Born in the wake of elevated concern about environmental pollution, EPA was established on December 2, 1970 to consolidate in one agency a variety of federal research, monitoring, standard-setting and enforcement activities to ensure environmental protection. Since its inception, EPA has been working for a cleaner, healthier environment for the American people.
Today, the U.S. Environmental Protection Agency (EPA) announced a new effort under the Toxic Substances Control Act (TSCA) to implement a streamlined and efficient process under the New Chemicals Program to assess risk and apply mitigation measures, as appropriate, for new chemicals with applications in batteries, electric vehicles, semiconductors and renewable energy generation.
Under TSCA, EPA’s New Chemicals Program plays an important role by reviewing all new chemical substances before they enter the marketplace in order to bring innovative chemistries to market in a way that does not harm human health or the environment.
“From job creation to energy security – clean energy sectors will power the future of our country,” said Assistant Administrator for the Office of Chemical Safety and Pollution Prevention Michal Freedhoff. “Streamlining our review of new chemical substances that make up electric vehicle batteries and that can be used in other vital emerging markets will allow manufacturers to super-charge production, bolstering our economy and advancing the Biden-Harris Administration’s goals to protect the environment and combat the climate crisis.”
The new process is for mixed metal oxides (MMOs), including new and modified cathode active materials (CAMs). MMOs are innovative chemistries and have numerous electrical applications in batteries as well as use as catalysts, adsorbents, and in ceramics. Notably, MMOs, including CAMs, are a key component in lithium-ion batteries used in electric vehicles, which are a growing and important industry. New MMOs can also be used for semi-conductors, and renewable energy generation and storage, such as solar cells and wind power turbines. They typically consist of lithium, nickel, cobalt and other metals, and they are the key material used in the production of the cathode in battery cells, which are subsequently assembled into a battery.
This effort supports President Biden’s bold agenda to tackle the climate crisis, and will complement the resources flowing to EPA from historic legislation signed by the President. There are incentives attached to clean energy under the Inflation Reduction Act, including tax credits for electric vehicles. Under the Bipartisan Infrastructure Law, there are also incentives to build a national network of electric vehicle chargers.
Like all chemical substances not listed on the TSCA Inventory, MMOs, including new and modified CAMs, are subject to section 5 of TSCA, which requires manufacturers (including importers) of new chemical substances to provide EPA with notice before initiating the activity by submitting a Premanufacture Notice (PMN). When EPA receives a PMN, TSCA requires the agency to fully assess all the potential hazards and exposures of the new chemical substance, make a determination as to whether it presents an unreasonable risk to human health or the environment, and take steps to address that risk before it can enter commerce
EPA has reviewed hundreds of TSCA section 5 submissions for MMOs, including CAMs and modified CAMs, since the 1980’s. To further describe this new effort, EPA will launch outreach and training for interested stakeholders to outline the new streamlined approach to reviewing MMOs, basics of TSCA statutory and regulatory requirements, and steps for navigating the new chemicals submission process.
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Today’s announcement is supplemented with the release of a Compliance Advisory that reaffirms that new MMOs, which includes CAMs and modified CAMs, are new chemical substances subject to TSCA. Anyone who plans to manufacture (including import) a CAM or modified CAM that is not on the TSCA Inventory must comply with the TSCA section 5 new chemical requirements and implementing regulations.
In January 2022, EPA launched a similar effort to streamline the review of dozens of PMNs for biofuels that could be used to displace current, higher greenhouse gas emitting transportation fuels. Under this effort, EPA has completed about 95 percent of all biofuel PMNs submitted since the initiative was announced.
More information about EPA’s review of new chemicals and MMOs.
Today, the U.S. Environmental Protection Agency (EPA) announced its intent to initiate a new rulemaking and anticipates proposing new rules for five persistent, bioaccumulative and toxic (PBT) chemicals that are the subject of final risk management rules under the Toxic Substances Control Act (TSCA). These rules address exposure to toxic chemicals that remain in the environment for long periods of time and build up in the body. Additionally, EPA is taking action to extend the compliance dates for the prohibitions on processing and distribution and the associated recordkeeping requirement of one of these PBT chemicals, phenol, isopropylated phosphate (3:1) (PIP (3:1)).
New Rulemaking on PBT Chemicals
TSCA directs EPA to take expedited action on certain PBT chemicals to reduce exposure and protect human health and the environment. Consistent with that mandate, final risk management rules restricting the use of five PBT chemicals were issued under the previous Administration in January 2021 and went into effect in February 2021.
In a March 2021 notice, EPA announced it was reviewing these rules in light of Executive Orders and other guidance provided by the Biden-Harris Administration and opened a public comment period to collect additional comments or information relevant to compliance dates, specifically requesting comment on the PIP (3:1) compliance dates for use in articles, and any aspect of the final PBT rules. After further review, EPA is considering revising all five of the final rules to further reduce exposures, promote environmental justice, and better protect human health and the environment. EPA plans to issue a proposal for a new separate rulemaking on all five PBT chemicals in the spring of 2023. The current provisions of the January 2021 risk management rules remain in effect while EPA is working on this new rulemaking effort, with the exception of PIP (3:1) as described below.
PIP (3:1) Compliance Date Extension
EPA is extending certain compliance dates for PIP (3:1) to March 8, 2022, to address the hardships inadvertently created by the original applicable compliance dates in the January 2021 final rule to ensure that supply chains are not disrupted for key consumer and commercial goods. EPA will also soon issue a notice of proposed rulemaking that, if finalized, would further extend the compliance dates.
Following the release of the January 2021 rule, stakeholders informed EPA that the prohibition on processing and distribution of PIP (3:1) could impact articles used in a wide variety of goods and noted that the complexity of international supply chains makes locating the presence of, and finding alternatives to, PIP (3:1) in components challenging.
Despite EPA’s extensive outreach conducted during development of the PBT rules, most stakeholders contacting EPA after the rule was finalized did not comment on the proposal or otherwise engage with the Agency on the PIP (3:1) rulemaking, and do not appear to have previously surveyed their supply chains to determine if PIP (3:1) was being used. As a result, EPA did not have a full understanding of the impact of the prohibition prior to issuing the January 2021 final rules. While some commenters on the 2019 proposed rule indicated that PIP (3:1) may be present in articles, their comments were very general and did not identify specific uses or specific concerns with the March 8, 2021, compliance date. In response to this information, in March 2021, EPA issued a “No Action Assurance” to ensure that the supply chain of these important articles was not interrupted.
In conjunction with issuing the “No Action Assurance,” EPA issued a notice requesting further comments and information from industry stakeholders on the impact of the compliance dates, including specific information about the articles for which the compliance dates would need to be extended and a timeline for removing PIP (3:1) from their supply chains. However, industry commenters indicated the need for varying time frames to remove PIP (3:1) from their supply chains, and many did not provide sufficiently specific information about their operations to support their assertions.
To ensure that supply chains continue uninterrupted, EPA has issued a final rule providing a short-term extension of the specified compliance dates for PIP (3:1) articles until March 8, 2022. Soon, EPA will issue a notice of proposed rulemaking seeking comment on a further extension of the compliance date for PIP (3:1) articles to align with certain comments received and the expected timing for the new rulemaking on PBT chemicals previously mentioned. EPA will be accepting public comments in docket EPA-HQ-OPPT-2021-0598 on www.regulations.gov for 60 days from publication of that proposed rule. EPA intends to finalize this proposed rulemaking, which would further extend certain compliance dates, before March 8, 2022.
As part of the separate rulemaking on all five PBT chemicals planned for 2023, EPA intends to reevaluate the current rules for PIP (3:1) and the other PBTs, as well as provide a description of the specific kinds of information the Agency will require to support any additional extensions to the compliance dates. EPA will expect industry commenters to provide documentation of the specific uses of PIP (3:1) in articles throughout their supply chains, documentation of concrete steps taken to identify, test, and qualify substitutes for those uses, documentation of specific certifications that would require updating and an estimate of the time that would be required. Without this more specific information from suppliers, EPA will be unlikely to extend the compliance dates again.
PIP (3:1)-containing articles covered by the short-term compliance date extension include those that might be used in cellular telephones, laptop computers and other electronic devices. They also include articles that might be used in industrial and commercial equipment used in various sectors including transportation, life sciences, and semiconductor production, as well as other consumer and commercial goods.
This final rule is effective upon publication.
Reaching Another TSCA milestone, EPA Identifies 40 Chemicals to Prioritize for Risk Evaluation
Contact Information: (press@epa.gov)
WASHINGTON (March 20, 2019) — Today, the U.S. Environmental Protection Agency (EPA) is publishing a list of 40 chemicals to begin the prioritization process – the initial step in a new process of reviewing chemicals currently in commerce under the amended Toxic Substances Control Act (TSCA).
“EPA continues to demonstrate its commitment to the successful and timely implementation of the Frank R. Lautenberg Chemical Safety for the 21st Century Act,” said EPA Administrator Andrew Wheeler. “We are delivering on the promise of Lautenberg to better assess and manage existing chemicals in commerce and provide greater certainty and transparency to the American public.”
“Initiating a chemical for high or low prioritization does not mean EPA has determined it poses unreasonable risk or no risk to human health or the environment; it means we are beginning the prioritization process set forth in Lautenberg,” said Alexandra Dapolito Dunn, Assistant Administrator for EPA’s Office of Chemical Safety and Pollution Prevention.
The Agency is releasing this list in order to provide the public an opportunity to submit relevant information such as the uses, hazards, and exposure for these chemicals. A docket has been opened for each of the 40 chemicals. The publication of this list in the Federal Register initiates a 90-day public comment period. Publication also activates a statutory requirement for EPA to complete the prioritization process in the next nine to 12 months, allowing EPA to designate 20 chemicals as high priority and 20 chemicals as low priority by December 2019.
TSCA requires EPA to publish this list of 40 chemicals to begin the prioritization process to designate 20 chemicals as “high-priority” for subsequent risk evaluation and to designate 20 chemicals as “low-priority,” meaning that risk evaluation is not warranted at this time.
One of the chemicals identified for high-priority evaluation is formaldehyde, a chemical that has been studied by EPA’s Integrated Risk Information System (IRIS) program for many years.
“Moving forward evaluating formaldehyde under the TSCA program does not mean that the formaldehyde work done under IRIS will be lost,” added Dunn. “In fact, the work done for IRIS will inform the TSCA process. By using our TSCA authority EPA will be able to take regulatory steps; IRIS does not have this authority,” she noted.
When prioritization is complete, chemicals designated as high priority will begin a 3-year risk evaluation process to determine if the chemical, under the conditions of use, presents an unreasonable risk to human health and the environment. The designation of a chemical as a low priority means that further risk evaluation is not warranted at this time.
The 20 high priority candidate chemicals include seven chlorinated solvents, six phthalates, four flame retardants, formaldehyde, a fragrance additive, and a polymer pre-curser. EPA has received a manufacturer request for a risk evaluation of two additional phthalates and is currently determining whether the request contains the minimum needed elements to proceed under EPA’s regulations. If complete, EPA has 15 days to provide notice of such a request.
The 20 low priority candidate chemicals have been selected from EPA’s Safer Chemicals Ingredients List, which includes chemicals that have been evaluated and determined to meet EPA's safer choice criteria.
The list of chemicals can be found here: https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/list-chemicals-undergoing-prioritization
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