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

Fact Sheet: Nanoscale Materials

Q1. What are nanoscale materials?

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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Q2. What action is EPA taking?

As part of the Agency's effort to ensure a more comprehensive understanding of nanoscale materials in commerce, on January 12, 2017 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, which was extended to August 14, 2017.

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Q3. What will EPA do with the information once it is collected?

EPA will use the data to decide if further action under TSCA, including additional information collection, is needed.

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Q4. Why is EPA interested in nanoscale materials?

There is a growing body of scientific evidence showing the differences that exist between some chemical substances manufactured at the nanoscale and their non-nanoscale counterparts. Nanoscale materials may have different or enhanced properties that could raise new questions, such as whether the material in the smaller form may present hazards to humans and the environment.

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Q5. What other action is EPA taking to address the potential risks of nanoscale materials?

New chemical substances manufactured at the nanoscale must be submitted to EPA for review as new chemical substances under TSCA before they can enter the marketplace. EPA also is developing scientific methods to study and evaluate unique properties of these substances and how nanoscale materials behave during manufacturing, product use, and end-of-life disposal.

Learn more about Control of Nanoscale Materials under TSCA.

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Q6. What are some of the uncertainties when assessing nanomaterials?

Some of the uncertainties associated with the assessment of chemical substances manufactured at the nanoscale include identification and characterization of these substances, understanding the environmental health and safety implications of the new properties of chemical substances at the nanoscale, and determining agreed-upon methods for testing substances. In addition to the scientific work described in Question #5, EPA is working with other federal agencies and international partners to address these uncertainties.

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Q7. How is this reporting rule different from Chemical Data Reporting (CDR) requirements?

CDR reporting requirements apply to chemical substances subject to TSCA including chemical substances manufactured at the nanoscale. However, the CDR requirements occur every four years and apply only to certain chemical substances that are manufactured in quantities greater than 25,000 pounds. The reporting requirements for chemical substances manufactured at the nanoscale involve one-time reporting for existing nanoscale materials and one-time reporting for new discrete nanoscale materials before they are manufactured or processed and is required for any production volume. In addition, the nanoscale reporting rule requires reporting more data specific to chemical substances manufactured at the nanoscale than does CDR reporting.

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Q8. What are the next steps?

Persons who manufactured or processed 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 final effective date, which is extended to August 14, 2017.

Persons who manufacture or process or intend to manufacture or process a reportable chemical substance after the effective date of August 14, 2017 that has not been previously reported must report as described in the rule.  See the reporting guidance and the response to comments document to the final rule for detailed descriptions of this requirement.

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