18 35:24

B

backbone 36:20

balance 4:7

base 34:22

based 6:6 9:16

9:25 10:1

16:17 28:24

29:17 30:4 37:23

38:4 39:21 42:11

bases 46:15

basic 36:7 36:16

basically 3:6

16:16

Bayer 31:12

bean 23:23

begin 17:15 18:7

beginning 37:5

behalf 4:24

behaviors 32:20

believe 5:5 13:17

believes 13:21

benefit 47:18

47:21

Berkeley 51:17

best 52:15

better 50:13 52:6

52:10 52:11

52:22 53:1

beyond 10:20

binomial 42:16

Bio/Dynamics

19:20

bioavailable

25:10

biochips 51:13

52:4 52:6

biological 32:17

biomonitoring

34:17

Biosciences 51:18

Black 30:22 39:10

blood 35:8

bluegills 23:12

25:25

body 20:13

24:23 27:3

27:4 27:5 27:9

27:11 29:14

29:15 31:4 32:22

32:25 34:6 34:20

38:22

body's 52:1

bond 13:16 13:17

bonds 24:18

bottom 13:8

break 17:12

breakdown 26:11

breaking 51:12

brief 4:15 11:15

briefly 12:6 13:5

bring 11:18

brings 53:2

broadly 24:5

brought 15:24

49:16

bubbling 24:16

build 38:13

burden 53:21

Bureau 30:25

C

C10 12:11 13:9

C-12 11:24 14:18

C-24 11:24

C30 12:11

calculated 33:3

California 51:17

CAMPANELLA 3:3

53:2 54:5

Campanella's 4:12

Canada 12:3 24:11

Cancer 33:15

capable 43:4

carbon 12:18

12:22 12:24

14:17 32:11

carbons 12:14

carcinogenicity

31:21

care 18:13 24:9

carefully 49:4

carried 42:4 42:8

CAS 14:2 14:15

14:17 14:22 15:1
US EPA MEETING 03/31/09 CCR#16194-1 62

15:2 15:9

15:12 15:19

case 9:21 10:15

18:8 25:3

26:23 30:21

cases 17:10 36:17

45:15

castor 23:15

23:21 23:22

23:23 23:25 24:2

24:5 24:7

24:14 24:15

24:16 24:22 25:1

25:7 25:9

25:10 25:16

39:10 48:14

categories

15:11 15:20 47:5

48:2

category 14:13

14:20 15:16 18:6

32:16 47:20 48:4

cause 22:9

45:20 46:18

53:10

causes 24:17

32:23

CD 22:8

ceased 29:5

cell 42:25

49:16 51:21

cells 16:18 22:20

22:22 43:3 52:2

Center 37:24 51:3

century 16:8

49:22

certain 2:2 2:9

5:20 10:23 17:3

Chaifetz 49:9

49:10

chain 12:10 12:17

12:18 12:18

12:21 13:12 14:8

14:10 14:15

14:20 20:9

Challenge 6:8

6:17 7:3 7:6 7:8

7:18 45:5

47:19 48:1

challenges

25:12 40:17

chance 17:12

changed 19:14

characteristic

6:20

characteristics

13:4 29:18

characterized

21:20 40:9 48:4

checklist 16:24

chemical 2:15

2:19 7:5 7:22

8:15 9:10

16:22 17:2

18:6 19:19 20:11

25:13 26:1

28:4 28:6 28:8

28:23 29:5

29:6 29:11 29:24

31:8 31:15 32:11

33:19 38:15 40:5

40:23 43:6 46:12

46:13 47:12

48:11 49:4 49:14

52:6

chemicals 2:9

2:21 5:9 5:20

5:23 6:1 6:14

7:14 7:25 8:7

8:20 8:23 9:15

10:7 10:9 17:9

18:19 25:20

32:17 32:22 36:4

36:9 36:12 36:14

37:8 37:11

38:1 38:3

38:16 38:21

39:12 39:20 40:1

40:21 43:11

46:17 48:2

49:2 49:21 49:25

52:23 53:18

chemical's

36:17 38:5

Chemicals 2:2 2:3

30:25 36:23

40:17

chemistry 12:7

47:13

Chip 51:14 51:15

chips 51:19

chlorinate 13:10

chlorinated

3:22 11:6

11:17 11:23 12:2

12:7 12:9

12:24 13:1 13:25

14:6 15:10

chlorination 13:2

13:18 13:21

chlorine 12:11

13:1 13:15

chlorines 12:16
US EPA MEETING 03/31/09 CCR#16194-1 63

13:11

chloro 11:24

choose 6:22 7:5

44:25

chosen 8:6

chromosomal 43:20

45:7

chronic 25:4

28:17 28:19

CI 39:10

circuit 9:22

cited 20:5 49:2

claim 10:1

claimed 46:10

clarify 15:5

class 32:11

classes 12:17

classified 43:12

classifies 26:1

classify 38:1

clear 15:3 16:25

clearly 19:11

41:19 49:23

close 53:3

closed 34:9

coagulation 41:8

coalition 37:21

coefficient 24:21

28:13

collaboration

50:25

collaborative

49:13

colleagues 51:5

collect 6:12

7:7 8:14 9:12

collection 7:7

7:21

Collins 50:3 50:5

50:11 50:17 52:8

co-manager 2:17

2:23

combined 23:17

30:1 31:9 32:6

43:16 44:7 44:15

45:2 45:13

coming 2:7 53:7

53:19

comment 3:16

5:1 16:4 44:21

45:19 45:25 46:7

46:23 46:24 47:1

48:18 53:3

comments 2:3

2:8 2:12 2:13

3:18 3:20 4:3

4:15 4:16 4:18

4:24 11:20

12:9 17:22 17:24

24:19 27:13

28:10 29:3 31:16

33:9 33:11 43:18

44:23 45:23 46:9

47:9 53:4 53:14

Commission 20:17

commissioned

34:25

commissioning

16:7

Committee 4:4

4:22

common 15:1 26:24

compact 22:19

22:24

companies 5:20

7:1 7:5 8:2

8:3 8:15 8:16

8:19 8:21 8:24

37:22 44:16 49:4

company 9:10

18:23 19:19

19:20 27:12

28:15

company's 9:3

44:10

comparable 41:6

comparing 34:16

compel 8:3

compelling 44:19

competed 15:17

completed 14:9

15:16

completely 24:8

completing 26:15

compositional

33:1

compounds 52:1

Computational

51:4

computer 34:15

concentration

27:17 27:23

32:23 42:2 42:10

42:12 43:6

concentrations
US EPA MEETING 03/31/09 CCR#16194-1 64

22:9 34:14

35:9 42:14

concept 38:13

concern 35:14

46:2

concerned 16:9

concerns 9:7

conclude 17:1

17:22 54:6

concluded 22:7

24:3 35:13 54:7

concludes 26:12

32:2 35:24

concluding 48:12

conclusion 10:1

13:19 15:7 48:9

conclusions 9:25

condensed 22:23

conduct 16:23

36:15 43:20 45:1

conducted 19:9

19:19 28:14 31:2

39:5 44:20

conducting 12:3

18:4 19:2

39:15 44:3

44:8 49:5

conference

21:23 49:13

50:16

conferred 10:21

confirm 9:18

confirmed 41:10

confusing 18:17

Congress 10:21

consequently

47:22

consider 20:23

25:19 29:23 33:7

47:5 48:10 53:10

considerable

47:21

consideration

18:24 30:13 40:9

considering

21:3 25:3

25:18 33:14

45:22

consistency 19:2

consists 9:15

consortia 28:3

constituents

32:20

constitute 10:16

consuming 47:16

49:24

consumption 30:7

contacted 3:6

contained 22:23

containing

22:25 51:20

contains 51:21

content 12:11

continued 50:6

continues 42:13

continuing 15:14

control 2:15 5:19

42:6

controlled 13:2

controls 34:9

43:8

converted 20:13

coordinated 41:11

copy 3:9 4:16

11:18 11:19

cornification

22:19

Corporation 28:11

29:4 31:14

correct 52:8

correctly 38:1

38:20

correlated 41:14

correlation 38:23

correlations

38:12

corresponding

47:18

corroborate 39:3

cosmetic 24:3

24:9

cosmetics 18:13

20:18

costly 45:1

costs 52:7

Council 33:10

37:17 47:13

Counsel 4:22

counter 24:1

court 3:7 9:22

9:24 10:4

10:10 54:4
US EPA MEETING 03/31/09 CCR#16194-1 65

courtroom 9:8 9:9

cover 14:15 15:11

covered 5:10 6:14

8:7 10:10

CPI 14:1

CPIA 11:22

11:25 15:14

CPs 15:16

created 51:15

critical 9:24

10:1 32:22 43:2

cross 50:23

crowning 52:19

crucial 6:19

cubic 27:7

culture 43:4

cultures 49:16

51:21

current 19:3 47:8

currently 8:22

39:15

cursory 17:7

cutting 52:7

cytotoxicity

38:18

D

damage 40:3 43:20

Daphnia 25:4

28:17 42:1 42:4

dark 22:23

darkness 49:20

DarT 22:4 41:1

41:3 41:14

data 5:8 5:12 6:2

6:6 6:7 6:7 6:13

6:16 6:22 6:24

7:2 7:7 7:11

7:14 7:16 7:21

8:7 8:14 8:16

8:17 8:20 8:24

8:25 9:2 9:4 9:5

9:7 9:13 9:13

9:19 10:2 10:3

10:6 10:9

10:24 11:2 15:20

15:25 17:1

17:8 17:16 17:18

17:25 19:24

19:25 21:4

22:1 23:14

24:5 24:20 25:18

27:14 28:3 28:18

28:21 28:24

29:23 31:1

32:1 32:9 33:5

34:11 34:17

34:22 34:23 35:1

35:2 35:20 35:23

36:3 37:19

38:9 38:12 38:23

39:11 41:15

41:21 42:15 46:8

46:15 46:16

46:19 46:22 47:3

48:6 48:19

49:1 49:5

50:20 51:14

database 22:5

23:11 25:24 30:5

30:9 32:21

databases 20:21

DataChip 51:14

51:20

Dataset 31:1

date 30:10 54:2

dawn 49:17

day 45:25

days 54:4 54:5

de 27:12

deal 52:13

death 37:9 40:4

decane 13:8

December 35:20

52:5

decene 13:7 13:7

decision 5:12

37:1 44:22

decisions 37:23

53:17

DECTP 28:25 29:11

29:12

defined 34:10

definition 14:18

definitive 39:16

degrades 26:7

26:13

degree 13:2

delay 45:20

deliver 52:6

delivery 54:2

demonstrates 17:9

demonstrating

20:21

dense 22:19
US EPA MEETING 03/31/09 CCR#16194-1 66

depressed 22:21

derivatives 23:15

23:21 24:2 25:16

39:11 48:14

derived 43:3

describe 6:19

17:18

design 37:7

designated 33:13

designation 46:10

desire 50:12 52:9

destroy 52:13

detail 6:19

detailed 48:24

DETDA 31:8

31:16 31:19

detected 26:17

determinations

10:6

determine 5:8 6:3

26:7

determined 26:9

43:5

determining 51:2

develop 5:12

6:5 16:7 53:11

developed 35:19

developing 35:10

development 5:2

22:21 23:4

41:7 41:18

developmental

17:21 18:3 19:10

22:2 22:4 23:9

26:21 31:10 32:7

35:1 35:2 35:3

42:24 43:2 43:13

44:6 45:12 48:23

diameter 22:25

dianhydride 26:18

39:10

dictates 12:23

die 52:3

diestrus 22:18

Diethyl 28:24

Diethyltoluenedia

mine 31:8

differ 13:22

difference 13:5

differences 32:18

32:19 50:6

different 13:3

differentiation

43:5 43:7

dilution 42:11

dimension 53:16

dimethyl-chlorothio 29:22

direct 20:16 30:6

40:7 52:25

Directive 20:18

directly 50:9

director 2:14

49:10 50:3 50:14

51:3

discriminates

38:20

discuss 49:20

discussed 6:18

9:22 32:14

discussing 52:10

discussion 2:17

disperses 24:8

disruption 32:17

dissolves 26:5

26:14

distinction 13:13

distribute 8:22

distribution

18:23 19:24

distributors 7:23

11:2

diverse 47:11

Division 2:15

2:20

docket 3:10

3:10 53:24

document 40:15

done 9:3 11:3

13:24 14:14

15:10

dose 18:3 23:17

26:20 27:6 27:10

30:1 31:10 31:10

31:20 32:6 37:20

38:6 43:17

44:6 44:18 45:12

doses 27:8

29:13 49:21

dossier 35:18

double 13:16

13:17 24:18

doubled 22:16
US EPA MEETING 03/31/09 CCR#16194-1 67

Dr 2:6 2:16

2:18 2:22 3:1

3:3 3:12 11:5

11:13 15:24 49:7

50:2 50:5

50:11 50:17 52:8

53:2 54:5

Draft 29:12

drag 49:20

dropped 15:9

18:19

drug 19:9 52:6

Due 35:6

duplicating 28:4

duplication 5:14

duplicative 23:14

49:5

Dupont 27:12

27:20 28:1

during 3:16 46:22

Dyno 26:2 26:12

26:16

E

earlier 48:24

Eastman 19:19

EC 42:3

echoed 50:17

ecological 40:3

economic 40:3

Economics 2:19

ECOSAR 31:16

40:19 48:6

ECOTOX 23:11

25:23

ecotoxicity 36:16

ECVAM 37:24 39:15

43:1

edema 26:25

effect 27:11 35:9

effective 38:6

effects 5:9 6:4

9:11 20:1

22:10 23:3

25:1 26:24 27:22

35:4 35:14 36:16

efficiency 46:2

effluent 41:17

effort 39:19

40:23 49:13

efforts 7:12 14:5

38:17

eggs 41:2 41:3

41:8

eighteen 12:20

eighty 14:19

either 37:12

elements 2:21

elevated 24:16

eliminate 13:12

elsewhere 6:18

46:14

email 3:5

embryonic 42:25

embryos 23:5

35:10

embryotoxic 23:6

embryotoxicity

27:7 43:1

embryoxtoxicity

43:5 43:12

empowers 7:22

enable 50:20

encourage 43:24

encouraged 43:21

encourages 8:9

endogenously 34:2

endpoint 28:16

43:2 48:7

endpoints 2:9

15:12 17:3

22:2 25:14 30:20

32:3 36:11 36:13

41:6 48:12

engineer 2:19

entered 53:24

entire 24:5

entirely 9:16

entities 43:25

entitled 40:15

enumerated 16:20

environment 52:16

environmental 2:1

6:3 12:1 12:5

14:11 26:17

34:15 34:19 36:8

36:18 41:12

49:12 50:15

51:23

Enzyme 51:13

enzymes 51:20

EPA 2:10 3:2

5:5 5:7 5:11

5:19 5:21 6:6
US EPA MEETING 03/31/09 CCR#16194-1 68

6:11 6:15 7:7

7:10 7:14 7:20

7:22 8:1 8:3 8:6

8:9 8:14 9:13

9:19 9:24 9:25

10:8 10:11 10:12

10:15 10:22

10:24 11:3

12:3 13:19 13:21

15:21 16:3

16:6 16:12 16:19

19:5 20:22

21:5 25:18

28:5 28:12 29:21

30:12 31:14

31:24 33:21 44:2

44:8 49:19 51:4

EPA's 5:12 6:10

9:14 29:12 35:20

36:1

era 49:17

especially 18:9

essence 46:12

essentially 11:21

13:2 13:6 13:12

EST 42:25 43:12

established 10:19

33:6

establishing 28:6

esters 29:18

estimate 40:19

estimated 24:21

31:17

estimates 33:4

et 22:16 23:5

ethical 3:21 4:18

4:25 16:2 52:8

ethics 52:19

ethylene 21:22

23:4

EU 15:1

Europe 14:6

European 20:17

30:25 37:22

37:24

evaluate 7:24

49:1 49:4

evaluated 24:6

34:13

evaluating 33:16

evaluation

19:21 46:7

event 29:10

everybody 11:7

everyone 2:7 3:4

evidence 19:6

19:8 21:4

25:18 39:4 48:15

exact 16:16

exactly 2:12

example 9:2 13:11

36:10 37:16

examples 38:14

exceeds 26:11

Excellence 35:12

excluded 47:8

exemption 44:20

exist 37:12 39:11

40:12

existence 22:17

existing 5:7

6:2 7:2 7:7

8:4 8:17 9:12

9:19 10:3

10:24 11:2

17:8 17:16 17:25

21:4 23:13 25:18

29:23 32:21 36:2

37:13 46:7 46:16

46:19 47:2 48:19

49:1

exists 29:11

exogenous 34:3

expansion 13:20

expectations 39:4

expected 28:23

32:10 39:17

expects 25:1 28:2

expenditure 5:15

expense 9:3

expensive 49:23

51:7 52:12

experience 17:3

17:8 21:9

25:15 48:11

experimentation

49:17 50:22

experiments 26:10

expert 24:3 35:11

explained 8:5

32:19

explosive 25:22

exposed 27:10

37:8 38:7

exposing 49:21

exposure 2:19
US EPA MEETING 03/31/09 CCR#16194-1 69

2:20 5:9 6:1

19:1 26:23

29:8 31:21

32:1 33:24

34:7 34:14 34:18

35:4 35:7

35:15 35:15 38:4

41:5 42:18

expressed 4:10

16:13

expressing 51:5

expression 52:25

extensive 20:20

24:1 26:23 33:11

extensively 21:21

extent 6:23

extrapolation

50:23

extreme 37:7

extremely 21:19

extremes 38:24

39:2

Exxon 28:22

F

fact 18:5 18:17

33:19 46:4

factor 42:11

factors 9:22

factual 10:17

fail 7:7 52:11

failed 9:12

26:8 48:10

fall 11:21 32:10

familiar 48:13

fatal 22:1

fate 36:8 36:18

fathead 25:25

28:20

fatty 18:11

20:7 20:9

24:18 25:8

favor 37:19

favorably 13:16

FDA 20:15 23:25

30:18 39:15

FDA's 30:4

February 49:11

50:18

federal 3:24 9:22

feedstock 12:23

feedstocks 12:25

feel 15:9

female 31:22

fertility 19:22

22:7

fertilized 41:2

fetus 35:14

fill 7:16

filled 28:17

final 2:25 3:11

8:13 13:4

14:13 15:16

15:19 18:20

19:11 19:13 28:7

44:4 44:9

44:22 45:25

53:11

finalizing 39:19

Finally 48:25

finding 6:7

6:15 9:13 9:14

9:17 19:5

findings 5:6 5:13

5:22 9:23

10:12 10:14

10:17 10:23

10:25 29:7 33:25

34:13

finish 14:12

finished 12:24

13:4 14:11 14:21

first 5:7 5:13

8:21 9:23 10:2

10:23 10:25

16:15 16:20

18:18 18:22 26:3

33:12 39:1 44:24

45:24 46:9 47:10

fish 17:20

21:13 21:17 23:9

23:10 23:19 25:5

25:23 26:19

27:23 28:9

29:1 30:3

30:23 31:2

31:9 31:17

32:8 32:21 32:25

38:7 38:9

39:22 39:24 40:1

40:3 40:6 40:6

40:7 40:10 40:12

40:14 40:25 41:3

41:16 41:20

41:21 41:22

41:24 41:25 42:5

42:20 42:21 48:6

48:22
US EPA MEETING 03/31/09 CCR#16194-1 70

five 13:11

14:19 36:11

36:13 42:5 42:19

45:24

flavor 33:22

flawed 44:10

flaws 51:6

focused 10:10

follicular 22:21

food 19:9 20:17

23:24 30:5

30:6 30:7 30:8

39:14 40:5

foods 18:13 21:21

former 11:4 50:14

forms 22:16

forward 52:18

53:11

forwarded 31:24

Foundation 5:3

38:11

fourteen 12:19

fourth 9:14

Francis 50:2

Franklin 2:18

free 9:4

frontiers 52:18

fulfill 48:6

fully 30:10

function 32:18

future 29:6

G

Gabardella 2:22

2:22

gaps 7:17

Gasoline 32:15

gastrulation 41:7

gather 8:7 10:9

gathering 10:5

general 4:22

10:16 10:17

17:22 36:5

40:1 43:18

generally 12:10

20:15 20:20 40:9

44:25

generate 50:20

generation

19:18 51:2

generations 20:3

genetic 18:2

43:16 43:21

44:14 44:17

Genome 50:3

German 41:11

germane 12:8

14:22

Germany 41:15

given 17:1

18:24 24:25 25:7

25:15 27:8 30:13

33:1

gives 51:1

glass 51:19

gluco 29:24

glucoheptonate

39:14

glucopheptonate

30:6

glycol 21:22 23:4

goal 16:13 36:2

36:24

goldfish 31:13

Goldman 22:16

gonad 27:11

Governmental

21:23

grams 21:25 24:23

27:3 27:4 27:5

31:3 38:21

GRAS 20:16

20:20 21:2

21:4 23:25 30:12

33:22

grasp 52:22

grater 28:13

great 52:13

greater 24:23

28:16 31:3

32:5 38:21 42:9

greatly 40:13

gross 19:24

grossly 48:15

ground 51:12

group 2:3 24:6

33:10

grouped 12:17

groups 36:12 42:6

growing 52:2

growth 43:8

guarantee 6:25
US EPA MEETING 03/31/09 CCR#16194-1 71

guidance 16:21

40:15

guideline 39:22

41:18

guidelines 6:9

19:3 20:10

34:5 34:11 37:19

guinea 27:5 29:14

H

hack 11:8

Hall 2:18 2:18

handling 32:1

handout 17:18

19:5

handouts 15:25

hard 3:9

hardly 46:1

harmful 28:23

49:25

Harmonization

37:17

hatch 41:3

having 15:22 21:7

hazard 29:11

41:21 52:15

headline 52:4

health 6:3 8:4

12:1 12:4

24:11 24:12

26:24 36:15

49:11 50:15

51:23 52:15

hear 53:14

heard 53:7

hearing 15:22

heartbeat 41:8

heights 52:19

held 49:12

help 7:16

heptonate 29:25

hexanoic 20:10

high 2:2 2:9 2:23

16:18 35:8 40:16

50:19

higher 34:3

highly 25:22

history 21:3

23:22

hope 46:17

hour 31:17 41:5

hours 42:18

house 27:14 46:18

HPV 3:13 6:8 6:10

6:17 7:3 7:6 7:8

7:17 7:24 10:6

13:25 15:18 16:4

16:12 16:21

16:22 18:19

38:16 40:21 45:5

47:19 48:1 52:23

human 5:25

16:18 17:3

17:8 24:12 25:15

26:23 29:8

30:7 34:1

34:14 34:17

48:11 49:16 50:3

51:20 52:15

humans 9:6 20:5

50:1 50:21 50:24

51:9

hundred 16:11

hydrocarbon

12:7 12:23 12:25

hydrocarbons

12:10 32:4 32:13

33:2 33:4 33:6

hydrophobic 32:22

Hygienists 21:24

I

IARC 33:15 33:21

ICCA 31:15

I'd 2:10 3:4 4:11

16:3 18:7 33:8

37:3 43:15

idea 54:3

ideal 40:22

identical 11:20

identified

15:12 31:23

identifies 40:19

ignored 16:12

16:19 48:16

ignoring 16:19

II 3:14

I'll 17:14

17:14 17:18

17:22

I'm 2:17 2:19

2:22 3:1 8:2

11:9 11:14 11:16

11:18 12:6

14:3 16:2

17:13 36:5 49:10
US EPA MEETING 03/31/09 CCR#16194-1 72

54:1

immature 22:25

immediate 39:6

41:19 43:9

immune 26:25

imperative 21:5

improper 5:4

Inc 19:20 51:18

incentive 8:23

incentives 8:25

include 7:4

15:2 27:15

41:7 49:15

included 3:10

11:24 17:9 18:18

18:21 19:4 19:15

27:13 28:10 49:2

includes 28:18

30:9 31:25

including 11:23

12:2 17:2

23:11 31:16

31:20 33:21

35:13 47:11

48:11

inclusion 3:9

18:6 45:19

47:9 48:13

incomplete 41:7

incomprehensible

21:18

inconceivable

25:17

inconsistent 36:1

incorporate

17:6 53:13

Incorporated

24:20 26:2

increase 5:16

36:25

incubated 51:25

indefinitely 43:4

indicate 20:1

35:3 38:20

indicated 18:25

22:17 25:5 32:3

indicates 30:10

indicating 39:12

indication

18:20 52:3

indicator 51:8

indices 19:22

indirect 30:8

individual

32:20 45:11

individually

17:16

individuals 4:6

industrial

21:24 34:8 36:22

industries 23:24

Industry 3:22

11:7 11:17

inefficient 51:7

inflicts 37:7

information

6:10 7:4 7:24

15:4 17:11 20:24

21:1 29:12 30:11

30:13 30:16

30:19 35:22 36:7

36:17 36:24

36:25 37:13

Ingredient 24:3

ingredients 24:4

inhalation 27:6

27:15 35:4

35:7 35:15

38:4 38:8

inherent 51:6

inhibit 43:7

inhibition 43:8

in-house 47:2

48:18

initiation 45:21

initiative 36:21

instead 8:9

18:5 25:5 44:1

44:7

Institute 50:4

50:15 51:16

51:23

Institutes 49:11

Institute's 32:15

insufficiency 6:7

6:16 9:14 9:17

10:2

insufficient

5:8 6:2

Integration 36:23

intelligent 36:20

intended 40:2

intense 21:9

intensive 45:1
US EPA MEETING 03/31/09 CCR#16194-1 73

47:16

intent 7:15

intention 3:7 3:8

interest 4:11

interested 3:17

6:23

interesting 53:7

Interestingly

10:15

intermediate

34:10

internal 32:23

internally 22:1

international

7:12 12:4

20:10 33:14

33:15 37:17

38:11 41:10

internationally

44:13

interpolation

42:16

interpreted 9:5

interstitial

22:19

introducing 2:10

invalid 9:17

invertebrates

27:24 40:8

investigate 30:21

investigation

29:17

invite 4:17

involvement 45:16

involving 20:25

30:15

Ionox 28:8

IPCS 33:16

33:21 34:5

irritation 27:1

35:6 35:17

issuance 5:4

issue 5:13 5:19

8:20 10:22

issued 16:21

issues 12:1

issuing 16:8

it's 3:6 11:8

12:8 12:12

52:3 53:14

IUCLID 30:25

35:18

IUR 29:5

I've 14:20 21:8

53:7

J

Jaques 11:11

11:13 11:16

Jersey 4:5 49:8

Jim 2:14 11:19

John 2:16

Johnson 9:21

10:15

joined 51:5

joint 50:10

jointly 5:1

Joseph 16:1

July 3:14 3:14

justification

26:14 44:19

justifications

18:2

justify 46:3

K

Kavlock 51:3

Kennedy 4:20 4:21

kidney 21:8

kill 18:16

23:10 23:20

39:23

killed 16:12

17:20 23:8

37:5 40:14 41:24

43:11 47:22

kilogram 24:23

27:3 27:4 27:5

27:19 29:20 31:4

32:24 38:22

Klug 23:5

knowledge 26:18

52:18

known 6:13 17:2

17:11 24:7

28:8 32:13 36:17

48:10

Kow 25:3

Kukatov 29:19

L

labeled 33:22

labels 20:19

laboratory 41:11
US EPA MEETING 03/31/09 CCR#16194-1 74

Labs 19:9

lack 20:21 24:25

lacking 36:9

large 8:22 40:4

49:24

last 3:14 3:14

11:21 16:9 37:16

50:5

later 7:15 11:9

39:17

latter 11:3

laudable 16:13

laughter 21:11

laxative 24:1

LC 31:12 31:17

42:8

LC50 23:12

24:13 31:4 42:14

LCCPs 15:20

LD 24:22 29:19

38:21 38:23

LD50 27:2 31:3

lead 16:6 43:18

least 30:19 39:11

45:16

leave 4:15 11:19

led 14:6

length 6:18

less 25:9 34:19

41:25 45:1 45:1

lethal 27:6 27:16

29:13 49:21

lethality 41:6

42:18

letter 20:22

Leuco 30:22 39:10

level 18:25 35:25

41:21 43:10

levels 20:19 34:2

34:16

liability 9:7

Library 22:3

life 52:24

likely 23:10

30:18 34:2 35:14

35:16 39:13 48:4

Likewise 45:11

48:6

limit 26:6

limited 6:23

20:12 34:5

34:8 35:16

limits 26:9

linoleic 20:8

list 11:6 11:11

49:7

listed 21:11

21:15 23:16

24:11 25:22

26:18 28:9 28:25

29:25 30:22 31:8

32:5

lists 20:15 23:25

29:13 30:5 31:14

liter 27:23 27:24

27:25 31:5 31:18

litter 19:22

22:12

litters 22:11

little 8:15 17:12

21:25

live 22:12

lives 45:10 45:14

48:5 52:14

living 41:2

LL50 33:4

loading 11:14

located 17:17

log 24:21 25:3

28:13

logical 26:14

long 12:18

12:21 14:10

14:14 14:19

23:22

loss 40:3

lost 16:15

lot 17:14 53:9

53:12

low 18:25 26:6

lower 42:13

lowest 27:6 42:3

lubricants 24:10

luteal 22:22

M

main 12:8

majority 38:1

male 31:22

mammalian 17:20

23:16 25:6 25:13

26:19 29:25

30:23 32:5
US EPA MEETING 03/31/09 CCR#16194-1 75

37:5 37:10

38:8 38:23 48:22

mammals 20:9 31:2

38:7

mandate 8:2 44:13

manufacture 5:21

manufacturers

6:13 7:22 11:1

38:15 46:18

47:12

Manuppello

15:24 16:2 53:9

March 2:5 3:25

51:24

Mark 4:21

mass 4:7 14:18

material 13:14

25:10

materials 14:13

MaterialScience

31:12

maternal 35:8

mating 19:22

maximize 36:2

may 4:7 5:25 7:12

8:19 8:24 9:3

17:1 28:21

33:3 34:9 40:18

maybe 14:24

MCCPs 15:20

mean 24:13 53:15

measures 8:12

mechanism 32:16

medaka 24:14

median 29:13

Medicine 4:4 4:23

Medicine's 22:3

medium 12:18

12:20 14:8 14:14

meeting 3:12 3:23

3:25 4:6 53:24

54:7

member 12:3 15:15

members 48:4

membrane 32:17

membranes 27:1

35:7

mention 15:2

mentioned 33:16

merely 19:2

metabolite

21:22 34:1

metabolites 20:14

23:4 34:7

metabolized 20:8

Metabolizing

51:13

MetaChip 51:13

51:20

meter 27:7

method 16:18 41:4

42:16 43:9

44:2 51:11

methods 37:13

37:15 37:25

40:12 44:1

46:4 46:11

mg 24:14

mg/kg 27:9

27:11 29:14

29:15

mg/l 23:12

27:17 31:13

mice 22:8 27:5

29:20

milestone 51:1

milligrams 27:7

27:19 27:23

27:24 27:25

29:19 31:5 31:17

millimolar 23:6

millimole 32:24

mimic 51:25

minimize 36:3

37:2

minimum 28:4

39:18

minnows 25:25

28:20

mitoses 23:2

mixture 32:9 33:2

33:8

Mobil 28:22

mode 32:12

model 38:13 40:18

40:19

modeling 34:16

moment 52:19

money 52:24

monitoring 34:15

Monsanto 19:20

morbidity 42:19
US EPA MEETING 03/31/09 CCR#16194-1 76

Moreover 9:14

morning 2:6 49:9

morphology 27:11

mortality 32:24

motor 28:22

Moving 21:7

36:4 39:20

MSDS 28:22 31:12

mucous 27:1 35:6

multi 41:10

multigeneration 19:6

multi-phase 47:17

multiple 31:20

N

narcosis 32:13

narrow 32:10

National 22:3

22:6 49:11

50:3 50:15

51:3 51:22

natural 23:22

naturally 18:11

20:7 21:20

26:8 34:20

nearly 22:14

47:25

necessarily 12:15

necessary 3:9

5:12 6:5 7:23

8:12 9:15 9:20

10:6

needless 5:15

neither 10:17

31:22

Nemours 27:12

neutral 32:12

32:22 38:18

Nevertheless 4:14

News 51:23

NIH 50:15

NIH/EPA 50:4

50:10 50:16

51:10

nixing 52:7

Nobel 26:2

26:12 26:16

nominated 41:17

non 37:15

non-animal 41:4

non-polar 32:13

Non-Test 36:23

non-testing 36:25

nontoxic 25:11

39:12

non-toxic 38:20

nor 10:18 31:22

normal 20:9 20:13

34:1 34:6

Notably 47:7

note 29:11

31:11 36:7 42:24

noted 9:24

22:22 30:11 34:4

44:24

notes 16:15 24:24

26:16 28:11

29:21 31:19

33:12 34:7 35:18

40:17

notice 3:25 4:5

6:6 6:18 7:10

8:5 9:16

Noting 18:1

NRC 16:7

NRU 38:18 38:25

39:16

NTP 22:10 25:12

nuclei 22:23

numerous 22:2

33:20

O

observation 19:25

36:5 38:5 40:1

observes 21:25

25:7 33:24 34:21

obtained 17:17

19:17 21:1 23:23

30:16 37:14

42:15 42:17

obtaining 37:19

occupational

31:25

occur 24:18

occurring 18:11

20:7 26:8

occurs 13:18

21:20

octanol 24:20

28:12

October 3:15
US EPA MEETING 03/31/09 CCR#16194-1 77

ocular 35:16

OECD 6:9 12:3

14:1 14:7 14:9

14:13 15:3 15:11

15:15 41:18

OECD/SIDS 34:10

OECD's 39:21

offer 2:7

Office 29:13

offspring 19:23

19:23 19:25

oil 23:16 23:21

23:22 23:23

23:25 24:2

24:5 24:7 24:8

24:14 24:15

24:16 24:22 25:1

25:7 25:9

25:10 25:16

28:15 28:18

28:22 39:11

48:14

okay 11:7 54:6

oleic 20:8

ones 38:22

53:15 53:15

onto 13:12

opinion 19:14

opportunities

48:3

opportunity

3:17 16:4

17:24 44:11

44:21 45:19 46:6

47:5 48:21 53:20

oppose 5:4

opposite 10:19

Optimized 36:22

oral 2:3 3:17

3:20 4:3 27:2

27:8 27:10 27:18

35:4 53:15

order 4:10 45:18

organ 35:4

organic 32:12

47:11

organisms 28:24

organizations

45:17 47:11

47:14

organized 28:3

organs 31:23

original 14:3

14:3

originally

33:13 45:7

orphan 33:19

OSIRIS 36:21

outline 37:3

outlined 6:9

ovarian 22:19

overcome 7:20

oversight 19:16

oxalic 21:7

21:8 21:10 21:11

21:15 21:20

21:24 22:8 22:11

23:6 48:14

oxidation 25:7

oxidative 24:17

oxidized 23:15

24:15 24:22 25:1

25:9

P

PAFA 30:5 30:9

page 7:10 7:15

16:15

pair 22:11

panel 24:3 35:11

paraffin 12:24

13:1

paraffins 3:22

11:6 11:17 11:23

12:2 12:9

13:21 13:25 14:6

15:10

paragraphs 9:16

participants 6:21

16:21 16:25

20:23

participate 7:5

participating 7:1

participation

6:22

particular

13:11 14:2 14:20

14:25 46:16

particularly

14:22 39:1 39:9

parties 3:17

partition 24:21

28:12

partitioning

32:20

parturition 19:23
US EPA MEETING 03/31/09 CCR#16194-1 78

passed 21:8

past 8:22

patience 11:13

Paul 2:22 4:12

pause 4:19

15:23 21:10

PCRM 4:23 4:25

5:2 9:21

Pentaerythritol 25:21

People 3:21

4:17 4:25 16:2

per 22:11 22:12

24:23 27:3

27:4 27:5 27:7

27:19 27:23

27:24 27:25

29:19 31:4

31:5 31:17 32:24

38:22

perceived 41:22

42:22

percent 12:12

14:19 20:20

22:10 22:12

22:13 22:14

41:24 42:2

43:7 43:8 45:6

45:11 48:7

percentage 22:15

performed 42:10

period 3:15

3:16 46:1

46:23 53:3

permitted 30:7

39:14

persistent 22:18

person 44:1 44:5

personal 18:13

21:9 24:9

persons 43:19

perusal 53:25

PETA 5:2

PETN 25:21 26:5

26:7 26:9

26:13 26:16

Petroleum 32:15

pharmaceutical

37:22

pharmaceuticals

23:24

phone 3:5

phosphate 29:22

phosphorochloro-thioate

28:25

physical/chemical

36:8 36:11 36:18

physically 13:23

Physicians 4:4

4:22

pigs 27:6 29:14

pioneering 49:15

plan 4:6 16:9

16:14 32:15

46:13 47:3 48:19

plans 45:5 45:9

45:18 46:6 47:25

48:8

plants 40:8

PMDA 27:22 28:1

point 4:12 12:8

37:3 50:10

points 53:9 53:13

poison 21:25

poisoned 37:9

polymerization

24:17

polymerized 25:8

Polytechnic 51:16

populations 40:6

positive 43:11

possessed 7:4

possession 7:2

8:18 11:3

possibility 21:13

possible 9:11

29:24

possibly 21:17

23:18 28:9

30:2 30:23 32:8

postmortem 19:25

potential 9:6

40:2

power 10:20

powers 8:6

precise 50:24

preclude 36:19

predict 5:9 6:3

40:2 49:25

predicted 38:9

predictions

39:3 41:13
US EPA MEETING 03/31/09 CCR#16194-1 79

predominant 14:18

pregnancy 19:22

preliminary 38:12

39:4 39:11

prepare 15:18

preregistered

28:2

present 3:17

17:16 52:3 53:21

presentation

11:10

presented 33:25

preservative

18:12 20:16

press 49:12 50:16

52:17

pressure 38:6

previous 26:9

previously

19:17 20:5 28:12

30:11 31:24 34:4

primarily 14:6

primary 48:15

primates 50:9

principle 16:20

48:15

principles

16:22 17:6

prior 9:17 18:4

40:9 44:20 44:22

Priority 30:4

probable 43:13

probably 11:14

54:1

problematic 24:25

procedural 47:16

procedure 7:20

10:13

procedures

10:11 47:9 49:15

proceed 20:24

30:14

proceeding 4:19

15:23

process 10:5

14:12 14:21

processors 6:13

7:23 11:1

produce 8:3

8:24 8:25 13:1

13:3 52:15

produced 5:23

24:16 34:2 34:20

producer 11:23

producers 11:22

producing 53:23

product 12:25

13:4 25:9 34:16

production 2:2

2:9 2:23 29:4

29:6 29:8

29:10 40:17

products 12:17

13:22 18:13

24:10 31:3

Profile 29:12

program 6:8

6:17 6:20 6:21

7:1 7:4 7:6

7:9 7:18 14:4

14:8 15:19 16:12

16:21 22:6 33:14

40:17 45:5 47:20

48:1 49:10

Programme 20:11

programs 7:7 7:21

14:1

project 2:24

prolonged 22:18

promise 52:6

properties 36:8

36:18

proposal 18:21

47:8 48:20

propose 15:7

proposed 2:3

2:8 2:24 3:13

3:15 5:4 5:10

6:6 6:14 7:13

8:7 10:10 15:6

15:8 18:14 18:19

21:6 36:7

37:10 37:17

39:24 43:19

44:13 44:24 45:7

45:24 46:11

46:22 47:4

48:2 49:3

proposing 44:16

proprietary 9:3

protection 2:1

41:12 45:17

47:13 49:12

protocol 44:7

44:15 45:13

proved 22:1
US EPA MEETING 03/31/09 CCR#16194-1 80

provide 4:18 6:22

7:23 8:17 11:2

33:3 45:18 46:16

47:4

provided 3:16 7:1

8:19 34:24

provides 7:19

providing 2:11

2:12 4:15 9:7

41:20

public 3:10

3:23 17:24 44:21

45:19 45:23

45:25 46:6 46:23

46:23 47:1 48:17

53:24 54:7

publication

3:13 45:18 46:5

publicly 46:8

46:15

publish 45:25

published 3:24

pull 11:10

pulmonary 26:25

pups 22:12 22:14

pure 26:10

purpose 46:21

pushing 52:18

pyromellitic

26:18 39:9

Q

QSAR 38:11

38:13 40:18

40:22

QSARS 33:3

qualitative 16:23

quantities 5:24

quite 49:23

quote 7:11 7:16

8:9 8:10 8:11

8:13 9:24 9:25

10:5 10:7

10:11 10:12

49:23 50:6

50:9 50:12 50:19

51:24 52:4

52:5 52:10

quote,:"that 51:7

quoted 50:17 51:4

R

race 52:20

range 12:10 12:22

12:24 14:17

20:12 32:10 34:6

ranges 12:18

ranging 29:14

rapidly 26:13

rat 22:16 23:5

rate 26:7 26:12

rather 16:24 28:4

52:23

rationale 44:3

44:8 44:10

rats 19:18 23:8

24:23 27:4

27:7 27:8

27:10 27:17

27:19 29:15 31:4

50:8

reach 26:6 26:8

28:2 35:19 37:1

reacted 12:25

reaction 13:3

reactions 52:1

read-across 48:3

ready 54:3

really 3:13 12:23

15:7

reason 46:2 46:5

reasonably 5:8

reasons 8:5

8:19 14:25 45:3

recall 4:11

received 3:19

47:10

recent 38:17

recently 21:7

recognize 33:25

recognized

20:16 25:11

33:18

recommendations

32:1

recommended 30:12

recommends 20:22

reconsider 21:5

31:7 39:8 48:21

red 24:8 38:18

reduce 40:13

41:23 43:10

50:21

reduced 22:11

22:13 22:14

reducing 17:19
US EPA MEETING 03/31/09 CCR#16194-1 81

37:4 47:21

reduction 39:6

reevaluated 29:9

reference 41:14

references 16:1

17:17 19:4

refine 37:12

refinement 42:17

regard 25:6 30:12

42:24

regarding 6:13

6:15 9:17 10:2

10:24 18:22

regardless 32:11

regards 21:24

Register 3:25

regulated 43:25

REGULATION 2:4

regulatory

33:20 34:8

37:1 37:22

related 12:2

Relationship

40:16

relative 43:8

relatively 26:6

release 2:21

46:18

relevance 20:5

41:9

relevant 8:10

8:20 17:16

21:2 30:17 50:20

reliability 41:9

reluctance 9:4

remain 7:11

remaining 13:17

removing 37:18

Rensselaer 51:16

repeated 18:3

23:17 26:20 30:1

31:10 31:10

31:20 32:6 37:20

43:16 44:6 44:17

45:11

replace 37:14

40:12

replaced 45:8

45:13

replacement 38:19

41:2 41:16 41:20

42:21 50:11

report 16:8 19:17

24:15 28:18

29:12 29:21 31:3

37:21 44:4

reported 19:21

22:10 22:17 23:5

25:11 26:24 27:3

28:12 37:25 42:8

51:22

Reporter 3:7 54:4

reporting 6:11

8:2 23:12

25:24 27:16

27:18

reports 7:24

8:4 24:13 26:4

27:22 28:15 29:4

29:19 31:12 44:9

represent 38:6

represents 11:22

reproduction 18:3

19:1 19:6

19:18 22:7 26:21

32:7 44:6 45:12

reproduction/

developmental

18:15 19:12

21:12 21:16

23:18 29:2

30:2 31:11 35:21

43:17 44:18

reproductive 19:7

22:2 22:4 22:8

23:8 31:22

32:2 34:11

35:1 35:2 35:3

requests 3:20

3:20 4:3

require 2:8

5:19 7:22 8:16

8:17 11:1

18:10 18:14

35:25 36:10

47:16

required 5:6 9:22

17:10 21:19

25:17 34:12 36:6

36:13 37:11

39:25 41:22 43:6

43:20 44:2

44:8 44:19 46:12

47:21

requirement 18:18

19:15 21:4 25:19

37:18

requirements
US EPA MEETING 03/31/09 CCR#16194-1 82

17:15 21:6

28:6 31:7

35:21 39:20

43:24

requiring 5:19

19:12 21:11

21:16 23:14

23:16 24:11

25:22 26:19 28:9

29:1 29:25 30:22

31:9 32:5

research 5:2 12:4

19:9 33:15 50:4

researchers 50:20

51:16

residue 32:23

resource 45:1

resources 5:15

respectively 38:7

respiratory 35:16

respond 45:23

response 3:19 4:2

44:23 46:9 46:14

47:10

Responsible 4:4

4:23

restrictions

20:19

result 5:14 13:22

19:16 24:9 26:12

29:7 35:8 35:9

38:8 39:6 40:7

48:20

resulted 45:15

47:20

resulting 40:3

results 18:24

20:4 22:5

23:11 25:8

26:3 26:4

27:15 28:5 37:23

39:17 39:19

46:19 47:2 48:18

retrospective

45:4 47:24

returned 22:5

returns 23:11

25:24

review 17:7

20:6 23:13

24:2 24:3 31:6

34:25 35:11

reviewed 9:18

10:3 33:20 34:23

revised 45:8

revisions 45:15

revisit 53:12

risk 14:11

18:25 28:4 35:12

36:22

Robert 51:3

robotics 49:16

robust 34:24

rodent 43:3

rote 16:24

roughly 42:1

route 38:4

routes 31:21

rule 2:8 2:23

2:24 3:14 3:15

5:5 5:10 5:13

5:19 6:14 7:13

8:8 8:13 10:10

10:22 11:25

13:20 14:2

14:3 14:16 14:25

16:5 16:10

17:9 17:23 18:14

18:19 18:20

18:22 19:11

19:13 21:7

26:4 28:7

30:20 36:7 36:10

37:10 39:24

43:19 43:19

43:23 44:13

44:24 45:24

45:25 46:10

46:11 46:17

46:22 47:4 47:10

49:3 53:11

rulemaking 3:11

6:6 7:16 47:17

rules 17:7

49:19 52:10

rulings 7:13

S

safe 20:16

23:22 24:4

safely 18:11

safety 8:4 12:1

20:11 24:2

24:4 49:18

salmon 31:5

sample 26:17

samples 26:8

Samuel 50:14

Sandoz 31:2
US EPA MEETING 03/31/09 CCR#16194-1 83

sandwiched 51:25

SAR 18:6 47:6

47:20

saturation 25:2

saved 45:10 45:14

scale 40:4

science 9:25 10:1

52:17

Sciences 50:16

51:23

scientific 10:3

10:18 45:3 49:17

50:18 52:5 52:9

scientifically

36:2

screen 23:9 23:18

26:21 30:2 31:10

31:11 32:7

screening 18:15

19:13 21:12

21:17 35:22

35:25 40:21

41:21 43:10

44:14

search 22:3 23:10

25:23

second 2:3 16:4

18:21 42:10

secondary 30:6

section 5:18

6:9 6:12 7:13

7:19 7:21 8:1

8:3 9:23 10:13

10:23 11:1

seeing 2:24

seeking 51:10

seems 10:18 21:18

30:18 43:23 46:1

sell 8:22

selling 9:10

semilogarithmic

42:12

seminiferous

22:24

sense 8:15

senseless 36:15

sensitive 25:22

41:25

sensitization

26:25

separate 18:3

44:5 44:17

series 42:12

serious 42:19

seriously 53:10

Sertolicells 23:1

setting 9:9

seven 37:11

54:4 54:5

seventeen 12:20

seventy 12:12

several 17:19

31:21 34:24

47:13

sex 19:24

Shaffer 2:16 2:16

share 9:4 23:21

28:3

sharing 6:24

sheet 3:4

Shell 28:14 28:18

shifted 14:7

short 12:17 12:19

14:8 20:9 32:16

shortcomings

7:8 7:20

showing 9:6 38:12

shown 4:8

shows 38:22

shrunken 22:23

sic 24:13 25:19

34:16

sick 52:2

SIDS 14:1 14:7

14:9 14:13

15:3 15:11 15:16

SIEF 28:2 28:6

sign 3:3

signed 3:4

significant

8:18 9:7 34:21

35:3 45:20 46:1

significantly 9:5

13:23 34:19

36:24

silico 40:11

similar 20:4 20:7

20:9 44:23

similarities

29:22

Similarly 44:5

simplest 13:8

simply 8:17
US EPA MEETING 03/31/09 CCR#16194-1 84

six 4:5 12:15

skin 27:1

slides 11:14

11:19 15:25 36:5

51:19 51:24

slowly 26:5

small 22:20 22:25

smears 22:17

Society 5:3

sodium 29:24 30:5

39:13

softeners 24:10

sole 11:23

solely 6:7

Solidus 51:17

solubility

24:25 26:4

26:6 26:9

26:12 38:5

somatic 22:10

somewhere 11:12

12:15

somite 41:7

sorbic 18:7 18:10

19:1 19:7

19:10 19:13 20:1

20:6 20:15 20:18

21:6 34:4 48:14

sorry 8:2 11:14

14:3

sort 50:19 53:21

sought 30:11

30:20

sound 45:2

sources 6:9

34:3 34:8 34:19

spare 44:11

spared 48:5

speaking 50:4

50:9

special 18:8

specially 34:25

Specialties 24:19

species 50:7

50:23

specific 22:1

36:4

specifically

8:1 17:5 20:23

spectrum 38:24

sperm 22:15

spermatogonia

23:1

sponsor 31:15

sponsored 14:1

33:13

sponsoring 12:4

sponsors 16:23

40:23 44:25 46:3

47:4

staff 2:10

stages 2:25

start 2:10

starting 12:22

13:14 25:10

state 13:21 49:14

stated 19:11 36:1

46:17

statement 4:16

statements

10:16 10:17

50:17

states 7:10

7:15 12:3

15:15 28:22

43:19 47:15

status 21:5

statutory 7:19

8:6 10:13

steelhead 28:19

stem 42:25 43:3

step 41:23 42:10

steps 15:6 47:17

stipulate 43:24

stone 21:8

stop 52:2

story 52:4

straight 12:9

strategic 16:9

16:13

Strategies 36:22

strategy 36:21

42:23

stressing 17:23

strong 21:24 35:6

strongly 8:9

42:23

structural 29:21

structurally

13:23

structure 20:7

Structure-
US EPA MEETING 03/31/09 CCR#16194-1 85

Activity 40:16

Stuart 49:10

studied 21:21

studies 8:11

13:15 18:24 19:6

19:16 23:14

26:23 28:5

31:1 31:7

31:20 31:23

34:25 37:20

subchronic 22:16

subject 14:15

43:25

subjected 5:17

subjecting 25:13

subjects 26:23

submission 8:10

submit 15:18 44:2

44:8 44:19

submitted 5:1

11:21 18:25

19:17 26:3 27:13

28:10 28:18 29:3

31:16 33:9

45:5 47:25

subsequent 17:7

29:5

subsequently 45:8

45:13

subsist 40:6

substance 23:15

24:11 51:8

substances 5:18

20:13 20:20 21:2

29:13 30:12 39:1

39:6 48:13

substantial

5:15 5:24 5:25

8:25 29:8

substitute 13:15

successive 20:2

sudden 46:1

suffering 37:7

sufficient 17:1

sufficiently 35:8

suggest 19:7

19:10 20:11 34:5

suggesting 26:5

47:9

suggests 26:11

29:7 38:25 45:17

suitable 41:19

suited 43:9

sulfated 23:15

24:7 24:14

Sulphur 30:22

39:10

summaries 27:13

34:24

summarize 33:9

summarized 24:20

summarizes 31:1

summit 52:20

superior 52:22

support 5:1

supports 32:22

supposed 21:10

sure 3:4 54:1

surprising 18:9

survival 19:23

19:24

survive 43:4

surviving 22:13

suspected 39:2

Synthetic 47:11

system 6:10

11:9 34:10

systemic 35:13

systems 16:17

T

talk 12:6

talking 13:5

target 31:23

32:19

TCSA 7:16

technological

51:12

technology 2:20

49:14 52:21

52:23

teleconference

50:5

temperatures

24:17

ten 12:14 12:15

12:19 16:10 54:4

54:5

tens 48:5

tentative 31:15

teratological

19:8

term 32:16
US EPA MEETING 03/31/09 CCR#16194-1 86

terminating 42:17

terms 13:24 15:6

test 5:13 5:19

5:20 8:16

10:22 11:25 14:2

14:16 14:25 16:4

16:10 17:7

17:9 17:15 17:23

18:14 18:15

18:19 18:22 19:2

19:13 21:3

21:7 21:12 21:13

21:17 21:17

23:10 23:17

23:19 24:4 25:23

26:3 26:19 26:20

28:10 28:17 29:1

29:2 30:1 30:3

30:20 30:23

30:24 31:9

32:6 32:8

32:15 35:22 36:6

36:10 36:23 37:6

37:8 38:19 39:22

39:22 41:1

41:3 41:4

41:10 41:14

41:15 41:18

41:22 41:23 42:5

42:10 42:15

42:18 42:22

42:25 43:1

43:3 43:6

43:11 43:18 44:3

44:24 44:25 45:5

45:8 45:9

45:24 46:3 46:10

46:11 46:11

46:12 46:17

46:22 47:3

47:4 47:10 47:25

48:8 48:19

49:3 49:14 51:11

tested 17:4 31:20

38:3 48:12

testes 22:24

testimony 11:15

testing 2:2 2:8

5:11 5:14 5:17

6:5 8:12 8:21

9:15 9:20 15:8

16:7 16:17 17:21

18:2 18:4 18:5

18:10 20:25 21:6

21:19 25:4

25:5 25:6

25:19 26:3 30:15

32:2 36:3

36:11 36:12

36:16 36:19

36:21 37:2

37:5 37:6

37:11 37:14

37:18 38:16 39:5

39:21 39:25 40:2

40:10 40:12 41:1

42:13 42:23

42:24 43:14

43:16 43:17

43:20 43:22

44:17 44:20

45:21 46:18

46:25 47:2 47:21

47:23 48:18

48:22 48:22

48:23 48:23

49:18 49:22

50:11 50:19 51:6

52:7 52:8 52:23

tests 17:10 20:12

23:20 24:24

25:17 26:4 26:15

31:21 34:6 37:24

42:1 42:4 42:8

44:7 44:9

44:11 44:14

44:18 45:2

45:7 45:12 45:20

46:11 48:1

49:6 52:12

tetra-nitrate

25:21

thank 11:5

15:21 15:21 16:3

49:6 49:7 53:1

53:6 53:19 53:22

54:6

thanks 2:7

11:13 17:14

21:13

That'll 21:15

that's 3:6

12:12 13:24 14:2

14:14 14:15

15:10 15:17

themselves 49:4

therefore 5:10

6:15 7:6

there's 12:14

13:6

these...this 15:9

thiophosphoric

29:18

third 47:25

thirteen 12:19

thirty 12:12

12:20

thoroughly
US EPA MEETING 03/31/09 CCR#16194-1 87

32:14 49:1

thoughtful

16:23 38:14

Thoughts 11:8

thousand 16:10

16:11

thousands 48:5

52:14

threshold 41:23

42:2

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throughout 47:19

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thus 37:1

tier 39:1

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22:20 22:24

32:19

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today 4:8 11:18

49:19 52:11 53:8

tone 52:9

tools 40:22

top 13:6

topping 52:19

totality 17:2

48:10

toxic 5:18 9:11

26:1 29:13 32:12

38:22 40:5

toxicant 19:7

19:10 22:9

toxicants 43:13

toxicities

32:18 51:2

toxicity 9:6 16:7

16:17 17:8 17:20

17:21 18:2

18:4 18:15 19:12

20:21 21:12

21:13 21:16

21:17 21:21 23:9

23:9 23:17 23:18

23:19 24:15

24:24 25:4

25:5 25:6

25:13 25:23

25:25 26:15

26:19 26:20

26:20 27:16

27:18 28:9 28:16

28:19 28:19 29:1

29:2 30:1 30:2

30:3 30:23 30:24

31:2 31:9 32:6

32:7 32:8 32:9

32:16 32:21 33:2

33:3 33:4

34:11 35:1

35:2 35:13 35:21

35:25 37:5

37:6 37:6

37:11 37:14

37:18 37:24 38:8

38:9 38:19 38:24

39:3 39:20 39:21

39:22 39:24 40:1

40:7 40:8

40:10 40:20

40:21 40:25

41:13 41:21 42:1

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43:17 43:21 44:6

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Track 5:21 9:23

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transcript 3:8

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Treatment 3:21

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triggered 3:13

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triglyceride 25:8

trimellitic 27:21

trout 28:19 31:5

true 39:13

truly 8:14

try 50:12

TSCA 5:6 6:12

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US EPA MEETING 03/31/09 CCR#16194-1 88

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52:25

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underway 14:5

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unlikely 35:8

unmet 7:11 7:14

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37:25 39:16

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25:4 25:12 28:13

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32:11

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various 12:4

vegetable 23:23

venture 50:10

verbatim 4:12

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24:24 25:6 25:12

viability 19:23

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39:3 40:11 40:25

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41:14 44:1 44:17

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volume 2:2 2:9

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voluntary 6:8

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volunteer 7:21

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warnings 9:11

waste 52:24

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water 17:13

24:8 24:21 24:25

26:4 26:5 26:6

26:8 26:10 26:17

28:12 38:5

weak 27:11

wealth 25:15
US EPA MEETING 03/31/09 CCR#16194-1 89

we'd 15:8

week 16:9

weight 12:12

19:24 21:4 22:13

24:23 25:18 27:3

27:4 27:5 27:9

27:11 29:14

29:15 31:4 32:25

38:22

welcome 2:7

welfare 16:22

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we're 14:12

16:9 53:12

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whenever 53:25

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15:23 54:7

whether 10:11

19:15 20:23

20:25 30:13

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whole 2:17 13:7

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widely 24:9

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3:12 11:5 49:7

Wilson 50:14

50:18 50:25

wise 53:17

work 2:20 13:24

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write 11:8

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11:20 31:16

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zebrafish 41:2