EDF Health

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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Raising the bar for chemical safety will spur, not stifle, innovation

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

An emerging chemical industry talking point in TSCA reform is the claim that imposing new requirements on new chemicals will somehow stifle innovation.  The milder manifestation of this perspective emanates from those who oppose requiring a safety determination for new chemicals unless they raise major red flags in an initial review.

But some in the industry go further, arguing that even requiring safety data for new chemicals would put the big chill on development of new chemicals.

I beg to differ with both arguments.  This post will make the opposite case, and will also argue that true innovation embraces rather than shuns safety, and demands the information needed to demonstrate it. Read More »

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EPA IG report: New Chemicals Program fails to assure protection

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

In a post to this blog nearly a year ago, I noted that many voices in the chemical industry were claiming that EPA’s New Chemicals Program (NCP) was robust and served as an excellent model for TSCA reform.  My post took considerable issue with that point of view, noting the many structural constraints TSCA imposes on EPA in its effort to review new chemicals:

  • No data, no problem: No up-front testing requirement or minimum data set applies to new chemicals.
  • Guessing game: EPA is forced to heavily rely on limited models and methods to predict the toxicity or behavior of a new chemical.
  • Catch-22: While EPA can require testing of a new chemical on a case-by-case basis, it must first show the chemical may pose a risk – not an easy task without any data in the first place!
  • One bite at the apple: EPA typically gets only a single opportunity to review a new chemical.
  • Crystal-ball gazing: EPA has to try to anticipate a new chemical’s for-all-time future production and use.
  • Black box: New chemical reviews lack transparency.
  • Anti-precaution: In deciding whether to require testing or controls for a new chemical, EPA equates lack of evidence of harm with evidence of no harm.

Lately, I’ve been hearing chemical industry representatives trying to resuscitate the NCP-as-model-for-TSCA-reform mantra.  So it is especially timely that a new report from EPA’s Office of Inspector General (OIG) has just been released that again thoroughly dismantles that notion.  The new report’s critique of the NCP closely mirrors the appraisal I provided earlier.  And adding weight to its analysis is the fact that EPA’s senior management has fully concurred with the report’s conclusions and recommendations. Read More »

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EPA’s New Chemicals Program: TSCA dealt EPA a very poor hand

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

[The first post in this series can be found here.]

Some in the chemical industry point to EPA’s New Chemicals Program as a robust program, one that could serve as a model for reform of the Toxic Substances Control Act (TSCA).  Most recently, the National Petrochemical & Refiners Association (NPRA) did so in its testimony at a recent House of Representatives subcommittee’s TSCA oversight hearing.  So just how robust is EPA’s program on new chemicals?  Read More »

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