Copper As An Antimicrobial – EPA Approval (Part 2 of 3)
By Harold Michels, Copper Development Association Senior Vice President of Technology and Technical Services
Harold Michels, PhD, a CDA engineer and senior vice president, conducted research that led to the 2008 EPA registration of 275 copper alloys with public health claims. Here’s his story about how he got there.
People are always interested in the antimicrobial properties of copper when the concept is introduced. I’ve never talked to an infectious disease doctor who doubted what we were saying. They know copper kills organisms. But we needed to have data that was bullet proof.
When I looked at that nurse’s study, I said “I wonder if this is really so and can we repeat it?” We ran the tests in the laboratory setting and indeed it worked against the bacteria, E.coli 0157:H7. Then we tested and found that the copper worked against the hospital infection MRSA, the virulent hospital super bug. I said, “Oh this is really interesting.” However, I didn’t just want to study something. If I can’t use the science, I’m not interested. I wanted to make things happen in the real world. If we could use copper alloys to kill harmful bacteria, it could provide help to fight the bacteria that cause hospital infections.
We began a four-year negotiation with the EPA. During our first meeting, they had a lot of requirements including the development of test protocols. So the next day I hired a regulatory consultant who we use to this day.
Then we went to the EPA Website and found the protocol that was testing sanitizers on a hard, chemically-impervious surface. So I said, “What if we are the surface and we add nothing to it?” We don’t expose the surface to a sanitizing liquid or gas. Can we alter this protocol? And we went back to the regulatory consultant who said that was a good idea. So that was our first test protocol, in 2005.
Then I went to the consultant and said, “Who can run this test?” We found only one lab that routinely conducted these tests and we’ve been working with them ever since. Two more test protocols also were required by the EPA. After we completed all three of the tests, the results were submitted. The EPA then indicated that they wanted to get opinions from the infectious disease community before they proceeded. It was nip and tuck for quite a while. Whenever we had a problem, we figured out how to solve it.
Finally, on Feb. 29, 2008, the EPA registered 275 copper alloys. You can read the CDA Website for more details on what the registration involves. But basically our testing demonstrated effective antibacterial activity against Methicillin-Resistant Staphylococcus aureus, Staphylococcus aureus, Enterobacter aerogenes, Pseudomonas aeruginosa, and E. coli 0157:H7. The registration also allows us to say copper alloy surfaces continuously reduce bacterial contamination, achieving 99.9% reduction within two hours of exposure. However, in order to be effective, the alloy surfaces can’t be coated in any way and must be free of dirt or other matter that can prevent contact with the surface. In addition, the alloy surfaces are a supplement and not a substitute for good hand hygiene and infection control practices.
So now we’re working on clinical trials and getting the word out to infectious disease specialists, hospital administrators, architects, component makers — you name it.
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