Author Archives: Richard Denison

No, chemical industry, you can’t have your cake and eat it too (Part 2)

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

[Part 1 here]

We have been watching with growing alarm the rapidly unfolding efforts by leadership in Congress and the Trump Administration to gut health and safety protections that provide millions of Americans with clean air, water and safe products.  Support by the American Chemistry Council (ACC) for such efforts, detailed below, gives us profound worry and deep frustration given the trade association’s support of major reforms to the Toxic Substances Control Act last year.

Many of ACC’s member companies worked for many years to move the industry towards strong federal legislation that can restore public and market confidence in the safety of their products.  Many of these companies have also been embracing sustainability commitments, and have acknowledged that a strong federal chemicals management system is critical for charting the path to a safer more sustainable future.  Those companies with a real commitment to safer chemicals and sustainability should be very alarmed that their trade association has endorsed legislation and the Trump Administration’s deregulatory executive order that would profoundly limit EPA’s and the rest of the Federal government’s ability to protect human health and the environment.

These actions by the executive and legislative branches will or would severely constrain EPA from acting to address chemical risks under the Lautenberg Act as well as other federal laws that protect our air, water, land, workplaces, schools and homes.

Here are the specifics:   Read More »

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No, chemical industry, you can’t have your cake and eat it too (Part 1)

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

There is an extreme anti-regulatory and anti-science bandwagon moving fast through Washington, and much of the chemical industry seems to have jumped right on board.  We’re also seeing growing signs of industry pushback against even modest early actions EPA is taking to implement the Lautenberg Act, which reformed the obsolete Toxic Substances Control Act (TSCA) and passed with strong bipartisan support only last June.

Companies have every right to provide their input to EPA and argue the case for their chemicals in accordance with designated processes the agency has established for this purpose.  But resorting to tactics of obstruction and delay won’t fool anyone.  That’s the very thing that brought about the public crisis in confidence surrounding this industry in the first place.

I’ll address these concerns in this and a second post to follow.  This post will address several attempts by some in the chemical industry to thwart EPA’s efforts to implement the new TSCA.  The second post will look at the industry’s main trade association’s unabashed – indeed, boisterous – support for a new Executive Order and multiple “regulatory reform” bills moving in Congress, which it embraces despite the fact that they would impose on EPA (and other agencies’) rulemakings – including those under the new TSCA – dozens of new knot-tying strictures, some of which the Lautenberg Act just got rid of.

This suggests that some in the industry have a very short memory:  What led the industry to finally support TSCA reform was its recognition that the public, other levels of government and the market itself have little confidence in the safety of its products or the ability of government to protect people and the environment from toxic chemicals.  Any relief it sought from its initial endorsement of a stronger federal chemical safety system will quickly dissipate if industry representatives – emboldened by the current political climate – take actions to stymie implementation of the new law and to buoy executive and legislative vehicles that would bring the regulatory system to a grinding halt.

So, let’s start with a few of the battles that some in the industry are waging to undercut recent EPA actions, authorized under the new TSCA, to restrict three highly toxic chemicals – trichloroethylene (TCE), methylene chloride (MC) and N-methylpyrrolidone (NMP) – the first such actions taken under TSCA in nearly 30 years.  Read More »

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Getting it up front: EPA clarifies substantiation requirements for CBI claims under the new TSCA

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

The Environmental Protection Agency (EPA) is publishing a notice in tomorrow’s Federal Register affirming that the Lautenberg Act requires upfront substantiation of all confidential business information (CBI) claims submitted under the Toxic Substances Control Act (TSCA), except for certain claims that the law exempts from substantiation requirements.

While EPA initially took a narrower approach on an interim basis in the flurry of activity following last June’s passage of the Lautenberg Act, today’s notice supersedes that earlier approach and clarifies the upfront substantiation requirement.

In today’s notice, EPA notes the strong support for its clarification in the statute itself as well as in the legislative history in both Houses of Congress leading up to its final passage.

This clarification hopefully won’t be controversial:  A broad swath of stakeholders have voiced support for the upfront substantiation requirement and have noted that it is a key reform made by the new law.

In November the American Alliance for Innovation (AAI) sent a letter to EPA Administrator McCarthy signed by more than 60 trade associations – including the American Chemistry Council, the Society of Chemical Manufacturers and Affiliates, the American Cleaning Institute, the American Petroleum Institute and the Consumer Specialty Products Association – noting that under the Lautenberg Act “[c]laims for CBI protection must be accompanied by an upfront substantiation.”

And back in 2013, the American Chemistry Council provided responses to questions for the record posed by then-Congressman Henry Waxman that stated that “[i]mprovements to the CBI provisions in a modernized TSCA should include … [r]equiring upfront substantiation of the CBI claim.”  The same response letter noted that:  “The American Chemistry Council and its members support up-front substantiation of CBI claims.”

Importantly, EPA’s notice makes clear that the substantiation requirement applies to all non-exempt CBI claims made since passage of the law last June, although EPA is providing an exceedingly generous length of time for companies to comply.

Given the law’s 90-day deadline for EPA review of CBI claims, there are strong policy reasons for requiring upfront substantiation of CBI claims:

  • First, EPA’s own experience based on recent chemical reporting it has required demonstrates that requiring upfront substantiation reduces the number of CBI claims asserted. That means fewer claims EPA has to review and a greater likelihood that claims are only asserted for information that warrants protection.
  • Second, when those reviews are conducted, EPA will already have the information it needs to review the claim instead of having to request it from the company, wasting precious days or weeks of the 90-day review period.
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EPA achieves major TSCA implementation milestone

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

The Environmental Defense Fund applauds the Environmental Protection Agency (EPA) for meeting a major milestone in implementing the Frank R. Lautenberg Chemical Safety for the 21st Century Act, the landmark legislation reforming the Toxic Substances Control Act (TSCA) that passed in June 2016 with overwhelming bipartisan support.

EPA reached this milestone this week when it released proposals for the three foundational rules that the Lautenberg Act mandates be finalized by June of this year, as well as three proposed rules restricting specific high-risk uses of several chemicals.

The management and staff of EPA’s Office of Chemical Safety and Pollution Prevention and Office of General Counsel deserve major kudos for their tireless work over these past seven months to reach this milestone. This should also bring satisfaction to the Members of Congress who authored the Lautenberg Act and included aggressive deadlines as part of the bipartisan effort to reform the law.   Read More »

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At last: EPA promulgates nanomaterial reporting rule

Richard Denison, Ph.D.is a Lead Senior Scientist. Lindsay McCormick is a Project Manager.  

nanomaterial-infographic

Today, EPA issued its long-awaited rule to gather risk-relevant information on nanoscale materials. The new rule will finally allow EPA to obtain basic data on use, exposure, and hazards from those that manufacture or process these materials, which has long been recognized by experts as essential to understand and manage their potential risks.

Nanomaterials – a diverse category of materials defined mainly by their small size – often exhibit unique properties that can allow for novel applications but also have the potential to negatively impact our health and the environment.  Some nanomaterials:  more easily penetrate biological barriers than do their bulk counterparts; exhibit toxic effects on the nervous, cardiovascular, pulmonary, and reproductive systems; or have antibacterial properties that may negatively impact ecosystems or lead to resistance.

Read More »

Posted in Emerging Science, EPA, Nanotechnology, Regulation| Comments are closed

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.

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.

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 …   Read More »

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