Final Rule: TSCA Chemical Reporting for Nanoscale Materials

US EPA today announced it has finalized new chemical reporting and recordkeeping regulations for chemical substances manufactured or processed as nanoscale materials.

The Final Rule will require manufacturers, importers, or processors of nanoscale materials to report information electronically to US EPA on a one-time basis per the Toxic Substances Control Act (TSCA) Section 8(a). Information required under this section of TSCA includes:

• Specific chemical identify
• Production volume
• Methods of manufacture and processing
• Data on use of the material
• Exposure and release information
• Available health and safety information

Under TSCA, affected facilities must keep a record of this information for 3 years.

New Regulatory Definitions for Nanoscale TSCA Reporting

In addition to the added reporting and recordkeeping requirements for nanoscale materials, EPA has made some changes to this TSCA rule since it was proposed in April 2015.

As published today, the Final Rule:

• Provides a definition for nanomaterials deemed reportable under TSCA, which reads, “chemical substances, as defined in section 3 of TSCA, that are solids at 25 degrees Celsius and standard atmospheric pressure; that are manufactured or processed in a form where any particles, including aggregates and agglomerates, are in the size range of 1-100 nanometers (nm) in at least one dimension; and that are manufactures or processed to exhibit one or more unique and novel properties.”
• Adds a definition of “unique and novel properties” (704.20(a)).
• Sets a numerical value for substances with “trace amounts” of nanomaterials of less than 1% by weight. These chemical substances are not reportable under the TSCA Section 8(a).

Who and What Is Exempt from This TSCA Final Rule?

Substances that are exempt from this new TSCA reporting requirement include:

• Certain biological materials (DNA, RNA, proteins, enzymes, etc.).
• Chemical substances that dissociate completely in water to form ions with a size of less than 1 nm.
• Substances formed at the nanoscale as part of a film on a surface. 

In addition, small manufacturers and processors—those that have sales of less than $11 million per year—are exempted from this nanoscale TSCA reporting requirement.

What Are Nanomaterials?

Nanoscale materials, also called nanomaterials, are defined as forms with particle sizes between 1 and 100 nanometers (nm). For perspective, a sheet of paper is 100,000 nanometers thick. A strand of human DNA is 2.5 nanometers in diameter.

How Are Nanoscale Materials Used in Commerce?

Manufacturers use nanomaterials in a wide variety of products:

• Nano silver is used in medical equipment, textiles, cosmetics, fabrics, and plastics.
• Carbon nanotubes are used in vehicles, sports equipment, coatings, plastics, and integrated circuits in electronics.
• Cerium dioxide is used in electronics, plastics, biomedical supplies, and fuel additives.
• Titanium dioxide is used in sunscreens, cosmetics, paints, and coatings.
• Nano iron is used to break down chlorinated hydrocarbons in hazardous waste sites.
• Micronized copper is used as a preservative in pressure-treated lumber.

TSCA Regulations Online Course

The Toxic Substances Control Act is complex and enforcement is stringent, making a comprehensive understanding of the TSCA rules critical for compliance.  The law has broad applicability, subjecting all companies that “manufacture, use, process, distribute, import, or export chemical products” to complex reporting and management requirements.

The TSCA Regulations Online Course is designed to help you meet your reporting, recordkeeping, and chemical management responsibilities. EPA fines for chemical management and reporting mistakes are as high as $37,500 per day, per violation.

Want live training? A full time Lion instructor will present the popular TSCA Reporting and Recordkeeping Webinar live on March 21, from 1—3 PM ET. Learn more or sign up here.

Tags: chemicals, EPA, new rules, TSCA