Public Comments on
EPA's 2017 "New Chemicals Decision Making Framework":
Summary and Response
EPA received public comments on the "New Chemicals Decision Making Framework: Working
Approach to Making Determinations under section 5 of TSCA" released in 2017. Commenters
included approximately 40 entities and individuals, including trade associations, coalitions of
chemical industry stakeholders, public health and environmental groups, other non-governmental
organizations, academic institutions, scientists, health and environmental professionals. All
comments, including a transcript of the December 2017 public meeting, are available in the
docket at'U H	I I < n_" o'V EPA appreciates
the time and efforts of these stakeholders to help EPA improve its new chemicals program and
has incorporated feedback where possible into the updated working approach.
Public comments can be grouped into three main categories: (1) general or specific comments on
the document itself and EPA's expected implementation, (2) the Agency's identification of
reasonably foreseen conditions of use, and (3) the role of section 5(e) orders and significant new
use rules in managing risks.
EPA received comments that prompted some important clarifications. For example, commenters
requested additional discussion on topics such as "information sufficiency," "reasoned
evaluation," "unreasonable risk," and testing requirements that may be associated with new
chemical reviews. Others sought assurance that the Agency would make decisions consistent
with the scientific standards in TSCA section 26. In response, EPA added additional content to
clarify the general principals and key concepts associated with the working approach.
Several commenters raised questions or concerns regarding EPA's expected implementation
efforts. Some commenters opposed the approach in the document and urged EPA to delay
implementation and/or change course while others strongly supported the approach.
Commenters raised questions or made comments regarding application of the approach that EPA
believes may have stemmed from a misunderstanding of the Agency's intent. In addition to
providing the clarifications and additional content on principals and key concepts, EPA added
new sections to describe the document's purpose and the Agency's approach to threshold
questions that have significant bearing on the section 5(a)(3) determination. EPA reorganized
the entire document to increase readability. EPA believes the updated working approach will
help clear up some of these misunderstandings and underscore EPA's commitment to continue to
implement new chemical determinations in a manner consistent with TSCA section 5, as
EPA also received comments regarding reasonably foreseen conditions of use. Generally,
commenters provided suggestions and/or requests for an expanded discussion of this concept.
Given the significant impact of identifying the conditions of use when making determinations on

new chemicals, EPA has expanded its description of intended, known and reasonably foreseen
conditions of use, and added a new section on how the Agency approaches the identification of
conditions of use.
Commenters suggested that EPA should limit its review to only those uses identified by a new
chemical submitter. EPA disagrees, as this approach would be inconsistent with the mandate in
TSCA to review new chemical substances under their conditions of use. Conditions of use
include not just those that are intended by a submitter, but also those other circumstances that are
known and reasonably foreseen. EPA believes its working approach is consistent with this
Finally, commenters expressed concern that EPA's working approach would lead to fewer
section 5(e) orders and much higher numbers of SNURs. Some suggested that SNURs are
ineffective tools for managing risks and were never intended to be a prilmary regulatory tool for
new chemicals under TSCA. Others indicated concern that SNURs may be burdensome for
industry in terms of compliance tracking. Several commenters indicated concern with delays
associated with an approach that relied on SNURs. In response to these comments, EPA added
new content to the document to clarify what a SNUR is, what it requires of certain manufacturers
and processors, and the different ways that EPA applies this tool to ensure the safety of
chemicals in the marketplace. EPA is not forgoing 5(e) orders; in fact, TSCA mandates issuance
of an order for a number of determinations under section 5(a)(3). EPA is continuously working
to streamline its processes for reviewing and managing new chemicals, including the
development of SNURs, and has made significant process to these ends.