 |
What are nanoscale materials?
Nanomaterials are chemical substances that have structures with dimensions at the nanoscale—approximately 1 to 100 nanometers (nm). To get an idea of their size, a human hair is approximately 80,000 to 100,000 nm wide.
The thinking is that nanomaterials may have properties different from the same chemical substances with structures at a larger scale, such as greater strength, lighter weight, and greater chemical reactivity. These different properties give nanoscale materials a range of potentially beneficial public and commercial applications. For example, they could improve products such as anti-cancer therapies, TVs, vehicles, batteries, and solar panels.
But, the same special properties may cause some of these chemical substances to behave differently from conventional chemicals under certain conditions. According to the EPA, there is a growing body of scientific evidence showing the differences that exist between some chemical substances manufactured at the nanoscale and their nonnanoscale counterparts. These differences could raise new questions, such as whether the material in the smaller form may present hazards to humans and the environment. So, the EPA recently proposed one-time recordkeeping and reporting requirements for nanomaterials under TSCA Section 8(a) in order to collect information about these materials.
Forget expensive calls to lawyers and consultants. With Enviro.BLR.com, you get instant access, 24/7. Try it out today and get the 2015 EHS Salary Guide, absolutely free. Download Now.
EPA points to potential nano dangers
While asserting that it is not making any presumptions about chemicals manufactured at nanoscale, EPA’s proposal cites studies wherein both laboratory animals and workers exposed to nanomaterials experience ill effects.
One of the consistent concerns is that nanomaterials have a unique capacity to penetrate into the respiratory system and cause decreased lung function. Other reported findings are that nanomaterials can trigger catalytic reactions that would not otherwise be anticipated based on their chemical composition and that they display the potential to transfer across environmental species, indicating possible bioaccumulation in species at the end of that part of the food chain.
The EPA says it has assessed over 170 nanoscale materials as new chemical substances and taken action to control exposures to prevent any potential unreasonable risks to human health or the environment pending development of information that will allow the Agency to more fully assess those risks.
Proposed nanomaterials reporting requirements
As part of the requirements under TSCA Section 8(a), manufacturers and importers must submit a onetime Manufacturer’s Report—Preliminary Assessment Information (Manufacturer’s Report) for each plant site involved in manufacturing or importing a chemical substance.
EPA’s proposed reporting requirements for nanomaterials include:
- Reportable chemicals are those that are solids at 25ºC 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 to 100 nm and exhibit unique and novel characteristics or properties because of their size.
- Manufacturers and processors of multiple nanoscale forms of the same chemical substance would, in some cases, need to report separately for each discrete form of the reportable chemical substance.
- Chemical substances that are manufactured or processed in a nanoscale form solely as a component of a mixture, encapsulated material, or composite would also have to be reported.
Everything You Need for Environmental Compliance
Enviro.BLR.com puts everything you need at your fingertips, including practical RCRA, CAA, CWA, hazardous waste regulatory analysis and activity, news, and compliance tools. Try it at no cost or risk and get a FREE report.
Proposed exemptions
Under EPA’s proposal, reporting would not be required for certain biological materials (e.g., DNA, RNA, and proteins), chemical substances that dissociate completely in water to form ions that are less than 1 nm, nanoclays, zinc oxide, and chemical substances manufactured at the nanoscale as part of a film on a surface.
Exemptions would also apply to small amounts of materials manufactured or processed for research and development purposes and to small manufacturers that meet EPA’s definition of small manufacturers.
Also, the proposed requirements would not apply to chemical substances that have only trace amounts of primary particles, aggregates, or agglomerates in the size range of 1 to 100 nm, such that the chemical substance does not exhibit unique and novel characteristics or properties because of particle size.