US Toxic Substances Control Act
August 19th, 2016
The Toxic Substances Control Act (TSCA) is the legislative framework for regulation of industrial chemicals in the USA. Following a lengthy period of review, a major revision of the Act has now been signed into law with immediate effect. This development brings significant changes for the chemicals industry as well as for the role of the US regulator, the Environmental Protection Agency (EPA).
Under the reformed TSCA, the EPA is now required to evaluate existing chemicals, in addition to new-to-market chemicals, for safety in terms of the environment and human health, using risk-based review criteria. In practice this is understood to mean a prioritised risk assessment programme undertaken by the regulator, similar to the EU’s former ‘Existing Substances Regulation’ (now repealed by the REACH Regulation). ‘Existing’ chemicals in the TSCA context means the many thousands of chemicals already on the market prior to the original legislation in 1976, and ‘grandfathered’ into the TSCA system with a presumption of safety; in the vast majority of cases, these have not been assessed further. A phased prioritisation programme for evaluation of these existing chemicals will be followed. To fulfil the data needs and avoid delays, the EPA is granted new regulatory powers to impose deadlines, raise fees, and require the industry to deliver new studies to fill data gaps.
The EPA is now required to make an affirmative determination of the associated risk for chemicals being commercialised for the first time, or for significant new uses of an existing chemical. Supply will be dependent on a finding that unreasonable risks are not likely.
The developments are expected to benefit consumer confidence, particularly due to the safety evaluation (risk assessment) process, which must cover vulnerable populations such as children and the elderly. It is expected that there will be an increase of transparency, for example through limitations on CBI claims, and through publication by the EPA of its findings.
The EPA can be expected to prioritize those existing substances which are persistent, bioaccumulative and with specific toxicity hazards (including carcinogenicity). The new Act sets out a timeline for the EPA to define how future prioritisation assessments will be made, and to complete the first set of its evaluations. The EPA has regularly announced updates to its work programme for several years, and the early priority substances for evaluation are expected to be drawn from this system.
Companies manufacturing or importing chemicals for US markets need to prepare to comply with the new requirements of TSCA. The passing of the new law appears well received by industry groups, despite the possibility that companies which manufacture, import or use priority chemicals can expect to face information requests as well as further testing costs. Bilateral arrangements with similar legislation in other parts of the world are not yet announced, though a work plan is maintained under the ‘statement of intent’ between the EPA and ECHA (to cooperate on technical issues in chemical safety) which sets out numerous topics for exchange of information.
Some consumer organisations cite state-level legislature proposals, now abandoned, that could have presented opportunities to set higher standards for safety. Under the ESR legislation in Europe, the processes of chemical prioritisation and detailed risk assessment were in some cases rather lengthy. Pushing both processes forward rapidly to deliver meaningful conclusions for such a large number of chemicals could present a significant challenge. Nevertheless, the amended TSCA represents a significant step forward for the standards of data completeness and safety. The coming months will bring more clarity on how the EPA will proceed to carry out its new responsibilities, and the detailed implications for the US chemicals industry.