TSCA and US state legislation: Navigating your chemical or agrochemical through the federal and state regulatory landscape in the USA

Registering your chemical or crop protection product with the US EPA under TSCA or FIFRA is the first and biggest step in its regulatory journey in the USA. But you will also need to navigate state-specific legislation and regulations, and for crop chemicals this includes registering in every state where they will be used.

Guard against delays to market by understanding the implications of these systems for your regulatory submissions.

What is the overall regulatory landscape for chemicals in the USA?

Federal legislation differs for chemicals (described here) and crop protection chemicals (discussed later). To be manufactured in or imported into the USA, a chemical must be registered with the US Environmental Protection Agency (EPA) under federal legislation encompassed by:

• Toxic Substances Control Act (TSCA) 1976, which is the primary national legislation and encompasses all chemicals other than pesticides, foods, drugs and cosmetics
• Lautenberg Chemical Safety for the 21^st Century Act (LCSA) 2016, which amended and updated TSCA.

TSCA gave the EPA responsibility for assessment and regulation of commercial chemical substances, with authority to require reporting, record-keeping and testing. It grandfathered in existing chemicals, presuming them safe. For new chemicals and new uses of existing chemicals, it authorized the EPA to regulate to eliminate unreasonable risk. Nevertheless, it was criticized for aspects such as directing the EPA to use the ‘least burdensome method’ for risk reduction, i.e. balancing risks with benefits, and for requiring inadequate safety data.   

The LCSA also aims to eliminate unreasonable risk by requiring health hazard, human exposure and environmental risk to be assessed for all new chemicals and new uses. However, it introduced stronger testing powers and increased public transparency for chemical information. It dropped the earlier approach of balancing risk with benefits, explicitly ruling out considerations of cost or other non-risk factors. It also introduced a program of risk evaluation of all existing TSCA-registered chemicals, with provisions for the EPA to request more information and studies on safety.

What is the relationship between TSCA and state regulations?

Once a chemical is registered under TSCA the individual states can superimpose more stringent rules, though they generally can’t approve chemicals absent from the TSCA inventory. So the regulatory landscape varies from state to state. States can restrict chemical uses in certain types of product, for example six states have limited the use of cadmium in children’s consumer products while not banning cadmium itself.

This divergence between federal and state regulation arose because, over time, the 1976 TSCA was increasingly regarded to be inadequately protective. The result was that state chemical regulation expanded. Introduction of LCSA’s more stringent requirements was expected to reduce expansion of state-level restrictions.  It grandfathered in all existing state requirements and, in principle, pre-empts state-level action on chemicals approved by the EPA. However, it hasn’t meant states ceased making regulatory decisions in relation to their environmental authorities on aspects such as air, water, waste disposal and treatment, and human safety, or when the EPA has not yet evaluated a chemical.

What are the TSCA submission processes and requirements?

The TSCA Inventory lists all chemicals which may be legally manufactured, processed, or imported in the USA. Any chemical which is not on the inventory is a “new chemical” for the purposes of regulation, unless it matches one of several reasons for exemption, for example if it is a naturally occurring material. All new chemicals must go through the TSCA registration process before they can be manufactured or imported, as summarized in Figure 1.

Figure 1: Submission process for registering a chemical with the US EPA under the LCSA and TSCA.

Data requirements under TSCA are not pre-set in the way that they are for Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) regulations such as EU-REACH and K-REACH, but they are similar. Accordingly, data pull-through from non-US submissions is encouraged by the EPA, with the aim of reducing animal use and with accompanying time and cost benefits. The EPA encourages companies to have a pre-submission meeting to discuss data requirements, and this is an opportunity to understand the EPA’s approach to screening for potential risks and identify data gaps to fill before submitting a pre-manufacture notice (PMN). It is fairly rare to have to perform new animal testing but more common to have to obtain new exposure data, for example dermal absorption of a chemical.

Key to regulatory success is:

• Demonstrating your chemical does not pose any “unreasonable risk” via human exposure or environmental effects
• Ensuring you do not supply “insufficient information” (now a ground for rejection)
• Including “conditions of use” (COIs): intended, known and reasonably foreseen

What is the scope of state-level chemical regulation?

Many states have their own separate chemical safety legislation, concentrating on the hazards that individual chemicals pose to the public or the environment. In this way a state can restrict a chemical registered under TSCA, unless EPA has determined there are no unreasonable risks.

The scope of legislation and the targeted chemicals vary from state to state. As Figure 2 shows, there is currently a focus on legislating with regard to use of chemicals in food packaging. These include per- and polyfluoroalkyl substances (PFAS), which leach from food packaging, and bisphenol A (BPA), used as a hardening substance in plastics and subject to restrictions enacted in 13 states since 2009.

Figure 2: The number of chemical bills proposed in individual US states in the first half of 2021 (data from Chemical Watch) the majority relating to PFAS (per- and polyfluoroalkyl substances), which include PFOS (perfluorooctanesulfonic acid) and PFOA, (perfluorooctanoic acid).  Numbers of chemicals are given in parentheses. BPA, bisphenol A; DIDP, di-isodecyl phthalate; TCEP, tris(2-chloroethyl) phosphate; TCPP, tris(1-chloro-2-propyl) phosphate.

PFAS – an example of increasing state legislation

Between 2007 and mid-2021, 20 US states adopted over 60 separate state policies on PFAS, on issues ranging from public authorities’ duties with respect to environmental monitoring and clean up, through to outright bans, for example:

• Requirement for water boards to monitor drinking water for PFAS, setting maximum levels
• Banning use of recycling symbols on products containing PFAS
• Empowering public authorities to seek compensation from responsible parties for PFAS clean up
• Arrangements for residents needing new water supplies due to PFAS contamination
• Prohibition of use in specific products, for example children’s products, cosmetics, firefighting foams and food packaging

For manufacturers and importers seeking regulatory approval of a new chemical or new use, chemical bans are of particular concern. Continuing with PFAS as an example, between 2008 and 2021 Maine adopted thirteen polices, finally legislating for an almost total ban on PFAS in any product, to commence in 2030 with exemptions only for unavoidable uses for example in medical devices.

Among US states, this contributes to Maine being regarded as a leader in chemical safety, with three statutes:

• Protect Children’s Health and the Environment from Toxic Chemicals in Toys and Children’s Products
• Toxic Use and Hazardous Waste Reduction
• Safer Chemicals in Consumer Products and Services

California – an example of a state regulatory framework

Another leader is California, with state regulation of chemicals housed by Cal-EPA: the California Office of Environmental Health Hazard Assessment (OEHHA) for chemicals and California Department of Pesticide Regulation for pesticides. The OEHHA implements the best-known state-level regulation: Safe Drinking Water and Toxic Enforcement Act of 1986 – “Proposition 65”. This requires businesses to provide public warnings of significant exposures to chemicals that cause cancer, birth defects or other reproductive harm. It also prohibits discharges into sources of drinking water. A typical warning is:

“⚠ WARNING: This product can expose you to chemicals including arsenic, which is known to the State of California to cause cancer. For more information, go to www.P65Warnings.ca.gov.”

Proposition 65 is a “right-to-know” law, enabling Californians to make informed choices. Although products with its warnings can legally be sold, in effect it is a ban in many instances because it entitles individuals and district/city attorneys to file a lawsuit against violators.

There are now >900 chemicals on the Proposition 65 list. An example is BPA, added in 2015 because of its effect on the female reproductive system. Proposition 65 has resulted in replacement of many chemicals in products, e.g. six phthalates in vinyls.

Opportunities when a state bans specific use of a chemical

If a state judges a chemical unsafe, you may be able to mitigate restrictions for your product. Some states will review scientific justifications, where there is no alternative substance for use in a specific product, as is the plan for PFAS after 2030 in Maine. If this option is unavailable or unsuccessful, you can seek an efficient substitute that performs the same function. In effect, you will be applying the principles of green chemistry (see later).

How do state and federal regulations differ for crop protection chemicals (CPCs)?

CPCs are also regulated by the US EPA though not under TSCA. They too are subject to separate state legislation.

At the federal level, CPCs are regulated by the EPA under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) with respect to registration and label approval, and under the Federal Food, Drug and Cosmetic Act (FFDCA) for setting tolerances in food or animal feed. They are also subject to provision of the Food Quality Protection Act (FQPA), the Pesticide Registration Improvement Act (PRIA) and the Endangered Species Act (ESA).

Unlike the updated TSCA process, EPA regulation of CPCs continues to balance their benefits against their risks, for example balancing raised yield against the risks associated with a CPC that would be used to achieve the yield.

Separate registration of CPCs is required in each state and territory where your active substance (AS) will be marketed. Additionally, in special circumstances FIFRA allows state registration of a CPC that is not otherwise permitted by the US EPA. These include specific local need (SLN) and experimental and emergency uses such as a “quarantine exemption”, which can be given for up to 3 years to control the introduction or spread of a new pest species.

A separate application to each state’s regulatory agency is required. Generally, this is done after EPA approval. However, for California it is best done on submission to the EPA: the California Department of Pesticide Regulation has the most exacting registration process and often more stricter data requirements than other states or the federal government, sometimes requiring further testing in the same way as the EPA does.

The National Pesticide Information Center lists regulatory agencies across US states and territories.

What relevance does green chemistry have in federal and state regulation of chemicals?

Green chemistry, also known as sustainable chemistry, is the design of chemical products and processes in a way that eliminates or reduces generation or use of hazardous substances across the lifecycle of a product. It is not regulatory driven at federal or state level but many states have statutes – a list is provided by the National Conference of State Legislatures (NCSL). It is worth applying the EPAs 12 principles of green chemistry when for your product you need to seek an alternative to a chemical that has a state ban, for example by choosing a chemical that breaks down to an innocuous substances after use so that it does not accumulate in the environment.

Also there may be benefit in moving your chemical beyond regulatory compliance to meet customer/investor expectations, by obtaining a green label from a program such as:

• US EPA Safer Choice listing
• US EPA Design for the Environment for pesticides (DfE) listing
• GreenScreen® certification (US based, globally recognized).

Data requirements for these programs are similar to those for US EPA, EU-REACH, etc.

What does the future hold?

The application of regulations is evolving as TSCA develops beyond its 2016 update. Just one instance is the 2021 plan to adopt a tiered data reporting (TDR) approach for evaluation of existing chemicals, increasing the depth of detail required for high-priority chemicals.

Furthermore, five states have statutes authorizing development of state-level comprehensive chemical regulatory programs (California, Maine, Minnesota, Oregon and Washington). Legislators and regulators will keep a keen eye on the growing chemical and agrochemical markets within their remit:

• US chemical market: c. 1000 new chemical notices received under TSCA each year, with US chemical imports over US$100 bn/year (>US$55 bn/year organic chemicals)
• US agrochemical market: consumption 11.2 million tons in 2019, with a rising focus on food security and a push to develop new (sustainable) agrochemicals

Conclusion

Multiple requirements exist at US federal and state level and the situation is constantly changing, for example 43 state laws on chemicals were passed in just the first half of 2021, 34 of them in the 10 most active states. It is anticipated that state legislation and processes will continue to vary widely and will continue to evolve.

You will need to plan to address the regulatory requirements of multiple states for your new and existing chemicals/agrochemicals. Consider partnering with a team who keep ahead of the shifting landscape. At Labcorp we combine global regulatory science expertise, federal and state regulatory experience and laboratory testing capabilities under one roof to help you navigate through it.