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EPA lacks authority to regulate nanomaterials, states EPA IG, even if regulations are soon issued under FIFRA and TSCA

Prior posts have noted the wide use of nanomaterials in consumer goods, and the threat to human health that particles of such size may pose.

An example of the risk posed by nanomaterials is sunscreen. Dermal penetration of some nanomaterials into the skin can potentially pose a hazard to human health. [Prior posts have noted that particles in this size range can breach the blood-brain "barrier."] Also, by washing sunscreen off by showering, users of materials containing nanomaterials may be unknowingly releasing nanomaterials into the water supply. Furthermore, because of titanium dioxide contaminants within the product, improper disposal of sunscreen presents a risk of harm greater than previously hypothecated. The titanium dioxide in an "empty" sunscreen bottle that is disposed in a landfill may eventually end up leaching into waterways and being ingested by humans.

Unfortunately, a report from the EPA Office of Inspector General (EPA IG) has concluded that the EPA lacks the data or ability to manage the challenges associated with nanomaterials. According to the report, the problem begins with the lack of data from manufacturers of nanomaterials and continues with EPA's lack of formal processes to handle information and lack of communication strategy to manage all nano-related data. The result of these organizational deficiencies, the report says, is that the agency "will not be able to assure that it is effectively managing nanomaterial risks" until these internal processes are improved.

Regarding the lack of data, most companies are unwilling to voluntarily provide information. As much as 90% of industry data is labeled as confidential and therefore was not accessible to EPA. According to the EPA IG's report, only 29 companies disclosed data about their use of 123 different nanomaterials. EPA also set up a program that encouraged companies to further provide information about research, development, and use of nanomaterials. However, only four companies participated.

In prior reports the EPA IG has noted that EPA has an action plan that is moving forward. The major question, of course, is will it be effective.

The EPA IG report can be found at

One component of the EPA action plan that is moving forward involves proposed mandatory reporting rules for nanomaterials under the FIFRA. Additionally, EPA is developing regulations under TSCA. The TSCA regulations would include four areas: premanufacture notification, a significant new use rule, an information gathering rule, and a test rule. However, as noted above, the EPA IG has questioned if EPA has sufficient information or processes to effectively manage the human health and environmental risks of nanomaterials. A primary shortcoming is the lack of environmental and human health exposure and toxicological data. The four main problems are the lack of a formal process for coordinating and disseminating mandated information; the lack of an overall message to external stakeholders about policy changes and risks; regulating nanomaterials as chemicals will be limited by the limitations of existing statutes; and, a lack of information about risks and a reliance on industry-submitted data.

The TSCA regulatory program for nanomaterials can be found at

Information on the over 1,000+ manufacturer identified products using nanomaterials can be found at Emerging Nanotechnologies: Consumer Products.

 Mother and Daughter Using Sunscreen at Beach

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