Authors: Mark Duvall and Ryan Carra
Beveridge & Diamond, P.C. , April 6, 2015
Click here for a PDF of this news alert.
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:
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:
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:
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:
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.
Beveridge & Diamond assists clients with the shifting regulatory landscape affecting nanomaterials. Working alongside our clients’ legal, EHS and technical teams, we help resolve critical environmental and sustainability issues relating to their facilities, products, and operations. For more information, please contact the authors or any member of our Nanotechnology practice group.
 See Beveridge & Diamond, P.C., “ EPA Reworks Strategy For Regulation of Nanomaterials Under TSCA: Proposed Rule Sent to OMB ” (Oct. 13, 2014).
 15 U.S.C. § 2607(a).