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ACETALDEHYDE WORKING GROUP 

,FCFI~~E [1 

1250 Connecticut Avenue, NW " Suite 700 " Washington, DC 2003$''' ~' 

Phone: 202-419-1500 " Email: info@vinylacetate.org 

I I MAR -7 AM 11 : 14 

March 2, 2011 

Jim Willis 

US EPA Headquarters 

Ariel Rios Building 

1200 Pennsylvania Avenue, NW 

Washington, DC 20460 

Via email: willis jim@epa.gov 

uu~uen~ruio~0 uumu0 uui 

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 EPA on 

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 TSCA Section 

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 of the 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 and presence of acetaldehyde in the drinking water and/or 

the vehicle that might be used for a gavage study as well as the feed. If a 

drinking water study were conducted, methods will be needed to validate the 

dosing solutions as well as the stability of acetaldehyde in water over the dosing 

period. Also, given that acetaldehyde is a natural component of different foods, 

' The Acetaldehyde Working Group is organized administratively under the 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 NO CBI 
Jim Willis 

March 2, 2011 

Page 2 of 3 

we feel it is important to establish the acetaldehyde content of the food and 

water that will be consumed by the rodents during the course of the 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, AWG members 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 of the 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 program on 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 (70 Fed. 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 . AWG believes it is critically important for 

the key Agency scientists and policy makers from both the TSCA Section 4 and EDSP 

programs to meet with the AWG in 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. 
Jim Willis 

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 

Room G099 

1200 Pennsylvania Avenue, NW 

Washington, DC 20460 

ATTN: TSCA Section 4 
ACETALDEHYDE WORKING GROUP 

1250 Connecticut Avenue, NW - Suite 700 " Washington, DC 20036 

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 of Acetaldehyde (CAS No 75- 07- 0) in "Endocrine 

Dlsruptor Screening Program: Second List of Chemicals for Tier 1 

Screening" [75 FR 70248~ 11/17/2010EPA-HQ-OPPT 2009 04771 

Dear Sir or Madam : 

The Acetaldehyde 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). AWG member companies2 

have an interest in acetaldehyde because some members manufacture acetaldehyde for 

commercial purposes and acetaldehyde is a metabolite of vinyl 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 appear justified in light of the statutory 

directive of § 1457 of the Safe Drinking Water Act since drinking water is a minor source 

of the public's exposure to acetaldehyde. At the same time, the AWG would welcome 

the opportunity to meet with EPA to discuss the need for testing of acetaldehyde. 

AWG members believe such a meeting should be arranged soon in light of the TSCA Section 4 Test Rule that EPA published on January 7, 2011 (76 Fed. Reg. 1067), 

which mandates that manufacturers of acetaldehyde conduct a 

reproductive/developmental effects screening study (40 CFR 9355) and an acute 

daphnid/algal toxicity study. This Test Rule is directed at the same companies identified 

in the proposed EDSP testing program and requires the conduct of a reproductive and 

development screening study. The main difference is that the EDSP program employs 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 under the Vinyl Acetate Council. 

2 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; LyondellBasell ; and, Wacker Chemie. 
Document Control Office (7407M) 

January 18, 2011 

Page 2 

AWG believes it is critically important for EPA (including the key Agency scientists and 

policy makers from both 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. 

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

Sincerely, 

Robert J. Fensterheim 

Executive Director