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The new TSCA law not REACH (in data requirements)

Posted by Neno Duplan

After a bipartisan accord, the US Congress overhauled the 40-year-old Toxic Substances Control Act (TSCA), with legislation to give the EPA greater powers to regulate about 100 hazardous chemicals. This is the first major statutory update to US environmental law that’s been passed in over 25 years. On a 403-12 vote, the U.S. House of Representatives on 24 May 2016 approved bipartisan legislation to amend the key provisions of the TSCA.

Under existing law, the Environmental Protection Agency (EPA) has succeeded in regulating only five toxic chemicals since 1976, prompting public health advocates to decry TSCA as broken. Part of the problem is that the law grants EPA only 90 days to decide whether a new chemical poses “unreasonable risk” before it can enter the market, and agency officials say they rarely get the toxicity data they need to make that call in time.

The compromise legislation will remove those procedural hurdles, require EPA to focus on “high priority” chemicals such as arsenic and asbestos, and give the agency new tools to collect data from companies. It also grandfathers in some existing state chemical safety laws, such as those enacted under California’s Proposition 65, but limits states’ authority to create their own restrictions on chemicals in the future. State pre-emption was a key point of contention between Democrats and Republicans during negotiations.

So how does the new TSCA law compare to the EU REACH program? REACH (Registration, Evaluation, Authorization and Restriction of Chemical substances) is a regulation of the European Union, adopted to improve the protection of human health and the environment from the risks that can be posed by chemicals. REACH also promotes alternative methods for the hazard assessment of substances to reduce the number of tests on animals. Under the REACH Regulation, companies are responsible for providing information on the hazards, risks and safe use of chemical substances that they manufacture or import.

One notable difference between  REACH and TOSCA is how they support downstream users in implementing their chemicals management programs. Regarding knowing chemicals in products, REACH provides clear direction that downstream users must communicate uses up to suppliers and know and publicly disclose (if requested) if their product contains substances of very high concern (SVHC). The TSCA  does essentially nothing to support downstream users in knowing chemicals in products and disclosing them to the public, and its requirements for upstream communication to suppliers on uses are uncertain.

Significantly, REACH requires companies to provide minimum data sets on the inherent hazards of chemicals. This data enables downstream users to evaluate and compare chemicals on their hazard characteristics. TSCA, while expanding the ability of the US EPA to require testing of chemicals, explicitly prohibits the agency from requiring minimum data sets.

While it is important to avoid the unnecessary testing of chemicals, it is also vital to have a data set on chemicals that enable their comparison on a common set of endpoints. The EPA needs the authority to establish a minimum data set on chemicals, although this may differ depending on the specific chemical.

On assessing the hazards of chemicals, the new  US law falls short of REACH and impedes harmonizing European and US requirements for chemical testing. Given that most US chemical companies sell into the European market, and therefore are already meeting those requirements, it is inefficient and wasteful to establish a totally separate testing regime in the US.

To support the use of inherently safer chemicals, REACH provides a clear and more streamlined process for identifying and restricting SVHCs. Over the course of seven years, the Regulation has identified 161 Candidate SVHCs, while over five years, the  US bill only requires the designation of 25 high priority chemicals and with new law extending that number to about 100 chemicals. Harmonization, consistency, and predictability are critical for downstream users, and these elements are all lacking in the new TSCA law.

 

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