# UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C. 20460

OFFICE OF

PREVENTION, PESTICIDES

AND TOXIC SUBSTANCES



# CERTIFIED MAIL

January 12, 2010

Ms. Lynn P. Georges

Regulatory Affairs Manager

Monterey AgResources

P.O. Box 35000

Fresno, CA 93745-5000

Re: Response to Monterey AgResources November 9, 2009 Letter Regarding Copper

Reregistration Eligibility Decision

EPA Registration Numbers 48142-1/-4/-7

Dear Ms. Georges:

EPA has received the November 9, 2009 co mments submitted by Monterey AgResources

regarding the Reregistration Eligibility Deci sion (RED) requirements for cuprous oxide.

According to your letter, cuprous oxide does not meet the acute toxicity category level which

mandates double notification and the most string ent early entry persona l protective equipment

(PPE) requirements. The Agency has reviewed the criteria for these requirements as set forth in

the Worker Protection Standard (WPS) as defined in 40 CFR 156.210-212.

Double notification requirements and early entr y PPE for all pesticid al uses within the

scope of the WPS are established on the basis of the acute toxicity of th e active ingredient or

product. The toxicity categories of the activ e ingredient for acute dermal and inhalation

toxicities, as well as eye and skin irritation potential, are used to determine the early entry PPE

requirements. Double notification requirements are determined based on acute dermal and skin

irritation acute toxicity classification.

As indicated in your letter, Table 5 of the Revised Copper RED cla ssifies cuprous oxide

with acute toxicity classifications of Category III and IV, as shown below. When all acute

dermal and skin irritation data are present, the WPS states that double notification is required

only for products which contain an acute toxicity Category I activ e ingredient for acute dermal

and skin irritation. Therefore, the Agency recognizes that this classification does not trigger the

need for double notification under the WPS.

# Copper Type PC

Code Acute Oral

LD 50 

# (mg/kg) Acute

Dermal

LD 50 

# (mg/kg) Acute

Inhalation

(mg/L) Primary Eye

Irritation Dermal

Irritation Dermal

Sensitization

Cuprous oxide

(83.9%) 025601 Tox Cat III

45246201 Tox Cat IV

45246202 Tox Cat IV

45246203 Tox Cat III

47046901 Tox Cat IV

45246204 Non-sensitizing

(guinea pig)

45246205



# Moreover, the early entry PPE requirement fo r cuprous oxide specifi ed in the Revised

Copper RED was inadvertently base d on the acute toxicity Category I requirements rather than

Category III. Instead, the appropriate early entry PPE fo r cuprous oxide consists of coveralls,

chemical-resistant gloves, and shoes plus socks.

EPA recommends that Monterey AgResources proceed with the product reregistration of

Registration Nos. 48142-1, 48142-4, and 48142-7 by disregarding the double notification

requirements for cuprous oxide in the Revise d Coppers RED and follow the early entry PPE

requirement set forth for Category III active ingr edients, which includes coveralls, chemicalresistant gloves, and shoes plus socks. These changes can also be viewed in the enclosed Table

29. Copper Compounds Labeling Changes Summary from the Revised Coppers RED (Amended

January 2010). All relevant personnel within EPA Pesticide Re-evalu ation Division and

Registration Division will be notified of this change. To assist with this matter, please include a

copy of this letter with any a dditional registration or reregi stration label changes or label

amendments of these products to avoid any comp lications. Please contact me with any questions

or concerns (Phone: 703-308-8172 or E-mail: keller.kaitlin@epa.gov ).

Sincerely,

Kaitlin Keller

Chemical Review Manager, RMIB III

Pesticide Re-evaluation Division

Office of Pesticide Programs

Enclosure:Table 29. Copper Compounds LabelingChanges Summary (Amended January 2010)In order to be eligible for reregistration, all product labels must be amended toincorporate the risk mitigation measures outlined in Section IV.The following table describes how language on the labels should be amended.DescriptionCopper Compounds Required Labeling LanguagePlacement on LabelManufacturing-Use ProductsRequired on all MUPs for allCopper Compoundscontaining directions for anyuse“Only for formulation into [fill blank with the appropriate pesticide type(s):fungicides, bactericides, algaecides, herbicides, leech control, freshwater snailcontrol, anti-foulants and wood preservatives] for the following use(s) [fill blankonly with those uses that are being supported by MP registrants].”Directions for UseOne of these statements maybe added to a label to allowreformulation of the productfor a specific use or alladditional uses supported bya 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 onthe MP label if the formulator, user group, or grower has complied with U.S. EPAsubmission requirements regarding support of such use(s).”“This product may be used to formulate products for any additional use(s) notlisted on the MP label if the formulator, user group, or grower has complied withU.S. EPA submission requirements regarding support of such use(s).”Directions for UseEnvironmental HazardsStatements Required by theRED and Agency LabelPolicies“This pesticide is toxic to fish and aquaticinvertebrates. Do not discharge effluentcontaining this product into lakes, streams, ponds, estuaries, oceans or other watersunless in accordance with the requirements of a National Pollutant DischargeElimination System (NPDES) permit and the permitting authority has beennotified in writing prior to discharge. Do not discharge effluent containing thisproduct to sewer systems without previously notifying the local sewage treatmentplant authority. For guidance contact your State Water Board or Regional Officeof the EPA.”Directions for UseRequired on all MUPs for AllCopper CompoundsFor all copper compounds label, the Ingredient Statement panel must state anddescribe the ingredient(s) in the following manner:-the original form/species (i.e., copper hydroxide, copper ethanolaminecomplex, 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 theFront Panel, IngredientStatement89DescriptionPlacement on LabelCopper Compounds Required Labeling Languagepercentage by weight directly below the Ingredient Statement.DescriptionCopper Compounds Required Labeling LanguagePlacement on LabelEnd-Use Products Intended for Occupational Use (WPS and non-WPS)Required on all EUPs for AllCopper Compounds,including products primarilyused by Consumers/HomeownersFor all copper compounds label, the Ingredient Statement panel must state anddescribe the ingredient(s) in the following manner:-the original form/species (i.e., copper hydroxide, copper ethanolaminecomplex, 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 thepercentage by weight directly below the Ingredient Statement.Ingredient StatementEnvironmentalHazards Statements forProduct with Only DirectAquatic UsesFor labels that include direct aquaticuses, include the following statements:“ENVIRONMENTAL HAZARDSThis pesticide is toxic to fish and aquaticinvertebrates. Waters treated with thisproduct may be hazardous to aquatic organisms. Treatment of aquatic weeds andalgae can result in oxygen loss from decomposition of dead algae and weeds. Thisoxygen loss can cause fish and invertebratesuffocation. To minimize this hazard,do not treat more than 1⁄2 of the waterbody to avoid depletion of oxygen due todecaying vegetation. Wait at least 10 to 14 days between treatments. Begintreatment along the shore and proceed outwards in bands to allow fish to moveinto untreated areas. Consult with the State or local agency with primaryresponsibility for regulating pesticides before applying to public waters, todetermine 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 50mg/L), increases the potential acute toxicity to non-target aquatic organisms.”Precautionary Statementsunder EnvironmentalHazards StatementEnvironmentalHazards Statements forProducts with TerrestrialUses OnlyFor labels that include terrestrial uses (remove “drift” if a granular formulation),include the following statements:“ENVIRONMENTAL HAZARDSPrecautionary Statementsunder EnvironmentalHazards90DescriptionCopper Compounds Required Labeling LanguagePlacement on LabelThis pesticide is toxic to fish and aquatic invertebrates and may contaminate waterthrough runoff. This product has a potential for runoff for several months or moreafter application. Poorly draining soilsand soils with shallow water tables aremore prone to produce runoff that containsthis product. Drift and runoff may behazardous to aquatic organisms in water adjacent to treated areas.Do not apply directly to water, to areas where surface water is present, or tointertidal areas below the mean high water mark. Do not contaminate water whendisposing of equipment washwater or rinsate.”EnvironmentalHazards Statements forProducts withbothTerrestrialand Aquatic UsesUse the exact Environmental Hazards aquaticand terrestrial statements above sothat the aquatic and terrestrial statements are clearly distinguishable from oneanother. Add:“For terrestrial uses” before “This pesticide... treated areas.”, and also before “Donot apply...equipment.”Precautionary Statementsunder EnvironmentalHazardsUser Safety Requirement forcopper compounds used totreat potable water sourcesFor end-use products that include use of copper compounds in waters destined foreventual use as drinking water, the following two statements must be included:”For applications in waters destined foruse as drinking water, those waters mustreceive additional and separate potable water treatment. Do not apply more than1.0 ppm as metallic copper in these waters”PrecautionaryStatements: Hazards toHumans and DomesticAnimalsMinimum Handler PPERequirements(All Copper Compounds)NOTE:In the case of multiple activeingredients, the moreprotective PPE must beplaced on the productlabeling. For guidance onwhich PPE is consideredmore protective, see PR“Personal Protective Equipment (PPE)”“Mixers, loaders, applicators, and other handlers must wear the following:- long-sleeved shirt,- long pants,- shoes plus socks.”Instruction to Registrant:If chemical resistant gloves, apron or footwear are required by the product specificdata, add the following statement:“Some materials that are chemical-resistant to this product are (registrant insertscorrect chemical-resistant material). If you want more options, follow thePrecautionaryStatements: Hazards toHumans and DomesticAnimals91DescriptionCopper Compounds Required Labeling LanguagePlacement on LabelNotice 93-7.instructions for category[registrant inserts A,B,C,D,E,F,G,or H] on an EPAchemical-resistance category selection chart.”Signal WordFor products subject to the WPS that are classified as toxicity category I or II mustalso bear the corresponding Spanish signal word and statement:”Si usted no entiende la etiqueta, busque aalguien para que se la explique a usteden detalle. (If you do not understand the label, find someoneto explain it to you indetail.)”Front PanelUser Safety Requirements(All Copper Compounds)“Follow manufacturer's instructions for cleaning/maintaining PPE. If no suchinstructions for washables exist, use detergent and hot water. Keep and wash PPEseparately from other laundry.”“Discard clothing and other absorbent material that have been drenched or heavilycontaminated with the product’s concentrate. Do not reuse them.”PrecautionaryStatements: Hazards toHumans and DomesticAnimals immediatelyfollowing the PPErequirementsUser SafetyRecommendations(All Copper Compounds)“USER SAFETY RECOMMENDATIONS”“Users should wash hands before eating,drinking, chewing gum, using tobacco, orusing the toilet.”“Users should remove clothing/PPE immediately if pesticide gets inside. Thenwash thoroughly and put on clean clothing.”“Users should remove PPE immediately after handling this product. As soon aspossible, wash thoroughly and change into clean clothing.”Note to Registrant: If gloves are required on the label (either for handlers or earlyentry workers), add the following in addition to the above:“Wash the outside of gloves before removing.”Precautionary Statementsunder: Hazards toHumans and DomesticAnimals immediatelyfollowing EngineeringControls(Must be placed in abox.)Restricted-Entry Intervalfor products with WPS usesNote: REI’s are determinedby the acute toxicity of each“Do not enter or allow worker entry into treated areas during the restrictedentryinterval of (insert the correct REI as specified below):Products containing any of the following copper compounds require a 48hour REI*:Basic copper chloride (008001)Directions for Use,Agricultural UseRequirements Box92DescriptionCopper Compounds Required Labeling LanguagePlacement on Labelcopper compound which canvary. For productscontaining more than onecopper compound, the mostrestrictive REI must appearon the label.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 24hour REI:Copper, metallic (022501)Copper ethylenediamine (024407)Products containing any of the following copper compounds require a 12hour REI:Copper octanoate (023306)Copper triethanolamine complex (024403)Cupric oxide (042401)Cuprous oxide (025601)For All Copper-containingProducts that are Registeredfor Use in Greenhouses with48-hour REIsFor all copper-containing products that are Registered for Use in Greenhousesonly may reduce the REI to 24-hours, provided that the following conditions aremet:-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:Directions for Use,Agricultural UseRequirements Box93DescriptionCopper Compounds Required Labeling LanguagePlacement on Label“For at least seven days following theapplication of copper-containing products ingreenhouses:-at least one container or station designed specifically for flushing eyesis available in operating condition with the WPS-requireddecontamination supplies for workers entering the area treated withcopper-containing products,-workers are informed orally, in a manner they can understand:- that residues in the treated area may be highly irritating to theireyes,- that they should take precautions, such as refraining fromrubbing their eyes, to keep the residues out of their eyes,- that if they do get residues in their eyes, they should immediatelyflush their eyes with the eye flush container for eye flush stationthat is located with the decontamination supplies, and- how to operate the eye flush container or eye flush station.”Early Entry PersonalProtective Equipment forproducts with WPS usesNote: Early Entry PPE isdetermined by the acutetoxicity of each coppercompound which can vary.For products containing morethan one copper compound,the most restrictive REI mustappear on the label.PPE required for early entry to treated areas that is permitted under the WorkerProtection Standard and that involves contact with anything that has been treated,such as soil or water, is (insert correct Early Entry PPE specified below)Products containing any of the copper compounds listed directly belowrequire 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, andprotective 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)Directions for Use,Agricultural UseRequirements Box94DescriptionCopper Compounds Required Labeling LanguagePlacement on LabelCopper naphthenate (023102)Copper ethanolamine complex (024409)Products containing any of the copper compounds listed directly belowrequire the following early entry PPE:Coveralls,shoes plus socks,chemical-resistant gloves made of any waterproof material, andprotective eyewear.Basic copper chloride (008001)Copper carbonate (022901)Copper hydroxide (023401)Copper sulfate pentahydrate (024401)Copper 8-quinolinolate (024002)Copper, metallic (022501)Early Entry PersonalProtective Equipment forproducts with WPS usesNote: Early Entry PPE isdetermined by the acutetoxicity of each coppercompound which can vary.For products containing morethan one copper compound,the most restrictive REI mustappear on the label.Products containing any of the copper compounds listed directly belowrequire the following early entry PPE:Coveralls,shoes plus socks,chemical-resistant gloves such as or made out of any waterproof material:Copper ethylenediamine (024407)Cupric oxide (042401)Cuprous oxide (025601)Copper octanoate (023306)Copper triethanolamine complex (024403)Copper salts of fatty and rosin acids (023104)Directions for Use,Agricultural UseRequirements BoxDouble NotificationStatementProducts containing any of the copper compounds listed directly below require thefollowing statement:“Notify workers of the application by warning them orally and by posting warningDirections for Use,Agricultural UseRequirements Box95DescriptionCopper Compounds Required Labeling LanguagePlacement on Labelsigns 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)Copper naphthenate (023102)Copper ethanolamine complex (024409)Entry Restrictionsfor products with non-WPSuses on the labelEntry Restriction for products applied as a spray:“Do not enter or allow others to enter until sprays have dried.”Entry Restriction for products applied dry:“Do not enter or allow others toenter until dusts have settled.”If no WPS uses on theproduct label, place theappropriate statement inthe Directions for UseUnder GeneralPrecautions andRestrictions. If theproduct also containsWPS uses, then create aNon-Agricultural UseRequirements box asdirected in PR Notice 93-7 and place theappropriate statementinside that box.General ApplicationRestrictions for products withWPS or non-WPS uses on thelabel“Do not apply this product in a way thatwill contact workers or other persons,either directly or through drift. Only protected handlers may be in the area duringapplication. For any requirements specific to your State or Tribe, consult the Stateor Tribal agency responsible for pesticide regulation.”Place in the Direction forUse, following themisuse statement.Spray Drift ManagementStatements for all coppercontaining products, exceptfor granularPesticide drift text must be added to the label and must read:"SPRAY* DRIFT MANAGEMENTA variety of factors including weather conditions (e.g., wind direction, wind speed,temperature, relative humidity) and method of application (e.g., ground, aerial,Place in the Direction forUse96DescriptionCopper Compounds Required Labeling LanguagePlacement on Labelairblast, chemigation) can influence pesticide drift. The applicator must evaluateall 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 meandiameter of 300 microns or greater for spinning atomizer nozzles.Wind SpeedDo not apply at wind speeds greater than 15 mph. Only apply this product if thewind direction favors on-target deposition(approximately 3 to 10 mph), and thereare no sensitive areas within 250 feet downwind.Temperature InversionsIf applying at wind speeds less than 3 mph,the applicator must determine if a)conditions of temperature inversion exist, or b) stable atmospheric conditions existat or below nozzle height. Do not make applications into areas of temperatureinversions or stable atmospheric conditions.Other State and Local RequirementsApplicators must follow all state and local pesticide drift requirements regardingapplication of copper compounds. Where states have more stringent regulations,they must be observed.EquipmentAll aerial and ground application equipment must be properly maintained andcalibrated 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 bladediameter.- Release spray at the lowest height consistent with efficacy and flight safety. Donot release spray at a height greater than 10 feet above the crop canopy unless agreater height is required for aircraft safety.- When applications are made with a crosswind, the swath must be displaced97DescriptionCopper Compounds Required Labeling LanguagePlacement on Labeldownwind. The applicator must compensate for this displacement at the up anddownwind edge of the application area by adjusting the path of the aircraftupwind.Additional requirements for ground boom application: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.Other ApplicationRestrictionsMaximum Application Rates, ApplicationInterval (days) and Seasonal MaximumApplication Rates must be specified on all product labels. See Appendix A for thecorrect application rates and intervals for each site or crop.Directions for Use underGeneral Precautions andRestrictions and/orApplication InstructionsProducts Primarily Used by Consumers/HomeownersEntry RestrictionsEntry Restriction for products applied as a spray:“Do not allow adults, children, or pets toenter the treated area until sprays havedried.”Entry Restriction for products applied dry:“Do not allow adults, children, or petsto enter the treated area until dusts havesettled.”Directions for use underGeneral Precautions andRestrictionsGeneral ApplicationRestrictions“Do not apply this product in a way that will contact adults, children, or pets,either directly or through drift.”Place in the Direction forUseEnvironmental Hazards“This pesticide is toxic to fish and aquatic invertebrates and may contaminatewater through runoff. For terrestrial uses, do not apply directly to water. Do notcontaminate water when disposing of equipment washwaters or rinsate.”Precautionary Statements98