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.
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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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U.S. Environmental Protection Agency
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