Selected category: TSCA Reform

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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On a roll: EPA proposes to ban or restrict two highly toxic paint stripping chemicals

Lindsay McCormick is a Project Manager.  

Yesterday, EPA proposed a rule to ban methylene chloride and either ban or restrict the use of N-methylpyrrolidone in paint stripping products, subject to certain national security exemptions. This proposal is the third such proposed action by the agency in the past month (see here and here). Below, find a short description of these chemicals and EPA’s proposed actions.

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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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EPA proposes second rule to ban more uses of toxic TCE

Jennifer McPartland, Ph.D., is a Senior Scientist with the Health Program.

The Environmental Protection Agency (EPA) took another significant step yesterday to protect against exposures to the highly toxic chemical, trichloroethylene (TCE), proposing a rule to ban its use as a vapor degreaser.

The proposed rule is the second issued under section 6 of the Toxic Substances Control Act (TSCA) as amended by last year’s Lautenberg Act.  It follows on EPA’s proposed rule last month to ban the use of TCE as an aerosol degreaser and spot cleaning agent in dry cleaning facilities. Both proposed rules on TCE are critical to protecting consumer and worker health from the harmful effects of TCE and should move swiftly toward finalization.   Read More »

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Government, NGOs, and industry gather for EPA TSCA New Chemicals Review Meeting

Joanna Slaney is the Legislative Director for EDF Health.

[UPDATE 1/17/17:  Today EPA posted a full transcript of the public comments made at its December 14, 2016, meeting, along with the presentations made by EPA staff.  MP3 audio files of the public comments are already posted (note they are huge files).]

EPA held a public meeting Wednesday on the implementation of the New Chemicals Review Program under the reformed Toxic Substances Control Act (TSCA). The Frank R. Lautenberg Chemical Safety for the 21st Century Act required EPA to begin implementation of the reforms to the program on the day the legislation was signed into law. The meeting was an opportunity to discuss the effort and progress to date.

As we’ve noted before, and as I noted on Wednesday, the changes made to the New Chemicals Review Program were fundamental to TSCA reform and the promise of a new system that better protects public health and the environment.

Representatives from state government, the Senate, NGOs, and industry gathered to hear a series of presentations by EPA about new chemicals reviews under the reformed law, scientific and data issues the Agency is navigating, and the types of information it needs from manufacturers and processors to facilitate a streamlined review process.

A series of oral comments from various stakeholders included a robust showing of support for EPA’s actions from public interest groups representing labor, the environment, and public health, as well as concerns from some in industry with certain aspects of implementation. EPA concluded with a commitment to meet again in six months to discuss its progress in implementing revisions to the New Chemicals Review Program.

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Remarks at EPA stakeholder meeting on New Chemicals Review Program

Joanna Slaney is the Legislative Director for EDF Health.

Today the EPA held a public meeting on the new requirements for the New Chemicals Review Program under the reformed Toxic Substances Control Act. EDF oral comments, as prepared for delivery, follow below.

Strong implementation restores public and market confidence.

EDF believes that the reforms to the New Chemicals program in the Frank R. Lautenberg Chemical Safety for the 21st Century Act, and the robust implementation of these reforms by the EPA, are absolutely essential to the task of restoring public and market confidence in our national chemical safety system. It is this shared objective, restoring public and market confidence, that allowed disparate stakeholders and lawmakers to come together to support the Lautenberg Act in the first place. And without a strong New Chemicals program, there is no restored public confidence.

Without a strong New Chemicals program, there is no restored public confidence.

It’s a public health issue.

With between 500 and 1,000 new chemicals entering the market every year, ensuring the safety of these chemicals is clearly a public health priority. It is critical that new chemicals clear a safety bar before they are allowed in products and in our homes. For decades, chemicals have been allowed on the market simply because there wasn’t enough information to make a safety decision one way or another. In 2007 EPA reported that 85% of pre-manufacture notices contained no health data. That’s not right, and it puts the public’s health at risk, most especially the health of vulnerable populations like children, pregnant women, and workers. Any chemical entering the market should be reviewed and managed to provide a reasonable assurance of its safety. In fact, I expect that most Americans believe that their government already does so in order to protect their health and the health of their families.

It’s congressional intent.

Many in Congress worked hard to drive significant improvements to the new chemicals provisions in the new law; indeed, for some it was a central reason for their involvement in reforming TSCA. And the record is clear that even where certain Members were less inclined to see the need for change, they acknowledged that significant changes were made to the New Chemicals program as part of the compromise legislation. The changes that were made were a compromise on both sides but they were not insignificant, and the new requirements are clearly laid out in the language of the Lautenberg Act.

It’s a primary purpose of TSCA.

It has been argued that EPA’s implementation of the new chemicals program under the Lautenberg Act risks impeding innovation and is at odds with the intent of the law. In fact, the intent of the law is quite clear:

It is the policy of the United States that— 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.

While innovation is central, it cannot come at the expense of protection for public health and the environment. Innovation without safety is not true innovation.

The changes made to the New Chemicals program are fundamental to the reform of TSCA and the promise of the new system. 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 realized other than through robust scrutiny of new chemicals prior to their commercialization.

The public has a right to expect that chemicals to which they may be exposed will not be allowed into use without adequate assurance of their safety.  The lack of that basic assurance has undermined consumer confidence in our chemical safety system.  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.

Environmental Defense Fund supports the actions taken by EPA to date in implementing the New Chemicals Program and believes they are clearly required under the new law.  We look forward to EPA continuing to implement a robust New Chemicals program that can restore public and market confidence in our national chemical safety system, while both protecting human health and the environment and fostering safe innovation.

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