The US Toxic Substance Control Act (TSCA) Uta Becker-Guerke May 2017

Toxic Substance Control Act (TSCA) Passed in 1976 5 out of less than 300 substances have been regulated 25 years ago EPA* last tried and failed to regulate an existing chemical (asbestos) EPA: Environmental Protection Agency 2

Toxic Substance Control Act (TSCA) Reform: The Frank Lautenberg Chemical Safety for the 21st Century Act (2016) Focuses on the use of a chemical and the risk to health and environment 3

The new Toxic Substance Control Act = The better REACH 4

TSCA vs REACH 5 TSCA REACH EPA determines the safety of a substance Industry is to show that the substance is safe to use („no data, no market“) EPA can require use information directly from the user Information on use from the supply chain is reported to the substance manufacturer Prioritization of chemicals: chemicals deemed high priority must undergo further evaluation All in-scope substances need evaluation Substance assessment based on risks to health and environment Substance assessment based on risks to health, environment and economy No set data requirements to determine unreasonable risk Mandatory tests to be performed for each substance that is registered 5

Toxic Substance Control Act (TSCA) How the Lautenberg Act works Existing Chemicals Identify Chemicals active substances Inactive substances Prioritize High-priority chemicals Low priority chemicals Evaluate Testing and assessment Determine Unreasonable risk to health and environ-ment? Manage Risk restriction ban Enforcable deadlines for each step 6

Toxic Substance Control Act (TSCA) How the Lautenberg Act works New Chemicals Notice Information about substance and uses Review and Evaluate Notice complete and correct? Produced in large amounts? Significant release or exposure? Determine Unreasonable risk to health or environment? Additional data needed? Manage Risk Restriction Ban 7

Toxic Substance Control Act (TSCA) The Basics Start of production of a new chemical or a new use triggers actions by EPA. Fees need to be paid for the handling of a substance by TSCA, starting from 100$ up to 2500$ with a maximum of either 25% or 25 million$ in annual user fees. A new fee structure is under development but not yet published. Small and Medium sized companies pay smaller fees and are exempted from certain reporting obligations Animal tests are to be reduced to the absolute minimum Substances on the substance lists from 2012 and 2014 will be used as a starting point 52 substances from the lists are not covered by REACH 10 substances have been prioritized The first prohibition covered Trichloroethylene used as aerosol degreaser 8

Toxic Substance Control Act (TSCA) The Basics Recent activities cover: Polychlorinated biphenyls Asbestos Mercury Formaldehyde Lead Methylene chloride NMP 9

TSCA vs GADSL and REACH 10

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Thank You for your Attention 12