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EPA's Pruitt Talks Backlog, Transparency Goals

Wednesday, August 9, 2017

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The Environmental Protection Agency released a statement on Monday (Aug. 7) saying that it has eliminated a monthslong backlog of new chemical cases that needed safety reviews.

“I am happy to report that the backlog of new chemical reviews is eliminated,” said Administrator Scott Pruitt, who took office in February.

Gage Skidmore, CC-BY-SA 2.0, via Wikimedia Commons

The Environmental Protection Agency released a statement on Monday (Aug. 7) saying that it has eliminated a months-long backlog of new chemical cases that needed safety reviews.

“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.”

The EPA is mandated to make a safety determination before a new chemical goes to market, ensured by the Toxic Substances Control Act (which was amended for the first time last year).

Recent Backlog

When Pruitt was confirmed, the EPA had about 600 new chemicals that were “stuck” in the review process. What’s considered a normal caseload for the agency at one time is about 300 cases, and as it stands now, there are approximately 308 under current review, with an additional 74 that are labeled for “testing and long-term information gathering by submitters.”

That second number is important to remember, said Charles Auer, a senior regulatory and policy adviser with Bergeson & Campbell. Bloomberg News reported that in a webinar last week, Auer reminded attendees that while the EPA’s safety decision is necessary, it’s not the final action, and that even after cases leave the review stage, it’s still a while before they can be released to the general market, especially if the agency decides it has concerns.

Auer, who worked at the EPA for 30 years, said that it’s typical for the agency to discuss several options with a manufacturer before moving forward.

Transparency Changes

After addressing the workload success, Pruitt went on to detail how he plans to make the whole process of reviewing and getting new chemicals ready for market more transparent to the public.

Environmental Protection Agency

What’s considered a normal caseload for the agency at one time is about 300 cases, and as it stands now, there are approximately 308 under current review, with an additional 74 that are labeled for “testing and long-term information gathering by submitters.”

“Not only do I support reducing the backlogs that have built up at this Agency, I also encourage continuous improvement and increased transparency,” Pruitt said.

According to the EPA, it will implement a number of new measures in its review of new chemicals including the following:

  • Where the intended uses in premanufacture notices or other Section 5 notices (such as low volume exemption requests) raise risk concerns, EPA will work with submitters, and, if the submitters submit timely amended PMNs addressing those concerns, EPA will generally make determinations based on those amended submissions.
  • Where EPA has concerns with reasonably foreseen uses, but not with the intended uses as described in a PMN or LVE application, as a general matter, those concerns can be addressed through significant new use rules.
  • Identification of reasonably foreseen conditions of use will be fact-specific.
  • The purpose of testing in a Section 5 order is to reduce uncertainty in regard to risk—specifically, it is to address risk concerns that gave rise to a finding of “may present unreasonable risk” or another Section 5 finding other than “not likely to present unreasonable risk."
  • In addition, consistent with the statute, any request for testing by EPA will be structured to reduce and replace animal testing as appropriate.

Improvements to the TSCA program include:

  • 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 reviews; and
  • Institutionalizing a voluntary pre-submission 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 EPA during the review process. .

Improvements to transparency include the following:

  • In fall 2017, EPA’s Office of Pollution Prevention and Toxics intends to release, for public comment and stakeholder engagement, draft documents that will provide the public with more certainty and clarity regarding how EPA makes new chemical determinations and what external information will help facilitate these determinations.
  • EPA will facilitate a public dialogue on the Agency’s goal of continued improvement in the new chemicals review program.
  • EPA will continue posting weekly web updates of program statistics, so that manufacturers and the public can determine the disposition of cases as quickly as possible.

“EPA has a tremendous responsibility to review new chemicals intended to enter the U.S. market for safety,” Pruitt said. “EPA can either be a roadblock to new products, or it can be supporter of innovation and ever-improving chemical safety.”


Tagged categories: Construction chemicals; Environmental Protection; Environmental Protection Agency (EPA); Safety; Toxicity

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