There are many compliance regulations that require manufacturers to abide by and maintain compliance with different standards of health and safety. One of the most well-known and far-reaching regulations in the United States is a federal regulation called the Toxic Substances Control Act (TSCA). Here we will detail the basics of TSCA as a compliance regulation, discuss recent updates and implications of the statute, and describe the ways in which Toxnot can be a tool to maintain TSCA compliance across your supply chain.
What is TSCA?
As mentioned above, TSCA stands for the Toxic Substances Control Act and was established in 1976. Broadly, TSCA provides the Environmental Protection Agency (EPA) with the authority to oversee the regulation of chemical substances and mixtures through reporting, record-keeping, testing requirements, and restrictions. TSCA is a robust piece of legislation, addressing the production, importation, use, and disposal of specific chemicals like PCBs (Polychlorinated Biphenyls), asbestos, and lead.
Not dissimilar to other governmental and corporate decision-making, a risk-based approach was used when TSCA was first set in motion. Upwards of 60,000 chemicals that were already on the market were grandfathered in, virtually assuming that all of those substances were considered safe until proven otherwise. However, this also exempted those 60,000+ chemicals from the notification process, failing to provide the EPA with the tools needed to appropriately manage and request data on chemicals of concern.
Luckily, in 2016 important revisions were made to TSCA through the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Chemical Safety Act) that was signed into law. Having received bipartisan support from both the House and Senate, the changes to TSCA included new mandatory requirements for the EPA to evaluate existing chemicals, risk-based chemical assessments, increased public transparency, and consistent funding for the EPA to meet the new requirements. Retroactive evaluation of 80,000+ chemicals in circulation is now the big task of the EPA. Additionally, TSCA’s Inventory (containing more than 86,000 chemicals) and the TSCA Section 6 restrictions list (containing 14 chemical groups) is expected to rapidly expand over the next several years.
What is certain is that TSCA compliance can be complex, having different requirements per industry and differing thresholds for certain substances and their allowable use cases. Simply put (but not to be mistaken for simple), compliance under TSCA requires the following:
- Documentation of restricted substance use, retained for a minimum of 3 years from use
- Communication of the presence of banned substances to customers and consumers
- Evaluation of consumables (hydraulic fluids, seals, or gaskets) and maintenance parts used for U.S.-based manufacturing if they contain TSCA substances
Compliance & Revisions to TSCA
As a federal regulation designed to protect human and environmental health, part of TSCA’s purpose is to be updated regularly while being strictly enforced by the EPA. An important update as a result of this is TSCA’s PBT review. In January of 2021, the EPA issued final rules to address its obligations under TSCA for a list of five persistent, bioaccumulative, and toxic (PBT) chemical compounds that met the EPA’s criteria for expedited action. These five PBTs include 2,4,6-tris(tert-butyl)phenol (2,4,6-TTBP) (CASRN 732-26-3); decabromodiphenyl ether (decaBDE) (CASRN 1163-19-5); phenol, isopropylated phosphate (3:1) (PIP (3:1)) (CASRN 68937-41-7); pentachlorothiophenol (PCTP) (CASRN 133-49-3); and hexachlorobutadiene (HCBD) (CASRN 87-68-3). The EPA plans to issue a proposal for new rulemaking on all PBTs in the Spring of 2023. Additionally, of the PBTs chemicals, PIP 3:1 is expected to have the biggest impact on global supply chains as a common replacement for older restricted brominated flame retardants. Up to this point, PIP 3:1 has even been a required additive in some thermoplastics and other industrial applications. For this reason, the EPA has extended compliance dates to October of 2024 for the prohibitions on processing, distribution, and record-keeping that will be required when using PIP 3:1 in certain articles. The takeaway here is that PBTs have been flagged as highly toxic substances that accumulate in the environment and bodies, making them high-priority chemicals to be removed from supply chains. The PBT revisions are one of many TSCA updates and it remains important to follow changes closely if not using a third-party tool to manage your product compliance.
Non-compliance with TSCA can also result in some serious consequences for both businesses and individuals. Depending on the violation, TSCA repercussions can range anywhere from a 1-year penalty, to fines up to $50,000 per day per violation, and even imprisonment. The seriousness of TSCA infractions underscores the importance of being proactive in your compliance.
If you engage with U.S. markets as a manufacturer, TSCA is something that should be top of mind for you and your company. The first and most important step to achieving or maintaining compliance is to ensure that you have your product data. This means you should have a complete and comprehensive product bill of materials (BOMs) for all of your inventory that tells you exactly what substances make up your merchandise. Without this information, you risk non-compliance and should prioritize getting that data to avoid repercussions.
Luckily, Toxnot is a one-stop-shop for your supply chain data collection, storage, and assessment. All within the platform you can collect the information you’re missing, store it safely, and screen your product library against TSCA lists that are maintained bi-weekly. Sign up for a free account today so you can breathe a little easier as you tackle your compliance needs.