On February 7, 2018, US Environmental Protection Agency (EPA) Administrator Scott Pruitt signed a proposed rule to establish user fees to defray EPA’s costs of administering its responsibilities under the Toxic Substances Control Act (TSCA), as amended by the 2016 Frank Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act). EPA estimates in the proposed rule that it will collect about $20.05 million per year in user fees, not counting any user fees associated with manufacturer-requested risk evaluations, which would range from $1.3 million to $2.6 million per evaluation. Continue Reading EPA’s Proposed TSCA Fees Rule – Key Issues

Last year, President Obama signed into law the amended Toxic Substances Control Act (TSCA). Congress made substantial changes with respect to how both existing and new chemical substances are regulated. Some of these changes are significant and will have a direct impact on US chemical manufacturers, importers, distributors and users. However, the US did not attempt to mimic the EU’s REACH Regulation.

This article provides a high-level comparison of the main building blocks of the two regimes, bringing out the main similarities and differences between them. Of course, these are two different jurisdictions and no direct comparison can be completely valid, but it is worth making the comparison nonetheless, because many companies operate across both regions and because other jurisdictions have mimicked REACH in their regulatory reform, whereas the US has chosen not to. Continue Reading Reformed TSCA and REACH: How Do They Compare?

Last year Congress directed the US Environmental Protection Agency (EPA) to review new chemicals by a new process. A major question for manufacturers and consumers is whether EPA can do this within a reasonable time period without unnecessarily getting in the way of innovation.

Since enactment of the Lautenberg Act amending the Toxic Substances Control Act (TSCA) in June 2016, the pace of EPA’s review of new chemicals has slowed dramatically. While EPA’s pre-enactment new chemicals program handled around 1,000 premanufacture notifications (PMNs) annually, EPA estimates that a backlog of about 600 new chemicals had built up by January 2017, which created a substantial concern in the regulated community.

Continue Reading EPA’s New Chemicals Review Program – A Status Report