On June 5, 2015, the U.S. Environmental Protection Agency (EPA) promulgated through a direct final rule significant new use rules (SNUR) for 22 chemical substances that were the subject of premanufacture notices (PMN), including graphene nanoplatelets having a predominant thickness of 1-10 layers with lateral dimension predominantly less than 2 microns (PMN Number P-14-763). This substance is subject to a Toxic Substances Control Act (TSCA) Section 5(e) consent order that includes the following requirements:
- Use of personal protective equipment involving impervious gloves and protective clothing (where there is a potential for dermal exposure) and a National Institute of Occupational Safety and Health (NIOSH)-certified respirator (where there is a potential for inhalation exposure).
- Establishment and use of a hazard communication program, including human health, environmental hazard precautionary statements on each label and the material safety data sheet (MSDS).
- Manufacturing, processing, or use of the PMN substance only as described in the consent order.
- No use of the PMN substance using an application method that generates a vapor, mist, or aerosol.
- Submission of certain toxicity testing prior to exceeding the confidential production volume limits of the PMN substances specified in the consent order.
- No predictable or purposeful release of the PMN substances from manufacturing, processing or use into the waters of the United States.
The SNUR designates as a significant new use the absence of these protective measures. EPA states that it determined that the results of certain particle size distribution and material characterization testing would be needed for the PMN substance. According to EPA, the company has agreed to submit the full chemical characterization testing described in the testing section of the consent order within the timeframes identified in the order. Depending on the results of the characterization testing, additional toxicity testing may be required at a confidential aggregate manufacture volume, as detailed in the consent order. The June 5, 2015, rule will take effect on August 4, 2015.