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

2. 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

3. 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

4. The new Toxic Substance Control Act=
The better REACH 4

5. 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

6. 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

7. 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

8. 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

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

10. TSCA vs GADSL and REACH 10

11. 11

12. Thank You for your Attention12