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EPA Study Gaps Leave Children at Risk

Pesticide in Soap, Toothpaste and Breast Milk - Is It Kid-Safe?: EPA Study Gaps Leave Children at Risk

July 17, 2008

EPA recently published a new, draft risk assessment for the antibacterial pesticide triclosan, as required by the pesticide re-registration provisions in federal law (EPA 2008a). In this draft assessment, EPA notes dozens of data gaps and uncertainties in triclosan exposure and safety studies, yet deems the available data "adequate for regulatory purposes," and bases all assessments of health and environmental risks on this deficient collection of studies. They've concluded that triclosan is safe for all consumer product uses. We question the validity of this conclusion.

Triclosan was long thought to pose little risk to people, since it works by suppressing production of a bacterial growth enzyme that humans don't have. But studies conducted over the past decade cast substantial doubt on that assumption. Widespread use of triclosan in over 140 everyday products, as well as detection of triclosan in the bodies of 75% of Americans (Calafat 2008), and in 58% of American streams and rivers (Kolpin 2002), makes a robust risk assessment of this pesticide essential to protecting human health and the environment.

EPA's cursory evaluation of exposures and health concerns associated with this antimicrobial agent could leave the public at risk. EWG has identified major gaps throughout the draft documents published in May (EPA 2008a), as detailed in a letter delivered to EPA on July 7, 2008. Specifically, EPA’s risk assessment:

  • Lacks full assessment of risk for young children, despite the unique exposures that infants and young children receive through contaminated breast milk, house dust, contaminated food, toys, bibs and children's clothing, and children's body care products and toothpaste. Triclosan poses particular risks to infants and young children, as a laboratory study of developmental toxicity linked in utero exposures to the chemical to reduced fetal weight and irregular skull formation (MRID 43817501: citation missing from EPA's Preliminary Risk Assessment for Pesticide Uses of Triclosan (EPA 2008b)). Other studies link the pesticide to disruption of both the thyroid system and levels of calcium ion in the body (Veldhoen 2006; Ahn 2008), which could impact growth and development especially with respect to the brain and nervous system.
    The two most glaring data gaps in EPA's evaluation of children's exposures to triclosan: use of an exposure dataset that does not include any information for Americans under 6 years of age (Calafat 2008), and complete disregard of the exposures infants receive through breast milk. A recent study indicates 97% of breast milk samples collected in the U.S. were contaminated with triclosan (Dayan 2007). Basic intake estimates for breastfed infants indicate that daily intake would be several times greater than exposures for older children (see EWG letter to EPA).

  • Does not provide an adequate margin of safety for children. The Agency's failure to provide an additional safety margin of 10 to account for potential neurodevelopmental effects and other impacts to which children may be especially vulnerable violates the intent of the nation’s pesticide law and leaves children at potential risk.
    Clearly missing from EPA's inadequate triclosan health and safety data is a study on the developmental neurotoxicity of triclosan. With no research probing this important potential health concern, and with evidence from other studies indicating triclosan could impact functions essential to brain and nervous system development, EPA's supposition that children do not require extra protections is entirely unwarranted.

  • Neglects full assessment of inhalation risks and other cumulative exposures to triclosan. EPA must assess risk from the full range of Americans' inhalation exposures, both residential and occupational, since studies show that triclosan is most toxic when it is inhaled, with harmful effects at every dose tested.
    Notably, EPA admits that inhalation studies have failed to find a safe dose; they show harmful effects from triclosan at all levels examined. Yet instead of requiring triclosan manufacturers to provide the studies needed to determine the safe dose, as EPA is empowered to do under pesticide law, the Agency has chosen to assess health risks using the flawed data, justifying their finding of safety by incorporating an additional fudge factor in their calculations to account for the data gap.
    In the home, average Americans can inhale triclosan when they sleep on a triclosan-infused pillowcase, pillow or mattress; when they breathe in contaminated house dust; when they spray triclosan-treated paint; or when they use spray and powdered personal care products. We identified 114 triclosan-containing, inhalable products like spray deodorants and body powders in EWG's Skin Deep cosmetics safety database (EWG 2008).

  • Ignores numerous triclosan risks to human health. The Agency based its health risk calculations on an animal study showing no adverse health effects at a level that is 4.6 times higher than that reported for a study documenting triclosan's ability to cause liver toxicity in mice (Trutter 1993; EPA 2008a). The Agency's cancer risk assessment relied on second-hand information rather than actual study data (See 1996), and involves a controversial assumption that some laboratory animal cancers are not relevant to human health (EPA 2008c). EPA further neglected any assessment of triclosan's potential to disrupt the endocrine system, despite a growing body of research indicating that the pesticide may affect thyroid and reproductive hormone systems (Foran 2000; Ishibashi 2004; Matsumura 2005; Veldhoen 2006; Ahn 2008; Gee 2008).
    Undoubtedly the most egregious data gap in EPA's assessment of human health data is its lack of access to critical cancer data. Liver adenomas and carcinomas were reported in a Colgate study of triclosan's effects on mice (See 1996), which the company refused to release to EPA. Lacking legal authority to demand the results, EPA was limited to reviewing a simple summary of information provided by FDA. As EPA conducted their new risk assessment, in the absence of Colgate’s cancer study data, the Agency chose to assume that the liver tumors observed were caused by a mechanism that doesn’t apply to humans, though there is no scientific consensus on this subject (Klaunig 2003; Peters 2005; Keshava 2006; NAS 2008). Rather than acknowledging the limitations of the health and safety information at its disposal, EPA repeatedly chose to make assumptions that minimize risks in its draft assessment of triclosan.

  • Lacks full assessment of risks to the environment. Triclosan is known to have significant acute effects on algae and other aquatic organisms at low levels, and is widely detected in streams across the U.S. In fact, triclosan is so toxic to aquatic life that EPA requires all triclosan raw materials to be labeled with this warning: "This pesticide is toxic to fish. Do not discharge effluent containing this product into lakes, streams, ponds, estuaries, oceans... Do not discharge effluent containing this product into sewer systems without previously notifying the local sewage treatment plant authority." Despite these facts, EPA's environmental risk assessment relies on a sparse group of ecotoxicological studies, and concludes that current uses pose no threat to the environment.
    EPA's collection of environmental data on triclosan is riddled with holes (EPA 2008a). First, EPA could find no studies that assessed chronic ecotoxicological effects of the pesticide. Further, EPA's evaluation identifies data gaps including the lack of acceptable studies of triclosan's acute effects on freshwater invertebrates, marine organisms, and selected plants. The Agency finds the potential for triclosan use to overlap with endangered species habitat, noting that a more refined analysis is needed, but not included, in its draft assessment.
    Triclosan persists in the environment for decades; a recent investigation revealed the presence of triclosan initially discharged 40 years ago in estuarine sediment in Chesapeake Bay (Miller 2008). Yet EPA disregards the effects of build-up of this pesticide in soils and sediments across the country. The Agency also ignores the risks posed by triclosan that contaminates biosolids applied to agricultural lands. EPA further neglects to assess the impact of exposure of low levels of antimicrobial agents like triclosan on the biological wastewater treatment systems essential to preserving the water quality of rivers and lakes throughout the country, as well as clean water supplies for downstream communities. Wastewater treatment plant operators fear that triclosan and other common antimicrobials in wastewater will begin to kill off the bacteria that break down human waste at the plant and are essential to cleaning it so that it can be discharged back to the environment (Tri-TAC 2008).

  • Ignores risks associated with toxic transformation products of triclosan. Triclosan breaks down or is transformed into very toxic chemicals, including a form of dioxin when sunlight hits it (Lores 2005); a chemical called methyl triclosan that is acutely toxic to aquatic life and is now found in rivers and streams the world over (Adolfsson-Erici 2002; Lindstrom 2002; Balmer 2004; Farré 2008); and the cancer-causing chemical chloroform when triclosan mixes with tap water that has been disinfected with chlorine (Fiss 2007).
    While EPA mentions methyl triclosan in its risk assessment, it makes no attempt to evaluate exposure or risk associated with this chemical (EPA 2008a). Other transformation products are entirely neglected. This appalling lack of attention to commonly observed toxic by-products of triclosan violates U.S. pesticide law.

  • Neglects risks relating to antimicrobial resistance. In the draft assessment, EPA has not assessed potential health risks that could result through development of antimicrobial resistance to triclosan. Laboratory evidence and common sense indicate that microbes can develop resistance to the antibiotic effects of triclosan, rendering the pesticide ineffective.
    EWG scientists assessed the growing body of evidence that indicates household use of triclosan could lead to the development of "super germs" and found clear cause for concern. Yet EPA made no attempt to evaluate this critical risk linked to unnecessary use of a pesticide that government agencies and leading scientists find does not provide the germ-fighting benefits that manufacturers of consumer and personal care products claim.

A risk assessment plagued by so many egregious flaws cannot be used as a basis for sound health protections. It is critical that EPA amend its assessment to fully evaluate a pesticide found in the bodies of three-quarters of Americans (Calafat 2008).

EPA's risk assessment of triclosan, necessary to reapprove its use as a pesticide, was limited to products under their jurisdiction. As such it does not address the safety of numerous FDA-approved body care products, including liquid hand soap, toothpaste and hand sanitizers. Though an advisory committee to FDA has found household use of "antibacterial" hand soap provides no health benefits over soap and water (FDA 2005), FDA continues to allow extensive application of the ingredient in a wide range of products. FDA is not obligated to consider the findings of EPA's investigation in any way, a failing plainly linked to fragmentation within the outdated system of chemical health protections in the U.S. Triclosan provides a clear case study supporting the need for reform of federal laws on toxic chemicals.

To take action now, EWG advises concerned consumers to avoid using "antibacterial" products. Soap and water provide the safest defense against germs in everyday life. Learn more from our Guide to Triclosan. You can check Skin Deep, EWG's cosmetics safety database, for body care products free of triclosan. Also avoid triclosan's chemical cousin, triclocarban. Other types of consumer products do not usually have ingredient lists – in this case, it's safest to avoid any product that makes "antibacterial" marketing claims.