The United States Environmental Protection Agency (EPA) recently submitted a final rule to the White House Office of Management & Budget that may impact chemical manufacturers nationwide, including those doing business here in California. Specifically, the rule will implement reporting and recordkeeping requirements on certain chemical substances when they are manufactured or processed as nanoscale materials. Potentially affected industries include: synesthetic dye and pigment manufacturing, rolled steel shape manufacturing, roofing, sliding, and insulation material merchant wholesalers, and even home furnishing merchant wholesalers.
Under the proposed rule, the scope of regulation is broadened in that manufacturers (including importers) and processors would need to electronically report to the EPA certain information including specific chemical identity, production volume, methods of manufacture and processing, use, exposure and release information, and available health and safety data. The EPA will then use the information obtained to decide whether to take further action under the Toxic Substances Control Act (TSCA), including additional information collection.
The proposed requirements would apply to "chemical substances that are solids at 25 Celsius and atmospheric pressure and that are manufactured or processed in a form where the primary particles, aggregates, or agglomerates are in the size range of 1-100 nanometers (nm) and exhibit unique and novel characteristics or properties because of their size." Notably, the proposed requirements would not apply to chemical substances containing "trace amounts" wherein the "chemical substances do not exhibit the unique and novel characteristics or properties because of particle size."
The EPA made it clear that these the proposals are not intended to create a new class of nanoscale materials, or that specific usage of the applicable materials should be considered harmful.
The rule was first proposed on March 25, 2015. During the comment period, organizations ranging from NGOs to business groups requested that the EPA clarify some of the proposed language, including definitions of "unique and novel properties" and the 135-day requirement for reporting on new forms of chemical substances. Manufacturers and processors were particularly concerned whether the 135-day requirement would require them to stop manufacturing while the EPA reviews the data.
Although the use of nanoscale materials predates modern era (i.e., use of gold and silver particles to create colors in stained glass windows), modern usage of nanoscale materials has allowed scientists and engineers to manipulate various chemical substances and enhance their properties, including greater chemical reactivity. Industries taking advantage of modern usage of nanoscale materials will undoubtedly face greater scrutiny under the proposed rule.