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 10, 2011

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 # 20 – 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 01 July 2010 and 01 January 2011 of the testing program set forth in the Alternative Tier 2 provisions of the testing regulation.

I would like to call two issues to your attent ion. First, the RG received a report amendment on September 21 st from the performing laboratory for the chronic study on Gasoline/MTBE Vapor Condensate. This is after EPA had accepted the final report for this study. The RG had an independent quality assurance review of the proposed amendment done and the performing laboratory is now preparing an amended report. The RG will send the amended report to EPA upon completion.

Second, the protocol and study schedule for pharmacokinetic studies on DIPE will be available soon. The RG will be asking EPA for an expedited re view of the protocol so the performing laboratories can keep to the study schedule.

1. Toxicology Testing 1

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 final report was submitted to EPA 16 June 2010.

1 All studies were conducted in rats, unless otherwise notedJuly 6, 2010 Page 2 of 3 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 – The second draft report was accepted by EPA on 17 December 2010. Preparation of the final report was in progress.

• Rat and mouse developmental toxicity studies – The final report of the rat study was submitted to EPA 07 July 2009. The mouse final report was submitted to EPA 04 June 2009. The final report of the repeat mouse study was submitted to EPA 06 May 2010.

• Chronic study – The final report was submitted to EPA 16 June 2010. An amended report was being prepared by the performing laboratory.

Gasoline/Ethanol Vapor Condensate:

• Subchronic study (with GFAP, genotoxicity, immunotoxicity, and neurotoxicity assays) –The final report was submitted to EPA on 24 February 2010.

• 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 accepted by EPA 09 December 2010. Preparation of the final report was in progress.

• 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) – Preparation of the final report, in response to EPA comments, was in progress.

• One-generation reproductive study – The second draft report was accepted by EPA on 17 December 2010. Preparation of the final report was in progress.

• Developmental toxicity study – The final report was submitted to EPA 17 D e cember 2008.

Gasoline/DIPE Vapor Condensate:

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

– EPA comments on the first draft report and responses to peer-reviewers comments were received 09 December 2010. Preparation of the second draft report was in progress.

• One-generation reproductive study - The second draft report was submitted to EPA on 28 July 2010. The second draft report was accepted by EPA on 17 December 2010. Preparation of the final report was in progress

.

• Developmental toxicity study – EPA comments on the first draft report and responses to peer-reviewers comments were received 17 December 2010. Preparation of the second draft report was in progress.July 6, 2010 Page 3 of 3 Gasoline/TBA Vapor Condensate:

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

– EPA comments on the first draft report and responses to peer-reviewers comments were received on 09 December 2010. Preparation of the second draft report was in progress.

• One-generation reproductive study - The second draft report was accepted by EPA on 17 December 2010. Preparation of the final report was in progress.

• Developmental toxicity stud y - The final report was submitted to EPA 16 October 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. Preparation of the definitive study protocol was in progress.

• TBA – Preparation of the final report for the pilot study was in progress.

2. Exposure Screening Studies

The report entitled “Section 211(B) Tier 2 Hi gh End Exposure Study of Conventional and Oxygenated Gasoline” and previously submitted associated materials were accepted by EPA on 19 May 2010.

Sincerely,

Russell White, Ph.D. Health Sciences Manager

cc: Joe Sopata, EPA (via email)