&EPA
United States Prevention, Pesticides EPA 738-R-05-XXX
Environmental Protection and Toxic Substances August 2005
Agency (7508C)
Reregistration
Eligibility
Decision (RED) for
Maneb
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Reregistration Eligibility Decision
for
Maneb
ListB
Case No. 0644
Approved By:
Debra Edwards, Ph.D.
Director, Special Review and
Reregistration Division
Date
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TABLE OF CONTENTS
MANEB REREGISTRATION ELIGIBILITY DECISION TEAM i
GLOSSARY OF TERM AND ABBREVIATIONS ii
EXECUTIVE SUMMARY iv
I. INTRODUCTION 1
II. CHEMICAL OVERVIEW 2
A. Regulatory History 2
B. Chemical Identification 3
1. Maneb 3
2. Ethylene thiourea (ETU) 4
C. Use Profile 4
D. Estimated Usage of Maneb 7
IE. SUMMARY OF METIRAMRISK ASSESSMENTS 9
A. Human Health Risk Assessment 9
1. Toxicity Assessment of Maneb 10
a. Acute Toxicity Profile for Maneb 10
b. FQPA Safety Factor Considerations for Maneb 11
c. Toxicological Endpoints for Maneb 12
2. Toxicity Assessment of ETU 14
a. Acute Toxicity Profile for ETU 14
b. FQP A Safety Factor Considerations for ETU 15
c. Toxicological Endpoints for ETU 16
3. Metiram and ETU Carcinogenicity 17
4. Metiram and ETU Endocrine Effects 18
5. Dietary Risk from Food 18
a. Exposure Assumptions 18
b. Population Adjusted Dose 19
1) Acute Dietary Risk from Food 19
2) Chronic Dietary Risk from Food 20
3) Cancer Dietary Risk from Food 21
6. Dietary Exposure from Drinking Water 22
a. Surface Water 22
b. Ground Water 23
7. Residential Exposure and Risk 23
8. Aggregate Risks from Food, Drinking Water and Residential Uses 25
a. Acute Aggregate 26
b. Short-Term Aggregate 27
c. Chronic (Non-Cancer) Aggregate 28
d. Cancer Aggregate 28
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9. Occupational Risks 28
a. Occupational Handler Exposure 29
1) Agricultural and Greenhouse Handler Risks 30
2) Handler Risk for Potato Seed-Piece Treatment 35
b. Post-Application Assessments 39
c. Human Incident Data 43
B. Environmental Risk Assessment 43
1. Environmental Fate and Transport 44
2. Ecological Risk Presumptions 44
3. Risk to Terrestrial Species 46
a. Birds and Mammals Exposure and Toxicity 46
b. Birds and Mammals Risk 47
c. Non-Target Plant Risk 48
d. Non-Target Insect Risk 49
4. Risk to Aquatic Species 49
a. Fish and Invertebrate Exposure and Toxicity 49
b. Fish and Invertebrate Risk 51
c. Non-Target Aquatic Plant Risk 52
5. Risk to Federally Listed Endangered and Threatened Species 55
6. Ecological Incidents 53
IV. RISK MANAGEMENT, REREGISTRATION AND TOLERANCE REASSESSMENT 54
A. Determination of Reregistration Eligibility 54
B. Public Comments and Responses 55
C. Regulatory Position 55
1. Food Quality Protection Act Findings 55
a. "Risk Cup" Determination 55
b. Determination of Safety for U. S. Population
(including Infants and Children) 55
c. Endocrine Disrupter Effects 56
d. Cumulative Risks 56
2. Tolerances Reassessment Summary 57
a. Tolerances Currently Listed Under 40 CFR § 180.110 57
b. Tolerances Listed Under 40 CFR § 180.110 (a) 57
c. Tolerances To Be Proposed Under 40 CFR § 180.110 (a) 58
d. Tolerance Listed Under 40 CFR § 180.110 (b) 58
e. Codex Harmonization 61
D. Regulatory Rationale 61
1. Human Health Risk Management 62
a. Dietary (Food) Risk Mitigation 62
b. Dietary (Drinking Water) Risk Mitigation 62
c. Residential Risk Mitigation 62
d. Aggregate Risk Mitigation 62
e. Occupational Risk Mitigation 63
1) Agricultural and Greenhouse Handler Risk Mitigation ... 63
2) Potato Seed-Piece Treatment Mitigation 66
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3 Post-Application Risk Mitigation 67
2. Environmental Risk Mitigation 67
a. Terrestrial Species Mitigation 67
b. Aquatic Species Mitigation 68
3. Significance of the EBDCs 68
4. Summary of Risk Mitigation Measures 70
E. Other Labeling Requirements 70
1. Endangered Species Considerations 70
2. Spray Drift Management 71
V. WHAT REGISTRANTS NEED TO DO 71
A. Manufacturing Use Products 72
B. End-Use Products 73
C. Labeling Changes Summary Table 74
VI. Appendices 85
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MANEB REREGISTRATION ELIGIBILITY DECISION TEAM
Office of Pesticide Programs:
Biological and Economic Analysis Assessment
Richard Michell, Plant Pathologist
Bill Phillips, Agronomist
Arnet (Skee) Jones, Branch Chief
David Donaldson, Economist
Tim Keily, Economist
David Widawsky, Branch Chief
Environmental Fate and Effects Risk Assessment
Ronald Parker, RAPL
Gabe Patrick, Eco Tox Risk Assessor
Mohammed Ruhman, Eco Fate
Jean Holmes, Team Leader
Mah Shamim, Branch Chief
Endangered Species
Arty Williams, Acting Associate Director
Health Effects Risk Assessment
Tim Dole, ORE Assessor
Christine Olinger, Residue Chemist
Felicia Fort, Residue Chemist
Kit Farwell, Toxicologist
Linda Taylor, Toxicologist
Michael Metzger, Branch Chief
Registration Support
Lisa Jones, Senior Reviewer
Mary Waller, PM, Team 21
Cynthia Giles-Parker, Branch Chief
Risk Management
Tawanda Spears, Maneb CRM
Kimberly Nesci, Team Leader
Michael Goodis, Branch Chief
Office of General Counsel
Kevin Minoli
Michele Knorr
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GLOSSARY OF TERMS AND ABBREVIATIONS
AGDCI Agricultural Data Call-In
ai Active Ingredient
aPAD Acute Population Adjusted Dose
AR Anticipated Residue
ARTF Agricultural Re-entry Task Force
BCF Bioconcentration Factor
CCA Comparative Cholinesterase Assay
CFR Code of Federal Regulations
cPAD Chronic Population Adjusted Dose
CSF Confidential Statement of Formula
CSFII USDA Continuing Surveys for Food Intake by Individuals
DCI Data Call-In
DEEM Dietary Exposure Evaluation Model
DFR Dislodgeable Foliar Residue
DNT Developmental Neurotoxicity
D WLOC Drinking Water Level of Comparison.
EC Emulsifiable Concentrate Formulation
EC Engineering Control
ED WC Estimated Drinking Water Concentration
EEC Estimated Environmental Concentration
EPA Environmental Protection Agency
EUP End-Use Product
FDA Food and Drug Administration
FIFRA Federal Insecticide, Fungicide, and Rodenticide Act
FFDCA Federal Food, Drug, and Cosmetic Act
FQPA Food Quality Protection Act
FOB Functional Observation Battery
G Granular Formulation
GENEEC Tier I Surface Water Computer Model
GLN Guideline Number
HAFT Highest Average Field Trial
IR Index Reservoir
LC50 Median Lethal Concentration. A statistically derived concentration of a substance that can be expected
to cause death in 50% of test animals. It is usually expressed as the weight of substance per weight or
volume of water, air or feed, e.g., mg/1, mg/kg or ppm.
LD50 Median Lethal Dose. A statistically derived single dose that can be expected to cause death in 50% of
the test animals when administered by the route indicated (oral, dermal, inhalation). It is expressed as a
weight of substance per unit weight of animal, e.g., mg/kg.
LOG Level of Concern
LOD Limit of Detection
LOAEL Lowest Observed Adverse Effect Level
MATC Maximum Acceptable Toxicant Concentration
ug/g Micrograms Per Gram
ug/L Micrograms Per Liter
mg/kg/day Milligram Per Kilogram Per Day
mg/L Milligrams Per Liter
MOE Margin of Exposure
MRID Master Record Identification (number). EPA's system of recording and tracking studies submitted.
MUP Manufacturing-Use Product
NA Not Applicable
NAWQA USGS National Water Quality Assessment
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NPDES National Pollutant Discharge Elimination System
NR Not Required
NOAEL No Observed Adverse Effect Level
OP Organophosphate
OPP EPA Office of Pesticide Programs
OPPTS EPA Office of Prevention, Pesticides and Toxic Substances
PAD Population Adjusted Dose
PCA Percent Crop Area
PDF USDA Pesticide Data Program
PHED Pesticide Handler's Exposure Data
PHI Preharvest Interval
ppb Parts Per Billion
PPE Personal Protective Equipment
ppm Parts Per Million
PRZM/EXAMS Tier II Surface Water Computer Model
Q! * The Carcinogenic Potential of a Compound, Quantified by the EP A's Cancer Risk Model
RAC Raw Agriculture Commodity
RED Reregistration Eligibility Decision
REI Restricted Entry Interval
RfD Reference Dose
RQ Risk Quotient
SCI-GROW Tier I Ground Water Computer Model
SAP Science Advisory Panel
SF Safety Factor
SLC Single Layer Clothing
SLN Special Local Need (Registrations Under Section 24©) of FFRA)
TGAI Technical Grade Active Ingredient
TRR Total Radioactive Residue
USDA United States Department of Agriculture
USGS United States Geological Survey
UF Uncertainty Factor
UFdb Database Uncertainty Factor
UV Ultraviolet
WPS Worker Protection Standard
ill
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EXECUTIVE SUMMARY
EPA has completed its review of public comments on the revised maneb risk assessments and
is issuing its risk management decision for maneb. There are currently 40 tolerances being reassessed
for maneb. The revised risk assessments are based on the Agency's review of the required data
supporting the use patterns of currently registered maneb products and additional information and
comments received. After considering the risks identified in the revised risk assessment, public
comments, and mitigation suggestions from interested parties, EPA developed its risk management
decision for uses of maneb that pose risks of concern. As a result, the Agency has determined that
maneb-containing products are eligible for reregistration provided that data needs are addressed, risk
mitigation measures are adopted, and labels are amended accordingly. The decision is discussed fully
in this document.
Maneb was first registered in the United States in 1962 as a broad spectrum fungicide.
Maneb is used on a wide variety of food/feed crops, including fruit and nut crops, vegetable crops,
field and forage crops, grapes, field crop seeds, and others; ornamental plants in nurseries and
greenhouses; and sod farms. There are no residential labels, and no agricultural uses that could result
in exposure to maneb in residential settings; however, because transplanted turf from sod farms can
result in potential residential exposure, a post-application scenario from this use was assessed.
Approximately 2.5 million pounds of maneb are used annually, mostly on almonds, lettuce, peppers,
and walnuts.
Maneb is a member of the ethylene bisdithiocarbamate (EBDC) group of fungicides, which
includes the related active ingredients mancozeb and metiram. This document summarizes risk
estimates for both maneb and its metabolite and environmental degradate ethylene thiourea (ETU).
Maneb and two other EBDC fungicides, mancozeb and metiram, are all metabolized to ETU in the
body and all degrade to ETU in the environment. Therefore, EPA has considered the aggregate or
combined risks from food, water and non-occupational exposure resulting from maneb alone, ETU
resulting from maneb use, and ETU from all sources (i.e., the other EBDC fungicides: mancozeb and
metiram). The aggregate risk from ETU from all sources must be considered to reassess the
tolerances for maneb, metiram and mancozeb.
Overall Risk Summary
Maneb dietary risks from food and drinking water sources are low and not of concern.
Although there are no registered residential uses of maneb, assessed toddler exposure to transplanted
turf is of concern. There are risk concerns for some occupational handlers, which will be mitigated
with additional personal protective equipment (PPE) and use restictions. In addition, some
application restrictions are to be added to product labels in order to maintain a 24 hour restricted entry
interval (REI). For ecological risks, maneb poses some chronic risk to birds and mammals, and acute
risk to aquatic species.
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Dietary Risk
Acute, chronic, and cancer dietary (food only) risk from maneb, maneb-derived ETU, and
ETU from all sources are low and below the Agency's level of concern. The drinking water exposure
assessment for maneb addresses concentrations of ETU only, since maneb is not expected to remain
in drinking water long enough to reach a location that would supply water for human consumption,
whether from surface or groundwater sources. Estimated concentrations of ETU, for both surface and
ground water sources of drinking water, are low and not of concern.
Residential Risk
There are no current labeled uses for residential applications of maneb. The only potential
residential exposure to maneb is from residues remaining on transplanted turf from sod farms.
EPA's original analysis indicated risks above levels of concern for toddler exposure to
transplanted turf for maneb. Recognizing that potential risk, the maneb registrants voluntarily agreed
to reduce the maximum application rate and/or extend the time between treatment and harvesting of
sod from one to three days (i.e., a 3 day PHI for transplanted turf). The reduced application rate
and/or extended PHI, combined with the logistics of transplanting turf and installation restrictions,
effectively reduced the potential contribution from this use pattern to a level not of concern to the
Agency.
Aggregate Risk/ETU
Aggregate risk refers to the combined risk from food, drinking water, and residential
exposures (as a result of residential exposures to ETU from mancozeb and maneb uses). In addition,
aggregate risk can result from one-time (acute), short-term and/or chronic (non-cancer and cancer)
exposures, and considers exposures from maneb-derived ETU and ETU from all sources, depending
upon the scenario assessed. Acute, short-term, and chronic (non-cancer) aggregate risks are low and
not of concern. Aggregate cancer risk estimates are within a negligible risk range, and therefore no
mitigation measures are needed.
Occupational Risk
Workers can be exposed to maneb and maneb-derived ETU through mixing, loading, and/or
applying (handlers) the pesticide to agricultural crops and ornamental plants, or re-entering treated
sites. To address predicted risks from these exposures, the registrant has agreed to voluntarily cancel
maneb use on sweet corn, grapes, apples, and Kadota figs; reduce the application rate on turf; and
restrict against the use of wettable powder formulation products for aerial and chemigation
application methods. Moreover, additional personal protective equipment (PPE), such as a PF5
(dust/mist) respirator are required for some mixer/loader and/or applicator scenarios, whereas for
other scenarios only single layer clothing is required. Engineering controls are also required for
commercial potato seed-piece treatment (dust collection equipment) and aerial applications (enclosed
cockpits).
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At the current restricted entry interval (REI) of 24 hours and use patterns on current labels,
predicted maneb and ETU exposures exceed standard levels of concern for post-application high-end
exposure scenarios for turf, sweet corn, grapes, Kadota figs, and apples. To address these risks, the
Agency is requiring that the application rate to turf be reduced. In addition, maneb use on sweet corn,
grapes, Kadota figs, and apples have since been cancelled. The Agency plans to maintain the current
24 hour REI for the remaining uses.
Ecological Risk
For terrestrial species, maneb acute risks are low to mammals, birds, and non-target insects.
However, the screening-level ecological risk assessment for terrestrial species indicates some risk
quotient (RQ) exceedance of the chronic levels of concern (LOCs), especially from maneb
applications to turf, almonds, and apples. In the aquatic environment, there is a potential acute risk to
freshwater/estuarine/marine fish and invertebrates. Currently, there are no data available to assess
chronic risks to freshwater invertebrates, estuarine/marine fish, or estuarine/marine invertebrates. The
Agency is requiring additional toxicity data as part of this RED to address these data gaps. Therefore,
to be more protective of these species that may be exposed to maneb, the technical registrant has
agreed to cancel some uses and to make some additional label changes to reduce potential risk, such
as reducing the maximum application rate for some uses.
Endangered Species
Based on available screening level information, there is a potential concern for maneb's acute
effects on listed freshwater and estuarine/marine animals and chronic effects on listed birds and
mammals should exposure actually occur. The Agency expects that maneb poses a low acute risk to
nontarget insects because maneb is practically nontoxic to honeybees (acute contact LD50 > 12
//g/bee). However, the Agency does not assess risk to bees using RQs because a screening-level RQ
assessment method for estimating the risk to bees is not available. The Agency does not currently
have enough data to quantify risks for maneb at the screening-level and cannot preclude potential
direct effects to the following taxinomic groups: listed nontarget terrestrial plants and vascular
aquatic plants, freshwater invertebrates, and estuarine/marine fish. These findings are based solely on
EPA's screening-level assessment and do not constitute "may affect" findings under the Endangered
Species Act (ESA) for any listed species. If the Agency determines use of metiram "may affect"
listed species or their designated critical habitat, EPA will employ the provisions in the Services
regulations (50 CFR Part 402).
Mitigation Summary
To address assessed risks of concern, the following mitigation measures will be implemented:
Maneb-All Formulations
Sweet Corn - Cancel Use
Grapes - Cancel Use
Apples - Cancel Use
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Kadota Figs - Cancel Use
Seed Treatment to Rice and Peanuts - Cancel Use
Oats Seed Treatment - Reduce maximum application rate from 0.003 lib ai/lb seed to
0.0021 Ib ai/lb seed
Almonds- Reduce maximum seasonal rate from 25.6 to 19.2 Ibs ai/acre/season and
retain maximum application rate of 6.4 Ibs ai/acre.
Sod Farm Turf- Reduce maximum application rate from 17.4 Ibs ai/acre to 8.7 Ibs
ai/acre, limit maximum seasonal rate to 34.8 Ibs ai/acre/season and add a 3 day pre-
harvest interval. Handlers mixing/loading of dry flowables and liquids for aerial or
chemigation application, add a PF5 Respirator.
Cut Flowers - Limit number of applications per year to 20
Commercial Potato Seed-Piece Treatment (dust) - require engineering controls (e.g.
dust collector equipment)
Maneb- Wettable Powder Formulation Only
Sod Farm Turf - Cancel Use
Chemigation/Aerial Applications - Delete Application Method
For mixing/loading all remaining uses add PF 5 Respirator.
Regulatory Decision
The Agency has determined that most uses of the active ingredient maneb are eligible for
reregistration provided that (1) current data gaps and confirmatory data needs identified herein are
addressed and (2) the risk mitigation measures outlined in this document are adopted, and labels are
amended to reflect these measures. The following uses of maneb are not eligible for reregistration
and are being voluntarily canceled by registrants and deleted from all maneb labels: sweet corn,
grapes, apples, and kadota figs.
Next Steps
The Agency provided several opportunities for public comment and interaction as this
decision was being developed. Therefore, the Agency is issuing this RED document for maneb
without a formal public comment period, as announced in a Notice of Availability published in the
Federal Register: However, the docket remains open, and any comments submitted in the future will
be placed in this public docket and addressed by the Agency, as appropriate.
EPA will issue a generic DCI for additional data necessary to confirm the conclusions of this
RED for the active ingredient maneb. EPA will also issue a product-specific DCI for data necessary
to complete product reregistration for products containing maneb.
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I. INTRODUCTION
The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) was amended in 1988 to
accelerate the reregistration of products with active ingredients registered prior to November 1, 1984.
The amended Act calls for the development and submission of data to support the reregistration of an
active ingredient, as well as a review of all submitted data by the U.S. Environmental Protection
Agency (referred to as EPA or "the Agency"). Reregistration involves a thorough review of the
scientific database underlying a pesticide's registration. The purpose of the Agency's review is to
reassess the potential risks arising from the currently registered uses of the pesticide; to determine the
need for additional data on health and environmental effects; and to determine whether or not the
pesticide meets the "no unreasonable adverse effects" criteria of FIFRA.
On August 3, 1996, the Food Quality Protection Act of 1996 (FQPA) was signed into law.
This Act amends FIFRA and the Federal Food Drug and Cosmetic Act (FFDCA) to require
reassessment of all existing tolerances for pesticides in food. FQPA also requires EPA to review all
tolerances in effect on August 3, 1996 by August 3, 2006. In reassessing these tolerances, the Agency
must consider, among other things, aggregate risks from non-occupational sources of pesticide
exposure, whether there is increased susceptibility to infants and children, and the cumulative effects
of pesticides with a common mechanism of toxicity. When a safety finding has been made that
aggregate risks are not of concern and the Agency concludes that there is a reasonable certainty of no
harm from aggregate exposure, the tolerances are considered reassessed. EPA decided that, for those
chemicals that have tolerances and are undergoing reregistration, tolerance reassessment will be
accomplished through the reregistration process.
As mentioned above, FQPA requires EPA to consider "available information" concerning the
cumulative effects of a particular pesticide's residues and "other substances that have a common
mechanism of toxicity" when considering whether to establish, modify, or revoke a tolerance.
Potential cumulative effects of chemicals with a common mechanism of toxicity are considered
because low-level exposures to multiple chemicals causing a common toxic effect by a common
mechanism could lead to the same adverse health effect as would a higher level of exposure to any
one of these individual chemicals. Maneb belongs to a group of pesticides called dithiocarbamates,
which also includes two other ethylene bis-dithiocarbamate (EBDC) fungicides metiram and
mancozeb. For the purposes of this reregistration eligibility decision (RED), EPA has concluded that
maneb does not share a common mechanism of toxicity with other substances. The Agency reached
this conclusion after a thorough internal review and external peer review of the data on a potential
common mechanism of toxicity. For more information, please see the December 19, 2001
memorandum, "The Determination of Whether Dithiocarbamate Pesticides Share a Common
Mechanism of Toxicity,'" which is available on the internet at
http ://www. epa. gov/oppsrrd 1/cumulative/dithiocarb .pdf However, the EBDCs share a common
metabolite and degradate, ethylene thiourea (ETU), which is considered in this RED.
This document presents EPA's revised human health and ecological risk assessments, its
progress toward tolerance reassessment, and the reregistration eligibility decision for maneb. The
document consists of six sections. Section I contains the regulatory framework for
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reregistration/tolerance reassessment. Section II provides a profile of the use and usage of the
chemical. Section III gives an overview of the revised human health and environmental effects risk
assessments based on data, public comments, and other information received in response to the
preliminary risk assessments. Section IV presents the Agency's reregistrati on eligibility and risk
management decisions. Section V summarizes label changes necessary to implement the risk
mitigation measures outlined in Section IV. Section VI contains the Appendices, which list related
information, supporting documents, and studies evaluated for the reregistration decision. The
preliminary and revised risk assessments for maneb are available in the Office of Pesticide Programs
(OPP) Public Docket, under docket numbers OPP-2004-0078 and OPP-2005-0178, respectively, on
the Agency's web page, http://www.epa.gov/edockets.
II. CHEMICAL OVERVIEW
A. Regulatory History
Maneb was first registered in the United States in!962 for use on food and ornamental
crops to prevent crop damage in the field and to protect harvested crops from deterioration in storage
or transport. Maneb is a member of the ethylene bisdithiocarbamate (EBDC) group of fungicides,
which includes the related active ingredients mancozeb and metiram. Moreover, it has been
determined that the EBDCs share the common degradate ethylenethiourea (ETU). The EBDCs have
been the subject of two Special Reviews. In 1977, the Agency initiated a Special Review for
products containing EBDCs based on evidence suggesting that the EBDCs and ETU, a contaminant,
metabolite and degradation product of these pesticides, posed potential risks to human health and the
environment. In 1982, the Agency concluded this Special Review by issuing a Final Determination
(PD 4) which required risk reduction measures to prevent unreasonable adverse effects pending
development and submission of additional data needed for improved risk assessment.
In 1987, EPA issued a second Notice of Initiation of Special Review of the EBDC pesticides
because of health concerns caused by ETU, including potential carcinogenic, developmental and
thyroid effects. The Special Review's Preliminary Determination (PD 2/3) was published on
12/20/89 (54 FR 52158) and the Final Determination (PD 4) on 3/2/92 (57 FR 7484). The Agency
concluded that the dietary risks of EBDCs exceeded the benefits for the following food/feed uses for
which one or more of the EBDC pesticides were registered: apricots, carrots, celery, collards, mustard
greens, nectarines, peaches, rhubarb, spinach, succulent beans, and turnips. Accordingly, EPA
canceled all maneb and other EBDC products registered on the above-listed food/feed crops.
The Maneb Registration Standard dated 8/22/86 required additional product chemistry data
concerning maneb. Addendum No. 1 to the Maneb Reregistration Standard dated 3/31/87 included
the review of data not available at the time of the original registration standard and required additional
product chemistry data. A comprehensive Data-Call-in (DCI) was issued 4/1/87 to all registrants of
maneb concerning product chemistry data requirements. The Product Chemistry Chapter of the
Maneb Registration Standard Update dated 5/13/88 included a review of data submitted in response
to the 4/1/87 DCI with regard to adequacy in fulfilling product chemistry requirements. A Guidance
Document for maneb was issued 10/88. Product chemistry data submitted in response to the
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Guidance Document were reviewed in the Maneb Registration Standard Update dated 8/11/92, and
additional data were required for the registration of maneb.
The 1992 Special Review decision initially set the pre-harvest interval (PHI) for use on
potatoes at fourteen (14) days for most states. The only exceptions to the 14 day PHI were
Connecticut, Florida, Maine, Massachusetts, New Hampshire, New York, Pennsylvania, Vermont,
and Wisconsin, where EPA determined that disease pressures caused by late blight justified a 3 day
PHI. Subsequently, presented with evidence of late blight in additional states, EPA extended the 3
day PHI to Delaware, Michigan, Rhode Island and Ohio. Recently, EPA received requests for
amendments to several EBDC product registrations and a petition to amend the 1992 cancellation
order to allow for a three day PHI in all states, due to an alleged increase in the occurrence of late
blight nationwide. EPA has not determined whether the petition warrants a hearing under 40 C.F.R. §
164 nor has it determined whether it will grant the attendant registration amendment requests.
Although EPA has not reached any conclusions on the merits of the petition or the amendment
requests, potential risks that would result from a nationwide reduction in the PHI for potatoes to 3
days have been considered in this RED. That consideration is for informational purposes only and
cannot be interpreted as an indication of the Agency's position on the petition or amendment requests.
B. Chemical Identification
1.
Chemical Structure:
Maneb
H
N
H
Mn
Common Name:
Chemical Name:
Trade Name:
Chemical Family:
Case Number:
Maneb
Manganese ethylene- 1,2-bisdithiocarbamate
Manex, Dithane-22
Dithiocarbamate
0642
CAS Registry Number: 12427-38-2
OPP Chemical Code: 014505
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Moleculer weight: (265.3)x
Empirical Formula: (C4H6MnN2S4)x
Basic Manufacturers: Cerexagri, Inc.
Technical maneb is a yellow powder which decomposes at 135 °C, and has a density of 0.4-
0.5 kg/L; it has a negligible vapor pressure of <10"7 mbar at 20 °C. Maneb is moderately soluble in
water (0.417 g/L at 22-24 °C), and is practically insoluble in organic solvents (<0.0010g/L in toluene,
0.0033 g/L in hexane, 0.0137 g/L in dichloromethane, and 0.133 g/L in methanol at 22-24 °C).
Maneb decomposes with heat and under acidic conditions.
2. Ethylene thiourea (ETU)
Ethylene thiourea (ETU) is a metabolite, environmental degradate, and cooking byproduct of
maneb and the other EBDC fungicides, metiram and mancozeb. Chemical information is provided
for ETU because many of the risk concerns for maneb and the other EBDCs are driven by risk from
ETU.
Chemical Structure:
HN
Chemical Name: Ethylene thiourea
CAS Registry Number: 96-45-7
OPP Chemical Code: 600016
Molecular Weight: 102.2
Empirical Formula: C3FLJN2S
Technical ethylene thiourea (ETU) is a crystalline solid with a white to pale green color, and a
faint amine odor. It has a melting point of 203-204°C. ETU has an octanol/water partition
coefficient of 0.22. ETU is considered soluble in water, with a water solubility of 20,000 ppm at
30°C, but it is also slightly soluble in methanol, ethanol, ethylene glycol, pyridine, acetic acid and
naphtha. When ETU is heated to decomposition, nitrogen and sulfur oxides are emitted.
C. Use Profile
The following is information on the currently registered uses including an overview of use
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sites and application methods. A detailed table of the uses of maneb eligible for reregistration is
contained in Appendix A.
Type of Pesticide: Fungicide
Target pest(s): Typical diseases targeted include various downy mildews, late blights, leaf spots,
root rots, twig and blossom blights, seedling diseases, fruit molds/rots, root rots, and leaf/stem blights.
Mode of action: Contact (non-systemic)
Use Sites:
Food/Feed Uses: Maneb is registered for foliar applications to food/feed crops including
almond, apple, banana, bean (dry), broccoli, Brussels sprout, cabbage (including Chinese
cabbage), cauliflower, collard, corn (sweet and pop), cranberry, cucumber, eggplant, endive,
fig, garlic, grape, kale, kohlrabi, lettuce (head and leaf), melon (cantaloupe, casaba, crenshaw,
honeydew, and watermelon), mustard greens, onion (dry bulb and green), papaya, pepper,
potato, pumpkin, squash (summer and winter), sugar beet, tomato, and turnip grown for
greens. Maneb is additionally registered for seed treatment of barley, corn (field), cotton,
flaxseed, oat, potato, rice, rye, safflower, sorghum, and wheat.
Non-Food & Residential Uses: Horticultural use is permitted on ornamental plants in
nurseries and greenhouses and on sod farms. There are no residential labels, and no
agricultural uses that could result in exposure to maneb in residential settings. The registrant
has agreed to modify labels for turf use to specify, "For Use on Sod Farms Only'' However,
because transplanted turf from sod farms can result in potential residential exposure, a
residential post-application scenario is included in the risk assessment.
Public Health Uses: None.
Use Classification: General Use
Formulation Types: Maneb formulations include dust, emulsifiable concentrate (EC), liquid and dry
flowable (water soluble granules) (DF), flowable concentrate (FC), and ready-to-use (RTU) solution.
Application Methods: Application methods include aerial, airblast, groundboom, chemigation, and
hand application using low-pressure handwand and backpack sprayers. The application methods for
seed and seed-piece treatment include commercial stationary equipment, on-farm stationary
equipment, and tractor-drawn planter boxes.
Application Rates: There are currently 30 active maneb labels and 1 FIFRA Section 24(c) Special
Local Need (SLN) registration. The application rates in agriculture range from 1.2 pounds of active
ingredient per acre (Ibs ai/A) for corn to 6.4 Ibs ai/A for almonds. Multiple applications are permitted
per season, ranging from 3 for cranberries to 15 for sweet corn, with application intervals of 7 to 14
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days. Some uses (e.g., grapes) have separate rates for eastern and western regions. The application
rates in horticulture are 1.2 Ib ai/A for most ornamentals up to 17.4 Ib ai/A for turf. Horticulture and
turf applications are allowed as much as once weekly with no annual limit.
Application Timing: Maneb is applied at foliar, pre-bloom, and pre-bloom through foliar stages and
also as a seed-piece treatment.
EBDCs Maximum Application Rates: As a result of Special Review, the Agency set usage
limitations on the EBDC fungicides (mancozeb, maneb, and metiram) to establish consistency
between the EBDCs registrations and Market Basket Survey data. The total poundage of all of the
EBDC fungicides (mancozeb, maneb, and metiram) used on each crop must not exceed the maximum
seasonal application rate for any one of these fungicides. The maximum season rate for all of the
EBDCs used is the same for most of the crops regardless of which EBDC is used, with the exception
of cucurbits (cucumbers, melons, and summer and winter squash), for which the maximum rate per
season depends upon which EBDC is used. The current maximum seasonal application rates for the
EBDCs, by crop, are summarized in Table 1.
Table 1. Maximum Label Application Rates for the EBDC Fungicides
Crop Group
Field Crops
Field Crops
Field Crops
Field Crops
Field Crops
Field Crops
Field Crops
Fruits
Fruits
Fruits
Fruits
Fruits
Fruits
Fruits
Miscellaneous
Non-Food
Non-Food
Nut Crops
Ornamentals
Ornamentals
Pome Fruits
Crop(s)
Barley, Oats, Rye, Triticale,
Wheat
Beans, Dry
Corn: hybrid seedcorn
Corn: field
Cotton
Peanuts
Sugar Beets
Bananas
Cranberries
Figs, Kodota
Grapes - West
Grapes- East
Papayas
Plantains
Christmas Trees, Douglas Fir
Tobacco fields
Tobacco seedlings
Almonds
Ornamentals, Pachysandra
Ornamentals, Variety
Apples
EBDC Used
MZ = Mancozeb
MN = Maneb
MT = Metiram
MZ
MN
MZ,MN
MZ
MZ
MZ
MZ,MN
MZ,MN
MZ,MN
MN
MZ,MN
MZ,MN
MZ,MN
MZ
MZ
MZ
MZ
MN
MZ
MZ,MN
MZ.MN.MT
Maximum Label Application Rates
(Ib ai/acre)
Per Application
1.6
1.6
1.2
1.2
1.6
1.6
1.6
2.4
4.8
2.4
2
3.2
2
2.4
3.2
1.5
2
6.4
13-14
1.2-1.6
2.4 or 4.8
Total EBDC
Per Season
4.8
9.6
12
12
6.4
12.8
11.2
24
14.4
2.4
6
19.2
28
24
NA
6
No Max
25.6
NA
NA
16.8 or 19.2
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Table 1. Maximum Label Application Rates for the EBDC Fungicides
Crop Group
Pome Fruits
Turf
Turf
Vegetables
Vegetables
Vegetables
Vegetables
Vegetables
Vegetables
Vegetables
Vegetables
Vegetables
Vegetables
Vegetables
Vegetables
Vegetables
Vegetables
Vegetables
Vegetables
Vegetables
Vegetables
Crop(s)
Pears, Crabapples, Quince
Sod Farm
Golf Course, Athletic Fields
Asparagus
Brassica
Corn: sweet/pop/seed: East of
Miss.
Corn: sweet/ pop/seed: West of
Miss.
Cucumbers
Fennel
Gourds: Edible
Lettuce
Melons
Onions: Dry Bulb, Garlic
Onions: Green
Peppers
Potatoes
Pumpkins
Shallots
Squash (winter)
Squash (summer)
Tomatoes
Watermelons
EBDC Used
MZ = Mancozeb
MN = Maneb
MT = Metiram
MZ
MZ,MN
MZ
MZ
MN
MZ,MN
MZ,MN
MZ,MN
MZ
MZ
MN
MZ,MN
MZ,MN
MN
MN
MZ,MN,MT
MN
MZ,MN
MN
MZ,MN
MZ,MN
MZ,MN
Maximum Label Application Rates
(Ib ai/acre)
Per Application
2.4 or 4.8
16.3 - 19
16.3 - 19
1.6
1.6
1.2
1.2
MZ = 2.4
MN= 1.6
1.6
2.4
1.6
MZ = 2.4
MN= 1.6
2.4
2.4
1.6 (w), 2.4 (e)
1.6
1.6
2.4
MZ = 2.4
MN= 1.6
2.4 (w), 1.6 (e)
2.4
Total EBDC
Per Season
16.8 or 19.2
NA
NA
6.4
9.6
18
6
MZ=19.2
MN = 12.8
12.8
19.2
6.4 (CA), 9.6 (US)
MZ=19.2
MN = 12.8
24
11.2
9.6 (w), 14.4 (e)
11.2
12.8
24
MZ=19.2
MN = 12.8
6.4 (w), 16.8 (e)
19.2
Note - Crops in bold have different rates depending upon which EBDC is used. Also, the not applicable (NA) reference is
because the use was not a part of Special Review.
(w) - West
(e) - East
D. Estimated Usage of Maneb
Table 2 below summarizes the best available estimates for the pesticide usage of maneb.
Based on Agency data, the average total annual domestic usage of maneb is approximately 2V2
million pounds. Agricultural uses are concentrated in (but not limited to) the following states:
Florida, Maine, Minnesota, North Dakota, New Jersey, Rhode Island, Texas, and Wisconsin.
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Table 2. Maneb Crop Usage Summary
Crop
Almonds
Apples
Beans, Dry
Beans, Green
Broccoli
Brussels Sprouts (*CA)
Cabbage
Cantaloupes
Carrots
Cauliflower
Celery
Collards
Corn (Field)
Cucumber
Dry Beans/Peas
Eggplant
Garlic
Grapes
Greens, Mustard
Kale
Lettuce
Onions
Pears
Peppers
Potatoes
Pumpkins
Spinach
Pounds of Active Ingredient
(Ibs. a.i.)/
Year
300,000
40,000
10,000
8,000
20,000
1,000
40,000
3,000
3,000
5,000
3,000
4,000
<500
30,000
20,000
7,000
30,000
20,000
2,000
1,000
600,000
70,000
5,000
200,000
100,000
4,000
10,000
% Crop Treated
Average
10
<1
<1
5
5
25
15
<1
<1
5
5
10
<1
5
<1
55
25
<1
5
5
65
10
<1
30
5
5
15
Maximum
15
5
<2.5
15
15
35
15
<2.5
5
10
5
25
5
5
<2.5
65
25
5
5
5
75
20
<2.5
45
10
5
45
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Table 2. Maneb Crop Usage Summary
Crop
Squash
Sugar Beets
Sweet Corn
Tomatoes
Walnuts
Watermelons
Pounds of Active Ingredient
(Ibs. a.i.)/
Year
10,000
40,000
10,000
100,000
300,000
20,000
% Crop Treated
Average
5
<1
<1
5
30
5
Maximum
15
5
<2.5
10
35
10
m. SUMMARY OF MANEB RISK ASSESSMENTS
The following is a summary of EPA's human health and ecological effects risk findings and
conclusions for the non-systemic fungicide maneb, as presented fully in the documents: Maneb.
Revised Health Effects Division (HED) Human Health Risk Assessment to Support Reregistration,
dated June 8, 2005; ETUfrom EBDCs: Health Effects Division (HED) Human Health Risk
Assessment of the Common Metabolite/Degradate ETUto Support Reregistration, dated June 8,
2005; and Environmental Fate and Ecological Risk Assessment for Maneb, Section 3 Reregistration
for Control of Fungal Diseases on Numerous Crops, Ornamental Plantings, and Turf (Phase 3
Response), dated June 21, 2005; hereafter referred to as the Environmental Fate and Effects Risk
Assessment.
The purpose of this section is to summarize the key features and findings of the risk
assessments in order to help the reader better understand the conclusions reached in the assessments.
Risks summarized in this RED document are those that result only from the use of maneb. While the
risk assessments and related addenda are not included in this RED, they are available from the Office
of Pesticide Programs (OPP) Public Docket: OPP-2004-0178 and may also be accessed on the
Agency's website at http ://www. epa. gov/edockets. Hard copies of these documents may be found in
the OPP public docket under this same docket number. The OPP public docket is located in Room
119, Crystal Mall II, 1801 South Bell Street, Arlington, VA, and is open Monday through Friday,
excluding Federal holidays, from 8:30 a.m. to 4:00 p.m.
A.
Human Health Risk Assessment
EPA released its preliminary risk assessments for maneb for public comment on November
24, 2004 for a 90 day public comment period (Phase 3 of the public participation process). The
preliminary risk assessments may be found in the OPP public docket at the address given above and
in EPA's electronic docket under docket number OPP-2004-0078. In response to comments received
and new studies submitted during Phase 3, the risk assessments were updated and refined. The risk
assessments were revised again in June 2005 to incorporate comments and additional studies
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submitted by the registrant. Revised risk assessments may be found in the OPP dockets under docket
number OPP-2005-0178. Major revisions to the maneb human health risk assessment include the
following:
Reduction of the database uncertainty factor from 10 to 1 for chronic dietary exposures,
incidental oral exposures, and dermal exposures.
Modification of residue values for tomatoes and leaf lettuce.
Assessment of toddler turf exposure at the existing label rate and the proposed reduced rate.
This document summarizes risk estimates for both maneb and its metabolite and
environmental degradate ethylene thiourea (ETU). Maneb and two other EBDC fungicides, metiram
and mancozeb, are all metabolized to ETU in the body and all degrade to ETU in the environment.
Therefore, EPA has considered the aggregate or combined risks from food, water and
non-occupational exposure resulting from maneb alone, ETU resulting from maneb use, and ETU
from all sources (i.e., the other EBDC fungicides: metiram and mancozeb). The aggregate risk from
ETU from all sources must be considered to reassess the tolerances for metiram, maneb and
mancozeb, in accordance with FQPA.
1. Toxicity Assessment of Maneb
Toxicity assessments are designed to predict if a pesticide could cause adverse health
effects in humans (including short-term or acute effects such as skin or eye damage; and lifetime or
chronic effects such as cancer, development and reproduction deficiencies, etc.) and the level or dose
at which such effects might occur. The Agency has reviewed all toxicity studies submitted for maneb
and has determined that the toxicological database is sufficient for reregistration.
For more details on the toxicity and carcinogen!city of maneb see the Maneb: HED
Toxicology Chapter for the Reregistration Eligibility Decision Document (RED), dated December 23,
1999 and the Maneb-Revised Report of the Hazard Identification Assessment Review Committee,
dated April 2, 2003, which are available at http ://www. epa. gov/edockets under docket number OPP-
2004-0078.
a. Acute Toxicity Profile of Maneb
Maneb demonstrates low acute toxicity via the oral (Toxicity Category IV), dermal (Toxicity
Category III) and inhalation (Toxicity Category III) routes of exposure. Because maneb is not
irritating to the eyes or the skin, it is in Toxicity Category in for both routes. However, maneb is a
skin sensitizer. The acute toxicity profile for maneb is summarized in Table 3.
Table 3. Acute Toxicity Profile for Maneb
Guideline
No.
870.1100
Study Type
Acute Oral - rat
MRID
41975601
Results
LD50 = >5000 mg/kg
Toxicity
Category
IV
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Table 3. Acute Toxicitv Profile for Maneb
Guideline
No.
870.1200
870.1300
870.2400
870.2500
870.2600
Study Type
Acute Dermal - rabbit
Acute Inhalation - rat
Primary Eye Irritation
Primary Skin Irritation
Dermal Sensitization
MRID
41975602
41975603
41975604
41975605
41975606
Results
LD50 = >2000 mg/kg
LC50 = >1.3mg/L
not an eye irritant
not a skin irritant
a dermal sensitizer
Toxicity
Category
III
m
m
m
N/A
* LD50 or LC50 = Median Lethal Dose or Concentration A statistically derived single dose or concentration that can
be expected to cause death in 50% of the test animals when administered by the route indicated (oral, dermal,
inhalation).
b. FQPA Safety Factors Considerations for Maneb
The Federal Food Drug and Cosmetic Act (FFDCA) as amended by the Food Quality
Protection Act (FQPA) directs the Agency to use an additional tenfold (10X) safely factor to take into
account potential pre- and post-natal toxicity and completeness of the data with respect to exposure
and toxicity to infants and children. FFDCA authorizes the Agency to modify the tenfold safety
factor only if reliable data demonstrate that the resulting level of exposure would be safe for infants
and children.
Special FQPA Safety Factor. The Agency concluded that there is qualitative indication of
increased sensitivity to infants and children based on the results of the rat developmental toxicity
study in which decreased fetal viability was observed at a dose level that produces decreased body-
weight gain/food consumption in the maternal rat. The decreased fetal viability is considered more
adverse than decreased body weight/food consumption. An adequate developmental toxicity study in
rabbits is not available with which to assess susceptibility. The Agency considered the degree of
concern for susceptibility within the context of all available toxicity data, and concluded there is low
concern for the observed qualitative susceptibility based on the following:
The doses selected for overall risk assessment address concerns seen in the prenatal
developmental toxicity study;
The dose-response in the rat developmental study was well-characterized;
There was a clear NOAEL/LOAEL (No/Lowest Observed Adverse Effect Level) for
maternal and developmental toxicity; and
The doses selected for risk assessment also address concerns for thyroid toxicity.
Since there are no residual uncertainties for pre- and/or post-natal toxicity, the Special FQPA
Safety Factor was removed (reduced to IX) for maneb.
Database Uncertainty Factor. The Agency concluded there is a concern for developmental
neurotoxicity following exposure to maneb. Evidence of neurotoxicity and neuropathology has been
seen in rats following oral exposure to maneb in both subchronic and chronic studies. The
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metabolite/degradate ETU has been shown to be a teratogen in rats, with effects seen in the central
nervous system, urogenital and skeletal systems. In addition, neurotoxic effects have been observed
in studies with another EBDC, metiram. Therefore, the Agency will be requiring a developmental
neurotoxicity study (DNT) for maneb.
A comparative thyroid study in young and adult animals had previously been required for
maneb and the other EBDC fungicides, as well as their common metabolite/degradate ETU.
Cerexagri, Inc. suggested that the comparative thyroid study be conducted with ETU and evaluated
prior to any similar testing with maneb, because ETU is believed responsible for thyroid toxicity
occurring in the EBDC toxicity studies.
As a result, the Agency has decided it is appropriate for the comparative thyroid study to be
conducted with ETU. ETU is a direct-acting thyroid toxicant which inhibits thyroid peroxidase
enzyme and is believed to be responsible for the thyroid toxicity with the EBDCs. The comparative
thyroid study should be conducted using ETU and requirement for a comparative thyroid study with
maneb, as well as the other EBDC fungicides, is reserved.
A dose analysis was conducted on maneb in order to determine the need for and size of a
database uncertainty factor (UFDB) in the absence of a submitted developmental neurotoxicity study
(DNT) for maneb. Assuming the doses tested in the required DNT will be similar to those in the
available 2-generation reproduction study, the doses will be 5/6, 21/24, and 83/100 mg/kg/day. The
assumed NOAEL (5/6 mg/kg/day) for offspring effects in the DNT is compared to the doses selected
for risk assessment, resulting in only the doses selected for the acute dietary endpoints exceeding the
assumed DNT NOAEL.
The Agency determined that a 10X database uncertainty factor (UFDB) is needed for acute
dietary exposures only to account for the lack of DNT study, however, the above analysis supports
reduction or removal of the 10X UFDB to IX for chronic dietary exposures, incidental oral exposures,
dermal exposures, and inhalation exposures because the doses did not exceed the assumed DNT
NOAEL.
c. Toxicological Endpoints for Maneb
The toxicological endpoints used in the human health risk assessment for maneb are listed in
Table 4. The safety factors used to account for interspecies extrapolation, intraspecies variability, the
potential for special susceptibility to infants and children (FQPA 10X), and database uncertainties
related to FQPA Safely Factor considerations are also described in Table 4 below.
Table 4. Toxicological Endpoints for Maneb.
Exposure
Scenario
Dose, Uncertainty Factors
(UFs), and Safety Factors
(SFs)
Population Adjusted Dose
(PAD) or
Target Margin of
Exposure (MOE)
Study and Toxicological
Effects
Maneb Dietary Exposures
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Table 4. lexicological Endpoints for Maneb.
Exposure
Scenario
Acute Dietary
Females 13-49
Acute Dietary
General Population
Chronic Dietary
General Population
Dose, Uncertainty Factors
(UFs), and Safety Factors
(SFs)
NOAEL = 20 mg/kg/day
UF=100X (inter and
intraspecies)
FQPA SF = IX
FQPAUF=10Xdabbase
Total UF=1000X
Acute RfD = 0.02 mg/kg/day
NOAEL=1000 mg/kg/day
UF=100X (inter and
intraspecies)
FQPA SF = IX
FQPAUF=10Xdabbase
Total UF=1000X
Acute RfD=1.0 mg/kg/day
NOAEL=5 mg/kg/day
UF=100X (inter and
intraspecies)
FQPA SF = IX
Total UF=100X
Chronic RfD = 0.05 mg/kg/day
Population Adjusted Dose
(PAD) or
Target Margin of
Exposure (MOE)
aPAD= Acute RID
FQPA SF
aPAD= 0.02 mg/kg/day
aPAD= Acute RID
FQPA SF
aPAD=1.0 mg/kg/day
cPAD = Chronic RID
FQPA SF
cPAD = 0.05 mg/kg/day
Study and Toxicological
Effects
Developmental Toxicity (Rat)
LUAnL too mg/Kg/day,
based on increased post-
implantation loss and
resorptions, decreased fetal
viability
Acute Neurotoxicity (Rat)
LOAEL=2000 mg/kg/day,
based on slight impairment of
forelimb grip strength
Subchronic toxicity, Rat
LOAEL-24 mg/kg/day based
on thyroid effects [increased
thyroid weight and follicular
cell hypertrophy in males and
decreased T4 in females]
Maneb Incidental Oral Exposures (Residential, Postapplication)
Any Duration
[1-30 days]
[>30 days to 6 mos.]
NOAEL = 5 mg/kg/day
UF=100X (inter and
intraspecies)
Residential MOE=100
Subchronic toxicity, Rat
LOAEL=24 mg/kg/day based
on thyroid effects [increased
thyroid weight and follicular
cell hypertrophy in males and
decreased T4 in females]
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Table 4. lexicological Endpoints for Maneb.
Exposure
Scenario
Dose, Uncertainty Factors
(UFs), and Safety Factors
(SFs)
Population Adjusted Dose
(PAD) or
Target Margin of
Exposure (MOE)
Study and Toxicological
Effects
Maneb Dermal Exposures
Any Duration
[1-30 days]
[>30 days to 6 mos.]
[>6 mos.]
Dermal NOAEL=300
mg/kg/day
UF=100X (inter and
intraspecies)
2% dermal absoprtion
observed in the rat; thus
adsorbed dose = 6.
Residential MOE=100
Occupational MOE=100
21 -day Dermal Toxicity,
Rabbit
LOAEL = 1000 mg/kg/day,
based on microscopic thyroid
changes [follicular cell
hypertrophy] in both sexes and
increased thyroid weights in
males.
Maneb Inhalation Exposure
Any Duration
[1-30 days]
[>30 days to 6 mos.]
[>6 mos.]
NOAEL=5 mg/kg/day
UF=100X (inter and
intraspecies)
Inhalation Absorption =100%
Residential MOE=100
Occupational MOE=100
Subchronic toxicity, Rat
LOAEL=24 mg/kg/day based
on thyroid effects [increased
thyroid weight and follicular
cell hypertrophy in males and
decreased T4 in females]
NOAEL- No Observable Adverse Effect Level, the highest dose at which no adverse health effect is observed.
LOAEL - Lowest Observable Adverse Effect Level, the lowest dose at which an adverse health effect is observed.
aPAD/cPAD - acute and chronic, respectively, population adjusted dose (PAD), a reference dose which has been
adjusted to account for the FQPA safety factor.
2. Toxicity Assessment of ETU
As previously mentioned, some of the toxicity of the parent EBDCs is attributed to their
common metabolite, ETU. The toxicology database for ETU contains a limited number of FIFRA
guideline studies; therefore, the Agency has relied on a combination of literature studies and
unpublished studies conducted according to the OPPTS testing guidelines. The thyroid is a target
organ for ETU, and thyroid toxicity as a result of ETU exposure has been noted in subchronic and
chronic rat, mouse, and dog studies. Overt liver toxicity was observed in one chronic dog study.
Developmental defects in the rat developmental study included hydrocephaly and related lesions,
skeletal system defects, and other gross defects. These defects showed increased susceptibility to
fetuses because they occurred at a dose that only caused decreased maternal food consumption and
body weight gain.
For more details on the toxicity and carcinogen! city of ETU, see the ETU- 3rd Report of the
Hazard Identification Assessment Review Committee, dated May 28, 2003, which is available on the
internet and in the public docket.
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a. Acute Toxicity Profile for ETU
ETU demonstrates low acute toxicity via dermal (Toxicity Category ID) and inhalation
(Toxicity Category IV) routes of exposure. Because ETU is not irritating to the eyes or the skin, it is
in Toxicity Category IV for both routes. However, acute oral and dermal sensitization studies with
ETU were not available to determine acute toxicity. The acute toxicity profile for ETU is
summarized in Table 5.
Table 5. Acute Toxicity Profile for ETU
Guideline No.
870.1100
870.1200
870.1300
870.2400
870.2500
870.2600
Study Type
Acute Oral - rat
Acute Dermal - rabbit
Acute Inhalation - rat
Primary Eye Irritation
Primary Skin Irritation
Dermal Sensitization
MRIDNos.
N/A
458881-01
458881-02
458881-04
458881-03
N/A
Results
N/A
LD50 > 2000 mg/kg
LC50 > 10.4 mg/L
No irritation
No irritation
N/A
Toxicity
Category
N/A
m
IV
IV
IV
N/A
b. FQPA Safety Factor Considerations for ETU
SpecialFOP A Safety Factor. Since there is evidence of increased susceptibility of fetuses
following exposure to ETU in the rat developmental studies, the Agency evaluated the level of
concern for the effects observed when considered in the context of all available toxicity data. In
addition, the Agency evaluated the database to determine if there were residual uncertainties after
establishing toxicity endpoints and traditional uncertainty factors to be used in the ETU risk
assessment. The Agency determined that the degree of concern for the susceptibility seen in ETU
developmental studies was low because:
The teratogenic effects have been well-characterized in numerous studies in the published
literature, as well as in a guideline study submitted by the registrant;
There is a clear NOAEL for these effects and the dose-response relationship, although steep,
is well-characterized in the numerous developmental studies in rats;
The developmental endpoint with the lowest NOAEL was selected for deriving the acute
RfD;and
The target organ toxicity (thyroid toxicity) was selected for deriving the chronic RfD as well
as endpoints for non-dietary exposures (incidental oral, dermal, and inhalation).
Since the ETU doses selected for overall risk assessments will address the concern for
developmental and thyroid toxicity, there are no residual uncertainties with regard to pre- and/or post-
natal toxicity. The Agency concluded that the Special FQPA Safety Factor could be reduced to IX
for ETU.
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Database Uncertainty Factor. The Agency concluded a developmental neurotoxicity study
for ETU is required, based on severe central nervous system defects observed in the developmental
toxicity study in rats. In addition to the developmental neurotoxicity study, the following data gaps
were identified:
Developmental toxicity study in rabbits
2-Generation reproduction study in rats
A study evaluating the comparative thyroid toxicity in adults and offspring
The Agency determined that a lOx database uncertainty factor (UFDB) is needed to account for the
lack of these studies since the available data provide no basis to support reduction or removal of the
10XUFDB.
c. Toxicological Endpoints for ETU
The toxicological endpoints used in the human health risk assessment for ETU are listed in
Table 6. The safety factors used to account for interspecies extrapolation, intraspecies variability, the
potential for special susceptibility to infants and children (FQPA 10X), and database uncertainties
related to FQPA saftey factor considerations are also described in Table 6 below.
Table 6. ETU Toxicological Endpoints for Use in Human Health Risk Assessment
Exposure
Scenario
Dose, Uncertainty Factors
(UFs), and Safety Factors (SFs)
Population Adjusted Dose
(PAD) or
Target Margin of Exposure
(MOE)
Study and Toxicological
Effects
ETU Dietary Exposures
Acute Dietary
Females 13 - 50
Acute Dietary
General Population
Chronic Dietary
NOAEL = 5 mg/kg/day
UF=100X (inter and
intraspecies)
FQPA SF = IX
FQPAUF=10Xdabbase
Total UF=1000X
Acute RfD = 0.005 mg/kg/day
Not Applicable
NOAEL = 0.18 mg/kg/day
UF=100X (inter and
intraspecies)
FQPA SF = IX
FQPAUF=10Xdabbase
Total UF=1000X
Chronic RfD=0.0002 mg/kg/day
aPAD = Acute RfD
FQPA SF
aPAD = 0.005 mg/kg/day
Developmental Rat Toxicity
(Khera Study, MPJD
45937601)
LOAEL = 10 mg/kg/day,
based on developmental
defects of brain.
No appropriate endpoint attributable to a single exposure
(dose) was identified.
cPAD = Chronic RfD
FQPA SF
cPAD = 0.0002 mg/kg/day
Dog Chronic Oral Toxicity
(MRIDNo. 42338101)
LOAEL= 1.99 mg/kg/day
based on thyroid toxicity
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Table 6. ETU lexicological Endpoints for Use in Human Health Risk Assessment
Exposure
Scenario
Dose, Uncertainty Factors
(UFs), and Safety Factors (SFs)
Population Adjusted Dose
(PAD) or
Target Margin of Exposure
(MOE)
Study and Toxicological
Effects
ETU Incidental Oral Exposures [Residential/PostappKcation]
Short-Term
[1-30 days]
Intermediate-Term
[>30 days to 6
months]
NOAEL = 7 mg/kg/day
UF = 100X (inter and
intraspecies)
FQPAUF=10Xdabbase
FQPA SF = IX
Residential MOE = 1000
Occupational MOE = N/A
4-week range-finding dog
study
LOAEL= 34 mg/kg/day
based thyroid toxicity
ETU Dermal Exposures
Short-Term
[1-30 days]
Females 13-49
Intermediate-Term
[30 days - 6 months]
Long-Term
[> 6 months]
NOAEL = 5 mg/kg/day
UF=100X (inter and
intraspecies)
FQPAUF=10Xdabbase
FQPA SF = IX
Dermal Absorption = 26%
NOAEL = 0.18 mg/kg/day
UF=100X (inter and
intraspecies)
FQPAUF=10Xdabbase
FQPA SF = IX
Dermal Absorption = 26%
Residential MOE = 1000
Occupational MOE = 100
Residential MOE = 1000
Occupational MOE = 100
Same as above for acute
dietary exposures.
Same as above for chronic
dietary exposures.
ETU Inhalation Exposures
Short-Term
[1-30 days]
Females 13-49
Intermediate-Term
[30 days - 6 months]
Long-Term
[>6 months]
NOAEL = 5 mg/kg/day
UF=100X (inter and
intraspecies)
FQPAUF=10Xdabbase
FQPA SF = IX
Inhalation Absorption = 100%
NOAEL = 0.18 mg/kg/day
UF=100X (inter and
intraspecies)
FQPAUF=10Xdabbase
FQPA SF = IX
Inhalation Absorption = 100%
Residential MOE = 1000
Occupational MOE = 100
Residential MOE = 1000
Occupational MOE = 100
Same as above for acute
dietary exposures.
Same as above for chronic
dietary exposures.
NOAEL- No Observable Adverse Effect Level, the highest dose at which no adverse health effect is observed.
LOAEL - Lowest Observable Adverse Effect Level, the lowest dose at which an adverse health effect is observed.
aPAD/cPAD - acute and chronic, respectively, population adjusted dose (PAD), a reference dose which has been
adjusted to account for the FQPA safety factor.
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3. Maneb and ETU Carcinogenicity
In assessing the carcinogen!city of pesticides, the Agency first evaluates evidence that the
pesticide is a carcinogen. If there is evidence, such as tumor formation, and the pesticide is classified
as a carcinogen, a quantitative assessment is conducted using a Qt* (non-threshold) or a Margin of
Exposure (threshold) approach. The mechanism of the tumor formation determines whether or not a
threshold or non-threshold assessment is conducted. Table 7 below provides a comparison of tumor
data for ETU, mancozeb, maneb, and metiram.
Table 7. Tumor Incidence in EBDC/ETU Carcinogenicity Studies in Rats and Mice
Species
Rats
Mice
ETU
Thyroid follicular cell
adenomas and carcinomas at
83 & 250 ppm
Thyroid follicular cell
adenomas and carcinomas,
pituitary adenomas,
hepatocellular adenomas and
carcinomas at 1000 ppm
Mancozeb
Thyroid follicular cell
adenomas and
carcinomas at 750
ppm (HDT)
[56 ppm ETU]
No increase in tumor
of any type at 1000
ppm (HDT)
[75 ppm ETU]
Maneb
No increase in tumor of
any type at 1000 ppm
(HDT)
[75 ppm ETU]
Increased incidence of
hepatocellular adenomas
and alveogenic adenomas
in the lungs at 2400 ppm
[180 ppm ETU]
Metiram
No increase in
tumor of any type
at 320 ppm (HDT)
[24 ppm ETU]
No increase in
tumor of any type
at 1000 ppm
[75 ppm ETU]
HDT - Highest Dose Tested
[Numbers in brackets represent ETU "dose" levels based on a 7.5% conversion of parent EBDC to ETU]
Historically, it has been assumed that maneb's potential for Carcinogenicity (as well as that of
the other EBDCs, metiram and mancozeb) is due to the formation of the metabolite ETU, which is
classified as a probable human carcinogen (B2), with a cancer potency factor (Qx ) of 0.0601
(mg/kg/day)"1 for risk assessment. On this basis, maneb cancer risk has been calculated by estimating
exposure to maneb-derived ETU (including the metabolic conversion) and using the ETU cancer
potency factor to provide a quantitative estimate of risk. In a 1999 Review, the Agency concluded
that cancer risk for maneb and the other EBDCs should continue to be evaluated in this way.
4.
Maneb and ETU Endocrine Effects
The available human health and ecological effects data for maneb suggest possible thyriod
effects, which may indicate potential endocrine disruption. EPA has considered these effects in the
human health risk assessment by selecting endpoints based on thyroid effects. To further address
these effects, EPA is requiring a confirmatory comparative thyroid toxicity study for maneb. Data on
ecological effects suggest possible hormonal effects to birds and mammals. These effects will be
addressed when the Agency's Endocrine Disrupter Screening and Testing Advisory Committee
develops appropriate screening and/or testing protocols. At that time, maneb may be subjected to
additional screening and/or testing to better characterize effects related to endocrine disruption.
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5. Dietary Risk from Food
a. Exposure Assumptions
EPA conducted acute, chronic, and cancer dietary (food) risk assessments for maneb and its
metabolite ETU using the Dietary Exposure Evaluation Model software with the Food Commodity
Intake Database (DEEM-FCID, Version 1.3), which incorporates consumption data from USDA's
Continuing Survey of Food Intakes by Individuals (CSFII), 1994-1996 and 1998. Because ETU is
both a metabolite and environmental degradate of maneb and the other two EBDC fungicides, it was
considered in the dietary risk assessment. The Agency conducted a dietary risk assessment for ETU
from all sources, because ETU can be derived from mancozeb, maneb, or metiram.
The acute and chronic dietary (food) risk analyses were conducted using anticipated residue
values from field trial and market basket survey data. The 1989-1990 market basket survey for
EBDCs and ETU was the largest of its kind, with 6000 samples (300 samples for each of 10 crops
and food forms). Processing factors, cooking factors, and estimated percent crop treated information
were also incorporated into the dietary risk assessment. EPA derived anticipated residues for ETU
from market basket survey data, ETU formed from the parent EBDCs during processing, and ETU
formed by metabolic conversion of the parent EBDCs.
b. Population Adjusted Dose
Dietary risk assessment incorporates both exposure and toxicity of a given pesticide. For
acute and chronic dietary assessments, the risk is expressed as a percentage of a level of concern (i.e.,
the dose predicted to result in no unreasonable adverse health effects to any human sub-population,
including sensitive members of such sub-populations). This level of concern is referred to as the
Population Adjusted Dose (PAD). Dietary risk is characterized in terms of the PAD, which reflects
the Reference Dose (RfD), either acute or chronic, that has been adjusted to account for the FQPA
Safety Factor.
Estimated dietary (food) risks less than 100% of the Population Adjusted Dose (PAD), either
acute (aPAD) or chronic (cPAD), are not of concern to the Agency. The aPAD is the dose at which a
person could be exposed at any given day with no adverse health effects expected. The cPAD is the
dose at which an individual could be exposed over the course of a lifetime with no adverse health
effects expected. Risk estimates from maneb and ETU residues in food are summarized below.
1) Acute Dietary Risk from Food
As previously mentioned, the acute dietary (food) risk assessment for maneb was conducted
using the DEEM-FCID computer model, anticipated residues, processing and cooking factors, and
estimates of percent crop treated. A highly refined, probabilistic acute dietary assessment was
conducted using a distribution of residue data for nonblended and partially blended commodities.
The Agency has high confidence in this assessment. Acute dietary risk values for maneb, ETU
resulting from maneb use, and ETU from all sources (that is, ETU resulting from the application of all
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three EBDC compounds, mancozeb, metiram, and maneb) are presented in Table 8. (For the acute
dietary endpoints see Table 4 for maneb and Table 6 for ETU)
Table 8. Summary of Acute Dietary Exposure Analysis
Population
Subgroup
U.S. Population
Females 13 to 49
years
Maneb3
99.9th Percentile
Exposure
(mg/kg/day)
0.014
0.018
%
aPAD
1.4
89
Maneb-Derived ETU"
99.9th Percentile
Exposure
(mg/kg/day)
%
aPAD
Not Applicable
0.003
52
ETU from All Sources"
99.9th Percentile
Exposure
(mg/kg/day)
%
aPAD
Not Applicable
0.0026
55
a aPAD is 1.0 mg/kg/day (general population) and 0.02 mg/kg/day (females 13 to 49) b aPAD is 0.005 mg/kg/day
For maneb per se, the acute dietary risk is below the Agency's level of concern. Dietary
exposure at the 99.9th percentile comprises 89% of the aPAD for females age 13-49, the population
subgroup with the highest exposure. Dietary exposure for the general U.S. population and all other
population subgroups, including infants and children, comprised <2% of the aPAD.
For maneb-derived ETU. the estimated acute dietary risk for ETU is below the Agency's
level of concern. Dietary exposure comprises 52% of the aPAD for females 13-49 years of age.
For ETU from all sources, the estimated acute dietary risk for total ETU is also below the
Agency's level of concern. Dietary exposure comprises 55% of the aPAD for females 13-49 years
old.
2) Chronic Dietary Risk from Food
Chronic (non-cancer) dietary risk from food is calculated by using the average consumption
value for foods and average residue values on those foods over a 70-year lifetime. The chronic
dietary (food) risk assessment was conducted using the DEEM-FCID computer model, anticipated
residues, processing and cooking factors, and estimates of percent crop treated. The chronic
assessment used deterministic methodology to provide point estimates of risk. Chronic dietary risk
values for maneb, maneb-derived ETU, and ETU from all sources are presented in Table 9. (For the
chronic dietary endpoints see Table 4 for the maneb and Table 6 for the ETU)
Table 9. Summary of Chronic (Non-Cancer) Dietary Exposure Analysis
Population Subgroup
Children (1-2)
Maneb a
Exposure
(mg/kg/day)
0.000076
%
cPAD
<1
Maneb-Derived ETU "
Exposure
(mg/kg/day)
0.000029
%
cPAD
14
ETU from All Sources'1
Exposure
(mg/kg/day)
0.000108
% cPAD
54
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Table 9. Summary of Chronic (Non-Cancer) Dietary Exposure Analysis
Population Subgroup
Females 13 - 49
U.S. population
Maneb3
Exposure
(mg/kg/day)
0.000103
0.000081
%
cPAD
<1
<1
Maneb-Derived ETU "
Exposure
(mg/kg/day)
0.000015
0.000016
%
cPAD
7.5
7.9
ETU from All Sources'1
Exposure
(mg/kg/day)
0.000027
0.000031
% cPAD
14
16
a cPAD is 0.05 mg/kg/day " cPAD is 0.0002 mg/kg/day
Maneb per se dietary risk estimates are all below the Agency's level of concern. The highest
exposed subgroup was females age 13-49, whose chronic dietary exposure comprised <1% of the
cPAD. Dietary exposure for the general U.S. population comprised <1% of the cPAD.
For maneb-derived ETU. the most exposed subgroup was children 1-2 years old, whose
chronic dietary exposure comprised 14% of the cPAD, which is below the Agency's level of concern.
For the general U.S. population, dietary exposure to maneb-derived ETU residues comprised 7.9% of
the cPAD.
For ETU from all sources, the estimated chronic dietary risk is also below the Agency's level
of concern. The dietary exposure from ETU from all sources comprises 54% of the cPAD for
children 1-2 years old, the most highly exposed population subgroup.
3) Cancer Dietary Risk from Food
Cancer dietary risk from food is calculated by using the average consumption values for food
and average residue values for those foods over a 70-year lifetime. The chronic exposure value is
multiplied by a linear low-dose, or Qj*, based on animal studies, to determine the lifetime cancer risk
estimate. For cancer dietary exposure, risk estimates within the range of an increased cancer risk of 1
x 10"6 (one in a million) are generally not of concern to the Agency.
As mentioned above, maneb's potential for carcinogenicity has been based on its metabolite
ETU. The ETU cancer potency factor has been used for assessing cancer risk associated with maneb
uses.
The Agency evaluated the carcinogenicity potential of ETU and classified ETU as a
"probable human carcinogen" (group B2). Based upon female mouse liver tumors in a National
Toxicology Program (NTP) study, the Qx* for ETU, using a 3/4 scaling factor to account for body
weight ratio from animal to human, was determined to be 6.01 x 10"2 mg/kg/day"1. On this basis,
maneb estimated cancer risk has been calculated by estimating exposure to maneb-derived ETU
(including the metabolic conversion of 0.075) and using the ETU cancer potency factor. Cancer
dietary risk values are listed in Table 10.
The cancer risk for maneb-derived ETU is approximately 9.6 x 10"7, which is less than 1 x 10"
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6 and therefore is not considered to be of concern to the Agency. The cancer risk for ETU from all
sources is approximately 1.86 x 10"6, which is within the negligible risk range of 10"6 and not
considered to be of concern.
Table 10. Cancer Dietary Exposure and Risk Summary for Maneb-derived ETU and ETU from all Sources.
Population
General U.S. Population
Maneb-derived ETU
Chronic Dietary
Exposure (mg/kg/day)
0.000016
Cancer Risk
Estimate*
9.6 x 10'7
ETU from All Sources
Chronic Dietary
Exposure
(mg/kg/day)
0.000031
Cancer Risk
Estimate**
1.86xlO-6
*Major contributors to this risk are mango and milk.
**Major contributors to this risk are lettuce and milk.
6. Dietary Exposure from Drinking Water
Drinking water exposure to pesticides can occur through surface and ground water
contamination. EPA considers acute (one day) and chronic (lifetime) drinking water risks and uses
either modeling and/or monitoring data, if the latter is available and of sufficient quality, to estimate
those exposures. Risks from exposure to ETU in drinking water are further discussed in the section
titled "Aggregate Exposure and Risk."
The Agency prepared a drinking water exposure assessment for ETU only. The parent EBDC
fungicides were not assessed because they are very short-lived in soil and water, and are not expected
to reach water used for human consumption, whether from surface water or groundwater sources.
ETU, however, is highly water soluble, and moderately mobile, and may reach both surface and
groundwater under some conditions. ETU has an aerobic soil half-life of about 3 days; in the absence
of data, the aerobic aquatic metabolism half-life was assumed to be about 6 days, or double the soil
half-life. The measured anaerobic aquatic metabolism half-life, however, is substantially longer (149
days), which may lead to the periodic detections in groundwater. The ETU estimated drinking water
concentrations (EDWCs) were generated using data from both monitoring and modeling. Table 9
shows the EDWCs used to assess exposure to ETU in drinking water from surface water and
groundwater.
Table 11. ETU Surface Water and Groundwater Estimated Drinking Water Concentrations (EDWC)
Drinking water source
Surface Water
Groundwater
Duration
Acute (Peak)
Chronic/Cancer
All Durations
EDWC (ppb)
25.2
0.1
0.21
Data Source
Modeling
Monitoring
Monitoring
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a. Surface Water
Monitoring data for ETU from a targeted surface water monitoring study conducted by the
ETU Task Force and representing vulnerable and high EBDC use sites were available for use in the
risk assessment. In the study, none of the tested surface water samples had concentrations above the
limit of detection of 0.1 ppb. Therefore, the chronic/cancer EDWC was assigned the value of 0.1 ppb
of ETU. The monitoring value of 0.1 ppb of ETU was also assigned to be the lower limit of the
acute EDWC. In addition, the Agency decided that a higher limit for the acute value is necessary
because monitoring samples were taken every 14 days during the application season and peak values
may have been missed. In order to obtain this value, the Agency performed PRZM/EXAMS
simulation modeling for 22 crop scenarios. In modeling, the Agency considered the use patterns for
all of the EBDCs and chose the highest application rate and lowest application intervals. Modeling
results showed the highest one-in-ten year acute surface water EDWC to be 25.2 ppb based on
application of EBDCs to peppers crop in Florida. Therefore, a range of acute EDWCs was
established with a lower limit, based on monitoring and an upper limit based on the PRZM/EXAMS
modeling described above. The established range of acute Estimated Drinking Water Concentration
(EDWC) values for surface water, at the national level, is expected to be between the detection limit
of 0.1 ppb (from monitoring) and the highest peak value 25.2 ppb (from modeling after adjustment by
the 0.87 national percent crop area factor or PC A). In summary, the Agency used a combined
approach to assess drinking water exposure using both targeted surface water monitoring and
simulation modeling to bracket the expected acute concentrations of ETU in drinking water between
0.1 and 25.2 ppb. Chronic surface water values were set conservatively at 0.1 ppb, the detection limit
for the monitoring data.
b. Ground Water
A groundwater EDWC was selected from a targeted monitoring study conducted in 2001 to
2003 for seven states chosen to represent the high historic EBDC use areas in the US. Based on the
monitoring results, the highest measured value in a public drinking water well was 0.210 ppb in Lee
County, Florida. Therefore, the groundwater EDWC is assigned the value of 0.21 ppb of ETU. In
this study, ETU was not detected in any of the treated community drinking water sampled from the
monitored 84 sites even when it was detected in the raw water. The absence of ETU in potable water
from community water supplies may be related to its rapid degradation resulting from aeration and
chemical treatment.
7. Residential Exposure and Risk
Residential exposure assessments consider all potential non-occupational pesticide exposure,
other than exposure due to residues in foods or in drinking water. There are no current labeled uses
for residential applications of maneb on residential areas or home gardens. The only potential
residential exposure to maneb is from residues remaining on transplanted turf from sod farms. Risk
to toddlers, the most sensitive sub-population, was evaluated for four post-application routes of
exposure: dermal exposure; incidental oral exposure from children putting their hands in their mouth
after touching treated turf (hand-to-mouth); children mouthing a handful of treated turf (object-to-
mouth); and children eating soil from treated sod (soil ingestion).
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To estimate residential risks, the Agency calculates a margin of exposure (MOE), which is the
ratio of the NOAEL selected for risk assessment to the exposure. This MOE is compared to a level of
concern which is the same value as the uncertainty factor (UF) applied to a particular toxicity study.
The standard UF is lOOx (lOx to account for interspecies extrapolation and lOx for intraspecies
variation), plus any additional FQPA safety factor retained due to concerns unique to the protection of
infants and children. For maneb, the Agency does not have risk concerns for MOEs greater than 100
for dermal and incidental oral exposures. For ETU, the target MOE is 1000 for dermal and incidental
oral exposures.
Although maneb is not registered for residential use, EPA has considered residential post-
application risk to transplanted sod treated with maneb on sod farms. EPA evaluated post-application
exposure and risk only for toddlers because they comprise the most sensitive subpopulation. MOEs
are presented on day 3 after application (the first day of potential exposure) and on the day when the
MOE is no longer of concern, which is the recommended pre-harvest interval (PFQ). These risk
estimates and PHIs for toddlers will be protective of all other subpopulations.
Table 12. Maneb Post-Application Risks for Toddlers Exposed to Turf
Exposure Pathway
Dermal
Hand-to-Mouth
(HTM)
Object-to-Mouth
(OTM)
Soil Ingestion
Total MOE**
Label Application Rate of 17.4 Ib ai/A
MOE on Day 3
(PHI = 1 day*)
48
62
250
62000
24
Pffl Needed to
Reach an MOE of
100 (days)
3
3
0
0
5
Proposed Label Rate of 8.7 Ibs ai/A
MOE on Day 3
(PHI =1 day*)
96
124
500
124000
49
Pffl Needed to
Reach an MOE of
100 (days)
2
1
0
0
3
* The current "PHI" is one day because the REI is 24 hours.
** Total MOE = l/[(l/Dermal MOE) + (1/HTM MOE) + (1/OTM MOE) + (I/Soil MOE)]
For maneb, the MOE for almost each exposure scenario is of risk concern on the first day of
potential exposure at the current label rate of 17.4 Ibs ai/A with the exception of soil ingestion.
However, as residues decline over time, MOEs reach acceptable levels. Likewise, the total MOE, or
sum of risk for all potential exposure scenarios is of concern on the first day of potential exposure but
reaches an acceptable level over time. Further, the total MOE for toddlers reaches 100 with a PHI of
3 days at a reduced maximum application rate of 8.7 Ibs ai/A proposed by the technical registrant and
5 days at the current label rate, as shown above in Table 12.
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Table 13. Maneb-Derived ETU Post-Application Risks for Toddlers Exposed to Turf
Exposure Pathway
Dermal
Hand-to-Mouth
(HTM)
Object-to-Mouth
(OTM)
Soil Ingestion
Total MOE**
Label Application Rate of 17.4 Ib ai/A
MOE on Day 3
(PHI = 1 day*)
460
1100
3600
24000
300
Pffl Needed to
Reach an MOE of
100 (days)
3
1
0
0
5
Proposed Label Rate of 8.7 Ibs ai/A
MOE on Day 3
(PHI =1 day*)
920
2200
7200
48000
600
Pffl Needed to
Reach an MOE of
1000 (days)
2
0
0
0
3
* The current "PHI" is one day because the REI is 24 hours.
** Total MOE = l/[(l/Dermal MOE) + (1/HTM MOE) + (1/OTM MOE) + (I/Soil MOE)]
For maneb-derived ETU, the MOE for dermal exposure is 460 at the current label rate and
920 at the reduced maximum application rate on the first potential day of exposure. MOEs for
incidental oral exposure are all greater than 1000 and not of concern. The MOE for total post-
application exposure to ETU is 300 and increases to 600 with the proposed label rate of 8.7 Ibs ai/A
on the first day of exposure. As ETU residues decline over time, MOEs reach 1000. A PHI of 5 days
at the current rate and 3 days at the proposed rate is necessary for the MOE from total exposure to
reach a MOE of 1000, as shown above in Table 13.
8. Aggregate Risks from Food, Drinking Water and Residential Uses
The FQPA amendments to the Federal Food, Drug, and Cosmetic Act (FFDCA, Section
408(b)(2)(A)(ii)) require "that there is a reasonable certainty that no harm will result from aggregate
exposure to the pesticide chemical residue, including all anticipated dietary exposures and other
exposures for which there is reliable information." Aggregate exposure will typically include
exposures from food, drinking water, residential uses of a pesticide, and other non-occupational
sources of exposure.
In accordance with the FQPA, the Agency must consider and aggregate pesticide exposures
and risks from three major sources or pathways: food, drinking water and, if applicable, residential or
other non-occupational exposures. For maneb, the Agency conducted a refined aggregate risk
assessment that combines exposures across all pathways. The Agency included acute, chronic and
cancer EDWCs directly in the dietary exposure assessments to calculate aggregate dietary (food +
drinking water) risk. This is done by using the relevant PRZM-EXAMS value as a residue for
drinking water (all sources) in the dietary exposure assessment conducted using the DEEM-FCID
model. The principal advantage of this approach is that the actual individual body weight and water
consumption data from the CSFII are used, rather than assumed weights and consumption estimates
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for broad age groups.
Short-term residential and other non-occupational exposure assessments consider all potential
pesticide exposure, other than exposure due to residues in food and/or in drinking water. Each route
of exposure (i.e., oral, dermal, inhalation) is assessed, where appropriate, and risk is expressed as a
Margin of Exposure (MOE), which is the ratio of estimated exposure to an appropriate NOAEL dose.
An MOE greater than or equal to the target MOE is considered adequately protective and not a risk of
concern. The target MOE is 100 for residential exposures to maneb, and the target MOE is 1000 for
exposure to ETU.
Risk estimates from all relevant pathways (i.e., food, drinking water, and residential or non-
occupational) for maneb per se, maneb-derived ETU, and ETU from all sources were calculated to
assess aggregate risks. When aggregating exposure and risk from various sources, both the route and
duration of exposure are considered. Exposure to multiple sources that are expected to co-occur are
detailed below.
Since exposure to maneb per se is not expected from the drinking water pathway, aggregate
exposure and risk for maneb per se are limited to combined food and residential exposures (i.e.,
transplanted turf that has been treated with maneb at a sod farm). The contribution from potential
exposures to maneb in food is insignificant relative to the contribution from exposure to maneb on
transplanted turf; therefore, the aggregate risk estimate is equivalent to the estimated risk from
transplanted turf (see Section HI. A.7).
For ETU resulting from maneb use, the Agency assessed the following aggregate exposure
scenarios:
acute aggregate (food + water)
non-cancer chronic aggregate (food + water)
cancer aggregate (food + water)
For ETU from all sources, the Agency assessed the following aggregate exposure scenarios:
acute aggregate (food + water)
short-term aggregate (food + water + residential [as a result of the residential uses of
mancozeb])
chronic (non-cancer) aggregate (food + water)
cancer aggregate (food + water + residential [as a result of the residential uses of mancozeb])
a. Acute Aggregate
Acute aggregate (food + drinking water) risk for maneb-derived ETU from both groundwater
and surface water sources of drinking water, when combined with exposure through food, is below
the Agency's level of concern. The acute aggregate risk for maneb-derived ETU is 86% of the aPAD
at the 99.9th percentile, which is less than 100% of the aPAD, as shown in Table 14.
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Table 14. Acute DWLOC Calculations for Maneb-Derived ETU
Population Subgroup
Females 13 - 49
aPAD
(mg/kg/day)
0.005
Estimated Drinking Water
Concentration
EDWC (ppb)
25.2
99.9 Percentile
Exposure
(mg/kg/day
0.004321
%
aPAD
86
Similarly, acute aggregate (food + drinking water) risk for ETU from all sources is also
calculated to be below the Agency's level of concern. The acute aggregate risk for ETU from all
sources is 87% of the aPAD at the 99.9th percentile, which is less than 100% of the aPAD.
b. Short-Term Aggregate
Short-term aggregate (food + drinking water + residential [as a result of residential exposures
from mancozeb uses]) risk for ETU from all sources is below the Agency's level of concern for
residential handlers, and children and adults exposed to ETU from re-entry activities. Short-term
aggregate risks were calculated for adults by aggregating chronic food exposure, chronic drinking
water exposure and post-application golfing or gardening exposures. Short-term aggregate MOEs are
significantly greater than the target MOE of 1000 (see Table 15).
EPA's original ETU analysis indicated risks above levels of concern for toddler exposure to
transplanted turf treated with maneb. Recognizing that potential risk, the maneb registrants agreed to
reduce the maximum application rate and/or extend the time between treatment and harvesting of sod
from one to three days (i.e., 3 day pre-harvest interval [PHI]). Additionally, given the typical one to
three day installation window following harvesting, the minimum time that would elapse between
treatment and installation of sod in a residential setting would be within the range of four to six days.
Further, the frequent and long duration of watering of newly installed sod and the need to restrict foot
traffic for several weeks after planting should also minimize children's exposure to residues on
transplanted turf. The reduced application rate and/or extended PHI, combined with the logistics of
transplanting turf and installation restrictions, effectively reduced the potential contribution from this
use pattern to a level not of concern to the Agency. The Agency has determined that aggregate risk
assessments for transplanted turf exposure scenarios are not necessary, because such exposures are
expected to be rare events.
Table 15. Short-Term Aggregate Post-Application Risk Estimates for ETU from All Sources.
Exposure Scenario
Golfing
Home Garden Handler (Handwand)
Home Garden Post- Application
Short-Term MOEs
6200
62000
14450
27 of 85
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c. Chronic (Non-Cancer) Aggregate
Chronic aggregate (food + drinking water) risk to maneb-derived ETU is below the Agency's
level of concern. The aggregate chronic risks to maneb-derived ETU were calculated using food and
drinking water only, because the potential residential exposure to ETU from maneb use is considered
a short-term exposure scenario. The chronic aggregate risk estimate of 18% (groundwater) and 16%
(surface water) of the cPAD for the most highly exposed population subgroup, children 1-2 years old,
is less than 100% of the cPAD and not of risk concern.
Chronic aggregate (food + drinking water) risk to ETU from all sources is also below the
Agency's level of concern. The chronic aggregate risk was calculated using food and drinking water
exposure only, because golfing, athletic field and toddler transplanted turf exposure scenarios for
ETU from all sources were considered to occur only on a short-term basis. The chronic aggregate
risk estimate of 56% (surface water) and 58% (groundwater) of the cPAD for the most highly
exposed population subgroup, children 1 to 2 years old, is less than 100% of the cPAD and not of risk
concern.
d. Cancer Aggregate
Cancer aggregate (food + drinking water) risk to maneb-derived ETU for the general U.S.
population 1.2 x 10"6, and considered to be negligible. In addition, aggregate cancer risk estimates for
exposure to ETU from all sources are in the range of 2 x 10"6 and considered to be negligible. The
cancer risks were aggregated using the food and drinking water exposure estimates for the general
population and the food, water and recreational exposure estimates for golfers, home gardeners and
athletes. Note that the recreational contribution to this risk estimate is a result of the application of
mancozeb.
9. Occupational Risks
Workers can be exposed to maneb and maneb-derived ETU through mixing, loading, and/or
applying the pesticide to fruit and nut crops; vegetable crops; field and forage crops; grapes; sod
farms; potato seed pieces; field crop seeds; and ornamental trees, shrubbery, annual plants, and
perennial plants; or re-entering treated sites. Some of these exposures are expected to occur in
greenhouses as a result of use in tomato production and on cut flowers. Occupational non-cancer risk
to workers is measured by a Margin of Exposure (MOE), which determines how close the
occupational exposure comes to a NOAEL. However, the occupational assessment does not consider
an FQPA SF for sensitive populations (infants or children), nor is it affected by the FQPA database
uncertainty factor being applied to dietary exposures for maneb. Thus, the target MOE for
occupational risk is 100, and MOEs greater than 100 do not exceed the Agency's level of concern.
For occupational cancer risks, as for dietary cancer risk and as described above in Section III. A.5.,
risk estimates within the range of an increased cancer risk of 1 x 10"6 (one in a million) generally do
not exceed the Agency's level of concern. When occupational MOE are less than 100 or
occupational cancer risks exceed the range of an increased cancer risk of 1 x 10"6, EPA strives to
reduce worker cancer risks through the use of personal protective equipment and engineering controls
or other mitigation measures. The Agency generally considers occupational cancer risks within the
28 of 85
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range of an increased risk of 1 x 10"6 or less to be negligible, but will consider risks as high as 10"4
when all mitigation measures that are feasible have been applied, and when evaluating the advantages
associated with the use of the pesticide. The cancer risks for application of maneb to agricultural
crops are as a result of exposure to ETU, and calculated by estimating 30 days of exposure per year.
References to ETU in the occupational risk section of this document refer to maneb-derived
ETU from three sources, ETU formed in tank mixes, ETU formed in the body by metabolic
conversion, and ETU formed in the environment through degradation. For both handler and post-
application assessments, the maneb dose considered ETU from metabolic conversion of maneb to
ETU and from maneb converted to ETU in tank mixes. Handler assessments addressed combined
dermal and inhalation exposures, but post-application risks were derived solely from dermal
exposure.
Occupational risk is assessed based on exposures at the time of application (termed "handler"
exposure) and following application, or post-application exposure. Application parameters are
generally defined by the physical nature of the formulation (e.g., formula and packaging), by the
equipment required to deliver the chemical to the use site, and by the application rate required to
achieve an efficacious dose. Post-application risk is assessed for activities such as scouting,
irrigating, pruning, and harvesting and is based primarily on dermal exposure estimates. Note that
occupational risk estimates are intended to represent pesticide workers, and on this basis assumptions
are made concerning acres treated per day and the seasonal duration of exposure.
For more information on the assumptions and calculations of potential risks to workers
handling maneb or working in maneb treated areas, see the Maneb: Occupational and Residential
Exposure Assessment and Recommendations for the Reregistration Eligibility Decision Document
dated June 8, 2005, which is available in the public docket (OPP-2005-0178).
a. Occupational Handler Exposure
For handlers, most exposures were considered to be short-term (1-30 days) or intermediate-
term (1-6 months) in duration, with the exception of greenhouse uses, which may result in chronic
(>180 days) exposure. For handler assessments that consider exposure to ETU, non-cancer short-
term and intermediate-term risks were the same, but chronic risks were assessed using a different
toxicological dose and endpoint. For both the maneb handler assessments and the ETU non-cancer
assessments, dermal and inhalation exposures were combined, since the endpoints selected as the
basis for risk assessment (thyroid effects) were similar.
No chemical-specific handler exposure studies were submitted in support of the reregistration
of maneb, so Pesticide Handler Exposure Database (PHED, Version 1.1, 1998) data were used to
calculate unit exposure values to estimate occupational handler exposures to maneb and ETU during
application to crops and ornamentals. There are no recent or adequate data (either chemical-specific
or in PHED) that reflect the specifics of the potato seed-piece treatment scenario; therefore, PHED
data for other scenarios were extrapolated to approximate seed-piece treatment. Moreover, standard
assumptions were used for the number of acres treated, body weight, hours worked, etc. for most
handler scenarios. For the potato seed-piece use, assumptions were based on conversations with
29 of 85
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experts in the potato industry.
Occupational handler assessments are conducted using increasing levels of protection. The
Agency typically evaluates all exposures with minimal protection and then considers additional
protective measures using a tiered approach (going from minimal to maximum levels of protection) in
an attempt to assess reduction in exposure achieved by each protective measure. The lowest tier is
represented by the baseline clothing scenario (i.e., single layer clothing, socks, and shoes), followed
by, if MOEs are of concern, increasing levels of risk mitigation, such as personal protective
equipment (PPE) and engineering controls (EC). End-use product PPE will be assessed on a product-
by-product basis. Maneb labels currently require double layer PPE and a chemical-resistant apron for
mixing/loading; double layer PPE without the apron for applying; and a respirator for use of the dust
formulation for potato seed treatment.
1) Agricultural and Greenhouse Handler Risks
To assess occupational agricultural and greenhouse handler risks, the Agency conducted the
following risk assessments:
Maneb - Agricultural and Greenhouse Handlers (Non-cancer; combined dermal and
inhalation MOEs)
ETU - Agricultural and Greenhouse Handlers (Non-cancer; combined dermal and inhalation
MOEs)
ETU - Agricultural and Greenhouse Handlers (Cancer)
To simplify this occupation risk summary, only maneb short/intermediate-term MOEs are
presented in this section. Short/intermediate-term maneb risks for occupational agricultural and
greenhouse handlers are summarized in Table 16. In addition, only ETU long-term MOEs are
presented, and are summarized in Table 17. Measures to mitigate the risks presented in Tables 16
and 17 will also address risks from short/intermediate-term exposures to ETU and long-term
exposures to maneb. ETU cancer risks for agricultural and greenhouse use are summarized in Table
18.
Table 16. Summary of Maneb Short/Intermediate-Term Combined MOEs for Agricultural
Crops
Exposure Scenario
Crop Type
Application
Rate
(Ib so/acre)
Acres
Treate
d/Day
Base-
line
Single
Layer
Single
Layer
+ PF5
Double
Layer +
PF5
Double
Layer
+ PF10
Eng.
Controls
Mixer/Loader (M/L)
M/L Wettable Powder (WP)
for Aerial Application or
Chemigation
turf: sod farms
fruits and nuts
field
crops, vegetables
17.4
2.0 to 6.4
1.2 to 2.4
350
0.55
>1.5
>4.0
1.3
>3.4
>9.1
5
>14
>36
5.3
>15
>39
8.9
>24
>64
140
>390
>1000
30 of 85
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Table 16. Summary of Maneb Short/Intermediate-Term Combined MOEs for Agricultural
Crops
Exposure Scenario
M/L WP for Ground-boom
M/L WP for Airblast
M/L WP for HP Handwand
M/L Dry Flowable (DF) for
Aerial Application or
Chemigation
M/L DF for Groundboom
M/L DF for Airblast
M/L DF for HP Handwand
M/L Liquids for Aerial
Application or Chemigation
M/L Liquids for
Groundboom
M/L Liquids for Airblast
M/L Liquids for HP
Handwand
Crop Type
turf: sod farms
cranberries, grapes
field crops,
vegetables
ornamentals
fruits and nuts
ornamentals,
tomatoes
turf: sod farms
fruits and nuts
field crops,
vegetables
turf: sod farms
All other crops
fruits and nuts
ornamentals,
tomatoes
turf: sod farms
fruits and nuts
field crops,
vegetables
turf: sod farms
all other crops
fruits and nuts
ornamentals,
tomatoes
Application
Rate
(Ib ai/acre)
17.4
2.0 to 4.8
1.2 to 2.4
1.2
2.0 to 6.4
1.2 to 2.4
17.4
2.0 to 6.4
1.2 to 2.4
17.4
1.2 to 4.8
2.0 to 6.4
1.2 to 2.4
17.4
2.0 to 6.4
1.2 to 2.4
17.4
1.2 to 4.8
2.0 to 6.4
1.2 to 2.4
Acres
Treate
d/Day
80
40
10
350
80
40
10
350
80
40
10
Base-
line
2.4
>8.7
>17
70
>13
>140
31
>84
>220
130
>400
>700
>1000
1.2
>3.2
>8.4
5.1
>18
>28
>290
Single
Layer
5.5
>20
>40
160
>30
>300
31
>84
>220
130
>400
>700
>1000
36
>99
>260
160
>500
>800
>1000
Single
Layer
+ PF5
22
>80
>160
640
>120
>1000
46
>130
>300
200
>700
>1000
>1000
92
>250
>670
400
>1000
>1000
>1000
Double
Layer +
PF5
23
>85
>170
680
>130
>1000
62
>170
>300
270
>900
>1000
>1000
110
>300
>800
480
>1000
>1000
>1000
Double
Layer
+ PF10
39
>140
>280
>1000
>210
>1000
67
>180
>300
290
>1000
>1000
>1000
110
>300
>1000
620
>1000
>1000
>1000
Eng.
Controls
620
>1000
>1000
>1000
>1000
>1000
ND
ND
ND
ND
ND
ND
ND
250
>600
>1000
>1000
>1000
>1000
>1000
Applicator
Aerial Application
Groundboom Application
Airblast Application
HP Handwand Application
turf: sod farms
All other crops
turf: sod farms
All other crops
fruits and nuts
ornamentals,
tomatoes
17.4
1.2 to 6.4
17.4
1.6 to 4.8
2.0 to 6.4
1.2 to 2.4
350
80
40
10
NA - It was assumed that only closed cockpit aircraft
are used.
260
>900
>130
>500
260
>900
>160
>1000
660
>1000
>280
>1000
750
>1000
>300
>1000
980
>1000
>330
>1000
380
>1000
>1000
>1000
>1000
>1000
Mixer/Loader/Applicator (M/L/A)
M/L/AWPwithLP
Handwand
M/L/A WP with Backpack
Sprayer
tomatoes,
ornamentals
1.2 to 2.4
0.4
No
Data
>290
>1000
>1000
>1000
N/A
No Data
31 of 85
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Table 16. Summary of Maneb Short/Intermediate-Term Combined MOEs for Agricultural
Crops
Exposure Scenario
Crop Type
Application
Rate
(Ib ai/acre)
Acres
Treate
d/Day
Base-
line
Single
Layer
Single
Layer
+ PF5
Double
Layer +
PF5
Double
Layer
+ PF10
Eng.
Controls
M/L/A DF with LP
Handwand or Backpack
Sprayer
No Data
M/L/A Liquids with LP
Handwand
>210
M/L/A Liquids with
Backpack Sprayer
No
Data
>1000
>1000
>1000 >1000
>1000
>1000
>1000 >1000
>1000
>1000
Flagger
Flag Aerial Applications
turf: sod farms
All other crops
17.4
1.2 to 6.4
350
110
>290
100
>280
210
>580
230
>600
260
>700
>1000
>1000
*MOEs in bold are less than 100 and are of concern^
Crop Groups
Fruits and nuts- includes almonds, cranberries, grapes and pome fruits.
Field crops - includes corn, dry beans, potatoes and sugar beets.
Vegetables - includes brassicca, curcurbits, garlic, greens, lettuce, onions, peppers and tomatoes
PPE Levels
Baseline - includes long pants and long sleeve shirts without gloves.
Single Layer (SL) - includes baseline PPE with chemical resistant gloves
Double Layer (DL) - includes coveralls over baseline PPE and chemical resistant gloves - typically required by the labels
PF5 - Filtering facepiece respirator (i.e. a dustmask) with a protection factor of 5
PF10 - Half face cartridge respirator with a protection factor of 10
EC - Engineering control - includes water soluble bags , closed loading systems and enclosed cabs.
Table 17. Summary of ETU Long-Term Combined MOEs for Agricultural Crops
Exposure Scenario
Crop Type
Application
Rate
(Ib ai/acre)
Acres
Treated
per Day
Base-
line
Single
Layer
Single
Layer
+ PF5
Single
Layer +
PF10
Double
Layer
+ PF10
Eng.
Controls
Mixer/Loader
Mix/Load WP for HP
Handwand
Mix/Load DF for HP
Handwand
Mix/Load Liquids for HP
Handwand
tomatoes (east)
tomatoes (west)
ornamentals
ornamentals,
tomatoes
tomatoes (East)
tomatoes (West)
ornamentals
2.4
1.6
1.2
1.2 to 2.4
2.4
1.6
1.2
10
10
10
10
10
49
73
97
>1000
88
130
180
140
220
290
>1000
>1000
520
780
1000
>1000
>1000
780
>1000
>1000
>1000
>1000
880
>1000
>1000
>1000
>1000
>1000
>1000
>1000
No Data
>1000
Applicator
HP Handwand Application
tomatoes (East)
tomatoes (West)
ornamentals
2.4
1.6
1.2
10
120
180
240
350
520
700
420
630
840
430
640
860
570
860
>1000
No Data
Mixer/Loader/Applicator
32 of 85
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Table 17. Summary of ETU Long-Term Combined MOEs for Agricultural Crops
Exposure Scenario
Mix/Load/Apply WP with LP
Handwand
Mix/Load/Apply WP with
Backpack Sprayer
Mix/Load/Apply DF with LP
Handwand or Backpack
Mix/Load/Apply Liquids
with LP Handwand
Mix/Load/Apply Liquids
with Backpack Sprayer
Crop Type
tomatoes (East)
tomatoes (West)
ornamentals
ornamentals,
tomatoes
ornamentals,
tomatoes
tomatoes (East)
tomatoes (West)
ornamentals
tomatoes (East)
tomatoes (West)
ornamentals
Application
Rate
(Ib ai/acre)
2.4
1.6
1.2
1.2 to 2.4
1.2 to 2.4
2.4
1.6
1.2
2.4
1.6
1.2
Acres
Treated
per Day
0.4
0.4
0.4
0.4
0.4
Base-
line
No
Data
Single
Layer
110
170
230
Single
Layer
+ PF5
300
450
590
Single
Layer +
PF10
370
560
750
Double
Layer
+ PF10
470
710
940
Eng.
Controls
N/A
No Data
No Data
43
64
85
ND
>1000
>1000
>1000
>1000
>1000
>1000
>1000
>1000
N/A
N/A
ND = No Data
N/A = Engineering Controls are Not Applicable
PPE Levels
Baseline - includes long pants and long sleeve shirts without gloves.
Single Layer (SL) - includes baseline PPE with chemical resistant gloves
Double Layer (DL) - includes coveralls over baseline PPE and chemical resistant gloves - typically required by the labels
PF5 - Filtering facepiece respirator (i.e. a dustmask) with a protection factor of 5
PF10 - Half face cartridge respirator with a protection factor of 10
EC - Engineering control - includes water soluble bags , closed loading systems and enclosed cabs.
Note: Ornamentals include carnations, chrysanthemums, dahlias, dogwood, gladiolus, lillies, pansies, peonies, roses, snapdragons, zinnias
Maneb Non-Cancer Risks. Several short/intermediate-term MOEs for maneb are of concern to the
Agency at the current level of PPE (Table 16). For example, handlers mixing and loading wettable
powders for aerial or chemigation applications to any crop; handlers mixing and loading wettable
powders for groundboom application to turf; and handlers mixing and loading dry flowable for aerial
or chemigation application to turf all require engineering controls to achieve MOEs >100. The
remaining scenarios are acceptable with the addition of varying levels of PPE. The long-term maneb
MOEs for all scenarios for which there are data are all 100 or greater at baseline PPE; therefore, these
are not of concern to the Agency and not presented in a table in this document.
ETU Non-Cancer Risks: The short/intermediate-term MOEs for ETU are all greater than the maneb
short/intermediate-term MOEs discussed above; therefore, these risk estimates are not presented in a
table in this document. Any mitigation necessary to address the maneb short/intermediate-term risk
will also adequately address the ETU short/intermediate term risks. The long-term MOEs for ETU
are all 100 or greater for all of the scenarios listed at single layer PPE (Table 17); therefore, these are
not of concern to the Agency
33 of 85
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Table 18. Summary of ETU Cancer Risks for Agricultural Handlers
Exposure Scenario
Crop Type
Application
Rate
(Ib ai/acre)
Acres
Treated
per Day
Base-
line
Single
Layer
Double
Layer
Double
Layer +
PF5
Double
Layer
+ PF10
Eng.
Controls
Mixer/Loader (M/L)
M/L WP for Aerial
Application or Chemigation
M/L WP for Ground-boom
M/L WP for Airblast
M/L WP for HP Handwand
M/L DF for Aerial Application
or Chemigation
M/L DF for Groundboom
M/L DF for Airblast
M/L DF for HP Handwand
M/L Liquids for Aerial App or
Chemigation
M/L Liquids for Groundboom
M/L Liquids for Airblast
M/L Liquids for HP
Handwand
turf: sod farms
fruits and nuts
field crops,
vegetables
turf: sod farms
grapes,
cranberries
field crops,
vegetables
ornamentals
fruits and nuts
ornamentals,
tomatoes
turf: sod farms
fruits and nuts
field crops,
vegetables
turf: sod farms
All other crops
fruits and nuts
ornamentals,
tomatoes
turf: sod farms
fruits and nuts
field crops,
vegetables
turf: sod farms
All other crops
fruits and nuts
ornamentals,
tomatoes
17.4
1.8 to 3.6
1.2 to 2.4
17.4
1.8 to 3.0
1.2 to 2.4
1.2
1.9 to 3.6
1.2 to 1.4
17.4
1.8 to 3.6
1.2 to 2.4
17.4
1.2 to 3.0
1.8 to 3.6
1.2 to 1.4
17.4
1.8to3.6
1.2 to 2.4
17.4
1.2 to 3.0
1.8 to 3.6
1.2 to 1.4
350
80
40
10
350
80
40
10
350
80
40
10
2e-03
<5e-04
<3e-04
5e-04
<9e-05
<7e-05
2e-05
<6e-05
<6e-06
4e-05
<9e-06
<6e-06
le-05
<2e-06
-------
Table 18. Summary of ETU Cancer Risks for Agricultural Handlers
Exposure Scenario
Crop Type
Application
Rate
(Ib ai/acre)
Acres
Treated
per Day
Base-
line
Single
Layer
Double
Layer
Double
Layer +
PF5
Double
Layer
+ PF10
Eng.
Controls
Mixer/Loader/Applicator (M/L/A)
M/L/A WP with LP Handwand
tomatoes,
ornamentals
1.2 to 1.4
0.4
M/L/A WP with Backpack ,
M/L/A DF with LP Handwand
M/L/A DF with Backpack
M/L/A Liquids with LP
Handwand
M/L/A Liquids with Backpack
tomatoes,
ornamentals
tomatoes,
ornamentals
1.2 to 1.4
1.2 to 1.4
0.4
0.4
ND
<2e-06
<2e-06
<8e-07
<6e-07
N/A
No unit exposure data are available for these scenarios.
<7e-06
ND
<8e-08
<2e-07
<8e-08
<2e-07
<3e-08
le-07
<3e-08
-------
Maneb - Potato Seed-Piece Treatment (Non-cancer - short/intermediate-term combined
dermal and inhalation MOEs)
ETU - Potato Seed-Piece Treatment (Non-cancer - short/intermediate-term combined dermal
and inhalation MOEs)
ETU - Potato Seed-Piece Treatment (Cancer)
Table 19. Maneb Combined Short/Intermediate Term MOEs for Potato Seed-Piece Treatment
Exposure Scenario
Treatment
Rate
Amount
Treated
per Day
Base-
line
Single
Layer
Single
Layer
+ PF5
Single
Layer +
PF10
Double
Layer +
PF10
Eng
Controls
Mix/Load
Load Dusts for Commercial Seed-Piece
Treatment
Load Dusts for On-Farm Seed-Piece
Treatment
0.08 Ib ai/cwt
0.08 Ib ai/cwt
10,000
cwt
800 cwt
4.2
52
9.5
120
38
480
61
770
68
850
1100
14000
Applicator
Apply Dusts During Commercial or On-
Farm Seed-Piece Treatment
0.08/cwt
10,000
cwt
There is no unit exposure data available for this scenario.
Secondary Handler Exposure
Load Treated Seed Pieces for Planting
Plant Treated Seed Pieces
1.6 Ib ai/acre
1.6 Ib ai/acre
40 acres
40 acres
3000
4000
3000
4100
12000
15000
19000
23000
24000
29000
No Data
22000
Maneb Non-Cancer Risks: Risks of concern are indicated for handlers mixing and loading maneb
dust formulations for commercial potato seed-piece treatment, and would require a closed-capture
(engineering control) system to exceed the target MOE of 100. Risks of concern are also indicated
for handlers mixing and loading dusts for on-farm potato seed-piece treatment, and would require the
addition of gloves (single layer PPE). There is no unit exposure data to assess risks to applicators
applying dusts; however, the Agency believes that these risks will not be greater than for handlers
mixing and loading dusts. There are no risks to secondary handlers handling the treated seed-pieces
at baseline PPE (Table 19).
ETU Non-Cancer Risks: The short/intermediate term ETU non-cancer MOEs for seed-piece
treatment are greater than the corresponding maneb non-cancer MOEs presented in Table 19 above
and are above 100 for all of the scenarios if gloves are worn. As such, these MOEs are not tabulated
in this document.
Table 20. ETU Cancer Risks from Maneb Potato Seed-Piece Treatment
Exposure Scenario
Typical
Application
Rate
Amount
Treated
Daily
Single
Layer
Single
Layer +
PF5
Single
Layer +
PF10
Double
Layer +
PF10
Eng
Controls
Mixer/Loader
Load Dusts for Commercial Seed-Piece Treatment
Load Dusts for On-Farm Seed- Piece Treatment
0.098 Ib ai/cwt
0.098 Ib ai/cwt
10000 cwt
800 cwt
le-04
8e-06
3e-05
2e-06
le-05
8e-07
7e-06
6e-07
le-06
9e-08
36 of 85
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Table 20. ETU Cancer Risks from Maneb Potato Seed-Piece Treatment
Exposure Scenario
Typical
Application
Rate
Amount
Treated
Daily
Single
Layer
Single
Layer +
PF5
Single
Layer +
PF10
Double
Layer +
PF10
Eng
Controls
Applicator
On-Farm Seed-Piece Treatment - Apply Dusts
0.098
No Data
No unit exposure data are available for this scenario.
Secondary Handler Exposure
Load Treated Seed Pieces for Tractor Planting
Tractor Plant Treated Seed Pieces
1.6 Ib ai/acre
40 acres
3e-07
2e-07
9e-08
8e-08
6e-08
3e-08
5e-08
2e-08
No Data
5e-08
ETU Cancer Risks: The cancer risks for loading dusts for commercial seed piece treatment are 10"4 at
single layer PPE. Engineering controls would be needed for this scenario to achieve a cancer risk
within the range of 10"6. The cancer risk for loading dusts for on-farm seed-piece treatment is greater
than 10"6 at single layer PPE; the addition of a dust/mist respirator is needed to mitigate these risks.
As stated above, no data are available to assess risks to applicators; however the Agency believes that
risks to applicators will not be greater than risks to handlers mixing and loading dusts for seed
treatment. The cancer risks of handling the treated seed pieces are less than 10~6 with single layer
PPE (Table 20).
Occupational Handler for Seed Treatment
To assess occupational handler seed treatment risks, the Agency conducted the risk
assessments listed below. Long term risks were not calculated for the seed treatment scenarios,
because the scenarios only occur for a few weeks or months at a time and do not occur on a year
round basis.
Maneb - Seed Treatment (Non-cancer - combined short/intermediate-term dermal and
inhalation MOEs)
ETU - Seed Treatment (Non-cancer - combined short/intermediate-term dermal and
inhalation MOEs)
ETU - Seed Treatment (Cancer)
Table 21. Maneb Short/Intermediate-Term Combined MOEs for Seed Treatment
Exposure Scenario
Loader/Applicator (1)
Bagger (2)
Sewer (3)
Seed Type
cotton (adl)
tomato
flax
safllower
peanuts
wheat
barley, rice, rye
corn (field)
sorghum
oats
Application
Rate
(Ib ai/lb seed)
0.0015
0.004
0.0035
0.001
0.008
0.0016
0.002
0.0027
0.0023
0.0031
Amount
Treated
(Ib seed/day)
160000
88000
160000
718000
120000
718000
718000
550000
718000
718000
Same as above
Same as above
Baseline
ND
ND
ND
ND
ND
ND
ND
ND
ND
ND
Single
Layer
1900
1300
810
630
470
390
320
300
270
200
Single
Layer +
PF5
3200
2200
1400
1100
790
660
530
510
460
340
Single
Layer +
PF10
3500
2400
1500
1200
860
720
580
560
500
370
Double
Layer +
PF10
4300
2900
1800
1400
1100
900
720
700
630
460
Eng
Control
ND
ND
ND
ND
ND
ND
ND
ND
ND
ND
Baseline MOEs are 500 or greater
Baseline MOEs are 470 or greater
37 of 85
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Table 21. Maneb Short/Intermediate-Term Combined MOEs for Seed Treatment
Exposure Scenario
Multiple Activities (4)
Planter Box Seed
Treatments Using
Dusts (5a)
Planter Box Seed
Treatments Using
Liquids (5a)
Plant Treated Seeds
(6)
Seed Type
cotton (adl)
tomato
flax
safllower
peanuts
wheat
barley, rice, rye
com (field)
sorghum
oats
com
rye
barley
wheat
oats
tomato
safllower
cotton adl
sorghum
field com
flax
rye
barley
wheat
oats
rice
peanuts
Application
Rate
(Ib ai/lb seed)
0.0015
0.004
0.0035
0.001
0.008
0.0016
0.002
0.0027
0.0023
0.0031
0.0017
0.0011
0.0013
0.0010
0.0020
0.0042
0.0011
0.0015
0.0023
0.0027
0.0035
0.0018
0.0021
0.0016
0.0031
0.0021
0.008
Same as above.
Amount
Treated
(Ib seed/day)
160000
88000
160000
718000
120000
718000
718000
550000
718000
718000
1440
6720
7200
9600
7200
80
1600
1200
1200
1440
3360
6720
7200
9600
7200
12000
11200
80 to 30000
Baseline
ND
ND
ND
ND
ND
ND
ND
ND
ND
ND
ND
ND
ND
ND
ND
ND
ND
ND
ND
ND
ND
ND
ND
ND
ND
ND
ND
ND
Single
Layer
630
430
270
210
160
130
110
100
92
68
660
220
170
170
110
4800
910
890
580
410
140
130
110
100
72
64
18
Single
Layer +
PF5
1400
970
610
480
360
300
240
230
210
150
660
220
170
170
110
4800
910
890
580
410
140
130
110
100
72
64
18
Single
Layer +
PF10
1700
1200
730
570
420
350
280
270
250
180
660
220
170
170
110
4800
910
890
580
410
140
130
110
100
72
64
18
Double
Layer +
PF10
ND
ND
ND
ND
ND
ND
ND
ND
ND
ND
ND
ND
ND
ND
ND
ND
ND
ND
ND
ND
ND
ND
ND
ND
ND
ND
ND
Eng
Control
ND
ND
ND
ND
ND
ND
ND
ND
ND
ND
ND
ND
ND
ND
ND
ND
ND
ND
ND
ND
ND
ND
ND
ND
ND
ND
ND
Single layer MOEs are 520 or greater.
Maneb Non-Cancer Risks: Most of the maneb short/intermediate-term combined MOEs for handlers
treating seeds or handlers planting treated seed exceed the target MOE of 100 with single layer PPE.
Handlers performing multiple activities to treat sorghum seeds and oat seeds with maneb exceed the
Agency's level of concern, and a dust/mist respirator is needed to mitigate those risks. Handlers
using liquid maneb formulation in planter box seed treatment to treat oats, rice, and peanut seeds
exceed the Agency's level of concern, even considering the use of additional PPE, and additional
mitigation measures (e.g., decreasing rates or cancelling the use) must be considered (Table 21).
ETUNon-Cancer Risks. The short/intermediate term ETU MOEs for seed treatment are greater than
the corresponding maneb MOEs and are above 100 for all of the scenarios. As such, these MOEs are
not tabulated in this document.
38 of 85
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Table 22. ETU Cancer Risks from Maneb Seed Treatment
Exposure Scenario
Seed Type
Application
Rate
(Ib ai/lb seed)
Amount
Treated
(Ib seed/day)
Baseline
Single
Layer
Single
Layer +
PF5
Single
Layer
+
PF10
Double
Layer +
PF10
Eng
Control
Commercial Seed Treatment
Loader/Applicator (1)
Bagger (2)
Sewer (3)
Multiple Activities (4)
cotton (adl)
tomato
flax
safllower
peanuts
wheat
barley, rice, rye
corn (field)
sorghum
oats
0.0015
0.004
0.0035
0.001
0.008
0.0016
0.002
0.0027
0.0023
0.0031
160000
88000
160000
718000
120000
718000
718000
550000
718000
718000
Same as above
Same as above
Same as above
ND
ND
ND
ND
ND
ND
ND
ND
ND
ND
7e-07
le-06
2e-06
2e-06
3e-06
3e-06
4e-06
4e-06
5e-06
6e-06
4e-07
7e-07
le-06
le-06
2e-06
2e-06
3e-06
3e-06
3e-06
4e-06
4e-07
6e-07
le-06
le-06
2e-06
3e-06
3e-06
3e-06
3e-06
4e-06
3e-07
5e-07
8e-07
le-06
le-06
2e-06
2e-06
2e-06
2e-06
3e-06
ND
ND
ND
ND
ND
ND
ND
ND
ND
ND
Baseline Cancer Risks are 2e-06 or less.
Baseline Cancer Risks are 2e-06 or less.
ND
<2e-05
<9e-06
<8e-06
ND
ND
On-Farm Seed Treatment
Planter Box Seed
Treatment Using Dusts (5a)
Planter Box Seed
Treatments Using Liquids
(5b)
com
rye
barley
wheat
oats
tomato
safflower
cotton adl
sorghum
field com
flax
rye
barley
wheat
oats
rice
peanuts
0.0017
0.0011
0.0013
0.0010
0.0020
0.0042
0.0011
0.0015
0.0023
0.0027
0.0035
0.0018
0.0021
0.0016
0.0031
0.0021
0.008
1440
6720
7200
9600
7200
80
1600
1200
1200
1440
3360
6720
7200
9600
7200
12000
11200
ND
ND
ND
ND
ND
ND
ND
ND
ND
ND
ND
ND
ND
ND
ND
ND
ND
8e-07
2e-06
3e-06
3e-06
5e-06
le-07
6e-07
6e-07
9e-07
le-06
4e-06
4e-06
5e-06
5e-06
7e-06
8e-06
3e-05
8e-07
2e-06
3e-06
3e-06
5e-06
le-07
6e-07
6e-07
9e-07
le-06
4e-06
4e-06
5e-06
5e-06
7e-06
8e-06
3e-05
8e-07
2e-06
3e-06
3e-06
5e-06
le-07
6e-07
6e-07
9e-07
le-06
4e-06
4e-06
5e-06
5e-06
7e-06
8e-06
3e-05
ND
ND
ND
ND
ND
ND
ND
ND
ND
ND
ND
ND
ND
ND
ND
ND
ND
ND
ND
ND
ND
ND
ND
ND
ND
ND
ND
ND
ND
ND
ND
ND
ND
ND
Planting Treated Seed
Plant Treated Seeds (6)
Same as above.
80 to 30000
ND
Single laver Cancer risks are 8e-07 or less.
ETU Cancer Risks: The cancer risks for handlers treating seeds (commercially or on farm) or
handlers planting treated seed are all equal to or less than 2 x 10"5 at single layer PPE. Cancer risks
associated with most scenarios are within the range of 1 x 10"6 with the addition of PPE including a
respirator with a protection factor of 10.
b. Post-Application Assessments
The post-application occupational risk assessment considers exposure to chemical maneb and
maneb-derived ETU from entering treated fields, sod farms, orchards, and greenhouses. Given the
nature of activities in these locations and that maneb is applied at various times during plant growth,
contact with treated surfaces is likely. A variety of post-application exposure scenarios were
identified by the type of activity involved and by the range of exposure expected, i.e., low, medium
and high exposure activities. Examples of low exposure activities include irrigation and scouting;
medium exposure activities may involve scouting of mature plants, or in greenhouses, hand pinching
39 of 85
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flowers. Potential high exposure activities include hand harvesting, and thinning and pruning apples,
and very high exposure activities include sweet corn hand harvesting. In the Worker Protection
Standard, a Restricted-Entry Interval (REI) is defined as the duration of time which must elapse
before residues decline to a level so entry into a previously treated area and engaging in any task or
activity would not result in exposures which are of concern.
Post-Application Exposures and Assumptions
Six chemical-specific dislodgeable foliar residue (DFR) studies were submitted for maneb,
and four of these were used, along with typical HED transfer coefficients, to estimate post-application
exposure and risk for all crops/ornamentals potentially treated with maneb. The six DFR studies were
conducted on apples in New York and Washington State, tomatoes in California and Florida, and
grapes in California. One of the apple studies (New York) is not being used because no field
fortification data were collected, and one of the Florida tomato studies is not being used because of
low field recovery and weak correlation. The DFR studies were extrapolated to other crops on which
maneb is used by considering the effects of application method, crop morphology, and climate. No
Turf Transferable Residue (TTR) studies were submitted for maneb, therefore, a mancozeb TTR
study was used as a source of surrogate data.
Maneb Non-Cancer Post-Application Risks: Current maneb label requirements specify a 24 hour
REI. Most of the short/intermediate-term maneb MOEs exceed 100 on day 0, and are not of concern
to the Agency. However, for workers reentering treated corn fields, tree fruit orchards, and grape
orchards to conduct high exposure activities, the time needed to achieve maneb MOEs of 100 ranges
up to 26 days, with the longest time needed for reentering grape orchards for training and tying in the
West (Table 23).
Table 23. Maneb Short/Intermediate-Term Post-Application Non-Cancer Risks
Crop Group
Berry, low (Cranberry)
Bunch/bundle (Banana)
Field/row crops, Low/Medium - West
Field/row crops, Low/Medium - East
Field/Row crop, tall (Corn) - West
Field/Row crop, tall (Com) - East
Flowers, cut
Ornamental Plants
Tree, fruit, deciduous - West
Tree, fruit, deciduous - East
Tree, fruit, evergreen (Papaya)
Tree, nut (Almond)
Application
Rate
(Ib a.i/acre)
4.8
2.4
1.6
1.6
1.2
1.2
1.2
1.2
2..4
2
6.4
MOE on Day 0 (Days when MOE > 100)
Low
220
4000
8200
5900
NA
NA
NA
7200
260
180
470
190
Medium
NA
300
550
400
2700
2000
NA
4500
NA
160
NA
High
NA
200
NA
NA
1100
790
160
2000
86(5)
58(6)
NA
NA
Very High
NA
NA
NA
NA
64(5)
46(11)
NA
NA
NA
NA
NA
40 of 85
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Table 23. Maneb Short/Intermediate-Term Post-Application Non-Cancer Risks
Crop Group
Turf - California
Turf - North Carolina
Turf - Pennsylvania
Vegetable, Brassica - West
Vegetable, Brassica - East
Vegetable, Cucurbit - West
Vegetable, Cucurbit - East
Vegetable, fruiting - West
Vegetable, fruiting - East
Vegetables, leafy - West
Vegetables, leafy - East
Vegetable, root - West
Vegetable, root - East
Vine/trellis (Grapes) - West
Vine/trellis (Grapes) - East
Application
Rate
(Ib a.i/acre)
17.4
17.4
17.4
1.6
1.6
1.6
1.6
1.6
2.4
1.6
1.6
2.4
2.4
2.0
3.2
MOE on Day 0 (Days when MOE > 100)
Low
18000
32000
41000
410
300
1600
1200
1600
790
1600
1200
1800
1300
590
260
Medium
NA
NA
NA
210
150
550
400
1200
560
550
400
370
260
290
130
High
550
960
1200
160
120
330
240
820
400
330
240
220
160
59(26)
26(14)
Very High
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
ETUNon-Cancer Post-Application Risks (Short/Intermediate Term): Current maneb label
requirements specify a 24 hour REI. Most of the short/intermediate-term ETU MOEs exceed 100 on
day 0, and are not of concern to the Agency. However, for workers reentering treated tree fruit
orchards, and grape orchards in the East to conduct high exposure activities, the time needed to
achieve ETU MOEs of 100 ranges up to 19 days, with the longest time needed for reentering tree fruit
orchards in the West for pruning, training, tying, and thinning (Table 24).
Table 24. ETU from Maneb Post-Application Non-Cancer Risks (Short/Intermediate Term)
Crop Group
Berry, low (Cranberry)
Bunch/bundle (Banana)
Field/row crops, Low/Medium - West
Field/row crops, Low/Medium - East
Field/Row crop, tall (Com) - West
Field/Row crop, tall (Com) - East
Flowers, cut
Ornamental Plants
Tree, fruit, deciduous - West
Tree, fruit, deciduous - East
Tree, fruit, evergreen (Papaya)
Tree, nut (Almond)
Application Rate
(Ib a.i./acre)
4.8
2.4
1.6
1.6
1.2
1.2
1.2
1.2
2.4
2.4
2
6.4
MOE on Day 0 (Days when MOE > 100)
Low
200
32000
52000
49000
NA
NA
NA
59000
150
160
3900
110
Medium
NA
2500
3500
3200
17000
16000
NA
37000
NA
NA
1300
NA
High
NA
1600
NA
NA
6900
6500
1300
16000
49 (19)
54(8)
NA
NA
Very High
NA
NA
NA
NA
410
380
NA
NA
NA
NA
NA
NA
41 of 85
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Table 24. ETU from Maneb Post-Application Non-Cancer Risks (Short/Intermediate Term)
Crop Group
Turf - California
Turf - North Carolina
Turf - Pennsylvania
Vegetable, Brassica - West
Vegetable, Brassica - East
Vegetable, Cucurbit - West
Vegetable, Cucurbit - East
Vegetable, fruiting - West
Vegetable, fruiting - East
Vegetables, leafy - West
Vegetables, leafy - East
Vegetable, root - West
Vegetable, root - East
Vine/trellis (Grapes) - West
Vine/trellis (Grapes) - East
Application Rate
(Ib a.i./acre)
17.4
17.4
17.4
1.6
1.6
1.6
1.6
1.6
2.4
1.6
1.6
2.4
2.4
2.0
3.2
MOE on Day 0 (Days when MOE > 100)
Low
14000
81000
110000
2600
2400
10000
9700
10000
6500
10000
9700
12000
11000
4500
240
Medium
NA
NA
NA
1300
1200
3500
3200
7400
4600
3500
3200
2300
2200
2100
120
High
410
2500
3400
1000
970
2100
1900
5200
3200
2100
1900
1400
1300
430
24(17)
Very High
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
ETU Non-Cancer Post-Application Risks (Chronic): The chronic ETU MOEs presented in Table 25
for greenhouse tomatoes, ornamental plants, and cut flowers exceed 100 on day 0 and are not of
concern to the Agency.
Table 25. ETU from Maneb Post-Application Non-Cancer Risks (Chronic)
Crop Group
Greenhouse Cut Flowers
Greenhouse Ornamental Plants
Greenhouse Tomatoes
Application Rate
(Ib ai/acre)
1.2
1.2
2.4
Long term MOE on Day 0 (Days when MOE >100)
Low
NA
2500
270
Medium
NA
1500
190
High
100
680
140
ETU Cancer Post-Application Risks: All ETU cancer risks are less than or in the range of 10"4 on the
day of application for all of the scenarios. The risks for many of the remaining high exposure
scenarios decline to within the range of less than 1 x 10"6 several weeks after application, with the
longest taking greater than 80 days (grapes in the West).
Table 26. ETU from Maneb Post-Application Cancer Risks
Crop Group
Berry, low (Cranberry)
Bunch/bundle (Banana)
Application
Rate
(Ib a.i./acre)
3
2.4
Cancer Risk on Day 0
Low
3e-05
0
Medium
NA
4e-06
High
NA
7e-06
Very High
NA
NA
42 of 85
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Table 26. ETU from Maneb Post-Application Cancer Risks
Crop Group
Field/row crops, Low/Medium - West
Field/row crops, Low/Medium - East
Field/Row crop, tall (Corn) - West
Field/Row crop, tall (Com) - East
Flowers, cut
Ornamental Plants
Tree, fruit, deciduous - West
Tree, fruit, deciduous - East
Tree, fruit, evergreen (Papaya)
Tree, nut (Almond)
Turf- California
Turf- North Carolina
Turf - Pennsylvania
Vegetable, Brassica - West
Vegetable, Brassica - East
Vegetable, Cucurbit - West
Vegetable, Cucurbit - East
Vegetable, fruiting - West
Vegetable, fruiting - East
Vegetables, leafy - West
Vegetables, leafy - East
Vegetable, root - West
Vegetable, root - East
Vine/trellis (Grapes) - West
Vine/trellis (Grapes) - East
Application
Rate
(Ib a.i./acre)
1.6
1.6
1.2
1.2
1.2
1.2
3.6
3.6
2
3.1
17.4
17.4
17.4
1.6
1.6
1.6
1.6
1.4
1.4
1.6
1.6
2.4
2.4
1.8
2.1
Cancer Risk on Day 0
Low
2e-07
2e-07
NA
NA
NA
2e-07
le-04
le-04
3e-06
5e-05
8e-07
le-07
9e-08
4e-06
4e-06
le-06
le-06
le-06
le-06
le-06
le-06
9.2e-07
9.8e-07
2e-06
3e-05
Medium
3e-06
3e-06
6e-07
7e-07
NA
3e-07
NA
NA
8e-06
NA
NA
NA
NA
8e-06
9e-06
3e-06
3e-06
1.2e-06
1.3e-06
3e-06
3e-06
5e-06
5e-06
5e-06
6e-05
High
NA
NA
2e-06
2e-06
4e-06
7e-07
2e-04
2e-04
NA
NA
3e-05
4e-06
3e-06
le-05
le-05
5e-06
6e-06
2e-06
2e-06
5e-06
6e-06
8e-06
8e-06
2e-05
3e-04
Very High
NA
NA
3e-05
3e-05
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
c.
Human Incident Data
The most recent assessment of maneb incidents was completed in 2002. Information sources
consulted included the OPP Incident Data System (IDS), the Poison Control Centers (1993 to 1998),
and the California Pesticide Illness Surveillance Program (1982 to 1999). There were no incidents
reported in the OPP Incident Data System from 1992 to 2001. There were 37 exposures reported to
the Poison Control Centers (1993-1998) and 24 received follow-up to determine medical outcome.
Ten experienced no symptoms and 14 experienced minor symptoms, primarily nausea and diarrhea.
There were four reports of dermal effects and three were considered to be related to their exposure.
There were 18 cases reported in the California Pesticide Illness Surveillance Program (1982-1999) in
which maneb was used alone or was judged to be responsible for the health effects. Twelve of these
cases involved post-application exposure to field residues and the most common effect was skin
rashes. The reports in the literature also indicated that maneb causes skin sensitization.
43 of 85
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B. Environmental Risk Assessment
A summary of the Agency's environmental risk assessment is presented below. For detailed
discussions of all aspects of the environmental risk assessment refer to the following document:
Environmental Fate and Ecological Risk Assessment for Maneb, Section 3 Reregistrationfor Control
of Fungal Diseases on Numerous Crops, Ornamental Plantings, and Turf (Error Correction
Response), dated June 21, 2005, which is available on the internet and in the public docket.
1. Environmental Fate and Transport
Maneb is a high molecular weight polymer composed of repeating single units containing
manganese ions/salts. Parent maneb is insoluble in water but is expected to decompose rather
quickly, by hydrolytic reactions, into a multi-species residue (maneb complex) consisting of transient
species and degradates including the degradate of concern ETU. Most of the species present in the
maneb residue are expected to partition into the soil/sediment particles; with varied strength of
bonding. These soil associated materials are not largely affected by abiotic degradation, but are
susceptible to very slow bio-degradation possibly further producing degradates, including ETU, at a
very slow rate.
Due to rapid hydrolytic decomposition, parent maneb is expected to exist in the natural
environment for a short duration (<1 day) when moisture is available. Parent maneb appears to be
stable in alkaline (3 hours at pH 9), neutral (3 hours at pH 7) and acidic (4 hours at pH 5) conditions.
In dry conditions and in soils with very low water holding capacity parent maneb decomposition is
slow. Maneb has low octanol/water partition coefficients (Kow) suggesting that it would not be
significantly bio-concentrated by aquatic organisms. Furthermore, maneb has a very low vapor
pressure, thus indicating that volatilization is not an important dissipation pathway. This rate is
largely dependent on moisture availability and, therefore, in dry conditions and in soils with very low
water holding capacity, parent maneb will persist.
The degradate of concern (ETU) is predicted to be susceptible to leaching due to its high
solubility and mobility. In the soil environment, ETU lacks stability which can limit its leaching;
however, its possible slow and steady formation from maneb complex can overcome the lack of
stability and make it available for leaching at low concentrations. ETU has an aerobic soil half-life of
about 3 days; in the absence of data, the aquatic aerobic metabolism half-life was assumed to be about
6 days, or double the soil half life. The measured anaerobic aquatic metabolism half-life, however, is
substantially longer (149 days) possibly leading to the periodic detections in ground water. ETU is
highly soluble in water (20,000 ppm), highly vulnerable to indirect photolysis (half-life= 1 day), and
moderately mobile (288 L/kg). It also has a high vapor pressure, but high solubility reduces the
possibility of losses from surface water due to volatilization.
2. Ecological Risk Presumptions
The pesticide use profile, exposure data, and toxicity information are used to determine risk
estimates to non-target terrestrial and aquatic organisms. The EECs are used to calculate RQs. An
RQ is the estimated ratio of exposure concentration to the toxicity endpoint. The calculated RQs use
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the EECs that are based on the maximum single application rate of maneb, which would yield the
maximum maneb exposure estimates. The RQ is then compared to the LOG to predict whether
exposure to maneb and its degradates could pose a risk to non-target organisms. Table 27 outlines the
Agency's LOCs and the corresponding risk presumptions.
Table 27. Agency's LOCs and Risk Presumptions
If RQ > LOC value given below
Terrestrial
Organisms
0.5
0.2
0.1
1
Aquatic
Organisms
0.5
0.1
0.05
1
Plants
1
N/A
1
N/A
Then EPA presumes .......
Risk Presumption
Acute Risk - there is potential for acute risk; regulatory
action may be warranted in addition to restricted use
classification.
Acute Restricted Use - there is potential for acute risk, but
may be mitigated through restricted use classification.
Acute Endangered Species - endangered species may be
adversely affected; regulatory action may be warranted.
Chronic Risk - there is potential for chronic risk; regulatory
action may be warranted.
Note that the following ecological risks are based on parent maneb only. EPA did not
estimate ETU exposure or potential ecological risk from ETU as a result of use of maneb. The
Agency expects ecological ETU exposure and risk resulting from maneb's uses to be encompassed by
ETU exposure and risk resulting from mancozeb's uses because the EBDCs share similar application
patterns. The Agency chose ETU from mancozeb uses as a surrogate assessment to determine
exposure and risk from any ETU because mancozeb has the broadest use pattern of the EBDCs, thus
providing a comprehensive view of risks posed by ETU. ETU exposure and risk as a result of
mancozeb application are addressed in the mancozeb RED.
In summary, chronic mammalian ETU RQs exceed the LOC for most of mancozeb's use
patterns, especially for small- and medium-sized mammals. ETU is practically acutely nontoxic to
mammals, and EPA does not expect acute risks to mammals from ETU exposure. EPA does not have
any toxicity data to evaluate ETU's toxicity to birds. In aquatic habitats, RQs are less than the LOCs
for ETU's acute risk to freshwater fish, freshwater invertebrates, and nonvascular plants from use of
mancozeb. The Agency does not have data to evaluate ETU's acute risks to estuarine/marine fish and
invertebrates, and vascular aquatic plants. Overall, based on available toxicity data, the ETU
ecological risks assessed for mancozeb use are less than the corresponding maneb parent risks. As
such, measures to address ecological risk from maneb parent, as part of this RED, will address
potential maneb-derived ETU exposures as well.
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3. Risk to Terrestrial Organisms
a. Birds and Mammals Exposure and Toxicity
The Agency assessed exposure to terrestrial organisms by first predicting the amount of
maneb residues found on animal food items and then, using information on typical food consumption
by various species of birds and mammals, to predict the amount of pesticide that could be consumed.
The amount of residues on animal feed items are based on the Fletcher nomogram which is a model
developed by Hoerger and Kenaga (1972) and modified by Fletcher (1994). Thus, EPA modeled the
maximum and mean residues of maneb, immediately following a single application at 1 Ib ai/A.
EPA's estimates of maneb residues on various wild animal food items are summarized in Table 28.
EPA used these EECs and standard food consumption values to estimate dietary exposure levels for
maneb to birds and mammals.
Table 28. Estimated Environmental Concentrations on Avian and Mammalian Food Items
Food Items
Short grass
Tall grass
Broadleaf/forage plants and small insects
Fruits, pods, seeds, and large insects
EEC (ppm) Predicted Maximum
Residue1
240
110
135
15
EEC (ppm) Predicted Mean
Residue1
85
36
45
7
1 Predicted maximum and mean residues are for a 1 Ib ai/a application rate and are based on Hoerger and Kenaga (1972)
as modified by Fletcher et al. (1994).
Maneb is categorized as practically nontoxic to avian species and small mammals on an acute
oral and subacute dietary basis. The acute toxicity profile for birds and mammals is summarized in
Table 29.
Table 29. Maneb Acute Toxicity Endpoints for Birds and Mammals
Toxicity Study
Test Species
%a.L
Endpoint
Toxicity
Category
MRTO
Author Year
Acute (Single dose by gavage)
Avian Oral
Mammalian Oral
Bobwhite
Quail
Laboratory
Rat
86
Unknown
LD50 = >2,150
mg/kg/day
LD50 = >5,000 (male&
female) mg/kg/day
Practically
nontoxic
Practically
nontoxic
40657001
D. Fletcher 1988
41975601
Subacute (Five days of treated feed)
Avian Dietary
Bobwhite
Quail
assumed 100%
LC50 = >10,OOOppmai
Practically
nontoxic
00104264
R. Fink 1975
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Table 29. Maneb Acute Toxicity Endpoints for Birds and Mammals
Toxicity Study
Avian Dietary
Test Species
Mallard
Duck
%a.L
86 (doses were
adjusted to 100%)
Endpoint
LC50 = >5,000 ppm ai
Toxicity
Category
Practically
nontoxic
MRTO
Author Year
40657002
D. Fletcher 1988
In a maneb avian reproduction study using the mallard duck, chronic toxic effects were seen
which included a reduction in the number of hatchlings as percentages of eggs laid, eggs set, and live
3-week old embryos, and a reduction in the number of 14-day old survivors as a percentage of eggs
set. Results from chronic 2-generation reproduction study for maneb in laboratory rats show parental
and fetal toxicity at a LOAEL of 300 ppm with parental toxicity resulting in significant increase in
lung weight (both generations) and liver weight in Fl (one generation removed from the original
parent generation) and an increased incidence of diffuse follicular epithelial hypertrophy/hyperplasia
(lesions on the organs' surfaces) in Fl. Fetal toxicity at this test concentration (300 ppm) was also
noted based on a slight delay in the startle response in the offspring. These endpoint are summarized
in Table 30.
Table 30. Maneb Chronic Toxicity Endpoints for Birds and Mammals
Test Species
Mallard Duck
Laboratory
Rat
%
a.i
91
87.3
NOAEC or
NOAEL
(ppm)
20
75
LOAEC or
LOAEL
(ppm)
100
300
Effects at LOAEC or LOAEL
Reduced hatchling survival at 14 days
Paternal - Increased lung (both generations)
and liver weight and increased lesions on
organs' surface
Fetal - Delay in the startle response
MRID
43586502
42049401
NOAEC / LOAEC = No Observable Adverse Effect Concentration, the highest dose at which no adverse health effect
is observed./ Lowest Observable Adverse Effect Concentration, the lowest dose at which an adverse health effect is
observed.
NOAEL / LOAEL= No Observable Adverse Effect Level, the highest dose at which no adverse health effect is
observed / Lowest Observable Adverse Effect Level, the lowest dose at which an adverse health effect is observed.
b.
Birds and Mammals Risk
The acute risk to terrestrial animals from maneb's use are a low risk concern since maneb has
been determined to be practically nontoxic to birds and mammals on an acute basis. Therefore, acute
RQs were not generated for birds or mammals. The Agency expects chronic risk to birds and
mammals from maneb's uses. Avian and mammalian RQs exceed the chronic LOCs for almost all
use maneb modeled exposures. Based on multiple applications, the chronic RQs for birds range from
a high of 265 on turf to a low of 0.4 on collards, turnips, and mustards (Georgia and Tennessee only)
using a half-life value of 3.2 days. Table 31 summarizes the avian chronic RQs from multiple
applications of maneb.
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Table 31. Avian Chronic RQs from Maneb Application
Crop
Turf
Almonds
Apples
Potatoes (MN only)
Mustard, Collards & Turnips (GA &
TNonly)
Maximum
Application
Rate
(Ibs a.L/A)
17.4
6.4
4.8
1.6
1.2
Avian Chronic RQs (NOAEC= 20 ppm)
Based on maximum EECs
Based on mean EECs
Range = Shortgrass - Seeds
265 - 17
98-6
74-5
29-2
15-1
94-8
35-3
26-2
10-1
5-0.4
Chronic RQs for mammals ranged from a high of 71 on turf to a low of 0.1 on collards,
turnips, and mustards (Georgia and Tennessee only). The Agency expects risk to maneb to be below
the LOG for acute risk to mammals, because maneb is practically nontoxic (rat LD50 > 5,000
mg/kg/day) to mammals on an acute basis. Thus, RQs for acute mammalian exposure were not
calculated. Table 32 summarizes the mammalian chronic RQs from multiple applications of
nongranular maneb products.
Table 32. Mammalian Chronic RQs from Maneb Application
Crop
Turf
Almonds
Apples
Potatoes (MN only)
Mustard, Collards & Turnips (GA &
TNonly)
Maximum
Application Rate
(Ibs a.i./A)
17.4
6.4
4.8
1.6
1.2
Chronic RQs (NOAEL= 75 ppm)
Based on maximum EECs
Based on mean EECs
Range = Shortgrass - Seeds
71-4
26-2
20-1
8-0.5
4-0.3
25-2
9-1
7-1
3-0.2
1-0.1
c. Non-Target Plant Risk
Terrestrial plants inhabiting dry and semi-aquatic areas may be exposed to pesticides from
direct applications via runoff, spray drift, or volatilization. RQs could not be calculated because
toxicity data for plants are not available. The potential for acute risks to non-endangered, endangered
and/or threatened terrestrial plants at use sites is unknown. Currently, the Agency does not perform
chronic risk assessments for terrestrial plants.
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d. Non-Target Insects Risk
Maneb is practically nontoxic to honeybees from acute exposure (LD50 > 12 jig/bee). The
Agency does not expect maneb exposure to pose acute risk to non-target insects because maneb is
practically nontoxic to honeybees and there are no incident data reporting adverse effects to
honeybees.
4. Risk to Aquatic Species
a. Fish and Invertebrate Exposure and Toxicity
The Agency expects maneb to reach aquatic environments through drift and runoff since
maneb is not labeled for direct application to aquatic environments. Maneb is insoluble in water but
the Agency expects it to decompose rather quickly, by hydrolytic reactions, into a multi-species
residue (maneb complex) consisting of transient species and degradates, including the degradate of
concern, ETU. Once maneb reaches the aquatic environment, the Agency believes the maneb
complex will be the portion of the maneb that is biologically available to aquatic organisms. The
Agency expects most of the transient species present in the maneb complex to partition into the
sediment particles with varied strength of bonding. Over time, ETU is the dominant transformation
product of the metiram complex. These metiram complex residues are short-lived in aquatic media,
but ETU is persistent in this media unless it is subjected to rapid degradation by microbes and/or
indirect photolysis.
Unlike the drinking water assessment described in the human health risk assessment section
of this document, the ecological water resource assessment does not include the Index Reservoir (IR)
and Percent-Crop Area (PCA) factor refinements. The IR and PCA factors represent a drinking water
reservoir, not the variety of aquatic habitats, such as ponds adjacent to treated fields, relevant to a risk
assessment for aquatic animals. Therefore, the EEC values used to assess exposure to aquatic animals
are not the same as the values used to assess human dietary exposure from drinking water sources.
EECs were estimated using tier II modeling, the linked PRZM and EXAMS models
(PRZM/EXAMS). In modeling, maneb uses on apples, peppers, potatoes, and tomatoes were chosen.
Apples, peppers, potatoes, and tomatoes were chosen because they are the major uses for maneb and
PRZM-EXAMS modeling scenarios exist for these uses. The EECs are used for assessing acute and
chronic risks to aquatic organisms. Acute risk assessments are performed using peak EEC values for
single and multiple applications. Chronic risk assessments are performed using the 21-day EECs for
invertebrates and 60-day EECs for fish. Table 33 summarizes the aquatic EECs for maneb.
Table 33. Tier n Estimated Environmental Concentrations (EECs) of Maneb in Surface Water (ppb)
Crop
Apples (NC)
Peppers (FL)
Rate
(Ibs ai/Acre)
4.8
1.6
Number of
Applications
4
6
Interval
7
7
Peak
84.0
113.0
96
Hour
14.4
16.7
21
Day
4.1
5.4
60
Day
1.8
2.1
Annual
Average
0.3
0.4
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Table 33. Tier n Estimated Environmental Concentrations (EECs) of Maneb in Surface Water (ppb)
Crop
Potatoes (ME)
Tomatoes (FL)
Rate
(Ibs ai/Acre)
1.6
1.6
Number of
Applications
7
7
Interval
5
7
Peak
47.6
197.9
96
Hour
6.7
31.6
21
Day
2.1
9.2
60
Day
1.0
4.0
Annual
Average
0.2
0.7
Acutely, maneb is very highly toxic to cold water freshwater fish (LC50 = 42 ppb), highly
toxic to slightly toxic to warm water freshwater fish (LC50 = 170 - 68,000 ppb) and highly toxic to
estuarine/marine fish (LC50 =180 ppb). Acute toxicity values for aquatic invertebrates suggest that
maneb is highly toxic to freshwater invertebrates (Daphnia EC50 = 120 ppb) and highly to very highly
toxic to estuarine/marine invertebrates (mysid shrimp EC50 = 3 ppb), as summarized in Table 34.
Table 34. Acute Toxicity Endpoints for Aquatic Species
Toxicity Study
Freshwater Fish (96-hr)
Estuarine/Marine Fish
(flow-through 96-hr)
Freshwater Invertebrate (static 48-hr)
Estuarine/Marine Invertebrate
(flow-through 96-hr)
Test Species
Rainbow Trout
Atlantic
Silverside
Daphnid
Mysid shrimp
% a.i.
84.8
84.8
84.8
84.8
LC50 or
EC50
(ppb)
42
180
120
3
Toxicity
Category
Veiy
Highly Toxic
Highly Toxic
Highly Toxic
Veiy
Highly Toxic
MRID
40706001
40943101
40749402
41000002
Early life-stage chronic freshwater fish NOAEC and LOAEC values were determined to be
6.1 and 12 ppb, respectively, with reduced hatchability, fish survival and length of fry being the
endpoints affected. Chronic freshwater fish toxicity data is summarized in Table 35.
Table 35. Maneb Chronic Toxicity Endpoints for Freshwater Fish
Toxicity Study
Freshwater Fish
Early Life-Stage
Test Species
Fathead minnow
%
a.i
87.3
NOAEC
(ppb)
6.1
LOAEC
(ppb)
12
Effects at
LOAEC
Reduced
hatchability
MRID
41346301
NOAEC / LOAEC = No Observable Adverse Effect Concentration, the highest dose at which no adverse health effect
is observed./ Lowest Observable Adverse Effect Concentration, the lowest dose at which an adverse health effect is
observed.
b.
Fish and Invertebrates Risk
There are potential acute risks to freshwater/estuarin/marine fish and invertebrates. Currently,
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there are no data available to assess chronic risks to freshwater invertebrates, estaurine/marine fish, or
estaurine/marine invertebrates. The Agency is requiring additional data acute and chronic toxicity
data as a part of this RED. Maneb acute and chronic RQs for freshwater fish, acute RQs for
freshwater invertebrates and estuarine/marine fish and invertebrates are summarized below in Table
36, 37, and 38, respectively.
Table 36. Acute and Chronic RQs for Freshwater Fish from Maneb Application
Crop
Apples
Pepper
Potatoes
(Maine Only)
Tomato
Maximum Single
Application Rate
(Ibs al/A)
4.8
1.6
1.6
2.4
Peak EEC
(ppb)
84
113
47.6
197.9
Freshwater Fish
RQs
Acute
(LC50=42ppb)
2
2.69
1.13
4.71
Chronic
(NOAEC=6.1ppb)
0.30
0.34
0.16
0.66
Table 37. Acute RQs for Freshwater Invertebrates from Maneb Application
Crop
Apples
Pepper
Potatoes
(Maine Only)
Tomato
Maximum Single
Application Rate
(Ibs a.i./A)
4.8
1.6
1.6
2.4
Peak EEC
(ppb)
84
113
47.6
197.9
Freshwater Invertebrates
Acute RQs
(LC50= 120 ppb)
0.70
0.94
0.40
1.65
Table 38. Acute RQs for Estuarine/Marine Fish and Invertebrates from Maneb Application
Crop
Apples
Pepper
Potatoes
(Maine Only)
Tomato
Maximum Single
Application Rate
(Ibs a.i./A)
4.8
1.6
1.6
2.4
Peak EEC
(ppb)
84
113
47.6
197.9
Estuarine/Marine
Acute RQs
Fish
(LCgr 180 ppb)
0.47
0.63
0.26
1.10
Invertebrates
(LC50=3ppb)
28
38
16
66
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c. Non-Target Aquatic Plants Risk
Like terrestrial plants, non-target aquatic plants may be exposed to pesticide from run-off,
spray drift or volatization of maneb. Available information suggest that maneb may be toxic to non-
vascular aquatic plants. The EC50 for freshwater green algae was 13 ppb based on growth inhibition,
and a nominal NOAEC of 5.0 ppb. The potential for acute risks to terrestrial, semi-aquatic and
aquatic vascular plants exposed to maneb at use sites is unknown due to lack of data. EPA will
require plant data to assess acute risks to terrestrial, semi-aquatic and aquatic plants. Acute aquatic
plant data are usually conducted for aquatic vascular plants using the surrogate duckweed Lemna
gibba. Currently, the Agency is not assessing chronic effects on aquatic plants.
Exposure to non-target aquatic plants may occur through runoff or spray drift from adjacent
treated sites. Runoff and drift exposure is computed from PRZM-EXAMS. The risk quotient is
determined by dividing the pesticide's initial or peak concentration in water by the plant EC50 value.
Acute risk quotients for freshwater, non-vascular plants based on green algae (Ankistrodesmus
bibraianus) data are presented in Table 39. The results indicate that the non-vascular, non-target
plant acute risk LOG of 1 is exceeded for maneb's assessed use patterns.
Table 39. Acute RQs for Aquatic Non-Vascular Plants from Maneb Application
Crop
Apples
Pepper
Potatoes (Maine
Only)
Tomato
Maximum Single
Application Rate
(Ibs a.i./A)
4.8
1.6
1.6
2.4
Peak EEC (ppb)
84
113
47.6
197.9
Aquatic Non-Vascular Plants
Acute RQs
(LCgr 13.4 ppb)
6.27
8.43
3.55
14.77
5. Risk to Federally Listed Endangered and Threatened Species
Based on available screening-level information there is a potential concern for maneb's acute
effects on listed freshwater and estuarine/marine animals and chronic effects on listed birds and
mammals should exposure actually occur. The Agency expects maneb poses a low acute risk to
nontarget insects because maneb is practically nontoxic to honeybees (acute contact LD50 > 12
//g/bee). However, the Agency does not assess risk to bees using RQs because a screening- level RQ
assessment method for estimating the risk to bees is not available. The Agency does not currently
have enough data to quantify risks for maneb at the screening-level and cannot preclude potential
direct effects to the following taxonomic groups: listed nontarget terrestrial plants and vascular
aquatic plants, freshwater invertebrates, and estuarine/marine fish (acute basis), and listed mammals
and birds (chronic basis). These findings are based solely on EPA's screening-level assessment and
do not constitute "may affect" findings under the Endangered Species Act (ESA) for any listed
species.
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The Agency has developed the Endangered Species Protection Program to identify pesticides
whose use may cause adverse impacts on federally listed endangered and threatened species, and to
implement mitigation measures that address these impacts. The ESA requires federal agencies to
ensure that their actions are not likely to jeopardize listed species or adversely modify designated
critical habitat. To analyze the potential of registered pesticide uses that may affect any particular
species, EPA uses basic toxicity and exposure data developed for the REDs and considers ecological
parameters, pesticide use information, the geographic relationship between specific pesticide uses and
species locations and biological requirements and behavioral aspects of the particular species. When
conducted, this analysis will consider regulatory changes recommended in this RED that are being
implemented at that time. A determination that there is a likelihood of potential effects to a listed
species may result in limitations on the use of the pesticide, other measures to mitigate any potential
effects, or consultations with the Fish and Wildlife Service or National Marine Fisheries Service as
appropriate. If the Agency determines use of maneb "may affect" listed species or their designated
critical habitat, EPA will employ the provisions in the Services regulations (50 CFR Part 402). Until
that species specific analysis is completed, the risk mitigation measures being implemented through
this RED will reduce the likelihood that endangered and threatened species may be exposed to maneb
at levels of concern.
6. Ecological Incidents
The Ecological Incident Information System (EIIS) reported maneb in three fish kill
incidents. An incident, occurring in August 1973 and reported by the Oregon Department of
Agriculture showed some fish in a 15 acre pond had been killed. Presumably drift from an aerial
application of maneb and endosulfan to potatoes caused the kill. No analysis of the dead fish were
provided. Both maneb and endosulfan are very highly toxic to freshwater fish [maneb rainbow trout
LC50 = 42.0 ppb and endosulfan rainbow trout LC50 = 0.37 ppb (Endosulfan RED, 2001) and both
pesticides could have been responsible for the fish kill, if in fact the kill was pesticide related.
However, the inadequate information provided with this reported incident and the lack of laboratory
analyzes make it difficult to charge this fish kill to either pesticide.
The second maneb related incident occurred in June 1994 and was reported by the North
Carolina Department of Agriculture. The owner of a 2.5 acre commercial fishpond filed a complaint
of a fish kill in the pond because of drift from applications of maneb, trifluralin, imazaquin,
pendimethalin, and acephate aerially applied to corn and soybean fields near the pond. The owner
felt the fish kill was a result of drift from these pesticides. The North Carolina Department of
Agriculture investigated this complaint and took samples for analysis but the sampling evidence did
not confirm the presence of maneb or the other pesticides listed in the samples taken. Based on the
investigation and the analysis of samples, it is unlikely that maneb contributed to this fish kill.
The final maneb related incident occurred in Augustl994 and was reported by the Maine
Department of Agriculture. In this incident, roughly 10,000 newly released brook trout were killed in
a pond that borders New Brunswick, Canada and Maine. Three pesticides (maneb, esfenvalerate, and
chlorothalonil) recently applied to potatoes surrounding this pond were suspected in this fish kill.
Tissue samples of the fish confirmed the presence of all three pesticides (maneb at 169 ppb,
esfenvalerate at 4.2 ppb, and chlorothalonil at 20 ppb) in the fish. These fish samples were taken
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from both the pond and brooks feeding the pond. Again, as in the first incident, all three of these
pesticides are very highly toxic to freshwater fish. Maneb's rainbow trout LC50 is 42.0 ppb,
esfenvalerate's rainbow trout LC50 is 0.26 ppb (Hicks, L., 1995) and chlorothalonil's rainbow trout
LC50 is 42.3 ppb (Chlorothalonil RED, 1998). The submitter of the incident report pointed out there
were severe thunderstorms in the area preceding the fish kill which suggest pesticide runoff was a
cause in this kill. Based on sampling evidence, the Agency believes maneb was a contributory cause
in this fish kill.
IV. RISK MANAGEMENT, REREGISTRATION, AND TOLERANCE REASSESSMENT
A. Determination of Reregistration Eligibility
Section 4(g)(2)(A) of FIFRA calls for the Agency to determine, after submission of relevant
data concerning an active ingredient, whether or not products containing the active ingredient are
eligible for reregistration. The Agency has previously identified and required the submission of
generic (i.e., active ingredient-specific) data to support reregistration of products containing maneb as
an active ingredient. The Agency has completed its review of these generic data, and has determined
that the data are sufficient to support reregistration of all products containing maneb.
The Agency has completed its assessment of the dietary, occupational, residential (as a result
of exposures from mancozeb and maneb only), and ecological risk associated with the use of
pesticide products containing the active ingredient maneb, including maneb-derived ETU and ETU
from all sources. Based on a review of these data and on public comments on the Agency's
assessments for the active ingredient maneb, the Agency has sufficient information on the human
health and ecological effects of maneb to make decisions as part of the tolerance reassessment process
under FFDCA and reregistration process under FIFRA, as amended by FQPA. The Agency has
determined that maneb containing products are eligible for reregistration provided that: (i) current
data gaps and confirmatory data needs are addressed; (ii) the risk mitigation measures outlined in this
document are adopted; and (iii) label amendments are made to reflect these measures. Label changes
are described in Section V. Appendix A summarizes the uses of maneb that are eligible for
reregistration. Appendix B identifies the generic data requirements necessary as part of the Agency's
determination of reregistration eligibility of maneb, and lists the submitted studies that the Agency
reviewed and found acceptable. Data gaps are identified as generic data requirements that have not
been satisfied with acceptable data.
Based on its evaluation of maneb, the Agency has determined that maneb products, unless
labeled and used as specified in this document, would present risks inconsistent with FIFRA and
FQPA. Accordingly, should a registrant fail to implement any of the risk mitigation measures
identified in this document, the Agency may take regulatory action to address the risk concerns from
the use of maneb. If all changes outlined in this document are incorporated into the product labels,
then all current risks for maneb will be adequately mitigated for the purposes of this reregistration
determination.
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B. Public Comments and Responses
Through the Agency's public participation process, EPA worked extensively with
stakeholders and the public to reach its regulatory decisions for maneb. During the public comment
period on the risk assessments, which closed on February 22, 2005, the Agency received comments
from the registrant, growers and grower groups. These comments in their entirety and the Agency's
response are available in the public docket (OPP-2005-0078) at http://www.epa.gov/edockets.
C. Regulatory Position
1. Food Quality Protection Act Findings
a. "Risk Cup" Determination
As part of the FQPA tolerance reassessment process, EPA assessed the risks associated with
this pesticide. EPA has determined that aggregate risk from exposure to maneb is within acceptable
levels, provided that the mitigation measures stipulated in this document are implemented. Because
maneb and the other EBDC fungicides (metiram and mancozeb) degrade to ETU in the environment
and metabolize to ETU in the body, an aggregate assessment for ETU derived from both maneb and
other EBDCs was also done. The Agency has determined that the human health risks from these
combined exposures to both maneb and ETU are within acceptable levels, provided the mitigation
measures stipulated in this document are implemented. In other words, EPA has concluded that the
tolerances for maneb meet FQPA safely standards.
b. Determination of Safety to U.S. Population
(including Infants and Children)
The Agency has determined that the established tolerances for maneb, with amendments and
changes as specified in this document, meet the safety standards under the FQPA amendments to
section 408(b)(2)(D) of the FFDCA, and that there is a reasonable certainty no harm will result to the
general population or any subgroup from the use of maneb. In reaching this conclusion, the Agency
has considered all available information on the toxicity, use practices and exposure scenarios, and the
environmental behavior of maneb and its ETU metabolite and degradate. EPA has also considered
information on the aggregate exposure to ETU, resulting both from the use of maneb and from the use
of the other EBDC fungicides.
As discussed in Section III of this document, acute, chronic and cancer dietary (food alone)
risks from maneb are not of concern. Aggregate risk, which combined food, drinking water and
residential exposures, where applicable, from maneb, maneb-derived ETU, and ETU from all sources
are also not of concern. The aggregate risk assessment for ETU considers residential scenarios,
because mancozeb has uses that may result in residential exposure to ETU.
c. Endocrine Disrupter Effects
EPA is required under the FFDCA, as amended by FQPA, to develop a screening program to
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determine whether certain substances (including all pesticide active and other ingredients) "may have
an effect in humans that is similar to an effect produced by a naturally occurring estrogen, or other
endocrine effects as the Administrator may designate." Following recommendations of its Endocrine
Disrupter Screening and Testing Advisory Committee (EDSTAC), EPA determined that there was a
scientific basis for including, as part of the program, the androgen and thyroid hormone systems, in
addition to the estrogen hormone system. EPA also adopted EDSTAC's recommendation that EPA
include evaluations of potential effects in wildlife. For pesticides, EPA will use FIFRA and, to the
extent that effects in wildlife may help determine whether a substance may have an effect in humans,
FFDCA authority to require the wildlife evaluations. As the science develops and resources allow,
screening of additional hormone systems may be added to the Endocrine Disrupter Screening
Program (EDSP).
The available human health and ecological effects data for maneb suggest possible thyroid
effects, which may indicate potential endocrine disruption. EPA has considered these effects in the
human health risk assessment by selecting endpoints based on thyroid effects. To further address
these effects, EPA is requiring a confirmatory comparative thyroid toxicity study for maneb. Data on
ecological effects suggest possible hormonal effects to birds, mammals, and aquatic organisms.
These effects will be addressed when the Agency's Endocrine Disrupter Screening and Testing
Advisory Committee develops appropriate screening and/or testing protocols. At that time, maneb
may be subjected to additional screening and/or testing to better characterize effects related to
endocrine disruption.
d. Cumulative Risks
Risks summarized in this document are those that result only from the use of maneb and its
metabolite, ETU. The FFDCA, as amended by FQPA, requires that the Agency consider "available
information" concerning the cumulative effects of a particular pesticide's residues and "other
substances that have a common mechanism of toxicity." The reason for consideration of other
substances is due to the possibility that low-level exposures to multiple chemical substances that
cause a common toxic effect by a common toxic mechanism could lead to the same adverse health
effect as would a higher level of exposure to any of the substances individually. Maneb belongs to a
group of pesticides called dithiocarbamates, which also includes the EBDC fungicides metiram and
mancozeb. For the purposes of this RED, EPA has concluded that maneb does not share a common
mechanism of toxicity with other substances. The Agency reached this conclusion after a thorough
internal review and external peer review of the data on a potential common mechanism of toxicity.
For more information, please see the December 19, 2001 memorandum, "The Determination of
Whether Dithiocarbamate Pesticides Share a Common Mechanism of Toxicity, "which is available on
the internet at http ://www. epa. gov/oppsrrd 1/cumulative/dithiocarb .pdf
2. Tolerance Reassessment Summary
a. Tolerances Currently Listed Under 40 CFR §180.110
Maneb tolerances are established under 40 CFR §180.110(a) and § 180.110(b). The
permanent tolerances listed under 40 CFR §180.110(a) are expressed in terms of the residues of the
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fungicide maneb (manganese ethylenebisdithiocarbamate), calculated as zinc
ethylenebisdithiocarbamate. The time-limited tolerance listed in 40 CFR §180.110(b) is currently
expressed in terms of the residues of maneb and its metabolite ethylenethiourea (ETU).
The only established maneb tolerances are for plant commodities. No maneb tolerances have
yet been established in livestock or processed food/feed commodities. The Agency is now
recommending that maneb tolerances also be established in livestock commodities. Based on a
reevaluation of the available plant and livestock metabolism studies, the Agency has reaffirmed that
the residues of toxicological concern to be included in risk assessment are the parent EBDC
(including maneb) and ETU. For regulatory/enforcement purposes, the Agency recommends that
tolerances in plant and livestock commodities at 40 CFR §180.110(a) be established for residues of
maneb per se. The Agency recommends that the EBDC (including maneb) tolerances be calculated
as carbon disulfide rather than as zineb.
Since issuance of the Maneb Update in 1992, the Agency has updated the list of raw
agricultural commodities (RACs) and processed commodities and feedstuffs derived from crops. As
a result of change to the livestock feeds table, to maneb tolerances for certain RACs that have been
removed from the livestock feeds table need to be revoked. Also, some commodity definitions must
be corrected. A summary of maneb tolerance reassessments is presented in Table 40.
b. Tolerances Listed Under 40 CFR §180.110 (a)
Sufficient data are available (or were translated when appropriate) to reassess the established
tolerances in/on the following commodities, pending label amendments for some crops including:
almonds; beans (dry form); broccoli; Brussels sprouts; cabbage; cauliflower; cucumbers; eggplant;
kohlrabi; melons; onions (bulb); pumpkins; sugar beet tops; summer squash; winter squash; and
tomatoes.
Although additional data are required to confirm the existing tolerance levels in/on the
following commodities, the Agency has no dietary, drinking water or residential risk concerns
associated with these tolerances and considers them reassessed: bananas; Chinese cabbage; collards;
cranberries; endive (escarole); kale; lettuce; mustard greens; onions (green); papayas; peppers;
potatoes; and turnip tops.
The established tolerances in/on the following commodities should be revoked since maneb
uses on certain crops were disallowed for reregistration as per EBDC Final Determination (PD 4) on
March 2, 1992 (57 FR 7484): apricots; beans (succulent form); carrots; celery; nectarines; and
peaches. Further, for apples, grapes, figs, and sweet corn, the registrant has requested voluntary
cancellation. Receipt of this request will be published in the near future.
A maneb tolerance for garlic has also not been established and need not be proposed. In
accordance with 40 CFR §180.1, the reassessed tolerance for onions (dry bulb) may apply to garlic,
since the registered use patterns of maneb on garlic and onions (dry bulb) are identical.
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c. Tolerances To Be Proposed Under 40 CFR §180.110 (a)
A tolerance should be established in 40 CFR§ 180.110(a) for "beet, sugar, roots" based on the
available field trial data. Tolerances should also be established in 40 CFR§ 180.110 (a) for the
following commodities after adequate field trial data have been submitted and evaluated: almond,
hulls; corn, pop, grain; corn, pop, stover; corn, sweet, forage; and corn, sweet, stover.
Based on the results of an acceptable sugar beet processing study, a tolerance for "beet, sugar,
pulp, dried" should be established. The processing studies submitted for grapes and tomatoes indicate
that residues of maneb and ETU did not concentrate in the respective processed commodities of these
crops.
Field residue data and tolerances in/on cowpea forage and hay will not be required provided
labels are amended such that maneb use on beans specifically exclude cowpeas.
Tolerances in eggs, milk, and the fat, meat byproducts, and meat of cattle, goats, hogs, horses,
poultry, and sheep should be established based on the results of reviewed livestock metabolism
studies.
Tolerances must be proposed that reflect either the maximum expected residue levels or, if no
measurable residues are detected, the limit of quantization of the analytical method.
d. Tolerances Listed Under 40 CFR §180.110 (a) and (b)
Sufficient data have been submitted to reassess the established time-limited tolerance in
walnuts associated with a Section 18 registration. The available data support establishment of a
permanent tolerance in walnuts currently proposed.
Table 40. Tolerance Reassessment Summary for Maneb.
Commodity
Established
Tolerance
(ppm)
Reassessed
Tolerance 1
(ppm)
Comment
[Correct Commodity Definition]
Tolerances Listed Under 40 CFR §180.110 (a)
Almond
Apple
Apricot
Bananas (not more than 0.5
ppm) shall be in the pulp after
peel is removed and discarded
(preharvest application only)
Bean (dry form)
Bean, succulent
Broccoli
0.1
2
10
4
7
10
10
0.1
Revoke 4
Revoke
TBD
2.5
Revoke
6
[Almond, nutmeat]
Registrant has requested voluntary
cancellation.
Disallowed for reregistation.
Additional banana field trial data and
submissions of foreign labels are required.
[Bananas, whole (Pre-H)}
[Bean, dry]
Disallowed for reregistation
Field trial data support the reduced tolerance
level
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Table 40. Tolerance Reassessment Summary for Maneb.
Commodity
Brussels sprouts
Cabbage
Cabbage, Chinese
Carrot, roots
Cauliflower
Celery
Collards
Cranberry
Cucumber
Eggplant
Endive (escarole)
Fig
Grape
Kale
Kohlrabi
Lettuce
Lettuce
Melon
Mustard greens
Nectarine
Onion
Papaya
Peach
Pepper
Potato
Pumpkin
Established
Tolerance
(ppm)
10
10
10
7
10
5
10
7
4
7
10
7
7
10
10
10
10
4
10
10
7
10
10
7
0.1
7
Reassessed
Tolerance J
(ppm)
6
21
TBD
Revoke
6
Revoke
TBD
TBD
2.0
2.5
TBD
Revoke4
Revoke4
TBD
6
TBD
TBD
3
TBD
Revoke
6
TBD
TBD
Revoke
TBD
TBD
3
Comment
[Correct Commodity Definition]
Translated from broccoli data.
Field trial data support the increased
tolerance level
Additional field trial data are required.
Disallowed for reregistration.
Translated from broccoli data.
Disallowed for reregistration.
Additional field trial data on collards are
required.
Additional cranberry field trial data are
required.
Field trial data support the reduced tolerance
level
Translated from tomato data.
To be translated from data requested for leaf
lettuce.
Registrant has requested voluntary
cancellation.
Registrant has requested voluntary
cancellation.
Additional field trial data on kale are
required
Translated from broccoli data.
Additional field trial data on head lettuce are
required. [Lettuce, head]
Additional field trial data on leaf lettuce are
required. [Lettuce, leaf]
Field trial data support the reduced tolerance
level
Additional field trial data on mustard greens
are required.
Disallowed for reregistration.
[Onion, bulb]
[Onion, green}
Additional papaya field trial data are
required.
Disallowed for reregistration.
Additional field trial data on non-bell peppers
are required.
\Pepper, bell and non-beW\
Additional potato field trial data are required.
Translated from melon data.
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Table 40. Tolerance Reassessment Summary for Maneb.
Commodity
Beet, sugar, tops
Squash, summer
Squash, winter
Sweet corn, kernel plus cob with
husks removed
Tomato
Turnip, greens
Turnip, roots
Established
Tolerance
(ppm)
45
4
4
5
4
10
7
Reassessed
Tolerance J
(ppm)
120
2.0
3
Revoke4
2.5
TBD
Revoke
Comment
[Correct Commodity Definition]
Field trial data support the increased
tolerance level
Translated from cucumber data.
Translated from melon data.
[Corn, sweet, kernel plus cob with husks
removed ]
Field trial data support the reduced tolerance
level
Additional field trial data on turnip tops are
required.
Turnips grown for roots may not be treated.
Tolerances To Be Proposed Under 40 CFR §180.110 (a) 3
Almond, hulls
Beet, sugar, root
Beet, sugar, pulp, dried
Cattle, fat
Cattle, mbyp
Cattle, meat
Eggs
Cattle, fat
Cattle, mbyp
Cattle, meat
Goats, fat
Goats, mbyp
Goats, meat
Hogs, fat
Hogs, mbyp
Hogs, meat
Horses, fat
Horses, mbyp
Horses, meat
Milk
Poultry, fat
Poultry, mbyp
Poultry, meat
Sheep, fat
Sheep, mbyp
Sheep, meat
None
None
None
None
None
None
None
None
None
None
None
None
None
None
None
None
None
None
None
None
None
None
None
None
None
None
TBD
1.2
2.5
0.02
0.02
0.02
0.02
0.02
0.02
0.02
0.02
0.02
0.02
0.02
0.02
0.02
0.02
0.02
0.02
0.02
0.02
0.02
0.02
0.02
0.02
0.02
Additional field trial data on almond hulls are
required.
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Table 40. Tolerance Reassessment Summary for Maneb.
Commodity
Established
Tolerance
(ppm)
Reassessed
Tolerance J
(ppm)
Comment
[Correct Commodity Definition]
Tolerance Listed Under 40 CFR §180.110 (b)
Walnut
0.05
0.03
Expiration/revocation date 12/3 1/07
associated with a Sec. 18
1 The reassessed tolerances are for the residues of maneb expressed as carbon disulfide per se, and are contingent upon
the recommended label revisions.
2 TBD = To be determined. Reassessment of tolerance(s) cannot be made at this time because additional data are
required.
3 Does not include tolerances that may be required from use of maneb on crops with seed or propagation stock
treatments.
4 The Agency intends to follow-up to the registrant's request with a Request for Voluntary Cancellation Notice in the
Federal Register which announces receipt of the request.
e. Codex Harmonization
There are no established or proposed Codex MRLs for residues of maneb per se; however,
Codex limits for dimethyldithiocarbamates fungicides are grouped under dithiocarbamates. The
maximum residue limits (MRLs) for dithiocarbamates are established for several commodities
resulting from the use of mancozeb, maneb, metiram, propineb, thiram, and ziram and are currently
expressed as ppm carbon disulfide. When the tolerance reassessments are finalized U.S. tolerances
will be harmonized with Codex MRLs with respect to residue definition. A numerical comparison of
the Codex MRLs and the corresponding reassessed U.S. tolerances for maneb are presented on the
internet at the Food and Agricultural Organization database website:
http://faostat.fao.org/faostat/collections?version=ext&hasbulk=0.
D. Regulatory Rationale
The following is a summary of the rationale for the mitigation measures necessary for
reregistration eligibility and for managing risks associated with the use of maneb. Where labeling
revisions are warranted, specific language is set forth in the summary table of Section V (Table 43 of
this RED document).
1. Human Health Risk Management
a. Dietary (Food) Risk Mitigation
Acute, chronic, and cancer dietary (food only) exposure and risk from maneb, maneb-derived
ETU, and ETU from all sources are below the Agency's level of concern. Since there are no acute,
chronic, cancer dietary (food only) risks of concern, no mitigation measures are necessary.
b. Drinking Water Risk Mitigation
The drinking water exposure assessment for maneb addresses concentrations of ETU only,
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since maneb is not expected to remain in drinking water long enough to reach a location that would
supply water for human consumption whether from surface or ground water. Estimated
concentrations of ETU, for both surface and ground water sources of drinking water, are low and not
of concern; therefore, no mitigation is needed.
c. Residential Risk Mitigation
The only potential residential exposure to maneb is from residues remaining on transplanted
turf from sod farms. Risk to toddlers, the most sensitive sub-population, was evaluated for post-
application exposure, and is of concern on the first day of potential exposure at the current maximum
label rate. However, as residues decline over time and/or application rates are reduced, MOEs reach
acceptable levels. To address risk concerns for toddlers who may be playing on transplanted sod
previously treated with maneb, the registrant has agreed to a 3-day pre-harvest interval (PHI). This
measure effectively prohibits maneb application to turf grown on sod farms for 3 days prior to harvest
of sod, thereby mitigating the short-term risk for toddlers who may play on transplanted sod. To
further address potential residential post-application exposure from turf, the registrant has agreed to
reduce maximum application rate for sod farm turf from 17.4 Ibs ai/A to 8.7 Ibs ai/A, and limit the
maximum seasonal rate to 34.8 Ibs ai/A/season.
d. Aggregate Risk Mitigation
Aggregate risk refers to the combined risk from food, drinking water, and residential (as a
result of residential exposures from mancozeb uses) exposures. In addition, aggregate risk can result
from one-time (acute), short-term and/or chronic (non-cancer and cancer) exposures. Below is a
discussion of the risk for each duration of exposure and any risks of concern.
Acute Aggregate: Since residues of maneb per se are not expected in drinking water, acute
aggregate risks for maneb consist of acute exposures to maneb-derived ETU and ETU from all
sources. Potential concentrations of maneb-derived ETU and ETU from all sources in drinking
water, when combined with exposure through food, are below Agency's level of concern for acute
aggregate risk (see Table 12). No mitigation measures are necessary for acute aggregate risk.
Short-term Aggregate: Short-term aggregate (food + drinking water + residential [as a result
of residential exposures from mancozeb uses]) risk for ETU from all sources is below the Agency's
level of concern for residential handlers, and children and adults exposed to ETU from re-entry
activities (see Section III.A.S.b and Table 15). Therefore, no mitigation is required.
Chronic (Non-Cancer) Aggregate: The chronic aggregate risks to maneb-derived ETU and
ETU from all sources were calculated using food and drinking water exposures only, because
residential and recreational exposure scenarios were considered to occur only on a short-term basis.
Aggregate (food + drinking water) chronic risks to maneb-derived ETU and ETU from all sources are
below the Agency's level of concern; therefore, no mitigation is required.
Cancer Aggregate: Aggregate (food + drinking water) cancer risk to maneb-derived ETU for
the general U.S. population is below the Agency's level of concern. The cancer risk from ETU from
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all sources was aggregated using food, drinking water and residential/recreational (as a result of
mancozeb uses) exposures. This risk estimate is 2 x 10"6, with the food exposure being the largest
contributor of cancer risk, followed by drinking water from groundwater sources. The Agency
considers cancer risks as high as 3 in 1 million are within the negligible risk range; thus, cancer
aggregate risks are not of concern. Therefore, the Agency believes no further mitigation is required
formaneb.
e. Occupational Risk Mitigation
It is the Agency's policy to mitigate occupational risk to the greatest extent necessary and
feasible. Mitigation measures may include reducing application rates, reducing the use of hazardous
formulations, and the use of engineering controls, such as closed cabs and water soluble packaging.
In cases when such measures are not feasible or do not reduce risks to acceptable levels, then personal
protective equipment (PPE) requirements are added to end product labels. A wide range of factors is
considering in making risk management decisions for worker risks. These factors include estimated
margins of exposure (MOEs), cancer risk estimates, incident data, the nature and severity of adverse
effects observed in animal studies, uncertainties in the risk assessment, alternative registered
pesticides, the importance of the chemical in integrated pest management (IPM) programs, and other
similar factors. Maneb is an EBDC fungicide of significant importance to agriculture, as described in
Section IV.D.3. of this document. Thus, in certain scenarios described below, no additional
mitigation has been deemed necessary by the Agency, though risk estimates slight exceed general
levels of concern.
1) Agricultural and Greenhouse Handler Risk Mitigation
Handler exposure assessments are completed by EPA considering the use of baseline PPE,
and, if warranted, increasing levels of PPE and engineering controls in order to estimate their
potential impact on exposure. The target MOE for occupational risk is 100, and MOEs greater than
100 do not exceed the Agency's level of concern. For occupational cancer risks, estimates in the
general range of 1 x 10"6 (one in a million) generally do not exceed the Agency's level of concern.
When occupational MOE are less than 100 or occupational cancer risks exceed the general range of 1
x 10"6, EPA strives to reduce worker risks through the use of personal protective equipment and
engineering controls or other mitigation measures. The Agency generally considers occupational
cancer risks in the range of 1 x 10"6 or less to be negligible, but may accept estimated risks as high as
1 x 10"4(1 in 10,000) when all mitigation measures that are feasible have been applied, and in
particular, when there are critical pest management needs associated with the use of the pesticide.
Levels of PPE considered are described below:
Baseline - long-sleeved shirt, long pants, and shoes and socks
Single layer - baseline plus gloves
Double layer - baseline plus gloves and coveralls
PF5 - a dust/mist filtering respirator
PF10 - a half face respirator with appropriate cartridges
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Non-Formulation-Specific Mitigation
In addition to the mitigation measures specific to each formulation of maneb being presented
below, the technical registrant has agreed to cancel maneb use on sweet corn, grapes, apples, and
kadota figs and reduce the maximum application rate on turf by half to 8.7 Ib ai/A.
Wettable Powder Formulations
As described in Section IHA.6. of this document, non-cancer risks to handlers mixing and
loading wettable powder formulations for aerial or chemigation application are of concern at the
maximum PPE (double layer and a PF10 respirator). MOEs ranged from 9 to 64, depending on the
crop. In addition, risks to handlers mixing and loading wettable powders for turf application are
above the Agency's level of concern at maximum PPE, with a MOE of 39. The registrant has agreed
to prohibit the use of wettable powders for aerial or chemigation application, and prohibit the use of
wettable powders for use on turf in order to mitigate this risk concern.
For all other handlers mixing and loading maneb in wettable powder formulations, the
Agency is requiring the use of single layer PPE and a PF5 respirator, as explained further in the
paragraphs below.
With the use of single layer PPE and a PF5 respirator, maneb short/intermediate-term MOEs
for handlers mixing and loading wettable powder for groundboom applications range from 640 to 80
and cancer risk estimates range from 9 x 10"6 to 2 x 10"6. For the majority of use sites, risk estimates
are in the 1 x 10"6 range. The use on cranberries results in the short/intermediate term MOE of 80 and
the cancer risk estimate of 9 x 10"6; these risk estimates slightly exceed the Agency's level of concern.
No further mitigation measures are needed.
With the use of single layer PPE and a PF5 respirator, the maneb short/intermediate-term
MOEs for handlers mixing and loading wettable powders for airblast application to fruits and nuts are
greater than 120 and the cancer risk estimates are less than 5 x 10"6. MOEs are not of concern to the
Agency, and cancer risk estimates are in the general range of 1 x 10"6. No further mitigation measures
are needed.
With the use of single layer PPE and a PF5 respirator, maneb MOEs for handlers mixing and
loading wettable powders for high-pressure handwand application to ornamental plants and tomatoes
are all greater than 500 (short/intermediate-term and long-term) and cancer risk estimates are in the
general range of 1 x 10-6. Risk estimates are not of concern to the Agency at the necessary level of
PPE.
With the use of single layer PPE and a PF5 respirator, maneb MOEs for handlers mixing,
loading, and applying wettable powders with a low-pressure handwand to ornamental plants and
tomatoes are all greater than 300 (short/intermediate-term and long-term), and cancer risk estimates
are in the general range of 1 x 10"6. Risk estimates could not be calculated for handlers mixing,
loading, and applying wettable powders with a backpack sprayer; however, these risk estimates are
not expected to be greater than for handlers mixing, loading, and applying with a low pressure
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handwand since these application scenarios are similar. Risk estimates are not of concern to the
Agency at the necessary level of PPE.
Dry Flowable Formulations
For handlers mixing and loading dry flowable formulations of maneb for aerial or
chemigation application on sod farms, the Agency is requiring the use of single layer PPE and a PF5
respirator. With the use of the proposed PPE and the decrease in application rates, the maneb MOE is
92 and the cancer risk estimate is approximately 1 x 10"5. These risk estimates slightly exceed the
Agency's level of concern. No further mitigation measures are needed at this time.
For handlers mixing and loading dry flowable formulations of maneb for all other uses, the
Agency is requiring the use of single layer PPE. Considering this mitigation, short/intermediate term
risk estimates for most uses do not exceed the Agency's level of concern with MOEs ranging from
130 to greater than 1000; however, MOEs for handlers mixing and loading dry flowable for aerial or
chemigation application to fruits and nuts slightly exceed the Agency's level of concern (MOE is 84
at the highest application rate). In addition, considering this mitigation, cancer risk estimates range
from 1 x 10"5 to significantly less than 1 x 10"6; the scenarios for which cancer risk estimates slightly
exceed the Agency's level of concern are handlers mixing and loading for the following uses:
groundboom application to turf and aerial or chemigation application to other crops. No further
mitigation is needed.
Risk estimates could not be calculated for handlers mixing, loading, and applying dry
flowable formulations with a backpack sprayer or a low pressure handwand; however, these risk
estimates are expected to be much lower than for handlers mixing, loading, and applying wettable
powders in the same manner (with a MOE of greater than 290 and a cancer risk estimate in the
general range of 1 x 10"6) because dry flowable formulations are much less dusty than wettable
powder formulations and result in less inhalation exposure to handlers. Therefore, these scenarios are
not of concern to the Agency.
Liquid Formulations
For handlers mixing and loading liquid formulations of maneb for aerial or chemigation
application to sod farms, the Agency is requiring the use of single layer PPE and a PF5 respirator,
which results in a maneb MOE of 184 and a cancer risk estimate of 5 x 10"6. These risk estimates
slightly exceed the Agency's level of concern. No further mitigation measures are needed at this
time.
For handlers mixing and loading, and for handlers mixing, loading, and applying liquid
formulations of maneb for all other uses, the Agency is requiring the use of single layer PPE). With
the proposed PPE, all short/intermediate term risk estimates are not of concern to the Agency; MOEs
range from 99 to greater than 1000. In addition, with the proposed PPE, cancer risk estimates range
from 7 x 10"6 to 8 x 10"8. The scenarios for which cancer risk estimates slightly exceed the Agency's
level of concern are handlers mixing and loading for the following uses: groundboom application to
turf; aerial or chemigation application to other crops; and high pressure handwand application to
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ornamentals and tomatoes. No further mitigation is needed at this time.
Applicators - All Formulations
For wettable powder formulations, the registrant has agreed to prohibit aerial and chemigation
applications. For handlers applying wettable powder formulations by any other application method,
the Agency is requiring the use of single layer PPE and a PF5 respirator. With the use of this PPE,
applicator MOEs range from 660 to greater than 1000 and are therefore below the Agency's level of
concern. Cancer risk estimates for applicators range from 4 x 10"6 to 2 x 10"8. Some of these cancer
risk estimates slightly exceed the Agency's level of concern (for handlers applying via groundboom
to turf and via airblast to fruits and nuts). No further mitigation measures are needed at this time.
For aerial application of dry flowable or liquid formulations, the Agency is requiring the use
of engineering controls (closed cockpits). For handlers applying dry flowable or liquid formulations
by any other method to any crop, the Agency is requiring the use of single layer PPE. With the use of
this PPE, applicator MOEs range from 260 to greater than 1000 and are therefore below the Agency's
level of concern. Applicator cancer risk estimates range from 9 x 10"6 to 4 x 10"8. Some of these
cancer risk estimates slightly exceed the Agency's level of concern (for handlers applying via
groundboom to turf and via airblast to fruits and nuts). No further mitigation measures are needed at
this time.
2) Potato Seed-Piece Treatment Mitigation
As described in Section in of this document, risks to handlers loading dust formulation for
potato seed piece treatment are of concern to the Agency at baseline PPE. As such, the Agency is
requiring and the technical registrant has agreed to the use of engineering controls (dust collection
equipment) for commercial potato seed-piece treatment (maneb MOE of 1100 and cancer risk
estimate of 1 x 10"6 with engineering controls), and the use of single layer PPE for on-farm potato
seed-piece treatment (maneb MOE of 120 and cancer risk estimate of 8 x 10"6). There is no data
available to assess risk to applicators applying dusts, however, the Agency believes that this risk will
not be greater than risk to mixer/loaders since applicators are handling the same amount of material.
The dust collection equipment requirement will protect applicators as well. The cancer risk slightly
exceeds the Agency's level of concern. No further mitigation is necessary.
For all seed treatment, the Agency is requiring the use of single layer PPE. As described in
Section III of this document, risks to handlers performing multiple activities to treat oat seeds and
handlers using liquid formulations to treat oat, rice, and peanut seed exceed the Agency's level of
concern at single layer PPE; however, all other seed treatment activities are not of concern to the
Agency. To mitigate this risk, the technical registrant has agreed to cancel seed treatment on rice and
peanuts, and is reducing the oat seed treatment rate to 0.0021 Ib ai/lb seed from 0.0031 Ib ai/lb seed.
Based on the decrease in rate on oats, and the use of single layer PPE, the MOEs previously of
concern become -90, which is not significantly different than 100 and not of concern to the Agency.
Cancer risk estimates range from 2 x 10"5 to 8 x 10"7, based on the use of single layer PPE and slightly
exceed the Agency's level of concern for some seeds. Risks will be lower with reduced application
rates; therefore, no further mitigation is necessary.
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3) Post-Application Risk Mitigation
When preparing post-application risk assessments, EPA considers dislodgeable foliar residue
(DFR) data, application rates, transfer coefficients based on crop type and exposure scenario (low,
medium, or high contact activities), and assumptions about average occupational workdays and adult
body weight. In the case of maneb, both maneb and its degradate ETU were considered in the
assessment. For the ETU cancer risk assessment, the Agency assumed that workers would be
exposed for 30 days each year.
At the current REI of 24 hours, for high-end exposure scenarios, there are maneb risks of
concern for workers reentering treated grape and tree fruit orchards. As such, the technical registrant
has agreed to cancel use on deciduous tree fruit (apples and Kadota figs) and grapes. In addition, the
registrant is cancelling use on corn, which has a risk estimate of 3 x 10"5 for very high activities at day
0. The registrant is also decreasing the application rate for turf (risk estimate of 3 x 10"5) by half, from
17.4 Ib ai/A to 8.7 Ib ai/A. Cancer risks for the remaining uses are between 5 x 10"5 (almonds) and 9
x 10"8 at day 0, and slightly exceed the Agency's level of concern for some crops. No further
mitigation is needed at this time.
2. Environmental Risk Mitigation
It is the Agency's policy to mitigate ecological risks to the greatest extent necessary and
feasible. Mitigation measures may include lowering application rates, reducing the number of
applications, restricting the timing of applications, minimizing runoff potential, and others.
a. Terrestrial Species Mitigation
From a short-term or acute maneb exposure, the Agency expects low risk to mammals and
birds. However, the screening-level ecological risk assessment indicates some exceedance of the
chronic screening LOCs for risk to birds and small mammals. In particular, the highest chronic RQs
result from maneb use on turf and almonds. With an assessed total of three applications at a rate of
17.4 Ibs ai/A to turf, the corresponding avian chronic RQs based on mean EECs range from 94 to 8
and the mammalian chronic RQs range from 25 to 2. Predicted exposures from maneb on almonds
also exceed screening levels of concern for birds and mammals, with RQs based on mean EECs
ranging from 35 to 3 for birds and 9 to 1 for mammals. Use on apples also results in high RQs
ranging from 26 to 2 for birds and 7 to 1 for mammals. These RQs are screening level estimates,
incorporating modeled estimated environmental concentrations. Nevertheless, to be more protective
of terrestrial species that may be exposed on a chronic basis, the technical registrant has agreed to
additional label changes to reduce potential risk. For example, the maximum application rate to turf
is being reduced from 17.4 to 8.7 Ibs ai/A and the maximum number of applications is also being
reduced for almonds from 4 times to 3 per year thus reducing the seasonal total amount of maneb
being applied. Moreover, the use on apples is being voluntarily cancelled. Refer to Table 41 for
summary of revisions to use site parameters.
The Agency does not expect maneb exposure to pose acute risk to non-target insects, because
maneb is practically nontoxic to honeybees and there are no incident data reporting adverse effects to
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honeybees. Therefore, no bee precautionary labeling is required on maneb product labeling.
b. Aquatic Species Mitigation
There are predicted acute risks to aquatic species (freshwater/estuarine/marine fish and
invertebrates) from maneb use. Currently, there are no toxicity data available to assess chronic risks
to freshwater invertebrate, estuarine/marine fish or estuarine/marine invertebrates. The Agency is
requiring additional toxicity data as part of this RED to address these data gaps.
Although the assessed acute and chronic RQs to aquatic species are relatively low, some LOG
exceedances exist. The same mitigation measures addressing terrestrial risks will also reduce these
risks, including reducing single maximum application rates, reducing maximum number of
applications per year and maximum seasonal application rates and voluntarily cancelling uses. Refer
to Table 41 for summary of revisions to use site parameters.
Table 41. Revised Use Site Parameters and Requirements for Maneb
Crop
Almonds
Turf
Cut Flowers
Single Application
Rates Ob ai/A)
Previous
6.4
17.4
1.2
Revised
6.4
8.7
1.2
Minimum
Retreatment
Interval
(days)
7
7
7
Maximum Number of
Applications Per Year
Previous
4
Unlimited
Unlimited
Revised
3
4
20
Yearly Maximum Rate
(lb ai/A)
Previous
25.6
Unlimited
Unlimited
Revised
19.2
34.8
24
3. Significance of the EBDCs
As mentioned above, EPA received many comments in response to the Federal Register
Notice published on November 24, 2004 (OPP-2004-0078) announcing the availability of the EBDC
risk assessments and requests for risk reduction options. The majority of the comments supported the
continued use of the EBDC products and data supporting the usefulness of the EBDCs to control
plant diseases. The Agency also obtained information from internal expertise, USDA's Office of
Pesticide Management and Policy (OPMP), and proprietary sources on several use sites.
Based on the information provided by a variety of resources, the Agency has determined that
the EBDCs are a class of fungicides that are particularly significant to agriculture and integrated pest
management (IPM) programs due to the use of the EBDCs in disease resistance management
programs. The EBDCs have a multi-site mode of action, and, as such, are not considered susceptible
to resistance development. This is supported by the fact that there has been no confirmed case of
fungal resistance to the EBDCs after over 50 years of use. Because of these characteristics, the
EBDCs are important resistance management partner chemicals for tank mixing or rotation with
newer and lower risk fungicides that have single-site modes of action such as the sterol inhibitors and
the strobilurins. This property helps to prolong the life of the newer and lower risk fungicides.
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The Agency is committed to long-term pest resistance management strategies, and an
important pesticide resistance management strategy is to avoid the repeated use of pesticides with the
same or similar mode/target site of action in the same field (OPP PR Notice 2001-5). Because of this,
the Agency has considered the advantages from the use of EBDCs as an important tool in fungicide
resistance management programs while making its reregistration decision for all 3 EBDCs,
mancozeb, maneb, and metiram.
Further, comparing the cost per treatment of EBDCs with other fungicides, cost information
demonstrated that the EBDCs are generally lower. The following paragraphs are summaries for
specific use sites.
Potatoes
Mancozeb, maneb, and metiram are used to control early blight and late blight as well as
several potato seed-piece diseases. The alternative fungicides include strobilurins (e.g. azoxystrobin,
trifloxystrobin), chlorothalonil, propamocarb, dimethomorph, cymoxanil, copper, triphenylin
hydoxide (TPTH), iprodione, and zoxamide fluazinam. However, there is no one alternative
fungicide registered to control all the potato diseases for which EBDCs are registered. Because there
has been reduced sensitivity of the strobilurins towards early blight on potatoes in some areas,
rotational applications of strobilurins with fungicides with a different mode of action are required
after every application.
Along with the EBDCs, chlorothalonil has been considered the standard early blight and late
blight treatments for years. However, EBDCs are needed for use when the seasonal allowance of
chlorothalonil per acre has been reached. Copper and tin products are less efficacious for early blight
in some areas. Lastly, applications of TPTH may result in injury to foilage of sensitive varieties, but
injury is reduced and efficacy is improved when TPTH is combined with an EBDC fungicide.
Tomatoes
When used alone mancozeb and maneb are labeled to control anthracnose, early blight, gray
leaf spot, late blight, leaf mold, and Septoria leaf spot fungal diseases. When tank-mixed with copper
fungicides, these chemicals also control bacterial spot and bacterial speck diseases. The principal
alternatives for fungal disease control are chlorothalonil, strobilurins (azoxystrobin, trifloxystrobin),
and Tanos (famoxadone + cymoxanil). The sole bacterial disease control alternative is Tanos, which
only claims to suppress these diseases.
The alternatives Tanos and the strobilurins and are both considered high risks for pest
resistance development and as such are labeled for a very limited number of applications and only in
tank-mixtures and alternations with the available broad spectrum protectant fungicides (i.e.,
chlorothalonil and EBDCs). Chlorothalonil is not labeled for control of bacterial diseases and has a
seasonal maximum rate that will sometimes preclude its use as a full-season EBDC fungicide
replacement for control of fungal diseases.
The use of EBDCs in combination with copper are claimed to be very important in the
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principal tomato production states of California and Florida, where it is considered the only reliable
control measure for bacterial spot and bacterial speck diseases. Additionally, the EBDC treatment
costs are about one-half that of the above-mentioned alternatives.
4. Summary of Risk Mitigation Measures
The following is a bulleted list that summarizes all mitigation measures necessary for the
reregistration of maneb:
Maneb-All Formulations
Sweet Corn - Cancel Use
Grapes - Cancel Use
Apples - Cancel Use
Kadota Figs - Cancel Use
Seed Treatment to Rice and Peanuts - Cancel Use
Oats Seed Treatment - Reduce maximum application rate from 0.003 lib ai/lb seed to 0.0021
Ib ai/lb seed
Almonds- Reduce maximum seasonal rate from 25.6 to 19.2 Ibs ai/acre/season and retain
maximum application rate of 6.4 Ibs ai/acre.
Sod Farm Turf - Reduce maximum application rate from 17.4 Ibs ai/acre to 8.7 Ibs ai/acre,
limit maximum seasonal rate to 34.8 Ibs ai/acre/season and add a 3 day pre-harvest interval.
Handlers mixing/loading of dry flowables and liquids for aerial or chemigation application,
add a PF5 Respirator.
Cut Flowers - Limit number of applications per year to 20
Commercial Potato Seed-Piece Treatment (dust) - require engineering controls (e.g. dust
collector equipment)
Maneb- Wettable Powder Formulation Only
Sod Farm Turf - Cancel Use
Chemigation/Aerial Applications - Delete Application Method
For mixing/loading all remaining uses add PF 5 Respirator.
E. Other Labeling Requirements
In order to be eligible for reregistration, various use and safety information will be included in
the labeling of all end-use products containing maneb. For the specific labeling statements and a list
of outstanding data, refer to Section V of this RED document.
1. Endangered Species Considerations
Based on available screening-level information there is a potential concern for maneb's acute
effects on listed freshwater and estuarine/marine animals and chronic effects on listed birds and
mammals should exposure actually occur. The Agency expects maneb poses a low acute risk to
nontarget insects because maneb is practically nontoxic to honeybees (acute contact LD50 > 12
//g/bee). However, the Agency does not assess risk to bees using RQs because a screening- level RQ
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assessment method for estimating the risk to bees is not available. The Agency does not currently
have enough data to quantify risks for maneb at the screening-level and cannot preclude potential
direct effects to the following taxonomic groups: listed nontarget terrestrial plants and vascular
aquatic plants, freshwater invertebrates, and estuarine/marine fish (acute basis), and listed mammals
and birds (chronic basis). These findings are based solely on EPA's screening-level assessment and
do not constitute "may affect" findings under the Endangered Species Act (ESA) for any listed
species.
The Agency has developed the Endangered Species Protection Program to identify pesticides
whose use may cause adverse impacts on federally listed endangered and threatened species, and to
implement mitigation measures that address these impacts. The ESA requires federal agencies to
ensure that their actions are not likely to jeopardize listed species or adversely modify designated
critical habitat. To analyze the potential of registered pesticide uses that may affect any particular
species, EPA uses basic toxicity and exposure data developed for the REDs and considers ecological
parameters, pesticide use information, the geographic relationship between specific pesticide uses and
species locations and biological requirements and behavioral aspects of the particular species. When
conducted, this analysis will consider regulatory changes recommended in this RED that are being
implemented at that time. A determination that there is a likelihood of potential effects to a listed
species may result in limitations on the use of the pesticide, other measures to mitigate any potential
effects, or consultations with the Fish and Wildlife Service or National Marine Fisheries Service as
appropriate. If the Agency determines use of maneb "may affect" listed species or their designated
critical habitat, EPA will employ the provisions in the Services regulations (50 CFR Part 402). Until
that species specific analysis is completed, the risk mitigation measures being implemented through
this RED will reduce the likelihood that endangered and threatened species may be exposed to maneb
at levels of concern.
2. Spray Drift Management
The Agency has been working closely with stakeholders to develop improved approaches for
mitigating risks to human health and the environment from pesticide spray and dust drift. As part of
the reregistration process, we will continue to work with all interested parties on this important issue.
From its assessment of maneb, as summarized in this document, the Agency concludes that
no drift management measures are needed for maneb. In the future, maneb product labels may need
to be revised to include additional or different drift label statements. Current, drift label statements
are listed in the "spray drift management" section of the label table (Table 43) in Section V of this
RED document.
V. WHAT REGISTRANTS NEED TO DO
The Agency has determined that maneb is eligible for reregistration provided that: (i)
additional data are submitted to confirm this decision; (ii) the risk mitigation measures outlined in this
document are adopted; and (iii) label amendments are made to reflect these measures. To implement
the risk mitigation measures, the registrants will be required to amend their product labeling to
incorporate the label statements set forth in the Label Summary Table (Table 43). In the near future,
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the Agency intends to issue Data Call-In Notices (DCIs) requiring product-specific data and
additional generic (technical grade) data at which time required label amendments will be submitted.
Generally, registrants will have 90 days from receipt of a DCI to complete and submit response forms
or request time extension and/or waiver requests with a full written justification. For product-specific
data, the registrant will have eight months to submit data and amended labels. For generic data, due
dates can vary depending on the specific studies being required. Below are additional generic data
and label amendments that the Agency intends to require for maneb to be eligible for reregistration.
A. Manufacturing-Use Products
Generic Data Requirements
The generic data base supporting the reregistration of maneb for the above eligible uses has
been reviewed and determined to be substantially complete. However, the data listed below in Table
42 are necessary to confirm this RED.
Table 42. Outstanding and Confirmatory Generic Data Requirements for Maneb and ETU
Guideline Study Name
New OPPTS
Guideline No.
Old Guideline
No.
Human Health
Directions for use
Storage Stability - Plants
Crop field trials [potato, turnip tops, green onions, endive, head and leaf lettuce,
loose-head Chinese cabbage, collards, kale, mustard greens, nonbell pepper,
cranberry, almond hull, popcorn grain and stover, banana, papaya, and seed
treatment (barley, field corn, cotton, flax, oats, rye, safflower, sorghum, wheat)]
Processing studies [potato]
Confined Accumulation in Rotational Crops
Subchronic Inhalation Toxicity - Rat
Developmental Toxicity - Rabbit**
Developmental Neurotoxicity - Rat**
Comparative Thyroid Assay **
UV/Visible Absorption
860.1200
860.1380
860.1500
860.1520
860.1850
870.3465
870.3700
870.6300
Special Study
830.7050
171-3
171-4e
171-4k
171-41
165-1
82-4
83-3
83-6
None
Ecological
Acute Fish Toxicity- Rainbow Trout (TGAI)
Acute Fish Toxicity- Rainbow Trout (TEP)
Whole Sediment Acute Toxicity - Freshwater Invertebrates
850.1075
850.1075
850.1735
72-1C
72-1D
None
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Table 42. Outstanding and Confirmatory Generic Data Requirements for Maneb and ETU
Guideline Study Name
Acute Estuarine/Marine Toxicity - Shrimp (TGAI)
Whole Sediment Acute Toxicity - Estuarine/Marine Invertebrates
Acute Estuarine/Marine Toxicity - Shrimp (TEP)
Early Life Stage Fish - Estuarine
Life Cycle Aquatic Invertebrate - Freshwater
Life Cycle Aquatic Invertebrate - Estuarine
Life Cycle Fish - Estuarine
Aquatic Plant Growth - Tier I
Aquatic Plant Growth - Tier II
New OPPTS
Guideline No.
850.1025
850.1740
850.1025
850.1350
850.1350
850.1350
850.1500
850.5400
850.4400
Old Guideline
No.
72-3C
None
72-3F
72-4A
72-4B
72-4B
72-5
122-2
123-2
TGAI= Technical Grade Active Ingredient TEP=Typical End-use Product
* The study must be conducted under the current protocol.
** ETU data requirement
Labeling for Manufacturing-Use Products
To ensure compliance with FIFRA, manufacturing-use product (MUP) labeling must be
revised to comply with all current EPA regulations, PR Notices, and applicable policies. The MUP
labeling must bear the labeling contained in Table 43.
B. End-Use Products
Additional Product-Specific Data Requirements
Section 4(g)(2)(B) of FIFRA calls for the Agency to obtain any needed product-specific data
regarding the pesticide after a determination of eligibility has been made. Registrants must review
previous data submissions to ensure that they meet current EPA acceptance criteria and if not, commit
to conduct new studies. If a registrant believes that previously submitted data meet current testing
standards, then the study MRID numbers should be cited according to the instructions in the
Requirement Status and Registrants Response Form provided for each product. The Agency intends
to issue a separate product-specific data call-in (PDCI), outlining specific data requirements.
Labeling for End-Use Products
To be eligible for reregistration, labeling changes are necessary to implement measures
outlined in Section IV above. Specific language to incorporate these changes is specified in Table 43.
Generally, conditions for the distribution and sale of products bearing old labels/labeling will be
established when the label changes are approved. However, specific existing stocks time frames will
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be established case-by-case, depending on the number of products involved, the number of label
changes, and other factors.
C. Labeling Changes Summary Table
In order to be eligible for reregistration, amend all product labels to incorporate the risk
mitigation measures outlined in Section IV. The following table (Table 43) describes how language
on the labels should be amended.
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Table 43. Summary of Labeling Changes for Maneb
Description
Amended Labeling Language
Placement on Label
Manufacturing Use Products
For all Manufacturing
Use Products
"Only for formulation into a fungicide for the following uses: [registrant fills in blank
with only those uses being supported by MP registrants]."
Technical and end-use product labels must be revised to delete all references to and
use-directions for the following cancelled use patterns: apples, kadota figs, grapes,
sweet corn, rice (seed treatment), and peanuts (seed treatment).
Manufacturers of products formulated as wettable powders must prohibit application
of wettable powder products by aerial and/or chemigation methods and use of
wettable powder products on turf/sod farms.
Manufacturers of products formulated as dusts must require closed systems for
commercial seed and seed-piece treatment.
Directions for Use
One of these
statements may be
added to a label to
allow reformulation
of the product for a
specific use or all
additional uses
supported by a
formulator or user
group
"This product may be used to formulate products for specific use(s) not listed on the
manufacturing use product label if the formulator, user group, or grower has complied
with U.S. EPA submission requirements regarding support of such use(s)."
"This product may be used to formulate products for any additional use(s) not listed
on the manufacturing use product label if the formulator, user group, or grower has
complied with U.S. EPA submission requirements regarding support of such use."
Directions for Use
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Table 43. Summary of Labeling Changes for Maneb
Description
Amended Labeling Language
Placement on Label
Environmental
Hazards Statements
Required by the RED
and Agency Label
Policies
"Do not discharge effluent containing this product into lakes, streams, ponds,
estuaries, oceans, or other waters unless in accordance with the requirements of a
National Pollutant Discharge Eliminations System (NPDES) permit and the
permitting authority has been notified in writing prior to discharge. Do not discharge
effluent containing this product to sewer systems without previously notifying the
local sewage treatment plant authority. For guidance, contact your State Water Board
or Regional Office of the Environmental Protection Agency."
Precautionary
Statements
End-Use Products Intended for Occupational Use (WPS and non-WPS)
PPE Requirements
Established by the
RED for Liquid (EC)
Formulations
"Personal Protective Equipment (PPE)"
"Some materials that are chemical-resistant to this product are [registrant inserts
correct material(s)]. If you want more options, follow the instructions for category
[insert A, B, C, D, E, F, G or H] on an EPA chemical-resistance category selection
chart."
"Mixers, loaders, applicators, and other handlers must wear:
- long-sleeve shirt,
- long pants,
- shoes and socks, and
- chemical-resistant gloves."
In addition, handlers mixing and loading for aerial or chemigation application to sod
farms must wear a NIOSH-approved respirator with:
- a dust/mist filter with MSHA/NIOSH approval number prefix TC-21C or
- any N*, R, P, or HE filter"
*Instruction to Registrant: Drop the "N" type filter from the respirator statement if the
pesticide product contains, or is used with, oil.
Immediately
following/below
Precautionary
Statements: Hazards to
Humans and Domestic
Animals
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Table 43. Summary of Labeling Changes for Maneb
Description
Amended Labeling Language
'See engineering controls for additional options and requirements.'
Placement on Label
PPE Requirements
Established by the
RED for Wettable
Powder (WP)
Formulation
"Personal Protective Equipment (PPE)"
"Some materials that are chemical-resistant to this product are [registrant inserts
correct material(s)]. If you want more options, follow the instructions for category
[insert A, B, C, D, E, F, G or H] on an EPA chemical-resistance category selection
chart."
"Mxer, loaders, applicators, and other handlers must wear:
- long-sleeve shirt,
- long pants,
- shoes and socks, and
- chemical-resistant gloves, and
- a dust/mist filtering respirator (MSHA/NIOSH approval number prefix TC-21C), or
a NIOSH approved respirator with any N*, R, P, or HE filter when mixing, loading,
cleaning up spills, or otherwise exposed to the concentrate."
*Instruction to Registrant: Drop the "N" type filter from the respirator statement if the
pesticide product contains, or is used with, oil.
"See Engineering Controls for additional options and requirements."
Immediately
following/below
Precautionary
Statements: Hazards to
Humans and Domestic
Animals
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Table 43. Summary of Labeling Changes for Maneb
Description
Amended Labeling Language
Placement on Label
PPE Requirements
Established by the
RED for Dry
Flowable (DF)
Formulation
"Personal Protective Equipment (PPE)
"Some materials that are chemical-resistant to this product are [registrant inserts
correct material(s)]. If you want more options, follow the instructions for category
[insert A, B, C, D, E, F, G or H] on an EPA chemical-resistance category selection
chart."
"Mixer, loaders, applicators, and other handlers must wear:
- long-sleeve shirt,
- long pants,
- shoes and socks, and
- chemical-resistant gloves.
In addition, handlers mixing and loading for aerial or chemigation application to sod
farms must wear a NIOSH-approved respirator with:
- a dust/mist filter with MSHA/NIOSH approval number prefix TC-21C or
- any N*, R, P, or HE filter."
*Instruction to Registrant: Drop the "N" type filter from the respirator statement if
the pesticide product contains, or is used with, oil.
"See engineering controls for additional options and requirements."
Immediately
following/below
Precautionary
Statements: Hazards to
Humans and Domestic
Animals
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Table 43. Summary of Labeling Changes for Maneb
Description
Amended Labeling Language
Placement on Label
PPE Requirements
Established by the
RED for Dust
Formulation.
"Personal Protective Equipment (PPE)
"Some materials that are chemical-resistant to this product are [registrant inserts
correct material(s)]. If you want more options, follow the instructions for category
[insert A, B, C, D, E, F, G or H] on an EPA chemical-resistance category selection
chart."
"Loaders, applicators, and other handlers must wear:
- long-sleeve shirt,
- long pants,
- shoes and socks, and
- chemical-resistant gloves (except when bagging treated seeds). "
"See engineering controls for additional options and requirements"
Immediately
following/below
Precautionary
Statements: Hazards to
Humans and Domestic
Animals
Engineering Controls:
Optional Use by
Handlers
Liquid, Dry Flowable,
and Wettable Powder
Formulations
Engineering Control Statement for Optional Use (WPS Only)
"Engineering Controls: When handlers use closed systems or enclosed cabs in a
manner that meets the requirements listed in the Worker Protection Standard (WPS)
for agricultural pesticides [40 CFR 170.240(d)(4) to (5)], the handler PPE
requirements may be reduced or modified as specified in the WPS."
Immediately
following/below
Precautionary
Statements: Hazards to
Humans and Domestic
Animals
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Table 43. Summary of Labeling Changes for Maneb
Description
Amended Labeling Language
Placement on Label
Engineering Controls:
Closed System for
Commercial Seed and
Seed Piece
Treatment.
Dust Formulations
"Loaders must use a closed system designed by the manufacturer to enclose the
pesticide to prevent it from contacting handlers or other people while it is being
handled. The system must have a properly functioning dust control system and
must be used and maintained in accordance with the manufacturer's written
operating instructions. Handlers using the closed mixing/loading system must:
wear the personal protective equipment required in the PPE section of this
labeling for loaders, and
be provided and must have immediately available for use in an emergency, such
as a broken package, spill, or equipment breakdown: a NIOSH-approved
respirator with a dust/mist filter with MSHA/NIOSH approval number prefix TC-
21C or any N, R, P, or HE filter."
Immediately
following/below
Precautionary
Statements: Hazards to
Humans and Domestic
Animals
User Safety
Requirements
"Follow manufacturer's instructions for cleaning/maintaining PPE. If no such
instructions for washables exist, use detergent and hot water. Keep and wash PPE
separately from other laundry."
Precautionary
Statements: Hazards to
Humans and Domestic
Animals immediately
following the PPE
requirements
User Safety
Recommendations
"USER SAFETY RECOMMENDATIONS'
"Users should wash hands before eating, drinking, chewing gum, using tobacco, or
using the toilet."
"Users should remove clothing/ PPE 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."
Precautionary Statements
under: Hazards to
Humans and Domestic
Animals
(Must be placed in a
box.)
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Table 43. Summary of Labeling Changes for Maneb
Description
Amended Labeling Language
Placement on Label
Restricted-Entry
Interval
"Do not enter or allow worker entry into treated areas during the restricted entry
interval (REI) of 24 hours."
Directions for Use, in
Agricultural Use
Requirements box
Early Reentry
Personal Protective
Equipment for
Products subject to
WPS as required by
Supplement Three of
PR Notice of 93-7
"PPE required for early entry to treated areas that is permitted under the Worker
Protection Standard and that involves contact with anything that has been treated, such
as soil or water, is:
- Coveralls,
- Shoes and socks, and
- Chemical-resistant gloves made of any waterproof material.
Directions for Use, in
Agricultural Use
Requirements Box
General Application
Restrictions
All Formulations
"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."
Place in the Directions
for Use directly above
the Agricultural Use Box
Application
Restrictions for
Wettable Powder
(WP) Formulation
only
"Aerial application is prohibited"
"Applying this product by chemigation is prohibited."
Technical and end-use product labels must be revised to delete all references to
and use directions for the following cancelled use pattern: Sod farm turf.
Directions for Use
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Table 43. Summary of Labeling Changes for Maneb
Description
Amended Labeling Language
Placement on Label
Application
Restrictions
All Formulations
Almonds: Reduce the maximum yearly application rate to 19.2 Ib ai/A
Cut Flowers: Limit to 20 applications per year.
Oat Seed Treatment: Reduce application rate to 0.0021 Ib ai/lb seed.
Sod Farm Turf: Reduce one-time application rate to 8.7 Ib ai/Acre and seasonal
maximum application rate to 34.8 Ib ai/A. Require a 3-day pre-harvest interval (PFn).
All turf labels must state: "For Use on Sod Farms Only"
The labels also must list the maximum application rates in pounds or gallons of
formulation.
Technical and end-use products must be revised to delete all references to and use
directions for the following cancelled use patterns: apples, kadota figs, grapes, sweet
corn, rice (seed treatment), and peanuts (seed treatment).
Directions for Use
Application
Restrictions for seed
or seed-pieces
that have been
treated with this
product and that are
then packaged or
bagged for future use
"Seed/Seed-pieces that have been treated with this product and that are then
packaged or bagged for future use must contain the following labeling on the
outside of the seed/seed-piece package or bag:"
"When opening this bag or loading/pouring the treated seed/seed-pieces, wear
long-sleeved shirt, long pants, shoes, socks, chemical resistant gloves, and a
NIOSH-approved respirator with:
- a dust/mist filter with MSHA/NIOSH approval number prefix TC-21C or
- any N*, R, P, or HE filter."
*Instructions: Drop the "N" type filter from the respirator statement if the
pesticide product contains, or is used with, oil.
"Treated Seed/Seed-Pieces - Do Not Use for Food, Feed, or Oil Purposes."
"After the seeds/seed-pieces have been planted, do not enter or allow worker entry
into treated areas during the restricted-entry interval (REI) of 24 hours. Exception:
Once the seeds are planted in soil or other planting media, the Worker Protection
Standard allows workers to enter the treated area without restriction if there will
Directions for Use
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Table 43. Summary of Labeling Changes for Maneb
Description
Amended Labeling Language
Placement on Label
be no worker contact with the soil/media subsurface."
Environmental
Hazards Statements
Required by the RED
and Agency Label
Policies
"This pesticide is toxic to aquatic organisms. Do not apply directly to water, or to
areas where surface water is present, or to inter-tidal areas below the mean high water
mark. Do not contaminate water when cleaning equipment or disposing of equipment
washwater or rinsate."
Precautionary
Statements: Hazards to
Humans and Domestic
Animals
Spray Drift Label
Language for
Products Applied as a
Spray
"SPRAY DRIFT MANAGEMENT"
"A variety of factors including weather conditions (e.g., wind direction, wind speed,
temperature, relative humidity) and method of application (e.g., ground, aerial, airblast,
chemigation) can influence pesticide drift. The applicator must evaluate all factors and
make appropriate adjustments when applying this product."
Wind Speed
"Do not apply at wind speeds greater than 15 mph.
Temperature Inversions
"If applying at wind speeds less than 3 mph, the applicator must determine if a)
conditions of temperature inversion exist, or b) stable atmospheric conditions exist at or
below nozzle height. Do not make applications into areas of temperature inversions or
stable atmospheric conditions."
Other State and Local Requirements
"Applicators must follow all state and local pesticide drift requirements regarding
application of maneb. Where states have more stringent regulations, they must be
observed."
Equipment
"All aerial and ground application equipment must be properly maintained and calibrated
using appropriate carriers or surrogates."
Spray Drift Label
Language for Products
Applied as a Spray
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Table 43. Summary of Labeling Changes for Maneb
Description
Amended Labeling Language
Placement on Label
Additional requirements for aerial applications:
1. "The boom length must not exceed 75% of the wingspan or 90% of the rotor blade
diameter."
2. "Release spray at the lowest height consistent with efficacy and flight safety. QO no^
release spray at a height greater than 10 feet above the crop canopy unless a greater height
is required for aircraft safety."
3. "When applications are made with a crosswind, the swath must be displaced
downwind. The applicator must compensate for this displacement at the up and
downwind edge of the application area by adjusting the path of the aircraft upwind."
Additional requirements for ground boom application:
1. "Do not apply with a nozzle height greater than 4 feet above the crop canopy."
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Note to Reader
The Appendices to the Maneb RED are undergoing final editing and will be made available in
January 2006.
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