An equal opportunity employer 

1220 L Street, Northwest Russell White

Washington, DC 20005-4070 Health Sciences Manager 

Tel 202-682-8344 

Fax 202-682-8270 

whiter@api.org

January 5, 2010 

Karl Simon 

Division Director, Office of Transportation and Air Quality Compliance and Innovative Strategies 

Division 

USEPA 1200 Pennsylvania Avenue, N.W. (6406J) 

Washington, D.C. 20460 

RE: Interim Report # 18 – Fuels and Fuel Additives Health Effects Testing Regulation; 

Pursuant to Section 211(b)(2) and 211(e) of the Clean Air Act. 

Dear Mr. Simon: 

The American Petroleum Institute (API), on behalf of the Section 211(b) Research Group (RG) 

is submitting this interim report on the progress and status between 1 July 2009 and 1 January 

2010 of the testing program set forth in the Alternative Tier 2 provisions of the testing regulation. 

1. Toxicology Testing1

Baseline Gasoline Vapor Condensate 

• Subchronic study (with GFAP, genotoxicity, immunotoxicity, and neurotoxicity assays) 

– The final report was submitted to EPA 05 July 2007. 

• Two-generation reproductive study – The final report was submitted to EPA 23 January 

2009. 

• Rat and mouse developmental toxicity studies – The rat final report was submitted to 

EPA 11 August 2008. The mouse final report was revised and resubmitted to EPA 

23 November 2009. 

• Chronic study – The second draft report was submitted to EPA on October 16, 

2009. 

Gasoline/MTBE Vapor Condensate: 

• Subchronic study (with GFAP, genotoxicity, immunotoxicity, and neurotoxicity assays) 

– The final report was submitted to EPA 14 September 2007. 

• Two-generation reproductive study – Preparation of the second draft report was in 

progress. 

• Rat and mouse developmental toxicity studies – The final report of the rat study was 

submitted to EPA on July 7, 2009. The mouse final report was submitted to EPA on 

04 June 2009. Preparation of the second draft report of the repeat mouse study was in 

progress.

• Chronic – The second draft report was submitted to EPA on October 16, 2009.

 

1

 All studies were conducted in rats, unless otherwise noted 
January 5, 2010 

Page 2 

Gasoline/Ethanol Vapor Condensate: 

• Subchronic study (with GFAP, genotoxicity, immunotoxicity, and neurotoxicity assays) 

– Preparation of the final report was in progress. 

• One-generation reproductive toxicity study – The final report was submitted to EPA 29 

May 2009.

• Developmental toxicity study -The final report was submitted to EPA 10 December 

2008.

Gasoline/TAME Vapor Condensate: 

• Subchronic study (with GFAP, genotoxicity, immunotoxicity, and neurotoxicity assays) 

– The second draft report was submitted to EPA on 16 October 2009. 

• One-generation reproductive study - The final report was submitted to EPA 29 May 

2009. 

• Developmental toxicity study – The final report was submitted to EPA 17 December 

2008.

Gasoline/ETBE Vapor Condensate: 

• Subchronic study (with GFAP, genotoxicity, immunotoxicity, and neurotoxicity assays) 

– The second draft report was submitted to EPA on 05 August 2009.

• One-generation reproductive study – Preparation of the second draft report was in 

progress.

• Developmental toxicity study – The final report was submitted to EPA 17 December 

2008.

Gasoline/DIPE Vapor Condensate: 

• Subchronic study (with GFAP, genotoxicity, immunotoxicity, and neurotoxicity assays) 

– The draft report and response to peer-reviewers comments was sent to EPA on 

December 14, 2009.

• One-generation reproductive study - Preparation of the second draft report was in 

progress. 

• Developmental toxicity study – Preparation of the RG response to peer reviewer 

comments on the first draft of the repeat study was in progress. 

Gasoline/TBA Vapor Condensate: 

• Subchronic study (with GFAP, genotoxicity, immunotoxicity, and neurotoxicity assays) - 

The draft report and response to peer-reviewers comments was sent to EPA on 

December 14, 2009.

• One-generation reproductive study - Preparation of the second draft report was in 

progress. 

• Developmental toxicity study - The final report was submitted to EPA on October 

16, 2009. 

Pharmacokinetic Studies on DIPE, ETBE, and TBA:

• ETBE – Preparation of the first draft report was in progress. 

• DIPE – Preparation of the first draft report for pilot studies was in progress. 

• TBA – EPA approved draft pilot study report on 31 March 2009. 
January 5, 2010 

Page 3 

2. Exposure Screening Studies

A supplemental report with expanded Tables and Figures for data on acetaldehyde and 

errata to the Section 211(B) Tier 2 High End Exposure Study of Conventional and 

Oxygenated Gasoline was sent to EPA on September 14, 2009. 

Sincerely, 

Russell White, Ph.D. 

Health Sciences Manager 

cc: Joe Sopata, EPA (via email)