Nanoscale Material Manufacturers, Importers, and Processors to Face Costs under USEPA’s Proposal to Expand TSCA Reporting Rule
Nanoscale materials are not new, but how they are regulated may change. In a proposed rule posted on April 6, 2015, United States Environmental Protection Agency (USEPA) put forward one-time reporting and recordkeeping requirements under Toxic Substances Control Act (TSCA) section 8(a) reporting requirements for substances (already in commerce) when they are manufactured or processed as nanoscale materials. Under the proposed rule, the affected industries are conservatively estimated to spend approximately $13.9 million in the first year and $1.5 million in subsequent years. Industries potentially affected include the following:
- Home Furnishings
- Roofing, Sliding, and Insulation
- Chemical, Synthetic Dyes and Pigments
- Steel and Carbon/graphite
- Semiconductor and Related Device Manufacturing
- Research and Development.
What are nanoscale materials?
Nanoscale materials are small-scale substances that have structural components smaller than 1,000 nanometers (nm) in at least one dimension, and include nanoparticles, which are particles with at least two dimensions between approximately 1 and 100 nm (a human hair is approximately 80,000-100,000 nanometers wide). Many nanoscale materials are regarded as “chemical substances” under the TSCA.
Nanoparticles can be found in sunscreens, toys, clothing, food, food packaging, appliances, drugs, candy, cosmetics, ceramics, paints, and many other common products. Nanoparticles can contribute to stronger, lighter, cleaner and “smarter” surfaces and systems. At the nanoscale, the properties of particles may change in unpredictable ways. Nanoparticles of titanium oxide used in sunscreens, for example, have the same chemical composition as the larger white titanium oxide particles used in conventional products for decades, but nanoscale titanium oxide is transparent. For instance, antimony tin oxide nanoparticles are incorporated into a coating to provide scratch-resistance and offer transparent protection from ultra-violet radiation, not seen with larger particles.
Nanoscale materials, because of their distinctive properties, have potentially beneficial applications, including medicine and public health, clean energy, pollution reduction and environmental cleanup, and improved products such as stronger, lighter, and more durable or conductive materials. However, early scientific evidence shows that as a direct consequence of decreasing size, chemical substances manufactured at the nanoscale may have different or enhanced properties, including electrical, chemical, magnetic, mechanical, thermal, or optical features.
What are the concerns with nanoscale materials?
USEPA is concerned that some of the properties that make nanoscale materials useful may, under specific conditions, pose risks to humans and the environment. A National Institute of Occupational Safety and Health (NIOSH) report of the available scientific information about nanoscale materials indicated nanoparticles have the potential to enter the body through the respiratory system and skin. They can also be ingested. Experimental studies in rats suggest equivalent mass doses of insoluble incidental nanoparticles are more potent than large particles of similar composition. Nanoparticles have the potential to bio-accumulate.
Who should track the proposed rule?
The proposed rule applies to entities that manufacture, process, or intend to manufacture or process nanoscale forms of certain chemical substances. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but will help determine if the proposed rule will apply to your organization:
- Chemical Manufacturing or Processing (NAICS codes 325).
- Synthetic Dye and Pigment Manufacturing (NAICS code 325130).
- Other Basic Inorganic Chemical Manufacturing (NAICS code 325180).
- Rolled Steel Shape Manufacturing (NAICS code 331221).
- Semiconductor and Related Device Manufacturing (NAICS code 334413).
- Carbon and Graphite Product Manufacturing (NAICS code 335991).
- Home Furnishing Merchant Wholesalers (NAICS code 423220).
- Roofing, Sliding, and Insulation Material Merchant Wholesalers (NAICS code 423330).
- Metal Service Centers and Other Metal Merchant Wholesalers (NAICS code 423510).
- Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology) (NAICS code 541712).
The proposed rule maintains the current TSCA exemptions; it does not target entities that manufacture or process, or intend to manufacture or process these chemical substances as part of articles, as impurities, or in small quantities solely for research and development.
What does the proposed rule entail?
Regulated entities would be required to report the specific chemical identity, production volume, methods of manufacture, processing, use, exposure and release information, and available health and safety data. This includes one-time reporting for both existing nanoscale materials and new discrete nanoscale materials before they are manufactured or processed. The proposed rule would contain exclusions for some nanomaterials (e.g., certain biological materials, such as DNA, chemical substances which dissociate completely in water to form ions that are less than 1 nanometer).
USEPA wants to use the information and available scientific evidence to evaluate the risks and current risk management strategies, examine the benefits and costs of further measures, and make decisions. The agency feels the information gathering will provide a sound scientific basis for assessing and managing potential impacts resulting from the introduction of chemical substances manufactured at the nanoscale into commerce.
USEPA is not proposing to publish an inventory of the nanoscale material information collected pursuant to these proposed TSCA section 8(a) reporting requirements, rather, the agency will make non-confidential information available under the proposed rule available in ChemView (see https://www.epa.gov/chemview/).
At what cost?
Information provided by USEPA indicates industry is conservatively estimated to incur an hourly burden of approximately 206,098 hours in the first year and 22,755 hours in subsequent years, with costs of approximately $13.9 million and $1.5 million, respectively. Discounted over a 10-year period at three and seven percent, total annualized costs are estimated by the USEPA to be approximately $2.80 million and $3.08 million, respectively.
What is the status of the proposed rule?
The public comment period closed August 5, 2015, and now USEPA will review and consider comments before issuing the final rule. EHS Support is tracking the proposed rule for clients and can assist you with evaluating the effect of this rule and assisting with the reporting and recordkeeping requirements. Please contact Amy Bauer or Kate Gibson for more information.