October 27, 2008 

Karl Simon

Division Director

Compliance and Innovative Strategies Division 

1200 Pennsylvania Avenue, N.W. 

Mail Code: 6406J

Washington, DC 20460

RE:	CAA Section 211(b) Fuels and Fuel Additives Health Effects Testing
Regulation:  Draft Final Report Gasoline with TBAVapor Condensate –
Whole Body Inhalation Developmental Toxicity Study in Rats with Gasoline
with TBA Vapor Condensate (Project Number 171834)

Dear Mr. Karl Simon:

The American Petroleum Institute (API), on behalf of the Section 211(b)
Research Group (RG), is submitting the following information for EPA
review and approval as partial fulfillment of the CAA Section 211(b)
Alternative Tier 2 requirements of the testing regulation:  

Draft Final Report: Whole Body Inhalation Developmental Toxicity Study
in Rats  with Gasoline with TBA Vapor Condensate 

Reviewer Checklist 

Tracked Changes:   Whole Body Inhalation Developmental Toxicity Study in
Rats  with Gasoline with TBA Vapor Condensate 

The Draft Final Report addresses all EPA and independent reviewer
comments as indicated, with page citation, in the Reviewer Checklist.   
 

When the RG receives EPA’s approval of this draft report, the final
study report will be submitted to you at the EPA Office of
Transportation and Air Quality, Transportation and Regional Programs
Division, as part of the requirements of Clean Air Act Section 211(b)(2)
and 211(e) (Docket No. A-90-07). If you require further information,
please contact me at 202-682-8344 or   HYPERLINK "mailto:whiter@api.org"
 whiter@api.org . 

Sincerely,

Russell D. White

Encl (3):	

Second Draft Final Report:   Whole Body Inhalation Developmental
Toxicity Study in Rats with 

Gasoline with TBA Vapor Condensate (Project Number 171834)

Reviewer Checklist 

Tracked Changes:   Whole Body Inhalation Developmental Toxicity Study in
Rats  with Gasoline with       TBA Vapor Condensate  (Project Number
171834)

	

Cc:	Gary Timmer, EMBSI Study Director (via email)

	211b RG Oversight and Technical Committees

	Joe Sopata, EPA (via email)

	Amanda Evans, EPA (via email)

	Dave Kortum, EPA (via email)

  Project Number 171834

October 27, 2008

Page   PAGE  2  of   NUMPAGES  2 

Russell D. White, Ph.D. DABT

Manager, Health Sciences

Regulatory and Scientific Affairs

1220 L Street, NW

Washington, DC  20005-4070

USA

Telephone	202-682-8344

Fax	202-682-8030

Email	whiter@api.org

www.api.org

