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EPA Cited for Ineffective Regulation of Antimicrobials

(Beyond Pesticides, January 7, 2011) The Office of the Inspector General (OIG) for the U.S. Environmental Protection Agency (EPA) has released a report criticizing the agency’s lack of regulation concerning antimicrobial products. Citing a number of failures, the report finds that the EPA’s Antimicrobial Testing Program (ATP) has been largely inadequate in testing products to ensure safety and efficacy, and has failed to remove products that did not meet program standards.

This report is especially of concern because some antimicrobials, such as triclosan, are known to cause dangerous public health and environmental hazards. Triclosan is one of the most prevalent antibacterial compounds found in products ranging from soaps and toothpastes to fabrics and toys. Studies have increasingly linked triclosan (and its chemical cousin triclocarban), to a range of adverse health and environmental effects, from skin irritation, allergy susceptibility, bacterial, endocrine disruption and compounded antibiotic resistant, tainted water, and dioxin contamination to destruction of fragile aquatic ecosystems.

Through ATP, antimicrobial products including hospital disinfectants and tuberculocides are meant to be tested to ensure that they meet health standards and that the claims on the product labels are accurate. However, OIG has found that “EPA’s implementation of the ATP has not delivered on its mission.” The report highlights the fact that, since 1991, more than 40% of antimicrobials (or 277 of 656) on the market have yet to be tested. Additionally, beginning in December 2008, the process for testing a product relied on manufacturers voluntarily submitting samples to be tested. This method limits the EPA’s ability to enforce regulations, since it could not ensure the scientific purity and integrity of the samples.

A surprisingly high number of products that were eventually tested by ATP failed to meet EPA standards and were found to require regulatory action. Since 2004, an average of one-third of products tested in a year failed. However, according to the report, “EPA does not have a strategy for informing hospitals and other likely end-users of failed test results or when enforcement actions are taken.” It simply relies on posting a notice to the ATP website. This means that ineffective products that can potentially be of risk to public health often remain in use by hospitals and health professionals.

Owing to these findings, the OIG report states that, “Rather than providing increased assurance that antimicrobial products are efficacious, [this case] raises concerns regarding the integrity of EPA’s product registration process.” The effectiveness of EPA in regulating pesticides has previously been brought into question in cases such as, among others, the recent linkage of the registered pesticide clothianidin to adverse impacts on honeybee health. According to the report, “As currently executed, the ATP does not ensure that hospital disinfectants and tuberculocides in the marketplace meet efficacy standards,” meaning that there is no way for the public to be confident that the products they are using hold up to manufacturer claims.

Antimicrobials are of particular concern due to the potentially dangerous effects they can have on human and environmental health. One of the most serious problems associated with their use is antibacterial resistance. There is substantial evidence that widespread use of antibacterial compounds promote the emergence of bacteria that are resistant to antibiotic medications and antibacterial cleansers. This makes antibacterial resistance a national health concern, due to the fact that it can make infections difficult or impossible to treat. In addition to bacterial resistance, another common concern stems from the potential of antimicrobials such as triclosan to lead to the formation of dioxin, either when they are synthesized or when they are incinerated. Dioxin is a highly toxic chemical which has been linked to cancer, weakened immune systems and reproductive problems.

While the OIG has concluded that the efficacy of many antimicrobials under the purview of ATP cannot be assured, there is, fortunately, one treatment proven to be effective at preventing household illness and infection that can be found in virtually every home and workplace across the country: soap and water. This simple treatment renders dangerous chemicals such as triclosan completely unnecessary. An article in the journal Clinical Infectious Diseases, entitled “Consumer Antibacterial Soaps: Effective or Just Risky?” (2007), concludes that antibacterial soaps show no health benefits over plain soaps. This follows a recommendation by the FDA Nonprescription Drugs Advisory Committee on October 20, 2005 in a statement that antibacterial soaps and washes are no more effective than regular soap and water in fighting infections.

We need your help before February 7, 2011! Your voice is critical in generating public comments on a petition, published in the Federal Register, calling on the EPA to remove triclosan from the market. We only have four more weeks to let EPA know that triclosan must be banned to protect the public, workers and the environment.

Submit electronic comments to the EPA at www.regulations.gov using docket number: EPA-HQ-OPP-2010-0548. Or you can go submit comments directly here. Please note that the Regulations.gov site is currently experiencing problems with the Google Chrome and Safari browsers, so if possible please use Internet Explorer or Mozilla Firefox to submit comments. If you are having any additional troubles submitting comments online, please contact the Regulations.gov Help Desk at 1-877-378-5457. Comments must be submitted by February 7, 2010.

For more information, including suggested sample comments see our Daily News story from January 4, 2011. Please send your own comments and notify your networks, listserves, faith organizations, etc. and post on your website, urging other people/organizations to comment. Click here for the document you can use to publicize the public comment period on the Ban Triclosan petition.

Additionally, you can join the ban triclosan campaign and sign the pledge to stop using triclosan today. Avoid products containing triclosan, and encourage your local schools, government agencies, and local businesses to use their buying power to go triclosan-free. Urge your municipality, institution or company to adopt the model resolution which commits to not procuring or using products containing triclosan.


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