p.1
v=/EPA
United States Prevention, Pesticides EPA 738-R-05-009
Environmental Protection and Toxic Substances September 2005
Agency (7508C)
Reregistration
Eligibility Decision for
Ferbam
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Registration Eligibility Decision (RED) Document for
Ferbam
ListB
Approved by:
Debra Edwards, Ph. D.
Director
Special Review and Reregistration Division
Date: September 2005
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Table of Contents
Abstract 8
I. Introduction 8
n. Chemical Overview 9
A. Chemical Identification 9
B. Use Profile 10
ffl. Summary of Ferbam Risk Assessments 12
A. Human Health Risk Assessment 12
1. Toxicity 12
2. Dietary Exposure and Risk from Food and Water 14
3. Chronic Aggregate Risk 18
4. Occupational Exposure and Risk 18
B. Environmental Risk Assessment 20
1. Environmental Fate and Transport 21
2. Ecological Risk Assessment 21
IV. Risk Management, Reregistration, and Tolerance Reassessment Decision 24
A. Determination of Reregistration Eligibility 24
B. Public Comments and Responses 24
C. Regulatory Position 25
1. Food Quality Protection Act Findings 25
2. Endocrine Disrupter Effects 25
3. Cumulative Risks 26
4. Tolerance Reassessment Summary 26
D. Regulatory Rationale 27
1. Endangered Species Considerations 27
2. Mitigation 28
3. Significance of Ferbam Use 29
4. Spray Drift Management 30
V. What Registrants Need to Do 30
A. Manufacturing Use Products 31
1. Additional Generic Data Requirements 31
2. Labeling for Manufacturing-Use Products 31
B. End-Use Products 31
1. Additional Product-Specific Data Requirements 31
2. Labeling for End-Use Products 32
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VI. Appendices ^9
Appendix A. Food/Feed Use Patterns for Ferbam 40
Appendix B. Data Supporting Guideline Requirements for the Reregistration of Ferbam ... 44
Appendix C. Technical Support Documents 48
Appendix D. Citations Considered to be Part of the Data Base Supporting the Interim
Reregistration Decision (Bibliography) 49
Appendix E. Generic Data Call-In 66
Appendix F. Product Specific Data Call-In 67
Appendix G. EPA's Batching of Ferbam Products for Meeting Acute Toxicity Data
Requirements for Reregistration 68
Appendix H. List of Registrants Sent This Data Call-In 70
Appendix I. List of Available Related Documents and Electronically Available Forms 71
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Ferbam Reregistration Eligibility Decision Team
Office of Pesticide Programs:
Biological and Economic Analysis Assessment
Richard Michell
Dave Donaldson
Environmental Fate and Effects Risk Assessment
Jose Luis Melendez
Nicholas Federoff
Health Effects Risk Assessment
Rebecca Daiss
Gary Otakie
Santhini Ramasamy
Registration Support
Olga Odiott
Risk Management
Amaris Johnson
Kelly Sherman White
Laura Parsons
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Glossary of Terms and Abbreviations
ai Active Ingredient
AR Anticipated Residue
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
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
GENEEC Tier I Surface Water Computer Model
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
LOAEL Lowest Observed Adverse Effect Level
jig/g Micrograms Per Gram
Hg/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 submitted studies.
MUP Manufacturing-Use Product
NA Not Applicable
NAWQA USGS National Ambient Water Quality Assessment
NPDES National Pollutant Discharge Elimination System
NR Not Required
NOAEL No Observed Adverse Effect Level
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
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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 EPA'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
SLN Special Local Need (Registrations Under Section 24©) of FIFRA)
TGAI Technical Grade Active Ingredient
USDA United States Department of Agriculture
UF Uncertainty Factor
WPS Worker Protection Standard
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Abstract
This document presents the Environmental Protection Agency's (hereafter referred to as EPA
or the Agency) decision regarding the reregistration eligibility of the registered uses of the fungicide
ferbam [ferric dimethyldithiocarbamate]. The Agency has determined that ferbam is eligible for
reregistration.
Ferbam is a fungicide used on citrus, pome and stone fruits, grapes, berries, and tobacco. It
has 27 tolerances which have been reassessed, and 18 of those tolerances are proposed for revocation.
There are no residential uses of ferbam, and it has no dietary or occupational risks of concern when
appropriate personal protective equipment is worn. There are ecological risks of concern to non-target
terrestrial and aquatic organisms, and worker risks.
To address the ecological and occupational risks of concern, label changes and the following
mitigation is required for ferbam to be eligible for reregistration: delete aerial application for all uses,
the registrant will voluntarily cancel use on three crops, reduce maximum single application rates for
pome fruits and citrus, limit the number of ferbam applications per year on all crops, and use scenario-
specific personal protective equipment. In addition, where there are data gaps, data must be generated
to confirm the reregistration eligibility decision documented in this RED.
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 to the EPA. 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 (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 that by August 2006, EPA must review
all tolerances in effect on the day before the enactment of the FQPA, which was August 2,1996.
FQPA also amends the FFDCA to require a safety finding in tolerance reassessment based on factors
including 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.
The Food Quality Protection Act (FQPA) requires that, when considering whether to
establish, modify, or revoke a tolerance, the Agency consider "available information" concerning the
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cumulative effects of a particular pesticide's residues and "other substances that have a common
mechanism of toxicity." Ferbam belongs to the dithiocarbamate group of fungicides which have
neuropathy as a common toxic effect. In December 2001 EPA concluded, based on the
recommendations of the Science Advisory Panel (SAP), that the neuropathy induced by the
dithiocarbamates can not be linked to a common mechanism of toxicity (Memorandum titled, The
Determination of Whether Dithiocarbamate Pesticides Share a Common Mechanism of Toxicity,
From: Marcia Mulkey to Lois Rossi, dated December 19, 2001). Further, EPA has concluded that the
dithiocarbamates should not be included in the cumulative assessment of the N-methyl carbamates
since they do not share acetylcholinesterase inhibition as their principal mechanism of toxicity. Thus,
for the purposes of this reregistration determination, EPA has assumed that ferbam does not share a
common mechanism of toxicity with other pesticides.
The document consists of six sections: Section I contains the regulatory framework for
reregistration and tolerance reassessment; Section II provides a profile of the use and usage of the
chemical; Section III gives an overview of the human health and environmental effects risk
assessments based on data, public comments, and other information received; Section IV presents the
Agency's reregistration eligibility and risk management decisions; Section V summarizes label
changes necessary to implement the risk mitigation measures outlined in Section IV as well as data
requirements; and Section VI comprises the appendices which list related information and supporting
documents. The preliminary and revised risk assessments for ferbam are available in the Public
Docket, under docket number OPP-2004-0337 and on the Federal Docket Management System
(FDMS) web page, http://www.regulations.gov.
II. Chemical Overview
A. Chemical Identification
Chemical Structure:
/
XS $' CH3
^Fe
Y
A
H3C CH3
Common Name: Ferbam
Trade Name: Ferbam Granuflo
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Chemical Name: [ferric dimethyldithiocarbamate]
CAS Registry Number: 14484-64-1
OPP Chemical Code: 034801
Case Number: 2180
Molecular Weight: 416.50
Empirical Formula: C9H18FeN3S6
Basic Manufacturers: Taminco, Inc.
Ferbam is a fine black powder which decomposes at 180 degrees C, and has a density of 1.36
g/mL at 20 degrees C and vapor pressure of <8.6 x 107 Torr. It has moderately low solubility in water
(120 ppm) and is soluble in acetone, acetonitrile, chloroform, and pyridine. Ferbam tends to
decompose upon exposure to heat and moisture with prolonged storage.
Ferbam has been registered in the United States since 1948 for use as a fungicide. The
Agency conducted a review of the scientific data underlying pesticide registrations and identified
missing or inadequate studies. A Phase IV Data Call-In (DCI) was issued in October 1991.
Subsequent data call-ins were issued in September 1993, March 1995, October 1995, and February
1996. This Reregistration Eligibility Decision (RED) reflects an assessment of all data submitted to
date.
Currently, there are four products containing ferbam registered under Section 3 of FIFRA.
Additionally, there are three Special Local Need (SLN) registrations including use on cranberries in
New Jersey and Massachusetts, and use on mangos in Florida. This RED evaluates risk from all
currently registered uses of ferbam.
B. Use Profile
The following is information on the currently registered uses including an overview of use
sites and application methods. A detailed table of the uses of ferbam eligible for reregistration is
contained in Appendix A.
Type of Pesticide: Ferbam is a broad-spectrum fungicide.
Summary of Use: It is registered for use on citrus crops, a variety of pome and stone fruits,
berries, ornamentals, conifers, and tobacco. There are no residential uses of
ferbam.
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Target Organisms: Anthracnose, downy mildew, leaf spots, Botrytis, fruit rots, and rusts.
Use Classification: General use
Formulation Types: Water dispersible granule (76% active ingredient).
Application Methods: Application methods are aerial, airblast, and groundboom.
Application Rates:
The maximum label application rate is 19.76 pounds active ingredient/acre (Ib
ai/A) for rough lemon nursery stock, although a higher application rate is on
labels for a SLN registration for spot treatment on cranberries. Refer to Table
1 for additional application rates:
Table 1. Application Rates for Ferbam
Crop
Citrus (grapefruit, lemons, limes, oranges,
tangelos, tangerines)
Apples
Pears
Cranberries (groundboom)
Peaches and Nectarines (dormant use only)
Grapes
Maximum Single Application
Rate (Ib ai/A)
11.4
6.08
4.56
4.56
3.42
3.04
Maximum Application Rate per
Season (Ib ai/A)
34.2
Not Specified
Not specified
22.8
6.84
9.12
Use Locations: Ferbam is primarily used in Massachusetts, New Jersey, and Florida.
Tolerances: Currently, there are 27 ferbam tolerances. The crops for which the Agency
will propose to revoke tolerances and/or cancel uses include apricots,
asparagus, beans, blueberries, blackberries, youngberries, cabbage,
caneberries, cucumbers, lettuce, papaya, peas, squash, and tomatoes, since
these uses are not being supported by the registrant.
Annual Pounds Used: Approximately 160,000 pounds.
Percent Crop Treated: Ferbam comprises approximately 10% of the crop treated for tangerines and
5% or less for all other crops.
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III. Summary of Ferbam Risk Assessments
The following is a summary of EPA's human health and ecological risk findings and
conclusions for ferbam, as presented fully in the documents "Revised Ferbam HED Risk Assessment
for Reregistration Eligibility Decision (RED) Document" written by R. Daiss, (4/19/05), "Addendum
to the Risk Assessment and Recommendations for the Reregistration Eligibility Decision (RED) for
Ferbam", and "EFED Error Correction for the RED Chapter for Ferbam" written by N.E. Federoff and
J.Melendez (2/23/05).
The purpose of this section is to highlight the key features and findings of the risk assessments
in order to help the reader better understand the risk management decisions reached by the Agency.
While the risk assessments and related addenda are not included in this document, they are available
in the OPP Public Docket http://epa.gov/edockets (docket number OPP-2004-0337) and may also be
accessed on the Agency's website at http://www.epa.gov/pesticides/reregistration/status.htni.
A. Human Health Risk Assessment
Although the Agency assumes no common mechanism of toxicity with other pesticides,
ferbam is similar in its toxicity to the structurally related compounds thiram and ziram. Also, there are
similarities in the metabolism of ferbam, thiram, and ziram. Thus, studies from the ziram and thiram
databases were used as surrogates for those lacking in the ferbam database.
1. Toxicity
Ferbam is a relatively low toxicity chemical. It has low acute toxicity (Category III) via the
oral and dermal routes, and moderate (Category II) acute toxicity via the inhalation route. It is a slight
eye irritant and weak dermal sensitizer. Ferbam is not considered to be mutagenic, and a
developmental neurotoxicity (DNT) study is not required.
Although there are limited evidence and data on developmental neurotoxicity in the ferbam
reproduction studies, the DNT study for thiram helps inform ferbam's developmental neurotoxicity.
The No Observable Adverse Effect Level (NOAEL) from thiram's DNT study is 1.4 mg/kg/day. This
study has been used to establish the acute dietary RfD for females, aged 13-49, and short-term and
intermediate term dermal endpoints. Based on information available on developmental neurotoxicity
for thiram, the Agency has determined that a DNT study for ferbam is not required.
The Agency has set an acute reference dose (RfD) of 0.05 mg/kg/day for population
subgroups other than females aged 13-49, based on a NOAEL of 5 mg/kg/day; effects observed at the
LOAEL were impaired functional observational batteries (FOB) from an acute neurotoxicity study of
thiram in rats. Additionally, the Agency has set a chronic RfD of 0.015 mg/kg/day based on a
NOAEL of 1.5 mg/kg/day; effects observed at the LOAEL were decreased body weight gain and
increased organ weight. The RfD is based on a combined chronic toxicity/carcinogenicity study of
thiram in rats and a 100-fold inter-/intra-species uncertainty factor (see Table 2).
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Table 2. SiunmaryofToxicoIogScalDcs«andIndpointsforFerbain
Exposure
Scenario ;
Acute Dietary
All Populations
except females age 13-
49)
Acute Dietary
(Females age 13-49)
Chronic Dietary
All Populations
Incidental Oral
All Durations
Dermal
Short-Term (1-30
days) Intermediate-
Term (1-6 mo)
Inhalation
All durations
Cancer
Oral, Dermal,
Inhalation
Dose Used in
Risk Assessment,
•UF=10tf-:
NOAEL= 1.5
mg/kg/day
Acute RfD =
0.05 mg/kg/day
NOAEL=1.4
mg/kg/day
Acute RfD =
0.014 mg/kg/day
NOAEL= 1.5
mg/kg/day
Chronic RfD =
0.0 15 mg/kg/day
Special FQPASF**
" Ix and Level of
Concern (LOC) for
Risk Assessment
aPAD =
acute RfD
FQPA SF
= 0.05 mg/kg/day
acute RfD
FQPA SF
= 0.014 mg/kg/day
cPAD =
chronic RfD
FQPA SF
= 0.0 15 mg/kg/day
Study and lexicological Effects
Acute Neurotoxicity Study - Rat
LOAEL = 1 50 mg/kg/day based on FOB effects
(lethargy, lower temperature, reduced startle response,
no tail pinch response) and reduced motor activity
Developmental Neurotoxicity Study - Rat
LOAEL = 3.7 mg/kg/day based on increases in motor
activity seen in female offspring on PND 17
Combined Chronic Toxicity/Carcinogenicity Study -
Rat
LOAEL = 7.3 mg/kg/day based on changes in
hematology, clinical chemistry, incidences of bile duct
hyperplasia, and reduction in mean body weight gain
Endpoints of concern were not selected for incidental oral exposure scenarios (short and
intermediate terms), since there are no residential uses (e.g., turf) supported for ferbam.
Oral study
NOAEL=1.4
mg/kg/day
(Dermal
absorption factor =
1%)
NOAEL=1.5
mg/kg/day
Inhalation
Absorption Rate =
100%
Residential LOC for
MOE = N/A
Occupational LOC
forMOE=100
Residential MOE
=N/A
Occupational MOE
= 100
Developmental Neurotoxicity Study - Rat
LOAEL = 3.7 mg/kg/day based on increases in motor
activity seen in female offspring on PND 17
Combined Chronic Toxicity/Carcinogenicity Study -
Rat
LOAEL = 7.3 mg/kg/day based on changes in
hematology, clinical chemistry , incidences of bile
duct hyperplasia, and reduction in mean body weight
gain
Not likely to be carcinogenic in humans
There were no tumor effects observed in the ferbam studies; therefore, no cancer assessment
was done. Thiram is classified as "not likely to be carcinogenic to humans" and ziram is classified as
"suggestive evidence of carcinogenicity to humans" with no quantitative risk assessment.
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FQPA Special Safety Factor.
The Food Quality Protection Act (FQPA) of 1996 directs EPA, in setting pesticide tolerances,
to use an additional tenfold margin of safety to protect infants and children, taking into account the
potential for pre- and postnatal toxicity and the completeness of the toxicology and exposure
databases. The statute authorizes EPA to modify this tenfold FQPA safety factor with a different
FQPA factor only if reliable data demonstrate that the resulting level of exposure would be safe for
infants and children.
After evaluating hazard and exposure data for ferbam, EPA reduced the default lOx FQPA
safety factor to Ix. The toxicity database for ferbam, which is bridged to thiram, includes acceptable
developmental and reproductive toxicity studies, and there is no evidence in the developmental
toxicity study of susceptibility following in utero exposure. Also, the Agency has a low level of
concern and no residual uncertainties regarding exposure or concerns for the effects seen in the
developmental toxicity studies after establishing toxicity endpoints and traditional uncertainty factors
to be used in the risk assessment. Therefore, the 10X FQPA special safety factor was reduced to IX.
Database Uncertainty Factor
The bridged lexicological database for ferbam is considered complete, and the Agency has
concluded that there is no need for a database uncertainty factor.
2. Dietary Exposure and Risk from Food and Water
(For a complete discussion, see Section 6.0 of the Revised Ferbam HED Risk Assessment for
Reregistration Eligibility Document (RED) by R.Daiss).
Dietary risk assessment incorporates both exposure to and toxicity of a given pesticide. The
risk is expressed as a percentage of a maximum acceptable dose (i.e., the dose which will result in no
unreasonable adverse health effects). This dose is referred to as the population adjusted dose (PAD).
The PAD is equivalent to the Reference Dose (RfD) divided by the special FQPA Safety Factor which
was reduced to Ix for ferbam; therefore the PAD = RfD. EPA is concerned when estimated dietary
risk exceeds 100% of the PAD.
The residue data for processed commodities of food/feed crops that are from presently
registered use sites have been evaluated and deemed adequate by the Agency. Based on these data, the
Agency intends to revise some tolerances and revoke several crop tolerances for uses which the
registrant will no longer support. All crops on current labels were included in the risk assessments,
even though the registrant intends to cancel various uses. As a result, the ferbam risk assessments are
conservative.
EPA has determined that, due to their similarity in metabolism, thiram and ziram data are
appropriate for use in the ferbam dietary exposure assessments. Therefore, where no ferbam-specific
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residue data are available, acceptable ziram and thiram field trial data have been translated to ferbam
(i.e., for common crops with comparable application rates, number of applications, and post-harvest
intervals (PHIs)). Available chemical specific data from processing studies were used for processed
commodities. An 85% washing reduction factor from a ziram peach processing/washing study was
applied to all assessed commodities. In addition, the percent crop treated (CT) was used for all
commodities for which data were available, and where no percent CT data were available, the dietary
analyses assumed 100% CT.
The most sensitive acute endpoint from the ferbam, ziram and thiram databases was selected
from a thiram DNT study. This endpoint is appropriate only for the population subgroup females of
child bearing age (ages 13 - 49). The endpoint for the U.S. population and other population subgroups
was selected from an acute neurotoxicity study. For the dietary (food and water) assessment, the
aPAD is not exceeded for any population subgroups and the percent of aPAD fits within the Agency's
risk cup. For more detail on the endpoint selection refer to the "Addendum to the Risk Assessment
and Recommendations for the Reregistration Eligibility Decision (RED) for Ferbam" dated 9/26/05
by R. Daiss.
As there is potential for concurrent exposure to ferbam via food and water, the combined
exposures are estimated for the acute (aggregate) and chronic (aggregate) dietary assessment.
Drinking Water
Drinking water exposure to pesticides can occur through ground water and surface water
contamination. EPA considers both acute (short term) and chronic (long term) drinking water risks
and uses either modeling or actual monitoring data, if available, to estimate the exposure. No water
monitoring data were available; therefore Tier II Estimated Drinking Water Concentrations (EDWCs)
of thiram were calculated using PRZM/EXAMs (surface water) and Tier I EDWCs were calculated
utilizing SCIGROW (ground water). Modeling is carried out in tiers of increasing refinement, but is
designed to provide high-end estimates of exposure.
EDWCs are calculated for thiram instead of ferbam because the environmental fate data
indicate that the parent compound either biodegrades or undergoes hydrolysis to thiram in 31 minutes
or less. The EDWCs for thiram are calculated based on a maximum application rate of ferbam of 19.8
Ib ai/A with the Florida citrus (rough lemon nursery stock) scenario for surface water. The estimated
acute concentration in surface water is 80.57 ppb of thiram, which represents a one in ten year highest
concentration from a vulnerable site. The estimated chronic concentration is 2.5 ppb, which represents
a high-end annual mean value over a 30-year period, also at a vulnerable site. The SCIGROW model
generated a Tier I ground water EDWC of 0.02 ppb of thiram, which is suitable for acute and chronic
estimates. The surface water values were used as high-end estimates for dietary risk (see Table 3).
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Table 3. Drinking Water EDWCs for Thiram from Ferbam Use
Drinking Water Source
Surface Water
Ground Water
Acute (ug/L)
81
0.02
Chronic (ug/L)
2.5
0.02
Acute Dietary Risk
The acute dietary risk assessment was conducted for all ferbam food uses and drinking water.
Acute dietary risk is calculated based on quantity of food eaten in one day and maximum, or high-end,
residue values in the food. Drinking water residues are derived from Tier I and Tier II aquatic models
and integrated into the dietary exposure models. As noted above, EDWCs were assessed for thiram,
instead of ferbam, because the environmental fate data indicate that the parent compound degrades
rapidly to thiram. A risk estimate that is less than 100% of the acute Population Adjusted Dose
(aPAD) (the dose at which an individual could be exposed on any given day and no adverse health
effects would be expected) is below the Agency's level of concern.
Field trial data for ferbam, ziram and thiram were used to estimate ferbam residues in or on
most commodities. Tolerance level residues were assumed for a few commodities that had no field
trial data to ensure that EPA would not underestimate potential exposure. No monitoring data were
available.
EPA evaluated the acute dietary risks using the Dietary Exposure Evaluation Model with the
Food Commodity Intake Database (DEEM-FCID™) Version 2.03. The acute dietary risk estimates
fell below EPA's level of concern for the general U.S. population and all population subgroups,
including infants and children at the 99.9th percentile of exposure. The most highly exposed subgroup
was children 1-2 years old, at 68% of the aPAD. Table 4. illustrates the acute risk estimates for the
combined acute dietary (food and drinking water) exposures.
Table 4. Ferbam Acute Dietary (Food and Water) Exposure Estimate and Percent of Acute PAD
Population Subgroup
General U.S. Population
All Infants (< 1 year old)
Children 1-2 years old
Children 3-5 years old
Children 6-12 years old
Females 13-49 years old
aPAD (mg/kg/day)
0.05
0.05
0.05
0.05
0.05
0.01*
DEI
Exposure (mg/kg/day)
99.9th percentile
0.0108
0.0183
0.0338
0.0236
0.0127
0.0021
EM
% aPAD
99.9th percentile
22
37
68
47
25
44
*Based on the thiram DNT study NOAEL of 1 .4 mg/kg/day
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The risk estimate for the population subgroup of children ages 1 - 2 is a conservative, high-end
value because of several factors, including: tolerances level residues were used for some crops, 100%
crop treated was assumed for various crops, and the EDWCs are calculated using a vulnerable site for
the modeling parameter.
For women of child bearing age, the thiram DNT study was chosen to provide a protective
endpoint for acute dietary assessment. The DEEM acute dietary exposure estimate for the population
subgroup of females age 13 - 49 is 44% of the aPAD, which is below EPA's level of concern. For
more detail on the acute dietary endpoints, refer to the "Addendum to the Risk Assessment and
Recommendations for the Reregistration Eligibility Decision (RED) for Ferbam" dated 9/26/05 by R.
Daiss.
Chronic Dietary Risk
Chronic dietary risk is calculated by using the average consumption values for foods and
average residue values on those foods. A risk estimate that is less than 100% of the chronic Population
Adjusted Dose (cPAD) (the dose at which an individual could be exposed over the course of a lifetime
and no adverse health effects would be expected) is below the Agency's level of concern. An
uncertainty factor of lOOx was applied to the chronic dietary assessment for inter- and intraspecies
variations, and the FQPA safety factor was reduced to Ix as discussed in the dietary risk section
above. The assessment incorporated tolerance level food residues adjusted for processing, washing
factors, and % CT, as well as a point estimate for water residues.
The ferbam chronic dietary exposure assessment was conducted using the DEEM-FCID™
Model Version 2.03. In this analysis the chronic dietary exposure and risk estimates resulting from
food intake were determined for the general U.S. population and various population subgroups.
The resulting food and drinking water risk estimates using the DEEM-FCID™ Model were 5%
or less of the cPAD for the U.S. population and all population subgroups. Children 1-2 years old were
the most highly exposed population subgroup, at an estimated 5% of the cPAD (see Table 5).
Table 5. Ferbam Chronic Dietary and Drinking Water Exposure Estimate and Percent of cPAD
Population Subgroup
General U.S. Population
All Infants (< 1 year old)
Children 1-2 years old
Children 3-5 years old
Children 6-12 years old
Youth 13 - Adults 50+ years
old
cPAD (mg/kg/day)
0.015
0.015
0.015
0.015
0.015
0.015
DEEM
Exposure (mg/kg/day)
0.0002
0.0006
0.0007
0.0005
0.0003
0.0002
% cPAD
1
4
5
4
2
1
17
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p. 18
3. Chronic Aggregate Risk
There are no residential uses for ferbam; as a result, a residential risk assessment was not
conducted and the aggregate risk is the same as the dietary (food and water) risk above.
4. Occupational Exposure and Risk
(For a complete discussion, see section 9.0 of the Revised Ferbam HED Risk Assessment for
Reregistration Eligibility Document (RED) by R. Daiss dated 4/19/05).
People can be exposed to a pesticide while working through handling, mixing, loading, or
applying a pesticide, and reentering a treated site. Handler and worker risks are measured by a Margin
of Exposure (MOE) which determines how close the occupational exposure comes to a No Observed
Adverse Effect Level (NOAEL) taken from animal studies. Generally, MOEs greater than 100 do not
exceed the Agency's level of concern.
For ferbam, only short and intermediate-term occupational exposures are expected based on
label specified use patterns. For the occupational assessment, the most sensitive endpoint was selected
from the thiram DNT study. The NOAEL from the acute thiram DNT is 1.4 mg/kg/day based on
females ages 13-49. Thus, the weight assumption for dermal exposure was changed from 70 kg to 60
kg to account for use of a dermal endpoint selected based on effects to females. For a more detailed
discussion of the occupational assessment using the thiram endpoint refer to the "Addendum to the
Risk Assessment and Recommendations for the Reregsitration Eligibility Decision (RED) For
Ferbam" dated 9/26/05 by R. Daiss.
In addition, short and intermediate term dermal endpoints were selected from a thiram 21-day
dermal toxicity study in rabbits. The NOAEL is 300 mg/kg/day and the LOAEL is 1000 mg/kg/day
based on decreases in body weight and food consumption as well as alterations in clinical chemistry.
The short and intermediate endpoints for inhalation exposure are based on a combined chronic
toxicity/carcinogenicity study in rats. The NOAEL is 1.5 mg/kg/day and the LOAEL is 7.3 mg/kg/day
based on changes in hematology, clinical chemistry, incidences of bile duct hyperplasia, and reduction
in mean body weight gain. These endpoints were used for assessment prior to the submission of the
thiram DNT study and formed the basis of the occupational assessment in the Revised Ferbam F£ED
Risk Assessment for the Reregistration Eligibility Document (RED) dated 4/19/05 by R. Daiss.
Occupational Handler Summary
Exposure analyses were performed using the Pesticide Handlers Exposure Database (PHED).
The target MOE for workers is 100, which includes the standard safety factors of 10X for intraspecies
variability (differences among humans) and 10X for interspecies variability (differences between
humans and animals). There are ten occupational handler exposure scenarios assessed for mixers,
loaders, and applicators applying water dispersible granule:
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1) mixing and loading granulars for aerial application (fruit trees and conifers)
2) mixing and loading granulars for airblast application (fruit trees, caneberries, conifers, rough
lemon nursery stock and field grown flowers)
3) mixing and loading granulars for groundboom application (cranberries, caneberries, tobacco,
conifers, rough lemon nursery stock and field grown flowers)
4) aerial application of liquids
5) application of liquid by air blast sprayer
6) application of liquid by groundboom
7) application of liquid by high pressure handwand (field grown flowers and rough lemon
nursery stock)
8) mixing, loading and applying liquids with low pressure handwand (tobacco plant beds and
spot treat cranberries)
9) mixing, loading and applying liquids with backpack sprayer (tobacco plant beds and spot treat
cranberries)
10) flagging for aerial spray application
The ten occupational scenarios resulted in the following PPE requirements and MOEs:
• At baseline PPE (long pants, long sleeved shirts, shoes and socks): mixing and loading for all
airblast and groundboom applications have MOEs above 100, except for rough lemon nursery
stock, for which the registrant has requested to voluntarily cancel use.
• At baseline PPE: applying sprays for all aerial and groundboom applications have MOEs
above 100; however, aerial application is being prohibited in order to eliminate handler
exposure with MOEs below the target of 100.
• Addition of chemical resistant gloves and PF5 respirator brings all mixers, loaders and
applicators using low pressure handwands to MOEs of 100 or above.
• Addition of chemical resistant gloves and a PF5 respirator brings all mixers, loaders and
applicators using high pressure hand wand applications to an MOE of 120.
• Addition of chemical resistant gloves and a PF10 respirator for all backpack sprayers
(cranberry spot treatment) brings the MOE to 90.
• Addition of chemical resistant gloves, double layers, and a PF5 respirator, for all airblast
applicators bring the MOEs between 115 to 227, when calculated using the revised maximum
rates (see Table 6).
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Table 6. Aggregate MOEs for Airblast Application
Crop
Citrus
Apples/Pears
Peaches/Cherries
New Max. App. Rate (Ib
ai/A) (previous typical rate)
6.0
3.5
3.42
MOE w/Baseline
PPE
40
80
80
MOE w/ Gloves, Double Layers,
and PF5 Respirator
115
200
202
Post-Application Occupational Risk
For workers entering a treated site, restricted-entry intervals (REIs) are calculated to determine
the minimum length of time required before workers can safely re-enter. Handler and worker risks
were assessed for the inhalation and dermal routes. Currently, all ferbam labels require a REI of 24
hours for all application scenarios.
The Agency has determined that workers may be exposed to ferbam upon entering areas
which have been previously treated to perform specific work activities in these areas (e.g., harvesting,
pruning, training, and thinning). Five post-application exposure scenarios were assessed for ferbam:
low berries, deciduous fruit-trees, cut flowers, Christmas trees and vine and trellis crops. The cut
flowers and Christmas trees scenarios will be voluntarily cancelled by the registrant.
The post application exposure and risk were assessed on the day of treatment (day 0), and
estimated using the thiram DNT endpoint of 1.4 mg/kg/day. When this thiram endpoint was used
along with the typical application rates for ferbam, the MOEs were above 100 (except for grapes,
MOE = 85). Using the current maximum application rates, some of the MOEs were below the target
of 100 (50 - 250). The typical application rates are most commonly used and reflect data from the
National Agriculture Statistics Survey (NASS). The Agency is confident that based on the typical
application rates applied, and an REI of 24 hours, workers have adequate protection in treated fields.
Therefore, maximum application rates on the following crops will be lowered to be
comparable with typical (reported) rates in order to provide adequate worker protection for post-
application activities. Maximum rates on the following crops will be reduced to: 3.5 Ib ai/A for
apples, pears, and cherries; 3.0 Ib ai/A for mangos; and 2.0 Ib ai/A for grapes. For a detailed
discussion of the post-application scenarios, please refer to the Memo entitled Addendum to the Risk
Assessment and Reregistration Eligibility Decision (RED) for Ferbam dated 9/26/05 by R. Daiss.
B.
Environmental Risk Assessment
A summary of the Agency's environmental risk assessment for ferbam is presented below.
Ferbam has the following registered uses which result in environmental exposures: groundboom
airblast, and aerial application to citrus, pome fruits, and stone fruits. In addition, low pressure hand
wand applications to cranberries have potential for environmental exposures. The registrant has
20
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requested voluntary cancellation on several crops, will decrease application rates, and will delete aerial
application from their labels, thereby limiting total potential environmental exposures. More detailed
information about the environmental risk from the use of ferbam can be found in the "EFED Error
Correction for the RED Chapter for Ferbam," dated 2/23/05. The complete environmental risk
assessment may be accessed in the OPP Public Docket (OPP-2004-0337) and on the Agency's
website at http://www.epa.gov/pesticides/reregistration/status.htm.
The environmental fate database is sufficient to characterize the environmental exposure
associated with ferbam use. However, EPA does intend to issue a DCI as part of this RED to require
submission of additional data for the parent compound to address areas of uncertainty. Studies on
aquatic invertebrates and freshwater fish will help to refine the environmental risk assessments and
provide the Agency with necessary data. These data are expected to confirm the conclusions of this
environmental risk assessment.
1. Environmental Fate and Transport
Ferbam is not persistent in the environment because it degrades rapidly via hydrolysis,
photodegradation, and aerobic soil metabolism to its major degradate thiram, with half-lives less than
or equal to 31 minutes. As thiram is more persistent in soils and water, the environmental fate
assessment focused on the levels of thiram in the environment.
2. Ecological Risk Assessment
To estimate potential ecological risk, EPA integrates the results of exposure and ecotoxicity
information using the quotient method. Risk quotients (RQs) are calculated by dividing exposure
estimates by ecotoxicity values, both acute and chronic, for various wildlife species. RQs are then
compared to levels of concern (LOCs). Generally, the higher the RQ, the greater the potential risk.
Risk characterization provides further information on the likelihood of adverse effects occurring by
considering the fate of the chemical in the environment, communities and species potentially at risk,
their spatial and temporal distributions, and the nature of the effects observed in studies.
Aquatic Organism Risk
The effects associated with ferbam exposure to aquatic organisms were evaluated based on
available data from acute toxicity studies on thiram since thiram is a primary degradate of ferbam in
aquatic systems. Based on these studies, thiram is classified as highly toxic to estuarine/marine aquatic
invertebrates (LCsoO.l ppm) and highly toxic to estuarine/marine fish and freshwater invertebrates
(LC5o=0.21 ppm).
Estuarine and marine aquatic invertebrates are the most susceptible aquatic species to thiram
exposure. As the highest application rates of ferbam occur for citrus crops in the Southeastern region,
there is potential concern for impact to estuarine and marine invertebrates. In the Northeast, ferbam is
applied to cranberries which are grown in coastal systems or close to freshwater river and lake
21
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systems. Spray drift may cause higher concentrations of ferbam and thiram in adjacent bodies of
water resulting in a higher risk to aquatic organisms.
For aquatic organisms, the acute risk LOG is 0.5, the acute restricted use LOG is 0.1, and the
acute endangered species risk LOG is 0.05. RQs which are greater than the LOG may pose a risk of
concern.
Acute Risks
The aquatic organism risk assessment was conducted assuming maximum application rates
and residue levels: Freshwater fish RQ values range from 0.15-1.14, and RQs for freshwater
invertebrates range from 0.03 - 0.22. Estuarine and marine fish RQs range from 0.011- 0.09, where as
estuarine and marine invertebrate RQs range from 1.8 -14.3. Endangered species LOCs were
exceeded for all crop scenarios for freshwater fish and estuarine/marine invertebrates.
Chronic Risks
No data are available assessing the chronic toxicity of thiram or ferbam to freshwater fish or
aquatic invertebrates. As a result, chronic risks of concern cannot be precluded for aquatic organisms.
The Agency intends to call in data on freshwater fish and aquatic invertebrates.
For the aquatic assessment, the highest exposure is expected for rough lemon and citrus crops
in Florida (which have the highest application rates), resulting in the highest estimated environmental
concentrations (EECs) and risks. However, the registrant will not support ferbam use on rough lemon
nursery stock, thereby eliminating the potential for this high exposure scenario.
For a more detailed discussion of risk to aquatic animals including a discussion of toxicity
data and aquatic modeling, see Section B. Risk Description - Interpretation of Direct Effects of the
EFED Error Correction for the RED Chapter for Ferbam dated 2/23/05.
Terrestrial Risk
Terrestrial wildlife exposure estimates are typically calculated for birds and mammals,
emphasizing a dietary exposure route for uptake of pesticide active ingredients. For exposure to
terrestrial organisms, such as birds and small mammals, pesticide residues on food items are
estimated, based on the assumption that organisms are exposed to a single pesticide residue in a given
exposure scenario. Maximum residue levels and application rates are assumed for the ELL-FATE
model used to conduct the terrestrial assessments.
Ferbam is categorized as slightly toxic to practically non-toxic to birds and practically non-
toxic to mammals on an acute basis. Thiram is categorized as slightly toxic to birds and practically
non-toxic to mammals. For terrestrial organisms, the acute LOG is 0.5, the acute restricted use LOG is
0.2, and the acute endangered species LOG is 0.1. RQs which exceed the LOG may pose a risk of
concern.
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The range of values in the terrestrial RQs results from conducting single and multiple
applications, as well as the variety of mammals used in the ELL-FATE model. The mammals used in
the model ranged in size from 15g to lOOOg, resulting in the following RQs:
Acute Risks for Birds
The acute RQs for single applications of thiram equivalents of ferbam range from 0.01 -1.0.
The acute RQs for multiple applications of thiram equivalents of ferbam range from 0.01 - 2.
Acute Risks for Mammals
The acute RQs for single applications of thiram equivalents of ferbam range from <0.01 -1.5.
The acute RQs for multiple applications of thiram equivalents of ferbam range from O.01 - 2.5.
Chronic Risks for Birds and Mammals
Reproductive studies in birds show that chronic dietary exposure can result in adverse effects
for several reproductive parameters, including decreased egg production, viable embryos and
hatchling survival and growth (No Observable Adverse Effect Concentration of 9.6 ppm ai). Harmful
effects include reproductive toxicity for birds, and decreased body weight for mammals.
Chronic RQs for both mammals and birds exceed the LOG for chronic effects (1.0) for all
scenarios. The chronic RQs for birds range from 5 - 400 and for mammals from 1.5 -137 with single
applications. Similarly, with multiple applications the RQs for birds range from 5 - 700 and for
mammals from 1.5 - 228.
This chronic assessment was conducted with some conservative assumptions including a
default foliar half-life of 35 days. This is likely a substantial overestimate of the persistence of thiram
in the environment. In addition, a generic bird or mammal is assumed to eat 100% of its food from the
treated area. As a result, it is estimated that young birds and small mammals may consume a toxic
dose large enough to cause adverse effects due to their lower body weights and higher energy
requirements. For more information on the risk to terrestrial animals refer to Section B. Risk
Description - Interpretation of Direct Effects of the EFED Error Correction for the RED Chapter for
Ferbam dated 2/23/05.
Ecological Incidents
The Agency has received no reports of ferbam ecological incidents.
Risk to Endangered Species
The Agency's preliminary risk assessment for endangered species indicates that RQs exceed
endangered species LOCs for all scenarios assessed. These findings are based solely on EPA's
screening level assessment and do not constitute "may affect" findings under the Endangered Species
Act.
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IV. Risk Management, Reregistration, and Tolerance Reassessment Decision
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 the
generic (i.e., active ingredient-specific) data to support reregistration of products containing ferbam as
an active ingredient.
The Agency has completed its review of submitted data and its assessment of the dietary,
occupational, and ecological risk associated with the use of pesticide products containing the active
ingredient ferbam. Based on a review of these data, the Agency has sufficient information on the
human health and ecological effects of ferbam to make decisions as part of the tolerance reassessment
process under FFDCA and the reregistration process under FIFRA, as amended by FQPA. The
Agency has determined that ferbam 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 ferbam that are eligible for
reregistration. Appendix B identifies the generic data that the Agency reviewed as part of its
determination for reregistration eligibility of ferbam, and lists the submitted studies that the Agency
found acceptable.
Based on its evaluation of ferbam, the Agency has determined that ferbam products, unless
labeled and used as specified in this document, would present risks inconsistent with FIFRA.
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 ferbam.
If all changes outlined in this document are incorporated into the product labels, then all current risks
for ferbam will be adequately mitigated for the purposes of this determination under FIFRA. Once the
Endangered Species assessment is completed, further changes to these registrations may be necessary
as explained in section D.I. Endangered Species Considerations, below.
B. Public Comments and Responses
Through the Agency's public participation process, EPA worked extensively with stakeholders
and the public to reach the regulatory decisions for ferbam. During the public comment period on the
risk assessments, which closed on June 27,2005, the Agency received three comments from two
private citizens, and Taminco/VJP Consulting. These comments in their entirety are available in the
public docket (OPP-2004-0337) at http://www.regulations.gov. A detailed Response to Comments
document is available in the public docket as well.
The RED and technical supporting documents for ferbam are available to the public through
EPA's electronic public docket and comment system, EPA Dockets, under docket identification (ID)
number OPP-2004-0337. The public may access EPA Dockets at http://www.epa.gov/edockets. In
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addition, the ferbam RED may be downloaded or viewed through the Agency's website at
http://www.epa.gov/pesticides/reregistration/status.htm.
C. Regulatory Position
1. Food Quality Protection Act Findings
As part of the FQPA tolerance reassessment process, EPA assessed the risks associated with
this pesticide. EPA has determined that risk from dietary (food and water sources) exposure to ferbam
is within its own "risk cup." An aggregate assessment was conducted for exposures through food and
drinking water. The Agency has determined that the human health risks from these combined
exposures are within acceptable levels. In other words, EPA has concluded that the tolerances for
ferbam meet FQPA safety standards. In reaching this determination, EPA has considered the available
information on the special sensitivity of infants and children, as well as aggregate exposure from food
and water. The FQPA Safety Factor has been reduced to IX for ferbam because acceptable
developmental and reproduction studies have been submitted and reviewed, and there is a low concern
and no residual uncertainties for pre- and postnatal toxicity or exposure. In addition, there are no
concerns for in utero exposure.
2. Endocrine Disrupter Effects
EPA is required under the FFDCA, as amended by FQPA, to develop a screening program to
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 data on ferbam indicated that there was no lexicologically significant evidence of
endocrine disruption effects. However, it has been found in chronic exposure studies that thiram
produces adverse reproductive effects in birds, including decreased egg production, viable embryos,
and hatchling survival and growth. These data suggest that future testing with appropriate screening
and/or testing protocols, could better characterize effects related to endocrine disruption.
25
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3.
Cumulative Risks
Risks summarized in this document are those that result only from the use of ferbam. The
Food Quality Protection Act (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. Unlike other pesticides for which EPA has followed a
cumulative risk approach based on a common mechanism of toxicity, EPA has not made a common
mechanism of toxicity finding for ferbam.
4. Tolerance Reassessment Summary
The existing tolerances for residues of ferbam (ferric dimethyldithiocarbamate) are established
under 40 CFR §180.406. The crops for which the Agency plans to revoke tolerances include apricots,
asparagus, beans, blueberries, blackberries, youngberries, caneberries, cabbage, cucumbers, lettuce,
papaya, peas, squash, and tomatoes (see Table 7).
Table 7. Tolerance Reassessment for Ferbam
Commodity
Current
Tolerance (as ppm
zineb)
Reassessed Tolerance
(as ppm CS2.)
Comment
Tolerances Established Under 40 CFR §180.114
Apple
Apricot
Asparagus
Bean
Blackberry
Blueberry (huckleberry)
Boysenberry
Cabbage
Cherry
Cranberry
Cucumber
Dewberry
Fruit, Citrus
Grape
Guava
Lettuce
Loganberry
7
7
7
7
7
7
7
7
7
7
7
7
7
7
7
7
7
TBD"
Revoke
Revoke
Revoke
Revoke
Revoke
Revoke
Revoke
TBD3
4
Revoke
Revoke
4
TBDa
Revoke
Revoke
Revoke
Use supported by registrant
Cancelled
Cancelled
Cancelled
Cancelled
Cancelled
Cancelled
Cancelled
IR-4 intends to support this use.
IR-4 intends to support this use.
Cancelled
Cancelled
Use supported by registrant
IR-4 intends to support this use.
Cancelled
Cancelled
Cancelled
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Table 7. Tolerance Reassessment for Ferbam
Commodity
Mango
Nectarines
Papaya
Peach
Pear
Pea
Raspberry
Squash
Tomato
Youngberry
Current
Tolerance (as ppm
zineb)
7
7
7
7
7
7
7
7
7
7
Reassessed Tolerance
(as ppm CS2.)
TED"
TBDa
Revoke
TBDa
TBDa
Revoke
Revoke
Revoke
Revoke
Revoke
Comment
Use supported by registrant (SLN)
Use supported by registrant
Cancelled
Use supported by registrant
Use supported by registrant
Cancelled
Cancelled
Cancelled
Cancelled
Cancelled
aTBD = To be determined. Although additional data are required to confirm the existing tolerances in or on the following
commodities, the Agency has no dietary or drinking water concerns associated with these tolerances and considers them
reassessed: peaches; nectarines; pears; mangos; grapes; cherries; and apples.
D. Regulatory Rationale
The Agency has determined that ferbam is eligible for reregistration provided that the risk
mitigation measures outlined in this document are adopted, and label amendments are made to reflect
these measures.
The following is a summary of the rationale for managing risks associated with the use of
ferbam. Where labeling revisions are warranted, specific language is set forth in the summary tables of
Section V of this document. Due to risk exceedances for aquatic invertebrates and terrestrial
organisms, ferbam labels must be amended to prohibit aerial application and limit total applications on
most crops to three per year. Likewise, rate reductions on pome fruits and citrus will reduce overall
exposure to ferbam. In addition, to decrease worker risk, scenario-specific PPE is required.
1. Endangered Species Considerations
From the screening level assessment, RQs exceeded the LOCs for endangered species for
many of the representative exposure scenarios considered. All chronic RQs for all uses exceeded
LOCs for endangered birds and mammals under both single applications (RQs for birds ranged from 5
to 400 and for mammals they ranged from 1.5 to 137) and multiple applications (RQs for birds ranged
from 5 to 700 and for mammals they ranged from 1.5 to 228). Since there were risks to endangered
birds and fish, risk to endangered reptiles and amphibians is also possible, should exposure actually
occur.
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The Agency has developed the Endangered Species Protection Program to identify pesticides
whose use may cause adverse impacts on endangered and threatened species, and to implement
mitigation measures that address these impacts. The Endangered Species Act (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 it
in relation to individual species and their locations by evaluating important ecological parameters,
pesticide use information, geographic relationship between specific pesticide uses and species
locations, and biological requirements and behavioral aspects of the particular species, as part of a
refined species-specific analysis. When conducted, this species-specific analysis will take into
consideration any regulatory changes recommended in this RED that are being implemented at that
time.
Following this future species-specific analysis, a determination that there is a likelihood of
potential impact to a listed species or its critical habitat may result in: limitations on the use of ferbam,
other measures to mitigate any potential impact, or consultations with the Fish and Wildlife Service or
the National Marine Fisheries Service as necessary. If the Agency determines use of ferbam "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 ferbam at levels of concern. EPA is not requiring specific ferbam
label language at the present time relative to threatened and endangered species. If, in the future,
specific measures are necessary for the protection of listed species, the Agency will implement them
through the Endangered Species Protection Program.
2. Mitigation
There were some occupational and ecological risks of concern identified for ferbam. To be
eligible for reregistration, the following mitigation measures are necessary:
Ecological and Occupational Mitigation:
• Delete aerial application for all uses. The Agency requires that aerial application be cancelled
to decrease risk to aquatic organisms from spray drift. In addition, the deletion of aerial
application will eliminate handler exposure which had MOEs below the target of 100 for
mixing and loading.
• Decrease single maximum application rate for some uses. The Agency requires that single
maximum application rates be decreased to 3.5 Ib ai/A for apples, pears and cherries; 3.0 Ib
ai/A for mangos; and 2.0 Ib ai/A for grapes. These decreased rates will result in post
application MOEs near or above the target MOE of 100, and lowered exposures to non-target
animals.
28
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Ecological:
• Limit the number offerbam applications to a maximum of three per year for all remaining uses
except SLNs. Current ferbam labels do not limit the number of applications per year, and this
mitigation measure will serve to decrease the potential environmental loading and resulting
residues offerbam in surrounding water bodies.
• Decrease single maximum application rate for citrus. The Agency requires that single
maximum application rates be decreased to 6.0 Ib ai/A for all remaining citrus uses. This
decreased rate will result in lowered exposures to non-target animals.
Voluntarily cancel ferbam use on rough lemon nursery stock, conifers, and flowering plants.
The cancellations will eliminate uses with high application rates and reduce overall ferbam
exposure to non-target organisms.
Occupational:
• Delete high pressure handwand application for all uses. The registrant is voluntarily
cancelling use on flowers (ornamentals) and rough lemon nursery stock which were the only
crops with high pressure handwand application. This deletion eliminates a handler scenario that
had MOEs below the target of 100 with baseline PPE.
• PF5 respirator, double layers, and chemical resistant gloves are required for all airblast
applications. Use of a PF5 respirator, double layers, and chemical resistant gloves brings all
MOEs for airblast above the target of 100.
3. Significance of Ferbam Use
There are many advantages to the use offerbam as a fungicide. EPA has received comments
supporting the continued use offerbam to control fungal outbreaks on a variety of crops. USD A,
private citizens, and grower organizations have expressed their need for the use offerbam as a
rotational partner with other fungicides, and a part of an efficacious pest management program.
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 of action. Ferbam has virtually no resistance issues, and there are no human
health risks of concern. Ferbam provides an important fungicidal niche use for citrus, mangos,
peaches, nectarines, and cranberries.
Ferbam is effective on citrus, by controlling the onset of postbloom fruit drop (PFD), and scab.
Approximately 45,000 Ib ai are applied to citrus crops in Florida. Thiophanate-methyl is one of the
alternatives for PFD, but it is permitted only as a section 18 for citrus use, and thus may not always be
available. To manage scab, ferbam and the strobilurins are both effective as rotational partners.
Ferbam is also a good rotational partner with the coppers and thiophanate-methyl.
29
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In New England and New Jersey, ferbam is effective for the treatment of leaf curl in peaches
and nectarines. In addition, ferbam is effective for treating anthracnose on mangos in Florida.
On cranberries, ferbam is used to treat fairy ring, the associated vine dieback, and fruit rot. The
higher ferbam application rate allowed by the SLN registrations in New Jersey and Massachusetts is
efficacious for spot treatment of fairy ring outbreaks. The other alternatives for control of fruit rot
include: azoxystrobin, chlorothalonil, the EBDC's mancozeb and maneb, as well as various copper
fungicides. Ferbam is effective for treatment of cranberries for the following reasons:
• low phytotoxicity for in-bloom applications,
• reasonable antifungal activity,
• no inhibition of the development of anthocyanins, and
• low risk for resistance development and complements azoxystrobin in this way.
The use of thiram on apples has been voluntarily cancelled as a result of the Thiram RED
(September 2004), and ferbam serves as a viable substitute to control fungal outbreaks in orchards.
Ferbam is efficacious in the control of apple scab, black rot, bitter rot, sooty blotch, fly speck, and
Brook's spot. Thus, ferbam provides an alternative fungicide to decrease the potential for resistance
problems in apples.
4. Spray Drift Management
The Agency has been working with the Spray Drift Task Force, EPA Regional Offices and
State Lead Agencies for pesticide regulation and other parties to develop the best spray drift
management practices. The Agency is proposing mitigation measures for aerial applications that
should be placed on product labels/labeling. The Agency has completed its evaluation of the new data
base submitted by the Spray Drift Task Force, a membership of U.S. pesticide registrants, and is
developing a policy on how to appropriately apply the data and the AgDRIFT computer model to its
risk assessments for pesticides applied by air, orchard airblast and ground hydraulic methods. After the
policy is in place, the Agency may impose further refinements in spray drift management practices to
reduce off-target drift and risks associated with aerial as well as other application types where
appropriate.
From its assessment of ferbam, as summarized in this document, the Agency concludes that no
additional drift mitigation measures are needed for ferbam. The deletion of aerial application from the
ferbam labels will reduce the amount of drift from crops. In the future, ferbam product labels may need
to be revised to include additional or different drift label statements.
V. What Registrants Need to Do
The Agency has determined that ferbam is eligible for reregistration provided that product-
specific data are submitted and the mitigation measures stated in this document are included in
upcoming label submissions. In the near future, the Agency intends to issue Data Call-In (DCIs) notices
30
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p. 31
requiring product specific data and generic confirmatory (technical grade) data. Generally, registrants
will have 90 days from receipt of a DCI to complete and submit response forms or request time
extensions and/or waiver requests with a full written justification. For product specific data, the
registrant will have 8 months to submit data and amended labels. For generic data, due dates can vary
depending on the specific studies being required. Listed below is the additional generic data that the
Agency intends to require.
A. Manufacturing Use Products
1. Additional Generic Data Requirements
The generic data base supporting the reregistration of ferbam for the above eligible uses has
been reviewed and determined to be substantially complete based on bridging to thiram data.
However, the data listed below are necessary to confirm the reregistration eligibility decision
documented in this RED (see Table 8).
Table 8. Data Requirements for the Ferbam Reregistration Eligibility Decision
Guideline Study Name
Crop Field Trials (Citrus Food Groups, Pome Fruits Groups,
Stone Fruits Group)
Storage Stability
Field Accumulation in Rotational Crops Study
Freshwater Fish Early Life-Stage
Aquatic Invertebrate Life-Cycle
Freshwater Fish Full Life-Cycle
New OPPTS Guideline
No:
860.15
885.24
860.19
850.13
850.135
850.15
Old Guideline No:
171- 4K
153 A- 9
165-2
72-4
72- 4B
72-5
2. Labeling for Manufacturing-Use Products
To ensure compliance with FIFRA, manufacturing use product (MUP) labeling should be
revised to comply with all current EPA regulations, PR Notices, and applicable policies. Based on the
review of the available data, the EPA has determined that ferbam is eligible for a 12 hour REI on all
product labels except for those containing other active ingredients with more restrictive REIs.
B. End-Use Products
1. 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. The Registrant must review
31
-------
p. 32
previous data submissions to ensure that they meet current EPA acceptance criteria and if not, commit
to conduct new studies. The Agency intends to issue a separate product-specific data call-in (PDCI),
outlining specific data requirements. 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.
2. Labeling for End-Use Products
In order for ferbam to be eligible for reregistration, all product labels must be amended to
incorporate the risk mitigation measures outlined in the Mitigation section, which include deleting
aerial application, decreasing the maximum number of applications per year, and decreasing the
maximum single application rates on pome fruits and citrus. Table 9 describes how language on the
labels should be amended.
32
-------
Table 9. Summary of Labeling Changes for Ferbam
Description
For all Manufacturing Use Products
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
Environmental Hazards Statements Required
by the RED and Agency Label Policies
Amended Labeling Language
"Only for formulation into a fungicide for the following use(s) [fill blank only
with those uses mat are being supported by MP registrant]"
End-use products must be amended to cancel use on rough lemon nursery stock,
ornamentals, and conifers.
hi addition, end-use labels to prohibit aerial application.
"This product may be used to formulate products for specific use(s) not listed on
the MP 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 of any additional use(s) not
listed on the MP label if the formulator, user group, or grower has complied with
U.S. EPA submission requirements regarding support of such use(s)."
"This pesticide is toxic to fish and aquatic invertebrates. 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 Pollution
Discharge Elimination 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 EPA."
Placement on Label
Directions for Use
Directions for Use
Precautionary Statements
End-Use Products Intended for Occupational Use
33
-------
PPE Requirements Established by the RED
for Dry Flowable Formulation
"Personal Protective Equipment (PPE)"
"Some materials that are chemical-resistant to this product are" (registrant
inserts correct chemical-resistant material). "If you want more options, follow
the instructions for category" [registrant inserts A,B,C,D,E,F,G,or H] "on an
EPA chemical-resistance category selection chart."
"All mixers, loaders, applicators and other handlers must wear:
-long sleeved shirts,
-long pants,
-shoes and socks,
-chemical resistant gloves and PF5 respirator when loading and applying with
low pressure handwand,
-chemical resistant gloves and a PF10 respirator when loading and applying with
a backpack sprayer,
-applicators must wear chemical resistant gloves, double layers, and a PF5
respirator when applying with airblast applicator."
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."
"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. As soon as
possible, wash thoroughly and change into clean clothing."
Precautionary Statements under:
Hazards to Humans and
Domestic Animals immediately
following Engineering Controls
(Must be placed in a box.)
34
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Environmental Hazards
This pesticide is toxic to fish. Do not apply directly to water, or to areas where
surface water is present or to intertidal areas below the mean high water mark.
Do not contaminate water when cleaning equipment or disposing of equipment
washwaters. Do not apply where runoff is likely to occur. Do not apply when
weather conditions favor drift from treated areas.
Precautionary Statements
immediately following the User
Safety Recommendations
Restricted-Entry Interval for products with
directions for use within scope of the Worker
Protection Standard for Agricultural Pesticides
(WPS)
"Do not enter or allow worker entry into treated areas during the restricted entry
interval (REI) of 24 hours."
Directions for Use, Under
Agricultural Use Requirements
Box
Early Entry Personal Protective Equipment for
products with directions for use within the
scope of the WPS
"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 plants, soil, or water, is:
* coveralls,
* shoes plus socks and,
* chemical-resistant gloves made of any waterproof material."
Directions for Use, Under
Agricultural Use Requirements
box
General Application Restrictions
"Do not apply this product in a way that will contact workers or other persons,
either directly or through drift. Only protected handlers may be in the area
during application."
Place in the Direction for Use
directly above the Agricultural
Use Box
•p
en
35
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Other Application Restrictions
(Note: The maximum allowable application
rate and maximum allowable rate per year must
be listed as pounds or gallons of formulated
product per acre, not just as pounds active
ingredient per acre.)
The following risk mitigation measures must be made on the labels that contain
these use-patterns.
Remove all directions for use for rough lemon nursery stock, conifers, and
flowering plants
Aerial application is prohibited.
Apples and Pears:
Add:
"Maximum of three ferbam applications per year. Maximum single application
rateof3.51bai/A."
Citrus:
Delete:'
All directions for use on rough lemon nursery stock
Add:
"Maximum of three ferbam applications per year. Maximum single application
rateof6Ibai/A."
Cherries:
Add:
"Maximum of three applications per year. Maximum single application rate of
3.5 Ib ai/A."
•p
o
36
-------
Nectarines and Peaches:
Add:
"Maximum of three ferbam applications per year
Maximum single application rate of 3.4 Ib ai/A"
Cranberries:
Add:
"For groundboom: maximum single application rate of 4.56 Ib ai/A
Maximum of 5 groundboom applications per year.
For spot treatment: apply 6.84 Ib ai/100 gallons of water and apply 0.76 gallon of
this mixture to a 1 sq. foot area = 2264 Ib ai/A
Maximum of 1 spot treatment application per year"
Mangos:
Add:
"Maximum single application rate of 3.0 Ib ai/A
Maximum of 16 applications per year."
Grapes:
Add:
"Maximum single application rate of 2.0 Ib ai/A
Maximum of 3 applications per year."
37
-------
Spray Drift Language for Products Applied
Outdoors
"SPRAY DRIFT MANAGEMENT'
This chemical can contaminate surface water through spray drift. A variety of
factors including weather conditions (e.g., wind direction, wind speed,
temperature, relative humidity) and method of application (e.g., ground and
airblast) can influence pesticide drift. The applicator must evaluate all factors and
make appropriate adjustments when applying this product
Do not allow this material to drift onto neighboring crops or non-crop areas or
use in a manner or at a time other than in accordance with label directions
because animal, plant or crop injury, illegal residues or other undesirable results
may occur
Wind Speed
" Do not apply at wind speeds greater than 15 mph."
Temperature Inversions
"Do not make applications into areas of temperature inversion or stable
atmospheric conditions"
For ground boom applications
• nozzle height no more than 10 feet above the ground or crop canopy
wind speed is 10 mph or less at the application site and,
medium or coarser spray according to ASAE 572 definition for
standard nozzles
•p
00
38
-------
p. 39
VI. Appendices
39
-------
p. 40
Appendix A. Food/Feed Use Patterns for Ferbam
Site
Application Type
Application
Equipment
Apples
Airblast
Pears
Airblast
Maximum Single
Application Rate (Ib
ai/A)
3.5
3.5
Maximum Number
of Applications
3
3
Minimum
Retreatment Interval
7
7
Use Limitations
The best use is in the
cover sprays. Do not
apply late season
where unsightly
residues may affect
the fresh fruit finish
of light-skinned
apple varieties. Do
not apply within 7
days of harvest.
For Scab: Make
applications at pink,
calyx, first and
second cover sprays,
and 1 Ib. in summer
sprays. Do not apply
late season where
unsightly residues
may affect the fresh
fruit finish of light-
skinned pear
varieties.
For Leaf Blight:
Make applications in
summer cover
sprays. Do not apply
late season where
unsightly residues
may affect the fresh
fruit finish of light-
skinned pear
varieties. Do not
apply within 7 days
ofharvest.
40
-------
p. 41
Cherries
Mangos
Grapes
Ground
Citrus
Broadcast foliar
application
Groundboom
3.5
3.0
2.0
6.0
3
16
3
3
7
7
7
14
Apply from petal fall
through cover sprays.
May also use 1 Ib of
Ferbam Granuflo
plus 3 Ibs of wettable
sulfur in petal fall
and cover sprays. To
aid in the control of
Leaf Spot, apply 1.5
Ibs per 100 gallons of
water immediately
prior to harvest but
prior to leaf drop.
Applications may be
made up to the day of
harvest.
Refer to Special
Local Need label
Do not apply in late
season sprays where
unsightly residues
may affect the fresh
fruit finish of light-
skinned grape
varieties. Taminco
recommends the use
of Ziram Granuflo
(East of the Rockies)
for late-season fresh
fruit sprays. Do not
make more than 3
applications per
season. Do not apply
within 7 days of
harvest.
For Anthracnose,
Scab, Postbloom
Fruit Drop: Apply
during pre-bloom
periods and 2/3 petal
fall. May be applied
in late summer and
early fall if a heavy
flush of growth
appears. May be
applied up to the day
of harvest.
41
-------
p. 42
Peaches and
Nectarines
Broadcast foliar
application
Tobacco
Groundboom
Cranberries
Groundboom
Spot Treatment
3.4
4.4
4.6
3
5
5
120
7
For Scab: Apply at 7
to 10 day intervals
and after heavy rains
during growing
periods
Apply during the
dormant period in the
fall after leaves drop
or in the Spring
before buds begin too
swell. If Leaf Curl
has been severe,
make 2 applications,
1 in the Fall and 1 in
the Spring during the
dormant period. Do
not apply within 21
days of harvest.
Apply at a rate of 3
gallons per 100
square yards when
plants are small,
increasing to 6
gallons when plants
are ready for
transplanting. Begin
applications when
plants are the size of
a dime or when Blue
Mold is reported in
the area, and repeat
twice weekly until
plants are
transplanted.
For Fruit Rots:
Begin applications
early in blossoming
period and repeat at 2
week intervals for a
total of 5
applications. Do not
apply within 28 days
after mid-bloom.
42
-------
p. 43
Apply 6.84 lbai/1 00
gallons of water and
apply 0.76 gallon of
this mixture to a 1 sq.
foot area = 2264 Ib
ai/A
1
7
For Fairy Ring:
Treat an area 3 feet
beyond the
advancing line of
dead vines and 2 feet
within this line.
Apply in the Fall
immediately after
harvest. Restriction:
Do not use water
from treated
cranberry bogs for
irrigating other crops.
For Spot Treatment
of Fairy Ring
43
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p. 44
Appendix B. Data Supporting Guideline Requirements for the Reregistration of Ferbam
New Guideline
Number
850.2100
850.2200
850.2300
850.1075
850.1010
None
850.1025
850.1035
850.1300
850.1350
850.1500
850.1500
850.4400
850.3020
870.1100
870.1200
870.1300
Old Guideline
Number
Description
Use Pattern
ECOLOGICAL EFFECTS
71-1
71-2
71-4
72-1
72-2
72-3a
72-3b
72-3c
72-4a
72-4b
72-5
72-2
123-2
141-1
Avian Oral LD50
Avian Dietary LCSO
Avian Reproduction
Freshwater Fish LC50
Freshwater
Invertebrate Acute
LC50
Estuarine/Marine
Fish LC50
Estuarine/Marine
Mollusk LC50
Estuarine/Marine
Shrimp LC50
Freshwater Fish
Early Life-Stage
Aquatic Invertebrate
Life-Cycle
Freshwater Fish Full
Life-Cycle
Aquatic Algal
Growth
Aquatic Plant
Growth
Honey Bee Acute
Contact LD50
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
Citation
00099594 (thiram)
00010616,00010618
(thiram)
45441201(thiram)
000708 10 (thiram)
00164662 (thiram)
42514401 (thiram)
42488301 (thiram)
42488302 (thiram)
DATA GAP
DATA GAP
DATA GAP
45441202 (thiram)
45441202 (thiram)
00003635 (thiram)
TOXICOLOGY
81-1
81-2
81-3
Acute Oral, Rat
Acute Dermal,
Rabbit
Acute Inhalation, Rat
AB
AB
AB
40561501 (ferbam)
40561 502 (ferbam)
41508101 (ferbam)
44
-------
p. 45
870.2400
870.2500
870.2600
870.3100
8703700
870.3700
870.3800
870.4100a
870.4100a
870.4 lOOb
870.4200
870.7485
81-4
81-5
81-6
82-la
83-3a
83-3a
83-4
83-la
83-la
83-lb
83-2a
85-1
Acute Eye Irritation,
Rabbit
Acute Dermal
Irritation, Rabbit
Skin Sensitization,
Guinea Pig
90-Day Oral Toxicity
CD Rats
Prenatal
Developmental in
Rats
Prenatal
Developmental in
Mice
Reproduction and
Fertility Effects
(Rats)
Chronic Toxicity 2
Year (Ex-Wistar
Rats)
Chronic Toxicity 80
Weeks (CD Rats)
Chronic Toxicity 1
Year, Dogs
Chronic Toxicity, 2
Years (Ex-Wistar
Rats)
Metabolism and
Pharmacokinetics
(Rats)
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
40561503 (ferbam)
40561505 (ferbam)
4056 1504 (ferbam)
00143817 (ferbam)
00143816 (ferbam)
00143816 (ferbam)
00143816, 00085454
(ferbam)
00083231 (ferbam)
00143817 (ferbam)
00083231 (ferbam)
00083231,00143817
(ferbam)
Literature Studies1
(ferbam)
ENVIRONMENTAL FATE
835.2120
835.2240
161-1
161-2
Hydrolysis
Photodegradation in
Water
AB
AB
44071801 (ferbam)
43999801 (ferbam)
40444704 (thiram)
'The data requirement has been satisfied by open literature sources and there is no
additional data required at this time.
45
-------
p. 46
835.2410
835.4100
835.4200
835.4400
835.4300
835.1240
835.1230
835.6100
840.1100
161-3
162-1
162-2
162-3
162-4
163-1
164-1
201-1
Photodegradation in
Soil
Aerobic Soil
Metabolism
Anaerobic Soil
Metabolism
Anaerobic Aquatic
Metabolism
Aerobic Aquatic
Metabolism
Leaching
Adsorption/Desorpti
on
Terrestrial Field
Dissipation
Droplet Size
Spectrum
AB
AB
AB
AB
AB
AB
AB
AB
43999802 (ferbam)
44368901 (ferbam)
43734901 (thiram)
44565303 (ferbam)
43628501, 45243401
(thiram)
45243401 (thiram)
43787501 (thiram)
supplemental
44724502 (thiram)
41336801 (thiram)
OCCUPATIONAL EXPOSURE
875.2100
132-1A
Foliar Residue
Dissipation
AB
43282101,43282102
(ziram)
RESIDUE CHEMISTRY
860.1200
860.1300
860.1300
860.1340
860.1380
171-3
171-4A
171-4B
171-4C
171-4E
Directions for Use
Nature of the
Residue-Plants
Nature of the
Residue-Livestock
Residue Analytical
Methods-Plant and
Animal commodities
Storage Stability
Data-Plant
Processed
commodities and
animal commodities
AB
AB
AB
AB
AB
refer to appendix A
4350001, 43562201
44992501 (ferbam
and ziram)
43803301,
42839201,
42677501 (ferbam,
thiram and ziram)
41229801,41223901
(ferbam)
43949701,
44565304,
42677501 (ferbam)
46
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p. 47
860.1500
860.1520
860.1900
885.2400
171-4K
171-4L
165-2
153A-9
Crop Field Trials
(citrus food groups,
pome fruit groups,
and stone fruits
groups)
Magnitude of
Residue in Processed
Food/Feed
Field Accumulation
in Rotational Crops
Study
Storage Stability
AB
AB
AB
AB
DATA GAP,
44565301,
44565302,
44565303,
44565304,45146101
(ferbam)
44565304 (ferbam)
DATA GAP
DATA GAP
47
-------
p. 48
Appendix C. Technical Support Documents
Additional documentation in support of this RED is maintained in the OPP docket, located in Room 119, Crystal
Mall #2,1801 South Bell Street, Arlington, VA. It is open Monday through Friday, excluding legal holidays, from 8:30 am
to 4 pm.
The docket initially contained preliminary risk assessments and related documents as of August 10,1998. Sixty
days later the first public comment period closed. The EPA then considered comments, revised the risk assessment, and
added the formal "Response to Comments" document and the revised risk assessment to the docket on June 16,1999.
All documents, in hard copy form, may be viewed in the OPP docket room or downloaded or viewed via the
Internet at the following site:
www.epa.gov/pesticides/reregistration
These documents include:
HED Documents:
I. Revised Ferbam HED Risk Assessment for the Reregistration Eligibility Decision (RED)
Document. April 19,2005.
II. Ferbam: Addendum to the Risk Assessment and Recommendations for the Reregistration
Eligibility Decision (RED) for Ferbam. October 11,2005.
III. Revised Ferbam Acute and Chronic Dietary Exposure Assessments for the Reregistration
Eligibility Decision. March 3,2005
IV. Thiram: Nature of the Residue in Animals - Goat Metabolism Study. October 5,2004
V. Ferbam: Magnitude of the Residue- Citrus Field Trials and Orange Processing Study. October
5,2004.
VI. Occupational Exposure Assessment and Recommendations for the Reregistration Eligibility
Decision (RED) for Ferbam. December 30,2004
VII. Revised Ferbam Residue Chemistry Considerations for Reregistration Eligibility Decision.
March 3,2005.
VIII. Ferbam Report of the Health Effects Division (HED) Risk Assessment Review Committee
(RARC). August 5,2004.
EFED Documents:
I. EFED Error Correction for the RED Chapter of Ferbam. February 23,2005.
II. Tier II Estimated Drinking Water Concentrations of Ferbam August 19,2004.
Appendix D. Citations Considered to be Part of the Data Base Supporting the Interim
Reregistration Decision (Bibliography)
48
-------
p. 49
GUIDE TO APPENDIX
1. CONTENTS OF BIBLIOGRAPHY. This bibliography contains citations of all studies
considered relevant by EPA in arriving at the positions and conclusions stated elsewhere in the
^registration Eligibility Document. Primary sources for studies in this bibliography have
been the body of data submitted to EPA and its predecessor agencies in support of past
regulatory decisions. Selections from other sources including the published literature in those
instances where they have been considered, are included.
2' U1iJr? 9F ENT*Y- , The ^ of entrv m this bibliography is called a "study". In the case of
published materials, this corresponds closely to an article. In the case of unpublished materials
submitted to the Agency, the Agency has sought to identify documents at a level parallel to the
published article from within the typically larger volumes in which they were submitted The
resulting "studies" generally have a distinct title (or at least a single subject), can stand alone for
purposes of review and can be described with a conventional bibliographic citation The
Agency has also attempted to unite basic documents and commentaries upon them treatine
them as a single study. ' &
1 IDENTIFICATIpN OF ENTRIES. The entries in this bibliography are sorted numerically by
Master Record Identifier, or "MRID" number. This number is unique to the citation and
should be used whenever a specific reference is required. It is not related to the six-digit
Accession Number" which has been used to identify volumes of submitted studies (see
paragraph 4(d)(4) below for further explanation). In a few cases, entries added to the
bibliography late in the review may be preceded by a nine character temporary identifier
These entries are listed after all MRID entries. This temporary identifying number is also to be
used whenever specific reference is needed.
4. FORM OF ENTRY. In addition to the Master Record Identifier (MRID), each entry consists
of a citation containing standard elements followed, in the case of material submitted to EPA
by a description of the earliest known submission. Bibliographic conventions used reflect the
standard of the American National Standards Institute (ANSI), expanded to provide for certain
special needs.
a Author. Whenever the author could confidently be identified, the Agency has chosen
to show a personal author. When no individual was identified, the Agency has shown
an identifiable laboratory or testing facility as the author. When no author or
laboratory could be identified, the Agency has shown the first submitter as the author.
b. Document date. The date of the study is taken directly from the document When the
date is followed by a question mark, the bibliographer has deduced the date from the
evidence contained in the document. When the date appears as (1999), the Agency was
unable to determine or estimate the date of the document.
c. Title. In some cases, it has been necessary for the Agency bibliographers to create or
enhance a document title. Any such editorial insertions are contained between square
brackets.
49
-------
p. 50
d. Trailing parentheses. For studies submitted to the Agency in the past, the trailing
parentheses include (in addition to any self-explanatory text) the following elements
describing the earliest known submission:
(1) Submission date. The date of the earliest known submission appears
immediately following the word "received."
(2) Administrative number. The next element immediately following the word
"under" is the registration number, experimental use permit number, petition
number, or other administrative number associated with the earliest known
submission.
(3) Submitter. The third element is the submitter. When authorship is defaulted to
the submitter, this element is omitted.
(4) Volume Identification (Accession Numbers). The final element in the trailing
parentheses identifies the EPA accession number of the volume in which the
original submission of the study appears. The six-digit accession number
follows the symbol "CDL," which stands for "Company Data Library." This
accession number is in turn followed by an alphabetic suffix which shows the
relative position of the study within the volume.
50
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California Turf and Bare Ground Plots Treated with Spotrete 75WDG- Lab
Project Number: 95049: F96318-810: 95049-CA1. Unpublished study
prepared by Compliance Services International. 818 p.
44724502
Dykeman, R. (1998) Determination of the Dissipation of Residues of Thiram in
North Carolina Turf and Bare Ground Plots Treated with Spotrete 75WDG:
Lab Project Number: 95051: 95051-NCI: F96194-054. Unpublished study
prepared by Compliance Services International. 1322 p.
45651201
Shepler, K.; Runes, H. (2002) Photodegradation of (Carbon 14) Thiram in
Sterilized Buffer at pH 5 by Artificial Light: Lab Project Number: 1042W.
Unpublished study prepared by PTRL West, Inc. 117 p.
ZIRAM
41229801
Orius Associates Inc. (1989) Ziram: Magnitude of the Residue in or on
Nectarines Treated by Ground and Aerial Equipment in Georgia and California,
1988: Proj. No. 30488. Unpublished study prepared in cooperation with Morse
Laboratories. 265 p.
41947301
Meikle, S. (1991) Exposure of Mixer/Loaders and Applicators to Ziram 76
WDG Fungicide Applied by Ground Equipment in California 1989: Lab
Project Number: 29588: 27-ZIR/91050. Unpublished study prepared by Orius
Associates Inc., in cooperation with Morse Labs and Research for Hire. 229 p.
42839201
Bodden, R. (1993) Nature of the Residue in Lactating Goats: Ziram: Final
Report: Lab Project Number: HLA 6225-101. Unpublished study prepared by
Hazleton Labs America, Inc. 103 p.
43283101
Meikle, S. (1993) Dislodgeable Foliar Residues of Ziram Granuflo Fungicide
Applied to Apples in New York, 1990: Lab Project Number: 30488:
ML90-0178-ZTF: 46-ZIR/91089. Unpublished study prepared by Orius
Associates, Inc.; Morse Labs; and ACDS, Inc. 169 p.
43282102
Meikle, S. (1993) Dislodgeable Foliar Residues of Ziram Granuflo Fungicide
Applied to Apples in California, 1990: Lab Project Number: 30488:
ML90-0178-ZTF: 46-ZIR/91026. Unpublished study prepared by Orius
Associates, Inc.; Morse Labs; and Research for Hire. 182 p.
43282503
Meikle, S. (1993) Ziram: Magnitude of the Residue in or on Peaches Treated
by Ground and Aerial Equipment in Georgia, 1990: Addendum: Lab Project
Number: 30488: ML90/0176/ZTF: 27/ZIR/ 92005. Unpublished study
prepared by Orius Associates Inc., Morse Lab., Georgia Agri-Scientific. 176 p.
62
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43500001
Wyss-Benz, M. (1994) (Carbon 14)-Ziram Plant Metabolism Study in Field
Grown Apple: Lab Project Number: 350673. Unpublished study prepared by
RCC UMWELTCHEMIE AG. 129 p.
43985801
Kim-Kang, H. (1996) Aerobic Soil Metabolism of (carbon 14)- Ziram: Lab
Project Number: XBL 94072: RPT00225. Unpublished study prepared by
XenoBiotic Labs, Inc. 180 p.
44097701
Kim-Kang, H. (1996) Aqueous Photolysis of (carbon 14)-Ziram: Lab Project
Number: XBL94073: RPT00223: IDC 433102. Unpublished study prepared by
XenoBiotic Labs, Inc. 245 p.
44228401
Reynolds, J. (1997) Photolysis of (carbon 14) Ziram on Soil: (Final Report):
Lab Project Number: 96001: RPT00296: XBL 96001. Unpublished study
prepared by XenoBiotic Laboratories, Inc. 179 p.
43985801
Kim-Kang, H. (1996) Aerobic Soil Metabolism of (carbon 14)- Ziram: Lab
Project Number: XBL 94072: RPT00225. Unpublished study prepared by
XenoBiotic Labs, Inc. 180 p.
44228402
Reynolds, J.; Smalley, J. (1997) Anaerobic Soil Metabolism of (carbon 14)
Ziram: (Final Report): Lab Project Number: XBL96002: RPT00297: XBL
96002. Unpublished study prepared by XenoBiotic Laboratories, Inc. 111 p.
43873501
Spare, W. (1995) Adsorption/Desorption of (carbon 14)-Ziram: Lab Project
Number: 2526: IDC 433102: 94072. Unpublished study prepared by
Agrisearch Inc. 162 p.
44548301
Novak, R.; Binari, L. (1998) Terrestrial Field Dissipation of Ziram 76 DF
Fungicide in North Carolina: Final Report: Lab Project Number: F96-7204:
GR96255: 96-0030. Unpublished study prepared by Grayson Research, Ltd.,
EN-CAS Analytical Laboratories, and NPC, Inc. 428 p.
44548302
Novak, R.; Binari, L. (1998) Terrestrial Field Dissipation of Ziram 76 DF
Fungicide in California: Final Report: Lab Project Number: F96-7203:
R319601: ML96-0606-ZTF. Unpublished study prepared by Research for
Hire, Morse Laboratories, Inc., and NPC, Inc. 401 p.
45002501
Castro, L. (1999) Dissipation of Dislodgeable Residues of Ziram 76DF from
Apple Leaves: Lab Project Number: KP-98-09. Unpublished study prepared by
Elf Atochem North America, Inc. 168 p. {OPPTS 875.2100}
45112501
Castro, L. (2000) Dissipation of Dislodgeable Residues of Ziram 76DF from
Grape Leaves: Lab Project Number: KP-98-10: 10A-98: 10B-98. Unpublished
63
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p. 64
study prepared by Elf Atochem North America, Inc. 157 p. {OPPTS
875.2100}
64
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Appendix E. Generic Data Call-In
See attached table for a list of generic data requirements. Note that a complete Data Call-In
(DCI), with all pertinent instructions, is being sent to registrants under separate cover.
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p. 66
Appendix F. Product Specific Data Call-In
See attached table for a list of product-specific data requirements. Note that a complete Data
Call-In (DCI), with all pertinent instructions, is being sent to registrants under a separate cover.
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p. 67
Appendix G. EPA's Batching of Ferbam Products for Meeting Acute Toxicity Data
Requirements for Reregistration
In an effort to reduce the time, resources and number of animals needed to fulfill the acute
toxicity data requirements for reregistration of products containing ferbam as the active ingredient, the
Agency has batched products which can be considered similar for purposes of acute toxicity. Factors
considered in the sorting process include each product's active and inert ingredients (identity, percent
composition and biological activity), type of formulation (e.g., emulsifiable concentrate, aerosol,
wettable powder, granular, etc.), and labeling (e.g., signal word, use classification, precautionary
labeling, etc.). Note that the Agency is not describing batched products as "substantially similar" since
some products within a batch may not be considered chemically similar or have identical use patterns.
Using available information, batching has been accomplished by the process described in the
preceding paragraph. Not with-standing the batching process, the Agency reserves the right to require,
at any time, acute toxicity data for an individual product should the need arise.
Registrants of products within a batch may choose to cooperatively generate, submit or cite a
single battery of six acute toxicological studies to represent all the products within that batch. It is the
registrants' option to participate in the process with all other registrants, only some of the other
registrants, or only their own products within a batch, or to generate all the required acute toxicological
studies for each of their own products. If a registrant chooses to generate the data for a batch, he/she
must use one of the products within the batch as the test material. If a registrant chooses to rely upon
previously submitted acute toxicity data, he/she may do so provided that the data base is complete and
valid by today's standards (see acceptance criteria attached), the formulation tested is considered by
EPA to be similar for acute toxicity, and the formulation has not been significantly altered since
submission and acceptance of the acute toxicity data. Regardless of whether new data is generated or
existing data is referenced, registrants must clearly identify the test material by EPA Registration
Number. If more than one confidential statement of formula (CSF) exists for a product, the registrant
must indicate the formulation actually tested by identifying the corresponding CSF.
In deciding how to meet the product specific data requirements, registrants must follow the
directions given in the Data Call-In Notice and its attachments appended to the RED. The DCI Notice
contains two response forms which are to be completed and submitted to the Agency within 90 days of
receipt. The first form, "Data Call-In Response," asks whether the registrant will meet the data
requirements for each product. The second form, "Requirements Status and Registrant's Response,"
lists the product specific data required for each product, including the standard six acute toxicity tests.
A registrant who wishes to participate in a batch must decide whether he/she will provide the data or
depend on someone else to do so. If a registrant supplies the data to support a batch of products, he/she
must select one of the following options: Developing Data (Option 1), Submitting an Existing Study
(Option 4), Upgrading an Existing Study (Option 5) or Citing an Existing Study (Option 6). If a
registrant depends on another's data, he/she must choose among: Cost Sharing (Option 2), Offers to
Cost Share (Option 3) or Citing an Existing Study (Option 6). If a registrant does not want to
participate in a batch, the choices are Options 1, 4, 5 or 6. However, a registrant should know that
choosing not to participate in a batch does not preclude other registrants in the batch from citing his/her
studies and offering to cost share (Option 3) those studies.
Four products were found which contain ferbam as the active ingredient. These products have not been
placed into a batch group based on the active and inert ingredients and type of formulation.
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p. 68
Batching Instructions:
No Batch: Each product in this batch should generate their own data.
NOTE: The technical acute toxicity values included in this document are for informational purposes
only. The data supporting these values may or may not meet the current acceptance criteria.
No Batch
EPA Reg. No.
5481-256
5481-268
8660-68
45728-7
Percent Active Ingredient
11.3
76.0
76.0
76.0
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Appendix H. List of Registrants Sent This Data Call-In
Taminco
1950 Lake Park Drive
Smyrna, GA 30080
VJP Consulting, Inc
21320 Sweet Clover Place
Ashburn,VA21047
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Appendix I. List of Available Related Documents and Electronically Available Forms
Pesticide Registration Forms are available at the following EPA internet site:
http ://www. epa. gov/opprdOO 1 /forms/
Pesticide Registration Forms (These forms are in PDF format and require the Acrobat reader)
Instructions
1.
2.
3.
Print out and complete the forms. (Note: Form numbers that are bolded can be filled
out on your computer then printed.)
The completed form(s) should be submitted in hardcopy in accord with the existing
policy. 6
Mail the forms, along with any additional documents necessary to comply with EPA
regulations covering your request, to the address below for the Document Processing
Desk. &
DO NOT fax or e-mail any form containing 'Confidential Business Information' or 'Sensitive
Information.'
If you have any problems accessing these forms, please contact Nicole Williams at (703) 308-5551
by e-mail at williams.mcole@epa.gov.
The following Agency Pesticide Registration Forms are currently available via the internet:
at the following locations:
or
8570-1
8570-4
8570-5
8570-17
8570-25
8570-27
Application for Pesticide
Registration/Amendment
Confidential Statement of Formula
Notice of Supplemental Registration of
Distribution of a Registered Pesticide
Product.
Application for an Experimental Use
Permit
Application for/Notification of State
Registration of a Pesticide To Meet a
Special Local Need
Formulator's Exemption Statement
http://www.eoa.gov/orJDrdOO l/forms/8570- 1 pdf
htto://www.eDa.gov/opprd001/forms/8570-4.pdf
http://www.epa.gov/opprd001/forms/8570-5.pdf
htto://www.eoa.gov/opprdOO l/forms/8570- 1 7 pdf
http://www.epa.gov/opprdOO l/forms/8570-25 pdf
http://www.epa.gov/opprd001/forms/8570-27.pdf
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8570-28
8570-30
8570-32
8570-34
8570-35
8570-36
8570-37
Certification of Compliance with Data
Gap Procedures
Pesticide Registration Maintenance Fee
Filing^
Certification of Attempt to Enter into an
Agreement with other Registrants for
Development of Data
Certification with Respect to Citations of
Data (PR Notice 98-5)
Data Matrix (PR Notice 98-5)
Summary of the Physical/Chemical
Properties (PR Notice 98-1)
Self-Certification Statement for the
Physical/Chemical Properties (PR Notice
httD://www.era.20v/opprd001/forms/8570-28.pdf
httD://www.eDa.eov/opprd001/forms/8570-30.pdf
http://www.epa.eov/ODDrd001/forms/8570-32.Ddf
http://www.eDa.sov/opppmsdl/PR Notices/pr98-5.
pdf
httD://www.eDa.20v/opDpmsdl /PR Notices/pr98-5
pdf
http://www.epa.eov/opppmsdl/PR Notices/pr98-l
pdf
httD://www.epa.eov/oDppmsdl/PR Notices/pr98-l
pdl
Pesticide Registration Kit
www.epa.eov/pesticides/registrationkit/
Dear Registrant:
For your convenience, we have assembled an online registration kit which contains the following
pertinent forms and information needed to register a pesticide product with the U.S. Environmental
Protection Agency's Office of Pesticide Programs (OPP):
1.
The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Federal Food
Drug and Cosmetic Act (FFDC A) as Amended by the Food Quality Protection Act
(FQPA)of 1996.
2. Pesticide Registration (PR) Notices
a.
b.
c.
d.
e.
f.
g-
h.
83-3 Label Improvement Program-Storage and Disposal Statements
84-1 Clarification of Label Improvement Program
86-5 Standard Format for Data Submitted under FIFRA
87-1 Label Improvement Program for Pesticides Applied through Irrigation
Systems (Chemigation) ^ 6
87-6 Inert Ingredients in Pesticide Products Policy Statement
90-1 Inert Ingredients in Pesticide Products; Revised Policy Statement
95-2 Notifications, Non-notifications, and Minor Formulation Amendments
98-1 Self Certification of Product Chemistry Data with Attachments (This
document is in PDF format and requires the Acrobat reader.)
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Other PR Notices can be found at http://www.epa.gov/opppmsdl/PR_Notices
3. Pesticide Product Registration Application Forms (These forms are in PDF format and
will require the Acrobat reader).
a. EPA Form No. 8570-1, Application for Pesticide Registration/Amendment
b. EPA Form No. 8570-4, Confidential Statement of Formula
c. EPA Form No. 8570-27, Formulator's Exemption Statement
d. EPA Form No. 8570-34, Certification with Respect to Citations of Data
e. EPA Form No. 8570-35, Data Matrix
4. General Pesticide Information (Some of these forms are in PDF format and will require
the Acrobat reader).
a. Registration Division Personnel Contact List
Biopesticides and Pollution Prevention Division (BPPD) Contacts
Antimicrobials Division Organizational Structure/Contact List
d- rortiPe 159^2'Pesticide Registration Procedures; Pesticide Data Requirements
(rJJr lormat)
e. 40 CFR Part 156, Labeling Requirements for Pesticides and Devices (PDF
lormat)
f 40 CFR Part 158, Data Requirements for Registration (PDF format)
g.. 50 F.R. 48833, Disclosure of Reviews of Pesticide Data (November 27,1985)
Before submitting your application for registration, you may wish to consult some additional
sources of information. These include:
1. The Office of Pesticide Programs' website.
2. The booklet "General Information on Applying for Registration of Pesticides in the United
States PB92-221811, available through the National Technical Information Service
(NTIS) at the following address:
National Technical Information Service (NTIS)
5285 Port Royal Road
Springfield, VA 22161
The telephone number for NTIS is (703) 605-6000.
3. The National Pesticide Information Retrieval System (NPIRS) of Purdue University's
Center for Environmental and Regulatory Information Systems. This service does charge
^?^ fe^?1*10,118 m(* custom searches. You can contact NPIRS by telephone at
(765) 494-6614 or through their website.
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4 The National Pesticide Telecommunications Network (NPTN) can provide information on
active ingredients, uses, toxicology, and chemistry of pesticides. You can contact NPTN
by telephone at (800) 858-7378 or through their website: ace.orst.edu/info/nptn.
The Agency will return a notice of receipt of an application for registration 9r amended
registration, experimental use permit, or amendment to a petition if the applicant or
petitioner encloses with his submission a stamped, self-addressed postcard. The postcard
must contain the following entries to be completed by OPP:
Date of receipt;
EPA identifying number; and
• Product Manager assignment.
Other identifying information may be included by the applicant to link the
acknowledgment of receipt to the specific application submitted. EPA will stamp the date
of receipt and provide the EPA identifying file symbol or petition number for the new
submission. The identifying number should be used whenever you contact the Agency
concerning an application for registration, experimental use permit, or tolerance petition.
To assist us in ensuring that all data you have submitted for the chemical are properly
coded and assigned to your company, please include a list of all synonyms, common and
trade names, company experimental codes, and other names which identify the chemical
(including "blind codes used when a sample was submitted for testing by commercial or
academic facilities). Please provide a chemical abstract system (CAS) number if one has
been assigned.
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