You asked for information on triclosan, including its regulation and associated health issues.

SUMMARY

Best known as the active ingredient in antimicrobial hand soaps, triclosan is also used as an antibacterial agent in toothpaste, deodorants, laundry detergent, facial tissues, and antiseptics for wounds. It is also used as a material preservative to ward off bacteria, fungus, mildew and odors in household items like toys, mattresses, toilet fixtures, clothing, furniture fabric, and paints.

Triclosan is regulated by both the U.S. Food and Drug Administration (FDA) and the Environmental Protection Agency (EPA). Use of triclosan as a pesticide is subject to a “reregistration eligibility decision” process by the EPA.

Concerns have been raised by some researchers and studies about (1) the relative effectiveness of personal hygiene products containing triclosan as compared to washing with plain soap and water, for example; (2) whether antibacterial hygiene and cleaning products are contributing to antimicrobial drug resistent bacteria; and (3) possible toxicological issues, as well as adverse effects on the environment, particularly water bodies and aquatic life.

TRICLOSAN EXPLAINED

Triclosan is a chemical with antibacterial properties that has been used widely in many consumer products for at least the past 20 years. It is an ingredient in many detergents, soaps, skin cleansers, deodorants, lotions, creams, toothpastes, and dishwashing liquids. Triclosan is also used as a material preservative to ward off bacteria, fungus, mildew, and odors in household items like toys, paints, mattresses, clothing, toilet bowls, and furniture fabric.

In terms of chemical structure and properties, triclosan is a white powdered solid with a slight aromatic/phenolic odor. It is a chlorinated aromatic compound, which has functional groups representative of both ethers and phenols. Phenols often show anti-bacterial properties.

Its International Union of Pure and Applied Chemistry (IUPAC) name is 5-Chloro-2-(2,4-dichlorophenoxy)phenol.

REGULATION OF TRICLOSAN

Triclosan is regulated by both the EPA and FDA. Basically, the EPA regulates the pesticide uses of triclosan while the FDA is concerned with its non-pesticide usage.

EPA Regulation

The EPA regulates the antimicrobial uses of triclosan when used as a bacteriostat, fungistat, mildewstat, and deodorizer. EPA-registered products containing triclosan as the active ingredient are formulated as ready-to-use, pelleted/tableted, emulsifiable concentrate, and impregnated materials. It is used in commercial, institutional, and industrial premises and equipment; residential and public access premises; and as a material preservative. Triclosan was first registered by the EPA in 1969; currently there are 20 antimicrobial registrations.

Commercial, institutional and industrial premises and equipment uses include conveyor belts, fire hoses, dye bath vats and ice making equipment. As a material preservative, triclosan is used in many products including adhesives, fabrics, vinyl, plastics (toys, toothbrushes for example), polyethylene, polyurethane, polypropylene, floor wax emulsions, textiles (footwear, clothing), caulking compounds, sealants, rubber, and latex paints.

Residential and public access uses include direct application to HVAC coils (limited to commercial applicators), and use as a materials preservative in toys, paints, mattresses, clothing, brooms, mulch, floors, shower curtains, awnings, tents, toilet bowls, urinals, garbage cans, refuse container liners, insulations, concrete mixtures, grouts, and upholstery fabrics.

FDA

When used in such products as soap, deodorant, toothpaste, laundry detergent, fabric softeners, facial tissues, antiseptics for wound care, and medical devices, and acne medication, triclosan comes under the jurisdiction of the FDA.

EPA “Reregistration Eligibility Decision” ( RED) for Registered Uses of Triclosan

Under section four of the federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), EPA is reevaluating existing pesticides to ensure that they meet current scientific and regulatory standards. Triclosan is subject to the RED. The RED process, according to the EPA,

“involves a thorough review of the scientific database underlying a pesticide's registration. The purpose of the Agency's review is to reassess the potential hazards arising from the currently registered uses of a pesticide, to determine the need for additional data on health and environmental effects, and to determine whether or not the pesticide meets the 'no unreasonable adverse effects, criteria of FIFRA” (EPA “Reregistration Eligibility Decision for Triclosan,” List B, Case No. 2340, September 2008).

EPA released a RED for triclosan in later October, 2008. In general, it concluded that all EPA-registered uses of triclosan are eligible for reregistration, with the exception of the use in paints (registrants have requested voluntary cancellation of this use), provided that the risk mitigation and data requirements outlined in the RED are fully implemented. EPA stated that it was “aware that research is ongoing regarding triclosan and the outcomes of this further research may require the Agency to revisit its regulatory decision in the future” (“Pesticide News Story: EPA Releases Reregistration Eligibility Decision for Triclosan,” EPA Release, November 13, 2008).

The RED assessments and related documents, including a response to comments on the preliminary risk assessment, are available at http://www.regulations.gov in docket number EPA-HQ-OPP-2—7-0513.

HEALTH AND ENVIRONMENTAL CONCERNS

CDC Survey

The Centers for Disease Control and Prevention (CDC) has examined human exposure to environmental chemicals. It reports that people are most likely exposed to triclosan by absorption through the skin or through the lining of the mouth (mucosa). CDC states that “the health effects of triclosan in people are unknown. Few adverse effects are seen in animal studies. More research is needed to determine whether exposure to this chemical, especially at levels found in the U.S. population, actually affects human health” (CDC “National Report on Human Exposure to Environmental Chemicals: Spotlight on Triclosan,' December 2007).

CDC scientists tested the urine of 2,517 people ages six years and older who took part in a nationwide National Health and Nutrition Examination Survey during 2003-2004. They found that (1) triclosan was detected in the urine of nearly 75% of those tested; (2) triclosan levels were greater among people in the highest income bracket than among those in either the middle or lower income brackets; and (3) no differences in triclosan levels were found either by sex or race/ethnicity.

Studies

A 2001 study by Stuart Levy of the Tufts University School of Medicine raised concerns about the escalating introduction of products containing antibacterial agents, such as triclosan, and their possible contribution to antibiotic resistance. He notes that antibacterial products were developed and have been successful in preventing transmission of disease-causing microorganisms among patients, particularly in hospitals. But they are now being added to products used in healthy households, even though added health benefits have not been demonstrated. Levy notes that scientists are concerned that the antibacterial agents will select bacteria resistant to them and cross-resistant to antibiotics (see Stuart B. Levy, “Antibacterial Household Products: Cause for Concern,” Emerging Infectious Diseases, Vol. 7, No. 3 Supplement, June 2001, pp. 512-515).

In 2005, a federal advisory panel to the FDA concluded that mass-marketed antiseptics were no more effective at preventing infections than washing hands with regular soap. A 2007 literature review of 27 studies on antibacterial hand soaps published in Clinical Infectious Diseases concluded that consumer soaps containing triclosan were no more effective than plain soap and water when it came to removing bacteria from the hands or slowing the spread of disease. A lead researcher in this review, Allison Aiello of the University of Michigan School of Public Health, indicated that where triclosan-based hand soaps were shown to have a benefit over plain soap, the concentration of triclosan was between 1 and 2% concentration, significantly higher than the 0.1% to 0.45 % found in most consumer products.

A 2008 study by University of California-Davis researchers calls into question the widespread use of two active ingredients (triclosan and triclocarban) in personal hygiene products, including anti-bacterial bar and liquid soaps. Using human and animal cell lines, they found that triclosan disrupts reproductive hormone activity and interferes with a type of cell signaling that occurs in brain, heart, and other cells. The study was published online in Environmental Health Perspectives, a publication of the National Institute of Environmental Health Sciences (one of the National Institutes of Health (NIH)).

Environmental Concerns

The EPA states that based on available data, triclosan is expected to be immobile in soil and is not expected to evaporate from soil (moist or dry) or water surfaces. In aquatic environments, triclosan is expected to attach to the surface of suspended solids and sediments and may bioaccumulate, potentially causing a concern for aquatic organisms. Based on monitoring data, EPA reports that triclosan was found in about 36 U.S. streams where effluent from activated sludge waste water treatment plants, trickle-down filtration, and sewage overflow appear to contribute to the occurrence of triclosan in open water.

EPA performed a qualitative environmental risk assessment using levels of triclosan found through monitoring data in waterways and toxicity values to develop risk quotients and compare them to levels of concern (LOC) for triclosan. LOCs were not exceeded for fish, but were exceeded for aquatic plants.

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