April 30, 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 Ethanol Vapor Condensate
– Whole Body Inhalation Developmental Toxicity Study in Rats with
Gasoline with Ethanol Vapor Condensate (Project Number 171434)

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 Ethanol Vapor Condensate 

Reviewer Checklist (1) 

Reviewer Checklist (2) – Additional Comments 

The Draft Final Report addresses all EPA and independent reviewer
comments as indicated, with page citation, in the Reviewer Checklist
(1).  Because the RG had additional comments when the revised report was
received from the laboratory, a second Reviewer Checklist (2) was
developed to separate new or follow-up comments from the original set.  
  

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

Manager, Health Sciences

Encl (3):	

Second Draft Final Report:   Whole Body Inhalation Developmental
Toxicity Study in Rats with Gasoline with Ethanol Vapor Condensate
(Project Number 171434)

Reviewer Checklist (1)

Reviewer Checklist (2) - Additional Comments

	

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 171434 

April 30, 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

