The U.S. Environmental Protection Agency (EPA) has recently issued a proposed Significant New Use Rule (SNUR) under the Toxic Substances Control Act (TSCA). The proposal heavily targets mixed metal oxide (MMO) substances utilized as Cathode Active Materials (CAM) in lithium-ion batteries and related energy storage sectors.
The key background and core regulatory requirements of this proposed rule are detailed below:
1. Regulatory Target: Battery Cathode Active Materials (MMO CAM)
The proposed rule applies to a specific category of chemical substances generically described as "cobalt lithium manganese nickel oxide, metals-doped substances." These substances serve as critical cathode active materials (CAM) powering electric vehicle (EV) batteries, energy storage systems (ESS), and next-generation battery technologies. Driven by the recent boom in the U.S. clean energy and EV sectors, the EPA has received an influx of Premanufacture Notices (PMNs) regarding these novel battery materials.
2. The Purpose Behind the Proposed SNUR
Under the TSCA framework, when the EPA reviews a new chemical substance, it frequently enters into a restrictive consent agreement—known as a TSCA Section 5(e) Order—with the original submitter. However, a Section 5(e) Order is a "one-on-one" agreement that legally binds only the specific company that signed it.
To ensure that all subsequent market entrants manufacturing, importing, or processing the same battery materials adhere to the identical environmental and safety baselines, the EPA "universalizes" these restrictions through a SNUR. Once the final rule takes effect, any entity intending to deviate from the designated safety limits must submit a Significant New Use Notice (SNUN) to the EPA at least 90 days prior to commencing the activity.
3. Core Regulatory Restrictions and Requirements
Based on the EPA's standardized risk assessments, these MMO battery materials potentially pose risks of carcinogenicity, reproductive toxicity, specific organ toxicity, dermal/respiratory sensitization, and aquatic toxicity during processing or recycling. Consequently, the proposal establishes stringent lifecycle compliance baselines:
Use Limitation: Strictly restricted to use as a battery component/battery manufacturing.
Engineering Controls for Dust: Facilities processing or manufacturing the substances must implement high-efficiency dust control systems, achieving an air capture and control efficiency of 99% or greater.
Respiratory Protection: Workers must wear NIOSH-certified respirators with an Assigned Protection Factor (APF ranging from 10 to 10,000), determined by the 8-hour Time-Weighted Average (TWA) concentration and the specific cobalt content. If airborne concentrations exceed designated thresholds, operations must cease immediately.
Dermal Protection: Mandatory provision and usage of impervious dermal Personal Protective Equipment (PPE).
Water Release Restrictions: Predictable or intentional release of the substances, or any process wastewater containing them, into any surface waters is strictly prohibited (Zero Liquid Discharge).
Compliant Disposal: Disposal of manufacturing waste and incineration ash is limited exclusively to hazardous waste landfills meeting RCRA Subtitle C standards.
Container Labeling: Containers of the substances, battery packaging, and down-stream recycling or reclamation stages must bear clear labels indicating the presence of a TSCA-regulated substance.
This proposal highlights the EPA's transition toward a standardized, institutionalized risk management approach tailored for the surging battery and new energy supply chain. It aims to ensure that while critical battery materials support the green transition, localized manufacturing, and circular recycling, their health and environmental risks throughout the entire lifecycle remain tightly controlled.
REACH24H Expert Recommendations
For overseas suppliers with export plans involving "metals-doped cobalt lithium manganese nickel oxides" to the U.S., REACH24H recommends the following immediate actions:
Closely Monitor the Legislative Progress: Once the final rule is officially promulgated, U.S. buyers will likely mandate that their overseas suppliers apply compliant TSCA labels to batteries and outer packaging to satisfy import compliance. Exporters should verify whether their commercial products fall under this proposal well in advance to prevent subsequent customs or trade disruptions.
Proactive Supply Chain Compliance Confirmation: Once the final rule officially takes effect, and prior to finalizing any export orders, suppliers should proactively inform U.S. buyers of these rigid SNUR restrictions. It is highly recommended to confirm the buyer's compliance capacity regarding import and processing requirements (e.g., 99% dust control, zero water discharge). This prevents commercial risks such as cargo rejection, order cancellation, or abrupt buyer shutdowns due to non-compliance, safeguarding the supplier's trade continuity and payment security.
Frequently Asked Questions (FAQ)
A: The core regulated category covers cobalt lithium manganese nickel oxide, metals-doped substances (generic name). In the Federal Register notice, the primary case PMN numbers are: P-25-152, P-25-73, P-25-151, and P-25-137.
Additionally, the proposal identifies the following 8 associated PMN cases as identical chemical substances: P-23-120, P-23-122, P-24-180, P-25-93, P-25-125, P-25-135, P-25-144, and P-25-145.
A: Because the original submitters claimed Confidential Business Information (CBI) protection during their PMN filings, the precise molecular formulas, elemental ratios, and specific chemical names are redacted in all public official documents. They are referenced exclusively by generic names or PMN tracking numbers.
If a company needs to determine whether its proprietary "metals-doped cobalt lithium manganese nickel oxide" matches the restricted identities, and suspects the substance is already listed on the TSCA Confidential Inventory, it can submit a Bona Fide Intent Notice (Bona Fide Notice) to the EPA for official compliance verification.
A: No. The obligation to submit a Significant New Use Notice (SNUN) is triggered only after the final rule is officially promulgated and becomes effective.
During the current proposed rule stage, companies may continue their commercial operations normally. However, it is vital to note that once the final rule is enacted, any ongoing "significant new uses" (such as processing without achieving 99% dust control efficiency or discharging process wastewater) must halt immediately until a SNUN is reviewed and approved by the EPA. Therefore, REACH24H suggests that relevant suppliers and U.S. importers utilize this window to proactively audit and upgrade their compliance protocols.
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