Qs&As about Triclosan Reregistration Eligibility Decision
On this page:
- What is the Agency announcing?
- What overall conclusion is presented in the RED?
- What data was used to conduct the aggregate risk assessment?
- How did the Agency conduct an ecological assessment?
- What risks of concern were identified in the supporting risk assessments and in what way will the Agency mitigate these risks of concern?
- To what degree will these mitigation measures impact industry?
- Does the use of triclosan cause antibiotic resistance?
- What are the major uses of triclosan?
- When will the Agency be re-evaluating triclosan again?
- Where can I find additional information?
EPA released the Reregistration Eligibility Decision (RED) for triclosan in 2008. Additional illustrative information on triclosan can be found at the website for the Scientific Advisory Panel (SAP) Consultation on Advancing 21st Century Toxicology in Pesticide Risk Assessment, May 24-26, 2011. The EPA is currently reevaluating triclosan in registration review.
EPA has determined that triclosan is eligible for reregistration provided the mitigation measures and associated label changes identified in the RED are implemented and required data are submitted.
The National Health and Nutrition Surveys (NHANES) data were used which are a series of U.S. national surveys of the health and nutrition status of the non-institutionalized civilian population conducted by the Centers for Disease Control and Prevention (CDC). The NHANES data are believed to be a more accurate predictor of aggregate exposure because not only are the data triclosan specific, they are also based on actual consumer use of the various triclosan products as they co-occur in practice.
The Agency used surface water monitoring data to evaluate the ecological risks associated with the antimicrobial uses of triclosan. In addition, the Agency performed consumer environmental modeling for triclosan (DTD and PDM). The results of the modeling indicate that concentrations of triclosan due to EPA-registered uses in surface water do not exceed concentrations of concern for acute risk presumptions for aquatic animals and plants. However, because it is unknown how much triclosan is released from industrial sites (where triclosan is incorporated into plastic and textile items) into the environment, the Agency required registrants to perform effluent discharge monitoring at textile industrial use sites. For plastic use sites, label modifications negated the need for monitoring.
In its risk assessments, the Agency identified risks of concern associated with residential and occupational use when applying paint; occupational use when applying triclosan to paint in a manufacturing setting; and occupational use when applying triclosan during pulp and paper manufacturing. The RED included mitigation measures to address these risks of concern. The paint use (inclusive of stains and coatings) has been voluntarily cancelled by the registrants. For the pulp and paper use, risks were mitigated by requiring the use of a closed delivery system when triclosan is applied in a manufacturing setting.
Based on input from the registrants, most manufacturing facilities already used a closed delivery system when applying triclosan in a pulp and paper manufacturing setting, so the impact should be minimal. The use of triclosan in paint comprised a very small percentage of the triclosan market. Therefore, the cancellation of this use had a very minimal impact on this market as there are numerous other materials preservatives that can be used in paint.
A number of studies have indicated a relationship between triclosan and the development of bacterial resistance but a causal relationship has not yet been established. Additional test data is needed to fully assess the potential for the development of bacterial resistance and to provide information regarding potential risk. The Agency is monitoring the issue of antimicrobial resistance and its links to antibiotic resistance through review of current literature.
Triclosan is primarily used in FDA-regulated applications (soaps, toothpaste, detergents, medical devices, etc.). However, there are several EPA-registered uses of triclosan when used as a material preservative in mattresses, plastics, textiles (footwear and clothing), toys and adhesives. Triclosan also has an HVAC coil application, which is limited to commercial applicators only.
The Agency is aware that research is ongoing regarding triclosan. The outcomes of this further research may require the Agency to revisit this decision in the future. Further, given the rapidly developing scientific database for this chemical, the Agency accelerated the schedule for the registration review process for triclosan by beginning the process in 2013.
For more information on the RED, visit the public docket for triclosan (EPA-HQ-2007-0513) at Regulations.gov.