Chemical Data Reporting; Guidance for Preparing and Submitting a Petition; Notice of Availability
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Abstract
The Environmental Protection Agency (EPA) is announcing the availability of and soliciting public comment on guidance on the processes applicable to the Toxic Substances Control Act (TSCA) Chemical Data Reporting (CDR) regulations: Petitions for full exemption of byproduct substances that are recycled or otherwise used within site-limited, physically enclosed systems and Petitions for partial exemption of chemicals for which the CDR processing and use information has been determined to be of "low current interest" by the Agency. This guidance is designed to elucidate the process and requirements of CDR-specific petitions and is consistent with both existing regulations and guidance. The CDR regulations require manufacturers (including importers) of certain chemical substances included on the TSCA Chemical Substance Inventory (TSCA Inventory) to report data on the manufacturing, processing, and use of the chemical substances.
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<title>Federal Register, Volume 86 Issue 160 (Monday, August 23, 2021)</title>
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[Federal Register Volume 86, Number 160 (Monday, August 23, 2021)]
[Notices]
[Pages 47102-47104]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-17950]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPPT-2018-0321; FRL-8888-01-OCSPP]
Chemical Data Reporting; Guidance for Preparing and Submitting a
Petition; Notice of Availability
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
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SUMMARY: The Environmental Protection Agency (EPA) is announcing the
availability of and soliciting public comment on guidance on the
processes applicable to the Toxic Substances Control Act (TSCA)
Chemical Data Reporting (CDR) regulations: Petitions for full exemption
of byproduct substances that are recycled or otherwise used within
site-limited, physically enclosed systems and Petitions for partial
exemption of chemicals for which the CDR processing and use information
has been determined to be of ``low current interest'' by the Agency.
This guidance is designed to elucidate the process and requirements of
CDR-specific petitions and is consistent with both existing regulations
and guidance. The CDR regulations require manufacturers (including
importers) of certain chemical substances included on the TSCA Chemical
Substance Inventory (TSCA Inventory) to report data on the
manufacturing, processing, and use of the chemical substances.
DATES: Comments must be received on or before December 21, 2021.
[[Page 47103]]
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2018-0321, using the Federal eRulemaking Portal
at <a href="http://www.regulations.gov">http://www.regulations.gov</a>. Follow the online instructions for
submitting comments. Do not submit electronically any information you
consider to be Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute. Additional
instructions on commenting or visiting the docket, along with more
information about dockets generally, is available at <a href="https://www.epa.gov/dockets/about-epa-dockets">https://www.epa.gov/dockets/about-epa-dockets</a>.
Due to the public health concerns related to COVID-19, the EPA
Docket Center (EPA/DC) and Reading Room is closed to visitors with
limited exceptions. The staff continues to provide remote customer
service via email, phone, and webform. For the latest status
information on EPA/DC services and docket access, visit <a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
FOR FURTHER INFORMATION CONTACT:
For technical information contact: Thomas Smith, Data Gathering and
Analysis Division (7406M), Office of Pollution Prevention and Toxics,
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington,
DC 20460-0001; telephone number: (202) 564-7200; email address:
<a href="/cdn-cgi/l/email-protection#0c7f6165786422786463616d7f6d4c697c6d226b637a"><span class="__cf_email__" data-cfemail="bccfd1d5c8d492c8d4d3d1ddcfddfcd9ccdd92dbd3ca">[email protected]</span></a>.
For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; email address: <a href="/cdn-cgi/l/email-protection#4b1f18080a6603243f2722252e0b2e3b2a652c243d"><span class="__cf_email__" data-cfemail="4511160604680d2a31292c2b20052035246b222a33">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by this action if you manufacture
(including import) chemical substances listed on the TSCA Inventory.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to represent each industry sector or
entity to which the guidance mentioned herein applies. The list is
intended to serve as a guide to help readers determine whether the
guidance applies to them. Potentially affected entities may include but
are not limited to:
<bullet> Chemical manufacturers (including importers) (NAICS codes
325 and 324110, e.g., chemical manufacturing and processing and
petroleum refineries).
<bullet> Chemical users and processors who may manufacture a
byproduct chemical substance (NAICS codes 22, 322, 331, and 3344, e.g.,
utilities, paper manufacturing, primary metal manufacturing, and
semiconductor and other electronic component manufacturing).
B. What should I consider as I prepare my comments for EPA?
1. Submitting CBI. Do not submit this information to EPA through
<a href="http://regulations.gov">regulations.gov</a> or email. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as
CBI and then identify electronically within the disk or CD-ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
2. Tips for preparing your comments. When preparing and submitting
your comments, see the commenting tips at <a href="http://www.epa.gov/dockets/comments.html">http://www.epa.gov/dockets/comments.html</a>.
II. What action is the Agency taking?
EPA is announcing the availability of guidance on the two petition
processes applicable to the TSCA CDR regulations and soliciting public
comment on the guidance. The guidance covers petitions for:
<bullet> Full exemption of byproduct substances that are recycled
or otherwise used within site-limited, physically enclosed systems (40
CFR 711.10(d)(1)) and
<bullet> Partial exemption of chemicals for which the CDR
processing and use information has been determined to be of ``low
current interest'' by the Agency (40 CFR 711.6(b)(2)).
The public comment period will be open for 120 days, but the public
may consult this guidance immediately. These comments will be taken
into consideration when determining if updating the guidance is
appropriate as part of EPA's efforts of continuous improvement.
The CDR data include information on the manufacture (including
import), industrial processing and use, and consumer and commercial use
of certain chemicals currently included on the TSCA Inventory, a list
of chemical substances manufactured or processed in the United States
for nonexempt commercial purpose. Manufacturing, processing, and use
information helps EPA screen and assess potential exposures to and
risks of reported chemicals to human health and the environment.
Certain chemicals for which processing and use information has been
determined to be of ``low current interest'' by the Agency are
partially exempted from reporting, and manufacturers of these chemicals
are not required to provide information on the processing and use of
their chemicals (only information on manufacturing (including import)
is required). Additionally, certain chemicals, when produced as
byproducts, may be fully exempted from reporting depending on how they
are manufactured, processed, or used. Two separate petition processes
exist for making amendments to the list of partially exempt chemical
substances (40 CFR 711.6(b)(2)(iv)) or the list of processes and
certain related byproduct substances (40 CFR 711.10(d)(1)(i)) that are
fully exempted when they are recycled or otherwise used within site-
limited, physically enclosed systems.
The primary goal of this guidance is to help the regulated
community comply with the CDR rule requirements in relation to its
applicable petition processes. This guidance identifies and clarifies
examples of the types of information submitters can provide to the
Agency in support of petitions for full or partial exemption from CDR
rule requirements. This guidance is expected to make the requirements
and process of submitting a CDR-specific petition more comprehensible,
enabling petitioners to determine if a petition is appropriate and to
better provide a petition containing the information needed for EPA to
reach a determination. Ultimately, this guidance will help both parties
to better meet regulatory deadlines associated with petition submission
and response.
The byproduct exemption petition process was established as part of
the CDR Revisions rulemaking of 2020 and the partial exemption petition
process has been available since the Inventory Update Rule (IUR)
Amendments rulemaking of 2003. The IUR is the predecessor to the CDR.
During the Office of Management and Budget (OMB)-led interagency review
for the CDR Revisions Rule, EPA agreed to make guidance particular to
the new byproduct petition process available to help potential
petitioners understand the types of information that a petition should
include and to facilitate EPA's determination of whether certain types
of manufacturing processes and associated byproduct substances meet the
criteria of this exemption. The guidance was requested by OMB and by
[[Page 47104]]
some commenters during the associated public comment period (e.g., in
the docket, see the document entitled: ``Response to Public Comments on
the Final TSCA Chemical Data Reporting (CDR) Revisions Rule,'' dated
February 2020).
The information in this guidance is similar to and expands upon
information that has already been available on the CDR website for the
existing partial exemption petition process (40 CFR 711.6(b)(2)). Given
that the new byproduct exemption petition process was modeled in part
after the existing partial exemption petition process, EPA decided to
have the guidance cover both petition processes.
III. Does this guidance document contain binding requirements?
As guidance, this document is not binding on the Agency or any
outside parties, and the Agency may depart from it where circumstances
warrant and without prior notice. While EPA has made every effort to
ensure the accuracy of the discussion in the guidance, the obligations
of EPA and the regulated community are determined by statutes,
regulations, or other legally binding documents. In the event of a
conflict between the discussion in the guidance document and any
statute, regulation, or other legally binding document, the guidance
document will not be controlling.
IV. Is this guidance subject to the Paperwork Reduction Act (PRA)?
This action does not contain any new or revised information
collections or burden subject to additional OMB approval under the PRA,
44 U.S.C. 3501 et seq. Burden is defined in 5 CFR 1320.3(b).
Information collection activities contained in CDR are already approved
by OMB under OMB Control No. 2070-0162 (EPA ICR No. 1884).
Under the PRA, an agency may not conduct or sponsor, and a person
is not required to respond to a collection of information that requires
OMB approval under the PRA, unless it has been approved by OMB and
displays a currently valid OMB control number. The OMB control numbers
for EPA's regulations in Title 40 of the CFR, after appearing in the
Federal Register, are listed in 40 CFR part 9, and included on the
related collection instrument, or form, as applicable.
The public reporting and recordkeeping burden associated with the
submission of a petition under the CDR regulation is estimated to be 1
hour per response. Send comments on the Agency's need for this
information, the accuracy of the provided burden estimates and any
suggested methods for minimizing respondent burden to the Regulatory
Support Division Director, U.S. Environmental Protection Agency
(2821T), 1200 Pennsylvania Ave. NW, Washington, DC 20460. Include the
OMB control number in any correspondence. Do not send the completed
form, petition or other information to this address.
(Authority: 15 U.S.C. 2607(a))
Dated: August 16, 2021.
Michal Freedhoff,
Assistant Administrator, Office of Chemical Safety and Pollution
Prevention.
[FR Doc. 2021-17950 Filed 8-20-21; 8:45 am]
BILLING CODE 6560-50-P
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