United States
Environmental Protection
Agency '
Prevention, Pesticides
And Toxic Substances
(7508W)
EPA-738-F-96-013
August 1996
R.E.D. FACTS
Bromacil
Pesticide
Reregistration
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.
Under the Food Quality Protection Act of 1996, EPA must consider
the increased susceptibility of infants and children to pesticide residues in -
food, as well as aggregate exposure of the public to pesticide residues from
all sources, and the cumulative effects of pesticides and other compounds
with a common mechanism of toxicity in establishing or reassessing
tolerances.
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. 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 0041, bromacil and salts, which includes bromacil per se
and the lithium salt of bromacil.
Bromacil is a broad spectrum herbicide used to control weeds in the
agricultural food crops citrus and pineapple. In addition, both bromacil and
its lithium salt are used to control weeds and brush hi nonagricultural areas
including utility right-of-ways, railroads, electrical switching stations, and
industrial yards. '
Formulations include emulsifiable concentrate, granular, liquid ready-
to-use, pellets or tablets, pressurized liquid, liquid soluble concentrate,
wettable powder, and water dispersible granules (dry flowable).
Bromacil is applied mainly by. sprayers including boom, hand-held,
knapsack, compressed air, tank-type, and power sprayers. Bromacil is also
applied using aerosol, shaker, or sprinkler cans. Solid forms of bromacil
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Regulatory
History
Human Health
Assessment
are spread using granule applicators and spreaders. Application using
aircraft is allowed only for Special Local Need registrations to control
vegetation on the Department of Defense's Yakima Firing Center in the
state of Washington. »
Use practice limitations include prohibitions on direct application to
water, areas where surface water is present or intertidal areas below the
mean high water mark. They also prohibit application through any type of
irrigation system. Bromacil may not be applied directly to water or
wetlands, and should be kept out of lakes, streams, and ponds.
Bromacil was first registered as a pesticide in the U.S. in 1961. EPA
issued a Registration Standard for bromacil in September 1982 (PB87-
110276). A Data Call-In (DCI) was issued in September of 1991 requiring
additional chemistry, toxicology, ecological, and environmental fate data.
As of April of 1996, 95 products were registered. In addition to federal
regulation, the states of Florida and California have imposed more stringent
regulations on the use of bromacil because of its occurrence in ground-water.
On August 3,1996, the Food Quality Protection Act of 1996 (FQPA) was
signed into law. FQPA amends both the Federal Food, Drug, and Cosmetic
Act (FFDCA), and the Federal Insecticide, Fungicide, and Rodenticide Act
(FIFRA) . The FQPA amendments went into effect immediately and were
considered during this reregistration decision.
Toxicity
In studies using laboratory animals, bromacil is slightly toxic by the
oral, dermal, and inhalation routes and has been placed in Toxicity Category
IV (the lowest of four categories) for these effects. Bromacil per seis
mildly irritating to the eyes (Toxicity Category III). The lithium salt of
bromacil, however, is moderately irritating to the eyes (Toxicity Category
II).
In a chronic feeding study using beagle dogs, bromacil caused
decreased body weight gain. In another chronic study using rats, effects in
addition to reduced body weight gain include (1) increased incidence of
thyroid cysts in the high dose males; (2) enlargement of the thymus in high
dose females; and (3) dose-related incidence of thyroid tumors in the males.
Bromacil has been evaluated for potential carcinogenic activity in rats
and mice. Bromacil is classified as a Group C possible human carcinogen
based on increases in incidence of liver tumors in male mice, and positive
trends in thyroid tumors in male rats, and, to a lesser extent, structural
activity relationship to similar compounds.
Bromacil demonstrates some evidence of causing developmental
toxicity effects in rats and rabbits. These effects are likely due to maternal
toxicity from exposure to bromacil rather than from specific developmental
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toxicity of bromacil. Therefore, the Agency does not consider bromacil a
developmental toxicant.
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Dietary Exposure
.People may be exposed to residues of bromacil through the diet.
Tolerances or Maximum Residue Limits (MRLs) have been established for
citrus and pineapple at 0.1 ppm (see 40 Code of Federal Regulations
180.210). EPA has reassessed the bromacil tolerances' in accordance with
FQPA and found that both are acceptable.
No MRLs for bromacil have been established by Codex for any
agricultural commodity. Therefore, no compatibility issues exist with
respect to U.S. tolerances.
Occupational Exposure
Based on current use patterns, handlers (mixers, loaders, and
applicators) may be exposed to bromacil during and after normal use in
agricultural and other settings.
Because bromacil is a possible human carcinogen and systemic
toxicity may result from intermediate exposure (one week to several
months), EPA assessed risk to workers using several major exposure
scenarios.
Human Risk Assessment
Bromacil generally is of low acute toxicity, but demonstrates thyroid,
adrenal, eye, and thymus effects in animal studies and has been classified as
a Group C, possible human carcinogen. EPA has reassessed the dietary risk
posed by bromacil's uses on citrus and pineapple and has concluded the
cancer and chronic toxicity risks posed to the general population are very
low. Dietary chronic risk is not of concern because present tolerances for
bromacil result in a Theoretical Maximum Residue Concentration which
represents less than one percent of the Reference Dose (the amount believed
not to cause adverse effects if consumed daily over a 70-year lifetime) for
the U.S. general population. This low fraction of the allowable RfD is
considered to be an acceptable dietary exposure risk.
Of greater concern is the risk posed to bromacil handlers, particularly
mixers/loaders/applicators. Margins of Exposure (MOEs) for subchronic
systemic effects are unacceptable (less than 100) for mixers/loaders of the
wettahle powder and dry flowable formulations. Exposure and risk to
workers will be mitigated by the use of Personal Protective Equipment
(PPE) required by the Agency's Worker Protection Standard; supplemented
by chemical resistant gloves for all formulations and a dust mask for the
wettable powder formulation, as required by this RED. PPE requirements
will be confirmed using the 28-day dermal study currently being developed
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by the registrant. Post-application reentry workers will be required to
observe a 12-hour (bromacil) or a 24-hour (bromacil lithium salt) Restricted
Entry Interval.
EPA conducted additional risk analyses using available data in
response to the new FQPA requirements. The Agency found that the
bromacil data base for pre- and post-natal effects is complete based on
current requirements, and that these studies indicate no special -sensiiivj^yof
young organisms to bromacil. EPA concludes that no additional safety
factor is warranted hi assessing risks to infants- and children. The EPA
considered aggregate exposures from all-sources of bromacil (food and
drinking water) and concluded that aggregate risks for infants and children
and the general population resulting from bromacil uses are not of concern.
Based on available information, bromacil does not appear to have a
common mode of toxicity with other substances and therefore cumulative
effects are not anticipated.
Environmental
Assessment Environmental Fate
Parent bromacil is persistent and highly mobile, and has been detected
in groundwater. Bromacil is stable to hydrolysis under normal
environmental conditions. The primary routes of dissipation appear to be
photolysis in water under alkaline conditions and microbial degradation in
anaerobic soil. Bromacil's persistence is demonstrated by half-lives of 124
to 155 days hi the field dissipation studies.
Ecological Effects
Acute toxicity to bromacil ranges from practically nontoxic to slightly
toxic for birds, mammals, honey bees, fish, and estuarine and marine
species. New studies are required to determine its chronic toxicity to
nontarget species. Bromacil is toxic to non-target plants.
Ecological Effects Risk Assessment
Acute as well as chronic exposures to nontarget organisms can result
from direct application, spray drift, and runoff from treated areas.
Agency levels of concern (LOCs) have been exceeded for acute
toxicity to birds, reptiles, and mammals at the historic higher application
rates which were as high as 32 pounds of active ingredient per acre (Ibs
ai/A). In addition, the concentration of bromacil that is estimated to occur
in puddles or shallow irrigation ditches exceeds the fish and amphibian
LOCs at most application rates. For non-target plants, the LOCs are
_ exceeded by very large margins in virtually all use situations.
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Risk Mitigation
Additional Data
Required
The Agency was unable to complete its assessment of the chronic and
reproductive effects from exposure to bromacil since it lacked the necessary
studies to assess risk. Potential for exposure to bromacil for non-target
terrestrial and aquatic animals is considered to be high because it is
persistent in soil and water, and may be applied repeatedly throughout the
year.
To lessen worker risk, and ecological and water quality risks posed by
bromacil, EPA is requiring the following mitigation measures from
registrants of bromacil-containing products.
° For all risk concerns:
Reduce the maximuirrrate of application from 32 Ibs ai/A to 12 Ibs
ai/A (except for undersurface treatment of toxic-waste holding ponds at 25
Ibs ai/A).
o To protect workers:
Additional PPE are being required for workers mixing, loading, and
applying bromacil. Chemical resistant gloves are required for most of the
formulations during mixing and loading. A dust mask is required for the
wettable powder formulation.
The total number of acres that may be treated by a worker in one day
is being restricted to to five for the toxic-waste holding pond liner
treatment.
° To protect non-target organisms:
Continue existing Jabel warnings addressing the potential exposure of
very sensitive areas, such as wetlands, to bromacil. Remove label
instructions that allow direct application to water (e.g. treating ditchbanks).
° To protect water resources, the Agency is requiring that registrants:
Develop training materials to explain management practices that can
reduce potential for contamination of water resources;
Standardize use rates for certain weed control situations (i.e. for use in
citrus orchards or to control specific problem weeds); and
Change labels to specifiy the time of application.
In addition, the Agency supports risk mitigation measures taken by
the states of California and Florida to protect their groundwater resources.
These include the ban on use of bromacil on the Central Ridge of Florida
and the creation of Pesticide Management Zones for bromacil in California.
EPA is requiring me following additional generic studies for bromacil
to confirm its regulatory assessments and conclusions:
• Avian Reproduction Quail [71-4 (a)]
• Avian Reproduction Duck [71-4 (b)]
• Early Life-Stage Fish [72-4(a)] ;
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Product Labeling
Changes
Required
• Life-Cycle Aquatic Invertebrate [72-4(b)]
• Dermal toXicity study [82-2]
• Groundwater monitoring studies [166-1]
The Agency also is requiring product-specific data including product
chemistry and acute toxiciry studies, revised Confidential Statements of
Formula (CSFs), and revised labeling for reregistration.
All bromacil end-use products must comply with EPA's current
pesticide product labeling requirements and with the following.
• Remove the statement: "It is permissible to treat the berm of ditches,
seasonally dry flood plains, deltas, marshes, swamps, bogs, and
transitional areas between upland and lowland sites."
• PPE/Engineering Control Requirements for Pesticide Handlers
For sole-active-ingredient end-use products that contain bromacil,
the product labeling must be revised to adopt the handler personal
protective equipment requirements set forth in this section. Any conflicting
requirements on the current labeling must be removed.
For multiple-active-ingredient end-use products that contain
bromacil, the handler personal protective equipment set forth in this section
must be compared to the requirements on the current labeling and the more
protective must be retained. For guidance on which requirements are
considered more protective, see PR Notice 93-7.
Products Intended Primarily for Occupational Use (WPS and non
WPS)
Minimum (Baseline^ PPE Control Requirements
EPA is establishing minimum (baseline) PPE requirements for
some occupational uses of bromacil end-use products. The
following is the minimum (baseline) PPE for all occupational
uses of bromacil end-use products formulated as a liquid,
wettable powder, or dry flowable:
"Applicators and other handlers must wear:
— long-sleeved shut and long pants,
— chemical-resistant gloves*, and
— shoes plus socks."
In addition, while mixing and loading the wettable powder
formulation, pesticide handlers are required to wear a dust mask.
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1 •
. * For the glove statement, use the statement established for
bromacil through the instructions in Supplement Three of PR
Notice 93-7.
EPA is not establishing minimum (baseline) PPE requirements
for bromacil end-use products formulated as granules and
pellets.
Determining PPE Requirements for End-use Product Labels
The PPE that would be established on the basis of the acute
toxicity category of the end-use product must be compared to
the active-ingredient-based minimum (baseline) personal
protective equipment specified above. The more protective PPE
must be placed on the product labeling. For guidance on which
PPE is considered more protective, see PR Notice 93-7.
Placement in Labeling
The personal protective equipment requirements must be placed
on the end-use product labeling in the location specified in PR
Notice 93-7, and the format and language of the PPE
requirements must be the same as is specified in PR Notice 93-
,7. ' ' ' , •
Entry Restrictions
For sole-active-ingredient end-use products that contain
bromacil, the prpduct labeling must be revised to adopt the entry
restrictions set forth in this section. Any conflicting entry
restrictions on the current labeling must be removed.
For multiple-active-jngredient end-use products that contain
bromacil, the entry restrictions set forth in this section must be
compared to the entry restrictions on the current labeling and the
more protective must be retained. A specific time period in
hours or days is considered more protective than "sprays have
dried" or "dusts have settled."
Products Intended Primarily for Agricultural Occupational Use
WPS Uses
Restricted-entry interval:
A 24-hour restricted-entry interval (REI) is required for uses
within the scope of the WPS on all lithium-salt bromacil end-
use products. A 12-hour restricted-entry interval (REI) is
required for uses within the scope of the WPS on all other (non-
lithium-salt) bromacil end-use products.
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Early-entry personal protective equipment (PPE):
The PPE required for early entry is:
— coveralls,
— chemical-resistant gloves, and,
— shoes plus socks.
For the lithium salt of bromacil, protective eyewear also is
required.
Placement in labeling: -
The REI must be inserted into the standardized REI statement
required by Supplement Three of PR Notice 93-7. The PPE
required for early entry must be inserted into the standardized
early-entry PPE statement required by Supplement Three of PR
Notice 93-7.
NonWPS uses
Entry restrictions:
The Agency is establishing the following entry restrictions for
nonWPS occupational uses of bromacil end-use products:
For liquid applications:
"Do not enter or allow others to enter the treated area until
sprays have dried."
For dry applications:
"Do not enter or allow others to enter the treated area until
dusts have settled."
Placement in labeling:
If WPS uses are also on label - Follow the instructions in PR
Notice 93-7 for establishing a Non-Agricultural Use
Requirements box, and place the appropriate nonWPS entry
restrictions in that box.
If no WPS uses are on the label — Place the appropriate
nonWPS entry restrictions in the Directions for Use, under the
heading "Entry Restrictions."
Other Labeling Requirements
Products Intended Primarily for Occupational Use
The Agency is requiring the following labeling statements to be
located on all end-use products containing bromacil that are
intended primarily for occupational use.
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Application Restrictions
"Do not apply this product in a way that will contact
workers or other persons, either directly or through drift.
Only protected handlers may be in the area during
application."
Engineering Controls
"When handlers use closed systems (including water-
soluble packets), enclosed cabs, or aircraft in a manner
that meets the requirements listed in the Worker
Protection Standard (WPS) for agricultural pesticides (40
CFR 170.240(d)(4-6), the handler PPE requirements may
be reduced of modified as specified in the WPS."
. User Safety Requirements • ;
For products with labeling which requires handlers to wear
coveralls:
"Discard clothing or other absorbent materials that have been
drenched or heavily contaminated with this product's
concentrate. Do not reuse them."
For all products:
"Follow manufacturer's instructions for
cleaning/maintaining PPE. If no such instructions are
provided for washables, use detergent and h'ol'water. Keep
and wash PPE separately from other laundry."
User Safety Recommendations
"Users should wash hands before eating, drinking,
chewing gum, using tobacco, oc, using the toilet."
"Users should remove clothing immediately if pesticide
gets inside. Then wash thoroughly and put on clean
clothing."
"Users should remove PPE immediately after handling this
product. Wash the outside of gloves before removing. As
soon as possible, wash thoroughly and change into clean
clothing."
Skin Sensitizer Statement
"This product may cause skin sensitization reactions
in some people."
• Application Rates, Amounts, and Timing
Labels must be revised to reduce the maximum allowed rates to
12 ai/A. If the state of Florida lifts the current ban on bfomacil, the
Agency will not allow application above the rate of 1.6 Ib ai/acre in
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Regulatory
Conclusion
For More
Information
that state. Registrants are required to reduce rates on citrus in Texas
from 6.4 to 2.4 Ib ai/A.
DuPont is required to change labels of products for
undersurface treatment for toxic-waste holding ponds to restrict the
number of acres that may be treated by a worker to a maximum of five
acres per day. Registrants must submit labels that specify the timing
of applications. Registrants must specify appropriate rate of
application for control of Russian thistle and kochia.
The use of currently registered products containing bromacil in
accordance with approved labeling as specified in the RED will not pose
unreasonable risks or adverse effects to humans or the environment.
- Therefore, all uses of these products are eligible for reregistration.
Bromacil products will be reregistered once the required product-
specific data, revised Confidential Statements of Formula, and revised
labeling are received and accepted by EPA.
EPA is requesting public comments on the Reregistration Eligibility
Decision (RED) document for bromacil 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 Response and Program Resources
Branch, Field Operations Division (7506C), Office of Pesticide Programs
(OPP), US EPA, Washington, DC 20460, telephone
703-305-5805.
Electronic copies of the RED and this fact sheet can be downloaded
from the Pesticide Special Review and Reregistration Information System
at 703-308-7224. They also are available on the Internet using ftp on
FTP.EPA.GOV, or using WWW (World Wide Web) on WWW.EPA.GOV.
Printed copies of the RED and fact sheet can be obtained from EPA's
National Center for Environmental Publications and Information
(EPA/NCEPI), PO Box 42419, Cincinnati, OH 45242-0419, telephone 513-
489-8190, fax 513-489-8695.
Following the comment period, the bromacil RED document also will
be available from the National Technical Information Service (NTIS), 5285
Port Royal Road, Springfield, VA 22161, telephone 703-487-4650.
For more information about EPA's pesticide reregistration program,
the bromacil RED, or reregistration of individual products containing
bromacil, please contact the Special Review and Reregistration Division
(7508W), 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
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the National Pesticides Telecommunications Network (NPTN). Call toll-
free 1-800-858-7378, between 9:30 am and 7:30 pm Eastern Standard Time,
Monday through Friday.
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