0796.16 Attachment 2

Response to Comments Received on the ICR Renewal entitled "Notification of Substantial
Risk of Injury to Health and the Environment under TSCA Section 8(e))" (EPA-HQ-OPPT-20150744-0003)
Background
Under section 8(e) of the Toxic Substances Control Act (TSCA), "any person who manufactures [including
imports], processes, or distributes in commerce a chemical substance or mixture and who obtains
information which reasonably supports the conclusion that such substance or mixture presents a
substantial risk of injury to health or the environment shall immediately inform the [EPA] Administrator
of such information unless such person has actual knowledge that the Administrator has been
adequately informed of such information." (15 U.S.C. 2607(e)).
TSCA section 8(e) continues to be an important and useful tool for early warning and identification of
potential substantial risk situations allowing EPA and others to focus their limited resources on
chemicals or mixtures of highest concern. The submission of section 8(e) information makes it possible
for the Agency and others to learn quickly about potential new chemical hazards/risks posed by
exposure to chemical substances, to conduct more complete assessments and, if needed, take effective
action to eliminate or reduce such risks in a timely manner.
The ICR is identified by EPA ICR No. 0794.16 and 0MB Control No. 2070-0046, and represents the
renewal of an existing ICR that is scheduled to expire on February 28, 2017.
The American Chemistry Council (ACC) and the Environmental Working Group (EWG) responded to the
Federal Register notice (81 FR 43601, July 5, 2016) announcing EPA's intent to submit the ICR renewal
for TSCA section 8(e) to 0MB. A summary of their comments and EPA's responses are contained herein.
Public Comments
American Chemistry Council (ACC)

TSCA Section B{e) Guidance
ACC states that EPA can reduce reporting burdens by updating its guidance to clarify what information
EPA considers to be known by the Agency.

TSCA Section B{e) Website
ACC asks that EPA's website include the previously publicly available TSCA section 8(e) Frequent
Questions and add text explaining the availability of TSCA section 8(e) submissions via EPA's Chemical
Data Access Tool (COAT) and ChemView.