UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON D.C., 20460

										

	

PC Code:  004003+

DP Barcode:  379419

	Date:  June 29, 2010

MEMORANDUM	

SUBJECT:	EFED Review of the Data Waiver Request for Allethrins and
Terrestrial Plant and Honey Bee Toxicity Data Requirements for
Registration Review

TO:		      Molly Clayton, Risk Manager Reviewer 		

Michael Goodis, Risk Manager

	Registration Division (7505P)

FROM:	Melissa Panger, Ph.D., Biologist

	Environmental Risk Branch IV

Environmental Fate and Effects Division (7507P)

REVIEWED

BY:	Anita Pease, Senior Biologist

	Environmental Risk Branch IV

Environmental Fate and Effects Division (7507P)

APPROVED

BY:	Mark Corbin, Acting Chief 

	Environmental Risk Branch IV

		      Environmental Fate and Effects Division (7507P)

The Environmental Fate and Effects Division (EFED) has reviewed the
request from Valent BioSciences Corporation (Valent) to waive the
terrestrial plant (850.4100 and 850.4150) and honey bee (Apis mellifera)
toxicity of residues on foliage (850.3030) data requirements requested
as part of the Registration Review process.  The data waiver request was
submitted as a public submission to the allethrins docket
(EPA-HQ-OPP-2010-0022-0013).  After reviewing Valent’s comments, EFED
still considers GLN 850.4100, 850.4150, and 850.3030 data gaps and
recommends that these data be requested for the allethrins Registration
Review ecological risk assessment.  Valent’s comments and EFED’s
response are detailed below. 

COMMENT FROM VALENT:

“In the anticipated risk assessment data need, the Agency indicated
that the following data would be required: Guideline number (GLN)
850.4100 – Seedling Emergence Phytotoxicity (Tier II), and GLN
850.4150 – Vegetative Vigor Phytotoxicity (Tier II).  The Problem
formulation document indicated that these requirements stem from 13
incidents reports between 1995 and 2005.  During the re-registration
process, many allethrins uses that have the potential for direct contact
with plants have been canceled as stated in the problem formulation
document (drainage systems, golf course turf, wide area/general outdoor
treatment, airports/landing fields, uncultivated agricultural areas,
paved areas).  The current allethrins outdoor uses as stated in table
3.2 consist of wasp and hornet nest/aerosol spray, yard and
patio/fogger, mosquito repellant/mat and localized spot treatments of
outdoor areas.  These uses involve direct sprays to plants but only as
spot treatments of localized areas.  Broadcast applications to plants
and other vegetation are prohibited.  Therefore, contact with vegetation
is extremely limited.  Examples of these uses involve foggers that
protect a patio area (3 second spray) during which surrounding
vegetation may be sprayed, limited spot treatments of lawns and
ornamental plants in landscape areas; wasp and hornet sprays (3 seconds
spray on the nest) and spot applications to trees to kill tent
caterpillars, and mosquito repellent mats.  Therefore, Valent Bioscience
Corporation, the technical registrant of allethrins, requests that these
studies be waived for lack of relevance based on the use pattern. 
Similarly, GLN 850.3030 – Honey Bee Toxicity of Residues on Foliage is
not applicable for the same reasons indicated above (very limited direct
contact with plant foliage and direct spray on plants).”

RESPONSE FROM EPA:

As stated in the Problem Formulation for the allethrins, registrants
have reported 13 aggregated terrestrial plant incidents for allethrins
that occurred from 1995 until 2005 (see Attachment 1).  At least eight
of the reported plant incidents (62%) were the result of wasp and hornet
spray applications of allethrins.  In the absence of additional
information on the remaining aggregated plant incidents, it is assumed
that these incidents were also associated with currently registered uses
of allethrins.  Therefore, based on the available incident data, there
is evidence that at least some of the current uses that Valent describes
as having “extremely limited” contact with vegetation (i.e., wasp
and hornet sprays) can cause adverse effects to non-target terrestrial
plants.  Without toxicity data from terrestrial plants it will not be
possible to determine a threshold of potential effects to plants
(primarily those that are federally listed as endangered or threatened)
from allethrin use and risks to terrestrial plants will be assumed. 
Therefore, if future endangered species risk assessments are performed
without these data, the Agency would have to presume risk to non-target
terrestrial plants from the use of allethrins.  As a result, use of the
allethrins and their formulated products may need to be restricted in
areas where listed species could be exposed.  The lack of these data
will limit the flexibility the Agency and registrants have in coming
into compliance with the Endangered Species Act and could result in use
restrictions for the allethrins that are unnecessarily severe.

Regarding GLN 850.3030, the Agency reiterates that under the 40 CFR Part
158 (July 1, 2009) guideline requirements, data on honey bee toxicity of
residues on foliage are required (OPPTS 850.3030) when the acute honey
bee contact LD50 <11 µg/bee and the use pattern(s) indicate(s) that
honey bees may be exposed to the pesticide.  The acute contact LD50 for
allethrin is 3.4 µg a.i./bee (allethrin, MRID 162751), and there is a
potential for exposure to bees from the currently registered uses. 
Therefore, the lack of information on toxicity of residues on foliage to
the honey bee is identified as a data gap.  Since there is no
precautionary honey bee language on allethrin product labels (at least
on a subset of labels reviewed for such language), EFED recommends
requesting a honey bee toxicity of residues on foliage study.  EFED will
assume risks to terrestrial invertebrates if honey bee toxicity of
residues on foliage data are not submitted.  As mentioned above, lack of
these data could result in unnecessarily severe restrictions for
allethrins in order to comply with the Endangered Species Act.

REFERENCE:

MRID: 162751

Stevenson, J. (1968) Laboratory studies on the acute contact and oral
toxicities of insecticides to honeybees. Ann. appl. Biol. 61:467-472. 

ATTACHMENT 1 : Aggregate Ecological Incident Reports for Allethrins.

OFFICE OF

CHEMICAL SAFETY AND

POLLUTION PREVENTION

