Document ID: EPA-HQ-OPP-2005-0263-0039
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2009-02-19T05:00Z

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON D.C., 20460

OFFICE  OF 

PREVENTION, PESTICIDES AND 

TOXIC SUBSTANCES

	CERTIFIED MAIL

Michael Schofield

MCPB Task Force

8325 Old Deer Trail

Raleigh, NC 27615

Subject:	MCPB: Response to Time Extension Request letters dated December
2, 2008 and 	February 2, 2009 from the MCPB Task force 

Dear Mr. Schofield:

The Agency has received two time extension request letters (dated
December 2, 2008 and February 2, 2009) regarding three generic data
call-in (GDCI) requirements, which includes an oyster acute toxicity
study (850.1025), acute fish toxicity study (850.1075), and a fish
early-life stage toxicity study (850.1400).  Since the submission of the
December 2, 2008 time extension request letter, the MCPB Task Force has
submitted two of the three outstanding data requirements from the MCPB
GDCI (the oyster acute toxicity study (850.1025), and the acute fish
toxicity study (850.1075)).

In your February 2, 2009 letter, the MCPB Task Force indicated that
chemicals within the water supply of the laboratory conducting the fish
early-life study (850.1400) had repeatedly caused 100% mortality of fish
within 48 hours.  This forced the MCPB Task Force to seek an alternate
contract laboratory to conduct the study.  As a result, the MCPB Task
Force requested to further extend the fish early-life stage toxicity
study due date from April 20, 2009 (which was requested in the December
2, 2008 time extension request letter) to August 24, 2009.

	The MCPB Task Force’s rationale and proposed timeframe for
conducting/submitting this study is adequate justification for a time
extension request.  Therefore, the Agency will extend the time extension
due date to August 24, 2009 for the (guideline 850.1400) fish early-life
stage toxicity data requirement.

If you have any questions, please contact James Parker of my staff at
(703) 306-0469.

							Sincerely, 

                                      				 

							(s)

							

							Richard P. Keigwin, Jr., Director 

							Special Review & Reregistration Division