UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON D.C., 20460

OFFICE  OF 

PREVENTION, PESTICIDES AND 

TOXIC SUBSTANCES

MEMORANDUM							DATE: 2 October 2009

SUBJECT:	Reply to Formal Response Concerning Use of Two Avian
Reproduction Studies to Fulfill Notice of Registration Requirement for
Chlorophacinone

FROM:	Andrew Shelby, Physical Scientist

		Environmental Fate and Effects Division, Environmental Risk Branch II

				

THRU:	Tom Bailey, Branch Chief

		Environmental Fate and Effects Division, Environmental Risk Branch II

TO:		Dan Peacock, Biologist

		Registration Division, Insecticide Rodenticide Branch

		

	The Agency has reviewed the request to waive the avian reproduction
study data requirement for chlorophacinone submitted by Liphatech Inc. 
The Agency is unable to accept the two studies suggested to fulfill this
requirement for the reasons outlined below.

	The first suggested study was “Subacute and Subchronic Toxicity of
Chlorophacinone in Japanese Quail” (MRID 47323201) published in the
Archives of Experimental Veterinary Medicine.  While we reserve the
discretion to include open literature studies in our risk assessments,
we cannot accept this open literature study as a replacement for the
avian reproduction study requirement.  Over 90% of the avian
reproduction endpoints are not measured.  Though total mass of eggs and
eggs per hen are measured, embryo survival endpoints, hatching endpoints
and hatchling survival endpoints are not determined.  Finally, raw data
is not included disallowing independent validation of the results.  

The second suggested study was “Avian Reproduction Study with
Difenacoum in the Japanese Quail” (MRID 46799101).  Chlorophacinone
and difenacoum are very distinct chemicals.  Treating difenacoum as a
surrogate chemical is inappropriate and cannot be justified without an
acceptable bridging strategy.  Disparate chemical structures preclude
the acceptance of this study for fulfilling the avian reproduction data
gap for chlorophacinone. 

	Please refer to OPPTS Harmonized Test Guideline 850.2300 for a more
thorough explanation as to how to fulfill this data requirement.  The
Agency welcomes constructive comments and suggestions through the
registration process.  However, your formal response does not satisfy
conditions of our May 13, 2009 Notice of Registration to your company. 
For further consideration of this new use registration of Rozol,
acceptable avian reproduction studies on two species must be submitted
in accordance with registration timelines.

