TSCA Chemical Data Reporting Revisions Under TSCA Section 8(a), 20122-20149 [2020-06076]
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ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 711
[EPA–HQ–OPPT–2018–0321; FRL–10005–
56]
RIN 2070–AK33
TSCA Chemical Data Reporting
Revisions Under TSCA Section 8(a)
SUPPLEMENTARY INFORMATION:
I. Executive Summary
Environmental Protection
Agency (EPA).
ACTION: Final Rule.
AGENCY:
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A. Does this action apply to me?
EPA is finalizing a rule under
the Toxic Substances Control Act
(TSCA) to amend the Chemical Data
Reporting (CDR) requirements. The CDR
rule requires manufacturers (including
importers) of certain chemical
substances listed on the TSCA Chemical
Substance Inventory (TSCA Inventory)
to report data on chemical
manufacturing, processing, and use
every four years. EPA is finalizing
several changes to the CDR rule to make
regulatory updates that align with new
statutory requirements of TSCA, to
improve the CDR data collected as
necessary to support the
implementation of TSCA, and
potentially to reduce burden for certain
CDR reporters. In addition, these
regulatory modifications may result in
additional information to EPA and the
public that is currently not collected;
improve the usability and reliability of
the reported data; and ensure that data
are available in a timely manner.
DATES: This final rule is effective May
11, 2020.
ADDRESSES: The docket for this action,
identified by docket identification (ID)
number EPA–HQ–OPPT–2018–0321, is
available at https://www.regulations.gov
or at the Office of Pollution Prevention
and Toxics Docket (OPPT Docket),
Environmental Protection Agency
Docket Center (EPA/DC), West William
Jefferson Clinton Bldg., Rm. 3334, 1301
Constitution Ave. NW, Washington, DC.
The Public Reading Room is open from
8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The
telephone number for the Public
Reading Room is (202) 566–1744, and
the telephone number for the OPPT
Docket is (202) 566–0280. Please review
the visitor instructions and additional
information about the docket available
at https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: For
technical information contact: Susan
Sharkey, Chemical Control Division,
Office of Pollution Prevention and
Toxics, Environmental Protection
Agency, 1200 Pennsylvania Ave. NW,
SUMMARY:
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Washington, DC 20460–0001; telephone
number: (202) 564–8789; email address:
sharkey.susan@epa.gov.
For general information contact: The
TSCA-Hotline, ABVI-Goodwill, 422
South Clinton Ave. Rochester, NY
14620; telephone number: (202) 554–
1404; email address: TSCA-Hotline@
epa.gov.
You may be potentially affected by
this action if you manufacture (defined
by statute at 15 U.S.C. 2602(9) to
include import) chemical substances,
including if you are a chemical user or
processor who manufactures byproduct
chemical substances. Any use of the
term ‘‘manufacture’’ in this document
will encompass ‘‘import,’’ the term
‘‘manufacturer’’ will encompass
‘‘importer,’’ and the term ‘‘chemical
substance’’ will encompass ‘‘byproduct
chemical substance,’’ unless otherwise
stated.
The potentially regulated community
consists of entities that produce
domestically or import into the United
States chemical substances listed on the
TSCA Inventory. The Agency’s previous
experience with TSCA section 8(a)
collections has shown that most
respondents affected by this collection
activity are from the following North
American Industrial Classification
System (NAICS) code categories:
• NAICS 325—Chemical
Manufacturing; and
• NAICS 324—Petroleum and Coal
Product Manufacturing.
In addition to the anticipated
respondents from the NAICS listed
previously, the potentially regulated
community consists of manufacturers of
byproducts that are required to report
under certain TSCA section 8(a) rules,
including CDR. Byproduct
manufacturers may be listed under a
different primary activity for a site, such
as NAICS codes 22, 322, 327310, 331,
and 3344, representing utilities, paper
manufacturing, cement manufacturing,
primary metal manufacturing, and
semiconductor and other electronic
component manufacturing, respectively.
The NAICS codes have been provided
to assist you and others in determining
whether this action might apply to
certain entities. To determine whether
you or your business may be affected by
this action, you should carefully
examine the applicable provisions at 40
CFR 711.8. If you have any questions
regarding the applicability of this action
to a particular entity, consult the
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technical contact person listed under
FOR FURTHER INFORMATION CONTACT.
B. What is the Agency’s authority for
taking this action?
TSCA section 8(a)(1) authorizes the
EPA Administrator to promulgate rules
under which manufacturers and
processors of chemical substances must
maintain such records, and submit such
information, as the EPA Administrator
may reasonably require (15 U.S.C.
2607). TSCA section 8(a) generally
excludes small manufacturers and
processors of chemical substances from
the reporting requirements established
in TSCA section 8(a). However, EPA is
authorized by TSCA section
8(a)(3)(A)(ii) to require TSCA section
8(a) reporting from small manufacturers
and processors with respect to any
chemical substance that is the subject of
a rule proposed or promulgated under
TSCA sections 4, 5(b)(4), or 6; that is the
subject of an order in effect under TSCA
sections 4 or 5(e); that is subject to a
consent agreement under TSCA section
4; or that is the subject of relief granted
pursuant to a civil action under TSCA
section 5 or 7.
TSCA section 8(a)(5) requires the EPA
Administrator, to the extent feasible, not
to require unnecessary or duplicative
reporting, and to minimize the cost of
compliance for small manufacturers.
TSCA section 14 imposes
requirements for the assertion,
substantiation, and Agency review of
confidential business information (CBI)
claims.
C. What action is the Agency taking?
In this action, EPA is promulgating
several amendments to the CDR rule,
taking into consideration comments
received on the proposed rule (EPA–
HQ–OPPT–2018–0321). Although
included in the proposal, EPA is
addressing the proposed amendment to
update the size standards definition for
small manufacturers for reporting and
recordkeeping requirements under
TSCA section 8(a) in a separate final
rule (identified by RIN 2070–AK57), as
discussed in the proposed rule (Ref. 1).
The following is a brief listing of the
primary amendments being finalized,
some of which have been modified from
the proposal, as described in this unit.
EPA is finalizing these modifications
based on comments received during the
public comment period. These
amendments are described in more
detail in Unit III.
1. Changing requirements for making
confidentiality claims, including to
identify when upfront substantiation is
required (which is being finalized as
proposed), update the substantiation
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questions, and identify data elements
that cannot be claimed as confidential
(which is being finalized as proposed),
so as to align with the Frank R.
Lautenberg Chemical Safety for the 21st
Century Act (2016 Amendments). The
substantiation questions have been
modified from the proposal based on
comments received during the public
comment period;
2. Replacing certain processing and
use codes (industrial function and
commercial/consumer product use)
with codes based on the Organisation
for Economic Co-operation and
Development’s (OECD) functional use
and product and article use codes. EPA
is also adding the requirement to report
the OECD-based functional use codes
for consumer and commercial use
information. This provision is being
finalized as proposed with some
modifications from the proposal: the
new codes will be codified in the Code
of Federal Regulations (CFR) rather than
listed in guidance, codes associated
with non-TSCA uses will be folded into
the overarching non-TSCA use code,
and reporting using the OECD-based
codes will be required during the 2020
CDR submission period for the chemical
substances designated in 2019 by EPA
as a high priority for risk evaluation (84
FR 71924, December 30, 2019) (FRL–
10003–15) and required for all chemical
substances during the 2024 CDR
submission (reporting using the OECDbased codes would be voluntary for all
reporters during the 2020 CDR
submission period);
3. Adding the requirement to report
the NAICS code(s) for the site of
manufacture, which is being finalized as
proposed;
4. Modifying the requirement to
indicate whether a chemical is removed
from the waste stream and recycled,
remanufactured, reprocessed, or reused,
by changing the requirement to indicate
whether a chemical is removed from the
waste stream and recycled. This
modification is being finalized as
proposed;
5. Adding a voluntary data element to
identify the percent total production
volume of a chemical substance that is
a byproduct. This proposed requirement
is being finalized with modification
from the proposal, by including that
percent byproduct reporting be in
ranges and making the reporting of the
data element voluntary;
6. Requiring that the secondary
submitter of a joint submission report
the specific function of the chemical
along with the percentage of the
chemical in the imported product. This
requirement is being finalized as
proposed;
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7. Modifying the reporting of ‘‘parent
company’’ to require the use of a
naming convention; add the
requirement to report a foreign parent
company, when applicable; and codify
reporting scenarios in a new definition
for ‘‘highest-level parent company.’’
These definitions, requirements, and
reporting scenario codifications are
being finalized with modification from
the proposal;
8. Simplifying the reporting process
by providing two reporting mechanisms
for co-manufacturers by enabling a
multi-reporter process for reporters to
separately report directly to EPA within
the e-CDRweb reporting tool. These
changes are being finalized with minor
modification from the proposal, with
the finalization of two separate
reporting methodologies;
9. Adding exemptions (1) for
specifically identified byproducts that
are recycled in a site-limited, enclosed
system (which is being finalized as
proposed with the addition of another
chemical substance) and (2) for
byproducts that are manufactured as
part of non-integral pollution control
and boiler equipment (which is being
finalized as proposed); and
10. Clarifying regulatory text by
removing outdated text and making
other improvements. These changes are
being finalized as proposed.
Some proposed provisions will not be
finalized based on comments received
during the public comment period. For
a more detailed discussion of what was
proposed but not finalized, please see
Unit II.C., Public Comments and Other
Public Input.
As described in the proposal, EPA is
taking other, non-regulatory steps to
minimize the burden on reporters, by
improving the reporting application and
database to be user-friendly and
dynamic, with straightforward questions
that include fill-in-the-blank fields,
check boxes, and drop-down menus. In
addition, EPA is replacing the current
pre-formatted Form U with a
customized report that will be based on
the actual information submitted by a
site through e-CDRweb, the electronic
reporting tool. This change will enable
fields to expand or contract as needed
to display the entered information in
one spot, eliminating the need for
continuation pages or for large empty
spaces in the printed report. For
example, some chemical names are very
short and need only 10 or 20 characters,
while other chemical names are very
long and use multiple lines of text.
Although these changes are not
discussed further in this final rule, they
are an important component of the effort
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to reduce burden and modernize the
data collection system.
EPA is making this update as a result
of feedback received from reporters and
other stakeholders following the 2016
submission period (Ref. 2) and during
an extensive negotiated rulemaking
effort, which included participation by
all stakeholder groups, and subsequent
public comment period from October
12, 2017–December 11, 2017, at the
conclusion of the negotiated rulemaking
(Ref. 3 and Ref. 4). EPA is adding an
addendum to the current CDR rule ICR
(OMB Control Number 2070–0162) for
the regulatory changes finalized in this
document (Ref. 5). In addition to the
changes outlined in this final rule, if
needed, EPA will provide a second
addendum to this ICR to address nonregulatory changes. As was done for
previous CDR collections, EPA will
provide reporters with the opportunity
to test and comment on the updated eCDRweb reporting tool prior to the 2020
CDR submission period. The testing, by
a group of volunteer reporters, will be
conducted under a generic ICR for EPA
software testing (OMB Control Number
2010–0042) (Ref. 6). EPA anticipates
holding a webinar to introduce the
revised e-CDRweb reporting tool to the
regulated community directly following
the publication of this rule. During the
webinar, EPA will issue a general
invitation to interested parties to
participate in a short testing period of
the revised e-CDRweb reporting tool.
EPA will open the testing period shortly
after publication of this rule. Because of
resource constraints, the testing period
will be limited to 25 participants. For
additional information, contact the
person under FOR FURTHER INFORMATION
CONTACT. Also, information will be
posted on the CDR website (https://
www.epa.gov/chemical-data-reporting).
D. Why is the Agency taking this action?
EPA is revising the CDR rule for three
primary reasons: First, aligning CDR
reporting with the 2016 Amendments;
second, improving the CDR data
collected to support the implementation
of TSCA; and third, potentially reducing
burdens for certain CDR reporters
pursuant to TSCA section 8(a)(5).
The 2016 Amendments to TSCA
changed requirements associated with
confidentiality claims, including
identifying the data elements eligible for
confidentiality claims and identifying
the situations under which
substantiation of claims is required.
EPA is revising the CDR rule to address
these changes.
As described in the proposed rule,
EPA is also finalizing changes to CDR
reporting so that the information
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collected is tailored to better meet the
Agency’s overall information needs and
is aligned with specific needs for
chemical substance prioritization and
risk evaluation under TSCA section 6.
TSCA section 2 specifies that ‘‘adequate
information should be developed with
respect to the effect of chemical
substances and mixtures on health and
the environment and that the
development of such information
should be the responsibility of those
who manufacture and those who
process such chemical substances and
mixtures’’ (TSCA section 2(b)(1)). EPA’s
changes include the addition of data
elements that must be reported, such as
site-specific NAICS codes; modification
to multi-reporter submission
requirements, including adding a
process for jointly reporting comanufactured chemicals; and changes to
current data elements, such as codes
used for reporting processing and use
information and the addition of the
percentage of a chemical that is a
byproduct (in ranges) as a data element
that can be reported voluntarily. In
addition, changes to the parent
company reporting requirements will
increase EPA’s ability to protect
confidential information while better
enabling EPA to make information
publicly available. As described in the
proposed rule, these changes should
help to meet the Agency’s requirement
under TSCA section 26(h), in carrying
out TSCA sections 4, 5, and 6, to make
scientific decisions consistent with the
best available science; to improve the
CDR data collected to support the
implementation of TSCA; and to
improve EPA’s ability to provide public
access to the information. Furthermore,
these changes should aid in meeting the
Agency’s objective to obtain new and
updated information relating to
potential exposures to a major subset of
chemical substances listed on the TSCA
Inventory.
EPA is interested in streamlining
reporting requirements and processes
while maintaining the Agency’s ability
to receive the information it needs to
understand exposure to these chemicals
(TSCA section 8(a)(5)). As described in
the proposed rule, EPA’s proposed
revisions were informed by information
provided in 2016 and 2017 during the
2016 CDR submission period, public
comment opportunities, and an
extensive negotiated rulemaking effort,
which included participation by all
stakeholder groups, and subsequent
public comment period from October
12, 2017, to December 1, 2017, at the
conclusion of the negotiated rulemaking
(Ref. 3 and Ref. 4).
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This final rule takes into account
comments received on the proposed
rule, from April 25, 2019, to June 24,
2019. EPA received 24 comments from
various stakeholders and the public that
helped inform the finalization of this
rule. In response to stakeholder input,
EPA is finalizing the introduction of two
new exemptions related to byproducts
and a revised approach to reporting for
co-manufactured chemicals. In addition,
harmonizing the function and product
codes with those used by OECD is
expected to reduce potential confusion
for those reporting under multiple
country requirements.
Additionally, EPA has received
comments that modernizing the CDR
data collection and public access to the
database may reduce reporting burden
and facilitate ease of use by reporters
and the public. These comments were
used to develop this final rule and will
be used to inform other non-regulatory
changes that EPA plans to make to the
reporting process, such as the reporting
tool modernization described in Unit
I.C.
E. What are the incremental costs of this
action?
EPA has evaluated the potential costs
and benefits of revising CDR reporting
requirements as required by the
rulemaking process. Some requirements
in this rule increase burden and cost,
while other requirements and
flexibilities decrease burden and result
in cost savings. Overall, EPA estimates
that the combined impact of all the
amendments would increase the total
burden and result in a cost to industry
and government reporters. This
analysis, which is available in the
docket (Ref. 7), is discussed in Unit III.,
and is briefly summarized here.
The finalized amendments are
estimated to result in an overall net
increase in burden and costs. The
estimated increases in burden and costs
include rule familiarization, increases in
compliance determination, and the
duration of time for form completion.
The next future cycle burden and costs
or cost savings are listed by type of
change:
(1) For changes to claiming
confidentiality (discussed in Unit III.A.),
the incremental burden is expected to
decrease by 14,000 hours with an
associated cost savings of $1.1 million.
The incremental burden and cost
changed from the proposed rule due to
a correction to a cell reference in the
model used for the unit burden
estimates (Ref. 8).
(2) For changes to modify or add
reportable data elements (e.g.,
processing and use codes, NAICS codes,
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byproduct percentage, chemical
function, and parent company—
discussed in Unit III.B.), the incremental
burden is expected to increase by
188,000 hours with an associated cost
increase of $14.5 million. The
incremental burden and cost estimates
changed from the proposed rule due to
the elimination of the site public
contact, the use of intelligent sorting
and search functions in the reporting
tool related to the reporting of
processing and use information, and the
addition of burden of the function
category for consumer and commercial
products (Table 4–13 in Ref. 7).
(3) For changes to add byproducts
exemptions (discussed in Unit III.D.),
the incremental burden is expected to
decrease by 68,000 hours with an
associated cost savings of $5.2 million.
In sum, the overall incremental
impacts to industry and government
reporters result in a net increase in
burden and cost. Estimates include rule
familiarization, compliance
determination, and CDR form
completion (Ref. 7). Estimated changes
to recordkeeping burden and cost are
negligible and estimated at zero. An
estimated 5,660 sites are expected to
report during the next CDR submission
period in 2020. The total incremental
burden and cost are estimated at 32,000
hours and $2.5 million for the CDR 2020
submission period (first cycle), 34,000
hours and $2.7 million for the 2024 CDR
submission period (second cycle), and
27,000 hours and $2.1 million for the
2028 CDR submission period (future
cycles). On an annualized basis, using a
3 percent and a 7 percent discount rate
over a 10-year period, the annualized
incremental cost both round to an
estimated $2.5 million per year (Ref. 7).
II. Background
A. What is the Chemical Data Reporting
rule?
As described in the proposed rule, the
CDR rule requires U.S. manufacturers of
certain chemicals listed on the TSCA
Inventory to report to EPA every four
years certain information about
chemical substances manufactured for
all years since the last principal
reporting year. To minimize reporting
burden, detailed information is required
only for the principal reporting year
(i.e., 2019), including a breakout of the
production volume to provide separate
volumes for domestically manufactured
and imported amounts. Generally,
reporting is required for substances
whose production volumes are 25,000
pounds or more at any single site during
any of the calendar years since the last
principal reporting year. However, a
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lower threshold applies for chemical
substances that are the subject of certain
TSCA actions (see 40 CFR 711.8(b)). The
CDR rule generally excludes several
groups of chemical substances from its
reporting requirements, e.g., polymers,
microorganisms, naturally occurring
chemical substances, certain forms of
natural gas, and water (see 40 CFR 711.5
and 711.6). For the 2016 CDR cycle,
EPA received CDR site reports (Form
U’s) from 5,660 sites with an associated
42,464 chemical reports, providing
information on 8,717 unique chemicals.
Persons domestically manufacturing
or importing chemical substances are
required to report information such as
company name, site location and other
identifying information, production
volume of the reportable chemical
substance, and exposure-related
information associated with the
manufacture of each reportable
chemical substance, including the
physical form and maximum
concentration of the chemical
substance, the number of potentially
exposed workers at the reporting site,
and certain processing and use
information (40 CFR 711.15). Under
CDR, submitters report information to
the extent that it is ‘‘known to or
reasonably ascertainable’’ (40 CFR
711.15), which means ‘‘all information
in a person’s possession or control, plus
all information that a reasonable person
similarly situated might be expected to
possess, control, or know’’ (40 CFR
711.3, referencing 40 CFR 704.3).
Reported information can be claimed as
confidential, with certain exceptions (40
CFR 711.30).
B. EPA’s Proposed Rule for Revisions to
the CDR Rule
On April 25, 2019, EPA proposed the
rule ‘‘TSCA Chemical Data Reporting
Revisions and Small Manufacturer
Definition Update for Reporting and
Recordkeeping Requirements under
TSCA section 8(a)’’ (Ref. 1). EPA
proposed several changes to the CDR
rule to make regulatory updates to align
with new statutory requirements of
TSCA and improve the CDR data
collected as necessary to support the
implementation of TSCA, which could
have potentially reduced or increased
burden for certain CDR reporters. In
particular, EPA proposed to:
1. Harmonize the CDR processing and
use codes with OECD codes;
2. Add the requirement to report the
NAICS code(s) for the site of
manufacture;
3. Modify the requirement to indicate
whether a chemical is removed from the
waste stream and recycled,
remanufactured, reprocessed, or reused
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to instead require an indication of
whether a chemical is removed from the
waste stream and recycled;
4. Add a requirement to identify the
percent total production volume of a
chemical substance that is a byproduct;
require that the secondary submitter of
a joint submission report the chemical
specific function along with the
percentage of the chemical in the
imported product;
5. Add a voluntary data element to
provide a public contact;
6. Modify the definition of ‘‘parent
company’’ to clarify the definition;
7. Add the requirement to report a
foreign parent company, when
applicable, and codify reporting
scenarios;
8. Simplify the reporting process for
co-manufacturers by enabling a multireporter process for reporters to
separately report directly to EPA within
the e-CDRweb reporting tool;
9. Allow reporting in specified metal
categories for inorganic byproducts;
10. Add exemptions for specifically
identified byproducts that are recycled
in a site-limited, enclosed system and
for byproducts that are manufactured as
part of non-integral pollution control
and boiler equipment;
11. Clarify regulatory text by
removing outdated text, consolidating
exemptions, and making other
improvements; and
12. Update the size standards
definition for small manufacturers for
reporting and recordkeeping
requirements under TSCA section 8(a)
(Ref. 1).1
C. Public Comments and Other Public
Input
The proposed rule provided for a 60day public comment period, ending on
June 24, 2019. EPA received 24
comments. Commenters included
industry trade associations (18
comments representing 23
organizations), government entities (one
comment), the National Tribal Toxics
Council (one comment), and nongovernmental organizations (three
comments representing six
organizations). Comments addressed
many provisions of EPA’s proposed rule
and generally supported EPA’s
proposal. Of the 24 comments received,
23 addressed provisions in this rule.
Specifically, EPA received 13 comments
regarding some proposed changes to
reportable data elements that either
supported EPA’s proposal or raised
1 While the CDR revisions and the updates to the
small manufacturer definition were proposed
together in the same document, EPA is addressing
the proposed small manufacturer definition in a
separate final rule, identified by RIN 2070–AK57.
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issues that EPA intends to address in
the Instructions for Reporting (Ref. 9).2
Separately, EPA received 12 comments
that provided information on the
reporting burden related to these or
similar data elements.
For the proposed co-manufacturing
reporting mechanism, comments were
generally supportive of the proposal but
requested additional flexibility. EPA
received 14 comments about the two
proposed exemptions for byproducts,
most of which were supportive.
Commenters who were not supportive
of the proposed exemptions for
byproducts explained that the
exemptions could increase the
complexity of reporting and that the
byproduct exemptions were not
sufficiently expansive to meaningfully
reduce reporting burden. EPA also
received 12 comments on changes to
existing exemptions and other potential
future changes, all of which are outside
of the scope of this action.
EPA received eight comments about
changes to requirements for claiming
confidentiality. Five commenters did
not support EPA’s proposal regarding
which data elements could not be
claimed as confidential, while other
commenters suggested that additional
data elements should not be able to be
claimed as confidential. Following
consideration of the comments received,
EPA is finalizing as proposed the
following: (1) Barring certain processing
and use data considered ‘‘general’’ from
confidentiality claims, and (2) requiring
upfront substantiation for all CBI claims
except for production volume. As
described in Unit III., EPA is finalizing
with some limited modifications the
proposed substantiation questions for
data elements requiring upfront
substantiation. In consideration of
comments received and with an interest
in engaging with reporters’ concerns
about disclosure, EPA is modifying the
proposed substantiation questions. An
overview of the revisions to the
substantiation questions in 40 CFR
711.30 is in Unit III.A.1. Additionally,
based on comments received, EPA is not
finalizing the proposed voluntary public
contact data element or the proposed
2 These proposed changes addressed by the
commenters included harmonizing the CDR
processing and use codes with OECD codes; adding
the requirement to report the NAICs code(s) for the
site of manufacture; requiring reporting of the
chemical-specific function in a joint submission;
modifying the definition of parent company and
requiring reporting of a foreign parent company;
modifying the requirement to indicate whether a
chemical is recycled, remanufactured, reprocessed,
or reused, by changing the requirement to indicate
whether a chemical is removed from the waste
stream and recycled; and adding a requirement to
identify the percent total production volume of a
chemical that is a byproduct.
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alternative reporting in specified
categories for inorganic byproducts.
In this preamble, EPA has responded
to many of the comments relevant to the
proposed revisions to CDR; EPA’s
comprehensive response to comments
related to this final action is in the
Response to Comments document (Ref.
10). EPA is finalizing in a separate
action an amendment to update the size
standards definition for small
manufacturers for reporting and
recordkeeping requirements under
TSCA section 8(a), which includes a
separate Response to Comment
document addressing comments specific
to the small manufacturing definition.
In addition to public comments
received on the proposal, EPA solicited
information through other mechanisms.
Specifically, EPA conducted two
identical sessions as part of tribal
outreach on the proposed rule to
provide background information on the
proposed rule and to obtain feedback
(Ref. 11). EPA received no follow-up
comments from the tribal outreach. EPA
also met with IPC (Association
Connecting Electronics Industries) at
EPA headquarters, toured a printed
circuit board manufacturing site (TTM
Technologies, Inc.), and, with Lehigh
Hanson Cement, toured a Portland
cement clinker manufacturing site. (Ref.
12, Ref. 13, and Ref. 14). In the meetings
and on these tours, EPA received
information on how byproducts and
wastes are stored and eventually
transported offsite for recycling; this
information was useful in the
development of this final rule.
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III. Detailed Discussion of the
Modifications to the CDR Rule
EPA is making a number of revisions
to the CDR rule, as described in this
Unit. The regulatory text of this
document describes the specific CDR
reporting requirements being amended
and includes both the modified and
selected unmodified portions of the
regulatory text (see 40 CFR part 711).
EPA has also developed information for
the public that includes specific
reporting instructions, questions and
answers, and case studies, and EPA
intends to conduct webinars to help
potential CDR submitters become
familiar with the revised reporting
processes and amended reporting
requirements. The information sources
and information on the webinars will be
available on the CDR website (https://
www.epa.gov/cdr).
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A. What changes have been made to
requirements for claiming
confidentiality?
EPA is finalizing changes to
requirements related to claiming CDR
data as confidential, so as to be
consistent with the new statutory
requirements in TSCA section 14. The
2016 amendments to TSCA included
mandated new procedural requirements
for the submission and Agency
management of CBI claims, including
new substantiation requirements, a
certification requirement, and a
requirement for Agency review of
specified CBI claims within 90 days
after receipt of the claim. The revisions
to this rule implement and facilitate the
new TSCA requirements. Specific
changes are discussed in this Unit and
in Unit III.A. of the proposed rule (Ref.
1). EPA estimates that the changes to the
CBI substantiation requirements will
result in a decrease in burden, which is
explained in detail in Chapter 4.3.2 in
the Economic Analysis (Ref. 7). Public
comments regarding claims of
confidentiality generally addressed:
Data elements that are not eligible for
confidentiality claims, data elements
that are exempt from upfront
substantiation, and substantiation
questions.
One commenter provided detailed
comments on the proposed questions
and additionally referenced a recent
Supreme Court decision (Food
Marketing Institute v. Argus Leader
Media, 139 S. Ct. 2356 (2019))
addressing the test for determining
whether commercial information
qualifies as ‘‘confidential’’ for purposes
of Exemption 4 of the Freedom of
Information Act (FOIA), 5 U.S.C.
552(b)(4). In that decision, the Court
rejected the ‘‘substantial competitive
harm’’ test that had long been applied
by the U.S. Court of Appeals for the D.C.
Circuit, under which certain
commercial information could not be
deemed ‘‘confidential’’ unless
disclosure was likely to cause
substantial harm to the competitive
position of the person from whom the
information was obtained. 139 S. Ct. at
2361, 2364–66. EPA also received a
request to reopen the comment period to
allow others to provide comment on this
Court decision (Ref. 15).
EPA determined that the Supreme
Court decision did not impact the
finalization of the substantiation
questions or CBI review criteria that
were proposed in this TSCA rulemaking
because Congress amended TSCA
section 14 in 2016 to, among other
things, specifically require any person
asserting a CBI claim under TSCA to
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include a certified statement that the
person has ‘‘a reasonable basis to
conclude that disclosure of the
information is likely to cause substantial
harm to the competitive position of the
person.’’ TSCA section 14(c)(1)(B)(iii),
(c)(5); see also TSCA section
14(c)(1)(C)(ii)(II) (referencing substantial
competitive harm). Based on these
requirements in TSCA section 14, EPA
determined that neither the ‘‘substantial
competitive harm’’ review criterion nor
any related substantiation question for
the TSCA CBI claims addressed in this
rulemaking should be removed based on
the Supreme Court’s decision. EPA
accordingly decided not to reopen the
comment period. See the Response to
Comments document for additional
discussion. (Ref. 10).
1. Substantiations. EPA interprets
TSCA section 14(c)(3) as requiring
substantiation of any non-exempt CBI
claim at the time the information
claimed as CBI is submitted to EPA (Ref.
16). The Agency is finalizing the
amendment of the CDR substantiation
provisions to require substantiation for
all confidentiality claims except for
those types of information exempt from
substantiation under TSCA section
14(c)(2), which are described later in
this Unit. EPA modified the proposed
regulatory text to remove references to
data elements that were proposed and
not finalized, such as the public contact
information discussed in Unit III.F.1., to
change text for clarity, and to correct
cross-references.
EPA is finalizing revisions to the
substantiation questions in 40 CFR
711.30, with some changes between the
proposed changes and those that are
being finalized. In consideration of
comments received and with an interest
in engaging with reporters’ concerns
about disclosure, EPA is modifying the
proposed substantiation questions. An
overview of the revisions to the
substantiation questions in 40 CFR
711.30 is as follows.
A set of standard questions, set forth
in 40 CFR 711.30(b), applies to all nonexempt CBI claims. In response to
comments received, EPA modified the
questions to facilitate clarity and
understanding of the questions
themselves and to help ensure that
submitters are correctly and
appropriately substantiating their
confidentiality claims. For example, to
the question about substantial
competitive harm (40 CFR 711.30(b)(1)),
EPA has expanded the proposed
statement ‘‘If you answered yes, explain
the substantial harm’’ to a clearer
description: ‘‘If you answered yes,
describe the substantial harmful effects
that would likely result to your
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competitive position if the information
is disclosed, including but not limited
to how a competitor could use such
information and the causal relationship
between the disclosure and the harmful
effects.’’ Likewise, EPA added
additional examples to the question
about where the information may have
been publicly disclosed (40 CFR
711.30(b)(3)), and split the question into
three parts so that the first part
discusses disclosure required under
other Federal law, the second part
addresses more general public
documents, and the third part is specific
to patents.
EPA proposed additional questions
that were targeted to specific data
elements. An additional series of four
questions for specific chemical identity
CBI claims is set forth in 40 CFR
711.30(c). The first proposed question,
at 40 CFR 711.30(c)(1), addresses
whether the chemical substance is
publicly known to be in commerce in
the United States. EPA modified this
question to remove language identified
as confusing by a commenter and to
clarify that the inquiry is intended to
address knowledge by the public at
large as well as by competitors within
the industry. The second and third
proposed questions, at 40 CFR
711.30(c)(2)–(3), address the ability for
others to reverse engineer the chemical
identity. The second question has been
slightly modified to be worded in a
consistent manner with other questions.
The third question has been modified to
clarify EPA’s expectation that the
response takes into account existing
technologies, and that it addresses
whether a chemical identity is ‘‘readily’’
discoverable. The fourth proposed
question, at 40 CFR 711.30(c)(4),
addresses the release of confidential
process information and has been
finalized as proposed.
Information about substantiating for
company, site, and technical contact
identity is finalized in 40 CFR
711.30(a)(6), proposed in 40 CFR
711.30(d). As proposed, there was one
additional question at 40 CFR
711.30(d)(1) for the substantiation of
these claims (Ref. 1). EPA did not
finalize this question because it is
substantially the same as the question
finalized at 40 CFR 711.30(b)(3), which
submitters must already answer for
these data element claims. EPA is
retaining the 40 CFR 711.30(d)
paragraph, finalized in 40 CFR
711.30(a)(6), because it explains when
the submitter may assert a claim for the
linkage between the company, site, or
technical contact identity and the
chemical substance.
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Requirements to substantiate
confidentiality claims for certain
processing and use information are set
forth in 40 CFR 711.30(a)(7). As
proposed, there were two additional
questions for these claims. EPA did not
finalize either question because EPA
determined that these questions
solicited the same information that
claimants would already be required to
provide in their responses to the
substantiation questions applicable to
all CBI claims, and would not provide
additional information that is uniquely
necessary for adjudicating CBI claims
for these data elements. The question
proposed at 40 CFR 711.30(e)(1) is
substantially the same as the question
finalized at 40 CFR 711.30(b)(3), and the
question proposed at 40 CFR
711.30(e)(2) is substantially the same as
the question finalized at 40 CFR
711.30(b)(2), which submitters must
already answer for these data element
claims.
EPA is finalizing, with some changes
from the proposal, 40 CFR 711.30(a)(3),
which describes the data elements that
are exempt from the requirement to
provide substantiations at the time the
data are submitted. EPA believes that
the only data elements collected under
CDR that may be subject to the TSCA
section 14(c)(2) exemption from upfront
substantiation requirements are (1)
production volume (711.30(a)(3)(i)) and
(2) supplier information associated with
joint submissions, such as supplier
identity and details of the full
composition of a mixture
(711.30(a)(3)(ii) and (iii)). In addition,
EPA believes that a petition submitted
under 40 CFR 711.6(b)(2)(iii) or 40 CFR
711.10(d)(1)(ii) may contain information
that is described in TSCA section
14(c)(2) (711.30(a)(3)(iv)). However, the
data elements that are exempted from
upfront substantiation may still be
subject to substantiation and CBI review
under the circumstances described in
TSCA section 14(f).
a. Regarding production volume. EPA
is finalizing its proposal not to require
substantiation at the time the claim of
confidentiality is made for five
production volume data elements (so,
for the 2020 reporting cycle, the volume
domestically manufactured in 2019, the
volume imported in 2019, and the total
production volume for each of the three
years 2016 through 2018). For each
reported chemical, total production
volume is reported for each of the years
since the last principal reporting year—
except for the current principal
reporting year, for which the production
volume is reported as domestically
manufactured and imported volumes.
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While commenters in general agreed
with the proposal, some commenters
wanted EPA to expand the exemption
from upfront substantiation to include
all data elements that contain a volume
(i.e., volume used on site and volume
directly exported) because such
information relates to the production
volume of a chemical substance. EPA
disagrees with the suggestion that TSCA
section 14(c)(2)(F), which exempts from
upfront substantiation requirements
‘‘[s]pecific production or import
volumes of the manufacturer or
processor,’’ is intended to exempt any
data element referencing a volume.
Because volume used on site and
volume directly exported provide
information about the disposition of the
chemical after it is produced or
imported, rather than information about
the total amount originally produced or
imported by the manufacturer, these
data elements are not the ‘‘production or
import volumes’’ listed in TSCA section
14(c)(2)(F). Therefore, EPA did not add
these two data elements to the list at 40
CFR 711.30(a)(3) of data elements that
do not require substantiation of
confidentiality claims at the time of
submission.
b. Regarding information associated
with a joint submission. EPA is
finalizing as proposed requirements
associated with making confidentiality
claims for joint submissions, described
in 40 CFR 711.30(d)(1). This includes
the requirement that in a joint
submission, the primary submitter
identify whether the supplier
information, including the supplier
identity and chemical substance name
(trade name), is confidential. Because
EPA interprets these data elements as
‘‘[i]nformation identifying a supplier’’
under TSCA section 14(c)(2)(C),
substantiation of the confidentiality
claims for this information will not be
required at the time of submission. The
secondary submitter of the joint
submission will provide its company
name and location, a technical contact,
trade name, chemical identity(ies), and
percentage of each chemical substance
in the composition of the substance or
mixture represented by the trade name.
The secondary submitter is
responsible for asserting all
confidentiality claims for the data
elements that it submits directly to EPA
and for substantiating those claims not
exempt under 40 CFR 711.30(a)(3)(iii).
Secondary submitters should note that
EPA is finalizing the requirement to
collect the function of each chemical in
the mixture in a joint submission, as
described in Unit III.B.5. The function
of the chemical is one of the processing
and use data elements that are barred
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from claims of confidentiality by 40 CFR
711.30(a)(2)(ii). Other data elements,
such as the chemical substance identity,
can be claimed as confidential by the
secondary submitter following the
provisions in 40 CFR 711.30. Except for
the percentage composition information,
which is generally exempt from
substantiation pursuant to TSCA section
14(c)(2)(D), all other reported data
elements are subject to substantiation at
the time the information is submitted.
2. Certification. The authorized
official submitting confidentiality
claims must certify that all claims for
confidentiality are true and correct, and
that all information submitted to
substantiate such claims is true and
correct. In addition, all persons
asserting a confidentiality claim must
include the statement described in
TSCA section 14(c)(1)(B), and the
authorized official must certify that this
statement is true and correct. EPA
previously combined these
requirements into a single certification
statement, which was implemented in
the CDR electronic reporting tool in
June 2016. EPA is finalizing as proposed
the codification of the language of the
certification statement in the CDR rule
(see the final regulatory text for 40 CFR
711.30(a)(5)).
3. Processing and use data not
protected from disclosure: EPA is
finalizing its proposal to bar
confidentiality claims for certain data
elements that are ineligible for
confidential treatment pursuant to
TSCA section 14(b)(3)(B). The finalized
regulatory text includes a correction to
the proposed regulatory text to match
the Agency’s intent as described in the
preamble to the proposed rule.
a. Final requirements. EPA is
finalizing the codification that the
following data elements cannot be
claimed as confidential because they
constitute general descriptions of
processes, functions, and uses,
including information that customarily
would be shared with the general public
or within an industry or industry sector,
under TSCA section 14(b)(3)(B):
• Certain Industrial processing and
use data elements. The data elements
directly related to how the chemical is
used or processed, i.e., the type of
process or use; the industrial sector; and
the industrial function (40 CFR
711.15(b)(4)(i)(A), (B), and (C)).
• Certain Consumer and Commercial
use data elements. The data elements
directly related to how the chemical is
used, i.e., the product category (40 CFR
711.15(b)(4)(ii)(A)); whether the
chemical is used in commercial or
consumer products (40 CFR
711.15(b)(4)(ii)(C)); whether the
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chemical is likely to be used in
children’s products (40 CFR
711.15(b)(4)(ii)(D)); and the function of
the chemical in the consumer or
commercial product (40 CFR
711.15(b)(4)(ii)(B)) (the function is a
new data element—see Unit III.B.1.a. for
additional information).
With the final regulatory text, EPA
corrected the proposed regulatory text to
include whether the chemical is likely
to be used in children’s products (40
CFR 711.15(b)(4)(ii)(D)) as a data
element that is barred from
confidentiality claims. The preamble to
the proposed rule described the
Agency’s intent to include this data
element as a general description of the
use of the chemical substance (Ref. 1).
Similarly, EPA is finalizing the
proposal that submitters may continue
to assert claims of confidentiality for the
following processing and use data
elements, because they do not offer a
‘‘general description’’ of a process or use
and therefore do not fall within the
limits of TSCA section 14(b)(3)(B):
• Certain Industrial Processing and
use data elements. Percent production
volume, number of sites, and number of
workers (40 CFR 711.15(b)(4)(i)(D), (E),
and (F)).
• Certain Consumer and Commercial
use data elements. Percent production
volume, maximum concentration, and
number of commercial workers (40 CFR
711.15(b)(4)(ii)(E), (F), and (G)).
b. Discussion of TSCA section
14(b)(3)(B) and public comments
received. TSCA section 14(b)(3)(B)
limits protection from disclosure for
general descriptions of process,
function, and use information,
including information that customarily
would be shared with the general public
or within an industry or industry sector.
EPA proposed to codify in the
regulatory text that several data
elements could not be claimed as
confidential because they constitute
general descriptions of processes and
uses that customarily would be shared
with the general public or within an
industry or industry sector. EPA
received comments that supported and
opposed the proposal to bar certain
confidentiality claims.
Some commenters opposed to barring
confidentiality claims disagreed with
the Agency position that TSCA section
14(b)(3)(B) categorically prohibits
protection from disclosure for any
particular information such as certain
processing and use data elements. EPA
disagrees with those comments, and
believes that the statutory text in TSCA
section 14(b)(3) (entitled ‘‘Other
information not protected from
disclosure’’) and (b)(5) is clear that the
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information described in section
14(b)(3)(B) is not eligible for the
protections from disclosure afforded to
businesses under TSCA section 14 or
FOIA Exemption 4 (pertaining to
confidential business information).
Other commenters opposed to barring
these confidentiality claims agreed that
these processing and use data elements
do not typically require CBI claims, but
asserted that with the proposed
expansion to the more-specific OECD
codes, there would be greater potential
for some combinations of codes to
reveal specific and unique use
information that may be confidential.
These commenters also asserted that in
certain situations, chemicals can have
unique functions in consumer/
commercial products, and therefore CBI
claims should be permitted. However,
none of the commenters offered
examples to illustrate situations in
which the combinations of generic
category codes would reveal specific
information about a use or function, as
opposed to a general description.
Following careful consideration of these
comments, EPA determined that, even
in combinations with the newlyfinalized OECD harmonized codes, the
information remains general and
therefore not eligible for CBI status
under TSCA section 14(b)(3)(B).
Commenters that supported barring
confidentiality claims for these data
elements asserted that EPA needs to do
more to prevent unjustified claims of
confidentiality, advocated for increased
transparency of CDR data, and asserted
that other data elements also qualify as
a ‘‘general description of a process used
in the manufacture or processing and
. . . functions and uses’’ under TSCA
section 14(b)(3)(B) that should be barred
from CBI status or alternatively are
barred from CBI status because they are
part of a health and safety study under
TSCA section 14(b)(2). EPA recognizes
the importance of transparency and the
need to enable submitters to protect
information that meets the standards for
confidentiality. Concerning the TSCA
section 14(b)(3)(B) assertion, the
commenters provided no support for
why other data elements might be
considered process information, a
necessary part of the ‘‘general
description of a process . . .’’ as
described in TSCA section 14(b)(3)(B).
Concerning the TSCA section 14(b)(2)
assertion, EPA disagrees with the
suggestion that data in a CDR
submission could be characterized as a
health and safety study or information
from a health and safety study. See the
Response to Comments for additional
discussion (Ref. 10).
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B. What changes have been made to the
reportable data elements?
1. Processing and use codes. The CDR
rule requires manufacturers to report
industrial, consumer, and commercial
processing and use information for
chemical substances manufactured
during the principal reporting year. EPA
is finalizing, with modification from the
proposal, changes to the data elements
comprising this processing and use
information. Specifically, EPA is
finalizing the replacement of the CDR
industrial function and commercial/
consumer product use codes with codes
based on OECD function, product, and
article use categories and adding the
requirement to report the function of the
chemical in commercial/consumer
products. As a result of public
comments received, EPA is phasing-in
the implementation of the OECD-based
codes, such that reporting during the
2020 CDR submission period for the
chemical substances designated by EPA
as a high priority for risk evaluation (84
FR 71924, December 30, 2019) are
required to use the OECD-based codes
and reporters for all other chemical
substances may report using either the
OECD-based codes or the current CDR
codes. Reporting using the OECD-based
codes will be fully implemented and
required for all chemical substances
beginning with the 2024 CDR
submission period. In addition, EPA
proposed to list the updated codes in
the instructions for CDR reporting. As a
result of public comments received,
EPA is codifying the updated codes in
the CFR.
Some commenters expressed concern
with the level of understanding that
manufacturers have for the downstream
processing and use of chemicals. EPA
recognizes that some manufacturers may
have less knowledge than other
manufacturers about the downstream
processing and use of their reported
chemical substances. As described in
the Instructions for Reporting,
submitters are to exercise certain levels
of due diligence in gathering the
information required by the CDR rule
and, if the knowledge is not known or
reasonably ascertainable, to indicate so
on the reporting form by selecting
‘‘NKRA.’’ See the Instructions for
Reporting for examples (Ref. 9). EPA
recognizes that downstream processors
and users may have better knowledge of
the functions and uses than the
chemical manufactures, but the agency
is balancing the need for reduced
reporting burden with maintaining the
ability to receive the information
needed to understand potential
chemical exposure.
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Other public comments related to the
proposed processing and use code
amendments, and EPA’s responses, can
be found in the response to comment
document (Ref. 10). These new codes
can be found at 40 CFR 711.15 in Tables
6 and 9.
At the time of proposal, EPA did not
develop burden estimates associated
with replacing the current CDR codes
with ones based on the OECD codes,
because such estimates heavily rely on
the e-CDRweb user interface that will
feature burden-reducing guided data
entry. EPA noted that the addition of the
function categories for commercial/
consumer products is a new data
element whose addition could
potentially result in an increase in
burden. Ultimately, EPA did not foresee
a substantial increase in burden due to
the use of the new codes and is
finalizing the use of these new codes as
proposed. To manage the potential
burden increase, EPA planned to take
non-regulatory steps to reduce burden,
including: (1) Incorporating intelligent
sorting and a smart search option into
the reporting tool, (2) publishing cross
references to current codes, and (3)
publishing detailed definitions and
examples for each code. EPA has
incorporated these features into the
eCDRweb reporting tool and the
Instructions for Reporting (Ref. 9). The
intelligent sorting feature will be
implemented into the eCDRweb
reporting tool for 2024 reporting; the
smart search option is implemented for
the 2020 reporting. Although the
number of codes has increased, the
inclusion of these features results in a
slight decrease in estimated burden
once all features are fully implemented
in the eCDRweb reporting tool (a
decrease of 0.461 hours per report, see
Appendix C of the Economic Analysis
(Ref. 7) for further details).
Under CDR, there are two main
categories of use codes: Function codes
and product codes. The function of a
chemical, combined with the type of
product that the chemical is used in,
provides information about an exposure
scenario with unique characteristics.
Information about exposure scenarios is
necessary for implementation of TSCA
section 6 for prioritization and risk
evaluations.
a. Function codes (industrial and
consumer/commercial). EPA is
finalizing the requirement to report
function categories for both industrial
applications and commercial/consumer
products and to adopt categories based
on the OECD functional use categories.
Under this final rule, the current 35
function codes have been replaced by
117 OECD-based function codes. EPA
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finalized the function codes as
proposed, with one modification. In
response to a comment that there was
not an appropriate code to report the
function of a substrate metal in an alloy
when the alloy is imported, EPA
changed the definition for function code
U040A from ‘‘Alloying Element—
Chemical substances that are added to
materials/metals formulated to modify
properties such as strength, hardness, or
to facilitate treatment’’ to ‘‘Alloys—
Chemical substances that are a
combination of materials/metals
formulated for specific properties such
as strength, hardness, or to facilitate
treatment.’’
In this final rule, not all of the OECD
harmonized codes are adopted as
individual CDR function codes because
some are for functional uses not covered
by TSCA (e.g., in the circumstances
where, because of a chemical’s
particular use, it is not a ‘‘chemical
substance’’ under TSCA section
3(2)(B)(vi)). For the proposal, EPA
requested comments on whether all of
the OECD harmonized codes should be
listed so that the codes are an exact
match, even if the uses are not covered
by TSCA. After consideration of the
public comments received, EPA has
finalized the list as proposed, which
does not separately list the functional
uses not covered by TSCA and
continues to include a non-TSCA code
as a blanket code for these applications,
such as for a food or cosmetic (other
than soap), when the chemical is
reportable to CDR because the chemical
is also used in a way that falls under the
jurisdiction of TSCA.
EPA is listing these codes in the CFR
at 40 CFR 711.15 Table 6. Additional
details about the function categories,
how they are related to the OECD
functional use categories, and a
crosswalk with the current CDR
function codes are in the supplemental
document Technical Support
Document: Harmonizing CDR
Functional and Product codes with
OECD Functional, Product, and Article
Codes (Ref. 17).
b. Commercial/consumer product
codes. Under this final rule, the current
33 consumer/commercial product
categories have been replaced by 96
OECD-based product categories. Under
TSCA, the definition of ‘‘chemical
substance’’ excludes certain products,
including pesticides, tobacco, and food.
Some of the OECD harmonized product
categories cover the TSCA-excluded
products; those particular codes were
not adopted in CDR. The former CDR
codes contained a catch-all ‘‘non-TSCA
code’’ for products that are not covered
under TSCA. Under this final rule, EPA
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will continue to provide the same ‘‘nonTSCA’’ code as a blanket code for these
applications. EPA also agrees with one
comment requesting ‘‘to exclude the use
of the OECD code for articles intended
for food contact’’ and, as a result, is
consolidating both C206A (Articles for
food contact, including metal articles)
and C301A (Articles intended for food
contact including paper articles; plastic
articles (soft); plastic articles (hard);
rubber articles; metal articles; fabrics,
textiles, and apparel) with CC990, the
‘‘Non-TSCA use’’ code (Ref. 10) For a
more detailed discussion of these
changes, see Unit III.B.1. of the
proposed rule (Ref. 1).
c. Implementation of the OECD-based
codes. Under this final rule, EPA is
phasing in reporting of the OECD-based
codes. For reporting during the 2020
CDR submission period, (from June 1,
2020, to September 30, 2020),
submitters are required to use the
OECD-based codes for the chemical
substances designated by EPA as a high
priority for risk evaluation and, for all
other chemical substances, may use
either the OECD-based codes or the CDR
codes. The chemical substances
designated by EPA as a high priority for
risk evaluation are listed in 40 CFR
711.15, Table 7. For reporting during the
2024 and future submission periods,
submitters are required to use the
OECD-based codes for all chemical
substances for which the submitter is
reporting processing and use
information.
2. NAICS codes for manufacturers.
EPA is finalizing the requirement that
submitters report the 6-digit NAICS
code that best describes the
manufacturing activities conducted at
the reporting site. The NAICS was
developed under the direction and
guidance of the Office of Management
and Budget (OMB) as the standard for
use by Federal statistical agencies in
classifying business establishments for
the collection, tabulation, presentation,
and analysis of statistical data. NAICS is
based on a production-oriented concept,
meaning that it groups establishments
into industries according to similarity in
the processes used to produce goods or
services (Ref. 18). Use of the standard
provides uniformity and comparability
in the presentation and understanding
of data. EPA estimates that this finalized
change will result in a small increase in
burden, which is explained in detail in
Chapter 4.3.2 in the Economic Analysis
(Ref. 7). For a more detailed discussion
of this change, see Unit III.B.2. of the
proposed rule (Ref. 1).
EPA received comments on the
proposed rule regarding the addition of
the NAICS codes for manufacturing sites
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that supported and opposed the
revision. Commenters that supported
the addition agreed with EPA that
including NAICS codes provides
practical utility for the Agency because
the use of NAICS codes will enable
industry-specific analysis and increase
the ability to combine CDR data with
other sources (e.g., TRI). Commenters
that opposed the addition stated that
identifying a single NAICS code for
some reporters could be overly
burdensome, especially for reporters
that consolidate imports at the company
headquarters, for which multiple NAICS
codes could apply. In consideration of
these comments, EPA is finalizing the
requirement for reporting a 6-digit
NAICS code, but will allow the reporter
to indicate up to three NAICS codes to
address the concerns expressed for some
importers that identifying a single
NAICS code would be difficult. Given
that CDR data are higher-level data
intended for screening purposes, EPA
determined that three NAICS codes
would be adequate. If more than three
NAICS codes could apply, the reporter
should identify and report the three
more representative NAICS codes. EPA
believes that the increase in burden
caused by this change is minimal,
compared to the increase in practical
utility the information can provide to
the Agency to better analyze the data by
industry sector. In most situations,
submitters will report the single NAICS
code that best represents the activities
associated with the site, to the extent
that it is known or reasonably
ascertainable. In situations where
multiple NAICS could apply and the
reporter is unable to identify a single
NAICS, such as for reporters that
consolidate imports for multiple sites,
submitters will be allowed to report up
to three NAICS codes that best represent
the activities associated with the
intended use of the imported chemical
substances. See the Instructions for
Reporting for examples (Ref. 9). For
more information, see the EPA’s
Response to Comment Document (Ref.
10).
3. Modifying recycled information.
EPA is finalizing as proposed the
requirement to report whether a
reportable chemical substance is
recycled or otherwise used for a
commercial purpose, instead of being
disposed of as a waste or included in a
waste stream. In past CDR reporting
periods, CDR submitters have identified
whether their reportable chemical
substance is recycled, remanufactured,
reprocessed, reused, or otherwise used
for a commercial purpose instead of
being disposed of as a waste or included
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in a waste stream. EPA is finalizing the
modification to this data element by
removing the terms ‘‘remanufactured,
reprocessed, reused,’’ as these terms
may be interpreted and applied too
broadly to obtain the information of
interest for this collection. These terms
are also not necessarily synonymous
with ‘‘recycle’’ in all scenarios. For a
more detailed discussion of this
changes, see Unit III.B.3. of the
proposed rule (Ref. 1).
For the proposed rule, EPA solicited
comment on whether submitters should
identify the percentage of total
production volume of their chemical
substance that is recycled, instead of
only designating whether recycling
occurred. While one commenter stated
that modifying the required recycling
data element to include the percentage
of total production volume would be
overly burdensome and impractical,
other commenters supported reporting
recycling by percentage if it is useful to
the Agency in prioritization of
chemicals for risk evaluation. EPA has
determined that knowing whether any
amount of the chemical is recycled or
otherwise used for a commercial
purpose, instead of being disposed of as
a waste, is currently sufficient for TSCA
purposes, and that the increased
specificity of this data element may not
warrant the associated potential
increase in reporting burden. As a result
of these comments, EPA is retaining a
‘‘yes or no’’ style of response and is not
finalizing a requirement for reporters to
identify the percent recycled when
reporting to CDR.
4. Percent byproduct. EPA is
finalizing as a voluntary reporting
element the reporting of the percent
total production volume (by weight) for
a chemical substance that is a byproduct
within four ranges: 0 percent, greater
than 0 but less than 50 percent, greater
than or equal to 50 percent but less than
100 percent, or 100 percent. This is a
modification from the proposal, which
proposed to require that the data
element be reported and that the
percentages for the percent byproduct
be rounded to the nearest 10 percent,
unless the percentage is less than 5
percent, rather than as a larger range.
EPA received comments that both
supported and opposed the addition of
reporting the percent byproduct. Those
who supported the addition stated that
knowing the percent byproduct was
useful for the Agency in order to
provide future exemptions for those
who recycle their byproducts, as it will
enable the identification of
manufacturers, such as the printed
circuit board fabricators, who report to
CDR solely due to their byproduct
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production. Other commenters stated
that it is well-known that byproducts
(organic and inorganic) can be
important sources of exposure and risk
and should be reported under the CDR
rule so EPA can have information to aid
with assessment of their health and
environmental impact and be better able
to ‘‘understand a larger spectrum of
potential exposure scenarios, by
improving understanding of the
connection between manufacturing and
downstream activities for the purposes
of substance life cycle assessments and
risk evaluation’’ (Ref. 10 and Ref. 19).
Commenters who opposed the addition
stated that this data element is
unnecessary and could add complexity
rather than reducing it.
Due to the comments received on this
proposed data element and the concern
that determining the specific percent
byproduct (to the nearest 10 percent or
more precisely if less than 5 percent)
would be unnecessarily burdensome,
EPA is finalizing the addition of this
data element as a voluntary data
element and to allow for reporting in
ranges to reduce submitter burden.
Rather than reporters providing the
specific percent byproduct as proposed,
EPA is finalizing a requirement that
reporters provide information about the
percent byproduct by selecting one of
four ranges.
A byproduct is a chemical substance
that is produced without a separate
commercial intent during the
manufacture, processing, use, or
disposal of another chemical
substance(s) or mixture(s); because it is
part of the manufacture of a chemical
product for a commercial purpose, it is
considered to be produced for the
purpose of obtaining a commercial
advantage and is therefore itself
considered manufactured for a
commercial purpose (40 CFR 704.3,
definitions for byproduct and
manufacture for commercial purposes).
EPA is adding this voluntary data
element to become more aware of which
industries primarily manufacture
byproducts and to be better able to
understand a larger spectrum of
potential exposure scenarios, for the
purposes of chemical substance life
cycle assessments and risk evaluation.
In addition, EPA will use this
information to inform future decisions
about potential changes to CDR
requirements.
Some commenters who opposed this
data element appeared to mistakenly
interpret that the percent byproduct
meant what percentage of the reported
chemical substance, which was not
itself a byproduct, had some percentage
of a byproduct remaining with the
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reported chemical substance. EPA is not
requesting the reporting of the
byproducts within the intended
product, which frequently are referred
to by industry as contaminants, but
rather the byproducts that are
manufactured and then separated from
the intended product; these byproducts
are required to be reported separately
unless the production volume is under
the reporting threshold or another
exemption identified in applies. EPA
will clarify how to report the percent
byproduct in the Instructions for
Reporting (Ref. 9). EPA believes that
additional clarification in the guidance
will improve understanding reporting
this data element and minimize
associated reporting burden. For a more
detailed discussion of this change, see
Unit III.B.4. of the proposed rule (Ref.
1). Public comments related to the
voluntary reporting of percent
byproduct and EPA’s responses can be
found in the response to comment
document (Ref. 10).
5. Chemical-specific function for
imported mixtures. EPA is finalizing as
proposed the requirement that the
secondary submitter of a joint
submission, typically the foreign
supplier, report the chemical-specific
function along with the already-required
information on chemical composition of
the imported product or mixture. A joint
submission is most typically used when
a substance or a mixture is imported
and the supplier does not provide to the
importer the specific chemical identity
of the substance or substances that
comprise the mixture. See Unit III.A. of
the proposed rule for additional
information about joint submissions
(Ref. 1).
EPA received a comment that
supported requiring the secondary
submitter of a joint submission to report
the chemical-specific function along
with information on chemical
composition of the imported product or
mixture. Another commenter stated that
providing this information on each joint
submission may require a significant
time to complete. EPA recognizes that
providing this information may require
some burden. EPA had already
accounted for the associated burden,
because the rule requires the function be
provided on a chemical-specific basis
but did not enable the appropriate party
to provide such information. For
example, for past submissions the
primary submitter would report the
function of the overall imported
mixture, and that function would be
applied to each chemical in the mixture.
The comments suggested and our
analysis supported having the primary
or secondary submitter determine the
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function for each chemical in the
mixture. Due to the suggestions received
in public comments, EPA has sufficient
support to justify support the secondary
submitter determining the function for
each chemical in the mixture. EPA’s
burden analysis for the final rule
assumes that there is no difference in
burden regardless of whether the
primary submitter or the secondary
submitter determines the function for
each chemical in the mixture. Therefore,
there is no increase in burden for the
secondary reporter to determine the
function for each chemical in the
mixture. See footnote 14 in section 4.1.3
of the Economic Analysis for additional
information (Ref. 7).
A commenter stated that EPA should
not require information on the chemical
composition of the imported product or
mixture. EPA notes that this is not a
new requirement. The composition
information, which is reported by the
secondary submitter of a joint
submission, is necessary to identify the
chemicals that are included in the
imported product and how much of the
imported volume to attribute to each
component chemical substance. EPA
clarified the requirement to report the
percentage of formulation for a chemical
substance in an imported product in the
regulatory text at 40 CFR
711.15(b)(3)(i)(A).
6. Parent Company identity. EPA is
finalizing as proposed two changes and
finalizing with modifications one
change associated with reporting the
parent company under CDR: (1) To add
the requirement to report a foreign
parent company in addition to reporting
the highest-level U.S. parent company,
when the ultimate parent company is
located outside of the United States; (2)
to remove the definition of U.S. parent
company from 40 CFR 711.3 and replace
it with a new definition for highest-level
parent company; and (3) to add a
requirement for reporters to report legal
name(s) and to follow a naming
convention for providing the parent
company name(s), the details of which
will be provided in the CDR Instructions
for Reporting (Ref. 9; see 40 CFR
711.35).
EPA received one comment that
supported the proposed changes to the
parent company identity and another
comment that expressed concern over
the use of a naming convention and
complications that will increase the
burden. The naming convention is
primarily a tool to streamline the
processes of capitalization, punctuation,
and so on when identifying a parent
company, and does not significantly
impact burden. EPA believes that the
use of the naming convention will not
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significantly impact the burden because
the reporter does not have to do
anything to collect or generate this
information, and is finalizing as
proposed. EPA was interested in
receiving comments on whether the
guidelines and these examples
encompass the representative range of
scenarios for reporting under CDR, and
whether the guidelines included in the
proposed definition are sufficient; EPA
did not receive any comment on this
aspect of the proposal.
EPA estimates that the addition of a
foreign parent company will slightly
increase the burden, which is explained
in detail in Chapter 4.3.2 in the
Economic Analysis (Ref. 7). EPA did not
estimate the burden reduction
associated with the reduced need to
contact companies for quality control
purposes after data submission.
a. Finalized changes to the definition
of U.S. parent company. EPA is
finalizing with modification from the
proposal the replacement of the
definition of U.S. parent company from
40 CFR 711.3 with a new definition for
highest-level parent company that
includes both U.S. and foreign parent
companies and provides guidelines for
different company structures. Under the
new definition, highest-level parent
company means the highest-level
company(s) of the site’s ownership
hierarchy as of the date of the
submission during which data are being
reported according to specified
instructions. The highest-level U.S.
parent company is located within the
United States, while the highest-level
foreign parent company is located
outside the United States. EPA modified
the descriptions of site ownership
scenarios contained in the new
definition to enhance understanding of
the scenarios.
b. Finalized reporting of foreign
parent company. In some situations, the
highest-level parent company is outside
of the United States. EPA is finalizing
with modifications from the proposed
the requirement that sites also identify
the highest-level worldwide parent
company, when applicable, and
therefore is also finalizing the
requirement to report the foreign parent
company under 40 CFR 711.15. Under
this final rule, reporters will continue to
report their highest-level U.S. parent
company, but will also report their
highest-level foreign parent company if
applicable. EPA recognizes that there
are a variety of ownership situations for
manufacturers reporting under CDR. In
Unit III.B.7. of the proposed rule (Ref.
1), EPA listed the scenario-specific
guidelines. EPA is finalizing the
guidelines as part of the finalized
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definition of highest-level parent
company in 40 CFR 711.3 with
modifications to make the ownership
situations easier to understand. The
guidelines include how to populate the
highest-level U.S. and foreign parent
company data elements.
c. Finalizing use of naming
convention. EPA is also finalizing the
requirement for sites to follow the CDR
instructions regarding standardized
conventions for the naming of a parent
company. These naming conventions
address common formatting
discrepancies, such as punctuation,
capitalization, and abbreviations (e.g.,
‘‘Corp’’ for ‘‘Corporation’’). The use of
these naming conventions will reduce
the number of inconsistencies with the
Parent Company Name data field, and
thus will increase the reliability and
usability of the data and reduce the
associated reporting burden due to the
Agency’s need to request corrections
from reporting companies.
C. How has the reporting process for comanufactured chemicals changed?
EPA is finalizing two new
methodologies for manufacturers to
report co-manufactured chemicals.
Although these finalized methodologies
reduce co-manufacturer confusion and
address other industry concerns, EPA
estimates that it will have a minimal
impact on the burden and therefore did
not include an estimate in the analysis.
See section 4.1.3.2 in the Economic
Analysis for additional information (Ref.
7). As discussed in the proposed rule,
EPA is avoiding the use of the term toll
manufacturer for this final rule, so as to
add clarity for the co-manufacturing
situation. For a more detailed
discussion of this change and additional
background on co-manufacturing, see
Unit III.C. of the proposed rule (Ref. 1).
In the proposed rule, EPA proposed a
primary solution to the comanufacturing mechanism, and
requested comment on two potential
alternatives to the reporting scenario.
Commenters were supportive of EPA’s
approach to updating the mechanism
that co-manufacturers report, but also
requested more flexibility to enable the
producing company to submit the CDR
report on behalf of both companies. EPA
agrees that additional flexibility is
necessary and has chosen to finalize two
different reporting methodologies for a
co-manufacturing situation. The two
following methodologies for reporting
are based on the desire to reduce
reporting burden and maintain
flexibility for both the contracting and
producing company. Contracting and
producing companies must work
together to select between the two
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following reporting methodologies for
preparing their CDR submission.
1. First reporting procedure. Under
the first reporting methodology, the
contracting company (as the primary
submitter) has the responsibility to
initiate a co-manufacturer report that
will prompt the reporting requirements
for the producing company (as the
secondary submitter). The contracting
company will start the chemical report
for the co-manufactured chemical,
identifying the chemical substance and
the producing company. The
contracting company will then initiate
the co-manufacturer report using eCDRweb reporting tool to send a
notification to the producing company.
Additionally, the contracting company
is responsible for completing the
volume manufactured (40 CFR
711.15(b)(3)) and the processing and
use-related section (40 CFR
711.15(b)(4)). Upon receipt of the email,
the producing company will have the
information needed to begin its portion
of the co-manufacturer report, which
will include the manufacturing-related
data elements from 40 CFR 711.15(b)(3),
including the production volume. Each
party will complete its part of the comanufacturer joint report as part of its
overall CDR submission and will not
have access to the information
submitted by the other party. For
example, the processing and use
information submitted by the
contracting company will not be
viewable by the producing company.
2. Second reporting procedure. To
create more flexibility for reporters, EPA
is also finalizing the alternative
reporting methodology proposed for the
co-manufacturing situation. This
reporting methodology requires the
contracting and producing company,
upon written agreement, to work
together to complete the reporting. For
this second methodology, the producing
company (instead of the contracting
company) initiates and completes the
reporting in e-CDR Web. The producing
company would provide the exposure
information from the manufacturing
site. The producing company would
then coordinate with the contracting
company to obtain the additional
information needed to complete the
submission. For example, in a comanufacturing situation, the producing
company is not likely to know the
processing and use information
associated with the co-manufactured
chemical, and therefore works with the
contracting company to complete Part
III of the CDR Form U. Therefore, any
‘‘not known or reasonably
ascertainable’’ (referred to as ‘‘NKRA’’
when reporting to CDR) responses in
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Part III would refer to the knowledge of
the contracting company and not the
knowledge of the producing company.
This coordination of information
between the two parties must be done
outside of e-CDRweb. Although the
producing company would be
submitting the report, both parties are
responsible for the report. Therefore, if
no report is filed, both the contracting
company and the producing company
can be held liable. This reporting
mechanism would be most appropriate
in a scenario in which the producing
company has the majority of the
information regarding the production of
a specific chemical.
3. Definition of site. EPA is finalizing
an amendment to the definition of site
by replacing the term toll manufacturer
with the term producing company. This
change makes terminology consistent
between the CDR definitions of site and
manufacture.
4. Relationship of co-manufacturing
to imports. Consistent with the past CDR
rule, only a domestically produced
chemical substance can be the subject of
a co-manufacturing report; an imported
chemical substance cannot be. Rather, a
chemical substance manufactured via an
arrangement with a foreign supplier will
be considered an imported chemical
substance, and the U.S. importer alone,
as the reporting manufacturer, is
responsible for reporting that substance.
D. How has the reporting of byproducts
changed?
EPA is finalizing two new exemptions
associated with byproducts, the first
finalized with a slight modification to
add an additional substance and the
second finalized as proposed. The
finalized exemptions are (1) to exempt
specifically-listed byproducts that are
recycled in a site-limited, enclosed
system and to provide for a petition
process for the public to request
additions to that list of exempted
manufacturing processes and related
byproduct substances; and (2) to exempt
byproducts manufactured in pollution
control and boiler equipment when that
equipment is non-integral to the
primary manufacturing process.
EPA also proposed, but is not
finalizing, an alternative method of
reporting by category for inorganic
metal byproducts. Several commenters
expressed concern that the proposal to
allow for categorical inorganic metal
byproduct reporting may actually
increase as opposed to decrease
reporting burden and/or add complexity
for the regulated community. EPA has
determined that the issues raised in the
public comments associated with this
optional reporting method outweigh the
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potential benefits. More information is
in Unit III.F.2.
Nine commenters supported to
various degrees EPA’s proposals specific
to byproducts, though some asserted
that additional clarification through
guidance would be needed for reporters
before finalization, and that there would
be limited time (i.e., less than a year) for
familiarization with the changes before
the next reporting cycle. Other
commenters specifically opposed the
proposed exemptions or changes for
byproduct reporting, stating that these
changes may constrain EPA’s ability to
obtain information it needs to carry out
its duties under TSCA (i.e., conducting
chemical prioritization, risk evaluation,
and risk management responsibilities).
EPA disagrees with the notion that the
new reporting exemptions hinder EPA’s
ability to carry out its obligations under
TSCA and believes that the reasons for
exempting these byproducts, laid out in
the Response to Public Comments and
in the proposed rule, are sufficient
(Refs. 1 and 10). The Agency carefully
considers its needs for the information
collected under CDR and the burden
associated with providing such
information. Some commenters opposed
the exemption by expressing that the
byproduct exemptions were not
extensive enough, claiming that all
byproducts should be exempted or that
beneficially used byproducts should be
exempted.
1. Specific site-limited recycled
byproducts. EPA is finalizing the
proposal to exempt specifically
identified byproducts that are recycled
on-site from two particular industries,
and is finalizing the petition process to
make changes to this exemption list
with some modifications to the
proposal.
In the proposed exemption, Portland
cement manufacturers that manufacture
Flue dust, portland cement (CASRN
68475–76–3) (referred to as cement kiln
dust), and manufacturers using the Kraft
pulping process to manufacture Sulfite
liquors and Cooking liquors, spent
(CASRN 66071–92–9) (often comprised
of what is referred to as black liquor)
and Carbonic acid calcium salt (1:1)
(CASRN 471–34–1) (referred to as
calcium carbonate) would be exempted
from reporting these byproduct
substances when (1) these substances
are recycled or otherwise used to
manufacture another chemical
substance within an enclosed system,
within the same overall manufacturing
process, and on the same site where the
byproduct was originally manufactured
and (2) the non-exempted portion of the
byproduct substance or a different
chemical substance that was
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manufactured from the byproduct or
manufactured in the same overall
manufacturing process is still reported
under CDR. For a more detailed
discussion of the rationale for including
these specific chemicals in this
exemption, see Unit III.D.2. of the
proposed rule (Ref. 1).
Four commenters were strongly
supportive of this exemption, although
some believe the exemption is too
narrow. One commenter indicated that
instead of listing processes and
substances, the exemption should be
self-determining, when the site
documents in its own records that its
self-identified process meets the
exemption conditions for its
manufactured byproducts. EPA
disagrees with this comment,
concluding that self-determination, as
this commenter describes it, is not
appropriate for this exemption, which is
based on a thorough understanding of
the engineering processes and controls
of the operation that EPA would need to
review (i.e., via the described petition
process) prior to allowing the
exemption. However, for manufacturers
that have evaluated EPA’s detailed
criteria for this exemption and have
determined that their site meets these
conditions, this exemption is in effect
self-executing for the substances already
listed at 40 CFR 711.10(d)(1)(i). For
additional discussion, see the response
to comments (Ref. 10).
Another commenter requested that
EPA provide a non-isolated
intermediate exemption determination
for five chemicals that they manufacture
related to the two original chemicals
listed from the Kraft pulping process.
Because EPA did not propose changes to
the non-isolated intermediate
exemption, this comment is largely out
of scope for this rulemaking. However,
EPA is taking this opportunity to
address this comment because of its
connection with the new byproduct
exemption in an effort to help the
commenter apply the updated CDR
reporting requirements in its 2020
reporting. EPA concluded that two of
these five chemicals (Green liquor
(CASRN 68131–30–6, Sulfite liquors
and Cooking liquors, green)) and Lime
(CASRN 1305–78–8, Calcium oxide
(CaO) may be an intermediate and,
depending on certain site-specific
conditions, may qualify for the nonisolated intermediate exemption. EPA
also determined that another of these
five chemicals (Black liquor, oxidized
(CASRN 68514–09–0, Sulfite liquors
and Cooking liquors, spent, oxidized)) is
a byproduct, is eligible for this new
byproduct exemption, and has been
added to the list of Kraft pulping
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process exempted substances. If, in the
future, new information is provided to
EPA to further inform EPA’s
understanding of the liquors and the
Kraft pulping process, EPA can revisit
its understanding. For additional
discussion, see the response to
comments (Ref. 10).
EPA also proposed a petition process
to enable the public to request changes
to the new list of specific exempted
byproduct substances as produced in
certain manufacturing processes.
Because there may be other
manufacturing processes and related
byproduct substances that meet the
criteria for this exemption, and because
EPA’s interest in these byproduct
substances may change, EPA may
amend the list of byproduct substances
and processes that have been included
in this exemption. The Agency may do
this on its own initiative or in response
to a request from the public, based on
EPA’s determination of whether the
manufacturing process and related
byproduct substance described meet the
criteria explained in this Unit. Most
commenters supported the proposed
petition process for the exemption while
also suggesting modifications and
guidance. Some argued that the
proposed process is too burdensome;
others requested that EPA clarify how
this process will operate, including by
clarifying the criteria for seeking an
amendment, how potentially sensitive
information can be claimed
confidential, and additional explanation
and examples of what constitutes
Agency ‘‘interest’’ in a byproduct
substance. EPA agrees that clarification
is needed regarding how the byproduct
exemption petition process will operate
and therefore will be providing
enhanced guidance that will include
examples of the types of information
that a petition should include to assist
EPA in its determination. The guidance
will also clarify the confidentiality
available for potentially sensitive
information provided through the
petition process, as well as what
constitutes EPA’s current interest. This
guidance will be published prior to the
start of the 2024 submission period.
EPA intended the proposed regulatory
text in 40 CFR 711.30(a)(1) to address
confidentiality concerns; specifically, as
proposed, ‘‘Any person submitting
information under this part may assert
a confidentiality claim for that
information at the time it is submitted.’’
To emphasize how confidentiality will
be addressed, EPA has included
additional references to this petition
process in the CBI substantiation
procedures described in Unit III.A., as
listed in 40 CFR 711.30(a)(3) and 40
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CFR 711.30(b), to further provide
certainty that information submitted as
part of any petition may be claimed as
confidential, and to clarify that such
confidentiality claims must be
substantiated at the time of submission
to the Agency, unless the information
claimed as confidential is described in
TSCA section 14(c)(2). Additionally,
EPA is requiring that if confidential
information is submitted in a petition,
the petitioner must also provide a
sanitized version of the petition with
the confidential information redacted,
so that it may be publicly posted by the
Agency.
Another commenter emphasized that
decisions to make any changes to the
list of exempted manufacturing
processes and substances need to be
subject to public notice and a public
comment opportunity. Because
rulemaking is required to change the list
of manufacturing processes and
chemicals eligible for the exemption in
40 CFR 711.10(d)(1)(i), the public will
receive notice of the change and could
comment.
This commenter also requested that
the regulatory text clearly indicate that
two of the listed considerations are
requirements for the exemption. To
better reflect the requirements of the
exemption, EPA has revised the
regulatory text at 40 CFR
711.10(d)(1)(ii)(B) to clearly indicate
that two of the four listed considerations
are requirements.
Other commenters requested that EPA
eliminate the second factor and stated a
belief that the factors will result in
additional analysis, tracking, and
reporting. EPA disagrees that the second
petition factor would result in more
analysis, tracking or reporting than is
already required. The second factor is a
requirement that the byproduct
substance itself (e.g., a portion of the
byproduct is used for a different
purpose and not recycled in an enclosed
system) or another chemical substance
from the same overall manufacturing
process is being reported. If the site has
previously reported under CDR, then
the site will have the information
needed to address this factor. Regarding
the second factor specifically, EPA
expects to be able to ascertain typical
exposure scenarios for an exempted
byproduct’s manufacturing process
based on information for other
substances that are reported at the
facility in the same manufacturing
process. If no other substances are
reported, EPA would not otherwise have
any exposure-related information
associated with the manufacturing site.
2. Byproducts generated by specified
non-integral processes. EPA is finalizing
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as proposed the exemption for
byproducts manufactured in certain
equipment via processes that are not
integral to the production process. An
integral process is the portion of the
manufacturing process that is
chemically necessary or provides
primary operational support for the
production of the intended product. For
the purposes of this exemption, certain
associated processes that are not
chemically required to produce the
intended product would be considered
non-integral. These may be required due
to other regulations or the need to
generate heat or electricity on-site, but
are not specifically necessary for the
manufacture of the intended product. In
this final rule, byproducts manufactured
due to the use of pollution control
equipment and boilers that generate
heat or electricity on-site, when such
equipment is not part of the main
production process, are exempted from
reporting under CDR. For a more
detailed discussion of this exemption,
see Unit III.D.3. of the proposed rule
(Ref. 1).
Most commenters supported this
proposed exemption; some commenters
requested that EPA expand the
exemption to include beneficially used
byproducts (i.e., coal combustion
residuals from utilities). However, the
production of coal combustion residuals
from utilities specifically is integral to
the generation of electricity (the utility’s
product) and therefore is not applicable
for this exemption, which is specifically
for byproducts from non-integral
equipment exemption. EPA disagrees
with the suggestion that a designation
under another statute (e.g., RCRA) of
‘‘beneficially used’’ should be an
indication that the substance should be
exempted under TSCA.
Other commenters requested that EPA
provide additional examples (i.e.,
wastewater treatment processes) and
explanation through enhanced
guidance. EPA is finalizing this
exemption as proposed and will be
providing guidance for this byproduct
exemption in the Instructions for
Reporting that will include examples of
specific scenarios that meet the criteria
of this exemption, such as wastewater
treatment, flue gas desulfurization, and
catalytic reduction systems. This
guidance will be finalized prior to the
start of the next submission period.
E. What technical modifications have
been made to the regulatory text?
1. Removing outdated regulatory text.
EPA is finalizing the proposal to remove
regulatory text specific to the 2012 CDR
submission period. This text is no
longer relevant because the submission
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period was completed more than five
years ago, and all phased-in reporting
requirements from the change from the
IUR to CDR have been fully in effect
since the 2016 reporting cycle. EPA did
not receive any public comment on
removing outdated regulatory text.
2. Simplifying and clarifying
regulatory text. EPA is finalizing the
proposal to change or add regulatory
text to simplify or clarify regulatory
requirements throughout 40 CFR part
711. These changes are in addition to
the finalized changes discussed
elsewhere in this notice, and include
revisions to the following provisions:
• 40 CFR 711.1, to update the title to
include ‘‘Enforcement’’, to more clearly
identify that the section discusses the
scope, compliance, and enforcement of
the CDR rule.
• 40 CFR 711.1(a), to remove the
discussion about compiling and keeping
current the TSCA Inventory, including
the discussion about adding new
chemicals to the Inventory. This
discussion is unnecessary for an
understanding of the scope of the CDR
rule.
• 40 CFR 711.1(c), to include a
statement about TSCA section 11
subpoena authority, as a reminder that
EPA has this authority for compliance
purposes.
• 40 CFR 711.3, to modify definitions
for e-CDRweb, Manufacture, and Site for
clarification purposes.
• 40 CFR 711.6(a)(4), to reverse the
order of ‘‘certain forms of natural gas’’
and ‘‘water’’ for clarification purposes.
• 40 CFR 711.10, to remove
duplicative wording and add clarity to
the requirements.
• 40 CFR 711.15(a), to add clarity to
the reporting requirements.
• 40 CFR 711.35(c)(1), to update
references.
F. What proposed provisions are not
being finalized?
In consideration of the public
comments received, EPA is not
finalizing at this time the following
proposed amendments to the current
CDR rule.
1. Public contact. EPA is not
finalizing the proposal to enable the
reporting of a public contact for each
CDR submission as a voluntary data
element. The addition of a public
contact to handle public inquiries was
modeled after TRI’s approach to the
public contact, albeit on a voluntary
basis. For a more detailed discussion of
this proposal, see Unit III.B.6. of the
proposed rule (Ref. 1). EPA solicited
comment on whether it would be
helpful to have a public contact
available, and whether it should be
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voluntary or required. One commenter
stated that a new field for public contact
is ‘‘not necessary and could be
misleading.’’ The commenter explained
that the reporter already provides a
technical contact for each submission
and that the purpose of CDR is not a
‘‘right-to-know’’ for the public which
would necessitate a direct line of
communication between individual
companies and the public. EPA
appreciates the feedback that the
proposed field of a voluntary public
contact may be misleading and,
therefore, is not finalizing this proposed
data element. See the response to
comment document (Ref. 10).
2. Alternative reporting in metal
compound categories for inorganic
byproducts. EPA is not finalizing the
proposal to allow, but not require, CDR
reporting within defined metal
compound categories for certain
elemental metals and inorganic metal
compounds that are produced as
inorganic byproducts. Manufacturers of
these inorganic byproducts would have
had the option to combine and report
multiple inorganic byproduct metal
substances, which otherwise would be
reported individually as listed on the
TSCA Inventory, into one or more
specifically-listed categories (e.g.,
Chromium & Chromium Compounds).
For a more detailed discussion of this
proposal, see Unit III.D.1. of the
proposed rule. Public comments related
to the reporting in metal compound
categories for inorganic byproducts and
EPA’s responses are in the response to
comment document (Ref. 10).
Three commenters supported the
proposed optional method of reporting
inorganic metal byproducts, while six
commenters either stated that optional
category reporting would add reporting
complexity or expressed doubt that it
would be used. Other commenters
opposed the proposal outright, bringing
a number of perspectives to EPA’s
attention. In consideration of the
stakeholder comments, EPA has
determined that the potential for
additional complexity and burden
associated with category reporting for
inorganic metal byproducts outweighs
the potential benefits. Accordingly, EPA
is not finalizing the proposed provision
for alternative reporting in metal
compound categories for inorganic
byproducts. Because this proposed
reporting approach is not being
finalized, EPA is also not finalizing a
specific definition of ‘‘inorganic
chemical substance’’ under CDR at 40
CFR 711.3.
3. Consolidating byproduct exemption
regulatory text. EPA is not finalizing the
proposal to consolidate regulations
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20135
regarding byproduct exemptions that
affect reporting under the CDR rule into
40 CFR 711.10, such that all the CDR
reporting exemptions regarding
manufacturer activities would be in one
place. Specifically, EPA proposed that
language from 40 CFR 720.30(g) and (h)
that is currently incorporated by
reference would be replicated in 40 CFR
711.10(c) without change.
Industry and environmental advocacy
commenters opposed bringing over the
exemptions from 40 CFR 720.30 (the
Premanufacture Notice (PMN) program)
without changes, suggesting that EPA
review the current definitions against
the current TSCA and EPA data needs,
justify exemptions that will continue,
and provide an opportunity for public
comment on the justification. If
exemptions were retained, commenters
suggested both regulatory and guidance
changes (Ref. 10).
The Agency has determined that
guidance is currently sufficient to
address these concerns. While there
appears to be confusion surrounding the
exemptions, that confusion in itself does
not justify altering or removing the
exemptions at this time. Obtaining
information on percent byproduct in the
next reporting cycle will further EPA’s
understanding of byproducts in
commerce and will help to inform any
future determination as to whether
alteration of the existing exemptions is
warranted.
IV. References
The following is a listing of the
documents that are specifically
referenced in this document. The docket
includes these documents and other
information considered by EPA,
including documents that are referenced
within the documents that are included
in the docket, even if the referenced
document is not physically located in
the docket. For assistance in locating
these other documents, please consult
the technical person listed under FOR
FURTHER INFORMATION CONTACT.
1. EPA. TSCA Chemical Data Reporting
Revisions and Small Manufacturer Definition
Updates for Reporting and Recordkeeping
Requirements Under TSCA section 8(a);
Proposed Rule, Federal Register, 84 FR
17692, April 25, 2019 (FRL–9982–16).
2. EPA. Public Webinar to Obtain Feedback
on Improving CDR; Outreach meeting.
Attended by public, reporters to CDR, and
EPA. Washington, DC. May 1, 2017.
3. Amy D Kyle. ‘‘Issues Raised by the
Regulatory Negotiation on Inorganic
Byproducts in the Toxic Substances Control
Act as amended.’’ December 13, 2017. (EPA
Docket EPA–HQ–OPPT–2016–0597–0087).
4. EPA. Chemical Data Reporting;
Requirements for Inorganic Byproduct
Chemical Substances; Notice of Public
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Meeting; Cancellation and Public Input
Opportunity. Proposed Rule, Federal
Register, 82 FR 47423, October 12, 2017
(FRL–9968–94).
5. EPA (2020). Supporting Statement for an
Information Collection Request (ICR)
Addendum Under the Paperwork Reduction
Act (PRA) (EPA ICR No. 1884.11; OMB
Control Number 2070–0162). March 2020.
6. EPA. Request for Approval under the
‘‘Generic Clearance for the Collection of
Routine Customer Feedback.’’ (OMB Control
Number: 2010–0042). February 2020.
7. EPA. Economic Analysis for the Final
Rule on TSCA Chemical Data Reporting
(CDR) Revisions—(RIN 2070–AK33). Office of
Pollution, Prevention, and Toxics.
Washington, DC. December 2019.
8. EPA. CBI Substantiation Estimator
Correction September 17, 2019. Office of
Pollution, Prevention, and Toxics.
Washington, DC. December 2019.
9. EPA. TSCA CDR Instructions for
Reporting. Office of Pollution Prevention and
Toxics. Washington, DC. February 2020.
10. EPA. Response to Public Comments on
the Final TSCA Chemical Data Reporting
(CDR) Revisions Rule. Office of Pollution
Prevention and Toxics. Washington, DC.
February 2020.
11. EPA. Meeting Memo—Tribal Outreach
Sessions. Office of Pollution Prevention and
Toxics. Washington, DC. July 30, and August
1, 2019.
12. EPA. Meeting Memo—Meeting with
IPC. Office of Pollution Prevention and
Toxics. Washington, DC. June 13, 2019.
13. EPA. Meeting Memo—IPC/TTM Site
Visit/Plant Tour. Office of Pollution
Prevention and Toxics. Sterling, VA. July 10,
2019.
14. EPA. Meeting Memo—Lehigh Hanson
Cement Site Visit/Plant Tour. Office of
Pollution Prevention and Toxics. Union
Bridge, MD. August 9, 2019.
15. Franz, Christina to Hartman, Mark,
August 9, 2019. Letter to EPA: ‘‘Request of
the American Chemistry Council for EPA to
Reopen CDR and CBI Rulemaking Comment
Periods in Light of Supreme Court Decision.’’
(EPA Docket EPA–HQ–OPPT–2018–0320–
0038). American Chemistry Council.
Washington, DC.
16. EPA. Statutory Requirements for
Substantiation of Confidential Business
Information (CBI) Claims Under the Toxic
Substances Control Act (TSCA) (82 FR 6522,
January 19, 2017). Office of Pollution
Prevention and Toxics. Washington, DC.
17. EPA (2018). OPPT. Technical Support
Document: Harmonizing CDR Functional and
Product codes with OECD Functional,
Product, and Article Codes. August 2018.
18. EPA. 1997 North American Industry
Classification System—1987 Standard
Industrial Classification Replacement.
Notice, Federal Register, 62 FR 17288. April
9, 1997.
19. Environment Defense Fund.
‘‘Environmental Defense Fund Comments on
TSCA Chemical Data Reporting Revisions
and Small Manufacturer Definition Update
for Reporting and Recordkeeping
Requirements.’’ June 24, 2019. (EPA Docket
EPA–HQ–OPPT–2018–0321–0107).
20. EPA. Economic Analysis for the
Proposed Rule on TSCA Section 8(a) Small
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Manufacturer Definition Update (RIN 2070–
AK33). Office of Pollution, Prevention, and
Toxics. Washington, DC. August 2018.
V. Statutory and Executive Order
Reviews
Additional information about these
statutes and Executive orders can be
found at https://www.epa.gov/lawsregulations-and-executive-orders.
A. Executive Order 12866: Regulatory
Planning and Review and Executive
Order 13563: Improving Regulations
and Regulatory Review
This action is a significant regulatory
action that was submitted to the Office
of Management and Budget (OMB) for
review under Executive Order 12866 (58
FR 51735, October 4, 1993) and 13563
(76 FR 3821, January 21, 2011). Any
changes made in response to OMB
recommendations have been
documented in the docket for this action
as required by section 6(a)(3)(E) of
Executive Order 12866.
EPA prepared an economic analysis of
the potential costs and benefits
associated with this action. A copy of
this economic analysis, entitled
Economic Analysis for the TSCA
Chemical Data Reporting Revisions
Final Rule (Ref. 7) is in the docket and
is briefly summarized in Unit I.E.
B. Executive Order 13771: Reducing
Regulation and Controlling Regulatory
Costs
This action is considered a regulatory
action under Executive Order 13771 (82
FR 9339, February 3, 2017). Details on
the estimated costs of this final rule can
be found in the Economic Analysis (Ref.
7) which is briefly summarized in Unit
I.E.
C. Paperwork Reduction Act (PRA)
For CDR, the information collection
requirements in 40 CFR part 711 related
to the submission of Form Us are
already approved by OMB under the
PRA, 44 U.S.C. 3501 et seq. That
Information Collection Request (ICR)
has been assigned EPA ICR No. 1884
and OMB Control No. 2070–0162.
Because this final rule involves new or
revised information collection activities
that require additional OMB approval,
EPA has prepared an addendum to the
currently approved ICR (ICR addendum)
(Ref. 5). You can find a copy of the ICR
addendum in the docket for this rule
(EPA–HQ–OPPT–2018–0321), and it is
briefly summarized here.
Respondents/affected entities: Entities
potentially affected by this ICR include
companies manufacturing (including
importing) chemical substances listed
on the TSCA Inventory and regulated
under TSCA section 8.
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Respondent’s obligation to respond:
Mandatory.
Estimated number of respondents:
5,660.
Frequency of response: The collection
occurs every four years. The next CDR
collection will occur in 2020.
Total estimated burden: 26,469 hours
per year. Burden is defined at 5 CFR
1320.3(b).
Total estimated cost: $2,053,700 per
year, includes $0 annualized capital or
operation and maintenance costs.
An agency may not conduct or
sponsor, and a person is not required to
respond to, a collection of information
unless it displays a currently valid OMB
control number. The OMB control
numbers for EPA’s regulations in 40
CFR are listed in 40 CFR part 9. When
OMB approves this ICR addendum, the
Agency will announce that approval in
the Federal Register and publish a
technical amendment to 4 CFR part 9 to
display the OMB control number for the
approved information collection action
contained in this final rule.
D. Regulatory Flexibility Act (RFA)
Pursuant to section 605(b) of the RFA,
5 U.S.C. 601 et seq., I certify that this
action will not have a significant
economic impact on a substantial
number of small entities. The Agency’s
basis is briefly summarized here and is
detailed in the Economic Analysis (Ref.
7).
Under RFA, small entities include
small businesses, small organizations,
and small governmental jurisdictions.
For purposes of assessing the impacts of
this rule on small entities, small entity
is defined as:
1. A small business, as defined by the
SBA’s regulations at 13 CFR 121.201.
2. A small governmental jurisdiction
that is a government of a city, county,
town, school district, or special district
with a population of less than 50,000.
3. A small organization that is any
not-for-profit enterprise which is
independently owned and operated and
is not dominant in its field.
For CDR, the regulated community
does not include small not-for-profit
organizations. Therefore, the focus of
the RFA analysis for this rule is on
small businesses and small
governments.
The existing CDR requirements, at 40
CFR 711, generally exempt from
reporting small businesses, defined at
40 CFR 704.3 as entities with annual
sales of less than $40 million and less
than 100,000 lb production of any given
chemical at a site; or annual sales of less
than $4 million. A small business would
be required to report under the final
rule, however, if it produces any
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chemical that is the subject of a
regulation proposed or promulgated
under TSCA sections 4, 5(b)(4), or 6, or
that is the subject of an order under
TSCA section 5(e), or that is the subject
of relief that has been granted pursuant
to a civil action under TSCA section 5
or 7. A small business may also report
voluntarily. No exemption for small
governments is provided in the existing
CDR requirements.
EPA estimates that 733 small industry
parent entities and four small
governmental entities would potentially
be affected by this rule. Based on
estimated maximum compliance costs
annualized over a ten-year period and
revenue data for parent entities, EPA
estimates that the cost-to-revenue ratio
of the CDR Revisions rule would be less
than 1% for 727 (99%) of small industry
parent entities subject to the rule. An
additional two small industry parent
entities are expected to incur cost
impacts between 1 and 3%, and four
small industry parent entities are
expected to incur cost impacts above
3%. None of the small government
parent entities are expected to incur cost
impacts of greater than 1% of revenues.
Therefore, EPA concludes that
compliance costs associated with the
CDR revisions final rule are not
expected to have a significant economic
impact on a substantial number of small
entities.
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E. Unfunded Mandates Reform Act
(UMRA)
This action does not contain an
unfunded mandate of $100 million or
more as described in UMRA, 2 U.S.C.
1531–1538, and would not significantly
or uniquely affect small governments.
According to the information derived
using the 2016 CDR, there are
government entities that report to CDR,
including: Seven municipalities, one
county-level public utility district, and
one tribal entity. Impacts would not
exceed $100 million for all
governments. The final rule is not
expected to result in expenditures by
State, local, and Tribal governments, in
the aggregate, or by the private sector, of
$100 million or more (when adjusted
annually for inflation) in any one year.
Accordingly, this final rule is not
subject to the requirements of sections
202, 203, or 205 of UMRA.
F. Executive Order 13132: Federalism
This action does not have federalism
implications because it is not expected
to have substantial direct effects on the
states, on the relationship between the
National Government and the states, or
on the distribution of power and
responsibilities among the various
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levels of government as specified in
Executive Order 13132 (64 FR 43255,
August 10, 1999). Thus, Executive Order
13132 does not apply to this action.
G. Executive Order 13175: Consultation
and Coordination With Indian Tribal
Governments
This action does not have tribal
implications because it is not expected
to have substantial direct effects on
tribal governments, on the relationship
between the Federal Government and
the Indian tribes, or on the distribution
of power and responsibilities between
the Federal Government and Indian
tribes as specified in Executive Order
13175 (65 FR 67249, November 9, 2000).
Thus, Executive Order 13175 does not
apply to this final rule. On July 30 and
August 1, 2019, EPA conducted two
presentations as part of tribal outreach
to provide background information on
the proposed rule and to obtain
feedback. Two identical outreach
sessions were conducted, and EPA
received no follow-up comments.
H. Executive Order 13045: Protection of
Children From Environmental Health
and Safety Risks
EPA interprets Executive Order 13045
(62 FR 19885, April 23, 1997), as
applying only to those regulatory
actions that concern environmental
health or safety risks, such that the
analysis required under section 5–501 of
Executive Order 13045 has the potential
to influence the regulation. This action
is not subject to Executive Order 13045
because it would not establish an
environmental standard intended to
mitigate health or safety risks.
Nevertheless, the information obtained
by the reporting required by this final
rule will be used to inform the Agency’s
decision-making process regarding
chemical substances to which children
may be disproportionately exposed.
This information would also assist the
Agency and others in determining
whether the chemical substances
covered in this final rule present
potential risks, allowing the Agency and
others to take appropriate action to
investigate and mitigate those risks.
I. Executive Order 13211: Actions
Concerning Regulations That
Significantly Affect Energy Supply,
Distribution, or Use
This action is not a ‘‘significant
energy action’’ as defined in Executive
Order 13211 (66 FR 28355, May 22,
2001) because it is not likely to have a
significant adverse effect on the supply,
distribution, or use of energy.
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J. National Technology Transfer and
Advancement Act (NTTAA)
Because this action does not involve
any technical standards, NTTAA section
12(d), 15 U.S.C. 272 note, does not
apply to this action.
K. Executive Order 12898: Federal
Actions To Address Environmental
Justice in Minority Populations and
Low-Income Populations
This action is not expected to have
high and adverse human health or
environmental effects on minority
populations, low-income populations,
and/or indigenous peoples as specified
in Executive Order 12898 (59 FR 7629,
February 16, 1994). The Agency believes
that the rule would improve the
information collected under CDR and
better assist EPA and others in
determining the potential hazards and
risks associated with the chemical
substances covered by the CDR. Because
the CDR is an information collection
requirement, the information that would
be improved through the final rule
would enable the Agency to target
educational, regulatory, or enforcement
activities towards industries or chemical
substances that pose the greatest risks
and/or to target programs for geographic
areas that are at the highest risk. Thus,
the information to be gathered under
this rule will help EPA make decisions
that would benefit potentially at-risk
communities, some of which may be
disadvantaged.
The rule is directed at manufacturers
(including importers) of chemical
substances. All consumers of these
chemical products and all workers who
come into contact with these chemical
substances could benefit if data
regarding the chemical substances’
health and environmental effects were
developed. Therefore, it would not
appear that the costs and the benefits of
the final rule would be
disproportionately distributed across
different geographic regions or among
different categories of individuals.
VI. Congressional Review Act (CRA)
This action is subject to the CRA, 5
U.S.C. 801 et seq., and EPA will submit
a rule report to each House of the
Congress and to the Comptroller General
of the United States. This action is not
a ‘‘major rule’’ as defined by 5 U.S.C.
804(2).
List of Subjects in 40 CFR Part 711
Environmental protection, Toxic
substances control act, TSCA chemical
data reporting and recordkeeping
requirements.
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Dated: March 17, 2020.
Alexandra Dapolito Dunn,
Assistant Administrator, Office of Chemical
Safety and Pollution Prevention.
Therefore, 40 CFR part 711 is
amended as follows:
PART 711—[AMENDED]
1. The authority citation for part 711
continues to read as follows:
■
Authority: 15 U.S.C. 2607(a).
2. Amend § 711.1 by revising the
section heading, and paragraphs (a) and
(c), to read as follows:
■
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§ 711.1 Scope, compliance, and
enforcement.
(a) This subpart specifies reporting
and recordkeeping procedures under
section 8(a) of the Toxic Substances
Control Act (TSCA) (15 U.S.C. 2607(a))
for certain manufacturers (including
importers) of chemical substances.
TSCA section 8(a) authorizes the EPA
Administrator to require reporting of
information necessary for the
administration of TSCA.
*
*
*
*
*
(c) TSCA section 15(3) makes it
unlawful for any person to fail or refuse
to submit information required under
this part. In addition, TSCA section
15(3) makes it unlawful for any person
to fail to keep, and permit access to,
records required by this part. Section 16
of TSCA provides that any person who
violates a provision of TSCA section 15
is liable to the United States for a civil
penalty and may be criminally
prosecuted. Pursuant to TSCA section
17, the Federal Government may seek
judicial relief to compel submission of
TSCA section 8(a) information and to
otherwise restrain any violation of
TSCA section 15. (EPA does not intend
to concentrate its enforcement efforts on
insignificant clerical errors in
reporting.) TSCA section 11 allows for
inspections to assure compliance, and
the Administrator may by subpoena
require the attendance and testimony of
witnesses and the production of reports,
papers, documents, answers to
questions, and other information that
the Administrator deems necessary.
*
*
*
*
*
■ 3. In § 711.3:
■ a. Revise the definitions of ‘‘eCDRweb’’ and ‘‘Manufacture’’;
■ b. Add alphabetically the definition
for ‘‘Highest-level parent company’’.
■ c. Revise paragraph (1) of the
definition for ‘‘Site’’;
■ d. Remove the definition for ‘‘U.S.
parent company’’;
The additions and revisions read as
follows:
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§ 711.3
Definitions.
*
*
*
*
*
e-CDRweb means the electronic, webbased tool provided by EPA for the
completion of Form U and submission
of the CDR data.
*
*
*
*
*
Manufacture means to manufacture,
produce, or import, for commercial
purposes. Manufacture includes the
extraction, for commercial purposes, of
a component chemical substance from a
previously existing chemical substance
or complex combination of chemical
substances. A chemical substance is comanufactured by the person who
physically performs the manufacturing
and the person contracting for such
production when that chemical
substance, manufactured other than by
import, is:
(1) Produced exclusively for another
person who contracts for such
production, and
(2) That other person dictates the
specific chemical identity of the
chemical substance and controls the
total amount produced and the basic
technology for the manufacturing
process.
*
*
*
*
*
Highest-level parent company means
the highest-level company of the site’s
ownership hierarchy as of the start of
the submission period during which
data are being reported according to the
following instructions. The highest-level
U.S. parent company is located within
the United States while the highest-level
foreign parent company is located
outside the United States. The following
rules govern how to identify the highestlevel U.S. parent company and highestlevel foreign parent company (if
applicable):
(1) If the site is entirely owned by a
single U.S. company that is not owned
by another company, that single
company is the U.S. parent company.
(2) If the site is entirely owned by a
single U.S. company that is, itself,
owned by another U.S.-based company
(e.g., it is a division or subsidiary of a
higher-level company), the highest-level
domestic company in the ownership
hierarchy is the United States parent
company. If there is a higher-level
parent company that is outside of the
United States, the highest-level foreign
company in the ownership hierarchy is
the foreign parent company.
(3) If the site is owned by more than
one company (e.g., company A owns 40
percent, company B owns 35 percent,
and company C owns 25 percent), the
company with the largest ownership
interest in the site is the parent
company. If a higher-level company in
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the ownership hierarchy owns more
than one ownership company, then
determine the entity with the largest
ownership by considering the lowerlevel ownerships in combination (e.g.,
corporation x owns companies B and C,
for a total ownership of 60 percent for
the site).
(i) If the parent company is a U.S.
company owned by another U.S.
company, then the highest-level
domestic company in the ownership
hierarchy is the U.S. parent company. If
the U.S. parent company has a higherlevel foreign company in the ownership
hierarchy, then the highest-level foreign
company in the ownership hierarchy is
the foreign parent company.
(ii) If the parent company is a foreign
company, then the site is its own U.S.
parent company and the foreign parent
company is the highest-level foreign
company in the ownership hierarchy.
(4) If the site is owned by a 50:50 joint
venture or a cooperative, the joint
venture or cooperative is its own parent
company. If the site is owned by a U.S.
joint venture or cooperative, the highest
level of the joint venture or cooperative
is the U.S. parent company. If the site
is owned by a joint venture or
cooperative outside the United States,
the highest level of the joint venture or
cooperative outside the United States is
the foreign parent company.
(5) If the site is entirely owned by a
foreign company (i.e., without a U.S.based subsidiary within the site’s
ownership hierarchy), the highest-level
foreign company in the ownership
hierarchy is the site’s foreign parent
company.
(6) If the site is federally owned, the
highest-level federal agency or
department is the U.S. parent company.
(7) If the site is owned by a nonfederal public entity, that entity (such as
a municipality, State, or tribe) is the
U.S. parent company.
*
*
*
*
*
Sites * * *
(1) For chemical substances
manufactured under contract, i.e., by a
co-manufacturer, the site is the location
where the chemical substance is
physically manufactured.
*
*
*
*
*
■ 4. Amend § 711.6 by revising the
section heading, the introductory text
and the paragraph (a)(4) subject heading
to read as follows.
§ 711.6 Chemical substances for which
information is not required.
The following groups or categories of
chemical substances are exempted from
some or all of the reporting
requirements of this part, with the
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following exception: A chemical
substance described in paragraph (a)(1),
(2), or (4), or (b) of this section is not
exempted from any of the reporting
requirements of this part if that
chemical substance is the subject of a
rule proposed or promulgated under
TSCA sections 4, 5(a)(2), 5(b)(4), or 6, or
is the subject of an enforceable consent
agreement (ECA) developed under the
procedures of 40 CFR part 790, or is the
subject of an order issued under TSCA
sections 4, 5(e), or 5(f), or is the subject
of relief that has been granted under a
civil action under TSCA sections 5 or 7.
*
*
*
*
*
(a) * * *
(4). Water and certain forms of
natural gas. * * *
*
*
*
*
*
■ 5. Amend § 711.8 by revising
paragraphs (a) and (b) to read as follows:
§ 711.8
Persons who must report.
*
*
*
*
*
(a) Persons subject to recurring
reporting. Any person who
manufactured (including imported) for
commercial purposes 25,000 lb (11,340
kg) or more of a chemical substance
described in § 711.5 at any single site
owned or controlled by that person
during any calendar year since the last
principal reporting year.
(b) Exceptions. Any person who
manufactured (including imported) for
commercial purposes any chemical
substance that is the subject of a rule
proposed or promulgated under TSCA
section 5(a)(2), 5(b)(4), or 6, or is the
subject of an order in effect under TSCA
section 4, 5(e) or 5(f), or is the subject
of relief that has been granted under a
civil action under TSCA sections 5 or 7
is subject to reporting as described in
§ 711.8(a), except that the applicable
production volume threshold is 2,500 lb
(1,134 kg).
■ 6. Revise § 711.9 to read as follows:
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§ 711.9
Persons not subject to this part.
A person described in § 711.8 is not
subject to the requirements of this part
if that person qualifies as a small
manufacturer or small government as
those terms are defined in 40 CFR 704.3.
Notwithstanding this exclusion, a
person who qualifies as a small
manufacturer or small government is
subject to this part with respect to any
chemical substance that is the subject of
a rule proposed or promulgated under
TSCA section 4, 5(b)(4), or 6, or is the
subject of an order in effect under TSCA
section 4 or 5(e), or is the subject of
relief that has been granted under a civil
action under TSCA section 5 or 7.
■ 7. Revise § 711.10 to read as follows:
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§ 711.10 Activities for which reporting is
not required.
A person described in § 711.8 is not
subject to the requirements of this part
with respect to any chemical substance
described in § 711.5, when:
(a) The person manufactured or
imported the chemical substance solely
in small quantities for research and
development.
(b) The person imported the chemical
substance as part of an article.
(c) The person manufactured the
chemical substance in a manner
described in 40 CFR 720.30(g) or (h).
(d) The person manufactured the
chemical substance in any of the
following manners:
(1) Byproduct substances listed in
paragraph (i) of this section for the
following manufacturing processes,
when recycled or otherwise used within
a site-limited, physically enclosed
system that is part of the same overall
manufacturing process from which the
byproduct substance was generated, and
when the site is reporting the byproduct
or a different chemical substance that
was manufactured from the recycled
byproduct or manufactured in the same
overall manufacturing process:
(i) List of processes and certain
related byproduct substances. (A)
Portland Cement Manufacturing (i.e.,
CASRN 68475–76–3, Flue dust,
portland cement).
(B) Kraft Pulping Process (i.e., CASRN
66071–92–9, Sulfite liquors and
Cooking liquors, spent; CASRN 68514–
09–0, Sulfite liquors and Cooking
liquors, spent, oxidized; and CASRN
471–34–1, Carbonic acid calcium salt
(1:1)).
(ii) Amendments. EPA may amend the
exemptions list in paragraph (d)(1)(i) of
this section on its own initiative or in
response to a request from the public
based on EPA’s determination of
whether the byproduct substance and
process described meet the criteria
explained in this paragraph (d)(1), based
on the requirements and considerations
listed in paragraphs (d)(1)(ii)(B) and (C)
of this section.
(A) Any person may request that EPA
amend the chemical substance list in
paragraph (d)(1)(i) of this section. Your
request must be in writing and must be
submitted to the address provided in 40
CFR 700.17(a). Please label your request
as follows: Attention: TSCA Chemical
Data Reporting—Byproduct Exemption
Request. Requests must identify the
manufacturing process and byproduct
chemical substance in question, as well
as its CASRN or other chemical
identification number as identified in 40
CFR 711.15(b)(3)(i), and must contain a
written rationale for the request that
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20139
provides sufficient specific information,
addressing the requirements and
considerations listed in paragraphs
(d)(1)(ii)(B) and (C) of this section,
including citations and relevant
documents, to demonstrate to EPA that
the byproduct substance and process in
question either does or does not meet
the criteria explained in this paragraph
(d)(1). If a request related to a particular
byproduct substance and process is
resubmitted, any subsequent request
must clearly identify new information
contained in the request. EPA may
request other information that it
believes necessary to evaluate the
request. EPA will issue a written
response to each request within 120
days of receipt of the request and will
maintain copies of these responses in a
docket that will be established for each
reporting cycle.
(B) In making its determination
whether this exemption should apply to
a particular manufacturing process and
related byproduct substance, the
following two requirements must be
met:
(1) The byproduct substance is
recycled or otherwise used to
manufacture another chemical
substance within an enclosed system,
within the same overall manufacturing
process, and on the same site as that
byproduct was originally manufactured.
(2) The site is reporting under CDR
other chemical substances, in particular
a chemical substance other than the
byproduct substance that was
manufactured from the byproduct or
manufactured in the same overall
manufacturing process.
(C) In addition to the requirements in
paragraph (d)(1)(ii)(B) of this section,
EPA will consider the totality of
information available for the process
and related byproduct substance in
question, including but not limited to,
one or both of the following
considerations:
(1) Whether EPA has a current interest
in the byproduct substance.
(2) Whether the byproduct substance
must have already been reported under
CDR, or would be expected to be
reported if not exempted by this
exemption.
(D) After granting a petition, the
Agency will initiate rulemaking to make
revisions to the list of substances in
paragraph (d)(1)(i) of this section.
(E) To assist EPA in reaching a
decision regarding a particular request
prior to a given principal reporting year,
requests must be submitted to EPA no
later than 12 months prior to the start
of the next principal reporting year.
(2) A quantity of the byproduct that is
manufactured solely in the following
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equipment when it is not integral to the
chemical manufacturing processes of
the site:
(i) Pollution control equipment.
(ii) Boilers used to generate heat or
electricity for that site.
■ 8. Revise § 711.15 to read as follows.
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§ 711.15
Reporting information to EPA.
Any person who must report under
this part, as described in § 711.8, must
submit the information described in this
section for each chemical substance
described in § 711.5 that the person
manufactured (including imported) for
commercial purposes in an amount of
25,000 lb (11,340 kg) or more (or in an
amount of 2,500 lb (1,134 kg) or more
for chemical substances subject to the
rules, orders, or actions described in
§ 711.8(b)) at any one site during any
calendar year since the last principal
reporting year (e.g., for the 2020
submission period, consider calendar
years 2016, 2017, 2018, and 2019,
because 2015 was the last principal
reporting year). The principal reporting
year for each submission period is the
previous calendar year (e.g., the
principal reporting year for the 2020
submission period is calendar year
2019). For all submission periods, a
separate report must be submitted for
each chemical substance at each site for
which the submitter is required to
report. A submitter of information under
this part must report information as
described in this section to the extent
that such information is known to or
reasonably ascertainable by that person.
(a) Reporting information to EPA. Any
person who reports information to EPA
must complete a Form U using the eCDRweb reporting tool provided by EPA
at the address set forth in § 711.35. The
submission must include all
information described in paragraph (b)
of this section. Persons must submit the
chemical reports on a separate single
Form U for each site for which the
person is required to report. The eCDRweb reporting tool is described in
the instructions available from EPA at
the website set forth in § 711.35.
(b) Information to be reported. The
information described in paragraphs
(b)(1) through (4) of this section must be
reported for each chemical substance
manufactured (including imported) in
an amount of 25,000 lb (11,340 kg) or
more (or in an amount of 2,500 lb (1,134
kg) or more for chemical substances
subject to the rules, orders, or actions
described in § 711.8(b)) at any one site
during any calendar year since the last
principal reporting year. The
requirement to report information
described in paragraph (b)(4) of this
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section is subject to exemption as
described in § 711.6.
(1) A certification statement signed
and dated by an authorized official of
the submitter company. The authorized
official must certify that the submitted
information has been completed in
compliance with the requirements of
this part and that the confidentiality
claims made on the Form U are true and
correct. The certification must be signed
and dated by the authorized official for
the submitter company, and provide
that person’s name, official title, and
email address.
(2) Company and site information.
The following currently correct parent
company and site information at the
date of CDR submission must be
reported for each site at which a
reportable chemical substance is
manufactured (including imported)
above the applicable production volume
threshold, as described in this section
(see § 711.3 for the ‘‘site’’ for importers
and special situations).
(i) The legal name, address, and Dun
and Bradstreet D–U–N–S® (D&B)
number for the highest-level parent
company located in the United States
and, if one exists, for the highest-level
foreign-based parent company. A
submitter under this part must obtain a
D&B number for the parent company if
none exists and must report using the
standardized conventions for the
naming of a parent company as
provided in the CDR Instructions for
Reporting identified in § 711.35.
(ii) The name of a person who will
serve as technical contact for the
submitter company who will be able to
answer questions about the information
submitted by the company to EPA, and
that technical contact person’s full
mailing address, telephone number, and
email address.
(iii) The legal name and full street
address of each site. A submitter under
this part must include the appropriate
D&B number for each site reported, and
the county or parish (or other
jurisdictional indicator) in which the
site is located. A submitter under this
part must obtain a D&B number for the
site reported if none exists. For a comanufacturing situation in which the
contracting company initiates the
report, the contracting company must
report both the site controlling the
contract and the producing company’s
site information.
(iv) The six-digit NAICS code for the
site. A submitter under this part must
include the appropriate six-digit NAICS
code for each site reported.
(3) Chemical-specific information.
The following chemical-specific
information must be reported for each
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reportable chemical substance
manufactured (including imported)
above the applicable production volume
threshold, as described in paragraph (b)
of this section:
(i) The specific, currently correct CA
Index name as used to list the chemical
substance on the TSCA Inventory and
the correct corresponding CASRN for
each reportable chemical substance at
each site. Submitters who wish to report
chemical substances listed on the
confidential portion of the TSCA
Inventory will need to report the
chemical substance using the
corresponding TSCA Accession Number
that is listed on the public portion of the
Inventory. In addition to reporting the
chemical identifying number itself,
submitters must specify the type of
number they are reporting by selecting
from among the codes in Table 1 to
paragraph (b)(3)(i).
TABLE 1 TO PARAGRAPH (b)(3)(i)—
CODES TO SPECIFY TYPE OF CHEMICAL IDENTIFYING NUMBER
Code
Number type
A .........
C ........
TSCA Accession Number.
Chemical Abstracts Service Registry Number (CASRN).
(A) If an importer submitting a report
cannot provide the information
specified in this paragraph (b)(3)(i)
because it is unknown to the importer
and claimed as confidential by the
supplier of the chemical substance or
mixture, the importer must use eCDRweb to ask the supplier to provide
the correct chemical identity and, in the
case of a mixture, the percentage of
formulation and chemical function
information directly to EPA in a joint
submission. Such request must include
instructions for submitting chemical
identity information electronically,
using e-CDRweb and CDX (see § 711.35),
and for clearly referencing the
importer’s submission. Contact
information for the supplier, a trade
name or other designation for the
chemical substance or mixture, and a
copy of the request to the supplier must
be included with the importer’s
submission.
(B) If a manufacturer submitting a
report cannot provide the information
specified in this paragraph (b)(3)(i)
because the reportable chemical
substance is manufactured using a
reactant having a specific chemical
identity that is unknown to the
manufacturer and claimed as
confidential by its supplier, the
manufacturer must use e-CDRweb to ask
the supplier of the confidential reactant
to provide the correct chemical identity
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of the confidential reactant directly to
EPA in a joint submission. Such request
must include instructions for submitting
chemical identity information
electronically using e-CDRweb and CDX
(see § 711.35), and for clearly
referencing the manufacturer’s
submission. Contact information for the
supplier, a trade name or other
designation for the chemical substance,
and a copy of the request to the supplier
must be included with the importer’s
submission.
(C) EPA will accept only joint
submissions that are submitted
electronically using e-CDRweb and CDX
(see § 711.35) and that clearly reference
the primary submission to which they
refer.
(ii) For the principal reporting year
only, a statement indicating, for each
reportable chemical substance at each
site, whether the chemical substance is
manufactured in the United States,
imported into the United States, or both
manufactured in the United States and
imported into the United States.
(iii) For the principal reporting year
only, the total annual volume (in
pounds) of each reportable chemical
substance domestically manufactured or
imported at each site. The total annual
domestically manufactured volume (not
including imported volume) and the
total annual imported volume must be
separately reported. These amounts
must be reported to two significant
figures of accuracy. In addition, the total
annual volume (domestically
manufactured plus imported volumes in
pounds) of each reportable chemical
substance at each site for each complete
calendar year since the last principal
reporting year.
(iv) For the principal reporting year
only, the volume used on site and the
volume directly exported of each
reportable chemical substance
domestically manufactured or imported
at each site. These amounts must be
reported to two significant figures of
accuracy.
(v) For the principal reporting year
only, a designation indicating, for each
imported reportable chemical substance
at each site, whether the imported
chemical substance is physically
present at the reporting site.
(vi) For the principal reporting year
only, a designation indicating, for each
reportable chemical substance at each
site, whether the chemical substance is
being recycled or otherwise used for a
commercial purpose instead of being
disposed of as a waste or included in a
waste stream.
(vii) For the principal reporting year
only, the total number of workers
reasonably likely to be exposed to each
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17:21 Apr 08, 2020
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reportable chemical substance at each
site. For each reportable chemical
substance at each site, the submitter
must select from among the ranges of
workers listed in Table 2 to paragraph
(b)(3)(vii) and report the corresponding
code (i.e., W1 through W8):
20141
chemical substance at each site, the
submitter must report as many physical
forms as applicable from among the
physical forms listed in this Unit:
(A) Dry powder.
(B) Pellets or large crystals.
(C) Water- or solvent-wet solid.
(D) Other solid.
(E) Gas or vapor.
TABLE 2 TO PARAGRAPH (b)(3)(vii)—
(F) Liquid.
CODES FOR REPORTING NUMBER OF
(x) For the principal reporting year
WORKERS REASONABLY LIKELY TO only, submitters must report the
BE EXPOSED
percentage, rounded off to the closest 10
percent, of total production volume of
Code
Range
the reportable chemical substance,
reported in response to paragraph
W1 ...... Fewer than 10 workers.
W2 ...... At least 10 but fewer than 25 workers.
(b)(3)(iii) of this section, that is
W3 ...... At least 25 but fewer than 50 workers.
associated with each physical form
W4 ...... At least 50 but fewer than 100 workers.
reported under paragraph (b)(3)(ix) of
W5 ...... At least 100 but fewer than 500 workers.
this section.
W6 ...... At least 500 but fewer than 1,000 workers.
W7 ...... At least 1,000 but fewer than 10,000 work(4) Chemical-specific information
ers.
related to processing and use. The
W8 ...... At least 10,000 workers.
following chemical-specific information
must be reported for each reportable
(viii) For the principal reporting year
chemical substance manufactured
only, the maximum concentration,
(including imported) above the
measured by percentage of weight, of
applicable production volume
each reportable chemical substance at
the time it is sent off-site from each site. threshold, as described in this section.
If the chemical substance is site-limited, Persons subject to paragraph (b)(4) of
this section must report the information
you must report the maximum
described in paragraphs (b)(4)(i) and (ii)
concentration, measured by percentage
of this section for each reportable
of weight of the reportable chemical
substance at the time it is reacted on-site chemical substance at sites under their
control and at sites that receive a
to produce a different chemical
reportable chemical substance from the
substance. This information must be
submitter directly or indirectly
reported regardless of the physical
form(s) in which the chemical substance (including through a broker/distributor,
from a customer of the submitter, etc.).
is sent off-site/reacted on-site. For each
Information reported in response to this
chemical substance at each site, select
paragraph must be reported for the
the maximum concentration of the
principal reporting year only and only
chemical substance from among the
to the extent that it is known to or
ranges listed in Table 3 to paragraph
(b)(3)(viii) and report the corresponding reasonably ascertainable by the
submitter. Information required to be
code (i.e., M1 through M5):
reported under this paragraph is limited
TABLE 3 TO PARAGRAPH (b)(3)(viii)— to domestic (i.e., within the customs
CODES FOR REPORTING MAXIMUM territory of the United States) processing
CONCENTRATION OF CHEMICAL SUB- and use activities. If information
responsive to a given data requirement
STANCE
under this paragraph, including
information in the form of an estimate,
Concentration
range
Code
(percent weight)
is not known or reasonably
ascertainable, the submitter is not
M1 ...... Less than 1 percent by weight.
M2 ...... At least 1 but less than 30 percent by required to respond to the requirement.
(i) Industrial processing and use
weight.
M3 ...... At least 30 but less than 60 percent by information—(A) A designation
weight.
indicating the type of industrial
M4 ...... At least 60 but less than 90 percent by
processing or use operation(s) at each
weight.
site that receives a reportable chemical
M5 ...... At least 90 percent by weight.
substance from the submitter site
(ix) For the principal reporting year
directly or indirectly (whether the
only, the physical form(s) of the
recipient site(s) are controlled by the
reportable chemical substance as it is
submitter site or not). For each chemical
sent off-site from each site. If the
substance, report the letters which
chemical substance is site-limited, you
correspond to the appropriate
must report the physical form(s) of the
processing or use operation(s) listed in
reportable chemical substance at the
Table 4 to paragraph (b)(4)(i)(A). A
time it is reacted on-site to produce a
particular designation may need to be
different chemical substance. For each
reported more than once, to the extent
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09APR3
20142
Federal Register / Vol. 85, No. 69 / Thursday, April 9, 2020 / Rules and Regulations
that a submitter reports more than one
sector (under paragraph (b)(4)(i)(B) of
this section) that applies to a given
designation under this paragraph.
TABLE 4 TO PARAGRAPH (b)(4)(i)(A)—
CODES FOR REPORTING TYPE OF INDUSTRIAL PROCESSING OR USE OPERATION
Operation
PC ..............
PF ...............
Processing as a reactant.
Processing—incorporation into formulation, mixture, or reaction product.
Processing—incorporation into article.
Processing—repackaging.
Use—non-incorporative activities.
TABLE 5 TO PARAGRAPH (b)(4)(i)(B)—
CODES FOR REPORTING INDUSTRIAL
SECTORS
Code
Sector description
IS1 ......
IS2 ......
Agriculture, forestry, fishing, and hunting.
Oil and gas drilling, extraction, and support
activities.
Mining (except oil and gas) and support
activities.
Utilities.
Construction.
Food, beverage, and tobacco product
manufacturing.
Textiles, apparel, and leather manufacturing.
Wood product manufacturing.
Paper manufacturing.
IS4 ......
IS5 ......
IS6 ......
IS7 ......
IS8 ......
IS9 ......
Sector description
IS10 ....
IS11 ....
IS12 ....
Printing and related support activities.
Petroleum refineries.
Asphalt paving, roofing, and coating materials manufacturing.
Petroleum lubricating oil and grease manufacturing.
All other petroleum and coal products
manufacturing.
Petrochemical manufacturing.
Industrial gas manufacturing.
Synthetic dye and pigment manufacturing.
Carbon black manufacturing.
All other basic inorganic chemical manufacturing.
Cyclic crude and intermediate manufacturing.
All other basic organic chemical manufacturing.
Plastics material and resin manufacturing.
Synthetic rubber manufacturing.
Organic fiber manufacturing.
Pesticide, fertilizer, and other agricultural
chemical manufacturing.
Pharmaceutical and medicine manufacturing.
Paint and coating manufacturing.
Adhesive manufacturing.
Soap, cleaning compound, and toilet preparation manufacturing.
Printing ink manufacturing.
Explosives manufacturing.
Custom compounding of purchased resins.
Photographic film, paper, plate, and chemical manufacturing.
All other chemical product and preparation
manufacturing.
Plastics product manufacturing.
Rubber product manufacturing.
Non-metallic mineral product manufacturing (includes cement, clay, concrete,
glass, gypsum, lime, and other non-metallic mineral product manufacturing).
Primary metal manufacturing.
Fabricated metal product manufacturing.
Machinery manufacturing.
Computer and electronic product manufacturing.
Electrical equipment, appliance, and component manufacturing.
Transportation equipment manufacturing.
Furniture and related product manufacturing.
Miscellaneous manufacturing.
Wholesale and retail trade.
Services.
Other (requires additional information).
IS14 ....
(B) A code indicating the sector(s) that
best describe the industrial activities
associated with each industrial
processing or use operation reported
under paragraph (b)(4)(i)(A) of this
section. For each chemical substance,
report the code that corresponds to the
appropriate sector(s) listed in Table 5 to
paragraph (b)(4)(i)(B). A particular
sector code may need to be reported
more than once, to the extent that a
submitter reports more than one
function code (under paragraph
(b)(4)(i)(C) of this section) that applies to
a given sector code under this
paragraph.
IS3 ......
Code
IS13 ....
Designation
PA ...............
PK ...............
U .................
(C) For each sector reported under
TABLE 5 TO PARAGRAPH (b)(4)(i)(B)—
CODES FOR REPORTING INDUSTRIAL paragraph (b)(4)(i)(B) of this section, the
applicable code(s) from Table 6 to
SECTORS—Continued
IS15
IS16
IS17
IS18
IS19
....
....
....
....
....
IS20 ....
IS21 ....
IS22
IS23
IS24
IS25
....
....
....
....
IS26 ....
IS27 ....
IS28 ....
IS29 ....
IS30
IS31
IS32
IS33
....
....
....
....
IS34 ....
IS35 ....
IS36 ....
IS37 ....
IS38
IS39
IS40
IS41
....
....
....
....
IS42 ....
IS43 ....
IS44 ....
IS45
IS46
IS47
IS48
....
....
....
....
paragraph (b)(4)(i)(C) must be selected
to designate the function category(ies)
that best represents the specific manner
in which the chemical substance is
used. For the 2020 submission period:
(1) Use column A in Table 6 to
paragraph (b)(4)(i)(C) for chemical
substances designated in 2019 as high
priority for risk evaluation (those
chemicals listed in Table 7 to paragraph
(b)(4)(i)(C)); and
(2) Use either column A or B in Table
6 to paragraph (b)(4)(i)(C) for chemical
substances not listed in Table 7 to
paragraph (b)(4)(i)(C). For the 2024 and
future submission periods, use only
column A in Table 6 to paragraph
(b)(4)(i)(C). A particular function
category may need to be reported more
than once, to the extent that a submitter
reports more than one industrial
processing or use operation/sector
combination (under paragraphs
(b)(4)(i)(A) and (B) of this section) that
applies to a given function category
under this paragraph. If more than 10
unique combinations of industrial
processing or use operations/sector/
function categories apply to a chemical
substance, submitters need only report
the 10 unique combinations for the
chemical substance that cumulatively
represent the largest percentage of the
submitter’s production volume for that
chemical substance, measured by
weight. If none of the listed function
categories accurately describes a use of
a chemical substance, the category
‘‘Other’’ may be used, and must include
a description of the use.
TABLE 6 TO PARAGRAPH (b)(4)(i)(C)—CODES FOR REPORTING FUNCTION CATEGORIES
Column A
khammond on DSKJM1Z7X2PROD with RULES3
Code
F001
F002
F003
F004
F005
F006
F007
F008
F009
F010
F011
F012
F013
Category
...................
...................
...................
...................
...................
...................
...................
...................
...................
...................
...................
...................
...................
VerDate Sep<11>2014
Column B
Code
Abrasives ..........................................................................
Etching agent.
Adhesion/cohesion promoter ............................................
Binder.
Flux agent.
Sealant (barrier).
Absorbent ..........................................................................
Adsorbent.
Dehydrating agent (desiccant).
Drier.
Humectant.
Soil amendments (fertilizers) ............................................
Anti-adhesive/cohesive .....................................................
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Category
U001
Abrasives.
U002
Adhesives and sealant chemicals.
U003
Adsorbents and absorbents.
U004
U005
Agricultural chemicals (non-pesticidal).
Anti-adhesive agents.
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09APR3
Federal Register / Vol. 85, No. 69 / Thursday, April 9, 2020 / Rules and Regulations
20143
TABLE 6 TO PARAGRAPH (b)(4)(i)(C)—CODES FOR REPORTING FUNCTION CATEGORIES—Continued
Column A
Code
khammond on DSKJM1Z7X2PROD with RULES3
F014
F015
F016
F017
F018
F019
F020
F021
F022
F023
F024
F025
F026
F027
F028
F029
F030
F031
F032
F033
F034
F035
F036
F037
F038
F039
F040
F041
F042
F043
F044
F045
F046
F047
F048
F049
F050
F051
F052
F053
F054
F055
F056
F057
F058
F059
F060
F061
F062
F063
F064
F065
F066
F067
F068
F069
F070
F071
F072
Column B
Category
...................
...................
...................
...................
...................
...................
...................
...................
...................
...................
...................
...................
...................
...................
...................
...................
...................
...................
...................
...................
...................
...................
...................
...................
...................
...................
...................
...................
...................
...................
...................
...................
...................
...................
...................
...................
...................
...................
...................
...................
...................
...................
...................
...................
...................
...................
...................
...................
...................
...................
...................
...................
...................
...................
...................
...................
...................
...................
...................
Code
F073 ...................
F074 ...................
Dusting agent.
Bleaching agent ................................................................
Brightener.
Anti-scaling agent .............................................................
Corrosion inhibitor.
Dye ....................................................................................
Fixing agent (mordant).
Hardener ...........................................................................
Filler.
Anti-static agent ................................................................
Softener and conditioner.
Swelling agent.
Tanning agents not otherwise specified.
Waterproofing agent.
Wrinkle resisting agent.
Flame retardant .................................................................
Fuel agents .......................................................................
Fuel.
Heat transferring agent .....................................................
Hydraulic fluids.
Insulators.
Refrigerants.
Anti-freeze agent ...............................................................
Intermediate ......................................................................
Monomers.
Ion exchange agent ..........................................................
Anti-slip agent ...................................................................
Lubricating agent.
Deodorizer .........................................................................
Fragrance.
Oxidizing agent .................................................................
Reducing agent.
Photosensitive agent .........................................................
Photosensitizers.
Semiconductor and photovoltaic agent.
UV stabilizer.
Opacifer .............................................................................
Pigment.
Plasticizer ..........................................................................
Plating agent .....................................................................
Catalyst .............................................................................
Chain transfer agent.
Chemical reaction regulator.
Crystal growth modifiers (nucleating agents).
Polymerization promoter.
Terminator/Blocker.
Processing aids, specific to petroleum production ...........
Antioxidant ........................................................................
Chelating agent.
Defoamer.
pH regulating agent.
Processing aids not otherwise specified.
Energy Releasers (explosives, motive propellant) ...........
Foamant.
Propellants, non-motive (blowing agents).
Cloud-point depressant .....................................................
Flocculating agent.
Flotation agent.
Solids separation (precipitating) agent, not otherwise
specified.
Cleaning agent ..................................................................
Diluent ...............................................................................
F075
F076
F077
F078
F079
F080
F081
Solvent.
Surfactant (surface active agent) ......................................
Emulsifier.
Thickening agent ...............................................................
Viscosity modifiers.
Laboratory chemicals ........................................................
Dispersing agent ...............................................................
...................
...................
...................
...................
...................
...................
...................
VerDate Sep<11>2014
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Category
U006
Bleaching agents.
U007
Corrosion inhibitors and anti-scaling agents.
U008
Dyes.
U009
Fillers.
U010
Finishing agents.
U011
U012
Flame retardants.
Fuels and fuel additives.
U013
Functional fluids (closed systems).
U014
U015
Functional fluids (open systems).
Intermediates.
U016
U017
Ion exchange agents.
Lubricants and lubricant additives.
U018
Odor agents.
U019
Oxidizing/reducing agents.
U020
Photosensitive chemicals.
U021
Pigments.
U022
U023
U024
Plasticizers.
Plating agents and surface treating agents.
Process regulators.
U025
U026
Processing aids, specific to petroleum production.
Processing aids, not otherwise listed.
U027
Propellants and blowing agents.
U028
Solids separation agents.
U029
U030
Solvents (for cleaning or degreasing).
Solvents (which become part of product formulation or
mixture).
U031
Surface active agents.
U032
Viscosity adjustors.
U033
U034
Laboratory chemicals.
Paint additives and coating additives not described by
other categories.
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09APR3
20144
Federal Register / Vol. 85, No. 69 / Thursday, April 9, 2020 / Rules and Regulations
TABLE 6 TO PARAGRAPH (b)(4)(i)(C)—CODES FOR REPORTING FUNCTION CATEGORIES—Continued
Column A
Code
F082
F083
F084
F085
F086
F087
F088
F089
F090
F091
F092
F093
F094
F095
F096
F097
F098
F099
F100
F101
F102
F103
F104
F105
F106
F107
F108
F109
F110
F111
F112
F113
F114
F115
F116
F999
Column B
Category
...................
...................
...................
...................
...................
...................
...................
...................
...................
...................
...................
...................
...................
...................
...................
...................
...................
...................
...................
...................
...................
...................
...................
...................
...................
...................
...................
...................
...................
...................
...................
...................
...................
...................
...................
...................
Code
Freeze-thaw additive.
Surface modifier.
Wetting agent (non-aqueous).
Aerating and deaerating agents .......................................
Explosion inhibitor.
Fire extinguishing agent.
Flavoring and nutrient.
Anti-redeposition agent.
Anti-stain agent.
Anti-streaking agent.
Conductive agent.
Incandescent agent.
Magnetic element.
Anti-condensation agent.
Coalescing agent.
Film former.
Demulsifier.
Stabilizing agent.
Alloys.
Density modifier.
Elasticizer.
Flow promoter.
Sizing agent.
Solubility enhancer.
Vapor pressure modifiers.
Embalming agent.
Heat stabilizer.
Preservative.
Anti-caking agent.
Deflocculant.
Dust suppressant.
Impregnation agent.
Leaching agent.
Tracer.
X-ray absorber.
Other.
U999
Category
Other (specify).
For the 2020 submission period: (1) Use column A for chemical substances designated in 2019 as high priority for risk evaluation (those
chemicals listed in Table 7 to paragraph(b)(4)(i)(C) and (2) use either column A or B for chemical substances not listed in Table 7 to paragraph
(b)(4)(i)(C).
For the 2024 and future submission periods, use only column A.
TABLE 7 TO PARAGRAPH (b)(4)(i)(C)—CASRNS OF CHEMICAL SUBSTANCES DESIGNATED AS HIGH PRIORITY FOR RISK
EVALUATION UNDER TSCA SECTION 6(b) ON DECEMBER 30, 2019
khammond on DSKJM1Z7X2PROD with RULES3
CASRN
Chemical substance
106–46–7 ..........
107–06–2 ..........
156–60–5 ..........
95–50–1 ............
79–00–5 ............
78–87–5 ............
75–34–3 ............
84–74–2 ............
85–68–7 ............
117–81–7 ..........
84–69–5 ............
84–61–7 ............
79–94–7 ............
115–96–8 ..........
115–86–6 ..........
106–93–4 ..........
106–99–0 ..........
1222–05–5 ........
50–00–0 ............
85–44–9 ............
VerDate Sep<11>2014
p-Dichlorobenzene.
1,2-Dichloroethane.
trans-1,2-Dichloroethylene.
o-Dichlorobenzene.
1,1,2-Trichloroethane.
1,2-Dichloropropane.
1,1-Dichloroethane.
Dibutyl phthalate (DBP) (1,2-Benzene-dicarboxylic acid, 1,2-dibutyl ester).
Butyl benzyl phthalate (BBP)—1,2-Benzene-dicarboxylic acid, 1-butyl 2(phenylmethyl) ester.
Di-ethylhexyl phthalate (DEHP)—(1,2-Benzene-dicarboxylic acid, 1,2-bis(2-ethylhexyl) ester).
Di-isobutyl phthalate (DIBP)—(1,2-Benzene-dicarboxylic acid, 1,2-bis-(2methylpropyl) ester).
Dicyclohexyl phthalate.
4,4′-(1-Methylethylidene)bis[2,6-dibromophenol] (TBBPA).
Tris(2-chloroethyl) phosphate (TCEP).
Phosphoric acid, triphenyl ester (TPP).
Ethylene dibromide.
1,3-Butadiene.
1,3,4,6,7,8-Hexahydro-4,6,6,7,8,8-hexamethylcyclopental[g]-2-benzopyran (HHCB).
Formaldehyde.
Phthalic anhydride.
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09APR3
Federal Register / Vol. 85, No. 69 / Thursday, April 9, 2020 / Rules and Regulations
(D) The estimated percentage,
rounded off to the closest 10 percent, of
total production volume of the
reportable chemical substance
associated with each combination of
industrial processing or use operation,
sector, and function category. Where a
particular combination of industrial
processing or use operation, sector, and
function category accounts for less than
5 percent of the submitter’s site’s total
production volume of a reportable
chemical substance, the percentage
must not be rounded off to 0 percent if
the production volume attributable to
that industrial processing or use
operation, sector, and function category
combination is 25,000 lb (11,340 kg) or
more during the reporting year. Instead,
in such a case, submitters must report
the percentage, rounded off to the
closest 1 percent, of the submitter’s
site’s total production volume of the
reportable chemical substance
associated with the particular
combination of industrial processing or
use operation, sector, and function
category.
(E) For each combination of industrial
processing or use operation, sector, and
function category, the submitter must
estimate the number of sites at which
each reportable chemical substance is
processed or used. For each
combination associated with each
20145
chemical substance, the submitter must
select from among the ranges of sites
listed in Table 8 to paragraph (b)(4)(i)(E)
and report the corresponding code (i.e.,
S1 through S7):
category(ies) that best describe the
consumer and commercial products in
which each reportable chemical
substance is used (whether the recipient
site(s) are controlled by the submitter
site or not). For the 2020 submission
TABLE 8 TO PARAGRAPH (b)(4)(i)(E)— period:
CODES FOR REPORTING NUMBERS
(1) Use column A in Table 9 to
OF SITES
paragraph (b)(4)(ii)(A) for chemical
substances designated in 2019 as high
Code
Range
priority for risk evaluation (those
S1 ....... Fewer than 10 sites.
chemicals listed in Table 7 to paragraph
S2 ....... At least 10 but fewer than 25 sites.
(b)(4)(i)(C); and
S3 ....... At least 25 but fewer than 100 sites.
S4 ....... At least 100 but fewer than 250 sites.
(2) Use either column A or B in Table
S5 ....... At least 250 but fewer than 1,000 sites.
9 to paragraph (b)(4)(ii)(A) for chemical
S6 ....... At least 1,000 but fewer than 10,000 sites.
S7 ....... At least 10,000 sites.
substances not listed in Table 7 to
paragraph (b)(4)(i)(C). For the 2024 and
(F) For each combination of industrial future submission periods, use only
processing or use operation, sector, and
column A in Table 9 to paragraph
function category, the submitter must
(b)(4)(ii)(A). If more than 10 codes apply
estimate the number of workers
to a chemical substance, submitters
reasonably likely to be exposed to each
reportable chemical substance. For each need only report the 10 codes for the
chemical substance that cumulatively
combination associated with each
represent the largest percentage of the
chemical substance, the submitter must
submitter’s production volume for that
select from among the worker ranges
chemical, measured by weight. If none
listed in paragraph (b)(3)(vii) of this
of the listed consumer and commercial
section and report the corresponding
product categories accurately describes
code (i.e., W1 though W8).
the consumer and commercial products
(ii) Consumer and commercial use
in which each reportable chemical
information—(A) Using the applicable
substance is used, the category ‘‘Other’’
codes listed in Table 9 to paragraph
(b)(4)(ii)(A), submitters must designate
may be used, and must include a
the consumer and commercial product
description of the use.
TABLE 9 TO PARAGRAPH (b)(4)(ii)(A)—CODES FOR REPORTING CONSUMER AND COMMERCIAL PRODUCT CATEGORIES
Column A
Code
Column B
Category
Code
Category
Chemical Substances in Furnishing, Cleaning, Treatment Care Products
CC101 ................
CC102 ................
CC103 ................
CC104 ................
CC105 ................
khammond on DSKJM1Z7X2PROD with RULES3
CC106 ................
CC107 ................
CC108
CC109
CC110
CC111
CC112
CC113
CC114
CC115
CC116
CC117
CC118
CC119
CC120
................
................
................
................
................
................
................
................
................
................
................
................
................
VerDate Sep<11>2014
Construction and building materials covering large surface areas including stone, plaster, cement, glass and
ceramic articles; fabrics, textiles, and apparel.
Furniture & furnishings including plastic articles (soft);
leather articles.
Furniture & furnishings including stone, plaster, cement,
glass and ceramic articles; metal articles; or rubber articles.
Leather conditioner ...........................................................
Leather tanning, dye, finishing, impregnation and care
products.
Textile (fabric) dyes.
Textile finishing and impregnating/surface treatment
products.
All-purpose foam spray cleaner ........................................
All-purpose liquid cleaner/polish.
All-purpose liquid spray cleaner.
All-purpose waxes and polishes.
Appliance cleaners.
Drain and toilet cleaners (liquid).
Powder cleaners (floors).
Powder cleaners (porcelain).
Dishwashing detergent (liquid/gel) ....................................
Dishwashing detergent (unit dose/granule).
Dishwashing detergent liquid (hand-wash).
Dry cleaning and associated products.
Fabric enhancers.
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C101
Floor coverings.
C102
Foam seating and bedding products.
C103
Furniture and furnishings not covered elsewhere.
C104
Fabric, textile, and leather products not covered elsewhere.
C105
Cleaning and furnishing care products.
C106
Laundry and dishwashing products.
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09APR3
20146
Federal Register / Vol. 85, No. 69 / Thursday, April 9, 2020 / Rules and Regulations
TABLE 9 TO PARAGRAPH (b)(4)(ii)(A)—CODES FOR REPORTING CONSUMER AND COMMERCIAL PRODUCT CATEGORIES—
Continued
Column A
Code
CC121
CC122
CC123
CC124
CC125
CC126
CC127
CC128
CC129
CC130
CC131
CC132
CC133
CC134
Column B
Category
................
................
................
................
................
................
................
................
................
................
................
................
................
................
CC135 ................
CC136 ................
CC137 ................
CC138 ................
Code
Laundry detergent (unit-dose/granule).
Laundry detergent (liquid).
Stain removers.
Ion exchangers .................................................................
Liquid water treatment products.
Solid/Powder water treatment products.
Liquid body soap ...............................................................
Liquid hand soap.
Solid bar soap.
Air fresheners for motor vehicles ......................................
Continuous action air fresheners.
Instant action air fresheners.
Anti-static spray ................................................................
Apparel finishing, and impregnating/surface treatment
products.
Insect repellent treatment.
Pre-market waxes, stains, and polishes applied to footwear.
Post-market waxes, and polishes applied to footwear
(shoe polish).
Waterproofing and water-resistant sprays.
Category
C107
Water treatment products.
C108
Personal care products.
C109
Air care products.
C110
Apparel and footwear care products.
Chemical Substances in Construction, Paint, Electrical, and Metal Products
CC201
CC202
CC203
CC204
CC205
CC206
CC207
CC208
CC209
CC210
CC211
CC212
CC213
CC214
CC215
CC216
CC217
................
................
................
................
................
................
................
................
................
................
................
................
................
................
................
................
................
CC218 ................
CC219 ................
CC220 ................
CC221 ................
CC222 ................
Fillers and putties ..............................................................
Hot-melt adhesives.
One-component caulks.
Solder.
Single-component glues and adhesives.
Two-component caulks.
Two-component glues and adhesives.
Adhesive/Caulk removers .................................................
Aerosol spray paints.
Lacquers, stains, varnishes and floor finishes.
Paint strippers/removers.
Powder coatings.
Radiation curable coatings.
Solvent-based paint.
Thinners.
Water-based paint.
Construction and building materials covering large surface areas, including wood articles.
Construction and building materials covering large surface areas, including paper articles; metal articles;
stone, plaster, cement, glass and ceramic articles.
Machinery, mechanical appliances, electrical/electronic
articles.
Other machinery, mechanical appliances, electronic/electronic articles.
Construction and building materials covering large surface areas, including metal articles.
Electrical batteries and accumulators ...............................
C201
Adhesives and sealants.
C202
Paints and coatings.
C203
C204
Building/construction materials—wood and engineered
wood products.
Building/construction materials not covered elsewhere.
C205
Electrical and electronic products.
C206
Metal products not covered elsewhere.
C207
Batteries.
Chemical Substances in Packaging, Paper, Plastic, Toys, Hobby Products
CC990 ................
CC301 ................
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CC302 ................
CC303 ................
CC304 ................
CC305 ................
CC306 ................
CC307 ................
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Non-TSCA use ..................................................................
Packaging (excluding food packaging), including paper
articles.
Other articles with routine direct contact during normal
use, including paper articles.
Packaging (excluding food packaging), including rubber
articles; plastic articles (hard); plastic articles (soft).
Other articles with routine direct contact during normal
use including rubber articles; plastic articles (hard).
Toys intended for children’s use (and child dedicated articles), including fabrics, textiles, and apparel; or plastic articles (hard).
Adhesives applied at elevated temperatures ...................
Cement/concrete.
17:21 Apr 08, 2020
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C301
C302
Food packaging.
Paper products.
C303
Plastic and rubber products not covered elsewhere.
C304
Toys, playground, and sporting equipment.
C305
Arts, crafts, and hobby materials.
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20147
TABLE 9 TO PARAGRAPH (b)(4)(ii)(A)—CODES FOR REPORTING CONSUMER AND COMMERCIAL PRODUCT CATEGORIES—
Continued
Column A
Code
CC308
CC309
CC310
CC311
CC312
CC313
CC314
CC315
CC316
CC317
Column B
Category
................
................
................
................
................
................
................
................
................
................
Code
Crafting glue.
Crafting paint (applied to body).
Crafting paint (applied to craft).
Fixatives and finishing spray coatings.
Modelling clay.
Correction fluid/tape ..........................................................
Inks in writing equipment (liquid).
Inks used for stamps.
Toner/Printer cartridge.
Liquid photographic processing solutions .........................
Category
C306
Ink, toner, and colorant products.
C307
Photographic supplies, film, and photochemicals.
Chemical Substances in Automotive, Fuel, Agriculture, Outdoor Use Products
CC401
CC402
CC403
CC404
CC405
CC406
CC407
CC408
CC409
CC410
CC411
CC412
CC413
CC414
CC415
CC416
CC417
CC418
................
................
................
................
................
................
................
................
................
................
................
................
................
................
................
................
................
................
Exterior car washes and soaps ........................................
Exterior car waxes, polishes, and coatings.
Interior car care.
Touch up auto paint.
Degreasers ........................................................................
Liquid lubricants and greases.
Paste lubricants and greases.
Spray lubricants and greases.
Anti-freeze liquids .............................................................
De-icing liquids.
De-icing solids.
Lock de-icers/releasers.
Cooking and heating fuels ................................................
Fuel additives.
Vehicular or appliance fuels.
Explosive materials ...........................................................
Agricultural non-pesticidal products ..................................
Lawn and garden care products .......................................
C401
Automotive care products.
C402
Lubricants and greases.
C403
Anti-freeze and de-icing products.
C404
Fuels and related products.
C405
C406
C407
Explosive materials.
Agricultural products (non-pesticidal).
Lawn and garden care products.
Chemical Substances in Products not Described by Other Codes
CC980 ................
CC990 ................
Other (specify) ..................................................................
Non-TSCA use ..................................................................
C909
C980
Other (specify).
Non-TSCA use.
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For the 2020 submission period: (1) Use column A for chemical substances designated in 2019 as high priority for risk evaluation (those
chemicals listed in Table 7 to paragraph (b)(4)(i)(C) and (2) use either column A or B for chemical substances not listed in Table 7 to paragraph
(b)(4)(i)(C).
For the 2024 and future submission periods, use only column A.
(B) For each consumer and
commercial product category reported
under paragraph (b)(4)(ii)(A) of this
section, the applicable code(s) described
in paragraph (b)(4)(i)(C) of this section
must be selected to designate the
function category(ies) that best
represents the specific manner in which
the chemical substance is used. For the
2020 submission period:
(1) Use column A in Table 6 to
paragraph (b)(4)(i)(C) for chemical
substances designated in 2019 as high
priority for risk evaluation (those
chemicals listed in Table 7 to paragraph
(b)(4)(i)(C); and
(2) Use either column A or B in Table
6 to paragraph (b)(4)(i)(C) for chemical
substances not listed in Table 7 to
paragraph (b)(4)(i)(C). For the 2024 and
future submission periods, use only
column A in Table 6 to paragraph
(b)(4)(i)(C). A particular function
category may need to be reported more
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17:21 Apr 08, 2020
Jkt 250001
than once, to the extent that a submitter
reports more than one consumer or
commercial product category (under
paragraph (b)(4)(ii)(A) of this section)
that applies to a given function category
under this paragraph. If none of the
listed function categories accurately
describes a use of a chemical substance,
the category ‘‘Other’’ may be used, and
must include a description of the use.
(C) An indication, within each
consumer and commercial product
category reported under paragraph
(b)(4)(ii)(A) of this section, whether the
use is a consumer or a commercial use.
(D) Submitters must determine,
within each consumer and commercial
product category reported under
paragraph (b)(4)(ii)(A) of this section,
whether any amount of each reportable
chemical substance manufactured
(including imported) by the submitter is
present in (for example, a plasticizer
chemical substance used to make
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pacifiers) or on (for example, as a
component in the paint on a toy) any
consumer products intended for use by
children age 14 or younger, regardless of
the concentration of the chemical
substance remaining in or on the
product. Submitters must select from
the following options: The chemical
substance is used in or on any consumer
products intended for use by children;
the chemical substance is not used in or
on any consumer products intended for
use by children; or information as to
whether the chemical substance is used
in or on any consumer products
intended for use by children is not
known to or reasonably ascertainable by
the submitter.
(E) The estimated percentage,
rounded off to the closest 10 percent, of
the submitter’s site’s total production
volume of the reportable chemical
substance associated with each
consumer and commercial product
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category. Where a particular consumer
and commercial product category
accounts for less than 5 percent of the
total production volume of a reportable
chemical substance, the percentage
must not be rounded off to 0 percent if
the production volume attributable to
that commercial and consumer product
category is 25,000 lb (11,340 kg) or more
during the reporting year. Instead, in
such a case, submitters must report the
percentage, rounded off to the closest 1
percent, of the submitter’s site’s total
production volume of the reportable
chemical substance associated with the
particular consumer and commercial
product category.
(F) Where the reportable chemical
substance is used in consumer or
commercial products, the estimated
typical maximum concentration,
measured by weight, of the chemical
substance in each consumer and
commercial product category reported
under paragraph (b)(4)(ii)(A) of this
section. For each chemical substance in
each commercial and consumer product
category reported under paragraph
(b)(4)(ii)(A) of this section, submitters
must select from among the ranges of
concentrations listed in Table 3 to
paragraph (b)(3)(viii) of this section and
report the corresponding code (i.e., M1
through M5).
(G) Where the reportable chemical
substance is used in a commercial
product, the submitter must estimate the
number of commercial workers
reasonably likely to be exposed to each
reportable chemical substance. For each
combination associated with each
substance, the submitter must select
from among the worker ranges listed in
Table 2 to paragraph (b)(3)(vii) of this
section and report the corresponding
code (i.e., W1 though W8).
■ 9. Revise § 711.20 to read as follows:
§ 711.20
When to report.
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All information reported to EPA in
response to the requirements of this part
must be submitted during an applicable
submission period, which runs from
June 1 to September 30 at 4-year
intervals, beginning in 2020. In each
submission period, any person
described in § 711.8 must report as
described in this part.
■ 10. Amend § 711.22 by revising
paragraph (c) to read as follows:
§ 711.22
Duplicative reporting.
*
*
*
*
*
(c) Co-manufactured chemicals. This
part requires that only one report per
site be submitted on each chemical
substance described in § 711.5.
However, both the contracting company
and producing company are liable if no
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17:21 Apr 08, 2020
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report is made. When a company
contracts with a producing company to
manufacture a chemical substance, and
each party meets the definition of
‘‘manufacturer’’ as set forth in § 711.3,
reporting of the co-manufactured
chemical can be performed by one of the
following methods:
(1) The contracting company initiates
the required report for that site as the
primary submitter. The contracting
company must indicate on the report
that this is a co-manufacturing situation,
notify the producing company, and
record the production volume
domestically co-manufactured as set
forth in § 711.15(b)(3) and processing
and use information set forth in
§ 711.15(b)(4). Upon notification by the
contracting company, the producing
company must also record the
production volume domestically comanufactured and complete the rest of
the report as prompted by e-CDRweb.
(2) Upon written agreement between
the contracting company and the
producing company, the producing
company completes the full report for
the co-manufactured chemical. The
contracting company supplies the
information not otherwise known to or
reasonably ascertainable by the
producing company.
*
*
*
*
*
■ 11. Revise § 711.30 to read as follows.
§ 711.30
Confidentiality claims.
(a) Making confidentiality claims—(1)
Generally. Any person submitting
information under this part may assert
a confidentiality claim for that
information at the time it is submitted,
except for information described in
paragraph (a)(2). Any such
confidentiality claims must be asserted
at the time the information is submitted.
These claims will apply only to the
information submitted with the claim.
Instructions for asserting confidentiality
claims are provided in the document
identified in § 711.35. Information
claimed as confidential in accordance
with this section will be treated and
disclosed in accordance with the
procedures in 40 CFR part 2 and section
14 of TSCA.
(2) Exceptions. Confidentiality claims
cannot be asserted:
(i) For chemical identities listed on
the public portion of the TSCA
Inventory;
(ii) For processing and use data
elements required by
§ 711.15(b)(4)(i)(A), (B), and (C) and
§ 711.15(b)(4)(ii)(A), (B), (C), and (D); or
(iii) When a response is left blank or
designated as ‘‘not known or reasonably
ascertainable.’’
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(3) Substantiations. All
confidentiality claims must be
substantiated at time of submission, in
accordance with the requirements in
paragraphs (b), (c), and (d)(1) of this
section, and must be signed and dated
by an authorized official.
Confidentiality claims for the following
data elements are exempt from this
substantiation requirement:
(i) Production volume information
required pursuant to § 711.15(b)(3)(iii).
(ii) Joint submission information from
the primary submitter, consisting of
trade name and supplier identification
required pursuant to § 711.15(b)(3)(i)(A)
and (B).
(iii) Joint submission information
from the secondary submitter,
consisting of the percentage of
formulation required pursuant to
§ 711.15(b)(3)(i)(A) and (B).
(iv) Information that is supplied in a
petition submitted under
§ 711.6(b)(2)(iii) or § 711.10(d)(1)(ii) and
that is described in section 14(c)(2) of
TSCA.
(4) Marking information claimed as
confidential in confidentiality
substantiation documentation. If any of
the information contained in the
answers to the questions listed in
paragraphs (b) and (c) of this section is
asserted to contain information that
itself is considered to be confidential,
you must clearly identify the
information that is claimed confidential.
(5) Certification statement for claims.
An authorized official representing a
person asserting a claim of
confidentiality must certify that the
submission complies with the
requirements of this part by signing and
dating the following certification
statement:
‘‘I certify that all claims for confidentiality
asserted with this submission are true and
correct, and all information submitted herein
to substantiate such claims is true and
correct. Any knowing and willful
misrepresentation is subject to criminal
penalty pursuant to 18 U.S.C. 1001. I further
certify that: (1) I have taken reasonable
measures to protect the confidentiality of the
information; (2) I have determined that the
information is not required to be disclosed or
otherwise made available to the public under
any other Federal law; (3) I have a reasonable
basis to conclude that disclosure of the
information is likely to cause substantial
harm to the competitive position of my
company; and (4) I have a reasonable basis
to believe that the information is not readily
discoverable through reverse engineering.’’
(6) Company, site, and technical
contact identity information. A
submitter may assert a claim of
confidentiality for a site, company, or
technical contact identity to protect the
link between that information and the
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09APR3
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reported chemical substance. Such
claim may be asserted only when the
linkage of that information to a
reportable chemical substance is
confidential and not publicly available.
(7) Processing and use information. A
submitter may assert a claim of
confidentiality for each data element
required by § 711.15(b)(4)(i)(D), (E) and
(F) and § 711.15(b)(4)(ii)(E), (F), and (G)
to protect the link between that
information and the reported chemical
substance. Such claim may be asserted
only when the linkage of that
information to a reportable chemical
substance is confidential and not
publicly available.
(b) All confidentiality claims requiring
substantiation at time of submission.
For each data element (or information
supplied in a petition submitted under
§ 711.6(b)(2)(iii)(A) or
§ 711.10(d)(1)(ii)(A)) that is claimed as
confidential, you must submit with your
report detailed written answers to the
following questions:
(1) Will disclosure of the information
claimed as confidential likely cause
substantial harm to your business’s
competitive position? If you answered
yes, describe the substantial harmful
effects that would likely result to your
competitive position if the information
is disclosed, including but not limited
to how a competitor could use such
information, and the causal relationship
between the disclosure and the harmful
effects.
(2) To the extent your business has
disclosed the information to others
(both internally and externally), has
your business taken precautions to
protect the confidentiality of the
disclosed information? If yes, please
explain and identify the specific
measures, including but not limited to
internal controls, that your business has
taken to protect the information claimed
as confidential.
(3)(i) Is any of the information
claimed as confidential required to be
publicly disclosed under any other
Federal law? If yes, please explain.
(ii) Does any of the information
claimed as confidential otherwise
appear in any public documents,
including (but not limited to) safety data
sheets; advertising or promotional
material; professional or trade
publications; state, local, or Federal
agency files; or any other media or
publications available to the general
public? If yes, please explain why the
information should be treated as
confidential.
(iii) Does any of the information
claimed as confidential appear in one or
more patents or patent applications? If
yes, please provide the associated patent
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17:21 Apr 08, 2020
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number or patent application number
(or numbers) and explain why the
information should be treated as
confidential.
(4) Does any of the information that
you are claiming as confidential
constitute a trade secret? If yes, please
explain how the information you are
claiming as confidential constitutes a
trade secret.
(5) Is the claim of confidentiality
intended to last less than 10 years (see
TSCA section 14(e)(1)(B))? If yes, please
indicate the number of years (between
1–10 years) or the specific date after
which the claim is withdrawn.
(6) Has EPA, another federal agency,
or court made any confidentiality
determination regarding information
associated with this chemical
substance? If yes, please provide the
circumstances associated with the prior
determination, whether the information
was found to be entitled to confidential
treatment, the entity that made the
decision, and the date of the
determination.
(c) Additional requirements for
specific chemical identity. A person
may assert a claim of confidentiality for
the specific chemical identity of a
chemical substance as described in
§ 711.15(b)(3) of this part only if the
identity of that chemical substance is
treated as confidential in the Master
Inventory File as of the time the report
is submitted for that chemical
substance. Generic chemical identities
and accession numbers may not be
claimed as confidential. To assert a
claim of confidentiality for the identity
of a reportable chemical substance, you
must submit with the report detailed
written answers to the questions from
paragraph (b) of this section and to the
following questions.
(1) Is this chemical substance publicly
known (including by your competitors)
to be in U.S. commerce? If yes, please
explain why the specific chemical
identity should still be afforded
confidential status (e.g., the chemical
substance is publicly known only as
being distributed in commerce for
research and development purposes, but
no other information about the current
commercial distribution of the chemical
substance in the United States is
publicly available). If no, please
complete the certification statement:
I certify that on the date referenced, I
searched the internet for the chemical
substance identity (i.e., by both chemical
substance name and CASRN). I did not find
a reference to this chemical substance that
would indicate that the chemical is being
manufactured or imported by anyone for a
commercial purpose in the United States.
[provide date].
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20149
(2) Does this particular chemical
substance leave the site of manufacture
(including import) in any form, e.g., as
a product, effluent, emission? If yes,
please explain what measures have been
taken to guard against the discovery of
its identity.
(3) If the chemical substance leaves
the site in a form that is available to the
public or your competitors, can the
chemical identity be readily discovered
by analysis of the substance (e.g.,
product, effluent, emission), in light of
existing technologies and any costs,
difficulties, or limitations associated
with such technologies? Please explain
why or why not.
(4) Would disclosure of the specific
chemical name release confidential
process information? If yes, please
explain.
(d) Special situations. (1) Joint
submissions. If a primary submitter asks
a secondary submitter to provide
information directly to EPA in a joint
submission under § 711.15(b)(3)(i)(A)
and (B), only the primary submitter may
assert a confidentiality claim for the
data elements that it directly submits to
EPA. The primary submitter must
substantiate those claims that are not
exempt under paragraph (a)(3)(ii) of this
section. The secondary submitter is
responsible for asserting all
confidentiality claims for the data
elements that it submits directly to EPA
and for substantiating those claims that
are not exempt under paragraph
(a)(3)(iii) of this section.
(2) Petitions. If a petition submitted
under § 711.6(b)(2)(iii)(A) or
§ 711.10(d)(1)(ii)(A) includes any
information claimed as confidential, the
petitioner must provide a version of the
petition that redacts the information
claimed as confidential.
(e) No claim of confidentiality.
Information not claimed as confidential
in accordance with the requirements of
this section may be made public
without further notice to the submitter.
12. Amend § 711.35 by revising
paragraph (c)(1) to read as follows:
■
§ 711.35
Electronic filing.
*
*
*
*
*
(c) * * *
(1) By website. Go to the EPA
Chemical Data Reporting internet
homepage at https://www.epa.gov/cdr
and follow the appropriate links.
*
*
*
*
*
[FR Doc. 2020–06076 Filed 4–8–20; 8:45 am]
BILLING CODE 6560–50–P
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Agencies
[Federal Register Volume 85, Number 69 (Thursday, April 9, 2020)]
[Rules and Regulations]
[Pages 20122-20149]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-06076]
[[Page 20121]]
Vol. 85
Thursday,
No. 69
April 9, 2020
Part IV
Environmental Protection Agency
-----------------------------------------------------------------------
40 CFR Part 711
TSCA Chemical Data Reporting Revisions Under TSCA Section 8(a); Final
Rule
Federal Register / Vol. 85 , No. 69 / Thursday, April 9, 2020 / Rules
and Regulations
[[Page 20122]]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 711
[EPA-HQ-OPPT-2018-0321; FRL-10005-56]
RIN 2070-AK33
TSCA Chemical Data Reporting Revisions Under TSCA Section 8(a)
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final Rule.
-----------------------------------------------------------------------
SUMMARY: EPA is finalizing a rule under the Toxic Substances Control
Act (TSCA) to amend the Chemical Data Reporting (CDR) requirements. The
CDR rule requires manufacturers (including importers) of certain
chemical substances listed on the TSCA Chemical Substance Inventory
(TSCA Inventory) to report data on chemical manufacturing, processing,
and use every four years. EPA is finalizing several changes to the CDR
rule to make regulatory updates that align with new statutory
requirements of TSCA, to improve the CDR data collected as necessary to
support the implementation of TSCA, and potentially to reduce burden
for certain CDR reporters. In addition, these regulatory modifications
may result in additional information to EPA and the public that is
currently not collected; improve the usability and reliability of the
reported data; and ensure that data are available in a timely manner.
DATES: This final rule is effective May 11, 2020.
ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPPT-2018-0321, is available at
https://www.regulations.gov or at the Office of Pollution Prevention and
Toxics Docket (OPPT Docket), Environmental Protection Agency Docket
Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 1301
Constitution Ave. NW, Washington, DC. The Public Reading Room is open
from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal
holidays. The telephone number for the Public Reading Room is (202)
566-1744, and the telephone number for the OPPT Docket is (202) 566-
0280. Please review the visitor instructions and additional information
about the docket available at https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: For technical information contact:
Susan Sharkey, Chemical Control Division, Office of Pollution
Prevention and Toxics, Environmental Protection Agency, 1200
Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number:
(202) 564-8789; email address: [email protected].
For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave. Rochester, NY 14620; telephone number: (202)
554-1404; email address: [email protected].
SUPPLEMENTARY INFORMATION:
I. Executive Summary
A. Does this action apply to me?
You may be potentially affected by this action if you manufacture
(defined by statute at 15 U.S.C. 2602(9) to include import) chemical
substances, including if you are a chemical user or processor who
manufactures byproduct chemical substances. Any use of the term
``manufacture'' in this document will encompass ``import,'' the term
``manufacturer'' will encompass ``importer,'' and the term ``chemical
substance'' will encompass ``byproduct chemical substance,'' unless
otherwise stated.
The potentially regulated community consists of entities that
produce domestically or import into the United States chemical
substances listed on the TSCA Inventory. The Agency's previous
experience with TSCA section 8(a) collections has shown that most
respondents affected by this collection activity are from the following
North American Industrial Classification System (NAICS) code
categories:
NAICS 325--Chemical Manufacturing; and
NAICS 324--Petroleum and Coal Product Manufacturing.
In addition to the anticipated respondents from the NAICS listed
previously, the potentially regulated community consists of
manufacturers of byproducts that are required to report under certain
TSCA section 8(a) rules, including CDR. Byproduct manufacturers may be
listed under a different primary activity for a site, such as NAICS
codes 22, 322, 327310, 331, and 3344, representing utilities, paper
manufacturing, cement manufacturing, primary metal manufacturing, and
semiconductor and other electronic component manufacturing,
respectively.
The NAICS codes have been provided to assist you and others in
determining whether this action might apply to certain entities. To
determine whether you or your business may be affected by this action,
you should carefully examine the applicable provisions at 40 CFR 711.8.
If you have any questions regarding the applicability of this action to
a particular entity, consult the technical contact person listed under
FOR FURTHER INFORMATION CONTACT.
B. What is the Agency's authority for taking this action?
TSCA section 8(a)(1) authorizes the EPA Administrator to promulgate
rules under which manufacturers and processors of chemical substances
must maintain such records, and submit such information, as the EPA
Administrator may reasonably require (15 U.S.C. 2607). TSCA section
8(a) generally excludes small manufacturers and processors of chemical
substances from the reporting requirements established in TSCA section
8(a). However, EPA is authorized by TSCA section 8(a)(3)(A)(ii) to
require TSCA section 8(a) reporting from small manufacturers and
processors with respect to any chemical substance that is the subject
of a rule proposed or promulgated under TSCA sections 4, 5(b)(4), or 6;
that is the subject of an order in effect under TSCA sections 4 or
5(e); that is subject to a consent agreement under TSCA section 4; or
that is the subject of relief granted pursuant to a civil action under
TSCA section 5 or 7.
TSCA section 8(a)(5) requires the EPA Administrator, to the extent
feasible, not to require unnecessary or duplicative reporting, and to
minimize the cost of compliance for small manufacturers.
TSCA section 14 imposes requirements for the assertion,
substantiation, and Agency review of confidential business information
(CBI) claims.
C. What action is the Agency taking?
In this action, EPA is promulgating several amendments to the CDR
rule, taking into consideration comments received on the proposed rule
(EPA-HQ-OPPT-2018-0321). Although included in the proposal, EPA is
addressing the proposed amendment to update the size standards
definition for small manufacturers for reporting and recordkeeping
requirements under TSCA section 8(a) in a separate final rule
(identified by RIN 2070-AK57), as discussed in the proposed rule (Ref.
1). The following is a brief listing of the primary amendments being
finalized, some of which have been modified from the proposal, as
described in this unit. EPA is finalizing these modifications based on
comments received during the public comment period. These amendments
are described in more detail in Unit III.
1. Changing requirements for making confidentiality claims,
including to identify when upfront substantiation is required (which is
being finalized as proposed), update the substantiation
[[Page 20123]]
questions, and identify data elements that cannot be claimed as
confidential (which is being finalized as proposed), so as to align
with the Frank R. Lautenberg Chemical Safety for the 21st Century Act
(2016 Amendments). The substantiation questions have been modified from
the proposal based on comments received during the public comment
period;
2. Replacing certain processing and use codes (industrial function
and commercial/consumer product use) with codes based on the
Organisation for Economic Co-operation and Development's (OECD)
functional use and product and article use codes. EPA is also adding
the requirement to report the OECD-based functional use codes for
consumer and commercial use information. This provision is being
finalized as proposed with some modifications from the proposal: the
new codes will be codified in the Code of Federal Regulations (CFR)
rather than listed in guidance, codes associated with non-TSCA uses
will be folded into the overarching non-TSCA use code, and reporting
using the OECD-based codes will be required during the 2020 CDR
submission period for the chemical substances designated in 2019 by EPA
as a high priority for risk evaluation (84 FR 71924, December 30, 2019)
(FRL-10003-15) and required for all chemical substances during the 2024
CDR submission (reporting using the OECD-based codes would be voluntary
for all reporters during the 2020 CDR submission period);
3. Adding the requirement to report the NAICS code(s) for the site
of manufacture, which is being finalized as proposed;
4. Modifying the requirement to indicate whether a chemical is
removed from the waste stream and recycled, remanufactured,
reprocessed, or reused, by changing the requirement to indicate whether
a chemical is removed from the waste stream and recycled. This
modification is being finalized as proposed;
5. Adding a voluntary data element to identify the percent total
production volume of a chemical substance that is a byproduct. This
proposed requirement is being finalized with modification from the
proposal, by including that percent byproduct reporting be in ranges
and making the reporting of the data element voluntary;
6. Requiring that the secondary submitter of a joint submission
report the specific function of the chemical along with the percentage
of the chemical in the imported product. This requirement is being
finalized as proposed;
7. Modifying the reporting of ``parent company'' to require the use
of a naming convention; add the requirement to report a foreign parent
company, when applicable; and codify reporting scenarios in a new
definition for ``highest-level parent company.'' These definitions,
requirements, and reporting scenario codifications are being finalized
with modification from the proposal;
8. Simplifying the reporting process by providing two reporting
mechanisms for co-manufacturers by enabling a multi-reporter process
for reporters to separately report directly to EPA within the e-CDRweb
reporting tool. These changes are being finalized with minor
modification from the proposal, with the finalization of two separate
reporting methodologies;
9. Adding exemptions (1) for specifically identified byproducts
that are recycled in a site-limited, enclosed system (which is being
finalized as proposed with the addition of another chemical substance)
and (2) for byproducts that are manufactured as part of non-integral
pollution control and boiler equipment (which is being finalized as
proposed); and
10. Clarifying regulatory text by removing outdated text and making
other improvements. These changes are being finalized as proposed.
Some proposed provisions will not be finalized based on comments
received during the public comment period. For a more detailed
discussion of what was proposed but not finalized, please see Unit
II.C., Public Comments and Other Public Input.
As described in the proposal, EPA is taking other, non-regulatory
steps to minimize the burden on reporters, by improving the reporting
application and database to be user-friendly and dynamic, with
straightforward questions that include fill-in-the-blank fields, check
boxes, and drop-down menus. In addition, EPA is replacing the current
pre-formatted Form U with a customized report that will be based on the
actual information submitted by a site through e-CDRweb, the electronic
reporting tool. This change will enable fields to expand or contract as
needed to display the entered information in one spot, eliminating the
need for continuation pages or for large empty spaces in the printed
report. For example, some chemical names are very short and need only
10 or 20 characters, while other chemical names are very long and use
multiple lines of text. Although these changes are not discussed
further in this final rule, they are an important component of the
effort to reduce burden and modernize the data collection system.
EPA is making this update as a result of feedback received from
reporters and other stakeholders following the 2016 submission period
(Ref. 2) and during an extensive negotiated rulemaking effort, which
included participation by all stakeholder groups, and subsequent public
comment period from October 12, 2017-December 11, 2017, at the
conclusion of the negotiated rulemaking (Ref. 3 and Ref. 4). EPA is
adding an addendum to the current CDR rule ICR (OMB Control Number
2070-0162) for the regulatory changes finalized in this document (Ref.
5). In addition to the changes outlined in this final rule, if needed,
EPA will provide a second addendum to this ICR to address non-
regulatory changes. As was done for previous CDR collections, EPA will
provide reporters with the opportunity to test and comment on the
updated e-CDRweb reporting tool prior to the 2020 CDR submission
period. The testing, by a group of volunteer reporters, will be
conducted under a generic ICR for EPA software testing (OMB Control
Number 2010-0042) (Ref. 6). EPA anticipates holding a webinar to
introduce the revised e-CDRweb reporting tool to the regulated
community directly following the publication of this rule. During the
webinar, EPA will issue a general invitation to interested parties to
participate in a short testing period of the revised e-CDRweb reporting
tool. EPA will open the testing period shortly after publication of
this rule. Because of resource constraints, the testing period will be
limited to 25 participants. For additional information, contact the
person under FOR FURTHER INFORMATION CONTACT. Also, information will be
posted on the CDR website (https://www.epa.gov/chemical-data-reporting).
D. Why is the Agency taking this action?
EPA is revising the CDR rule for three primary reasons: First,
aligning CDR reporting with the 2016 Amendments; second, improving the
CDR data collected to support the implementation of TSCA; and third,
potentially reducing burdens for certain CDR reporters pursuant to TSCA
section 8(a)(5).
The 2016 Amendments to TSCA changed requirements associated with
confidentiality claims, including identifying the data elements
eligible for confidentiality claims and identifying the situations
under which substantiation of claims is required. EPA is revising the
CDR rule to address these changes.
As described in the proposed rule, EPA is also finalizing changes
to CDR reporting so that the information
[[Page 20124]]
collected is tailored to better meet the Agency's overall information
needs and is aligned with specific needs for chemical substance
prioritization and risk evaluation under TSCA section 6. TSCA section 2
specifies that ``adequate information should be developed with respect
to the effect of chemical substances and mixtures on health and the
environment and that the development of such information should be the
responsibility of those who manufacture and those who process such
chemical substances and mixtures'' (TSCA section 2(b)(1)). EPA's
changes include the addition of data elements that must be reported,
such as site-specific NAICS codes; modification to multi-reporter
submission requirements, including adding a process for jointly
reporting co-manufactured chemicals; and changes to current data
elements, such as codes used for reporting processing and use
information and the addition of the percentage of a chemical that is a
byproduct (in ranges) as a data element that can be reported
voluntarily. In addition, changes to the parent company reporting
requirements will increase EPA's ability to protect confidential
information while better enabling EPA to make information publicly
available. As described in the proposed rule, these changes should help
to meet the Agency's requirement under TSCA section 26(h), in carrying
out TSCA sections 4, 5, and 6, to make scientific decisions consistent
with the best available science; to improve the CDR data collected to
support the implementation of TSCA; and to improve EPA's ability to
provide public access to the information. Furthermore, these changes
should aid in meeting the Agency's objective to obtain new and updated
information relating to potential exposures to a major subset of
chemical substances listed on the TSCA Inventory.
EPA is interested in streamlining reporting requirements and
processes while maintaining the Agency's ability to receive the
information it needs to understand exposure to these chemicals (TSCA
section 8(a)(5)). As described in the proposed rule, EPA's proposed
revisions were informed by information provided in 2016 and 2017 during
the 2016 CDR submission period, public comment opportunities, and an
extensive negotiated rulemaking effort, which included participation by
all stakeholder groups, and subsequent public comment period from
October 12, 2017, to December 1, 2017, at the conclusion of the
negotiated rulemaking (Ref. 3 and Ref. 4).
This final rule takes into account comments received on the
proposed rule, from April 25, 2019, to June 24, 2019. EPA received 24
comments from various stakeholders and the public that helped inform
the finalization of this rule. In response to stakeholder input, EPA is
finalizing the introduction of two new exemptions related to byproducts
and a revised approach to reporting for co-manufactured chemicals. In
addition, harmonizing the function and product codes with those used by
OECD is expected to reduce potential confusion for those reporting
under multiple country requirements.
Additionally, EPA has received comments that modernizing the CDR
data collection and public access to the database may reduce reporting
burden and facilitate ease of use by reporters and the public. These
comments were used to develop this final rule and will be used to
inform other non-regulatory changes that EPA plans to make to the
reporting process, such as the reporting tool modernization described
in Unit I.C.
E. What are the incremental costs of this action?
EPA has evaluated the potential costs and benefits of revising CDR
reporting requirements as required by the rulemaking process. Some
requirements in this rule increase burden and cost, while other
requirements and flexibilities decrease burden and result in cost
savings. Overall, EPA estimates that the combined impact of all the
amendments would increase the total burden and result in a cost to
industry and government reporters. This analysis, which is available in
the docket (Ref. 7), is discussed in Unit III., and is briefly
summarized here.
The finalized amendments are estimated to result in an overall net
increase in burden and costs. The estimated increases in burden and
costs include rule familiarization, increases in compliance
determination, and the duration of time for form completion. The next
future cycle burden and costs or cost savings are listed by type of
change:
(1) For changes to claiming confidentiality (discussed in Unit
III.A.), the incremental burden is expected to decrease by 14,000 hours
with an associated cost savings of $1.1 million. The incremental burden
and cost changed from the proposed rule due to a correction to a cell
reference in the model used for the unit burden estimates (Ref. 8).
(2) For changes to modify or add reportable data elements (e.g.,
processing and use codes, NAICS codes, byproduct percentage, chemical
function, and parent company--discussed in Unit III.B.), the
incremental burden is expected to increase by 188,000 hours with an
associated cost increase of $14.5 million. The incremental burden and
cost estimates changed from the proposed rule due to the elimination of
the site public contact, the use of intelligent sorting and search
functions in the reporting tool related to the reporting of processing
and use information, and the addition of burden of the function
category for consumer and commercial products (Table 4-13 in Ref. 7).
(3) For changes to add byproducts exemptions (discussed in Unit
III.D.), the incremental burden is expected to decrease by 68,000 hours
with an associated cost savings of $5.2 million.
In sum, the overall incremental impacts to industry and government
reporters result in a net increase in burden and cost. Estimates
include rule familiarization, compliance determination, and CDR form
completion (Ref. 7). Estimated changes to recordkeeping burden and cost
are negligible and estimated at zero. An estimated 5,660 sites are
expected to report during the next CDR submission period in 2020. The
total incremental burden and cost are estimated at 32,000 hours and
$2.5 million for the CDR 2020 submission period (first cycle), 34,000
hours and $2.7 million for the 2024 CDR submission period (second
cycle), and 27,000 hours and $2.1 million for the 2028 CDR submission
period (future cycles). On an annualized basis, using a 3 percent and a
7 percent discount rate over a 10-year period, the annualized
incremental cost both round to an estimated $2.5 million per year (Ref.
7).
II. Background
A. What is the Chemical Data Reporting rule?
As described in the proposed rule, the CDR rule requires U.S.
manufacturers of certain chemicals listed on the TSCA Inventory to
report to EPA every four years certain information about chemical
substances manufactured for all years since the last principal
reporting year. To minimize reporting burden, detailed information is
required only for the principal reporting year (i.e., 2019), including
a breakout of the production volume to provide separate volumes for
domestically manufactured and imported amounts. Generally, reporting is
required for substances whose production volumes are 25,000 pounds or
more at any single site during any of the calendar years since the last
principal reporting year. However, a
[[Page 20125]]
lower threshold applies for chemical substances that are the subject of
certain TSCA actions (see 40 CFR 711.8(b)). The CDR rule generally
excludes several groups of chemical substances from its reporting
requirements, e.g., polymers, microorganisms, naturally occurring
chemical substances, certain forms of natural gas, and water (see 40
CFR 711.5 and 711.6). For the 2016 CDR cycle, EPA received CDR site
reports (Form U's) from 5,660 sites with an associated 42,464 chemical
reports, providing information on 8,717 unique chemicals.
Persons domestically manufacturing or importing chemical substances
are required to report information such as company name, site location
and other identifying information, production volume of the reportable
chemical substance, and exposure-related information associated with
the manufacture of each reportable chemical substance, including the
physical form and maximum concentration of the chemical substance, the
number of potentially exposed workers at the reporting site, and
certain processing and use information (40 CFR 711.15). Under CDR,
submitters report information to the extent that it is ``known to or
reasonably ascertainable'' (40 CFR 711.15), which means ``all
information in a person's possession or control, plus all information
that a reasonable person similarly situated might be expected to
possess, control, or know'' (40 CFR 711.3, referencing 40 CFR 704.3).
Reported information can be claimed as confidential, with certain
exceptions (40 CFR 711.30).
B. EPA's Proposed Rule for Revisions to the CDR Rule
On April 25, 2019, EPA proposed the rule ``TSCA Chemical Data
Reporting Revisions and Small Manufacturer Definition Update for
Reporting and Recordkeeping Requirements under TSCA section 8(a)''
(Ref. 1). EPA proposed several changes to the CDR rule to make
regulatory updates to align with new statutory requirements of TSCA and
improve the CDR data collected as necessary to support the
implementation of TSCA, which could have potentially reduced or
increased burden for certain CDR reporters. In particular, EPA proposed
to:
1. Harmonize the CDR processing and use codes with OECD codes;
2. Add the requirement to report the NAICS code(s) for the site of
manufacture;
3. Modify the requirement to indicate whether a chemical is removed
from the waste stream and recycled, remanufactured, reprocessed, or
reused to instead require an indication of whether a chemical is
removed from the waste stream and recycled;
4. Add a requirement to identify the percent total production
volume of a chemical substance that is a byproduct; require that the
secondary submitter of a joint submission report the chemical specific
function along with the percentage of the chemical in the imported
product;
5. Add a voluntary data element to provide a public contact;
6. Modify the definition of ``parent company'' to clarify the
definition;
7. Add the requirement to report a foreign parent company, when
applicable, and codify reporting scenarios;
8. Simplify the reporting process for co-manufacturers by enabling
a multi-reporter process for reporters to separately report directly to
EPA within the e-CDRweb reporting tool;
9. Allow reporting in specified metal categories for inorganic
byproducts;
10. Add exemptions for specifically identified byproducts that are
recycled in a site-limited, enclosed system and for byproducts that are
manufactured as part of non-integral pollution control and boiler
equipment;
11. Clarify regulatory text by removing outdated text,
consolidating exemptions, and making other improvements; and
12. Update the size standards definition for small manufacturers
for reporting and recordkeeping requirements under TSCA section 8(a)
(Ref. 1).\1\
---------------------------------------------------------------------------
\1\ While the CDR revisions and the updates to the small
manufacturer definition were proposed together in the same document,
EPA is addressing the proposed small manufacturer definition in a
separate final rule, identified by RIN 2070-AK57.
---------------------------------------------------------------------------
C. Public Comments and Other Public Input
The proposed rule provided for a 60-day public comment period,
ending on June 24, 2019. EPA received 24 comments. Commenters included
industry trade associations (18 comments representing 23
organizations), government entities (one comment), the National Tribal
Toxics Council (one comment), and non-governmental organizations (three
comments representing six organizations). Comments addressed many
provisions of EPA's proposed rule and generally supported EPA's
proposal. Of the 24 comments received, 23 addressed provisions in this
rule. Specifically, EPA received 13 comments regarding some proposed
changes to reportable data elements that either supported EPA's
proposal or raised issues that EPA intends to address in the
Instructions for Reporting (Ref. 9).\2\ Separately, EPA received 12
comments that provided information on the reporting burden related to
these or similar data elements.
---------------------------------------------------------------------------
\2\ These proposed changes addressed by the commenters included
harmonizing the CDR processing and use codes with OECD codes; adding
the requirement to report the NAICs code(s) for the site of
manufacture; requiring reporting of the chemical-specific function
in a joint submission; modifying the definition of parent company
and requiring reporting of a foreign parent company; modifying the
requirement to indicate whether a chemical is recycled,
remanufactured, reprocessed, or reused, by changing the requirement
to indicate whether a chemical is removed from the waste stream and
recycled; and adding a requirement to identify the percent total
production volume of a chemical that is a byproduct.
---------------------------------------------------------------------------
For the proposed co-manufacturing reporting mechanism, comments
were generally supportive of the proposal but requested additional
flexibility. EPA received 14 comments about the two proposed exemptions
for byproducts, most of which were supportive. Commenters who were not
supportive of the proposed exemptions for byproducts explained that the
exemptions could increase the complexity of reporting and that the
byproduct exemptions were not sufficiently expansive to meaningfully
reduce reporting burden. EPA also received 12 comments on changes to
existing exemptions and other potential future changes, all of which
are outside of the scope of this action.
EPA received eight comments about changes to requirements for
claiming confidentiality. Five commenters did not support EPA's
proposal regarding which data elements could not be claimed as
confidential, while other commenters suggested that additional data
elements should not be able to be claimed as confidential. Following
consideration of the comments received, EPA is finalizing as proposed
the following: (1) Barring certain processing and use data considered
``general'' from confidentiality claims, and (2) requiring upfront
substantiation for all CBI claims except for production volume. As
described in Unit III., EPA is finalizing with some limited
modifications the proposed substantiation questions for data elements
requiring upfront substantiation. In consideration of comments received
and with an interest in engaging with reporters' concerns about
disclosure, EPA is modifying the proposed substantiation questions. An
overview of the revisions to the substantiation questions in 40 CFR
711.30 is in Unit III.A.1. Additionally, based on comments received,
EPA is not finalizing the proposed voluntary public contact data
element or the proposed
[[Page 20126]]
alternative reporting in specified categories for inorganic byproducts.
In this preamble, EPA has responded to many of the comments
relevant to the proposed revisions to CDR; EPA's comprehensive response
to comments related to this final action is in the Response to Comments
document (Ref. 10). EPA is finalizing in a separate action an amendment
to update the size standards definition for small manufacturers for
reporting and recordkeeping requirements under TSCA section 8(a), which
includes a separate Response to Comment document addressing comments
specific to the small manufacturing definition.
In addition to public comments received on the proposal, EPA
solicited information through other mechanisms. Specifically, EPA
conducted two identical sessions as part of tribal outreach on the
proposed rule to provide background information on the proposed rule
and to obtain feedback (Ref. 11). EPA received no follow-up comments
from the tribal outreach. EPA also met with IPC (Association Connecting
Electronics Industries) at EPA headquarters, toured a printed circuit
board manufacturing site (TTM Technologies, Inc.), and, with Lehigh
Hanson Cement, toured a Portland cement clinker manufacturing site.
(Ref. 12, Ref. 13, and Ref. 14). In the meetings and on these tours,
EPA received information on how byproducts and wastes are stored and
eventually transported offsite for recycling; this information was
useful in the development of this final rule.
III. Detailed Discussion of the Modifications to the CDR Rule
EPA is making a number of revisions to the CDR rule, as described
in this Unit. The regulatory text of this document describes the
specific CDR reporting requirements being amended and includes both the
modified and selected unmodified portions of the regulatory text (see
40 CFR part 711). EPA has also developed information for the public
that includes specific reporting instructions, questions and answers,
and case studies, and EPA intends to conduct webinars to help potential
CDR submitters become familiar with the revised reporting processes and
amended reporting requirements. The information sources and information
on the webinars will be available on the CDR website (https://www.epa.gov/cdr).
A. What changes have been made to requirements for claiming
confidentiality?
EPA is finalizing changes to requirements related to claiming CDR
data as confidential, so as to be consistent with the new statutory
requirements in TSCA section 14. The 2016 amendments to TSCA included
mandated new procedural requirements for the submission and Agency
management of CBI claims, including new substantiation requirements, a
certification requirement, and a requirement for Agency review of
specified CBI claims within 90 days after receipt of the claim. The
revisions to this rule implement and facilitate the new TSCA
requirements. Specific changes are discussed in this Unit and in Unit
III.A. of the proposed rule (Ref. 1). EPA estimates that the changes to
the CBI substantiation requirements will result in a decrease in
burden, which is explained in detail in Chapter 4.3.2 in the Economic
Analysis (Ref. 7). Public comments regarding claims of confidentiality
generally addressed: Data elements that are not eligible for
confidentiality claims, data elements that are exempt from upfront
substantiation, and substantiation questions.
One commenter provided detailed comments on the proposed questions
and additionally referenced a recent Supreme Court decision (Food
Marketing Institute v. Argus Leader Media, 139 S. Ct. 2356 (2019))
addressing the test for determining whether commercial information
qualifies as ``confidential'' for purposes of Exemption 4 of the
Freedom of Information Act (FOIA), 5 U.S.C. 552(b)(4). In that
decision, the Court rejected the ``substantial competitive harm'' test
that had long been applied by the U.S. Court of Appeals for the D.C.
Circuit, under which certain commercial information could not be deemed
``confidential'' unless disclosure was likely to cause substantial harm
to the competitive position of the person from whom the information was
obtained. 139 S. Ct. at 2361, 2364-66. EPA also received a request to
reopen the comment period to allow others to provide comment on this
Court decision (Ref. 15).
EPA determined that the Supreme Court decision did not impact the
finalization of the substantiation questions or CBI review criteria
that were proposed in this TSCA rulemaking because Congress amended
TSCA section 14 in 2016 to, among other things, specifically require
any person asserting a CBI claim under TSCA to include a certified
statement that the person has ``a reasonable basis to conclude that
disclosure of the information is likely to cause substantial harm to
the competitive position of the person.'' TSCA section
14(c)(1)(B)(iii), (c)(5); see also TSCA section 14(c)(1)(C)(ii)(II)
(referencing substantial competitive harm). Based on these requirements
in TSCA section 14, EPA determined that neither the ``substantial
competitive harm'' review criterion nor any related substantiation
question for the TSCA CBI claims addressed in this rulemaking should be
removed based on the Supreme Court's decision. EPA accordingly decided
not to reopen the comment period. See the Response to Comments document
for additional discussion. (Ref. 10).
1. Substantiations. EPA interprets TSCA section 14(c)(3) as
requiring substantiation of any non-exempt CBI claim at the time the
information claimed as CBI is submitted to EPA (Ref. 16). The Agency is
finalizing the amendment of the CDR substantiation provisions to
require substantiation for all confidentiality claims except for those
types of information exempt from substantiation under TSCA section
14(c)(2), which are described later in this Unit. EPA modified the
proposed regulatory text to remove references to data elements that
were proposed and not finalized, such as the public contact information
discussed in Unit III.F.1., to change text for clarity, and to correct
cross-references.
EPA is finalizing revisions to the substantiation questions in 40
CFR 711.30, with some changes between the proposed changes and those
that are being finalized. In consideration of comments received and
with an interest in engaging with reporters' concerns about disclosure,
EPA is modifying the proposed substantiation questions. An overview of
the revisions to the substantiation questions in 40 CFR 711.30 is as
follows.
A set of standard questions, set forth in 40 CFR 711.30(b), applies
to all non-exempt CBI claims. In response to comments received, EPA
modified the questions to facilitate clarity and understanding of the
questions themselves and to help ensure that submitters are correctly
and appropriately substantiating their confidentiality claims. For
example, to the question about substantial competitive harm (40 CFR
711.30(b)(1)), EPA has expanded the proposed statement ``If you
answered yes, explain the substantial harm'' to a clearer description:
``If you answered yes, describe the substantial harmful effects that
would likely result to your
[[Page 20127]]
competitive position if the information is disclosed, including but not
limited to how a competitor could use such information and the causal
relationship between the disclosure and the harmful effects.''
Likewise, EPA added additional examples to the question about where the
information may have been publicly disclosed (40 CFR 711.30(b)(3)), and
split the question into three parts so that the first part discusses
disclosure required under other Federal law, the second part addresses
more general public documents, and the third part is specific to
patents.
EPA proposed additional questions that were targeted to specific
data elements. An additional series of four questions for specific
chemical identity CBI claims is set forth in 40 CFR 711.30(c). The
first proposed question, at 40 CFR 711.30(c)(1), addresses whether the
chemical substance is publicly known to be in commerce in the United
States. EPA modified this question to remove language identified as
confusing by a commenter and to clarify that the inquiry is intended to
address knowledge by the public at large as well as by competitors
within the industry. The second and third proposed questions, at 40 CFR
711.30(c)(2)-(3), address the ability for others to reverse engineer
the chemical identity. The second question has been slightly modified
to be worded in a consistent manner with other questions. The third
question has been modified to clarify EPA's expectation that the
response takes into account existing technologies, and that it
addresses whether a chemical identity is ``readily'' discoverable. The
fourth proposed question, at 40 CFR 711.30(c)(4), addresses the release
of confidential process information and has been finalized as proposed.
Information about substantiating for company, site, and technical
contact identity is finalized in 40 CFR 711.30(a)(6), proposed in 40
CFR 711.30(d). As proposed, there was one additional question at 40 CFR
711.30(d)(1) for the substantiation of these claims (Ref. 1). EPA did
not finalize this question because it is substantially the same as the
question finalized at 40 CFR 711.30(b)(3), which submitters must
already answer for these data element claims. EPA is retaining the 40
CFR 711.30(d) paragraph, finalized in 40 CFR 711.30(a)(6), because it
explains when the submitter may assert a claim for the linkage between
the company, site, or technical contact identity and the chemical
substance.
Requirements to substantiate confidentiality claims for certain
processing and use information are set forth in 40 CFR 711.30(a)(7). As
proposed, there were two additional questions for these claims. EPA did
not finalize either question because EPA determined that these
questions solicited the same information that claimants would already
be required to provide in their responses to the substantiation
questions applicable to all CBI claims, and would not provide
additional information that is uniquely necessary for adjudicating CBI
claims for these data elements. The question proposed at 40 CFR
711.30(e)(1) is substantially the same as the question finalized at 40
CFR 711.30(b)(3), and the question proposed at 40 CFR 711.30(e)(2) is
substantially the same as the question finalized at 40 CFR
711.30(b)(2), which submitters must already answer for these data
element claims.
EPA is finalizing, with some changes from the proposal, 40 CFR
711.30(a)(3), which describes the data elements that are exempt from
the requirement to provide substantiations at the time the data are
submitted. EPA believes that the only data elements collected under CDR
that may be subject to the TSCA section 14(c)(2) exemption from upfront
substantiation requirements are (1) production volume (711.30(a)(3)(i))
and (2) supplier information associated with joint submissions, such as
supplier identity and details of the full composition of a mixture
(711.30(a)(3)(ii) and (iii)). In addition, EPA believes that a petition
submitted under 40 CFR 711.6(b)(2)(iii) or 40 CFR 711.10(d)(1)(ii) may
contain information that is described in TSCA section 14(c)(2)
(711.30(a)(3)(iv)). However, the data elements that are exempted from
upfront substantiation may still be subject to substantiation and CBI
review under the circumstances described in TSCA section 14(f).
a. Regarding production volume. EPA is finalizing its proposal not
to require substantiation at the time the claim of confidentiality is
made for five production volume data elements (so, for the 2020
reporting cycle, the volume domestically manufactured in 2019, the
volume imported in 2019, and the total production volume for each of
the three years 2016 through 2018). For each reported chemical, total
production volume is reported for each of the years since the last
principal reporting year--except for the current principal reporting
year, for which the production volume is reported as domestically
manufactured and imported volumes.
While commenters in general agreed with the proposal, some
commenters wanted EPA to expand the exemption from upfront
substantiation to include all data elements that contain a volume
(i.e., volume used on site and volume directly exported) because such
information relates to the production volume of a chemical substance.
EPA disagrees with the suggestion that TSCA section 14(c)(2)(F), which
exempts from upfront substantiation requirements ``[s]pecific
production or import volumes of the manufacturer or processor,'' is
intended to exempt any data element referencing a volume. Because
volume used on site and volume directly exported provide information
about the disposition of the chemical after it is produced or imported,
rather than information about the total amount originally produced or
imported by the manufacturer, these data elements are not the
``production or import volumes'' listed in TSCA section 14(c)(2)(F).
Therefore, EPA did not add these two data elements to the list at 40
CFR 711.30(a)(3) of data elements that do not require substantiation of
confidentiality claims at the time of submission.
b. Regarding information associated with a joint submission. EPA is
finalizing as proposed requirements associated with making
confidentiality claims for joint submissions, described in 40 CFR
711.30(d)(1). This includes the requirement that in a joint submission,
the primary submitter identify whether the supplier information,
including the supplier identity and chemical substance name (trade
name), is confidential. Because EPA interprets these data elements as
``[i]nformation identifying a supplier'' under TSCA section
14(c)(2)(C), substantiation of the confidentiality claims for this
information will not be required at the time of submission. The
secondary submitter of the joint submission will provide its company
name and location, a technical contact, trade name, chemical
identity(ies), and percentage of each chemical substance in the
composition of the substance or mixture represented by the trade name.
The secondary submitter is responsible for asserting all
confidentiality claims for the data elements that it submits directly
to EPA and for substantiating those claims not exempt under 40 CFR
711.30(a)(3)(iii). Secondary submitters should note that EPA is
finalizing the requirement to collect the function of each chemical in
the mixture in a joint submission, as described in Unit III.B.5. The
function of the chemical is one of the processing and use data elements
that are barred
[[Page 20128]]
from claims of confidentiality by 40 CFR 711.30(a)(2)(ii). Other data
elements, such as the chemical substance identity, can be claimed as
confidential by the secondary submitter following the provisions in 40
CFR 711.30. Except for the percentage composition information, which is
generally exempt from substantiation pursuant to TSCA section
14(c)(2)(D), all other reported data elements are subject to
substantiation at the time the information is submitted.
2. Certification. The authorized official submitting
confidentiality claims must certify that all claims for confidentiality
are true and correct, and that all information submitted to
substantiate such claims is true and correct. In addition, all persons
asserting a confidentiality claim must include the statement described
in TSCA section 14(c)(1)(B), and the authorized official must certify
that this statement is true and correct. EPA previously combined these
requirements into a single certification statement, which was
implemented in the CDR electronic reporting tool in June 2016. EPA is
finalizing as proposed the codification of the language of the
certification statement in the CDR rule (see the final regulatory text
for 40 CFR 711.30(a)(5)).
3. Processing and use data not protected from disclosure: EPA is
finalizing its proposal to bar confidentiality claims for certain data
elements that are ineligible for confidential treatment pursuant to
TSCA section 14(b)(3)(B). The finalized regulatory text includes a
correction to the proposed regulatory text to match the Agency's intent
as described in the preamble to the proposed rule.
a. Final requirements. EPA is finalizing the codification that the
following data elements cannot be claimed as confidential because they
constitute general descriptions of processes, functions, and uses,
including information that customarily would be shared with the general
public or within an industry or industry sector, under TSCA section
14(b)(3)(B):
Certain Industrial processing and use data elements. The
data elements directly related to how the chemical is used or
processed, i.e., the type of process or use; the industrial sector; and
the industrial function (40 CFR 711.15(b)(4)(i)(A), (B), and (C)).
Certain Consumer and Commercial use data elements. The
data elements directly related to how the chemical is used, i.e., the
product category (40 CFR 711.15(b)(4)(ii)(A)); whether the chemical is
used in commercial or consumer products (40 CFR 711.15(b)(4)(ii)(C));
whether the chemical is likely to be used in children's products (40
CFR 711.15(b)(4)(ii)(D)); and the function of the chemical in the
consumer or commercial product (40 CFR 711.15(b)(4)(ii)(B)) (the
function is a new data element--see Unit III.B.1.a. for additional
information).
With the final regulatory text, EPA corrected the proposed
regulatory text to include whether the chemical is likely to be used in
children's products (40 CFR 711.15(b)(4)(ii)(D)) as a data element that
is barred from confidentiality claims. The preamble to the proposed
rule described the Agency's intent to include this data element as a
general description of the use of the chemical substance (Ref. 1).
Similarly, EPA is finalizing the proposal that submitters may
continue to assert claims of confidentiality for the following
processing and use data elements, because they do not offer a ``general
description'' of a process or use and therefore do not fall within the
limits of TSCA section 14(b)(3)(B):
Certain Industrial Processing and use data elements.
Percent production volume, number of sites, and number of workers (40
CFR 711.15(b)(4)(i)(D), (E), and (F)).
Certain Consumer and Commercial use data elements. Percent
production volume, maximum concentration, and number of commercial
workers (40 CFR 711.15(b)(4)(ii)(E), (F), and (G)).
b. Discussion of TSCA section 14(b)(3)(B) and public comments
received. TSCA section 14(b)(3)(B) limits protection from disclosure
for general descriptions of process, function, and use information,
including information that customarily would be shared with the general
public or within an industry or industry sector. EPA proposed to codify
in the regulatory text that several data elements could not be claimed
as confidential because they constitute general descriptions of
processes and uses that customarily would be shared with the general
public or within an industry or industry sector. EPA received comments
that supported and opposed the proposal to bar certain confidentiality
claims.
Some commenters opposed to barring confidentiality claims disagreed
with the Agency position that TSCA section 14(b)(3)(B) categorically
prohibits protection from disclosure for any particular information
such as certain processing and use data elements. EPA disagrees with
those comments, and believes that the statutory text in TSCA section
14(b)(3) (entitled ``Other information not protected from disclosure'')
and (b)(5) is clear that the information described in section
14(b)(3)(B) is not eligible for the protections from disclosure
afforded to businesses under TSCA section 14 or FOIA Exemption 4
(pertaining to confidential business information).
Other commenters opposed to barring these confidentiality claims
agreed that these processing and use data elements do not typically
require CBI claims, but asserted that with the proposed expansion to
the more-specific OECD codes, there would be greater potential for some
combinations of codes to reveal specific and unique use information
that may be confidential. These commenters also asserted that in
certain situations, chemicals can have unique functions in consumer/
commercial products, and therefore CBI claims should be permitted.
However, none of the commenters offered examples to illustrate
situations in which the combinations of generic category codes would
reveal specific information about a use or function, as opposed to a
general description. Following careful consideration of these comments,
EPA determined that, even in combinations with the newly-finalized OECD
harmonized codes, the information remains general and therefore not
eligible for CBI status under TSCA section 14(b)(3)(B).
Commenters that supported barring confidentiality claims for these
data elements asserted that EPA needs to do more to prevent unjustified
claims of confidentiality, advocated for increased transparency of CDR
data, and asserted that other data elements also qualify as a ``general
description of a process used in the manufacture or processing and . .
. functions and uses'' under TSCA section 14(b)(3)(B) that should be
barred from CBI status or alternatively are barred from CBI status
because they are part of a health and safety study under TSCA section
14(b)(2). EPA recognizes the importance of transparency and the need to
enable submitters to protect information that meets the standards for
confidentiality. Concerning the TSCA section 14(b)(3)(B) assertion, the
commenters provided no support for why other data elements might be
considered process information, a necessary part of the ``general
description of a process . . .'' as described in TSCA section
14(b)(3)(B). Concerning the TSCA section 14(b)(2) assertion, EPA
disagrees with the suggestion that data in a CDR submission could be
characterized as a health and safety study or information from a health
and safety study. See the Response to Comments for additional
discussion (Ref. 10).
[[Page 20129]]
B. What changes have been made to the reportable data elements?
1. Processing and use codes. The CDR rule requires manufacturers to
report industrial, consumer, and commercial processing and use
information for chemical substances manufactured during the principal
reporting year. EPA is finalizing, with modification from the proposal,
changes to the data elements comprising this processing and use
information. Specifically, EPA is finalizing the replacement of the CDR
industrial function and commercial/consumer product use codes with
codes based on OECD function, product, and article use categories and
adding the requirement to report the function of the chemical in
commercial/consumer products. As a result of public comments received,
EPA is phasing-in the implementation of the OECD-based codes, such that
reporting during the 2020 CDR submission period for the chemical
substances designated by EPA as a high priority for risk evaluation (84
FR 71924, December 30, 2019) are required to use the OECD-based codes
and reporters for all other chemical substances may report using either
the OECD-based codes or the current CDR codes. Reporting using the
OECD-based codes will be fully implemented and required for all
chemical substances beginning with the 2024 CDR submission period. In
addition, EPA proposed to list the updated codes in the instructions
for CDR reporting. As a result of public comments received, EPA is
codifying the updated codes in the CFR.
Some commenters expressed concern with the level of understanding
that manufacturers have for the downstream processing and use of
chemicals. EPA recognizes that some manufacturers may have less
knowledge than other manufacturers about the downstream processing and
use of their reported chemical substances. As described in the
Instructions for Reporting, submitters are to exercise certain levels
of due diligence in gathering the information required by the CDR rule
and, if the knowledge is not known or reasonably ascertainable, to
indicate so on the reporting form by selecting ``NKRA.'' See the
Instructions for Reporting for examples (Ref. 9). EPA recognizes that
downstream processors and users may have better knowledge of the
functions and uses than the chemical manufactures, but the agency is
balancing the need for reduced reporting burden with maintaining the
ability to receive the information needed to understand potential
chemical exposure.
Other public comments related to the proposed processing and use
code amendments, and EPA's responses, can be found in the response to
comment document (Ref. 10). These new codes can be found at 40 CFR
711.15 in Tables 6 and 9.
At the time of proposal, EPA did not develop burden estimates
associated with replacing the current CDR codes with ones based on the
OECD codes, because such estimates heavily rely on the e-CDRweb user
interface that will feature burden-reducing guided data entry. EPA
noted that the addition of the function categories for commercial/
consumer products is a new data element whose addition could
potentially result in an increase in burden. Ultimately, EPA did not
foresee a substantial increase in burden due to the use of the new
codes and is finalizing the use of these new codes as proposed. To
manage the potential burden increase, EPA planned to take non-
regulatory steps to reduce burden, including: (1) Incorporating
intelligent sorting and a smart search option into the reporting tool,
(2) publishing cross references to current codes, and (3) publishing
detailed definitions and examples for each code. EPA has incorporated
these features into the eCDRweb reporting tool and the Instructions for
Reporting (Ref. 9). The intelligent sorting feature will be implemented
into the eCDRweb reporting tool for 2024 reporting; the smart search
option is implemented for the 2020 reporting. Although the number of
codes has increased, the inclusion of these features results in a
slight decrease in estimated burden once all features are fully
implemented in the eCDRweb reporting tool (a decrease of 0.461 hours
per report, see Appendix C of the Economic Analysis (Ref. 7) for
further details).
Under CDR, there are two main categories of use codes: Function
codes and product codes. The function of a chemical, combined with the
type of product that the chemical is used in, provides information
about an exposure scenario with unique characteristics. Information
about exposure scenarios is necessary for implementation of TSCA
section 6 for prioritization and risk evaluations.
a. Function codes (industrial and consumer/commercial). EPA is
finalizing the requirement to report function categories for both
industrial applications and commercial/consumer products and to adopt
categories based on the OECD functional use categories. Under this
final rule, the current 35 function codes have been replaced by 117
OECD-based function codes. EPA finalized the function codes as
proposed, with one modification. In response to a comment that there
was not an appropriate code to report the function of a substrate metal
in an alloy when the alloy is imported, EPA changed the definition for
function code U040A from ``Alloying Element--Chemical substances that
are added to materials/metals formulated to modify properties such as
strength, hardness, or to facilitate treatment'' to ``Alloys--Chemical
substances that are a combination of materials/metals formulated for
specific properties such as strength, hardness, or to facilitate
treatment.''
In this final rule, not all of the OECD harmonized codes are
adopted as individual CDR function codes because some are for
functional uses not covered by TSCA (e.g., in the circumstances where,
because of a chemical's particular use, it is not a ``chemical
substance'' under TSCA section 3(2)(B)(vi)). For the proposal, EPA
requested comments on whether all of the OECD harmonized codes should
be listed so that the codes are an exact match, even if the uses are
not covered by TSCA. After consideration of the public comments
received, EPA has finalized the list as proposed, which does not
separately list the functional uses not covered by TSCA and continues
to include a non-TSCA code as a blanket code for these applications,
such as for a food or cosmetic (other than soap), when the chemical is
reportable to CDR because the chemical is also used in a way that falls
under the jurisdiction of TSCA.
EPA is listing these codes in the CFR at 40 CFR 711.15 Table 6.
Additional details about the function categories, how they are related
to the OECD functional use categories, and a crosswalk with the current
CDR function codes are in the supplemental document Technical Support
Document: Harmonizing CDR Functional and Product codes with OECD
Functional, Product, and Article Codes (Ref. 17).
b. Commercial/consumer product codes. Under this final rule, the
current 33 consumer/commercial product categories have been replaced by
96 OECD-based product categories. Under TSCA, the definition of
``chemical substance'' excludes certain products, including pesticides,
tobacco, and food. Some of the OECD harmonized product categories cover
the TSCA-excluded products; those particular codes were not adopted in
CDR. The former CDR codes contained a catch-all ``non-TSCA code'' for
products that are not covered under TSCA. Under this final rule, EPA
[[Page 20130]]
will continue to provide the same ``non-TSCA'' code as a blanket code
for these applications. EPA also agrees with one comment requesting
``to exclude the use of the OECD code for articles intended for food
contact'' and, as a result, is consolidating both C206A (Articles for
food contact, including metal articles) and C301A (Articles intended
for food contact including paper articles; plastic articles (soft);
plastic articles (hard); rubber articles; metal articles; fabrics,
textiles, and apparel) with CC990, the ``Non-TSCA use'' code (Ref. 10)
For a more detailed discussion of these changes, see Unit III.B.1. of
the proposed rule (Ref. 1).
c. Implementation of the OECD-based codes. Under this final rule,
EPA is phasing in reporting of the OECD-based codes. For reporting
during the 2020 CDR submission period, (from June 1, 2020, to September
30, 2020), submitters are required to use the OECD-based codes for the
chemical substances designated by EPA as a high priority for risk
evaluation and, for all other chemical substances, may use either the
OECD-based codes or the CDR codes. The chemical substances designated
by EPA as a high priority for risk evaluation are listed in 40 CFR
711.15, Table 7. For reporting during the 2024 and future submission
periods, submitters are required to use the OECD-based codes for all
chemical substances for which the submitter is reporting processing and
use information.
2. NAICS codes for manufacturers. EPA is finalizing the requirement
that submitters report the 6-digit NAICS code that best describes the
manufacturing activities conducted at the reporting site. The NAICS was
developed under the direction and guidance of the Office of Management
and Budget (OMB) as the standard for use by Federal statistical
agencies in classifying business establishments for the collection,
tabulation, presentation, and analysis of statistical data. NAICS is
based on a production-oriented concept, meaning that it groups
establishments into industries according to similarity in the processes
used to produce goods or services (Ref. 18). Use of the standard
provides uniformity and comparability in the presentation and
understanding of data. EPA estimates that this finalized change will
result in a small increase in burden, which is explained in detail in
Chapter 4.3.2 in the Economic Analysis (Ref. 7). For a more detailed
discussion of this change, see Unit III.B.2. of the proposed rule (Ref.
1).
EPA received comments on the proposed rule regarding the addition
of the NAICS codes for manufacturing sites that supported and opposed
the revision. Commenters that supported the addition agreed with EPA
that including NAICS codes provides practical utility for the Agency
because the use of NAICS codes will enable industry-specific analysis
and increase the ability to combine CDR data with other sources (e.g.,
TRI). Commenters that opposed the addition stated that identifying a
single NAICS code for some reporters could be overly burdensome,
especially for reporters that consolidate imports at the company
headquarters, for which multiple NAICS codes could apply. In
consideration of these comments, EPA is finalizing the requirement for
reporting a 6-digit NAICS code, but will allow the reporter to indicate
up to three NAICS codes to address the concerns expressed for some
importers that identifying a single NAICS code would be difficult.
Given that CDR data are higher-level data intended for screening
purposes, EPA determined that three NAICS codes would be adequate. If
more than three NAICS codes could apply, the reporter should identify
and report the three more representative NAICS codes. EPA believes that
the increase in burden caused by this change is minimal, compared to
the increase in practical utility the information can provide to the
Agency to better analyze the data by industry sector. In most
situations, submitters will report the single NAICS code that best
represents the activities associated with the site, to the extent that
it is known or reasonably ascertainable. In situations where multiple
NAICS could apply and the reporter is unable to identify a single
NAICS, such as for reporters that consolidate imports for multiple
sites, submitters will be allowed to report up to three NAICS codes
that best represent the activities associated with the intended use of
the imported chemical substances. See the Instructions for Reporting
for examples (Ref. 9). For more information, see the EPA's Response to
Comment Document (Ref. 10).
3. Modifying recycled information. EPA is finalizing as proposed
the requirement to report whether a reportable chemical substance is
recycled or otherwise used for a commercial purpose, instead of being
disposed of as a waste or included in a waste stream. In past CDR
reporting periods, CDR submitters have identified whether their
reportable chemical substance is recycled, remanufactured, reprocessed,
reused, or otherwise used for a commercial purpose instead of being
disposed of as a waste or included in a waste stream. EPA is finalizing
the modification to this data element by removing the terms
``remanufactured, reprocessed, reused,'' as these terms may be
interpreted and applied too broadly to obtain the information of
interest for this collection. These terms are also not necessarily
synonymous with ``recycle'' in all scenarios. For a more detailed
discussion of this changes, see Unit III.B.3. of the proposed rule
(Ref. 1).
For the proposed rule, EPA solicited comment on whether submitters
should identify the percentage of total production volume of their
chemical substance that is recycled, instead of only designating
whether recycling occurred. While one commenter stated that modifying
the required recycling data element to include the percentage of total
production volume would be overly burdensome and impractical, other
commenters supported reporting recycling by percentage if it is useful
to the Agency in prioritization of chemicals for risk evaluation. EPA
has determined that knowing whether any amount of the chemical is
recycled or otherwise used for a commercial purpose, instead of being
disposed of as a waste, is currently sufficient for TSCA purposes, and
that the increased specificity of this data element may not warrant the
associated potential increase in reporting burden. As a result of these
comments, EPA is retaining a ``yes or no'' style of response and is not
finalizing a requirement for reporters to identify the percent recycled
when reporting to CDR.
4. Percent byproduct. EPA is finalizing as a voluntary reporting
element the reporting of the percent total production volume (by
weight) for a chemical substance that is a byproduct within four
ranges: 0 percent, greater than 0 but less than 50 percent, greater
than or equal to 50 percent but less than 100 percent, or 100 percent.
This is a modification from the proposal, which proposed to require
that the data element be reported and that the percentages for the
percent byproduct be rounded to the nearest 10 percent, unless the
percentage is less than 5 percent, rather than as a larger range. EPA
received comments that both supported and opposed the addition of
reporting the percent byproduct. Those who supported the addition
stated that knowing the percent byproduct was useful for the Agency in
order to provide future exemptions for those who recycle their
byproducts, as it will enable the identification of manufacturers, such
as the printed circuit board fabricators, who report to CDR solely due
to their byproduct
[[Page 20131]]
production. Other commenters stated that it is well-known that
byproducts (organic and inorganic) can be important sources of exposure
and risk and should be reported under the CDR rule so EPA can have
information to aid with assessment of their health and environmental
impact and be better able to ``understand a larger spectrum of
potential exposure scenarios, by improving understanding of the
connection between manufacturing and downstream activities for the
purposes of substance life cycle assessments and risk evaluation''
(Ref. 10 and Ref. 19). Commenters who opposed the addition stated that
this data element is unnecessary and could add complexity rather than
reducing it.
Due to the comments received on this proposed data element and the
concern that determining the specific percent byproduct (to the nearest
10 percent or more precisely if less than 5 percent) would be
unnecessarily burdensome, EPA is finalizing the addition of this data
element as a voluntary data element and to allow for reporting in
ranges to reduce submitter burden. Rather than reporters providing the
specific percent byproduct as proposed, EPA is finalizing a requirement
that reporters provide information about the percent byproduct by
selecting one of four ranges.
A byproduct is a chemical substance that is produced without a
separate commercial intent during the manufacture, processing, use, or
disposal of another chemical substance(s) or mixture(s); because it is
part of the manufacture of a chemical product for a commercial purpose,
it is considered to be produced for the purpose of obtaining a
commercial advantage and is therefore itself considered manufactured
for a commercial purpose (40 CFR 704.3, definitions for byproduct and
manufacture for commercial purposes). EPA is adding this voluntary data
element to become more aware of which industries primarily manufacture
byproducts and to be better able to understand a larger spectrum of
potential exposure scenarios, for the purposes of chemical substance
life cycle assessments and risk evaluation. In addition, EPA will use
this information to inform future decisions about potential changes to
CDR requirements.
Some commenters who opposed this data element appeared to
mistakenly interpret that the percent byproduct meant what percentage
of the reported chemical substance, which was not itself a byproduct,
had some percentage of a byproduct remaining with the reported chemical
substance. EPA is not requesting the reporting of the byproducts within
the intended product, which frequently are referred to by industry as
contaminants, but rather the byproducts that are manufactured and then
separated from the intended product; these byproducts are required to
be reported separately unless the production volume is under the
reporting threshold or another exemption identified in applies. EPA
will clarify how to report the percent byproduct in the Instructions
for Reporting (Ref. 9). EPA believes that additional clarification in
the guidance will improve understanding reporting this data element and
minimize associated reporting burden. For a more detailed discussion of
this change, see Unit III.B.4. of the proposed rule (Ref. 1). Public
comments related to the voluntary reporting of percent byproduct and
EPA's responses can be found in the response to comment document (Ref.
10).
5. Chemical-specific function for imported mixtures. EPA is
finalizing as proposed the requirement that the secondary submitter of
a joint submission, typically the foreign supplier, report the
chemical-specific function along with the already-required information
on chemical composition of the imported product or mixture. A joint
submission is most typically used when a substance or a mixture is
imported and the supplier does not provide to the importer the specific
chemical identity of the substance or substances that comprise the
mixture. See Unit III.A. of the proposed rule for additional
information about joint submissions (Ref. 1).
EPA received a comment that supported requiring the secondary
submitter of a joint submission to report the chemical-specific
function along with information on chemical composition of the imported
product or mixture. Another commenter stated that providing this
information on each joint submission may require a significant time to
complete. EPA recognizes that providing this information may require
some burden. EPA had already accounted for the associated burden,
because the rule requires the function be provided on a chemical-
specific basis but did not enable the appropriate party to provide such
information. For example, for past submissions the primary submitter
would report the function of the overall imported mixture, and that
function would be applied to each chemical in the mixture. The comments
suggested and our analysis supported having the primary or secondary
submitter determine the function for each chemical in the mixture. Due
to the suggestions received in public comments, EPA has sufficient
support to justify support the secondary submitter determining the
function for each chemical in the mixture. EPA's burden analysis for
the final rule assumes that there is no difference in burden regardless
of whether the primary submitter or the secondary submitter determines
the function for each chemical in the mixture. Therefore, there is no
increase in burden for the secondary reporter to determine the function
for each chemical in the mixture. See footnote 14 in section 4.1.3 of
the Economic Analysis for additional information (Ref. 7).
A commenter stated that EPA should not require information on the
chemical composition of the imported product or mixture. EPA notes that
this is not a new requirement. The composition information, which is
reported by the secondary submitter of a joint submission, is necessary
to identify the chemicals that are included in the imported product and
how much of the imported volume to attribute to each component chemical
substance. EPA clarified the requirement to report the percentage of
formulation for a chemical substance in an imported product in the
regulatory text at 40 CFR 711.15(b)(3)(i)(A).
6. Parent Company identity. EPA is finalizing as proposed two
changes and finalizing with modifications one change associated with
reporting the parent company under CDR: (1) To add the requirement to
report a foreign parent company in addition to reporting the highest-
level U.S. parent company, when the ultimate parent company is located
outside of the United States; (2) to remove the definition of U.S.
parent company from 40 CFR 711.3 and replace it with a new definition
for highest-level parent company; and (3) to add a requirement for
reporters to report legal name(s) and to follow a naming convention for
providing the parent company name(s), the details of which will be
provided in the CDR Instructions for Reporting (Ref. 9; see 40 CFR
711.35).
EPA received one comment that supported the proposed changes to the
parent company identity and another comment that expressed concern over
the use of a naming convention and complications that will increase the
burden. The naming convention is primarily a tool to streamline the
processes of capitalization, punctuation, and so on when identifying a
parent company, and does not significantly impact burden. EPA believes
that the use of the naming convention will not
[[Page 20132]]
significantly impact the burden because the reporter does not have to
do anything to collect or generate this information, and is finalizing
as proposed. EPA was interested in receiving comments on whether the
guidelines and these examples encompass the representative range of
scenarios for reporting under CDR, and whether the guidelines included
in the proposed definition are sufficient; EPA did not receive any
comment on this aspect of the proposal.
EPA estimates that the addition of a foreign parent company will
slightly increase the burden, which is explained in detail in Chapter
4.3.2 in the Economic Analysis (Ref. 7). EPA did not estimate the
burden reduction associated with the reduced need to contact companies
for quality control purposes after data submission.
a. Finalized changes to the definition of U.S. parent company. EPA
is finalizing with modification from the proposal the replacement of
the definition of U.S. parent company from 40 CFR 711.3 with a new
definition for highest-level parent company that includes both U.S. and
foreign parent companies and provides guidelines for different company
structures. Under the new definition, highest-level parent company
means the highest-level company(s) of the site's ownership hierarchy as
of the date of the submission during which data are being reported
according to specified instructions. The highest-level U.S. parent
company is located within the United States, while the highest-level
foreign parent company is located outside the United States. EPA
modified the descriptions of site ownership scenarios contained in the
new definition to enhance understanding of the scenarios.
b. Finalized reporting of foreign parent company. In some
situations, the highest-level parent company is outside of the United
States. EPA is finalizing with modifications from the proposed the
requirement that sites also identify the highest-level worldwide parent
company, when applicable, and therefore is also finalizing the
requirement to report the foreign parent company under 40 CFR 711.15.
Under this final rule, reporters will continue to report their highest-
level U.S. parent company, but will also report their highest-level
foreign parent company if applicable. EPA recognizes that there are a
variety of ownership situations for manufacturers reporting under CDR.
In Unit III.B.7. of the proposed rule (Ref. 1), EPA listed the
scenario-specific guidelines. EPA is finalizing the guidelines as part
of the finalized definition of highest-level parent company in 40 CFR
711.3 with modifications to make the ownership situations easier to
understand. The guidelines include how to populate the highest-level
U.S. and foreign parent company data elements.
c. Finalizing use of naming convention. EPA is also finalizing the
requirement for sites to follow the CDR instructions regarding
standardized conventions for the naming of a parent company. These
naming conventions address common formatting discrepancies, such as
punctuation, capitalization, and abbreviations (e.g., ``Corp'' for
``Corporation''). The use of these naming conventions will reduce the
number of inconsistencies with the Parent Company Name data field, and
thus will increase the reliability and usability of the data and reduce
the associated reporting burden due to the Agency's need to request
corrections from reporting companies.
C. How has the reporting process for co-manufactured chemicals changed?
EPA is finalizing two new methodologies for manufacturers to report
co-manufactured chemicals. Although these finalized methodologies
reduce co-manufacturer confusion and address other industry concerns,
EPA estimates that it will have a minimal impact on the burden and
therefore did not include an estimate in the analysis. See section
4.1.3.2 in the Economic Analysis for additional information (Ref. 7).
As discussed in the proposed rule, EPA is avoiding the use of the term
toll manufacturer for this final rule, so as to add clarity for the co-
manufacturing situation. For a more detailed discussion of this change
and additional background on co-manufacturing, see Unit III.C. of the
proposed rule (Ref. 1).
In the proposed rule, EPA proposed a primary solution to the co-
manufacturing mechanism, and requested comment on two potential
alternatives to the reporting scenario. Commenters were supportive of
EPA's approach to updating the mechanism that co-manufacturers report,
but also requested more flexibility to enable the producing company to
submit the CDR report on behalf of both companies. EPA agrees that
additional flexibility is necessary and has chosen to finalize two
different reporting methodologies for a co-manufacturing situation. The
two following methodologies for reporting are based on the desire to
reduce reporting burden and maintain flexibility for both the
contracting and producing company. Contracting and producing companies
must work together to select between the two following reporting
methodologies for preparing their CDR submission.
1. First reporting procedure. Under the first reporting
methodology, the contracting company (as the primary submitter) has the
responsibility to initiate a co-manufacturer report that will prompt
the reporting requirements for the producing company (as the secondary
submitter). The contracting company will start the chemical report for
the co-manufactured chemical, identifying the chemical substance and
the producing company. The contracting company will then initiate the
co-manufacturer report using e-CDRweb reporting tool to send a
notification to the producing company. Additionally, the contracting
company is responsible for completing the volume manufactured (40 CFR
711.15(b)(3)) and the processing and use-related section (40 CFR
711.15(b)(4)). Upon receipt of the email, the producing company will
have the information needed to begin its portion of the co-manufacturer
report, which will include the manufacturing-related data elements from
40 CFR 711.15(b)(3), including the production volume. Each party will
complete its part of the co-manufacturer joint report as part of its
overall CDR submission and will not have access to the information
submitted by the other party. For example, the processing and use
information submitted by the contracting company will not be viewable
by the producing company.
2. Second reporting procedure. To create more flexibility for
reporters, EPA is also finalizing the alternative reporting methodology
proposed for the co-manufacturing situation. This reporting methodology
requires the contracting and producing company, upon written agreement,
to work together to complete the reporting. For this second
methodology, the producing company (instead of the contracting company)
initiates and completes the reporting in e-CDR Web. The producing
company would provide the exposure information from the manufacturing
site. The producing company would then coordinate with the contracting
company to obtain the additional information needed to complete the
submission. For example, in a co-manufacturing situation, the producing
company is not likely to know the processing and use information
associated with the co-manufactured chemical, and therefore works with
the contracting company to complete Part III of the CDR Form U.
Therefore, any ``not known or reasonably ascertainable'' (referred to
as ``NKRA'' when reporting to CDR) responses in
[[Page 20133]]
Part III would refer to the knowledge of the contracting company and
not the knowledge of the producing company. This coordination of
information between the two parties must be done outside of e-CDRweb.
Although the producing company would be submitting the report, both
parties are responsible for the report. Therefore, if no report is
filed, both the contracting company and the producing company can be
held liable. This reporting mechanism would be most appropriate in a
scenario in which the producing company has the majority of the
information regarding the production of a specific chemical.
3. Definition of site. EPA is finalizing an amendment to the
definition of site by replacing the term toll manufacturer with the
term producing company. This change makes terminology consistent
between the CDR definitions of site and manufacture.
4. Relationship of co-manufacturing to imports. Consistent with the
past CDR rule, only a domestically produced chemical substance can be
the subject of a co-manufacturing report; an imported chemical
substance cannot be. Rather, a chemical substance manufactured via an
arrangement with a foreign supplier will be considered an imported
chemical substance, and the U.S. importer alone, as the reporting
manufacturer, is responsible for reporting that substance.
D. How has the reporting of byproducts changed?
EPA is finalizing two new exemptions associated with byproducts,
the first finalized with a slight modification to add an additional
substance and the second finalized as proposed. The finalized
exemptions are (1) to exempt specifically-listed byproducts that are
recycled in a site-limited, enclosed system and to provide for a
petition process for the public to request additions to that list of
exempted manufacturing processes and related byproduct substances; and
(2) to exempt byproducts manufactured in pollution control and boiler
equipment when that equipment is non-integral to the primary
manufacturing process.
EPA also proposed, but is not finalizing, an alternative method of
reporting by category for inorganic metal byproducts. Several
commenters expressed concern that the proposal to allow for categorical
inorganic metal byproduct reporting may actually increase as opposed to
decrease reporting burden and/or add complexity for the regulated
community. EPA has determined that the issues raised in the public
comments associated with this optional reporting method outweigh the
potential benefits. More information is in Unit III.F.2.
Nine commenters supported to various degrees EPA's proposals
specific to byproducts, though some asserted that additional
clarification through guidance would be needed for reporters before
finalization, and that there would be limited time (i.e., less than a
year) for familiarization with the changes before the next reporting
cycle. Other commenters specifically opposed the proposed exemptions or
changes for byproduct reporting, stating that these changes may
constrain EPA's ability to obtain information it needs to carry out its
duties under TSCA (i.e., conducting chemical prioritization, risk
evaluation, and risk management responsibilities). EPA disagrees with
the notion that the new reporting exemptions hinder EPA's ability to
carry out its obligations under TSCA and believes that the reasons for
exempting these byproducts, laid out in the Response to Public Comments
and in the proposed rule, are sufficient (Refs. 1 and 10). The Agency
carefully considers its needs for the information collected under CDR
and the burden associated with providing such information. Some
commenters opposed the exemption by expressing that the byproduct
exemptions were not extensive enough, claiming that all byproducts
should be exempted or that beneficially used byproducts should be
exempted.
1. Specific site-limited recycled byproducts. EPA is finalizing the
proposal to exempt specifically identified byproducts that are recycled
on-site from two particular industries, and is finalizing the petition
process to make changes to this exemption list with some modifications
to the proposal.
In the proposed exemption, Portland cement manufacturers that
manufacture Flue dust, portland cement (CASRN 68475-76-3) (referred to
as cement kiln dust), and manufacturers using the Kraft pulping process
to manufacture Sulfite liquors and Cooking liquors, spent (CASRN 66071-
92-9) (often comprised of what is referred to as black liquor) and
Carbonic acid calcium salt (1:1) (CASRN 471-34-1) (referred to as
calcium carbonate) would be exempted from reporting these byproduct
substances when (1) these substances are recycled or otherwise used to
manufacture another chemical substance within an enclosed system,
within the same overall manufacturing process, and on the same site
where the byproduct was originally manufactured and (2) the non-
exempted portion of the byproduct substance or a different chemical
substance that was manufactured from the byproduct or manufactured in
the same overall manufacturing process is still reported under CDR. For
a more detailed discussion of the rationale for including these
specific chemicals in this exemption, see Unit III.D.2. of the proposed
rule (Ref. 1).
Four commenters were strongly supportive of this exemption,
although some believe the exemption is too narrow. One commenter
indicated that instead of listing processes and substances, the
exemption should be self-determining, when the site documents in its
own records that its self-identified process meets the exemption
conditions for its manufactured byproducts. EPA disagrees with this
comment, concluding that self-determination, as this commenter
describes it, is not appropriate for this exemption, which is based on
a thorough understanding of the engineering processes and controls of
the operation that EPA would need to review (i.e., via the described
petition process) prior to allowing the exemption. However, for
manufacturers that have evaluated EPA's detailed criteria for this
exemption and have determined that their site meets these conditions,
this exemption is in effect self-executing for the substances already
listed at 40 CFR 711.10(d)(1)(i). For additional discussion, see the
response to comments (Ref. 10).
Another commenter requested that EPA provide a non-isolated
intermediate exemption determination for five chemicals that they
manufacture related to the two original chemicals listed from the Kraft
pulping process. Because EPA did not propose changes to the non-
isolated intermediate exemption, this comment is largely out of scope
for this rulemaking. However, EPA is taking this opportunity to address
this comment because of its connection with the new byproduct exemption
in an effort to help the commenter apply the updated CDR reporting
requirements in its 2020 reporting. EPA concluded that two of these
five chemicals (Green liquor (CASRN 68131-30-6, Sulfite liquors and
Cooking liquors, green)) and Lime (CASRN 1305-78-8, Calcium oxide (CaO)
may be an intermediate and, depending on certain site-specific
conditions, may qualify for the non-isolated intermediate exemption.
EPA also determined that another of these five chemicals (Black liquor,
oxidized (CASRN 68514-09-0, Sulfite liquors and Cooking liquors, spent,
oxidized)) is a byproduct, is eligible for this new byproduct
exemption, and has been added to the list of Kraft pulping
[[Page 20134]]
process exempted substances. If, in the future, new information is
provided to EPA to further inform EPA's understanding of the liquors
and the Kraft pulping process, EPA can revisit its understanding. For
additional discussion, see the response to comments (Ref. 10).
EPA also proposed a petition process to enable the public to
request changes to the new list of specific exempted byproduct
substances as produced in certain manufacturing processes. Because
there may be other manufacturing processes and related byproduct
substances that meet the criteria for this exemption, and because EPA's
interest in these byproduct substances may change, EPA may amend the
list of byproduct substances and processes that have been included in
this exemption. The Agency may do this on its own initiative or in
response to a request from the public, based on EPA's determination of
whether the manufacturing process and related byproduct substance
described meet the criteria explained in this Unit. Most commenters
supported the proposed petition process for the exemption while also
suggesting modifications and guidance. Some argued that the proposed
process is too burdensome; others requested that EPA clarify how this
process will operate, including by clarifying the criteria for seeking
an amendment, how potentially sensitive information can be claimed
confidential, and additional explanation and examples of what
constitutes Agency ``interest'' in a byproduct substance. EPA agrees
that clarification is needed regarding how the byproduct exemption
petition process will operate and therefore will be providing enhanced
guidance that will include examples of the types of information that a
petition should include to assist EPA in its determination. The
guidance will also clarify the confidentiality available for
potentially sensitive information provided through the petition
process, as well as what constitutes EPA's current interest. This
guidance will be published prior to the start of the 2024 submission
period.
EPA intended the proposed regulatory text in 40 CFR 711.30(a)(1) to
address confidentiality concerns; specifically, as proposed, ``Any
person submitting information under this part may assert a
confidentiality claim for that information at the time it is
submitted.'' To emphasize how confidentiality will be addressed, EPA
has included additional references to this petition process in the CBI
substantiation procedures described in Unit III.A., as listed in 40 CFR
711.30(a)(3) and 40 CFR 711.30(b), to further provide certainty that
information submitted as part of any petition may be claimed as
confidential, and to clarify that such confidentiality claims must be
substantiated at the time of submission to the Agency, unless the
information claimed as confidential is described in TSCA section
14(c)(2). Additionally, EPA is requiring that if confidential
information is submitted in a petition, the petitioner must also
provide a sanitized version of the petition with the confidential
information redacted, so that it may be publicly posted by the Agency.
Another commenter emphasized that decisions to make any changes to
the list of exempted manufacturing processes and substances need to be
subject to public notice and a public comment opportunity. Because
rulemaking is required to change the list of manufacturing processes
and chemicals eligible for the exemption in 40 CFR 711.10(d)(1)(i), the
public will receive notice of the change and could comment.
This commenter also requested that the regulatory text clearly
indicate that two of the listed considerations are requirements for the
exemption. To better reflect the requirements of the exemption, EPA has
revised the regulatory text at 40 CFR 711.10(d)(1)(ii)(B) to clearly
indicate that two of the four listed considerations are requirements.
Other commenters requested that EPA eliminate the second factor and
stated a belief that the factors will result in additional analysis,
tracking, and reporting. EPA disagrees that the second petition factor
would result in more analysis, tracking or reporting than is already
required. The second factor is a requirement that the byproduct
substance itself (e.g., a portion of the byproduct is used for a
different purpose and not recycled in an enclosed system) or another
chemical substance from the same overall manufacturing process is being
reported. If the site has previously reported under CDR, then the site
will have the information needed to address this factor. Regarding the
second factor specifically, EPA expects to be able to ascertain typical
exposure scenarios for an exempted byproduct's manufacturing process
based on information for other substances that are reported at the
facility in the same manufacturing process. If no other substances are
reported, EPA would not otherwise have any exposure-related information
associated with the manufacturing site.
2. Byproducts generated by specified non-integral processes. EPA is
finalizing as proposed the exemption for byproducts manufactured in
certain equipment via processes that are not integral to the production
process. An integral process is the portion of the manufacturing
process that is chemically necessary or provides primary operational
support for the production of the intended product. For the purposes of
this exemption, certain associated processes that are not chemically
required to produce the intended product would be considered non-
integral. These may be required due to other regulations or the need to
generate heat or electricity on-site, but are not specifically
necessary for the manufacture of the intended product. In this final
rule, byproducts manufactured due to the use of pollution control
equipment and boilers that generate heat or electricity on-site, when
such equipment is not part of the main production process, are exempted
from reporting under CDR. For a more detailed discussion of this
exemption, see Unit III.D.3. of the proposed rule (Ref. 1).
Most commenters supported this proposed exemption; some commenters
requested that EPA expand the exemption to include beneficially used
byproducts (i.e., coal combustion residuals from utilities). However,
the production of coal combustion residuals from utilities specifically
is integral to the generation of electricity (the utility's product)
and therefore is not applicable for this exemption, which is
specifically for byproducts from non-integral equipment exemption. EPA
disagrees with the suggestion that a designation under another statute
(e.g., RCRA) of ``beneficially used'' should be an indication that the
substance should be exempted under TSCA.
Other commenters requested that EPA provide additional examples
(i.e., wastewater treatment processes) and explanation through enhanced
guidance. EPA is finalizing this exemption as proposed and will be
providing guidance for this byproduct exemption in the Instructions for
Reporting that will include examples of specific scenarios that meet
the criteria of this exemption, such as wastewater treatment, flue gas
desulfurization, and catalytic reduction systems. This guidance will be
finalized prior to the start of the next submission period.
E. What technical modifications have been made to the regulatory text?
1. Removing outdated regulatory text. EPA is finalizing the
proposal to remove regulatory text specific to the 2012 CDR submission
period. This text is no longer relevant because the submission
[[Page 20135]]
period was completed more than five years ago, and all phased-in
reporting requirements from the change from the IUR to CDR have been
fully in effect since the 2016 reporting cycle. EPA did not receive any
public comment on removing outdated regulatory text.
2. Simplifying and clarifying regulatory text. EPA is finalizing
the proposal to change or add regulatory text to simplify or clarify
regulatory requirements throughout 40 CFR part 711. These changes are
in addition to the finalized changes discussed elsewhere in this
notice, and include revisions to the following provisions:
40 CFR 711.1, to update the title to include
``Enforcement'', to more clearly identify that the section discusses
the scope, compliance, and enforcement of the CDR rule.
40 CFR 711.1(a), to remove the discussion about compiling
and keeping current the TSCA Inventory, including the discussion about
adding new chemicals to the Inventory. This discussion is unnecessary
for an understanding of the scope of the CDR rule.
40 CFR 711.1(c), to include a statement about TSCA section
11 subpoena authority, as a reminder that EPA has this authority for
compliance purposes.
40 CFR 711.3, to modify definitions for e-CDRweb,
Manufacture, and Site for clarification purposes.
40 CFR 711.6(a)(4), to reverse the order of ``certain
forms of natural gas'' and ``water'' for clarification purposes.
40 CFR 711.10, to remove duplicative wording and add
clarity to the requirements.
40 CFR 711.15(a), to add clarity to the reporting
requirements.
40 CFR 711.35(c)(1), to update references.
F. What proposed provisions are not being finalized?
In consideration of the public comments received, EPA is not
finalizing at this time the following proposed amendments to the
current CDR rule.
1. Public contact. EPA is not finalizing the proposal to enable the
reporting of a public contact for each CDR submission as a voluntary
data element. The addition of a public contact to handle public
inquiries was modeled after TRI's approach to the public contact,
albeit on a voluntary basis. For a more detailed discussion of this
proposal, see Unit III.B.6. of the proposed rule (Ref. 1). EPA
solicited comment on whether it would be helpful to have a public
contact available, and whether it should be voluntary or required. One
commenter stated that a new field for public contact is ``not necessary
and could be misleading.'' The commenter explained that the reporter
already provides a technical contact for each submission and that the
purpose of CDR is not a ``right-to-know'' for the public which would
necessitate a direct line of communication between individual companies
and the public. EPA appreciates the feedback that the proposed field of
a voluntary public contact may be misleading and, therefore, is not
finalizing this proposed data element. See the response to comment
document (Ref. 10).
2. Alternative reporting in metal compound categories for inorganic
byproducts. EPA is not finalizing the proposal to allow, but not
require, CDR reporting within defined metal compound categories for
certain elemental metals and inorganic metal compounds that are
produced as inorganic byproducts. Manufacturers of these inorganic
byproducts would have had the option to combine and report multiple
inorganic byproduct metal substances, which otherwise would be reported
individually as listed on the TSCA Inventory, into one or more
specifically-listed categories (e.g., Chromium & Chromium Compounds).
For a more detailed discussion of this proposal, see Unit III.D.1. of
the proposed rule. Public comments related to the reporting in metal
compound categories for inorganic byproducts and EPA's responses are in
the response to comment document (Ref. 10).
Three commenters supported the proposed optional method of
reporting inorganic metal byproducts, while six commenters either
stated that optional category reporting would add reporting complexity
or expressed doubt that it would be used. Other commenters opposed the
proposal outright, bringing a number of perspectives to EPA's
attention. In consideration of the stakeholder comments, EPA has
determined that the potential for additional complexity and burden
associated with category reporting for inorganic metal byproducts
outweighs the potential benefits. Accordingly, EPA is not finalizing
the proposed provision for alternative reporting in metal compound
categories for inorganic byproducts. Because this proposed reporting
approach is not being finalized, EPA is also not finalizing a specific
definition of ``inorganic chemical substance'' under CDR at 40 CFR
711.3.
3. Consolidating byproduct exemption regulatory text. EPA is not
finalizing the proposal to consolidate regulations regarding byproduct
exemptions that affect reporting under the CDR rule into 40 CFR 711.10,
such that all the CDR reporting exemptions regarding manufacturer
activities would be in one place. Specifically, EPA proposed that
language from 40 CFR 720.30(g) and (h) that is currently incorporated
by reference would be replicated in 40 CFR 711.10(c) without change.
Industry and environmental advocacy commenters opposed bringing
over the exemptions from 40 CFR 720.30 (the Premanufacture Notice (PMN)
program) without changes, suggesting that EPA review the current
definitions against the current TSCA and EPA data needs, justify
exemptions that will continue, and provide an opportunity for public
comment on the justification. If exemptions were retained, commenters
suggested both regulatory and guidance changes (Ref. 10).
The Agency has determined that guidance is currently sufficient to
address these concerns. While there appears to be confusion surrounding
the exemptions, that confusion in itself does not justify altering or
removing the exemptions at this time. Obtaining information on percent
byproduct in the next reporting cycle will further EPA's understanding
of byproducts in commerce and will help to inform any future
determination as to whether alteration of the existing exemptions is
warranted.
IV. References
The following is a listing of the documents that are specifically
referenced in this document. The docket includes these documents and
other information considered by EPA, including documents that are
referenced within the documents that are included in the docket, even
if the referenced document is not physically located in the docket. For
assistance in locating these other documents, please consult the
technical person listed under FOR FURTHER INFORMATION CONTACT.
1. EPA. TSCA Chemical Data Reporting Revisions and Small
Manufacturer Definition Updates for Reporting and Recordkeeping
Requirements Under TSCA section 8(a); Proposed Rule, Federal
Register, 84 FR 17692, April 25, 2019 (FRL-9982-16).
2. EPA. Public Webinar to Obtain Feedback on Improving CDR;
Outreach meeting. Attended by public, reporters to CDR, and EPA.
Washington, DC. May 1, 2017.
3. Amy D Kyle. ``Issues Raised by the Regulatory Negotiation on
Inorganic Byproducts in the Toxic Substances Control Act as
amended.'' December 13, 2017. (EPA Docket EPA-HQ-OPPT-2016-0597-
0087).
4. EPA. Chemical Data Reporting; Requirements for Inorganic
Byproduct Chemical Substances; Notice of Public
[[Page 20136]]
Meeting; Cancellation and Public Input Opportunity. Proposed Rule,
Federal Register, 82 FR 47423, October 12, 2017 (FRL-9968-94).
5. EPA (2020). Supporting Statement for an Information
Collection Request (ICR) Addendum Under the Paperwork Reduction Act
(PRA) (EPA ICR No. 1884.11; OMB Control Number 2070-0162). March
2020.
6. EPA. Request for Approval under the ``Generic Clearance for
the Collection of Routine Customer Feedback.'' (OMB Control Number:
2010-0042). February 2020.
7. EPA. Economic Analysis for the Final Rule on TSCA Chemical
Data Reporting (CDR) Revisions--(RIN 2070-AK33). Office of
Pollution, Prevention, and Toxics. Washington, DC. December 2019.
8. EPA. CBI Substantiation Estimator Correction September 17,
2019. Office of Pollution, Prevention, and Toxics. Washington, DC.
December 2019.
9. EPA. TSCA CDR Instructions for Reporting. Office of Pollution
Prevention and Toxics. Washington, DC. February 2020.
10. EPA. Response to Public Comments on the Final TSCA Chemical
Data Reporting (CDR) Revisions Rule. Office of Pollution Prevention
and Toxics. Washington, DC. February 2020.
11. EPA. Meeting Memo--Tribal Outreach Sessions. Office of
Pollution Prevention and Toxics. Washington, DC. July 30, and August
1, 2019.
12. EPA. Meeting Memo--Meeting with IPC. Office of Pollution
Prevention and Toxics. Washington, DC. June 13, 2019.
13. EPA. Meeting Memo--IPC/TTM Site Visit/Plant Tour. Office of
Pollution Prevention and Toxics. Sterling, VA. July 10, 2019.
14. EPA. Meeting Memo--Lehigh Hanson Cement Site Visit/Plant
Tour. Office of Pollution Prevention and Toxics. Union Bridge, MD.
August 9, 2019.
15. Franz, Christina to Hartman, Mark, August 9, 2019. Letter to
EPA: ``Request of the American Chemistry Council for EPA to Reopen
CDR and CBI Rulemaking Comment Periods in Light of Supreme Court
Decision.'' (EPA Docket EPA-HQ-OPPT-2018-0320-0038). American
Chemistry Council. Washington, DC.
16. EPA. Statutory Requirements for Substantiation of
Confidential Business Information (CBI) Claims Under the Toxic
Substances Control Act (TSCA) (82 FR 6522, January 19, 2017). Office
of Pollution Prevention and Toxics. Washington, DC.
17. EPA (2018). OPPT. Technical Support Document: Harmonizing
CDR Functional and Product codes with OECD Functional, Product, and
Article Codes. August 2018.
18. EPA. 1997 North American Industry Classification System--
1987 Standard Industrial Classification Replacement. Notice, Federal
Register, 62 FR 17288. April 9, 1997.
19. Environment Defense Fund. ``Environmental Defense Fund
Comments on TSCA Chemical Data Reporting Revisions and Small
Manufacturer Definition Update for Reporting and Recordkeeping
Requirements.'' June 24, 2019. (EPA Docket EPA-HQ-OPPT-2018-0321-
0107).
20. EPA. Economic Analysis for the Proposed Rule on TSCA Section
8(a) Small Manufacturer Definition Update (RIN 2070-AK33). Office of
Pollution, Prevention, and Toxics. Washington, DC. August 2018.
V. Statutory and Executive Order Reviews
Additional information about these statutes and Executive orders
can be found at https://www.epa.gov/laws-regulations-and-executive-orders.
A. Executive Order 12866: Regulatory Planning and Review and Executive
Order 13563: Improving Regulations and Regulatory Review
This action is a significant regulatory action that was submitted
to the Office of Management and Budget (OMB) for review under Executive
Order 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821,
January 21, 2011). Any changes made in response to OMB recommendations
have been documented in the docket for this action as required by
section 6(a)(3)(E) of Executive Order 12866.
EPA prepared an economic analysis of the potential costs and
benefits associated with this action. A copy of this economic analysis,
entitled Economic Analysis for the TSCA Chemical Data Reporting
Revisions Final Rule (Ref. 7) is in the docket and is briefly
summarized in Unit I.E.
B. Executive Order 13771: Reducing Regulation and Controlling
Regulatory Costs
This action is considered a regulatory action under Executive Order
13771 (82 FR 9339, February 3, 2017). Details on the estimated costs of
this final rule can be found in the Economic Analysis (Ref. 7) which is
briefly summarized in Unit I.E.
C. Paperwork Reduction Act (PRA)
For CDR, the information collection requirements in 40 CFR part 711
related to the submission of Form Us are already approved by OMB under
the PRA, 44 U.S.C. 3501 et seq. That Information Collection Request
(ICR) has been assigned EPA ICR No. 1884 and OMB Control No. 2070-0162.
Because this final rule involves new or revised information collection
activities that require additional OMB approval, EPA has prepared an
addendum to the currently approved ICR (ICR addendum) (Ref. 5). You can
find a copy of the ICR addendum in the docket for this rule (EPA-HQ-
OPPT-2018-0321), and it is briefly summarized here.
Respondents/affected entities: Entities potentially affected by
this ICR include companies manufacturing (including importing) chemical
substances listed on the TSCA Inventory and regulated under TSCA
section 8.
Respondent's obligation to respond: Mandatory.
Estimated number of respondents: 5,660.
Frequency of response: The collection occurs every four years. The
next CDR collection will occur in 2020.
Total estimated burden: 26,469 hours per year. Burden is defined at
5 CFR 1320.3(b).
Total estimated cost: $2,053,700 per year, includes $0 annualized
capital or operation and maintenance costs.
An agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information unless it displays a
currently valid OMB control number. The OMB control numbers for EPA's
regulations in 40 CFR are listed in 40 CFR part 9. When OMB approves
this ICR addendum, the Agency will announce that approval in the
Federal Register and publish a technical amendment to 4 CFR part 9 to
display the OMB control number for the approved information collection
action contained in this final rule.
D. Regulatory Flexibility Act (RFA)
Pursuant to section 605(b) of the RFA, 5 U.S.C. 601 et seq., I
certify that this action will not have a significant economic impact on
a substantial number of small entities. The Agency's basis is briefly
summarized here and is detailed in the Economic Analysis (Ref. 7).
Under RFA, small entities include small businesses, small
organizations, and small governmental jurisdictions. For purposes of
assessing the impacts of this rule on small entities, small entity is
defined as:
1. A small business, as defined by the SBA's regulations at 13 CFR
121.201.
2. A small governmental jurisdiction that is a government of a
city, county, town, school district, or special district with a
population of less than 50,000.
3. A small organization that is any not-for-profit enterprise which
is independently owned and operated and is not dominant in its field.
For CDR, the regulated community does not include small not-for-
profit organizations. Therefore, the focus of the RFA analysis for this
rule is on small businesses and small governments.
The existing CDR requirements, at 40 CFR 711, generally exempt from
reporting small businesses, defined at 40 CFR 704.3 as entities with
annual sales of less than $40 million and less than 100,000 lb
production of any given chemical at a site; or annual sales of less
than $4 million. A small business would be required to report under the
final rule, however, if it produces any
[[Page 20137]]
chemical that is the subject of a regulation proposed or promulgated
under TSCA sections 4, 5(b)(4), or 6, or that is the subject of an
order under TSCA section 5(e), or that is the subject of relief that
has been granted pursuant to a civil action under TSCA section 5 or 7.
A small business may also report voluntarily. No exemption for small
governments is provided in the existing CDR requirements.
EPA estimates that 733 small industry parent entities and four
small governmental entities would potentially be affected by this rule.
Based on estimated maximum compliance costs annualized over a ten-year
period and revenue data for parent entities, EPA estimates that the
cost-to-revenue ratio of the CDR Revisions rule would be less than 1%
for 727 (99%) of small industry parent entities subject to the rule. An
additional two small industry parent entities are expected to incur
cost impacts between 1 and 3%, and four small industry parent entities
are expected to incur cost impacts above 3%. None of the small
government parent entities are expected to incur cost impacts of
greater than 1% of revenues. Therefore, EPA concludes that compliance
costs associated with the CDR revisions final rule are not expected to
have a significant economic impact on a substantial number of small
entities.
E. Unfunded Mandates Reform Act (UMRA)
This action does not contain an unfunded mandate of $100 million or
more as described in UMRA, 2 U.S.C. 1531-1538, and would not
significantly or uniquely affect small governments. According to the
information derived using the 2016 CDR, there are government entities
that report to CDR, including: Seven municipalities, one county-level
public utility district, and one tribal entity. Impacts would not
exceed $100 million for all governments. The final rule is not expected
to result in expenditures by State, local, and Tribal governments, in
the aggregate, or by the private sector, of $100 million or more (when
adjusted annually for inflation) in any one year. Accordingly, this
final rule is not subject to the requirements of sections 202, 203, or
205 of UMRA.
F. Executive Order 13132: Federalism
This action does not have federalism implications because it is not
expected to have substantial direct effects on the states, on the
relationship between the National Government and the states, or on the
distribution of power and responsibilities among the various levels of
government as specified in Executive Order 13132 (64 FR 43255, August
10, 1999). Thus, Executive Order 13132 does not apply to this action.
G. Executive Order 13175: Consultation and Coordination With Indian
Tribal Governments
This action does not have tribal implications because it is not
expected to have substantial direct effects on tribal governments, on
the relationship between the Federal Government and the Indian tribes,
or on the distribution of power and responsibilities between the
Federal Government and Indian tribes as specified in Executive Order
13175 (65 FR 67249, November 9, 2000). Thus, Executive Order 13175 does
not apply to this final rule. On July 30 and August 1, 2019, EPA
conducted two presentations as part of tribal outreach to provide
background information on the proposed rule and to obtain feedback. Two
identical outreach sessions were conducted, and EPA received no follow-
up comments.
H. Executive Order 13045: Protection of Children From Environmental
Health and Safety Risks
EPA interprets Executive Order 13045 (62 FR 19885, April 23, 1997),
as applying only to those regulatory actions that concern environmental
health or safety risks, such that the analysis required under section
5-501 of Executive Order 13045 has the potential to influence the
regulation. This action is not subject to Executive Order 13045 because
it would not establish an environmental standard intended to mitigate
health or safety risks. Nevertheless, the information obtained by the
reporting required by this final rule will be used to inform the
Agency's decision-making process regarding chemical substances to which
children may be disproportionately exposed. This information would also
assist the Agency and others in determining whether the chemical
substances covered in this final rule present potential risks, allowing
the Agency and others to take appropriate action to investigate and
mitigate those risks.
I. Executive Order 13211: Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use
This action is not a ``significant energy action'' as defined in
Executive Order 13211 (66 FR 28355, May 22, 2001) because it is not
likely to have a significant adverse effect on the supply,
distribution, or use of energy.
J. National Technology Transfer and Advancement Act (NTTAA)
Because this action does not involve any technical standards, NTTAA
section 12(d), 15 U.S.C. 272 note, does not apply to this action.
K. Executive Order 12898: Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Populations
This action is not expected to have high and adverse human health
or environmental effects on minority populations, low-income
populations, and/or indigenous peoples as specified in Executive Order
12898 (59 FR 7629, February 16, 1994). The Agency believes that the
rule would improve the information collected under CDR and better
assist EPA and others in determining the potential hazards and risks
associated with the chemical substances covered by the CDR. Because the
CDR is an information collection requirement, the information that
would be improved through the final rule would enable the Agency to
target educational, regulatory, or enforcement activities towards
industries or chemical substances that pose the greatest risks and/or
to target programs for geographic areas that are at the highest risk.
Thus, the information to be gathered under this rule will help EPA make
decisions that would benefit potentially at-risk communities, some of
which may be disadvantaged.
The rule is directed at manufacturers (including importers) of
chemical substances. All consumers of these chemical products and all
workers who come into contact with these chemical substances could
benefit if data regarding the chemical substances' health and
environmental effects were developed. Therefore, it would not appear
that the costs and the benefits of the final rule would be
disproportionately distributed across different geographic regions or
among different categories of individuals.
VI. Congressional Review Act (CRA)
This action is subject to the CRA, 5 U.S.C. 801 et seq., and EPA
will submit a rule report to each House of the Congress and to the
Comptroller General of the United States. This action is not a ``major
rule'' as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 711
Environmental protection, Toxic substances control act, TSCA
chemical data reporting and recordkeeping requirements.
[[Page 20138]]
Dated: March 17, 2020.
Alexandra Dapolito Dunn,
Assistant Administrator, Office of Chemical Safety and Pollution
Prevention.
Therefore, 40 CFR part 711 is amended as follows:
PART 711--[AMENDED]
0
1. The authority citation for part 711 continues to read as follows:
Authority: 15 U.S.C. 2607(a).
0
2. Amend Sec. 711.1 by revising the section heading, and paragraphs
(a) and (c), to read as follows:
Sec. 711.1 Scope, compliance, and enforcement.
(a) This subpart specifies reporting and recordkeeping procedures
under section 8(a) of the Toxic Substances Control Act (TSCA) (15
U.S.C. 2607(a)) for certain manufacturers (including importers) of
chemical substances. TSCA section 8(a) authorizes the EPA Administrator
to require reporting of information necessary for the administration of
TSCA.
* * * * *
(c) TSCA section 15(3) makes it unlawful for any person to fail or
refuse to submit information required under this part. In addition,
TSCA section 15(3) makes it unlawful for any person to fail to keep,
and permit access to, records required by this part. Section 16 of TSCA
provides that any person who violates a provision of TSCA section 15 is
liable to the United States for a civil penalty and may be criminally
prosecuted. Pursuant to TSCA section 17, the Federal Government may
seek judicial relief to compel submission of TSCA section 8(a)
information and to otherwise restrain any violation of TSCA section 15.
(EPA does not intend to concentrate its enforcement efforts on
insignificant clerical errors in reporting.) TSCA section 11 allows for
inspections to assure compliance, and the Administrator may by subpoena
require the attendance and testimony of witnesses and the production of
reports, papers, documents, answers to questions, and other information
that the Administrator deems necessary.
* * * * *
0
3. In Sec. 711.3:
0
a. Revise the definitions of ``e-CDRweb'' and ``Manufacture'';
0
b. Add alphabetically the definition for ``Highest-level parent
company''.
0
c. Revise paragraph (1) of the definition for ``Site'';
0
d. Remove the definition for ``U.S. parent company'';
The additions and revisions read as follows:
Sec. 711.3 Definitions.
* * * * *
e-CDRweb means the electronic, web-based tool provided by EPA for
the completion of Form U and submission of the CDR data.
* * * * *
Manufacture means to manufacture, produce, or import, for
commercial purposes. Manufacture includes the extraction, for
commercial purposes, of a component chemical substance from a
previously existing chemical substance or complex combination of
chemical substances. A chemical substance is co-manufactured by the
person who physically performs the manufacturing and the person
contracting for such production when that chemical substance,
manufactured other than by import, is:
(1) Produced exclusively for another person who contracts for such
production, and
(2) That other person dictates the specific chemical identity of
the chemical substance and controls the total amount produced and the
basic technology for the manufacturing process.
* * * * *
Highest-level parent company means the highest-level company of the
site's ownership hierarchy as of the start of the submission period
during which data are being reported according to the following
instructions. The highest-level U.S. parent company is located within
the United States while the highest-level foreign parent company is
located outside the United States. The following rules govern how to
identify the highest-level U.S. parent company and highest-level
foreign parent company (if applicable):
(1) If the site is entirely owned by a single U.S. company that is
not owned by another company, that single company is the U.S. parent
company.
(2) If the site is entirely owned by a single U.S. company that is,
itself, owned by another U.S.-based company (e.g., it is a division or
subsidiary of a higher-level company), the highest-level domestic
company in the ownership hierarchy is the United States parent company.
If there is a higher-level parent company that is outside of the United
States, the highest-level foreign company in the ownership hierarchy is
the foreign parent company.
(3) If the site is owned by more than one company (e.g., company A
owns 40 percent, company B owns 35 percent, and company C owns 25
percent), the company with the largest ownership interest in the site
is the parent company. If a higher-level company in the ownership
hierarchy owns more than one ownership company, then determine the
entity with the largest ownership by considering the lower-level
ownerships in combination (e.g., corporation x owns companies B and C,
for a total ownership of 60 percent for the site).
(i) If the parent company is a U.S. company owned by another U.S.
company, then the highest-level domestic company in the ownership
hierarchy is the U.S. parent company. If the U.S. parent company has a
higher-level foreign company in the ownership hierarchy, then the
highest-level foreign company in the ownership hierarchy is the foreign
parent company.
(ii) If the parent company is a foreign company, then the site is
its own U.S. parent company and the foreign parent company is the
highest-level foreign company in the ownership hierarchy.
(4) If the site is owned by a 50:50 joint venture or a cooperative,
the joint venture or cooperative is its own parent company. If the site
is owned by a U.S. joint venture or cooperative, the highest level of
the joint venture or cooperative is the U.S. parent company. If the
site is owned by a joint venture or cooperative outside the United
States, the highest level of the joint venture or cooperative outside
the United States is the foreign parent company.
(5) If the site is entirely owned by a foreign company (i.e.,
without a U.S.-based subsidiary within the site's ownership hierarchy),
the highest-level foreign company in the ownership hierarchy is the
site's foreign parent company.
(6) If the site is federally owned, the highest-level federal
agency or department is the U.S. parent company.
(7) If the site is owned by a non-federal public entity, that
entity (such as a municipality, State, or tribe) is the U.S. parent
company.
* * * * *
Sites * * *
(1) For chemical substances manufactured under contract, i.e., by a
co-manufacturer, the site is the location where the chemical substance
is physically manufactured.
* * * * *
0
4. Amend Sec. 711.6 by revising the section heading, the introductory
text and the paragraph (a)(4) subject heading to read as follows.
Sec. 711.6 Chemical substances for which information is not required.
The following groups or categories of chemical substances are
exempted from some or all of the reporting requirements of this part,
with the
[[Page 20139]]
following exception: A chemical substance described in paragraph
(a)(1), (2), or (4), or (b) of this section is not exempted from any of
the reporting requirements of this part if that chemical substance is
the subject of a rule proposed or promulgated under TSCA sections 4,
5(a)(2), 5(b)(4), or 6, or is the subject of an enforceable consent
agreement (ECA) developed under the procedures of 40 CFR part 790, or
is the subject of an order issued under TSCA sections 4, 5(e), or 5(f),
or is the subject of relief that has been granted under a civil action
under TSCA sections 5 or 7.
* * * * *
(a) * * *
(4). Water and certain forms of natural gas. * * *
* * * * *
0
5. Amend Sec. 711.8 by revising paragraphs (a) and (b) to read as
follows:
Sec. 711.8 Persons who must report.
* * * * *
(a) Persons subject to recurring reporting. Any person who
manufactured (including imported) for commercial purposes 25,000 lb
(11,340 kg) or more of a chemical substance described in Sec. 711.5 at
any single site owned or controlled by that person during any calendar
year since the last principal reporting year.
(b) Exceptions. Any person who manufactured (including imported)
for commercial purposes any chemical substance that is the subject of a
rule proposed or promulgated under TSCA section 5(a)(2), 5(b)(4), or 6,
or is the subject of an order in effect under TSCA section 4, 5(e) or
5(f), or is the subject of relief that has been granted under a civil
action under TSCA sections 5 or 7 is subject to reporting as described
in Sec. 711.8(a), except that the applicable production volume
threshold is 2,500 lb (1,134 kg).
0
6. Revise Sec. 711.9 to read as follows:
Sec. 711.9 Persons not subject to this part.
A person described in Sec. 711.8 is not subject to the
requirements of this part if that person qualifies as a small
manufacturer or small government as those terms are defined in 40 CFR
704.3. Notwithstanding this exclusion, a person who qualifies as a
small manufacturer or small government is subject to this part with
respect to any chemical substance that is the subject of a rule
proposed or promulgated under TSCA section 4, 5(b)(4), or 6, or is the
subject of an order in effect under TSCA section 4 or 5(e), or is the
subject of relief that has been granted under a civil action under TSCA
section 5 or 7.
0
7. Revise Sec. 711.10 to read as follows:
Sec. 711.10 Activities for which reporting is not required.
A person described in Sec. 711.8 is not subject to the
requirements of this part with respect to any chemical substance
described in Sec. 711.5, when:
(a) The person manufactured or imported the chemical substance
solely in small quantities for research and development.
(b) The person imported the chemical substance as part of an
article.
(c) The person manufactured the chemical substance in a manner
described in 40 CFR 720.30(g) or (h).
(d) The person manufactured the chemical substance in any of the
following manners:
(1) Byproduct substances listed in paragraph (i) of this section
for the following manufacturing processes, when recycled or otherwise
used within a site-limited, physically enclosed system that is part of
the same overall manufacturing process from which the byproduct
substance was generated, and when the site is reporting the byproduct
or a different chemical substance that was manufactured from the
recycled byproduct or manufactured in the same overall manufacturing
process:
(i) List of processes and certain related byproduct substances. (A)
Portland Cement Manufacturing (i.e., CASRN 68475-76-3, Flue dust,
portland cement).
(B) Kraft Pulping Process (i.e., CASRN 66071-92-9, Sulfite liquors
and Cooking liquors, spent; CASRN 68514-09-0, Sulfite liquors and
Cooking liquors, spent, oxidized; and CASRN 471-34-1, Carbonic acid
calcium salt (1:1)).
(ii) Amendments. EPA may amend the exemptions list in paragraph
(d)(1)(i) of this section on its own initiative or in response to a
request from the public based on EPA's determination of whether the
byproduct substance and process described meet the criteria explained
in this paragraph (d)(1), based on the requirements and considerations
listed in paragraphs (d)(1)(ii)(B) and (C) of this section.
(A) Any person may request that EPA amend the chemical substance
list in paragraph (d)(1)(i) of this section. Your request must be in
writing and must be submitted to the address provided in 40 CFR
700.17(a). Please label your request as follows: Attention: TSCA
Chemical Data Reporting--Byproduct Exemption Request. Requests must
identify the manufacturing process and byproduct chemical substance in
question, as well as its CASRN or other chemical identification number
as identified in 40 CFR 711.15(b)(3)(i), and must contain a written
rationale for the request that provides sufficient specific
information, addressing the requirements and considerations listed in
paragraphs (d)(1)(ii)(B) and (C) of this section, including citations
and relevant documents, to demonstrate to EPA that the byproduct
substance and process in question either does or does not meet the
criteria explained in this paragraph (d)(1). If a request related to a
particular byproduct substance and process is resubmitted, any
subsequent request must clearly identify new information contained in
the request. EPA may request other information that it believes
necessary to evaluate the request. EPA will issue a written response to
each request within 120 days of receipt of the request and will
maintain copies of these responses in a docket that will be established
for each reporting cycle.
(B) In making its determination whether this exemption should apply
to a particular manufacturing process and related byproduct substance,
the following two requirements must be met:
(1) The byproduct substance is recycled or otherwise used to
manufacture another chemical substance within an enclosed system,
within the same overall manufacturing process, and on the same site as
that byproduct was originally manufactured.
(2) The site is reporting under CDR other chemical substances, in
particular a chemical substance other than the byproduct substance that
was manufactured from the byproduct or manufactured in the same overall
manufacturing process.
(C) In addition to the requirements in paragraph (d)(1)(ii)(B) of
this section, EPA will consider the totality of information available
for the process and related byproduct substance in question, including
but not limited to, one or both of the following considerations:
(1) Whether EPA has a current interest in the byproduct substance.
(2) Whether the byproduct substance must have already been reported
under CDR, or would be expected to be reported if not exempted by this
exemption.
(D) After granting a petition, the Agency will initiate rulemaking
to make revisions to the list of substances in paragraph (d)(1)(i) of
this section.
(E) To assist EPA in reaching a decision regarding a particular
request prior to a given principal reporting year, requests must be
submitted to EPA no later than 12 months prior to the start of the next
principal reporting year.
(2) A quantity of the byproduct that is manufactured solely in the
following
[[Page 20140]]
equipment when it is not integral to the chemical manufacturing
processes of the site:
(i) Pollution control equipment.
(ii) Boilers used to generate heat or electricity for that site.
0
8. Revise Sec. 711.15 to read as follows.
Sec. 711.15 Reporting information to EPA.
Any person who must report under this part, as described in Sec.
711.8, must submit the information described in this section for each
chemical substance described in Sec. 711.5 that the person
manufactured (including imported) for commercial purposes in an amount
of 25,000 lb (11,340 kg) or more (or in an amount of 2,500 lb (1,134
kg) or more for chemical substances subject to the rules, orders, or
actions described in Sec. 711.8(b)) at any one site during any
calendar year since the last principal reporting year (e.g., for the
2020 submission period, consider calendar years 2016, 2017, 2018, and
2019, because 2015 was the last principal reporting year). The
principal reporting year for each submission period is the previous
calendar year (e.g., the principal reporting year for the 2020
submission period is calendar year 2019). For all submission periods, a
separate report must be submitted for each chemical substance at each
site for which the submitter is required to report. A submitter of
information under this part must report information as described in
this section to the extent that such information is known to or
reasonably ascertainable by that person.
(a) Reporting information to EPA. Any person who reports
information to EPA must complete a Form U using the e-CDRweb reporting
tool provided by EPA at the address set forth in Sec. 711.35. The
submission must include all information described in paragraph (b) of
this section. Persons must submit the chemical reports on a separate
single Form U for each site for which the person is required to report.
The e-CDRweb reporting tool is described in the instructions available
from EPA at the website set forth in Sec. 711.35.
(b) Information to be reported. The information described in
paragraphs (b)(1) through (4) of this section must be reported for each
chemical substance manufactured (including imported) in an amount of
25,000 lb (11,340 kg) or more (or in an amount of 2,500 lb (1,134 kg)
or more for chemical substances subject to the rules, orders, or
actions described in Sec. 711.8(b)) at any one site during any
calendar year since the last principal reporting year. The requirement
to report information described in paragraph (b)(4) of this section is
subject to exemption as described in Sec. 711.6.
(1) A certification statement signed and dated by an authorized
official of the submitter company. The authorized official must certify
that the submitted information has been completed in compliance with
the requirements of this part and that the confidentiality claims made
on the Form U are true and correct. The certification must be signed
and dated by the authorized official for the submitter company, and
provide that person's name, official title, and email address.
(2) Company and site information. The following currently correct
parent company and site information at the date of CDR submission must
be reported for each site at which a reportable chemical substance is
manufactured (including imported) above the applicable production
volume threshold, as described in this section (see Sec. 711.3 for the
``site'' for importers and special situations).
(i) The legal name, address, and Dun and Bradstreet D-U-N-S[supreg]
(D&B) number for the highest-level parent company located in the United
States and, if one exists, for the highest-level foreign-based parent
company. A submitter under this part must obtain a D&B number for the
parent company if none exists and must report using the standardized
conventions for the naming of a parent company as provided in the CDR
Instructions for Reporting identified in Sec. 711.35.
(ii) The name of a person who will serve as technical contact for
the submitter company who will be able to answer questions about the
information submitted by the company to EPA, and that technical contact
person's full mailing address, telephone number, and email address.
(iii) The legal name and full street address of each site. A
submitter under this part must include the appropriate D&B number for
each site reported, and the county or parish (or other jurisdictional
indicator) in which the site is located. A submitter under this part
must obtain a D&B number for the site reported if none exists. For a
co-manufacturing situation in which the contracting company initiates
the report, the contracting company must report both the site
controlling the contract and the producing company's site information.
(iv) The six-digit NAICS code for the site. A submitter under this
part must include the appropriate six-digit NAICS code for each site
reported.
(3) Chemical-specific information. The following chemical-specific
information must be reported for each reportable chemical substance
manufactured (including imported) above the applicable production
volume threshold, as described in paragraph (b) of this section:
(i) The specific, currently correct CA Index name as used to list
the chemical substance on the TSCA Inventory and the correct
corresponding CASRN for each reportable chemical substance at each
site. Submitters who wish to report chemical substances listed on the
confidential portion of the TSCA Inventory will need to report the
chemical substance using the corresponding TSCA Accession Number that
is listed on the public portion of the Inventory. In addition to
reporting the chemical identifying number itself, submitters must
specify the type of number they are reporting by selecting from among
the codes in Table 1 to paragraph (b)(3)(i).
Table 1 to Paragraph (b)(3)(i)--Codes To Specify Type of Chemical
Identifying Number
------------------------------------------------------------------------
Code Number type
------------------------------------------------------------------------
A............................... TSCA Accession Number.
C............................... Chemical Abstracts Service Registry
Number (CASRN).
------------------------------------------------------------------------
(A) If an importer submitting a report cannot provide the
information specified in this paragraph (b)(3)(i) because it is unknown
to the importer and claimed as confidential by the supplier of the
chemical substance or mixture, the importer must use e-CDRweb to ask
the supplier to provide the correct chemical identity and, in the case
of a mixture, the percentage of formulation and chemical function
information directly to EPA in a joint submission. Such request must
include instructions for submitting chemical identity information
electronically, using e-CDRweb and CDX (see Sec. 711.35), and for
clearly referencing the importer's submission. Contact information for
the supplier, a trade name or other designation for the chemical
substance or mixture, and a copy of the request to the supplier must be
included with the importer's submission.
(B) If a manufacturer submitting a report cannot provide the
information specified in this paragraph (b)(3)(i) because the
reportable chemical substance is manufactured using a reactant having a
specific chemical identity that is unknown to the manufacturer and
claimed as confidential by its supplier, the manufacturer must use e-
CDRweb to ask the supplier of the confidential reactant to provide the
correct chemical identity
[[Page 20141]]
of the confidential reactant directly to EPA in a joint submission.
Such request must include instructions for submitting chemical identity
information electronically using e-CDRweb and CDX (see Sec. 711.35),
and for clearly referencing the manufacturer's submission. Contact
information for the supplier, a trade name or other designation for the
chemical substance, and a copy of the request to the supplier must be
included with the importer's submission.
(C) EPA will accept only joint submissions that are submitted
electronically using e-CDRweb and CDX (see Sec. 711.35) and that
clearly reference the primary submission to which they refer.
(ii) For the principal reporting year only, a statement indicating,
for each reportable chemical substance at each site, whether the
chemical substance is manufactured in the United States, imported into
the United States, or both manufactured in the United States and
imported into the United States.
(iii) For the principal reporting year only, the total annual
volume (in pounds) of each reportable chemical substance domestically
manufactured or imported at each site. The total annual domestically
manufactured volume (not including imported volume) and the total
annual imported volume must be separately reported. These amounts must
be reported to two significant figures of accuracy. In addition, the
total annual volume (domestically manufactured plus imported volumes in
pounds) of each reportable chemical substance at each site for each
complete calendar year since the last principal reporting year.
(iv) For the principal reporting year only, the volume used on site
and the volume directly exported of each reportable chemical substance
domestically manufactured or imported at each site. These amounts must
be reported to two significant figures of accuracy.
(v) For the principal reporting year only, a designation
indicating, for each imported reportable chemical substance at each
site, whether the imported chemical substance is physically present at
the reporting site.
(vi) For the principal reporting year only, a designation
indicating, for each reportable chemical substance at each site,
whether the chemical substance is being recycled or otherwise used for
a commercial purpose instead of being disposed of as a waste or
included in a waste stream.
(vii) For the principal reporting year only, the total number of
workers reasonably likely to be exposed to each reportable chemical
substance at each site. For each reportable chemical substance at each
site, the submitter must select from among the ranges of workers listed
in Table 2 to paragraph (b)(3)(vii) and report the corresponding code
(i.e., W1 through W8):
Table 2 to Paragraph (b)(3)(vii)--Codes for Reporting Number of Workers
Reasonably Likely To Be Exposed
------------------------------------------------------------------------
Code Range
------------------------------------------------------------------------
W1.............................. Fewer than 10 workers.
W2.............................. At least 10 but fewer than 25 workers.
W3.............................. At least 25 but fewer than 50 workers.
W4.............................. At least 50 but fewer than 100
workers.
W5.............................. At least 100 but fewer than 500
workers.
W6.............................. At least 500 but fewer than 1,000
workers.
W7.............................. At least 1,000 but fewer than 10,000
workers.
W8.............................. At least 10,000 workers.
------------------------------------------------------------------------
(viii) For the principal reporting year only, the maximum
concentration, measured by percentage of weight, of each reportable
chemical substance at the time it is sent off-site from each site. If
the chemical substance is site-limited, you must report the maximum
concentration, measured by percentage of weight of the reportable
chemical substance at the time it is reacted on-site to produce a
different chemical substance. This information must be reported
regardless of the physical form(s) in which the chemical substance is
sent off-site/reacted on-site. For each chemical substance at each
site, select the maximum concentration of the chemical substance from
among the ranges listed in Table 3 to paragraph (b)(3)(viii) and report
the corresponding code (i.e., M1 through M5):
Table 3 to Paragraph (b)(3)(viii)--Codes for Reporting Maximum
Concentration of Chemical Substance
------------------------------------------------------------------------
Code Concentration range (percent weight)
------------------------------------------------------------------------
M1.............................. Less than 1 percent by weight.
M2.............................. At least 1 but less than 30 percent by
weight.
M3.............................. At least 30 but less than 60 percent
by weight.
M4.............................. At least 60 but less than 90 percent
by weight.
M5.............................. At least 90 percent by weight.
------------------------------------------------------------------------
(ix) For the principal reporting year only, the physical form(s) of
the reportable chemical substance as it is sent off-site from each
site. If the chemical substance is site-limited, you must report the
physical form(s) of the reportable chemical substance at the time it is
reacted on-site to produce a different chemical substance. For each
chemical substance at each site, the submitter must report as many
physical forms as applicable from among the physical forms listed in
this Unit:
(A) Dry powder.
(B) Pellets or large crystals.
(C) Water- or solvent-wet solid.
(D) Other solid.
(E) Gas or vapor.
(F) Liquid.
(x) For the principal reporting year only, submitters must report
the percentage, rounded off to the closest 10 percent, of total
production volume of the reportable chemical substance, reported in
response to paragraph (b)(3)(iii) of this section, that is associated
with each physical form reported under paragraph (b)(3)(ix) of this
section.
(4) Chemical-specific information related to processing and use.
The following chemical-specific information must be reported for each
reportable chemical substance manufactured (including imported) above
the applicable production volume threshold, as described in this
section. Persons subject to paragraph (b)(4) of this section must
report the information described in paragraphs (b)(4)(i) and (ii) of
this section for each reportable chemical substance at sites under
their control and at sites that receive a reportable chemical substance
from the submitter directly or indirectly (including through a broker/
distributor, from a customer of the submitter, etc.). Information
reported in response to this paragraph must be reported for the
principal reporting year only and only to the extent that it is known
to or reasonably ascertainable by the submitter. Information required
to be reported under this paragraph is limited to domestic (i.e.,
within the customs territory of the United States) processing and use
activities. If information responsive to a given data requirement under
this paragraph, including information in the form of an estimate, is
not known or reasonably ascertainable, the submitter is not required to
respond to the requirement.
(i) Industrial processing and use information--(A) A designation
indicating the type of industrial processing or use operation(s) at
each site that receives a reportable chemical substance from the
submitter site directly or indirectly (whether the recipient site(s)
are controlled by the submitter site or not). For each chemical
substance, report the letters which correspond to the appropriate
processing or use operation(s) listed in Table 4 to paragraph
(b)(4)(i)(A). A particular designation may need to be reported more
than once, to the extent
[[Page 20142]]
that a submitter reports more than one sector (under paragraph
(b)(4)(i)(B) of this section) that applies to a given designation under
this paragraph.
Table 4 to Paragraph (b)(4)(i)(A)--Codes for Reporting Type of
Industrial Processing or Use Operation
------------------------------------------------------------------------
Designation Operation
------------------------------------------------------------------------
PC................................ Processing as a reactant.
PF................................ Processing--incorporation into
formulation, mixture, or reaction
product.
PA................................ Processing--incorporation into
article.
PK................................ Processing--repackaging.
U................................. Use--non-incorporative activities.
------------------------------------------------------------------------
(B) A code indicating the sector(s) that best describe the
industrial activities associated with each industrial processing or use
operation reported under paragraph (b)(4)(i)(A) of this section. For
each chemical substance, report the code that corresponds to the
appropriate sector(s) listed in Table 5 to paragraph (b)(4)(i)(B). A
particular sector code may need to be reported more than once, to the
extent that a submitter reports more than one function code (under
paragraph (b)(4)(i)(C) of this section) that applies to a given sector
code under this paragraph.
Table 5 to Paragraph (b)(4)(i)(B)--Codes for Reporting Industrial
Sectors
------------------------------------------------------------------------
Code Sector description
------------------------------------------------------------------------
IS1............................. Agriculture, forestry, fishing, and
hunting.
IS2............................. Oil and gas drilling, extraction, and
support activities.
IS3............................. Mining (except oil and gas) and
support activities.
IS4............................. Utilities.
IS5............................. Construction.
IS6............................. Food, beverage, and tobacco product
manufacturing.
IS7............................. Textiles, apparel, and leather
manufacturing.
IS8............................. Wood product manufacturing.
IS9............................. Paper manufacturing.
IS10............................ Printing and related support
activities.
IS11............................ Petroleum refineries.
IS12............................ Asphalt paving, roofing, and coating
materials manufacturing.
IS13............................ Petroleum lubricating oil and grease
manufacturing.
IS14............................ All other petroleum and coal products
manufacturing.
IS15............................ Petrochemical manufacturing.
IS16............................ Industrial gas manufacturing.
IS17............................ Synthetic dye and pigment
manufacturing.
IS18............................ Carbon black manufacturing.
IS19............................ All other basic inorganic chemical
manufacturing.
IS20............................ Cyclic crude and intermediate
manufacturing.
IS21............................ All other basic organic chemical
manufacturing.
IS22............................ Plastics material and resin
manufacturing.
IS23............................ Synthetic rubber manufacturing.
IS24............................ Organic fiber manufacturing.
IS25............................ Pesticide, fertilizer, and other
agricultural chemical manufacturing.
IS26............................ Pharmaceutical and medicine
manufacturing.
IS27............................ Paint and coating manufacturing.
IS28............................ Adhesive manufacturing.
IS29............................ Soap, cleaning compound, and toilet
preparation manufacturing.
IS30............................ Printing ink manufacturing.
IS31............................ Explosives manufacturing.
IS32............................ Custom compounding of purchased
resins.
IS33............................ Photographic film, paper, plate, and
chemical manufacturing.
IS34............................ All other chemical product and
preparation manufacturing.
IS35............................ Plastics product manufacturing.
IS36............................ Rubber product manufacturing.
IS37............................ Non-metallic mineral product
manufacturing (includes cement, clay,
concrete, glass, gypsum, lime, and
other non-metallic mineral product
manufacturing).
IS38............................ Primary metal manufacturing.
IS39............................ Fabricated metal product
manufacturing.
IS40............................ Machinery manufacturing.
IS41............................ Computer and electronic product
manufacturing.
IS42............................ Electrical equipment, appliance, and
component manufacturing.
IS43............................ Transportation equipment
manufacturing.
IS44............................ Furniture and related product
manufacturing.
IS45............................ Miscellaneous manufacturing.
IS46............................ Wholesale and retail trade.
IS47............................ Services.
IS48............................ Other (requires additional
information).
------------------------------------------------------------------------
(C) For each sector reported under paragraph (b)(4)(i)(B) of this
section, the applicable code(s) from Table 6 to paragraph (b)(4)(i)(C)
must be selected to designate the function category(ies) that best
represents the specific manner in which the chemical substance is used.
For the 2020 submission period:
(1) Use column A in Table 6 to paragraph (b)(4)(i)(C) for chemical
substances designated in 2019 as high priority for risk evaluation
(those chemicals listed in Table 7 to paragraph (b)(4)(i)(C)); and
(2) Use either column A or B in Table 6 to paragraph (b)(4)(i)(C)
for chemical substances not listed in Table 7 to paragraph
(b)(4)(i)(C). For the 2024 and future submission periods, use only
column A in Table 6 to paragraph (b)(4)(i)(C). A particular function
category may need to be reported more than once, to the extent that a
submitter reports more than one industrial processing or use operation/
sector combination (under paragraphs (b)(4)(i)(A) and (B) of this
section) that applies to a given function category under this
paragraph. If more than 10 unique combinations of industrial processing
or use operations/sector/function categories apply to a chemical
substance, submitters need only report the 10 unique combinations for
the chemical substance that cumulatively represent the largest
percentage of the submitter's production volume for that chemical
substance, measured by weight. If none of the listed function
categories accurately describes a use of a chemical substance, the
category ``Other'' may be used, and must include a description of the
use.
Table 6 to Paragraph (b)(4)(i)(C)--Codes for Reporting Function Categories
----------------------------------------------------------------------------------------------------------------
Column A Column B
----------------------------------------------------------------------------------------------------------------
Code Category Code Category
----------------------------------------------------------------------------------------------------------------
F001.......................... Abrasives..................... U001............. Abrasives.
F002.......................... Etching agent.................
F003.......................... Adhesion/cohesion promoter.... U002............. Adhesives and sealant
chemicals.
F004.......................... Binder........................
F005.......................... Flux agent....................
F006.......................... Sealant (barrier).............
F007.......................... Absorbent..................... U003............. Adsorbents and absorbents.
F008.......................... Adsorbent.....................
F009.......................... Dehydrating agent (desiccant).
F010.......................... Drier.........................
F011.......................... Humectant.....................
F012.......................... Soil amendments (fertilizers). U004............. Agricultural chemicals (non-
pesticidal).
F013.......................... Anti-adhesive/cohesive........ U005............. Anti-adhesive agents.
[[Page 20143]]
F014.......................... Dusting agent.................
F015.......................... Bleaching agent............... U006............. Bleaching agents.
F016.......................... Brightener....................
F017.......................... Anti-scaling agent............ U007............. Corrosion inhibitors and anti-
scaling agents.
F018.......................... Corrosion inhibitor...........
F019.......................... Dye........................... U008............. Dyes.
F020.......................... Fixing agent (mordant)........
F021.......................... Hardener...................... U009............. Fillers.
F022.......................... Filler........................
F023.......................... Anti-static agent............. U010............. Finishing agents.
F024.......................... Softener and conditioner......
F025.......................... Swelling agent................
F026.......................... Tanning agents not otherwise
specified.
F027.......................... Waterproofing agent...........
F028.......................... Wrinkle resisting agent.......
F029.......................... Flame retardant............... U011............. Flame retardants.
F030.......................... Fuel agents................... U012............. Fuels and fuel additives.
F031.......................... Fuel..........................
F032.......................... Heat transferring agent....... U013............. Functional fluids (closed
systems).
F033.......................... Hydraulic fluids..............
F034.......................... Insulators....................
F035.......................... Refrigerants..................
F036.......................... Anti-freeze agent............. U014............. Functional fluids (open
systems).
F037.......................... Intermediate.................. U015............. Intermediates.
F038.......................... Monomers......................
F039.......................... Ion exchange agent............ U016............. Ion exchange agents.
F040.......................... Anti-slip agent............... U017............. Lubricants and lubricant
additives.
F041.......................... Lubricating agent.............
F042.......................... Deodorizer.................... U018............. Odor agents.
F043.......................... Fragrance.....................
F044.......................... Oxidizing agent............... U019............. Oxidizing/reducing agents.
F045.......................... Reducing agent................
F046.......................... Photosensitive agent.......... U020............. Photosensitive chemicals.
F047.......................... Photosensitizers..............
F048.......................... Semiconductor and photovoltaic
agent.
F049.......................... UV stabilizer.................
F050.......................... Opacifer...................... U021............. Pigments.
F051.......................... Pigment.......................
F052.......................... Plasticizer................... U022............. Plasticizers.
F053.......................... Plating agent................. U023............. Plating agents and surface
treating agents.
F054.......................... Catalyst...................... U024............. Process regulators.
F055.......................... Chain transfer agent..........
F056.......................... Chemical reaction regulator...
F057.......................... Crystal growth modifiers
(nucleating agents).
F058.......................... Polymerization promoter.......
F059.......................... Terminator/Blocker............
F060.......................... Processing aids, specific to U025............. Processing aids, specific to
petroleum production. petroleum production.
F061.......................... Antioxidant................... U026............. Processing aids, not
otherwise listed.
F062.......................... Chelating agent...............
F063.......................... Defoamer......................
F064.......................... pH regulating agent...........
F065.......................... Processing aids not otherwise
specified.
F066.......................... Energy Releasers (explosives, U027............. Propellants and blowing
motive propellant). agents.
F067.......................... Foamant.......................
F068.......................... Propellants, non-motive
(blowing agents).
F069.......................... Cloud-point depressant........ U028............. Solids separation agents.
F070.......................... Flocculating agent............
F071.......................... Flotation agent...............
F072.......................... Solids separation
(precipitating) agent, not
otherwise specified.
F073.......................... Cleaning agent................ U029............. Solvents (for cleaning or
degreasing).
F074.......................... Diluent....................... U030............. Solvents (which become part
of product formulation or
mixture).
F075.......................... Solvent.......................
F076.......................... Surfactant (surface active U031............. Surface active agents.
agent).
F077.......................... Emulsifier....................
F078.......................... Thickening agent.............. U032............. Viscosity adjustors.
F079.......................... Viscosity modifiers...........
F080.......................... Laboratory chemicals.......... U033............. Laboratory chemicals.
F081.......................... Dispersing agent.............. U034............. Paint additives and coating
additives not described by
other categories.
[[Page 20144]]
F082.......................... Freeze-thaw additive..........
F083.......................... Surface modifier..............
F084.......................... Wetting agent (non-aqueous)...
F085.......................... Aerating and deaerating agents U999............. Other (specify).
F086.......................... Explosion inhibitor...........
F087.......................... Fire extinguishing agent......
F088.......................... Flavoring and nutrient........
F089.......................... Anti-redeposition agent.......
F090.......................... Anti-stain agent..............
F091.......................... Anti-streaking agent..........
F092.......................... Conductive agent..............
F093.......................... Incandescent agent............
F094.......................... Magnetic element..............
F095.......................... Anti-condensation agent.......
F096.......................... Coalescing agent..............
F097.......................... Film former...................
F098.......................... Demulsifier...................
F099.......................... Stabilizing agent.............
F100.......................... Alloys........................
F101.......................... Density modifier..............
F102.......................... Elasticizer...................
F103.......................... Flow promoter.................
F104.......................... Sizing agent..................
F105.......................... Solubility enhancer...........
F106.......................... Vapor pressure modifiers......
F107.......................... Embalming agent...............
F108.......................... Heat stabilizer...............
F109.......................... Preservative..................
F110.......................... Anti-caking agent.............
F111.......................... Deflocculant..................
F112.......................... Dust suppressant..............
F113.......................... Impregnation agent............
F114.......................... Leaching agent................
F115.......................... Tracer........................
F116.......................... X-ray absorber................
F999.......................... Other.........................
----------------------------------------------------------------------------------------------------------------
For the 2020 submission period: (1) Use column A for chemical substances designated in 2019 as high priority for
risk evaluation (those chemicals listed in Table 7 to paragraph(b)(4)(i)(C) and (2) use either column A or B
for chemical substances not listed in Table 7 to paragraph (b)(4)(i)(C).
For the 2024 and future submission periods, use only column A.
Table 7 to Paragraph (b)(4)(i)(C)--CASRNs of Chemical Substances
Designated as High Priority for Risk Evaluation Under TSCA Section 6(b)
on December 30, 2019
------------------------------------------------------------------------
CASRN Chemical substance
------------------------------------------------------------------------
106-46-7................. p-Dichlorobenzene.
107-06-2................. 1,2-Dichloroethane.
156-60-5................. trans-1,2-Dichloroethylene.
95-50-1.................. o-Dichlorobenzene.
79-00-5.................. 1,1,2-Trichloroethane.
78-87-5.................. 1,2-Dichloropropane.
75-34-3.................. 1,1-Dichloroethane.
84-74-2.................. Dibutyl phthalate (DBP) (1,2-Benzene-
dicarboxylic acid, 1,2-dibutyl ester).
85-68-7.................. Butyl benzyl phthalate (BBP)--1,2-Benzene-
dicarboxylic acid, 1-butyl 2(phenylmethyl)
ester.
117-81-7................. Di-ethylhexyl phthalate (DEHP)--(1,2-Benzene-
dicarboxylic acid, 1,2-bis(2-ethylhexyl)
ester).
84-69-5.................. Di-isobutyl phthalate (DIBP)--(1,2-Benzene-
dicarboxylic acid, 1,2-bis-(2methylpropyl)
ester).
84-61-7.................. Dicyclohexyl phthalate.
79-94-7.................. 4,4'-(1-Methylethylidene)bis[2,6-
dibromophenol] (TBBPA).
115-96-8................. Tris(2-chloroethyl) phosphate (TCEP).
115-86-6................. Phosphoric acid, triphenyl ester (TPP).
106-93-4................. Ethylene dibromide.
106-99-0................. 1,3-Butadiene.
1222-05-5................ 1,3,4,6,7,8-Hexahydro-4,6,6,7,8,8-
hexamethylcyclopental[g]-2-benzopyran
(HHCB).
50-00-0.................. Formaldehyde.
85-44-9.................. Phthalic anhydride.
------------------------------------------------------------------------
[[Page 20145]]
(D) The estimated percentage, rounded off to the closest 10
percent, of total production volume of the reportable chemical
substance associated with each combination of industrial processing or
use operation, sector, and function category. Where a particular
combination of industrial processing or use operation, sector, and
function category accounts for less than 5 percent of the submitter's
site's total production volume of a reportable chemical substance, the
percentage must not be rounded off to 0 percent if the production
volume attributable to that industrial processing or use operation,
sector, and function category combination is 25,000 lb (11,340 kg) or
more during the reporting year. Instead, in such a case, submitters
must report the percentage, rounded off to the closest 1 percent, of
the submitter's site's total production volume of the reportable
chemical substance associated with the particular combination of
industrial processing or use operation, sector, and function category.
(E) For each combination of industrial processing or use operation,
sector, and function category, the submitter must estimate the number
of sites at which each reportable chemical substance is processed or
used. For each combination associated with each chemical substance, the
submitter must select from among the ranges of sites listed in Table 8
to paragraph (b)(4)(i)(E) and report the corresponding code (i.e., S1
through S7):
Table 8 to Paragraph (b)(4)(i)(E)--Codes for Reporting Numbers of Sites
------------------------------------------------------------------------
Code Range
------------------------------------------------------------------------
S1.............................. Fewer than 10 sites.
S2.............................. At least 10 but fewer than 25 sites.
S3.............................. At least 25 but fewer than 100 sites.
S4.............................. At least 100 but fewer than 250 sites.
S5.............................. At least 250 but fewer than 1,000
sites.
S6.............................. At least 1,000 but fewer than 10,000
sites.
S7.............................. At least 10,000 sites.
------------------------------------------------------------------------
(F) For each combination of industrial processing or use operation,
sector, and function category, the submitter must estimate the number
of workers reasonably likely to be exposed to each reportable chemical
substance. For each combination associated with each chemical
substance, the submitter must select from among the worker ranges
listed in paragraph (b)(3)(vii) of this section and report the
corresponding code (i.e., W1 though W8).
(ii) Consumer and commercial use information--(A) Using the
applicable codes listed in Table 9 to paragraph (b)(4)(ii)(A),
submitters must designate the consumer and commercial product
category(ies) that best describe the consumer and commercial products
in which each reportable chemical substance is used (whether the
recipient site(s) are controlled by the submitter site or not). For the
2020 submission period:
(1) Use column A in Table 9 to paragraph (b)(4)(ii)(A) for chemical
substances designated in 2019 as high priority for risk evaluation
(those chemicals listed in Table 7 to paragraph (b)(4)(i)(C); and
(2) Use either column A or B in Table 9 to paragraph (b)(4)(ii)(A)
for chemical substances not listed in Table 7 to paragraph
(b)(4)(i)(C). For the 2024 and future submission periods, use only
column A in Table 9 to paragraph (b)(4)(ii)(A). If more than 10 codes
apply to a chemical substance, submitters need only report the 10 codes
for the chemical substance that cumulatively represent the largest
percentage of the submitter's production volume for that chemical,
measured by weight. If none of the listed consumer and commercial
product categories accurately describes the consumer and commercial
products in which each reportable chemical substance is used, the
category ``Other'' may be used, and must include a description of the
use.
Table 9 to Paragraph (b)(4)(ii)(A)--Codes for Reporting Consumer and Commercial Product Categories
----------------------------------------------------------------------------------------------------------------
Column A Column B
----------------------------------------------------------------------------------------------------------------
Code Category Code Category
----------------------------------------------------------------------------------------------------------------
Chemical Substances in Furnishing, Cleaning, Treatment Care Products
----------------------------------------------------------------------------------------------------------------
CC101......................... Construction and building C101............. Floor coverings.
materials covering large
surface areas including
stone, plaster, cement, glass
and ceramic articles;
fabrics, textiles, and
apparel.
CC102......................... Furniture & furnishings C102............. Foam seating and bedding
including plastic articles products.
(soft); leather articles.
CC103......................... Furniture & furnishings C103............. Furniture and furnishings not
including stone, plaster, covered elsewhere.
cement, glass and ceramic
articles; metal articles; or
rubber articles.
CC104......................... Leather conditioner........... C104............. Fabric, textile, and leather
products not covered
elsewhere.
CC105......................... Leather tanning, dye,
finishing, impregnation and
care products.
CC106......................... Textile (fabric) dyes.........
CC107......................... Textile finishing and
impregnating/surface
treatment products.
CC108......................... All-purpose foam spray cleaner C105............. Cleaning and furnishing care
products.
CC109......................... All-purpose liquid cleaner/
polish.
CC110......................... All-purpose liquid spray
cleaner.
CC111......................... All-purpose waxes and polishes
CC112......................... Appliance cleaners............
CC113......................... Drain and toilet cleaners
(liquid).
CC114......................... Powder cleaners (floors)......
CC115......................... Powder cleaners (porcelain)...
CC116......................... Dishwashing detergent (liquid/ C106............. Laundry and dishwashing
gel). products.
CC117......................... Dishwashing detergent (unit
dose/granule).
CC118......................... Dishwashing detergent liquid
(hand-wash).
CC119......................... Dry cleaning and associated
products.
CC120......................... Fabric enhancers..............
[[Page 20146]]
CC121......................... Laundry detergent (unit-dose/
granule).
CC122......................... Laundry detergent (liquid)....
CC123......................... Stain removers................
CC124......................... Ion exchangers................ C107............. Water treatment products.
CC125......................... Liquid water treatment
products.
CC126......................... Solid/Powder water treatment
products.
CC127......................... Liquid body soap.............. C108............. Personal care products.
CC128......................... Liquid hand soap..............
CC129......................... Solid bar soap................
CC130......................... Air fresheners for motor C109............. Air care products.
vehicles.
CC131......................... Continuous action air
fresheners.
CC132......................... Instant action air fresheners.
CC133......................... Anti-static spray............. C110............. Apparel and footwear care
products.
CC134......................... Apparel finishing, and
impregnating/surface
treatment products.
CC135......................... Insect repellent treatment....
CC136......................... Pre-market waxes, stains, and
polishes applied to footwear.
CC137......................... Post-market waxes, and
polishes applied to footwear
(shoe polish).
CC138......................... Waterproofing and water-
resistant sprays.
----------------------------------------------------------------------------------------------------------------
Chemical Substances in Construction, Paint, Electrical, and Metal Products
----------------------------------------------------------------------------------------------------------------
CC201......................... Fillers and putties........... C201............. Adhesives and sealants.
CC202......................... Hot-melt adhesives............
CC203......................... One-component caulks..........
CC204......................... Solder........................
CC205......................... Single-component glues and
adhesives.
CC206......................... Two-component caulks..........
CC207......................... Two-component glues and
adhesives.
CC208......................... Adhesive/Caulk removers....... C202............. Paints and coatings.
CC209......................... Aerosol spray paints..........
CC210......................... Lacquers, stains, varnishes
and floor finishes.
CC211......................... Paint strippers/removers......
CC212......................... Powder coatings...............
CC213......................... Radiation curable coatings....
CC214......................... Solvent-based paint...........
CC215......................... Thinners......................
CC216......................... Water-based paint.............
CC217......................... Construction and building C203............. Building/construction
materials covering large materials--wood and
surface areas, including wood engineered wood products.
articles.
CC218......................... Construction and building C204............. Building/construction
materials covering large materials not covered
surface areas, including elsewhere.
paper articles; metal
articles; stone, plaster,
cement, glass and ceramic
articles.
CC219......................... Machinery, mechanical C205............. Electrical and electronic
appliances, electrical/ products.
electronic articles.
CC220......................... Other machinery, mechanical
appliances, electronic/
electronic articles.
CC221......................... Construction and building C206............. Metal products not covered
materials covering large elsewhere.
surface areas, including
metal articles.
CC222......................... Electrical batteries and C207............. Batteries.
accumulators.
----------------------------------------------------------------------------------------------------------------
Chemical Substances in Packaging, Paper, Plastic, Toys, Hobby Products
----------------------------------------------------------------------------------------------------------------
CC990......................... Non-TSCA use.................. C301............. Food packaging.
CC301......................... Packaging (excluding food C302............. Paper products.
packaging), including paper
articles.
CC302......................... Other articles with routine
direct contact during normal
use, including paper articles.
CC303......................... Packaging (excluding food C303............. Plastic and rubber products
packaging), including rubber not covered elsewhere.
articles; plastic articles
(hard); plastic articles
(soft).
CC304......................... Other articles with routine
direct contact during normal
use including rubber
articles; plastic articles
(hard).
CC305......................... Toys intended for children's C304............. Toys, playground, and
use (and child dedicated sporting equipment.
articles), including fabrics,
textiles, and apparel; or
plastic articles (hard).
CC306......................... Adhesives applied at elevated C305............. Arts, crafts, and hobby
temperatures. materials.
CC307......................... Cement/concrete...............
[[Page 20147]]
CC308......................... Crafting glue.................
CC309......................... Crafting paint (applied to
body).
CC310......................... Crafting paint (applied to
craft).
CC311......................... Fixatives and finishing spray
coatings.
CC312......................... Modelling clay................
CC313......................... Correction fluid/tape......... C306............. Ink, toner, and colorant
products.
CC314......................... Inks in writing equipment
(liquid).
CC315......................... Inks used for stamps..........
CC316......................... Toner/Printer cartridge.......
CC317......................... Liquid photographic processing C307............. Photographic supplies, film,
solutions. and photochemicals.
----------------------------------------------------------------------------------------------------------------
Chemical Substances in Automotive, Fuel, Agriculture, Outdoor Use Products
----------------------------------------------------------------------------------------------------------------
CC401......................... Exterior car washes and soaps. C401............. Automotive care products.
CC402......................... Exterior car waxes, polishes,
and coatings.
CC403......................... Interior car care.............
CC404......................... Touch up auto paint...........
CC405......................... Degreasers.................... C402............. Lubricants and greases.
CC406......................... Liquid lubricants and greases.
CC407......................... Paste lubricants and greases..
CC408......................... Spray lubricants and greases..
CC409......................... Anti-freeze liquids........... C403............. Anti-freeze and de-icing
products.
CC410......................... De-icing liquids..............
CC411......................... De-icing solids...............
CC412......................... Lock de-icers/releasers.......
CC413......................... Cooking and heating fuels..... C404............. Fuels and related products.
CC414......................... Fuel additives................
CC415......................... Vehicular or appliance fuels..
CC416......................... Explosive materials........... C405............. Explosive materials.
CC417......................... Agricultural non-pesticidal C406............. Agricultural products (non-
products. pesticidal).
CC418......................... Lawn and garden care products. C407............. Lawn and garden care
products.
----------------------------------------------------------------------------------------------------------------
Chemical Substances in Products not Described by Other Codes
----------------------------------------------------------------------------------------------------------------
CC980......................... Other (specify)............... C909............. Other (specify).
CC990......................... Non-TSCA use.................. C980............. Non-TSCA use.
----------------------------------------------------------------------------------------------------------------
For the 2020 submission period: (1) Use column A for chemical substances designated in 2019 as high priority for
risk evaluation (those chemicals listed in Table 7 to paragraph (b)(4)(i)(C) and (2) use either column A or B
for chemical substances not listed in Table 7 to paragraph (b)(4)(i)(C).
For the 2024 and future submission periods, use only column A.
(B) For each consumer and commercial product category reported
under paragraph (b)(4)(ii)(A) of this section, the applicable code(s)
described in paragraph (b)(4)(i)(C) of this section must be selected to
designate the function category(ies) that best represents the specific
manner in which the chemical substance is used. For the 2020 submission
period:
(1) Use column A in Table 6 to paragraph (b)(4)(i)(C) for chemical
substances designated in 2019 as high priority for risk evaluation
(those chemicals listed in Table 7 to paragraph (b)(4)(i)(C); and
(2) Use either column A or B in Table 6 to paragraph (b)(4)(i)(C)
for chemical substances not listed in Table 7 to paragraph
(b)(4)(i)(C). For the 2024 and future submission periods, use only
column A in Table 6 to paragraph (b)(4)(i)(C). A particular function
category may need to be reported more than once, to the extent that a
submitter reports more than one consumer or commercial product category
(under paragraph (b)(4)(ii)(A) of this section) that applies to a given
function category under this paragraph. If none of the listed function
categories accurately describes a use of a chemical substance, the
category ``Other'' may be used, and must include a description of the
use.
(C) An indication, within each consumer and commercial product
category reported under paragraph (b)(4)(ii)(A) of this section,
whether the use is a consumer or a commercial use.
(D) Submitters must determine, within each consumer and commercial
product category reported under paragraph (b)(4)(ii)(A) of this
section, whether any amount of each reportable chemical substance
manufactured (including imported) by the submitter is present in (for
example, a plasticizer chemical substance used to make pacifiers) or on
(for example, as a component in the paint on a toy) any consumer
products intended for use by children age 14 or younger, regardless of
the concentration of the chemical substance remaining in or on the
product. Submitters must select from the following options: The
chemical substance is used in or on any consumer products intended for
use by children; the chemical substance is not used in or on any
consumer products intended for use by children; or information as to
whether the chemical substance is used in or on any consumer products
intended for use by children is not known to or reasonably
ascertainable by the submitter.
(E) The estimated percentage, rounded off to the closest 10
percent, of the submitter's site's total production volume of the
reportable chemical substance associated with each consumer and
commercial product
[[Page 20148]]
category. Where a particular consumer and commercial product category
accounts for less than 5 percent of the total production volume of a
reportable chemical substance, the percentage must not be rounded off
to 0 percent if the production volume attributable to that commercial
and consumer product category is 25,000 lb (11,340 kg) or more during
the reporting year. Instead, in such a case, submitters must report the
percentage, rounded off to the closest 1 percent, of the submitter's
site's total production volume of the reportable chemical substance
associated with the particular consumer and commercial product
category.
(F) Where the reportable chemical substance is used in consumer or
commercial products, the estimated typical maximum concentration,
measured by weight, of the chemical substance in each consumer and
commercial product category reported under paragraph (b)(4)(ii)(A) of
this section. For each chemical substance in each commercial and
consumer product category reported under paragraph (b)(4)(ii)(A) of
this section, submitters must select from among the ranges of
concentrations listed in Table 3 to paragraph (b)(3)(viii) of this
section and report the corresponding code (i.e., M1 through M5).
(G) Where the reportable chemical substance is used in a commercial
product, the submitter must estimate the number of commercial workers
reasonably likely to be exposed to each reportable chemical substance.
For each combination associated with each substance, the submitter must
select from among the worker ranges listed in Table 2 to paragraph
(b)(3)(vii) of this section and report the corresponding code (i.e., W1
though W8).
0
9. Revise Sec. 711.20 to read as follows:
Sec. 711.20 When to report.
All information reported to EPA in response to the requirements of
this part must be submitted during an applicable submission period,
which runs from June 1 to September 30 at 4-year intervals, beginning
in 2020. In each submission period, any person described in Sec. 711.8
must report as described in this part.
0
10. Amend Sec. 711.22 by revising paragraph (c) to read as follows:
Sec. 711.22 Duplicative reporting.
* * * * *
(c) Co-manufactured chemicals. This part requires that only one
report per site be submitted on each chemical substance described in
Sec. 711.5. However, both the contracting company and producing
company are liable if no report is made. When a company contracts with
a producing company to manufacture a chemical substance, and each party
meets the definition of ``manufacturer'' as set forth in Sec. 711.3,
reporting of the co-manufactured chemical can be performed by one of
the following methods:
(1) The contracting company initiates the required report for that
site as the primary submitter. The contracting company must indicate on
the report that this is a co-manufacturing situation, notify the
producing company, and record the production volume domestically co-
manufactured as set forth in Sec. 711.15(b)(3) and processing and use
information set forth in Sec. 711.15(b)(4). Upon notification by the
contracting company, the producing company must also record the
production volume domestically co-manufactured and complete the rest of
the report as prompted by e-CDRweb.
(2) Upon written agreement between the contracting company and the
producing company, the producing company completes the full report for
the co-manufactured chemical. The contracting company supplies the
information not otherwise known to or reasonably ascertainable by the
producing company.
* * * * *
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11. Revise Sec. 711.30 to read as follows.
Sec. 711.30 Confidentiality claims.
(a) Making confidentiality claims--(1) Generally. Any person
submitting information under this part may assert a confidentiality
claim for that information at the time it is submitted, except for
information described in paragraph (a)(2). Any such confidentiality
claims must be asserted at the time the information is submitted. These
claims will apply only to the information submitted with the claim.
Instructions for asserting confidentiality claims are provided in the
document identified in Sec. 711.35. Information claimed as
confidential in accordance with this section will be treated and
disclosed in accordance with the procedures in 40 CFR part 2 and
section 14 of TSCA.
(2) Exceptions. Confidentiality claims cannot be asserted:
(i) For chemical identities listed on the public portion of the
TSCA Inventory;
(ii) For processing and use data elements required by Sec.
711.15(b)(4)(i)(A), (B), and (C) and Sec. 711.15(b)(4)(ii)(A), (B),
(C), and (D); or
(iii) When a response is left blank or designated as ``not known or
reasonably ascertainable.''
(3) Substantiations. All confidentiality claims must be
substantiated at time of submission, in accordance with the
requirements in paragraphs (b), (c), and (d)(1) of this section, and
must be signed and dated by an authorized official. Confidentiality
claims for the following data elements are exempt from this
substantiation requirement:
(i) Production volume information required pursuant to Sec.
711.15(b)(3)(iii).
(ii) Joint submission information from the primary submitter,
consisting of trade name and supplier identification required pursuant
to Sec. 711.15(b)(3)(i)(A) and (B).
(iii) Joint submission information from the secondary submitter,
consisting of the percentage of formulation required pursuant to Sec.
711.15(b)(3)(i)(A) and (B).
(iv) Information that is supplied in a petition submitted under
Sec. 711.6(b)(2)(iii) or Sec. 711.10(d)(1)(ii) and that is described
in section 14(c)(2) of TSCA.
(4) Marking information claimed as confidential in confidentiality
substantiation documentation. If any of the information contained in
the answers to the questions listed in paragraphs (b) and (c) of this
section is asserted to contain information that itself is considered to
be confidential, you must clearly identify the information that is
claimed confidential.
(5) Certification statement for claims. An authorized official
representing a person asserting a claim of confidentiality must certify
that the submission complies with the requirements of this part by
signing and dating the following certification statement:
``I certify that all claims for confidentiality asserted with
this submission are true and correct, and all information submitted
herein to substantiate such claims is true and correct. Any knowing
and willful misrepresentation is subject to criminal penalty
pursuant to 18 U.S.C. 1001. I further certify that: (1) I have taken
reasonable measures to protect the confidentiality of the
information; (2) I have determined that the information is not
required to be disclosed or otherwise made available to the public
under any other Federal law; (3) I have a reasonable basis to
conclude that disclosure of the information is likely to cause
substantial harm to the competitive position of my company; and (4)
I have a reasonable basis to believe that the information is not
readily discoverable through reverse engineering.''
(6) Company, site, and technical contact identity information. A
submitter may assert a claim of confidentiality for a site, company, or
technical contact identity to protect the link between that information
and the
[[Page 20149]]
reported chemical substance. Such claim may be asserted only when the
linkage of that information to a reportable chemical substance is
confidential and not publicly available.
(7) Processing and use information. A submitter may assert a claim
of confidentiality for each data element required by Sec.
711.15(b)(4)(i)(D), (E) and (F) and Sec. 711.15(b)(4)(ii)(E), (F), and
(G) to protect the link between that information and the reported
chemical substance. Such claim may be asserted only when the linkage of
that information to a reportable chemical substance is confidential and
not publicly available.
(b) All confidentiality claims requiring substantiation at time of
submission. For each data element (or information supplied in a
petition submitted under Sec. 711.6(b)(2)(iii)(A) or Sec.
711.10(d)(1)(ii)(A)) that is claimed as confidential, you must submit
with your report detailed written answers to the following questions:
(1) Will disclosure of the information claimed as confidential
likely cause substantial harm to your business's competitive position?
If you answered yes, describe the substantial harmful effects that
would likely result to your competitive position if the information is
disclosed, including but not limited to how a competitor could use such
information, and the causal relationship between the disclosure and the
harmful effects.
(2) To the extent your business has disclosed the information to
others (both internally and externally), has your business taken
precautions to protect the confidentiality of the disclosed
information? If yes, please explain and identify the specific measures,
including but not limited to internal controls, that your business has
taken to protect the information claimed as confidential.
(3)(i) Is any of the information claimed as confidential required
to be publicly disclosed under any other Federal law? If yes, please
explain.
(ii) Does any of the information claimed as confidential otherwise
appear in any public documents, including (but not limited to) safety
data sheets; advertising or promotional material; professional or trade
publications; state, local, or Federal agency files; or any other media
or publications available to the general public? If yes, please explain
why the information should be treated as confidential.
(iii) Does any of the information claimed as confidential appear in
one or more patents or patent applications? If yes, please provide the
associated patent number or patent application number (or numbers) and
explain why the information should be treated as confidential.
(4) Does any of the information that you are claiming as
confidential constitute a trade secret? If yes, please explain how the
information you are claiming as confidential constitutes a trade
secret.
(5) Is the claim of confidentiality intended to last less than 10
years (see TSCA section 14(e)(1)(B))? If yes, please indicate the
number of years (between 1-10 years) or the specific date after which
the claim is withdrawn.
(6) Has EPA, another federal agency, or court made any
confidentiality determination regarding information associated with
this chemical substance? If yes, please provide the circumstances
associated with the prior determination, whether the information was
found to be entitled to confidential treatment, the entity that made
the decision, and the date of the determination.
(c) Additional requirements for specific chemical identity. A
person may assert a claim of confidentiality for the specific chemical
identity of a chemical substance as described in Sec. 711.15(b)(3) of
this part only if the identity of that chemical substance is treated as
confidential in the Master Inventory File as of the time the report is
submitted for that chemical substance. Generic chemical identities and
accession numbers may not be claimed as confidential. To assert a claim
of confidentiality for the identity of a reportable chemical substance,
you must submit with the report detailed written answers to the
questions from paragraph (b) of this section and to the following
questions.
(1) Is this chemical substance publicly known (including by your
competitors) to be in U.S. commerce? If yes, please explain why the
specific chemical identity should still be afforded confidential status
(e.g., the chemical substance is publicly known only as being
distributed in commerce for research and development purposes, but no
other information about the current commercial distribution of the
chemical substance in the United States is publicly available). If no,
please complete the certification statement:
I certify that on the date referenced, I searched the internet
for the chemical substance identity (i.e., by both chemical
substance name and CASRN). I did not find a reference to this
chemical substance that would indicate that the chemical is being
manufactured or imported by anyone for a commercial purpose in the
United States. [provide date].
(2) Does this particular chemical substance leave the site of
manufacture (including import) in any form, e.g., as a product,
effluent, emission? If yes, please explain what measures have been
taken to guard against the discovery of its identity.
(3) If the chemical substance leaves the site in a form that is
available to the public or your competitors, can the chemical identity
be readily discovered by analysis of the substance (e.g., product,
effluent, emission), in light of existing technologies and any costs,
difficulties, or limitations associated with such technologies? Please
explain why or why not.
(4) Would disclosure of the specific chemical name release
confidential process information? If yes, please explain.
(d) Special situations. (1) Joint submissions. If a primary
submitter asks a secondary submitter to provide information directly to
EPA in a joint submission under Sec. 711.15(b)(3)(i)(A) and (B), only
the primary submitter may assert a confidentiality claim for the data
elements that it directly submits to EPA. The primary submitter must
substantiate those claims that are not exempt under paragraph
(a)(3)(ii) of this section. The secondary submitter is responsible for
asserting all confidentiality claims for the data elements that it
submits directly to EPA and for substantiating those claims that are
not exempt under paragraph (a)(3)(iii) of this section.
(2) Petitions. If a petition submitted under Sec.
711.6(b)(2)(iii)(A) or Sec. 711.10(d)(1)(ii)(A) includes any
information claimed as confidential, the petitioner must provide a
version of the petition that redacts the information claimed as
confidential.
(e) No claim of confidentiality. Information not claimed as
confidential in accordance with the requirements of this section may be
made public without further notice to the submitter.
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12. Amend Sec. 711.35 by revising paragraph (c)(1) to read as
follows:
Sec. 711.35 Electronic filing.
* * * * *
(c) * * *
(1) By website. Go to the EPA Chemical Data Reporting internet
homepage at https://www.epa.gov/cdr and follow the appropriate links.
* * * * *
[FR Doc. 2020-06076 Filed 4-8-20; 8:45 am]
BILLING CODE 6560-50-P