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EPA announced that changes need to be made to the size standards used to determine which small manufacturers and processors are exempt from TSCA Section 8(a) reporting. Read the Federal Register notice.

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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.

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:

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

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 has developed guidance on this rule that 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.

Rutile (TiO2)

If you have questions not covered in this general guidance, please contact Jim Alwood (alwood.jim@epa.gov), and these questions will be answered on a case-by-case basis. EPA intends to add further questions/answers and update the guidance as warranted based on further questions we may receive.

Reporting under the Rule

Contact Us to ask a question, provide feedback, or report a problem.

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.

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).

​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.

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

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.

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.

Other Resources and Related Links

Nano Home Inventory

The Project on Emerging Nanotechnologies at the Woodrow Wilson International Center for Scholars today launched The Nanotechnology Consumer Products Inventory. This is the first and only publicly accessible online inventory of nanotechnology consumer products. The inventory currently contains information on 212 manufacturer-identified nano products. This far exceeds the existing federal government-accepted estimate of approximately 80 consumer products.

The inventory furthers the Project on Emerging Nanotechnology's mission to encourage discussion about nanotechnology's benefits and its promise, as well as its safety and environmental impacts. Currently, the searchable database catalogs consumer products using nanotechnology or containing nano materials – from sunscreens to refrigerators and cultured diamonds. While not complete, it is the most comprehensive repository of nanotechnology consumer products available to the public, policymakers, and industry.

'We are at the vanguard of discovering the endless benefits of nanotechnology for applications like targeted cancer treatments and more efficient solar cells. With this inventory, we also are learning that this technology is already being incorporated into our daily lives. It's on store shelves and being sold in every part of the world,' said David Rejeski, director of the Project on Emerging Nanotechnologies, which is supported by The Pew Charitable Trusts.

Until now, there was no known broad list of specific products using or containing nanotechnology that was readily accessible to consumers, retailers, researchers, and the media. The U.S. government relies on data compiled by EmTech Research regarding how nanotechnology is marketed and used commercially. The Project's inventory was developed in response to consumer interest in nanotechnology and its commercial uses. It provides the public with a first look at the vast array of acknowledged products companies are currently making available to shoppers.

Findings
Beginning in 2005, the Project began compiling products and materials containing nanotechnology from around the globe for inclusion in the consumer inventory. Entry to the list is based primarily on online, English language information provided by the product manufacturers. It does not include nanotechnology consumer products which companies have not identified as such.

With these caveats, notable findings from the data in the inventory include:

• Health and fitness is the most robust category in the inventory, with 125 products to-date, everything from face creams to hockey sticks. Electronics and computers make up the second largest category with 30 products, followed by the home and garden category;
• Within the health and fitness category, clothing—such as stain-resistant shirts, pants and neckties—constitutes the largest sub-category with 34 products, followed closely by sporting goods (33 products) and cosmetics (31 products);
• The U.S. is the overwhelming leader in consumer nanotechnology product development with 126; East Asia and Europe follow with 42 and 35 nano products respectively; and
• Nanoengineered carbon is the most common material used in the nano products included within the inventory, followed by silver and silica.

'Nanotechnology's potential is vast and it's real. The opportunity for nanotechnology ranges from improving Olympic sports equipment to discovering better treatments for Alzheimer's disease,' said Andrew Maynard, science advisor of the Project on Emerging Nanotechnologies. 'But our ability to reap the long-term benefits of nanotechnology – in areas from energy production to medicine – will depend on how well industry and government manage the safety and performance of this first generation of products.'

About Nanotechnology
Nanotechnology is the ability to measure, see, manipulate and manufacture things usually between 1 and 100 nanometers. A nanometer is one billionth of a meter; a human hair is roughly 100,000 nanometers wide.

The National Science Foundation predicts that the global marketplace for goods and services using nanotechnologies will grow to $1 trillion by 2015. The U.S. invests approximately $3 billion annually in nanotechnology research and development, which accounts for approximately one-third of the total public and private sector investments worldwide.

Inventory Data
Every item contained in the inventory is manufacturer-identified. Any statements, claims and views expressed by a manufacturer or third-party contained in this inventory are solely those of the party making the statement or claim.

Product details include: the product name, company/manufacturer or supplier information, country of origin, and category or subcategory, as well as a product photograph and description, hyperlink to the product website and the date that the product was added to the index.

Products are grouped according to categories based loosely on publicly available consumer product classification systems, which include health and fitness, electronics and computers, home and garden, food and beverage, automotive, appliances and children's goods. The inventory also uses sub-categories. For example, paint is a sub-category labeled under the home and garden main category.

The inventory will be updated regularly as new information is available. Users are encouraged to submit new product information for consideration to nano@wilsoncenter.org.

Special Launch Event and Webcast
The Center will formally release the Nanotechnology Consumer Products Inventory at a special launch event today from 2:00 – 3:00 p.m. EST at the Woodrow Wilson International Center for Scholars, located at 1300 Pennsylvania Avenue, N.W., Washington, D.C., 5th floor conference room.

High resolution photos of products in the nanotechnology consumer products inventory are available to the media at ftp://wwicsftp.wilsoncenter.org Username: WWICSFtp Password: p+F$c1WW. Questions regarding photos should be directed to Alex Parlini: alex.parlini@wilsoncenter.org or (202) 691-4282.

About the Organizations
The Project on Emerging Nanotechnologies is an initiative launched by the Wilson Center and The Pew Charitable Trusts in 2005. It is dedicated to helping business, government and the public anticipate and manage possible health and environmental implications of nanotechnology.

The Pew Charitable Trusts is a national charitable organization serving the public interest by informing the public, advancing policy solutions and supporting civic life. Based in Philadelphia, with an office in Washington, D.C., the Trusts will invest $204 million in fiscal year 2006 to provide organizations with fact-based research and practical solutions for challenging issues.

The Woodrow Wilson International Center for Scholars is the living, national memorial to President Wilson established by Congress in 1968 and headquartered in Washington, D.C. The Center establishes and maintains a neutral forum for free, open, and informed dialogue. It is a nonpartisan institution, supported by public and private funds and engaged in the study of national and international affairs.