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.
                                                   ,'
 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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