c\ UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

a WASHINGTON, D.C. 20460

P OFFICE OF CHEMICAL SAFETYI 3 luH ' AND POLLUTION PREVENTION

Micah T. Reynolds &•».,.„ ...,.;,;,_ „; .Senior Regulatory ConsultantTechnology Sciences Group, Inc.Agent for Libertas Copper, LLC dba Hussey Copper1150 18th Street, Suite 1000Washington, D. C., 2003 6

-Subject: MD-CU29 4EPA Registration No.: 89187-4Application Date: April 11, 2014Receipt Date: April, 15, 2014

Dear Mr. Reynolds:

The notification referred to above, submitted in connection with the Federal Insecticide,Fungicide, and Rodenticide Act, FIFRA, as amended, to update the product labeling by addingoptional statements and installation instructions, is acceptable.

This notification has been made a permanent part of this file.

If you have any questions concerning this letter, please contact Jose Gayoso at (703) 347-8652.

Sincerely,

Marshall SwindellProduct Manager 33Regulatory Management Branch 1Antimicrobials Division (751 OP)

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

£EPA. United States

Environmental Protection AgencyWashington, DC 20460

D RegistrationH] AmendmentKl Other

OPP Identifier Number

Application for Pesticide - Section I1. Company/Product Number

89187-44. Company/Product (Name)

MD-CU29 4

2. EPA Product Manager

Marshall SwindellPM#

33

3. Proposed Classification

^ None I I Restricted

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

Libertas Copper LLC dba Hussey Copper100 Washington StreetLeetsdale, Pennsylvania 15056

| | Check if this is a new address

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.

Product Name

Section II

I I Amendment - Explain below.

I | Resubmission in response to Agency letter dated .

EXI Notification - Explain below.

I I Final Printed labels in response toAgency letter dated

| | "Me Too" Application.

I I Other - Explain Below.

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

Submission of Label Notification to add optional statements/installation instructions to fabricated product label.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 may be 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: mrevnolds@tsqusa.com. phone (202) 828-8967, or fax (202) 872-0745.

Section1. Material This Product Will Be Packaged In:

Child Resistant Packaging

. D Yes*

D No

* Certification mustbe submitted

Unit Packaging

D Yes

n NOIf "Yes"Unit Packaging wgt.

No. perContainer

Water Soluble Packaging

HH Yes

D No

If "Yes"Unit Packaging wgt.

No. perContainer

2. Type of Container

Metal

Plastic

GlassPaper

Other (Specify).

3. Location of Net Contents Information

I I Label I I Container

4. Size(S) Retail Container 5. Lpcation 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.) t t [•,

NameMicah T. Reynolds, Technology Sciences Group, Inc.

TitleSenior Regulatory Consultant

Telep^hon^Np. (Include Area Code)(202)828-8967 e .:

CertificationI 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 or" '• ;•'both under applicable law.

2. Signature

4. Typed NameMicah T. Reynolds

3. TitleRegulatory Consultant to Hussey CopperLtd.

5. Date

April 11, 2014

S; Date Application• Received L 1

(Stamped)

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

c

Technology Sciences Group Inc.1150 18th Street, Suite 1000

Washington, DC 20036

Direct: (202)828-8967 '

Fax: (202)872-0745E-Mail: MReynolds@TSGUSA.com

Micah T. ReynoldsSenior Regulatory Consultant

April 11, 201 4

Hussey CopperMD-CLU 4. EPA Reg. No. 89187-4Label Notification rllll<

c c c cMr. Marshall Swindell, PM-33Antimicrobials Division (751 OP)Office of Pesticide Programs eU.S~ Environmental Protection Agency • r r e c c eDocument Processing Center (NOTIF) G

Room S-4900, One Potomac Yard cc cct

2777 South Crystal Drive ce cArlington, Virginia 22202 '• c "c

t c c c t c

Dear Mr. Swindell: c c c e c

c

Technology Sciences Group, Inc., on behalf of Libertas Copper, LLC dba Hussey Copper, issubmitting the enclosed label notification that adds minor text to the fabricated product label thataids to call out the option for having a multi-packed product (i.e. multiple switch covers in apack) and provides reference to a method of product installation. No other changes are beingmade at this time. Please find enclosed the following documents supporting this notification:

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

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@tsgusa.com.

Sincerely,

Regulatory Consultant to Hussey CopperEnclosuresCC: C. Acors, J. Linton, J. Chi.(Hussey Copper)

Washington, D.C. California Canada

1150 18'" 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

rMD-CUM 4 (EPA Reg. No. 89187-4)

Master Label version dated April 11, 2014

II

MD-CU29 4ANTIMICROBIAL COPPER ALLOYS

AND ASSOCIATED FABRICATED PRODUCTSMASTER 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 MD-CUig 4.

[Alloy Label - Front Panel]

MD-CU29 4AND ASSOCIATED FABRICATED PRODUCTS

Oatt Reviewed:

Active Ingredient:CopperOther

Total

66.5%33.5%

100%

,

EPA Registration No. 89187-4EPA Establishment No. *****

Net Weight: XXX Ibs XXX ounces of MD-CU29 4

Made in the United States byHussey Copper

100 Washington StreetLeetsdale, Pennsylvania 15056

N A . -MD-CU29 4 (EPA Reg. No. 89187-4)

Master Label version dated April 11, 2014

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

MD-CU™ 4

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 MD-CUag 4 Antimicrobial Copper Alloys andfabricated products made from MD-CU29 4 under EPA Registration Number 89187-4.]

A list of components that may be fabricated out of MD-CU29 4 Antimicrobial Copper Alloys isspecified below. MD-CU29 4 Alloys are not approved for direct food contact or food packaginguses.

Touch Surface Components

Healthcare Facilitiesp 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,q 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, handle c !:o Paper towel holders, facial tissue holders, toilet paper holders c,, ^ < - \ t ' ' ' £o Air hand dryer, controls and push buttons on air hand dryers c !; c

o Hydrotherapy tanks (whirlpool tanks): shells, covers, headrests, dramcfittings; c(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 doorso Towel bars

r.MD-CU29 4 (EPA Reg. No. 89187-4)

Master Label version dated April 11,2014

o 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 tiles ,o 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, bars c c c t c 0 0 c c co Physical therapy equipment: physical therapy tables, treatment chairs aiid portable

taping tables • e ^ - c c c c , , , ; (

o Chairs (shower chairs, patient chairs, visitor chairs): rails, backs, legs, seats *"o Lighting products: X-ray illuminators, operating rooms, patient examination-L c''!:

rooms, surgical suites, and reading lamps for hospital rooms and assisted living c

facilities etc. Components can include bases, arms, housings, handles0, hingec) ,,•o Headwall systems: the unit themselves, outlet covers, knobs and dials, lighting

units (lamp housings and adjustable arms), CRT monitors with rotating knobs arid'levers and adjustments. Baskets, monitor housings, knobs, baskets, tables, I V ' l 'poles

MD-CU29 4 (EPA Reg. No. 89187-4)Master Label version dated April 11, 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 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 covero 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; c

button plate [ <c

o Paper towel dispensers. Housing itself, (turn) handle, (push) handle, co Soap holdero Soap dispenser (wall mounted): push bar and dispenser itself c c c ^ l|o Soap dispenser (sitting on counter): dispenser housing itself, push rhechanismo Toilet paper dispenser (housing) < - ^ c co Windows (crank), Locking mechanism, pull handles •-o 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)

cMD-CU29 4 (EPA Reg. No. 89187-4)

Master Label version dated April 11,2014

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

Residential Buildings (including homes, apartments, apartment buildings and other/residences)

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 Handrails ,o 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 buttons ' 11,; L,, c L , . , ' <o Toilet seat inlay for lifting of seat < c !~ ,o Light switches, switch plates ,o Thermostat covers, control knobs and wheelso Telephone handsets and surfaces (housings), keypad (

o 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)

cMD-CU29 4 (EPA Reg. No. 89187-4)

Master Label version dated April 11, 2014

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, seatso Window sills, pulls, and handleso Signageo Vending machines (non-food contact only)

Laboratories<- C C <-

o Incubator interior and outside surfaces, including culture chambers,; walls,shelving and support brackets, handles, circulating fan assemblies; pah <

o Laboratory surfaces: table tops, counter tops, handles, cabinet doc-rshinges, pulls, backsplash, hoods, control knobs

o Laboratory carts, trays, and panso - Door handles, knobs, latches and lockso Laboratory equipment: safety cabinets, enclosures, vent hoods

O

Other ^o Play area equipment (indoor only): bars, handles, chains, push plates, handrails,'

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

C L (. t

C r '°I'Z.C.MD-CU29 4 (EPA Reg. No. 89187-4)

Master Label version dated April 11, 2014

o Eye glass frames and protective eye wearo Penso Combso Ashtrays

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

MD-CU?g 4 - Fabricated Products

The MD-CU29 4 fabricated products listed above may be sold and distributed under EPARegistration Number 89187-4. Products fabricated with MD-CU29 4 must bear the EPAapproved fabricated product label [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 c c. cC

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rMD-CU29 4 (EPA Reg. No. 89187-4)

Master Label version dated April 11, 2014

life

MD-CU29 4Fabricated Product Label

FRONT BACK

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

MD-CU29 4Active Ingredient:

Copper 66.5%Other 33.5%[Total 100.0%]See [Back/Side Panel][lnsert] for Directions forUseNet Weight: XXX Ibs XXX ounces of MD-CU29

4

[THIS TOUCH SURFACE IS A U.S. EPAREGISTERED ANTIMICROBIAL COPPERBACTERIA* KILLING SOLID METALPRODUCT ((X) PACK) (WITH) (SELF)(ADHESIVE) (SWITCH COVER)]

This product is made of MD-CU29 4 antimicrobial copper.Laboratory testing has shown that when cleaned regularly this surface:- [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.]- [This product/product name] [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 (copperj(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 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 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.

Not approved for direct food contact or food packaging uses.

[Items exposed to outdoor environmental conditions/ero not re^roie.^tative ofindoor laboratory test conditions, and, therefore, m?y iftpart reduce.d efficacy ifnot cleaned when visibly soiled.] L '••

STORAGE AND DISPOSAL i ^ ' ' ' c

Dispose of by recycling or put in trash. ' L , '" c , , ,C t I

WARRANTY STATElfolirit« l ' L

[If used as intended, this product is wear-resistant and fce durableantibacterial properties will remain effective for as long as theLr>roduot remainsin place and is used as directed.] [If product is defective,cc'o(itactHusseyCopper at the address below for return authorization guidelines.]

[For more available products and to learn more about MD-Cu-ig $.i*\n the codewith your smart phone] [www.md-cu29.com] [Patent Pending]

EPA Reg. No. 89187-4 EPA Est. No. [Product Manufacturer Number) 89187-XX-XXXManufactured by: [Product Manufacturer Company Name and Address]Hussey Copper, 100 Washington Street, Leetsdale. Pennsylvania 15056

f r \lMD-CU29 4 (EPA Reg. No. 89187-4)

Master Label version dated April 11,2014

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

Copper

TM

Made In [the] U.S.A[American Flag image][QRcode][Images of product placement and/or installation/instructions]

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