On October 5, 2022, the U.S. Environmental Protection Agency (“EPA”) announced its plan to streamline the typical review process for Mixed Metal Oxides (“MMOs”), including certain cathode active materials, which are key components in electric vehicles’ lithium-ion batteries, as well as clean energy generation and storage technology, including wind turbines and solar cells.  MMOs can also be used in semiconductors. 

As we have written about previously, increasing the domestic supply of EVs and semiconductors, and expanding the country’s clean energy capacity are among the core policy objectives of the Biden Administration.

Each of these supply chains could utilize these new MMOs, which are not currently listed on the Toxic Substances Control Act (“TSCA”) Inventory.  Because they are not listed, MMOs are subject to Section 5 of TSCA — a point that EPA confirmed in a separate compliance advisory.

Given this backdrop, manufacturers and importers of new MMOs must submit a Premanufacture Notice (“PMN”) to EPA before manufacturing or importing these substances.  Upon receipt of a PMN, EPA considers the potential hazards and exposures associated with the substance, and determines whether steps must be taken to reduce the risk to human health or the environment before the substance can enter the U.S. marketplace.  It is critical that manufacturers and importers submit such a notice when required to do so, including because TSCA prohibits using for a commercial purpose any chemical that the person knew or should have known does not comply with aspects of TSCA, including the requirement to submit a PMN or qualify for an exemption from that requirement.  15 U.S.C. § 2614.  Manufacturers and importers do not need to submit PMN for MMOs already on the inventory (or that become added to the inventory).

EPA’s announced plan to streamline this review process is good news for the EV, clean energy, and semiconductor industries.  Under recent similar streamlining initiatives for biofuels, EPA has been able to complete its review for nearly all of the dozens of PMNs it has received since January 2022.  This streamlining appears to be, in part, a response to concerns that EPA has acknowledged with respect to the speed of its new chemical reviews. 

More details are forthcoming, and the EPA has announced that it will provide outreach and training sessions for interested stakeholders to describe the new streamlined review process.

EPA已安排了一个利益相关者会议，于6月11日在华盛顿特区讨论其根据有毒物质控制法(TSCA)提出的纳米尺度材料规则。拟议的规则将要求纳米材料制造商向EPA提供有关其纳米材料的某些信息，包括与健康和安全相关的信息。公众意见截止日期为2015年7月6日。EPA拟议的规则具有重要意义，部分原因是EPA打算使用根据拟议规则收集的信息来确定是否根据TSCA对纳米级物质采取进一步行动。

EPA于2015年4月6日发布了提案规则。该规则将要求在该规则生效前三年内生产纳米级物质的实体在该规则最终确定后六个月内向EPA提供所需的信息。EPA还提出了一项持续的要求，要求在该规则生效日期之后开始生产纳米级材料的制造商在开始生产前至少135天向EPA提供相同的信息。要求向EPA报告的信息包括化学品特性、生产量、制造方法、接触和释放信息以及健康和安全信息。

通过本提议的报告规则收集的信息将用于“确定是否有必要根据TSCA采取任何进一步行动”，例如额外的信息收集或监管。EPA已就拟议规则的若干方面征求意见，包括关于要求定期报告纳米级物质制造的潜在未来规则，并已邀请参与者在即将召开的利益相关者会议上就这些问题提供意见。拟议的规则承认纳米材料具有“一系列潜在的有益”应用，如“清洁能源、减少污染和清理环境”，但也指出纳米材料可能会提出“问题”，即该材料是否会“对人类和环境造成更大的危害”。 That a material is nanoscale is not “an indication of, or criterion for, hazard or exposure potential,” that the proposal does not make any finding about the potential risks of nanoscale material, and that all evaluations of nanomaterials “will be based on the specific nanoscale chemical substance’s own properties.”   Nevertheless, an underlying premise of EPA’s rulemaking efforts is that nanoscale substances may have significantly different characteristics from the same substances on a more conventional scale.