Attachment 11 - Public Comment__ACC

February 25, 2022
Katherine Sleasman, Mission Support Division (7101M)
Office of Program Support
Environmental Protection Agency
1200 Pennsylvania Ave. NW
Washington, DC 20460–0001
Submitted via: www.regulations.gov
Subject:

Agency Information Collection Activities; Proposed Renewal and
Consolidation of Two Currently Approved Collections Under Section 5 of the
Toxics Substances Control Act; Comment Request; Docket Identification
(ID) Number EPA-HQ-OPPT-2021-0660-0001

Dear Ms. Sleasman:
The American Chemistry Council (ACC) appreciates the opportunity to provide comments on
the EPA’s December 27, 2021 information collection request (ICR), proposed renewal and
consolidation of two currently approved collections under Section 5 of the Toxics Substances
Control Act. ACC and its members have consistently supported transparency and consistency in
the data collection process. We recognize that the information gathered during the
premanufacture review of new chemical substances and the reviews of significant new use rules
for new and existing chemical substances help to support EPA’s activities to meet its mission of
protecting human health and the environment.
As the EPA is considering consolidating and renewing the current ICRs it must ensure that: (1) it
accurately captures the cost to U.S. businesses; (2) provides more clarity in what information is
being sought, the process for considering the information provided, and how that information
will be used to support the agency’s decision-making during the review process; and (3) improve
the electronic submission processes to minimize the burden on submitters. ACC offers the
following comments that the agency should address prior to finalizing any renewals to the
current ICRs.


Update the Estimated Delay Cost – The agency should update its “Supporting
Statement for an Information Collection Request (ICR) Under the Paperwork Reduction
Act (PRA)” to better reflect the actual estimated delay cost for premanufacture notices
(PMNs) and significant new use notices (SNUNs) resulting from delays in the submission
review process. EPA has estimated delay cost of $34,290 for a PMN or a SNUN based on
calculating the average cost per submission, using the midpoint of the low and high delay
cost estimates (1993 dollars) and inflating to 2016 dollars using the Bureau of Labor
Statistics’ Producer Price Index data for the Chemical Manufacturing industry. This

americanchemistry.com®

700 Second St., NE | Washington, DC  20002 | (202) 249.7000                                                

Page 2
estimate does not appear to fully capture the resulting loss of profits by manufactures due
to the sometimes year long delays in the review process. For example, one company
indicated an anticipated loss of approximately $150,000 due to a PMN that went well
beyond the 90-day review period. Delays with respect to PMNs and SNUNs may not
only impact the cost to manufactures in lost sales and potentially result in supply chain
disruptions, but also could result in the offshoring of manufacturing. EPA should provide
additional detail in how delay costs are calculated, including if there is a set delay
timeframe that is being used to calculate the delay costs (e.g., X dollars in loss of profit
per day times the number of days of the delay in excess of the original review timeline).


Provide More Clarity in the Process for Review and Approval – The agency must
ensure that its reviews are focused on evaluating potential for human health and
environmental risk and not only on hazard. This includes using the most up-to-date
exposure modeling and data provided by the submitter. The Agency is specifically
encouraged to update its “Points to Consider When Preparing TSCA New Chemical
Notifications” to reflect additional information regarding the established processes for
submitters to provide additional information and amendments to their original
submissions. This will not only help aid EPA with refining its assumptions but also
minimize delays in the review process. It would be helpful if the agency provided
additional clarification regarding: the process for when and how amendments to
submissions are requested; if there is a time limit or limit to the number of amendments
allowed during the PMN or SNUN process; and if there is an opportunity to establish a
clearer schedule between the “Initial Chemistry Review,” the “Chemical Review and
Search Strategy,” the Structure Activity Team (“SAT”) and the regulatory decision
making to ensure regular discussions between the EPA and the submitters are occurring
throughout the review process. Providing more guidance regarding this process and the
opportunity for submission of additional information will allow the submitter to provide
relevant information in a timely manner to inform EPA decision-making and potentially
minimize the number of amendments to submissions. While these comments are focused
on the PMN and SNUN process, they are also applicable to the Low Volume Exemption
(LVE) process, and EPA should work to incorporate best practices and process
improvements to ensure the application of the most relevant data.



Provide Clarity in How Collected Data Informs Decision-Making – It continues to
remain unclear how the information that EPA collects during this process is ultimately
utilized, in lieu of default assumptions or modeling, to reach decisions about human
health or environmental risk. EPA should better articulate how the collection of
information related to manufacturing, formulation, and application for PMN and SNUN
submissions along with exposure and environmental release data is used in the
development of exposure scenarios and characterizing risk.



Improve the Electronic Submission Processes – Submission for new chemical reviews
occur primarily through the EPA’s Central Data Exchange (CDX). ACC has previously
noted ongoing technical issues with EPA’s CDX and continues to encourage the agency
to perform a complete overhaul of the system.

americanchemistry.com®

700 Second St., NE | Washington, DC  20002 | (202) 249.7000                                                      

Page 3
ACC appreciates the opportunity to provide these comments and encourages the Agency to
incorporate this feedback prior to finalizing the ICRs. Please feel free to contact me by phone:
202-249-6129 or email: [email protected] with any questions.
Sincerely,

^tà ZtÄx
Kat Gale
Director, Regulatory & Scientific Affairs

americanchemistry.com®

700 Second St., NE | Washington, DC  20002 | (202) 249.7000