United States
Environmental Protection
Agency
Prevention, Pesticides
And Toxic Substances
(7508C)
EPA-738-F-05-007
September 2005
R.E.D. FACTS
Pesticide
Reregistration
Chloroneb
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 generally 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 chloroneb (Chemical Code
027301 and Case No. 0007).
Use Profile
Chloroneb (l,4-dichloro-2,5-dimethoxybenzene) is a fungicide currently
registered for use on a wide variety of food crops but is primarily used for pre-plant
cottonseed treatment as well as on commercial turf and ornamentals. The markets
for chloroneb seed treatment uses include: sugar beets, soybeans, cotton, and
beans.
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Treated cottonseed are used in the cotton growing states of CA, AZ, MS, LA, AR,
TX and KS with lower use in AL, GA, SC, TN and NC. Turf uses are primarily in
midwestern and northeastern states as well as FL for use on golf courses.
Chloroneb can be applied as a seed treatment, foliar spray, chemigation, ground
spray, drip, and soil drench.
Human Health Acute Toxicity
Assessment
Chloroneb has been shown to have low dermal, oral and inhalation toxicity.
It is classified as Toxicity Category IV for oral ingestion, dermal toxicity, and
inhalation toxicity, and Toxicity Category III for eye irritation. Chloroneb is a
dermal sensitizer.
The category ratings are:
Category I = very highly or highly toxic
Category II = moderately toxic
Category III = slightly toxic
Category IV = practically non-toxic
Dietary Exposure and Risk
EPA has assessed the dietary risk (food and drinking water) posed by
chloroneb. No acute dietary assessment was performed since an endpoint
attributable to a single exposure was not identified from the available database.
Chronic (non-cancer) risks from combined food and water are below the Agency's
level of concern and the Agency concluded that chloroneb is unlikely to pose a
dietary cancer risk.
Residential and Occupational Exposure and Risk
There is a potential risk from postapplication exposure (dermal and incidental
oral) in residential settings, such as recreational areas, golf courses, and home lawns
resulting from entering areas previously treated with chloroneb. There is also a
potential risk from occupational exposure from the application of chloroneb on both
food and non-food use sites resulting from handling chloroneb products (i.e.,
mixer/loaders and applicators) and for occupational postapplication exposure
resulting from entering areas previously treated with chloroneb.
FQPA Considerations
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The Environmental Protection Agency (EPA) has concluded its reregistration
eligibility decision for chloroneb and determined that the chemical is eligible for
reregistration provided that: (1) current data gaps and additional data needs are
addressed; (2) the risk mitigation measures outlined in this document are adopted;
and (3) label amendments are made to implement these measures. The 24
tolerances for chloroneb are now considered reassessed as safe under section
408(q) of FFDCA, as amended by FQPA.
The Agency concluded that the toxicology data base for chloroneb is not
complete, since an acceptable 2-generation reproduction study is not available and
therefore an FQPA 10X database uncertainty factor has been retained. In
addition, the Agency is requiring other studies for the reregistration of chloroneb.
Potential exposures from food, drinking water, and residential scenarios were
considered, and aggregated for chloroneb. The pathways for adults lead to
exposure via the oral (dietary) and dermal (residential) routes. The pathways for
children lead to exposure via the oral (dietary) and, dermal and incidental oral
(residential) routes. The aggregate risks from residential exposure alone (excluding
dietary exposure), all had risks of concern.
EPA has found no information indicating chloroneb shares a common
mechanism of toxicity with other substances. Chloroneb does not appear to
produce a toxic metabolite produced by other substances. Therefore, for the
purposes of tolerance reassessment and a decision on reregistration eligibility, EPA
is not assuming that chloroneb shares a common mechanism of toxicity with other
compounds. In the future, if additional information suggests chloroneb shares a
common mechanism of toxicity with other compounds, additional testing may be
required and a cumulative assessment may be necessary.
Environmental
Assessment
The assessment of the fate and transport properties of chloroneb is based
upon an incomplete data set. Therefore, there are uncertainties associated with the
fate and transport behavior of chloroneb and its major degradates. Based on
available data, chloroneb is expected to leach to ground water under sandy soils, as
degradation would be expected to slow down when chloroneb leaches below the
root zone. Chloroneb is mobile and is expected to be transported to surface water,
through runoff.
For ecological risks, there are exceedences of the level of concern (LOG)
for endangered species, or no data to dismiss the concern for endangered species,
in the following taxa: avian, mammal, freshwater fish and invertebrates, and
estuarine/marine organisms. For avian and freshwater organisms, the risk quotients
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exceeded the endangered species acute LOG, and no chronic data are available.
For mammals and estuarine/marine organisms, no relevant acute or chronic data are
available to dismiss the concern for endangered species.
Risk Mitigation To mitigate residential and occupational risks to chloroneb and to reduce
potential exposures to wildlife, the registrant has agreed to:
voluntarily cancel the use of chloroneb on residential lawns and turf, as well
as on lawns and turf at parks and schools;
• amend its label to remove ornamentals, all other turf, bedding plants, ferns,
and on-farm seed treatment from its label pending the Agency receipt,
review, and acceptance of a 21-day dermal toxicology study and
reevaluation of risk; and,
voluntarily amend labeling for turf uses as follows, if the revised risk
assessment based on the dermal toxicity study indicates (see above)
acceptable risks:
• restrict use on turf to golf course tees, greens, collars, aprons, and spot
treatment of fairways, as well as, professional athletic turf (football,
baseball fields, etc.)
• limit the number of applications on golf courses to 6 per year; 4
applications at 7 Ib ai/A and 2 applications at 16 Ib ai/A
limit maximum use per year on golf courses to 60 Ib ai/acre/year
require a minimum retreatment interval of 14 days for golf course tees,
greens, and aprons, and professional athletic fields;
• replace the wettable powder formulation with the use of water soluble
packaging for commercial seed treatment, and require a closed loading
system when loading/applying liquid for commercial seed treatment.
EPA is requiring confirmatory data for chloroneb. These include: (1) the 2-
Additinnal Data generation reproduction data in the rat; (2) oncogenicity data in the mouse; and (3)
Required combined chronic toxicity/oncogenicity data in the rat. In addition, the Agency is
requiring other studies for the reregistration of chloroneb. For a complete listing of
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required studies with corresponding guideline number, see Section V. of the
chloroneb RED document.
Product Labeling The chloroneb end-use product must comply with EPA's pesticide product
Changes Required labeling requirements summarized in the RED. For a comprehensive list of labeling
requirements, please see Section V. of the chloroneb RED document.
Regulatory
Conclusion
EPA has concluded its reregistration eligibility decision for chloroneb and
determined that the chemical is eligible for reregistration provided that: (1) current
data gaps and additional data needs are addressed; (2) the risk mitigation measures
outlined in this document are adopted; and (3) label amendments are made to
implement these measures.
For More
Information
EPA is making the Reregistration Eligibility Decision (RED) document and all
supporting documents for chloroneb available, as announced in a Notice of
Availability published in the Federal Register November 16, 2005. To obtain a
copy of the RED document, please contact the Pesticide Docket, Public
Information and Records Integrity Branch, Information Technology and Resource
Management Division (7502C), Office of Pesticide Programs (OPP), US EPA,
Washington, DC 20460, telephone 703-305-5805. Please refer to EPA Docket
number OPP-2004-0369.
Electronic copies of the RED and this fact sheet are available on the Internet.
See : //www. gov/pesti ci on/status .htm.
For more information about EPA's pesticide reregistration program, the
chloroneb RED, or reregistration of individual products containing chloroneb,
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. The NPIC internet address is hj^^/nguxorstedu.
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