United States Prevention, Pesticides EPA 738-F-06-024
Environmental Protection And Toxic Substances August 2006
Agency (7508P)
I.R.E.D. FACTS
Carbofuran
Pesticide Registration
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 reregi strati on, 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 reregi strati on, EPA explains the basis for its
decision in an Interim Reregi strati on Eligibility Decision (IRED) document. This fact
sheet summarizes the information in the IRED document for the N-methyl carbamate
pesticide carbofuran, case number 0101
Regulatory History
Carbofuran was first registered in the United States in 1969 and is classified as a
restricted use pesticide.
Through an agreement between EPA and the technical registrant in 1991, granular
carbofuran has been limited to the sale of 2,500 Ibs per year in the U.S. since 1994, and to
use on spinach grown for seed, pine seedlings, cucurbits, and bananas only.
Additionally, in the late 1990s the technical registrant made a number of changes
to labels for flowable carbofuran in order to reduce drinking water and ecological risks of
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concern. These included reducing application rates and numbers of applications for
alfalfa, cotton, corn, potatoes, soybeans, sugarcane, and sunflowers.
Three human studies have been conducted for carbofuran - one oral and two
dermal. These studies were reviewed by the Agency's Human Studies Review Board
(HSRB) in May 2006. The HSRB concluded that, while informative, the studies are not
appropriate for use by the Agency in either the individual carbofuran or N-methyl
carbamate cumulative risk assessment. The Agency did not use any of the human studies
in the risk assessment for carbofuran.
Uses
Carbofuran is a systemic, broad spectrum N-methyl carbamate insecticide and
nematicide registered for control of soil and foliar pests on a variety of field, fruit,
and vegetable crops. There are no residential uses.
Nearly 1 million pounds of carbofuran are applied annually.
Carbofuran is a restricted use pesticide.
Health Effects
As with other N-methyl carbamate pesticides, the critical effect of carbofuran for
various exposure durations is cholinesterase inhibition; that is, it can
overstimulate the nervous system causing nausea, dizziness, confusion, and at
very high exposures (e.g. accidents or major spills), respiratory paralysis and
death. Similar to other N-methyl carbamate pesticides, inhibition is followed by
rapid recovery of cholinesterase.
Carbofuran is classified as "Not Likely" to be a human carcinogen.
Ecological Effects
Carbofuran is very highly toxic to birds on an acute basis, and highly toxic on a
sub-acute basis. A chronic effect level could not be established due to the fact
that all concentrations tested caused mortality in the test subjects.
Carbofuran is highly toxic to mammals on an acute basis. Chronic toxicity testing
on laboratory rats showed reduced offspring survival and body weight reductions.
Carbofuran is very highly toxic to freshwater and estuarine/marine fish on an
acute basis. The available chronic test showed larval survival as the most
sensitive endpoint for freshwater fish and embryo hatching as the most sensitive
endpoint for estuarine/marine fish.
Carbofuran is considered to be very highly toxic to freshwater and
estuarine/marine invertebrates on an acute basis. Chronic tests showed
reproductive effects.
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Risks
• Three lines of evidence were considered in assessing ecological risks from
carbofuran: a screening level deterministic assessment, a refined probabilistic
assessment, and an evaluation of available field data. All three lines of evidence
support the same conclusion: ecological risks are of concern from all uses of
flowable carbofuran. A screening level assessment for granular carbofuran also
shows risks of concern from all uses of granular carbofuran.
• Occupational risks are of concern from most mixer/loader/applicator scenarios,
even when assessed with engineering controls (i.e. MOEs fail to reach 100).
Additionally, post-application risk assessments indicate the need for restricted
entry intervals (REIs) which are longer than REIs required by current labels.
• Acute dietary risk from food alone is estimated at 260% of the aPAD and 490%
of the aPAD for children 1-2 years old, the population subgroup with the highest
estimated dietary exposure. Chronic dietary risks were not assessed because
cholinesterase inhibition due to carbofuran exposure reverses rapidly. EPA
believes that the acute dietary assessment would be protective of any chronic
exposures in the diet.
• Since acute exposures exceed the aPAD for food alone, EPA is concerned about
any additional exposure (to all subpopulations) through drinking.
Risk Mitigation
To address the assessed risks of concern, the following mitigation measures will be
implemented:
• Cancellation based on high ecological and worker risks and low economic
benefits for growers
Sorghum Alfalfa Sweet corn
Cotton Grapes Field corn and popcorn
Wheat Potatoes Bananas/plantains
Cucurbits (flowable) Oats Soybeans
Barley Tobacco Fallow/idle land
Sugarcane Ornamentals Sugar beets
Peppers (except Chile)
• 4-year Phase-out for the crops which have moderate benefits to growers.
Artichokes, Chile peppers in the Southwestern U.S., cucurbits (granular
formulation only), sunflowers, spinach grown for seed, and pine seedlings
in the Southeastern U.S.
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Regulatory Conclusion
Based on the assessment of ecological and human health risks associated with
carbofuran uses, the Agency has determined that all uses of carbofuran are ineligible for
reregi strati on.
The Agency is proposing to retain tolerances for sugarcane, rice, bananas, and
coffee for imported commodities. The dietary risk from these commodities (food alone)
is 56% of the aPAD for children 1-2 years old, the population subgroup with the highest
estimated dietary exposure.
For More Information
Electronic copies of the Carbofuran IRED and all supporting documents are
available in the public docket EPA-HQ-OPP-2005-0162 located online in the Federal
Docket Management System (FDMS) at http://www.regulations.gov.
For more information about EPA's pesticide reregi strati on program, the
carbofuran IRED, or reregistration of individual products containing carbofuran, 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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