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.)  

Section 5 of TSCA provided EPA with authority to review new chemicals prior to market entry.  However, it imposed substantial constraints on EPA in conducting those reviews.  Under TSCA, a company is generally free to start making and selling a new chemical at the end of a 90-day review period, unless EPA finds the chemical “may present an unreasonable risk.”  That is, no affirmative safety decision is required, and the burden is on EPA to find a concern even when safety data are wholly lacking.

I have blogged extensively about the limitations of EPA’s new chemicals reviews.  Let me briefly summarize the key problems here, and refer readers to these blog posts for more detail.

  • 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 effectively equates lack of evidence of harm with evidence of no harm.

How would TSCA reform legislation address these problems?

The Lautenberg Act mandates for the first time that EPA make an affirmative finding of safety for each new chemical as a condition for market access.  It makes clear that manufacture of a new chemical can only start if EPA determines it is likely to meet the safety standard.  Where EPA determines the chemical is not likely to meet the safety standard, it must preclude manufacture or impose restrictions sufficient for EPA then to find the chemical is likely to meet the safety standard.

If EPA finds it has insufficient information to make a determination, it can suspend the review pending receipt of the information, or impose restrictions sufficient for it to make the likely-safe determination even in the absence of the information.  While the bill does not require up-front safety data sets for new chemicals, as noted in my first post in this series, EPA can require testing of new chemicals as needed.  It can do so by issuing orders as well as through negotiating consent agreements.  And it need not first show potential risk or high release or exposure in order to require testing.

Once a new chemical enters commerce, it becomes subject to the bill’s prioritization process.  EPA can review the chemical at any time based on new information that it develops or obtains after the chemical is on the market.  The bill also requires EPA to make public all documents relating to new chemicals and EPA reviews, subject to the bill’s confidential business information (CBI) protections.

The new chemicals provisions of the Lautenberg Act go far to address the fundamental problems with TSCA’s Section 5.

The House discussion draft makes no changes at all to section 5 of TSCA, leaving in place all of the constraints EPA faces under current law.

One final note:  It is interesting how much of the debate over TSCA reform legislation has focused on provisions that would affect far smaller numbers of chemicals than those that pass through EPA’s New Chemicals Program every year.  Major contention has surrounded the number of existing chemicals EPA should be reviewing (with even the most ambitious proposal setting that number at 75 chemicals over a several-year period).  Similarly, there has been much debate over the limited number of high-priority chemicals that states might want to, but under S. 697 could not, regulate during the period between when EPA takes up such a chemical and when it takes final action.  While those questions are important, far less attention has been paid to how EPA’s reviews of new chemicals would be affected by the various TSCA reform proposals; yet, many hundreds of new chemicals undergo such reviews year in and year out.  As this post makes clear, the reform proposals differ starkly with respect to how new chemicals would be reviewed prior to market entry.


Next up:  How chemicals are selected for safety evaluations.

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One Comment

  1. Anthony C. Tweedale
    Posted April 17, 2015 at 8:32 am | Permalink

    Very cogent observation, Richard (futility of # of new chems vs. focus on allowing review of 25 or 75/yr.). One workaround worth seeing if it gets any bipartisan support: require not just new, but existing chems to submit a review of its published literature alone (not the harder to access grey literature, industry & government tox studies).

    Especially for long-marketed or HPV (or any other chem subject to the “Matthew Effect” (Grandjean et al.), this would bring to the fore the best quality (generally speaking; peer reviewed & published; financially independent) data.

    Then of course the far bigger task is to persuade EPA or states that industry’s TG studies are not reliable data. But at least this would shift attention away from the cloistered diseased world of risk assesors; encouraging discussions of whose is the better quality data.

    The big three drivers of TG method tests’ insensitivity (after alll , it was the petrochem industry that invented these test methods):
    – Use the end of acute dose levels to test chronic tox. Result is mostly kidney, liver tox & weight loss. Meanwhile academics keep on publishing tens of thousands of real tox. findings…ignored;
    – Kill the animals before most of any induced chronic disease can develop;
    – Allow abuse of controls, to disappear any inconvenient tox that is found (e.g. in the bPA Tyl et al. ’08 key study; or MON for glyphosate).

    So thanks for including that industry test methods are insensitive in your post!