On April 6, EPA published a proposed rule that would impose one-time reporting requirements under the Toxic Substances Control Act (TSCA) on manufacturers and processors of nanoscale forms of certain chemical substances. The rule would mark the first time EPA has used TSCA to require the submission of information on nanoscale materials currently in the marketplace. EPA has said that it intends to use the information to determine if any further action under TSCA, including additional information collection, is warranted. Comments on the proposed rule are due by July 6, 2015.
EPA has effectively regulated new nanomaterials (those not on the TSCA Inventory) through the requirement to submit premanufacture notices (PMNs) or low volume exemption applications; through significant new use rules for all or most of those PMN substances; and through section 5(e) orders issued following review of PMNs and significant new use notices. This regulatory mechanism has not addressed existing nanomaterials (those on the TSCA Inventory), however. A nanoscale version of a chemical substance reported for the Inventory in a macroscale form is not a new chemical substance if it has the same “particular molecular identity,” including molecular structure. After a considerable delay due to a lengthy review by the Office of Management and Budget, EPA is now addressing existing nanomaterials.
Section 8(a) of TSCA allows EPA to issue rules requiring manufacturers or processors of chemicals to issue such reports as EPA may reasonably require. EPA issued the proposed section 8(a) rule after its voluntary Nanoscale Materials Stewardship Program (NMSP), which was designed in part to collect information on domestic manufacturing of nanoscale materials, reportedly gathered information on only about 10% of the domestic market.
EPA stated that more comprehensive information about the domestic market and available studies would aid in the further evaluation of nanoscale materials. It cited growing scientific evidence showing that chemical substances have different properties in nanoscale form. Although these properties can be desirable for commercial applications, EPA stated that they also may also present increased hazards to humans and the environment.
Scope of Chemical Substances Subject to Proposed Rule
The rule would apply to chemical substances that are solid at 25 °C and atmospheric pressure and that are manufactured or processed in a form where the primary particles (defined as particles or droplets that form during manufacture before aggregation or agglomerization), aggregates, or agglomerates are in the size range of 1-100 nm and exhibit unique and novel characteristics because of their size. The rule would not apply to chemical substances that only have trace amounts of primary particles, aggregates, or agglomerates in the size range of 1-100 nm, such that the chemical substances do not exhibit the unique and novel characteristics or properties because of particle size.
Each discrete form of a covered nanoscale material would be subject to the rule. EPA proposed three factors to distinguish discrete forms:
- A change in process to affect a change in size and/or a change in properties of the chemical substances manufactured at the nanoscale;
- A change in mean particle size of 10% or greater; and
- The measured change in zeta potential, specific surface area, dispersion stability, or surface reactivity, is greater than 7 times the standard deviation of the measured values.
Additionally, nanoscale forms of a distinct morphology or shape, or those carrying a different coating, would also qualify as discrete forms.
EPA proposed to exempt the following chemical substances from the rule:
- Zinc oxide
- Chemical substances manufactured at the nanoscale as part of a film on a surface
- Chemical substances which dissociate completely in water to form ions that are smaller than 1 nm
Notably, titanium dioxide would not be exempted.
EPA has also proposed to include all of the exemptions applicable to section 8(a) rules generally in 40 C.F.R. § 704.5. In particular, the articles exemption would apply, so that the rule would not require reporting of nanoscale materials imported or processed solely as part of an article. Further, the R&D exemption would apply; thus, non-commercialized nanoscale materials still at the R&D stage would be excluded from the scope of the rule.
Entities Subject to Proposed Rule
Manufacturers and processors of chemicals in scope would be subject to the rule unless they qualified for one or more exemptions. EPA has proposed exemptions for the following entities:
- Those who have already reported the information that would be required under the proposed rule to EPA, including through notices under section 5 of TSCA or the NMSP.
- Those with annual sales of less than $4 million.
- Those whose nanoscale materials are only used in small quantities for research and development.
Timing of Reporting
For companies that have manufactured or processed chemicals in scope at any time during the three years prior to the final effective date of the rule, EPA has proposed a reporting deadline of six months after the final effective date of the rule. EPA has also proposed a continuing requirement for companies who plan to manufacture or process chemicals in scope to report within 135 days before commencement of manufacture or processing. This continuing requirement would apply to the planned manufacture or processing of existing nanomaterials not already reported or exempt. In addition, it arguably could impact new nanoscale materials that may be the subject of a PMN whose 90-day review period would be encompassed by the 135-day reporting period. If so, such reporting would be duplicative of some information in the PMN, but other information that would be required by the proposed rule is not specifically mandated by the PMN reporting requirements.
Information to be Submitted
The rule would require the following information be submitted to EPA:
- Common trade name, specific chemical identity, and molecular structure of each chemical substance or mixture
- Material characteristics, including particle size, morphology, and surface modifications
- Physical/chemical properties
- Maximum weight percentage of impurities and byproducts resulting from the manufacture, processing, use, or disposal of each chemical substance
- Past annual production volume and estimated future production volume information
- 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 of 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 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 handling, transport, use, or disposal of the substance
- Existing data concerning the environmental and health effects
EPA has proposed that the information be submitted through CDX, its electronic reporting portal. Companies submitting information under the proposed rule could claim part or all of the submission as confidential business information eligible for protection from disclosure under EPA’s regulations at 40 C.F.R. Part 2 and 40 C.F.R. § 704.7.