EPA to Publish Chemical Guidance on Nanoengineered Material

An official with the U.S. Environmental Protection Agency (EPA) has announced that the agency will be publishing guidelines later this summer to assist manufacturers in determining whether a nanoengineered material they are developing is a new or existing chemical. These guidelines are intended to help manufacturers better understand their regulatory obligations regarding the materials they are producing.

EPA has taken the lead in the U.S. regulation of nanotechnology, primarily under the authority of the Toxic Substances Control Act (TSCA). Under its TSCA authority, EPA could propose a rule to require testing not only of potential environmental impacts of nanomaterials, but of potential human health impacts, as well. If testing identifies potential risks, EPA could impose conditions on the manufacture and use of nanoscale materials and products containing those materials.

Amy Farrell, EPA’s deputy assistant administrator for prevention, pesticides, and toxic substances, explained that the new guidance will help chemical manufacturers determine whether a nanomaterial is a “new” chemical, for which TSCA requires pre-manufacture notification to the EPA, or an “existing” chemical.

EPA is strongly encouraging early consultations between chemical manufacturers and the EPA under the TSCA New Chemicals Program. A chemical manufacturer can submit to EPA a bona fide notice of its intent to manufacture or import a chemical that it believes already exists and does not need EPA review. EPA would then reply with a letter stating whether the agency believes the substance to be new or existing. In order to help expedite this voluntary review process, chemical manufacturers are encouraged to meet with agency staff about new chemicals long before the chemicals are submitted for EPA review.

Arent Fox is monitoring regulatory developments relating to nanotechnology for our clients and friends involved in this technology. Please do not hesitate to contact Rachel Lattimore at 202.857.8958 if you have any questions regarding this e-mail or regarding nanotechnology regulatory compliance generally

Rachel G. Lattimore