260 Madison Avenue New York, New York 10016-2401
Tel: (212) 251-7212 Fax: (212) 251-7234
Antimicrobial Copper Products
(updated April 2011)
Background on the Registration of Antimicrobial Copper Alloys
In 2004, after preliminary laboratory research demonstrated that copper and certain copper alloys, such as brass and bronze, exhibit inherent antimicrobial properties, the Copper Development Association (“CDA”) initiated a four-year effort to obtain an EPA registration under the Federal Insecticide, Fungicide, and Rodenticide Act (“FIFRA”) for Antimicrobial Copper Alloys. That effort included developing test protocols in cooperation with the U.S. Environmental Protection Agency (“EPA”) to demonstrate and quantify, under Good Laboratory Practice (“GLP”) conditions, the antimicrobial properties of copper and various copper-based alloys. That testing revealed that 275 copper alloys, each of which contains at least approximately 65 percent copper, kill 99.9 percent or more of bacteria within two hours of contact, even after repeated contamination. Based on these test data, on February 29, 2008, five different groups of copper alloys (based on five different ranges of copper content) were registered with EPA (EPA Reg. Nos. 82012-1 through 5). In July 2009, a sixth registration was granted increasing the total number of registered alloys to 282 and lowering the required copper content to 60%. In February 2011, 73 additional copper alloys were added to the registration bringing the current total to 355 as of March 2011.3
Antimicrobial Copper alloys are solid, non-porous, and completely recyclable metals that can be bent, formed, stamped, joined, cut and fastened to create durable products such as I.V. poles, countertops, grab rails, and other touch surface applications. No other solid, touch surface materials have obtained this type of registration to date.
As a condition of registration, CDA agreed with EPA that responsible stewardship of the products was necessary, particularly given the unique antimicrobial characteristics of copper and copper alloys. In particular, it is important for users to understand that the registered copper alloys are a supplement to and not a substitute for standard infection control practices, and that all current infection control practices, including those related to cleaning and disinfection of environmental services, must continue to be followed. Antimicrobial Copper products are intended to provide supplemental antimicrobial action in between routine cleaning of environmental or touch surfaces in healthcare settings, as well as in public buildings, mass transit, and the home. For these reasons, the outreach program was developed to reinforce these messages and to ensure a proper understanding of the potential role Antimicrobial Copper products may play in infection control programs.
CDA member companies fabricate Antimicrobial Copper alloys in various forms (e.g. sheet, tubing, wire, etc.). The bulk Antimicrobial Copper alloy forms are supplied to component manufacturers who manufacture the stock metal into end-use, Antimicrobial Copper products like a door knob or an I.V. pole. This process is analogous to how cloth is cut and sewn (manufactured) into retail articles of clothing. Suppliers of bulk Antimicrobial Copper alloys must register with EPA on the federal and state level, and ensure their manufacturing partners market Antimicrobial Copper products with approved health claims and proper label language.
Following is a summary of the primary aspects of CDA’s outreach effort: (1) the approved claims and registered applications for Antimicrobial Copper products; (2) the Stewardship Website; and (3) the Antimicrobial Copper Working Group. In addition, we provide a brief overview of how Antimicrobial Copper products may be marketed, including labeling requirements and the global branding campaign.
Appropriate Claims and Uses of Antimicrobial Copper Alloys
Antimicrobial Copper alloys have been approved for use in a variety of non-food contact touch surfaces in healthcare facilities, mass transit applications, and public, commercial, and residential buildings. A list of the approved applications in healthcare facilities is attached.
The approved EPA registration allows touch surface products made from registered copper alloys to be marketed with certain antibacterial claims. The basic claim is that laboratory testing has shown that Antimicrobial Copper surfaces kill 99.9% or more of bacteria within two hours of exposure. In making these claims, to be consistent with the EPA-approved label and registration, marketers also must convey that regular cleaning to remove dirt and grime that could prevent contact with the Antimicrobial Copper surface should be conducted to ensure effective performance. Further, the following message must be conveyed:
The use of an Antimicrobial Copper surface is a supplement to and not a substitute for standard infection control practices; users must continue to follow all current infection control practices, including those practices related to cleaning and disinfection of environmental surfaces. The Antimicrobial Copper surface material has been shown to reduce microbial contamination, but it does not necessarily prevent cross contamination.
In addition, in order to be effective, the alloys must not be coated in any way and routine cleaning and sanitization practices must be followed.
Accordingly, Antimicrobial Copper surfaces are NOT designed to replace current cleaning and sanitization procedures. Rather, Antimicrobial Copper surfaces can help reduce levels of bacteria on environmental surfaces in between regular cleaning and sanitization activities. It is imperative that routine cleaning and sanitization procedures continue to be implemented to reduce the potential for infection and to keep the Antimicrobial Copper surface free of dirt and grime that could prevent contact with the surface and inhibit antimicrobial performance.
In summary, the infection control community should keep in mind the following important messages regarding the proper use and care of Antimicrobial Copper surfaces:
- Antimicrobial Copper surfaces are a supplement to and not a substitute for standard infection control practices, and users must continue to follow all current infection control practices, including those practices related to cleaning and disinfection of environmental surfaces.
- Antimicrobial Copper surfaces have been shown to reduce microbial contamination, but not necessarily prevent cross contamination.
- Regular cleaning should be conducted to remove dirt and grime that could prevent contact with the Antimicrobial Copper surface and inhibit antibacterial performance.
- Antimicrobial Copper surfaces must not be coated in any way.
Antimicrobial Copper Cu+ Brand
A new global brand (shown below) was launched in 2010 to unify regional efforts and information:
This brand was developed to increase awareness of the antimicrobial properties of copper alloys and assure the public that products using this brand are made from EPA-registered materials that will perform as advertised. The Antimicrobial Copper Cu+ brand is incorporated throughout the stewardship website: www.AntimicrobialCopper.com and can be seen in advertisements and related marketing collateral.
For Further Information
For further information, please contact:
Harold T. Michels, Ph.D.
Senior Vice President, Technology & Technical Services
Copper Development Association
260 Madison Avenue
New York, New York 10016-2401