EPA Administrator Scott Pruitt’s “core statutory mission” includes implementing the 2016 amendments to the Toxic Substances Control Act (TSCA) and particularly completing new chemical reviews more quickly. Upon taking charge of the Agency, one of Pruitt’s initial challenges was reducing a backlog of 600 new chemicals stuck in the EPA review process. Now, 6 months later, Pruitt has announced that the backlog has been eliminated.
More Staff and a LEAN Approach
TSCA requires that the EPA approve new chemicals once it is assured that the chemical is not likely to carry unreasonable risks for its intended and reasonably foreseen uses. According to Pruitt, the Agency has accelerated new chemical risk reviews by:
- Redeploying staff to increase the number of full-time equivalent staff working on new chemicals.
- Initiating a LEAN exercise to streamline work processes around new chemical review.
- Institutionalizing a voluntary presubmission consultation process so that submitters have a clear understanding of what information will be most useful for EPA’s review of their new chemical submission and of what they can expect from the Agency during the review process. While such engagement before submission is an additional up-front time and resource commitment by submitters and the EPA, it should more than pay for itself with faster, better-informed EPA reviews, says the Agency.
“With the ongoing commitment of the staff working on TSCA reviews, and input from stakeholders, our goal is to ensure a new chemicals program that is both protective of human health and the environment, while also being supportive of bringing new chemicals to market,” said Pruitt.
Also in the announcement, Pruitt said he is dedicating the Agency to a more predictable and transparent process for making safety determinations through a commitment to following operating principles; continuously improving; and, increasing the transparency in the decision making for new chemical safety determinations.
Abrogating the Amendments, Claims Scientist
“Today’s announcement shows real and deliberate progress toward this important goal, but there is still work to be done to completely clear the backlog and prevent it from recurring,” said the American Chemistry Council in response to the announcement.
But Richard Dennison, a scientist with the Environmental Defense Fund who is often quoted on TSCA issues, said EPA’s announcement follows “relentless pressure from the chemical industry—and internally from new industry-friendly [EPA] senior management—not only to speed up reviews, but to return to pre-[TSCA amendment] 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.”
Dennison said he is specifically concerned that the EPA is moving away from the law’s clear requirements that the Agency rigorously review both intended and foreseen uses of new chemicals and, where the Agency identifies potential risks or lacks sufficient information, it issue an order imposing conditions on the manufacture of the new chemical sufficient to mitigate the potential risk.
“EPA 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,” said Dennison.