EPA Publishes Documents for New Chemicals Meeting

NOVEMBER 13, 2017

EPA has released the materials for its December 6 public meeting on the review of new chemicals under the June 2016 amendments to the Toxic Substances Control Act (TSCA).

The Agency’s draft New Chemicals Decision-Making Framework document provides an overview of EPA’s “working approach to making determination under Section 5 of TSCA” and discusses specific considerations regarding how the Agency will reach one of the conclusions mandated by the law.

Under the June 2016 TSCA amendments, EPA must now conclude that a new chemical presents an unreasonable risk, it is not likely to present an unreasonable risk, or that the Agency does not have a sufficient amount of information to render a decision. Previously, the Agency could simply “drop” a PMN that would allow a manufacturer to proceed to commercialization.

EPA sets out in the draft document how it will consider and ultimately conclude that a substance presents an unreasonable risk or that it is not likely to present an unreasonable risk:

Presents Unreasonable Risk


  • As a result of the review process, EPA concludes there is sufficient information to conduct a reasoned evaluation. That is, data on the chemical substance or on analogs are adequate to characterize, with an acceptable degree of certainty, the hazard of the substance and its exposure potential.
  • Health or environmental risks under the conditions of use are above risk benchmarks; and.
  • Risk-related factors — such as severity of endpoint, reversibility of effect, or exposure-related considerations—lead EPA to determine that the risks are unreasonable under the conditions of use.
  • EPA’s concerns regarding the conditions of use have not been adequately addressed through amendment of the pre-manufacture notice (PMN) made during the review period in conjunction with the issuance of a SNUR, or issuance of a SNUR without amendment of the PMN.

Not Likely to Present Unreasonable Risk


  • As a result of the review process, EPA concludes there is sufficient information to conduct a reasoned evaluation. That is, data are adequate to characterize, with an acceptable degree of certainty, the hazard of the substance and its exposure potential.
  • Health and environmental risks for the conditions of use are below our benchmarks; or,
  • Health and environmental risks are above the appropriate benchmarks, but other risk-related factors — such as severity of endpoint, reversibility of effect, or exposure-related considerations (duration, magnitude, population, etc.) — lead EPA to determine that the risks are not likely to be unreasonable.
  • If EPA had concerns regarding the conditions of use, such concerns were adequately addressed through amendment of the PMN made during the review period in conjunction with the issuance of a SNUR, or issuance of a SNUR without amendment of the PMN.

The December 6 new chemicals review meeting is scheduled from 9:00 a.m.-5:00 p.m. (EST) in Washington, D.C. ILMA members interested in participating remotely can register here.

The agenda and other documents, including the draft discussed above, can be viewed here.