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Why significant but balanced changes are needed to TSCA’s new chemicals provisions

Richard Denison, Ph.D.is a Lead Senior Scientist.

A key need for reform of the Toxic Substances Control Act (TSCA) is making enhancements to the law’s provisions addressing new chemicals prior to their commercial manufacture.  The Senate bill makes moderate but critical improvements to these provisions.

These improvements arose through extended negotiations that sought to carefully balance two legitimate competing interests:  On the one hand, ensuring that the safety of new chemicals is carefully examined and a reasonable assurance of safety is provided before market entry – which the current law does not provide.  On the other hand, ensuring an efficient short process is utilized that doesn’t unduly slow or create too high a bar for market entry or have the unintended consequence of impeding innovation – which the current law does provide.

That balance was struck through a set of provisions that:

  • require for the first time that EPA make an affirmative safety finding as a condition for market entry, but using a standard – that a new chemical is likely to meet the safety standard – that is lower than that applicable to existing chemicals undergoing full reviews;
  • maintain current TSCA’s typical 90-day review period for new chemicals, even shortening that period when EPA can make a positive safety determination more quickly;
  • ensure that new chemicals can’t enter the market when information is not sufficient to make an affirmative safety finding, while retaining TSCA’s lack of a requirement for a minimum up-front data set for new chemicals; and
  • require EPA to carefully consider the need to extend to other companies any conditions or restrictions it places on a company that first brings a chemical into commerce, and either do so or explain why that is not needed.

I believe that this compromise, while unlikely to please anyone completely, represents significant improvement over the status quo, retaining its positive features while addressing its shortcomings.

There is actually considerable support that has been voiced for this balanced approach, including from industry and from the Environmental Protection Agency (EPA), as well as groups like my own.   Read More »

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TSCA reform legislation: EPA review of new chemicals

Richard Denison, Ph.D.is a Lead Senior Scientist.

Part 1              Part 2              Part 3              Part 4              Part 5

[UPDATE 5-17-15:  On April 28, 2015, the Senate Environment and Public Works Committee passed a revised version of the Lautenberg Act out of the committee on a bipartisan 15-5 vote.  On May 14, 2015, the House Subcommittee on Environment and the Economy passed a revised version of the TSCA Modernization Act of 2015 out of the subcommittee on a bipartisan 21-0 vote.  UPDATE 5-28-15:  The legislation was formally introduced as H.R. 2576 on May 26, 2015.  The new versions made no significant changes to the new chemicals provisions discussed below.]

This is the second in a series of blog posts looking at less talked-about, but critically important, elements of bipartisan legislative proposals to reform the Toxic Substances Control Act (TSCA).  This post deals with EPA authority to review new chemicals prior to their entry into commerce.

TSCA divided the universe of chemicals into two groups:  “Existing chemicals” are those on the market at the time the first TSCA Inventory was established (1979), numbering some 62,000 chemicals.  These chemicals were grandfathered in by the original law, with no mandate for them to be tested or reviewed for safety.  “New chemicals” are those that entered commerce at some point since 1979, numbering some 23,000 chemicals.  Between 500 and 1,000 new chemicals enter commerce in a typical year.  (Given these large numbers, it’s surprising how relatively little focus there has been on the way bipartisan reform proposals would address new chemicals.  I’ll amplify on this point at the end of this post.)   Read More »

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