( \ \ lUNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C. 20460

OFFICE OF CHEMICAL SAFETYAND POLLUTION PREVENTION

August 26, 2014

Joseph J. GreenAgent for Copper Development Association (CDA)Kelley Drye & Warren LLP3050 K Street, N.W., Suite 400Washington, District of Columbia 20007

Subject: Additional Indoor Non-Food Use'SitesEPA Reg. No. 82012-4Notification Letter Dated August 1,2014

This letter acknowledges receipt of the Notification identified above submitted under theprovisions of section 3(c)(9) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA),as amended and PR Notice 98-10.

Based on a review of the submitted information, this notification is acceptable. This informationhas been made a part of your file. Please note that if you would like a stamped label, you mustsubmit an amendment request.

Should you have any questions concerning this letter, please contact Elizabeth Watkins at (703)347-0241.

Sincerely,

Elizabeth WatkinsRisk ManagerRegulatory, Management Branch 1Antimicrobials Division (751 OP)

cPtette ned Instruction* on r»vor*m baton completing form. Form Approved. OMB No. 207(MX)60

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United States

Environmental Protection AgencyWashington, DC 20460

xRegistrationAmendment

OPP Wentifi'r Numb<"

Application for Pesticide - Section 11 . Company/Product Number82012-4

4. Company/Product (Name)Antimicrobial Copper Allovs Group IV

2. EPA Product ManagerEric Miederhoff

33

3. Proposed Classification

[ X j None I I Restricted

5. Name and Address of Applicant {include ZIP Codei

Copper Development Association, Inc.260 Madison Avenue, New York, NY 10016

6. Expedited Review. In accordance with FIFRA Section 3(c)(3)(b)(i), my product is similar or identical in composition and labelingto.

EPA R a N

1 _ ICheck if this is a new address Product Name

Section - II

| | Amendment - Explain below.

| | Resubmission in response to Agency letter dated.

I X I Notification - Explain below.

Dnn

Final printed labels in response toAgency letter dated"Me Too* Application.

Other - Explain below.

Explanation: Use additional page(s) if necessary. (For section 1 and Section 11.)

Notification of additional use sites per PR Notice 98-1 0. See attached for additional statement.

Section -1. Material Thw Product Will B« Packaged In:

Child-Resistant Packaging

Yes"

No

» Certification mustbe submitted

Unit Packaging

Yes

No

If "Yes" No. perUnit Packaging wgt. container

Water Soluble Packaging

Yes

No

If "Yes-Package wgt

No. percontainer

2. Type of Container

MetalPlasticGlassPaperOther (Specify)

3. Location of Net Contents Information

[Xj Label I I Container

4. Size(s) Retail Container

n/a no container

6. Manner in Which Label is Affixed to Product

5. Location of Label DirectionsOn LabelOn Labeling accompanying product

LithographPaper gluedStenciled '

x| Other

Section - IV1 . Contact Point (Complete items directly below for identification of individual to be contacted, if necessary, to process this applicrton.1

NameJoseph J. Green

TitleCounsel to CDA

Telephone No. (Include Area Gj

202.342.8849 ° "

Certificationcertify that the statements have made on this form and all attachments thereto are true, accurate and complete.

1 acknowledge that any knowingly false or misleading statement may be punishable by fine or imprisonment orboth unoW applicable law.

2. Signature 1

4. Typed Name

Joseph J. Green

3- Title

Counsel to Copper Development Assoc.

5. Date

August 1,201 4

6. Date ApplicationRecLiiv0c! c

' (Stamped) , i

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EPA Form 8570-1 (Rev. 8-94) Previous editions are obsolete. White-- EPA File Copy (original) Yellow - Applicant Copy

•bill/(Attachment)

This notification is consistent with the provisions of PR Notice 98-10 and EPA regulations at 40C.F.R. 152.46, and no other changes have been made to the labeling or the confidential statementof formula of this product. I understand that it is a violation of 18 U.S.C. Sec. 1001 to willfullymake any false statement to EPA. I further understand that if this notification is not consistentwith the terms of PR Notice 98-10 .and 40 C.F.R. 152.46, this product may be in violation ofFIFRA and I may be subject to enforcement action and penalties under sections 12 and 14 ofFIFRA.

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Antimicrobial Copper Alloys - f'ip IV (EPA Reg. No. 820.12-4)Master Lk.,..i version dated August 1, 2014

ANTIMICROBIAL COPPER ALLOYS - GROUP IVAND ASSOCIATED FABRICATED PRODUCTS

MASTER LABEL

The Master Label consists of the label that will accompany the Antimicrobial Alloys and a labelthat will accompany each product fabricated using a registered alloy from Antimicrobial CopperAlloys - Group IV.

[Alloy Label - Front Panel]

ANTIMICROBIAL COPPER ALLOYS - GROUP IVAND ASSOCIATED FABRICATED PRODUCTS

Active Ingredient:Copper 73.0%Other" " . 27.0%

Total 100%

EPA Registration No: 82012-4 Made in the United States by*******EPA Establishment No. ***** Distributed by*******

Net Weight: XXX Ibs XXX ounces of [brand name]

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Antimicrobial Copper Alloys - <T~ 'ip IV (EPA Reg. No. 82012-4)Master Li, .1 version dated August 1, 2014

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

Antimicrobial Copper Alloys - Group IV

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 Antimicrobial Copper Alloys - Group IV andfabricated products made from Antimicrobial Copper Alloys - Group IV under EPA RegistrationNumber 820 12-4.]

A list of components that may be fabricated out of Antimicrobial Copper Alloys - Group IV isspecified below. Antimicrobial Copper Alloys - Group IV are not approved for direct foodcontact or food packaging uses.

Touch Surface Components

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 plates -o 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 Hydro therapy tanks (whirlpool tanks): shells, covers, headrests, drain fitting:

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

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Antimicrobial Copper Alloys - Q" -ip IV (EPA Reg. No. 82012-4) f/lh 7Master Lu. .t version dated August 1, 2014 v/^ I I/

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 plateso 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 components c

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o Computer keyboards: keys, housings, computer mouse surfaces c^ "c

o Exercise and rehabilitation equipment, handles, bars c c c

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o Physical therapy equipment: physical therapy tables, treatment chairs and portabletaping tables

o Chairs (shower chairs, patient chairs, visitor chairs): rails, backs, legs, seats , c\ t

o Lighting products: X-ray illuminators, operating rooms, patient examination ou crooms, surgical suites, and reading lamps for hospital rooms and assisted livingfacilities etc. Components can include bases, arms, housings, handles, hingbsj)'' <•

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

/" Antimicrobial Copper Alloys - <?""" -ip IV (EPA Reg. No. 82012-4) "11 I 7/V Master L,L i version dated August 1,2014 *

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 curtains >•o 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 covero Braceletso Pens .o Badge clipso Name tagso Patient gown snapso Window sills, pulls and lockso Electrical wallplateso Medical equipment washers: exterior surfaces, housing, handles, pulls

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' tableso Exercise equipment, handles, bars c

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o Ice and water dispensers (outer surfaces without water contact) "c" ̂o Elevator: handrail, control panel, buttons, interior walls, floor tiles, exterior .csfltc

button plateo Paper towel dispensers. Housing itself, (turn) handle, (push) handleo Soap holder r 11,o Soap dispenser (wall mounted): push bar and dispenser itself ° c cu' co Soap dispenser (sitting on counter): dispenser housing itself, push mechanism *•o Toilet paper dispenser (housing) " c < < ' . <o Windows (crank), Locking mechanism, pull handles ' ,. ((o Window treatments (cord pulls), Venetian blinds (wands, cord pulls) t <- '<- <-o Jalousie Windows (crank)o Casement (cranks, levers, hinges)

/" Antimicrobial Copper Alloys - Q" -tp IV (EPA Reg. No. 82012-4) £L I1?V Master ll. , version dated August 1,2014 L / [ l ( /

o Single and double-hung windows (locks and pulls)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 dispenserso Gym/Health Club: locker room seats, bencheso Water fountains: knobs, buttons, handles, drains, push bar, basino Restrooms: toilet flush valves, flush buttons, faucet handles, hand dryer activation

buttons, soap dispenser push bar/button

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 bathtubs c

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o Towel barsc c <

o Showerheads " i c ' c 0

o Countertops and tabletopso Hinges, locks, latches, and trimo Door stops, door pulls, and protector guardso Toilet and urinal hardware, levers, push buttons c c cc 't-o Toilet seat inlay for lifting of seato Light switches, switch plates ! t c < 1>o Thermostat covers, control knobs and wheels "" 1 1 1 1

o Telephone handsets and surfaces (housings), keypad . . . ! < .o Floor tileso Ceiling tiles (non-porous)

/' Antimicrobial Copper Alloys - <7" <ip IV (EPA Reg. No. 82012-4) Ql 1 9^V Master LV ..< version dated August 1,2014 «

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)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 hookso Shower curtain ringso Radiator covero Window sillso 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, seats c c c c

o Window sills, pulls, and handleso Signageo Vending machines (non-food contact only) < '<; ' 'o Elevator buttons <- <-;- <- <•;

Laboratories

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o Incubator interior and outside surfaces, including culture chambers, walls,shelving and support brackets, handles, circulating fan assemblies, pan ' L

o Laboratory surfaces: table tops, counter tops, handles, cabinet doors, cabinethinges, pulls, backsplash, hoods, control knobs

o Laboratory carts, trays, and panso Door handles, knobs, latches and locks

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/" Antimicrobial Copper Alloys-<?' 'ip IV (EPA Reg. No. 82012-4) \\)\\ Master LL_ < version dated August 1, 2014 »

o 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 pewso Eye glass frames and protective eye wearo Penso Combso Ashtrayso Massager, hand-held: handle, buttons, knobso Push/pull deviceo Smartphone and tablet covers and caseso Stylus for touch screenso Personal headphone touch surfaceso Hand-held door opening deviceo Bottle openers

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

Antimicrobial Copper Alloys - Group IV- Fabricated Products

The Antimicrobial Copper Alloys - Group IV fabricated products listed above may be soldand distributed under EPA Registration Number 82012-4. Products fabricated withAntimicrobial Copper Alloys - Group IV must bear the EPA approved fabricated productlabel, below, with one or more of the listed claims.

STORAGE AND DISPOSAL

Dispose of excess by recycling.

WARRANTY STATEMENT

If used as intended, this product is wear-resistant and the durable antibacterial properties willremain effective for as long as the product remains in place and is used as directed.

C Antimicrobial Copper Alloys - C?"~ ip IV (EPA Reg. No. 82012-4)Master lL. .< version dated August 1,2014

ANTIMICROBIAL COPPER ALLOYS - GROUP IVFabricated Product Label

BACKFRONT

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

AntimicrobialCopper Alloys -

Group IVActive Ingredient:

Copper 73.0%Other 27.0%[Total 100.0%]See [Back/Side Panel][lnsert] for Directions forUseNet Weight: XXX Ibs XXX ounces of [brandname] '

ANTIMICROBIAL COPPER ALLOYS - GROUP IVLaboratory 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* action, remaining effective in

killing greater than 99.9% of bacteria* within 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 hours of exposure

between routine cleaning and sanitizing steps.- [This product/component name] is made (out of)(from) a (copper)(touch)

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

- Staphylococcus aureus, Enterobacter aerogenes, Methicillin-ResistantStaphylococcus aureus (MRSA), Escherichia coli O157:H7, Pseudomonasaeruginosa and, Vancomycin - Resistant Enterococcus faecalis (VRE).

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

Proper Care and Use. Clean and sanitize according to standard practice.Healthcare facilities must maintain the product in accordance with infectioncontrol guidelines. The use of this surface is a supplement to and not asubj>titute_for_standard_ infection control practices; users must continue tofollow'all current ihfectioTTco'ntrol 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 performance of this surface. Cleaningagents typically used for traditional hard, non-porous touch surfaces arepermissible. 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 effectiveness. 11 c c

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STORAGE AND DISPOSAL c t ,, <Dispose of by recycling or put in trash. c i ^ L L c '

WARRANTY STATEMENTIf used as intended, this product is wear-resistant and the di.rable[antibacterialproperties will remain effective for as long as the product rernaihs in place andis used as directed. ( .. <..

EPA Reg. No. 82012-4 EPA Est. No. [Product Manufacturer l.u,nV>er] 82012-NY-001Manufactured by: [Product Manufacturer Company Name and Address]Copper Development Association, 260 Madison Ave., NY, NY 10016-240

Antimicrobial Copper Alloys - Group IV (EPA Reg. No. 82012-4)Master Label version dated August 1, 2014

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

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