The Environmental Protection Agency has issued a final rule allowing it for the first time to use its authority under section 8(a) of the Toxic Substances Control Act to collect health and safety information on chemicals currently in the marketplace when imported, manufactured, or processed as nanoscale materials. This rule will be effective as of May 12.
This rule applies to chemical substances that are solids at 25 ºC and standard atmospheric pressure; that are imported, 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 imported, manufactured, or processed to exhibit one or more unique and novel properties.
Persons that do or intend to import, manufacture, or process these chemical substances must electronically report certain information, including the specific chemical identity, production volume, methods of manufacture and processing, use, exposure and release information, and existing data concerning environmental and health effects. This rule involves one-time reporting for existing discrete forms of certain nanoscale materials and a standing one-time reporting requirement for new discrete forms of certain nanoscale materials before they are imported, manufactured, or processed.
This rule does not apply to the following.
- chemical substances imported, manufactured, or processed in forms that contain less than one percent by weight of any particles, including aggregates and agglomerates, in the size range of 1-100 nm
- certain biological materials including DNA, RNA, proteins, enzymes, lipids, carbohydrates, peptides, liposomes, antibodies, viruses, and microorganisms
- chemical substances that dissociate completely in water to form ions with a size of less than 1 nm (except chemical substances manufactured at the nanoscale that release ions but do not dissociate in water to form those ions)
- chemical substances formed at the nanoscale as part of a film on a surface
- persons that do or intend to import, manufacture, or process the subject chemical substances only in small quantities for research and development
- any manufacturer or processor with sales of less than $11 million per year
The EPA notes that this rule is not intended to conclude that nanoscale materials will cause harm to human health or the environment; instead, the agency plans to use the information gathered to determine if any further action under TSCA, including additional information collection, is needed.
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