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.  

EPA has consistently offered testimony supporting these types of enhancements to the new chemicals program, noting that they are called for by the Administration’s principles for TSCA reform.  See, for example, EPA testimony here, here and here.  The Administration again reiterated this position earlier this year, in its January letter to House and Senate negotiators expressing preferences for or concerns about specific provisions in one or both of the bills.

Leading industry representatives have also supported the improvements made in the Senate’s legislation to TSCA’s new chemicals provisions.  These include Cal Dooley, President and CEO American Chemistry Council (ACC) and Ernie Rosenberg, President and CEO of the American Cleaning Institute (ACI).  In response to direct questioning from House Energy and Commerce Subcommittee Chairman John Shimkus at a hearing the House held on the Senate’s Chemical Safety Improvement Act (CSIA, the precursor for the Senate’s Lautenberg Act), they expressly supported the most significant of the changes to the new chemicals provisions made by the Senate legislation: a requirement for EPA to make an affirmative safety decision prior to commencement of manufacture.

Here is the relevant excerpt (emphases added):

SHIMKUS: Are the changes to TSCA Section 5 in the Senate bill needed and why? Cal, if you would start.

DOOLEY: ACC, you know, supports the provisions of the modifications of Section 5 in CSIA. We recognize that it is important, even with the new chemicals, that you do have provisions that do allow for EPA to make an affirmative determination that the new chemical will likely meet the safety standard, and that we accept that it is an obligation upon the industry and the manufacturer to provide that information to allow them to make that determination.

SHIMKUS: Mr. Rosenberg?

ROSENBERG: So the changes that are made in Section 5 in the bill do one important thing. They do what we’re really looking for which is create a more credible program. And the fact that there’s an affirmative determination gives at least most people a level of comfort that things haven’t just gone through because the deadline expired.

I fully recognize there are some in industry who have argued no changes should be made to TSCA’s new chemicals provisions, just as there are health and environmental advocates who believe the Senate bill’s provisions don’t go far enough and seek a bigger overhaul.

Given the mixed views on this contentious issue, isn’t the right approach to find a balance between the competing concerns here?  That is just what the Senate’s bill does – the result of careful negotiations and input from all of the stakeholders over the course of the past three years.

As I have reread the extensive testimony offered on TSCA reform over the past two Congresses, one point made over and over again by the business community jumps out:  the need for reforms that are sufficient to restore confidence in the system.

That is one of the reasons why I so strongly believe that more credible oversight of chemicals before they reach the market must be a cornerstone of a new TSCA.  Not to robustly address such a big issue is simply a recipe for renewed public concerns to be voiced over the new law starting the day it passes.  And that would be good for no one – not legislators who have worked hard to address these issues, not for business, and certainly not for consumers.


For those wanting more background on TSCA’s new chemicals provisions and their shortcomings, I provide additional detail below.

Background on TSCA and new chemicals

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.

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.  In addition, Section 5 of TSCA provides no mandate for EPA to review new chemicals prior to market entry.

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, 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 TSCA Modernization Act makes no changes to section 5 of TSCA.

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