On April 6 2015, the U.S. Environmental Protection Agency (EPA) proposed to impose one-time Toxic Substances Control Act (TSCA) reporting requirements for the manufacture or import of nanoscale chemical substances. Although the EPA currently regulates new nanomaterials, which are those not included on the TSCA Inventory, through premanufacture notice (PMN) requirements, this is the first regulation to address existing nanomaterials that are already on the TSCA Inventory. Public comments on the proposed rule will be accepted until July 6, 2015.
Scope of the proposed TSCA Reporting Requirement
The proposed rule imposes a one-time reporting requirement for existing nanoscale materials as well as for new discrete pre-manufactured nanoscale materials. The proposed rule defines a reportable nanoscale chemical as a substance that is solid at 25 °C and atmospheric pressure. The substance must also be manufactured or processed in a form where the primary particles aggregate or agglomerate in the size range of 1-100 nm and exhibit unique and novel characteristics due to their size.
The proposed rule requires manufacturers, importers, or processors of such substances to use the EPA’s electronic reporting system (CDX) to report certain information about their nanoscale chemicals.
- If a manufacturer has processed a qualifying nanoscale chemical within 3 years prior to the effective date of this rule, that company must report within 6 months of this rule’s implementation.
- For existing nanomaterials not already reported or exempt, the EPA has also proposed that companies planning to manufacture or process covered chemicals to report within 135 days prior to manufacture.
Releasing data concerning Environmental and Health effects
The information that must be reported to EPA includes the specific chemical identity, production volume, methods of manufacture and processing, exposure and release information, and existing data concerning environmental and health effects. The EPA believes that this measure would facilitate information gathering and help determine if any further action on such chemicals under TSCA is required.
Exemptions from this nanoscale chemical reporting requirement
Several materials would be exempt from this nanoscale chemical reporting requirement, including :
- zinc oxide,
Furthermore, all of the exemptions under TSCA section 8(a) rules would apply to this rulemaking as well. For example, the R&D, low volume, and small manufacturer exemptions would apply and exclude qualifying manufacturers from the scope of this requirement.
The EPA is accepting public comment on the proposed TSCA nanoscale chemical reporting rule until July 6, 2015.
Red-on-line EHS Legal specialist
Proposed Rule: Chemical Substances When Manufactured or Processed as Nanoscale Materials; TSCA Reporting and Recordkeeping Requirements, Federal Register, 80 FR 18330, April 6, 2015 (amending 40 CFR 704).
40 CFR 704