United States
Environmental Protection
Agency
Prevention, Pesticides
And Toxic Substances
(75O8W) ..
EPA-738-F-9.f-009
M3V1998
&EPA R.E.D. FACTS
Butralin
Pesticide All pesticides sold or distributed in the United States must be
Reregistration 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.
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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 tbxicity. 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.
Use Profile
Regulatory
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 2075, Butralin.
Butralin is a>dinitroaniline herbicide used as a plant growth regulator
on flue-cured and air-cured tobacco. The one end use product formulation
is a ready-to-use solution. Tobacco use is considered to be a non food use.
Butralin was first registered as a pesticide in the U.S. in 1976. As
part of the re-registration process the Agency issued a Data Call-In (DCI)
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Human Health
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required additional data to support the turf grass uses registered at
that time. In addition, there were tolerances for food uses that were no
longer on the label. The food uses were not supported and the Agency is in
the process of revoking the tolerances.
Toxicity
In studies using laboratory animals, butralin generally has been shown
Jto be of|low acute toxicity_. It has been placed in Toxicity Category III for
feS «<3[Ui!i£:i&23LfP4&i i8liiieS°,,?u,r,e, ^4, eZe, JEJMJP, nit i and i Toxicity
lategory IV for the dermal and inhalation routes. The carcinogenicity
classification for butralin has been not determined.
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Dietary, Exposure
People are not likely to be exposed to residues of butralin either
through their diet or drinking water since there are no food or feed uses and
groundwater contamination from butralin is unlikely.
Occupational Exposure ' ' ' ' '
"Workers: can^beexposed to this pesticide during mixing/loading and
application to tobacco fields as well as from post application exposure.
EPA is generally not concerned with occupational risk if MOEs
(margins of exposures) are greater than 100. For butralin, the calculation
for intermediate-term dermal risk show that,MOEs are less than 100 for:
1). mixing/loading liquids for groundboom;
2). mixing/loading/applicators spraying with a backpack sprayer;
3). mixing/loading/applicators spraying with a low volume pressure,
hand wand; and,
i 4). by jug Application.
All of the above use scenarios have acceptable MOEs with the use of
chemical resistant gloves.
Other ConsTdelratlpns '
Because butr^J|n nas no foc^ uses tne Specjfic determinations outlined
l| FQPA are not required. Therejre^no,residential uses and exposure from
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The Agency has not made a determination whether butralin and any
otfier pesticide have a common mechanism of toxicity that would require a
cumulative risk assessment. F.or the purposes of this RED, EPA has
considered only the risks from butralin. If required, cumulative risks will
be assessed when methodologies for determining common mechanism of
and for performing cumulative risk assessments are finalized.
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Environmental
Assessment
Environmental Fate
For the currently registered use of butralin, the Agency typically
requires an abbreviated set of environmental fate data on hydrolysis,
metabolism, and mobility.
Based on existing data, butralin is likely to be moderately persistent to
persistent and relatively immobile in terrestrial environments. Butralin is
stable to abiotic hydrolysis and photodegradation on soil. It does not exhibit
fate and transport characteristics similar to chemicals that are known to
leach to groundwater. >
Risk Mitigation
Additional Data
Required
Product Labeling
Changes Required
Ecological Effects/Risk
Calculated acute avian risks do not exceed the Level of Concern
(LOG). The acute LOC has,been exceeded for small mammals such as the
meadow vole and least shrew, but the Agency is riot recommending a
restricted use classification since the actual exposure is expected to be
reduced because of the directed spray application method to the tobacco
plant. The acute LOC to freshwater fish has not been exceeded although
they have been for freshwater invertebrates. The acute LOC for estuarine
and marine fish and shrimp have been slightly exceeded. The Agency
concludes that the overall acute impact on freshwater and terrestrial non-
target organisms from the use of butralin qn tobacco will be minimal. The
Agency is requiring Tier 2 testing for terrestrial and aquatic plants. The
Agency cannot determine the impact of butralin to non-target plants but it
can be assumed that the plant growth regulator will adversely affect non-
target plants if they are exposed.
The Agency is requiring the use of chemical resistant gloves and a 12
hour re-entry interval. The Agency is also establishing the minimum
Worker Protection Standard (WPS) Personal Protective Equipment (PPE) of
coveralls, chemical-resistant gloves, shoes and socks for early re-entry.
EPA is requiring product-specific data including product chemistry
and acute toxicity studies, and revised labeling for reregistration. Some
additional ecological effects and environmental fate data are being required
for confirmatory purposes.
All butralin end-use products must comply with EPA's current
pesticide product labeling requirements and the chemical resistant glove
requirement, the 12 hour restricted entry interval, the early entry PPE
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;i:;Regulatory
Conclusion
TheTise of currently registered products containing butralin in
accordance with changes specified in this document will not pose
unreasonable risks of adverse effects to humans or the environment.
Therefore, all uses of these products are eligible for reregistration.
.; For Morel
Information
Butralin products will be reregistered once the required product-
specific data, any Teqwedco^mato^ generic datsi, product specific data,
CSFs, and revised labeling are received and accepted by EPA.
EPA is requesting public comments on the Reregistration Eligibility
Decision (RED) document for butralin 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
''''' n> DC 20460, telephone
703-305-5805.
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Electronic copies of the RED and this fact sheet are available on the
Internet. See http://www.epa.gov/oppsrrdl/REDs/.
Printed copies of the RED and fact sheet can be obtained from EPA's
National Center for Environmental Publications and Information
(EPA/NCEPIX PO Bait 42419" Cincinnati^ OH 45242-2419, phone 1-800-
490-9198; fax 513-489-8695.
Following the comment period, the butralin RED document also will
tie available (from .the .National TecMcd JnfprrnatiQn Service (NTIS), 5285
Port Royal Road, Springfield, VA 22161, phone 703-605-6000
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For more information^about EPA's pesticide reregistration program,
the butralin RED, or reregistration of individual products containing
butralin, please contact the Special Review and Reregistration Division
(7508W), OPP, US EPA, Washington, DC 20460, phone 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 Pesticides Telecommunications Network (NPTN). 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.
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