2

Table of Contents

EXECUTIVE SUMMARY..........................................................................................................................3

I. BACKGROUND ..................................................................................................................................................... 5

II. INERT INGREDIENT PROFILE ........................................................................................................................... 6

III. HUMAN HEALTH ASSESSMENT................................................................................................................... 6

A. Summary of Toxicity Data ...................................................................................................................7

B. Toxicity Endpoint Selection.................................................................................................................9

C. Special Considerations for Infants and Children..................................................................................9

IV. EXPOSURE ASSESSMENT................................................................................................................................... 10

A. Aggregate Exposure: ..........................................................................................................................10

V. OCCUPATIONAL EXPOSURE/RISK PATHWAY............................................................................................ 10

VI. CUMULATIVE EXPSOURE........................................................................................................................... 11

VII. ENVIRONMENTAL JUSTICE STATEMENT ............................................................................................... 11

VIII. ENVIRONMENTAL FATE CONSIDERATIONS.......................................................................................... 12

IX. ECOTOXICITY................................................................................................................................................ 12

X. RISK CHARACTERIZATION............................................................................................................................. 12

REFERENCES............................................................................................................................................................... 14
3

EXECUTIVE SUMMARY

OhSo Clean, Inc. (315 Pacific Avenue, San Francisco, CA 94111) is requesting that EPA 

expand the current copper sulfate pentahydrate tolerance exemption. Copper sulfate pentahydrate

(CAS Reg. No. 7758-99-8) is already approved as a nonfood use inert ingredient and has an

existing tolerance exemption for use as a pesticide active ingredient. The current request is to

include the use of copper sulfate pentahydrate as an inert ingredient (emulsion stabilizer) in 

antimicrobial formulations in accordance with 40 CFR 180.940(a), which includes use on food 

contact surfaces in public eating places, dairy processing equipment, and food processing 

equipment and utensils at no more than 80 ppm for ready-to-use products and end use dilutions of 

antimicrobial products.

The acute toxicity profile can be found in the 2006 Coppers RED. The acute oral LD50 for 

rats is 790 mg/kg for males and 450 mg/kg for females which represents a Toxicity Category of II. 

The dermal LD50 was determined to be >2,000 mg/kg, Toxicity Category of IV. No acute 

inhalation study was available in the database. A primary skin irritation study on rabbits showed 

that copper is non-irritating. The primary eye irritation study on rabbits showed severe eye 

irrigation from day 1 to 21 which is a Toxicity Category of I. No dermal sensitization study was 

available in the database.

 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.

Acute and chronic dietary (food and drinking water) risks from pesticides containing 

copper 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. 

Some copper species may cause acute dermal and eye irritation in exposed individuals. 

Workers can be exposed to copper pesticides through contact with surfaces where the product has 

been applied or though inhalation. Since no systemic toxicological endpoints of concern were 

identified for dermal exposures to copper, no dermal, oral or inhalation endpoints of toxicological 

concern were established. Occupational and residential exposures to pesticides containing copper 

are not of concern to the Agency.

In humans, there does not appear to be any reports in the literature of teratogenesis induced 

by exposure to excess copper. The only teratogenic effect 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 humans than toxicity from the 

excess, and since the dietary (food and drinking water) contribution of copper to the total diet is 
4

low, endpoints to quantitatively assess dietary risk were not selected. EPA has low concentrations 

and no residual uncertainties with regard to pre- or postnatal toxicity from copper exposures.

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 the lack of systemic toxicity, copper exposures from 

combined sources do not pose any health risks of concern.

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 coppercontaining 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 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.

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. 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. However 

based on the proposed use pattern and rate limits, the Agency does not expect the environmental 

fate or ecotoxicity of copper sulfate pentahydrate to be of concern. 

Taking into consideration all available information on copper sulfate pentahydrate, EPA 

concludes there is a reasonable certainty that no harm to any population subgroup will result from 

aggregate exposure to copper sulfate pentahydrate when considering occupation; dietary exposure 

and all other non-occupational sources of pesticide exposure for which there is reliable 

information. Therefore, the establishment of an exemption from tolerance under 40 CFR 

180.940(a) for residues of copper sulfate pentahydrate (CAS Reg. No. 7758-99-8) when used as a 

pesticide inert ingredient at no more than 80 ppm in antimicrobial formulations on food-contact 

surfaces in public eating places, dairy processing equipment, food processing equipment and 

utensils can be considered assessed as safe under section 408(q) of the FFDCA.
5

I. BACKGROUND

OhSo Clean, Inc. (315 Pacific Avenue, San Francisco, CA 94111) is requesting that EPA 

expand the current copper sulfate pentahydrate tolerance exemption. Copper sulfate pentahydrate

(CAS Reg. No. 7758-99-8) is already approved as a nonfood use inert ingredient and has an

existing tolerance exemption for use as a pesticide active ingredient. The current request is to

include the use of copper sulfate pentahydrate as an inert ingredient (emulsion stabilizer) in 

antimicrobial formulations in accordance with 40 CFR 180.940(a), which includes use on food 

contact surfaces in public eating places, dairy processing equipment, and food processing 

equipment and utensils at no more than 80 ppm for ready-to-use products and end use dilutions of 

antimicrobial products.

The information presented in this document is summarized primarily from the EPA 

Reregistration Eligibility Document (RED) for Coppers dated July 2006, Amended Reregistration 

Eligibility Decision (RED) dated May 2009 and the Revised Addendum to the 2009 Revised 

Coppers RED: Antimicrobial uses of Copper dated August 12, 2010 documents. 

Copper pesticides are extensively used in various agricultural settings. Tens of millions of 

pounds are applied annually, predominantly in crop and algaecide applications. 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 antifoulant and preservative in 

wood and other materials. 

Copper is also 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. 

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 reregistration. 

Reregistration of Copper was completed in 2006 Reregistration Eligibility Document (RED 

for Coppers). In May 2009 an Amended Reregistration Eligibility Decision (RED) was completed 

to address the comments after the first reregistration document was completed. Then in August 

2010 a Revised Addendum to the 2009 Revised Coppers RED: Antimicrobial uses of Copper was 

completed. 
6

II. INERT INGREDIENT PROFILE

A. Summary of Uses

Copper is a broad-spectrum fungicide, bactericide, aquatic herbicide, algaecide and 

mollusicde 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 the RED 

included citrus, strawberry, tomato, pepper, rice, filbert, walnut, peach, apple, and grape. 

B. Physical Chemical Properties

Some of the physical and chemical characteristics of copper sulfate pentahydrate, along 

with its structure and nomenclature, are found in Table 1.

Table 1. Physical and Chemical Properties of Copper Sulfate Pentahydrate

Parameter Value Source

Structure Hazardous Substance Data 

Base (HSDB)

CAS # 7758-99-8 Hazardous Substance Data 

Base (HSDB)

Molecular Weight (g/mol) 249.69 Sigma-Aldrich MSDS

Common Names Cupric Sulfatepentahydrate Sigma-Aldrich MSDS

Physical State Crystalline Sigma-Aldrich MSDS

Melting Point (°C) 110 Sigma-Aldrich MSDS

Boiling Point (°C) @ 19 hPa N/A

Density (g/cm3 @ 20°C) 2.284 Sigma-Aldrich MSDS

Vapor Pressure (mmHg @ 

25°C) 7.3 Sigma-Aldrich MSDS

Partition Coefficient (Log P) N/A

Water Solubility (g/L) N/A

pH 3.7 – 4.5 at 50g/L @ 25 °C Sigma-Aldrich MSDS

Henry's Law Constant N/A

III. HUMAN HEALTH ASSESSMENT
7

A. Summary of Toxicity Data 

Copper sulfate pentahydrate readily dissociates to copper and sulfate ions in solution. 

Sulfate ions have been previously assessed and are found in many food substances and a 

mammalian (human) metabolite. Sulfate ions are not expected to be of toxicological 

concern. The component of toxicological interest in copper pesticide is elemental copper 

(cupric ion). Humans have effective homeostatic capabilities to regulate copper in the 

body. 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 copper compounds. These acute studies show that copper generally has low 

acute toxicity however copper sulfate pentahydrate has a toxicity category I for primary eye 

irritation and toxicity category II for acute oral toxicity. Based on available literature and 

previously reviewed studies, 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 Oral Toxicity

Please reference 2006 Reregistration Eligibility Decision for Coppers.

Dermal Toxicity

Please reference 2006 Reregistration Eligibility Decision for Coppers.

Inhalation Toxicity

Please reference 2006 Reregistration Eligibility Decision for Coppers.

Primary Eye Irritation

Please reference 2006 Reregistration Eligibility Decision for Coppers.

Primary Skin Irritation

Please reference 2006 Reregistration Eligibility Decision for Coppers.

Dermal Sensitization

Please reference 2006 Reregistration Eligibility Decision for Coppers.

The results of the available acute toxicity studies are summarized in Table 3 of the 2006 

Reregistration Eligibility Decision for Coppers. The table below is specifically for copper 

sulfate pentahydrate while the 2006 table includes many copper-containing compounds.

Table 3. Acute Toxicity Profile of Copper Sulfate Pentahydrate

Study Type Results

Toxicity 

Category MRIDs # /Reference

Acute Oral - rat LD50 (male) = 790 mg/kg bw

LD50 (female) = 450 mg/kg/bw

II 2006 Copper RED

MRID 43396201

Acute Dermal - N/A LD50 > 2000 mg/kg bw IV 2006 Copper RED

MRID 43452201

Acute Inhalation - N/A N/A N/A N/A
8

Table 3. Acute Toxicity Profile of Copper Sulfate Pentahydrate

Study Type Results

Toxicity 

Category MRIDs # /Reference

Primary Eye Irritation -

rabbit

Severe eye irritation day 1 to day 

21

I 2006 Copper RED

MRID 43396201

Primary Skin Irritation -

rabbit

Non-irritating IV 2006 Copper RED

MRID 43396201

Dermal Sensitization N/A N/A N/A

Subchronic and Chronic Toxicity -

Based on available data summarized in the 2006 Reregistration Eligibility Decision for 

Coppers, there is no evidence of any dietary, oral, and dermal or inhalation adverse effects 

warranting quantitative assessment of sub-chronic or chronic risk. Available short-term 

feeding studies with rats and mice indicate decreased food and water intake with increasing 

oral concentrations of copper. Irritation of the stomach was seen at higher copper 

concentrations. Longer-term feeding studies indicate decreased feed intake with reductions 

in body weight gains, and increased copper concentration of the liver. 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.

Carcinogenicity

The following was cited from the 2006 Reregistration Eligibility Decision for Coppers.

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.

Developmental and Reproductive Toxicity – Rats

The following was cited from the 2006 Reregistration Eligibility Decision for Coppers.

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.

Immunotoxicity

No immunotoxicity studies were available in the database.

Neurotoxicity

No neurotoxicity studies were available in the database.

Mutagenicity and Genotoxicity

No mutagenicity or genotoxicity studies were available in the database.
9

Metabolism and Pharmacokinetics

The following was cited from the 2006 Reregistration Eligibility Decision for Coppers.

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 from 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 Cirrohosis, 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. 

B. Toxicity Endpoint Selection

Current available data in animals do not show any evidence of upper limit toxicity level 

that warrant determining acute or chronic toxicity endpoints for any potential routes of 

exposure.

C. Special Considerations for Infants and Children

The following was cited from the 2006 Reregistration Eligibility Decision for Coppers:

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 
10

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 effect 

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 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 concentrations 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.

IV. EXPOSURE ASSESSMENT

A. Aggregate Exposure:

The following was cited from the 2006 Reregistration Eligibility Decision for Coppers:

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 a reliable 

information.” In accordance with the FQPA, the 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 form aggregate dietary and residential exposures. 

V. OCCUPATIONAL EXPOSURE/RISK PATHWAY

The following was cited from the 2006 Reregistration Eligibility Decision for Coppers:
11

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 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.

VI. CUMULATIVE EXPSOURE 

Section 408(b)(2)(D)(v) of FFDCA requires that, when considering whether to establish, 

modify, or revoke a tolerance, 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.”

EPA has not found copper sulfate pentahydrate to share a common mechanism of toxicity 

with any other substances, and that copper sulfate pentahydrate does not appear to produce 

a toxic metabolite produced by other substances. For the purposes of this tolerance action, 

therefore, EPA has assumed that copper sulfate pentahydrate does not have 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 EPA's website at 

http://www.epa.gov/pesticides/cumulative.

VII. ENVIRONMENTAL JUSTICE STATEMENT 

Potential areas of environmental justice concerns, to the extent possible, were considered in 

this human health risk assessment, in accordance with U.S. Executive Order 12898, 

"Federal Actions to Address Environmental Justice in Minority Populations and LowIncome Populations," http://www.eh.doe.gov/oepa/guidance/justice/eo12898.pdf.

As a part of every pesticide risk assessment, OPP considers a large variety of consumer 

subgroups according to well-established procedures. In line with OPP policy, RD 

estimates risks to population subgroups from pesticide exposures that are based on patterns 

of that subgroup’s food and water consumption, and activities in and around the home that 

involve pesticide use in a residential setting. Extensive data on food consumption patterns 

are compiled by the USDA under CSFII and are used in pesticide risk assessments for all 
12

registered food uses of a pesticide. These data are analyzed and categorized by subgroups 

based on age, season of the year, ethnic group, and region of the country. Additionally, 

OPP is able to assess dietary exposure to smaller, specialized subgroups and exposure 

assessments are performed when conditions or circumstances warrant. Whenever 

appropriate, non-dietary exposures based on home use of pesticide products and associated 

risks for adult applicators and for toddlers, youths, and adults entering or playing on treated 

areas post-application are evaluated. Further considerations are currently in development 

as OPP has committed resources and expertise to the development of specialized software 

and models that consider exposure to bystanders and farm workers as well as lifestyle and 

traditional dietary patterns among specific subgroups

VIII. ENVIRONMENTAL FATE CONSIDERATIONS

The following was cited from the 2006 Reregistration Eligibility Decision for Coppers:

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.

IX. ECOTOXICITY

The following was cited from the 2006 Reregistration Eligibility Decision for Coppers:

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.

X. RISK CHARACTERIZATION 

Taking into consideration all available information on copper sulfate pentahydrate , EPA 

concludes there is a reasonable certainty that no harm to any population subgroup will 

result from aggregate exposure to copper sulfate pentahydrate when considering 

occupation; dietary exposure and all other non-occupational sources of pesticide exposure 

for which there is reliable information. Therefore, the establishment of an exemption from 
13

tolerance under 40 CFR 180.940(a) for residues of copper sulfate pentahydrate (CAS Reg. 

No. 7758-99-8) when used as a pesticide inert ingredient at no more than 80 ppm in 

antimicrobial formulations on food-contact surfaces in public eating places, dairy 

processing equipment, food processing equipment and utensils can be considered assessed 

as safe under section 408(q) of the FFDCA.
14

REFERENCES

U.S. EPA. 2006 Reregistration Eligibility Document (RED for Coppers).

U.S. EPA. May 2009 Amended Reregistration Eligibility Decision (RED).

U.S. EPA. August 2010 Revised Addendum to the 2009 Revised Coppers RED: Antimicrobial 

uses of Copper.