TSCA

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EPA’s new policy may result in public disclosure of confidential business information if confidentiality is not properly claimed.

By Julia A. Hatcher, Ann Claassen, and Stijn van Osch

The US Environmental Protection Agency (EPA) announced on July 15, 2019 that, beginning August 15, 2019, EPA would no longer provide notices of deficiency to businesses that submit procedurally flawed confidential business information (CBI) claims under the Toxic Substances Control Act (TSCA). Instead, EPA will only send a notice that the agency does not consider such information confidential, and will make such information available to the public. This policy change, which EPA published in the Federal Register on July 16, means that businesses should take care to provide complete and accurate substantiation for CBI, or risk public disclosure of confidential information.

By Paul Davies, Julia Hatcher and Alice Gunn

Barack Obama signed the bipartisan Frank R. Lautenberg Chemical Safety for the 21st Century Act on 22 June of this year. This Act, which came into immediate effect, amends the core provisions of the Toxic Substances Control Act (TSCA), the primary federal law governing chemicals for the first time in 40 years.

The amendments mandate potentially significant actions by the US Environmental Protection Agency (EPA), including: risk screening to identify “high-priority” chemicals; risk evaluation of those chemicals; and promulgation of restrictions (including a possible ban) on any chemical deemed to “present an unreasonable risk”. The amendments not only allow states and localities to continue enforcement of their existing chemicals laws, but also grant states some latitude – and, in the event of EPA inaction, wide latitude – to enact new laws.

The TSCA amendments establish a series of ambitious deadlines to implement the measures. Within the first six months, EPA must begin risk evaluations on 10 “high priority” substances. Within the first year, EPA is required to complete several formal rulemakings, including to establish processes for prioritisation of additional chemicals as “high priority”, for risk evaluation and for “resetting” the inventory of chemicals in commerce. Within the following six months, the EPA must work on additional guidance documents, policies and activities, including with respect to the protection of confidential business information (CBI).