United State*            Office of Pesticides and Toxic Substances
                     Environmental Protection      Office of Pesticide Programs (TS-766C)
                     Agency                Washington, OC 20460
                                                                 540/FS-89-005
  x>EPA      Pesticide
                     Fact Sheet
                     Name of Chemical: MANEB
                     Reason for Issuance: REGISTRATION STANDARD
                     Date Issued:  octoberis, 1988
                     Fact Sheet Number: 182
1.  DESCRIPTION OF CHEMICAL

    Chemical Name:  Manganese ethylene bisdithiocarbamate

    ANSI Common Name:  Maneb

    Principal Trade Names:   Dithane M-22", Manzate"

    EPA (Shaughnessy) Code:   014505

    Chemical Abstracts Service (CAS) Number:  12427-38-2

    Year of Initial Registration:  Late 1940's

    Pesticide Type:  Fungicide

    Chemical Family:  Ethylene bisdithiocarbamate (EBDC)

    U.S. and Foreign Producers:  Pennwalt

2.  USE PATTERNS AND FORMULATIONS

    Registered uses:   Terrestrial food crop (fruits, vegetables, seed
                     crops, nuts, flax, and grains); terrestrial non-food
                     crop (ornamentals, lawns,  turf); greenhouse food
                     (tomatoes, rhubarb) and non-food crop (ornamentals)

    Predominant uses:  Apples, potatoes, tomatoes and sweet corn

    Pests controlled:  Foliar fungal diseases of  selected fruit, nut,
                     vegetable, grain, field and ornamental (including
                     turf)  crops.

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  Types of Formulations:  Technical, formulation intermediate, dust,
                          granular, wettable powder, wettable powder/
                          dust, flowable concentrate, and ready-to-use.

  Types and Method of     Foliar application to vegetable crops and
   Application:           apples by aerial equipment or ground equipment.
                          Foliar treatment of tobacco or vegetable seed
                          beds, application of sprays or dusts might
                          be by means of hand held compressed air sprayers
                          or dusting equipment.  Potato and tomato foliage
                          may be treated by means of solid set, wheel
                          move, or center pivot sprinkler irrigation equipment.

  Application Rates:      Terrestrial food crop: 0.01 - 8.4 Ib. ai/A
                          Terrestrial nonfood crop: 0.8 - 3.2 Ib. ai/A
                          Grerihouse food crop: 1.1 - 2.4 Ib. ai/100 gal.
                          Greenhouse nonfood crop: 0.8 - 2.4 Ib. ai/100 gal.
                                   /
3.  SCIENCE FINDINGS

a.  Chemical Characteristics

        Physical state:  Powder
        Color:  Yellow
        Cdor:  faint
        Molecular Formula:
    Toxicology Characteristics

        Acute Oral:  UD$Q = 4,400 mg/kg bw (rat) (Toxicity Category III)

        Acute Dermal:  LDJJQ > 2 gm/kg bw (rabbit) (Toxicity Category III)

        Acute Inhalation:  IC$Q > 2.22 + 0.26 mg/1 (rat); (Toxicity Category III)

        Primary Dermal Irritation:  Non-irritating (rabbit) (Toxicity Category IV)

        Primary Eye Irritation:  Severe eye irritant (rabbit) (Toxicity Category I)

        Dermal Sensitization:  Sensitizer (guinea pig)

        Major Routes of Exposure: Oral, dermal and inhalation

        Subchronic Toxicity: No observed effect level (NOEL)  = 100 ppm,
                       r
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        Reproduction:  Study required

        Teratogenicity & Developmental Toxicity: Studies  required

        Mutagenicity:  Mutagenicity testing showed that maneb was positive
                     for inducing chromosomal damage  in an  in vitro SCE
                     (sister chromatid exchange) assay with metabolic activation.
                     Evidence showed that maneb is most likely not an
                     initiating agent and the evidence on promotion
                     capability was negative.  Additional data are required
                     before the unscheduled DMA synthesis (UDS) assay can
                     be upgraded to acceptable status.  Hie following
                     studies were negative: Sister chromatid exchange in
                     CHO cells in the absence of a metabolic activation and
                     Host mediated assay in mice.

    Physiological and Biochemical Characteristics

        Metabolism and Persistence in Plants and Animals:

            Metabolism of maneb is not completely understood.  Additional
            data are being required in plants and livestock.  ETCJ is a
            major metabolite of concern.

    Environmental Characteristics

    Maneb degrades to ETU and other transient degradates  in water and
soil.  ETU is stable in water at pH 5-9 and under sunlight and the degradation
of ETU on soil is not enhanced by sunlight radiation.

    Maneb degrades very rapidly under anaerobic aquatic soil conditions
but ETU is relatively stable under these conditions.

    ETU is stable in water at pH 5-9 and under sunlight and the degradation
of ETU on soil is not enhanced by sunlight radiation.  ETU  is the degradate
of major environmental concern.  There are indications that ETU may
leach and enter groundwater.  However,  additional data are  required to
complete the groundwater assessment.

    Ecological Characteristics

       o Maneb has been found to be practically nontoxic  to birds and
    mammals.

         Avian dietary toxicity:   ££50 > 9,000 ppm (bobwhite)

       o The toxicity of a 80% product to warmwater fish  is highly toxic.

4.  TOLERANCE ASSESSMENT

     Tolerances,  expressed as zinc ethylene bisdithiocarbamate, have been
established for residues of maneb in a variety of raw agricultural commodities
(40 CFR 180.110).

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    The toxicology data for maneb are insufficient to determine an
Acceptable Daily Intake (ADI) or whether the toxicity observed in the
studies is due to maneb or ETU.  A subchronic study has been used to
calculate a Provisional ADI (PADI).  Because a subchronic study was used,
an uncertainty factor of 1000 was employed.  The PADI for maneb is 0.0005
mg/kg/day based on the six month feeding study with a NOEL of 5 rog/kg/day.

    The theoretical maximum residue contribution (TMPC), based on the
assumption that 100 percent of each crop is treated and contains residues
at the tolerance level, is 0.030 or approximately 600 percent of the PADI.
Based on a more realistic dietary assessment, using anticipated field
residues and estimate of percent crop treated, the estimated average
consumption for the U.S. population is 0.0036 mg/kg/day or 70 percent
of the PADI.

5.  SUMflVPY OF REGULATORY POSITIONS

     The Agency has initiated a Special Review for maneb along with the
other EBDC's in June 1987 because of concern about the oncogenic risk to
consumers from dietary exposure to ETU from food treated with these pesticides,
and the risks of teratogenicity and adverse thyroid effects to applicators
and mixer/loaders from exposure to ETU.

o  ETU has been classified as a 83 oncogen (probable human
   carcinogen).

o  The Agency will not consider establishment of new food use tolerances
   for maneb because the current residue chemistry and toxicology data
   are not sufficient to assess existing tolerances and the toxicology
   data base is insufficient to determine an ADI and also does not
   allow a decision as to whether observed toxicity is due to maneb or ETU.

0  The Agency will consider the need for establishment of tolerances for
   ETU and any intermediate metabolites when data are sufficient to permit
   such decisions.

0  The Agency will not establish any food/feed additive regulations pursuant
   to Section 409 of the Federal Pood,  Drug and Cosmetic Act (FFDCA) and is
   deferring action on previously established food/feed additive regulations.

0  Protective clothing labeling for maneb products, as specified as a result
   of the 1982 Decision Document should be updated.

0  The Agency is requiring reentry data for maneb.   In order to remain in
   compliance with FIFRA,  an interim 24-hour reentry interval requirement
   must be placed on the label of all maneb end-use products registered
   for agricultural uses,  until the required data are submitted and evaluated
   and any change in this reentry interval is announced.

0  The Agency has screened and reviewed the environmental fate data to
   determine if maneb/ETU and/or its degradate(s) have the potential to
   leach in to ground water.   The Agency has decided that a small-scale
   retrospective groundwater monitoring study is required to further
   define the extent of the ground water problem.

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o  While the data gaps are being filled, currently registered manufacturing-use
   products (MP's) and end-use products (EP's) containing maneb as the
   sole active ingredient may be sold, distributed, formulated and used,
   subject to the terms and conditions specified in this Standard.
   However, new uses will not be registered.  Registrants must provide
   or agree to develop additional data, as specified in the Data Appendices
   of the Registration Standard, in order to maintain existing registrations.

6.  LABELING REQUIREMENTS

     All naneb products must bear appropriate labeling as specified in
40 CFR 156.10.  Appendix II of the Registration Standard contains information
on labeling.

The following are the major labeling specification:

    0 Environmental hazard statement
    4 Protective clothing requirements
    0 Preharvest interval
    0 Worker safety rules
    0 Grazing restrictions for almonds, apples,  beans,  corn, peanuts,  potato,
      sugar beets, ornamental grasses, ornamental turf.

7.  SUMMARY OF DATA GAPS

    Product Chemistry  All

    Toxicology

    Subchronic dermal (21-Day)
    Subchronic inhalation (90-Day)
    Chronic toxicity (rodent and nonrodent)
    Oncogenicity (rat and mouse)
    Teratology (rabbit and rat)
    Reproduction (rat)
    Mutagenicity (gene mutation) (other genotoxic effects)
    Dermal absorption

    Residue Chemistry

    Nature of the Residue in Plants and Livestock
    Analytical Methods
    Magnitude of Residue for Variety of Commodities

    Environmental Fate

    Hydrolysis
    Photodegradation studies in water and soil
    Aerobic soil studies
    Aerobic aquatic
    Leaching and absorption/desorption
    Aquatic (sediment)

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     Dissipation Soil Studies
     Small-scale retrospective monitoring study
     Fish accumulation

     Reentry Protection

     Reentry Studies on Foliar and Soil Dissipation

Wildlife and Aquatic Organisms

     Avian oral  toxicity
     Avian dietary toxicity
     Avian reproduction
     Freshwater  fish toxicity
     Acute freshwater invertebrates
     Estuarine and marine organism toxicity
     Fish early  life stage and invertebrate life-cycle
     Aquatic organism accumulation

EIU  Data Requirements

Toxicology

     Chronic (rodent and non-rodent)
     Reproduction

Environmental Fate

    Aerobic and anaerobic soil metabolism
    Aerobic aquatic
    Lab volatility
    Degradation (soil)
    Aquatic (sediment)
    Degradation (soil long-term)
    Fish accumulation

8.  CONTACT PERSON AT EPA

    Lois A.  Boss!
    Product Manager (21)
    Fungicide-Herbicide Branch
    Registration Division (TS-767C)
    Office of Pesticide Programs
    Environmental Protection Agency
    401 M St., SW
    Washington, D.C.  20460

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    Office location and phone number:
    Room 227, Crystal Mall #2
    1921 Jefferson Davis Highway
    Arlington, VA
    (703) 557-1900   •

9.  DISCLAIMER:  The information in this Pesticide Fact Sheet is a summary
only and may not be used to satisfy data requirements for pesticide regis-
tration and reregistration.  The complete Registration Standard for the
pesticide may be obtained from the National Technical Information Service.
Contact the Product Manager listed above for further information.

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