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.  

While many details of the shifts EPA is making remain murky, EDF is concerned that EPA is moving away from the law’s clear requirements that:

  • EPA rigorously review both intended and reasonably foreseen uses of new chemicals and,
  • where EPA identifies potential risks or lacks sufficient information, it issue an order imposing conditions on the manufacturer of the new chemical sufficient to mitigate the potential risk.

Among other concerns, EPA’s intent not to issue such orders and merely to promulgate so-called significant new use rules to require notification of reasonably foreseen uses – even assuming it can timely issue such rules – is squarely at odds with what the law requires.

EPA also appears to be seeking to re-create the infamous Catch-22 of old TSCA under which EPA could only require testing where it already had evidence of risk.  In today’s release, EPA signals that testing will only be required “to address risk concerns.”

Finally, apart from today’s release, EPA’s recent approach of sharing information on these anticipated changes only with new chemical submitters is highly disturbing, and further undercuts public confidence in EPA’s implementation of the reformed law.


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