Triclosan (2,4,4’ –trichloro-2’-hydroxydiphenyl ether) is an antimicrobial active ingredient incorporated into a variety of products to slow or stop the growth of bacteria, fungi, and mildew.
Triclosan has been used as a pesticide since 1969. Uses of triclosan as a pesticide include:
- commercial, institutional, and industrial premises and equipment;
- residential and public access premises; and
- as a materials preservative.
In commercial, institutional, and industrial premises and equipment, triclosan is incorporated into items such as conveyor belts and ice-making equipment and applied directly to HVAC coils as an antimicrobial pesticide to prevent microbial growth. As a materials preservative in residential and public access premises, triclosan is used in floors, shower curtains, and mattresses. Triclosan is also used as a materials preservative in adhesives, fabrics, textiles (footwear, clothing) and carpeting.
Drug and personal care products containing triclosan are regulated by the Food and Drug Administration (FDA) under the Federal Food, Drug, and Cosmetic Act (FFDCA). The FDA issued a final rule stating that over-the-counter consumer antiseptic wash products (including hand soaps formulated as liquids, foams, and gels; bar soaps; and body washes) containing certain active ingredients (including triclosan) will no longer be permitted to be marketed.
- Read about FDA’s regulation of antibacterial ingredients in consumer products.
- Read the final FDA rule on the safety and effectiveness of antibacterial soaps.
FDA and EPA have been closely collaborating on scientific and regulatory issues related to triclosan. This joint effort will help to ensure government-wide consistency in the regulation of this chemical. By sharing information, the two agencies will be better able to measure the exposure and effects of triclosan and how differing uses of triclosan may affect human health. Although the uses FDA regulates are not covered under FIFRA, EPA considers these exposures in its aggregate risk assessment.
In 2008, EPA conducted a human health risk assessment for triclosan leading up to its reregistration eligibility decision (RED). This assessment was inclusive of all triclosan-related exposures whether uses were regulated by EPA or FDA. No dietary risks of concern were identified. Triclosan data from the National Health and Nutrition Examination Survey (NHANES) showed the aggregate (dietary + residential exposure) risks did not result in unreasonable adverse effects.
EPA performed a screening-level assessment in 2007 for pesticidal uses of triclosan to determine the risks to aquatic organisms from triclosan potentially released from wastewater treatment plants. The assessment showed no significant acute and chronic risks to aquatic organisms downstream of municipal waste water treatment plants.
Triclosan is currently undergoing registration review, a program that re-evaluates all pesticides on a 15-year cycle. During registration review, EPA will:
- Conduct an updated human health risk assessment and consider all available data on triclosan, including data on endocrine effects, developmental and reproductive toxicity, chronic toxicity, and carcinogenicity.
- Conduct an aggregate assessment to account for exposure to triclosan from dietary and residential exposures.
- The use of pesticide products containing triclosan may result in indirect dietary exposure, i.e., consuming food with triclosan residue as a result of triclosan in paper, adhesives, countertops, cutting boards, ice making equipment, and conveyor belts.
- The aggregate assessment will estimate risk based on combined triclosan exposures using the most recent biological monitoring data from the NHANES. A separate estimate for children under six years old will be included.
- Assess ecological risks and is requiring data to evaluate the potential direct and indirect effects of triclosan on organisms in the environment. The environmental assessment will consider modeling and monitoring data of releases from pesticidal uses.
Registrants are generating new data in response to the Agency’s data call-in issued in July 2015. EPA will evaluate the data in the risk assessment phase of registration review. View the July 2015 triclosan data call-in.
The Agency plans to complete a Draft Risk Assessment for triclosan in late 2018 and complete a Proposed Decision in 2019. Each of these steps will include a public comment period.
In May 2015, EPA responded to the Citizen Petition for a Ban on Triclosan filed by Food & Water Watch and Beyond Pesticides by granting one request and denying others. The petition requested that EPA take a variety of actions – including canceling registered pesticide products containing triclosan and assessing risks under the Federal Insecticide, Fungicide, and Rodenticide Act; Federal Food, Drug, and Cosmetic Act; Clean Water Act; Safe Drinking Water Act; and Endangered Species Act (ESA).
EPA has determined that the currently available information does not support canceling registered pesticide products containing triclosan. EPA will, however, evaluate and conduct a biological assessment of the potential for effects on listed species under the ESA in the ongoing triclosan registration review, the process to review pesticide registrations to ensure each pesticide continues to satisfy the statutory standard for registration.
The petition, supporting documents, comments, EPA’s decisions with respect to the petition, and response to significant public comments can be found in the docket for this action at www.regulations.gov, Docket ID #EPA-HQ-OPP-2010-0548.
- EPA Registration Review Process
- FDA’s Assessment of Triclosan
- 2011 FIFRA SAP Panel meeting on triclosan
- Triclosan Reregistration Documents
- Triclosan Registration Review Documents
- Triclosan Petition Documents