By Jake Meyer
On October 31 and November 5, 2008, the Environmental Protection Agency (EPA) announced regulatory policies relating to nanotechnology. The EPA defines nanotechnology as involving “research and technology development at the atomic, molecular or macromolecular levels, in the length scale of approximately 1 - 100 nanometer range; the creation and use of structures, devices and systems that have novel properties and functions because of their small size; and the ability to control or manipulate matter on an atomic scale.” Despite the EPA’s recognition of “novel properties and functions” due to the size of nanotechnology, the EPA appears to be regulating nanotechnology as if it were more ordinary than extraordinary. The EPA’s October and November 2008 regulations apply the Toxic Substances and Control Act (TSCA), which is used to regulate chemical substances and mixtures, to nanotechnology.
The TSCA classifies chemical substances as either an “existing” chemical substance or as a “new” chemical substance. A company must file a notice with the EPA 90 days before manufacturing or processing “new” chemical substances. “Existing” chemical substances are also subject to a 90 day notification requirement if an activity is a “significant new use” of the “existing” chemical substances. The notification provides the EPA with an opportunity to evaluate the chemical substance and if necessary, to limit or prohibit use of the chemical substance. If a chemical substance is considered an “existing” chemical substance without a “significant new use,” then there is no notification requirement.
In determining whether a nanomaterial is a “new” chemical substance or an “existing” chemical substance, the EPA does not take into account the chemical substance’s particle size. The EPA will consider a nanomaterial a “new” chemical substance if it is structurally different at the molecular level from an “existing” chemical substance. On October 31st, 2008, the EPA announced that carbon nanotubes are considered “new” chemical substances under the TSCA. The EPA stated that carbon nanotubes are distinct from other forms of carbon.
On November 5th, 2008, the EPA announced that the use of two nanoparticles as an additive was a “significant new use”: siloxane modified silica nanoparticles and siloxane modified alumina nanoparticles. For both particles, the EPA was concerned about inhalation and dermal exposure and stated that use or manufacture without impervious gloves or a respirator “may cause serious health effects.” The EPA recommended that tests be performed for each of the two particles to help characterize the health effects from inhalation.
It is commendable that the EPA is applying regulations to nanomaterials before they are manufactured and available on a commercial basis. Some nanomaterials may have serious health effects, and it is important that companies manufacturing and processing nanomaterials are regulated in order to protect the health and safety of people coming into contact with nanomaterials.
However, the EPA’s approach to regulating nanomaterials may not be comprehensive enough.
Nanomaterials which are not structurally different at the molecular level from an “existing” chemical substance will only be subject to a notification requirement if the EPA determines a use of an individual nanomaterial is a “significant new use.” Although the EPA does not consider size in classifying chemical substance, a nano-sized version of a chemical substance may have greater permeability, greater reactivity, and new properties which could have adverse health effects not realized in larger versions of the chemical substance.
A more appropriate regulatory scheme for the EPA might be to consider all chemical substances with a particle size smaller than 100 nanometers as “new” chemical substances. Companies would then be required to submit a notification for all chemical substances meeting the EPA’s definition of nanotechnology. Such an alternative regulatory scheme would alleviate the need for the EPA to act affirmatively by announcing “significant new uses” for individual nanomaterials.
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