Author Archives: Richard Denison

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.

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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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Bipartisan group of Senators urges new Administration to ensure strong implementation of new TSCA

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

Yesterday a bipartisan group of nine Senators who were deeply involved in passage of the Lautenberg Act wrote to President-Elect Trump’s transition team to urge that EPA under the next Administration “vigorously implement the new law.”  The Lautenberg Act amended the Toxic Substances Control Act of 1976 (TSCA) and was signed into law by President Obama on June 22, of this year.

The group went on to state that strong implementation “includes moving expeditiously to identify and address chemicals with the greatest potential impact on public health, especially those affecting vulnerable populations.  … Successful implementation of this law will also help ensure there is certainty and restore confidence in the marketplace for manufacturers, consumer product producers, and the public.”

The Senators urged that the transition team work with EPA “to communicate on critical steps that are underway and to get a full appreciation of the new law’s deadlines.  We urge that you view appointments, funding and staffing to this office with the utmost importance.  It is essential to maintain momentum during the Presidential transition and in the early months of the new Administration to ensure that this new law is successful.”

The signatories to the letter are Sens. Tom Udall (D-NM), James Inhofe (R-OK), Cory Booker (D-NJ), Shelley Moore Capito (R-WV), Tom Carper (D-DE), Mike Crapo (R-ID), Ed Markey (D-MA), Jeff Merkley (D-OR) and Sheldon Whitehouse (D-RI).

Posted in EPA, Health Policy, TSCA Reform| Tagged | Comments are closed

Off and running: EPA identifies first 10 chemical for review under new TSCA

Richard Denison, Ph.D.is a Lead Senior Scientist.  Lindsay McCormick and Jennifer McPartland contributed to this post.

Today, in advance of the December 19, 2016 deadline specified under the new TSCA, EPA has announced the first 10 chemicals to undergo risk evaluations (see list below).

This is a very important early step called for under the Lautenberg Act, which passed Congress with overwhelming bipartisan support.  Early action by EPA was seen by stakeholders across the spectrum as essential to begin the process of restoring public and market confidence in our nation’s chemical safety system.  So EPA’s issuance of this list in advance of the statutory deadline next month is a welcome sign of timely implementation of the new law.

While not every chemical that everyone may have wanted is included among the first 10, that is because there are many more than 10 chemicals that need far greater scrutiny as to their safety.  Indeed, the longer “Work Plan Chemicals” list from which EPA drew the first 10 consists of nearly 100 chemicals that present significant potential risk.

What is most important is that EPA gets started, so that it can complete risk evaluations of the first 10 and move on to the next.  EPA now has 6 months to establish the scope of its risk evaluations for these chemicals, identifying the uses, hazards, exposure and vulnerable populations it will evaluate.   Read More »

Posted in EPA, Health Policy, TSCA Reform| Tagged | Comments are closed
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