United States Prevention, Pesticides EPA 738-R-09-304
Environmental Protection and Toxic Substances May 2009
Agency (7508P)
Reregistration
Eligibility Decision
(RED) for Coppers
Revised May 2009
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REREGISTRATION ELIGIBILITY DECISION
FOR COPPERS
Case Nos. 0636, 0649,4025,4026
Revised May 2009
Approved by:
Date:
Richard P. Keigwin, Jr.
Director, Special Review and Reregistration Division
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TABLE OF CONTENTS
Glossary of Terms and Abbreviations v
Amendment to the Coppers Reregistration Eligibility Decision 1
EXECUTIVE SUMMARY 8
II. Chemical Overview 15
A. Regulatory History 15
B. Chemical Identification 15
C. Use Profile 18
D. Estimated Usage of Copper Pesticides 21
III. Summary of Coppers Risk Assessments 25
A. Human Health Risk Assessment 25
1. Background on Copper 26
2. Exposure Sources of Copper 26
3. Human Metabolism of Copper 27
4. Toxicity Summary for Copper 27
5. FQPA Safety Factor Considerations 31
6. Aggregate Risk from Coppers (Dietary and Residential) 32
7. Occupational Exposure 32
8. Incidence Data on Copper Exposure 33
B. Ecological Risk Assessment 33
1. Environmental Fate 34
2. Ecological Exposure and Risk 35
3. Ecological Incidents 59
A. Determination of Reregistration Eligibility 61
B. Public Comments and Responses 61
C. Regulatory Position 62
1. FQPA Findings 62
2. Endocrine Disrupter Effects 63
3. Cumulative Risks 63
4. Endangered Species 64
D. Tolerance Reassessment Summary 64
1. Tolerances Proposed to be Revoked 64
2. Tolerances Listed Under 40 CFR §180.1021 65
E. Regulatory Rationale 66
1. Human Health Risk Management 66
2. Ecological Risk Management for Non-target Organisms 68
3. Urban Uses 78
4. Advisory Language 80
5. 303(d) - Designated Impaired Water Bodies 81
V. What Registrants Need to Do 86
A. Manufacturing-Use Products 86
1. Generic Data Requirements 86
2. Labeling for Manufacturing-Use Products 86
B. End-Use Products 86
1. Additional Product-Specific Data Requirements 86
ii
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C. Labeling Changes Summary Table 88
APPENDIX A 100
APPENDIX B 106
APPENDIX C 112
APPENDIX D 113
APPENDIX E 122
APPENDIX F 123
APPENDIX G 148
in
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Coppers Reregistration Eligibility Decision Team
Office of Pesticide Programs
Antimicrobials Division
Diane Isbell
Kathryn Jakob
Biological and Economic Analysis Division
Andrew Lee
Jenna Carter
Richard Michell
William Phillips, II, Ph.D.
Environmental Fate and Effects Division
James Hetrick, Ph.D.
Paige Doelling Brown, Ph.D.
Health Effects Division
Alan Nielsen
Christina Jarvis
Elissa Reaves
Registration Division
Tony Kish
Risk Management
Rosanna Louie
Kevin Costello
Neil Anderson
Office of General Counsel
Andrew Simons
IV
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Glossary of Terms and Abbreviations
ai Active Ingredient
aPAD Acute Population Adjusted Dose
APHIS Animal and Plant Health Inspection Service
ARTF Agricultural Re-entry Task Force
BCF Bioconcentration Factor
CDC Centers for Disease Control
CDPR California Department of Pesticide Regulation
CFR Code of Federal Regulations
ChEI Cholinesterase Inhibition
CMBS Carbamate Market Basket Survey
cPAD Chronic Population Adjusted Dose
CSFII USDA Continuing Surveys for Food Intake by Individuals
CWS Community Water System
DCI Data Call-in
DEEM Dietary Exposure Evaluation Model
DL Double layer clothing {i.e., coveralls over SL}
EC Emulsifiable Concentrate Formulation
EDSP Endocrine Disrupter Screening Program
EDSTAC Endocrine Disrupter Screening and Testing Advisory Committee
EEC Estimated Environmental Concentration. The estimated pesticide concentration in an environment,
such as a terrestrial ecosystem.
EP End-Use Product
EPA U.S. Environmental Protection Agency
EXAMS Tier II Surface Water Computer Model
FDA Food and Drug Administration
FFDCA Federal Food, Drug, and Cosmetic Act
FIFRA Federal Insecticide, Fungicide, and Rodenticide Act
FOB Functional Observation Battery
FQPA Food Quality Protection Act
FR Federal Register
GL With gloves
IDFS Incident Data System
IPM Integrated Pest Management
RED Reregistration Eligibility Decision
LADD Lifetime Average Daily Dose
LC50 Median Lethal Concentration. Statistically derived concentration of a substance expected to cause
death in 50% of test animals, 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. Statistically derived single dose causing death in 50% of the test animals
when administered by the route indicated (oral, dermal, inhalation), expressed as a weight of
substance per unit weight of animal, e.g., mg/kg.
LOAEC Lowest Observed Adverse Effect Concentration
LOAEL Lowest Observed Adverse Effect Level
LOG Level of Concern
LOEC Lowest Observed Effect Concentration
mg/kg/day Milligram Per Kilogram Per Day
MOE Margin of Exposure
MP Manufacturing-Use Product
MRID Master Record Identification (number). EPA's system of recording and tracking studies submitted.
MRL Maximum Residue Level
N/A Not Applicable
NASS National Agricultural Statistical Service
NAWQA USGS National Water Quality Assessment
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NG No Gloves
NMFS National Marine Fisheries Service
NOAEC No Observed Adverse Effect Concentration
NOAEL No Observed Adverse Effect Level
NPIC National Pesticide Information Center
NR No respirator
OPP EPA Office of Pesticide Programs
ORETF Outdoor Residential Exposure Task Force
PAD Population Adjusted Dose
PCA Percent Crop Area
PDCI Product Specific Data Call-In
POP USDA Pesticide Data Program
PF10 Protections factor 10 respirator
PF5 Protection factor 5 respirator
PHED Pesticide Handler's Exposure Data
PHI Preharvest Interval
ppb Parts Per Billion
PPE Personal Protective Equipment
PRZM Pesticide Root Zone Model
RBC Red Blood Cell
RED Reregistration Eligibility Decision
REI Restricted Entry Interval
RfD Reference Dose
RPA Reasonable and Prudent Alternatives
RQ Risk Quotient
RTU (Ready-to-use)
RUP Restricted Use Pesticide
SCI-GROW Tier I Ground Water Computer Model
SF Safety Factor
SL Single layer clothing
SLN Special Local Need (Registrations Under Section 24(c) of FIFRA)
TEP Typical End-Use Product
TGAI Technical Grade Active Ingredient
TTRS Transferable Turf Residues
UF Uncertainty Factor
USDA United States Department of Agriculture
USFWS United States Fish and Wildlife Service
USGS United States Geological Survey
WPS Worker Protection Standard
VI
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Amendment to the Coppers Reregistration Eligibility Decision
This document serves as an amendment to the Coppers Reregistration Eligibility
Decision (RED), completed in July 2006 and published in August 2006, which initiated a public
comment period. A total of 46 submissions were received, which included comments from
various growers that use copper products, university extension services, registrants, and publicly-
owned treatment works facilities. Comments received included information on application rates,
copper use in aquatic areas and water treatment facilities, and human health exposures. The
Agency has also revised the RED document to reflect the current status of the Office of Pesticide
Programs initiatives, namely, the Endangered Species Program. The list of copper compounds
technical registrants has also been updated to reflect the most recent companies which retain
copper-containing technical registrations.
In consideration of various comments, and other decisions that occurred after the RED
was published, the RED and the Label Table has been updated to reflect current labeling
requirements. Appendix A, which is a summary of the use sites and applications eligible for
reregi strati on, has also been updated based on comments received during the comment period.
The revised coppers RED and its appendices, in conjunction with this summary, present the
Agency's response to these comments. The following are a summary of the comments received
and the Agency's response:
REI Changes
Available acute toxicity studies indicate that products containing certain copper
compounds can cause severe eye, dermal, or inhalation irritation if exposed to the handler and/or
applicator of that product. As a result, the RED listed a number of copper compounds whose
restricted-entry intervals (REI) were increased from 12- or 24-hours to 48-hours. Comments
were received questioning the Agency's reasons for increasing these REIs, considering the low
concern for potential systemic toxicity from these uses. The Agency considered requests to
review updated information and studies of certain copper compounds that impacted REIs for
products containing cuprous oxide, and addressed an eye exposure mitigation proposal for
products that are labeled for use in greenhouses. The following are the Agency's response to
comments and decisions regarding the REIs for products containing certain copper compounds.
Copper-Containing Products Registered for Greenhouse Use
The majority of copper-containing products registered for agricultural applications are
applied outdoors to large acreages, with some products registered for use in greenhouses. Since
certain copper compounds can cause severe acute irritation, namely eye irritation, the Worker
Protection Standard (WPS, 40 CFR Part 156) requires a 48-hour REI to reduce the potential for
these adverse exposures, as there are few means to effectively mitigate eye exposures in the
middle of large fields. In 2001, Phyton Corporation requested that the Agency consider reducing
the REI from 48 to 24 hours for copper products used in greenhouse. To address the potential
for eye exposures, the registrant proposed following criteria and conditions in order to mitigate
eye irritation concerns.
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For at least seven days following the application of copper-containing products in
greenhouses:
- at least one container or station designed specifically for flushing eyes is available in
operating condition with the WPS-required decontamination supplies for workers
entering the area treated with copper-containing products,
- workers are informed orally, in a manner they can understand:
- that residues in the treated area may be highly irritating to their eyes,
- that they should take precautions, such as refraining from rubbing their eyes, to
keep the residues out of their eyes,
- that if they do get residues in their eyes, they should immediately flush their
eyes with the eye flush container for eye flush station that is located with the
decontamination supplies, and
- how to operate the eye flush container or eye flush station.
The Agency accepted this proposal because it believes that greenhouses will readily have
access to a limitless source of running water at a temperature that will not harm the eyes.
Provided that the only WPS trigger for a 48-hour REI is due to severe eye irritation (Toxicity
Category I or II), the above criteria and conditions are met and included on product labels, and
all labeling changes are completed, all copper-containing products that would otherwise have a
48-hour REI may be decreased to 24 hours for greenhouse uses only. For additional information
on this decision, please refer to the EPA memorandum titled Proposal by Phyton Corporation to
Reduce the Restricted-Entry Interval for Phyton-27 New Dimension (EPA Registration Number
49538) - an End-Use Product that Contains 3.98 Percent of Copper Sulfate Pentahydrate, dated
February 6, 2007.
Copper Hydroxide, Basic Copper Sulfate, Copper Sulfate Pentahydrate
Comments were received questioning the Agency's decision in the 2006 RED to increase
the REI to 48 hours for copper hydroxide, basic copper sulfate, and copper sulfate pentahydrate.
Commenters requested that the REIs be reduced back to 12 or 24 hours, considering that the
Agency has no systemic toxicity concerns for exposures to copper-containing products. The
length of the REIs is determined based on the Toxicity Category ratings for each active
ingredient or product, following the criteria outlined in the WPS. REIs for each pesticide
product are determined based on results of acute toxicity studies, rather than systemic toxicity.
In the case of copper hydroxide, basic copper sulfate, and copper sulfate pentahydrate,
available acute toxicity studies indicate the potential for products containing these coppers to
cause severe irritation to workers or handlers via skin, eye, or inhalation exposure routes. Based
on these data, with the exception of greenhouse uses described above, labels of agricultural
products that contain any of these copper compounds above must retain the 48-hour REI, as
originally determined in the RED. Stakeholders and the public are encouraged to submit any
new data or information for the Agency to consider in reducing potential exposures and
providing adequate eye and dermal protection from the acute irritation effects of copper.
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Cuprous Oxide
A review of more recently conducted acute toxicity studies conducted with cuprous oxide
indicate that the highest rating is Toxicity Category III and, therefore, the REI should be reduced
from 48 to 12 hours.
Sewer Root Killer Treatment
The Agency received comments from various public water districts in California during
the Phase 3 Public Comment Period, which was open February 2006 - April 2006 (71 FR 45550-
45551). The commenters stated their opposition to the reregi strati on of copper sulfate
pentahydrate use in homeowner sewer root killer treatment products. Publicly-owned treatment
works (POTW) facilities commented that the use of these products has contributed to elevated
copper levels in water entering their facilities. POTWs also noted that they are required under
existing National Pollutant Discharge Effluent System regulations to ensure that all pollutant
levels in effluent water do not exceed the Total Maximum Daily Loads (TMDL) prior to release
into receiving water bodies or systems. Commenters stated that the cost of reducing levels of
copper in effluent water to meet the TMDLs would be a financial burden to POTWs. They also
referenced studies conducted in a number of California counties that they believe demonstrated
the reduction of copper concentrations detected in monitored water bodies after prohibition of
the sale and use of copper sulfate pentahydrate sewer root killer treatment products.
Because limited available information on the use sewer root killer products at the time of
the coppers RED, the Agency solicited additional information to determine the importance of
these products, as well as the potential burden of the use of these products in other POTWs,
during the comment period. The only information received was from the Copper Sulfate Task
Force, stating that approximately 180,000 pounds of copper sulfate pentahydrate are sold
annually that is labeled for use as a sewer root killer treatment. The Agency did not receive any
information or additional public comments on the use of copper-containing sewer root killer
products which could indicate how much was used in any other region outside of California,
whether they were considered necessary products, or posed as a point-source burden for POTWs
elsewhere in the nation.
States and localities have the authority to impose more restrictive laws than that posed by
the EPA. As stated by the commenters, these specific products were banned in a number of
counties in California, as well as some counties in New York. Therefore, while the Agency does
not have sufficient information to affect a ban nationwide, current available options and
authorities afforded at the state level are appropriate to mitigate concerns from the use of
pesticides containing copper sulfate pentahydrate as a sewer root killer treatment for specific
localities.
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Ecological Assessment
Antimicrobial Uses of Copper-containing Pesticides
A number of water districts in California noted concern for potential impacts of copper in
water from swimming pools, spas, fountains, and urban runoff or sewer discharge. The Agency
intends to complete a separate ecological assessment to assess all antimicrobial applications of
copper-containing pesticides, including these identified by the water districts, as well as other
uses, such as anti-fouling treatments and wood preservatives.
Revised Application Rates and Exposure Estimates to Nontarget Organisms
Based on comments received on the coppers RED during the comment period in 2006,
the Agency has updated Appendix A to reflect the current use rates and practices for various
crops. For some crops, these changes include the allowance for increased single application rate,
or maximum annual application rate. Currently, the highest single application rate is for dormant
applications to fruit or nut trees, 8.0 pounds of metallic copper per acre (Ibs Cu2+/A). This rate is
still significantly lower than the highest assessed single application rate of 31.8 Ibs Cu2+/A for
applications to filberts in the ecological assessment. For the other additional crops that are
identified in Table 2 below, all single maximum application rates remain less than the highest
assessed single application rate of 3.2 Ibs Cu2+/A for row crops. Even in consideration of these
additional or higher application rates, the exposure and risk estimates described in the July 2006
ecological assessment, as well as the conclusions and required mitigation outlined in the 2006
RED, continue to reflect the Agency's current understanding of the potential exposure and
impact to nontarget organisms.
Generic Data Requirements
At the time of the RED, it was determined that additional data, specifically, certain
studies to address spray drift concerns (OPPTS 840.1100 Spray Droplet Size Spectrum and
835.4200 Spray Drift Field Deposition), were needed to support the continued reregi strati on of
copper pesticides. After considering available information on the potential for spray drift when
applying copper pesticides, the Agency believes that the two studies would not provide any new
information that would affect the conclusions made in the 2006 RED. Additionally, the Agency
is requiring additional spray drift language to reduce the potential for inadvertent movement of
copper-containing pesticides to non-target areas. Therefore, these two studies are no longer
required in support of the reregistration of the conventional uses of copper pesticides.
Application Rates Clarification
The Agency had received several comments on application rate recommendations for
specific crops. Several growers highlighted specific registered crops that were not listed in
Appendix A of the coppers RED, as well as certain environmental conditions that would warrant
higher use rates to manage the target pest. The Agency also recognizes the importance of copper
pesticides to growers as an important broad-spectrum fungicide, as well as the significance of
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copper products to organic growers as one of the few pesticides permitted in certified organic
production. At the time of the RED, based on the information received from the registrants and
other stakeholders, the crops listed in Appendix A were representative of the majority of crops
for which copper pesticides are registered for.
Since then, the Agency has had several discussions during and following the
development of the coppers RED with various stakeholders, including registrants, grower and
user groups, and the USD A, who provided additional crop information, copper application rates,
and other use information. This use information is representative of current use patterns for
copper pesticides in agricultural applications and do not impact the human health or ecological
conclusions made in the 2006 RED. Based on these discussions and concurrent regulatory
efforts that impact labeling statements, the Agency has revised the Label Table and the Appendix
A to incorporate these changes. All "not for use in California" restrictions have been removed,
as these statements are an artifact of prior labeling that no longer applies. Table 1 summarize the
changes in application rates, and Table 2 below lists additional crops not previously listed in the
2006 RED; information from both tables are reflected in the updated Appendix A.
Table 1 . Changes Made in the Coppers Appendix A Application Rates Information for Crops
Use Site
Algae
Control
Cranberry
Currant,
gooseberry
(ribes)
Mango
Olive
Papaya
Previous Information
maximum concentration of 0.4 parts
per million per application
maximum annual application rate of
6.3 Ibs Cu2+/A
maximum single application rate of
2.5 Ibs Cu2+/A
maximum annual application rate of
10.0 Ibs Cu2+/A
maximum single application rate of
2.6 Ibs Cu2+/A
maximum annual application rate of
18.2 Ibs Cu2+/A
minimum retreatment interval of 30
days
maximum single application rate of
3.151bsCu2+/A
maximum annual application rate of
6.3 Ibs Cu2+/A
minimum retreatment interval of 14
days
Revision Made
maximum concentration of 0.4 parts
per million per application only in
aquaculture ponds when fish are
present
increased maximum annual
application rate to 12.6 Ibs Cu2+/A
increased maximum single application
rate to 4.0 Ibs Cu2+/A
increased maximum annual
application rate to 16.0 Ibs Cu2+/A
increased maximum single application
rateto3.21bsCu2+/A
increased maximum annual
application rate to 48.0 Ibs Cu2+/A
decreased minimum retreatment
interval to 7 days
increased maximum single application
rate to 6.0 Ibs Cu2+/A
increased maximum annual
application rate to 18.0 Ibs Cu2+/A
decreased minimum retreatment
interval to 7 days
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Use Site
Pome Fruit
(apple,
loquat, pear,
quince)
Stone Fruit
Tomato
Turfgrass
Walnut
Previous Information
no application rate information
between silver-tip and green-tip
maximum single application rate of
0.5 Ibs Cu2+/A for bloom, growing
season
dormant, late dormant
no application rate information for
fresh market tomato
maximum annual application rate to
9.0 Ibs Cu2+/A
maximum single application rate of
3.151bsCu2+/A
maximum annual application rate of
25.2 Ibs Cu2+/A
Revision Made
- addition of a maximum single
application rate of 6.0 Ibs Cu2+/A
between silver-tip and green-tip
- maximum of one application per
season
increased maximum single application
rate to 1.5 Ibs Cu2+/A for bloom,
growing season
Clarification to include dormant
application up to the pink bud stage
- maximum single application rate of
1.61bsCu2+/A
- maximum annual application rate of
8.0 Ibs
- minimum retreatment interval of 3
days
increased maximum annual
application rate to 21.0 Ibs Cu2+/A
increased maximum single application
rate to 4.0 Ibs Cu2+/A
increased maximum annual
application rate of 32.0 Ibs Cu2+/A
Table 2. Additional Crops and Application Rates Information for the Coppers RED Appendix A
Use Site
Artichoke
Asparagus
Chard
Chestnut
Chicory
Chinese Cabbage
Citron
Citron Melon
Clover
Coriander
Dewberry
Kale (crucifer)
Kohlrabi (crucifer)
Leek
Mamey Sapote
Millet
Maximum Single
Application Rate
(Ibs Cu2+/A)
0.53
1.0
0.79
2.1
1.31
0.53
3.15
1.0
0.53
0.53
2.0
0.53
0.53
1.0
2.1
0.53
Maximum Annual
Application Rate
(Ibs Cu2+/A)
2.65
5.0
3.75
8.4
7.86
2.65
12.6
5.25
4.74
2.65
10.0
2.65
2.65
6.0
8.4
1.06
Retreatment
Interval
(in Days)
7
10
7
14
10
7
7
5
7
10
7
7
7
7
14
10
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Use Site
Mint
Nutmeg
Radish
Rosemary
Rhubarb
Rye
Rutabaga
Shallot
Sorghum
Sugarcane
Turnip
Waxgourd
Maximum Single
Application Rate
(Ibs Cu2+/A)
0.53
2.1
1.31
0.53
0.79
0.53
1.31
1.0
0.53
0.53
1.31
1.0
Maximum Annual
Application Rate
(Ibs Cu2+/A)
2.65
8.4
7.86
2.65
3.95
1.06
7.86
6.0
1.06
1.06
7.86
5.25
Retreatment
Interval
(in Days)
10
14
10
10
7
10
10
7
10
10
10
5
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EXECUTIVE SUMMARY
EPA has completed its review of public comments on the revised copper risk assessments
and is issuing its risk management decision for conventional (agricultural) uses of copper
pesticides. There are currently three tolerances being reassessed for coppers. The revised risk
assessments are based on review of the required target data base supporting the use patterns of
currently registered products and additional information received. After considering the risks
identified in the revised risk assessments, comments, and mitigation suggestions from interested
parties, EPA developed its risk management decision for uses of copper that pose risks of
concern. As a result, the Agency has determined that the agricultural uses of copper-containing
products are eligible for reregi strati on provided that data needs are addressed, risk mitigation
measures outlined in this document are adopted, and labels are amended accordingly. The
decision is discussed fully in this document.
Copper pesticides (copper or cupric ion) are extensively used in various agricultural
settings. Tens of millions of pounds are applied annually, predominantly in crop and algaecide
applications. Major crops and/or crops with high application rates include citrus, tree nuts,
tomato, pepper, grape, berries and peach. Included in the scope of the ecological risk
assessments are its use as a broad-spectrum fungicide on many food and ornamental crops, and
direct water applications as an algaecide, aquatic herbicide, bactericide and molluscicide.
Coppers also have residential uses as a garden and lawn fungicide and as a root-killer in sewer
systems. Coppers are also registered for antimicrobial applications, including uses as an anti-
foulant and preservative in wood and other materials. Although there are several forms of
copper-containing active ingredients under review, the active component of toxicological interest
is the cupric ion. Within the scope of this Reregi strati on Eligibility Decision (RED), the human
health assessment addressed cupric ion sources from both agricultural and antimicrobial
applications of copper-containing products, whereas the ecological assessment addresses
agricultural uses only. The Agency will complete its ecological assessment on antimicrobial
applications of copper products at a later date in a separate document.
Risk Summary
Copper is a naturally occurring metal that is efficiently regulated in the human system
and current available literature and studies do not indicate any systemic toxicity associated with
copper exposure. Thus, a qualitative human health assessment was conducted. Copper dietary
exposures do not pose any risks of concern. There are no residential or occupational risks of
concern resulting from exposure to copper products. Because several current agricultural
product labels do not specify typical application rates, minimum retreatment intervals or
frequency of treatments, the Agency made several assumptions on how coppers were applied to
assess potential exposure to non-target organisms. Based on these conservative assumptions, the
screening-level ecological assessment indicated that copper can pose acute risks to various
organisms, with the greatest risk to aquatic organisms resulting from direct water applications
and runoff from fields adjacent to water bodies.
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Dietary Risk. Acute and chronic dietary (food and drinking water) risks from copper pesticides
are not of concern to the Agency. Copper is ubiquitous and naturally occurs in many food
sources such as nuts, organ meats and grains. Humans have the capability to metabolize and
regulate copper levels in the body. Given the role copper plays as an essential element to the
human body, its ubiquitous nature in food and drinking water, and the lack of systemic toxicity
resulting from copper, acute and chronic dietary endpoints were not selected. Thus, a
quantitative toxicity assessment was not conducted for dietary, dermal, oral or inhalation
exposures.
Occupational and Residential Risk. Some copper species may cause acute dermal and eye
irritation in exposed individuals. Workers can be exposed to copper pesticides through mixing,
loading and/or applying the pesticide (handlers) or re-entering treated sites. Exposure may also
occur to residential handlers from home-use products. The irritating effects of individual
coppers are addressed through appropriate Personal Protective Equipment (PPE) or
precautionary labeling language for occupational or residential users, respectively. Since no
systemic toxicological endpoints of concern were identified for dermal exposures to coppers, no
dermal, oral or inhalation endpoints of toxicological concern were established. Occupational and
residential exposures to copper pesticides are not of concern to the Agency.
Aggregate Risk. Aggregate risk refers to the combined risk from dietary (food and drinking
water) and residential or other non-occupational exposures. Aggregate risk can result from one-
time (acute), short-term or chronic exposures. Because of the lack of systemic toxicity, copper
exposures from combined sources do not pose any health risks of concern.
Ecological Risk. The ecological risk assessment addresses only agricultural and direct aquatic
uses of copper-containing pesticides. The Biotic-Ligand Model was used to assess potential
exposures and risk to freshwater aquatic animals, whereas standard available models were used
to assess exposures to all other freshwater and marine/estuarine non-target organisms.
Terrestrial Organisms. The screening-level ecological risk assessment suggests potential risk to
terrestrial animals exposed to copper resulting from use as an agricultural pesticide. Risk
quotients (RQs) reflecting dietary exposure and toxicity to birds and mammals exceed both acute
and chronic levels-of-concern (LOCs). The ecological risk assessment presents both maximum
labeled rates and average typical application rates for terrestrial crops. Mitigation measures
which will reduce the maximum application rates for crop uses of coppers down to levels similar
to the typical rates evaluated result in significantly reduced acute and chronic RQs, but these
RQs still exceed acute and chronic LOCs for most feed items and weight classes of animals
considered.
There is some uncertainty in the finding of risk to birds and mammals because although
copper is toxic at high concentrations, it is also an important essential trace element for
organisms. Animals have the ability to cope with some amount of excess copper exposure by
storing it in the liver and bone marrow. As indicated by the laboratory toxicity studies, exposure
to high levels of copper in the diet can overwhelm the ability of birds and mammals to maintain
homeostasis. However, animals which are repeatedly exposed to levels of copper which do not
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cause permanent harm may undergo enzymatic adaptation which allows them to cope with
greater levels of exposure.
RQs based on limited toxicity data for terrestrial plants do not exceed the acute LOG
from exposure through spray drift. Available data from a honey bee acute toxicity study
indicated that copper is practically nontoxic to honey bees. However, because exposure
estimates for other insects cannot readily be determined, the potential risk of copper pesticides to
other insects is unknown.
Aquatic Organisms. Aquatic organisms also require some amount of copper as a nutrient, but
the main cause of copper toxicity to aquatic organisms is through rapid binding to the gill
membranes, which causes damage and interferes with osmoregulatory processes. Copper in the
water column occurs as dissolved ions and as a part of inorganic and organic complexes. The
toxic form of copper in water is the cupric ion. The amount of cupric ion in the environment,
and its toxicity to aquatic animals through gill damage, is dependent on a number of water
quality parameters including pH, alkalinity, and dissolved organic carbon.
The screening-level ecological risk assessment considered a wide range of water
chemistries, as represented by 811 water samples collected by the United States Geological
Survey nationwide. Risk to freshwater animals is presented as a percentage of the 811 resulting
RQs which exceed either acute or chronic levels of concern. Since the model used to perform
this analysis cannot currently be used for aquatic plants or estuarine/marine animals, these were
assessed using a single RQ per taxon.
Fewer than 1% of the 811 RQs for freshwater fish exceed the acute level of concern for
application rates up to 7.5 Ibs Cu2+/A; the percentage exceeding the chronic LOG ranges from
0% at 1 Ib Cu2+/A to 5.3% at 7.5 Ibs Cu2+/A. Almost all revised maximum application rates for
agricultural pesticidal uses of copper fall below 7.5 Ibs Cu2+/A. There is a greater percentage of
RQs which exceed LOCs for freshwater invertebrates. At 1.0 Ib Cu2+/A, 3.2% and 4.2% of the
811 RQs exceed the acute and chronic LOCs, respectively. At 7.5 Ibs Cu2+/A, these percentages
increase to 25% and 32%, respectively. RQs for freshwater non-vascular plants exceed the acute
LOG for application rates of 1.5 Ibs Cu2+/A or greater, and acute and chronic LOCs for
estuarine/marine animals at rates of about 3.0 Ibs Cu2+/A and above. The screening assessment
does not indicate a risk to freshwater vascular plants or estuarine/marine plants.
The percentage of freshwater animal RQs exceeding acute and chronic LOCs and the
magnitude of RQs for other aquatic organisms at revised application rates are significantly
reduced from those derived for maximum application rates on current copper pesticide labels.
Advisory language describing conditions which might result in greater spray drift of copper to
water bodies will help reduce that potential exposure. In addition, advisory language will be
added which describes the water quality conditions which would likely result in greater
concentrations and toxicity of copper in nearby water bodies.
The risk assessment concludes that direct water applications of copper would result in
greater than 95% of RQs exceeding acute and chronic LOCs for freshwater fish, invertebrates
10
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and plants. The risk assessment assumes treatment of an entire water body to achieve the
maximum application rate, a water concentration of 1 ppm. Even with input from the user
community indicating that standard practice for most aquatic uses requires a lower application
rate, and treatment of only a portion (up to 25-33%) of a water body at a time, direct aquatic
applications may result in risk to aquatic organisms. Treatment of only a portion of a water body
may allow fish and some invertebrates to leave the area being treated. Those that do not, or
cannot leave the treated area, may be at risk of adverse effects.
Benefits of Copper Use. Copper is significant as a cost-effective pesticide on crops and for
direct aquatic applications with no toxicity concerns to humans. The use of coppers on
agricultural crops as a fungicide and bactericide is significant to growers, as copper is generally
cost-effective, broad-spectrum, and in some cases the only available pesticide to manage the
target pest(s). Coppers are also among the few pesticides that are permitted for use on crops with
organic certifications. Copper products are one of the few registered herbicides registered for
use in moving water systems, namely irrigation canals, used extensively for the management of
nuisance algae, aquatic weeds, mollusks, leeches. Algae and aquatic weeds may block and
restrict water quality and flow in irrigation and drinking water systems, which would require
much costlier management measures if these pests are not properly controlled. Algae may also
produce various toxic chemicals that may cause various problems for humans and animals,
ranging from dermal reactions to more severe toxicity problems, and in some cases, death for
exposed animals. Catfish aquaculture relies on copper sulfate to manage algae that may produce
toxins that cause off-flavors, rendering the entire fish crop unmarketable. Management of
aquatic pests is important for drinking water quality, as well as recreational waters to manage
snail populations that may host schistosomes that cause Swimmer's Itch, and leeches.
Endangered Species. At certain application rates, risk quotients in the screening-level risk
assessment for coppers exceed acute and chronic LOCs for various listed species of animals and
plants, should exposure actually occur. Acute and chronic LOCs are exceeded for birds,
mammals, and marine/estuarine fish and invertebrates. Freshwater non-vascular plants exceed
the acute LOCs. Screening-level modeling indicates that a number of sites exceed the
endangered species LOG for freshwater fish and invertebrates. Further, potential indirect effects
to any listed species dependent upon a species that experiences effects from use of copper can
not be precluded based on the screening level ecological risk assessment. These findings are
based solely on EPA's screening-level assessment and do not constitute "may affect" findings
under the Endangered Species Act for any listed species. If the Agency determines that the use
of copper "may affect" listed species or their designated critical habitat, EPA will employ
provisions in the Services regulations (50 CFRPart 402). Until species and site-specific
analyses are complete, the risk mitigation measures being implemented in this RED will reduce
the likelihood that endangered and threatened species may be exposed to copper at levels of
concern.
Regulatory Decision. The Agency has determined that all agricultural uses (terrestrial and
aquatic crops, bactericide on crops, urban fungicide, and sewer root-killer treatment) of copper
pesticides are eligible for reregi strati on provided that the risk mitigation measures and label
11
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refinements outlined in this document are adopted, and label amendments are made to reflect
these measures.
Mitigation Summary. Because of the high number of registered crop sites, the Agency assessed
a subset of crops based on high application rates, high frequency of applications, and/or high
usage of copper products on that particular crop. EPA worked with the registrants and USD A to
conduct extensive outreach efforts to the user community for additional refined information on
the actual use and needs of copper pesticides. Based on use information from the user
community, refined data indicated that most typical use rates are significantly lower than current
labeled maximum use rates. As a result, the registrants have agreed to refine their labels by
reducing application rates, defining application intervals, and determining seasonal maximum
application rates. Additional use pattern details for each crop are described in Appendix A.
Label language restricting spray applications of copper pesticides under certain weather
conditions, and advisory language describing steps users can take to minimize spray drift, will be
added to the agricultural use labels for copper pesticides. Registrants of copper-based pesticides
will be required to provide spray drift study data to fulfill guideline requirements. In addition,
advisory language will be added to copper pesticide product labels to inform users of surface
water quality conditions which can lead to greater bioavailability and toxicity of copper to non-
target aquatic organisms.
Next Steps. The Agency issued the RED document for public comment in August 2006 for
agricultural uses of copper pesticides as announced in a Notice of Availability in the Federal
Register (71 FR 45550). Based on comments received on the RED, and other decisions that
occurred after the RED was published, this document has been revised to address these updates
to the 2006 RED. EPA is currently working with registrants to complete product reregi strati on,
which includes companies making the required label amendments for all affected products as
part of adopting the required mitigation measures outlined in Chapter IV of this RED and the
Label Table, Table 29.
12
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I. Introduction
The Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) was amended in 1988
to accelerate the reregistration of products with active ingredients registered prior to November
1, 1984. The amended Act calls for the development and submission of data to support the
reregistration of an active ingredient, as well as a review of all submitted data by the U.S.
Environmental Protection Agency (EPA or the Agency). Reregistration involves a thorough
review of the scientific database underlying a pesticide's registration. The purpose of the
Agency's review is to reassess the potential risks arising from the currently registered uses of the
pesticide, to determine the need for additional data on health and environmental effects, and to
determine whether or not the pesticide meets the "no unreasonable adverse effects" criteria of
FIFRA.
On August 3, 1996, the Food Quality Protection Act of 1996 (FQPA) was signed into
law. This Act amends FIFRA and the Federal Food, Drug and Cosmetic Act (FFDCA) to require
reassessment of all existing tolerances for pesticides in food. FQPA also requires EPA to review
all tolerances in effect on August 2, 1996, by August 3, 2006. In reassessing these tolerances,
the Agency must consider, among other things, aggregate risks from non-occupational sources of
pesticide exposure, whether there is increased susceptibility to infants and children, and the
cumulative effects of pesticides with a common mechanism of toxicity. When a safety finding
has been made that aggregate risks are not of concern and the Agency concludes that there is a
reasonable certainty of no harm from aggregate exposure, the tolerances are considered
reassessed. EPA decided that, for those chemicals that have tolerances and are undergoing
reregistration, tolerance reassessment will be accomplished through the reregistration process.
As mentioned above, FQPA requires EPA to consider available information concerning
the cumulative effects of a particular pesticide's residues and "other substances that have a
common mechanism of toxicity" when considering whether to establish, modify, or revoke a
tolerance. 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 as to the copper ion and any other substances, and the
copper ion does not produce toxic metabolites produced by other substances. For the purposes of
this tolerance action; therefore, EPA has not assumed that the copper ion has a common
mechanism of toxicity with other substances.
This document presents EPA's revised human health and ecological risk assessments, its
progress toward tolerance reassessment, and the RED for agricultural uses of copper. The
ecological risk assessment addressing antimicrobial applications of copper will be assessed at a
later date. The Agency worked extensively with the registrants, USDA and the grower
community to reach the decisions as outlined in the RED. The document consists of six sections.
Section I contains the regulatory framework for reregistration tolerance reassessment. Section II
provides a profile of the use and usage of the chemical. Section III gives an overview of the
13
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revised human health and ecological risk assessments based on submitted data, public comments,
input and data received as a result of extensive communications with the grower community
through USD A, and other information received in response to the preliminary risk assessments.
Section IV presents the Agency's reregi strati on eligibility and risk management decisions.
Section V summarizes label changes necessary to implement the risk mitigation measures
outlined in Section IV. Section VI contains the Appendices, which list related information,
supporting documents, and studies evaluated for the reregi strati on decision. The revised risk
assessments for copper are available in the Federal Public Docket, under docket number EPA-
HQ-OPP-2005-0558, at www.regulations.gov.
14
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II. Chemical Overview
A. Regulatory History
The first recorded use of copper as a fungicide was in the mid-1700s, treating cereal
seeds with copper sulfate pentahydrate to control stinking smut or bunt. In the 1880s, the French
scientist Pierre Marie Alexis Millardet discovered the broad-spectrum fungicidal properties of
copper from the use of copper sulfate in the form of Bordeaux mixture (copper sulfate, hydrated
lime and water). The first registration for a copper-containing pesticide was issued in 1956.
Currently, 16 copper active ingredients (ai) have active food use registrations subject to tolerance
reassessment and reregi strati on review.
EPA issued Registration Standards for copper sulfate in March 1986, Guidance for the
Reregistration of Pesticide Products Containing Copper Sulfate as the Active Ingredient, and for
the Group II copper compounds, Guidance for the Reregistration of Pesticide Products
Containing Group II Copper Compounds as the Active Ingredient in April 1987. As a result,
Generic Data Call-In (GDCI) notices were issued in 1987 to the registrants for various copper
compounds to submit data in support of reregi strati on.
These comprehensive DCIs required various ecological fate and effects studies.
Additional DCIs were issued in 1993, which required various product chemistry studies, avian
toxicity studies and residue studies. These DCIs were issued so that data required by 40 CFR
Part 158 would be available to EPA before reregi strati on occurred.
In support of reregi strati on, as required by FIFRA and FFDCA, and amended by FQPA,
the Agency completed the coppers RED, signed in July 2006. The RED and its supporting
documents were published for public comment in August 2006.
B. Chemical Identification
Agricultural copper pesticides are formulated using various forms of copper, which
ultimately dissociates into the cupric ion, the active component of concern. Copper is a broad-
spectrum fungicide, bactericide, aquatic herbicide, algaecide and molluscicide for use on a
variety of agricultural crops, ornamentals and turf.
Common Name: Copper
Trade Names: Major trade names include Kocide, CuproFix, Basicop, K-Tea,
Cutrine Ultra, and Triangle Brand.
Technical Registrants:
In support of the agricultural uses of copper, the Copper Sulfate Task Force (CSTF) was
formed in 1986 to represent the interests of several registrants. The antimicrobial uses are
15
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supported by the Copper Reregi strati on Task Force (CRTF). The respective current member
companies of the CSTF and the CRTF are listed below.
Copper Sulfate Task Force Members (agricultural and non-agricultural applications)
Albaugh, Inc.
Chem One Ltd.
Drexel Chemical Company
E.I. DuPont De Nemours and Company, Incorporated
Fabrica de Sulfato el Aguila S.A. de C.V.
Freeport-McMoran Sierrita, formerly Phelps Dodge Sales Company, Incorporated
Industrias Quimicas del Valles, S.A.
Ingenieria Industrial, S.A. DE C.V.
Isagro Copper S.P.A.
Nordox Industrier AS, c/o Monterey Chemical Co.
NuFarm Americas, Inc.
Old Bridge Chemical Company
Phibro-Tech, Inc.
Quimetal Industrial S.A.
Spiess-Urania Chemicals GMBH
United Phosphorus, Incorporated
Viance, LLC
Copper Reregi strati on Task Force (antimicrobial applications)
FULL MEMBERS:
American Chemet Corporation Osmose, Inc.
Arch Wood Protection, Inc. Peninsula Copper Industries
Bardyke Chemicals Ltd. PhibroWood, LLC
Chemical Specialties, Inc. SCM Metal Products, Inc.
Nordox AS
ASSOCIATE MEMBERS:
3M
International Paint LLC (Akzo Nobel Chemicals Inc.)
ISP Minerals
Non-Task Force Members
Applied Biochemists
16
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Table 3 lists the copper pesticides and its respective cases that are addressed in the RED.
Table 3. Copper Compounds Subject to Reregistration.
Case
Copper Sulfates
#0636
Group II Copper
Compounds
#0649
Copper and
Oxides
#4025
Copper Salts
#4026
Other Copper
Compounds
Chemical Name
Basic Copper Sulfate
Copper Sulfate Pentahydrate
Copper sulfate monohydrate
Copper sulfate Anhydrous
Copper Chloride
Copper Ammonium Carbonate
Basic Copper Carbonate
Copper Hydroxide
Copper Oxychloride
Copper Oxychloride Sulfate
Copper Ammonia Complex
Chelates of Copper Copper
Gluconate
Copper chloride dihydrate
Copper Nitrate
Copper Oxalate
Chelates of copper citrate
Cuprous Oxide
EPA PC
Code
008101
024001
024402
024408
008001
022703
022901
023401
023501
023503
022702
023305
023701
076102
023305
044005
025601
C.A.S. Number
1344.73-6
7758-99-8
1332-14-5
7758-98-7
1332-40-7
33113-08-5
1184-64-1
20427-59-2
1332-65-6
8012-69-9
16828-95-8
814-91-5
10125-13-0
3251-23-8
814-91-5
10402-15-0
1317-39-1
Registrants
CSTF
Cancelled
CSTF
CSTF
CSTF
Cancelled
CRTF
Antimicrobial Uses Only
Copper (metal)
Cupric Oxide
Copper Salts of Fatty and Rosin
Acids
Copper Ethylenediamine
Copper Triethanolamine Complex
Copper 2-ethylhexanoate (hexanoic
acid)
Copper etidronic acid complex
Copper dehydroabietyl ammonium
2-ethylhexanoate
Copper ethylenediaminetetraacetate
(EDTA)
Copper linoleate
Copper oleate
Copper salts of the Acids of Tall
Oil
Cupric ferric subsulfate complex
022501
042401
023104
024407
024403
041201
024404
041202
039105
023303
023304
023103
042402
7440-50-8
1317-38-0
9007-39-0
13426-91-0
82027-59-6
22221-10-9
50376-91-5
53404-24-3
12276-01-6
7721-15-5
10402-16-1
61789-22-8
12168-20-6
CRTF
CSTF
Applied Biochemists
Cancelled
Unsupported
Cancelled
Antimicrobial Uses Only
Copper Naphthenate
Copper 8-quinolinolate
Copper Octanoate
Copper Ethanolamine Complex
023102
024002
023306
024409
1338-02-9
10380-28-6
20543-04-8
14215-52-2
CRTF
CSTF
Applied Biochemists
17
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Case Numbers: Reregi strati on cases included in the scope of this RED includes
#0636, #0649, #4025, #4026, and other food-use copper
compounds.
Chemical Properties: Table 4 describes the chemical properties for each of the copper
compounds that have registered food uses.
Table 4. Copper Chemical Properties
Common name
Copper sulfate pentahydrate
Basic copper sulfate
Copper hydroxide
Cuprous oxide
Copper carbonate
Copper ammonium complex
Copper ammonium carbonate
complex
Basic copper chloride
Copper oxychloride
Copper oxychloride sulfate
Copper salts of fatty and rosin acids
Copper ethylenediamine
Copper triethanolamine complex
Copper ethanolamine complex
Copper octanoate
Formula*
CuSO4-5H2O
3Cu(OH)2-CuSO4
Cu(OH)2
Cu2O
Cu(OH)2CuCO3
Cu(NH3)42+
CuNH3(HCO3)2
3Cu(OH)2-CuCl2
Cu2Cl(OH)3
3Cu(OH)2-CuCl2 +
3Cu(OH)2-CuSO4
Mixture of compounds
C2H8N2Cu
C6H1503NCu+2
C2H7ONCu+2
C8H16O2Cu
Molecular weight*
249.65
468.29
81.56
143.08
221.12
131.58
190.54
427.133
213.57
879.43
NA
123.54
212.54
124.54
207.54
Percent Copper*
25.4
54.2
77.9
88.8
57.5
48.3
33.3
59.5
59.5
57.8
NA
51.43
29.89
51.01
30.61
Approximate formula, may vary slightly depending on manufacturing processes, molecular weight and percent
copper calculated based on formula
C.
Use Profile
Copper is a broad-spectrum fungicide, bactericide, aquatic herbicide, algaecide and
molluscicide for use on a variety of agricultural crops, ornamentals and turf. There are over two
hundred registered agricultural use sites, which include food, direct aquatic applications and
home-owner uses. The major crops that were assessed in this RED include citrus, strawberry,
tomato, pepper, rice, filbert, walnut, peach, apple, and grape. The following is information on
the currently registered agricultural and direct aquatic uses of coppers, including an overview of
use sites and application methods. A detailed description of uses of copper eligible for
reregi strati on is available in Appendix A.
18
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Type of Pesticide:
Target Pests:
Mode of Action:
Use Sites:
Coppers are registered for use as a fungicide, bactericide,
algaecide, herbicide, insecticide (leech), anti-fouling, wood
preservative.
Copper compounds control a broad spectrum of pests, including
fungi, bacteria, aquatic weeds, algae, mollusks, and leeches.
With fungal and algae organisms, the cupric ion binds to various
groups including sulfidal groups, imidazoles, carboxyls and
phosphate (thiol) groups that result in non-specific denaturing of
proteins, leading to cell leakage. In mollusks, copper disrupts
peroxidase enzymes and affects the functioning of the surface
epithelia.
Agricultural Crops. Copper is registered for use on virtually all
food/feed crops, including orchard, row, field, and aquatic crops.
Crops include, but are not limited to: root and tubers, leafy
vegetables (including brassica), bulb vegetables, fruiting
vegetables, citrus, stone fruit, pome fruit, legumes, cucurbits,
berries, cereals and tree nuts. Copper is also registered for several
ornamental crops, such as flowering/non-flowering plants and
trees.
Aquatic Applications of Copper Pesticides Copper is registered
for use on numerous aquatic use sites. Below is a description of
algaecide, herbicide, molluscicide, and macro-invertebrate use.
Algaecide Applications. Copper applications for algae control
include: aquaculture facilities, drainage systems (canal, ditch and
lateral), ponds (farm, industrial and recreational), fountains,
lakes, reservoirs (crop and non-crop irrigation, potable), sewage
lagoons, stocking (tank, water trough and ponds) and irrigation
canals.
Herbicide Applications. Copper applications for aquatic weed
control include: aquaculture facilities, drainage systems (canal,
ditch and lateral), ponds (farm, industrial and recreational), lakes,
reservoirs (crop and non-crop irrigation, potable), sewage lagoons,
stocking (tank, water trough and ponds) and irrigation canals.
Molluscicide and Macro-Invertebrate Applications. Copper is
registered for use to control freshwater snails that may be a vector
for harmful trematodes. Copper is also used to control leeches,
and tadpole shrimp in rice fields.
19
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Tolerances:
Use Classification:
Formulation Types:
Application Methods:
Application Rates:
Antimicrobial Applications. Copper is registered for use as a
wood preservative, mildewcide, water treatment, bactericide, and
as an anti-fouling in many products including paint, glue, building
materials and construction materials.
There are currently three tolerances established for coppers: 40
CFR§180.136, 40 CFR§180.538, and 40 CFR§180.1021.
Copper is a general use pesticide for agricultural, residential and
industrial applications.
Formulations of copper-containing pesticides include dust, liquid
concentrate, dry flowable, wettable powder (including water-
soluble packets), granule, water-dispersible granule, powder,
ready-to-use liquid, aerosol, and solid.
Agricultural copper application methods include aerial, airblast,
groundboom, rights-of-way equipment, mechanical duster, low-
and high-pressure handwand sprayer, handgun sprayer, push-type
spreader, dips, drip system, hose-end sprayer, and automatic-
metering system.
Application methods for direct aquatic applications of copper
include broadcast dry, broadcast spray, dragging, injection
(flowing water), slug or dump, or spot spray.
The ecological risk assessment addresses a range of application
rates up to the maximum labeled use rates. Copper application
rates vary depending on the use pattern and the severity of disease
or pest infestation. Additionally, input from user growers indicate
that actual use rates are lower than current maximum labeled rates.
From various efforts with outreach to the public through the CSTF
and USD A, refined use rates information was used to refine and
characterize the risk assessment. Below is a description of the use
rates assessed in the ecological assessment.
Maximum Labeled Rates. The highest maximum labeled rate
assessed was for filberts at 31.8 Ibs pounds of metallic copper per
acre (Ibs Cu2+/A), and for potatoes at 3.2 Ibs Cu2+/A. For both
uses, the Agency assumed four applications at weekly application
intervals.
Typical Use Rates. The highest typical application rate for food
crops is 6 Ibs Cu2+/A for filbert crops. However, the typical use
rate for all other crops ranges from 0.25 Ibs Cu2+/A up to
approximately 4.0 Ibs Cu2+/A. For control of tadpole shrimp in
20
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rice fields, up to 2.5 parts per million (ppm) may be used. For
direct water applications of copper for management of aquatic
weeds and algae control, the maximum concentration of metallic
copper is 1.0 ppm. For leech or snail control, up to 1.25 ppm of
metallic copper may be used. Because rates vary depending on
disease pressure or severity of pest infestation, determining a
maximum number of applications was not feasible. Thus, The
Agency assumed the same four applications at weekly application
intervals, as for the maximum labeled rates previously described.
The maximum residential application use rate is 0.5 Ib Cu2+/A for
root control in sewer systems.
Application Timings: Depending on the crop and stage of development, applications are
recommended during virtually all stages of crop/fruit development
including dormant applications; petal fall; bud break; early bloom;
post bloom; early spring; early summer; late summer; early fall;
late fall; after harvest. Treatment timings for direct aquatic uses
vary, depending on the proliferation of the target pest.
D. Estimated Usage of Copper Pesticides
Available usage data on the use of copper compounds on growing crops greatly varies.
The Agency's Screening Level Usage Analysis (SLUA) for the two major copper compounds is
described below. According to other available data sources, there is some uncertainty as to the
actual figures of copper used for agricultural crops, such as reporting errors of the copper
compound used on that site. The CSTF estimated that 9-11 million pounds of elemental copper
in the form of copper sulfate pentahydrate are applied each year solely for algae and weed
control. Applied Biochemists Company estimates that 300,000 pounds of elemental copper in
various forms of complexed copper compounds are applied annually for algae and weed control.
SLUA for Copper Hydroxide
Crop Lbs. A.I. Percent Crop Treated
Avg. Max.
1 Almonds 600,000 25 30
2 Apples 100,000 10 15
3 Apricots 40,000 30 45
4 Avocados 100,000 5 10
5 Beans, Green 70,000 25 50
6 Blackberries 4,000 30 35
7 Blueberries 4,000 20 55
8 Broccoli 1,000 <1 5
9 Cabbage 6,000 5 10
10 Cantaloupes 3,000 <1 5
11 Carrots 20,000 10 20
21
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12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
31
32
33
34
35
36
37
38
39
40
41
42
43
44
45
46
47
48
49
50
51
52
53
54
55
Cauliflower
Celery
Cherries
Collards
Cucumber
Cucumbers
Dry Beans/Peas
Eggplant
Garlic
Grapefruit
Grapes
Greens, Mustard
Greens, Turnip
Hazelnuts (Filberts)
Lemons
Lettuce
Limes
Nectarines
Olives
Onions
Oranges
Peaches
Peanuts
Pears
Peas, Green
Pecans
Peppers
Pistachios
Potatoes
Prunes & Plums
Pumpkins
Raspberries
Rice
Spinach
Squash
Strawberries
Sugar Beets
Sweet Corn
Tangelos
Tangerines
Tomatoes
Walnuts
Watermelons
Wheat
1,000
30,000
100,000
1,000
40,000
20,000
80,000
3,000
9,000
700,000
400,000
<500
1,000
20,000
50,000
3,000
30,000
90,000
30,000
100,000
1,800,000
200,000
20,000
30,000
4,000
20,000
200,000
70,000
90,000
100,000
20,000
4,000
10,000
6,000
10,000
5,000
4,000
1,000
20,000
60,000
800,000
1,400,000
50,000
5,000
5 5
35 45
15 25
5 5
10 15
10 20
5 5
35 60
10 15
55 70
65 95
5 5
5 5
10 15
20 30
<1 5
85 85
40 55
15 20
30 40
40 50
25 30
<1 5
10 25
<1 <2.5
<1 <2.5
35 50
10 15
5 15
15 15
10 25
25 40
<1 <2.5
10 25
10 15
5 10
<1 <2.5
<1 <2.5
60 65
45 65
30 65
45 55
15 25
<1 <2.5
22
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SLUA for Copper Sulfate Pentahydrate
Crop
Lbs. A.I.
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
31
32
33
34
35
36
37
38
39
40
41
Almonds
Apples
Apricots
Avocados
Beans, Green
Blackberries
Blueberries
Cabbage
Cantaloupes
Carrots
Cauliflower
Celery
Cherries
Cotton
Cucumber
Cucumbers
Dry Beans/Peas
Grapefruit
Grapes
Hazelnuts (Filberts)
Lemons
Lettuce
Limes
Onions
Oranges
Peaches
Peanuts
Pears
Pecans
Peppers
Pistachios
Potatoes
Prunes & Plums
Pumpkins
Raspberries
Rice
Spinach
Squash
Strawberries
Sugar Beets
Sweet Corn
100,000
60,000
9,000
40,000
10,000
1,000
2,000
1,000
1,000
10,000
<500
5,000
50,000
6,000
2,000
1,000
10,000
100,000
100,000
10,000
40,000
<500
<500
10,000
900,000
100,000
20,000
10,000
3,000
30,000
1,000
30,000
30,000
5,000
7,000
300,000
2,000
3,000
<500
20,000
1,000
Percent
Avg.
5
5
10
<1
5
10
5
<1
<1
<1
<1
5
5
<1
<1
<1
<1
15
15
10
15
<1
<1
<1
15
10
<1
5
<1
5
<1
<1
5
<1
30
<1
5
<1
<1
<1
<1
Crop Treated
Max.
5
5
15
5
10
10
20
<2.5
<2.5
5
<2.5
5
10
<2.5
<2.5
5
<2.5
25
30
10
20
<2.5
<2.5
5
35
20
<2.5
10
<2.5
10
<2.5
5
5
5
40
5
10
5
5
5
<2.5
23
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42 Tangelos 1,000 5 10
43 Tangerines 5,000 10 10
44 Tomatoes 40,000 <1 5
45 Walnuts 200,000 5 10
46 Watermelons 3,000 <1 <2.5
47 Wheat 3,000 <1 <2.5
24
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III. Summary of Coppers Risk Assessments
The following is a summary of EPA's human health and ecological risk assessments for
coppers, as presented fully in the documents, "Coppers: Revised Human Health Chapter of the
Reregistration Eligibility Decision Document (RED). Reregistration Case numbers 0636, 0649,
4025 and 4026, " dated June 29, 2006, and "Error Corrections for the Ecological Risk
Assessment for Re-Registration of copper sulfate (case #0636), group II copper compounds (case
#0649), and copper salts (case #0649) for use on crops and as direct water applications, " dated
April 20, 2006. The human health and ecological risk assessment documents and supporting
information listed in Appendix C were used to reach the safety finding and regulatory decision
for coppers. The revised risk assessments and related documents are available online at
www.regulations.gov under Public Docket EPA-OPP-HQ-2005-0558.
As part of the public participation process, the Agency solicited additional information
from the public, including grower groups, to further refine the risk assessments and to provide
input for risk mitigation suggestions. Because current agricultural-use labels for copper-
containing products contain inconsistent use rates and use application information, the Agency
made several assumptions in the ecological risk assessment. After conducting the preliminary
risk assessments, EPA determined that additional information on use rates and other application
information were necessary in order to refine the risk assessments.
In October 2005, the Agency requested that the registrants collect additional use
information from user groups, which was submitted shortly before the Phase 3 public comment
period. Although there was insufficient time to fully review the received data at that time, a
preliminary cursory review showed that this data was insufficient to fully refine the risk
assessments. Thus, the Agency solicited additional specific use information on major crops and
direct aquatic uses during the Phase 3 public comment period. As a result of response from the
public as well as outreach to the user community, several groups provided refined use
information that was considered and incorporated in the revised risk assessments, as well as in
the RED. This information was used to refine labels to further mitigate estimated risks.
As a result of comments received during the Phase 3 public comment period, the
following major revisions were made to the ecological risk assessment:
Assessment of root-killer sewer treatment use with the E-F AST model
Addition of screening spray drift assessment for agricultural uses
Inclusion of available information on mammalian homeostatic capabilities, including
a 22% absorption factor to account for dietary metabolism effects
Addition of screening risk assessment for marine/estuarine organisms
Incorporation of typical use rates
A. Human Health Risk Assessment
This section of the document summarizes the human health risk estimates for exposures
to pesticide products containing copper as the active ingredient. In this qualitative assessment,
25
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the EPA has considered aggregate or combined exposures from food, drinking water and non-
occupational sources. The aggregate risk from all copper sources must be considered to reassess
the tolerance for residues of copper in food and water, in accordance with FQPA. EPA's reliance
on any study in the risk assessment is in accordance with the Agency's Final Rule promulgated
on January 26, 2006, related to Protections for Subjects in Human Research, which is codified in
40CFRPart26.
1. Background on Copper
Copper is a naturally-occurring, ubiquitous element in the environment. Copper is found
in water, air, and occurs naturally in various foods including organ meats, seafood, beans, nuts,
and whole grains. In most foods, copper is bound to macromolecules rather than as a free ion.
For many animals, copper is essential for the homeostasis of life. The role of copper in
maintaining normal health both in humans and animals has been recognized for many years.
Copper is an essential cofactor for approximately a dozen copper-binding proteins for the proper
regulation of copper homeostasis in humans. A deficiency of copper or a defect in copper-
carrying proteins may result in symptoms such as anemia, defective blood vessel development,
growth retardation, a compromised immune function or connective tissue symptoms.
2. Exposure Sources of Copper
Humans are exposed to copper primarily from food and drinking water sources, as well
as in the air. Copper is found naturally in various foods, including organ meats, seafood, beans,
nuts, and whole grains. It has been estimated that approximately 40% of dietary copper is
consumed from yeast breads, white potatoes, tomatoes, cereals, beef, dried beans and lentils.
The recommended dietary allowance (RDA) of copper, as established by the National Academy
of Science, ranges from 0.34 milligrams per day (mg/d) in young children to 1.3 mg/d for
pregnant and lactating females. The estimated total daily oral intake of copper (food plus
drinking water) is between 1 and 2 mg/d, although oral intake may sometimes exceed 5 mg/d.
Copper may also be found in drinking water, commonly due to the use of copper
plumbing fixtures and water pipes. Copper may also enter drinking water systems via
contamination from mining operations, incineration, industrial discharges, water treatments and
sewage treatment facilities. Other non-biological sources of copper include smelters, iron
foundries, power stations and combustion sources such as municipal incinerators. For water
quality management, a Maximum Contaminant Level Goal (MCLG) of 1.3 milligrams per liter
(mg/L, or 1.3 ppm) has been set by the EPA for copper in drinking water.
In addition to dietary sources, copper pesticide use may also result in oral, dermal and
inhalation exposures. There is potential for exposure to occupational mixers, loaders, and
applicators of copper pesticide products, as well as to residential homeowners who may apply
copper-containing pesticide products in and around their homes.
26
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3. Human Metabolism of Copper
Although the metabolism pathways are not clearly known, the mechanisms for regulating
total copper in the body appear to be efficient in maintaining a generally consistent level of
copper needed for homeostasis. The efficiency of copper absorption varies greatly, depending
on dietary intake. When dietary copper is high and more copper is absorbed, mainly through the
gastrointestinal tract, excretion of copper from the body increases, protecting against excess
accumulation of copper in the body. Depending on the copper status in the body at the time,
approximately 20 to 60% of dietary copper may be absorbed. Copper absorption is also affected
by other factors such as species, age, chemical form, and pregnancy. When copper intake is low,
little copper is excreted from the body, protecting against copper depletion. Generally, current
available data and literature studies indicate that there is a greater risk from the deficiency of
copper intake than from excess intake. A deficiency of copper or a defect in copper carrying
proteins may result in symptoms such as anemia, defective blood vessel development, or
connective tissue symptoms.
Some less common genetic conditions in humans may cause abnormal copper
metabolism, causing either excessive retention or incapable of absorbing copper. Some disorders
that result in copper toxicity include Wilson's Disease, Occipital Horn Syndrome, Tyrolean
Infantile Cirrhosis, Indian Childhood Cirrhosis, Idiopathic Copper Toxicosis, and
aceruloplasminanemia. For example, Wilson's disease is due to the inability for biliary excretion
of copper which leads to the gradual accumulation of copper predominately in the liver and
brain. In contrast, Menkes disease is an X-linked neurodegenerative disorder in infants
characterized by poor growth and unusual "kinky" hair texture. In Menkes disease, clinical
effects include low ceruloplasmin concentrations and decreased concentrations of copper in the
liver and brain. The major cause of this copper deficiency is minimal copper absorption by the
intestinal mucosa and transport of copper across the blood-brain-barrier, independent of copper
intake.
4. Toxicity Summary for Copper
Toxicity assessments are designed to predict whether a pesticide could cause adverse
health effects in humans (including short-term or acute effects such as skin or eye damage, and
lifetime or chronic effects such as cancer, development and reproduction deficiencies, etc.) and
the level or dose at which such effects might occur. The Agency has reviewed all toxicity
studies submitted for copper and has determined that the toxicological database is sufficient to
assess the hazard from pesticides containing copper.
The component of toxicological interest in copper pesticides is elemental copper (cupric
ion). Humans have homeostatic capabilities to regulate copper in the system. Effects such as
severe dermal, eye, and inhalation irritation seen in acute toxicity studies are a function of the
body's response mechanisms to reduce excessive copper exposure, rather than as a result of
systemic toxicity. Acute toxicity studies are available for several of the copper compounds.
These acute studies show that copper generally has low acute toxicity, with the exception of
cuprous oxide for acute inhalation. Based on available literature and studies submitted by the
27
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registrant, there is no evidence of copper or its salts being carcinogenic or posing any other
systemic toxicity in animals having normal copper homeostasis. Thus, endpoints were not
established to quantify any potential risks from exposure to copper.
Acute Toxicity. Acute toxicity studies are available for most copper species, with the exception
of copper ammonium carbonate, copper-ammonia complex, chelates of copper gluconate, copper
oxychloride sulfate, basic copper sulfate, and copper ethanolamine complex. Table 5 below
describes available acute toxicity studies on the respective copper compounds.
Table 5. Available Acute Toxicity Studies on Copper-Containing Compounds
Copper Type
Copper chloride
(57.7% Cu)
Chelates of
copper gluconate
Copper
ammonium
carbonate
Copper carbonate
(96%)
Copper
hydroxide (77%)
Copper-ammonia
complex
Copper
oxychloride
(94.1%)
Copper
oxychloride
sulfate
Basic copper
sulfate
Copper sulfate
anhydrous
PC
Code
008001
024405
022703
022901
023401
022702
023501
023503
008101
024408
Acute Oral
LD50
(mg/kg)
M= 1796
F= 2006
Tox Cat. Ill
43769501
Acute
Dermal
LD50
(mg/kg)
> 2000 (M
&F)
Tox Cat III
43769502
Acute
Inhalation
(mg/L)
None
Available
Primary Eye
Irritation
Comeal opacity
cleared by 21
days
Tox Cat. II
43769503
Dermal
Irritation
Non-
irritating
Tox Cat. IV
43769504
Dermal
Sensitization
None Available
None Available
None Available
>2000
Tox Cat III
41889302
M = 2253
F=2160
Tox Cat. Ill
41421602
None
Available
>2000
Tox Cat III
00159371
00259424
None
Available
77%
M= 1.53
mg/L
F=1.04
mg/L
00160580
88% F = 0.5
mg/L
Tox Cat. Ill
Corrosive,
opacity at 21
days
Tox Cat I
41889301
Irritative
Comeal
opacity, iris
irritation,
chemosis,
invasion of
cornea by
blood vessels
Tox. Cat. I
Non-
irritating
Tox Cat IV
41889302
At 72 hrs,
very slight
erythema
Tox Cat. IV
None Available
Non-sensitizing
Guinea Pig
None Available
M= 1537
F=1370
Tox Cat. Ill
00155931
M&F=710
(281-1791)
Tox Cat II
> 1.7 mg/L
Tox Cat. Ill
00155932
Comeal opacity
redness and
vascularization
Tox Cat. I
00155934
Non-
irritating
Tox Cat IV
00155935
Nonsensitizing
00155936
None Available
None Available
None Available
28
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Copper Type
Copper sulfate
pentahydrate
(99%)
Copper metallic
Cupric oxide
(97.6%)
Cuprous oxide
(83.9%)
Copper from
triethanolamine
complex
[K-TEA]
Copper 8-
quinolinolate
Elemental copper
(ethyenediamine)
PC
Code
024401
022501
042401
025601
024403
024002
024407
Acute Oral
LD50
(mg/kg)
M=790
F=450
Tox Cat II
43396201
50% copper
M= 1414
F= 1625
Tox Cat. Ill
00162424
>5050
(M&F)
Tox Cat IV
41502401
Tox Cat III
45246201
99%
M=1170
F= 1312
Tox Cat. Ill
41759301
99.5%
>5000 M&F
Tox Cat. IV
KOMEEN
96%, K-Tea
99%
M=527
F=462
Tox Cat. II
41759201
Acute
Dermal
LD50
(mg/kg)
>2000
Tox Cat IV
43452201
8.5%
elemental
>2000
Tox Cat. Ill
00150641
>2020
(M&F)
Tox Cat III
41502402
Tox Cat IV
45246202
99%
>2000
mg/kg
No deaths
Tox Cat. Ill
41759302
99.5%
>2000 M&F
Tox Cat. Ill
43558501
KOMEEN
& K-Tea
>2000
Tox Cat. Ill
41759202
Acute
Inhalation
(mg/L)
None
Available
23% metallic
>0.1 but
O.59
Tox Cat III
00156396
>2.08 (M&F)
Tox Cat III
41502403
Tox Cat IV
45246203
None
Available
96%
0.09 M& 0.03
F
Tox Cat. II
43611901
KOMEEN &
K-Tea
M= 1.36
F= 0.56
Tox Cat. Ill
42130001
Primary Eye
Irritation
Severe eye
irritation day 1
to day 21
Tox Cat. I
43396201
50% metallic
opacity,
irritation,
redness,
chemosis,
cleared by day
21
Tox Cat. II
00126194
Irritation
cleared in 7
days
Tox Cat III
41502404
Tox Cat III
47046901
99%
moderate
irritation of
cornea, iris,
conjunctive
cleared by day
7.
Tox Cat. Ill
41759303
98%
comeal opacity,
redness to day
21
Tox Cat. I
KOMEEN &
K-Tea
moderate
irritation
Tox Cat. Ill
41759203
Dermal
Irritation
Non-
irritating
Tox Cat IV
43396201
50%
metallic
erythema,
edema,
irritation,
cleared day
14
Tox Cat. IV
00126194
Irritation
cleared day
21
PI Index=
1.49
Tox Cat III
41502405
Tox Cat IV
45246204
99%
mild
irritation
cleared by
day 3
Tox Cat. IV
41759304
99.7%
Non-
irritating
Tox Cat. IV
KOMEEN
& K-Tea
redness,
edema,
cleared by
day 3
41759204
Dermal
Sensitization
26% metallic
nonsensitizing
guinea pig
00144555
8.5% elemental
nonsensitizing
rabbit
00152166
Non-sensitizing
(guinea pig)
41502406
Non-sensitizing
(guinea pig)
45246205
None Available
99.7%
Non-sensitizing
guinea pig
KOMEEN &
K-Tea
non sensitizing
guinea pig
42130002
29
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Copper Type
Copper
naphthenate
Copper
octanoate, 10%
fatty acids
Copper salts of
fatty and rosin
acids
(Cu & zinc
neoisoate 35%)
Cuprous
thiocyanate
(99%)
Copper
ethanolamine
complex
PC
Code
023102
023306
023104
025602
024409
Acute Oral
LD50
(mg/kg)
8% Cu
M= >5050
F= >5050
Tox Cat. IV
43643701
>2000 M&F
Tox Cat. Ill
43947504
>7000
Tox Cat. IV
>5000
Tox Cat IV
40834601
Acute
Dermal
LD50
(mg/kg)
8% Cu
M= >2020
F= >2020
Tox Cat. Ill
43643702
>2000
M&F
Tox Cat. Ill
43947505
>2000
Tox Cat. Ill
>2000
Tox Cat III
40834601
Acute
Inhalation
(mg/L)
9.5% Cu
M&F=>2.96
Tox Cat. Ill
> 0.38 M&F
Tox Cat. Ill
43970201
None
Available
> 0.5 mg/L
Tox Cat. II
40834605
Primary Eye
Irritation
1. 8%Cu
irritation,
chemosis,
cleared by 48
hrs,
Tox Cat. Ill
43643703
2. 45% Cu
opacity,
redness,
chemosis &
discharge at 72
hrs
Tox Cat. I
00266172
irritation,
cleared by 48
hrs.
Tox Cat. IV
43937506
no irritation
Tox Cat. IV
non-irritant
40834605
Dermal
Irritation
8% Cu
erythema/es
char
slight edema
PIS=1.1
Tox Cat. Ill
43642704
2. 80% Cu
72 hrs
severe
erythema,
edema
Tox Cat. II
00260891
slight
erythema,
edema,
cleared by
72 hrs.
Tox Cat. IV
43947507
Edema,
erythema,
PIS=1.0
Tox Cat III
non-irritant
40834604
Dermal
Sensitization
9.5% Cu
sensitizer
Non-sensitizing
guinea pig
44116101
None Available
non-sensitizing
40834603
None Available
Copper generally has moderate to low toxicity (Toxicity Category II, III and IV) based on
acute oral, dermal and inhalation studies in animals. However, available studies indicate that
some copper species may cause severe irritation (Toxicity Category I), such as copper sulfate
pentahydrate, cuprous oxide, and copper 8-quinolinolate. Most dermal irritation studies indicate
Toxicity Category III or IV; however, cuprous oxide produced Toxicity Category I irritation.
Copper was generally non-sensitizing in animals, except for copper naphthenate which was a
skin sensitizer. When ingested, copper can be a gastric irritant and produce corrosion of the
gastric and intestinal epithelium. Open literature and data submitted by the registrants indicate
that acute responses to large copper concentrations are a result of acute irritation. Inhalation of
copper as dusts or mists is likely to be irritating to the respiratory system. Acute responses to
ingesting large amounts of copper may produce a metallic taste, abdominal pain, nausea and
vomiting, or diarrhea, especially if the stomach is empty and copper is taken with acidic foods,
beverages, or with other supplements.
30
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All effects resulting from acute exposure to these copper-containing pesticides are due to
acute body responses to minimize excessive absorption or exposure to copper. Given the role
copper plays as an essential element to the human body, its ubiquitous nature in food and
drinking water, the long-standing tolerance exemptions for the pesticidal use of copper on
growing crops, as well as on meat, milk, poultry, eggs, fish, shellfish, and irrigated crops, and the
lack of systemic toxicity resulting from copper, a quantitative acute toxicity assessment was not
conducted for acute dietary, dermal, oral or inhalation exposures. Current available data in
animals do not show any evidence of upper limit toxicity level that warrant determining acute
toxicity endpoints.
Sub-chronic and Chronic Toxicity. Based on available data, there is no evidence that warrants
determining any dietary, oral, dermal or inhalation endpoints to quantify sub-chronic and chronic
toxicity. Available short-term feeding studies with rats and mice indicate decreased food and
water intake with increasing oral concentrations of copper, with irritation of the stomach at
higher copper concentrations. High levels of excess copper administered in the drinking water of
mice suggested an altered immune response; however, the inhibition of immune responses is not
unusual since other trace elements have been linked with immuno-suppression. In addition,
cations like zinc, mercury, and lead have also been reported to alter immune responses. The
mechanism by which copper may be exerting a response in the immune system has not been
fully determined.
Longer feeding studies indicate decreased feed intake with reductions in body weight
gains, and increased copper concentration of the liver. Some available literature indicates that
chronic inhalations of copper may become cancerous, specifically seen in some professional
vineyard workers that were chronically exposed to Bordeaux mixture (copper sulfate and
hydrated lime mixture). However, this information is not definitive since no information is
available on the level of copper exposure to the workers, or any other substances with which they
might have come into contact. Available reproductive and developmental studies by the oral
route of exposure generally indicate that the main concern in animals for reproductive and
teratogenic effects of copper has usually been associated with the deficiency rather than the
excess of copper. Current available data in animals do not show any evidence of upper limit
toxicity level that warrant determining chronic toxicity endpoints for any potential routes of
exposure.
5. FQPA Safety Factor Considerations
FFDCA, as amended by FQPA, directs the Agency to use an additional 10X safety factor
(SF), to account for potential pre- and postnatal toxicity and completeness of the data with
respect to exposure and toxicity to infants and children. FQPA authorizes the Agency to modify
the 10X FQPA SF only if reliable data demonstrate that the resulting level of exposure would be
safe for infants and children. In humans, there does not appear to be any reports in the literature
of teratogenesis induced by exposure to excess copper. The only teratogenic effects observed in
available animal studies occurred after exposure with copper salts at high doses which were
likely maternally toxic. Moreover, there is no evidence to suggest susceptibility in infants and
children. Since copper is an essential trace element, with copper deficiency more common in
31
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humans than toxicity from the excess, and since the dietary (food and drinking water)
contribution of copper to the total diet is low, endpoints to quantitatively assess dietary risk were
not selected. EPA has low concerns and no residual uncertainties with regard to pre- or postnatal
toxicity from copper exposures. Since a qualitative assessment was conducted for potential
human health exposure to copper, the 10X FQPA SF was not retained.
6. Aggregate Risk from Coppers (Dietary and Residential)
The FQPA amendments to the Federal Food, Drug, and Cosmetic Act (FFDCA, Section
408(b)(2)(A)(ii)) require "that there is a reasonable certainty that no harm will result from
aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures
and other exposures for which there is reliable information." In accordance with the FQPA, the
Agency must consider and aggregate pesticide exposures and risks from three major sources or
pathways: food, drinking water, and if applicable, residential or other non-occupational
exposures.
Copper is a ubiquitous, naturally occurring metal that is essential to human health, found
naturally at low levels in a variety of food products as well as in drinking water from copper
plumbing pipes. Additionally, copper generally has low to moderate acute toxicity via the oral,
dermal, and inhalation routes of exposure. Available literature and studies do not indicate any
systemic toxicity associated with copper exposure. Effects seen in the existing data base are as a
result of response mechanisms that protect the body from excessive exposure to copper.
Considering all available information on copper and the relatively low toxicity via all exposure
routes from all sources, the cupric ion (regardless of the original form/species of copper) when
used in pesticide products is unlikely to pose a significant hazard to the general public or any
population subgroup. Based on available studies and literature, there are no human health
aggregate risks of concern resulting from aggregate dietary and residential exposures.
7. Occupational Exposure
Copper compounds are used on a variety of agricultural, commercial, and residential use
sites as fungicides, bactericides, algaecides, herbicides, wood preservatives, and anti-fouling
agents. There is potential for exposure to occupational mixers, loaders and applicators of
copper-containing pesticides. There is also the potential for post-application exposure.
However, adverse effects resulting from dermal, oral or inhalation exposures are due to the
irritating properties of copper, rather than a result of systemic toxicity. No dermal, oral or
inhalation endpoints were established to determine any potential systemic toxicity resulting from
occupational uses of copper products. Thus, there are no occupational risks of concern to the
Agency. Although there are no occupational risks of concern, the severe irritating properties of
some coppers warrant appropriate precautionary labeling to address any handler or post-
application exposures based on acute toxicity categories for individual copper compounds.
32
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8. Incidence Data on Copper Exposure
The EPA's Incident Data System (IDS) has seven recorded pesticide incidents for copper;
five involve copper hydroxide and two involve copper sulfate pentahydrate. According to a
review of the scientific literature, copper compounds formulated as dusts and as powders are
irritating to the skin, respiratory tract, and the eyes. Most copper compounds have low systemic
toxicity, due mainly to their limited solubility and absorption. Occupational exposure to copper
containing compounds frequently results in irritation effects. The majority of the noted effects
involved skin and eye irritation, nausea, vomiting, and headaches. These findings from the
scientific literature reflect the reported incidents from IDS.
The principle types of copper fungicides included in the Poison Control Center data
(1993-2003) are copper sulfate and copper hydroxide. Of the 82 copper exposures identified in
the Poison Control Center data, only 20 were seen in a health care facility, and three cases had a
moderate medical outcome. The leading symptoms included ocular irritation, vomiting, nausea,
and dermal irritation. Data from the California Department of Pesticide Regulation (1982-2003)
show that 156 cases (out of 494 reported) were due to copper compounds. The majority of these
cases show eye effects, skin effects, or other acute effects (i.e., respiratory effects). Of the top
200 chemicals for which the NPIC received calls from (1984-1991), copper hydroxide was
ranked 167th and copper sulfate was ranked 179th, with 15 and 13 reports of illness to humans,
respectively. National Institute for Occupational Safety and Health Sentinel Event Notification
Systems for Occupational Risks (NIOSH SENSOR) data reveal that out of 5899 reported cases
between 1998- 2003, only 34 cases were documented as involving copper (copper sulfate
pentahydrate, copper hydroxide, and copper-ammonia complex). Twenty-five of the 34
documented cases were from California, and most likely overlap the cases discussed above from
the California Department of Pesticide Regulation.
Given the long history of copper use over the past several centuries and the extensive use
of copper compounds in agricultural and direct aquatic applications, the number of reported
incidents related to copper is relatively low. Reported effects (i.e., eye and dermal irritation,
emesis, nausea, etc.) were consistent with acute irritation effects that may occur when exposed to
products containing copper. These reported incidents do not indicate systemic toxicity effects
resulting from copper exposure, but do support a conclusion that acute irritation effects are the
primary concern for exposures to copper compounds. The potential acute irritation effects of
some copper pesticides warrant appropriate precautionary labeling to address any handler or
post-application exposures. With these protective measures in place to reduce potential
exposures, there are no risks of concern to the Agency.
B. Ecological Risk Assessment
A summary of the Agency's environmental risk assessment for coppers is presented
below. As a bridging strategy to address the range of copper compounds included in this
assessment, the Agency has evaluated all copper active ingredients with registered agricultural
uses on the basis of the cupric ion (Cu2+) regardless of the original form of the copper compound.
Antimicrobial applications of copper will be assessed separately at a later date. The complete
33
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revised environmental risk assessment for agricultural uses of coppers may be accessed online at
www.regulations.gov under Public Docket EPA-OPP-HQ-2005-0558. This risk assessment was
refined and updated to incorporate comments and additional data submitted by the registrants
and other stakeholders.
1.
Environmental Fate
Copper naturally occurs in the environment, and continuously cycles through natural
geothermodynamic processes that binds or releases copper ions. Because copper is an element, it
cannot break down any further via hydrolysis, metabolism, or any other degradation processes.
The free cupric ion has a high sorption affinity for soil, sediments and organic matter, and copper
applied to the surface is not expected to readily move into groundwater.
The copper ion is highly reactive, especially in aquatic environments. Copper can exist
in various organic and inorganic forms, including the cupric ion (Cu2+), cuprous ion (Cu+),
inorganic complexes, organic complexes and minerals. In this assessment, the term "speciation"
refers to the relative proportion of total copper in these various forms. Figure 1 provides an
overview of the chemistry of copper in aqueous systems.
Cu (II)
Minprolc
/ Natural \
^/ r~ n \
^ ClF
4 Cl£+
\ /
V CLf J
^
^
Organic Cu
OnmnlpYP^
t
k
i
r
Inorganic Cu
Complexes
Figure 1 - Environmental Fate Bridging Strategy for Cu Minerals and Complexes
Copper can exist in various oxidation states as inorganic complexes, organic complexes
and minerals; Figure 1 distinguishes these mineral states with Roman numerals (e.g., Cu(I) and
Cu(II)). The oxidation of Cu(0) to Cu(I) or Cu(II) depends on the redox conditions. Redox
potential is the tendency of the environment to deplete molecular oxygen from the system to
34
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form oxygen-containing compounds. Redox potential can be measured as an electrical potential
in millivolts (mV). It also controls the chemical forms of other compounds in the environment.
The form in which Cu(I) or Cu(II) species is found depends on the pH of the medium and the
nature and concentration of other chemical species that can form copper-containing species.
This ecological assessment addresses terrestrial crop and direct aquatic uses of Cu(II)
salts, oxides, hydroxides, and organic complexes. When used as a pesticide, the cupric ion is
released via dissolution of copper salts, oxides/hydroxides and/or by the breakdown of organic
complexes and/or degradation of the organic moiety. The extent of dissociation of copper
species is controlled by the solubility of the compound, which is dependent on the pH of the
environment. It also depends on redox potential, dissolved organic carbon (DOC) and
competing ligands. However, for the purposes of this assessment, copper compounds reaching
surface water (as simulated by PRZM/EXAMS) is assumed to completely and instantaneously
dissociate. As described below, speciation of this loading of dissolved copper is then simulated
using the Biotic-Ligand Model (BLM).
Since copper is a naturally occurring element, there are always background
concentrations of copper from which point and non-point sources cannot easily be distinguished.
Aside from natural environmental releases of copper, there are other sources, such as pesticides,
anti-foulants and wood preservatives, leaching from mining operations, industrial runoff,
architectural uses, and brake pads. Therefore, concentrations of copper measured in soil or water
can also reflect other point or non-point sources of copper besides pesticides.
2. Ecological Exposure and Risk
The Agency has used the existing environmental database and open literature for coppers
to characterize the environmental exposure associated with copper agricultural uses for this
screening-level assessment. The risk assessment is based on a subset of representative labels of
copper sulfate pentahydrate and copper hydroxide for agricultural uses, which represents a wide
range of application rates. Although there are several other registered active ingredients
containing copper, the risk assessment assumes instantaneous disassociation of the cupric ion
from its counter ion or ligand, which is a conservative estimate for the potential bioavailable
amount of copper to exposed organisms. The Agency assessed both maximum labeled rates and
typical average use rates. All copper concentrations are expressed in the risk assessments as the
copper or cupric ion, the toxic ion of concern.
The Agency's ecological risk assessment compares toxicity endpoints from ecological
toxicity data to estimated environmental concentrations (EECs) based on environmental fate
characteristics, soil and water chemistry, and pesticide use data. To evaluate the potential risks
to nontarget organisms from the use of copper pesticides, the Agency calculates a Risk Quotient
(RQ), which is the ratio of the EEC to the most sensitive toxicity endpoint values, such as the
median lethal dose (LDso) or the median lethal concentration (LCso).
RQ values are compared to the Agency's levels of concern (LOCs), which indicate
whether a pesticide, when used as labeled, has the potential to cause adverse effects on nontarget
35
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organisms. When the RQ exceeds the LOG for a particular category, the Agency presumes a
potential risk of concern to that category. Table 6 describes the Agency's LOCs and its
respective risk presumptions. These RQ values may be further refined by characterization of the
risk assessment. Use, toxicity, fate and exposure are considered when characterizing the risk, as
well as the levels of certainty and uncertainty in the assessment.
Table 6. Agency's LOCs and Risk Presumptions
Risk Presumption
Acute Risk - there is potential for acute risk;
regulatory action may be warranted.
Acute Endangered Species - there is potential for
endangered species risk; regulatory action may be
warranted.
Chronic Risk - there is potential for chronic risk;
regulatory action may be warranted.
LOC
Terrestrial Animals
0.5
0.1
1
LOC
Aquatic Animals
0.5
0.05
1
LOC
Plants
1
1
N/A
Copper is an essential nutrient required for proper homeostasis in all organisms. Most
organisms have homeostatic mechanisms to process excess copper or to manage the deficiency
of copper levels. However, aquatic animals are exposed to copper by more than just dietary
routes, and are more sensitive to copper than terrestrial animals. The mode of toxicity for
aquatic organisms is different than for terrestrial animals in that copper rapidly binds and causes
damage to the gill membranes, and interferes with osmoregulatory processes. Aquatic plants,
which are target organisms for most direct aquatic uses of copper, are also more sensitive to
copper than terrestrial plants.
The toxicity of copper to aquatic animals depends on the amount of bioavailable cupric
ion in the water. To address potential risk to freshwater organisms, the Agency used the Biotic-
Ligand Model (BLM) (Windows Version 2.0.0, 4/03) in addition to standard current methods to
assess exposure and toxicity to potentially exposed freshwater organisms. The BLM method is
discussed in greater detail below.
The BLM has not yet been parameterized for estuarine/marine organisms, as it has for
freshwater animals. This would require evaluating data for specific estuarine/marine species
under a sufficient range of water quality conditions to determine the effect of these conditions on
copper toxicity. Therefore, since the BLM could not be used, RQs for estuarine/marine animals
were calculated using estimates of total dissolved copper, and are therefore calculated using
conservative exposure values. For freshwater plants, saltwater organisms and terrestrial animals
and plants, standard Agency models and methods were used to assess potential copper
exposures.
For a more detailed explanation of the ecological risks posed by the agricultural use of
coppers, refer to Error Corrections for the Ecological Risk Assessment for Re-Registration of
copper sulfate (case #0636), group II copper compounds (case #0649), and copper salts (case
#0649) for use on crops and as direct water applications, dated April 20, 2006.
36
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a. Aquatic Organisms
1. Freshwater Fish and Invertebrates
Agricultural Uses
The EECs of total dissolved copper (versus Cu2+ only) in surface water resulting from
agricultural uses of copper pesticides were simulated using the Agency's standard pesticide
transport models PRZM and EXAMS (PRZM/EXAMS). However, the selection of input
parameters for these models was complicated by the elemental nature of copper.
PRZM/EXAMS require input for both persistence and mobility of the pesticide, and while the
various formulations of copper are assumed in the risk assessment to dissociate immediately in
water to release the cupric ion, the cupric ion itself does not degrade. All metabolism and
degradation parameters were set with half-lives long enough that copper would essentially not
degrade over the 30-year simulation. The one exception was the use of a 10-day aquatic
dissipation half-life in place of an aerobic aquatic metabolism half-life in EXAMS. This allowed
consideration of chronic exposure in the water column, imitating the preferential partitioning of
copper away from the dissolved phase and into a bound state in sediment. Soil partitioning
coefficients for sand and clay soils were used to allow consideration of scenarios in which
greater and lesser amounts of copper were bound to the soil.
Thirty-two separate PRZM/EXAMS modeling scenarios were selected to represent the
various crop groupings, which provided a range of geographic conditions and use rates. Use
rates for copper sulfate, copper sulfate pentahydrate, and copper hydroxide were derived from
representative labels. Because of the vast array of labels, a representative subset of labels was
chosen to assess the range of copper application rates. The screening-level risk assessment was
based on use sites with the highest application rates found for agricultural uses on crops that
account for the majority of agricultural use of copper hydroxide and copper sulfate. The number
of applications and application intervals were generally not specified on labels. Therefore, the
modeling was conducted assuming four applications at weekly intervals.
Because the PRZM/EXAMS model cannot account for chemical speciation of copper,
which affects its toxicity, the BLM was used to estimate the cupric ion concentration in surface
water. The BLM, essentially a combined speciation and toxicity model, allows calculation of
toxicity values based on site-specific water chemistry. Use of the BLM in this pesticide risk
assessment is consistent with the method used by the EPA's Office of Water (OW), which used
the BLM to revise the Aquatic Life Criteria (ALC) for copper in 2003. EPA OW is currently
preparing guidance on the use of the BLM to derive site-specific ALC for copper based on site-
specific water chemistry. Figure 2 describes the use of the BLM in the ecological risk
assessment.
37
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Exposure:
Developing Activity-based
Site Specific EECs
Effects:
Developing Activity-
based
Site Specific LC50s
PRZM/EXAMS
SIMULATIONS
(Site Specific
Scenarios)
EECs (ppb)
[Cu]
total dissolved
Site Specific
USGS Water Quality
Monitoring Data
Biotic Ligand Model
(Toxicity Mode)
Biotic Ligand Model
(Speciation Mode)
Site Specific
Daphnia magna LC50 (ppb)
T
r
Site Specific Daphnia magna
LC50 (mol Cu2+/L)
Site Specific RQs
Daphnia magna
(unitless)
Figure 2. Site-specific aquatic assessment using the BLM
For the copper pesticides risk assessment, PRZM/EXAMS estimated total copper
concentrations (peak and 21-day average concentration) for low Kd (sandy soil) and high Kd
(clay soil) for each crop scenario to derive the copper input concentration in the BLM model. In
order to portion out speciated copper among its various forms in water, the BLM also requires
water quality input parameters which are mostly not input parameters for PRZM/EXAMS.
Water quality input parameters for the BLM model were populated using United States
Geological Service (USGS) water quality monitoring data for filtered water, from nationwide
monitoring programs such as NAWQA and NASQAN. The USGS water quality monitoring
data were censored to remove all samples with water input parameters outside the range of the
model. The samples that were removed were excluded predominantly for having water
temperature higher than the range handled by the BLM. However, the other water quality
parameters from these samples suggest that the copper exposure and toxicity that would result
would likely be within the range for the large number of USGS samples that were used in the
BLM.
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Eight-hundred eleven USGS sites representing median water quality conditions were
used in the BLM to assess a representative range of water column conditions in surface water
across the United States. Median conditions were selected rather than worst case conditions
because they represent the conditions most likely to occur. Table 7 describes the range of water
quality data inputs used in the BLM. Variability across sites is expected to be greater than
variability at a single site. BLM simulations provided an estimation of the cupric ion activity
(moles/liter) in water for each of the 811 sites.
Table 7. Summary of USGS Water Quality Data Used in the BLM1
Parameter
Temperature
pH
Cu
DOC
Humic Acid2
Ca2+
Mg2+
Na+
K+
so42-
cr
Alkalinity
s2-
Units
°C
none
ug/L
mg/L
%
mg/L
mg/L
mg/L
mg/L
mg/L
mg/L
mg/L
mg/L
Data Range for
BLM
10 to 25
4.9 to 9.2
ND
0.05 to 29.65
10 to 60
0.204 to 120.24
0.024 to 51. 9
0.16 to 236.9
0.039 to 278.4
0.096 to 278.4
0.32 to 279.72
1.99 to 360
ND
Missing
Data
0
0
363
0
0
0
0
0
0
0
0
0
811
Low Value
10
5.05
1.0
0.2
10
0.95
0.18
0.88
0.09
0.10
0.32
2.0
ND
High
Value
24.5
9.2
51.4
29.2
29.15
114
51.8
190
18
270
266
311
ND
Median
Value
17.4
8.0
1.2
3.00
14.90
37.6
10.6
10.3
2.2
26.1
11
116
ND
Average
Value
17.2
7.85
2.61
4.06
16.69
40.62
13.02
21.09
2.93
44.46
22.66
120.61
ND
1 - Data represent median site water quality conditions within the range of data for development of BLM
2 - Humic acid percentage was estimated from the DOC concentration
ND - No data available, oxic conditions assumed
Typically, the Agency would calculate RQs using the most sensitive LCso for a
taxonomic group and the 1-in-10-year acute and chronic EECs from PRZM/EXAMS. However,
potential copper toxicity in natural waters is largely a function of water chemistry, so the toxicity
to a particular organism will vary from site to site. Copper is most toxic in waters of low ionic
strength and/or low in dissolved organic carbon (DOC). The pH of the water also affects
toxicity.
Because the toxicity of copper varies greatly depending on water chemistry, the same
water chemistry data collected by USGS was input to the BLM to calculate LCsoS for Daphnia
magna (cladoceran, representing aquatic invertebrates), and Pimephalespromelas (fathead
minnow, representing fish). Daphnia were the most sensitive genera of aquatic invertebrates for
which data were available, and the most sensitive aquatic species overall. Salmonids (genus
Onchorynchus; genus mean acute value (GMAV) of 29.11 |ig/L) are the most sensitive fish
species, but at the time of this assessment, the BLM had not yet been implemented to calculate
39
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the LCso for this genus, thus the fathead minnow LCsoS produced by the BLM was adjusted by
the ratio of the Onchorynchus GMAV to the Pimephales GMAV (29.11 |ig/L:72.07 |ig/L;
adjustment factor 0.404).
The chronic toxicity of copper to aquatic animals was also calculated in a manner
consistent with that used by OW to derive ALC for copper. The minimum data requirements for
developing chronic ALC were not met, so OW elected to use the acute-to-chronic ratio (ACR)
approach to derive chronic criteria. OW determined an ACR of 3.23 for freshwater organisms,
which was a central value derived from a range of ACRs for freshwater species for which both
acute and chronic toxicity data were available. For the ecological risk assessment, the ACR was
applied to the acute toxicity value for each of the 811 sites to establish a chronic toxicity value
for RQ calculation.
At the time the ecological risk assessment for copper pesticides was conducted, many
product labels had inconsistent information on the maximum amount of copper that can be used
on many crops. The ecological risk assessment assumes four applications applied one week
apart at the maximum label rate in cases when the maximum rates and minimum intervals are not
described on the label. In order to allow an evaluation of potential risk at different application
rates that might be established on revised copper labels, the Agency performed a regression on
the peak cupric ion concentrations based on various application rates in the 32 PRZM/EXAMS
simulations run for copper. The data points used to calculate the regression and the resulting
regression equation are shown in Figure 3, below.
Relationship of Cu Application Rate
and Peak Cu Concentration
100
80 -
60 -
40 -
20 -
Y=-0.3800+2.5358(X) I2=0.75
10
15
20
25
30
35
2+
Cu Application Rate (Ib Cu/A)
Figure 3 - Correlation of Peak Cu Concentrations in the Standard Small Water Body with
Application Rates
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The peak cupric ion concentrations generated from PRZM/EXAMS were the inputs used
in the BLM. Using the BLM to estimate site-specific cupric ion concentrations and toxicity
endpoints, individual RQs were calculated for each of the 811 USGS sample sites. The resulting
RQs were compared to the Agency's LOCs for aquatic animals. The potential for acute risk to
aquatic animals is described in terms of percentages of the 811 sites that exceed the Agency's
LOG for a range of potential application rates.
The screening-level risk assessment indicates that there are risks greater than the LOG to
freshwater invertebrates from terrestrial uses of copper at some portion of the 811 sites modeled,
regardless of the application rate. At the maximum label application rate considered in the risk
assessment, 31.8 pounds of metallic copper per acre (Ibs Cu2+/A) for filberts, RQs for nearly all
sites exceeded the acute and chronic LOCs. Over 99% of the sites exceeded the acute LOG for
invertebrates, and 80% exceeded for fish. Over 98% of the sites exceeded the chronic LOG for
invertebrates and 44.9% exceeded for fish.
The percentage of sites for which RQs exceed the acute LOG is significantly less for
typical rates more likely to be applied. The percentage of sites ranges from 3.2% at 1.0 Ib
Cu2+/A, and increases to about 25% of sites at an application rate of 7.5 Ibs Cu2+/A. The RQs
derived for freshwater fish with the BLM exceed the acute LOG for less than 1% of sites for
application rates of 1.0 Ib Cu2+/A and above.
The same exposure estimates translate into a greater number of sites exceeding the acute
endangered species LOG of 0.05. As shown in Table 8 below, even at a rate of 1.0 Ib Cu2+/A,
aquatic RQs exceed that LOG in 19% of the 811 sites for freshwater invertebrates, while only
exceeding the LOG for 1% of those sites for freshwater fish. The level of exceedence of the
acute endangered species LOG for freshwater invertebrates and fish increases to 84% and 17%,
respectively, based on an application rate of 7.5 Ibs Cu2+/A.
Table 8. Summary of Acute LOG Exceedences in Freshwater Environments from Agricultural Uses
Rate
Ibs Cu2+/A (ppb)
1.0 (2.2)
1.5 (3.4)
3.0 (7.2)
5.0(12.3)
7.5 (18.6)
Acute
Invertebrate1
3.2%
5.0%
10.3%
17.0%
24.6%
Fish1
<1%
<1%
<1%
<1%
<1%
Acute Endangered Species
Invertebrate1
19.0%
29.6%
53.4%
71.5%
84.0%
Fish1
1.0%
1.4%
6.0%
10.4%
17.1%
1 Presented in terms of the percentage of sites in the USGS data set exceeding the acute risk LOG or acute
endangered species LOG.
As part of the development of the ALC for copper, OW derived an acute-to-chronic ratio
(ACR) of 3.23 for freshwater organisms (USEPA 2003a). The BLM only estimates acute
toxicity, so the ACR was applied to site specific LC50s for both the daphnids and salmonids to
generate site specific chronic toxicity values. These were compared to the 21-day EECs
speciated by the BLM to derive chronic RQs. Table 9 shows the percentage of sites for which
freshwater animal RQs exceed the chronic LOG. RQs for fish are usually calculated using the
41
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60-day EEC, but a suitable regression could not be fit to the 60-day EECs from the 32
PRZM/EXAMS scenarios. Therefore, although RQs for few sites exceed the chronic LOG for
fish at rates up to 7.5 Ib Cu2+/A, the assessment should be considered conservative because the
21-day EECs are higher than 60-day EECs for any particular site.
Table 9. Summary of Chronic Risk LOG Exceedences in Aquatic Environments
Rate
Ibs Cu2+/A(Cu ppb)
1.0 (2.2)
1.5 (2.9)
3.0 (5.3)
5.0 (8.4)
7.5(12.3)
Freshwater
Invertebrate1
4.2%
6.3%
13.4%
22.2%
32.4%
Fish1
0.0%
0.1%
1.0%
2.5%
5.3%
Presented in terms of percentage of sites in the USGS data set exceeding the chronic risk LOCs
The distribution of the 811 RQ values reflects the distribution of the water quality
parameters from the 811 USGS sampling sites. Therefore, the shape of the distribution is the
same for each application rate. An example from the ecological risk assessment shows the range
of RQs for application to apples at an application rate of 3.8 Ibs Cu2+/A. Table 10 below shows
that the acute LOCs are exceeded for freshwater invertebrates, with a RQ range of 0.01 to 498.
The median value, however, is 0.47. Although nearly half of the RQs exceed the acute LOG of
0.5, the distribution of RQs is skewed toward the lower values in the distribution. The acute RQ
distribution for fish and the chronic RQ distribution for invertebrates and fish show this same
pattern.
Table 10. Aquatic RQ Summary: Orchard Average Application Rate (3.8 Ibs Cu2+/A)
Endpoint for RQ
Minimum RQ
Median RQ
Maximum RQ
Acute
Invertebrate
Fish
0.01
0.00
0.47
0.02
498
41
Chronic
Invertebrate
Fish
0.02
0.01
0.66
0.05
352
6.1
Acute LOG for invertebrates and fish = 0.5, Acute endangered species LOG for invertebrates and fish = 0.05, acute,
chronic LOG for invertebrates, fish =1.0
Exposure via Spray Drift
There is some uncertainty in the level of exceedances because spray drift was not
included as part of the potential total copper exposure in the BLM analysis. The assessment did
not include spray drift because the labels did not specify the method by which copper would be
applied. A screening-level spray drift analysis was conducted separately in the revised risk
assessment to evaluate the impact of copper spray drift from terrestrial crop uses on aquatic
environments. The analysis assumes drift loadings of 5% of the application rate for aerial spray
and 1% of application rate for ground spray into the standard farm pond used in EXAMS. Peak
42
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concentrations of copper from spray drift were speciated using the BLM model to estimate the
concentration of cupric ion in the pond. Median USGS monitoring site water quality data for the
811 sites were used as input parameters for the BLM model.
Site exceedences of the aquatic LOG and endangered species aquatic LOG were found
for both ground and aerial spray drift loadings. At the highest application rate proposed for
reregi strati on (6 Ibs Cu2+/A, for filberts), a single aerial application would result in 28% and 5%
of sites exceeding the acute LOG for freshwater invertebrates and fish, respectively. A
corresponding ground spray application would result in 7% and 4% exceedances, respectively.
The same simulated exposure suggests that the freshwater invertebrate endangered species LOG
would be exceeded at 89% and 32% of sites from aerial and ground spray, respectively. Lower
application rates associated with other crops would result in lower estimated exposure, and a
smaller percentage of sites at which the LOCs would be exceeded.
Uncertainties in Freshwater Animal Risk Assessment
There is some uncertainty in the level of exceedances of the acute and acute endangered
species LOCs from agricultural uses of copper, because the regression used to predict the
exposure input to the BLM was derived from 32 scenarios representing climatic and soil
conditions from around the country. In addition, the peak value from each of the 32 scenarios
was from a single year of modeling with PRZM/EXAMS. Standard exposure assessments with
PRZM/EXAMS simulate 30 years of applications with 30 years of daily rainfall and climate data
from a nearby weather station. Since elemental copper does not degrade, the effect of 30 years
of applications would be to accumulate copper in the static pond simulated by EXAMS. The
EEC simulated from the first of the 30 years of data would likely be less than the standard 1-in-
10-year exposure value calculated from a full 30-year simulation, although some of the 32 sites
would simulate heavier rainfall in that single year, and others would simulate light rainfall years.
The choice of the soil-partitioning coefficient (Kd) used as input to PRZM/EXAMS
served to make the estimated number of sites with RQs exceeding acute and chronic LOCs more
conservative. The environmental fate assessment reports a range of Kd values from 0.4 L/g (sand
soil) to 3.6 L/g(clay soil). PRZM-EXAMS models were used to estimate copper concentrations
for the low Kd and high Kd values for each crop scenario to derive the copper input concentration
for the BLM model. The regression used to estimate EECs for different application rates used
the output from the low Kd modeling runs, which causes the model to simulate more copper
transport from the field, and more copper in the dissolved phase in the pond (and less in the bed
sediment). This results in higher copper input to the BLM, and a conservative estimate of the
number of sites that would exceed an LOG for a particular application rate.
In addition, the number of applications and application interval was not the same for all
32 simulations, although the majority of them assumed four applications spaced a week apart.
The need to assume a number of applications and an application interval is a result of
inconsistent product labels for copper pesticides which do not specify the maximum number of
applications and minimum treatment interval. Imprecise product labels (unspecified application
intervals and application frequencies) represent the greatest source of uncertainty in the
43
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ecological risk assessment for copper pesticides. Because the labels do not specify these limits,
the potential maximum loading of the chemical into the environment may grossly underestimate
or overestimate potential risk.
Finally, as mentioned earlier, the mean water quality characteristics from 811 USGS
sampling sites result in a wide range of copper exposure and toxicity values, but may not
represent the full range of potential conditions. This data set of 811 sites represents 47 states (no
sites in Maine, South Carolina, or Virginia), but does not represent every region equally. For
instance, since the available data set was censored to remove any sites with temperature values
outside the range that can be assessed by the BLM, the southeastern United States is not as well
represented as other parts of the country.
Aquatic Uses
The aquatic risk assessment for direct application of copper pesticides to water uses the
EXAMS model in conjunction with the BLM to produce RQs over a range of water quality
conditions. EXAMS accounts for sediment-to-water partitioning, and the BLM incorporates the
effects of copper speciation. Use data indicate a target concentration for algae and aquatic weeds
control of 0.1-1 ppm. For snails, leeches, and other similar organisms, application rates may be
higher, ranging from 1-2.5 ppm. The risk assessment indicates that for an application rate of 1
ppm, peak concentrations of Cu2+ are predicted by EXAMS to be approximately 0.9 ppm if the
pesticide were to be applied to the entire water body. The estimated average 21-day
concentration at this rate is 522 ppb, and the estimated average 60-day concentration is 234 ppb.
For invertebrates, fish, and aquatic plants, >99% of sites exceed the endangered species
LOG and the acute risk LOG at this application rate. The chronic risk LOCs for aquatic
invertebrates, and fish are exceeded at >96% of the sites. The water body simulated by EXAMS
is a 1-hectare, 2-meter deep pond with no outlet. However, were an entire reservoir treated at the
same rate (which would require proportionally more copper), the level of predicted risk would be
the same.
The risk assessment also considers the potential for risk when only a portion of a water
body is treated. The EXAMS model was run in conjunction with the BLM to determine the
percentage of water bodies with characteristics of the 811 USGS samples would that exceed
LOCs for partial applications. A regression of these simulations suggests risk to freshwater fish
and invertebrates.
There is some uncertainty in this finding of risk for partial treatment of water bodies, due
to limitations of the exposure model itself. The EXAMS model simulates instantaneous mixing
of applied pesticide throughout the approximately 20,000,000-liter pond. Therefore, these
simulations of partial treatments are equivalent to full-pond treatments at a fraction of the
maximum application rate. Because of the great variance in water body chemistries across the
US, this will overestimate the potential risk to some aquatic organisms, and underestimate it for
others. The purpose of treating a portion of a water body can be to avoid killing enough plant
matter at one time to sharply increase oxygen-demand, and/or to give mobile aquatic animals the
44
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opportunity to leave the treated area. When only a portion of the water body is treated,
organisms in the vicinity of the treatment can be exposed to the full concentration of copper
applied, while others farther from the treated area may not be exposed at all. This is especially
true for water bodies such as drinking water reservoirs, which are larger than the standard pond
simulated by EXAMS, both because of their size, and the amount of time it takes for total mixing
of water in those water bodies.
However, for almost any direct water application of copper products, there are likely to
be effects on invertebrates and a reduction of primary production. Fish and larger, more mobile
invertebrates may be able to move out of the treated zone until the copper dissipates from the
water column, but smaller and more sedentary invertebrates will be affected. Recovery of the
affected organisms will vary on a site-to-site basis, and the specific effects on any given
ecosystem are impossible to predict given the scale of this assessment. Populations of
phytoplankton and zooplankton (the organisms most likely to be lethally affected by use of
copper) are dynamic. In aquatic systems where copper is applied frequently the community may
shift to more copper tolerant organisms, and/or some of the organisms present may develop
metabolic pathways for dealing with higher copper loading.
The potential risk to aquatic organisms must be considered in conjunction with the
environmental benefit intended for some uses of copper. Excessive algal growth in lakes or
ponds caused by high nutrient input can damage aquatic life by causing high oxygen demand, in
some cases leading to eutrophication. In other cases, copper is used to control invasive aquatic
plants which can out-compete and replace native plants, changing the ecosystem and reducing
food sources for aquatic and terrestrial animals in or near the water. The use of copper for
control of parasites (through snail control) benefits swimmers in recreational waters and fish that
can be infected.
Urban Uses
One of the risk assessment goals of the Office of Pesticide Programs (OPP) is to estimate
pesticide exposure through all significant routes of exposure from both agricultural and non-crop
uses. However, the ecological risk assessment for copper pesticides focuses on the agricultural
uses, because pesticide transport models are available to estimate potential aquatic exposure
from these uses. Based on laboratory toxicity tests with aquatic animals, aquatic exposure could
cause adverse effects in the environment.
Copper is used for a number of non-crop pesticidal uses, including use as a wood
treatment, lawn fungicide, pool and fountain algaecide, sanitary sewer root killer and ingredient
in anti-fouling paints. The wood treatment, anti-foulants, and other antimicrobial uses will be
addressed in a separate ecological risk assessment to be produced at a later date by the Agency's
Antimicrobials Division. This document addresses the root-killer and lawn uses to a limited
degree.
The root-killer use involves flushing two pounds of copper sulfate pentahydrate crystals
(0.5 Ib elemental copper) down a toilet as often as every six months to control tree root growth in
45
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domestic sewer systems. Alternatively, label directions recommend one-half pound of product
each month as a "maintenance" treatment. The copper sulfate pentahydrate crystals cling to
roots and kill them over time.
The ecological risk assessment evaluates the sanitary sewer root-killer use with the
"down-the-drain" model E-FAST 2.0. In these simulations, wastewater containing copper
crystals flows from the building and passes through a sanitary sewer and publicly owned
treatment works (POTW) before being discharged to surface water. The E-FAST model uses the
total national production of a pesticide and distributes it among all households in the nation.
However, since the amount of copper sulfate pentahydrate produced for this use could not be
distinguished from that manufactured for other uses, the ecological risk assessment made the
conservative assumption that each household in the United States applies 0.5 Ib of elemental
copper for root-control two times a year. This equates to approximately 2.2 million pounds of
metallic copper annually. The CSTF subsequently provided a preliminary estimate of potential
use of approximately 857,000 pounds of metallic copper annually. The assessment uses a copper
sulfate removal efficiency at the POTW of 1.8%, which was estimated using the model EPISuite.
The ecological risk assessment took the resulting concentrations of copper and used them
as input to the BLM. The resulting site-specific copper concentration estimates were compared
to the toxicity endpoints the BLM generated for each site. The assessment concluded that if all
households in the nation were to apply copper sulfate pentahydrate for root-control at maximum
recommended rates, then the acute LOG would be exceeded for 85% and 20% of model sites for
freshwater invertebrates and fish, respectively. The corresponding percentage of sites for which
the chronic level of concern could be exceeded would be 74% and 13%, respectively. However,
freshwater fish and invertebrates will not be directly exposed to the full amount of copper
applied for root control, since POTWs are required to first treat waste water received from
sanitary sewers.
The finding of risk described above should be considered an upper bound, since not every
household in the United States uses copper sulfate pentahydrate for root control. Since this
product label states that it is not for use in septic systems, even the total number of households
which could potentially use the product is lower than assumed in the risk assessment. However,
the use of copper sulfate pentahydrate in this manner does represent a direct introduction of
copper into the wastewater stream, which was a point of concern for commenters representing
POTWs. Tri-TAC, a technical advisory group for POTWs in California, commented that an
estimated 5 to 12% of copper received by POTWs in their state was a result of root-killer use.
The California Department of Pesticide Regulation has prohibited the use of copper sulfate
pentahydrate in nine counties in California out of concern that POTWs in the San Francisco Bay
area could not comply with water quality criteria for copper if this use continued.
The E-FAST model allowed a conservative, qualitative estimate of potential exposure
from the root-killer use, but no analogous exposure model has been developed to allow a similar
screening-level assessment for pesticides applied in an outdoor urban setting. As a result, the
Agency has had to take a qualitative approach to characterize the potential aquatic risk from
urban and suburban use of copper.
46
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For outdoor urban uses, the Agency assumes that runoff water from rain and/or lawn
watering may transport pesticides to storm sewers and then directly to surface water. Copper
transported by runoff or erosion in an urban setting would take a path not only over lawns, but
also impervious surfaces such as walkways, driveways and streets. The Agency is unaware of
any model which can simulate the different application methods for urban use and the physical
representation of the urban landscape, storm sewer and receiving water configuration.
There are models available which can be calibrated to simulate sites and pesticides for
which extensive flow and pollutant data have been collected in advance. The HSPF/NPSM
model, for instance, which is included in the EPA's BASINS shell, has been used to calibrate
stream flow and copper pesticide use data to simulate loading of these pesticides consistent with
concentrations measured in surface water monitoring. Risk assessors with the California
Department of Environmental Protection confirmed in conversations with the Agency that they
also have used watershed models to calibrate previously collected flow and pesticide monitoring
data, but that they did not know of any models capable of predicting concentrations of pesticides
that might occur because of outdoor urban uses.
Development of a screening model which could simulate the fate and transport of
pesticides applied in an urban setting would require a large body of data which is currently
unavailable. For instance, an urban landscape cannot be simulated as easily as an agricultural
field. The PRZM model simulates runoff from an agricultural field using readily available data
describing surface soil characteristics and laboratory data detailing the persistence and mobility
of pesticides in these soils. The agricultural field simulated is homogenously planted to a single
crop, and soil and water are transported from the field to a receiving water body with dimensions
consistent with USDA farm-pond construction guidelines.
By contrast, an urban landscape or suburban housing development consists of impervious
surfaces such as streets and sidewalks, and pervious surfaces such as lawns and parkland. One
could expect much greater mobility for pesticides applied to impervious surfaces, but laboratory
soil metabolism studies may not provide an accurate measure of the persistence of pesticides on
these surfaces. The path runoff water and eroded sediment might take is less obvious for an
urban setting than an agricultural field. First, an urban landscape cannot be considered
homogeneous, as the proportion of impervious and pervious surfaces varies for different
locations. In addition, the flow path of runoff water and sediment is not necessarily a direct path
over land, but can pass below ground through storm sewer networks, be directed, or slowed by
pumping stations or temporary holding ponds.
Finally, the timing and magnitude of urban uses is less well defined for urban uses than
agricultural uses. While agricultural uses would occur within a predictable window during the
growing season, the need for urban uses could occur at different times each year, and might
occur at different times within the same watershed. In addition, since records of how and to
what extent copper pesticides are applied by homeowners are not well defined, it is harder to
estimate the total load to model.
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2.
Freshwater Plants
Because the BLM has not been parameterized for freshwater plants, it could not be used
to assess potential copper exposure and toxicity from the cupric ion to freshwater plants. RQs
for freshwater plants were calculated using estimates of total dissolved copper using
PRZM/EXAMS, which overestimates the amount of copper that is potentially toxic to exposed
organisms. The RQs for aquatic plants are presented in Table 11 as individual RQs for each
application rate, because the actual toxicity posed by the cupric ion to these organisms cannot yet
be simulated by the BLM.
The most sensitive aquatic plant species tested, the green alga, Selenastrum
capricornutum, (LCso = 3.1 ppb, NOEC = 0.2 ppb) was selected to represent non-vascular
aquatic plants. Duckweed, Lemna minor, (LCso = 2.3 ppm, NOEC = 0.1 ppm) was selected to
represent vascular aquatic plants. Since site-specific exposure and toxicity values for plants were
not generated using the BLM, risk is not described as a percentage of RQs above the LOG; rather
a single RQ is presented for each application rate, with EECs calculated using the regression
described above. Acute RQs based on the green alga, a target species for direct applications of
copper to water, exceed the acute and acute endangered species LOG of 1.0 for application rates
at or above 1 Ib Cu2+/A. RQs for vascular plants do not exceed the acute or acute endangered
species LOCs. Table 11 is a summary of the acute LOG exceedances for aquatic plants.
Table 11. Summary of Acute LOG Exceedences in Aquatic Environments from Agricultural Uses
Rate
Ibs Cu2+/A (ppb)
1.0 (2.2)
1.5 (3.4)
3.0 (7.2)
5.0(12.3)
7.5 (18.6)
Acute
Algae RQ
0.7
1.1
2.3
4.0
6.0
Vascular RQ
<0.01
0.01
0.01
0.01
O.01
Acute Endangered Species
Algae RQ
1.1
1.7
3.6
6.2
9.3
Vascular RQ
0.02
0.03
0.07
0.12
0.19
3.
Estuarine/Marine Fish and Invertebrates
Because the BLM has not been parameterized for estuarine/marine organisms, it could
not be used to assess potential copper exposure and toxicity from the cupric ion to
estuarine/marine animals. RQs for estuarine/marine animals and plants were calculated using
estimates of total dissolved copper using PRZM/EXAMS, which overestimates the amount of
copper that is potentially toxic to exposed organisms. In addition, the water body simulated by
PRZM/EXAMS, a static farm pond with no outflow, is smaller than estuarine and marine water
bodies, and does not take into account the dilutive effect of untreated seawater.
Acute toxicity values for saltwater fish and invertebrates were selected based on the most
sensitive assessed species. The most sensitive invertebrate is the mussel (Mytilus) with an LCso
of 6.49 ppb and the most sensitive fish is the summer flounder (Paralichthys dentatus), with an
LCso of 12.66 ppb. Chronic toxicity data were not available for estuarine/marine animals, so the
48
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ACR of 3.23 used for freshwater animals was used to derive chronic RQs for marine/estuarine
animals.
As for the freshwater organism assessment, RQs for estuarine/marine organisms were
calculated using the same regression on the peak copper concentrations that resulted from
various application rates in the 32 PRZM/EXAMS simulations run for copper. At approximately
3 Ibs Cu2+/A, acute RQs exceedences occur for both fish and invertebrates. Table 12 lists the
acute RQs for marine/estuarine organisms for a range of copper application rates.
Table 12. Risk Quotients for Estuarine/Marine Animals
Application Rate
Ibs Cu2+/A
1.0
1.5
3.0
5.0
7.5
Acute RQ
Fish
0.17
0.27
0.56
0.99
1.5
Invertebrate
0.35
0.55
1.2
2.0
3.0
Chronic RQ
Fish
1.1
1.5
2.8
4.4
6.4
Invertebrate
0.6
0.8
1.3
2.1
3.1
4.
Estuarine/Marine Plants
Because the BLM has not been parameterized for estuarine/marine plants, it could not be
used to assess potential copper exposure and toxicity from the cupric ion to estuarine/marine
plants. RQs for estuarine/marine plants were calculated using estimates of total dissolved copper
using PRZM/EXAMS, which overestimates the amount of copper that is potentially toxic to
exposed organisms. The single estuarine/marine plant species tested, the marine diatom,
Skeletonema costatum, (LCso = 0.25 ppm, NOEC = 0.124 ppm) was selected to represent
estuarine/marine plants.
Since site-specific exposure and toxicity values for plants were not generated using the
BLM, risk is not described as a percentage of RQs above the LOG; rather a single RQ is
presented for each application rate, with EECs calculated using the regression described above.
RQs for estuarine/marine plants do not exceed the acute or acute endangered species LOG of 1.0.
Table 13 summarizes potential acute risk for estuarine/marine plants.
Table 13. Acute Risk Quotients for Estuarine/Marine Plants
Application Rate
Ibs Cu2+/A (Cu ppb)
1.0 (2.2)
1.5 (3.4)
3.0 (7.2)
5.0(12.3)
7.5 (18.6)
Acute RQ
O.01
0.01
0.03
0.05
0.07
Acute Endangered Species RQ
0.02
0.03
0.06
0.1
0.13
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b. Terrestrial Organisms
1. Birds and Mammals
Copper Exposure to Birds and Mammals
For birds and small mammals, dietary exposure to copper was estimated using the
Terrestrial Exposure (TREX, Version 1.1) model. Based on the Kenaga nomogram (Hoerger and
Kenaga 1972, Fletcher et al. 1994), TREX calculates estimated copper resides on food items
animals may consume. In this screening assessment, the Agency assumes that organisms forage
100% of the time in a treated area and that 100% of their diet is comprised of a particular food
item.
A default foliar dissipation half-life for copper of 35 days was assumed, as no foliar
dissipation studies have been submitted for the copper compounds addressed in this RED.
Because copper is an element, it will not degrade by photolysis or hydrolysis into any other
metabolites or other byproducts. Thus, the primary means of removal is wash-off due to
precipitation or irrigation (e.g., drip) that governs how long copper remains on plant surfaces.
Because the amount of wash-off depends on the amount of precipitation, a plant dissipation
study would not capture the variability of wash-off rates across the country; thus, data from this
study would not provide any additional information to reduce any uncertainty or risk. Therefore,
the Agency is not requiring this study at this time.
The Agency modeled potential exposure to terrestrial animals from residues on forage
items based on the highest label application rates and the highest average application rates of
copper for orchard and row crops. Current copper labels indicate that the highest orchard label
application rate is 31.8 Ibs Cu2+/A for filberts and the highest row crop label application rate is
3.2 Ibs Cu2+/A for potatoes. Because intervals between applications and the maximum number
of applications were not specified on the product labels, the Agency assumed four applications
on a weekly basis per growing season. However, based on use data provided by the CSTF and
user groups, typical use is lower. These rates, 3.8 Ibs Cu2+/A for orchards (apples) and 0.8 Ib
Cu2+/A for row crops (potatoes), were also considered in the risk assessment.
Toxicity to Birds and Mammals
Copper is an essential micronutrient to many organisms, including birds and mammals.
Copper atoms are an important component of several enzymes, and reserve copper is stored in
the liver and bone marrow. Unlike aquatic animals, in which toxicity occurs when the cupric ion
binds to the gills, acute poisoning of terrestrial organisms requires dietary ingestion of toxic
levels of copper.
Terrestrial animals have varying degrees of homeostatic capability to metabolize copper
when ingested. Two studies (Johnson and Lee 1988, Yu et al., 1993) estimated copper
absorption in rats from dietary sources. Dependent on dose and method of estimation, absorption
efficiencies for rats with no known metabolic deficiencies ranged from 22-63%. Absorption
efficiency was consistently lower at high doses. Dietary copper concentrations ranged from 0.4-
50
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100 ppm. In a study evaluating bioaccumulation models for mice (Torres and Johnson 2001),
the authors calculated a "GI absorption-elimination factor" of 28% based on data in the ASTDR1
Toxicological Profile for Copper. Thus, it appears that at least up to dietary concentrations
measured in these studies, small mammals have compensatory mechanisms to increase
absorption of copper at low concentrations, and reduce absorption of copper at high
concentrations, at least from dietary sources. No data were located to indicate at what copper
concentration these compensatory mechanisms might be overwhelmed, nor were similar data
available for birds.
The TREX model assumes that 100% of the ingested chemical is bioavailable, and uses
that estimate as an effective dose (adjusted by allometric equations). Based on the existing data,
this does not appear to be the case for copper. Dietary-based endpoints likely incorporate these
uptake effects, but dose-based endpoints will not. In order to account for these mechanisms, an
absorption efficiency correction of 22% (a high copper availability situation) was applied to the
mammal dose-based risk quotient calculations. Bird dose-based calculations were not corrected,
as it is uncertain to what extent the actual percentages may be valid across taxa, and dietary-
based data were available for acute effects.
Coppers are categorized as moderately toxic to birds on an acute oral and dietary basis.
The Agency assessed toxicity to avian species based on the acute oral LD50 of 98 mg/kg-bw, the
acute dietary LCso of 991 ppm of copper in feed and the chronic NOAEL of 58 mg/kg-bw.
Available avian guideline data are described in Table 14 below.
Table 14. Avian Guideline Data
Species
Compound
LD50/LC50
(mg/kg)
LOAEL (mg/kg)
NOAEL (mg/kg)
Acute oral
Bob white
Copper sulfate pentahydrate
as metallic copper
384
98a
ND
ND
Acute dietary
Bob white
Tri-basic copper sulfate
as metallic copper
1829
991a
NR
NR
Reproductive
Bob white
Copper oxychloride sulfate
as metallic copper
NR
500
289
100
58a
toxicity endpoint used in assessment
ND - not determined, NR - not reported
Available oral data on mammals indicate that copper is moderately toxic on an acute
basis. The Agency assessed toxicity to mammals based on the acute oral LD50 of 114 mg/kg-bw.
Because no reproductive or two-generation copper studies conducted with small mammals were
available, the Agency opted to use the chronic NOAEL study conducted on the mink from the
Superfund site-screening guideline studies. The NOAEL in this study was 85.5 mg/kg diet (11.7
Agency for Toxic Substances and Disease Registry
51
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mg/kg-bw on a dose basis). Available acute oral rat toxicity data and chronic mammalian
screening values are described below in Tables 15 and 16, respectively.
Table 15. Acute Oral Toxicity in Rats
Compound
Copper sulfate
pentahydrate
As Copper Compound
LD50
(mg/kg-bw)
790 (male)
450 (female)
As Metallic Copper
LD50
(mg/kg-bw)
200 (male)
114 (female)3
a toxicity endpoint used in assessment
Table 16. Chronic Mammalian Screening Values
Category
Mammals
Test species: mink
Benchmark
NOAEL
11.7mg/kg-bwa
85.5mg/kgdieta
LOAEL
15.1 mg/kg-bw
110.5 mg/kgdiet
Effects
Chronic dietary exposure during reproduction. Effects were
reduced survivorship of kits. Copper dose represented a base in
food (60.5 ppm) plus a supplement (25, 50, 100, and 200 ppm).
At 25 ppm in diet, kit survivorship was greater than in controls.
Reduced survivorship of kits was noted in the 50 ppm treatment
group.
a toxicity endpoint used in assessment
Risk to Birds and Mammals
The terrestrial animal risk assessment for copper pesticides assessed the potential for risk
at the highest application rate on any copper label for use on orchards and on row crops. These
application rates are 31.8 Ibs Cu2+/A for orchards (filberts) and 3.2 Ibs Cu2+/A for row crops
(potatoes). RQs were also calculated for the highest average application rate for orchards and for
row crops, as determined by the best data available to the Agency at the time the risk assessment
was completed. These rates were 3.8 Ibs Cu2+/A for orchards (apples) and 0.8 Ib Cu2+/A for row
crops (potatoes). Because the maximum number of applications and minimum application
interval were not specified on the product labels for these rates, the assessment assumed four
applications spaced seven days apart.
The RQs for the maximum application rates exceeded nearly all acute and chronic LOCs
for all weight classes of birds and mammals. However, as part of the stakeholder process in
formulating risk management decisions, the Agency has worked with copper pesticide registrants
and the user community to revise the labels to require lower application rates and more clearly
defined seasonal maximum use rates. Therefore, the RQs based on average application rates
shown below better reflect the lower rates to be established on revised copper product labels.
The RQs calculated using typical application rates indicate the potential for acute and
chronic risk to birds and mammals from dietary exposure. Dietary toxicity studies, in which
animals are exposed through ingestion of treated feed, would be expected to reflect the ability of
the animals to cope with exposure to a certain amount of copper beyond their dietary need
through homeostasis. However, this coping mechanism was clearly overwhelmed in the animals
which died in the laboratory toxicity tests.
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The design of the laboratory studies leaves some uncertainty in how these effects would
translate to effects in the wild. Birds and mammals in the laboratory studies are only fed treated
feed, and the RQs in the risk assessment also assume that animals will derive 100% of their diet
from treated feed. Although animals in the wild need to eat more than their counterparts in the
laboratory (since lab feed is more nutritious, generally), most birds and mammals will spend only
a fraction of the time in or at the edge of a treated field. Animals which eat untreated feed as a
portion of their diet may have more of an opportunity to cope with ingested copper when the
exposure is not continuous. In addition, animals which are repeatedly exposed to levels of
copper which do not cause permanent harm may undergo enzymatic adaptation which allows
them to cope with greater levels of exposure. The sensitivity to copper toxicity, and the ability to
adapt to repeated exposures, should be expected to vary within species, and between species of
birds and mammals.
Birds
Dose-based and dietary-based endpoints from available avian studies were used to
calculate acute RQs. Chronic endpoints for birds were based on data from reproductive studies
conducted on the bobwhite quail. The EECs are adjusted to reflect potential dietary exposure
based on the size of the animal and the respective amount of feed consumed.
Orchard Applications
The highest label rate for orchard applications was for filberts (31.8 Ibs Cu2+/A). At this
application rate, all size classes of birds exceed the acute, acute endangered species, and chronic
levels of concern for all food items. Table 17 describes the avian RQs for acute dose-based and
dietary-based RQs, and chronic RQs based on orchard labeled rates.
Table 17. Avian RQ Summary - Orchard Maximum Label Rate (31.8 Ibs Cu2+/A)
Feed Item
Short grass
Tall grass
Broadleaf plants/small insects
Fruits/pods/seeds/large insects
Acute dose-based RQs
20g bird
220
101
124
13.8
lOOg bird
98.7
45.3
55.5
6.2
1000 g bird
31.2
14.3
17.5
2.0
Acute
dietary-based RQs
All birds
13.5
6.2
7.6
0.9
Chronic
RQs
All birds
231
106
130
14.5
The highest average rate for orchard applications was for apples (3.8 Ibs Cu +/A). At this
application rate, all size classes of birds exceed the endangered species acute risk LOG and the
chronic risk LOG for all food items. Birds consuming the short grass, tall grass, and broadleaf
plants food categories all exceed the acute risk and chronic risk LOCs, whereas with the fruit
food item, larger birds and birds assessed with dietary-based endpoints are below the acute risk
LOG. Table 18 describes the avian RQs for acute dose-based and dietary-based RQs, and
chronic RQs based on orchard average application rate of 3.8 Ibs Cu2+/A.
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Table 18. Avian RQ Summary - Orchard Average Rate (3.8 Ibs Cuz7A)
Feed item
Short grass
Tall grass
Broadleaf plants/small insects
Fruits/pods/seeds/large insects
Acute dose-based RQs
20g bird
49.3
22.6
27.7
3.1
lOOg bird
22.1
10.1
12.4
1.4
1000 g bird
7.0
3.2
4.0
0.4
Acute
dietary-based RQs
All birds
3.0
1.4
1.7
0.2
Chronic
RQs
All birds
51.7
23.7
29.1
3.2
Row Crop Applications
The highest label rate for row crop applications was for potatoes (3.2 Ibs Cu2+/A). At this
application rate, all size classes of birds consuming the short grass, tall grass, and broadleaf plant
food categories exceed the acute risk levels of concern. The small (20g) and medium (lOOg)
birds consuming a diet of fruits, pods, seeds, or large insects exceed the acute risk LOG, using
the dose-based calculation. All size classes of birds consuming all food types exceed the
endangered species acute risk LOG and the chronic risk LOG. Table 19 describes the avian RQs
for acute dose-based and dietary-based RQs, and chronic RQs based on row crop maximum
application rate of 3.2 Ibs Cu2+/A.
Table 19. Avian RQ Summary - Row Crop Maximum Label Rate (3.2 Ibs Cuz7A)
Feed Item
Short grass
Tall grass
Broadleaf plants/small insects
Fruits/pods/seeds/large insects
Acute dose-based RQs
20g bird
41.5
19.0
23.3
2.6
lOOg bird
18.6
8.5
10.5
1.2
lOOOg bird
5.9
2.7
3.3
0.4
Acute
dietary-based RQs
All birds
2.6
1.2
1.4
0.2
Chronic RQs
All birds
43.5
20.0
24.5
2.7
The highest average rate for row crop applications was for potatoes (0.8 Ib Cu2+/A). At
this application rate, birds consuming the short grass, tall grass, and broadleaf plant categories
exceed the endangered species acute risk LOG and the chronic risk LOG. Using dose-based
RQs, all bird consuming these food categories also exceed the acute risk LOG. Only birds
consuming short grass exceed the acute risk LOG using the dietary-based RQs. Birds consuming
the fruits and pods food category exceed the endangered species acute risk LOG using dose-
based RQs, but not dietary-based RQs. Only the small bird (20g) in this category exceeds the
acute risk LOG using the dose-based RQ. Table 20 describes the avian RQs for acute dose-based
and dietary-based RQs, and chronic RQs based on row crop average application rate of 0.8 Ib
Cu2+/A.
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Table 20. Avian RQ Summary - Row Crop Average Rate (0.8 Ib Cuz7A)
Feed Item
Short grass
Tall grass
Broadleaf plants/small insects
Fruits/pods/seeds/large insects
Acute dose-based RQs
20g bird
10.4
4.8
5.8
0.7
lOOg bird
4.7
2.1
2.6
0.3
1000 g bird
1.47
0.67
0.83
0.1
Acute
dietary-based RQs
All birds
0.6
0.3
0.4
<0.1
Chronic
RQs
All birds
10.9
5.0
6.1
0.7
Mammals
Acute RQs from dose-based acute mammalian studies have been adjusted to include a
22% absorption factor to account for dietary effects described above. Because dietary-based
chronic data were available, the chronic dose-based values were not adjusted.
Orchard Applications
The highest labeled application rate for orchard use was for filberts at 31.8 Ibs Cu2+/A,
assuming four applications at weekly intervals. At this application rate, RQs for all size classes
of mammals consuming plants or small insects exceed the acute risk, endangered species acute
risk, and chronic risk LOCs. Except for l,000g granivores, all size classes and food groups
evaluated exceed the endangered species acute risk LOG. Table 21 summarizes acute and
chronic risks to mammals.
Table 21. Mammal RQ Summary - Orchard Maximum Label Rates (31.8 Ibs Cu2+/A)
Feed Items
Short grass
Tall grass
Broadleaf plants/small insects
Fruits/pods/seeds/large insects
Seeds (granivores)
Acute dose-based RQs
(adjusted for 22%
absorption efficiency)
15g
11.2
5.1
6.3
0.7
0.15
35g
9.6
4.4
5.4
0.6
0.14
lOOOg
5.1
2.3
2.8
0.3
0.06
Chronic dose-based RQs
15g
381
175
214
23.8
5.3
35g
327
150
184
20.5
4.7
lOOOg
172
78.8
96.8
10.8
2.2
Chronic
dietary-based RQs
All mammals
157
71.9
88.3
9.8
Not determined
The highest average application rate for orchard use was apples at 3.8 Ibs Cu2+/A (4
applications, 7-day interval). RQs for all size classes of organisms consuming the short grass,
tall grass, broadleaf plants, and small insects exceed both the acute risk LOG and the endangered
species LOG. Endangered species acute risk LOCs are also exceeded for the 15g and 35g
mammals consuming fruits and large insects. RQs for all diet classes exceed the chronic risk
LOG. RQs presented below are based on upper-bound EECs from the Kenaga nomogram
(Hoerger and Kenaga 1972, Fletcher et al. 1994). Table 22 describes the mammalian RQs for
55
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acute dose-based and dietary-based RQs, and chronic RQs based on orchard average application
rateof3.81bsCu2+/A.
Table 22. Mammal RQ Summary - Orchard Average Rate (3.8 Ibs Cu /A)
Feed item
Short grass
Tall grass
Broadleaf plants/small insects
Fruits/pods/seeds/large insects
Seeds (granivores)
Acute dose-based RQs
(adjusted for 22%
absorption efficiency)
15g
2.5
1.2
1.4
0.16
0.03
35g
2.2
0.98
1.21
0.13
0.03
lOOOg
1.13
0.52
0.63
0.07
0.01
Chronic dose-based RQs
15g
85.2
39.1
47.9
5.3
1.2
35g
73.2
33.5
41.2
4.6
1.0
lOOOg
38.5
17.6
21.6
2.4
0.5
Chronic
dietary-based RQs
All mammals
35.1
16.1
19.7
2.2
Not determined
Row Crop Applications
The highest average application rate for row crop use was potatoes at 0.8 Ib Cu2+/A (4
applications, 7-day interval). Only the RQs for the small mammals consuming short grass
exceed the acute risk LOG, although RQs for all size classes of mammals consuming grass,
broadleaf plants, and small insects exceed the endangered species acute risk LOG. Dietary-based
RQs for the mammals consuming grass, broadleaf plants, and small insects exceed the chronic
LOG. RQs presented below are based on upper-bound EECs from the Kenaga nomogram
(Hoerger and Kenaga 1972, Fletcher et al. 1994). Table 23 describes the mammalian RQs for
acute dose-based and dietary-based RQs, and chronic RQs based on row crop average
application rate of 0.8 Ib Cu2+/A.
Table 23. Mammal RQ Summary - Row Crop Average Rates (0.8 Ib Cu2+/A)
Feed item
Short grass
Tall grass
Broadleaf plants/small insects
Fruits/pods/seeds/large insects
Seeds (granivores)
Acute dose-based RQs
(adjusted for 22%
absorption efficiency)
15g
0.53
0.24
0.30
0.03
0.01
35g
0.45
0.21
0.25
0.03
0.01
lOOOg
0.24
0.11
0.13
0.01
0.01
Chronic dose-based RQs
15g
17.9
8.2
10.1
1.1
0.3
35g
15.4
7.1
8.7
1.0
0.2
lOOOg
8.1
3.8
4.6
0.5
0.1
Chronic
dietary-based RQs
All mammals
7.4
3.4
4.2
0.5
Not Determined
2. Nontarget Insects
Available data from a honey bee acute toxicity study indicated that copper is practically
nontoxic to honey bees, with an acute LD50 > 100 jig/bee. However, because exposure estimates
56
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for other insects cannot readily be determined, the potential risk of copper pesticides to other
insects is unknown.
3. Terrestrial Plants
The Agency assessed potential indirect exposure and risk to plants adjacent to treated
areas. The Agency used the TerrPlant model, which calculates EECs for upland and wetland
areas adjacent to the application site based on a combination of the potential runoff from the field
and spray drift from the method of application. This type of exposure is then compared to
seedling emergence endpoints to derive acute RQs. To assess effects from spray drift, estimated
EECs are compared against a vegetative vigor endpoint to derive "drift only" RQs.
The Agency could not conduct a complete terrestrial plant risk assessment, since the
toxicity dataset for copper is incomplete. Vegetative vigor data for both monocots and dicots
were available from the public literature, but no suitable data from the registrant or open
literature were found to evaluate the effects of copper on seedling emergence. Therefore, it was
only possible to assess the potential risk from drift of copper pesticides alone. Copper is not
expected to pose a risk to plants through its fungistatic mode of action. As described above, data
available through the ECOTOX database were used to determine that copper pesticides does not
appear to pose a risk to terrestrial plants via adverse effects to vegetative vigor. Furthermore,
copper did not exceed the acute or endangered species levels-of-concern for vascular aquatic
plants. Hence, no additional data is required at this time, as it appears unlikely that copper would
pose a risk to terrestrial plants.
Consideration of terrestrial plant exposure from drift from the highest label application
rates for copper are sufficient to evaluate the potential risk from vegetative vigor effects. The
highest orchard application rate on copper labels at the time the risk assessment was developed
was 31.8 Ibs Cu2+/A for filberts. Because the Terr-Plant model assumes a default spray drift
exposure of 1% of applied pesticide for ground-spray applications, and 5% for aerial
applications, the drift exposure from that maximum application rate is 0.03 Ib Cu2+/A and 0.16 Ib
Cu2+/A, respectively.
Raw data to calculate the EC25 (used to determine the acute RQ) were not available. The
more sensitive NOAEC, which is used to evaluate potential effects on endangered plants, was
available for both monocots and dicots. Hence, RQs were calculated for endangered species
vegetative vigor endpoints for both monocots and dicots, also using the maximum label rates for
orchards of 31.8 Ibs Cu2+/A. As with other effects endpoints, the data were corrected to express
the toxicity value in terms of elemental copper. No RQs exceeded the acute endangered species
LOG at this rate, which is substantially higher than the maximum application rate on filberts will
be after mitigation measures detailed in Section IV take effect. Therefore, there appears to be no
acute risk to non-endangered or listed terrestrial plants from spray drift. Toxicity endpoints and
RQs for terrestrial plants are summarized below in Table 24.
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Table 24. Coppers RQs for Terrestrial Plants for Spray Drift
Plant Type
Monocot
Dicot
Type of Endpoint
Vegetative vigor
NOAEC
(Ibs Cu2+/Acre)
6.8
36.7
Acute Endangered Species RQ
Ground Spray
0.05
0.01
Aerial, airblast, spray
chemigation
0.24
0.04
c. Endangered Species
The risk assessment for copper pesticides indicates a potential for direct effects on listed
species as noted below, should exposure actually occur at modeled levels:
Terrestrial organisms
o
o
Mammals
Acute RQs exceed the endangered species LOG for all mammals feeding
on short grass, tall grass, broadleaf forage and small insects for all
application rates modeled.
Chronic RQs exceed the LOG for all mammals feeding on short grass, tall
grass, broadleaf forage and small insects, and fruits/pods/seeds/large
insects for all rates modeled (except lOOOg mammals feeding on
fruits/pods/seeds/large insects for application rate of 0.8 Ib Cu2+/A). The
chronic RQ for granivores exceeds for smaller mammals at higher
application rates (such as the 3.8 Ibs Cu2+/A representing an average
orchard application rate).
Birds
o
o
Acute RQs exceed the endangered species LOG for birds feeding on short
grass, tall grass, broadleaf forage and small insects, and
fruits/pods/seeds/large insects for all application rates modeled.
Chronic RQs exceed the LOG for all birds feeding on short grass, tall
grass, broadleaf forage and small insects, and fruits/pods/seeds/large
insects for all rates modeled (except for birds feeding on
fruits/pods/seeds/large insects for application rate of 0.8 Ib Cu2+/A). The
chronic RQ for birds feeding on fruits/pods/seeds/large insects exceeds the
LOG at higher application rates (such as the 3.8 Ibs Cu2+/A representing
an average orchard application rate).
Aquatic Organisms
Freshwater animals
o The percentage of acute RQs for freshwater fish modeled with
PRZM/EXAMS and the BLM that exceed the endangered species LOG
ranges from 1.0% at 1.0 Ib Cu2+/A to 17.1% at 7.5 Ibs Cu2+/A for
agricultural uses of copper.
58
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o The percentage of acute RQs for freshwater invertebrates modeled with
PRZM/EXAMS and the BLM that exceed the endangered species LOG
ranges from 19.0% at 1.0 Ib Cu2+/A to 84.0% at 7.5 Ibs Cu2+/A for
agricultural uses of copper .
o The percentage of chronic RQs for freshwater fish modeled with
PRZM/EXAMS and the BLM that exceed the endangered species LOG
ranges from 0.0% at 1.0 Ib Cu2+/A to 5.3% at 7.5 Ibs Cu2+/A for
agricultural uses of copper.
o The percentage of chronic RQs for freshwater invertebrates modeled with
PRZM/EXAMS and the BLM that exceed the endangered species LOG
ranges from 4.2% at 1.0 Ib Cu2+/A to 32.4% at 7.5 Ibs Cu2+/A for
agricultural uses of copper.
o For freshwater invertebrates and fish, >99% of sites modeled with
PRZM/EXAMS and the BLM exceed the acute endangered species LOG
at an application rate of 1 ppm.
Estuarine/Marine
o The acute endangered species LOG is exceeded for estuarine/marine fish
and invertebrates for agricultural uses at application rates of 1.0 Ib Cu2+/A
and above.
o The chronic endangered species LOG is exceeded for estuarine/marine
fish for agricultural uses at application rates of 1.0 Ib Cu2+/A and above.
o The chronic endangered species LOG is exceeded for estuarine/marine
invertebrates for agricultural uses at application rates of around 3.0 Ibs
Cu2+/A and higher.
Plants
o The acute endangered species LOG is exceeded for non-vascular
freshwater plants for agricultural uses at application rates of 1.0 Ib Cu2+/A
and higher.
Further, potential indirect effects to any listed species dependent upon a species that
experiences effects from use of copper can not be precluded based on the screening level
ecological risk assessment. These conclusions are based solely on EPA's screening-level
assessment and do not constitute "may effect" findings under the Endangered Species Act for
any listed species.
3. Ecological Incidents
Although copper pesticides have been used for over one hundred years and several
million pounds of copper are applied each year, there are relatively few reported incidents
associated with copper compounds. For the active ingredients addressed in this RED, the
Agency's Ecological Incident Information System (EIIS) reports 24 incidents related to copper
pesticide applications. Of the 24 incidents, seven were associated with terrestrial plants with
certainty rated as possible or probable. One reported case of damage to tomatoes in Washington
state occurred when copper applications were made according to labeled use instructions. The
other six incidents affecting corn and peanuts in Indiana, Minnesota and Oklahoma, reported
59
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effects including plant damage, incapacitation and pinched corn ears. None of these six incidents
reported the legality of the use. Seventeen of the incidents were associated with kills of aquatic
organisms, primarily consisting offish. Of these incidents, ten were classified as possible,
probable or highly probable, with the assumption that coppers were used in accordance with the
registered label. Reported incidents were generally fish kills, with deaths ranging from 100 to
1,000, with the exception of one case in New York, where the report states that over one million
fish were killed. In all cases, mortalities effects were reported, but the mechanisms of toxicity
were not specified (direct toxicity or secondary effects such as low dissolved oxygen). The
remaining aquatic incidents were cases of misuse or described effects which are unlikely to be
related to copper pesticide applications.
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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
ingredients are eligible for reregi strati on. The Agency has previously identified and required the
submission of the generic data required to support reregi strati on of products containing copper as
an active ingredient. The Agency has completed its review of these generic data and has
determined that the data are sufficient to support reregi strati on of all products containing copper
that have registered agricultural uses.
The Agency has completed its assessment of the dietary, occupational, residential, and
ecological risk (agricultural uses only) associated with the use of pesticide products containing
the active ingredient copper. Based on a review of these data and on public comments on the
Agency's assessments for copper, the Agency has sufficient information on the human health
and ecological effects of copper to make decisions as part of the tolerance reassessment process
under FFDCA and reregi strati on process under FIFRA, as amended by FQPA. The Agency has
determined that copper-containing products registered for agricultural uses are eligible for
reregi strati on provided that the risk mitigation measures outlined in this document are adopted
and label amendments are made to reflect these measures. Label changes are described in
Section V. The antimicrobial ecological assessment of copper compounds will be conducted at a
later date. Appendix A summarizes the uses of copper that are eligible for reregi strati on.
Appendix B identifies the generic data requirements that the Agency reviewed as part of its
determination of reregi strati on eligibility of copper, and lists the submitted studies that the
Agency found acceptable. Data gaps are identified as generic data requirements that have not
been satisfied with acceptable data.
Based on its evaluation of copper, the Agency has determined that agricultural uses
(terrestrial and aquatic crops, direct aquatic uses, urban uses) of copper 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 copper. If all changes outlined in this document are incorporated into the product labels,
then all current risks for copper will be adequately mitigated for the purposes of this
determination under FIFRA. Once an Endangered Species assessment is completed, further
changes to these registrations may be necessary.
B. Public Comments and Responses
Through the Agency's public participation process, EPA worked extensively with
registrants, stakeholders and the public to reach the regulatory decisions for copper. Because the
June 2005 preliminary ecological risk assessment indicated significant risk exceedances for
virtually all non-target organisms, the Agency requested refined use information from the
registrants. The Agency initiated outreach efforts with the CSTF and USDA to contact the
61
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grower community to provide additional information reflective of actual use rates and other use
information on copper agricultural products. However, these data were still inadequate to fully
revise the ecological risk assessment. Thus, EPA requested additional refined use information
during the Phase 3 Public Comment period for the grower community and other user groups to
provide use information and other input on the use of copper products labeled for agricultural
uses. During the public comment period on the risk assessments, which closed on March 27,
2006, the Agency received extensive comments from registrants, commodity/grower groups,
cooperative extension specialists, and university/research facilities. The refined use information
provided by user groups was used to refine the ecological risk assessment. User groups also
provided information on the significance of coppers in agricultural and aquatic applications.
These comments in their entirety and the Agency's response are available in the public docket
(EPA-HQ-OPP-2005-0558) at http://www.regulations.gov.
C. Regulatory Position
1. FQPA Findings
a. Risk Determination
As part of the FQPA tolerance reassessment process, EPA assessed the risks associated
with exposure to copper pesticides. EPA has determined that individual and aggregate risk from
all sources of exposure (food, drinking water and residential uses) to copper, including
agricultural, direct aquatic, and antimicrobial uses, will not exceed EPA's LOCs. The EPA has
concluded that the tolerances for copper 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 copper.
b. Determination of Safety to U.S. Population
The Agency has determined that the established tolerances for copper, with amendments
and changes as specified in this document, meet the safety standards under the FQPA
amendments to section 408(b)(2)(D) of the FFDCA, and that there is a reasonable certainty no
harm will result to the general population or any subgroup from the use of copper pesticides. In
reaching this conclusion, the Agency has considered all available information on the toxicity, use
practices and exposure scenarios, and the environmental behavior of copper.
As discussed in Section III, the total acute and chronic dietary risks from copper do not
exceed EPA's LOG. Also, aggregate risk from exposure to copper from all sources, including
agricultural, direct aquatic, and antimicrobial uses, is not of concern. Aggregate exposures
include dietary (food and drinking water) and residential uses of copper.
c. Determination of Safety to Infants and Children
EPA has determined that the established tolerances for copper meet the safety standards
under the FQPA amendments to section 408(b)(2)(C) of the FFDCA, that there is a reasonable
62
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certainty of no harm for infants and children. The safety determination for infants and children
considers factors on the toxicity, use practices and environmental behavior noted above for the
general population, but also takes into account the possibility of increased dietary exposure due
to the specific consumption patterns of infants and children, as well as the possibility of
increased susceptibility in this population subgroup.
In determining whether or not infants and children are particularly susceptible to toxic
effects from exposure to residues of copper, the Agency considered the completeness of the
hazard database for developmental and reproductive effects, the nature of the effects observed,
and other information. Since copper is a natural essential trace element, with deficiency more
common in humans than toxicity from excess, and the low total dietary contribution of copper,
toxicity endpoints were not selected. As described in Section IV above, due to an absence of
systemic toxicity, risks were not quantified and application of an FQPA SF was unnecessary.
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 such endocrine effects as the Administrator may designate. "
Following the recommendations of its Endocrine Disrupter Screening and Testing Advisory
Committee (EDSTAC), EPA determined that there were scientific bases for including, as part of
the program, androgen and thyroid hormone systems, in addition to the estrogen hormone
system. EPA also adopted EDSTAC's recommendation that the Program include evaluations of
potential effects in wildlife. When the appropriate screening and/or testing protocols being
considered under the Agency's Endocrine Disrupter Screening Program (EDSP) have been
developed and vetted, coppers may be subjected to additional screening and/or testing to better
characterize effects related to endocrine disruption. For further information on the status of the
Endocrine Disrupter Screening Program please visit our website: http://www.epa.gov/endo/.
3. Cumulative Risks
The FFDCA, as amended by FQPA, requires that the Agency consider "available
information" concerning the cumulative effects of a particular pesticide's residues and "other
substances that have a common mechanism of toxicity." The reason for consideration of other
substances is due to the possibility that low-level exposures to multiple chemical substances that
cause a common toxic effect by a common toxic mechanism could lead to the same adverse
health effect as would a higher level of exposure to any of the substances individually. 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 as to the
copper ion and any other substances, and the copper ion does not produce toxic metabolites
produced by other substances. For the purposes of this RED, therefore, EPA has not assumed
that the copper ion has a common mechanism of toxicity with other substances. For information
regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity
and to evaluate the cumulative effects of such chemicals, see the policy statements released by
63
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the Agency concerning common mechanism determinations and procedures for cumulating
effects from substances found to have a common mechanism on EPA's website at
http://www.epa.gov/pesticides/cumulative/.
4. Endangered Species
The Endangered Species Act requires federal agencies to ensure that their actions are not
likely to jeopardize listed species or adversely modify designated critical habitat. To assess the
potential of registered pesticide uses that may affect any particular species, EPA puts basic
toxicity and exposure data developed for each pesticide's registration into context for individual
listed species and considers ecological parameters, pesticide use information, the geographic
relationship between specific pesticide uses and species locations and biological requirements
and behavioral aspects of the particular species. When conducted, these analyses take into
consideration any regulatory changes recommended in this RED being implemented at that time.
The Agency has not yet conducted a risk assessment that supports a complete endangered
species determination. The ecological risk assessment planned during registration review will
allow the Agency to determine whether the use of copper compounds has "no effect" or "may
affect" federally listed threatened or endangered species (listed species) or their designated
critical habitats. When an assessment concludes that a pesticide's use "may affect" a listed
species or its designated critical habitat, the Agency will consult with the U.S. Fish and Wildlife
Service and/or National Marine Fisheries Service (the Services), as appropriate.
D. Tolerance Reassessment Summary
Tolerance exemptions for residues of copper in/on plant, animal and processed
commodities are established under 40 CFR §180.1021. Additional tolerances for potable water
and post-harvest use on pears are established under 40 CFR §180.538 and 40 CFR §180.136,
respectively.
The Agency has determined that both the 3 ppm tolerance for residues of basic copper
carbonate in or on pears of combined copper from post-harvest use under 40 CFR §180.136, and
the 1 ppm tolerance for copper residues in potable water under 40 CFR §180.538 should be
revoked because these two tolerances are not necessary for human health protection. The
Agency has also determined that the copper tolerance expression under 40 CFR §180.1021
should be revised to include all current copper active ingredients with registered food uses.
1. Tolerances Proposed to be Revoked
40 CFR §180.136. The 3 ppm tolerance for residues of basic copper carbonate in or on pears of
combined copper from post-harvest use should be revoked. This 3 ppm tolerance is not
necessary for human health protection, as many food commodities not treated with copper
pesticides have naturally-occurring levels of copper that are higher than those found in or on
pears as a result of residues from treated paper wrappers. In addition, toxicological studies
support that potential copper residue levels from the use of treated pear wrappers do not pose a
significant risk to human health. Thus, retaining this tolerance is not necessary.
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40 CFR §180.538. The 1 ppm tolerance for copper residues in potable water should be revoked,
as this is an outdated tolerance and no longer applies to current regulations for managing copper
residues in drinking water. This 1 ppm tolerance is not necessary for human health protection.
2. Tolerances Listed Under 40 CFR §180.1021
The listed copper active ingredients are currently exempt from tolerance requirements on
all raw agricultural commodities under 40 CFR §180.1021. As part of the reregi strati on process
for copper, the Agency concludes that all food use copper formulations are still exempt from the
requirement of a tolerance. Should any additional copper active ingredients be registered for
new food uses in the future, the need for a tolerance for these formulations will be evaluated at
that time.
Copper linoleate and copper oleate should be removed from the list of copper compounds
described in 40 CFR § 180.102l(4)(b), because there are no current registrations that contain
either copper linoleate or copper oleate. Both copper compounds are currently unsupported in
the United States. Bordeaux mixture and copper-lime mixture should also be removed from 40
CFR § 180.102l(4)(b), because copper sulfate is the active ingredient in these mixtures, which
has been assessed as part of this RED, and is already included as part of 40 CFR
§ 180.102l(4)(b). Cupric oxide should be removed from 40 CFR § 180.102l(4)(b) as well, as
there are no current products that contain cupric oxide that are registered for food use
applications.
There are some copper compounds that have registered agricultural uses on food crops
that are not currently described under 40 CFR §180.1021. The Agency has determined that even
with the inclusion of these copper compounds as part of tolerance reassessment, that the
tolerance exemption is still appropriate for all currently registered copper compounds when used
as labeled on growing crops, and the list described under 40 CFR § 180.102l(4)(b) should be
expanded to include the following copper compounds listed in Table 25.
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Table 25. List of Copper Compounds to Address under 40 CFR §180.1021(4)(b)
Chemical Name
Basic Copper Sulfate
Copper Sulfate Pentahydrate
Copper Chloride
Copper Ammonium Carbonate
Basic Copper Carbonate
(malachite)
Copper Hydroxide
Copper Oxychloride
Copper Oxychloride Sulfate
Copper Ammonia Complex
Copper in the form of chelates of
citrate and gluconate
Cuprous Oxide
Copper Salts of Fatty and Rosin
Acids
Copper Ethylenediamine
Complex
Copper Octanoate
EPA PC Code
008101
024401
008001
022703
022901
023401
023501
023503
022702
024405
025601
023104
024407
023306
C.A.S.
Number
1344.73-6
7758-99-8
1332-40-7
33113-08-5
1184-64-1
20427-59-2
1332-65-6
8012-69-9
16828-95-8
10402-15-0
1317-39-1
9007-39-0
13426-91-0
20543-04-8
Comments
No change
Needs to be added
No change
Needs to be added
No change
No change
Needs to be added
Needs to be added
Needs to be added
Needs to be added
No change
Needs to be added
No change
No change
Copper Compounds to Remove
Cupric Oxide
Copper oleate
Copper linoleate
Bordeaux Mixture
Copper Lime Mixtures
042401
023304
023303
None
None
1317-38-0
10402-16-1
7721-15-5
None
None
Remove; no currently registered food
uses.
Remove; this compound was cancelled
Remove; this compound was cancelled
Remove; active ingredient is copper
sulfate, which is already included.
Remove; active ingredient is copper
sulfate, which is already included.
E. Regulatory Rationale
The following is a summary of the rationale for mitigation measures necessary for
managing risks associated with the use of coppers and for agricultural copper products to be
eligible for reregi strati on. Where labeling revisions are warranted, specific language is set forth
in the summary table of Section V (Table 29 of this document).
1. Human Health Risk Management
All potential human health acute and chronic exposures (dietary, aggregate, residential,
and occupational) are below EPA's level of concern to the Agency for the U.S. general
population and all population subgroups, including infants and children. Copper is a ubiquitous
element that is essential for proper homeostasis in human health. Residues of copper on foods
resulting from agricultural pesticide use are not expected to significantly contribute to the overall
dietary intake of copper, as several foods already have naturally-occurring levels of copper.
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Based on available literature and studies, there is no indication of systemic effects
resulting from copper exposures. Therefore, the minimum handler PPE (long-sleeved shirt and
long pants, socks and shoes) for occupational workers will be required by the RED. However,
copper can be a severe irritant with effects resulting from dermal, oral, eye or inhalation
exposure that are solely due to the irritating properties of copper. These irritation effects are a
result of the body's mechanisms to reduce excessive exposure to copper. Each copper
compound and its product formulations can cause different degrees of acute oral, dermal, eye,
and inhalation irritation effects. To minimize irritation via these routes, commercial uses of
copper-based pesticides will be adequately protected through label-specified handler PPE (based
on the toxicity categories of the end-use product) and industrial workplace safety standards.
Depending on the acute toxicity of the active ingredient, the minimum re-entry interval (REI) is
12 hours, but may be up to 48 hours for copper compounds with greater acute toxicity categories.
To determine the appropriate specific PPE, registrants will need to submit product-specific data
as outlined in the product-specific DCIs (PDCI) subsequent to the issuance of this RED.
Post-application restrictions (REIs and early-entry PPE) will default to the measures as
required by the Worker Protection Standard (WPS) in 40 CFR §170. Depending on the acute
toxicity of the copper compound, the minimum REI is 12 hours, but may be up to 48 hours for
copper compounds with greater acute toxicity categories. The early-entry PPE will also be
determined by the acute toxicity of the active ingredient. Table 26 below describes the REI for
each copper compound. Appropriate REIs and early-entry PPE for each copper compound is
described in Table 29. For formulations with residential uses, dermal and eye irritation effects
will be addressed via end-use product labeling language.
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Table 26. REIs for each Copper Compound
REI
48-hour*
(Toxicity category I or
II)
*Except for
greenhouse uses only;
see Table 29 for
specific information.
24-hour
(Toxicity Category II)
12-hour
(Toxicity Category
III or IV)
Copper Compound
Basic Copper chloride
Chelates of copper gluconate
Copper ammonium carbonate
Copper carbonate
Copper hydroxide
Copper ammonia complex
Copper oxychloride
Copper oxychloride sulfate
Basic copper sulfate
Copper sulfate anhydrous
Copper sulfate pentahydrate
Copper 8-quinolinolate
Copper naphthenate
Copper salts of fatty and rosin
acids
Copper ethanolamine complex
Copper, metallic
Copper ethylenediamine
Copper octanoate
Copper triethanolamine complex
Cupric oxide
Cuprous oxide
PC Code
008001
024405
022703
022901
023401
022702
023501
023503
008101
024408
024401
024002
023102
023104
024409
022501
024407
023306
024403
042401
025601
Study Reference
No studies available for dermal
sensitization
No studies available
No studies available
Primary eye irritation
Primary eye irritation
No studies available
Primary eye irritation
No studies available
No studies available
No studies available
Primary eye irritation
Primary eye irritation
Primary eye irritation
No studies available for acute dermal
sensitization
No studies available
Primary eye irritation
Acute oral irritation
Toxicity category III for acute oral,
dermal and irritation studies
Toxicity category III for acute oral,
dermal, and inhalation irritation
Toxicity category III for acute dermal,
primary eye and dermal irritation
Toxicity category III for acute oral and
primary eye irritation
Given the role copper plays as an essential element to the human body, its ubiquitous
nature in food and drinking water, low toxicity profile, and the lack of incidents showing any
effects resulting from systemic toxicity, there are no systemic human health risks of concern to
the Agency; thus, no mitigation is needed beyond that which is required to address the irritation
effects associated with copper compounds.
2. Ecological Risk Management for Non-target Organisms
Ecological risk mitigation measures may include lowering application rates, reducing the
number of applications in a given year, restricting the timing of applications, extending the
period between applications (application interval), and changing pesticide application methods to
reduce the potential for spray drift or runoff.
The screening-level ecological risk assessment for copper suggests acute and chronic risk
concerns for both freshwater and marine/estuarine organisms resulting from copper exposure at
maximum labeled rates. Additionally, the risk assessment suggests potential risk to terrestrial
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animals exposed to high levels of copper resulting from pesticidal use. However, imprecise
product labels represent the greatest source of uncertainty in the ecological risk assessment for
copper pesticides. The ecological risk assessment assumed a number of applications and an
application interval for most uses because product labels for copper pesticides do not specify the
maximum number of applications and minimum treatment interval. Because the labels do not
specify these limits, the Agency made conservative assumptions with maximum application and
use information, which may underestimate or overestimate potential risk.
The registrants, grower groups, and other stakeholders have agreed to mitigation
measures to address potential risks to terrestrial and aquatic animals. Labels for agricultural uses
of copper will be revised to more accurately reflect use rates typically required to control specific
pests and diseases. This will result in lower maximum allowed application rates for most crops.
These labels will define maximum single application rate for each crop, minimum application
intervals for each use, and will specify the maximum amount of copper that can be applied each
year. The establishment of maximum individual and annual application rates and minimum
application intervals will reduce the potential loading of copper into ecosystems by preventing
unnecessarily high rates previously permitted and by limiting the frequency of exposure to non-
target organisms.
Additional advisory language will be required to minimize potential adverse ecological
effects. To reduce any adverse effects from potential spray drift, labels will be revised to include
advisory language on reducing the potential for spray drift. Labeling measures include aerial
applications only at or below certain wind speed and larger droplet size to reduce drift potential.
In addition, registrants will be required to submit spray drift data.For more details on additional
labeling requirements, refer to the Table 29. Because the chemistry of a water body greatly
influences potential copper toxicity, additional advisory language describing chemistry
conditions that likely would lead to increased copper toxicity potential (i.e., low pH and low
DOC) will be required on revised labels. Appendix A describes the refined single maximum
application rates, defined application intervals with a minimum number of days between
retreatments, and maximum seasonal rate that is permitted to be applied per year.
a. Benefits of Copper Pesticides
Through extensive outreach to the public as well as additional comments and refined
information provided by the user community, the Agency has determined that there are many
benefits that support the significance and continued agricultural uses of copper pesticides. A
significant benefit is that copper exposure from all sources, including use as a pesticide in
agricultural settings, does not pose any human health concerns. Although there is still potential
for ecological effects to non-target organisms, there are many benefits to retain agricultural uses
of copper pesticides. For detailed discussions on the benefits of the continued use of copper
pesticides on the respective major crops/use sites, please refer to the Cursory Alternatives and
Assets Analysis of the Agricultural Uses of Copper Group II Pesticides, dated June 20, 2006, and
the Copper (Cu++) Alternatives Analysis for the Primary Aquatic Uses, dated June 20, 2006.
Below is a description of specific areas where the benefits of coppers are significant, and where
applicable, a discussion of general comparisons against available alternatives.
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1. Terrestrial Uses
Coppers are significant for use as a broad-spectrum fungicide and bactericide on
agricultural crops. Based on its history of use for many centuries, there is little evidence to
indicate any significant pest-resistance problems. Copper pesticides are also used to remedy
copper-deficient soils. Coppers are used in some Integrated Pest Management (IPM) systems,
alternated with some systemic fungicides that have a high risk of developing resistance or have
shown early indications of some pesticide resistance. Comments provided by the University of
Georgia indicated that IPM programs using copper alternated with antibiotics is used in peach
productions. Copper use can reduce heavy reliance on the use of antibiotics for control of
bacterial diseases for some crops.
Copper use is significant in various market niches, including those in the US as well as
exported commodities. Although organically-grown crops represent a relatively small portion of
the agricultural market, organic growers rely heavily on copper pesticides. Several organic
growers reasserted that copper is one of the few pesticides available to growers to effectively and
efficiently manage target pests, namely bacterial diseases. Another specific niche is the use of
treating and preventing Septoria Spot on navel oranges from California for export to the
Republic of Korea. There is a current export agreement that requires a pesticide treatment
protocol that includes copper treatments on navel oranges for the treatment of Septoria Spot
caused by Septoria citri.
For many of the major crops, growers have indicated that there are few or sometimes no
suitable alternatives to copper pesticides for certain target pests. For example, the Florida Fruit
& Vegetable Association noted that copper products are the only registered and effective
pesticide available to manage citrus canker to avoid major crop losses. Although citrus canker
has only been found in Florida, other major citrus producers outside of Florida such as the Texas
Citrus Mutual group has expressed similar concerns and asserted the importance of retaining this
use. Copper is currently the only viable or available option to control some bacterial diseases for
which there are no registered antibiotics or where pests have developed resistance to some
available alternatives. Some growers have reported the lack of suitable alternatives for bacterial
diseases in blueberries, apples, citrus, cherries, and strawberries. The Texas Vegetable
Association stated that there are no alternatives for controlling bacterial leaf spot on peppers and
tomatoes. In many cases, copper fungicides are the most cost-effective treatment that allows for
frequent retreatments and are effective in suppressing or managing bacterial diseases for which
there are no suitable alternatives.
2. Aquatic Weeds and Algae
Copper is extensively used in direct aquatic applications including the management of
algae, aquatic weeds, and mollusks that may host harmful parasites. Below is a description of
some major areas where the use of copper pesticides is significant for its respective target pests.
Aquaculture. A comment from the University of Mississippi noted that aquaculture ponds
containing certain cyanobacteria species can cause off-flavors in farm-raised catfish. Unlike
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many other market animal or grain crop products, an off-flavor in farm-raised fish does not result
in a payment penalty; rather, it results in the rejection of all fish destined for market from that
particular farm until the algae is properly managed and the off-flavors are purged from the fish.
As a preventative measure, full-pond treatments are sometimes used for cyanobacteria control to
minimize potential algal blooms that may cause off-flavors. Copper is the only registered
chemical for which treatment of these off-flavor causing algae. In the past, special temporary
use permits (FIFRA Section 18s) allowed for the use of diuron to control cyanobacteria in catfish
and hybrid striped bass aquaculture ponds due to the rejection of off-flavor fish destined for
market, but is costlier than using copper.
Drinking Water. Algae can clog water filters, reducing filter run times and requiring frequent
backwashing, which all lead to greater coagulant demand and other treatments that impose
greater costs to treatment facilities. Some species of algae can cause various off-flavors in
drinking water, such as cyanobacteria, which can produce chemicals called cyanotoxins that lead
to earthy or musty flavors. Only rarely are taste and odor problems the result of algal toxins in
drinking water. Cyanobacterial blooms are not consistent and predictable, but often proliferate
quickly during a summer drought. Thus, this requires early detection and treatment of algae to
ensure effective treatment with the minimum amount of pesticide needed. These cyanotoxins
and other chemicals are often difficult and more expensive to remove during water treatment.
The use of copper for this application can be costly, but often times necessary for drinking water
quality. Current labels for copper compounds allow for up to 1 ppm of copper in drinking water,
which is in accordance with the Agency's 1.3 ppm MCLG for residues of copper in drinking
water.
Irrigation/Conveyance Systems. In the western part of the US, 68% of the crops produced rely
on irrigated water. Thus, regular maintenance of distribution canals in important for optimal
water flow to receiving fields. Dense mats of vegetation can be a mechanical hindrance to
valves and gate which divert and control the flow of water. Cyanobacteria and filamentous algae
can lead to clogging of water intake screens in lakes and aqueducts. This reduction in water flow
can result in millions of dollars lost due to failed crops as well as up-system flooding of areas
surrounding the canal. Aquatic weed control in irrigation systems is essential, since debris from
weeds can decrease water flow. In addition, physical clogging by weeds can cause obstructions
to valves and gates needed to control or divert water flow to receiving fields.
Quiescent Water Bodies (Recreational Ornamental). Control of aquatic weeds in quiescent
water bodies, such as ponds and lakes, is needed to maintain the safety of recreants and
recreational activity operations that include fishing, water sports or swimming. In addition,
many of these water bodies are also used as drinking water supplies. On rare occasion,
cyanobacteria are known to produce hepatotoxins that may be harmful to humans and other
mammals. Excess algae and other vegetation in quiescent or near-quiescent water bodies can
impact overall water quality that may lead to decreased food availability and even fish kills.
Dense algal or weed mats can block sunlight from reaching submerged biota, potentially
affecting the entire ecological cycle, and even pose physical barriers for mobile animals. As the
plant debris die back, increased microbial decay would lead to the decrease of dissolved oxygen
available to fish and other organisms living in the same water body.
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Alternatives. There are several limitations with the available alternatives to copper compounds.
For example, dyes and colorants cannot be used in moving waters with an outflow, and some
biocides may pose some human health exposure concerns. Multiple herbicides would be
required to replace the copper compounds in these systems. Some available alternatives only
control vegetation that has emerged above the water surface, while others may only control
certain types of weeds.
3. Aquatic Invertebrate Control
Leech. The macro-invertebrates that are controlled by copper sulfate pentahydrate are leeches
and tadpole shrimp. Leeches are often a problem in ponds and quiescent waters under drought
conditions. While leeches are usually a problem for fish, humans splashing in quiescent waters
may become an alternate host to leeches. Currently, copper sulfate pentahydrate is the only
registered compound for leech control in open water.
Tadpole Shrimp. Tadpole shrimp are often a problem in rice production, causing damage to
newly emerged/young rice plants. Carbaryl is available as an alternative to copper for tadpole
shrimp; however, copper sulfate pentahydrate has no human health risks of concern and is the
only available pesticide that would still allow for organic rice growers to retain certification for
organically-grown rice.
Freshwater Snails. Copper sulfate can be used to control freshwater snails to minimize potential
exposure to problematic trematodes. Freshwater snails may act as a vector to schistosomes and
other trematode cercariae that may affect exposed swimmers or farm-raised fish. Specific to
humans, these schistosomes may penetrate human skin, causing Swimmer's Itch. In catfish
production ponds, snails may be infected with a trematode from the Bolbophorus species. These
trematodes may also cause lesions in exposed catfish, rendering them unmarketable. There is no
treatment available for fish infected with this trematode.
b. Terrestrial Organisms
1. Birds and Mammals
The Agency modeled potential exposure to terrestrial animals from residues on forage
items based on the highest label application rates and the highest average application rates of
copper for orchard and row crops. Current copper labels indicate that the highest orchard label
application rate modeled is 31.8 Ibs Cu2+/A for filberts and the highest row crop label application
rate is 3.2 Ibs Cu2+/A for potatoes. The highest actual average application rate for orchards and
for row crops, as determined by the best data available to the Agency at the time the risk
assessment was completed, were 3.8 Ibs Cu2+/A for orchards (apples) and 0.8 Ib Cu2+/A for row
crops (potatoes). Because intervals between applications and the maximum number of
applications were not specified on the product labels, the Agency assumed four applications on a
weekly basis per growing season.
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The RQs for the maximum and highest average application rates exceeded nearly all
acute and chronic LOCs for all weight classes of birds and mammals. However, RQs for the
average application rates are much lower, reflecting the significantly reduced EECs. For
instance, the highest dose-based acute RQ for birds based on maximum orchard application rates
is 220 and the corresponding dietary-based acute RQ is 13.5. By contrast, the highest dose-based
acute RQ for birds based on average orchard application rates is 49 and the corresponding
dietary-based acute RQ is 3.0.
The RQs for the highest average application rates more closely reflect the actual
application rates currently used, and that will be updated on copper product labels after the
mitigation measures described above are put into effect. An exception to this is the 6 Ibs Cu2+/A
single application rate for filberts, the highest actual application rate for any crop. However, this
high rate will only apply to a small, defined area in the Pacific Northwest where copper is
applied on filberts. According to the USD A, approximately 2,000 acres of filberts in this region
are treated with copper. Application rates for other crops, which have been chosen based on
input received after extensive outreach to grower groups and the public, will range from less than
one pound up to 4 Ibs Cu2+/A. Grower groups indicated that, depending on the crop, disease
pressure, and timing, many applications are made at longer than the weekly interval assumed for
most crops in the risk assessment. As described in Appendix A, longer minimum application
intervals will be established for copper application to many crops.
Because the RQs for the average application rates exceed acute and chronic LOCs,
application according to the revised labels can still potentially result in dietary risk to birds and
mammals. However, there are some uncertainties in this finding of risk associated with
assumptions used in the screening-level assessment itself, and with the response of birds and
mammals exposed to copper. For instance, RQs in this assessment were calculated using 95th
percentile residues from the Kenaga nomogram; mean residues from the Kenaga nomogram are
about 2/3 less per application. Therefore, a typical application of copper would be expected to
result in lower EECs than indicated in the assessment. In addition, a default foliar dissipation
half-life of 35 days was used in the terrestrial exposure model T-REX, because data were not
available to indicate how quickly copper might dissipate from leaf surfaces through wash-off. A
shorter foliar dissipation half-life would result in lower RQs for every crop to which multiple
applications of copper are made.
As described in the risk assessment, there is additional uncertainty in the risk finding
because terrestrial animals have varying degrees of homeostatic capability to metabolize ingested
copper. Copper is an essential micronutrient to many organisms, including birds and mammals.
The dietary-based RQs for birds likely incorporate these uptake effects to some extent, and an
absorption efficiency correction factor was applied to the mammal dose-based RQ calculations.
These RQs still exceed LOCs, but the design of the laboratory studies leaves some
uncertainty in how these effects would translate to effects in the wild. Birds and mammals in the
laboratory studies are only fed treated feed, and the RQs in the risk assessment also assume that
animals will derive 100% of their diet from treated feed. Although animals in the wild need to
eat more than their counterparts in the laboratory (since lab feed is more nutritious, generally),
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most birds and mammals will spend only a fraction of the time in or at the edge of a treated field.
Animals which eat untreated feed as a portion of their diet may have more of an opportunity to
cope with ingested copper when the exposure is not continuous. In addition, animals which are
repeatedly exposed to levels of copper which do not cause permanent harm may undergo
enzymatic adaptation which allows them to cope with greater levels of exposure. The sensitivity
to copper toxicity, and the ability to adapt to repeated exposures, should be expected to vary
within species, and between species of birds and mammals.
Based on these factors, EPA has determined that the reduction in application rates and
defining minimum retreatment intervals will greatly reduce potential adverse exposures to non-
target terrestrial animals. In addition, this screening-level assessment includes conservative
assumptions, such as the animal feeding in a treated area 100% of the time. To date, there are no
reported bird or mammal incidents.
2. Terrestrial Plants
The Agency could not conduct a complete terrestrial plant risk assessment, since the
toxicity dataset for copper is incomplete. No suitable data from the registrant or open literature
were available for evaluating seedling emergence effects. Vegetative vigor data for both
monocots and dicots were available from the public literature.
No RQs exceeded the acute or acute endangered species LOG at the rate of 31.8 Ibs
Cu2+/A for filberts, which is substantially higher than all rates, that will be on copper pesticide
labels after mitigation measures detailed above take effect. Therefore, there appears to be no
acute risk to non-endangered or listed terrestrial plants from spray drift. In any case, the reduced
maximum application rates will reduce the maximum amount of copper to which terrestrial
plants will potentially be exposed, and no further mitigation is needed.
3. Insects
Available data from a honey bee acute toxicity study indicated that copper is practically
nontoxic to honey bees, with an acute LD50 > 100 jig/bee. However, because exposure estimates
for other insects cannot readily be determined, the potential risk of copper pesticides to other
insects is unknown. Based on available data, no additional mitigation to address exposure to
non-target insects is needed at this time.
c. Aquatic Organisms
1. Agricultural Uses
The Agency's screening-level ecological risk assessment for copper suggests acute and
chronic risk concerns for both freshwater and marine/estuarine organisms resulting from copper
exposure at maximum labeled rates, assuming four applications at weekly intervals. However,
exposure is expected to be significantly lower based on application rates, defined retreatment
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intervals, seasonal maximum rates, and advisory spray drift language that will be on copper
product labels after the mitigation measures described above are put into effect.
Freshwater Animals
The screening-level risk assessment indicates that there are risks greater than the LOG to
freshwater invertebrates from terrestrial uses of copper at some portion of the 811 sites modeled,
both at the typical and at the maximum labeled application rate. At the maximum application
rate considered in the risk assessment, 31.8 Ibs Cu2+/A for filberts, RQs for nearly all sites
exceeded the acute and chronic LOCs. Over 99% of the sites exceeded the acute LOG for
invertebrates, and 80% exceeded for fish. Over 98% of the sites exceeded the chronic LOG for
invertebrates and 44.9% exceeded for fish.
The rate reductions that will be brought about through mitigation are expected to
significantly reduce the number of sites at which freshwater animals are at risk from exposure to
copper applied as an agricultural pesticide. The percentage of sites with acute exceedences for
invertebrates, for instance, ranges from 3.2% at 1.0 Ib Cu2+/A applied, and increases to about
25% of sites at an application rate of 7.5 Ibs Cu2+/A. The RQs derived for freshwater fish with
the BLM exceed the acute LOG for less than 1% of sites for application rates of 1 Ib Cu2+/A up
to7.51bsCu2+/A.
Table 27 shows some examples of the reductions in application rates for some of the high
application rates for the respective crops. The reduction in the maximum application rate for
citrus and grapes, with defined application interval and maximum seasonal rates, brings
maximum potential exposure down to a level at which 10% of the 811 RQs considered in the
assessment would exceed the acute LOG for freshwater invertebrates, and < 1% of RQs would
exceed the acute RQ for fish. Approximately 13% and 1% of the sites would exceed the chronic
LOG for freshwater invertebrates and fish, respectively.
Table 27. Example Comparison of Rates Used in Risk Assessment and Revised Label Rates
Crop
Citrus
Filbert
Peach
Current Labeled Rate
or Revised Rate
Current
Revised (algal spot,
melanose, scab)
Current
Revised (eastern filbert
blight)
Current
Revised (dormant
application)
Application Rate
Ibs Cu2+/A
15.43
3.15
31.8
6
6.75
3.15
Application
Interval (days)
7 (assumed)
7
7 (assumed)
14
7 (assumed)
30
Seasonal Maximum
Application
(Ibs Cu2+/A)
61.72 (assumed)
12.6
63.6 (assumed)
24
13.5 (assumed)
6.3
Appendix A lists the revised maximum application rates, minimum retreatment intervals
and maximum seasonal rates for agricultural uses of copper. The refined maximum single
application rates for these crops are significantly less than the highest labeled rate considered in
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the risk assessment, where most are 3.15 Ibs Cu2+/A or less. The majority of retreatment
intervals are 7 days or longer, with only a few exceptions such as tomatoes and peppers.
Although these crops have a 3-day application interval, single application rates were 0.79 and 1.6
Ibs Cu2+/A for peppers and tomatoes, respectively. The crop with the highest seasonal
application rate is Easter lilies, but the registrant has indicated that this crop is grown in a very
small portion of the country, and will revise labels to include language limiting treatment to only
one season every four years.
Although the rate reductions are expected to result in fewer freshwater bodies having
aquatic animals potentially at risk, there is some uncertainty in the percentage of sites. As
detailed earlier, the risk estimates for each application rate were calculated using a regression of
the peak values from 32 PRZM/EXAMS scenarios. Because label instructions were inconsistent
for use of copper on many crops, many of the 32 scenarios were run based on the maximum
single application rate, assuming four applications a week apart. As indicated in Appendix A,
revised labels will include the maximum single application rate, maximum seasonal rates, and
defined minimum application intervals.
There is also some uncertainty in the peak values used in the regression. Screening
assessments were performed using PRZM/EXAMS use the 1-in-10-year peak value as the acute
EEC. Because of concerns that EXAMS could not properly simulate 30 years of successive
application of a stable pesticide, the peak value from the first year of application was used as the
EEC. The EEC simulated from the first of the 30 years of data would likely be less than the
standard 1-in-10-year exposure value calculated from a full 30-year simulation, although some of
the 32 sites would simulate heavier rainfall in that single year, and others would simulate light
rainfall years.
Therefore, EPA has determined that with the reduction of rates, establishing minimum
retreatment intervals and defining seasonal maximum rates, estimated exposures described in the
screening-level ecological assessment will be significantly lower. Adding advisory language to
product labels to minimize potential spray drift and water chemistry criteria that may lead to
greater copper toxicity in water bodies will also reduce potential adverse effects.
Freshwater Plants
Because the BLM has not been parameterized to assess freshwater plants, it could not be
used to assess potential copper exposure and toxicity to freshwater plants. RQs for freshwater
plants were calculated using estimates of total dissolved copper using PRZM/EXAMS, which
overestimates the amount of copper that is potentially toxic to exposed organisms. The risk
assessment provides a single RQ for a range of application rates, based on a regression of results
from 32 PRZM/EXAMS scenarios. These RQs signal a potential risk to non-vascular plants
(based on algae data) for application rates of 1.5 Ibs Cu2+/A and above. However, RQs for
aquatic vascular plants and endangered species are below the Agency's level of concern.
In addition to the use of total dissolved copper EECs in the calculation of aquatic plant
RQs, the uncertainties described above for the regression of the peak values from 32
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PRZM/EXAMS scenarios also apply to the aquatic plant assessment. Some potential for risk to
aquatic plants is not unexpected, since algae and aquatic plants are target species for direct water
applications of copper pesticides. However, the reductions in maximum application rates, and
the establishment of maximum seasonal rates and minimum application intervals will reduce the
potential for risk to aquatic plants from agricultural applications of copper.
Marine/Estuarine Organisms
As with freshwater aquatic plants, the RQs for estuarine/marine organisms used in the
assessment should be considered conservative because estimates of copper concentrations are for
total copper, not the cupric ion. The BLM has not been parameterized for estuarine/marine
organisms, so it could not be used to assess potential copper exposure and toxicity to
estuarine/marine animals. As for the freshwater organism assessment, RQs for estuarine/marine
organisms were calculated using the same regression on the peak copper concentrations that
resulted from various application rates in the 32 PRZM/EXAMS simulations run for copper. At
a rate of approximately 3 Ibs Cu2+/A, acute and chronic RQs exceedences occur for both
estuarine/marine fish and invertebrates, respectively. Acute RQs for invertebrates are exceeded
at 1.5 Ibs Cu2+/A, and chronic RQs for fish are exceeded at 1 Ib Cu2+/A. RQs for
estuarine/marine plants did not exceed the acute LOG.
In addition to the use of total dissolved copper EECs in the calculation of aquatic plant
RQs, and the uncertainties described for use of the peak EEC regression, there is also uncertainty
in the use of the PRZM/EXAMS static pond scenario to represent exposure in an estuary. Many
crops can be grown adjacent to estuaries, and transport to estuaries in parts of the copper use area
is likely. However, the static pond does not simulate the daily ebb and flow of freshwater and
saltwater in an estuary, and the resulting changing salinity and hardness of the water would also
affect the speciation of dissolved copper.
In spite of these uncertainties, the reductions in maximum application rates, and the
establishment of maximum seasonal rates and minimum application intervals will reduce the
potential for risk to estuarine/marine animals from agricultural applications of copper.
2. Direct Aquatic Uses
Because of the inconsistent and incomplete use application information on current labels
for direct aquatic uses, the Agency made several assumptions in the aquatic risk assessment. The
risk assessment assumes treatment of an entire water body to achieve the maximum application
rate, a water concentration of 1 ppm. For invertebrates, fish, and aquatic plants, RQs for this rate
exceed the endangered species LOG and the acute risk LOG at >99% of sites simulated by the
BLM. The chronic risk LOCs for aquatic invertebrates, and fish are exceeded at >96% of the
sites
Input from major user groups indicates that typical rates are significantly lower than the
maximum rate allowed, ranging from 0.2 to 0.5 ppm for algae management, the greatest use of
copper products in direct aquatic applications. Use rates will greatly fluctuate, depending on pest
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infestation in a given water body. In addition, users indicated that it is standard practice for most
aquatic uses to treat only a portion (up to 25-33%) of a water body at a time. The EXAMS
model is used in the risk assessment to evaluate the risk from application to a fraction of the
water body, but because of limitations in the model, this in essence is an assessment of a
fractional application to the entire water body.
As discussed in the risk assessment, even application of copper to only a portion of a
water body is likely to result in risk to aquatic organisms. When only a portion of the water body
is treated, organisms in the vicinity of the treatment can be exposed to the full concentration of
copper applied, while others further from the treated area may not be exposed at all. Fish and
larger, more mobile invertebrates may be able to move out of the treated zone until the copper
dissipates from the water column, but smaller and more sedentary invertebrates will be affected.
Recovery of the affected organisms will vary on a site-to-site basis, and the specific
effects on any given ecosystem are impossible to predict given the scale of this assessment.
Populations of phytoplankton and zooplankton (the organisms most likely to be lethally affected
by use of copper) are dynamic, as the recovery of these populations is difficult to predict to
determine its impact on the rest of the ecosystem. In aquatic systems where copper is applied
frequently the community may shift to more copper tolerant organisms, and/or some of the
organisms present may develop metabolic pathways for dealing with higher copper exposure.
Because of the great variance in water body chemistries across the US, this will
overestimate the potential risk to some aquatic organisms, and underestimate it for others.
However, based on refined use information provided by user groups, estimated exposures will be
significantly lower. Typical application rates are significantly lower than the maximum assessed
rate in the screening-level ecological assessment; thus, adverse effects to non-target organisms
are expected to be lower. Additionally, the benefits of properly managing the target pests are
significant in protecting human health and animals, including potential harmful toxins from algal
blooms, and water body maintenance to reduce the development and decay of algal and plant
matter than can reduce DOC needed by organisms.
3. Urban Uses
One of the risk assessment goals of the Agency is to estimate pesticide exposure through
all significant routes of exposure from both agricultural and non-crop uses. However, the
ecological risk assessment for copper pesticides focuses on the agricultural and direct aquatic
uses, being the greatest usage of copper pesticides, and pesticide-transport models are available
to estimate potential aquatic exposure from these uses. Based on laboratory toxicity tests with
aquatic animals, adverse effects could occur to exposed organisms in aquatic environments.
Other potential sources of copper-treated products/sites that may result from a number of
non-crop pesticidal uses, including use as a wood treatment, lawn fungicide, pool and fountain
algaecide, sanitary sewer root killer and ingredient in anti-fouling paints. The wood treatment,
anti-foulants, and other antimicrobial uses will be addressed in a separate ecological risk
assessment to be produced at a later date by the Agency. The ecological risk assessment
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addresses the root-killer and lawn uses to a limited degree.
Root Control in Sewer Lines
The national-scale risk assessment for use of copper sulfate as a sewer line root-killer
discussed in the previous chapter provides an upper bound estimate of potential risk. The E-
FAST model requires an estimate of total production of a pesticide to come up with a per capita
loading estimate, but the total production of copper sulfate pentahydrate for root control can not
be distinguished from other uses on the same label. Therefore, the risk assessment assumes that
every household in the United States applies a total of 0.5 Ib Cu2+ per application twice a year.
This equates to approximately 2.2 million pounds of metallic copper. The CSTF subsequently
provided a preliminary estimate of potential use of approximately 857,000 pounds of metallic
copper annually.
The ecological risk assessment indicates that if all households in the nation were to apply
copper sulfate pentahydrate for root-control at maximum recommended rates in a single year,
then the acute LOG would be exceeded for 85% and 20% of model sites for freshwater
invertebrates and fish, respectively. The corresponding percentage of sites for which the chronic
LOG could be exceeded would be 74% and 13%, respectively. This assessment assumes that all
of the copper applied to sanitary sewers will be transported to water bodies in which aquatic
animals and plants might be exposed. In fact, much of this copper must be removed by publicly
owned treatment works (POTWs), which must limit the amount of copper that pass through to
surface water according to the terms of waste-water discharge permits.
Although there are no available models or data to refine the screening-level assessment
on urban uses, as well as uncertainties with the available data, the Agency believes that actual
exposures are significantly lower. As stated earlier in Section III with respect to the root-killer
treatment, the "down-the-drain" model assumes that all households simultaneously used the
sewer treatment at the maximum labeled rate. Available information indicates that
approximately 25% of all households have septic systems, for which treatments of copper in this
type of sewer system is not permitted. Alternatives to homeowner root-killer treatments include
mechanical removal of invasive roots such as high pressure water jet, mechanical snake, and a
steel cutter. Other available chemical alternatives include products that contain lye or sulfuric
acid.
At least one jurisdiction has considered the risks and benefits of the root control use of
copper sulfate pentahydrate on a more regional scale, and determined that mitigation was
warranted. For instance, the California Department of Pesticide Regulation has prohibited the
use of copper sulfate pentahydrate in nine counties in California out of concern that POTWs in
the San Francisco Bay area could not comply with water quality criteria for copper if this use
continued. Tri-TAC, a technical advisory group for POTWs in California, commented that an
estimated 5 to 12% of copper received by POTWs in their state was a result of root-killer use.
Similar load estimates to POTWs from use of copper as a root killer were not available
for other regions. The assessment of copper sources in the San Francisco Bay watershed
performed for the Clean Estuary watershed concentrated on urban runoff, not inputs from
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sanitary sewers to POTWs. Their description of other studies in Maryland and Sweden of copper
loadings concentrated on runoff and storm water in a like manner. TMDLs may potentially
discuss discharge of copper from POTWs as a point source, but not detail the sources of copper
to the POTW itself.
Since this product label states that it is not for use in septic systems, approximately 25%
of households cannot use this product. In addition, while it is certain that not all of the remaining
households use copper sulfate for root control in the same year, it is not possible to estimate the
number that do in any particular year. Homeowners can choose to apply alternative chemicals
for root control; some options include sulfamic or sulfuric acid and sodium or potassium
hydroxide (Ohio Department of Agriculture, 2002). Even if the amount of root killer product
sold were estimated, there are no records of how much homeowners actually use. The
preliminary estimate provided by the CSTF is more than 1/3 of the Agency's highly conservative
estimate that was assessed. Even with the estimate that the CSTF provided, the Agency believes
that this estimate is a conservative value, as this figure is based on annual marketing data.
Professional root control services may use copper sulfate pentahydrate, but are more likely to
remove roots mechanically. Professionals may also use chemical alternatives such as metam
sodium and dichlobenil, diquat or others.
A risk-benefit decision for the root control use of copper sulfate pentahydrate would
therefore require consideration of the additional burden placed on POTWs to remove excess
copper from the waste stream in addition to the potential risk to aquatic animals and plants. Use
data is not available to allow such an evaluation on a nationwide scale. Therefore, no changes
will be made to the copper sulfate pentahydrate label for root control use at this time.
Other Urban Uses
As described in Section III, above, the Agency does not currently have a model capable
of predicting concentrations of pesticides that might occur because of outdoor urban uses, such
as the use of copper as a lawn fungicide. Furthermore, the amount of copper used by
homeowners for this use cannot be precisely determined. The relative importance of lawn uses
of copper as a potential source of loading to surface water will vary between different
watersheds, as there are many other potential urban sources of copper, as described above. No
mitigation is proposed for other urban or suburban uses of copper at this time.
4. Advisory Language
To be eligible for reregi strati on, labeling changes are necessary to implement mitigation
measures outlined above. Specific language to incorporate these changes is specified in the
Table 29. Generally, conditions for the distribution and sale of products bearing old
labels/labeling will be established when the label changes are approved. However, specific
existing stocks time frames will be established case-by-case, depending on the number of
products involved, the number of label changes, and other factors.
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For agricultural products containing copper to be eligible, revised labels need to include
the following advisory language to ensure that copper pesticides are used appropriately and to
minimize potential adverse exposure effects to humans and other non-target organisms in the
environment. To minimize effects to non-target aquatic organisms, aquatic hazard statements on
the labels must be revised to describe water chemistry conditions (e.g., low pH level and low
DOC) that would likely lead to greater copper toxicity to non-target organisms. Labels also need
to include advisory language on measures which users can adopt to reduce spray drift potential,
such as language recommending that:
Application not occur during temperature inversions;
Applications be made when wind velocity favors on-target deposition (approximately 3
to lOmph);
Application not be made when wind speed exceeds 15 mph;
Aerial spray should be released at the lowest height consistent with pest control and flight
safety;
Ground boom and aerial applications use only medium or coarse spray nozzles; and
For aerial applications, the spray boom should be mounted on the aircraft as to minimize
drift caused by wingtip or rotor vortices. The minimum practical boom length should be
used.
Specific label language including these recommendations is detailed in Table 29. With
the implementation of these additional advisory label language points, risk to non-target
organisms will be reduced.
5. 303(d) - Designated Impaired Water Bodies
Under section 303(d) of the 1972 Clean Water Act (CWA), states, territories, and
authorized tribes in the US are required to develop lists of impaired waters. These impaired
waters do not meet water quality standards that states, territories, and authorized tribes have set
for them, even after point sources of pollution have installed the minimum required levels of
pollution control technology. The law requires that these jurisdictions establish priority rankings
for waters on the lists and develop Total Maximum Daily Loads (TMDL) for these waters, which
establishes the allowable loadings or other quantifiable parameters for a water body to provide
the basis to establish water quality-based controls. When a water body is listed as impaired by
an identified pollutant, States may be required to devise a plan to regulate the of the pollutant
entering the water body through point and non-point sources. The development of a TMDL
requires identification of the sources of the pollutant in the watershed, and an estimate of the
relative load from each source.
At the time of the when the RED was completed in July 2006, TMDLs were approved for
246 of the 626 water bodies for which copper is listed as a cause of impairment. A majority of
these sites list other metals in addition to copper as pollutants, either from mining or other non-
agricultural sources. As of May 2009, copper has been named as a cause for water quality
impairments for 867 water bodies, of which TMDLs have been approved for 307 for them.
However, no additional sites attributed to pesticidal applications were identified since the time of
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the 2006 RED. Below is a summary of the 303(d) impaired water bodies potentially attributed to
the uses of copper-containing pesticides.
Impairments Potentially Due to Agricultural Use of Copper
Eight of the 246 approved TMDLs for copper identify agricultural use of copper as the
most likely source causing the impairment. These eight are all in Kansas. Land use in the eight
watersheds is 95 to 99% combined cropland/pasture and rangeland, with no less than 68% of any
watershed characterized as cropland/pasture. The water quality criteria for copper in Kansas are
site-specific, based on an equation that takes the hardness of the water into account.
The eight TMDLs for copper in Kansas identify a number of possible agricultural sources
of copper. An important source identified is the use of copper sulfate to treat livestock for hoof
diseases. Copper sulfate is also used in these watersheds at 3 to 6 Ibs Cu2+/A to alleviate copper
deficiency in soybeans, and as a feed supplement for swine. Finally, the TMDLs mention that
copper can be applied to agricultural crops such as orchards.
The King County Department of Natural Resources and Parks (KCDNRP) in Washington
reported water body impairments that might be related to use of copper as an agricultural
pesticide. Washington State water quality criteria for copper are 0.0070 mg/L (acute) and 0.0075
mg/L (chronic) at median hardness. The compliance standard is that the 1-hour concentration
cannot be exceeded more than once every 3 years. The chronic criterion was reported to be
exceeded once at Mill creek (0.0056 mg/L, presumably at a lower hardness) during base flow
and the acute criterion once at a tributary of Newaukum Creek (0.0072 mg/L) during storm flow
(KCDNRP, 2004).
The Agency's TMDL web site indicates that a TMDL has not been submitted for the
Green-Duwamish watershed, in which these Washington water bodies are located. In addition,
the State of Washington has not reported the potential sources of the copper pollutant in these
waters. However, the report prepared for the KCDNRP identifies the sampling location for
Newaukum Creek as representing agricultural and pasture land uses. Land use in the Mill Creek
basin is reported to be forest, residential and agricultural.
The Calleguas Creek Watershed located in southeast Ventura Country and part of western
Los Angeles County, California, drains an area of about 343 square miles to Mugu Lagoon in the
southwest. Approximately 26% of land is currently used for agriculture.The 2002 CWA
identified the lower reaches of the Calleguas Creek watershed (reaches 1, 2 and 3) as impaired
for copper.
Impairments from Aquatic Use of Copper
Two water bodies in California are listed as impaired due to the use of copper as an
algaecide applied directly to water. In 2002, the Tinemaha Reservoir in California, which had
previously been listed under 303(d) of the CWA for generic "metals" contamination, was more
specifically listed for copper pollution caused by use of copper sulfate as an algaecide for taste
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Two water bodies in California are listed as impaired due to the use of copper as an
algaecide applied directly to water. In 2002, the Tinemaha Reservoir in California, which had
previously been listed under 303(d) of the CWA for generic "metals" contamination, was more
specifically listed for copper pollution caused by use of copper sulfate as an algaecide for taste
and odor control in drinking water. However, 10 months of surface water sampling undertaken
for the development of a TMDL for the reservoir showed the reservoir to be in compliance with
water quality standards for both total and dissolved copper. Therefore, the staff of the
CRWQCB recommended in a published report that the Tinemaha Reservoir be removed from the
list of impaired water bodies during the next listing cycle.
The Haiwee Reservoir in California was also listed as impaired due primarily to
application of copper as an algaecide. In addition to the discharge of copper sulfate to the
reservoir itself, copper sources include a percentage of "unspecified" copper, such as copper
coming in from the Los Angeles Aqueduct (LAA) with no readily identifiable source from the
available data and naturally occurring contributions of copper. Potential sources of this copper
are historic mining activities, elevated copper in ground or surface waters due to copper-bearing
minerals in soil or rock and undetermined water supply management practices in the watershed.
The Washington Department of Ecology (WDOE) identifies Steilacoom Lake as a water
body impaired by copper with an approved TMDL
http://www.ecv.wa.gov/programs/wq/tmdl/approved tmdls.html. In their report, "Copper in
Sediments from Steilacoom Lake, Pierce County, WA," the WDOE reports that copper levels in
sediment range to over 1000 mg/kg dry weight, and that the "primary source of the metal in the
sediments is many years of application of the algaecide, copper sulfate." Steilacoom Lake is a
320 acre man-made lake with a maximum depth of 20 feet. This urban lake is surrounded by
single family homes, and is classified as eutrophic.
The WDOE performed a series of bioassays with the sediment, and reports that aquatic
invertebrates Hyalella azteca and Hexagenia limbata showed significant adverse acute response
in bioassays (WDOE, 1992). Both of these invertebrates spend at least a portion of their life
span dwelling in bottom sediment. When exposed to Steilacoom Lake sediment, Hyalella azteca
suffered 30% mortality over 14 days, and Hexagenia limbata suffered 50% mortality. No
adverse effects were observed in acute or chronic bioassays using Daphnia magna,
Ceriodaphnia dubia, and Chironomus tentans.
Impairments Due to Antimicrobial Use of Copper
As described above, ecological exposures from antimicrobial uses of copper are not
considered in this RED. These uses will be evaluated in a subsequent risk assessment planned to
be completed at a later date.
TMDLs have been developed for two water bodies in California impaired by the use of
copper in anti-fouling paints applied to boat hulls. An analysis of the likely sources of copper in
the Shelter Island Yacht Basin in San Diego Bay concluded that as much as 98% of the copper
detected was from leaching of anti-fouling paints from boat hulls and the scrubbing of boat
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bottoms treated with this paint. The Agency's Technical Support Document (TSD) for the San
Diego Creek and Newport Bay Toxics TMDL (U.S. EPA, 2002) used information from the
Shelter Island Yacht Basin TMDL to estimate sources of copper leading to impairment. The
document estimates that 50,000 of 58,000 pounds of copper per year are attributable to copper
from anti-fouling paint, with the rest due to urban road runoff, contaminated sediments,
atmospheric deposition, and sea water.
A 2004 report titled "Copper Sources in Urban Runoff and Shoreline Activities,"
prepared for the Clean Estuary Partnership, summarized the sources of copper carried to the San
Francisco Bay via runoff, or introduced directly by shoreline activities. The report also
attempted to quantify the loading of copper from each of the sources. Although the uncertainty
in these loading estimates varied between sources, and for some sources may have been as high
as a 10-fold error in their judgment, it allowed the authors to rank the sources for the amount of
copper introduced to the bay. The San Francisco Bay is not currently listed as impaired by
copper, but the report details many sources of copper beyond those included in this RED which
can lead to impairment of water bodies.
The report lists the pesticidal use of copper in anti-fouling paints on boat hulls as the
greatest source of copper in San Francisco Bay (an estimated 20,000 pounds annually).
Additional copper contribution from direct application of pesticides to the Bay and its tributaries
as an algaecide was considered a smaller contribution, at an estimated 4,000 pounds annually.
Other urban copper pesticide uses included landscaping fungicide uses, use as wood
preservatives, and use as an algaecide in pools, spas and fountains (<8,000 - < 10,000 pounds per
year total). The lower source contribution of these other copper pesticides uses is due in part to
efforts by municipalities in the San Francisco Bay watershed to reduce the use of copper-based
pesticides, both through public outreach and the prohibition of the sale and use of copper-based
root control products.
Other urban sources of copper were predicted to add an additional 27,000 pounds of
copper to the total load annually. These included wear of vehicle brake pads (>10,000 pounds
per year) and vehicle fluid leaks and dumping. Also included in the estimates were deposition of
copper air emissions, soil erosion, architectural use of copper, industrial effluent and copper in
domestic storm water.
Comparison of Ecological Risk Assessment and Watershed Loading Assessments
The screening-level ecological risk assessment indicates the potential for agricultural uses
to pose acute and chronic risk to aquatic animals (and acute risk to aquatic plants) under certain
water quality conditions. However, there are aspects of the scenario simulated by the combined
PRZM/EXAMS model which limit its utility as a tool for predicting which surface water bodies
might become impaired from the agricultural use of copper pesticides. PRZM/EXAMS is not a
watershed model; it simulates application to a 10-hectare field which is directly adjacent to a
pond that is one hectare and two meters deep. Applied pesticide is transported to the pond by
runoff and drift, and the pesticide load is instantaneously mixed throughout the 20,000,000-liter
pond.
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In a typical screening-level ecological risk assessment, 30 years of applications and
weather data are used to calculate daily concentrations in the pond. These daily concentrations
represent the concentration from the previous day reduced by a day's worth of biotic and abiotic
degradation, plus the instantaneous mixing of additional load added that day. Since the model
simulates a static pond, the concentration is not reduced by outflow from the pond.
The exercise of predicting if a specific water body or stream segment could become
impaired is more complex than the edge-of-field model represented by PRZM/EXAMS. The
loading of a pesticide within a watershed is likely to come from fields at varying distances from
a water body. The entire watershed is unlikely to be treated with the pesticide. In addition, the
different sizes of water bodies and the possibility of flow would result in slower mixing than
simulated by the model, or flashiness in the concentrations caused by flow of the contaminant
downstream.
The screening-level risk assessment is meant to represent a vulnerable scenario which
allows the Agency to be confident in a finding of no risk if no LOCs are exceeded. When an
LOG is exceeded, the Agency does not assume that specific water bodies will be at risk, but
those classes of organisms in some waters with certain characteristics and/or associated land use
may be at risk from particular pesticide uses. In the case of copper, the BLM allows further
refinement of the assessment in that certain water quality conditions in surface water may lead to
increased exposure, due to increased bioavailability and toxicity to aquatic organisms.
Although the assessment does not attempt to predict copper loading from agricultural
uses on a watershed scale, mitigation measures put in place in response to risks identified by the
screening assessment will serve to reduce potential loading from these uses. As indicated in the
ecological risk assessment, the percentage of sites (represented by 811 USGS sampling stations)
which have estimated RQs above the LOCs for freshwater animals would be significantly lower
at application rates lower than the maximum rates previously allowed on copper product labels.
The RQs for estuarine/marine animals and plants, although not calculated with the BLM for a
range of sites, are also significantly reduced at lower application rates.
As mentioned previously, the Agency's Office of Water (OW) has established a draft
ALC for copper, and is working on a revised ALC which will use the BLM to take site-specific
water chemistry into account. OPP has collaborated with OW during the development of the
copper RED on the use of BLM, sharing information gathered in the process to help in the
development of the revised ALC for copper. Once the revised ALC is completed, states will be
able to use the BLM to derive consistent, site-specific standards that meet local needs.
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V. What Registrants Need to Do
The Agency has determined that agricultural uses of coppers are eligible for reregi strati on
provided that the risk mitigation measures outlined in this document are adopted and label
amendments are made to reflect these measures. To implement the risk mitigation measures, the
registrants are required to amend their product labeling to incorporate the label statements set
forth in the Label Table (Table 29) below. The Agency issued Data Call-In (DCI) Notices in
December 2007 requiring label amendments and product-specific data. Generally, registrants
will have 90 days from receipt of a DCI to complete and submit response forms or request time
extension and/or waiver requests with a full written justification. For product-specific data, the
registrant will have eight months to submit data and amended labels. Instructions for responding
to the DCI, as well as Table 29 that includes the required product label amendments for copper-
containing pesticides in order to be eligible for reregi strati on.
A. Manufacturing-Use Products
1. Generic Data Requirements
The generic data base supporting the reregi strati on of agricultural uses of copper has been
reviewed and determined to be substantially complete. At this time, the Agency does not require
any additional generic data in support of the reregi strati on of conventional pesticides that contain
copper.
2. Labeling for Manufacturing-Use Products
To ensure compliance with FIFRA, manufacturing-use product (MP) labeling should be
revised to comply with all current EPA regulations, PR Notices, and applicable policies. The
MP labeling should bear the labeling contained in Table 29.
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. Registrants must
review previous data submissions to ensure that they meet current EPA acceptance criteria and if
not, commit to conduct new studies. If a registrant believes that previously submitted data meet
current testing standards, then the study MRID numbers should be cited according to the
instructions in the Requirement Status and Registrants Response Form provided for each
product. The Agency intends to issue a separate product-specific data call-in (PDCI), outlining
specific product-specific data requirements. These data requirements will also be included in the
PDCI.
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Within 90 days from receipt of the PDCI:
(1) completed response forms to the PDCI (i.e. DCI response form and requirements
status and registrant's response form); and
(2) submit any time extension and/or waiver requests with a full written justification.
Within eight months from receipt of the PDCI:
(1) submit two copies of the confidential statement of formula, EPA form 8570-4;
(2) a completed original application for reregi strati on (EPA form 8570-1). Indicate
on the form that it is an "application for reregi strati on";
(3) five copies of the draft label incorporating all label amendments outlined in Table
29 of this document;
(4) a completed form certifying compliance with data compensation requirements
(EPA Form 8570-34);
(5) if applicable, a completed form certifying compliance with cost share offer
requirements (EPA Form 8570-32); and
(6) the product-specific data responding to the PDCI.
Please refer to Table 28 below to determine the appropriate chemical manager contact for
any questions regarding product reregi strati on and/or the PDCI containing the respective copper
active ingredient. All materials submitted in response to the PDCI should be addressed to:
Table 28. Product Reregistration and Product Data Call-In Chemical Manager Contact
Copper Compounds (Case #0649)
Copper Sulfates (Case #0636)
and Copper Salts (Case #4026)
By U.S. mail:
Document Processing Desk (DCI/SRRD)
Attn: Bonnie Adler
U.S. EPA(7508P)
1200 Pennsylvania Ave., NW
Washington, D.C. 20460
By express or courier service:
Document Processing Desk (DCI/SRRD)
Attn: Bonnie Adler
U.S. EPA(7508P)
2777 South Crystal Drive
Arlington, VA 22202
By U.S. mail:
Document Processing Desk (DCI/SRRD)
Attn: Veronica Dutch
U.S. EPA(7508P)
1200 Pennsylvania Ave., NW
Washington, D.C. 20460
By express or courier service:
Document Processing Desk (DCI/SRRD)
Attn: Veronica Dutch
U.S. EPA(7508P)
2777 South Crystal Drive
Arlington, VA 22202
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2. Labeling for End-Use Products
To be eligible for reregi strati on, labeling changes are necessary to implement measures
outlined in Section IV above. Specific language to incorporate these changes is specified in
Table 29. Generally, conditions for the distribution and sale of products bearing old
labels/labeling will be established when the label changes are approved. However, specific
existing stocks time frames will be established case-by-case, depending on the number of
products involved, the number of label changes, and other factors.
C. Labeling Changes Summary Table
For coppers to be eligible for reregi strati on, all agricultural labels of copper-containing
products must be amended to incorporate the risk mitigation measures outlined in Section IV.
Table 29 describes specific label amendments.
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Table 29. Copper Compounds Labeling Changes Summary
In order to be eligible for reregistration, all product labels must be amended to incorporate the risk mitigation measures outlined in Section IV.
The following table describes how language on the labels should be amended.
Description
Copper Compounds Required Labeling Language
Placement on Label
Manufacturing-Use Products
Required on all MUPs for all
Copper Compounds
containing directions for any
use
"Only for formulation into [fill blank with the appropriate pesticide type(s):
fungicides, bactericides, algaecides, herbicides, leech control, freshwater snail
control, anti-foulants and wood preservatives] for the following use(s) [fill blank
only with those uses that are being supported by MP registrants]."
Directions for Use
One of these statements may
be added to a label to allow
reformulation of the product
for a specific use or all
additional uses supported by
a formulator or user group.
Note: Manufacturing Use Products can not have end use directions. Similarly,
End Use Products can not have formulation directions.
"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 for 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)."
Directions for Use
Environmental Hazards
Statements Required by the
RED and Agency Label
Policies
"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 Pollutant 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 the EPA."
Directions for Use
Required on all MUPs for All
Copper Compounds
For all copper compounds label, the Ingredient Statement panel must state and
describe the ingredient(s) in the following manner:
the original form/species (i.e., copper hydroxide, copper ethanolamine
complex, copper sulfate pentahydrate) as the active ingredient,
the percentage of active ingredient contained in the product,
Front Panel, Ingredient
Statement
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Description
Copper Compounds Required Labeling Language
the respective Chemical Abstracts Service (CAS) number must be listed,
and the amount of metallic copper equivalent must be expressed as the
percentage by weight directly below the Ingredient Statement.
Placement on Label
Description
Copper Compounds Required Labeling Language
Placement on Label
End-Use Products Intended for Occupational Use (WPS and non-WPS)
Required on all EUPs for All
Copper Compounds,
including products primarily
used by Consumers/
Homeowners
For all copper compounds label, the Ingredient Statement panel must state and
describe the ingredient(s) in the following manner:
the original form/species (i.e., copper hydroxide, copper ethanolamine
complex, copper sulfate pentahydrate) as the active ingredient,
the percentage of active ingredient contained in the product,
the respective Chemical Abstracts Service (CAS) number must be listed,
and the amount of metallic copper equivalent must be expressed as the
percentage by weight directly below the Ingredient Statement.
Ingredient Statement
Environmental
Hazards Statements for
Product with Only Direct
Aquatic Uses
For labels that include direct aquatic uses, include the following statements:
"ENVIRONMENTAL HAZARDS
This pesticide is toxic to fish and aquatic invertebrates. Waters treated with this
product may be hazardous to aquatic organisms. Treatment of aquatic weeds and
algae can result in oxygen loss from decomposition of dead algae and weeds. This
oxygen loss can cause fish and invertebrate suffocation. To minimize this hazard,
do not treat more than !/> of the water body to avoid depletion of oxygen due to
decaying vegetation. Wait at least 10 to 14 days between treatments. Begin
treatment along the shore and proceed outwards in bands to allow fish to move
into untreated areas. Consult with the State or local agency with primary
responsibility for regulating pesticides before applying to public waters, to
determine if a permit is required.
Certain water conditions including low pH (<6.5), low dissolved organic carbon
(DOC) levels (3.0 mg/L or lower), and "soft" waters (i.e., alkalinity less than 50
90
Precautionary Statements
under Environmental
Hazards Statement
-------
Description
Copper Compounds Required Labeling Language
Placement on Label
mg/L), increases the potential acute toxicity to non-target aquatic organisms."
Environmental
Hazards Statements for
Products with Terrestrial
Uses Only
For labels that include terrestrial uses (remove "drift" if a granular formulation),
include the following statements:
"ENVIRONMENTAL HAZARDS
This pesticide is toxic to fish and aquatic invertebrates and may contaminate water
through runoff. This product has a potential for runoff for several months or more
after application. Poorly draining soils and soils with shallow water tables are
more prone to produce runoff that contains this product. Drift and runoff may be
hazardous to aquatic organisms in water adjacent to treated areas.
Do not apply directly to water, to areas where surface water is present, or to
intertidal areas below the mean high water mark. Do not contaminate water when
disposing of equipment washwater or rinsate."
Precautionary Statements
under Environmental
Hazards
Environmental
Hazards Statements for
Products with both Terrestrial
and Aquatic Uses
Use the exact Environmental Hazards aquatic and terrestrial statements above so
that the aquatic and terrestrial statements are clearly distinguishable from one
another. Add:
"Forterrestrial uses" before "This pesticide... treated areas.", and also before "Do
not apply...equipment."
Precautionary Statements
under Environmental
Hazards
User Safety Requirement for
copper compounds used to
treat potable water sources
For end-use products that include use of copper compounds in waters destined for
eventual use as drinking water, the following two statements must be included:
"For applications in waters destined for use as drinking water, those waters must
receive additional and separate potable water treatment. Do not apply more than
1.0 ppm as metallic copper in these waters"
Precautionary
Statements: Hazards to
Humans and Domestic
Animals
Minimum Handler PPE
Requirements
(All Copper Compounds)
"Personal Protective Equipment (PPE)"
"Mixers, loaders, applicators, and other handlers must wear the following:
- long-sleeved shirt,
- long pants,
Precautionary
Statements: Hazards to
Humans and Domestic
Animals
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Description
Copper Compounds Required Labeling Language
Placement on Label
NOTE:
In the case of multiple active
ingredients, the more
protective PPE must be
placed on the product
labeling. For guidance on
which PPE is considered
more protective, see PR
Notice 93-7.
- shoes plus socks."
Instruction to Registrant:
If chemical resistant gloves, apron or footwear are required by the product specific
data, add the following statement:
"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."
Signal Word
For products subject to the WPS that are classified as toxicity category I or II must
also bear the corresponding Spanish signal word and statement:
"Si usted no entiende la etiqueta, busque a alguien para que se la explique a usted
en detalle. (If you do not understand the label, find someone to explain it to you in
detail.)"
Front Panel
User Safety Requirements
(All Copper Compounds)
"Follow manufacturer's instructions for cleaning/maintaining PPE. jf no sucn
instructions for washables exist, use detergent and hot water. Keep and wash PPE
separately from other laundry."
"Discard clothing and other absorbent material that have been drenched or heavily
contaminated with the product's concentrate. Do not reuse them."
Precautionary
Statements: Hazards to
Humans and Domestic
Animals immediately
following the PPE
requirements
User Safety
Recommendations
(All Copper Compounds)
"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.)
92
-------
Description
Copper Compounds Required Labeling Language
Placement on Label
Note to Registrant: If gloves are required on the label (either for handlers or early
entry workers), add the following in addition to the above:
'Wash the outside of gloves before removing."
Restricted-Entry Interval
for products with WPS uses
Note: REI's are determined
by the acute toxicity of each
copper compound which can
vary. For products
containing more than one
copper compound, the most
restrictive REI must appear
on the label.
"Do not enter or allow worker entry into treated areas during the restricted entry
interval of (insert the correct REI as specified below):
Products containing any of the following copper compounds require a 48
hour REI*:
Basic copper chloride (008001)
Chelates of copper gluconate or copper citrate (024405)
Copper ammonium carbonate (022703)
Copper carbonate (022901)
Copper hydroxide (023401)
Copper ammonia complex (022702)
Copper oxychloride (023501)
Copper oxychloride sulfate (023503)
Basic copper sulfate (008101)
Copper sulfate pentahydrate (024401)
Copper 8-quinolinolate (024002)
Copper naphthenate (023102)
Copper ethanolamine complex (024409)
Copper salts of fatty and rosin acids (023104)
*except for green house uses, which require a 24-hour REI.
Products containing any of the following copper compounds require a 24
hour REI:
Copper, metallic (022501)
Copper ethylenediamine (024407)
Directions for Use,
Agricultural Use
Requirements Box
93
-------
Description
For All Copper-containing
Products that are Registered
for Use in Greenhouses with
48-hour REIs
Early Entry Personal
Protective Equipment for
Copper Compounds Required Labeling Language
Products containing any of the following copper compounds require a 12
hour REI:
Cupric oxide (042401)
Cuprous oxide (025601)
Copper octanoate (023306)
Copper triethanolamine complex (024403)
For all copper-containing products that are Registered for Use in Greenhouses
only that currently have a 48-hour REI may be reduced to 24-hour REI, provided
that the following conditions are met:
the only WPS trigger for a 48-hour REI is due to severe eye irritation
Toxicity Category I or II),
all labeling changes are completed, and
registrants must include the following statements on the product label:
"For at least seven days following the application of copper-containing products in
greenhouses:
at least one container or station designed specifically for flushing eyes
is available in operating condition with the WPS-required
decontamination supplies for workers entering the area treated with
copper-containing products,
workers are informed orally, in a manner they can understand:
- that residues in the treated area may be highly irritating to their
eyes,
- that they should take precautions, such as refraining from
rubbing their eyes, to keep the residues out of their eyes,
- that if they do get residues in their eyes, they should immediately
flush their eyes with the eye flush container for eye flush station
that is located with the decontamination supplies, and
- how to operate the eye flush container or eye flush station."
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,
Placement on Label
Directions for Use,
Agricultural Use
Requirements Box
Directions for Use,
Agricultural Use
94
-------
Description
Copper Compounds Required Labeling Language
Placement on Label
products with WPS uses
Note: Early Entry PPE is
determined by the acute
toxicity of each copper
compound which can vary.
For products containing more
than one copper compound,
the most restrictive REI must
appear on the label.
such as soil or water, is (insert correct Early Entry PPE specified below)
Products containing any of the copper compounds listed directly below
require the following early entry PPE:
Coveralls over long-sleeved shirt and long pants,
chemical-resistant gloves made of any waterproof material,
chemical-resistant footwear plus socks,
chemical resistant headgear if overhead exposure, and
protective eyewear:
Chelates of copper gluconate or copper citrate (024405)
Copper ammonium carbonate (022703)
Copper ammonia complex (022702)
Copper oxychloride (023501)
Copper oxychloride sulfate (023503)
Basic copper sulfate (008101)
Cuprous oxide (025601)
Copper naphthenate (023102)
Copper ethanolamine complex (024409)
Products containing any of the copper compounds listed directly below
require the following early entry PPE:
Coveralls,
shoes plus socks,
chemical-resistant gloves made of any waterproof material, and
protective eyewear.
Basic copper chloride (008001)
Copper carbonate (022901)
Copper hydroxide (023401)
Requirements Box
95
-------
Description
Copper Compounds Required Labeling Language
Placement on Label
Copper sulfate pentahydrate (024401)
Copper 8-quinolinolate (024002)
Copper, metallic (022501)
Early Entry Personal
Protective Equipment for
products with WPS uses
Note: Early Entry PPE is
determined by the acute
toxicity of each copper
compound which can vary.
For products containing more
than one copper compound,
the most restrictive REI must
appear on the label.
Products containing any of the copper compounds listed directly below
require the following early entry PPE:
Coveralls over long-sleeved shirt and long pants,
shoes plus socks,
chemical-resistant gloves such as or made out of any waterproof material:
Copper ethylenediamine (024407)
Cupric oxide (042401)
Copper octanoate (023306)
Copper triethanolamine complex (024403)
Copper salts of fatty and rosin acids (023104)
Directions for Use,
Agricultural Use
Requirements Box
Double Notification
Statement
Products containing any of the copper compounds listed directly below require the
following statement:
"Notify workers of the application by warning them orally and by posting warning
signs at entrances to treated areas."
Chelates of copper gluconate (024405)
Copper ammonium carbonate (022703)
Copper ammonia complex (022702)
Copper oxychloride (023501)
Copper oxychloride sulfate (023503)
Basic copper sulfate (008101)
Cuprous oxide (025601)
Copper naphthenate (023102)
Copper ethanolamine complex (024409)
Directions for Use,
Agricultural Use
Requirements Box
Entry Restrictions
for products with non-WPS
Entry Restriction for products applied as a spray:
If no WPS uses on the
product label, place the
96
-------
Description
Copper Compounds Required Labeling Language
Placement on Label
uses on the label
"Do not enter or allow others to enter until sprays have dried."
Entry Restriction for products applied dry:
"Do not enter or allow others to enter until dusts have settled."
appropriate statement in
the Directions for Use
Under General
Precautions and
Restrictions. Ifthe
product also contains
WPS uses, then create a
Non-Agricultural Use
Requirements box as
directed in PR Notice 93-
7 and place the
appropriate statement
inside that box.
General Application
Restrictions for products with
WPS or non-WPS uses on the
label
"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. For any requirements specific to your State or Tribe, consult the State
or Tribal agency responsible for pesticide regulation."
Place in the Direction for
Use, following the
misuse statement.
Spray Drift Management
Statements for all copper-
containing products, except
for granular
Pesticide drift text must be added to the label and must read:
"SPRAY* DRIFT MANAGEMENT
A variety of factors including weather conditions (e.g., wind direction, wind speed,
temperature, relative humidity) and method of application (e.g., ground, aerial,
airblast, chemigation) can influence pesticide drift. The applicator must evaluate
all factors and make appropriate adjustments when applying this product.
Droplet Size**
Apply only as a medium or coarser spray (ASAE standard 572) or a volume mean
diameter of 300 microns or greater for spinning atomizer nozzles.
Wind Speed
Do not apply at wind speeds greater than 15 mph. Only apply this product if the
97
Place in the Direction for
Use
-------
Description
Copper Compounds Required Labeling Language
Placement on Label
wind direction favors on-target deposition (approximately 3 to 10 mph), and there
are no sensitive areas within 250 feet downwind.
Temperature Inversions
If applying at wind speeds less than 3 mph, the applicator must determine if a)
conditions of temperature inversion exist, or b) stable atmospheric conditions exist
at or below nozzle height. Do not make applications into areas of temperature
inversions or stable atmospheric conditions.
Other State and Local Requirements
Applicators must follow all state and local pesticide drift requirements regarding
application of copper compounds. Where states have more stringent regulations,
they must be observed.
Equipment
All aerial and ground application equipment must be properly maintained and
calibrated using appropriate carriers or surrogates.
Additional requirements for aerial applications:
- The boom length must not exceed 75% of the wingspan or 90% of the rotor blade
diameter.
- Release spray at the lowest height consistent with efficacy and flight safety. QO
not release spray at a height greater than 10 feet above the crop canopy unless a
greater height is required for aircraft safety.
- When applications are made with a crosswind, the swath must be displaced
downwind. The applicator must compensate for this displacement at the up and
downwind edge of the application area by adjusting the path of the aircraft
upwind.
Additional requirements for ground boom application:
98
-------
Description
Other Application
Restrictions
Copper Compounds Required Labeling Language
Do not apply with a nozzle height greater than 4 feet above the crop canopy."
Note to Registrant:
* The word "spray" may be removed if product is a dust formulation.
** The Droplet Size statement may be removed if product is a dust formulation.
Maximum Application Rates, Application Interval (days) and Seasonal Maximum
Application Rates must be specified on all product labels. See Appendix A for the
correct application rates and intervals for each site or crop.
Placement on Label
Directions for Use under
General Precautions and
Restrictions and/or
Application Instructions
Products Primarily Used by Consumers/Homeowners
Entry Restrictions
General Application
Restrictions
Environmental Hazards
Entry Restriction for products applied as a spray:
"Do not allow adults, children, or pets to enter the treated area until sprays have
dried."
Entry Restriction for products applied dry:
"Do not allow adults, children, or pets to enter the treated area until dusts have
settled."
"Do not apply this product in a way that will contact adults, children, or pets,
either directly or through drift."
"This pesticide is toxic to fish and aquatic invertebrates and may contaminate
water through runoff. For terrestrial uses, do not apply directly to water. Do not
contaminate water when disposing of equipment washwaters or rinsate."
Directions for use under
General Precautions and
Restrictions
Place in the Direction for
Use
Precautionary Statements
99
-------
APPENDIX A.
Copper Refined Actual Use Rates for Crops
Crop
Maximum per
Application Rate
(Ibs Cu^/A)1
Maximum Annual
Rate (Ibs Cu2+/A)2
Minimum
Retreatment
Interval3
Notes
TREE FRUIT
Pome Fruit
(apple, loquat,
pear, quince)
Fall, late dormant
Between silver-tip and
green-tip
Bloom, growing
season
Atemoya, Sugar Apple (Annona)
Avocado
Banana
Carambola
Cherimoya (custard apple)
Citrus (citron, grapefruit, kumquat, lemon,
orange, pummelo, tangelo, tangerine, lime)
Guava
Mamey Sapote
Mango
Olive
Papaya
Persimmon
Stone Fruit
(apricot, cherry,
nectarine, peach,
Dormant, late
dormant, up to pink
bud
8.0
6.0
1.5
3.15
3.15
1.05
2.1
2.1
3.15
1.23
2.1
3.2
6.0
2.63
1.0
8.0
16.0
12.6
18.9
18.9
10.5
8.4
12.6
4.92
8.4
48.0
18.0
21.2
6.0
18.0
n/a
(only 1 application
per season permitted)
n/a
(only 1 application
per season permitted)
5 days
7 days
14 days
7 days
7 days
14 days
7 days
7 days
14 days
7 days
30 days
7 days
14 days
7 days
100
-------
Copper Refined Actual Use Rates for Crops
Crop
plum, prune) Bloom/ growing
season
Maximum per
Application Rate
(Ibs Cu^/A)1
1.5
Maximum Annual
Rate (Ibs Cu2+/A)2
Minimum
Retreatment
Interval3
5 days
Notes
TREE NUTS
Dormant, late dormant
Almond Bloom/ growing
season
Betel Nut (Guam)
Cacao
Chestnut
Coffee
Filbert
Litchi
Macadamia
Nutmeg
Pecan, Pistachio
Walnut
8.0
1.5
0.75
2.25
2.1
2.1
6.0
1.23
2.36
2.1
2.1
4.0
18.0
8.25
15.75
8.4
12.6
24
4.92
9.44
8.4
8.4
32.0
7 days
5 days
7 days
14 days
14 days
14 days
14 days
7 days
7 days
14 days
14 days
7 days
Permitted only in
Washington State and
Oregon
FIELD CROPS
Alfalfa
Cereal Grains (barley, millet, oat, rye,
sorghum, wheat)
Clover
Corn (Field Corn, Popcorn, Sweet Corn)
Peanut
Potato
0.53
0.53
0.53
1.05
0.79
2.5
1.12
1.06
4.74
4.2
4.74
25
30 days
10 days
7 days
7 days
7 days
5 days
101
-------
Copper Refined Actual Use Rates for Crops
Crop
Soybean
Sugar Beet
Sugarcane
Tobacco
Maximum per
Application Rate
(Ibs Cu^/A)1
0.79
1.31
0.53
2.0
Maximum Annual
Rate (Ibs Cu2+/A)2
4.74
7.86
1.06
8.0
Minimum
Retreatment
Interval3
7days
10 days
10 days
10 days
Notes
SMALL FRUITS
Brambles (aurora, blackberry, boysen,
cascasde, chehalem, dewberry, logan,
marion, raspberry, santiam, thornless
evergreen)
Blueberry
Cranberry
Currant, Gooseberry (Ribes)
Strawberry
2.0
2.1
2.1
4.0
1.5
1.0
10.0
8.4
12.6
16.0
8.19
7 days
7 days
7 days
10 days
7 days
VEGETABLE
Artichoke
Asparagus
Bean (Dry, Green)
Beet (Table Beet, Beet Greens)
Carrot
Celery, Celeriac
Chard
0.53
1.0
0.79
1.31
1.0
1.0
0.79
2.65
5.0
4.74
7.86
5.0
5.3
3.95
7 days
10 days
7 days
10 days
7 days
7 days
7 days
102
-------
Copper Refined Actual Use Rates for Crops
Crop
Crucifers (broccoli, brussel sprout,
cabbage, cauliflower, Chinese cabbage,
collard greens, kale, kohlrabi, mustard
greens,
turnip greens)
Cucurbits (cantaloupe, casaba, chayote,
citron melon, cucumber, gourd, honeydew,
muskmelon, pumpkin, squash (summer
and winter), watermelon, waxgourd)
Eggplant
Garlic
Leek
Lettuce (endive, escarole)
Okra
Onion
Pea
Pepper (bell, chili)
Radish
Rhubarb
Rutabaga
Shallot
Spinach
Tomato (processing)
Tomato (fresh market)
Turnip
Watercress
Maximum per
Application Rate
(Ibs Cu^/A)1
0.53
1.05
0.79
1.0
1.0
1.0
1.05
1.0
0.79
0.79
1.31
0.79
1.31
1.0
0.79
0.53
1.6
1.31
0.53
Maximum Annual
Rate (Ibs Cu2+/A)2
2.65
5.25
7.9
6.0
6.0
8.0
5.25
6.0
3.95
11.85
7.86
3.95
7.86
6.0
3.95
17.4
8.0
7.86
2.12
Minimum
Retreatment
Interval3
7 days
5 days
7 days
7 days
7 days
5 days
5 days
7 days
7 days
3 days
10 days
7 days
10 days
7 days
7 days
3 days
3 days
10 days
7 days
Notes
103
-------
Copper Refined Actual Use Rates for Crops
Crop
Maximum per
Application Rate
(Ibs Cu^/A)1
Maximum Annual
Rate (Ibs Cu2+/A)2
Minimum
Retreatment
Interval3
Notes
VINES
Grape
Hops
Kiwi
Passion Fruit
3.0
0.53
2.1
2.36
20.0
2.65
6.3
9.44
3 days
10 days
30 days
7 days
MISCELLANEOUS
Chicory
Chives
Cinnamon
Coriander
Dill
Ginseng
Mint
Parsley
Rosemary
Turfgrass
1.31
0.53
3.15
0.53
0.79
1.05
0.53
1.0
0.53
3.0
7.86
2.65
18.9
2.65
3.95
5.25
2.65
2.0
2.65
21.0
10 days
7 days
14 days
10 days
7 days
7 days
10 days
10 days
10 days
10 days
ORNAMENTALS
Lilies, Easter
All Other Ornamentals
2.5
2.0
75.0
20.0
7 days
7 days
Maximum pounds of
metallic copper which may
be applied in a 12 month
period. Do not apply any
additional copper pesticide
to this land for 36 months.
DIRECT AQUATIC RATES
Sewer Line Treatment
0.5
2.0
6 months
104
-------
Copper Refined Actual Use Rates for Crops
Crop
Algae, cyanobacteria, aquatic weeds
(Elodea spp., hydrilla, Potamogeton spp.,
irrigation canal weed, annual naiads) for all
aquatic application sites
Schistosome-infected freshwater snail
control
Algae control in aquaculture when fish are
present
Tadpole shrimp in rice fields
Leech control
Maximum per
Application Rate
(Ibs Cu^/A)1
1 part per million
(ppm)
1.5 ppm
0.4 ppm
2.5 ppm
1.5 ppm
Maximum Annual
Rate (Ibs Cu2+/A)2
n/a
n/a
n/a
n/a
n/a
Minimum
Retreatment
Interval3
14 days
n/a
n/a
n/a
n/a
Notes
No more than !/> of the water
body may be treated at one
time. If the treated water is
to be used as a source of
potable water, the metallic
copper concentration must
not exceed 1 ppm.
1 - Maximum pounds of metallic copper which may be applied to an acre for each application.
described in liquid units or pounds of total product.
2 - Maximum amount of metallic copper which may be applied to an acre each calendar year.
frequencies may be used.
3 - Minimum number of days between each application.
Product labels must also include application rates
Lower single application rates at higher application
105
-------
APPENDIX B. Citations in Support of the Coppers RED
Data Supporting Guideline Requirements for the Reregistration of Coppers
REQUIREMENT
USE
PATTERN
CITATION(S)
PRODUCT CHEMISTRY
New
Guideline
Number
830.1550
830.1600
830.1670
830.1700
830.1750
830.1800
Old Guideline Number
61-1
6 1-2 A
61-2B
62-1
62-2
62-3
Product Identity and Composition
Start. Mat. & Mnfg. Process
Formation of Impurities
Preliminary Analysis
Certification of limits
Analytical Method
All
All
All
All
All
All
Supplemental
43363801 -PC 023401
43364301 -PC 023501
PC 008001
Acceptable
43364001 -PC 023503
Supplemental
43363801 -PC 023401
43364301 -PC 023501
PC 008001
Acceptable
43364001 -PC 023503
Supplemental
43363801 -PC 023401
43364301 -PC 023501
PC 008001
Acceptable
43364001 -PC 023503
Acceptable
43363802 -PC 023401
43364302 -PC 008001,
PC 023501
43364002 - PC 023503
Supplemental
43363803 -PC 023401
43364303 -PC 023501
PC 008001
Acceptable
43364003 - PC 023503
Supplemental
43363804 -PC 023401
43364304 -PC 023501
PC 008001
43364004 - PC 023503
106
-------
830.6302
830.6303
830.6304
830.7050
830.7200
830.7220
830.7300
830.7840
830.7860
830.7950
63-2
63-3
63-4
None
63-5
63-6
63-7
63-8
63-9
Color
Physical State
Odor
UV/Visible Absorption
Melting Point
Boiling Point
Density
Solubility
Vapor Pressure
All
All
All
All
All
All
All
All
All
Acceptable
43363805 -PC 023401
43364305 -PC 008001,
PC 023501
43364005 - PC 023503
Acceptable
43363805 -PC 023401
43364305 -PC 008001,
PC 023501
43364005 - PC 023503
Acceptable
43363805 -PC 023401
43364305 -PC 008001,
PC 023501
43364005 - PC 023503
Acceptable
43363805 -PC 023401
43364305 -PC 008001,
PC 023501
Acceptable
43363805 -PC 023401
43364305 -PC 008001,
PC 023501
43364005 - PC 023503
Acceptable
43363805 -PC 023401
43364305 -PC 008001,
PC 023501
43364005 - PC 023503
Acceptable
43363805 -PC 023401
43364305 -PC 008001,
PC 023501
43364005 - PC 023503
Acceptable
43363805 -PC 023401
43364305 -PC 008001,
PC 023501
43364005 - PC 023503
Acceptable
43363805 -PC 023401
43364305 -PC 008001,
PC 023501
43364005 - PC 023503
107
-------
830.7370
830.7550
830.7000
830.6313
63-10
63-11
63-12
63-13
Dissociation Constant
Octanol/Water Partition Coefficient
pH
Stability
All
All
All
All
Acceptable
43363805 -PC 023401
43364305 -PC 008001,
PC 023501
43364005 - PC 023503
Acceptable
43363805 -PC 023401
43364305 -PC 008001,
PC 023501
43364005 - PC 023503
Acceptable
43363805 -PC 023401
43364305 -PC 008001,
PC 023501
43364005 - PC 023503
Acceptable
43363805 -PC 023401
43364305 -PC 008001,
PC 023501
43364005 - PC 023503
ECOLOGICAL EFFECTS
850.2100
850.2200
850.2200
850.2400
850.2300
850.2300
850.1075
850.1075
850.1010
850.1075
850.1025
850.1035
850.1045
850.1400
850.1300
850.1350
850.1500
850.4225
71-1
7 1-2 A
71-2B
71-3
7 1-4 A
71-4B
72-1A
72- 1C
72-2A
72-3A
72-3B
72-3C
72-4A
72-4B
72-5
123-1A
Avian Acute Oral Toxicity
Avian Dietary Toxicity - Quail
Avian Dietary Toxicity - Duck
Wild Mammal Toxicity
Avian Reproduction - Quail
Avian Reproduction - Duck
Fish Toxicity Bluegill
Fish Toxicity Rainbow Trout
Invertebrate Toxicity
Estuarine/Marine Toxicity - Fish
Estuarine/Marine Toxicity - Mollusk
Estuarine/Marine Toxicity - Shrimp
Fish- Early Life Stage
Estuarine/Marine Invertebrate Life
Cycle
Life Cycle Fish
Seed Germ./ Seedling Emergence
All
All
All
All
All
All
All
All
All
All
All
All
All
All
All
All
00067456, 00106120
00134362
00099587
none
43338001
43396301
none
Onchorynchus
(salmonids) - BLM
Pimephales promelas
(fathead minnow) - BLM
Daphnia magna- BLM
summer flounder
(Paralichthys dentatus)-
BLM
mussel (Mytilus)- BLM
none
none
none
none
none
108
-------
850.4250
850.4400
123-1B
123-2
Vegetative Vigor
Aquatic Plant Growth
All
All
44317, 405 5 9 (from
ECOTOX database)
43363601 43363602
43363603 43363604
43363605
TOXICOLOGY
870.1100
870.1200
870.1300
81-1
81-2
81-3
Acute Oral Toxicity-Rat
Acute Dermal Toxicity-Rabbit/Rat
Acute Inhalation Toxicity-Rat
All
All
All
43769501 -PC 008001
41889302 -PC 022901
41421602 -PC 023401
00155931 -PC 023501
43396201 -PC 024401
00162424 -PC 022501
41502401 -PC 042401
00078971 -PC 025601
41759301 -PC 024403
41759201 -PC 024407
43643701 -PC 023 102
43947504 - PC 023306
43769502 -PC 008001
00159371 and
00152505 -PC 023401
43452201 -PC 024401
00150641 -PC 022501
41502402 -PC 042401
00078972 -PC 025601
41759302 -PC 024403
41759202 -PC 024407
43643702 -PC 023 102
43947505 - PC 023306
00160580 -PC 023401
00155932 -PC 023501
00156396 -PC 022501
41502403 -PC 042401
42240303 -PC 025601
42130001 -PC 024407
43970201 -PC 023306
109
-------
870.2400
870.2500
870.2600
870.3100
870.3200
870.3700
870.3700
870.5140
870.7485
81-4
81-5
81-6
82-1A
82-2
83-3A
83-3B
84-2A
85-1
Primary Eye Irritation-Rabbit
Primary Skin Irritation
Dermal Sensitization
90-Day Feeding - Rodent
21 -Day Dermal - Rabbit/Rat
Developmental Toxicity - Rat
Developmental Toxicity - Rabbit
Gene Mutation (Ames Test)
General Metabolism
All
All
All
All
All
All
All
All
All
43769503 -PC 008001
41889301 -PC 022901
00155934 -PC 023501
43396201 -PC 024401
00126194 -PC 022501
41502404 -PC 042401
00078974 -PC 025601
41759303 -PC 024403
41759204 -PC 024407
43937506 -PC 023306
43769504 -PC 008001
00155935 -PC 023501
43396201 -PC 024401
00126194 -PC 022501
41502405 -PC 042401
00078970 -PC 025601
41759304 -PC 024403
41759204 -PC 024407
00155896 -PC 023102
40834604 -PC 023 104
00155936 -PC 023501
00152166 -PC 022501
41502406 -PC 042401
00078970 -PC 025601
42130002 -PC 024407
44116101 -PC 023104
00058020 and
00075 116 -PC 024401
44 127507 -PC 024403
44 127507 -PC 024407
44 127507 -PC 024407
44 127506 -PC 024403
46377501, 2 -PC 023401
00085218 -PC 024401
00062085 -PC 024401
ENVIRONMENTAL FATE
835.2120
835.2240
835.2410
835.2370
835.4100
835.4200
161-1
161-2
161-3
161-4
162-1
162-2
Hydrolysis
Photodegradation - Water
Photodegradation - Soil
Photodegradation - Air
Aerobic Soil Metabolism
Anaerobic Soil Metabolism
All
All
All
All
All
All
Not applicable*
Not applicable*
Not applicable*
Not applicable*
Not applicable*
Not applicable*
110
-------
835.4400
835.4300
835.1240
None
162-3
162-4
163-1
165-4
Anaerobic Aquatic Metabolism
Aerobic Aquatic Metabolism
Leaching/Adsorption/De sorption
Bioaccumulation in Fish
Aquatic field dissipation
All
All
All
All
Not applicable*
Not applicable*
Jones and Hetrick, 1991
MRID 00099539,
00062074,411890-01)
OTHER
850.3020
141-1
Honey Bee Acute Contact
All
40764701, 2 -PC 023401
* = Copper is an element and will not be affected by these processes; thus, these studies are not required.
Ill
-------
APPENDIX C. Technical Support Documents
Additional documentation in support of the coppers RED is maintained in the OPP
Regulatory Public Docket, located in Room S-4400 One Potomac Yard (South Building), 2777
S. Crystal Drive, Arlington, VA. It is open from Monday through Friday, excluding legal
holidays, from 8:30 a.m. to 4:00 p.m. All documents may be viewed in the OPP Docket room or
viewed and/or downloaded via the Internet at http://www.regulations.gov. The Agency's
documents in support of this Red include the following:
1. U.S. EPA. Coppers: Revised Human Health Chapter of the Reregi strati on Eligibility
Decision Document (RED). Reregi strati on Case numbers 0636, 0649, 4025 and 4026,"
dated June 19, 2006. Memorandum from Reaves, E. et al to Louie, R.
2. U.S. EPA. Error Corrections for the Ecological Risk Assessment for Re-Registration of
copper sulfate (case #0636), group II copper compounds (case #0649), and copper salts
(case #0649) for use on crops and as direct water applications. June 15, 2005.
Memorandum from Doelling Brown, P. and Hetrick, J. to Louie, R.
3. U.S. EPA. Typical Application Information for Copper Products for Algaecide, Aquatic
Herbicide, Molluscicide, Leech, and Tadpole Shrimp Control. February 15, 2006.
Memorandum from Phillips, W. to Louie, R.
4. U.S. EPA. Addendum to the Memorandum "Typical Application Information for Copper
Products for Algaecide, Aquatic Herbicide, Molluscicide, Leech, and Tadpole Shrimp
Control." April 26, 2006. Memorandum from Phillips, W. to Louie, R.
5. U.S. EPA. Copper Alternatives Analysis for the Primary Aquatic Uses. June 15, 2006.
Memorandum from Phillips, W. and Costello, K. to Louie, R.
6. U.S. EPA. Overview of the Agricultural Uses of Copper Grouop II Pesticides and Their
Alternatives. June 28, 2006. Memorandum from Michell, R. and Lee, A. to Louie, R.
112
-------
APPENDIX D. Bibliography
43363801 Landis, W. (1994) Copper Hydroxide: Product Identity and Disclosure of
Ingredients, Including Manufacturing Process and Discussion of Formation of
Impurities. Unpublished study prepared by Copper Sulfate Task Force. 28 p.
58020 Applied Biochemists, Incorporated (1971) Copper in Stock and Wildlife Watering.
(Unpublished study received Oct 22, 1976 under 8959-11; CDL:226389-D)
62074 Nelson, J.L.; Bruns, V.F.; Coutant, C.C.; et al. (1969) Behavior and reactions of
Copper sulfate in an irrigation canal. Pesticides Monitoring Journal 3(3): 186-189.
(Available from: Superintendent of Documents, U.S. Government Printing Office,
published study; CDL:228175-1)
62085 Lai, S.; Sourkes, T.L. (1971) Deposition of Copper in rat tissues - the effect of
dose and duration of administration of Copper sulfate. Toxicology and Applied
Pharmacology 20:269-283. (Also In unpublished submission received Aug 25,
1976 under 37952-1; submitted by Canadian Metafma Chemicals, New
Westminster, British Columbia; CDL:228175-T)
67456 WARF Institute, Incorporated (1977) Report: WARF Institute No. 7020979.
(Unpublished study received Jul 11, 1977 under 1109-7; submitted by Cities
Service Co., Atlanta, Ga.; CDL: 230839-C)
75116 National Academy of Sciences (1977) Copper in animals. In Copper. By author.
N.P. (Available from: National Technical Information Service, Springfield, VA;
for Environmental Protection Agency; published study; CDL:243555-E)
78970 Auletta, C.S.; Hogan, G.K.; Hodge, P.S.; et al. (1981) A Dermal Sensitization
Study in Guinea Pigs: Project No. 6588-81. (Unpublished study received Jul 21,
1981 under 46197-1; prepared by Bio/dynamics, Inc., submitted by Kansai Paint
Co., Ltd., Rahway, N.J.; CDL:245650-A)
78971 Auletta, C.S.; Hodge, P.S.; Erickson, J.; et al. (1981) Acute Oral Toxicity Study in
Rats: Project No. 6580-81. (Unpublished study received Jul 21, 1981 under
46197-1; prepared by Bio/dynamics, Inc., submitted by Kansai Paint Co., Ltd.,
Rahway, N.J.; CDL: 245650-B)
78972 Auletta, C.S.; Hodge, P.S.; Erickson, J.; et al. (1981) Primary Dermal Irritation
Study in Rabbits: Project No. 6583-81. (Unpublished study received Jul 21, 1981
under 46197-1; prepared by Bio/dynamics, Inc., submitted by Kansai Paint Co.,
Ltd., Rahway, N.J.; CDL:245650-C)
113
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78974 Auletta, C.S.; Hodge, P.S.; Erickson, 1; et al. (1981) Eye Irritation Study in
Rabbits: Project No. 6582-81. (Unpublished study received Jul 21, 1981 under
46197-1; prepared by Bio/dynamics, Inc., submitted by Kansai Paint Co., Ltd.,
Rahway, N.J.; CDL: 245650-E)
85218 Lemma, A.; Ames, B.N. (1975) Screening for mutagenic activity of some
molluscicides. Transactions of the Royal Society of Tropical Medicine and
Hygiene 69(1): 167-168. (Also In unpublished submission received Dec 8, 1977
under 464-431; submitted by Dow Chemical U.S.A., Midland, Mich.;
CDL:232666-Q)
99539 Deubert, K.; Demoranville, I. (1970) Copper sulfate in flooded cranberry bogs.
Pesticides Monitoring Journal 4(1): 11-13. (Available from: Superintendent of
Documents, U.S. Government Printing Office, Washington, DC 20402; published
study; CDL: 228173-T)
99587 Fink, R.; Reno, F. (1974) Final Report: Eight-day Dietary LC50 - Mallard Ducks:
TriBasic Copper Sulfate: Project No. 811-104. (Unpublished study received Mar
22, 1974) prepared by Environmental Sciences Corp. and Truslow Farms,
submitted by Cities Service Co., Atlanta, GA; CDL:235522-A)
106120 Warf Institute, Inc. (1977) Report: Warf Institute No. 7012485. (Unpublished
study received Jul 11, 1977 under 1109-13; submitted by Cities Service Co.,
Atlanta, GA; CDL:233920-A)
126194 Phillips, A.; Spalding, T. (1982) Toxicity Study: Lacco Copper Oxychloride
Sulfate 50% Sprayable Fungicide: NVP No. X2J016. (Unpublished study received
Feb 8, 1983 under 962-342; prepared by Northview Pacific Laboratories, Inc.,
submitted by Los Angeles Chemical Co., South Gate, CA; CDL:249611-A)
126194 Phillips, A.; Spalding, T. (1982) Toxicity Study: Lacco Copper Oxy Chloride
Sulfate 50% Sprayable Fungicide: NVP No. X2J016. (Unpublished study received
Feb 8, 1983 under 962-342; prepared by Northview Pacific Laboratories, Inc.,
submitted by Los Angeles Chemical Co., South Gate, CA; CDL:249611-A)
134362 Fink, R.; Reno, F. (1974) Eight-day Dietary LC50-Bobwhite Quail: Tribasic
Copper Sulfate: Project No. 811-103. Final rept. (Unpublished study received Mar
22, 1974 under 1109-13; prepared by Hazleton Laboratories, Inc., submitted by
Tennessee Chemical Co., Atlanta, GA; CDL:223695-B)
150641 Majnarich, J. (1984) Acute Dermal Toxicity of "Copper Control". Unpublished
study prepared by BioMed Research Laboratories, Inc. 14 p.
152166 Majnarich, J. (1984) Dermal Sensitization Study of "Copper Control": Series 81-6.
Unpublished study prepared by BioMed Research Laboratories, Inc. 4 p.
114
-------
152505 Galloway, C. (1984) Rabbit Acute Dermal Toxicity: Cupric Hydroxide: Project
No. 3480-84. Unpublished study prepared by Stillmeadow, Inc. 9 p.
155896 Berlin, C. (1985) Skin Irritation Test - EPA (of M-Gard, S-520 on Rabbits): Lab
No. 2778. Unpublished study prepared by Applied Biological Sciences
Laboratory, Inc. 17 p.
155931 Rosenfeld, G. (1984) Acute Oral Toxicity Study in Rats: Copper Oxychloride
Technical: C.S.E. #88687-4: Study #1144A. Unpublished study prepared by
Cosmopolitan Safety Evaluation, Inc. 29 p.
155932 Rosenfeld, G. (1984) Acute Inhalation Toxicity Study in Rats: Copper
Oxychloride Technical: C.S.E. #88687-4: Study #1144C. Unpublished study
prepared by Cosmopolitan Safety Evaluation, Inc. 31 p.
155934 Rosenfeld, G. (1984) Primary Eye Irritation Study in Rabbits: Copper Oxychloride
Technical: C.S.E. #88687-4: Study #1144D. Un- published study prepared by
Cosmopolitan Safety Evaluation, Inc. 23 p.
155935 Rosenfeld, G. (1984) Primary Dermal Irritation Study in Rabbits: Copper
Oxychloride Technical: C.S.E. #88687-4: Study #1144E. Unpublished study
prepared by Cosmopolitan Safety Evaluation, Inc. 13 p.
155936 Rosenfeld, G. (1984) Guinea Pig Sensitization Study (Buehler): Copper
Oxychloride Technical: C.S.E. #88687-4: Study #1144F. Unpublished study
prepared by Cosmopolitan Safety Evaluation, Inc. 15 p.
156395 Rosenfeld, G. (1984) Primary Dermal Irritation Study in Rabbits; Test Article:
Copper Oxychloride 3#Flowable Concentrate: C.S.E. #88687-3: Study No. 1143E.
Unpublished study prepared by prepared by Cosmopolitan Safety Evaluation
(C.S.E.), Inc. 13 p.
159371 Deenihan, M. (1985) Acute Oral Toxicity (LD50); Acute Dermal Toxic- ity;
Primary Skin Irritation; Primary Eye Irritation: NVP Report No. X5J030G.
Unpublished study prepared by Northview Pacific Laboratories, Inc. 33 p.
160580 Newton, P. (1986) Four Hour Acute Dust Aerosol Inhalation Toxicity Study in
Rats of Copper Hydroxide Formulated - 50% Cu: Study No. 420-2611.
Unpublished study prepared by American Biogenics Corp. 47 p.
162424 Collier, T.; Wilson, J. (1985) OECD Acute Oral Toxicity Test: Determination of
the Acute Oral Median Lethal Dose (LDso) of Copper Nordox Fungicide in the
Rat: Experiment No. 297/8404. Unpublished study prepared by Safepharm
Laboratories, Ltd. 28 p.
115
-------
40764701 Hoxter, K. (1988) Copper Hydroxide: An Acute Contact Toxicity Study with the
Honey Bee: Wildlife International Ltd. Project No. 190- 140. Unpublished study
prepared by Wildlife International Ltd. 14 p.
40764702 Hoxter, K. (1988) Copper Ammonium Complex: An Acute Contact Toxicity
Study with the Honey Bee: Wildlife International Ltd. Project No. 190-141.
Unpublished study prepared by Wildlife International Ltd. 14 p.
40834603 Cuthbert, I; Carr, S. (1988) Cuprous Thiocyanate: Magnusson-kligman
Maximisation Test in Guinea Pigs: IRI Project No. 239623. Unpublished study
prepared by Inveresk Research International. 22 p.
41189001 Hosmer, A.; Beaver, I; Brantly, T. (1988) An Aquatic Sediment Dissipation
Study of Copper Sulfate in the Hillsborough Reservoir, Florida: Project ID 241-
101. Unpublished study prepared by Wildlife International LTD. 482 p.
41421602 Rush, R. (1989) Acute Oral Toxicity Study in Rats with GX-240 LF (I): Lab
Project Number: 3159.81. Unpublished study prepared by Springborn Life
Sciences, Inc. 75
41502401 Kuhn, J. (1989) Acute Oral Toxicity Study in Rats: OG-9219 Copper Oxide: Lab
Project Number: 6602-89. Unpublished study prepared by Stillmeadow, Inc. lip.
41502402 Kuhn, J. (1989) Acute Dermal Toxicity Study in Rabbits: OG-9219 Cooper Oxide:
Lab Project Number: 6603-89. Unpublished study prepared by Stillmeadow, Inc.
12 p.
41502403 Holbert, M. (1990) Acute Inhalation Toxicity Study in Rats: Cupric Oxide OG-
0014: Lab Project Number: 6844-90. Unpublished study prepared by Stillmeadow,
Inc. 17 p.
41502404 Kuhn, J. (1989) Primary Eye Irritation Study in Rabbits: OG-9219 Copper Oxide:
Lab Project Number: 6604-89. Unpublished study prepared by Stillmeadow, Inc.
18 p.
41502405 Kuhn, J. (1989) Primary Dermal Irritation Study in Rabbits: OG-9219 Copper
Oxide: Lab Project Number: 6605-89. Unpublished study prepared by
Stillmeadow, Inc. 12 p.
41502406 Kuhn, J. (1990) Dermal Sensitization Study in Guinea Pigs: Cupric Oxide OG-
0014: Lab Project Number: 6843-90. Unpublished study prepared by Stillmeadow,
Inc. 18 p.
41759201 Rush, R. (1990) Acute Oral Toxicity in Rats with Komeen: Lab Project Number:
3236.5. Unpublished study prepared by Springborn Labs, Inc. 62 p.
116
-------
41759202 Rush, R. (1990) Acute Dermal Toxicity Study in Rabbits with Komeen: Lab
Project Number: 3236. 6. Unpublished study prepared by Springborn Labs, Inc. 26
P-
41759203 Rush, R. (1990) Primary Skin Irritation Study in Rabbits with Komeen: Lab
Project Number: 32326.8. Unpublished study prepared by Springborn
Laboratories, Inc. 19 p.
41759204 Rush, R. (1990) Primary Eye Irritation Study in Rabbits with Komeen: Lab
Project Number: 3236.7. Unpublished study prepared by Springborn Laboratories,
Inc. 25 p.
41759301 Rush, R. (1990) Acute Oral Toxicity Study in Rats with K-Tea: Lab Project
Number: 3236.1. Unpublished study prepared by Springborn Labs, Inc. 59 p.
41759302 Rush, R. (1990) Acute Dermal Toxicity Study in Rabbits with K-Tea: Lab Project
Number: 3236.2. Unpublished study prepared by Springborn Labs, Inc. 28 p.
41759303 Rush, R. (1990) Primary Eye Irritation Study in Rabbits with K-Tea: Lab Project
Number: 3236.3. Unpublished study prepared by Springborn Labs, Inc. 25 p.
41759304 Rush, R. (1990) Primary Skin Irritation Study in Rabbits with K-Tea: Lab Project
Number: 3236.4. Unpublished study prepared by Springborn Labs, Inc. 19 p.
41889301 O'Meara, R. (1991) Acute Toxicology Testing (Primary Eye Irritation): Copper
Carbonate Light: Lab Project Number: XOL068G. Unpublished study prepared by
Northview Pacific Laboratories, Inc. 15 p.
41889302 Hendrick, B. (1990) Acute Toxicology Testing (Acute Dermal Toxicity and
Primary Irritation: Rabbits): Copper Carbonate: Lab Project Number: XOG143G.
Unpublished study prepared by Northview Pacific Laboratories, Inc. 17 p.
42130001 Rush, R. (1991) Acute Inhalation Toxicity Study in Rats with Komeen: Lab
Project Number: 3159.95. Unpublished study prepared by Springborn Labs, Inc.
99 p.
42130002 James, C. (1991) Guinea Pig Sensitization Study-Buehler Method Using Test
Article Komeen: Lab Project Number: 66244-15. Unpublished study prepared by
Arthur D. Little, Inc. 34 p.
42240303 Shapiro, R. (1992) EPA Acute Inhalation-Defined LC50 in Rats: Cuprous Oxide,
Lot #05109010: Lab Project Number: T-l 169. Unpublished study prepared by
Product Safety Labs. 63 p.
117
-------
42957802 Hagemann, (?) (1990) 28 Day Repeated Dose Dermal Toxicity Study in the Rat:
Lab Project Number: 911205: CGA 281881: Final Report: Lab No. 911205.
Unpublished study prepared by Ciba-Geigy Limited. 178 p.
43338001 Redgrave, V. (1994) Copper Oxychloride Sulfate and Copper Hydroxide: Effects
on Reproduction in the Bobwhite Quail After Dietary Administration: Lab Project
Number: CSF/6: CSF/6/942180. Unpublished study prepared by Huntingdon
Research Centre Ltd. 208 p.
43363601 Bell, G. (1994) Copper Sulfate Pentahydrate: Algal Growth Inhibition (Navicula
pelliculosa): Lab Project Number: CSF 7(D)/941118: CSF 7(D). Unpublished
study prepared by Huntingdon Research Centre Ltd. 32 p.
43363602 Bell, G. (1994) Copper Sulfate Pentahydrate: Algal Growth Inhibition (Anabaena
flos-aquae): Lab Project Number: CSF 7(C)/ 941123: CSF 7(C). Unpublished
study prepared by Huntingdon Research Centre Ltd. 31 p.
43363603 Bell, G. (1994) Copper Sulfate Pentahydrate: Algal Growth Inhibition
(Selenastrum capricornutum): Lab Project Number: CSF 7(B)/941112: CSF 7(B).
Unpublished study prepared by Huntingdon Research Centre Ltd. 31 p.
43363604 Bell, G. (1994) Copper Sulfate Pentahydrate: Higher Plant (Lemna) Growth
Inhibition Test: Lab Project Number: CSF 7(A)/941127: CSF 7(A). Unpublished
study prepared by Huntingdon Research Centre Ltd. 30 p.
43363605 Bell, G. (1994) Copper Sulfate Pentahydrate Algal Growth Inhibition
(Skeletonema costatum): Lab Project Number: CSF 7(E)/941129: CSF 7(E).
Unpublished study prepared by Huntingdon Research Centre Ltd. 33 p.
43363802 Lumsden, A.; Mullee, D.; Bradburn, N. et al. (1994) Copper (II) Hydroxide:
Preliminary Analysis: Lab Project Number: 605/3. Unpublished study prepared by
Safepharm Lab., Ltd. 88 p. September 8, 1994.
43363803 Landis, W. (1994) Copper Hydroxide: Certification of Limits. Unpublished study
prepared by Copper Sulfate Task Force. 7 p. September 8, 1994.
43363804 Landis, W. (1994) Copper Hydroxide: Determination of Copper Content in
Copper Salts. Unpublished study prepared by Copper Sulfate Task Force. 7 p.
Septembers, 1994.
43363805 Landis, W. (1994) Copper Hydroxide: Physical and Chemical Characteristics.
Unpublished study prepared by Copper Sulfate Task Force. 25 p. September 8,
1994.
118
-------
43364001 Landis, W. (1994) Copper Oxychloride Sulfate: Product Identity and Disclosure of
Ingredients, Including Manufacturing Process and Discussion of Formation of
Impurities. Unpublished study prepared by Copper Sulfate Task Force. 24 p.
Septembers, 1994.
43364002 Lumsden, A.; Mullee, D.; Bradburn, N. et al. (1994) Copper Oxychloride Sulfate:
Preliminary Analysis. Unpublished study prepared by Safepharm Labs. Ltd. 59 p.
Septembers, 1994.
43364003 Landis, W. (1994) Copper Oxychloride Sulfate: Certification of Limits.
Unpublished study prepared by Copper Sulfate Task Force. 7 p. September 8,
1994.
43364004 Landis, W. (1994) Copper Oxychloride Sulfate: Determination of Copper Content
in Copper Salts. Unpublished study prepared by Copper Sulfate Task Force. 5 p.
Septembers, 1994.
43364005 Landis, W. (1994) Copper Oxychloride Sulfate: Determination of Copper Content
in Copper Salts. Unpublished study prepared by Copper Sulfate Task Force. 14 p.
43364301 Landis, W. (1994) Basic Copper Chloride (Copper Oxychloride): Product Identity
and Disclosure of Ingredients, Including Manufacturing Process and Discussion of
Formation of Impurities. Unpublished study prepared by Copper Sulfate Task
Force. 22 p. September 8, 1994.
43364302 Mullee, D.; Bartlett, A. (1994) Basic Copper Chloride: Preliminary Analysis: Lab
Project Number: 605/6. Unpublished study prepared by Safepharm Labs Ltd. 56 p.
Septembers, 1994.
43364303 Landis, W. (1994) Basic Copper Chloride: Copper Oxychloride Certification of
Limits. Unpublished study prepared by Copper Sulfate Task Force. 7 p. September
8, 1994.
43364304 Landis, W. (1994) Basic Copper Chloride: (Copper Oxychloride) Determination
of Copper Content in Copper Salts. Unpublished study prepared by Copper Sulfate
Task Force. 5 p. September 8, 1994.
43364305 Landis, W. (1994) Basic Copper Chloride: (Copper Oxychloride) Physical and
Chemical Characteristics. Unpublished study prepared by Copper Sulfate Task
Force. 12 p.
43396201 Deenihan, M. (1987) Fine 20 Copper Sulfate Pentahydrate-Acute Toxicology
Testing: Lab Project Number: X7G040G. Unpublished study prepared by
Northview Pacific Labs, Inc. 48 p.
119
-------
43396201 Deenihan, M. (1987) Fine 20 Copper Sulfate Pentahydrate-Acute Toxicology
Testing: Lab Project Number: X7G040G. Unpublished study prepared by
Northview Pacific Labs, Inc. 48 p.
43396201 Deenihan, M. (1987) Fine 20 Copper Sulfate Pentahydrate-Acute Toxicology
Testing: Lab Project Number: X7G040G. Unpublished study prepared by
Northview Pacific Labs, Inc. 48 p.
43396301 Redgrave, V. (1994) Copper Oxychloride Sulfate and Copper Hydroxide: Effects
on Reproduction in the Mallard Duck After Dietary Administration: Lab Project
Number: CSF/5: CSF 5/942114. Unpublished study prepared by Huntingdon
Research Centre, Ltd. 177 p.
43452201 Brammer, A. (1994) Butylate: Subchronic Neurotoxicity Study in Rats: Lab
Project Number: CTL/P/4423: PR0970. Unpublished study prepared by Zeneca
Central Toxicology Lab. 304 p.
43558501 Driscoll, R. (1993) Oxine Copper Technical (K-37): Acute Dermal Toxicity
(Limit Test) in the Rat: Lab Project Number: 386/39. Unpublished study prepared
by Safepharm Labs., Ltd. 16 p.
43642701 Kuhn, J. (1995) (Inert Ingredient) Acute Oral Toxicity Study in Mice: Final
Report: Lab Project Number: 1910-95. Unpublished study prepared by
Stillmeadow, Inc. 25 p.
43643702 Kuhn, J. (1992) Acute Dermal Toxicity Study in Rabbits: A00101 8% Copper
Naphthenate: Lab Project Number: 9543-92. Unpublished study prepared by
Stillmeadow Inc. 24 p.
43769501 Luperi, L. (1989) Acute Oral Toxicity in Rats: Test Substance: Copper
Oxychloride Technical (Basic Copper Chloride): Lab Project Number: 128001-
ST-01487. Unpublished study prepared by Life Science Research. 71 p.
43769502 Luperi, L. (1989) Acute Dermal Toxicity in Rabbits: Test Substance: Copper
Oxychloride Technical: (Basic Copper Chloride): Lab Project Number: 128004-
ST-01787. Unpublished study prepared by Life Science Research. 56 p.
43769503 Luperi, L. (1989) Acute Eye Irritation in Rabbits: Test Substance: Copper
Oxychloride Technical: (Basic Copper Chloride): Lab Project Number: 128003-
ST-01687. Unpublished study prepared by Life Science Research. 48 p.
43769504 Luperi, L. (1989) Primary Skin Irritation in Rabbits: Test Substance: Copper
Oxychloride Technical: (Basic Copper Chloride): Lab Project Number: 128002-
ST-01587. Unpublished study prepared by Life Science Research. 36 p.
120
-------
43947504 Rijcken, W. (1995) NEU1140F End-Use Product: Toxicology Data: Acute Oral
Toxicity Study (in Rats): Lab Project Number: 154801: 50778. Unpublished study
prepared by NOTOX 16. p.
43947505 Rijcken, W. (1995) NEU1140F End-Use Product: Toxicology Data: Acute Dermal
Toxicity Study (in Rat): Lab Project Number: 154812: 50778. Unpublished study
prepared by NOTOX. 16 p.
43970201 Grunert, B. (1996) Acute Inhalation Toxicity Study (in Rats): NEU1140F End-
Use Product: Lab Project Number: 95 10 42 197. Unpublished study prepared by
BioChem GmbH. 56 p.
44116101 Rijcken, W. (1996) Assessment of Contact Hypersensitivity to NEU1140F in the
Albino Guinea Pig (Maximization-Test): Lab Project Number: 171271: NOTOX
PROJECT 171271: NEU 1140 F. Unpublished study prepared by Notox. 21 p.
44127506 Stump, D. (1996) A Developmental Toxicity Screening Study of K-Tea and
Komeen in Rats: Final Report: Lab Project Number: WIL-157014: 95-030.
Unpublished study prepared by WIL Research Labs, Inc. 359 p.
44127507 Kiplinger, G. (1996) A 12-Day Dermal Range-Finding Study of K-Tea and
Komeen in Rats: Final Report: Lab Project Number: WIL-157013: 95-030.
Unpublished study prepared by WIL Research Labs, Inc. 165 p.
46377501 Munley, S. (2003) Copper Hydroxide: Pilot Developmental Toxicity Study in
Rabbits. Project Number: DUPONT/11861, 14341, HN/25562. Unpublished study
prepared by E.I. Du Pont de Nemours & Co., Inc. 107 p.
46377502 Munley, S. (2003) Copper Hydroxide: Developmental Toxicity Study in Rabbits.
Project Number: DUPONT/11862, 14341. Unpublished study prepared by E.I.
DuPont de Nemours & Co., Inc. 162 p.
121
-------
APPENDIX E. Generic Data Call-In
In support of the coppers RED, the Agency determined that the database were
substantially complete based on available databases, accepted study submissions, and open
literature sources. Thus, no additional generic data are needed at this time and a generic data
call-in will not be issued in support of this RED.
122
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APPENDIX F. Product Data Call-In (PDCI)
The following product data call-in reflects all product-specific data that are required from
the respective registrants that wish to maintain their product registrations. Because all data
requirements are the same for each respective AI, an example PDCI for only one AI is included
in this document. Table 27 shows the list of AIs affected by this PDCI.
Table 27. List of Copper Compounds Affected by the PDCI
Case
Copper Sulfates
#0636
Group II Copper
Compounds
#0649
Copper Salts
#4026
Other Copper
Compounds
Chemical Name
Basic Copper Sulfate
Copper Sulfate Pentahydrate
Copper Chloride
Copper Ammonium Carbonate
Basic Copper Carbonate
Copper Hydroxide
Copper Oxychloride
Copper Oxychloride Sulfate
Copper Ammonia Complex
Chelates of Copper Copper Gluconate
Copper Salts of Fatty and Rosin Acids
Copper Ethylenediamine
Copper Triethanolamine Complex
Copper Octanoate
Copper Ethanolamine Complex
EPA PC Code
008101
024401
008001
022703
022901
023401
023501
023503
022702
023305
023104
024407
024403
023306
024409
C.A.S. Number
1344-73-6
7758-99-8
1332-40-7
33113-08-5
1184-64-1
20427-59-2
1332-65-6
8012-69-9
16828-95-8
814-91-5
9007-39-0
13426-91-0
82027-59-6
20543-04-8
14215-52-2
123
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DRAFT COPY
Page 1 of 1
United States Environmental Protection OMB Approval 2070-0107
Agency Washington, D.C. 20460 OMB Approval 2070-0057
DATA CALL-IN RESPONSE
INSTRUCTIONS: Please type or print in ink. Please read carefully the attached instructions and supply the information requested on this form. Use
additional sheet(s) if necessary.
1 . Company Name and Address 2. Case # and Name 3. Date and Type of DCI and Number
SAMPLE COMPANY 0649 Copper Compounds: Grp II DD-MMM-YYYY
NO STREET ADDRESS Chemical* and Name 008001 PRODUCT SPECIFIC
NO CITY, XX 00000 Basic copper chloride |D# pDC|.008001.NNNN
4. EPA Product
Registration
NNNNNN-NNNNN
5. I wish to
cancel this
product regis-
tration volun-
tarily
6. Generic Data
6a. I am claiming a Generic
Data Exemption because I
obtain the active ingredient
from the source EPA regis-
tration number listed below.
N.A.
6b. I agree to satisfy Generic
Data requirements as indicated
on the attached form entitled
"Requirements Status and
Registrant's Response."
N.A.
7. Product Specific Data
7a. My product is an MUP and I
agree to satisfy the MUP
requirements on the attached
form entitled "Requirements
Status and Registrant's
Response."
7b. My product is an EUP and I
agree to satisfy the EUP
requirements on the attached
form entitled "Requirements
Status and Registrant's
Response."
8. Certification I certify that the statements made on this form and all attachments are true, accurate, and complete. I acknowledge that any know n^y Qate
false or misleading statement may be punishable by fine, imprisonment or both under applicable law.
Signature and Title of Company's Authorized Representative
10. Name of Company 11. Phone Number
-------
DRAFT COPY
Page 1 of 3
United States Environmental Protection
Agency Washington, D.C. 20460
REQUIREMENTS
STATUS AND REGISTRANT'S RESPONSE
OMB Approval 2070-0107
OMB Approval 2070-0057
INSTRUCTIONS: Please type or print in ink. Please read carefully the attached instructions and supply the information requested on this form. Use
additional sheet(s) if necessary.
1 . Company Name and Address
SAMPLE COMPANY
NO STREET ADDRESS
NO CITY, XX 00000
4. Guideline
Requirement
Number
830.1550
830.1600
830.1620
830.1650
830.1670
830.1700
830.1750
830.1800
830.6302
830.6303
830.6304
5. Study Title
2. Case # and Name 3. Date and Type of DCI and Number
0649 Copper Compounds: Grp II DD-MMM-YYYY
PRODUCT SPECIFIC
EPA Reg. No.NNNNNN-NNNNN
Product Chemistry Data Requirements (Conventional Chemical
Product Identity and composition
(10)
Description of materials used to produce the product (1 1 )
Description of production process
Description of formulation process
Discussion of formation of impurities
Preliminary analysis
Certified limits
Enforcement analytical method
Color
Physical state
Odor
(12)
(13)
(14)
(15,16,17)
(18,19)
(20)
(21)
(22)
(23)
P
R
O
T
O
c
O
L
Progress
Reports
1
2
3
6. Use
Pattern
A, B, C, D, E, F, G, H,
I, J, K, L, M, N, O
A, B, C, D, E, F, G, H,
I, J, K, L, M, N, O
A, B, C, D, E, F, G, H,
I, J, K, L, M, N, O
A, B, C, D, E, F, G, H,
I, J, K, L, M, N, O
A, B, C, D, E, F, G, H,
I, J, K, L, M, N, O
A, B, C, D, E, F, G, H,
I, J, K, L, M, N, O
A, B, C, D, E, F, G, H,
I, J, K, L, M, N, O
A, B, C, D, E, F, G, H,
I, J, K, L, M, N, O
A, B, C, D, E, F, G, H,
I, J, K, L, M, N, O
A, B, C, D, E, F, G, H,
I, J, K, L, M, N, O
A, B, C, D, E, F, G, H,
I, J, K, L, M, N, O
7. Test
Substance
TGAI/MP/EP
TGAI/MP/EP
TGAI
MP/EP
TGAI/MP/EP
TGAI
TGAI/MP/EP
TGAI/MP/EP
TGAI/MP/EP
TGAI/MP/EP
TGAI/MP/EP
8. Time
Frame
(Months)
8
8
8
8
8
8
8
8
8
8
8
9. Registrant
Response
10. Certification I certify that the statements made on this form and all attachments are true, accurate, and complete. I acknowledge that any 11. Date
knowingly false or misleading statement may be punishable by fine, imprisonment or both under applicable law
Signature and Title of Company's Authorized Representative
12. Name of Company
13. Phone Number
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DRAFT COPY
Page 2 of 3
United States Environmental Protection
Agency Washington, D.C. 20460
REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE
OMB Approval 2070-0107
OMB Approval 2070-0057
INSTRUCTIONS: Please type or print in ink. Please read carefully the attached instructions and supply the information requested on this form. Use
additional sheet(s) if necessary.
1 . Company Name and Address 2. Case # and Name
SAMPLE COMPANY 0649 Copper Compounds: Grp II
NO STREET ADDRESS
NO CITY, XX 00000
EPA Reg. No.NNNNNN-NNNNN
4. Guideline
Requirement
Number
830.6313
830.6314
830.6315
830.6316
830.6317
830.6319
830.6320
830.6321
830.7000
830.7050
830.7100
5. Study Title
Stability to sunlight, normal and elevated temperatures (24 ,25)
metals, and metal ions
Oxidizing or reducing action (26)
Flammability (27)
Explodability (28)
Storage stability of product (29)
Miscibility (30)
Corrosion characteristics (31)
Dielectric breakdown voltage (32)
pH of water solutions or suspensions (33 ,34)
UV/Visible absorption
Viscosity (35)
Initial to indicate certification as to information on this page (full
text of certification is on page one).
P
R
O
T
O
c
O
L
Progress
Reports
1
2
3
6. Use
Pattern
3. Date and Type of DCI and Number
DD-MMM-YYYY
PRODUCT SPECIFIC
ID# PDCI-008001-NNNN
A, B, C, D, E, F, G,
I, J, K, L, M, N, O
A, B, C, D, E, F, G,
I, J, K, L, M, N, O
A, B, C, D, E, F, G,
I, J, K, L, M, N, O
A, B, C, D, E, F, G,
I, J, K, L, M, N, O
A, B, C, D, E, F, G,
I, J, K, L, M, N, O
A, B, C, D, E, F, G,
I, J, K, L, M, N, O
A, B, C, D, E, F, G,
I, J, K, L, M, N, O
A, B, C, D, E, F, G,
I, J, K, L, M, N, O
A, B, C, D, E, F, G,
I, J, K, L, M, N, O
A, B, C, D, E, F, G,
I, J, K, L, M, N, O
A, B, C, D, E, F, G,
I, J, K, L, M, N, O
H,
H,
H,
H,
H,
H,
H,
H,
H,
H,
H,
7. Test
Substance
TGAI
MP/EP
MP/EP
MP/EP
MP/EP
MP/EP
MP/EP
MP/EP
TGAI/MP/EP
TGAI/PAI
MP/EP
Date
8. Time
Frame
(Months)
8
8
8
8
8
8
8
8
8
8
8
9. Registrant
Response
-------
DRAFT COPY
Page 3 of 3
United States Environmental Protection
Agency Washington, D.C. 20460
REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE
OMB Approval 2070-0107
OMB Approval 2070-0057
INSTRUCTIONS: Please type or print in ink. Please read carefully the attached instructions and supply the information requested on this form. Use
additional sheet(s) if necessary.
1 . Company Name and Address 2. Case # and Name
SAMPLE COMPANY 0649 Copper Compounds: Grp II
NO STREET ADDRESS
NO CITY, XX 00000
EPA Reg. No.NNNNNN-NNNNN
4. Guideline
Requirement
Number
830.7200
830.7220
830.7300
870.1100
870.1200
870.1300
870.2400
870.2500
870.2600
5. Study Title
Melting point/melting range (36 ,37)
Boiling point/boiling range (38 ,39)
Density/relative density (40,41)
Toxicoloav Data Requirements (Conventional Chemical)
Acute Oral Toxicity (1 )
Acute dermal toxicity (2 ,3)
Acute inhalation toxicity (4)
Acute eye irritation (5)
Acute dermal irritation (6 ,7)
Skin sensitization (8 ,9)
Initial to indicate certification as to information on this page (full
text of certification is on page one).
P
R
O
T
O
c
O
L
Progress
Reports
1
2
3
6. Use
Pattern
A, B, C, D, E, F, G,
I, J, K, L, M, N, O
A, B, C, D, E, F, G,
I, J, K, L, M, N, O
A, B, C, D, E, F, G,
I, J, K, L, M, N, O
A, B, C, D, E, F, G,
I, J, K, L, M, N, O
A, B, C, D, E, F, G,
I, J, K, L, M, N, O
A, B, C, D, E, F, G,
I, J, K, L, M, N, O
A, B, C, D, E, F, G,
I, J, K, L, M, N, O
A, B, C, D, E, F, G,
I, J, K, L, M, N, O
A, B, C, D, E, F, G,
I, J, K, L, M, N, O
3. Date and Type of DCI and Number
DD-MMM-YYYY
PRODUCT SPECIFIC
ID# PDCI-008001-NNNN
H,
H,
H,
H,
H,
H,
H,
H,
H,
7. Test
Substance
TGAI
TGAI
TGAI/MP/EP
TGAI.EP.dilute EP?
TGAI.EP.dilute EP?
TGAI & EP
TGAI & EP
TGAI & EP
TGAI & EP
Date
8. Time
Frame
(Months)
8
8
8
8
8
8
8
8
8
9. Registrant
Response
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DRAFT COPY
Page 1 of 5
United States Environmental Protection
Agency Washington, D.C. 20460
FOOTNOTES AND KEY DEFINITIONS FOR GUIDELINE REQUIREMENTS
Case # and Name: 0649 Copper Compounds: Grp II
DCI Number: PDCI-008001-NNNN
Key: MP/EP = Manufacturing-Use Product, Pure Active Ingredient; TGAI = Technical Grade Active Ingredient [TGAI]; TGAI & EP = Technical Grade of the Active Ingredient and End-Use Product;
TGAI,EP,dilute EP? = Technical Grade of the Active Ingredient, End Use Product, and possibly diluted End Use Product; TGAI/MP/EP = Manufacturing-Use Product, Pure Active Ingredient and Techn
Grade Active Ingredient; TGAI/PAI = Technical Grade Active Ingredient, Pure Active Ingredient
Use Categories Key:
A - Terrestrial food crop D - Aquatic food crop G - Aquatic non-food residential J - Forestry use
B- Terrestrial feed crop E- Aquatic nonfood outdoor use H- Greenhouse food crop K- Residential
C - Terrestrial nonfood crop F - Aquatic nonfood industrial use I - Greenhouse nonfood crop L - Indoor food use
Footnotes: [The following notes are referenced in column two (5. Study File) of the REQUIREMENTS STATUS AND REGISTRANTS RESPONSE form.]
1 Not required if test material is a gas or a highly volatile liquid.
Not required if test material is a gas or a highly volatile liquid.
Not required if test material is corrosive to skin or has a pH of less than 2 or greater than 11.5.
Required if the product consists of, or under conditions of use will result in, a respirable material (e.g., gas, vapor, aerosol, or particulate).
Not required if test material is corrosive to skin or has a pH of less than 2 or greater than 11.5.
Not required if test material is a gas or a highly volatile liquid.
Not required if test material is corrosive to skin or has a pH of less than 2 or greater than 11.5.
Not required if test material is corrosive to skin or has a pH of less than 2 or greater than 11.5.
Required if repeated dermal exposure is likely to occur under conditions of use.
M - Indoor nonfood use
N - Indoor medical use
O - Residential Indoor use
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DRAFT COPY Page2of5
United States Environmental Protection
Agency Washington, D.C. 20460
FOOTNOTES AND KEY DEFINITIONS FOR GUIDELINE REQUIREMENTS
Case # and Name: 0649 Copper Compounds: Grp II
DCI Number: PDCI-008001-NNNN
Key: MP/EP = Manufacturing-Use Product, Pure Active Ingredient; TGAI = Technical Grade Active Ingredient [TGAI]; TGAI & EP = Technical Grade of the Active Ingredient and End-Use Product;
TGAI,EP,dilute EP? = Technical Grade of the Active Ingredient, End Use Product, and possibly diluted End Use Product; TGAI/MP/EP = Manufacturing-Use Product, Pure Active Ingredient and Techn
Grade Active Ingredient; TGAI/PAI = Technical Grade Active Ingredient, Pure Active Ingredient
Footnotes: [The following notes are referenced in column two (5. Study File) of the REQUIREMENTS STATUS AND REGISTRANTS RESPONSE form.]
10 Data must be provided in accordance with the "Product Composition" Section.(158.155)
11 Data must be provided in accordance with the "Description of Materials used to Produce the Product" Section.(158.160)
12 Data must be provided in accordance with the "Description of Production Process" Section.(158.162)
13 Data must be provided in accordance with the "Description of Formulation Process" Section.(158.165)
14 Data must be provided in accordance with the "Description of Formation of Impurities" Section(158.167)
15 Data must be provided in accordance with the "Preliminary Analysis" Section.(158.170)
16 Required for TGAIs and products produced by an integrated system.
17 If the TGAI cannot be isolated, data are required on the practical equivalent of the TGAI (i.e., if the active ingredient is either an acid, base or ionic form, and it is formulated into salts or esters, the
concentration of the active ingredient in these products must be expressed in acid equivalent or active equivalent).
18 Data must be provided in accordance with the "Certified Limits" Section(158.175)
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DRAFT COPY Page3of5
United States Environmental Protection
Agency Washington, D.C. 20460
FOOTNOTES AND KEY DEFINITIONS FOR GUIDELINE REQUIREMENTS
Case # and Name: 0649 Copper Compounds: Grp II
DCI Number: PDCI-008001-NNNN
Key: MP/EP = Manufacturing-Use Product, Pure Active Ingredient; TGAI = Technical Grade Active Ingredient [TGAI]; TGAI & EP = Technical Grade of the Active Ingredient and End-Use Product;
TGAI,EP,dilute EP? = Technical Grade of the Active Ingredient, End Use Product, and possibly diluted End Use Product; TGAI/MP/EP = Manufacturing-Use Product, Pure Active Ingredient and Techn
Grade Active Ingredient; TGAI/PAI = Technical Grade Active Ingredient, Pure Active Ingredient
Footnotes: [The following notes are referenced in column two (5. Study File) of the REQUIREMENTS STATUS AND REGISTRANTS RESPONSE form.]
19 If the TGAI cannot be isolated, data are required on the practical equivalent of the TGAI (i.e., if the active ingredient is either an acid, base or ionic form, and it is formulated into salts or esters, the
concentration of the active ingredient in these products must be expressed in acid equivalent or active equivalent).
20 Data must be provided in accordance with the "Enforcement Analytical Method" Section.(158.180)
21 If the TGAI cannot be isolated, data are required on the practical equivalent of the TGAI (i.e., if the active ingredient is either an acid, base or ionic form, and it is formulated into salts or esters, the
concentration of the active ingredient in these products must be expressed in acid equivalent or active equivalent).
22 If the TGAI cannot be isolated, data are required on the practical equivalent of the TGAI (i.e., if the active ingredient is either an acid, base or ionic form, and it is formulated into salts or esters, the
concentration of the active ingredient in these products must be expressed in acid equivalent or active equivalent).
23 If the TGAI cannot be isolated, data are required on the practical equivalent of the TGAI (i.e., if the active ingredient is either an acid, base or ionic form, and it is formulated into salts or esters, the
concentration of the active ingredient in these products must be expressed in acid equivalent or active equivalent).
24 If the TGAI cannot be isolated, data are required on the practical equivalent of the TGAI (i.e., if the active ingredient is either an acid, base or ionic form, and it is formulated into salts or esters, the
concentration of the active ingredient in these products must be expressed in acid equivalent or active equivalent).
25 Data on the stability to metals and metal ions is required only if the active ingredient is expected to come in contact with either material during storage.
26 Required if the product contains an oxidizing or reducing agent
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DRAFT COPY Page 4 of 5
United States Environmental Protection
Agency Washington, D.C. 20460
FOOTNOTES AND KEY DEFINITIONS FOR GUIDELINE REQUIREMENTS
Case # and Name: 0649 Copper Compounds: Grp II
DCI Number: PDCI-008001-NNNN
Key: MP/EP = Manufacturing-Use Product, Pure Active Ingredient; TGAI = Technical Grade Active Ingredient [TGAI]; TGAI & EP = Technical Grade of the Active Ingredient and End-Use Product;
TGAI,EP,dilute EP? = Technical Grade of the Active Ingredient, End Use Product, and possibly diluted End Use Product; TGAI/MP/EP = Manufacturing-Use Product, Pure Active Ingredient and Techn
Grade Active Ingredient; TGAI/PAI = Technical Grade Active Ingredient, Pure Active Ingredient
Footnotes: [The following notes are referenced in column two (5. Study File) of the REQUIREMENTS STATUS AND REGISTRANTS RESPONSE form.]
27 Required when the product contains combustible liquids.
28 Required when the product is potentially explosive.
29 Please see attached "Additional Information and Requirements Pertaining to Storage Stability (OPPTS 830.6317) and Corrosion Characteristics (OPPTS 830.6320) Data Requirements of the Pro
Specific Data Call-Ins issued under the Reregistration Eligibility Decision (RED)/lnterim Reregistration Eligibility Decision (IRED) Documents."
30 Required if the product is an emulsifiable liquid and is to be diluted with petroleum solvents.
31 Please see attached "Additional Information and Requirements Pertaining to Storage Stability (OPPTS 830.6317) and Corrosion Characteristics (OPPTS 830.6320) Data Requirements of the Pro
Specific Data Call-Ins issued under the Reregistration Eligibility Decision (RED)/lnterim Reregistration Eligibility Decision (IRED) Documents."
32 Required if the end-use product is a liquid and is to be used around electrical equipment.
33 If the TGAI cannot be isolated, data are required on the practical equivalent of the TGAI (i.e., if the active ingredient is either an acid, base or ionic form, and it is formulated into salts or esters, the
concentration of the active ingredient in these products must be expressed in acid equivalent or active equivalent).
34 Required if the product is dispersible with water.
35 Required if the product is a liquid.
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DRAFT COPY Page5of5
United States Environmental Protection
Agency Washington, D.C. 20460
FOOTNOTES AND KEY DEFINITIONS FOR GUIDELINE REQUIREMENTS
Case # and Name: 0649 Copper Compounds: Grp II
DCI Number: PDCI-008001-NNNN
Key: MP/EP = Manufacturing-Use Product, Pure Active Ingredient; TGAI = Technical Grade Active Ingredient [TGAI]; TGAI & EP = Technical Grade of the Active Ingredient and End-Use Product;
TGAI,EP,dilute EP? = Technical Grade of the Active Ingredient, End Use Product, and possibly diluted End Use Product; TGAI/MP/EP = Manufacturing-Use Product, Pure Active Ingredient and Techn
Grade Active Ingredient; TGAI/PAI = Technical Grade Active Ingredient, Pure Active Ingredient
Footnotes: [The following notes are referenced in column two (5. Study File) of the REQUIREMENTS STATUS AND REGISTRANTS RESPONSE form.]
36 If the TGAI cannot be isolated, data are required on the practical equivalent of the TGAI (i.e., if the active ingredient is either an acid, base or ionic form, and it is formulated into salts or esters, the
concentration of the active ingredient in these products must be expressed in acid equivalent or active equivalent).
37 Required when the TGAI is solid at room temperature.
38 If the TGAI cannot be isolated, data are required on the practical equivalent of the TGAI (i.e., if the active ingredient is either an acid, base or ionic form, and it is formulated into salts or esters, the
concentration of the active ingredient in these products must be expressed in acid equivalent or active equivalent).
39 Required if the TGAI is liquid at room temperature.
40 If the TGAI cannot be isolated, data are required on the practical equivalent of the TGAI (i.e., if the active ingredient is either an acid, base or ionic form, and it is formulated into salts or esters, the
concentration of the active ingredient in these products must be expressed in acid equivalent or active equivalent).
41 True density or specific density are required for all test substances. Data on bulk density is required for MPs that are solid at room temperature.
-------
United States Environmental Protection
Agency Washington, D.C. 20460
LIST OF ALL REGISTRANTS SENT THIS DATA CALL-IN NOTICE
Case # and Name: 0649, Copper Compounds: Grp II
Co. Nr.
11656
19713
45002
51036
55146
79558
80289
81293
82571
Company Name Agent For
WESTERN FARM SERVICE, INC
DREXEL CHEMICAL CO
ALBAUGH, INC.
BASF SPARKS LLC
NUFARM AMERICAS INC.
ISAGRO S.P.A. ISAGRO USA
ISAGRO S.P.A. ISAGRO, USA
CANTOXU.S..INC.
MARTIN OPERATING
Address
PO Box 1168
1700 CHANNEL AVENUE
PO Box 21 27
PO Box 1 3528
150 HARVESTER DRIVE SUITE 200
430 DAVIS
430 DAVIS DRIVE, SUITE 240
1011 ROUTE 22 WEST, SUITE 200
4200 STONE ROAD
City & State
FRESNO
MEMPHIS
VALDOSTA
RESEARCH
TRIANGLE PARK
BURR RIDGE
MORRISVILLE
MORRISVILLE
BRIDGEWATER
KILGORE
Zip
CA 937151168
TN 38106
GA 316042127
NC 27709
IL 60527
NC 27560
NC 27560
NJ 08807
TX 75662
PARTNERSHIP, LP
-------
United States Environmental Protection
Agency Washington, D.C. 20460
LIST OF ALL REGISTRANTS SENT THIS DATA CALL-IN NOTICE
Co. Nr.
4
192
352
769
802
829
1812
5481
5887
7401
11656
17545
19713
34704
35253
35935
42750
45002
46923
51036
55146
57538
70506
82571
Case # and Name
Company Name
BONIDE PRODUCTS, INC.
VALUE GARDENS SUPPLY, LLC
E. I. DU PONT DE NEMOURS AND
CO., INC.
VALUE GARDENS SUPPLY, LLC
CENTRAL GARDEN & PET D/B/A
LILLY MILLER BRANDS/EXCEL
GARDEN
SOUTHERN AGRICULTURAL
INSECTICIDES, INC.
GRIFFIN L.L.C.
AMVAC CHEMICAL CORPORATION
VALUE GARDENS SUPPLY, LLC
VOLUNTARY PURCHASING
GROUPS, INC.
WESTERN FARM SERVICE, INC
MONTEREY AGRESOURCES
DREXEL CHEMICAL CO
LOVELAND PRODUCTS, INC.
AGRA CHEM SALES COMPANY,
INC.
NUFARM LIMITED
ALBAUGH INC
ALBAUGH, INC.
OLD BRIDGE CHEMICAL CO.
BASF SPARKS LLC
NUFARM AMERICAS INC.
STOLLER ENTERPRISES, INC
UNITED PHOSPHORUS, INC
MARTIN OPERATING
0636, Copper Sulfate
Agent For Address
6301 SUTLIFF ROAD
PO Box 585
PO Box 30 STINE-HASKELL RESEARCH CENTER
PO Box 585
REGISTRATIONS BY DESIGN, INC. 1 181/2 EAST MAIN ST., SUITE 1
PO Box 21 8
DUPONTCROP POBoxSO
PROTECTION/STINE-HASKELL RESEARCH
CENTER
4695 MACARTHUR COURT, SUITE 1250
PO Box 585
PO Box 460, 230 FM 87
PO Box 1168
PO Box 35000
1700 CHANNEL AVENUE
PO Box 1286
BRANDT CONSOLIDATED, INC. PO Box 350 211 W. ROUTE 125
NUFARM LIMITED PO Box 1 3439
ALBAUGH, INC PO Box 2127
PO Box 21 27
PO Box 1 75
PO Box 1 3528
150 HARVESTER DRIVE SUITE 200
4001 W. SAM HOUSTON PKWY N, SUITE 100
630 FREEDOM BUSINESS CENTER, SUITE 402
4200 STONE ROAD
City & State
ORISKANY
SAINT JOSEPH
NEWARK
SAINT JOSEPH
SALEM
PALMETTO
NEWARK
NEWPORT BEACH
SAINT JOSEPH
BONHAM
FRESNO
FRESNO
MEMPHIS
GREELEY
PLEASANT PLAINS
RTP
VALDOSTA
VALDOSTA
OLD BRIDGE
RESEARCH
TRIANGLE PARK
BURR RIDGE
HOUSTON
KING OF PRUSSIA
KILGORE
Zip
NY 13424
MO 64502
DE 197140030
MO 64502
VA 241533805
FL 34220
DE 197140030
CA 926601706
MO 64502
TX 75418
CA 937151168
CA 937455000
TN 38106
CO 806321 286
IL 62677
NC 27709
GA 316042127
GA 316042127
NJ 08857
NC 27709
IL 60527
TX 77043
PA 19406
TX 75662
PARTNERSHIP, LP
-------
United States Environmental Protection
Agency Washington, D.C. 20460
LIST OF ALL REGISTRANTS SENT THIS DATA CALL-IN NOTICE
Case # and Name: 0649, Copper Compounds: Grp II
Co. Nr. Company Name Agent For Address
City & State Zip
909
10465
54705
CENTRAL GARDEN & PET D/B/A REGISTRATIONS BY DESIGN, INC.
LILLY MILLER BRANDS/EXCEL
GARDEN
CHEMICAL SPECIALTIES INC
LAWN AND GARDEN PRODUCTS, LYNNE ZAHIGIAN REGULATORY
INC. CONSULTING
1181/2 EAST MAIN ST., SUITE 1
ONE WOODLAWN GREEN 350
PO Box 1566
SALEM
CHARLOTTE
FALLON
VA 241533805
NC 28217
NV 89407
-------
United States Environmental Protection
Agency Washington, D.C. 20460
LIST OF ALL REGISTRANTS SENT THIS DATA CALL-IN NOTICE
Case # and Name: 0649, Copper Compounds: Grp II
Co. Nr.
3008
83997
Company Name Agent For Address
OSMOSE INC. 980 ELLICOTT ST
VIANCE, LLC ONE WOODLAWN GREEN, SUITE 350
City & State Zip
BUFFALO NY 14209
CHARLOTTE NC 28217
-------
United States Environmental Protection
Agency Washington, D.C. 20460
LIST OF ALL REGISTRANTS SENT THIS DATA CALL-IN NOTICE
Case # and Name: 4026,Copper salts,
Co. Nr.
Company Name
Agent For
Address
City & State
Zip
4
352
5887
67690
BONIDE PRODUCTS, INC.
E. I. DU PONT DE NEMOURS AND
CO., INC.
VALUE GARDENS SUPPLY, LLC
SEPROCORP
6301 SUTLIFF ROAD ORISKANY
PO Box 30 STINE-HASKELL RESEARCH CENTER NEWARK
PO Box 585
11550 N. MERIDIAN ST SUITE 600
SAINT JOSEPH
CARMEL
NY 13424
DE 197140030
MO 64502
IN 46032
-------
United States Environmental Protection
Agency Washington, D.C. 20460
LIST OF ALL REGISTRANTS SENT THIS DATA CALL-IN NOTICE
Case # and Name:
Co. Nr. Company Name Agent For Address City & State Zip
67702 W. NEUDORFF GMBH KG WALTER G TALAREK P.O. 1008 RIVA RIDGE DR GREAT FALLS VA 22066
-------
LIST OF ALL
United States Environmental Protection
Agency Washington, D.C. 20460
REGISTRANTS SENT THIS DATA CALL-IN NOTICE
Case # and Name: 0649, Copper Compounds: Grp II
Co. Nr.
100
352
1022
1812
9779
10163
11435
19713
34704
35896
42750
45002
51036
54471
55146
60061
64744
67690
68292
71653
79558
80289
81015
Company Name
SYNGENTA CROP PROTECTION,
INC.
E. I. DU PONT DE NEMOURS AND
CO., INC.
IBC MANUFACTURING CO
GRIFFIN L.L.C.
WINFIELD SOLUTIONS, LLC
GOWAN CO
CP CHEMICALS INC.
DREXEL CHEMICAL CO
LOVELAND PRODUCTS, INC.
PHIBRO-TECH INC
ALBAUGH INC
ALBAUGH, INC.
BASF SPARKS LLC
COPPER CARE WOOD
PRESERVATIVES, INC,
NUFARM AMERICAS INC.
KOP-COAT, INC
SPIESS-URANIA CHEMICALS
GMBH
SEPROCORP
EDM INDUSTRIES INC.
GENICSINC.
ISAGRO S.P.A.
ISAGRO S.P.A.
OLD BRIDGE METALS &
Agent For Address
PO Box 1 8300
PO Box 30 STINE-HASKELL RESEARCH CENTER
41 6 E. BROOKS ROAD
DUPONTCROP POBoxSO
PROTECTION/STINE-HASKELL RESEARCH
CENTER
PO Box 64589
PO Box 5569
65 CHALLENGER ROAD, 3RD FLOOR
1700 CHANNEL AVENUE
PO Box 1 286
2395 CAINS MILL ROAD
ALBAUGH, INC PO Box 2127
PO Box 21 27
PO Box 1 3528
PO Box 707
150 HARVESTER DRIVE SUITE 200
436 SEVENTH AVENUE
CERTIS USA, LLC. 91 45 GUILFORD ROAD, SUITE 1 75
1 1 550 N. MERIDIAN ST SUITE 600
PO Box 8552
SRS INTERNATIONAL CORP. 7700 LEESBURG PIKE, SUITE 208
ISAGRO USA 430 DAVIS
ISAGRO, USA 430 DAVIS DRIVE, SUITE 240
PO Box 194 OLD WATERWORKS ROAD
City & State
GREENSBORO
NEWARK
MEMPHIS
NEWARK
ST PAUL
YUMA
RIDGEFIELDPARK
MEMPHIS
GREELEY
SUMTER
VALDOSTA
VALDOSTA
RESEARCH
TRIANGLE PARK
COLUMBUS
BURR RIDGE
PITTSBURGH
COLUMBIA
CARMEL
PORTERVILLE
FALLS CHURCH
MORRISVILLE
MORRISVILLE
OLD BRIDGE
Zip
NC 274198300
DE 197140030
TN 38109
DE 197140030
MN 551 640589
AZ 853665569
NJ 07660
TN 38106
CO 806321 286
SC 29154
GA 316042127
GA 316042127
NC 27709
NE 686020707
IL 60527
PA 15219
MD21046
IN 46032
CA 93258
VA 22043
NC 27560
NC 27560
NJ 08867
82481
CHEMICALS CO.
TEXAS MARINE COATINGS, INC. JIM YOWELL
10805 W. TIMBER WAGON CIRCLE
SPRING
TX 77380
-------
United States Environmental Protection
Agency Washington, D.C. 20460
LIST OF ALL REGISTRANTS SENT THIS DATA CALL-IN NOTICE
Co. Nr.
9779
34704
35253
45002
51036
74307
81293
Case # and Name: 0649, Copper Compounds: Grp II
Company Name Agent For
WINFIELD SOLUTIONS, LLC
LOVELAND PRODUCTS, INC.
AGRA CHEM SALES COMPANY, BRANDT CONSOLIDATED, INC.
INC.
ALBAUGH, INC.
BASF SPARKS LLC
AGRO VALLEY ENTERPRISES,
INC.
CANTOXU.S., INC.
Address
PO Box 64589
PO Box 1 286
PO Box 350 211 W. ROUTE 125
PO Box 21 27
PO Box 13528
3136EASTKERCKHOFF
1011 ROUTE 22 WEST, SUITE 200
City & State
ST PAUL
GREELEY
PLEASANT PLAINS
VALDOSTA
RESEARCH
TRIANGLE PARK
FRESNO
BRIDGEWATER
Zip
MN 551640589
CO 806321 286
IL 62677
GA 316042127
NC 27709
CA 93702
NJ 08807
-------
United States Environmental Protection
Agency Washington, D.C. 20460
LIST OF ALL REGISTRANTS SENT THIS DATA CALL-IN NOTICE
Case # and Name: 0649, Copper Compounds: Grp II
Co. Nr. Company Name Agent For Address
City & State Zip
10951
34704
45002
55146
BRITZ FERTILIZERS INC
LOVELAND PRODUCTS, INC.
ALBAUGH, INC.
NUFARM AMERICAS INC.
ROBINSON ASSOCIATES
583 CANYON RD
PO Box 1286
PO Box 2127
150 HARVESTER DRIVE SUITE 200
REDWOOD CITY CA 94062
GREELEY CO 806321286
VALDOSTA GA 316042127
BURR RIDGE IL 60527
-------
United States Environmental Protection
Agency Washington, D.C. 20460
LIST OF ALL REGISTRANTS SENT THIS DATA CALL-IN NOTICE
Co. Nr.
352
829
1022
1258
1278
1386
1706
1812
2217
2800
3432
3525
5905
7124
7364
7401
7687
7792
8622
8660
8999
10266
10779
10807
11435
12204
Case # and Name
Company Name
E. I. DU PONT DE NEMOURS AND
CO., INC.
SOUTHERN AGRICULTURAL
INSECTICIDES, INC.
IBC MANUFACTURING CO
ARCH CHEMICALS, INC.
PHELPS DODGE REFINING
CORPORATION
UNIVERSAL COOPERATIVES INC
NALCO COMPANY
GRIFFIN L.L.C.
PBI/GORDON CORP
HUMCO HOLDING GROUP INC
N.JONAS SCO., INC.
QUALCO INC
HELENA CHEMICAL CO
ALDEN LEEDS INC
GLB POOLS SPA
VOLUNTARY PURCHASING
GROUPS, INC.
HERCULES CHEM CO INC
ROEBIC LABS, INC.
AMERIBROM, INC
UNITED INDUSTRIES CORP.
INTERPETLLC
UTILITY MANUFACTURING CO INC
SCOTCH CORP
AMREP, INC
CP CHEMICALS INC.
MID-AMERICAN RESEARCH CHEM.
0636, Copper Sulfate
Agent For Address
PO Box 30 STINE-HASKELL RESEARCH CENTER
PO Box 21 8
41 6 E. BROOKS ROAD
1955 LAKE PARK DRIVE, SUITE 100
PO Box 20001
1300 CORPORATE CENTER CURVE
1601 WEST DIEHL ROAD
DUPONTCROP POBoxSO
PROTECTION/STINE-HASKELL RESEARCH
CENTER
PO Box 01 4090 1 21 7 WEST 1 2TH STREET
7400 ALUMAX DRIVE
PO Box 425 4520 ADAMS CIRCLE
225 PASSAIC ST
225 SCHILLING BOULEVARD, SUITE 300
55 JACOBUS AVE.
SUITE 234
PO Box 460, 230 FM 87
111 SOUTH STREET
BRAZOS ASSOCIATES, INC. 1 806 AUBURN DRIVE
95 MACCORKLE AVENUE, SOUTHWEST
PO Box 142642
180 LPENROD COURT
700 MAIN ST.
PO Box 4466
990 INDUSTRIAL PARK DRIVE
65 CHALLENGER ROAD, 3RD FLOOR
PO Box 927
City & State
NEWARK
PALMETTO
MEMPHIS
SMYRNA
EL PASO
EAGAN
NAPERVILLE
NEWARK
KANSAS CITY
TEXARKANA
BENSALEM
PASSAIC
COLLIERVILLE
SOUTH KEARNY
GERMANTOWN
BONHAM
PASSAIC
CARROLLTON
SOUTH
CHARLESTON
ST. LOUIS
GLEN BURNIE
WESTS URY
DALLAS
MARIETTA
RIDGEFIELDPARK
COLUMBUS
Zip
DE 197140030
FL 34220
TN 38109
GA 30080
TX 79998
MN 55121
IL 605631198
DE 197140030
MO 641 01 0090
TX 75501
PA 19020
NJ 07055
TN 38017
NJ 07032
Wl 530224799
TX 75418
NJ 07055
TX 750071451
WV 253031 41 1
MO 63 11 40642
MD21061
NY 11590
TX 75208
GA 30062
NJ 07660
NE 686020927
CORP
-------
United States Environmental Protection
Agency Washington, D.C. 20460
LIST OF ALL REGISTRANTS SENT THIS DATA CALL-IN NOTICE
Co. Nr.
19713
27588
33034
33136
35056
35896
35935
41246
46923
49538
54564
56576
58412
64962
65109
66675
67712
70131
70204
70246
70264
70303
71146
71686
71983
72083
73123
Case # and Name: 0636, Copper Sulfate
Company Name Agent For
DREXEL CHEMICAL CO
DIVERSIFIED WATERSCAPES INC
JUNGLE LABORATORIES LANDIS INTERNATIONAL, INC.
CORPORATION
BREWER INTERNATIOANL, INC.
BIO-DEX LABORATORIES
PHIBRO-TECH INC
NUFARM LIMITED NUFARM LIMITED
BAY CHEMICALS SUPPLY
COMPANY
OLD BRIDGE CHEMICAL CO.
PHYTON CORPORATION LEWIS & HARRISON, LLC
FLORIDA WATER WORKS INC
CHEM ONE LTD.
LO-CHLOR, L.C.
EARTH SCIENCE LABORATORIES,
INC.
SSI CORP
MAGNA-BON II, LLC
ZODIAC POOL CARE, INC.
PURE POOLS, INC.
TRI-CHEM INC
CHEMTECH INC
ALTIVIA CORPORATION
BIOTEX LABORATORIES LEWIS & HARRISION, LLC
INTERNATIONAL LIMITED
CNM TECHNOLOGIES
DMC H20 INC. DELTA MARKETING NTERNATIONAL, LLC
TAMKO BUILDING PRODUCTS,
INC.
HALOSOURCE, INC.
CRYSTAL CLEAR POOL & SPA C/O
Address
1700 CHANNEL AVENUE
27324 CAMINO CAPISTRANO, SUITE 213
PO Box 51 26
PO Box 690037
501 WEST LONE CACTUS DRIVE
2395 CAINS MILL ROAD
PO Box 13439
PO Box 11 60
PO Box 1 75
122CSTNWSTE740
PO Box 471 267
8017 PINEMONT DRIVE #100
5841 POWERLINE ROAD, SUITE 202
1 1 3 SE 22ND STREET, SUITE 1
PO Box 9
1531 NW25TH DRIVE
2028 NW25TH AVENUE
880 JUPITER PARK DR. #14
PO Box 682
PO Box 31 80
100LOUISANA, SUITE 31 60
122 C STREET NW, STE. 740
94 GARDINERS AVE - STE 242
3 MATT AVENUE
220 WEST FOURTH STREET
1631 220TH STREET, SE, SUITE 100
4087 LOWER VALLEY ROAD
City & State
MEMPHIS
LACUNA NIGUEL
VALDOSTA
VERO BEACH
PHOENIX
SUMTER
RTP
ODEM
OLD BRIDGE
WASHINGTON
LAKE MONROE
HOUSTON
FT. LAUDERDALE
BENTONVILLE
JULESBURG
OKEECHOBEE
POMPANO BEACH
JUPITER
ELIZABETHTOWN
MUNCIE
HOUSTON
WASHINGTON
LEVITTOWN
PLATTSBURG
JOPLIN
BOTHELL
PARKESBURG
Zip
TN 38106
CA 926779905
GA 316035126
FL 329690037
AZ 85027
SC 29154
NC 27709
TX 78370
NJ 08857
DC 20001
FL 32747
TX 770406519
FL 33309
AR 72712
CO 80737
FL 34972
FL 33069
FL 33458590
NC 283370682
IN 47307
TX 77002
DC 20001
NY 11756
NY 12901
MO 64801
WA 98021
PA 19365
CAPO IND.
-------
United States Environmental Protection
Agency Washington, D.C. 20460
LIST OF ALL REGISTRANTS SENT THIS DATA CALL-IN NOTICE
Co. Nr.
73385
74942
75526
75613
81943
83190
83232
83742
Case # and Name: 0636, Copper Sulfate
Company Name Agent For
FABRICA DE SULFATO EL AGUILA, LANDIS INTERNATIONAL, INC.
S.A. DE C.V.
BENT OAK FARM SUPPLY
ARCHANGEL LLC
STORMOLLEN A/S
PHOENIX ENVIRONMENTAL CARE, RIVENDELL CONSULTING USA, LLC
LLC
BLUE WATER CHEM GROUP REGISTRATIONS BY DESIGN, INC.
QUADRUAL, LLC
THE POND GUY, INC. RIVENDELL CONSULTING USA, LLC
Address
PO Box 51 26
251 SAGAMORE CIRCLE
636 HAMPSHIRE STREET, SUITE 208
636 HAMPSHIRE, SUITE 208
400 EAST JANE STREET
1181/2 E. MAIN STREET, SUITE 1
54 DANBURY ROAD, #299
400 EAST JANE STREET
City & State
VALDOSTA
COLUMBUS
QUINCY
QUINCY
VALDOSTA
SALEM
RIDGEFIELD
VALDOSTA
Zip
GA 316035126
MS 39705
IL 62301
IL 62301
GA 31601
VA 241533805
CT 06877
GA 31601
-------
United States Environmental Protection
Agency Washington, D.C. 20460
LIST OF ALL REGISTRANTS SENT THIS DATA CALL-IN NOTICE
Co. Nr.
3432
5185
5481
7124
7364
7616
8959
42177
45309
53735
55146
57787
67262
67690
69681
81943
83742
Case # and Name: 4026, Copper salts,
Company Name Agent For
N.JONAS SCO., INC.
BIO-LAB, INC.
AMVAC CHEMICAL CORPORATION
ALDEN LEEDS INC
GLB POOLS SPA
CHEM LAB PRODUCTS INC
APPLIED BIOCHEMISTS
ALLIANCE TRADING, INC.
AQUA CLEAR INDUSTRIES, LLC.
KING TECHNOLOGY INC.
NUFARM AMERICAS INC.
HAVILAND CONSUMER
PRODUCTS, INC.
RECREATIONAL WATER
PRODUCTS, INC.
SEPROCORP
ALLCHEM PERFORMANCE ALLCHEM PERFORMANCE PRODUCTS
PRODUCTS, LP
PHOENIX ENVIRONMENTAL CARE, RIVENDELL CONSULTING USA, LLC
LLC
THE POND GUY, INC. RIVENDELL CONSULTING USA, LLC
Address
PO Box 425 4520 ADAMS CIRCLE
PO Box 300002
4695 MACARTHUR COURT, SUITE 1250
55 JACOBUS AVE.
SUITE 234
51 60 E. AIRPORT DR.
SUITE 234
109 NORTHPARK BLVD., 4TH FLOOR
PO Box 2456
530 11TH AVENUE SOUTH
150 HARVESTER DRIVE SUITE 200
421 ANN STREET, NW
PO Box 1 449
1 1 550 N. MERIDIAN ST SUITE 600
601 ONW FIRST PLACE
400 EAST JANE STREET
400 EAST JANE STREET
City & State
BENSALEM
LAWRENCEVILLE
NEWPORT BEACH
SOUTH KEARNY
GERMANTOWN
ONTARIO
GERMANTOWN
COVINGTON
SUWANEE
HOPKINS
BURR RIDGE
GRAND RAPIDS
BUFORD
CARMEL
GAINESVILLE
VALDOSTA
VALDOSTA
Zip
PA 19020
GA 300491 002
CA 926601706
NJ 07032
Wl 530224799
CA 91761
Wl 530224799
LA 70433
GA 300240980
MN 55343
IL 60527
Ml 495042075
GA 3051 51 449
IN 46032
FL 32607
GA 31601
GA 31601
-------
Co. Nr.
8959
67690
United States Environmental Protection
Agency Washington, D.C. 20460
LIST OF ALL REGISTRANTS SENT THIS DATA CALL-IN NOTICE
Case # and Name: 4026, Copper salts,
Company Name Agent For Address
APPLIED BIOCHEMISTS SUITE 234
SEPRO CORP 1 1 550 N. MERIDIAN ST SUITE 600
City & State Zip
GERMANTOWN Wl 530224799
CARMEL IN 46032
-------
United States
Environmental Protection
Agency Washington, D.C. 20460
Co. Nr.
1258
3008
7364
8959
11474
46043
75506
LIST OF ALL REGISTRANTS
Case # and Name:
Company Name Agent For
ARCH CHEMICALS, INC.
OSMOSE INC.
GLB POOLS SPA
APPLIED BIOCHEMISTS
SUNGRO CHEMICALS, INC.
SUNCOAST CHEMICALS CO
ARCH TREATMENT
SENT THIS DATA CALL-IN NOTICE
Address
1955 LAKE PARK DRIVE, SUITE 100
980 ELLICOTT ST
SUITE 234
SUITE 234
PO Box 24632
1448062NDSTN
1955 LAKE PARK DRIVE
City & State
SMYRNA
BUFFALO
GERMANTOWN
GERMANTOWN
LOS ANGELES
CLEARWATER
SMYRNA
Zip
GA 30080
NY 14209
Wl 530224799
Wl 530224799
CA 90024
FL 33760
GA 30080
83997
TECHNOLOGIES, INC.
VIANCE, LLC
ONE WOODLAWN GREEN, SUITE 350
CHARLOTTE
NC 28217
-------
APPENDIX G. EPA's Batching of Copper 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 reregi strati on of products containing copper 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.
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. The following pages shows
the respective batching of products at the completion of the RED.
148
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
OFFICE OF
PREVENTION, PESTICIDES
AND TOXIC SUBSTANCES
August 14, 2008
MEMORANDUM
SUBJECT: Acute Mammalian Toxicity Batching Appendix for Copper Compounds RED
Document.
FROM: Bentley Gregg, Toxicologist
Product Reregi strati on Branch
Special Review and Reregi strati on Division (7508P)
TO: Rosanna Louie, CRM
Reregi strati on Branch 3
Special Review and Reregi strati on Division (7508P)
Attached is the batching appendix for the Copper Compounds. Please let us know if you
have any questions regarding this document.
Sent to CRMs in RB3 and PRB on 8/14/08
149
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EPA'S BATCHING OF THE COPPER COMPOUNDS PRODUCTS FOR MEETING ACUTE
MAMMALIAN 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 reregi strati on of products containing copper compounds as
the active ingredient(s), 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 all the products within a batch as "substantially similar" because some products
within the 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. Notwithstanding 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 are generated or existing data are
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
registrant'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
150
-------
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.
Fifteen OPP Chemical Codes were found which contain copper compounds as their active
ingredient(s) for these copper compounds. These OPP Chemical Codes were distributed among
four reregi strati on Cases, plus two Chemical Codes not assigned to Cases. This batching
exercise has placed the respective products in batches, as well no batch groups, within each OPP
Chemical Code, in accordance with the active and inert ingredients and type of formulation. The
names of each of the OPP Chemical Codes are listed verbatim as they appear in OPPIN Query,
with alternate names listed in brackets, with the Chemical Code Number also listed in brackets.
Batching Instructions:
Products listed in Batches having higher Batch Numbers may choose to rely on Toxicity
Category III/IV acute data performed with the Technical Grade products. Products in the "No
Batch" group should generate their own acute mammalian toxicity data. Please note that the any
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.
CASE # 0636: COPPER SULFATES
Sulfuric acid, copper (2+), salt basic [basic copper sulfatel [0081011:
Batch 1
EPA Reg. No.
352-683
769-709
802-12
829-258
1812-372
19713-72
19173-289
42750-168
45002-8
46923-9
51036-12
51036-15
51036-24
81449-3
Percent Active Ingredient
Tribasic Copper sulfate monohydrate: 95 (metallic Cu equivalent 53%)
Tribasic Copper sulfate: 53 (metallic Cu equivalent 53%)
Basic Copper sulfate: 95 [on Label: 90] [metallic Cu equivalent 50%)
Basic Copper sulfate: 98 (metallic Cu equivalent 53.0%)
Basic Copper sulfate: 98.0 (metallic Cu equivalent 53%)
Basic Copper sulfate: 98.0 (metallic Cu equivalent 53.0%)
Basic Copper sulfate: 98.0 (metallic Cu equivalent 53.0%)
Basic Copper sulfate: 94.34 (metallic Cu equivalent 50.0%)
Basic Copper sulfate: 98.0 (metallic Cu equivalent 53.0%)
Basic Copper sulfate: 99 (metallic Cu equivalent 53%)
Basic Copper sulfate: [95.3] (metallic Cu equivalent 50.0%)
Basic Copper sulfate: 98.0 (metallic Cu equivalent 53%)
[in 1970s, product formulated with copper oxide, based on both CSFs and Labels]
Basic Copper sulfate: 98.0 (metallic Cu equivalent 53%)
Basic Copper sulfate: 98.5 (metallic Cu equivalent 53%)
Batch 2
EPA Reg. No.
4581-395
Percent Active Ingredient
Basic Copper sulfate: 47.0 (metallic Cu equivalent 25.5%)
151
-------
17545-7
19173-81
45002-21
51036-272
55146-14
Basic Copper sulfate: 47.1 (metallic Cu equivalent 25%; plus as an inert,
specifically, metallic zinc equivalent, derived from zinc oxysulfate: 25%)
Basic Copper sulfate: 45.0 (metallic Cu equivalent 23.85%)
Basic Copper sulfate: 46.3 (metallic Cu equivalent 25.0%; plus, as an inert:
elemental zinc, derived from zinc oxide [78%], present at 31.5%))
Basic Copper sulfate: 46.3 (metallic Cu equivalent 25.0%; plus, as an inert:
elemental zinc equivalent, derived from zinc oxide: 25.0%))
Basic Copper sulfate: 45.2 (metallic Cu equivalent 24%; plus, as an inert:
elemental zinc equivalent, derived from zinc oxide: 24%)
Batch 3
EPA Reg. No.
4581-396
35253-5
Percent Active Ingredient
Basic Copper sulfate: 36.9 (metallic Cu equivalent 20%)
Basic Copper sulfate: 39 (metallic Cu equivalent: 6 pounds of powdered
50% copper fungicides per one gallon of product [?])
Batch 4
EPA Reg. No.
5905-483
35935-3
51036-28
55146-9
Percent Active Ingredient - Granular, Powders, or Tablets
Basic Copper sulfate: 26. 12 (metallic Cu equivalent: not stated on label
"This product contains 3.5 Ibs. Metallic Copper per gallon. Copper source is
Tribasic Copper Sulfate.")
[this product is listed in OPP Chem Code 024401, Copper sulfate pentahydrate]
Basic Copper sulfate: 27.1 (metallic Cu equivalent 14.9%)
Basic Copper sulfate: 29.4 (metallic Cu equivalent 15.9%)
Basic Copper sulfate: 28.9 (metallic Cu equivalent 15%)
Batch 5
EPA Reg. No.
192-191
769-852
829-6
5481-135
5887-41
33955-97
Percent Active Ingredient
(Products in this batch may be batched with Batch 2 of Copper Sulfate
Pentahydrate, which also represent Bordeaux Mixture products)
Basic Copper sulfate, expressed as metallic copper: 12.75
Basic Copper sulfate, expressed as metallic copper: 12.75
Basic Copper sulfate: 13.3 (metallic Cu equivalent 7.10%)
Copper (in Bordeaux Mixture), expressed as metallic copper: 12.5
Basic Copper sulfate, expressed as metallic copper: 12.75
Copper, expressed as metallic (in the form of Bordeaux Mixture):
13.3 [product is incorrectly listed in OPP Chem Code 024405, Chelates of
copper]
Batch 6
EPA Reg. No.
5481-322
7401-373
Percent Active Ingredient
Copper (in Basic Copper Sulfate), expressed as metallic copper: 7.0
Copper (from Tri-Basic Copper Sulfate), expressed as metallic
copper: 7.0
No Batch
EPA Reg. No.
4-29
Percent Active Ingredient
Basic Copper sulfate, expressed as metallic:
Carbaryl: 1.25
Rotenone: 0.50
7.00
152
-------
4-30
4-53
4-58
4-107
4-458
35935-4
4581-397
4581-412
4581-413
51036-208
57538-6
Other Cube Resins: 1.00
Basic Copper sulfate, expressed as metallic: 7.00
Rotenone: 0.75
Other Cube Resins: 1.50
Basic Copper sulfate, expressed as metallic: 7.0
Rotenone: 1.5
Other Cube Resins: 2.20
Basic Copper sulfate: 7.00 (metallic Cu equivalent 3.76%)
Basic Copper sulfate: 5.00 (metallic Cu equivalent 2.7%)
Pyrethrins: 0.03
Rotenone: 0.50
Other Cube Resins: 0.75
Sulfur (4-5 microns): 25.00
Basic Copper sulfate, expressed as metallic: 7
Carbaryl: 2
Basic Copper sulfate: 60 (metallic Cu equivalent 33.1%)
[this product is listed in OPP Chem Code 024401, Copper sulfate pentahydrate]
Basic Copper sulfate: 22. 1 (metallic Cu equivalent 12%)
Mancozeb: 30.4
Basic Copper sulfate: 90.3 (metallic Cu equivalent 50.8%)
Basic Copper sulfate: 77. 1 (metallic Cu equivalent 40%)
Basic Copper sulfate: 27.5 (metallic Cu equivalent 14%)
Sulfur: 15.5
Basic Copper sulfate: 8.4 (metallic Cu equivalent 4.4%)
Sulfur: 50
Copper sulfate pentahydrate [0244011:
Batch 1
EPA Reg. No.
829-210
1022-573
1278-5
1278-8
1386-304
1706-55
1812-293
1812-304
1812-313
1812-314
1812-379
2800-58
7401-326
7401-384
Percent Active Ingredient
Copper sulfate (Pentahydrate): 99 (metallic Cu equivalent 25.2%)
Copper sulfate pentahydrate: 99 (metallic Cu equivalent 25.2%)
Copper sulfate pentahydrate: 99 (metallic Cu equivalent 25.2%)
Copper sulfate pentahydrate: 99 (metallic Cu equivalent 25.2%)
Copper sulfate pentahydrate: 99 (metallic Cu equivalent 25.2%)
Copper sulfate pentahydrate: 80 (metallic Cu equivalent 20.4%)
Copper sulfate pentahydrate: 99 (metallic Cu equivalent 25.2%)
Copper sulfate pentahydrate: 99 (metallic Cu equivalent 25.2%)
Copper sulfate pentahydrate: 99 (metallic Cu equivalent 25.2%)
Copper sulfate pentahydrate: 99 (metallic Cu equivalent 25.2%)
Copper sulfate pentahydrate: 99 (metallic Cu equivalent 25.2%)
Copper sulfate pentahydrate: 99 (metallic Cu equivalent 25.2%)
Copper sulfate pentahydrate: 99 (metallic Cu equivalent 25.2%)
Copper sulfate pentahydrate: 99 (metallic Cu equivalent 25.2%)
153
-------
7687-1
7792-1
8660-65
10266-1
10779-1
10807-208
19713-406
19713-407
34797-39
35896-19
35896-20
46923-4
56501-2
56576-1
71146-2
73385-1; -2
Copper sulfate pentahydrate: 96.9 (metallic Cu equivalent 24.6%)
Copper sulfate pentahydrate: 99 (metallic Cu equivalent 25.2%)
Copper sulfate pentahydrate: 99 (metallic Cu equivalent 25.2%)
Copper sulfate pentahydrate: 99 (metallic Cu equivalent 25%)
Copper sulfate pentahydrate: 99 (metallic Cu equivalent 25.4%)
Copper sulfate pentahydrate: 99 (metallic Cu equivalent 25.2%)
Copper sulfate pentahydrate: 99 (metallic Cu equivalent 25.2%)
Copper sulfate pentahydrate: 99 (metallic Cu equivalent 25.2%)
Copper sulfate pentahydrate: 99 (metallic Cu equivalent 25.2%)
Copper sulfate pentahydrate: 99 (metallic Cu equivalent 25.2%)
Copper sulfate pentahydrate: 99.5 (metallic Cu equivalent 25.2%)
Copper sulfate pentahydrate: 99 (metallic Cu equivalent 25.2%)
Copper sulfate pentahydrate: 99 (metallic Cu equivalent 25.2%)
Copper sulfate pentahydrate: 99 (metallic Cu equivalent not less than 25%)
Copper sulfate pentahydrate: 99 (metallic Cu equivalent 25.2%)
Copper sulfate pentahydrate: 99 (metallic Cu equivalent 25.2%)
Batch 2
EPA Reg. No.
2217-613
8660-44
Percent Active Ingredient
(Products in this batch may be batched with Batch 5 of Basic Copper Sulfate,
which also represent Bordeaux Mixture products)
Copper (in form of Bordeaux Mixture), expressed as metallic: 13.3
Copper (in form of Bordeaux Mixture), expressed as metallic: 12.50
Batch 3
EPA Reg. No.
3432-68
5905-524
7124-51
7364-26
71686-1
Percent Active Ingredient - Granular, Powders, or Tablets
Copper sulfate pentahydrate: 24.70 (metallic Cu equivalent 6.29%)
Copper sulfate pentahydrate: 23 .70 (metallic Cu equivalent 6.0%)
Copper sulfate pentahydrate: [25.2] (metallic Cu equivalent 6.24%)
Copper sulfate pentahydrate: 19.91 (metallic Cu equivalent 5.0%)
Copper sulfate pentahydrate: 20.0 (metallic Cu equivalent 5.0%)
Batch 4
EPA Reg. No.
7792-5
11435-3
12204-1
33136-1
41246-4
49538-5
61943-1
64962-1
65109-1
66675-1
66675-3
66675-4
Percent Active Ingredient - Water-Based
Copper sulfate pentahydrate: 19.8 (metallic Cu equivalent 4.95%)
Copper sulfate pentahydrate: [22.81] (metallic Cu equivalent 6.0%)
Copper sulfate pentahydrate: 19.8 (metallic Cu equivalent 5.04%)
Copper sulfate pentahydrate: 19.8 (metallic Cu equivalent 5.04%)
Copper sulfate pentahydrate: 25.0 (metallic Cu equivalent "not less than
6.30%")
Copper sulfate pentahydrate: 21.36 (metallic Cu equivalent 5.5%)
Copper sulfate pentahydrate: 19.8 (metallic Cu equivalent 5%)
Copper sulfate pentahydrate: 19.8 (metallic Cu equivalent 5%)
Copper sulfate pentahydrate: 20 (metallic Cu equivalent 5%)
Copper sulfate pentahydrate: 19.8 (metallic Cu equivalent 5.0%)
Copper sulfate pentahydrate: 19.8 (metallic Cu equivalent 5.0%)
Copper sulfate pentahydrate: 19.8 (metallic Cu equivalent 5.0%)
154
-------
70204-1
70204-2
70246-1
70264-5
70845-1
74942-1
83190-1
Copper sulfate pentahydrate: 19.8 (metallic Cu equivalent 5.1%)
Copper sulfate pentahydrate: 19.8 (metallic Cu equivalent 5.1%)
From Copper sulfate pentahydrate: metallic Cu equivalent 5.1%
Copper sulfate pentahydrate: 25.0 (metallic Cu equivalent "not less than
6.30%")
Copper sulfate pentahydrate: [20.0] (metallic Cu equivalent 5.0%)
Copper sulfate pentahydrate: 19.7 (metallic Cu equivalent 5.0%)
Copper sulfate pentahydrate: 19.8 (metallic Cu equivalent 5.04%)
Batch 5
EPA Reg. No.
54564-2
71537-1
73123-1
Percent Active Ingredient - Granular, Powders, or Tablets
Copper sulfate pentahydrate: 9.08 (metallic Cu equivalent 2.3%)
Copper sulfate pentahydrate: [12.5] (metallic Cu equivalent 3.125%)
Copper sulfate pentahydrate: 13 (metallic Cu equivalent 3.25%)
Batch 6
EPA Reg. No.
5185-473
5185-474
27588-2
58412-1
72083-1
Percent Active Ingredient - Water-Based
Copper sulfate pentahydrate : [13.0] (metallic Cu equivalent 3.3%; contains
polymeric polyacrylate and gluconate stabilizing agents)
Copper sulfate pentahydrate : [13.0] (metallic Cu equivalent 3.3%; contains
polymeric polyacrylate and gluconate stabilizing agents)
Copper sulfate pentahydrate: 10.9 (metallic Cu equivalent 2.7%)
Copper sulfate pentahydrate: 1 1 .83 (metallic Cu equivalent 3.03%)
Copper sulfate pentahydrate: 11.8 (metallic Cu equivalent 3.0%)
Batch 7
EPA Reg. No.
49538-3
71983-1
Percent Active Ingredient - Water-Based
Copper sulfate pentahydrate: 3.98 (metallic Cu equivalent 1.0%)
Copper sulfate pentahydrate: 3.91 (metallic Cu equivalent 1.0%)
Batch 8
EPA Reg. No.
41246-5
41246-6
Percent Active Ingredient - Water-Based
Copper sulfate pentahydrate: 1.0 (metallic Cu equivalent "not less than
0.25%")
Copper sulfate pentahydrate: 1.0 (metallic Cu equivalent "not less than
0.25%")
Batch 9
EPA Reg. No.
67712-1
67712-5
Percent Active Ingredient
Copper sulfate pentahydrate: 8.23 (metallic Cu equivalent 2.0%)
Metallic silver, from silver nitrate: 3.51
Copper sulfate pentahydrate: 9.43 (metallic Cu equivalent 2.40%)
Metallic silver, from silver nitrate: 2.33
Batch 10
EPA Reg. No.
33034-2
33034-3
Percent Active Ingredient
Copper sulfate pentahydrate: 0.05
Diuron: 0.67
Copper sulfate pentahydrate: 0.05
Diuron: 0.67
155
-------
No Batch
EPA Reg. No.
352-707
1258-1244
3525-102
5905-486
7152-20
7364-46
8622-68
8999-3
33034-1
35056-4
49538-2
70131-1
70303-1
75526-1
Percent Active Ingredient
Copper sulfate pentahydrate: 26.2
Copper Hydroxide: 17.1
(total metallic Cu equivalent from the two active ingredients: 20%)
[this product is also listed in OPP Chem Code 023401, Copper hydroxide]
Copper sulfate pentahydrate : 1.5
Trichloro-5-triazinetrione: 93.5%
Copper sulfate pentahydrate: 4.0 (metallic Cu equivalent 1.01%)
[Copper sulfate pentahydrate : 15.9] (metallic Cu equivalent 4%)
[this product is listed in OPP Chem Code 024408, Copper Sulfate (Anhydrous),
based on Active Ingredient listed on label (at 1 0. 0%), but all available CSFs list
TGAI as Copper Sulfate Pentahydrate, at 15.9% (@, 99.5%, = 15.82%)]
[Copper sulfate pentahydrate: 5.4]
[n-]Alkyl (5%Ci2, 60%Ci4, 30%Ci6, 5%Ci8) dimethyl benzyl
ammonium chloride: 2.54%
Dialkyl (5%Ci2, 60%Ci4, 30%Ci6, 5%Ci8) dimethyl benzyl
ammonium chloride: 0.01%
[this product is listed in OPP Chem Code 024408, Copper Sulfate (Anhydrous),
based on the Active Ingredient listed on Labels, but the most-recent CSF lists a
TGAI which was Copper Sulfate Pentahydrate]
Copper sulfate pentahydrate: 2.2 (as metallic copper)
Sodium dichloro-5-triazinetrione: 93.5%
Copper sulfate pentahydrate: [0.24] (metallic Cu equivalent 0.15%)
Mono- and dipotassium salts of Phosphorous Acid: 10.30
Copper sulfate pentahydrate: [6.34] ([metallic Cu equivalent 1.61%])
Copper sulfate pentahydrate: 1 .02
Diuron: 0.51
Copper sulfate pentahydrate: 28.029 (metallic Cu equivalent 7.1%)
[n-]Alkyl (5%Ci2, 60%Ci4, 30%Ci6, 5%Ci8) dimethyl benzyl
ammonium chloride: 0.625%
[n-]Alkyl (68%Ci2, 32%Ci4) dimethyl ethylbenzyl ammonium
chloride: 0.625%
Copper sulfate pentahydrate: 21.36 (metallic Cu equivalent 5.5%)
Copper sulfate [pentahydrate] : 1 . 6 [ 1 . 5 8]
[listed as "Ready-to-Use Solution " in OPP IN Query, but actually a powder]
Copper sulfate pentahydrate: 1 1 .24 (metallic Cu equivalent 3.1%)
[n-]Alkyl (40%Ci2, 50%Ci4, 10%Ci6) dimethyl benzyl ammonium
chloride: 4.54%
Copper sulfate pentahydrate: 2.66 (metallic Cu equivalent 0.68%)
Copper sulfate (anhydrous) [0244081:
[There are no products which should be placed within the Chemical Code, based on the CSFs of
the only two active products in OPPIN Query; these two products, 5905-486 and 7152-20, are
156
-------
batched in OPP Chemical Code 008101, the Copper Sulfate Pentahydrate products above.]
CASE # 0649: GROUP II COPPER COMPOUNDS
Basic copper chloride [0080011 & Copper oxychloride (Cu2Cl(OH)3) [0235011:
[Note: no products within the 008001 OPP Chemical Code actually contain Copper Chloride;
instead all contain Copper Oxychloride, based on the respective CSFs and most-recent Labels]
Batch 1
EPA Reg. No.
1812-333
1812-345
1812-383
19713-365
19713-366
19713-390
45002-17
55146-15
55146-40
55146-43
79558-1
79558-3
81449-2
35253-4
45002-6
51036-124
51036-125
51036-273
51036-277
Percent Active Ingredient
Chemical Code 008001 : Basic Copper Chloride
Copper Oxychloride: 99.4 (metallic Cu equivalent 57.6%)
Copper Oxychloride: 85 (metallic Cu equivalent 50%)
Copper Oxychloride: 92 (metallic Cu equivalent 53%)
Copper Oxychloride: 98.25 (metallic Cu equivalent 58%)
Copper Oxychloride: 97.0 (metallic Cu equivalent 57%)
Copper Oxychloride: 85.0 (metallic Cu equivalent 50%)
Copper Oxychloride: 86.2 (metallic Cu equivalent 50%)
Copper Oxychloride: 98 (metallic Cu equivalent 58%)
Copper Oxychloride: [87.72] (metallic Cu equivalent 50.0%)
Copper Oxychloride: 98 (metallic Cu equivalent 58%)
Copper Oxychloride: 97.0 (metallic Cu equivalent 57%)
Copper Oxychloride: 85 (metallic Cu equivalent 50%)
Copper Oxychloride: 98.5 (metallic Cu equivalent 58%)
Chemical Code 023501: Copper Oxychloride
Copper Oxychloride: 86.2 (metallic Cu equivalent 50%)
Copper Oxychloride: 98.25 (metallic Cu equivalent 58%)
Copper Oxychloride: 86.2 (metallic Cu equivalent 50%)
Copper Oxychloride: 91.4 (metallic Cu equivalent 53%)
Copper Oxychloride: 86.2 (metallic Cu equivalent 50%)
Copper Oxychloride: 98.25 (metallic Cu equivalent 58%)
Batch 2
EPA Reg. No.
45002-23
51036-274
Percent Active Ingredient
Chemical Code 023501: Copper Oxychloride
Copper Oxychloride: 67.22 (metallic Cu equivalent 40%)
Copper Oxychloride: 67.22 (metallic Cu equivalent 40%)
Batch 3
EPA Reg. No.
81293-2
81293-3
Percent Active Ingredient
Chemical Code 008001 : Basic Copper Chloride
Copper Oxychloride: 11.7 (metallic Cu equivalent 6.9%)
Chemical Code 023501: Copper Oxychloride
Copper Oxychloride: 11.7 (metallic Cu equivalent 6.9%)
157
-------
No Batch
EPA Reg. No.
51036-82
9779-339
74307-1
80289-3
Percent Active Ingredient
Chemical Code 008001 : Basic Copper Chloride
Copper Oxychloride: [42.0] (metallic Cu equivalent 23.08%)
Chemical Code 023501: Copper Oxychloride
Copper Oxychloride: [26.3] (metallic Cu equivalent 24%)
Chlorothalonil: 24
Copper Oxychloride: 15.00 (metallic Cu equivalent 8.7%)
Sulfur: 30.00
[metallic zinc equivalent derived from basic zinc salts: 8.5%]
Copper Oxychloride: 17.6
Copper hydroxide: 16.4
(total metallic Cu equivalent from the two active ingredients: 20%)
[this product is also listed in OPP Chem Code 023401, Copper Hydroxide]
Copper oxychloride sulfate [0235031:
Batch 1
EPA Reg. No.
34704-326
55146-22
55146-23
55146-31
Percent Active Ingredient
Copper oxychloride: 30.4
Basic Copper sulfate: 14.2
(metallic Cu equivalent from the two active ingredients: 50%)
[this product is listed in OPP Chem Code 008101, Basic Copper Sulfate, and in
023501, Copper Oxychloride, as well as in 023503 ]
From Copper oxychloride sulfate: expressed as copper metallic: 53
From Copper oxy chloride sulfate: expressed as copper metallic: 50
(metallic Cu from Cu oxychloride: 48%, and from Cu sulfate: 2%)
From Copper oxychloride sulfate: expressed as copper metallic: 57
Batch 2
EPA Reg. No.
45002-16
51036-190
55146-5
Percent Active Ingredient
Copper in the form of copper oxychloride sulfate: expressed as
metallic copper: 50
Copper present as copper oxychloride sulfate: expressed as metallic
copper: 50
From Copper oxychloride-sulfate: expressed as copper metallic: 56
Batch 3
EPA Reg. No.
2935-535
10951-11
34704-393
11656-103
Percent Active Ingredient
Basic Copper sulfate: 7.11
Copper oxychloride: 19.36
(total metallic Cu equivalent from these two active ingredients: not listed)
Sulfur: 25.00
Copper oxychloride [CSF: 19.6] and Basic Copper sulfate [CSF: 7.4]
(total metallic Cu equivalent from the two active ingredients: 15%)
Sulfur: 25.0
Copper oxychloride [CSF: 19.21] and Basic Copper sulfate [CSF: 7.64]
(total metallic Cu equivalent from the two active ingredients: 15%)
Sulfur: 25.0
Copper oxychloride: 19.5
158
-------
[was 8 1449-4]
82571-5
Basic Copper sulfate: 7.6
(total metallic Cu equivalent from the two active ingredients: 15%)
Sulfur: 25.0
[this product is listed in OPP Chem Code 008101, Basic Copper Sulfate, and in
008001, Basic Copper Chloride, but not yet in 023503]
Basic Copper sulfate: 7.6
Copper oxychloride: 19.5
(total metallic Cu equivalent from the two active ingredients: 15%)
Sulfur: 25.0
[this product is listed in OPP Chem Code 008101, Basic Copper Sulfate, and in
008001, Basic Copper Chloride, but not yet in 023503 /
No Batch
EPA Reg. No.
34704-320
34704-401
Percent Active Ingredient
From Copper oxychloride and Basic Copper sulfate: expressed as
copper metallic: 6
Copper Oxychloride: [36.30]
Basic Copper sulfate: [6.40]
(metallic Cu equivalent 24% in the "form of basic sulphates and chlorides"; plus as
an inert: metallic zinc equivalent, derived from basic zinc sulfate: 24%)
Copper carbonate [0229011:
Batch 1
EPA Reg. No.
1812-384
3008-96
35896-28
38871-1
38871-2
46923-8
55146-74
56248-2
65345-3
Percent Active Ingredient
Copper carbonate: 96.0 (metallic Cu equivalent 55%)
Copper carbonate: 96.8 (metallic Cu equivalent 55.6%)
Copper carbonate: 97.2 (metallic Cu equivalent 55%)
Copper carbonate: 97.75 (metallic Cu equivalent 56. 17%)
Copper carbonate: 87.25 (metallic Cu equivalent 50. 14%)
Copper carbonate: 96.0 (metallic Cu equivalent 55%)
Copper carbonate: 97.2 (metallic Cu equivalent 55%)
Copper carbonate: 98.0 (metallic Cu equivalent 57%)
Copper carbonate: 97.69 (metallic Cu equivalent 56%)
Batch 2
EPA Reg. No.
3008-92
35896-27
Percent Active Ingredient
Copper carbonate: 57.6 (metallic Cu equivalent 33.3 1%)
Copper carbonate: 48.0 (metallic Cu equivalent 27.6%)
Batch 3
EPA Reg. No.
3008-90
11435-6
Percent Active Ingredient
Copper carbonate: 35.37 (metallic Cu equivalent 20.46%)
Didecyl dimethyl ammonium carbonate and Didecyl dimethyl
ammonium bicarbonate: 12.80
Copper carbonate: 36.7 (metallic Cu equivalent 20.46%)
Didecyldimethylammonium carbonate and
Didecyldimethylammonium bicarbonate: 12.80
159
-------
Batch 4
EPA Reg. No.
75506-2
75506-4
Percent Active Ingredient
Basic copper carbonate: 16.73
Boric acid: 9.25
Tebuconazole: 0.51
Basic copper carbonate: 16.10
Boric acid: 9.25
Tebuconazole: 0.37
Batch 5
EPA Reg. No.
61718-3
61718-1
84127-1
Percent Active Ingredient
Copper carbonate:
Copper carbonate:
Copper carbonate:
Label: 1.3 [actually 2.55%] (metallic Cu equivalent
1.3%)
[cellulose: 91.45%]
Label: 1.3 [actually 2.55%] (metallic Cu equivalent
1.3%)
Ethoxyquin: 0.1%
[cellulose: 91.45%]
Label: 1.3 [actually 2.55%] (metallic Cu equivalent
1.3%)
Ethoxyquin: 0.1%
[contains cellulose: 91.45%]
Batch 6
EPA Reg. No.
11435-4
11435-5
35896-32
67690-9
67690-10
Percent Active Ingredient
Cooper carbonate: 1 7.94 (monoethanolamine complex of copper carbonate)
(metallic Cu equivalent 10.31%)
Cooper carbonate: 1 5 .66 (monoethanolamine complex of copper carbonate)
(metallic Cu equivalent 9.00%)
Cooper carbonate: 1 7.94 (monoethanolamine complex of copper carbonate)
(metallic Cu equivalent 10.31%)
Cooper carbonate: 15.9 (metallic Cu equivalent 9. 1%)
Cooper carbonate: 15.9 (metallic Cu equivalent 9. 1%)
Batch 7
EPA Reg. No.
11435-8
11435-10
Percent Active Ingredient
Basic copper carbonate: 34.795 (metallic Cu equivalent 20.0%)
Tebuconazole: 0.812
Basic copper carbonate: 34.795 (metallic Cu equivalent 20.0%)
Tebuconazole: 0.812
No Batch
EPA Reg. No.
11435-9
65345-2
71406-2
75269-2
Percent Active Ingredient
Copper carbonate: 34.8 (metallic Cu equivalent 20.0%)
Copper carbonate: 77.8 (metallic Cu equivalent 45%)
Copper carbonate: 16.3
Bis-(N-Cyclohexyldiazeniumdioxy)copper: 3.5
Boric acid: 5.0
(metallic Cu equivalent 10%)
Copper carbonate: 17.61
Didecyl-&/X2-hydroxyethyl)ammonium: 5.54
160
-------
75506-1
Boric acid: 8.0
(metallic Cu equivalent not specified on Label or CSF)
Basic copper carbonate: 18.18
Boric acid: 9.74
Propiconazole: 0.40
Copper (2+), tetraamine [copper ammonium complex] [0227021):
Batch 1
EPA Reg. No.
909-92
1812-298
10465-3
19713-509
54705-7
Percent Active Ingredient
Copper, metallic: 8.0 (from Copper Ammonium Complex)
Copper as elemental: 8.0 (from Copper-Ammonium Complex)
Copper ammonium complex: 31.4 (metallic Cu equivalent 8.0%)
Copper, metallic: 8.0 (from Copper Ammonium Complex)
Copper ammonium complex: 31.4 (metallic Cu equivalent 8.0%)
Copper ammonium carbonate [0227031:
Batch 1
EPA Reg. No.
3008-89
10465-33
Percent Active Ingredient
Copper ammonium carbonate: 24. 1 (metallic Cu equivalent 8.0%)
Copper ammonium carbonate: 24. 1 (metallic Cu equivalent 8.0%)
No Batch
EPA Reg. No.
3008-85
Percent Active Ingredient
Copper ammonium carbonate: 21.88 (metallic Cu equivalent 9.3%)
n-Alkyl (67%Ci2, 25%Ci4, 7%Ci6, !%Ci8) dimethyl benzyl
ammonium chloride: 4.6%
[this product is actually listed in OPP Chem Code 022901, Copper Carbonate]
Copper hydroxide [0234011:
Batch 1
EPA Reg. No.
352-682
352-711
1812-292
1812-347
10163-159
19713-327
19713-328
19713-329
35896-30
45002-5
Percent Active Ingredient
Copper hydroxide: 88 (metallic Cu equivalent 57.3%)
Copper hydroxide: 95.6 (metallic Cu equivalent 62.2%)
Copper hydroxide: 88 (metallic Cu equivalent 57.3%)
Copper hydroxide: 88 (metallic Cu equivalent 57.3%)
Copper hydroxide: 90 (metallic Cu equivalent 57%)
Copper hydroxide: 88 (metallic Cu equivalent 57.3%)
Copper hydroxide: 90 (metallic Cu equivalent 58.6%)
Copper hydroxide: 90 (metallic Cu equivalent 58.6%)
Copper hydroxide: 88 (metallic Cu equivalent 57.3%)
Copper hydroxide: 90 (metallic Cu equivalent 57%)
161
-------
51036-276
55146-3
55146-60
79558-2
Copper hydroxide: 90 (metallic Cu equivalent 57%)
Copper hydroxide: 88 (metallic Cu equivalent ? [not reported on label])
Copper hydroxide: 95.2 (metallic Cu equivalent 62.0%)
Copper hydroxide : 93.5 (metallic Cu equivalent 60%)
Batch 2
EPA Reg. No.
352-681
9779-298
10163-107
11435-7
19713-321
34704-969
42740-132
45002-4
45002-7
51036-269
51036-270
55146-1
64744-1
81015-1
Percent
Copper hydroxide:
Copper hydroxide:
Copper hydroxide:
Copper hydroxide:
Copper hydroxide:
Copper hydroxide:
Copper hydroxide:
Copper hydroxide:
Copper hydroxide:
Copper hydroxide:
Copper hydroxide:
Copper hydroxide:
Copper hydroxide:
Copper hydroxide:
Active Ingredient
77 (metallic Cu equivalent 50%)
77 (metallic Cu equivalent 50%)
77 (metallic Cu equivalent 50%)
77 (metallic Cu equivalent 50%)
77 (metallic Cu equivalent 50%)
77 (metallic Cu equivalent 50%)
77 (metallic Cu equivalent 50%)
77 (metallic Cu equivalent 50%)
77 (metallic Cu equivalent 50%)
77 (metallic Cu equivalent 50%)
77 (metallic Cu equivalent 50%)
77 (metallic Cu equivalent 50%)
77 (metallic Cu equivalent 50%)
77 (metallic Cu equivalent 50%)
Batch 3
EPA Reg. No.
352-656
352-688
45002-22
51036-271
55146-57
67690-37
80289-2
Percent Active Ingredient
Copper hydroxide: 53.8 (metallic Cu equivalent 35%)
Copper hydroxide : 61.4 (metallic Cu equivalent 40%)
Copper hydroxide : 61.4 (metallic Cu equivalent 40%)
Copper hydroxide : 61.4 (metallic Cu equivalent 40%)
Copper hydroxide: 57.6 (metallic Cu equivalent 37.5%)
Copper hydroxide: 53.8 (metallic Cu equivalent 35%)
Copper hydroxide : 61.3 (metallic Cu equivalent 40%)
Batch 4
EPA Reg. No.
352-662
55146-50
67690-33
Percent Active Ingredient
Copper hydroxide: 46.1 (metallic Cu equivalent 30%)
Copper hydroxide: 46.1 (metallic Cu equivalent 30%)
Copper hydroxide: 43 . 1 (metallic Cu equivalent 28%)
Batch 5
EPA Reg. No.
352-684
352-685
1812-301
9779-275
19173-301
42750-75
Percent Active Ingredient
Copper hydroxide: 37.5 (metallic Cu equivalent 24.4%)
Copper hydroxide: 30.7 (metallic Cu equivalent 20%)
Copper hydroxide: 30 (metallic Cu equivalent 19.4%)
Copper hydroxide: 37.5 (metallic Cu equivalent? [not reported on label]
"4.5 Ibs cupric hydroxide per gallon")
Copper hydroxide: 37.5 (metallic Cu equivalent 24.4%)
Copper hydroxide: 37.5 (metallic Cu equivalent 24.4%)
162
-------
42750-167
51036-268
55146-16
55146-64
Copper hydroxide: 37.5 (metallic Cu equivalent 24.4%)
Copper hydroxide: 37.5 (metallic Cu equivalent 24.4%)
Copper hydroxide: 30.7 (metallic Cu equivalent 20%)
Copper hydroxide: 37.5 (metallic Cu equivalent 24.4%)
Batch 6
EPA Reg. No.
1812-338
45002-20
51036-275
55146-41
67690-27
67690-29
Percent Active Ingredient
Copper hydroxide: 23 (metallic Cu equivalent 15%)
Copper hydroxide: [26. 1 ] (metallic Cu equivalent 17.0%)
Copper hydroxide: [26. 1 ] (metallic Cu equivalent 17.0%)
Copper hydroxide: 23 (metallic Cu equivalent 15%)
Copper hydroxide: 23 (metallic Cu equivalent 15%)
Copper hydroxide: 19.6 (metallic Cu equivalent 12.8%)
Batch 7
EPA Reg. No.
45002-14
67690-26
67690-28
68292-3
Percent Active Ingredient
Copper hydroxide: 4.15 (metallic Cu equivalent 2.74%)
Copper hydroxide: 7. 1 (metallic Cu equivalent 4.6%)
Copper hydroxide: 7. 1 (metallic Cu equivalent 4.6%)
Copper hydroxide: 3.6 (metallic Cu equivalent 2. 16%)
Batch 8
EPA Reg. No.
60061-39
60061-40
Percent Active Ingredient
Copper hydroxide: [8]
Cuprous oxide: [48]
(metallic Cu equivalent ? [not reported on label]) (need new CSF and new
Copper hydroxide: [8]
Cuprous oxide: [48]
(metallic Cu equivalent ? [not reported on label]) (need new CSF and new
Label)
Label)
Batch 9
EPA Reg. No.
352-690
67690-35
Percent Active Ingredient
Copper hydroxide: 46.1 (metallic Cu equivalent 30%)
Mancozeb: 15.0
Copper hydroxide: 46.1 (metallic Cu equivalent 30%)
Mancozeb: 15.0
No Batch
EPA Reg. No.
100-804
352-707
1022-551
1812-295
Percent Active Ingredient
Copper hydroxide: 60.0 (metallic Cu equivalent 39. 1%)
Mefenoxam: 5.0
Copper hydroxide: 17.1
Copper sulfate pentahydrate: 26.2
(total metallic Cu equivalent from the two active ingredients: 20%)
[this product is also listed in OPP Chem Code 024001, Copper sulfate pentahydrate]
Copper hydroxide : 15.4 (metallic Cu equivalent 10%)
Copper hydroxide: 26 (metallic Cu equivalent 16.9%)
Sulfur: 15
163
-------
54471-10
60061-38
71653-2
71653-4
82481-1
80289-3
Copper hydroxide: 3 . 1 (metallic Cu equivalent 2.0%)
Sodium tetraborate decahydrate: 43.5% (Boric Oxide equivalent 16.4%)
Copper hydroxide: [10]
Cuprous oxide: [24]
(metallic Cu equivalent ? [not reported on label]) (need new CSF and new Label)
Copper hydroxide: 2.9 (metallic Cu equivalent 2.6%)
Disodium octaborate tetrahydrate: 90.6%
Boric acid: 4.7%
Copper hydroxide: 8.8 (metallic Cu equivalent not specified)
Disodium octaborate: 83.3%
Boric acid: 4.7%
Copper hydroxide: 1.4
Cuprous oxide: 32.5
(total metallic Cu equivalent from the two active ingredients: 30.261)
Copper hydroxide: 16.4
Copper oxychloride: 17.6
(total metallic Cu equivalent from the two active ingredients: 20%)
[this product is also listed in OPP Chem Code 008001, Basic Copper Chloride]
Copper as metallic (in the form of chelates of copper citrate and copper gluconate) [the
chelates of copper citrate and/or gluconatel [0244051:
Batch 1
EPA Reg.
No.
5185-493
67262-35
Percent Active Ingredient
Copper, in form of chelates of citrates and gluconates: 0.26
Sodium dichloro-s-triazinetrione: 63.05
Copper, in form of chelates of citrates and gluconates: 0.26
Sodium dichloro-s-triazinetrione: 63.05
No Batch
EPA Reg.
No.
7364-9
7364-10
Percent Active Ingredient
Copper, in form of chelates of citrates and gluconates: 5.0
Copper, in form of chelates of citrates and gluconates: 0.5
164
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CASE #4026: COPPER SALTS
Copper salts of fatty and rosin acids [0231041:
Batch 1
EPA Reg. No.
352-694
1812-377
5887-163
67690-36
Percent Active Ingredient
Copper Salts of Fatty and Rosin Acids 58 (metallic Cu equivalent 5.14%)
Copper Salts of Fatty and Rosin Acids 48 (metallic Cu equivalent 4.0%)
Copper Salts of Fatty and Rosin Acids 48 (metallic Cu equivalent 4.0%)
Copper Salts of Fatty and Rosin Acids 58 (metallic Cu equivalent 5.14%)
No Batch
EPA Reg. No.
Percent Active Ingredient
4-436
Copper Salts of Fatty and Rosin Acids 25.0% (metallic Cu equivalent 2%)
RotenoneO.5%
Other Associated Resins 1.1%
Pyrethrins 0.4%
Copper ethylene diamine complex [copper as elemental from copper-ethylenediamine
complex] [0244071:
Batch 1
EPA Reg. No.
8959-54
67690-25
81943-1
Percent Active Ingredient
Copper-ethylenediamine complex: 24% (metallic Cu equivalent 8%)
Derived from copper-ethylenediamine complex and copper sulfate
pentahydrate (metallic Cu equivalent 8%)
Copper sulfate pentahydrate [contains "Ethyleneamine" as a
"Complexing Agent"] : 3 1 .27 (metallic Cu equivalent 8.0%)
Copper, ((^,2',2"-nitrilotris(ethanolato))(^-)-N,O,O',O")- [copper from triethanolamine
complexl [0244031:
Batch 1
EPA Reg. No.
1258-1280
3432-79
7124-100
8959-20
45309-28
55146-42
57787-17
67690-11
67690-23
Percent Active Ingredient
From copper triethanolamine, copper as elemental: 7.1%
From copper triethanolamine complex: 24.75%
[copper as elemental: ? [not reported on label]; ~ 7%]
From copper triethanolamine complex, copper as elemental: 7.0%
From copper triethanolamine complex, copper as elemental: 10.88%
From copper triethanolamine, copper as elemental: 7.1%
From copper triethanolamine complex, copper as elemental: 7.0%
From copper triethanolamine complex, copper as elemental: 7.0%
From copper "triethanolamine complexes", copper as elemental: 8%
[this product is also listed in OPP Chem Code 022409, Copper Ethanolamine
Complex] (need new CSF and new Label)
From copper triethanolamine complex, copper as elemental: 8.0%
165
-------
67690-24
67690-43
69681-12
81943-2
83742-1
From copper triethanolamine complex, copper as elemental: 8.0%
From Copper- Triethanolamine Complex and Copper Hydroxide,
copper as elemental: 7.0%
From copper triethanolamine, copper as elemental: 7.1%
From copper triethanolamine complex, copper as elemental: 8.0%
From Copper- Triethanolamine Complex and Copper Hydroxide,
copper as elemental: 8.0%
Batch 2
EPA Reg. No.
7616-68
45309-42
53735-9
67690-8
Percent Active Ingredient
From copper triethanolamine complex, copper as elemental: 3.5%
From copper triethanolamine complex, copper as elemental: 4.0%
From copper triethanolamine complex, copper as elemental: 3.03%
From copper triethanolamine complex, copper as elemental: 1.8%
Batch 3
EPA Reg. No.
3432-65
7346-83
45309-36
45309-41
Percent Active Ingredient
From copper triethanolamine complex, copper as elemental: 0.59%
From copper triethanolamine complex, copper as elemental: 1.05%
From copper triethanolamine, copper as elemental: 0.59%
From copper triethanolamine complex, copper as elemental: 0.59%
Batch 4
EPA Reg. No.
5481-140
7346-84
Percent Active Ingredient
From copper triethanolamine complex, copper as elemental: 0.142%
From copper triethanolamine complex, copper as elemental: 0.25%
Batch 5
EPA Reg.
No.
5185-382
42177-44
67262-24
Percent Active Ingredient
From copper triethanolamine complex, copper as elemental: 7.1%
Alkyl (40%Ci2, 50%Ci4, 10%Ci6) dimethyl benzyl ammonium
chloride: 2.5%
From copper triethanolamine complex, copper as elemental: 7.1%
Alkyl (40%Ci2, 50%Ci4, 10%Ci6) dimethyl benzyl ammonium
chloride: 2.5%
From copper triethanolamine complex, copper as elemental: 7.1%
Alkyl (40%Ci2, 50%Ci4, 10%Ci6) dimethyl benzyl ammonium
chloride: 2.5%
No Batch
EPA Reg.
No.
8959-31
57787-25
Percent Active Ingredient
From copper triethanolamine complex, copper as elemental: 4.58%
Alkyl (40%Ci2, 50%Ci4, 10%Ci6) dimethyl benzyl ammonium
chloride: 39.29%
From copper triethanolamine complex, copper as elemental: 7.1%
Poly(oxy- 1 ,2-ethanediyl(dimethylimino)- 1 ,2-
ethanediyl(dimethylimino)-l,2-ethanediyl di chloride: 20%
166
-------
(need new CSF and new Label)
EDTA, copper salt [copper ethylenediaminetetraacetatel [0391051:
Batch 1
EPA Reg.
No.
278-45
3525-95
Percent Active Ingredient
Copper, as elemental: 2.5% ["From copper ethylenediaminetetraacetic acid
complex"]
Copper, as elemental: 2.57% [From Copper Sulfate Pentahydrate" but also
with tetrasodium EDTA added]
No Batch
EPA Reg.
No.
Percent Active Ingredient
7144-39
Copper sulfate: 13.00% [as elemental copper, 3.24%, with EDTA added];
n-Alkyl (5%Ci2, 60%Ci4, 30%Ci6, 5%Ci8) dimethyl benzyl
ammonium chloride: 10.08%
Dialkyl (5%Ci2, 60%Ci4, 30%Ci6, 5%Ci8) methyl benzyl
ammonium chl ori de: 1.92%
Copper, bis(8-quinolinolato-Nl,O8)- [copper 8-quinolinolatel [0240021: In AD RED?
[from Case 4026 as listed in Rainbow Report]
Copper thiocvanate [0256021: In AD RED?
[from Case 4026 as listed in Rainbow Report]
Copper naphthenate [0231021: In AD RED? (from CASE 3099)
[from Case 3009 as listed in Rainbow Report]
UNSCHEDULED COPPER COMPOUNDS
Octanoic acid, copper salt [copper octanoatel [0233061:
No Batch
EPA Reg. No.
67702-2
67702-1
Percent Active Ingredient
10
0.08
Copper ethanolamine complex [0244091:
Batch 1
EPA Reg. No.
1258-1321
Percent Active Ingredient
From mixed copper ethanolamine complexes, copper as elemental: 9.0%
167
-------
3008-86
3008-87
7346-96
8959-2
8959-10
8959-28
8959-32
8959-33
8959-53
10465-36
46043-26
67690-11
75506-8
Copper as elemental: 9.0% (from mixed copper ethanolamine complexes)
From mixed copper ethanolamine complexes, copper as elemental: 9.0%
From mixed copper ethanolamine complexes, copper as elemental: 9.09%
From mixed copper ethanolamine complexes, copper as elemental: 7.41%
From mixed copper ethanolamine complexes, copper as elemental: 9.0%
[this product is listed in OPP Chem Code 024403, Copper Triethanolamine Complex]
From mixed copper ethanolamine complexes, copper as elemental: 9.3%
From mixed copper ethanolamine complexes, copper as elemental: 9.0%
[this product is listed in OPP Chem Code 024403, Copper Triethanolamine Complex]
From mixed copper ethanolamine complexes, copper as elemental: 9.0%
[this product is listed in OPP Chem Code 024403, Copper Triethanolamine Complex]
From mixed copper ethanolamine complexes, copper as elemental: 9.0%
[this product is listed in OPP Chem Code 024403, Copper Triethanolamine Complex]
From mixed copper ethanolamine complexes, copper as elemental: 9.0%
From mixed copper ethanolamine complexes, copper as elemental: 7.41%
From copper "tri ethanolamine complexes", copper as elemental: 8%
[this product is also listed in OPP Chem Code 024403, Copper Triethanolamine
Complex]
From mixed copper ethanolamine complexes, copper as elemental: 9.0%
Batch 2
EPA Reg. No.
8959-5
8959-12
8959-34
11474-15
8959-51
Percent Active Ingredient
From mixed copper ethanolamine complexes, copper as elemental: 2.09%
From mixed copper ethanolamine complexes, copper as elemental: 3.7%
From mixed copper ethanolamine complexes, copper as elemental: 1.25%
[this product is listed in OPP Chem Code 024403, Copper Triethanolamine Complex]
From mixed copper ethanolamine complexes, copper as elemental: 2.1%
From mixed copper ethanolamines, in an emulsified formulation, copper
as elemental: 3.825%
Batch 3
EPA Reg. No.
Percent Active Ingredient
3008-83
From mixed copper ethanolamine complexes, expressed as copper
oxide equivalent: 9.2 (metallic Cu equivalent as elemental 7.4%)
n-Alkyl (67%Ci2, 25%Ci4, 7%Ci6, !%Ci8) dimethyl benzyl
ammonium chloride: 4.6%
10465-39
From mixed copper ethanolamine complexes, expressed as copper
oxide equivalent: 9.2 (metallic Cu equivalent as elemental 7.4%)
n-Alkyl (67%Ci2, 25%Ci4, 7%Ci6, !%Ci8) dimethyl benzyl
ammonium chloride: 4.6%
Batch 4
EPA Reg. No.
8959-14
Percent Active Ingredient
From mixed copper ethanolamine complexes, expressed as copper:
(metallic Cu equivalent as elemental 3.07%)
n-Alkyl (67%Ci2, 25%Ci4, 7%Ci6, !%Ci8) dimethyl benzyl
ammonium chloride: 26.34%
168
-------
46043-25
From mixed copper ethanolamine complexes, expressed as copper:
(metallic Cu equivalent as elemental 3.07%)
n-Alkyl (40%Ci2, 50%Ci4, 10%Ci6) dimethyl benzyl ammonium
chloride: 26.34%
CASE # 4025: COPPER, and ITS OXIDES
[These will be included in the RED issued by AD.]
169
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