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

J anuary 13 , 201 2

Byron J. Bunker, Acting Division Director Compliance Division Office of Transportation and Air Quality US Environmental Protection Agency 2000 Traverwood Drive Ann Arbor, Michigan 48105

RE: Interim Report # 22

– Fuels and Fuel Additives Health Effects Testing Regulation; Pursuant to Section 211(b)(2) and 211(e) of the Clean Air Act.

Dear Mr. Bunker :

The American Petroleum Institute (API), on behalf of the Secti on 211(b) Research Group is submitting this interim report on the progress and status between 01 J uly 2011 and 0 1 J anuary 2012 of the testing program set forth in the Alternative Tier 2 provisions of the testing regulation.

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 20 10

. 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 final report was submitted to EPA 07 J uly 20 11

.

 Rat and mouse developmental toxicity studies

– The final report of the rat study wa s submitted to EPA 07 July 2009

. The mouse final report was submitted to EPA 04 June 2009. The final r eport of the repeat mouse study was submitted to EPA 06 May 2010.

 Chronic study

– The final report was submitted to EPA 16 June 2010

. A report amendm ent was submitted to EPA on 21 April 2011

.

1 All studies were conducted in rats, unless otherwise notedJuly 18 , 201 1 Page 2 of 3
Gasoline/Ethanol Vapor Condensate:

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

– The final report was submitted to EPA on 24 February 2 0 10.

 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 final r e p o r t w a s s u b m i t t e d t o E P A o n 2 7 D e c e m b e r 2 0 1 1

.

 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 final report was submitted to EPA on 23 March 2011

.

 One

- generation reproductive study

– The final report was submitted to EPA 06 May 2010

.

 Developmental toxicity study

– The final report was submitted to EPA 17 D e cember 2008.

Gasoline/DIPE Vapor Condensate:

 Subchronic study (with GFAP, genotoxicity, immunotoxi city, 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 final report was submitted to EPA 0 2 S e p t e m b e r 201 1

.

 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.

Gasoline/TBA Vapor Condensate:

 Subchronic study (with GFAP, genotoxicity, immunotoxic ity, 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 final report was submitted to EPA 0 2 S e p t e m b e r 201 1

.

 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

– T he definitive study protocol was in f i n a l i z e d a n d t h e i n - l i f e s t u d i e s w e r e i n i t i a t e d i n D e c e m b e r 2 0 1 1

.

 TBA

– Preparation of the final report for the pilot study was in progress.July 18 , 201 1 Page 3 of 3

2. Exposure Screening Studies

T he report entitled “ Section 211(B) Tier 2 High End Exposure Study of Conventional and Oxygenated Gasoline ” and previously submitted associated materials were accepted by EPA on 1 9 May 2010

. A compiled version of the final r eport was submitted to EPA on 10 June 2011, completing the Section 211(B) Tier 2 exposure screening study requir e ments.

Sincerely,

Russell White, Ph.D. Health Sciences Manager

cc: Joe Sopata, EPA (via email)