Document ID: EPA-HQ-OAR-2003-0065-0422
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2007-11-14T05:00Z

July 25, 2007

Karl Simon

Division Director

Compliance and Innovative Strategies Division

OTAQ

OAR

USEPA

1200 Pennsylvania Avenue, N. W. 

Mail Code: 6406J

Washington, DC 20460

RE:	CAA Section 211(b) Fuels and Fuel Additives Health Effects Testing
Regulation:  TBA pharmacokinetic protocols for EPA approval 

Dear Mr. Simon:

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

Protocol for a Single Oral Dose Study in Fischer 344 Rats on the Blood
Pharmacokinetics of TBA  

Protocol for a Single- and Repeated-Exposure Inhalation Study in Fischer
344 Rats on the Retained Dose, Metabolism and Distribution  of TBA  

The RG requests EPA approval of the protocols.

After EPA’s approval the RG will post the final protocols to the
Research Group website.  A copy of the ratified  protocols will be
available in the study reports which will be forwarded to 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) (EDocket ID #  EPA-HQ-OAR-2003-0065). If you
require further information, please contact Tom Gray by mail at this
address.

Regards,

Thomas M. Gray, M.S., D.A.B.T.

Encl (2):	TBA Protocols for PK/ADME Studies on TBA

cc:	211b RG Oversight and Technical Committees (via email)

	Joe Sopata, EPA (via email)

	Amanda Evans, EPA (via email)

	Dave Kortum, EPA (via email)

	Monica Alvarez, EPA (via email)

	Stan Durkee, EPA (via email)

	JMichael Davis, EPA (via email)

	William Boyes, EPA (via email)

	Elaina Kenyon, EPA (via email)

		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