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 Consid erations 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

................................ ................................ ................................ ................................ ............................... 143 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 LD 50 for rats is 790 mg/kg for males and 450 mg/kg for females which represents a Toxicity Category of II.

The dermal LD 50 was determined to be >2,000 mg/kg, Toxicity Category of I V . 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 r ole 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 asses sment 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 expo sures 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 s tudies 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 com mon in humans than toxicity from the excess, and since the dietary (food and drinking water) contribution of copper to the total diet is4 low, endpoints to quantitatively assess dietary risk were not selected. EPA has low concentrations

and no residual unce rtainties 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 (acu te),

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 f ungicides, 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 potent ial 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 appropr iate 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 pro cesses 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 matte r, 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 de ficiency 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 t hat 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. Ho wever 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 Reregi s tration 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

- kill er in sewer systems. Coppers are also registered for antimicrobial applications, including uses as an antifoulant and preservative in

wood and other materials.

Copper is a lso a naturally

- occurring, ubiquitous element in the environment. Copper is

found i n 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 maintain ing 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 d eficiency 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 cit rus, 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/cm 3 @ 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 ASSESSMENT7 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 a s 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 seve ral 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 litera ture 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 fro m 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 Sensitiz ation 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 Categ ory MRIDs # /Reference

Acute Oral

- rat LD 50 (male) = 790 mg/kg bw

LD 50 (female) = 450 mg/kg/bw II 2006 Copper RED

MRID 43396201

Acute Dermal

- N/A LD 50 > 2000 mg/kg bw I V 2006 Copper RED

MRID 43452201

Acute Inhalation

- N/A N/A N/A N/A8 Table 3. Acute Toxicity Profile of Copper Sulfate Pentahydrate

Study Type Results Toxicity Categ ory 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. Availabl e 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 teratogen ic 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 informat ion 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 rat her than the excess of copper.

Immunotoxicity

No i mmunotoxicity 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 ab sorbed, 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 coppe r 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 de velopment, 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, indepen dent of copper intake.

B. Toxicity Endpoint Selection

Current available data in animals do not show any evidence of up per limit toxicity level that warrant determining acute or chronic toxicity endpoints for any potential routes of

exposure.

C. Special Consid erations 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 and10 children. In humans, there does not appear to be any reports in the literature of teratogenesis induced by exposure to exc ess 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 r isk 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 die tary 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 occurrin g 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 inha lation 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 t o 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 sig nificant 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

. O CCUPATIONAL EXPOSURE/RISK PA THWAY

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 s ystemic 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. C UMULATIVE 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 chemical s, see EPA's website at http://www.epa.gov/pesticides/cumulative

.

VII

. E NVIRONMENTAL 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 Low

Income 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, R D estimates risks to population subgroups from pesticide exposures that are based on pa tterns 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 ris k assessments for all12 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, sp ecialized 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, a nd 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

. E NVIRONMENTAL 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 degra dation 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.

I X. E COTOXICITY

The following was cited from the 2006 Reregistr ation 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 a nimals 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

. R ISK 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

o ccupation; dietary exposure and all other non

- occupational sources of pesticide exposure for which there is reliable information. Therefore, the establishment of an exemption from13 tolerance under 40 CFR 180.940(a) for residues of copper sulfate pentahydrat e (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.