Document ID: EPA-HQ-OPP-2005-0323-0014
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2007-09-18T04:00Z

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 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 that describe the human
health and environmental effects of each pesticide.  To implement
provisions of the Food Quality Protection Act (FQPA) 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
current human health and safety standards and can be used without posing
unreasonable risks to human health and 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 the pesticide Sethoxydim
(2-[1-(ethoxyimino)butyl]-5-[2-(ethlthio)propyl]3-hydroxy-2-cyclohexen-1
-one]), case number 02600.





Sethoxydim is a cyclohexenone herbicide. 

Sethoxydim is only registered as a 13% emulsifiable concentrate.

Sethoxydim is currently registered for use in or on at least 86
different agricultural crops such as various grains, fruits, tree nuts,
vegetables and herbs, as well as non-agricultural sites, including
ornamentals and flowering plants, recreational areas, rights-of-way,
along fences, hedgerows, and public and commercial buildings/structures.

The principal sethoxydim uses are on soybeans, sunflowers, alfalfa, dry
peas/beans, sugar beets, peanuts and corn. 

Application rates range from 0.09 to .47 lb ai/A in or on actively
growing crops. 

Sethoxydim is used post-emergence for selective control of annual and
perennial grass weeds in broadleaf crops.

Approximately one million pounds of the active ingredient sethoxydim are
applied each year, with the vast majority being used in the agricultural
setting.

Sethoxydim is moderately toxic via oral, dermal and inhalation routes of
exposure.

Sethoxydim is not irritating to the skin or eye.

The most prevalent concerns about sethoxydim are associated with effects
on the liver.

The Agency considers the sethoxydim database to be adequate to assess
developmental toxicity without the need to require a developmental
neurotoxicity (DNT) study. 

Sethoxydim inhalation risks do not exceed the Agency’s level of
concern (LOC) for all exposure scenarios and no dermal endpoint of
concern was identified for sethoxydim, thus no dermal assessment was
conducted. 

Sethoxydim is not likely to be carcinogenic in humans based on lack of
evidence of carcinogenicity in rats and mice.

Dietary Exposure and Risk

Acute and chronic dietary risks for food and drinking water are below
the Agency’s LOC (i.e., less than 100 percent of the population
adjusted dose (PAD)).  

The most highly exposed population subgroups for acute and chronic
dietary risk were children 1-2 years old and children 3-5 years old, at
approximately 9.2% of the acute PAD and infants (<1 year old) at an
estimated 7.5% of the chronic PAD.  

Aggregate risks resulting from exposure to sethoxydim in food and
drinking water, are below the agency’s LOC. 

Occupational and Residential Exposure and Risk

Sethoxydim is classified in Toxicity Category III for acute oral, dermal
and inhalation, and Toxicity Category IV for and primary eye and skin
irritation; therefore, the current REI of 12 hours is appropriate and
will remain on labels. 

Pesticide Handlers Exposure Database (PHED) data were used with other
Agency standard values for areas treated per day, body weight and the
level of personal protective equipment (PPE) and engineering controls to
assess handler exposures to sethoxydim. 

Occupational handler inhalation risks do not exceed EPA’s LOC (i.e.,
MOEs > 100) for all exposure scenarios. 



Sethoxydim has a high solubility and mobility with a low octanol/water
partition coefficient and is unlikely to contaminate ground or surface
waters because it is not persistent under most conditions. 

Sethoxydim (technical) is practically non-toxic to mammals on an acute
basis and no risks are expected for maximum label rates. 

For terrestrial plants, sethoxydim is selectively toxic to grasses,
which are monocot plants, and is not particularly toxic to dicot plants.

Aquatic grasses (monocots) were not tested for their response to
sethoxydim.

Sethoxydim is practically non-toxic to honey bees. Adverse effects to
beneficial insects are not expected at maximum label rates.

Sethoxydim is practically non-toxic to birds on an acute basis

The Agency’s LOC is exceeded for direct chronic effects to birds, and
effects to terrestrial and semi-aquatic monocots. 

Acute and chronic risk to fish and invertebrates are below the
agency’s LOC. 

The chronic LOC was exceeded for all animals consuming short grass from
applications to citrus and tree nut sites.

The Agency is not requiring any additional risk-based mitigation
measures for sethoxydim at this time. 

	EPA is requiring the following additional generic studies for
sethoxydim to confirm its regulatory assessments and conclusions:

Ecological Data Requirements

OPPTS GLN 850.4525	Seedling emergence (using TEP)

OPPTS GLN 850.2300	Avian Reproduction

OPPTS GLN 850.1400	Early-life stage Estuarine Fish (using 40% TEP or the
technical sethoxydim)

OPPTS GLN 850.1350	Life Cycle Aquatic Invertebrate 

OPPTS GLN 850.4225	Seedling Emergence

OPPTS GLN 850.4250	Vegetative Vigor (Partial)

OPPTS GLN 850.SS1		Vascular aquatic plant for grasses (using TEP)

Residue Chemistry

OPPTS GLN 1500		Two safflower field trails from Region 10

The sethoxydim end-use product must comply with EPA's current pesticide
product labeling requirements and with the following.  For a
comprehensive list of labeling requirements, please see the sethoxydim
RED document.      

EPA has determined that all supported uses of sethoxydim are eligible
for reregistration 

Electronic copies of the sethoxydim RED and all supporting documents are
available in Docket #EPA-HQ-OPP-2005-0323 at http://www.regulations.gov.

For more information about EPA's pesticide reregistration program, the
sethoxydim RED, or reregistration of individual products containing
sethoxydim, please contact the Special Review and Reregistration
Division (7508P), Office of Pesticide Programs, 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 am Pacific Time, or 9:30
am to 7:30 pm Eastern Standard Time, seven days a week.  The NPIC
internet address is http://npic.orst.edu. 

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United States			Prevention, Pesticides		EPA -738-F-07-008

Environmental Protection		And Toxic Substances		September 2007

Agency				(7508P)

R.E.D. FACTS

Sethoxydim

Pesticide Reregistration

Use Profile

Human Health Assessment

Environmental Assessment

Risk Mitigation

Additional Data Required

Product Labeling Changes Required

Regulatory Conclusion

For More Information