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GlobalChem 2014: Spotlight on TSCA reform, chemical risk assessment

It’s a wrap for another successful GlobalChem conference.

For more than two decades, this annual meeting has provided a very productive venue for industry leaders, regulators and stakeholders to discuss fundamental chemical management issues, both here in the U.S. and abroad. Despite some challenging weather, this year covered a lot of ground.

Thanks to our media partners, Chemical Watch and ICIS, you can see the highlights of the conference by visiting this page. You can also learn more about the key issues that were discussed by downloading the conference supplement.

The first day of the conference focused on the U.S., particularly on the progress to update the Toxic Substance Control Act (TSCA), and on the effort to improve chemical risk assessments.

TSCA reform continues to gain momentum

When the late Senator Frank Lautenberg and Senator David Vitter introduced the bipartisan Chemical Safety Improvement Act (CSIA), many up to that point said that such a compromise was not possible, and that it was unlikely Congress would be able to advance legislation to update TSCA.

With 13 Republican and 12 Democratic co-sponsors, the CSIA is proof positive for what some said could never come to be – a true, bipartisan compromise bill that will make significant and meaningful improvements to TSCA.

This historic breakthrough helped set the stage for conversations around improving TSCA and action in the House. Last month, Congressman John Shimkus released a discussion draft of the Chemicals in Commerce Act of 2014 (CICA), a bill to update TSCA.

At GlobalChem on Tuesday, Energy and Commerce Committee general counsel David McCarthy said Subcommittee Chairman Shimkus is committed to moving forward with the draft CICA legislation to complement the effort in the Senate.

What the draft legislation is trying to achieve, as McCarthy explained it, is something virtually everyone can agree to: instilling greater confidence that “Made in America” is the new gold standard for innovative products of chemistry that can be used safely – and a new regulatory system that drives innovation, rather than inhibits it, while enhancing safety.

Connie Deford, director of global product sustainability and compliance at Dow Chemical, agreed that the U.S. has reached an all-time low for public confidence in the safety of chemicals, yet we know more about chemicals than ever before. TSCA reform done right can help change that, she said, and getting chemical safety regulations right is “a shared responsibility between government, industry, value chain and consumers,” Deford concluded.

Future of federal chemical risk assessments

Getting federal chemical risk assessments back on track is also a key component of setting a gold-standard chemical regulatory system in the U.S.

What we have in place right now are chemical assessment programs that frequently fail to deliver scientifically sound, timely results.  Speaking at GlobalChem on Tuesday, Dr. Vincent Cogliano, acting director of EPA’s Integrated Risk Information System (IRIS), said he wants to change that.

Dr. Cogliano noted that EPA has made progress on implementing some key changes to IRIS assessments – and they have plans to do more in the coming months.

According to Dr. Cogliano, EPA wants to “improve the fundamental science of assessments” by adopting systematic review principles and strengthening its peer-review process. They are looking for ways to increase productivity – assessing more chemicals and at a faster rate – to better meet stakeholder needs. And the Agency wants to increase transparency so any concerns or technical issues with are identified and sorted out early in the assessment process, rather than during peer review.

Also participating in the panel discussion was ACC Senior Director of Regulatory Science Policy Dr. Nancy Beck, who illustrated her vision of a future in which IRIS, TSCA Work Plan Chemicals and EPA’s National Center for Computational Toxicology all follow a more efficient, more credible process for conducting risk assessments.

To get there, according to Dr. Beck, Agencies must follow a series of steps:

  • Assessments should begin with a formulation of the problem and have a clear scope (that is, they must be “fit for purpose”);
  • Agencies should use pre-defined criteria to determine, first, which studies to evaluate and second, whether those studies are high-quality;
  • Risk assessment staff should follow a systematic weight of evidence approach to integrate all high quality and relevant data;
  • In the end, they must produce a transparent and realistic assessment;
  • And, after publishing the assessment, Agencies should be responsive to public input and peer reviewer comments.

Virtually everyone can agree on that last point, and it’s also one of the most important. As Dr. Kenneth Olden, director of EPA’s National Center for Environmental Assessment, told a crowd of stakeholders attending an EPA-sponsored public dialogue around 18 months ago:

[quote]The best way to deal with complex issues, whether they be scientific or otherwise, is through public dialogue and transparency.[/quote]

A recent survey on regulatory risk assessment brought to light many of these same concerns. The survey, conducted by the George Mason University Center for Media and Public Affairs and Center for Health and Risk Communication, identified gaps between what  experts would like to see done and what is actually put into practice.

By continuing to engage with stakeholders and outside experts, like those surveyed by GMU, EPA can more effectively improve the objectivity and quality of chemical risk assessments, start to finish. And by continuing to actively seek public input, the Agency can ensure its latest enhancements are implemented correctly and that future improvements can be made without delay.

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