EPA Proposes One-Time Reporting on Nanoscale Materials
The U.S. Environmental Protection Agency (EPA) issued a proposed rule for one-time reporting and recordkeeping requirements on nanoscale chemical substances in the marketplace under Section 8(a) of the Toxic Substances Control Act (TSCA). This proposed rule would require companies that manufacture or process certain nanoscale materials to provide EPA with information such as volume, methods of manufacture and processing, exposure and release information, and available health and safety data.
This proposed rule defines nanoscale chemical substances as:
a chemical substance that is solid at 25ºC and atmospheric pressure that is manufactured or processed in a form where the primary particles, aggregates, or agglomerates are in the size range of 1-100 nm and exhibit unique and novel characteristics or properties because of their size.
A reportable chemical substance does not include a chemical substance that only has trace amounts of primary particles, aggregates, or agglomerates in the size range of 1-100 nm, such that the chemical substance does not exhibit the unique and novel characteristics or properties because of particle size.
The proposed reporting and recordkeeping requirements will be open to public comment 90 days from publication in the Federal Register. EPA also anticipates holding a public meeting during the comment period.
Details on reportable information
The proposed rule will allow EPA to obtain “known or reasonably ascertainable” information:
(1) The common or trade name, the specific chemical identity including the correct Chemical Abstracts (CA) Index Name and available Chemical Abstracts Service (CAS) Registry Number, and the molecular structure of each chemical substance or mixture.
Material characteristics including particle size, morphology, and surface modifications.
The maximum weight percentage of impurities and byproducts resulting from the manufacture, processing, use, or disposal of each chemical substance.
Importers, manufacturers, and processors of existing reportable substances must report the annual production volume for the previous three years before the effective date of the final rule and an estimate of the maximum production volume for any consecutive 12-month period during the next two years of production after the final effective date of this rule.
Importers, manufacturers, and processors of new reportable substances must report the estimated maximum 12-month production volume and the estimated maximum production volume for any consecutive 12-month period during the first three years of production.
Estimates for items (i) and (ii) must be on 100% chemical basis of the discrete form of the solid nanoscale material.
Use information describing the category of each use by function and application, estimates of the amount manufactured or processed for each category of use, and estimates of the percentage in the formulation for each use.
Detailed methods of manufacturing or processing.
Exposure information with estimates of the number of individuals exposed in their places of employment, descriptions and duration of the occupational tasks that cause such exposure, descriptions and estimates of any general population or consumer exposures.
Release information with estimates of the amounts released, descriptions and duration of the activities that cause such releases, and whether releases are directly to the environment or to control technology.
Risk management practices describing protective equipment for individuals, engineering controls, control technologies used, any hazard warning statement, label, safety data sheet, customer training, or other information which is provided to any person who is reasonably likely to be exposed to this substance regarding protective equipment or practices for the safe handing, transport, use, or disposal of the substance.
Existing data concerning the environmental and health effects.