Document ID: EPA-HQ-OPP-2004-0032-0038
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2006-12-21T05:00Z

SEQ CHAPTER \h \r 1 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON D.C., 20460

  SEQ CHAPTER \h \r 1 OFFICE OF

PREVENTION, PESTICIDES AND TOXIC SUBSTANCES

SUBJECT:	Response to Public Comments on the Formetanate Hydrochloride
Interim Reregistration Eligibility Decision.

TO:		Formetanate Hydrochloride FDMS Docket EPA-HQ-OPP-2004-0032

FROM:	Debbie Edwards, Director

		Special Review and Registration Division 

	The Agency is responding to comments submitted by the public in regards
to the Formetanate Hydrochloride (HCL) Interim Reregistration
Eligibility Decision (IRED).  The IRED was issued for a 60-day comment
period, which ended on August 28, 2006. As a result, the Agency received
five comments from a variety of stakeholders including a private
citizen, Gowan, Co. (the registrant), Northwest Horticultural Council,
California Grape and Tree League (via USDA) and California Citrus
Mutual. 

	Many of the comments received by the Agency from the registrant
addressed toxicological concerns regarding the selection of the dermal
and inhalation endpoints (found in the Health Effects Science Chapter). 
After reviewing the comments regarding the endpoints used in the human
health risk assessment for the IRED, the Agency agrees that the
inhalation endpoint may have been over estimated, and that the more
appropriate point of departure (endpoint) is the BMDL10 of 0.18 mg/kg
calculated from the registrant’s comparative cholinesterase (CCA)
study.  Furthermore, the Agency also reviewed the studies used to select
the dermal endpoint and determined that the 10 mg/kg/day dermal endpoint
was based on non-statistically significant data.  Therefore, the Agency
concluded that the 15 mg/kg/day NOAEL from a 21- day dermal exposure
study would provide a more appropriate dermal endpoint.   As a result of
the increased dermal and inhalation endpoints, the Margin of Exposures
(MOEs) increased which indicated a lower assessed risk when compared to
the risks characterized in the IRED.   

	

	Based on the revised endpoints and increased MOEs, some of the
occupational mitigation measures listed in the IRED (signed on March 15,
2006), have been changed.  Specifically, the revised risk assessment
resulted in acceptable MOEs for orchard air-blast applications when
using double layer PPE.  Therefore, the requirement of a closed cab for
air-blast applications to orchards is no longer required.  Additionally,
the revised dermal endpoints resulted in shorter re-entry intervals
(REI).  Hence, the Restricted Entry Intervals (REIs) were reduced (from
9 to 4 days for alfalfa, 8 to 5 days for pome and stone fruit and 10 to
9 days for citrus fruit). For additional information in regards to the
revised endpoints, please review the Heath Effects Division (HED) memo
(Response to Registrant’s Comments on EPA’s Interim Reregistration
Eligibility Decision for Formetanate HCl).

	The Agency also received comments in regards to aerial applications on
orchards at times when air-blast applications are not possible.  The
MOEs for mixing and loading (for aerial applications) increased due to
the revised endpoints, but the assessed risks remained above the
Agency’s level of concern.  Furthermore, the Biological and Economic
Analysis Division addressed this comment in their response to comments
memorandum (Response to public comments received in response to the IRED
decision for the Formetanate HCl).  Consequently, the Agency determined
that situations which would require the aerial application of
formetanate HCL in orchards are rare and that alternative insecticides
which are registered for aerial use are available.   Therefore, the
prohibition for aerial applications to orchard crops will remain in the
Formetanate HCL IRED.  

	

	Furthermore, there were no comments received in regards to ecological
risks pertaining to formetanate HCl.  

	In conclusion, the Agency has completed its review of the submitted
comments and determined that alternative dermal and inhalation endpoints
are appropriate and therefore have resulted in mitigation changes in the
Formetanate HCl IRED, EPA-HQ-OPP-2004-0032.  Furthermore, the Agency
will be revising the label table and preparing a FR notice to amend the
occupational risk mitigation required by the IRED.