On 22 June 2016, the ‘Frank R. Lautenberg Chemical Safety for the 21st Century Act’ became law in the USA. This act amended the ‘Toxic Substances Control Act’ (TSCA), which is the primary US chemicals management law. One year on, on 22 June 2017,2 the Environmental Protection Agency (EPA) fulfilled its statutory duty by issuing additional rules and guidance. But what will the new TSCA achieve and how will it impact chemical producers and importers? Read on to find out more.
A brief overview of TSCA legislation
In 1976, TSCA was first enacted to give authority to the EPA to police the production, importation, use and disposal of chemical substances and/or mixtures in the USA. The TSCA empowered the EPA to determine reporting, recordkeeping, testing requirements and restrictions for chemicals.
The new 2016 act was designed to mandate the evaluation of existing chemicals, define new risk-based safety standards, increase the public transparency of chemical information and enshrine funding of the EPA to enable it to carry out these duties. Learn more by reading our informative "Toxic Substances Control Act (TSCA) reform" white paper.
|In 1976, TSCA was first enacted to give authority to the EPA
to police the production, importation, use and disposal of
chemical substances and/or mixtures in the USA
The specific rules that the EPA uses to implement the 2016 act were published in 2017. These included:
- A prioritization rule that establishes the process and criteria for identifying 'high-priority' chemicals requiring risk evaluation from 'low priority' chemicals
- An inventory update rule to enable the classification of substances as either 'active' or 'inactive' in the US market over a ten-year 'look-back period' ending on 21 June 2016
- A risk evaluation rule, which outlines how chemicals will be assessed for their risk to health or the environment. This includes consideration of the conditions of use and the impact on potentially susceptible populations
- External risk evaluation guidance, which is a document outlining the science, standards and processes required for risk evaluation submissions
- Scoping documents for the first ten chemical substances, which outline the risk evaluations, hazards, exposures, conditions of use and potentially susceptible populations that the EPA will consider
The aim of the 2016 TSCA legislation was to make it easier for the EPA to undertake its work on three main areas, namely:
- New chemicals - the estimated 1,000 new substances entering the market every year
- Existing chemicals - the estimated 85,000 substances currently on the TSCA inventory
- High-priority or high-risk substances on the work plan list of the ten first substances
The 2016 legislation had bipartisan support across the US government, with wide support from industry, scientists and environmental groups; however, some of the changes implemented between publication of the draft and final rules have led to disputes and a possible legal challenge. The prioritization rule, specifically the definition of ‘conditions of use’, is causing the main controversy. This is because the ‘circumstances’ in which a substance is used determine its risk priority, and some stakeholders fear that the industry view of these ‘circumstances’ will prevail over any public viewpoint.
Impact on industry and importers
The new legislation has many benefits and implication for producers and importers:
- No set data requirement means that, under the TSCA, the EPA can order specific tests to determine chemical risk. This has the benefit of a very targeted methodology, but it also demands a detailed understanding of the chemistry and biology of each test substance
- A reduction in animal testing will mean a greater use of non-animal technologies such as QSARs, read-across and ToxCast. Leveraging these approaches for each chemical requires expertise, experience and insight.
- Data sharing under the TSCA may allow the reuse of data from other regulatory submissions such as REACH and K-REACH, saving time and money. The exact approach for data sharing has not been elucidated, so knowledge from across regulations may help transition data appropriately.
Learn more by reading our informative "Toxic Substances Control Act (TSCA) reform" white paper.
About the author
Naheed is Business Lead Consultant for Chemicals, and provides Envigo with the leadership and direction in terms of future scientific and regulatory developments, particularly in the innovations space and potential impact with emerging global regulations.Other recent blogs include: