Document ID: EPA-HQ-OPP-2005-0163-0165
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2006-11-15T05:00Z

Mr. George Fenwick, President					

American Bird Conservancy

P. O. Box 249

4249 Loudoun Ave

The Plains, VA 20198-0249

Dear Mr. Fenwick:

I am writing to respond to your August 28, 2006 letter regarding
aldicarb and its risk to birds.  Your letter indicates that the Agency
has already required the registrant to submit additional avian
reproductive data.  In addition, your letter suggests that the Agency
should wait for this data before issuing a reregistration decision on
aldicarb.  Let me first clarify the status of the two studies that you
have inquired about and then address your second point.  

The Agency has identified the need for two avian reproduction studies in
previously released ecological risk assessments for the N-methyl
carbamate pesticide, aldicarb.  These studies are 71-4(a) Avian
Reproduction – Quail, and 71-4(b) Avian Reproduction – Duck.  In
response to the identified data gaps, Bayer CropScience has commented
that these studies are unnecessary.  It is important to note that the
Agency has not issued a data call in (DCI) notice to Bayer CropScience
requesting these studies.  In other words, the Agency has not formally
requested or required these studies.  When the RED is issued, we may
indeed require these studies as part of the DCI; however, that decision
is yet to come, pending public comment.  Likewise, Bayer CropScience has
not refused to do these studies, but simply presented their argument on
why they feel they are not necessary.  As part of the reregistration
process, the registrant is allowed to comment, as well as other
interested parties, on why they think that additional studies are needed
or not needed, and in turn, the Agency must review these arguments and
will determine if they are valid.  In the case of aldicarb, these
studies have been identified as data gaps and the Agency has responded
to Bayer CropScience’s comments informing them we may  require these
studies, pending public comment.  

In general, when the Agency issues a reregistration decision, the
registrants are sent a DCI after publication of the decision and then
are required to respond accordingly.  The Agency completes
reregistration decisions with the results from studies previously
required of the registrant(s) and will require additional data as
necessary to confirm its decision.  When the Agency receives and reviews
the confirmatory data, changes to the regulatory decision will be made,
if appropriate.

	In responding to your second point that the Agency should wait for the
avain reproduction studies before making a reregistration decision;
it’s important to note that, as mentioned above, these studies have
not previously been required of the registrants.  Given this, the
potential for mortality to birds is an area of initial focus.  Once the
risks and benefits are addressed for acute effects, the potential
chronic reproductive concerns, which are important, can be evaluated
based on the extent of remaining exposure potential that would be
associated with any label changes.

The Agency is currently in Phase 4 of the reregistration process for
aldicarb and will soon be seeking public comment on how to address risks
that aldicarb poses to birds, as well as the benefits of aldicarb use. 
We look forward to receiving your input on risk mitigation options and
continuing to work with you in the future.

Sincerely,

/s/

Debra Edwards, Ph.D.

Director

Special Review and Reregistration Division

Dated November 13, 2006

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C. 20460

OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES