U.S. ENVIRONMENTAL PROTECTION AGENCY

TESTING OF CERTAIN HIGH PRODUCTION VOLUME CHEMICALS SECOND GROUP OF CHEMICALS

ORAL COMMENTS ON A PROPOSED REGULATION

MEETING

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 1201 CONSTITUTION AVENUE, NW EAST BUILDING WASHINGTON, D.C. 20460 SEPTEMBER 9, 2010 1:10 P.M.EPA MEETING 09/09/10 CCR#16194-6 2

1 U.S. ENVIRONMENTAL PROTECTION AGENCY 2 TESTING OF CERTAIN HIGH PRODUCTION 3 VOLUME CHEMICALS 4 SECOND GROUP OF CHEMICALS 5 ORAL COMMENTS ON A PROPOSED REGULATION 6 September 9, 2010 7 MR. WILLIS: All right, why don't we go 8 ahead and get started, then? I'd like to welcome 9 everyone to this public meeting to offer comments on 10 the proposed HPV3 test rule. This covers 29 high 11 production volume chemicals and is the third in the 12 series of four test rules under section 4A(1)(b) of 13 TOSCA. 14 My name is Jim Willis. I'm Director of 15 the Chemical Control Division here at EPA. And let me 16 suggest there are microphones around the room in the 17 event people want to make statements here, so if you do 18 wish to make a statement, you should feel free to do 19 so, but use the microphone and please introduce 20 yourself beforehand. 21 The proposed rule was published on July 22 24th, and the comment period...well, sorry, this can't 23 be right...yeah, the comment period on this closed on 24 May 26th of 2010, and that's where we provided 25 opportunity for people to provide comment.EPA MEETING 09/09/10 CCR#16194-6 3

1 We have two entities who wish to provide 2 comment here. Those are PETA, the People for Ethical 3 Treatment of Animals, and as well as the Nease 4 Corporation. Just so that everyone knows, we do have a 5 court reporter present who will record the proceedings 6 of the meeting, prepare a summary document that will 7 include hard copy of anything that is provided during 8 the course of the meeting today. 9 For us at EPA, after this meeting, we 10 will review the comments in aggregate, that is, all 11 those comments provided during the comment period and 12 comments received here before we finalize this test 13 rule. 14 So, if you make oral comments here, we'd 15 invite you to also leave any copies of your statement 16 with us so that we can ensure that we get it exactly 17 correctly. 18 And let me...first, let me say, are 19 there any questions on...on process? 20 (No response.) 21 MR. WILLIS: First, then, let me 22 invite...sorry...Joseph Mannupello from PETA to present 23 your comments. 24 MR. MANNUPELLO: I'm going to pass out 25 some handouts with my presentation and if I...EPA MEETING 09/09/10 CCR#16194-6 4

1 MR. WILLIS: Podium, or I guess you 2 could probably...I could move the microphone over. You 3 could sit here and scroll through your slides if that 4 would be easier. 5 MR. MANNUPELLO: I'd like to thank the 6 Agency for the opportunity to present these comments on 7 behalf of People for the Ethical Treatment of Animals. 8 PETA has...can you not hear? 9 SPEAKER: We don't hear you very well. 10 MR. MANNUPELLO: I just wanted to thank 11 the Agency for the opportunity to present these 12 comments on behalf of People for the Ethical Treatment 13 of Animals. PETA and the Physicians Committee for 14 Responsible Medicine have commented on every test plan 15 submitted under the HPV challenge program for which 16 animal testing was proposed. 17 Once again, we're very concerned that 18 the Agency is still proposing to require extensive 19 animal tests for HPV chemicals, tests that, if 20 conducted, would add another 20,000 animals to the more 21 than 150,000 who have already been killed in the HPV 22 program. 23 SPEAKER: It's still very difficult to 24 hear you. 25 MR. MANNUPELLO: Okay. All right.EPA MEETING 09/09/10 CCR#16194-6 5

1 SPEAKER: That's better. 2 MR. MANNUPELLO: Okay. So, in so doing, 3 the Agency ignores the primary animal welfare principle 4 enumerated in its October,1999 guidance to HPV program 5 participants. This advises HPV chemical sponsors to 6 conduct a thoughtful, qualitative analysis rather than 7 use a rote checklist approach, and it makes clear that 8 participants may conclude that there is sufficient 9 data, given the totality of what is known about a 10 chemical, including human experience, that certain 11 endpoints need not be tested. 12 While the Agency specifically agreed and 13 the White House committed to incorporate these animal 14 welfare principles into any subsequent test rules, 15 review of existing toxicity data and human experience 16 with the chemicals included in this test rule 17 demonstrates that, in many cases, the required tests 18 would add no useful information to what is already 19 known. 20 I'll consider the test requirements for 21 several of the included chemicals individually and 22 present relevant existing data we've located. I'll 23 also summarize additional information submitted by 24 manufacturers and reporters. 25 I'll begin with 1-tetracosanol and 1-EPA MEETING 09/09/10 CCR#16194-6 6

1 hexacosanol. These two chemicals are listed in the 2 proposed rule as requiring fish and mammalian acute 3 toxicity tests and combined repeated dose toxicity 4 studies with reproduction developmental toxicity 5 screens. If conducted on both chemicals, these tests 6 would kill approximately 1600 animals. 7 We called the Agency's attention to the 8 fact that the aluminum salts of these chemicals are 9 included in the aluminum alkoxides category, sponsored 10 by the Soap and Detergent Association, or SDA. I 11 understand that SDA has recently changed its name to 12 the American Cleaning Institute. 13 In its test plan for this category, SDA 14 presented evidence that aluminum alkoxides rapidly 15 hydrolyze into alumina and the corresponding alcohols. 16 SDA already used data from these alcohols, including 17 tetra and hexacosanol to fulfill all endpoints for the 18 aluminum alkoxides. In addition, the supporting robust 19 summary, site summary for long-chain aliphatic 20 alcohols, and ICCA initiative category, includes both 21 alcohols. In its comments on this proposed rule, Sasol 22 North America...I'm not sure how to say that...compiled 23 relevant data from this summary. 24 Regarding aquatic toxicity, SDA argued 25 that these chemicals are unlikely to be toxic, due toEPA MEETING 09/09/10 CCR#16194-6 7

1 their predicted insolubility. SDA provided water 2 solubility data, indicating a clear pattern of 3 decreasing values with increasing carbon chain length 4 and observed that alcohols with carbon chain lengths 5 above C16, including tetra and hexacosanol, are 6 insoluble. 7 Similarly, octanol water partition 8 coefficients increase with increasing carbon chain 9 length. SDA and Sasol estimated that these 10 values...they estimated these values to be 10.66 for 11 tetracosanol and 11.65 for hexacosanol. 12 Further, SDA observed that aliphatic 13 alcohols fit into the neutral organics class of 14 compounds and generally exert toxicity through a non15 polar narcosis mode of action. A clear pattern of 16 increasing toxicity was observed with increasing chain 17 length until approximately C14. Beyond this cutoff, no 18 toxicity was observed, because saturation occurs below 19 the concentration that is toxic to fish. 20 Sasol provided a summary and complete 21 study report for a company sponsored 96-hour acute 22 toxicity test on fathead minnows with C18 to 22 23 alcohols, completed in January of this year. No 24 mortality or overt signs of toxicity were observed at 25 the test concentration of 100 mg/l.EPA MEETING 09/09/10 CCR#16194-6 8

1 In its test plan for the aluminum 2 alkoxides, SDA reported acute oral LD50 values in rats 3 greater than 5000 mg/kg body weight for both tetra and 4 hexacosanol. On the basis of a clear inverse 5 relationship between chain length and toxicological 6 properties as well as the lack or very low incidence of 7 reproductive or developmental toxicity across a wide 8 range of carbon chain lengths, SDA proposed no further 9 testing. 10 Similarly, Sasol concludes from this 11 observed pattern that it is reasonable to predict that 12 tetra and hexacosanol have even lower potential 13 toxicities than other alcohols in the category for 14 which health effects have already been reported. 15 Consequently, existing data can be used as conservative 16 predictors of the health effects of these alcohols. 17 In addition, Sasol notes that the health 18 effects database in the long chain alcohols...see its 19 initial assessment report...includes studies of C24 20 through 34 alcohols which is a mixture including 21 significant amounts of tetra and hexacosanol. 22 In its comments on the SDA test plan, 23 the Agency agreed that using data for the corresponding 24 alcohols to address the SIDS health effects and 25 environmental fate effects endpoints for the aluminumEPA MEETING 09/09/10 CCR#16194-6 9

1 alkoxides was reasonable for the purposes of the HPV 2 program. The Agency also agreed that adequate data 3 were available on the alcohol hydrolysis products to 4 address the SIDS health effects endpoints. 5 Finally, Sasol notes that the amounts of 6 these substances imported recently have been 7 significantly less than 1 million pounds per year, that 8 these substances are both produced naturally and occur 9 commonly in mosses and...in mosses and other peat 10 forming plants, and that occupational exposure to and 11 environmental release of these substances is expected 12 to be minimal because of low volatility, the use of 13 protective clothing, and significant removal at waste 14 treatment facilities. 15 Since tetra and hexacosanol have already 16 been thoroughly evaluated as part of the aluminum 17 alkoxides category and the ICCA initiative long-chain 18 aliphatic alcohols category, their inclusion in the 19 proposed test rule is unnecessary, and they should be 20 removed. 21 The next chemical I'll address is 22 sulfurized 1-decene which is listed as requiring fish 23 and mammalian acute toxicity tests and a combined 24 repeated dose toxicity study with reproduction 25 developmental toxicity screen. These tests would killEPA MEETING 09/09/10 CCR#16194-6 10

1 approximately 800 animals. 2 Sulfurized decene was one of five 3 chemicals originally included in the Alkyl sulfides 4 category sponsored by the ACC's Health, Environmental, 5 and Regulatory Task Group. It was dropped from the 6 category in the final test plan revision. 7 In a personal communication, the ACC 8 explained that the panel dropped sponsorship, because 9 none of the members continue to manufacture or import 10 this chemical. In light of this information, the 11 Agency must verify that this chemical is still HPV. 12 In its comments on the original alkyl 13 sulfides category test plan, the Agency found the 14 category minimally acceptable for four of the 15 chemicals, including sulfurized decene. In particular, 16 the Agency believed that these chemicals were unlikely 17 to pose acute aquatic hazards, due to their high 18 hydrophobicity, and they suggested that the daphnia 19 chronic flow through test be done as an alternative for 20 the fish acute toxicity test unless measured water 21 solubilities were sufficiently low to eliminate the 22 need for chronic toxicity testing as well. 23 Regarding mammalian acute toxicity, the 24 Agency noted that the existing data show that the four 25 tested compounds are similar in that they have lowEPA MEETING 09/09/10 CCR#16194-6 11

1 acute toxicity by a variety of routes. 2 In its final test plan revision, HERTG 3 reported results from fish and mammalian acute toxicity 4 tests for several category members and from a 1- 5 generation reproductive toxicity study in rats 6 conducted for the propanol dodecatheon derivative. 7 While the Agency questioned the 8 selection of this chemical for health effects testing 9 in its comments, we urge the Agency to reconsider the 10 results of this study before requiring new repeated 11 dose and reproduction development toxicity studies for 12 sulfurized decene. In any case, fish and mammalian 13 acute toxicity tests are clearly unnecessary, 14 considering the alkyl sulfides category test plan 15 submission, and these tests should be removed from the 16 proposed test rule. 17 1-chloro-4-trifluoromethyl benzene, also 18 known as parachlorobenzotrifluoride or PCBTF, is listed 19 in the proposed test rule as requiring fish acute 20 toxicity and reproduction developmental toxicity 21 screening tests. These tests would kill approximately 22 800 animals. 23 In their comments, Brenntag North 24 America, Culla American, Miami Chemical, and Univar USA 25 as well as Special Materials Company, or SMC, inEPA MEETING 09/09/10 CCR#16194-6 12

1 separate comments, cite data supplied to the Agency by 2 Occidental Chemical Corporation between 1983 and '85 in 3 fulfillment of a negotiated testing agreement. These 4 include data from acute toxicity tests in bluegill 5 sunfish and rainbow trout and from a GOP 2-generation 6 reproductive toxicity study in rats. The original 7 study reports are attached to these companies' 8 comments. 9 After evaluating these data, the Agency 10 concluded, in October 1985 in a Federal Register 11 notice, that the acute and subchronic environmental 12 effects of PCBTF on aquatic species were well 13 characterized and that additional testing was not 14 necessary. Similarly, the Agency concluded that data 15 from the reproductive toxicity study were sufficient to 16 reasonably predict the health effects of PCBTF and 17 raised no concerns for the need for additional testing. 18 These companies also note that the 19 National Toxicology Program has initiated a 90-day 20 inhalation study in rats and that a 2-year 21 carcinogenicity study and teratology tests in rats are 22 planned. In addition, SMC notes that data being 23 generated in response to REACH requirements is likely 24 to satisfy most or all of the Agency's data 25 requirements. At a minimum, the Agency must wait forEPA MEETING 09/09/10 CCR#16194-6 13

1 the results from these tests before requiring 2 duplicative tests in this test rule. 3 1,2-dimethyl-3-nitrobenzene or 3NOX is 4 listed as requiring a mammalian acute toxicity test and 5 a combined repeated dose toxicity study with 6 reproduction developmental toxicity screen. These 7 tests would kill approximately 680 animals. 8 In its comments, BASF Chemical Company 9 notes that it believes that 3NOX is no longer an HPV 10 chemical, citing data from 2002 and 2006 inventory 11 update reporting periods that indicate that the 12 manufacture and import of this substance is well below 13 the 1 million pound threshold. BASF was the only known 14 3NOX reporter during these periods, and the annual 15 production volumes reported have been less than 100,000 16 pounds. 17 BASF also states that it has no plans to 18 exceed 100,000 pounds in the future. Again, the Agency 19 must verify that this chemical is still HPV. 20 In addition, a search of Toxline 21 returned an abstract from a 1994 German toxicology 22 assessment of the occupational safety of industrial 23 chemicals. 3NOX is described as being of low acute 24 toxicity on oral administration with LD50s in rats 25 greater than 2100 mg/kg body weight. In repeated doseEPA MEETING 09/09/10 CCR#16194-6 14

1 toxicity testing, reduced weight gain and reduced feed 2 intake were observed only at the highest doses. 3 The Agency must review this study with 4 regard to acute and repeated dose toxicity. In 5 particular, it should be determined whether 6 reproductive organs were examined in the repeated dose 7 study. 8 In additional, BASF suggests that the 9 Agency may wish to review the test plan and robust 10 summary submitted by BASF previously on the surrogate 11 compound, 1,2-dimethyl-4-nitrobenzene or 4NOX. BASF 12 used several analogs, including 2,4-dimethyl-1- 13 nitrobenzene and 4-nitrotoluene to complete the SIDS 14 data set for this chemical. EPA found that adequate 15 development and reproductive toxicity data were 16 available for 4-nitrotoluene. 17 We urge the Agency to consider these 18 data with regard to 3NOX as well. It seems likely that 19 the weight of existing evidence is sufficient to 20 eliminate the requirement for a new developmental 21 reproductive toxicity study. 22 3-pentanone is listed in the proposed 23 rule as requiring a mammalian acute toxicity test and a 24 combined repeated dose toxicity study with reproduction 25 developmental toxicity screen. These tests would killEPA MEETING 09/09/10 CCR#16194-6 15

1 approximately 680 animals. 2 A search of fragrance raw materials 3 monographs returned a reproduction toxicity study of 3- 4 pentanone in mice. Reference is here. We also note 5 that the similar chemical, 2-pentanone, was sponsored 6 in the HPV program by Eastman Chemical Company. All 7 health effects data for 2-pentanone were fulfilled by 8 existing data, including data from the OECD number 421 9 reproduction developmental toxicity screen conducted 10 under GOP assurances. 11 We urge the Agency to consider these 12 data and data from other short chain aliphatic ketones 13 with regard to 3-pentanone. For example, methylethyl 14 ketone differs from 3-pentanone only in having a methyl 15 instead of an ethyl group. It is extremely well 16 studied, with numerous evaluations of reproduction 17 developmental toxicity. 18 Sodium 3-nitrobenzene sulfonate is 19 listed in the proposed test rule as requiring a 20 reproduction and developmental toxicity screening test. 21 This test would kill approximately 675 animals. 22 A search of Toxline returned an abstract 23 from a 1996 article in the Journal of the American 24 College of Toxicology which reported an oral LD50 in 25 rats of 5000 mg/kg body weight. In addition, a chronicEPA MEETING 09/09/10 CCR#16194-6 16

1 oral toxicity study of a composite hair dye formulation 2 containing 2.25 percent sodium 3- 3 nitrobenzosulfonate...benzene sulfonate indicated 4 neither gross nor microscopic changes in beagle dogs. 5 The same hair dye formulation was not classified as a 6 reproductive toxicant in studies involving rats and 7 rabbits. 8 We also urge the Agency to consider the 9 possibility of read across from the sponsored HPV 10 program chemicals, benzene sulfonic acid and 11 hydroxybenzene sulfonic acid, for reproduction 12 developmental toxicity endpoints. 13 For the few remaining chemicals, I'll 14 summarize comments submitted by chemical companies with 15 regard to animal testing. All of the original comments 16 are available in the docket. 17 The first one I was going to talk about 18 is...is alkyl sulfonic acid, but we have a 19 representative from Nease here who I imagine is going 20 to be speaking about that, so I think I'll just skip 21 that. I guess I'm safe? All right. 22 For 2-propenoic acid, 2-carboxyethyl 23 ester or BCA, SOCMA confirmed that the combined 24 production volume is well below 1 million pounds and 25 unlikely to increase significantly. Rhodia,EPA MEETING 09/09/10 CCR#16194-6 17

1 Incorporated has already submitted a CVI letter to the 2 docket with its production import volume data, and 3 Bimax, Incorporated is expected to follow suit. Since 4 BCA...BCEA is very likely no longer HPV, it should be 5 removed from the current test rule. 6 For methanesulfonamide or CD3, the 7 International Imaging Industry Association, or IAAA, 8 surveyed all companies that reported CD3 manufacture or 9 importation since 1986, using a list supplied by Darryl 10 Ballard of EPA on May 5th of this year. The result 11 was...was that with all known companies reporting, the 12 2009 production volume of CD3 was just under 436,000 13 pounds. Again, since this is significantly less than 14 the HPV threshold of 1 million pounds, CD3 should be 15 removed from the current test rule. 16 IAAA went on to summarize the data from 17 the...that the Agency requires in a static multi18 species screening test for acute toxicity. The LC50 in 19 fathead minnows was 1 to 10 mg/l while in the flow 20 through test, the dynamic LC50 was 3.6 mg/l. 21 IAAA also summarized results from 22 carcinogenicity studies in Syrian golden hamsters by 23 the oral and endotracheal routes of exposure. No 24 biologically significant treatment related effects were 25 noted. This was supported by repeated dose toxicityEPA MEETING 09/09/10 CCR#16194-6 18

1 data for the analog, hydroxyethyl phenylenediamine 2 sulfide, from two oral exposure studies in rats. 3 With the exception of decreased body 4 weight gain at the high dose levels, no treatment 5 related effects were noted. 6 Reproductive organs were among those 7 examined in the carcinogenicity study with CD3. In 8 addition, IAAA summarized dominant lethal and 9 developmental toxicty studies for an analog conducted 10 by the oral route of exposure in rats. 11 The dominant lethal test used subchronic 12 dosing in males for the duration of its spermatogenic 13 process, followed by mating with untreated females. No 14 significant differences were noted in reproductive 15 parameters, suggesting that the analog did not induce 16 male reproductive toxicity. 17 In the developmental toxicity study, no 18 significant skeletal or visceral malformations were 19 noted, while the pregnancy rates for the mid and high20 dose groups were decreased. Internal toxicity 21 reflected in non-statistically significant decreases in 22 body weight occurred at the highest dose level. 23 For DMT residue, Invista notes that it 24 has already completed many of the studies identified in 25 the proposed test rule and intends to submit the finalEPA MEETING 09/09/10 CCR#16194-6 19

1 reports. Invista argues that the proposed combined 2 repeated dose reproductive developmental toxicity study 3 is not necessary, because there is minimal potential 4 for environmental release and human exposure. 5 The Agency should consider Invista's 6 exposure data and wait for the report that Invista will 7 submit before finalizing testing requirements for DMT 8 residue. 9 The American Coke and Coal Chemicals 10 Institute, or ACCCI, proposes creating a category for 11 the six coal tar substances. In addition, ACCCI 12 summarizes data for acute toxicity in fish and mammals 13 that is too voluminous to reproduce here as well as 14 several repeated dose and reproductive developmental 15 toxicity studies of coal tar and creosote. 16 ACCCI suggests a reasonable strategy for 17 conducting any additional testing that may be required 18 for coal tar substances. Tests would be conducted in a 19 step-wise fashion, focusing on one substance, and going 20 on to others only if it is determined that data from 21 that substance does not suffice to conduct read across 22 for the remaining coal tar substances. 23 The Agency must review the extensive 24 data provided by ACCCI and evaluate its proposals. 25 In conclusion, the Agency has notEPA MEETING 09/09/10 CCR#16194-6 20

1 adequately considered the totality of what is known 2 about each of these chemicals before proposing new 3 animal tests. The Agency must thoroughly evaluate the 4 existing data we have cited for the chemicals included 5 in this proposed test rule as well as that submitted by 6 chemical manufacturers and importers. 7 We appeal to the Agency and to chemical 8 companies themselves to carefully evaluate all 9 available data to avoid conducting duplicative animal 10 tests, and we will be returning to the White House 11 Council on Environmental Quality to ask it to maintain 12 its 2000 commitment should the Agency fail to do so. 13 Thank you. 14 MR. WILLIS: All right, thank you very 15 much for your comments. Next, I would like to invite 16 Mr. Phillip Benes from the Nease Corporation. 17 MR. BENES: Thank you. Good afternoon. 18 I would like to thank the Agency for the time to listen 19 to my comments. 20 I'm going to talk about one chemical 21 only. The previous speaker talked about all of them. 22 We have one chemical that's on the list. 23 I wasn't sure about what format you all 24 wanted to see this in. What I'm going to do is we 25 submitted an oral comments...I'm sorry...in writtenEPA MEETING 09/09/10 CCR#16194-6 21

1 comments back in May a report that we had contracted 2 through TERA to address the concerns of the testing 3 protocol. I'm going to highlight some things in that 4 in my report this afternoon and will be more than happy 5 to entertain any questions you might have. 6 But what I would like to do, if I can 7 figure out how to make this thing work...the green 8 button, forward button, the backwards button. Ah. 9 I would like to spend just a couple 10 minutes on my company, who we are. To you all, it's a 11 chemical. To us, it's our business, it's jobs, it's 12 people, so I want to spend just a couple of minutes on 13 that. I want to explain the rationale. We believe 14 that there is existing data on this compound as well as 15 a lot of work that was done on surrogate compounds. A 16 little bit on the evaluation of the SIDS endpoints that 17 were brought up in the proposed test rule. Talk a 18 little bit about what data is available and the 19 proposed testing protocol. I do have some references 20 available, and I do have attachments. 21 I brought most of these with me today. 22 You already should have those electronically, but I can 23 leave those with you today if you'd like me to, but a 24 lot of this work was based upon the surrogate work that 25 was done over the course of time.EPA MEETING 09/09/10 CCR#16194-6 22

1 Para toluene sulfonic acid was an HPV 2 chemical that we were part of a consortium when the 3 first rule went through, and a lot of that is going to 4 be based upon that study that was done. 5 But we're...in the world of chemical 6 manufacturers, we're a little guy. We employ about 65 7 employees. We...our facility is in Harrison, Ohio. We 8 have one plant. We've been there since 1959, primarily 9 as a supplier to one of the large detergent companies 10 that happens to be just down the road from us. 11 But we're a chemical manufacturer. We 12 do batch sulfonation. That's what our expertise is, 13 and that is what our call to fame is. We make 14 primarily hydrotropes. Those are coupling agents that 15 go into detergents. We also participate in catalyst 16 market, alkyl and sulfonates, and then we have a 17 specialty line of chemicals. 18 Customers that we serve, these are 19 primarily detergent companies. We also sell to a lot 20 of the major chemical manufacturers that use some of 21 our...our compounds as catalysts in their production. 22 So, that's a little bit about who we are. 23 But what I wanted to talk to you today 24 about was the proposed test rule. The specific 25 compound is benzenesulfonic acid, dimethyl, or as weEPA MEETING 09/09/10 CCR#16194-6 23

1 call it in our corporation, XSA90. That's 2 xylenesulfonic acid. We're shown on the IUR reporting 3 as a...in 2006 as an HPV manufacturer. 4 We chose not to sponsor this material 5 voluntarily, because we could not find anybody else 6 that was willing to stand with us. There is one other 7 manufacturer in North America that we're aware of, but 8 I don't believe that if this comes to pass, if a test 9 is required, I believe they will withdraw the chemical 10 from the marketplace. 11 The chemical extract service STM entry 12 does not specify the attachment of the methyl group. 13 Therefore, several isomers exist, and we try to address 14 that as well. 15 The compound that...that we're talking 16 about today is specifically that one, the dimethyl, 17 these are the relative surrogate compounds that we're 18 asking the Agency to consider. Both the acid form and 19 the salts forms of these materials exist as 20 xylenesulfonic acid, 4-toluene sulfonates, and then the 21 benzenesulfonic acids as well. A lot of work has been 22 done on those particular compounds. 23 Data for xylenesulfonic sulfonate was 24 used for mammalian toxicity endpoints. It has 25 precedence with high nucleic for xylenesulfonic acidEPA MEETING 09/09/10 CCR#16194-6 24

1 and xylenesulfonate where one chemical is used as a 2 surrogate for another in appropriate studies. 3 The toxicological data for 4 paratoluenesulfonic acid...that was an HPV 5 compound...and toluenesulfonate were used as surrogate 6 data for the benzenesulfonic acids. Found the same 7 rationale and further supported by the consistency in 8 the results for endpoints where the data was available 9 for more than one area sulfonate. That was part of the 10 original HPV challenge program that we participated in. 11 One current evaluation was conducted by 12 TERA. That's Toxicology Excellence for Risk 13 Assessment. They are an independent consulting agency 14 that...that we hired and paid to put together the...the 15 report that we have submitted to you concerning our 16 written comments, and these are the parts of their 17 report that I'm talking about today. 18 And then the xylenesulfonic acid and 19 toluenesulfonic acid salts were part of the hydrotrope 20 screening initial data set that was done by OECD in 21 2005, and high nucleic and MSDS sheets were used for 22 reference as well. 23 The...the physicochemical endpoints are 24 fairly well known for this material. It is a solid at 25 room temperature, freely soluble in water. The dataEPA MEETING 09/09/10 CCR#16194-6 25

1 for the SIDS matrix table has been estimated and data 2 for paratoluenesulfonic acid and benzenesulfonic acid 3 has been approved for comparison. 4 We also used data measured or estimated 5 for xylenesulfonic acids, is not included as a salt, 6 versus the proteic acid would likely significantly 7 affect the measurements. 8 Data for benzenesulfonic acid and 9 paratoluenesulfonic acid are included, as these 10 substances are in their acid form. 11 For the measurement of each substance, 12 the effects of the varying amounts of methylation would 13 be likely to be less than the effects of the solid 14 versus the proteinated form. So, really what we're 15 talking about is the effect of one, two, or three 16 methyl groups. 17 The estimated data for xylenesulfonic 18 acid are consistent with small hydrophilic organic 19 compounds. Also, this chemical is very likely to 20 ionize in water and exists primarily as a salt in 21 aqueous media. 22 Concerning environmental fate, the 23 bioaccumulation data was available for the sodium 24 xylenesulfonate and is less than 2.3. The modified 25 serum OECD 301(b) test data is available for sodiumEPA MEETING 09/09/10 CCR#16194-6 26

1 xylenesulfonate and calcium xylenesulfonate and show 85 2 percent biodegradation value. 3 The half-life for reaction with hydroxy 4 radicals in the atmosphere were estimated. Results 5 show that increased methylation...an increase in 6 reaction with hydroxy radicals, and distribution in the 7 environment was estimated using the fugacity model, 8 including the epi suite based upon the k level 3 9 calculations and was greater than 99 percent remains in 10 the water form. So, it's...it's in the water form. It 11 does not end up in the sediment. 12 Concerning ecotoxicity, data for sodium 13 and calcium xylenesulfonate for fish, daphnia, and 14 green algae acute toxicity is available, and they were 15 all shown to be greater than 100 mg/l. Ecostar was 16 used to estimate the toxicity for xylenesulfonic acid, 17 and the estimated effect was greater than 1000 mg/l for 18 all species. Data for benzenesulfonic acid and 19 paratoluenesulfonic acid are also included in the data 20 set. 21 For mammalian toxicity, sulfonic acids 22 are very safe. They're comparable to sulfuric acid in 23 concentrated forms and would show local effect at the 24 site of contact. This association constant is low, and 25 therefore, absorption is expected to be low in theEPA MEETING 09/09/10 CCR#16194-6 27

1 gastro and...and dermal tracts. 2 Since environmental exposure would most 3 likely be the deprobated form, xylene sulfates and 4 salts were used as surrogate endpoints. Absorbed 5 sulfonates are quickly distributed throughout the 6 system and rapidly excreted. 7 The LD50 in rats, based on a 14-day 8 study, was greater than 5000 mg per age and body 9 weight, and the interperitoneal LD50 was...that should 10 be...it's a typo...it should be...it was 500 mg/kg in 11 mice. 12 For genetic toxicity, there is no data 13 on this endpoint for xylenesulfonic acid. However, the 14 age and chromosomal aberration tests for sodium 15 xylenesulfonate are both negative. 16 For repeated dose testing, there's no 17 data for the acid form, but various data sets exist for 18 the sodium xylenesulfonate. There were 90-day rat 19 studies that were conducted, and you can read the 20 results up there. They're very positive. There were 21 no effects observed in mice orally exposed to doses, 22 again, fairly high dosing rates for the sodium 23 xylenesulfonate for 90 days. 24 The dermal studies resulted in NOAELs 25 800 mg in rats, 440 in male mice, 540 in female mice,EPA MEETING 09/09/10 CCR#16194-6 28

1 and you can read the OEL levels further down the page 2 there. The two-year dermal study in mice and rats 3 found no effects at 700.7 mg per age and body weight 4 per day and 240 mg per age and body weight per day 5 respectively, also in mice and rats. 6 Concerning reproductive and 7 developmental toxicity, no data was available for 8 xylenesulfonic acid. However, a 90-day oral feeding 9 study in rats exposed to the salt, sodium 10 xylenesulfonate, showed no effects on reproductive 11 organs, and development study in rats resulted in an 12 NOAEL of 3000 mg/kg per body weight per day. That 13 would have been about 1000 mg exactly if you read the 14 material, and fetal toxicity of calcium 15 xylenesulfonate. 16 This kind of summarizes all the test 17 data that is available. The plus sign up here means 18 that this data is available currently. The read-across 19 can be found from some of the references that I 20 supplied. 21 So, basically, to conclude, it is our 22 opinion that there is adequate physio, chemical, 23 environmental, ecotox, and mammalian data that are 24 available today. In light of that available data, our 25 feeling is that no further testing is required.EPA MEETING 09/09/10 CCR#16194-6 29

1 Based on the size of our company and the 2 fact that Nease is more than likely the only company to 3 be manufacturing this in commercial quantities, the 4 additional expense of doing all of this testing, not to 5 mention the number of animals as the representative 6 from PETA talked about a few minutes ago, killed, 7 basically, puts a significant financial burden on our 8 company that we have to look at whether or not it still 9 makes financial sense for us to commercially 10 manufacture this material. So, that would mean jobs as 11 well. 12 Additional testing on animals is not 13 necessary in view of the wealth of data available, and 14 additional data is available in the TERA report and the 15 appendices that have been provided before, and we'd be 16 happy to supply you with a copy today. 17 So, I ran through that pretty quick, but 18 that's...you should have seen everything before today 19 that I put up here. So, I hope that met your needs. 20 MR. WILLIS: All right, thank you very 21 much. That brings us to the end of those who have 22 requested the opportunity to comment. Let me invite 23 now if anyone else who did not register would like to 24 make a public comment at this point. 25 MS. BECK: Am I on?EPA MEETING 09/09/10 CCR#16194-6 30

1 MR. WILLIS: You're on. 2 MS. BECK: Okay. I was wondering if it 3 would be possible or make sense to apply some of the 4 approaches that have been developed at the National 5 Center for Computational Toxicology here to these HPV 6 chemicals. It's clear that the Agency is interested in 7 developing new tools and moving toxicology forward. 8 So, it seems like this would be a great opportunity to 9 apply some of these new approaches. 10 And what I'm thinking is that instead of 11 proposing a rule that requires extensive animal testing 12 from the start, it would make a lot of sense to first 13 run the HPV chemicals in question through the TOX CAST 14 assays to obtain a profile of potential toxicity. 15 Then, you'd look at that profile along with all 16 the...seems like extensive existing data, according to 17 the presentations we heard today, to consider in a 18 weight of evidence approach to inform any additional 19 testing which could then be called for in the rule. 20 And I realize TOX CAST is in its 21 relative infancy and that the TOX signatures and 22 preactivity of the signatures are still being 23 evaluated, but the point of the HPV program, as 24 everyone knows, is to generate screening level data, 25 not necessarily, you know, definitive data, if such aEPA MEETING 09/09/10 CCR#16194-6 31

1 thing exists. So, I would encourage the Agency to 2 think about whether TOX CAST and other tools at NCCT 3 could provide the necessary info for the purposes of 4 the HPV program. 5 And I know that EPA is already applying 6 TOX CAST, as it was used earlier this summer to assess 7 the oil dispersants that were used in the Gulf. Within 8 a month or so, they were tested, and we had tox 9 profiles for them from the TOX CAST software, and TOX 10 CAST has also been used to prioritize chemicals for 11 inclusion in the EDSP. 12 So, I guess I'm posing a question or 13 proposing that the Agency capitalize on those tools and 14 take this as an opportunity to use them for the HPV 15 chemicals that would provide staff outside of NCCT with 16 experience in looking at and interpreting new different 17 kinds of data than, you know, they're traditionally 18 used to looking at to make assessments and figure out 19 how to use it in guiding decision making. 20 So, I guess what I...my main point is I 21 think it's important to start using these other 22 approaches in order to refine them and facilitate 23 the paradigm shift in toxicology that EPA seems to be 24 trying to make. 25 MR. WILLIS: Thank you. Could youEPA MEETING 09/09/10 CCR#16194-6 32

1 identify yourself? 2 MS. BECK: Oh, sorry. Nancy Beck, PCRM. 3 MR. WILLIS: All right, thank you. Any 4 other comments? 5 MR. DETTINGER: I have a question. I'm 6 Joe Dettinger with Bimax. What we're interested in is 7 the time frame on your decision for HPV chemical in 8 question, it's CAS number 24615-84-7. This is the 9 chemical that we submitted before, we do not believe it 10 is HPV. 11 MR. WILLIS: Sorry, was that a chemical 12 in the proposed rule? 13 MR. DETTINGER: Yes. 14 MR. WILLIS: Yeah. Well, we will 15 address that along with all of the other chemicals that 16 were listed in the proposed rule. What we need to do 17 is...is conclude our review of all of the comments 18 received on all of the chemicals plus the comments 19 received here in this discussion and then proceed with 20 finalizing the rule, taking into consideration all of 21 those comments. 22 So, I can't give you a...a specific 23 date, but it should be on the order of, I'd say, six to 24 nine months, roughly, to work through those issues and 25 run through our incredibly bureaucratic process.EPA MEETING 09/09/10 CCR#16194-6 33

1 SPEAKER: You say six to nine months 2 before this Rule is finalized? 3 MR. WILLIS: Hopefully. 4 Optimistically. I tend to be optimistic. Please? 5 MR. GUNNULFSON: Just a question. Jeff 6 Gunnulfson from NPRA, and just a question. Will EPA be 7 making any exposure findings through a Pair-rule? 8 MR. WILLIS: Sorry, I'm not sure I 9 understand the question. Could you maybe rephrase 10 that? 11 MR. GUNNULFSON: Yes. Will there be 12 exposure findings in the final rule through a Pair13 rule, or if the next step you have to do is exposure 14 findings, what vehicle will you be doing...doing those? 15 MR. WILLIS: Sorry. Are you asking 16 whether we will do any additional rulemaking to support 17 making an exposure finding? 18 MR. GUNNULFSON: Yes. 19 MR. WILLIS: Yeah. We do not have any 20 additional information-gathering rulemaking planned at 21 this time. 22 MR. GUNNULFSON: Okay. 23 MR. WILLIS: That's, indeed, the 24 inventory update rule or IUR is largely tailor-made for 25 this sort of rulemaking, and doing test rules was oneEPA MEETING 09/09/10 CCR#16194-6 34

1 of our considerations in setting up the data elements 2 in...in the IUR. 3 Any further comments? 4 MR. HELMES: I'm Tucker Helmes from 5 ETAD. Any sense yet of when the final rule for the 6 second HPV test rule will be published? The...the 7 proposed rule was July of '08. 8 MR. WILLIS: Soon. 9 MR. HELMES: Soon? 10 MR. WILLIS: Soon, under 10 days, 11 probably. 12 MR. HELMES: Oh, really? 13 MR. WILLIS: Yeah. 14 MR. HELMES: Okay. 15 MR. WILLIS: But everybody's cleared it. 16 Right? Within a month. Optimistic again. 17 SPEAKER: What HPV Rule, I'm sorry? 18 MR. WILLIS: The HPV 2 final rule. 19 I don't think much further needs to 20 happen. It needs to be encoded for the Federal Register 21 and signed, but, again, these are...these are steps in 22 the process outside of our control. 23 Any further comments? Christina? 24 MS. FRANZ: Hi. Christina Franz. Can 25 you hear me? Okay, Christina Franz with the AmericanEPA MEETING 09/09/10 CCR#16194-6 35

1 Chemistry Council. 2 A couple of...of points. We certainly 3 support the Agency looking back at existing data such 4 as the presentations that were made here today and 5 utilizing that data. We certainly don't want industry 6 to have to spend any more money, test on any more 7 animals than necessary, and we certainly support the 8 animal welfare principles and Nancy's suggestion of the 9 computational TOX. 10 What I did want to ask a question about 11 was earlier, we had had you, Jim, over at ACC, and you 12 had noted a...had made a couple comments about the 13 Agency's thoughts about the fourth proposed rule on 14 additional HPV orphans, and you had mentioned possibly 15 using or issuing a SNUR on some of those HPVs, and I 16 was wondering if there's been any more development on 17 that and whether you could comment at all on it. 18 MR. WILLIS: Yeah, I'm not sure I can. 19 The...the draft HPV 4 rule isn't quite into Agency-wide 20 review yet, and so, it's a...it's a bit early to 21 predict formally what that will look like, but you're 22 correct, the Agency has considered doing test rules in 23 conjunction with significant new use rules so that in 24 those cases where chemicals may sort of slip under the 25 necessary numerics for the findings, they would stillEPA MEETING 09/09/10 CCR#16194-6 36

1 be captured in case they re...re-emerge as high2 production, high-exposure type chemicals. 3 So, currently, it's a...it's an approach 4 under consideration but remains to be seen if we will 5 actually issue rules along those lines. 6 MS. FRANZ: Thank you. 7 MR. WILLIS: Any further comments? 8 (No response.) 9 MR. WILLIS: All right, seeing none, 10 just a reminder there will be a transcript of this, and 11 that, together with any written documentation provided 12 here and comments received during the comment period 13 will all be in the docket for the rulemaking. And when 14 we finalize it, our responses to all of the comments 15 will also be included, of course. 16 Thank you very much, and the meeting is 17 adjourned. 18 (WHEREUPON, the Meeting was concluded at 2:01 p.m.) 19 20 21 22 23 24 25EPA MEETING 09/09/10 CCR#16194-6 37

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 25EPA MEETING 09/09/10 CCR#16194-6 38

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 MARK REIF, COURT REPORTER / NOTARY 25 SUBMITTED ON SEPTEMBER 9, 2010EPA MEETING 09/09/10 CCR#16194-6 39 0 08 34:7

1 1 5:25 9:7 11:4 13:13 16:24 17:14 17:19 1,2-dimethyl-3- nitrobenzene 13:3 1,2-dimethyl-4- nitrobenzene 14:11 10 17:19 34:10 10.66 7:10 100 7:25 26:15 100,000 13:15 13:18 1000 26:17 28:13 11.65 7:11 14-day27:7 150,000 4:21 1600 6:6 1959 22:8 1983 12:2 1985 12:10 1986 17:9 1994 13:21 1996 15:23 1-chloro-4- trifluoromethyl 11:17 1-decene 9:22 1-tetracosanol 5:25

2 2 34:18 2,4-dimethyl-1 14:12 2.25 16:2 2.3 25:24 2:01 36:18 20,000 4:20 2000 20:12 2002 13:10 2005 24:21 2006 13:10 23:3 2009 17:12 2010 2:6 2:24 2100 13:25 22 7:22 240 28:4 24615-84-7 32:8 24th 2:22 26th 2:24 29 2:10 2-carboxyethyl 16:22 2-generation 12:5 2-pentanone 15:5 15:7 2-propenoic 16:22 2-year 12:20

3 3 15:3 16:2 26:8 3.6 17:20 3000 28:12 301(b 25:25 34 8:20 3-nitrobenzene 15:18 3NOX 13:3 13:9 13:14 13:23 14:18 3-pentanone 14:22 15:13 15:14

4 4 35:19 421 15:8 436,000 17:12 440 27:25 4A(1)(b 2:12 4-nitrotoluene 14:13 14:16 4NOX 14:11 4-toluene 23:20

5 500 27:10 5000 8:3 15:25 27:8 540 27:25 5th 17:10

6 65 22:6 675 15:21 680 13:7 15:1EPA MEETING 09/09/10 CCR#16194-6 40

7 700.7 28:3

8 800 10:1 11:22 27:25 85 12:2 26:1

9 9 2:6 90 27:23 90-day12:19 27:18 28:8 96-hour 7:21 99 26:9

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35:12 a...in 23:3 a...it's 35:20 36:3 aberration 27:14 Absorbed27:4 absorption 26:25 abstract 13:21 15:22 ACC 10:7 35:11 ACCCI 19:10 19:11 19:16 19:24 acceptable 10:14 according 30:16 ACC's 10:4 acid16:10 16:11 16:18 16:22 22:1 22:25 23:2 23:18 23:20 23:25 24:18 24:19 25:2 25:2 25:6 25:8 25:9 25:10 25:18 26:16 26:18 26:19 26:22 27:13 27:17 28:8 acid...that24:4 acids 23:21 24:6 25:5 26:21 across 8:7 16:9 19:21 action 7:15 actually 36:5 acute 6:2 7:21 8:2 9:23 10:17 10:20 10:23 11:1 11:3 11:13 11:19 12:4 12:11 13:4 13:23 14:4 14:23 17:18 19:12 26:14 add4:20 5:18 addition 6:18 8:17 12:22 13:20 15:25 18:8 19:11 additional 5:23 12:13 12:17 14:8 19:17 29:4 29:12 29:14 30:18 33:16 33:20 35:14 address 8:24 9:4 9:21 21:2 23:13 32:15 adequate 9:2 14:14 28:22 adequately20:1 adjourned36:17 administration 13:24 advises 5:5 affect25:7 afternoon 20:17 21:4 age 27:8 27:14 28:3 28:4 agency2:1 4:6 4:11 4:18 5:3 5:12 8:23 9:2 10:11 10:13 10:16 10:24 11:7 11:9 12:1 12:9 12:14 12:25 13:18 14:3 14:9 14:17 15:11 16:8 17:17 19:5 19:23 19:25 20:3 20:7 20:12 20:18 23:18 24:13 30:6 31:1 31:13 35:3 35:22 Agency's 6:7 12:24 35:13 Agency-wide 35:19 agents 22:14 aggregate 3:10 ago 29:6 agreed 5:12 8:23 9:2EPA MEETING 09/09/10 CCR#16194-6 41

agreement 12:3 Ah 21:8 ahead2:8 alcohol 9:3 alcohols 6:15 6:16 6:20 6:21 7:4 7:13 7:23 8:13 8:16 8:20 8:24 9:18 alcohols...see 8:18 algae 26:14 aliphatic 6:19 7:12 9:18 15:12 alkoxides 6:9 6:14 6:18 8:2 9:1 9:17 alkyl 10:3 10:12 11:14 16:18 22:16 already 4:21 5:18 6:16 8:14 9:15 17:1 18:24 21:22 31:5 alternative 10:19 alumina 6:15 aluminum

6:8 6:9 6:14 6:18 8:1 8:25 9:16 Am 29:25 America 11:24 23:7 America...I'm 6:22 American 6:12 11:24 15:23 19:9 34:25 among 18:6 amounts 8:21 9:5 25:12 analog18:1 18:9 18:15 analogs 14:12 analysis 5:6 and...and27:1 and...in 9:9 animal 4:16 4:19 5:3 5:13 16:15 20:3 20:9 30:11 35:8 animals 3:3 4:7 4:13 4:20 6:6 10:1 11:22 13:7 15:1 15:21 29:5 29:12 35:7 annual 13:14 anybody 23:5 anyone 29:23 anything3:7 appeal 20:7 appendices 29:15 apply 30:3 30:9 applying31:5 approach 5:7 30:18 36:3 approaches 30:4 30:9 31:22 appropriate 24:2 approved25:3 approximately 6:6 7:17 10:1 11:21 13:7 15:1 15:21 aquatic 6:24 10:17 12:12 aqueous 25:21 are...these 34:21 area 24:9 argued 6:24 argues 19:1 article 15:23 assays 30:14 assess 31:6 assessment8:19 13:22 24:13 assessments 31:18 association 6:10 17:7 26:24 assurances 15:10 atmosphere 26:4 attached12:7 attachment23:12 attachments 21:20 attention 6:7 available 9:3 14:16 16:16 20:9 21:18 21:20 24:8 25:23 25:25 26:14 28:7 28:17 28:18 28:24 28:24 29:13 29:14 avoid20:9EPA MEETING 09/09/10 CCR#16194-6 42

aware 23:7

B backwards 21:8 Ballard

17:10 based21:24 22:4 26:8 27:7 29:1 BASF 13:8 13:13 13:17 14:8 14:10 14:11 basically 28:21 29:7 basis 8:4 batch 22:12 BCA 16:23 BCA...BCEA

17:4 be...it27:10 be...it's 27:10 beagle 16:4 Beck 29:25 30:2 32:2 32:2 beforehand

2:20 begin 5:25 behalf 4:7 4:12 believe 21:13 23:8 23:9 32:9 believed10:16 believes 13:9 Benes 20:16 20:17 benzene 11:17 16:10 benzenesulfonic 22:25 23:21 24:6 25:2 25:8 26:18 better 5:1 Beyond 7:17 Bimax 17:3 32:6 bioaccumulation 25:23 biodegradation 26:2 biologically 17:24 bit 21:16 21:18 22:22 35:20 bluegill 12:4 body 8:3 13:25 15:25 18:3 18:22 27:8 28:3 28:4 28:12 Brenntag11:23 brings 29:21 brought21:17 21:21 burden 29:7 bureaucratic 32:25 business 21:11 button 21:8 21:8 21:8

C C14 7:17 C16 7:5 C18 7:22 C24 8:19 calcium

26:1 26:13 28:14

calculations 26:9 capitalize 31:13 captured36:1 carbon 7:3 7:4 7:8 8:8 carcinogenicity 12:21 17:22 18:7 carefully 20:8 CAS 32:8 case 11:12 36:1 cases 5:17 35:24 CAST 30:13 30:20 31:2 31:6 31:9 31:10 catalyst 22:15 catalysts 22:21 category 6:9 6:13 6:20 8:13 9:17 9:18 10:4 10:6 10:13 10:14 11:4 11:14 19:10 CD3 17:6 17:8 17:12 17:14 18:7 Center 30:5 certain 2:2 5:10 certainly 35:2 35:5 35:7 chain 7:3 7:4 7:8 7:16 8:5 8:8 8:18 15:12 challenge 4:15 24:10 changed

6:11EPA MEETING 09/09/10 CCR#16194-6 43

changes 16:4 characterized 12:13 checklist 5:7 chemical 2:15 5:5 5:10 9:21 10:10 10:11 11:8 11:24 12:2 13:8 13:10 13:19 14:14 15:5 15:6 16:14 20:6 20:7 20:20 20:22 21:11 22:2 22:5 22:11 22:20 23:9 23:11 24:1 25:19 28:22 32:7 32:9 32:11 chemicals 2:3 2:4 2:11 4:19 5:16 5:21 6:1 6:5 6:8 6:25 10:3 10:15 10:16 13:23 16:10 16:13 19:9 20:2 20:4 22:17 30:6 30:13 31:10 31:15 32:15 32:18 35:24 36:2 Chemistry 35:1 chose 23:4 Christina 34:23 34:24 34:25 chromosomal 27:14 chronic 10:19 10:22 15:25 cite 12:1 cited20:4 citing13:10 class 7:13 classified

16:5 Cleaning6:12 clear 5:7 7:2 7:15 8:4 30:6 cleared

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10:25 21:15 22:21 23:17 23:22 25:19 computational 30:5 35:9 concentrated 26:23 concentration 7:19 7:25 concerned4:17 concerning 24:15 25:22 26:12 28:6 concerns 12:17 21:2 conclude 5:8 28:21 32:17 concluded12:10 12:14 36:18 concludes 8:10 conclusion 19:25 conduct5:6 19:21 conducted4:20 6:5 11:6 15:9 18:9 19:18 24:11 27:19 conducting 19:17 20:9 confirmed16:23 conjunction 35:23 Consequently 8:15 conservative 8:15 consider 5:20 14:17 15:11 16:8 19:5 23:18 30:17 consideration 32:20 36:4 considerations 34:1 considered

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22:2 constant 26:24 consulting24:13 contact26:24 containing16:2 continue 10:9 contracted

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D daphnia 10:18 26:13 Darryl 17:9 data 5:9 5:15 5:22 6:16 6:23 7:2 8:15 8:23 9:2 10:24 12:1 12:4 12:9 12:14 12:22 12:24 13:10 14:14 14:15 14:18 15:7 15:8 15:8 15:12 15:12 17:2 17:16 18:1 19:6 19:12 19:20 19:24 20:4 20:9 21:14 21:18 23:23 24:3 24:6 24:8 24:20 24:25 25:1 25:4 25:8 25:17 25:23 25:25 26:12EPA MEETING 09/09/10 CCR#16194-6 45

26:18 26:19 27:12 27:17 27:17 28:7 28:17 28:18 28:23 28:24 29:13 29:14 30:16 30:24 30:25 31:17 34:1 35:3 35:5 database 8:18 date 32:23 day 28:4 28:4 28:12 days 27:23 34:10 decene 10:2 10:15 11:12 decision 31:19 32:7 decreased18:3 18:20 decreases 18:21 decreasing7:3 definitive 30:25 demonstrates 5:17 deprobated

27:3 derivative 11:6 dermal 27:1 27:24 28:2 described13:23 detergent 6:10 22:9 22:19 detergents 22:15 determined

14:5 19:20 Dettinger 32:5 32:6 32:13 developed30:4 developing30:7 development11:11 14:15 28:11 35:16 developmental 6:4 8:7 9:25 11:20 13:6 14:20 14:25 15:9 15:17 15:20 16:12 18:9 18:17 19:2 19:14 28:7 differences 18:14 different 31:16 differs 15:14 difficult 4:23 dimethyl 22:25 23:16 Director 2:14 discussion 32:19 dispersants 31:7 distributed

27:5 distribution 26:6 Division 2:15 DMT 18:23 19:7 docket16:16 17:2 36:13 document 3:6 documentation 36:11 dodecatheon 11:6 dogs 16:4 doing...doing 33:14 dominant 18:8 18:11 done 10:19 21:15 21:25 22:4 23:22 24:20 dose 6:3 9:24 11:11 13:5 13:25 14:4 14:6 14:24 17:25 18:4 18:20 18:22 19:2 19:14 27:16 doses 14:2 27:21 dosing18:12 27:22 draft 35:19 dropped

10:5 10:8 due 6:25 10:17 duplicative 13:2 20:9 duration 18:12 during3:7 3:11 13:14 36:12 dye 16:1 16:5 dynamic 17:20

E earlier 31:6 35:11 early 35:20 easier 4:4 Eastman 15:6 Ecostar 26:15 ecotox28:23 ecotoxicity 26:12 EDSP 31:11EPA MEETING 09/09/10 CCR#16194-6 46

effect25:15 26:17 26:23 effects 8:14 8:16 8:18 8:24 8:25 9:4 11:8 12:12 12:16 15:7 17:24 18:5 25:12 25:13 27:21 28:3 28:10 electronically 21:22 elements 34:1 eliminate 10:21 14:20 else 23:5 29:23 employ22:6 employees 22:7 encoded

34:20 encourage 31:1 endotracheal 17:23 endpoint 27:13 endpoints 5:11 6:17 8:25 9:4 16:12 21:16 23:24 24:8 24:23 27:4 ensure 3:16 entertain 21:5 entities 3:1 entry 23:11 enumerated

5:4 environment26:7 environmental 2:1 8:25 9:11 10:4 12:11 19:4 20:11 25:22 27:2 28:23 EPA 2:15 3:9 14:14 17:10 31:5 31:23 33:6 epi 26:8 ester 16:23 estimate 26:16 estimated7:9 7:10 25:1 25:4 25:17 26:4 26:7 26:17 ETAD 34:5 Ethical 3:2 4:7 4:12 ethyl 15:15 evaluate 19:24 20:3 20:8 evaluated9:16 30:23 evaluating12:9 evaluation 21:16 24:11 evaluations 15:16 event 2:17 everybody's 34:15 everyone 2:9 3:4 30:24 everything29:18 evidence 6:14 14:19 30:18 exactly 3:16 28:13 examined14:6 18:7 example 15:13 exceed 13:18 Excellence 24:12 exception 18:3 excreted27:6 exert 7:14 exist 23:13 23:19 27:17 existing5:15 5:22 8:15 10:24 14:19 15:8 20:4 21:14 30:16 35:3 exists 25:20 31:1 expected9:11 17:3 26:25 expense 29:4 experience 5:10 5:15 31:16 expertise 22:12 explain 21:13 explained10:8 exposed

27:21 28:9 exposure 9:10 17:23 18:2 18:10 19:4 19:6 27:2 33:7 33:12 33:13 33:17 extensive 4:18 19:23 30:11 30:16 extract23:11 extremely 15:15EPA MEETING 09/09/10 CCR#16194-6 47

F facilitate 31:22 facilities 9:14 facility 22:7 fact 6:8 29:2 fail 20:12 fairly24:24 27:22 fame 22:13 fashion 19:19 fate 8:25 25:22 fathead

7:22 17:19 Federal 12:10 34:20 feed14:1 feeding28:8 feel 2:18 feeling28:25 female 27:25 females 18:13 fetal 28:14 figure 21:7 31:18 final 10:6 11:2 18:25 33:12 34:5 34:18 finalize 3:12 36:14 finalized33:2 finalizing19:7 32:20 Finally 9:5 financial 29:7 29:9 finding33:17 findings 33:7 33:12 33:14 35:25 first 3:21 16:17 22:3 30:12 fish 6:2 7:19 9:22 10:20 11:3 11:12 11:19 19:12 26:13 fit 7:13 five 10:2 flow10:19 17:19 focusing19:19 form 23:18 25:10 25:14 26:10 26:10 27:3 27:17 formally 35:21 format20:23 forming9:10 forms 23:19 26:23 formulation 16:1 16:5 forward

21:8 30:7 fourth35:13 fragrance 15:2 frame 32:7 Franz 34:24 34:24 34:25 36:6 free 2:18 freely24:25 fugacity 26:7 fulfill 6:17 fulfilled15:7 fulfillment12:3 future 13:18

G gain 14:1 18:4 gastro 27:1 generally 7:14 generate 30:24 generated12:23 generation 11:5 genetic 27:12 German 13:21 given 5:9 golden 17:22 GOP 12:5 15:10 great 30:8 greater 8:3 13:25 26:9 26:15 26:17 27:8 green 21:7 26:14 gross 16:4 group 2:4 10:5 15:15 23:12 groups 18:20 25:16 guess 4:1 16:21 31:12 31:20 guidance 5:4 guiding31:19 Gulf 31:7EPA MEETING 09/09/10 CCR#16194-6 48

Gunnulfson 33:5 33:6 33:11 33:18 33:22 guy 22:6

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I I...my31:20 IAAA 17:7 17:16 17:21 18:8 ICCA 6:20 9:17 I'd2:8 4:5 32:23 identified

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J January 7:23 Jeff 33:5 Jim 2:14 35:11 jobs 21:11 29:10 Joe 32:6 Journal 15:23 July 2:21 34:7

K ketone 15:14 ketones 15:12 kill 6:6 9:25EPA MEETING 09/09/10 CCR#16194-6 50

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L lack 8:6 large 22:9 largely 33:24 LC50 17:18 17:20 LD50 8:2 15:24 27:7 27:9 LD50s 13:24 leave 3:15 21:23 length7:3 7:9 7:17 8:5 lengths 7:4 8:8 less 9:7 13:15 17:13 25:13 25:24 lethal 18:8 18:11 letter 17:1 level 18:22 26:8 30:24 levels 18:4 28:1 light 10:10 28:24 likely12:23 14:18 17:4 25:6 25:13 25:19 27:3 29:2 line 22:17 lines 36:5 list 17:9 20:22 listed 6:1 9:22 11:18 13:4 14:22 15:19 32:16 listen 20:18 little 21:16 21:18 22:6 22:22 local 26:23 located

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measurements 25:7 media 25:21 Medicine 4:14 meeting2:9 3:6 3:8 3:9 36:16 36:18 members 10:9 11:4 mention 29:5 mentioned35:14 met 29:19 methanesulfonamid e 17:6 methyl 15:14 23:12 25:16 methylation 25:12 methylation... an 26:5 methylethyl 15:13 mg27:8 27:25 28:3 28:4 28:13 mg/kg 8:3 13:25 15:25 27:10 28:12 mg/l 7:25 17:19 17:20 26:15 26:17 Miami 11:24 mice 15:4 27:11 27:21 27:25 27:25 28:2 28:5 microphone 2:19 4:2 microphones 2:16 microscopic 16:4 mid18:19 million 9:7 13:13 16:24 17:14 minimal 9:12 19:3 minimally 10:14 minimum

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N Nancy 32:2 Nancy's 35:8 narcosis 7:15 National 12:19 30:4 naturally 9:8 NCCT 31:2 31:15 Nease 3:3 16:19 20:16 29:2 necessarily 30:25 necessary 12:14 19:3 29:13 31:3 35:7 35:25 negative 27:15 negotiated

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personal 10:7 PETA 3:2 3:22 4:8 4:13 29:6 phenylenediamine 18:1 Phillip 20:16 Physicians 4:13 physicochemical 24:23 physio 28:22 plan 4:14 6:13 8:1 8:22 10:6 10:13 11:2 11:14 14:9 planned

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S safe 16:21 26:22 safety13:22 salt 25:5 25:20 28:9EPA MEETING 09/09/10 CCR#16194-6 56

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surrogate 14:10 21:15 21:24 23:17 24:2 24:5 27:4 surveyed17:8 Syrian 17:22 system 27:6

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tools 30:7 31:2 31:13 TOSCA2:13 totality 5:9 20:1 tox 30:13 30:20 30:21 31:2 31:6 31:8 31:9 31:9 35:9 toxic 6:25 7:19 toxicant 16:6 toxicities 8:13 toxicity 5:15 6:3 6:3 6:4 6:24 7:14 7:16 7:18 7:22 7:24 8:7 9:23 9:24 9:25 10:20 10:22 10:23 11:1 11:3 11:5 11:11 11:13 11:20 11:20 12:4 12:6 12:15 13:4 13:5 13:6 13:24 14:1 14:4 14:15 14:21 14:23 14:24 14:25 15:3 15:9 15:17 15:20 16:1 16:12 17:18 17:25 18:16 18:17 18:20 19:2 19:12 19:15 23:24 26:14 26:16 26:21 27:12 28:7 28:14 30:14 toxicological 8:5 24:3 toxicology 12:19 13:21 15:24 24:12 30:5 30:7 31:23 toxicty 18:9 Toxline 13:20 15:22 tracts 27:1 traditionally 31:17 transcript36:10 treatment 3:3 4:7 4:12 9:14 17:24 18:4 trout 12:5 try 23:13 trying31:24 Tucker 34:4 two-year 28:2 type 36:2 typo...it 27:10

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W wait 12:25 19:6 was...that27:9 was...was 17:11EPA MEETING 09/09/10 CCR#16194-6 60

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