(Beyond Pesticides, February 24, 2010) 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.
Triclosan, a controversial antibacterial agent found in hundreds of consumer products, from hand sanitizers to toys, is one of 13 chemicals being assessed by FDA for environmental impacts according to their proposed uses. According to FDA regulations, the agency must conduct EAs before chemicals are approved for use in OTC drug products. In this case, triclosan is being considered for use in acne and antiplaque/antigingivitis products. Even though this action is being taken, FDA has never been able to finalize and approve the use of triclosan in any OTC products, despite the proliferation of these products in the consumer marketplace. It appears that EAs for the vast majority of triclosan uses have been completed. Other FDA regulations on triclosan have not been updated since 1994 and much of the data used by the FDA dates back to the late 1970s and early 1980s.
Triclosan is regulated by both the FDA and the Environmental Protection Agency (EPA) however, neither agency has moved to restrict triclosan despite the emerging science that supports the limitation of the chemical’s use. Last month, Beyond Pesticides, Food and Water Watch and over 75 concerned environmental and health groups petitioned EPA to ban triclosan use, citing numerous statutes under which the government must act to stop non-medical uses of triclosan, including laws regulating pesticide registration, use and residues, clean and safe drinking water, and endangered species. Last summer, Beyond Pesticides and others submitted an amended petition to FDA requiring that the agency ban the use of the controversial pesticide triclosan for non-medical applications on the basis that those uses violate the Federal Food, Drug and Cosmetics Act.
Chief among those issues is bacterial resistance to antibiotic medications and bacterial cleansers, a problem for all people, but especially vulnerable populations such as infants and the elderly. Triclosan is also an endocrine disruptor and has been shown to affect male and female reproductive hormones, which could potentially increase risk for breast cancer. Further, the pesticide can also transform to dioxins, thereby exposing consumers to even more dangerous chemicals. A recent study found that triclosan alters thyroid function in male rats. Other studies have found that due to its extensive use in consumer goods, triclosan and its metabolites are present in waterways, fish, human milk. The CDC’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. Due to the fact that many products containing triclosan are washed down the drain, triclosan also shows up in water systems and sewage sludge. Accumulation of the pesticide in waterways and soil has been shown to threaten ecosystems and produce residues in fish and possibly food crops. A U.S Geological Survey (USGS) study found that triclosan is one of the most detected chemicals in U.S. waterways and at some of the highest concentrations. Triclosan has been found to be highly toxic to different types of algae, keystone organisms for complex aquatic ecosystems. A recent EPA survey of sewage sludge found that triclosan and its cousin triclocarban were detected in sewage sludge at the highest concentrations out of 72 tested pharmaceuticals.
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, Rockville, MD 20852.
Comments must be submitted by May 24, 2010.