United States
                       Environmental Protection
                       Prevention, Pesticides
                       And Toxic Substances
October, 2002
         Use Profile
     All pesticides sold or distributed in the United States must be registered by
EPA, based on scientific studies showing that they can be used without posing
unreasonable risks to people or the environment. Because of advances in
scientific knowledge, the law requires that pesticides which were first registered
before November 1,1984, be reregistered to ensure that they meet today's more
stringent standards.
     In evaluating pesticides for reregistration, EPA obtains and reviews a
complete set of studies from pesticide producers, describing the human health and
environmental effects of each pesticide. To implement provisions of the Food
Quality Protection Act of 1996, EPA considers the special sensitivity of infants
and children to pesticides, as well as aggregate exposure of the public to pesticide
residues from all sources, and the cumulative effects of pesticides and other
compounds with common mechanisms of toxicity. The Agency develops any
mitigation measures or regulatory controls needed to effectively reduce each
pesticide's risks.  EPA then reregisters pesticides that meet the safety standard of
the FQPA and can be used without posing unreasonable risks to human health or
the environment.
     When a pesticide is eligible for reregistration, EPA explains the basis for its
decision in a Reregistration Eligibility Decision (RED) document. This fact sheet
summarizes the information in the RED document for reregistration case 2490,

     Oxyfluorfen is a diphenyl-ether herbicide used for broad spectrum pre- and
post-emergent control of annual broadleaf and grassy weeds in a variety of tree
fruit, nut, vine, and field crops. The largest agricultural markets in terms of total
pounds active ingedient are wine grapes and almonds. There are also non-
agricultural ornamental and forestry uses. Oxyfluorfen is also used for weed
control in landscapes, patios, driveways, and similar areas in residential sites.

     Oxyfluorfen was first registered in the United States in 1979 to control pre-
emergent and post-emergent broadleaf and grassy weeds in a variety of field,
fruit, and vegetable crops, ornamentals, as well as non-crop sites. It is
manufactured by Dow AgroSciences and Makhteshim-Agan under the trade
names Goal and Galigan.  Data call-ins were issued in 1991,1993, and 1995. In
January 2002, the risk Assessments were made publicly available for comment
and a close-out conference call was conducted on July 25,2002, to discuss the
risk management decisions and resultant changes to the oxyfluorfen labels.

Human Health    Toxicity
  Assessment        Oxyfluorfen is of low acute oral, dermal, and inhalation toxicity. The
                     primary toxic effects are alterations in blood parameters (anemia) and in the liver.
                     Oxyfluorfen is classified as a possible human carcinogen based on combined
                     hepatocellular adenomas/carcinomas in the mouse carcinogenicity study. A
                     cancer potency factor (Ql *) was used to estimate human risk. The FQPA Safety
                     Factor for protection of infants and children was reduced to IX for all population
                     subgroups as there was no increased susceptibility in animals due to pre- or post-
                     natal exposure to Oxyfluorfen.

                     Dietary Exposure
                         No adverse effects reflecting a single dose were identified in lexicological
                     studies; therefore, no acute endpoint was selected and an acute dietary risk
                     assessment was not conducted. EPA's dietary risk analysis for Oxyfluorfen
                     evaluated chronic (non-cancer) and cancer risk.  For these chronic food risk
                     assessments, anticipated residues were calculated using either USDA Pesticide
                     Data Program (PDP) monitoring data or field trial data. Both data sets are
                     consistent in that they show all non-detectable residues.
                         Based on this analysis, the percentage of cPAD utilized is expected to be
                     less than 1 percent for the U.S. population and all subpopulations. Therefore, the
                     chronic (non-cancer) dietary risk estimate from food alone is not of concern.
                     Cancer risk from food is  calculated by using a linear low-dose risk model
                     ("Qi*") to determine the lifetime cancer risk estimate. The Agency generally
                     considers risks greater than 1 x 10"6 (1  in 1 million) to exceed its level of concern
                     for cancer dietary exposure. Using the Q}* of 7.32 x 10 '2 results in a maximum
                     estimated lifetime cancer risk to the U.S. general population of 3.8 x 10"7.
                     Therefore, the cancer risk from food alone is also not of concern.
                         People may be exposed to residues of oxyfluorfen through the diet.
                     Tolerances or maximum residue limits have been established for 33 fruits,
                     vegetables and nut trees as well as meat commodities (please see 40 CFR
                     180.381). EPA has reassessed the oxyfluorfen tolerances and found that the
                     majority are acceptable. New tolerances must be proposed/established for cotton
                     gin byproducts, soybean forage, soybean hay, and grass forage, grass hay, and
                     grass seed screenings.

                     Occupational and Residential Exposure
                         Based on current use patterns, handlers (mixers, loaders, and applicators)
                     may be exposed to oxyfluorfen during and after  normal use of liquid and granular
                     formulations in agricultural and other settings. Oxyfluorfen is used in the
                     residential environment by homeowners to kill weeds on patios, driveways and
                     similar surfaces, Oxyfluorfen homeowner products are intended solely for spot
                     treatment; they are not used for broadcast treatment of lawns because they kill

                      FQPA Considerations
                          Chronic (non-cancer) Aggregate Risk - This assessment addresses exposure
                      to oxyfluorfen residues in food and water only, as there are no chronic residential
                      scenarios identified. Comparison of the chronic DWLOCs with the
                      environmental concentrations of oxyfluorfen shows that estimated surface and
                      groundwater concentrations are substantially less than the DWLOCs for all
                      populations. Consequently, the Agency concludes that residues of oxyfluorfen in
                      food and drinking water do not result in a chronic aggregate risk of concern.
                          Short-term Aggregate Risk - Short-term DWLOCs were calculated based
                      upon average food residues, and the residential handler exposure which resulted
                      in the greatest risk (spot treatment of weeds using a RTU trigger pump sprayer).
                      DWLOC calculations are for adults only since the residential exposure is to
                      applicators.  Surface and ground water concentrations estimated using
                      conservative modeling are less than the short-term DWLOCs for oxyfluorfen.
                      Consequently, there are no short-term aggregate risk concerns  from food,
                      drinking water and residential exposures.
                          Cancer Aggregate Risk - The chronic food cancer risk estimate of 3.8 x 10"7,
                      combined with the highest residential cancer risk estimate of 8.7 x 10"7, results in
                      a food + residential cancer risk of 1.3 x 10**. Since the Agency's level of concern
                      is 1.0 x 10 "*, cancer risk slightly exceeds EPA's level of concern when
                      considering both food and residential exposures.  However, since PDF
                      monitoring and field trial data showed all residues on food were non-detects, the
                      food risk estimate is considered upper-bound. Screening-level surface water
                      modeling indicates that there may be a concern for oxyfluorfen in drinking water,
                      but this water modeling  is also considered upper-bound.

                      Occupational and Residential Risk
                          Cancer risk to workers is of greater concern than non-cancer risk.
                      Occupational cancer risks, when calculated without personal protective
                      equipment or engineering controls, can range up to  1 x 10"3. With the protection
                      specified on several current labels, most scenarios result in cancer risks in the 10"5
                          The residential assessment for oxyfluorfen only addresses the applicator,
                      because negligible postapplication exposure is anticipated from spot treatment of
                      weeds.  None of the residential applicator scenarios are of concern because the
                      short-term MOEs are greater than 100 and the cancer risks are less than 1.0 x

Environmental        Oxyfluorfen has the potential to affect terrestrial plants and aquatic
  Assessment    ecological systems at all levels, as it is toxic to plants, invertebrates, and fish, and
                      has been shown to drift from application sites to nearby areas.  Birds and
                      mammals may also experience subchronic and chronic effects from oxyfluorfen

Environmental Fate
     Oxyfluorfen is persistent and relatively immobile in soil. The most likely
route of dissipation is soil binding. Laboratory data suggest that once the soil-
bound oxyfluorfen reaches deep or turbid surface water it will persist since it is
stable to hydrolysis and since light penetration would be limited; however, it may
degrade by photolysis in clear, shallow water. Oxyfluorfen can contaminate
surface water through spray drift and runoff; however, it is unlikely to
contaminate ground water because it is relatively immobile in the soil column;
therefore, the likelihood of leaching is small. No degradates were identified, and
therefore, only the parent, oxyfluorfen, is of toxicological concern for risk
Ecological Effects
     For acute exposures, oxyfluorfen is practically non-toxic to birds, mammals,
and bees, and the Agency has no risk concerns.  However,  subchronic and
chronic risks to terrestrial birds and mammals do present a concern.  These toxic
effects may be manifested as reproductive, developmental, and hemolytic
consequences. Assuming maximum residue values, the chronic level of concern
is exceeded when oxyfluorfen is applied to crops at application rates greater than
or equal to 0,25 Ibs ai/acre/year for birds and greater than or equal to 2.0 Ibs
ai/acre for mammals. In addition, the potential of oxyfluorfen (as a light-
dependent peroxidizing herbicide) to be more toxic in the presence of intense
light may lead to the occurrence of more serious environmental effects that are
not predicted by standard guideline toxicity tests.  Oxyfluorfen is highly toxic to
very highly toxic to fish and aquatic invertebrates.  However, concentrations
predicted by the Agency's surface water models from normal use are generally
not high enough to cause an acute concern for fish. Chronic risk to fish and acute
and chronic risk to aquatic invertebrates may occur from some uses of
     There are acute concerns for freshwater algal plants for all uses of
oxyfluorfen.  The risk to vascular aquatic plants cannot be  assessed due to lack of
data.  Oxyfluorfen is expected and has been shown to negatively impact seedling
emergence and vegetative vigor of terrestrial plants. Non-target terrestrial plants
are exposed to oxyfluorfen as a result of spray drift and runoff and most incidents
reported to the Agency are related to plants affected by spray drift. Acute levels
of concern are exceeded for all uses of oxyfluorfen for terrestrial plants and semi-
aquatic plants adjacent to treated areas.

Ecological Effects Risk Assessment
     Generally, the Agency believes that oxyfluorfen presents the greatest risks
to terrestrial plants and to aquatic organisms through spray drift of liquid
formulations and runoff of dissolved and soil entrained oxyfluorfen.

    Risk Mitigation
    Additional Data
  Product Labeling
Changes Required
     To lessen the risks of cancer from drinking water, occupational risks, and
risks to wildlife posed by oxyfluorfen, EPA is requiring the following risk
mitigation measures:
o Lower the maximum rate to 1.5 Ibs ai/broadcast acre/season for food crops and
2 Ibs ai/acre/season for conifer seedlings,
o For liquid formulations and granulars applied to field-grown ornamentals,
registrants have agreed to lower this seasonal maximum rate to 4,5 Ibs ai/A (1.5
Ibs ai/A/application). For granulars applied to containerized ornamentals, the rate
will be lowered to a seasonal  maximum of 6 Ibs ai/A (2 Ibs ai/A/application).
 Label language will be added to require 25 foot, no-spray, vegetative buffer
zones around surface water bodies such as rivers, lakes, streams, and ponds.
o To minimize oxyfluorfen drift, only use of a coarse, very coarse, or extremely
coarse spray will be allowed according to the ASAE 572 definitions for standard
nozzles, or a volume median diameter (VMD) of 385 microns or larger for
spinning atomizer nozzles.
 The maximum application  rate on residential products will be reduced to 3 Ibs
ai/A or less unless efficacy data support the need for higher rates.
o Closed mixing/loading systems to support applications to corn, cotton,
soybeans, and aerial applications to fallow land.
 Enclosed cab for applications to corn, and closed cockpit aircraft for
applications to fallow land.
o Double layer Personal Protective Equipment  (PPE) for all other mixers,
loaders, and applicators.

     EPA is requiring the following additional generic studies for oxyfluorfen to
confirm its regulatory assessments and conclusions:  21-day Dermal Toxicity
Study in Rats; Crop Field Trials in Bananas and Cacao Beans; Estuarine/marine
Fish Early-life Stage; Whole Sediment Invertebrate Freshwater Acute Toxicity;
Whole Sediment Invertebrate Estuarine/marine Acute Toxicity; Seed
Germination/Seedling Emergence; Vegetative Vigor; Aquatic Plant Growth;
Dislodgeable Foliar Residue Study in Conifers; Fish Phototoxicity Study; and
Edge of Field Water and Sediment Monitoring.

     All oxyfluorfen end-use products must comply with EPA's current pesticide
product labeling requirements. For a comprehensive list of labeling requirements,
please see the oxyfluorfen RED document. The labeling requirements table is
available as a separate document.
         Regulatory         T"e use of currently registered products containing oxyfluorfen in
         Conclusion    accordance with approved labeling will not pose unreasonable risks or adverse
                          effects to humans or the environment. Therefore, all uses of these products are
                          eligible for reregistration.

                      All products will be reregistered once the required product-specific data,
                 revised Confidential Statements of Formula, and revised labeling are received and
                 accepted by EPA.

   For More         EPA. is requesting public comments on the Reregistration Eligibility
Information    Decision (RED) document for oxyfluorfen during a 60-day time period, as
                 announced in a Notice of Availability published in the Federal Register.  To
                 obtain a copy of the RED document or to submit written comments, please
                 contact the Pesticide Docket, Public Information and Records Integrity Branch,
                 Information Resources and Services Division (7502C), Office of Pesticide
                 Programs (OPP), US EPA, Washington, DC 20460, telephone 703-305-5805.
                      Electronic copies of the RED and this fact sheet are available on the
                 Internet. See http://www.epa.gov/REDs.
                      Printed copies of the RED and fact sheet can be obtained from EPA's
                 National Service Center for Environmental Publications (EPA/NSCEP),  PO Box
                 42419, Cincinnati, OH 45242-2419, telephone 1-800-490-9198; fax 513-489-
                      Following the comment period, the oxyfluorfen RED document also will be
                 available from the National Technical Information Service (NTIS), 5285 Port
                 Royal Road, Springfield, VA 22161, telephone 1-800-553-6847, or 703-605-
                      For more information about EPA's pesticide reregistration program, the
                 oxyfluorfen RED, or reregistration of individual products containing oxyfluorfen,
                 please contact the Special Review and Reregistration Division (7508C), OPP, US
                 EPA, Washington, DC 20460, telephone 703-308-8000.
                      For information about the health effects of pesticides, or for assistance in
                 recognizing and managing pesticide poisoning symptoms, please contact the
                 National Pesticide Information Center (NPIC). Call toll-free 1-800-858-7378,
                 from 6:30 am to 4:30 pm Pacific Time, or 9:30 am to 7:30 pm Eastern Standard
                 Time, seven days a week.  Their internet address is http://npic.orst.edu.