Frequent Questions Associated with the RED
Current as of November 17, 2008
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 has released the Reregistration Eligibility Decision (RED) for triclosan.
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 is requiring registrants to perform environmental modeling and surface water 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 includes mitigation measures that will address these risks of concern. The paint use (inclusive of stains and coatings) has been requested to be voluntarily cancelled by the registrants. Once the action to terminate the paint use is completed, any risks associated with triclosan-treated paint will be mitigated. For the pulp and paper use, risks will be 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 triclosan in paint comprises a very small percentage of the triclosan market, therefore the cancellation of this use will also have a very minimal impact on this market as there are numerous other materials preservatives which can be used in paint.
Antimicrobial resistance differs from antibiotic resistance, the latter of which can be a concern in hospital or medical settings. There is currently some research attempting to demonstrate a connection between antimicrobial resistance and antibiotic resistance in regard to triclosan, but the linkage has not been expressly proven. The Agency continues to look into the issue of antimicrobial resistance and its links to antibiotic resistance through review of current literature and membership in the Interagency Task Force on Antimicrobial Resistance. The Task Force has a number of goals stated in the Public Health Action Plan to Combat Antimicrobial Resistance (PDF) (About PDF).
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 triclosan, the Agency intends to accelerate the schedule for the registration review process for this chemical. Currently, the Agency intends to begin that process in 2013, ten years earlier than originally planned, pending receipt and review of new data.