New chemicals under the new TSCA: Growing pains now, but a stronger system going forward

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

In the many conversations I have had over these last many years about the Toxic Substances Control Act (TSCA), the single thing that most resonated with people about why the old law didn’t work was about new chemicals. Folks were stunned when they learned that the old law didn‘t require our government to review chemicals and determine they were safe before they were allowed onto the market.  People simply assumed this was the case and were shocked to find it wasn’t.  I heard repeatedly, what could be a more basic need to ensure protection of the public’s health?

That is why many in Congress worked so hard to drive improvements to the new chemicals provisions in the new law – that, and a clear understanding of the many ways in which the old law hamstrung EPA when it came to new chemicals.  In my view, these reforms and robust implementation of them by EPA are absolutely essential to the task of restoring public and market confidence in our national chemical safety system – the shared objective that allowed disparate stakeholders and lawmakers to come together to support the Lautenberg Act.

[pullquote]For too long, economic factors have dominated over the public’s right to expect that chemicals to which they may be exposed will not be allowed into use without adequate assurance of their safety.  That has undermined consumer confidence in our chemical safety system.  The public understands that the most efficient and effective stage at which to provide assurance of safety is before commercial production and use begins, rather than waiting and then having to try to mitigate risks that arise after a new chemical is embedded in commerce.[/pullquote]

I have blogged previously about why the new chemicals reforms in the new law represent a balanced approach, 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; and, on the other hand, ensuring an efficient process that doesn’t unduly slow or create too high a bar for market entry.

Of course, even as it has supported the new law’s balanced reforms, the chemical industry did and continues to assert that the old new chemicals system worked just fine.  I’ve always maintained that’s because it rarely required much of them.   It’s not wholly surprising, therefore, that the industry is expressing angst over EPA’s implementation of the new requirements.  Change is hard.

Bear in mind also that the new requirements of the law not only changed the status quo significantly, they also became effective immediately upon passage of the law, without any time given to EPA to migrate to the new regimen.  That, too, has been a source of the growing pains felt by both EPA and the regulated community.  Abrupt change is even harder.

But a broader and longer view of the new law is called for.  The bulk of this post will describe why EDF believes that EPA’s implementation to date is not only consistent with the new law but in fact mandated by it, and why, despite initial growing pains, the new system will be a major improvement over the long run for both public health and business.  But first …  

Playing the “don’t-stifle-innovation” card

But before doing so, I want to briefly address an overarching argument that industry uses to try to lend greater weight to its complaints about EPA’s actions under the new law:  that those actions threaten to impede innovation, which they assert is directly at odds with Congress’ intent under TSCA.

This claim relies on the only reference to innovation in all of TSCA, in a list of the law’s policy intentions (section 2(b)(3), same language in both the old and new law).  Industry typically paraphrases this provision as saying that, under TSCA, EPA shouldn’t act in a manner that impedes innovation.  But that is a selective reading of the actual provision; I quote it in its entirety below (emphasis added):

(b) POLICY.—It is the policy of the United States that—

…

(3) authority over chemical substances and mixtures should be exercised in such a manner as not to impede unduly or create unnecessary economic barriers to technological innovation while fulfilling the primary purpose of this Act to assure that such innovation and commerce in such chemical substances and mixtures do not present an unreasonable risk of injury to health or the environment.

Given that the development and application of new chemicals are a clear source of innovation, how else is that primary purpose of TSCA – providing an  assurance that innovation and commerce in chemicals do not present unreasonable risk – to be provided other than through robust scrutiny of new chemicals prior to their commercialization?

Congress clearly got it that innovation without safety doesn’t really qualify as innovation.

New chemical reviews under old vs. new TSCA

The Lautenberg Act made five major improvements to the new chemicals provisions of TSCA, each of which addressed a critical flaw in the original law:

• It mandates that EPA review each new chemical and make an affirmative finding as to its safety. The old law had neither mandate.
• If EPA lacks sufficient information on a new chemical, it must issue an order prohibiting or limiting the chemical in order to mitigate any unreasonable risk. The old law essentially forced EPA to allow manufacture to commence for a new chemical lacking sufficient information – such chemicals typically were simply dropped from further review and manufacture could start at the end of the review period.
• It requires EPA to consider and mitigate unreasonable risks of a new chemical under its “conditions of use,” which the new law defines to include “reasonably foreseen” circumstances of production, processing, distribution use or disposal, as well as those intended by the company providing the new chemical notice to EPA. Under the old law EPA had to confine any risk finding it did make to the specific uses identified by the company.
• It requires EPA to protect against potential risks to “potentially exposed or susceptible subpopulations,” including workers. Such a provision did not exist in the old law.
• Where EPA imposes conditions on the manufacturer of a new chemical, it must consider whether to promulgate a Significant New Use Rule (SNUR) to apply those conditions to other companies making the same chemical. It must either initiate the SNUR rulemaking or publish a statement explaining why it is not doing so.  Under the old law taking such action was entirely discretionary and, until recently, was infrequent.

In implementing these new requirements, which took effect immediately upon the law’s enactment, EPA has taken a number of actions.  Our understanding of these actions has been informed both through various conversations with companies and EPA staff, and by examination of EPA’s interim recommendations on pre-manufacture notices (PMNs) that are made publicly available here.

Support in the law for EPA’s actions to date

Based on the information available to us, EDF supports each of EPA’s actions described below, both as consistent with or required by the law and as representing sound policy and practice:

First, EPA reset the baseline 90-day clock on reviews that were already in process on the date of enactment.  Because the new requirements applied immediately to these new chemicals, that action was both appropriate and necessary.  (EPA has explained the legal basis for its decision here [see answer to question 11].)

Second, EPA has identified a number of new chemicals for which it either lacked sufficient information to “permit a reasoned evaluation” or had information that led it to make a finding that the chemical “may present an unreasonable risk.”  In such cases, EPA is proceeding, as required under section 5(e) of the new law, to impose testing or other requirements through an order, typically a consent order being negotiated with the company.  As was longstanding practice under the old law, the additional time required for testing or negotiating a consent order also typically necessitates an extension of the initial 90-day review period, which is authorized under section 5(c) of the law, or a suspension of the review period done at the request of the PMN submitter.

Third, it appears EPA has identified a number of new chemicals for which it has identified “reasonably foreseen” conditions of use that “may present an unreasonable risk.”  This finding may have been reached even where EPA did not find that the intended conditions of use identified by the company may present such risk.  Sections 5(e) and 5(f) of the law expressly require that, where EPA finds a new chemical presents or may present an unreasonable risk under its conditions of use – which is defined in the law to include both intended and reasonably foreseen circumstances (section 3(4)) – it must issue an order imposing conditions sufficient to mitigate such risk.  It appears that EPA has taken just such action, in some cases by limiting the company to its intended conditions of use – which is necessary to support the affirmative finding that the new chemical is not likely to present an unreasonable risk under its conditions of use, as required to allow manufacture to commence.

Fourth, EPA has identified a number of new chemicals the characteristics of which raise particular concern for workers, especially with regard to the potential for adverse chronic health effects associated with long-term exposures to contaminated air in the workplace.  In such cases, we understand EPA is requesting that companies conduct testing to inform its decision as to whether the chemical presents or may present, or is not likely to present, an unreasonable risk.  Based on information available to us, EDF believes this is a prudent approach.  It is also wholly consistent with the law, which provides EPA with authority to mitigate potential risks posed by new chemicals in workplaces, including where workers represent a “potentially exposed or susceptible subpopulation.”

Looking past growing pains to better incentives and renewed public confidence

EDF recognizes that these changes being implemented in EPA’s new chemicals review process, while fully consistent with and required by the new law, are resulting in development of more orders and longer review times compared to the program under the old law.  This outcome is not unexpected as EPA develops and implements new procedures and practices to meet the new mandates under the law.  We expect that EPA’s processes will become more efficient over time and allow in many cases for more expeditious reviews.

We also hope that companies will now have greater incentive both to:  1) provide EPA with more information about their new chemicals to facilitate EPA’s mandated review and safety finding; and 2) anticipate when filing new chemical notices that their chemicals may well be produced and used for purposes beyond those they initially intend once those chemicals enter commercial distribution.

Companies have noted repeatedly that they often lack knowledge of the full range of uses of chemicals they make and may have little or no control over such uses once those chemicals are being commercially distributed.  Hence it is vital – as well as mandated by the new law – that EPA consider reasonably foreseen uses of new chemicals in making the required safety findings.

Companies concerned that limitations placed on their ability to produce and use a new chemical may impede innovation or competitive position can and should incorporate a broader range of conditions of use into their new chemical notices and provide EPA with the information it will need to evaluate that broader range of conditions of use.

By acting on these strengthened incentives to provide more information and anticipate future uses, companies can better ensure that the much-needed enhanced review of the safety of new chemicals mandated by the Lautenberg Act can be achieved without impeding innovation or the ability to compete.

For too long, economic factors have dominated over the public’s right to expect that chemicals to which they may be exposed will not be allowed into use without adequate assurance of their safety.  That has undermined consumer confidence in our chemical safety system.  The public understands that the most efficient and effective stage at which to provide assurance of safety is before commercial production and use begins, rather than waiting and then having to try to mitigate risks that arise after a new chemical is embedded in commerce.