Manufacturers seeking to bring novel catalysts to market in the United States face a regulatory landscape that is considerably more demanding than their counterparts in Europe or Canada.
Under the Toxic Substances Control Act, the U.S. Environmental Protection Agency conducts a rigorous review and risk assessment for even minute quantities of a catalyst used at industrial sites.
Unlike the European Union or Canada, the United States has no de minimis quantity threshold below which premarket notification is not required for new chemical substances.
Low Volume Exemptions, known as LVEs, go through the same review process as premanufacture notices and must clear a higher bar than many industry participants realise.
Specifically, the EPA must conclude that the LVE “will not present” unreasonable risk before granting it, a standard that demands thorough and well-prepared submissions from notifiers.
A poorly supported LVE submission often increases the time needed for EPA’s review and the chance of EPA denying the LVE, which can set commercial deadlines back many months, at a minimum.
Catalysts present particular challenges because EPA frequently identifies significant toxicity concerns related to the catalyst itself, its ligands, or its degradation products.
EPA may also identify the metal in a catalyst as a persistent, bioaccumulative, and toxic substance, and TSCA does not permit LVEs for per- and polyfluoroalkyl substances or such PBT substances.
In cases where EPA concludes it has insufficient hazard information, the hazard is viewed by EPA as being infinitely high, meaning that exposure or release in any quantity results in denial of the LVE.
Notifiers can address these challenges by preparing and submitting a thorough hazard assessment that considers the catalysts, metabolites, degradation products, and known impurities for both health and aquatic toxicity endpoints.
Eliminating solids handling, for example by manufacturing or importing and processing only liquid solutions, can eliminate concerns EPA has for workers and the general population possibly exposed to dust.
Binding the LVE to a relatively low production volume will minimise release estimates, since EPA will otherwise assess a notification at 10,000 kg per year, the maximum allowed under an LVE.
Binding to “no predictable or purposeful releases” to water can also be an effective strategy for obtaining an LVE grant, provided the supply chain can accommodate this restriction.
Where notifiers distribute the LVE substance to customers who must implement restrictions, EPA can require the exchange of a letter with customers to memorialise the basis for granting the LVE and inform them of their obligations.
LVEs hold many advantages over premanufacture notices, including a shortened review period and a lower submission fee, making them an attractive first step toward commercialisation.
EPA announced efforts in 2025 to increase throughput of LVEs and help clear backlogged cases, adding further tailwinds to this approval pathway for notifiers seeking timely grants.
After an LVE is granted, a notifier may later submit an LVE Modification if restrictions need to be changed, or submit a premanufacture notice if a production volume higher than 10,000 kg per year is needed.