Selected tag(s): New chemicals

EPA issues first decisions mandated under the new TSCA

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

Today, EPA posted on its website risk determinations for four new chemicals it has reviewed under the new standards prescribed by the Lautenberg Act.  While the premanufacture notices (PMNs) for these chemicals were received by EPA prior to the June 22 signing of the new TSCA, EPA has reviewed them in the context of the new requirements.  (Unlike reviews of chemicals already in use, which may take some years to conduct, EPA reviews of new chemicals are generally to be completed within 90 days, which is why we’re already seeing these appear so soon after enactment.)

These decisions are notable in that they are the very first formal decisions EPA has made under the new law.  Based on an admittedly quick review of the decisions, I’ll offer a few observations.   Read More »

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

Why significant but balanced changes are needed to TSCA's new chemicals provisions

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

A key need for reform of the Toxic Substances Control Act (TSCA) is making enhancements to the law's provisions addressing new chemicals prior to their commercial manufacture.  The Senate bill makes moderate but critical improvements to these provisions.

These improvements arose through extended negotiations that sought to carefully balance two legitimate competing interests:  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 – which the current law does not provide.  On the other hand, ensuring an efficient short process is utilized that doesn’t unduly slow or create too high a bar for market entry or have the unintended consequence of impeding innovation – which the current law does provide.

That balance was struck through a set of provisions that:

  • require for the first time that EPA make an affirmative safety finding as a condition for market entry, but using a standard – that a new chemical is likely to meet the safety standard – that is lower than that applicable to existing chemicals undergoing full reviews;
  • maintain current TSCA’s typical 90-day review period for new chemicals, even shortening that period when EPA can make a positive safety determination more quickly;
  • ensure that new chemicals can’t enter the market when information is not sufficient to make an affirmative safety finding, while retaining TSCA’s lack of a requirement for a minimum up-front data set for new chemicals; and
  • require EPA to carefully consider the need to extend to other companies any conditions or restrictions it places on a company that first brings a chemical into commerce, and either do so or explain why that is not needed.

I believe that this compromise, while unlikely to please anyone completely, represents significant improvement over the status quo, retaining its positive features while addressing its shortcomings.

There is actually considerable support that has been voiced for this balanced approach, including from industry and from the Environmental Protection Agency (EPA), as well as groups like my own.   Read More »

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

Links to essential reading on Senate and House TSCA reform legislation

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

[UPDATE 2/26/16:  Updated versions of (1) our detailed side-by-side comparison of Senate and House bills — now with bill section references — and (2) our 5-part series have been posted below.]

On December 17, 2015, the full Senate passed the Frank R. Lautenberg Chemical Safety for the 21st Century Act (S. 697, the Lautenberg Act), which would amend the nearly 40-year-old Toxic Substances Control Act (TSCA).

The House of Representatives already passed its TSCA reform bill in June, the TSCA Modernization Act of 2015, H.R. 2576.

Next up in the New Year will be efforts to reconcile these two bills.  In anticipation of this, I am posting here updated analyses of the two bills that examine how and to what extent they would address key flaws in TSCA.  These analyses include:

  • brief and detailed side-by-sides of TSCA and the two bills,
  • a comparison of how the bills deal with the contentious issue of preemption of state authority,
  • a comparison of how well the bills meet the Administration’s principles for TSCA reform, and
  • an earlier blog post on the importance of understanding which chemicals are in use today.

All of these materials (including this post) are available at blogs.edf.org/health.

ANALYSES:

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

New chemical reforms are vital to TSCA legislation, says former top official for EPA toxics office

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

In an op-ed published in today’s Roll Call, Dr. Lynn Goldman, Dean of the Milken Institute School of Public Health at the George Washington University, makes the case for why TSCA reform legislation needs to include changes to the provisions of the Toxic Substances Control Act (TSCA) that govern requirements for new chemicals prior to market entry.

The op-ed is notable for two reasons.  First, it addresses a key difference between the Senate and House versions of TSCA reform legislation.  The Frank R. Lautenberg Chemical Safety for the 21st Century Act (S. 697) includes numerous upgrades to Section 5 of TSCA governing new chemicals and significant new uses of existing chemicals.  Dr. Goldman’s op-ed points to the critical improvements the Senate bill would make.  In contrast, the TSCA Modernization Act of 2015 (H.R. 2576) passed by the House of Representatives would leave Section 5 unchanged.

Second, Dr. Goldman is uniquely qualified to address this issue, having served as Assistant Administrator at the Environmental Protection Agency from 1993 to 1998, overseeing the office that implements TSCA.

Dr. Goldman, a pediatrician, stresses the importance to public health of reforming how EPA reviews and regulates new chemicals prior to their entry into commerce.  These provisions have never been amended since TSCA was adopted nearly 40 years ago.  That’s why it’s a vital element to include in any meaningful reform of our nation’s obsolete chemical safety law.

For more on how the Senate and House TSCA legislation compare, see these earlier posts.

 

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

TSCA reform legislation: EPA review of new chemicals

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

Part 1              Part 2              Part 3              Part 4              Part 5

[UPDATE 5-17-15:  On April 28, 2015, the Senate Environment and Public Works Committee passed a revised version of the Lautenberg Act out of the committee on a bipartisan 15-5 vote.  On May 14, 2015, the House Subcommittee on Environment and the Economy passed a revised version of the TSCA Modernization Act of 2015 out of the subcommittee on a bipartisan 21-0 vote.  UPDATE 5-28-15:  The legislation was formally introduced as H.R. 2576 on May 26, 2015.  The new versions made no significant changes to the new chemicals provisions discussed below.]

This is the second in a series of blog posts looking at less talked-about, but critically important, elements of bipartisan legislative proposals to reform the Toxic Substances Control Act (TSCA).  This post deals with EPA authority to review new chemicals prior to their entry into commerce.

TSCA divided the universe of chemicals into two groups:  “Existing chemicals” are those on the market at the time the first TSCA Inventory was established (1979), numbering some 62,000 chemicals.  These chemicals were grandfathered in by the original law, with no mandate for them to be tested or reviewed for safety.  “New chemicals” are those that entered commerce at some point since 1979, numbering some 23,000 chemicals.  Between 500 and 1,000 new chemicals enter commerce in a typical year.  (Given these large numbers, it’s surprising how relatively little focus there has been on the way bipartisan reform proposals would address new chemicals.  I’ll amplify on this point at the end of this post.)   Read More »

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