Reviewing New Chemicals under the Toxic Substances Control Act (TSCA)

Control of Nanoscale Materials under the Toxic Substances Control Act

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Nanoscale Materials

Many nanoscale materials are regarded as "chemical substances" under the Toxic Substances Control Act (TSCA). Specifically, chemical substances that have structures with dimensions at the nanoscale -- approximately 1-100 nanometers (nm) -- are commonly referred to as nanoscale materials or nanoscale substances. A human hair is approximately 80,000-100,000 nanometers wide.

These chemical substances may have properties different than the same chemical substances with structures at a larger scale, such as greater strength, lighter weight, and greater chemical reactivity. These enhanced or different properties give nanoscale materials a range of potentially beneficial public and commercial applications; however, the same special properties may cause some of these chemical substances to behave differently than conventional chemicals under specific conditions.

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Regulatory Approach

To ensure that nanoscale materials are manufactured and used in a manner that protects against unreasonable risks to human health and the environment, EPA is pursuing a comprehensive regulatory approach under TSCA including:

  • Premanufacture notifications for new nanomaterials
  • An information gathering rule on new and existing nanomaterials

Premanufacture Notifications

TSCA requires manufacturers of new chemical substances to provide specific information to the Agency for review prior to manufacturing chemicals or introducing them into commerce. EPA can take action to ensure that chemicals that may or will 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. 

Read about EPA's regulation of new chemical substances.

Since 2005, EPA has received and reviewed over 160 new chemical notices under TSCA for nanoscale materials, including carbon nanotubes, and that number will increase over time. The Agency has taken a number of actions to control and limit exposures to these chemicals, including:

  • Limiting the uses of the nanoscale materials,
  • Requiring the use of personal protective equipment and engineering controls,
  • Limiting environmental releases, and
  • Requiring testing to generate health and environmental effects data.

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 discussed above).

Information Gathering Rule

As part of the Agency's effort to ensure a more comprehensive understanding of nanoscale materials in commerce, 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 TSCA section 8(a). 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

  • specific chemical identity;
  • production volume;
  • methods of manufacture;
  • processing, use, exposure and release information; and
  • available health and safety data.

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 effective date. On May 12, 2017, EPA extended the effective date of the rule to August 14, 2017.

EPA is also asking the public for input on its draft guidance document for the rule. This guidance provides answers to questions the Agency has received from manufacturers (includes importers) and processors of certain chemical substances when they are manufactured or processed at the nanoscale as described in the final rule.

Read and comment on the draft guidance for the rule.

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International Cooperation

Fully understanding the environmental applications and implications of nanotechnology requires the concerted efforts of scientists and policy makers across the globe. EPA is working collaboratively with stakeholders both domestically and internationally to address nanoscale materials and their research needs, and to develop international standards for nanotechnology.

International organizations such as the International Organization for Standardization (ISO) and the Organization for Economic Cooperation and Development (OECD), are engaged in nanotechnology issues.

Canada-U.S. Regulatory Cooperation Council (RCC) Nanotechnology Initiative

On February 4, 2011, Prime Minister Stephen Harper and U.S. President Barack Obama announced the creation of the Canada-U.S. Regulatory Cooperation Council to better align the two countries' regulatory approaches in various areas, including nanotechnology. As part of this initiative, a Nanotechnology Work Plan was developed to increase regulatory transparency and coordination between both countries with respect to nanomaterials.

An important outcome of the initiative was the development of consistent policy principles on the regulatory oversight of nanomaterials, which have now been endorsed by Canada.

The initiative recommended ways Canada and the United States can align their work on nanomaterials that are classified as new substances, regulated in Canada and the United States under the Canadian Environmental Protection Act, 1999 (CEPA, 1999) and TSCA, respectively.

Learn more about the Canada-U.S. Regulatory Cooperation Council Nanotechnology Initiative.

Organisation for Economic Cooperation and Development (OECD)

OECD has established a Working Party on Manufactured Nanomaterials (WPMN);that is engaged in a variety of projects to further understanding of the properties and potential risks of nanomaterials:

  • Testing and assessment
  • Risk assessment and regulatory programmes
  • Exposure assessment and mitigation
  • Cooperation on the environmentally sustainable use of nanotechnology

Learn more about OECD's Working Party on Manufactured Nanomaterials.Exit

EPA is actively participating in the Working Party and contributes to all of the projects which help leverage international expertise and resources. EPA hosted the OECD Expert Meeting on Categorization of Manufactured Nanomaterials on September 17-19, 2014, in Washington, DC. The outcome of the workshop and these OECD projects will contribute to EPA's efforts to evaluate the potential impacts of nanoscale materials on human health and the environment.

Read the materials from the OECD Expert Meeting on Categorization of Manufactured Nanomaterials.

International Organization for Standardization (ISO)

The ISO has established a technical committee to develop international standards for nanotechnology. This technical committee, ISO/TC 229, is working to develop standards for terminology and nomenclature, metrology and instrumentation, including:

  • Specifications for reference materials,
  • Test methodologies,
  • Modeling and simulation, and
  • Science-based health, safety and environmental practices.

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Other Resources and Related Links

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