Document ID: EPA-HQ-OPP-2009-0113-0006
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2009-09-29T04:00Z

Garlic Oil 

Final Work Plan

Registration Review Case 4007



Docket Number: EPA-HQ-OPP-2009-0113

Garlic Oil 

Final Work Plan 

Registration Review Case Number: 4007

					Approved By:

					____________________

							Keith A. Matthews 

Acting Director

                                      				Biopesticides and Pollution
Prevention Division

							

							

Date: __________________

I.  	INTRODUCTION 

This document is EPA’s Final Work Plan for Garlic Oil. The work plan
includes the expected registration review time lines.  The final work
plan is intended to address any public comments received concerning the
Preliminary Work Plan in the Summary Document, which was posted in the
Garlic Oil registration review docket (EPA-HQ-OPP-2009-0113) concerning
the initial docket postings.  The Summary Document provided information
on what EPA knows about the pesticide and what additional risk analyses
and data or information the Agency believes are needed to make a
registration review decision.

The Food Quality Protection Act (FQPA) of 1996 mandated the continuous
review of existing pesticides.  All pesticides distributed or sold in
the United States must generally be registered by EPA, based on
scientific data showing that they will not cause unreasonable risks to
human health (including occupational and non occupational exposures), or
the environment when used as directed on product labeling.  The
registration review program is intended to make sure that, as the
ability to assess risk evolves and as policies and practices change, all
registered pesticides continue to meet the statutory standard of no
unreasonable adverse effects to human health or the environment. 
Changes in science, public policy, and pesticide use practices will
occur over time.  Through the registration review program, the Agency
periodically reevaluates pesticides to make sure that as change occurs,
products in the marketplace can continue to be used safely.  Information
on this program is provided at:   HYPERLINK
"http://www.epa.gov/oppsrrd1/registration_review/" 
http://www.epa.gov/oppsrrd1/registration_review/ . 

In 2006, the Agency implemented the Registration Review program pursuant
to FIFRA Section 3(g) and will review each registered pesticide every 15
years to determine whether it continues to meet the FIFRA standard for
registration. 

The EPA first registered a product containing garlic oil in 1983.  There
are 11 products registered with the Agency containing garlic, garlic
oil, and garlic powder.  The labels for these products list the active
ingredient as Garlic Oil, Garlic Juice, Garlic Water, or Garlic.  The
Agency considers all such variations 

of garlic or garlic oil as falling under the PC Code 128827 and Registry
Number 8000-78-0. Further references herein are to garlic oil or garlic.
  Of the 11 registered products containing garlic oil as an active
ingredient, two products are registered as insect repellents for
agricultural use. The remaining products are registered for use as
animal and insect repellents.  Two of the 11 products contain garlic oil
as the only active ingredient.   The other products contain additional
minimal risk products such as capsaicin, and putrescent whole egg solids
as active ingredients along with garlic. All products are water-based
compounds with extract of garlic or garlic powder. 

As a biochemical active ingredient, garlic oil is used as a repellent
for the control of insects, mites, birds, deer, rabbits and squirrels
and is registered for use on terrestrial food and feed such as
vegetables, fruits nuts and grains. Garlic oil is also registered for
use on terrestrial non-food crops such as ornamental plants and shrubs. 

II. 	RESPONSES TO COMMENTS

During the 60 day comment period that closed on May 26, 2009, the Agency
received no comments. 

 

RISK ASSESSMENT AND DATA NEEDS

Product Chemistry Assessment  

All product chemistry data requirements for garlic oil have been
satisfied.  Assessment of these data show that they continue to meet the
standard for registration under FIFRA, as amended by the FQPA. No
further product chemistry data are required.  For currently registered
label uses of garlic oil, please refer to the Garlic Oil Summary
document posted in the initial docket (EPA-HQ-OPP-2009-0113) for a more
detailed discussion. 

		Human Health Risk Assessment  

Based on the available data and information, the Agency does not foresee
the need for new data or for a new human health risk assessment.  All
data requirements per 40 CFR 158.2050 have been fulfilled for garlic
oil.  Please refer to the Garlic Oil Summary document posted in the
initial docket (EPA-HQ-OPP-2009-0113) for a more detailed discussion.  

Environmental Fate and Ecological Risk Assessment  

Effects on Nontarget Organisms 

All nontarget toxicity data requirements for garlic oil have been
fulfilled and meet the standard for registration required under FIFRA,
as amended by FQPA.  Based on the available information for garlic oil,
the Agency does not foresee the need for additional ecotoxicity data or
a new risk assessment.   Please refer to the Garlic Oil Summary document
posted in the initial docket (EPA-HQ-OPP-2009-0113) for a more detailed
discussion. 

Endangered Species Risk Assessment 

The Agency has not completed an endangered species risk assessment at
this time.  An endangered species assessment will be conducted prior to
the issuance of the Proposed Final Decision. 

		IV.	ESTIMATED TIMELINE

 

Activities	Estimated Month/Year

Open  Public Comment Period for Garlic Docket  	March 2009

Close Public Comment Period 	May  2009

Phase 2:  Case Development

Develop Final Work Plan (FWP)	September 2009

Complete Endangered Species Assessment	October2009

Phase 3: Registration Review Decision

Open Public Comment Period for  Proposed Registration  Review Decision 
February 2010

Close Public Comment Period 	April  2010

Final Decision and Begin Post-Decision Follow-up	September 2010

*Estimated Total (years)	                1 year 5 months

*  EPA has created the following estimated timeline for completion of
the garlic registration review case.  This schedule is subject to
revision should unforeseen issues arise during the registration review
process.  

V.	NEXT STEPS

As mentioned in the Risk Assessment and Data Needs section above, an
Endangered Species assessment is ongoing and will be complete in advance
of the announcement of a Proposed Registration Review Decision.  

	Page   PAGE  2  of   NUMPAGES  5 

Docket Number: EPA-HQ-OPP-2009-0113

  HYPERLINK "http://www.regulations.gov"  www.regulations.gov