Attachment L

September 24, 2018
Charlotte Bertrand
Acting Principal Deputy Assistant Administrator
Office of Chemical Safety and Pollution Prevention
US Environmental Protection Agency
William Jefferson Clinton Building
1200 Pennsylvania Avenue, NW
Washington, DC 20460
Subject: Agency Information Collection Activities; Proposed Renewal of an Existing Collection
entitled, “Premanufacture Review Reporting and Exemption Requirements for New
Chemical Substances and Significant New Use Reporting Requirements for Chemical
Substances,” EPA-HQ-OPPT-2017-0645, EPA ICR No. 0574.18, OMB Control No.
2070-0012
Dear Ms. Bertrand:
The American Chemistry Council (ACC)1 is pleased to submit these comments on EPA’s
Information Collection Request (ICR) on Premanufacture Review Reporting and Exemption
Requirements for New Chemical Substances and Significant New Use Reporting Requirements
for Chemical Substances. This ICR represents the renewal of an existing ICR that is scheduled
to expire on November 30, 2018. The ICR seeks information regarding TSCA Section 5
premanufacture review reporting and exemption requirements for new chemical substances and
Significant New Use Reporting Requirements.
The Toxic Substances Control Act (TSCA) was substantially amended in 2016. As of June 22,
2018, changes to Section 5 of the statute, covering new chemicals, became immediately
effective. These changes have resulted in significantly increased overall reporting burdens.
Increased Burden During Preconsultation Process and PMN/Exemption Review Process
As EPA notes in the ICR, TSCA Section 5 requires EPA to make determinations regarding the
manufacture, processing, distribution in commerce, use and/or disposal of new chemical
substances or significant new uses. This process is initiated by the submission of a PreManufacture Notice (PMN) or exemption request (e.g., Low Volume Exemption) for new
chemicals. Following the 2016 amendments, EPA has increasingly offered pre-submission
consultations to manufacturers in order to provide greater clarity to the types of information that
1

The American Chemistry Council’s member companies manufacture, distribute, process, import, use and dispose of chemical
substances regulated under the Toxic Substances Control Act (TSCA). As such, they are obligated to provide information related
to the TSCA Inventory and, at times, may need to correct information on that Inventory. ACC’s member companies are directly
affected by and have a significant interest in this ICR.

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American Chemistry Council Comments on ICR
EPA-HQ-OPPT-2017-0645
April 9, 2018
Page 2

would improve and speed EPA’s review of the PMN. On June 20, 2018, EPA issued guidance
entitled “Points to Consider When Preparing TSCA New Chemical Notifications” to further
improve the pre-consultation process.
In addition, as part of its TSCA amendment implementation, EPA may be proposing more
Significant New Use Rules (SNURs) than in the past. A SNUR may require a Significant New
Use Notification (SNUN).
EPA’s ICR reports an increase of 146,312 hours in the total estimated respondent burden
compared with that identified in the ICR currently approved by OMB. The agency notes that
this increase is both an adjustment as well as a program change. We agree that manufacturers
have experienced increased burden in the New Chemicals program since the passage of the
TSCA amendments; however, we are concerned that the estimates do not fully reflect time and
burden in the pre-consultation process. In particular, since EPA’s Points to Consider document
just became available on June 20, it is not clear that this ICR includes revised estimates to fully
reflect the substantial time invested by manufacturers to engage in this process before submitting
PMNs or exemption requests. We recommend EPA include an additional upward adjustment, at
a minimum, to reflect the time needed by manufacturers to familiarize themselves with this
document and process.

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Thank you for the opportunity to comment. If you have any questions regarding ACC’s
comments, please feel free to contact me at [email protected], 202-2496130.
Very truly yours,

Karyn M. Schmidt

Karyn M. Schmidt
Senior Director
Regulatory & Technical Affairs

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