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FDA Acknowledges Adverse Effects of Triclosan, U.S. Rep Urges Ban

(Beyond Pesticides, April 9, 2010) U.S. Representative Edward J. Markey (D-Mass), Chairman of the Energy and Environment Subcommittee of the Energy and Commerce Committee, yesterday called for a ban on many applications of the antimicrobial chemical triclosan —which is found in many consumer soaps and countless other products ranging from toys to lipstick. Rep. Markey called for the ban in conjunction with the release of correspondence from the Food and Drug Administration (FDA) and the Environmental Protection Agency (EPA) that raise serious concerns regarding the use of the chemical triclosan. In response to the FDA and EPA letters, Chairman Markey also announced plans to introduce legislation that will accelerate the evaluation and regulation of substances such as triclosan that may harm the human endocrine system.

“Despite the fact that this chemical is found in everything from soaps to socks, there are many troubling questions about triclosan’s effectiveness and potentially harmful effects, especially for children,” said Chairman Markey. In January 2010, Chairman Markey sent letters of concern regarding triclosan to FDA and to EPA.

In FDA’s response letter to Chairman Markey, the FDA stated that, “existing data raise valid concerns about the [health] effects of repetitive daily human exposure to these antiseptic ingredients.” FDA further stated that it is “not aware of any evidence that antibacterial washes were superior to plain soap and water for reducing transmission of or preventing infection for consumers.” However, FDA has not finalized its rules that govern topical antiseptics including soaps, and has not announced plans to address the use of triclosan in cosmetics or other products.

The EPA response letter noted that a review of the substance under the Endocrine Disruptor Screening Program (EDSP) provided evidence of its endocrine disrupting potential. However, the letter also noted that EPA does not currently plan to reevaluate its regulations surrounding the use of triclosan until 2013. Additionally, EPA acknowledged that it does not currently set drinking water standards for triclosan, and it does not consider antibiotic resistance as a factor when deciding which chemicals to monitor or regulate in drinking water.

“There is clear evidence that many consumer products that contain it are no more effective than those that do not. However, triclosan continues to be used in products that saturate the marketplace. Consumers, especially parents, need to know that many of these products are not only ineffective, they may also be dangerous,” said Chairman Markey.

A factsheet on triclosan prepared by Chairman Markey’s office, highlights some of the major problems with the chemical. For instance, scientific studies have shown that triclosan, which has been detected in drinking water and in 60 percent of U.S. streams, may damage the human endocrine system and can increase antibiotic resistance, which could lead to infections that are not treatable using today’s medications. However, most consumer products containing the chemical are no more effective in protecting against illness than products that do not. Given these findings, the American Medical Association (AMA) Council on Scientific Affairs reported in 2000 that “there is little evidence to support the use of antimicrobials in consumer products such as topical hand lotions and soaps.”

Triclosan is also banned or restricted in several other countries, including the EU, which recently banned triclosan’s use in products that come into contact with food, stating that the chemical’s manufacturer “does not consider the use of the substance in plastics intended to come into contact with food appropriate any more.”

In response to the FDA and EPA letters, Chairman Markey announced that, “I plan to introduce legislation that will mandate that EPA more quickly test and regulate chemicals such as triclosan that have serious health implications, particularly for children.” Chairman Markey also made several recommendations for the immediate ban on some products containing triclosan as well as improvements to the manner in which other similar compounds are regulated:

1. FDA should quickly finalize its regulations in order to ban the use of triclosan in personal care products, particularly soaps and other cleansers, and determine whether any of these should contain any antimicrobial ingredients, which have not been shown to provide benefits over plain soap and water. FDA should also determine whether to regulate the use of triclosan in cosmetics.
2. EPA and FDA should ban the use of triclosan in any products that are intended to come into contact with food.
3. EPA and Consumer Product Satety Commission (CPSC) should ban the use of triclosan in products that are marketed for children aged 12 and under.
4. EPA should act more quickly – well before 2013 – to reevaluate its rules surrounding all uses of triclosan.
5. FDA should re-evaluate its approval of the use of triclosan in Colgate Total toothpaste, since this approval was granted before concerns about triclosan’s endocrine disrupting potential or possible contribution to antibacterial resistance were known.
6. EPA should take steps to evaluate the potential of drinking water contaminant candidates to contribute to antibiotic resistance when considering or taking regulatory actions under the Safe Drinking Water Act.

According to Beyond Pesticides research, triclosan was originally developed as an anti-bacterial agent for hospital settings and is a known endocrine disruptor, is linked to antibiotic resistance, and can affect male and female reproductive hormones, which could potentially increase risk for cancer. Due to its prevalence in so many products, triclosan is now showing up in many things, from human breast milk to earthworms and marine life. The U.S. Centers for Disease Control and Prevention’s Fourth National Report on Human Exposure to Environmental Chemicals reports that triclosan is found in the urine of about 75% of the U.S. population. When exposed to UV light, triclosan has also been shown to convert to dioxin, an environmental pollutant and known carcinogen. Because many products that contain triclosan wash down the drain, it is a common contaminant in rivers, streams and drinking water, and is often present in the sewage sludge used to fertilize food crops.

Beyond Pesticides, in partnership with Food and Water Watch and 78 other groups, submitted petitions to both the FDA and EPA requiring that they all non-medically prescribed triclosan uses on the basis that those uses violate several federal statutes.

“Non-medical uses of triclosan are totally unnecessary,” said Nichelle Harriot, research associate for Beyond Pesticides. “The constant exposure to triclosan becomes a health and environmental hazard, which is why Beyond Pesticides is actively working to get federal action for the removal of triclosan from the market place as well as continuing to work with retailers and manufacturers to remove triclosan from their products and store shelves.”

TAKE ACTION NATIONALLY: On February 22, 2010 the U.S. Food and Drug Administration (FDA) issued a federal notice requesting data and information regarding the potential environmental impact of triclosan’s use in acne and antiplaque/antigingivitis products. The agency, in order to comply with the National Environmental Protection Act (NEPA), must complete environmental assessments (EA) for active ingredients before they are included in the agency’s over-the-counter (OTC) drug regulation system. Tell FDA that triclosan use in acne, antigingivitis/antiplaque and other products poses and unreasonable harm to our environment. Submit electronic comments to the FDA at www.regulation.gov using docket number: FDA-1996-N-0006. Submit written comments to the Division of Dockets Management HFA-305, 5630 Fishers Lane, Rm. 1061, and Rockville, MD 20852. Comments must be submitted by May 24, 2010.

TAKE ACTION LOCALLY: Get your municipality, institution, school or company to adopt the Triclosan Model Resolution to not buy products with triclosan and support broader elimination of non-medically prescribed uses.

For more information on triclosan and its impacts on human and environmental health, visit Beyond Pesticides’ antibacterial program page.

Source: The Washington Post



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