f

UNITED STATES ENVIRONMENTAL PROTECTION AGENCYWASHINGTON, D.C. 20460i

3SK/OCT232013

OFFICE OFPREVENTION, PESTICIDES AND

TOXIC SUBSTANCES

Mr. Micah ReynoldsRegulatory Consultant for,c/o Global Brass and Copper, Inc.1150 18th Street, N.W.Suite 1000Washington, D.C. 20036

Subject: CuVerro VIEPA Registration Number 85353-6Your Notification Dated September 23, 2013EPA Received Date September 24, 2013

The notification referred to above, submitted in connection with registrationunder the Federal Insecticide, Fungicide, and Rodenticide Act(FIFRA), asamended, to update non-food use sites, add descriptive language and addlogo consistent with alternate brand name, is acceptable.

The notification has been made part of the permanent file.

If you have any questions concerning this letter, please contact Karen M.Leavy at (703)-308-6237.

Sincerely,

-Marshall SwineProduct Manager 33Regulatory Management Branch IAntimicrobial Division(751 OP)

Please read instructions on reverse side before completing form. Form Approved. OMB No. 2070-0060. Approval expires 05-31-98

United States

Environmental Protection AgencyWashington, DC 20460

RegistrationAmendment

I Other

OPP Identifier Number

Application for Pesticide - Section I1. Company/Product Number

85353-64. Company/Product (Name)

CuVerro® VI

2. EPA Product Manager

Marshall SwindellPM#

33

3. Proposed Classification

IXI None J Restricted

5. Name And Address Of Applicant (Include ZIP Code)

Global Brass and Copper, Inc.427 North Shamrock StreetEast Alton, Illinois 62024

6. Expedited Review. In accordance with FIFRA Section 3(c)(3)(b)(i), my product is similar or identical in composition and labelingto:EPA Reg. No.

Check if this is a new addressProduct Name

Section II

Amendment - Explain below.

Resubmission in response to Agency letter dated

Notification - Explain below.

Final Printed labels in response toAgency letter dated

"Me Too" Application.

Other - Explain Below.

Explanation: Use additional page(s) if necessary. (For section I and Section II.)

Submission of Label Notification to update non-food use sites (consistent with parent product), add descriptive text consistentwith antimicrobial claims, and add logo consistent with alternate brand name.This notification is consistent with the provisions of PR Notice 98-10 and EPA regulations at 40 CFR 152.46, and no other changes have been made to thelabeling or the confidential statement of formula of this product. I understand that it is a violation of 18 U.S.C. Sec. 1001 to willfully make any false statementto EPA. I further understand that if this notification is not consistent with the terms of PR Notice 98-10 and 40 CFR 152.46, this product maybe in violationof FIFRA and I may be subject to enforcement action and penalties under sections 12 and 14 of FIFRA.

Please confirm receipt with Micah Reynolds: mreynoldstajtsqusa.com, phone (202) 828-8967, or fax (202) 872-0745.

Section III1. Material This Product Will Be Packaged In:

Child Resistant Packaging

D Yes*

I I No

* Certification mustbe submitted

Unit Packaging

D Yes

No

If "Yes" No. perUnit Packaging wgt. Container

Water Soluble Packaging

D Yes

] No

If "Yes"Unit Packaging wgt.

No. perContainer

2. Type of Container

Metal

Plastic

Glass

Paper

Other (Specify)

3. Location of Net Contents Information

jj Label _] Container

4. Size(S) Retail Container 5. Location of Label DirectionsOn LabelOn Labeling accompanying product

6. Manner in Which Label is Affixed to Product LithographedPager gluedStenciled

Other

Section IV1. Contact Point (Complete items directly below for identification of individual to be contacted, if necessary, to process this application.)

NameMicah T. Reynolds, Technology Sciences Group, Inc.

TitleSenior Regulatory Consultant

Telephone No. (Include Area Code)(202) 828-8967

Certification

I certify that the statements I have made on this form and all attachments thereto are true, accurate and complete.I acknowledge that any knowingly false or misleading statement may be punishable by fine or imprisonment orboth under applicable law.

2. Signat

4. Typed NameMicah T. Reynolds

3. TitleRegulatory Consultant to Global Brass andCopper, Inc.

5. Date

September 23, 2013

6. Date ApplicationReceived

(Stamped)

EPA Form 8570-1 (Rev. 8-94) Previous editions are obsolete

Technology Sciences Group Inc.115018th Street, Suite 1000Washington, DC 20036Direct: (202)828-8967Fax: (202)872-0745E-Mail: MReynolds@TSGUSA.com

Micah T. ReynoldsSenior Regulatory Consultant

September 23, 2013

Global Brass and Copper, Inc.Label Notification for CuVerro® Vi;EPA Req. No. 85353-6

( •Mr. Marshall Swindell, PM-33Antimicrobials Division (751 OP)Office of Pesticide Programs (NOTIF)U.S. Environmental Protection AgencyDocument Processing CenterRoom S-4900, One Potomac Yard2777 South Crystal DriveArlington, Virginia 22202

Dear Mr. Swindell:

Technology Sciences Group, Inc., on behalf of Global Brass and Copper, Inc., is submitting theenclosed label notification to: 1) update the non-food use sites (products from which the productmay be fabricated) consistent with the same recent updates made by the Copper DevelopmentAssociation's parent product (82012-6); 2) add alternate verbiage (i.e. "bactericidal") to selectantimicrobial claims that are consistent with the original claim; and 3) add a logo consistent witha previously approved alternate brand name. These changes are consistent with previouslychanges made to other Global Brass and Copper products (85353-1 through 85353-5). Pleasefind enclosed the following documents supporting this notification:

1) Application for Notification (EPA Form 8570-1);2) One (1) copy of the label with changes highlighted;3) Three (3) copies of revised product labeling.

If you have any questions or require additional information or clarification, please do not hesitateto contact me by phone at (202) 828-8967 or by e-mail at mreynolds(ia)tsgusa.com.

Sincerely,

Regulatory Consultant toGlobal Brass and Copper, Inc.

EnclosuresCC: M. Visnack (Global Brass and Copper, Inc.)

Washington, D.C. California Canada1150 18'h St., NW, Suite 1000 712 Fifth St., Suite A 275 Slater St., Suite 900

Washington, D.C. 20036 Davis, CA 95616 Ottawa, Ontario KIP 5H9

Phone: (202) 223-4392 Phone: (530) 757-1245 Phone: (613) 247-6285

If. ? /«?-CuVerro* IV (EPA Reg. No. 85353-6)

Master Label version dated June 5.2013

[Alternate Brand Names: CuVerro® VI Antimicrobial Copper Alloy]CuVerro® VI Bactericidal Copper Surfaces]

CuVerro® VIAND ASSOCIATED FABRICATED PRODUCTS

MASTER LABEL

The Master Label consists of the label that will accompany the CuVerro VI AntimicrobialAlloys and a label that will accompany each product fabricated using a registered CuVerro VIalloy.

[Alloy Label - Front Panel]

CuVerro® VIAND ASSOCIATED FABRICATED PRODUCTS

• .' ' € (

Active Ingredient:Copper 62.0%Other 38.0%

Total 100%

EPA Registration No. 85353-6 Made in the United States byEPA Establishment No. 85353-XX Global Brass and Copper, Inc.

427 N. Shamrock StreetEast Alton, IL 62024

Net Weight: XXX Ibs XXX ounces of CuVerro® VI

[See insert (side panel) (back panel) for Directions for Use]

? Id-CuVerro* IV (EPA Reg. No. 85353-6)

Master Label version dated June 5,2013

DIRECTIONS FOR USEIt is a violation of Federal law to use this product in a manner inconsistent with its labeling.

CuVerro® VI Antimicrobial Copper Alloys

These alloys are only intended for the manufacture and fabrication of touch surface componentsfor use in hospitals, healthcare facilities, laboratories, and various public, commercial, andresidential buildings. [The claims listed on the attached fabricated product label may be made inconnection with the marketing and sale of CuVerro® VI Antimicrobial Copper Alloys andfabricated products made from CuVerro VI Antimicrobial Copper Alloys under EPARegistration Number 85353-6.]

i i

A list of components that may be fabricated out of CuVerro VI Antimicrobia' Copper Alloys isspecified below. CuVerro® VI Antimicrobial Copper Alloys are not approved for direct foodcontact or food packaging uses.

Touch Surface Componentsi

Healthcare Facilitieso Bedrails, footboardso Over-bed tableso Bed-side tables in hospitals, extended care facilities, senior housing etc. (knobs,

pulls, handles; surfaces)o Handrails, (corridor/hallways) ( Senior housing), automatic door push plateso Stair rails, handrails, tubular railing, and supports, rail fittings T's, elbows and

bracketso Bedrails, assistance rails,o Toilet safety railso Carts

Hospital carts (table surfaces, handles, legs)Computer cartsRecord cartsPhlebotomy cartsOther Carts (tables/surfaces, shelving, railings, handles, pulls)

o Equipment carts (horizontal surfaces, frames, handles)o Door push plates, kick plates, mop plates, stretcher plateso Sinks: spigots, drains, sinks themselveso Faucet: handles, spigot, drain control levero Water fountains: bubbler head, drain strainer, handleo Alcohol sanitizer dispenser, handleo Paper towel holders, facial tissue holders, toilet paper holderso Air hand dryer, controls and push buttons on air hand dryerso Hydrotherapy tanks (whirlpool tanks): shells, covers, headrests, drain fittings

(outer surfaces without water contact)o Door handles, doorknobs (outer touch surfaces)o Grab bars in bathrooms showers and bathtubso Panic bars on emergency room doors

(CuVerro* IV (EPA Reg. No. 85353-6)

Master Label version dated June 5. 2013

o Towel barso Showerheadso Countertops and tabletops (non-food use only)o Hinges, locks, latches, and trimo Door stops, door pulls, and protector guardso Toilet and urinal hardware, levers, push buttonso Toilet seat inlay for lifting of seato Closureso Vertical locking armso Vertical cover guardso Protection barso Light switches, switch plates° - • t (o Visitor chairs: armrests, metal frameso Thermostat covers, control knobs and wheelso Telephone handsets and surfaces (housings), keypado Kitchen surfaces (non-food contact only): table tops, counter tops, handles

(microwave, refrigerator, stove), cabinet doors, cabinet hinges, pulls, backsplash,hoods, control knobs (appliances, fans)

o Floor tileso Ceiling tiles (non-porous)o Wall tileso Instrument handles

Medical equipment knobs, pulls and handles for:• Drug delivery systems• Monitoring systems• Hospital beds• Office equipment• Operating room equipment• Stands and fixtures

Types of knobs: e.g., Prong, fluted, knurled, push/pull, T-handle, tapered, andball knobs

o Intravenous (IV) poles, bases, hangers, clipso Trays (instruments, non-food contact)o Pans(bed)o Walkers, wheelchair handles, and tubular componentso Computer keyboards: keys, housings, computer mouse surfaceso Exercise and rehabilitation equipment, handles, barso Physical therapy equipment: physical therapy tables, treatment chairs and portable

taping tableso Chairs (shower chairs, patient chairs, visitor chairs): rails, backs, legs, seatso Lighting products: X-ray illuminators, operating rooms, patient examination

rooms, surgical suites, and reading lamps for hospital rooms and assisted livingfacilities etc. Components can include bases, arms, housings, handles, hinges)

o Headwall systems: the unit themselves, outlet covers, knobs and dials, lightingunits (lamp housings and adjustable arms), CRT monitors with rotating knobs andlevers and adjustments. Baskets, monitor housings, knobs, baskets, tables, IVpoles

( 79-1*-CuVerro® IV (EPA Reg. No. 85353^6)

Master Label version dated June 5,2013

o Critical care cart: Table top, drawer, drawer pull, lock, copper wire baskets forstorage of equipment and charts.

o Bedside lavatory: sink, faucet, handles, drawer pulls, toilet seat, toilet seat cover,toilet handle, door and cabinet facings, counter tops

o Medical records: Chart holders, clipboards, filing systemso Storage Shelving: wire shelving etc. for medical supplieso Grab handles on privacy curtainso Lids of laundry hampers, trash canisters, and other containerso Bedside pitcherso Closet rods and hangerso Television controls: knobs, buttons, remoteo Monitor (television, computer, etc.) housingo Cup Holdero Toothbrush holdero Soap holder, dispensero Magazine racko Signageo Coat rack and hookso Shower curtain ringso Radiator cover ' <o Braceletso Penso Badge clipso Name tagso Patient gown snapso Window sills, pulls and lockso Electrical wallplates

Community Facilities (including various public and commercial buildings)o Shopping cart handles, child seats, handrailso Cash registers: housing, keypadso ATM machines: keys, housingo Gym/Health club lockers, locker handles, locker shelving, trainers' tables,o Exercise equipment, handles, barso Ice and water dispensers (outer surfaces without water contact)o Elevator: handrail, control panel, buttons, interior walls, floor tiles, exterior call

button plateo Paper towel dispensers. Housing itself, (turn) handle, (push) handleo Soap holdero Soap dispenser (wall mounted): push bar and dispenser itselfo Soap dispenser (sitting on counter): dispenser housing itself, push mechanismo Toilet paper dispenser (housing)o Windows (crank), Locking mechanism, pull handleso Window treatments (cord pulls), Venetian blinds (wands, cord pulls)o Jalousie Windows (crank)o Casement (cranks, levers, hinges)o Single and double-hung windows (locks and pulls)

CuVerro® IV (EPA Reg. No. 85353-6)Master Label version dated June 5. 2013

o Light switches, switch plateso Lids of laundry hampers, trash canisters, and other containerso Magazine racko Signageo Coat rack and hookso Shower curtain ringso Radiator covero Braceletso Badge clipso Name tagso Vending machines (non-food contact only)o Window sillso Electrical wallplateso Clip boardso Office supplies: paper clips, staplers, tape dispensers

cI

Residential Buildings (including homes, apartments, apartment buildings and otherresidences)

o Kitchen surfaces (non-food contact only): table tops, counter tops, handles(microwave, refrigerator, stove), cabinet doors, cabinet hinges, pulls, backsplash,hoods, control knobs (appliances, fans)

o Bedrails, footboardso Handrailso Stair railso Door push plateso Sinks: spigots, drains, sinks themselveso Faucet: handles, spigot, drain control levero Paper towel holders, facial tissue holders, toilet paper holderso Door handles, doorknobs (outer touch surfaces)o Grab bars in bathrooms showers and bathtubso Towel barso Showerheadso Countertops and tabletopso Hinges, locks, latches, and trimo Door stops, door pulls, and protector guardso Toilet and urinal hardware, levers, push buttonso Toilet seat inlay for lifting of seato Light switches, switch plateso Thermostat covers, control knobs and wheelso Telephone handsets and surfaces (housings), keypado Floor tileso Ceiling tiles (non-porous)o Wall tileso Computer keyboards: keys, housings, computer mouse surfaceso Exercise equipment, handles, barso Windows (crank), Locking mechanism, pull handleso Window treatments (cord pulls), Venetian blinds (wands, cord pulls)

'• ICuVerro® IV (EPA Reg. No. 85353-6)

Master Label version dated June 5. 2013

o Jalousie Windows (crank)o Casement (cranks, levers, hinges)o Single and double-hung windows (locks and pulls)o Television control knobs and buttonso Lids of laundry hampers, trash canisters, and other containerso Bedside pitcherso Closet rods and hangerso Television remoteo Cup Holdero Toothbrush holdero Soap holder, dispensero Magazine racko Coat rack and hooks ,o Shower curtain ringso Radiator covero Window sills

i

o Electrical wallplateso Baby cribs: rails, fittings, brackets, supportso Bowl standso Office supplies: paper clips, staplers, tape dispenserso Monitor (television, computer, etc.) housing

Mass Transit Facilitieso Handrailso Stair rails, tubular railing, and supports; elbows and bracketso Door push plates, kick plateso Door handles, door knobs (outer touch surfaces)o Grab bars and handleso Tiles: wall, floor, ceiling (non-porous)o Chairs and benches: rails, backs, legs, seatso Window sills, pulls, and handleso Signageo Vending machines (non-food contact only)

Laboratorieso Incubator interior and outside surfaces, including culture chambers, walls.

shelving and support brackets, handles, circulating fan assemblies, pano Laboratory surfaces: table tops, counter tops, handles, cabinet doors, cabinet

hinges, pulls, backsplash, hoods, control knobso Laboratory carts, trays, and panso Door handles, knobs, latches and lockso Laboratory equipment: safety cabinets, enclosures, vent hoods

Othero Play area equipment (indoor only): bars, handles, chains, push plates, handrails,

stair rails and risers, wheels, knobs, flooringo Chapel pews

(CuVerro* IV (EPA Reg. No. 85353-6)

Master Label version dated June 5.2013

o Eye glass frames and protective eye wearo Penso Combso Ashtrays

Do not wax, paint, lacquer, varnish, or otherwise coat touch surfaces.

Cu Verro® VI - Fabricated Productsi

The CuVerro® VI fabricated products listed above may be sold and distributed under EPARegistration Number 85353-6. Products fabricated with CuVerro® VI AntimicrobialCopper Alloys must bear the EPA approved fabricated product label, btlo«, with cne crmore of the listed claims.

i

STORAGE AND DISPOSALt {(

Dispose of excess by recycling.

WARRANTY STATEMENT

If used as intended, this product is wear-resistant and the durable antibacterial (bactericidal)properties will remain effective for as long as the product remains in place and is used asdirected.

//CuVerro* IV (EPA Reg. No. 85353-6)

Master Label version dated June 5.2013

CuVerro® VIFabricated Product Label

BACKFRONT

[This (touch surface) (product)] made from

CuVerro® VIActive Ingredient:

Copper 62.0%Other 38.0%[Total 100.0%]See [Back/Side Panel][lnsert] for Directions forUseNet Weight: XXX Ibs XXX ounces of CuVerro*VI

CuVerro"VILaboratory testing has shown that when cleaned regularly this surface:- Continuously reduces bacteria* contamination, achieving 99.9% reduction

within 2 hours of exposure.- Kills greater than 99.9% of Gram-negative and Gram-positive bacteria* within

2 hours of exposure.- Delivers continuous and ongoing antibacterial* (bactericidal*) action,

remaining effective in killing greater than 99.9% of bacteria* ,v:lr in 2 hours.- Kills greater than 99.9% of bacteria* within two hours and continues to kill

99% of bacteria* even after repeated contaminations.- Helps inhibit the buildup and growth of bacteria* within 2 hoi-s of exposure

between routine cleaning and sanitizing steps.- [This product/component name] is made VGLU o.')(from) a (cjpper)(touch)

surface that continuously kills bacteria* hft behind [by eVy hands][on thesurface] killing more than 99.9% of bacteria within 2 hours.

- Staphy/ococcus aureus, Enterobacter atrogeies, Methicillin-ResistantStaphylococcus aureus (MRSA), Escherichia co/i O157:HV, Ps&iidomonasaeruginosa and, Vancomycin - Resistant £,i.e.ccoccus faejL.lis ?.'RE).

DIRECTIONS FOR USEIt is a violation of Federal law to use this product in a manner inconsishrt -Y'ti it" labeling.

Proper Care and Use. Clean and sanitize according to standard practice.Healthcare facilities must maintain the product in accordance wifn infectioncontrol guidelines. The use of this surface is a supplement to and not asubstitute for standard infection control practices; users must continue tofollow all current infection control practices, including those practices related tocleaning and disinfection of environmental surfaces. This surface has beenshown to reduce microbial contamination, but does not necessarily preventcross contamination.

This surface may be subject to recontamination and the level of active bacteriaat any time will depend on the frequency and timing of recontamination andcleanliness of the surface (among other factors). In order to have properantimicrobial effect, this product must be cleaned and maintained according tothe directions for use.

Do not wax, paint, lacquer, varnish, or otherwise coat this product.

Routine cleaning to remove dirt and filth is necessary for good sanitation andto assure the effective antibacterial (bactericidal) performance of this surface.Cleaning agents typically used for traditional hard, non-porous touch surfacesare permissible. The appropriate cleaning agent depends on the type of soilingand the measure of sanitization required. Normal tarnishing or wear of thissurface will not impair antibacterial (bactericidal) effectiveness.

Not approved for direct food contact or food packaging uses.

[Items exposed to outdoor environmental conditions are not representative ofindoor laboratory test conditions, and, therefore, may impart reduced efficacy ifnot cleaned when visibly soiled.]

STORAGE AND DISPOSALDispose of by recycling or put in trash.

WARRANTY STATEMENTIf used as intended, this product is wear-resistant and the durable antibacterial(bactericidal) properties will remain effective for as long as the product remainsin place and is used as directed.

EPA Reg. No. 85353-6 EPA Est. No. (Product Manufacturer Number] 85353-XX-XXXManufactured by: [Product Manufacturer Company Name and Address]Global Brass and Copper, Inc. 427 North Shamrock Street East Alton, IL 62024

(CuVerro* IV (EPA Reg. No. 85353-6)

Master Label version dated June 5. 2013

[Optional Logo for Use with Alloy Label or Fabricated Product Label!

AntimicrobialCopper

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Bactericidal Copper Surfaces

Antimicrobial Copper Surfaces