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## ,FCFI~~E[1 1250 Connecticut Avenue, NW "Suite 700"Washington, DC 2003$''' ~' Phone: 202-419-1500 " Email : info@vinylacetate.org 

## I I MAR -7 AM11 : 14 March 2, 2011 JimWillis US EPAHeadquarters Ariel Rios Building 

### 1200 Pennsylvania Avenue, NW Washington, DC 20460 Via email : willisjim@epa.gov 

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RE: Extension Request to Comply with TSCA Section 4 Test Rule on Acetaldehvde; Request for Meeting with Section 4 and EDSP Professionals Dear Jim : On behalf of the membership in the Acetaldehyde Working Group (AWG)1, I am writing to request a ten (10) month extension of time to submit the Reproductive/ Developmental Screening Test ("Screening Test")ori acetaldehyde that is required by the Toxic Substances Control Act (TSCA) Section,4 Test Rule issued by EPAon January 7, 2011 (76 Fed. Reg. 1067) . We have alsd determined that it may be advantageous to undertake several up-front research projects to enhance the utility of the Screening Test results for purposes of assessing any risk to human health. We further request a meeting with key scientists involved in the TSCASection 4 Test Program, as well as those involved in the Endocrine Disruption Screening Program

(EDSP), to discuss testing needs for acetaldehyde. We believe such a meeting is critical to ensure that testing is both cost-effective and does not result in excessive use of animals to fulfill the testing requirements. We hope such a meeting can be scheduled within the next forth-five (45) days. 

### Part ofthe rationale for the extension request is based on the reactivity of acetaldehyde. Additional time is needed to develop and validate analytical methods that can be used to: Measure the stability andpresence of acetaldehyde in the drinking water and/or the vehicle that might be used for a gavage study as well as the feed. Ifa drinking water study were conducted, methods will be needed to validate the dosing solutions as well as the stability ofacetaldehyde in water over the dosing period. Also, given that acetaldehyde is a natural component ofdifferent foods, ' The Acetaldehyde Working Group is organized administratively underthe Vinyl Acetate Council . Members of the Vinyl Acetate Council and Acetaldehyde Working Group include : Celanese, Ltd. ; The Dow Chemical Company; E.I . DuPont de Nemours; Eastman Chemical Company; Lyondell Basell ; and Wacker Chemie. 

## CONTAINS NOCBIJimWillis

March 2, 2011 Page 2 of 3 

### we feel it is important to establish the acetaldehyde content ofthe food and water that will be consumed by the rodents during the course ofthe study. The results from

these analytical measurements are likely necessary to determine whether to conduct the study via drinking water or gavage. Develop/validate an analytical method for measuring acetaldehyde in blood. While the testing guidelines do not explicitly require blood measurements, we feel that it is important to establish a baseline measurement of blood and perhaps other biologic tissues in order to assess changes in blood measurements during the course of the study . 

### In addition, AWGmembers would like additional time to: Investigate whether it is feasible/cost-effective to incorporate into the test compound a small amount of low-level radiolabelled material for possible tissue analysis at a later date. Assuming cost-effective, we might want to preserve the tissues for later analysis in order to enhance the pharmacokinetic information available on acetaldehyde. Investigate whether it would be useful to collect and preserve cells for possible DNA adduct analysis at a later date. These latter two activities represent potential supplemental actions that we are considering undertaking to enhance the value ofthe Section 4 studies and any required EDSP studies. We would like to discuss with the Agency these potential research initiatives as well as the overall testing programon acetaldehyde, taking into account the TSCA Section 4 requirements and the testing proposed under the EDSP. As highlighted in the comments we filed (attached) on the proposed EDSP List 2 notice (70Fed. Reg. 70248), we feel there is a need for greater coordination of professionals within the Agency's two programs as both programs address reproductive endpoints but use markedly different approaches/protocols. AWGbelieves it is critically important for the key Agency scientists and policy makers fromboth the TSCA Section 4 and EDSP programs to meet with the AWGin order to discuss comprehensively the various testing needs for acetaldehyde. If these programs are not coordinated, we believe there may be a wasteful expenditure of both public and private sector resources and an excessive use of animals that is not consistent with minimization of animal use in toxicity testing. 

### Thank you in advance for your attention to this matter. I will plan to contact your office later this week to discuss organizing a meeting.JimWillis

March 2, 2011 Page 3 of 3 

### Sincerely,

Robert J. Fensterheim cc: John Schaeffer, EPA schaeffer.john@epa.gov Document Control Office (7407) Office of Pollution Prevention and Toxics, US Environmental Protection Agency RoomG099 1200 Pennsylvania Avenue, NW Washington, DC 20460 

### ATTN : TSCA Section 4

### ACETALDEHYDE WORKING GROUP 1250ConnecticutAvenue, NW - Suite 700" Washington, DC20036 Phone: 202-419-1500 " Email : info@vinylacetate.org 

### January 18, 2011 Document Control Office (7407M) Office of Pollution Prevention &Toxics Environmental Protection Agency 1200 Pennsylvania Avenue, NW Washington, DC 20460 

### RE: Comments on Inclusion ofAcetaldehyde (CAS No 75-07-0) in "Endocrine Dlsruptor Screening Program : Second List ofChemicals for Tier 1 Screening" [75 FR 70248~ 11/17/2010EPA-HQ-OPPT 2009 04771 Dear Sir or Madam

: TheAcetaldehyde Working Group' (AWG) appreciates the opportunity to provide comments on the US Environmental Protection Agency's (EPA) announcement of a second list of chemicals for which EPA is considering issuing Test Orders in accordance with the Endocrine Disruptor Screening Program(EDSP) . AWGmember companies2 have an interest in acetaldehyde because some members manufacture acetaldehyde for commercial purposes and acetaldehyde is a metabolite ofvinyl acetate monomer, an important commercial product manufactured and/or processed by members of the Vinyl Acetate Council . As discussed in the comments, the inclusion of acetaldehyde as a "drinking water contaminant" on the EDSP List 2, does not appearjustified in light of the statutory directive of §1457 ofthe Safe Drinking Water Act since drinking water is a minor source of the public's exposure to acetaldehyde. At the same time, the AWGwould welcome the opportunity to meet with EPAto discuss the need for testing ofacetaldehyde. 

### AWGmembers believe such a meeting should be arranged soon in light ofthe TSCA Section 4 Test Rule that EPApublished onJanuary 7, 2011 (76 Fed. Reg. 1067), which mandates that manufacturers ofacetaldehyde conduct a reproductive/developmental effects screening study (40 CFR9355) and an acute daphnid/algal toxicity study. This Test Rule is directed at the same companies identified in the proposed EDSPtesting programand requires the conduct of a reproductive and development screening study. The main difference is that the EDSP programemploys an extensive battery of endocrine screening assays that will be used, in a still to be defined weight of evidence evaluation, to decide on the need for more extensive and robust in vivo reproduction effects testing than the protocol required by the TSCA rule. As such, ' The Acetaldehyde Working Group is organized administratively underthe Vinyl Acetate Council . 2 Members ofthe Vinyl Acetate Council and Acetaldehyde WorkingGroup include: Celanese, Ltd.; The Dow Chemical Company

; E.I . DuPont de Nemours; Eastman Chemical Company; LyondellBasell ; and, Wacker Chemie.Document Control Office (7407M)

January 18, 2011 Page 2 AWGbelieves it is critically important for EPA(including the key Agency scientists and policy makers fromboth the TSCA Section 4 and EDSP) to meet with the affected industry to discuss comprehensively the various testing needs for acetaldehyde. If these programs are not coordinated, we believe the result will be a wasteful expenditure of both public and private sector resources and an inefficient use of animals that is not consistent with minimization of animal use in toxicity testing. 

### Ifyou have any questions regarding these comments, please contact me at (202) 419-1500 or rfensterheim@regnet .com . Sincerely,

Robert J. Fensterheim Executive Director