Document ID: EPA-HQ-OAR-2003-0065-0447
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2008-04-10T04:00Z

November 5, 2007

Karl Simon

Acting 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:  Second Draft Final Report Gasoline Ethanol Vapor Condensate
- A One-Generation Whole-Body Inhalation Reproduction Toxicity Study in
Rats (Study No. 00-4203)

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:

Second Draft Final Report: Gasoline Ethanol Vapor Condensate - A
One-Generation Whole-Body Inhalation Reproduction Toxicity Study in Rats
(Study No. 00-4203)

Reviewer Checklist

List of Final Revisions 

The Second Draft Final Report addresses all EPA and independent reviewer
comments as indicated, with page citation, in the Reviewer Checklist.
Additionally, during the RG review of the second draft report, a few
minor items needing correction were noted as described in the List of
Final Revisions. These final revisions to be made to the report do not
affect the conclusions from the study.

The RG requests EPA approval of the report pending appropriate report
revision as specified in the List of Final Revisions.  The List of Final
Revisions will be sent to the laboratory after receipt of EPA’s
approval.

When the RG receives EPA’s approval of the second 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 Tom Gray by mail at this address.

Regards,

Thomas M. Gray

Encl (3):	Second draft final report: Gasoline Ethanol Vapor Condensate -
A One-Generation Whole-Body	Inhalation Reproduction Toxicity Study in
Rats (Study No. 00-4203)

	Reviewer Checklist

	List of Final Revisions

Cc:	Gary Hoffman, HLS Study Director (via email)

	211b RG Oversight and Technical Committees

	Joe Sopata, EPA (via email)

	Monica Alvarez, EPA (via email)

	Amanda Evans, EPA (via email)

	Dave Kortum, EPA (via email)

  FILENAME  \* MERGEFORMAT  2007_march20_ETHANOL_1gen_ cvrletter 		An
equal opportunity employer

Thomas M. Gray 

211(b) Technical Manager 

1220 L Street, Northwest	

Washington, DC  20005-4070	

Tel	202-682-8479

Fax 	202-682-8031

E-mail	grayt@api.org