In 2008, the US EPA created the Nanoscale Materials Stewardship Program (NMSP) to collect information about the EHS risks of nanomaterials on a voluntary basis from participating manufacturers. Although the NMSP provided US EPA with useful information regarding a limited number of nanoscale materials in commerce, a significant number of the environmental health and safety data gaps remain. To address these gaps and prevent potential risks that may be posed by nanoscale materials, EPA is taking a number of regulatory actions under the Toxic Substances Control Act (TSCA).
In June 2016, President Obama signed the Frank R. Lautenberg Chemical Safety for the 21st Century Act, which updates the Toxic Substances Control Act. Further information about the new law, including summary information and frequently asked questions, is available on the EPA website.
Many nanoscale materials are regarded as "chemical substances" under TSCA. In order to ensure that nanoscale materials are manufactured and used in a manner that protects against unreasonable risks to human health and the environment, the US EPA is pursuing implementation of a comprehensive regulatory approach under TSCA, most notably:
TSCA requires manufacturers of new chemical substances to provide specific information to the EPA for review prior to manufacturing chemicals or introducing them into commerce. Through this, EPA may take action to ensure that those chemicals that pose an unreasonable risk to human health or the environment are effectively controlled. Manufacturers are encouraged to contact EPA if they need assistance determining whether their nanoscale materials are subject to new chemical notification requirements.
The EPA states that since 2005, it has received and reviewed over 160 new chemical notices under TSCA for nanoscale materials, including carbon nanotubes (EPA, 2011). The Agency has taken a number of actions to control and limit exposures to these chemicals, including:
In addition, EPA has permitted limited manufacture of new chemical nanoscale materials through the use of consent orders or Significant New Use Rules (SNUR) under TSCA. The Agency has also allowed the manufacture of new chemical nanoscale materials under the terms of certain regulatory exemptions, but only in circumstances where exposures were tightly controlled to protect against unreasonable risks (using, for example, the exposure and environmental release limitations as outlined above).
As part of continued efforts to ensure a more comprehensive understanding of nanoscale materials in commerce, on the 11th January 2017 the US EPA issued a final regulation requiring one-time reporting and recordkeeping of existing exposure and health and safety information on nanoscale chemical substances in commerce pursuant to its authority under Section 8(a) of the Toxic Substances Control Act (TSCA).
This rule requires companies that manufacture (including import) or process certain chemical substances already in commerce as nanoscale materials notify EPA of certain information, including:
EPA seeks to facilitate innovation while ensuring safety of the substances. The information collection is not intended to conclude that nanoscale materials will to cause harm to human health or the environment. Rather, EPA will use the information gathered to determine if any further action under TSCA, including additional information collection, is needed.
EPA proposed and took comment on this rule. Persons who manufacture or process a reportable chemical substance during the three years prior to the final effective date of this rule must report to EPA within a year of the rule's publication.
Further information on the EPA's nanotechnology activities in general can be found on the EPA website.