In December 2022, the U.S. Environmental Protection Agency (EPA) updated a section of its website to provide a general overview of EPA’s new chemicals workload, track the current status of active cases currently under review by EPA, and illustrate general statistics for all new chemical submissions received since the Toxic Substances Control Act (TSCA) was amended in June 22, 2016.
The website is intended to provide greater transparency into EPA’s status on its New Chemical Review and additional metrics for both the public and regulated companies.
The website also allows visitors to view statistics related to new chemical submissions prior to the 2016 TSCA reauthorization, New Chemical Program Statistics Prior to June 22, 2016.
TSCA requires EPA to review the potential risks of new chemicals before they enter the U.S. market and, when necessary, put safeguards in place to protect human health and the environment from any risks.
The revised TSCA Section 5 requires any company that plans to manufacture — including import — a new chemical substance for a commercial purpose to provide EPA with notice and obtain EPA’s approval before commercialization. This notice is known as a pre-manufacture notice (PMN). Under the TSCA statute, EPA has 90 days to review the PMN submission and make a determination about effects on human health and/or the environment by evaluating any intended, known or reasonably foreseen uses of the chemical, without consideration of costs or other non-risk factors. EPA’s review must consider effects on susceptible populations such as workers, children and communities located near industrial facilities.
However, the mandate of evaluating PMNs prior to commercialization has led to a significant backlog at EPA and delays in PMN approvals, exceeding the 90-day review period specified in the statute. This has resulted in companies delaying or canceling introduction of new chemical technologies to the U.S. market, or seeking foreign markets for new products. Where prior to the TSCA amendments, companies could begin commercial activity 90 days after a PMN submission, companies now often wait a year or more before EPA completes evaluation of a PMN, leading to uncertainty and derailed market innovation.
Prior to the 2016 amendments to TSCA, EPA issued risk determinations for approximately 20% of new chemical submissions. In 80% of cases, EPA “dropped” the chemical from further review and allowed it to go to market. Following the 2016 amendments to TSCA, EPA is required to make an affirmative risk determination on 100% of new chemical notices submitted under TSCA section 5. Because EPA only made determinations on around 20% of submissions under the pre-2016 law, the amendments resulted in an approximate 5-fold increase in workload for the agency.
Despite the increase in workload, the TSCA new chemicals program has been operating with insufficient resources to meet all the requirements under the amended law. According to EPA, the agency considers a variety of factors in prioritizing new chemical submissions for review including:
- The date of receipt of submission (e.g., EPA generally strives for a first-in-first-out approach, absent extenuating circumstances)
- Statutory and regulatory deadlines
- The extent to which the submitter has provided additional information DURING the review period – subsequent to the original submission – and the level of effort needed to potentially rework some or all of the risk assessment as a result
- Applicability of new innovative approaches EPA has developed to standardize reviews for certain new chemicals (e.g., biofuels, mixed metal oxides (MMO) /cathode active materials (CAMs), etc.)
In the last few years, EPA has received an average of about 500 TSCA section 5 notices and other applications each year. This includes premanufacture notices (PMNs), significant new use notices (SNUNs), and microbial commercial activity notices (MCANs) – all of which must be reviewed within 90 days. EPA’s total new chemicals workload also includes applications for exemptions from the full PMN review process (e.g., low volume (LVE), low release and low exposures (LoREX), test market (TME), etc.). These applications represent over 50% of annual applications, have between 30 and 60 days review periods, and are also reviewed by EPA using a robust risk assessment process. EPA review may indicate that an exemption can be granted only if the submitter amends the exemption request to include certain additional limitations on processing, use or disposal. Grants for LVEs only apply to the LVE submitter, any other manufacturer is required to send a new chemical notice before manufacture.
Contact ACA’s Riaz Zaman for more information.