EPA is proposing significant new use rules (SNURs) under the Toxic Substances Control Act (TSCA) for chemical substances that were the subject of premanufacture notices (PMNs) and a Microbial Commercial Activity Notice (MCAN) and are also subject to a TSCA Order Basis for TSCA Order. In the case of graphene nanoplatelets, The PMN states that the generic (non-confidential) use will be as an additive for paint coatings. According to EPA and based on comparison to analogous chemical substances, there are concerns for lung effects and systemic effects. To protect against these risks, the Order requires:
• No manufacture of the PMN substance other than by import into the United States in the form of a solution (i.e., no domestic manufacture);
• No processing of the PMN substance in any manner that results in inhalation exposure;
• No processing or use of the PMN substance other than in a liquid formulation;
• No use of the PMN substance other than for the confidential use listed in the Order;
• No use of the PMN substance in an application method where the concentration of the PMN substance in the formulation exceeds the confidential concentration listed in the Order;
• No release of the PMN substance, or any waste stream containing the PMN substance, into waters of the United States;
• Use of personal protective equipment where there is a potential for dermal exposure;
• Use of a NIOSH-certified combination particulate and gas/vapor respirator with an APF of at least 50 where there is a potential for inhalation exposure; and
• Establishment of a hazard communication program, including human health precautionary statements on each label and in the SDS.
The SNURs require persons who intends to manufacture (defined by statute to include import) or process any of these chemical substances for an activity that is proposed as a significant new use by this rule to notify EPA at least 90 days before commencing that activity. The required notification initiates EPA's evaluation of the conditions of use for that chemical substance. In addition, the manufacture or processing for the significant new use may not commence until EPA has conducted a review of the required notification, made an appropriate determination regarding that notification, and taken such actions as required by that determination.
