Selected tag(s): New chemicals

More questions than answers: EDF submits extensive questions to EPA in advance of public meeting on new chemical reviews

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

Environmental Defense Fund yesterday submitted questions to EPA that we hope are answered by the agency at the public meeting it is convening on December 6th on changes to its new chemicals reviews.

Despite providing some new documents in advance of the public meeting, details about EPA’s new policies and practices for reviewing new chemicals under the reforms made to TSCA by the Lautenberg Act remain scant.  We identified a number of serious concerns when these changes were first announced by Administrator Pruitt in a news release issued on August 7 – concerns that the meeting background materials EPA has provided only serve to heighten.

The questions we submitted today relate to our concerns in the following topics:

  • The statutory and scientific basis for EPA’s new policies, the timing of their application, and omissions from the new framework
  • EPA’s plan to use so-called “non-5(e) SNURs” in lieu of consent orders
  • Recent policy changes not included in EPA’s agenda for the public meeting
  • Public access to information
  • Confidential business information claims
  • Use of section 5(e) SNURs

EDF has been raising concerns for some time now over the recent redirection of the new chemicals program starkly away from the approach taken following last year’s enactment of the Lautenberg Act.

Many of the questions we’ve just submitted were formally submitted by letter to EPA’s Office of Pollution Prevention and Toxics (OPPT) more than 3 months ago, on August 16, 2017.  Unfortunately, we have yet to receive responses to them.  We hope they will be addressed at the December 6th meeting.

Posted in EPA, Health Policy, Regulation, TSCA Reform| Also tagged | Leave a comment

EPA’s announced changes to new chemicals review process put industry demands for ready market access above public health protection

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

Last year’s Lautenberg Act, which overhauled the badly broken Toxic Substances Control Act (TSCA), made fundamental changes intended to improve EPA’s review of new chemicals prior to their commercialization, by requiring more scrutiny of those chemicals to better ensure they are safe.  Until recently, the Environmental Protection Agency (EPA) was on track in implementing the new requirements in a health-protective manner.  With the addition of more staff, EPA was also steadily reducing the temporary backlog in new chemical reviews that had developed – a result of the fact that the law’s new requirements took effect immediately upon passage.

In recent months, however, agency staff have faced relentless pressure from the chemical industry – and internally from new industry-friendly senior management – not only to speed up reviews, but to return the program to its pre-Lautenberg practices.  There were growing signs that EPA was considering changes that would circumvent the law’s requirements in the name of increasing program “throughput.”   The agency’s press release today makes clear that this is now happening.   Read More »

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

Pace and outcomes of EPA new chemical reviews appear to be on track

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

The Environmental Protection Agency (EPA) yesterday updated its website to provide a current snapshot of the status of new chemical reviews it has been conducting under last year’s amendments to the Toxic Substances Control Act (TSCA).  The statistics show that, despite being faced immediately with a substantial increase in responsibilities and workload as a result of the major changes made to TSCA, EPA has made enormous progress in implementing the new requirements.

Because the changes made by the Lautenberg Act to TSCA’s new chemicals program were both extensive and immediately effective upon enactment, a temporary backlog developed while EPA implemented the new requirements in reviewing both chemicals that were under review at the time of the law’s passage and those that came in subsequently.

Yesterday's announcement and the related statistics indicate that the backlog has markedly declined since January, falling from 300 to below 150 cases.  In a press release EPA says it is committed to eliminating the backlog entirely by July.

Equally important in the statistics is the fact that many more chemicals are being subject to orders imposing conditions on their commercialization, relative to the old law:  For about half of the reviews completed to date, EPA has issued a consent order.  This is to be expected:  The new law requires EPA to issue such orders whenever it either lacks sufficient information to evaluate a new chemical, or makes a risk- or exposure-based finding that indicates potential concern.  In such cases, the orders must impose conditions sufficient to mitigate the concern.

Yesterday’s announcement is welcome.  EPA needs to stay the course.  And the chemical industry needs to recognize that restoring public and market confidence in our chemical safety system requires a robust new chemicals program.

Posted in Health Policy, Regulation, TSCA Reform| Also tagged | Comments are closed

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.

Read More »

Posted in EPA, TSCA Reform| Also tagged | Comments are closed

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.

Posted in EPA, Flint, Health Policy, Industry Influence, Regulation, TSCA Reform| Also tagged , , | 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 »

Posted in EPA, Health Policy, TSCA Reform| Also tagged | Read 1 Response
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