[Federal Register Volume 84, Number 80 (Thursday, April 25, 2019)]
[Proposed Rules]
[Pages 17692-17727]
[FR Doc No: 2019-07716]

Vol. 84

Thursday,

No. 80

April 25, 2019

Part V

 Environmental Protection Agency

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40 CFR Parts 704, 711, and 712

 TSCA Chemical Data Reporting Revisions and Small Manufacturer
Definition Update for Reporting and Recordkeeping Requirements Under
TSCA Section 8(a); Proposed Rule

Federal Register / Vol. 84 , No. 80 / Thursday, April 25, 2019 /
Proposed Rules

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 704, 711, and 712

[EPA-HQ-OPPT-2018-0321; FRL-9982-16]
RIN 2070-AK33

TSCA Chemical Data Reporting Revisions and Small Manufacturer
Definition Update for Reporting and Recordkeeping Requirements Under
TSCA Section 8(a)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: EPA is proposing to amend the Toxic Substances Control Act
(TSCA) section 8(a) Chemical Data Reporting (CDR) requirements and the
TSCA section 8(a) size standards for small manufacturers. The current
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 4 years. EPA is proposing several changes to the CDR rule
to make regulatory updates to align with new statutory requirements of
TSCA, improve the CDR data collected as necessary to support the
implementation of TSCA, and potentially reduce burden for certain CDR
reporters. Proposed updates to the definition for small manufacturers,
including a new definition for small governments, are being made in
accordance with TSCA section 8(a)(3)(C) and impact certain reporting
and recordkeeping requirements for TSCA section 8(a) rules, including
CDR. The definitions may reduce burden on chemical manufacturers by
increasing the number of manufacturers considered small. Overall, these
regulatory modifications may better address EPA and public information
needs by providing additional information 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: Comments must be received on or before June 24, 2019.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2018-0321, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute.
     Mail: Document Control Office (7407M), Office of Pollution
Prevention and Toxics (OPPT), Environmental Protection Agency, 1200
Pennsylvania Ave. NW, Washington, DC 20460-0001.
     Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at http://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:<PHONE_NUMBER>; 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 chemical users or processors who may manufacture
byproduct chemical substances, and are therefore subject to either of
the following: (1) Reporting under the TSCA Chemical Data Reporting
(CDR) requirements at 40 CFR part 711 or (2) TSCA reporting and
recordkeeping requirements at 40 CFR part 704 or other TSCA reporting
requirements which reference the small manufacturer standards at 40 CFR
704.3. 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 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 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?

    Section 8(a)(1) of TSCA 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 section 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)(3)(B) authorizes the EPA Administrator, after
consultation with the Administrator of the Small Business
Administration (SBA), to prescribe by rule the standards for
determining the manufacturers and processors which qualify as small
manufacturers and processors. Pursuant

to TSCA section 8(a)(3)(C), on November 30, 2017, EPA determined that
revision of the standards is warranted (82 FR 56824).
    TSCA section 8(a)(5) requires the EPA Administrator, to the extent
feasible, to not require unnecessary or duplicative reporting and
minimize the cost of compliance for small manufacturers.
    TSCA section 14 imposes requirements for the assertion,
substantiation and review of confidential business information (CBI)
claims.

C. What action is the Agency taking?

    In this action, EPA is proposing several amendments to the current
CDR rule requirements. These amendments, described in more detail in
Unit III., include:
     Changing requirements for making confidentiality claims,
including to identify when upfront substantiation is required, update
the substantiation questions, and identify data elements that cannot be
claimed as confidential to align with the Lautenberg Chemical Safety
for the 21st Century Act (2016 Amendments);
     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, including adding
reporting of the OECD-based functional use codes for consumer and
commercial use information;
     Adding the requirement to report the NAICS code(s) for the
site of manufacture;
     Modifying the requirement to indicate whether a chemical
is removed from the waste stream and recycled, remanufactured,
reprocessed, or reused with the requirement to indicate whether a
chemical is removed from the waste stream and recycled;
     Adding a requirement to identify the percent total
production volume of a chemical substance that is a byproduct;
     Requiring that the secondary submitter of a joint
submission report the chemical specific function along with the
percentage of the chemical in the imported product;
     Adding a voluntary data element to provide a public
contact;
     Modifying the definition of ``parent company'' to clarify
the definition, add the requirement to report a foreign parent company,
when applicable, and codify reporting scenarios;
     Simplifying 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;
     Allowing reporting in specified metal categories for
inorganic byproducts;
     Adding 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; and
     Clarifying regulatory text by removing outdated text,
consolidating exemptions, and making other improvements.
    Additionally, EPA is proposing an amendment to update the size
standards definition for small manufacturers for reporting and
recordkeeping requirements under TSCA section 8(a). Further details of
this amendment are in Unit IV.
    EPA is also giving notice of some aspects of the amendments to TSCA
from the Frank R. Lautenberg Chemical Safety for the 21st Century Act
(2016 Amendments) that may impact, more broadly, TSCA submitters. For
example, under TSCA section 14(e)(1)(B), the Agency is charged with
implementing a ten year ``sunset'' provision for confidentiality
claims.
    Because the small manufacturer size standard under TSCA section
8(a) impacts the CDR rule more than other TSCA section 8(a) reporting
rules at this time, EPA included these two actions as one proposed
rule. However, EPA recognizes that the changes made to the small
business definition will impact current and future TSCA section 8(a)
reporting rules and intends to finalize these amendments as two
separate actions.
    EPA is taking other, non-regulatory steps to minimize the burden on
all reporters, including small entities, by improving the reporting
application and database to be user-friendly and dynamic, consisting of
straightforward questions that include fill-in-the-blank (number)
fields, check boxes, and drop-down menus. In addition, EPA is replacing
the current pre-formatted Form U with a customized report based on the
actual information submitted by a site through e-CDRweb, the electronic
reporting tool. Although these changes are not discussed further in
this proposal, they are an important component of the effort to reduce
burden and modernize the data collection system. EPA is adding an
addendum to the current CDR rule ICR (OMB Control Number 2070-0162) for
the regulatory changes proposed in this document. In addition to the
changes outlined in this proposed 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 industry with the
opportunity to test and comment on the updated e-CDRweb prior to the
2020 CDR submission period. EPA anticipates holding a webinar to
introduce the revised e-CDRweb to the regulated community directly
following the finalization of the CDR Revisions 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. EPA will
open the testing period within 4 months after this proposal is
finalized, and currently anticipates that testing will occur in the
February to March 2020 timeframe. 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 proposing revisions to the CDR rule for three primary
reasons: Align with amendments to TSCA from the Frank R. Lautenberg
Chemical Safety for the 21st Century Act (2016 Amendments), improve the
CDR data collected as necessary to support the implementation of TSCA,
and reduce burden for 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 when substantiation of claims
is required. EPA is proposing revisions to the CDR rule to address
these changes.
    EPA is proposing to modify the definition for small manufacturers,
as a result of the 2016 Amendments revision of TSCA section 8(a)(3)(C),
which requires EPA, after consultation with the Administrator of the
SBA, to review the adequacy of the standards for determining which
manufacturers and processors qualify as small manufacturers and
processors for purposes of TSCA sections 8(a)(1) and 8(a)(3). EPA
published a determination that revision of the TSCA section 8(a) size
standards for small manufacturers as warranted in a Federal Register
Notice published November 30, 2017 (82 FR 56824). EPA's determination,
supporting documents, and comments received can be found at
regulations.gov under docket number EPA-HQ-OPPT-2016-0675. This
proposed change may reduce burden for some manufacturers

that would be considered small manufacturers under CDR and other TSCA
section 8(a) rules relying on the small manufacturer definition in 40
CFR part 704.3.
    EPA is also proposing to make some changes to the CDR data
reporting so the information collected is tailored to better meet the
Agency's overall information needs and aligned with specific needs for
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)). These
proposed changes include the addition of data elements, such as a site-
specific NAICS code and how much of a chemical is a byproduct;
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. In addition, proposed changes to the
parent company reporting requirements would increase EPA's ability to
protect confidential information while better enabling EPA to make
information publicly available and the addition of a voluntary public
contact would direct inquiries from the public to a designated
individual rather than to the technical contact. These changes would
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, improve the CDR data
collected as necessary to support the implementation of TSCA, and
improve EPA's ability to effectively provide public access to the
information. Furthermore, these changes would meet 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.
    At the same time, EPA is interested in reducing burden on industry
while maintaining the Agency's ability to receive the information it
needs to understand exposure to these chemicals (TSCA section 8(a)(5)).
EPA used experiences from the 2016 CDR submission period, concerns
identified by users of CDR information, and burden-reduction
suggestions made as part of public comment opportunities, including
public comments solicited in conjunction with Executive Order 13777,
Enforcing the Regulatory Reform Agenda (EPA-HQ-OA-2017-0190 and 82 FR
17793, April 13, 2017) and as part of the renewal of the Information
Collection Request (ICR) (EPA-HQ-OPPT-2017-0648 and 83 FR 36928, July
31, 2018). In addition, EPA identified ways to reduce burden
specifically for manufacturers of inorganic byproducts as part of an
extensive negotiated rulemaking effort, which included participation by
all stakeholder groups, and subsequent public comment period in 2017
(EPA-HQ-OPPT-2016-0597 and 82 FR 47423, October 12, 2017). Taking into
account these experiences and stakeholder input, EPA is proposing the
following changes to reduce burden: The new ability to alternatively
report inorganic byproducts within defined metal categories, the
introduction of two new exemptions related to byproducts, a revised
approach to reporting for co-manufactured chemicals, and the
harmonization of function and product codes with those used by other
countries.
    Additionally, EPA has received comments that modernizing the CDR
data collection and public access to the database would reduce
reporting burden and facilitate ease of use by reporters and the public
(81 FR 90843; EPA-HQ-OPPT-2016-0597 and Refs. 1, 2, and 3). These
comments were used to develop this proposal and to inform other, non-
regulatory changes that EPA plans to make to the reporting process.

E. What are the estimated incremental impacts of this action?

    EPA has evaluated the potential costs and benefits of revising CDR
reporting requirements and modifying standards for small manufacturers
in CDR and other TSCA section 8(a) reporting. Some aspects of the
proposal increase burden and cost while other aspects decrease burden
and result in cost savings. Overall, EPA estimates that the combined
impact of all the proposed amendments would decrease the total burden
and result in a cost savings to industry and government reporters.
These analyses, which are available in the docket (Refs. 4 and 5), are
discussed in Units III. and IV. and are briefly summarized here.
    1. CDR revisions economic impacts summary. The proposed amendments
are estimated to result in an overall net decrease in burden with
associated cost savings. The estimated changes include increases in
rule familiarization, compliance determination, and form completion.
The future cycle burden and costs or cost savings are listed by type of
change:
     For changes to modify or add reportable data elements
(e.g., processing and use codes, NAICS codes, byproduct percentage,
chemical function, public contact, and parent company--discussed in
Units III.B. and III.C.), the incremental burden is expected to
increase by 45,000 hours with an associated cost increase of $3.5
million.
     For changes to claiming confidentiality (discussed in Unit
III.A.), the incremental burden is expected to decrease by 340 hours
with an associated cost savings of $0.03 million.
     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.
     For changes to implement consolidated category reporting
for certain inorganic metals (discussed in Unit III.D.), the
incremental burden is expected to decrease by 13,000 hours with an
associated cost savings of $1.0 million.
     For changes that affect CDR reporting eligibility
(targeted to certain sites with varying reductions to the number of
chemicals reported per site), the incremental burden is expected to
result in a net decrease by 81,000 hours with associated cost savings
at $6.3 million. There are increases in burden and costs for several
requirements, such as the need to assess whether exemptions apply
(compliance determination) and the need to familiarize oneself with
modifications to the rule (rule familiarization), estimated at 3,000
hours with an associated cost of $0.24 million. However, the changes to
form completion in the aggregate are estimated to result in an overall
net decrease in burden and cost savings due to decreases in the number
of sites reporting and or the number of chemical reports from a site.
These decreases are due to the proposed byproduct exemptions (discussed
in Units III.D.2. and III.D.3.) and consolidated category reporting
(discussed in Unit III.D.1.).
    In sum, the overall incremental impacts to industry and government
reporters result in a net decrease in burden and cost savings.
Estimates include rule familiarization, compliance determination, and
CDR form completion (Ref. 4). Note that 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 reduction and
cost savings are estimated at a 36,000 hour reduction and $2.79 million
cost savings. On an annualized basis using a 3 percent and

a 7 percent discount rate over a 10-year period, the annualized
incremental cost savings is estimated at $0.66 million and $0.65
million per year, respectively (Ref. 4).
    2. TSCA section 8(a) small manufacturer definition economic impacts
summary. The proposed modified standards for small manufacturers would
affect TSCA section 8(a) rules, including CDR. These rules use the TSCA
section 8(a) small manufacturer definition to identify the entities
exempted from reporting or for other reduced reporting requirements.
The impact from the proposal is focused on the CDR rule and may impact
whether a site is required to report or the number of chemicals a site
would report. There is no measurable impact to other TSCA section 8(a)
rules either because EPA has not received any chemical reports for the
rule for an extended period of time or because the rule uses a
different definition that is not being changed by this proposal (see
Unit IV.A. for a more detailed discussion). The proposed definition,
discussed in detail in Unit IV., results in a cost savings.
    a. Impact of proposed small manufacturer definition. The proposal
is estimated to eliminate reporting entirely for 93 industry sites and
reduce reporting by eliminating the need to report at least one
chemical for additional 129 industry sites (Ref. 5). This reduction in
reporting is in addition to the sites already not reporting because
they meet the current small manufacturer definition.
    Under this proposed definition, incremental future cycle burden
reductions and cost savings are estimated at 64,000 hours and $5.0
million, respectively, over a four-year CDR reporting cycle (Ref. 5).
On an annualized basis, using a 3 percent and 7 percent discount rate
over a 10-year period yields net annualized incremental cost savings of
$1.2 million and $1.2 million per year, respectively (Ref. 5). This
proposal also includes a small government exemption (described in this
unit).
    b. Impact of proposed small government definition. The following
government entities report under CDR: Seven municipalities, one county-
level public utility district, and one tribal entity. Under the
proposed small government definition, four government entities would be
exempted from the need to report. The burden and cost savings
associated with the exempted entities, in future reporting cycles, are
included in the estimates for the proposed definition with incremental
future cycle burden reduction and cost savings estimated at 500 hours
and $39,000 respectively, over a four-year CDR reporting cycle (Ref.
5).
    3. Total economic impacts summary for proposal. The amendments in
this proposal may affect the number of reports submitted during a
submission period and the burden to prepare a report. EPA estimates
that the combined impact of all the proposed amendments would decrease
the total burden and cost to industry associated with CDR reporting.
Tables 1A and 1B present the summaries of burden and cost impacts,
respectively, for the proposed CDR revisions and TSCA section 8(a)
small manufacturer definition update. In the tables, estimates are
presented for the CDR four-year first cycle and in the future cycle. In
the first cycle, higher burdens and costs are incurred, because all
reporters need to familiarize themselves with the changes and may take
longer to complete reporting activities. After the first cycle, and for
future cycles, experienced reporters (85%) are familiar with the
changed requirements. In addition to estimates that cover the four-year
CDR cycle, Tables 1A and 1B present annual estimates. These annual
estimates are the four-year estimates divided by four. EPA acknowledges
that activities may be spread unevenly across the four years. On an
annualized basis, using a 3 percent and 7 percent discount rate over a
10-year period yields a net annualized incremental cost savings of
$1.85 million and $1.83 million per year, respectively, for the overall
proposed rule.

                            Table 1A--Summary of Economic Impacts, Burden Reductions
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                                                            First cycle                    Future cycles
                                                 ---------------------------------------------------------------
                                                     Four-year        Annual         Four-year        Annual
                                     Number of         cycle     ----------------      cycle     ---------------
                                  affected sites ----------------                ----------------
                                                      Burden          Burden          Burden          Burden
                                                     reduction       reduction       reduction       reduction
                                                      (hours)         (hours)         (hours)         (hours)
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CDR Revisions...................           5,660          31,306           7,827          36,005           9,001
8(a) Small Manufacturer                    5,627          56,162          14,040          64,295          16,074
 Exemption \1\..................
Small Government Exemption \2\..              33             454             113             504             126
                                 -------------------------------------------------------------------------------
    Net Incremental Change......           5,660          87,922          21,980         100,804          25,201
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General Note: Annual estimates are based on changes applied evenly across the four-year cycle. However, due to
  rounding issues, results may not be readily derived using this table.
Footnotes:
\1\ Under the proposed exemptions, incremental changes represent the net change due to the proposed rule and
  therefore include sites and chemical reports that are exempted. Note that sites and reports can be entirely
  affected or undergo a split effect, with a portion of the site's chemical reports exempted.
\2\ Four small governments are identified to qualify for the small government exemption under the proposed small
  government exemption.

                               Table 1B--Summary of Economic Impacts, Cost Savings
----------------------------------------------------------------------------------------------------------------
                                                            First cycle                    Future cycles
                                                 ---------------------------------------------------------------
                                                     Four-year        Annual         Four-year        Annual
                                     Number of         cycle     ----------------      cycle     ---------------
                                  affected sites ----------------                ----------------
                                                   Cost savings    Cost savings    Cost savings    Cost savings
                                                      (2017$)         (2017$)         (2017$)         (2017$)
----------------------------------------------------------------------------------------------------------------
CDR Revisions...................           5,660      $2,428,630        $607,157      $2,792,871        $698,218
8(a) Small Manufacturer                    5,627       4,357,362       1,089,341       4,988,270       1,247,068
 Exemption \1\..................
Small Government Exemption \2\..              33          35,132           8,783          39,025           9,756
                                 -------------------------------------------------------------------------------
    Net Incremental Change......           5,660       6,821,124       1,705,281       7,820,166       1,955,042
----------------------------------------------------------------------------------------------------------------
General Note: Annual estimates are based on changes applied evenly across the four-year cycle. However, due to
  rounding issues, results may not be readily derived using this table.
Footnotes:
\1\ Under the proposed exemptions, incremental changes represent the net change due to the proposed rule and
  therefore include sites and chemical reports that are exempted. Note that sites and reports can be entirely
  affected or undergo a split effect, with a portion of the site's chemical reports exempted.
\2\ Four small governments are identified to qualify for the small government exemption under the proposed small
  government exemption.

F. What should I consider as I prepare my comments for EPA?

    1. Submitting CBI. Do not submit CBI to EPA through regulations.gov
or email. Clearly mark the part or all of the information that you
claim to be CBI. For CBI information in a disk or CD-ROM that you mail
to EPA, mark the outside of the disk or CD-ROM as CBI and then identify
electronically within the disk or CD-ROM the specific information that
is claimed as CBI. In addition to one complete version of the comment
that includes information claimed as CBI, a copy of the comment that
does not contain the information claimed as CBI must be submitted for
inclusion in the public docket. Information so marked will not be
disclosed except in accordance with procedures set forth in 40 CFR part
2.
    2. Tips for preparing your comments. When preparing and submitting
your comments, see the commenting tips at http://www.epa.gov/dockets/comments.

II. Background

A. What is the Chemical Data Reporting (CDR) rule?

    The CDR rule requires U.S. manufacturers of certain chemicals
listed on the TSCA Inventory to report to EPA every four years the
identity of chemical substances manufactured for all years since the
last principal reporting year. For example, for the 2020 submission
period, the principal reporting year is 2019 and the last principal
reporting year for the 2016 submission period was 2015. Reporting
during the 2020 submission period covers the manufacture of chemicals
in 2016, 2017, 2018, and 2019. To help 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
lower threshold applies for chemical substances that are the subject of
certain TSCA actions (see 40 CFR 711.8(b)). The CDR regulation
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, EPA received 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). The processing and use
information that is currently required includes: Process or use
category; NAICS code; industrial function category; percent production
volume associated with each process or use category; number of sites;
number of potentially exposed industrial or commercial workers; and
consumer/commercial information such as use category, use in or on
products intended for use by children, and maximum concentration. 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 (40 CFR 711.30).

B. How are the CDR data used by EPA?

    EPA uses the data reported pursuant to the CDR rule to support
health, safety, and environmental protection activities related to
chemical manufacturing and use. Manufacturing, processing and use
information about chemicals in commerce helps EPA understand exposure
to these chemicals and screen and prioritize chemicals to identify
potential human health and environmental effects. EPA uses the data
reported under the CDR rule to support many activities under TSCA and
to provide overall support for EPA and other federal, state, local, and
tribal health, safety, and environmental protection activities (Ref. 6
and 83 FR 36928, July 31, 2018 (EPA-HQ-OPPT-2017-0648)).
    CDR provides basic exposure-related data which EPA uses in a wide
variety of its activities, from choosing the chemicals EPA will focus
on for prioritization and assessment activities to informing response
actions, such as to hurricanes and other disasters. For example, in
accordance with TSCA section 6(b)(1)(A), EPA is required to consider
``the conditions of use or significant changes in conditions of use of
the chemical substance, and the

volume or significant changes in the volume of the chemical substance
manufactured or processed.'' CDR provides information directly
pertaining to the conditions of use, such as the number of sites, the
number of workers reasonably likely to be exposed, and how and why the
chemical is used, based on the CDR processing and use information. In
addition, CDR provides the production volume, the production volume
over time, and changes in the volumes under different conditions of
use. Such information is expected to contribute to improved
understanding of the chemical, including during the prioritization
process. For example, EPA used the 2012 and 2016 CDR data to assist in
identifying current uses and production volumes and, inversely, uses
that are no longer ongoing, to help determine the scope of the risk
evaluations for the first 10 chemicals being reviewed under amended
TSCA. EPA grouped uses for these chemicals based on CDR categories such
as industrial, commercial, and consumer use. Additionally, the problem
formulations for the first 10 chemicals, which were published in June
2018, used CDR data to identify the number of sites where exposure may
occur and approximate workers who may be exposed to the chemicals. For
example, in the Problem Formulation of the Risk Evaluation for
Perchloroethylene (Ethene, 1,1,2,2-Tertrachloro), EPA used CDR data to
identify conditions of use for Perchloroethylene (Ref. 7). CDR data
will continue to inform future prioritization, risk evaluation, and
risk management work under TSCA.
    For another example, to help prepare EPA and others to respond to
hurricane disasters that occurred in 2018, EPA prepared information
about chemicals expected to be in the affected areas from data sources
such as CDR.
    In 2012, EPA published its TSCA Work Plan for Chemical Assessments.
CDR data were used extensively in the development of this Work Plan.
Using CDR data collected during the 2012 CDR submission period, EPA
updated the exposure rankings for the chemicals initially screened as
part of the original Work Plan and, in 2014, published a revised Work
Plan (2014 Work Plan). TSCA requires that at least 50 percent of all
chemical substances undergoing risk evaluation (High-Priority
designations) come from the 2014 Work Plan, until the Work Plan
chemical list is exhausted.
    The Interagency Testing Committee (ITC), an independent advisory
committee to the EPA Administrator, uses CDR data when updating the
Priority Testing List (PTL). The ITC designates or recommends chemicals
to the PTL that the Agency may prioritize when requiring testing under
TSCA section 4 or collecting information under TSCA sections 8(a) or
8(d). In making those determinations, production volumes reported to
CDR are used to identify the opportunity for exposure to a particular
chemical.
    OECD member countries develop Emission Scenario Documents (ESD).
EPA is an active participant of the OECD Task Force and regularly works
on the development of ESDs that are reviewed by the Task Force and
added to the published series of ESDs. ESDs developed by EPA cover both
occupational exposures and environmental releases due to EPA's review
responsibilities under TSCA. In a separate and related effort, EPA has
regularly developed industry-specific generic scenarios which are
similar to an OECD ESD, as tools to assist in the assessment of the
many types of uses for new chemicals reviewed under TSCA. CDR data are
used to identify the chemicals commonly used in specific industries,
estimate the number of potentially exposed workers, and develop
estimates of exposure and releases that support the development of
these documents and scenarios.
    Additional examples of how EPA uses CDR data include use by the
Office of Research and Development to characterize the life cycle of
chemicals for life cycle inventories, to develop conceptual models, and
to develop standardized emission and release estimates from chemical
production. The Office of Water uses CDR data to identify facilities in
specific industry sectors while developing effluent guidelines and to
identify chemicals of interest and their associated processing and use
activities for Effluent Guidelines Annual Review Reports.

C. What are the current standards for small manufacturers and
processors?

    In 1988, EPA established the general TSCA section 8(a) small
manufacturer definition for use in other rules issued under TSCA
section 8(a), which are codified at 40 CFR 704.3. These are the current
standards that apply to CDR:
    Small manufacturer or importer means a manufacturer or importer
that meets either of the following standards:
    1. First standard. A manufacturer or importer of a substance is
small if its total annual sales, when combined with those of its parent
company (if any), are less than $40 million. However, if the annual
production or importation volume of a particular substance at any
individual site owned or controlled by the manufacturer or importer is
greater than 45,400 kilograms (100,000 pounds), the manufacturer or
importer shall not qualify as small for purposes of reporting on the
production or importation of that substance at that site, unless the
manufacturer or importer qualifies as small under standard (2) of this
definition.
    2. Second standard. A manufacturer or importer of a substance is
small if its total annual sales, when combined with those of its parent
company (if any), are less than $4 million, regardless of the quantity
of substances produced or imported by that manufacturer or importer.
    3. Inflation index. EPA must use the Producer Price Index for
Chemicals and Allied Products, as compiled by the U.S. Bureau of Labor
Statistics, for purposes of determining the need to adjust the total
annual sales values and for determining new sales values when
adjustments are made. EPA may adjust the total annual sales values
whenever the Agency deems it necessary to do so, provided that the
Producer Price Index for Chemicals and Allied Products has changed more
than 20 percent since either the most recent previous change in sales
values or the date of promulgation of the rule (i.e., 40 CFR 704),
whichever is later. EPA shall provide Federal Register notification
when changing the total annual sales values.
    Pursuant to authority under TSCA section 8(a)(3)(B), certain TSCA
section 8(a) rules codify slight variations of the general TSCA section
8(a) small manufacturer definition at 40 CFR 704.3 (see, e.g., 40 CFR
704.45). There is no general small processor standard, and EPA is not
proposing one in this action. However, other rules issued under TSCA
section 8(a) establish analogous standards for small processors in
those particular rules. See Unit IV.A. for additional discussion.

III. Detailed Discussion of the Proposed Modifications to CDR

A. Changes to Claiming Confidentiality

    EPA is proposing changes to requirements related to claiming CDR
data as confidential to be consistent with the new statutory
requirements in TSCA section 14. TSCA requires the Agency to review and
make determinations regarding the validity of confidential claims for
information submitted to EPA. EPA estimates that this proposed change
would result in a decrease in burden, which is explained in detail in
Table 4-14 in the Economic Analysis (Ref. 4).

    New statutory provisions that are pertinent to reporting under CDR
include the following:
     Under TSCA section 14(c)(3), all claims of confidentiality
must be substantiated at the time the information is submitted to EPA,
except for those types of information exempt under TSCA section
14(c)(2).
     The submitter must provide a statement supporting the
claim, as described in TSCA section 14(c)(1)(B) and must certify that
the statement is true and correct, as described in TSCA section
14(c)(5).
     TSCA section 14(b)(3)(B) limits confidentiality claims for
reported use information that customarily would be shared with the
general public or within an industry or industry sector.
     Under TSCA section 14(e)(1)(B), confidentiality claims on
information not described in TSCA section 14(c)(2) expire after ten
years, unless a request for extension is submitted and granted.
    The proposed amendments to the CDR rule address these new
provisions, with the exception of the TSCA section 14(e)(1)(B) CBI
expiration provision which while it will impact all TSCA submissions
filed after June 22, 2016 does not distinctively impact the CDR data
collections.
    This preamble discussion also includes information about other
provisions of TSCA relating to actions EPA must take, but that do not
impact the regulatory text or require specific submitter actions.
    1. Substantiations. EPA interprets TSCA section 14(c)(3) as
requiring substantiations of non-exempt CBI claims at the time the
information claimed as CBI is submitted to EPA (82 FR 6522, January 19,
2017). The Agency is proposing to amend 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.
Submission of substantiations at the time of assertion of
confidentiality enables EPA to fulfill its obligation under TSCA
section 14(g) to review all confidentiality claims for specific
chemical identity, plus a representative subset (comprising at least 25
percent) of all other non-exempt confidentiality claims.
    EPA is proposing revisions to the current substantiation questions
in 40 CFR 711.30 and the addition of new substantiation questions to
address data elements which, prior to amended TSCA, did not require
substantiation at the time of submission. The questions are in the
proposed regulatory text at the end of this notice. In addition,
Appendix B of the CDR Revisions EA (Ref. 4) provides a summary of the
questions prior to the 2016 TSCA Amendments and those that are being
proposed in this action (Ref. 4). These questions would facilitate the
Agency's implementation of TSCA section 14 and the requirement to
review and approve, approve in part, deny in part, or fully deny
requests for confidentiality. These CDR-specific questions are designed
to encourage thoughtful consideration of the need for confidential
treatment, improve the consistency of EPA's review of the responses,
and reduce the need for multiple discussions between EPA and the
submitter regarding the substantiations that may otherwise hinder the
Agency's ability to timely fulfill its review obligations under TSCA.
    The questions have been carefully drafted to elicit the required
information to allow for a CBI review and determination, without
imposing an unnecessary burden. A set of standard questions, set forth
in proposed 40 CFR 711.30(b), would apply to all non-exempt CBI claims.
These questions generally ask about the impact of disclosure on the
submitter's competitive position, whether the information has been made
available to others, and the controls used to protect the confidential
information. These are similar in concept to questions under the
current CDR at 40 CFR 711.30. Additional questions are targeted to
specific data elements. For chemical substance identity confidentiality
claims, the additional substantiation questions, set forth in proposed
40 CFR 711.30(c), are substantively the same as exist under the current
CDR at 40 CFR 711.30(b). An additional question for company, site, and
technical contact identity is set forth in proposed 40 CFR 711.30(d).
Although substantively the same as exists for site identity
substantiations in the current CDR at 40 CFR 711.30(c), it is newly
applied to company name and technical contact confidentiality claims.
Additional questions for processing and use information are set forth
in proposed 40 CFR 711.30(e) and are substantively the same as exist in
the current CDR at 40 CFR 711.30(d).
    a. Exceptions to the substantiation requirements. TSCA section
14(c)(2) identifies certain information that shall not be subject to
substantiation requirements under this rule. This includes:
     Specific information describing the processes used in
manufacture or processing of a chemical substance, mixture, or article;
     Marketing and sales information;
     Information identifying a supplier or customer;
     In the case of a mixture, details of the full composition
of the mixture and the respective percentages of constituents;
     Specific information regarding the use, function, or
application of a chemical substance or mixture in a process, mixture,
or article;
     Specific production or import volumes of the manufacturer
or processor; and
     Prior to the date on which a chemical substance is first
offered for commercial distribution, the specific chemical identity of
the chemical substance, including the chemical name, molecular formula,
Chemical Abstracts Service number, and other information that would
identify the specific chemical substance, if the specific chemical
identity was claimed as confidential at the time it was submitted in a
notice under TSCA section 5.
    EPA believes that the only data elements collected under CDR that
may be subject to the TSCA section 14(c)(2) limit on substantiation
requirements are: (1) Production volume and (2) supplier information
associated with joint submissions, such as supplier identity and
details of the full composition of a mixture. However, these two data
elements may still be subject to substantiation and CBI review under
the circumstances described in TSCA section 14(f).
    i. Regarding production volume. EPA is proposing to not require
substantiation at the time the claim of confidentiality is made for
five production volume data elements (e.g., 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 when the production volume is reported
as domestically manufactured and imported volumes. As an example, for
the 2020 CDR submission period, production volume is collected for the
calendar years 2016, 2017, and 2018. For calendar year 2019, the
production volume is reported as domestically manufactured and imported
volumes. EPA believes that these five data elements are exactly the
kinds of specific production or import volumes identified in TSCA
section 14(c)(2)(F).
    ii. Regarding information associated with a joint submission. Joint

submissions are necessary under limited circumstances. Currently these
circumstances are: (1) A company imports a chemical or a mixture under
a trade name and the substance identity, or individual components, are
not known to the importer or (2) a manufacturer cannot provide the
entire chemical identity of a chemical substance it manufactures
because the chemical substance is manufactured using a reactant having
an identity that the reactant supplier claims as confidential. In these
circumstances, the supplier has identified that it will not disclose to
the manufacturer (or importer) or does not, itself, know the chemical
identity.
    A joint submission is a submission started by a primary submitter,
typically an importer. The primary submitter provides the trade name of
the subject chemical substance or mixture, the name and address of the
supplier, and other information as appropriate. Given the requirements
of amended TSCA, EPA proposes to require that the primary submitter
identify whether the supplier information, including the supplier
identity and chemical substance name (trade name) is confidential.
Substantiation of the confidentiality claims for this information is
not required at the time of submission under the proposed rule because
EPA believes it is exempt from substantiation as ``[i]nformation
identifying a supplier'' under TSCA section 14(c)(2)(C).
    The secondary submitter of the joint submission provides their
company name and location, a technical contact, trade name, and
chemical identity(ies) and percentage of each chemical substance in the
composition of the substance or mixture represented by the trade name.
In addition, as explained in Unit III.B.5., EPA proposes to collect the
function of each chemical in the mixture. Given the requirements of
amended TSCA, EPA is proposing to provide the ability for the secondary
submitter to specifically identify whether this information is claimed
as confidential. 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.
    b. Chemical identity. Only chemical substances listed on the
confidential portion of the TSCA Inventory (the Inventory) can be
claimed as confidential. This provision is not new and is reflected in
the current CDR rule at 40 CFR 711.30(b). Such a confidentiality claim
applies to the specific identity of the chemical substance as it is
listed on the confidential portion of the Inventory. CDR reported
chemical identities, including generic chemical names, that are listed
on the public portion of the Inventory cannot be claimed as
confidential and would be made publicly available. EPA included this
discussion for clarification purposes only and is not proposing any
changes to this approach.
    c. Connection between company, site, or technical contact identity
and chemical-specific information. EPA is proposing to require
assertion and substantiation of a claim of confidentiality at the time
of submission, on a chemical-specific basis, for the linkage between
company or technical contact identity and chemical substance
information. This is the same as is currently required under 40 CFR
711.30(c) for site identity, when on a chemical-specific basis, one
must claim the linkage between the site identity and the chemical
substance information as confidential by asserting and substantiating
the claim at the time of submission. There would likely be instances
where a confidentiality claim for a company name would not be
appropriate, but one for site identity or technical contact might be
appropriate.
    d. Benefits of proposed changes to CBI substantiation. The reduced
amount of information subject to confidentiality limitations will
facilitate greater interagency and public sharing of data and will
decrease the number of inappropriate or unnecessary claims of
confidentiality, which will increase the transparency and public
accessibility of the CDR. Clarification of which data elements can be
claimed as confidential will improve the consistency of EPA's review of
CBI substantiation information and will decrease the need for multiple
conversations between EPA and reporters about substantiation responses,
thus reducing burden for the Agency and for reporters.
    2. Certification. The authorized official submitting
confidentiality claims must certify all claims for confidentiality are
true and correct, and all information submitted to substantiate such
claims is true and correct. As required by TSCA sections 14(c)(1)(B)
and 14(c)(5). EPA combined these requirements into a single
certification statement, which was implemented in the CDR electronic
reporting tool in June 2016. EPA is proposing to codify the language of
the certification statement in the CDR rule (see the proposed
regulatory text for 40 CFR 711.30(h)).
    3. Processing and use data not protected from disclosure. TSCA
section 14(b)(3)(B), as amended by the 2016 Amendments, prohibits
confidentiality claims for the following submitted information: ``a
general description of a process used in the manufacture or processing
and industrial, commercial, or consumer functions and uses of a
chemical substance, mixture, or article containing a chemical substance
or mixture, including information specific to an industry or industry
sector that customarily would be shared with the general public or
within an industry or industry sector.''
    This statutory provision directly impacts and limits
confidentiality claims for certain CDR processing and use data. Thus,
EPA proposes to codify in the regulatory text that the following data
elements cannot 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:
     Certain Industrial processing and use data elements. The
data elements which directly relate 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 which directly relate to how the chemical is used, i.e.,
the product category (Sec.  711.15(b)(4)(ii)(A)); whether the chemical
is used in commercial or consumer products (Sec.  711.15(b)(4)(ii)(B));
whether the chemical is likely to be used in children's products (Sec.
711.15(b)(4)(ii)(C)); and the function of the chemical in the consumer
or commercial product (the function is a proposed data element--see
Unit III.B.5. for additional information).
    For the purposes of this proposal, EPA believes that other CDR
processing and use data elements do not offer a ``general description''
and therefore do not fall within the limits of TSCA section
14(b)(3)(B). Under this proposal, submitters may continue to assert
claims of confidentiality for the following processing and use data
elements:
     Certain Industrial Processing and use data elements.
Percent production volume, number of sites, and number of workers
(Sec.  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 (Sec.  711.15(b)(4)(ii)(D), (E), and (F)).

    4. Time duration of confidentiality claims. In accordance with TSCA
section 14(e)(1)(B), non-exempt confidentiality claims are initially
protected from disclosure for a period of 10 years from the date of
submission and confidentiality assertion, assuming all other relevant
requirements of the statute are met. Information on confidential
business information under TSCA is available on EPA's website at
https://www.epa.gov/tsca-cbi. One of the proposed new substantiation
questions asks whether the submitter anticipates that the claim's
duration would last less than the 10-year statutory time frame.
Respondents would indicate when the claim would no longer be needed,
and EPA would incorporate the release date into its data system,
enabling the information to be made publicly available at that time.

B. Modifications to 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 proposing multiple changes to the data elements
comprising this processing and use information. Specifically, EPA is
proposing to replace the CDR industrial function and commercial/
consumer product use codes with OECD function, product, and article use
categories and to add OECD function categories for commercial/consumer
products. EPA is listing these codes in the CDR instructions, rather
than codifying them in the CFR, which would enable EPA to limit the
codes to just those considered relevant for CDR reporting, with a
catch-all ``non-TSCA'' code for the OECD codes that do not fit under
TSCA. EPA would then be able to update the Instructions prior to each
CDR submission period to align with any changes to the OECD codes.
    EPA did not develop burden estimates associated with replacing the
current CDR codes with ones based on the OECD codes because such an
estimate heavily relies on the e-CDRweb user interface which will
feature burden-reducing guided data entry. 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 (not
estimated at this time). For additional information, see section
<IP_ADDRESS> in the Economic Analysis (Ref. 4).
    The OECD Internationally Harmonized Functional, Product, and
Article Use Categories were developed through the OECD Working Party on
Exposure Assessment (Task Force on Exposure Assessment) under the
leadership of the EPA, based on a review of current functional use and
product categories from the United States, Canada, and the European
Union; bilateral discussions with the European Chemicals Agency (ECHA);
and multiple reviews from task force members. The OECD categories are
described in the document ``Internationally Harmonised Functional,
Product and Article Use Categories'' (referred to herein as the OECD
Category Document) (Ref. 8).
    Harmonizing CDR use codes with the OECD codes would expand the
utilization of applicable use and exposure-related information from
international sources to support EPA risk evaluation and risk
assessment activities for new and existing chemicals. Additionally,
this harmonization would provide industry with international uniformity
in use and exposure information reporting, enabling industry to better
streamline their different country-specific reporting requirements.
    EPA has received requests to harmonize CDR data categories and
descriptions with other countries to the extent possible. In
particular, industry stakeholder groups such as the American Chemistry
Council have expressed a desire to harmonize with Canadian and OECD
data collections in order to provide common global terminology and
preciseness in risk evaluation (Ref. 9). EPA worked closely with Canada
in the development of the current CDR processing and use codes, and
both EPA and Canada were involved in the development of the OECD
Harmonized codes.
    Under CDR, there are two main categories of use codes: Function use
codes and product use codes. The function of a chemical combined with
the type of product that the chemical is used in provides an exposure
scenario with unique characteristics. These exposure scenarios are
necessary for implementation of TSCA for the prioritization of the
chemical and for further consideration for the development of exposure
and risk evaluations.
    a. Function codes (industrial and consumer/commercial). EPA
currently requires the reporting of function categories for chemical
substances used in industrial products but does not require the
reporting of a chemical substance's function for commercial/consumer
products. EPA is proposing to require reporting of function use
categories for both industrial and commercial/consumer products and to
adopt the OECD functional use categories.
    Function codes are based on the intended physical or chemical
characteristic for when a chemical substance or mixture is consumed as
a reactant; incorporated into a formulation, mixture, reaction product,
or article; repackaged; or used (e.g., as an abrasive, a catalyst, or
an elasticizer). EPA uses information regarding the function of a
chemical substance in combination with the industrial sector and
processing or use operation to identify an exposure scenario or the
type of application in which a chemical would be used (such as solvents
for cleaning and degreasing). Understanding the exposure scenarios or
the type of application of the chemical would inform assessment of the
potential route, duration, frequency and magnitude of exposure.
    During screening and risk evaluation activities, EPA evaluates how
the chemical substance is manufactured, processed, distributed in
commerce, used, and disposed of. Currently, CDR requires the reporting
of consumer and commercial product categories but does not require the
reporting of chemical function within the product category. The lack of
functional use information for consumer and commercial applications has
restricted EPA's ability to provide more complete evaluations or more
realistic characterizations of exposure for consumer and commercial
applications; instead, EPA relies in many cases on scenarios using
potentially conservative assumptions. (Ref. 10) The addition of
information on the function of the chemical in combination with the
consumer or commercial product category would improve EPA's ability to
consider exposures to consumers and in commercial applications,
providing a more accurate and real-world understanding of the uses of
chemical substances throughout their life cycle.
    As explained in the OECD Category Document, the OECD product and
article use categories are intended to focus on the end-use application
of chemicals within products and articles, rather than upstream
manufacturing and processing. However, the functional use categories
cover the life cycle and describe the specific function that a chemical
provides when used in the formulation of a product or article, or when
used within an industrial process. While the function of a chemical may
be the same across its life cycle, certain functions may only be
appropriate for consideration in an industrial setting,

while others may be relevant for a consumer or commercial setting.
    Adopting the OECD functional use codes would provide greater detail
by expanding the function categories from the 35 codes currently used
by CDR to 117 codes. For example, the broad current CDR category
Adhesives and Sealants corresponds to four categories under the OECD
harmonized codes in this proposal: Adhesion/Cohesion Promoters,
Binders, Flux Agents, and Sealants (Barrier). In this proposed rule,
not all of the OECD harmonized codes would be adopted to CDR because
some are for 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)). The current CDR codes
contain a catch-all ``non-TSCA code'' for uses that are not covered
under TSCA. Under this proposed rule, EPA would continue to provide the
same 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 interested in receiving 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.
Would the exact match make it easier for submitters to report
information under CDR and other reporting requirements using the OECD
harmonized codes?
    EPA is listing these codes in the CDR instructions discussed in
Unit III.B.1. Additional details about the proposed 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. 11).
    b. Commercial/consumer product codes. CDR currently requires the
reporting of product category codes for manufactured chemical
substances that have consumer or commercial uses. The current product
codes consist of both article and other non-article products; they
correlate to the OECD Product and Article Use Categories described in
the OECD Category document (Ref. 8). The OECD Category document uses
the term ``product'' to mean consumable liquids, aerosols, semi-solids,
or solids that are used a given number of times before they are
depleted and the term ``articles'' to generally mean solids, polymers,
foams, metals, and woods, all of which are always present within indoor
environments for the duration of their useful life, which may be
several years (Ref. 8). These terms were developed for the OECD
Category document because, for the purposes of exposure assessment,
products and articles are treated differently. Formulations,
anticipated use patterns, and available approaches to estimate exposure
are different, and certain chemicals may only be added to articles,
others only used to formulate products, and others could be used for
both. Because of these differences, OECD provides separate lists of
product and article use categories. EPA is proposing to adopt the OECD
codes and to consolidate the separate OECD lists into one list to be
consistent with the current CDR approach of listing the article and
other non-article products in one list of CDR Product Categories.
    CDR product categories are broader than the OECD categories. Using
the OECD categories would provide a specificity that would be more
helpful to EPA in carrying out its responsibilities under TSCA. For
example, a broad CDR category is Fuels and Related Products, which,
under the OECD product codes, is divided into three categories: Cooking
and Heating Fuels, Fuel Additives, and Vehicular or Appliance Fuels
(Ref. 11). Under this proposal, the current 33 consumer/commercial
product categories would be replaced by 98 categories. For a listing of
the proposed product categories, see Appendix D of the Instructions for
Reporting (Ref. 12). Under TSCA, the definition of ``chemical
substance'' excludes certain uses such as pesticide, tobacco, food, and
other specifically listed uses. Some of the OECD harmonized product
categories cover the TSCA-excluded uses; those particular codes were
not adopted in CDR. The current CDR codes contain a catch-all ``non-
TSCA code'' for uses that are not covered under TSCA. Under this
proposed rule, EPA would continue to provide the same ``non-TSCA'' code
as a blanket code for these applications. EPA is interested in
receiving comments on whether all of the OECD harmonized codes should
be listed, even if the uses are not covered by TSCA, to make it easier
for submitters to report information under CDR and in response to other
reporting requirements using the OECD harmonized codes. Additional
details about the proposed product categories, how they are related to
the OECD product and article categories, and a crosswalk with the
current CDR product codes are in the supplemental document Technical
Support Document: Harmonizing CDR Functional and Product codes with
OECD Functional, Product, and Article Codes (Ref. 11).
    2. NAICS codes for manufacturers. EPA is proposing to require
submitters to 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 (62 FR 17288). Use of the standard
provides uniformity and comparability in the presentation and
understanding of data. EPA estimates that this proposed change would
result in a slight increase in burden, which is explained in detail in
Table 4-11 in the Economic Analysis (Ref. 4).
    EPA would use the NAICS code information in its analysis of the
reported manufacturing-related information to better analyze the data
by industry sector. EPA's insight into particular industry sectors has
been limited without this particular data element. For example, during
the 2017 negotiated rulemaking, participants asked EPA to analyze
specific industries to determine if there was overlap in reporting
among different Agency programs and to determine if EPA could trace the
life cycle of some chemical substances from their manufacture through
their use and to their disposal (Refs. 13 and 14). NAICS codes would
have better enabled EPA to fulfill the requests because many other EPA
programs, such as the Toxics Release Inventory (TRI), require the
reporting of NAICS codes. By adding the site's NAICS code as a required
data element for CDR, EPA would be better able to use information from
CDR in conjunction with TRI data to support implementation of TSCA.
    Because reporting under CDR is done by the site that is conducting
the manufacturing activity, the site is expected to be sufficiently
knowledgeable to be able to determine the appropriate NAICS code. EPA
believes sites would be able to identify a single NAICS code per site;
however, the Agency is interested in comments on whether the CDR
reporting tool should enable the reporting of multiple NAICS codes
based on each chemical substance, similar to how the technical contact
is reported.

    a. Relationship to processing and use industrial sector codes. For
processing and use information, often conducted at sites other than the
manufacturing site, submitters currently report an industrial sector
(IS) code instead of the NAICS codes. The IS codes divide the entire
range of NAICS codes into sectors such that there is a sector
corresponding to any NAICS code. Initially, submitters reported NAICS
codes when describing the industrial processing and use of their
reported chemicals. In the 2011 Inventory Update Reporting (IUR)
Modifications final rule, EPA replaced the NAICS codes with the
industrial sector codes. (76 FR 50816, August 16, 2011; EPA-HQ-OPPT-
2009-0187-0393). Respondents to the 2006 IUR, the predecessor to the
CDR, submitted 342 unique 5-digit NAICS codes. So many codes made it
difficult for EPA to group chemical substances based on industrial
processing and use scenarios. In all, the 2006 IUR database has 2,330
unique combinations of processing or use codes, NAICS codes, and
industrial function categories. This large number of unique
combinations increased the difficulty and time required by EPA to sort
and classify chemical substances because EPA either would need to
develop exposure scenarios for each unique combination or determine the
three-code combinations that have similar exposure scenarios and can be
grouped. The use of the IS codes for the 2012 and subsequent CDR
reporting cycles has reduced the number of unique combinations, thereby
increasing the usability of the data and reducing the associated
reporting burden.
    EPA believes that the manufacturing of chemicals incorporates a
narrower range of NAICS codes than the processing and use of chemicals.
Therefore, identifying the more specific NAICS code for the
manufacturing site is not expected to result in the large number of
combinations experienced in 2006 for the processing and use
information.
    b. Improving outreach and reporting assistance. EPA would also use
the NAICS codes to improve outreach and reporting assistance for
manufacturers in specific industry sectors. For the 2016 submission
period, EPA developed industry sector-specific Fact Sheets for the
printed circuit board, metal mining, and electricity-generating sectors
(Refs. 15, 16, and 17). Each Fact Sheet addressed reporting
requirements specific to that industry, including the use of specific
and unique examples designed to better illustrate the sector's
reporting requirements. EPA expects to continue this practice for other
industries, and having NAICS codes available in the CDR dataset would
facilitate expansion of this outreach.
    3. Modifying recycled information. Currently, CDR submitters
identify 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 proposing to modify this data element by removing the
terms ``remanufactured, reprocessed, reused'' as this 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. It is EPA's intention
that this data element identify the chemical substances that would
otherwise be disposed of as a waste, and EPA believes the revised
phrase ``recycled or otherwise used for a commercial purpose instead of
being disposed of as a waste or included in a waste stream'' best
describes this intention. This proposed change is also intended to
reduce confusion, and thus burden, and provide greater specificity as
to what this data element requires. For example, the term ``reused''
might cause the site to consider the need to report other chemical
substances that it simply purchased and used if the site found a way to
reuse that substance. Such reporting would be erroneous, because a site
is only required to report a substance that it manufactures, not that
it has merely purchased. However, if a manufactured (including
imported) substance is reused instead of being disposed of as a waste,
then that would be reported. EPA does not anticipate a change in burden
associated with this proposed change. See section 4.1.3 of the Economic
Analysis for additional information (Ref. 4). EPA is soliciting public
comments on modifying this data element to better capture recycling in
CDR.
    EPA is soliciting 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, the
burden associated with providing such an estimate, and any difficulties
industry might encounter in estimating such a percentage (either to the
nearest 10 percent or more accurately). EPA believes that the percent
production volume for a chemical substance that is being recycled or
otherwise used for a commercial purpose instead of being disposed of as
a waste or included in a waste stream would be information relevant to
the exposure profile of a chemical substance and indicates efficiencies
within the chemical manufacturing industry. EPA is interested in the
exposures from these activities. In addition, information about whether
certain types of industries recycle or whether certain types of
chemicals are recycled and if such recycling is increasing or
decreasing provides information about changes in the manufacturing
environment that inform EPA's TSCA activities. Collecting specific
percentages about recycling could give EPA a better understanding of
the recycling reporting universe and provide EPA the opportunity to
grant more targeted reporting exemptions and burden reduction
activities in future reporting cycles.
    4. Percent byproduct. EPA is proposing to add the requirement to
report the percent total production volume for a chemical substance
that is a byproduct. EPA believes this data element would provide
information to better understand the manufacturing of byproduct
chemical substances and the impact of current or potential future
exemptions to reporting. EPA is interested in this change in order to
increase transparency by identifying important submitter subpopulations
and their representations in CDR with respect to production volume. EPA
estimates that this proposed change would result in an increase in
burden, which is explained in detail in Table 4-11 in the Economic
Analysis (Ref. 4).
    Information about byproduct reporting has been of particular
interest due to requirements of the 2016 amendments to TSCA to conduct
a negotiated rulemaking for manufacturers of inorganic byproducts.
During the deliberations of the negotiated rulemaking committee, EPA
was unable to specifically identify, from the CDR data, chemical
substances manufactured as byproducts or byproduct manufacturers who
would be impacted by changes to the reporting requirements. With the
addition of this data element, EPA will be able to identify those
manufacturers that recycle portions of their substances or only report
to CDR due to their byproduct production. EPA would consequently 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. In addition, EPA would use
this information to inform future decisions about potential changes to
CDR requirements.

    There are situations where the same chemical substance is
manufactured both as a primary chemical substance and a byproduct.
While this is rare, it is a known occurrence. For example, when
commercial stearic acid is manufactured, it is known to contain
significant amounts of palmitic acid and oleic acid as byproducts. Such
a producer would also be likely to separately manufacture palmitic acid
and/or oleic acid as primary chemical products. In this situation, if
the palmitic acid that is manufactured as a byproduct is used for a
reportable commercial purpose, its volume would be reported along with
the volume of palmitic acid that is separately manufactured at the same
site and its volume would be counted as the byproduct portion when
calculating the percent manufactured as a byproduct. It is important to
recognize that an overproduction of the primary manufactured substance
does not meet the regulatory definition of a byproduct, and thus is not
considered a byproduct for the purposes of CDR, and should not be
counted as such when calculating the percent manufactured for this data
element.
    Reporting in percentages. As with other percentage production
volume reporting requirements in the CDR regulation, EPA is proposing
to require that the percentages for the percent byproduct be rounded to
the nearest 10 percent, unless the percentage is less than 5 percent.
EPA would allow the reporting of more specific percent production
volumes. In situations where the percentages account for less than 5
percent of the submitter's total production volume for the reportable
chemical substance, the submitter would not round off to zero if the
production volume attributable to that amount is greater than or equal
to 25,000 lbs. (or in an amount of 2,500 lbs. or more for chemical
substances subject to the rules, orders, or actions described in Sec.
711.8(b)). In such cases, submitters would report the percentage of
production volume attributable to that portion to the nearest 1 percent
of production volume. This exception to the general rounding off rule
is being proposed to differentiate situations where no portion or a
very low portion of the chemical substance is a byproduct, to ensure
that adequate manufacturing information would be reported for the
larger production volume chemical substances. The 25,000 lbs. (or 2,500
lbs.) level was selected for consistency with the current threshold for
reporting under CDR. EPA is interested in receiving comment on whether
reporting the percent production volume to the nearest 10 percent or 1
percent for 5 percent or below is a lower burden than simply reporting
to the nearest 1 percent for any percentage. EPA is interested in the
difficulty that industry might encounter in estimating a percentage
rounded to the nearest ten percent or a more accurate percentage of
byproduct that is produced in the manufacturing process and what
challenges industry may encounter in calculating this estimate. EPA is
also interested in the burden estimate associated with calculating this
data element. EPA is also interested in receiving general comment on
the reporting requirements in this proposed rule, including on the
effort required by a submitter to provide the percent production volume
that is a byproduct.
    5. Chemical specific function for imported mixtures. EPA is
proposing to require 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. 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. for additional information about joint
submissions. Currently, the importer identifies the function of the
imported product. In some circumstances, the function of the imported
product can be correctly applied to the specific chemical substance.
However, in the circumstance where the imported product is a multi-
component mixture, applying the function of the imported product to
each component of the mixture can result in identifying a function for
an individual chemical substance that is not appropriate. For example,
a dye or a fragrance that is part of a cleaning mixture should not be
identified as a cleaner, but rather as a dye or a fragrance. Providing
the appropriate function for the component of the mixture would inform
the assessment process by improving the understanding of the conditions
of use for a chemical (e.g., formulation, use rate, etc.). EPA does not
anticipate a change in burden associated with this proposed change
because the burden associated with reporting the function of the
chemical for the secondary submitter is already captured in the
baseline burden. See section 4.1.3 of the Economic Analysis for
additional information (Ref. 4).
    6. Public contact. EPA is proposing to enable the reporting of a
public contact for each CDR submission as a voluntary data element.
Currently, a technical contact familiar with the information provided
in the form is required to be reported. The public contact would be in
addition to the technical contact and would be an individual who may be
contacted by the general public with questions related to the publicly
available information reported by the company under CDR. This person
has been designated by the site or company to handle public inquiries.
The addition of a public contact to handle public inquiries is modeled
after TRI's approach to the public contact, albeit on a voluntary
basis, and would include the contact's name, phone number, and email
address. Because the public contact is intended to be made available to
the public, this voluntary data element would not be able to be claimed
as confidential. EPA is interested in receiving comment on whether it
would be helpful to have a public contact available. EPA estimates that
this proposed change would result in a slight increase in burden, which
is explained in detail in Table 4-11 in the Economic Analysis (Ref. 4).
    Difference between public contact and technical contact. Submitters
to CDR are already required to supply, and may claim as confidential, a
technical contact(s) who should be a person able to answer technical
questions about the reported chemical substance(s). Typically, a person
located at the manufacturing site is best able to answer such
questions. The public contact, which would be voluntarily reported, is
intended to be a more general, public-facing company representative who
would be available to answer questions the public might ask the
company.
    7. Parent company identity. EPA is proposing three changes
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 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 would be
provided in the CDR Instructions (see 40 CFR 711.35). As a whole, EPA
believes these changes would increase the usefulness of the CDR data by
improving consistency in reporting, better enabling EPA to protect
information claimed as confidential, and reducing the after-reporting
quality control effort for both EPA and

submitters. EPA estimates that the proposed addition of a foreign
parent company would slightly increase the burden, which is explained
in detail in Table 4-11 in the Economic Analysis (Ref. 4). EPA did not
estimate the burden reduction associated with the reduced need to
contact companies for quality control purposes after data submission.
    Currently, sites required to report to CDR must report their U.S.
parent company, which is defined to mean the highest-level company
located in the United States that directly owns at least 50 percent of
the voting stock of the manufacturer (see 40 CFR 711.3). The site must
report its U.S. parent company name, address, and Dun and Bradstreet D-
U-N-S[supreg] (D&B) number (see 40 CFR 711.15(b)(2)(i)).
    Proposed change to definition of U.S. parent company. EPA is
proposing to replace the definition of U.S. parent company from 40 CFR
711.3 with a new definition for parent company that includes both U.S.
and foreign parent companies and provides guidelines for different
company structures. In developing this definition, EPA considered
solely using the definition of ``parent company'' already found in 40
CFR 704.3, but decided to propose the specifically listed guidelines in
the regulatory text for clarity and consistency with other programs.
Please review the proposals in the following paragraphs. EPA is
requesting comment on this approach.
    Proposed reporting of foreign parent company. In some situations,
the highest-level parent company is outside of the United States. EPA
is proposing that sites also identify the highest-level worldwide
parent company, when applicable, and therefore is also adding the
requirement to report the foreign parent company under 40 CFR 711.15.
Under this proposal, reporters would continue to report their U.S.
parent company, but also report their foreign parent company if the
situation applies.
    Including the foreign parent company would increase the ability of
EPA to protect information claimed as confidential. Currently, some
confidential information may be inadvertently disclosed due to
challenges in identifying connections between sites when the parent
companies are outside of the United States. EPA takes such
relationships into account when aggregating confidential information.
By reporting the foreign parent company, EPA would be able to better
identify company groupings for data aggregation and, ultimately,
protection of information claimed as confidential.
    This modification would be responsive to industry concerns
expressed during the 2016 CDR submission period with not being able to
report their ``true'' parent company when that company is outside of
the United States. In many cases, sites know the foreign corporation's
name more readily than the U.S. parent company's name.
    As opposed to relying exclusively on the foreign parent company
(where applicable), EPA is retaining the U.S. parent company reporting
requirement to allow EPA to align future CDR collections with
historical data; inclusion of the U.S. parent company for 2020
reporting would enable EPA to correlate with past reporting cycles and
potentially to increase consistency in reporting among sites associated
with the same parent company. Including both the U.S. and the foreign
parent companies would provide data users greater flexibility when
combining CDR data with data from other sources, some of which are
limited to only U.S. information.
    Application of parent company definition to different situations.
EPA recognizes that there are a variety of ownership situations for
manufacturers reporting under CDR. The scenario-specific information
listed in this document is based on the guidelines included in the
proposed definition and contains additional examples illustrating the
application of the proposed parent company definition and reporting
requirements. The guidelines include how to populate the U.S. and a
foreign parent company data elements. EPA is 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. The
examples are as follows:
    (1) If the site is entirely owned by a single U.S. company that is
not owned by another company, then that single company is the U.S.
parent company and there is no foreign 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 company in the
ownership hierarchy is the U.S. 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 of the site), the highest-level U.S. company with the largest
ownership interest in the site is the U.S. parent company. Under this
scenario, this would be either company A itself (if it doesn't have a
U.S.-based parent company), company A's parent, or, if it exists, a
single parent company that owns both company B and company C, in which
case that single parent company would have the largest ownership
interest. If there is a higher-level foreign company in the site's
ownership hierarchy, that company is the foreign parent company. There
may be the situation where the highest U.S. company is company A's
parent company but a foreign company owns both company B and company C.
In this situation, the foreign parent company would be the highest-
level parent company that owns companies B and C and the U.S. parent
company would be the parent company of company A.
    (4) If the site is ultimately owned by a 50:50 joint venture or a
cooperative, the joint venture or cooperative is its own U.S. 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 facility's ownership
hierarchy), the highest-level foreign parent company is the facility's
foreign parent company. In this situation, the U.S. parent company
would be the site itself.
    (6) If the site is a 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.
    Proposed use of naming convention. EPA is also proposing to require
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 would reduce the number of inconsistencies
with the Parent Company Name data field, and thereby would 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. Changes to Reporting Process for Co-Manufactured Chemicals

    EPA is proposing to change the method manufacturers use to report
co-manufactured chemicals. A co-manufacturing relationship occurs when
a chemical substance, manufactured other than by import, is produced
exclusively for another person who contracts for such production. To be
considered a co-manufacture situation, the producing company produces
the chemical substance exclusively for another person (the contracting
company) under contract for that production. If the chemical substance
is produced for other purposes, then the situation fails this first
test of ``co-manufacturing.'' For example, if a company manufactures a
chemical for speculative purposes based on expectations of the market,
the company is not operating in a co-manufacturing situation. In
addition, the other person contracting the manufacture (i.e., the
contracting company) specifies the identity of the chemical substance,
the total amount produced, and the basic technology for the plant
process. This is the second test of ``co-manufacturing.'' To be
considered co-manufacturers, both of these tests must be met. See 40
CFR 711.3 (definition of ``manufacture''). Although this proposed
change reduces co-manufacturer confusion and addresses other industry
concerns, EPA estimates that it would have a minimal impact on the
burden and therefore did not include an estimate in the analysis. See
section <IP_ADDRESS> in the Economic Analysis for additional information
(Ref. 4).
    EPA is avoiding the use of the term toll manufacturer for this
proposal and future guidance to add clarity for the co-manufacturing
situation. In instructions, guidance, and other communication with
submitters, EPA may previously have referred to co-manufacturing as
toll manufacturing, and more specifically to the two parties as the
contracting manufacturer and the toll manufacturer. Because EPA does
not specifically define the term ``toll manufacturer,'' EPA now
believes the use of this term may be open to mis-interpretation and it
would be clearer to use terms associated with the CDR definition of
manufacturer in 40 CFR 711.3. Additionally, EPA believes the chemical
industry often refers to toll manufacturing in a more general manner,
where both of the tests included in the CDR definition for manufacture
are not met. These tests are: (1) The chemical substance is produced
exclusively for another person who contracts for such production, and
(2) that other person specifies the identity of the chemical substance
and controls the total amount produced and the basic technology for the
plant process.
    Current reporting requirements. Under the current CDR rule, the
contracting company and the producing company are jointly responsible
for reporting and submitting to CDR. Only one report may be submitted
per reportable chemical and per production site. In order to report,
the contracting company and the producing company must work together
and identify who will submit the report they are both responsible for,
to prevent duplicate reporting and ensure both parties have met their
reporting obligations.
    Pursuant to the CDR definition of ``site'' at 40 CFR 711.3, the
site reported is the site of physical manufacture (i.e., the producing
company's site). This is true irrespective of whether it is the
producing company or the contracting company who completes the report.
If both parties fail to report, both the contracting company and
producing company are liable.
    The companies must designate a single technical contact for the
specified chemical(s), who can be an employee of either the contracting
company or the producing company (or a consultant). This technical
contact should be knowledgeable about the specific chemical and should
be the best equipped to answer questions about the certain chemical.
    Submitters have identified multiple concerns with the current
reporting process for co-manufacturers. Current issues associated with
using this method for reporting include:
     The contracting company and producing company are unsure
who should be primarily or solely responsible for CDR reporting and are
concerned regarding the shared liability.
     The producing company has information (such as the number
of workers likely to be exposed) that the contracting company does not
have, and the contracting company has information (such as information
about the processing and use of the chemical substance) that the
producing company does not have. However, when currently completing the
CDR chemical report, one company may not be willing to share
information it considers confidential with the other company.
     In situations where the producing company is reporting for
additional chemical substances, the current co-reporting requirement
may result in the need to submit multiple CDR reports for the producing
company's site. This created a complicated situation that required
special handling and increased confusion and burden for the submitter.
    Proposed reporting methodology. EPA is proposing to change the
reporting mechanism for co-manufacturers by developing a multi-
submitter process, similar to that used by importers, where the
contracting company is the primary submitter and the producing company
is the secondary submitter. When evaluating the co-manufacturing
reporting process, EPA considered industry's desire for a flexible
reporting mechanism and the need to protect the confidential
information of both the contracting company and the producing company.
These considerations were made apparent through documented
correspondence between EPA and reporters to the 2016 CDR who were
either a contracting company or a producing company regarding issues
with the co-manufacturing mechanism. EPA also met with representatives
from reporting companies to discuss the co-manufacturing mechanism and
the challenges related to coordinating a dual effort between the
contracting companies and producing companies during the 2016 reporting
period (Ref. 18).
    In response, EPA is proposing a new methodology for the 2020 and
future reporting cycles. Under this new reporting methodology, the
contracting company (as the primary submitter) would have the
responsibility to initiate a co-manufacture report that would prompt
the reporting requirements for the producing company (as the secondary
submitter). The contracting company would start the chemical report for
the co-manufactured chemical, identifying the chemical substance and
the producing company. The contracting company would then initiate the
co-manufacture report using e-CDRweb 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-manufacture report, which would include the
manufacturing-related data elements from 40 CFR 711.15(b)(3), including
the production volume.
    Although the manufacturing information section includes the
chemical identity field, it is EPA's belief, based on the two tests for
a co-manufacturing situation in which the contracting company specifies
the

chemical to be manufactured and the process to be used, that the
contracting company would be best situated to complete the chemical
identity field. EPA also believes that both parties should report the
volume manufactured because both are responsible for reporting other
data elements and an associated percent production volume. To ensure
the percent production volume is correctly interpreted by both data
reporters and data users, the basis for that percent production volume
must be known. EPA is interested in receiving comments on whether this
split in the data elements is reflective of the knowledge of each party
in the co-manufacturing relationship.
    This improved reporting mechanism would protect the confidentiality
of both the producing company and contracting company by ensuring that
the contracting company would not require any potentially confidential
information from the part of the producing company. This method also
would eliminate confusion between the two involved parties by
designating the contracting company as the primary submitter
responsible for initiating the reporting process. As with current
reporting, both parties would remain liable for reporting the co-
manufactured chemical because each party has a portion of the
information required under CDR. In addition, this co-manufacture
reporting procedure enables the use of one Form U per site, because the
contracting company indicates the producing company's site without
starting a separate Form U and the producing company completes an
independent report for any other, non-co-manufactured chemicals in its
own site report.
    Alternative reporting methodologies. EPA considered alternatives to
the proposed approach for reporting in a co-manufacturing situation.
The first alternative would require the producing company (instead of
the contracting company) to initiate the reporting and to be primarily
liable for reporting. In this alternative, the producing company would
initiate reporting via a co-manufacture report and provide the exposure
information from the manufacturing site. Using e-CDRweb, the producing
company would notify the contracting company of the need to provide the
remainder of the information. EPA does not favor this option at this
time because it believes that the contracting company is likely to be
more knowledgeable about the chemical identity and other information
required by CDR and therefore better able to complete the reporting
requirements.
    The second alternative would be to retain the current reporting
mechanism (described in Current reporting requirements) where the
contracting company and the producing company are jointly responsible
for reporting and submitting under CDR. This alternative could include
the addition of an indication that the chemical is being co-
manufactured and, for the contracting company, the addition of the
producing company site location. As is currently the case, only one
report may be submitted per reportable chemical and per production
site; therefore, the contracting company and the producing company must
determine who is responsible to submit the one report to prevent
duplicate reporting, and work together to provide a single complete
report.
    EPA requests comments on the proposed reporting methodology where
the contracting company is the primary submitter and on the two
alternative reporting scenarios (where the producing company is the
primary submitter or retaining the current reporting mechanism without
a primary or secondary submitter) for improving the reporting process
for co-manufacturing situations. In addition to comments on the general
approaches, EPA is interested in comments on the information that
should be included on each portion of the co-manufacturing report (for
the proposed and first alternative).
    Definition of site. EPA is proposing to modify the definition of
site by replacing the term toll manufacturer with the term producing
company. This change would make terminology consistent between the
definitions of site and manufacture.
    Relationship of co-manufacturing to imports. As with the current
CDR rule, a co-manufactured chemical substance cannot be an import.
Rather, the chemical substance produced via an arrangement with a
foreign supplier results in an imported chemical substance, and the
U.S. importer alone, as the reporting manufacturer, is responsible for
reporting that substance.

D. Reporting of Byproducts

    EPA is proposing three changes that directly impact manufacturers
of byproduct substances, including inorganic byproducts, to: (1) Allow
reporting in metal categories for inorganic byproducts; (2) exempt
specifically listed byproducts that are recycled in a site-limited
manner; and (3) exempt byproducts manufactured in pollution control and
boiler equipment when that equipment is non-integral to the primary
manufacturing process. Byproducts are defined at 40 CFR 704.3 to mean a
chemical substance produced without a separate commercial intent during
the manufacture, processing, use, or disposal of another chemical
substance(s) or mixture(s). In developing these proposals, EPA relied
on information gathered during the negotiated rulemaking process (EPA-
HQ-OPPT-2016-0597 and 81 FR 90843, December 15, 2016) and from other
public comments (EPA-HQ-OA-2017-0190 and 82 FR 17793, April 13, 2017),
with the intent to develop proposals for addressing burden for these
byproduct manufacturers while maintaining the information needed by
EPA, as described in Unit I.C.
    1. Alternative reporting in metal compound categories for inorganic
byproducts. EPA is proposing 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 the
option to combine and report multiple inorganic byproduct metal
substances, that otherwise would be reported individually as listed on
the TSCA Inventory, into one or more specifically-listed categories
(e.g., Chromium & Chromium Compounds).
    If the manufacturer has multiple inorganic byproduct chemical
substances to report, they would be able to choose to report some
byproduct substances in categories and other different byproduct
substances as specific substances. However, the manufacturer would not
be able to bifurcate the production volume of the same byproduct
chemical substance and report a portion in a category and another
portion as a specific chemical substance unless the bifurcation is due
to having different metal elements present in the byproduct. Some
substances would be required to be reported as listed on the TSCA
Inventory and not as part of these metal compound categories, because
they are of particular interest to EPA. They are described later in
this unit.
    EPA believes this proposed method of reporting in categories would
simplify reporting and ease reporting burden for manufacturers whose
inorganic byproduct metal-containing substances have chemical
compositions that are non-specific and difficult to identify, while
also providing information that meets EPA's needs. Additionally,
because manufacturers would retain the ability to report to CDR by
specific substances contained on the TSCA Inventory (as is currently
required), manufacturers of these byproduct

substances would have the flexibility to report these substances in the
manner that they prefer.
    Inorganic metal substances that are manufactured as products and
not as byproducts would be ineligible to report within a metal category
because these non-byproduct substances are intended products and should
be more easily identifiable by their manufacturers.
    EPA has the explicit authority under TSCA section 26(c) to take any
actions authorized or required by TSCA with respect to categories of
chemical substances, and the Agency has experience assessing chemicals
in categories under TSCA. For an example of how EPA could use
information reported in metal compound categories, see the Antimony
Trioxide (ATO) Risk Assessment conducted in 2014 (Ref. 19). Because ATO
is not specifically listed on the TRI, releases reported under the
broader category of antimony compounds were used as a surrogate to
evaluate the potential for aquatic exposures.
    The proposed defined inorganic metal compound categories are
designed in part to allow CDR reporting to align more closely with
those chemical substances and compound categories on the 2014 Update to
the TSCA Work Plan for Chemical Assessments.
    TRI also uses a similar option of reporting under compound
categories, many of which are metals. EPA recognizes that many
companies report to both statutory programs and is interested in
aligning TRI and CDR to the extent possible and reasonable given the
differing purposes of the two rules.
    The proposed CDR metal categories list is comprised of the
following categories from the 2014 Update to the TSCA Work Plan for
Chemical Assessments and from TRI (Refs. 20 and 21). In the future, EPA
may modify, by rulemaking, the metal categories list as more chemicals
are evaluated as part of the existing chemical program:

 Antimony & Antimony Compounds
 Arsenic & Arsenic Compounds
 Barium & Barium Compounds
 Beryllium & Beryllium Compounds
 Cadmium & Cadmium Compounds
 Chromium & Chromium Compounds
 Cobalt & Cobalt Compounds
 Copper & Copper Compounds
 Lead & Lead Compounds
 Manganese & Manganese Compounds
 Mercury & Mercury Compounds
 Molybdenum & Molybdenum Compounds
 Nickel & Nickel Compounds
 Selenium & Selenium Compounds
 Silver & Silver Compounds
 Thallium & Thallium Compounds
 Vanadium & Vanadium Compounds
 Zinc & Zinc Compounds

    To better characterize which substances would be reportable within
these metal compound categories, EPA is proposing to use the definition
of inorganic chemical substances that was originally part of the IUR
(51 FR 113, June 12, 1986). For the purposes of this rule, inorganic
substances would be defined to mean those substances that do not
contain carbon or contain carbon only in the form of carbonato [=CO3],
cyano [-CN], cyanato [-OCN], isocyano [-NC], or isocyanato [-NCO]
groups, or the chalcogen analogues of such groups (e.g., thiocarbonato
(=CS3-xOx, where x = 0-2), thiocyanato (-SCN), or isothiocyanato (-
NCS)). It should be noted that EPA does not consider organometallics to
be inorganic chemical substances, and therefore such substances would
not be reportable under metal compound categories. Examples of
organometallic substances listed on the TSCA Inventory are: Ferrocene,
benzoyl- (CASRN 1272-44-2), Plumbane, tetraethyl- (CASRN 78-00-2),
Stannane, tetrabutyl- (CASRN 1461-25-2), Mercury, dimethyl- (CASRN 593-
74-8), and Cobalt, di-.mu.-carbonylhexacarbonyldi-, (Co-Co) (CASRN
10210-68-1).
    As an example of how to use this inorganic metal compound category
reporting method, a manufacturer who is domestically producing Copper
chloride, Copper hydroxide, and Copper sulfide as byproduct substances
would have the option to report all of these inorganic byproducts under
a single report of Copper and Copper compounds, aggregating their
volumes. If reporting by category, the manufacturer in this example
would first assess if it meets the threshold for reporting by combining
the production volumes for all three substances (Copper chloride,
Copper hydroxide, and Copper sulfide). If the combined threshold for
any of the years since the last principal reporting year is 25,000 lbs.
or greater, the manufacturer has met the reporting threshold for the
copper compound category (e.g., for 2020 CDR, consider the production
volumes for 2016, 2017, 2018, and 2019), which would prompt the need
for the manufacturer to report for that category of chemicals (Ref.
22).
    In terms of reporting, however, EPA is proposing that only the
weight of the parent metal portion of the metal category compound would
be reported (for example, if reporting by categories, 34,000 pounds of
Copper chloride (CuCl2) (CASRN 7447-39-4) would be reported based on
16,072 pounds in the category ``copper and copper compounds'') (Ref.
22). This approach is proposed because it is similar to the methodology
used by TRI (Ref. 23). Although the type of threshold prompting the
need to report would be similar to that for reporting in categories
under TRI, it is important to note that reporting under CDR is for
amounts manufactured (and imported), while reporting under TRI is for
amounts released. It is also important to recognize that this method is
different than reporting under CDR using a TSCA-listed chemical
substance identity.
    EPA is interested in obtaining comment on the proposal to allow
reporting of inorganic substances in metal compound categories,
including the methodology for how to report using categories.
Specifically, EPA is interested in receiving comments on deviating from
the standard approach used for CDR of reporting the volume of substance
manufactured and instead using the approach of reporting the weight of
the metal in the compounds when reporting by the metal category. Would
it be more appropriate to report the full weight of the chemical
substance instead of the metal weight? Are submitters likely to report
using this approach?
    Exclusions from category reporting. EPA is also proposing to
require various substances to be reported as listed on the TSCA
Inventory and not as part of these metal compound categories. Such
substances are of particular interest to EPA, and would include:
     Substances that have been individually identified on the
2014 Update to the TSCA Work Plan for Chemical Assessments (Ref. 20):
specifically, Carbonic acid, barium salt (1:1) (CASRN 513-77-9)
(referred to as Barium carbonate);
     Substances that are the subject of certain TSCA actions as
listed in 40 CFR 711.6, including TSCA section 5(a)(2) Significant New
Use Rules (SNURs), TSCA section 5(b)(4) rules, TSCA sections 4, 5(e)
and 5(f) orders, TSCA section 6 rules, TSCA section 4 test rules,
Enforceable Consent Agreements (ECAs) developed under the procedures of
40 CFR part 790, and TSCA section 5 or 7 civil actions. Note that lists
of subject chemicals can be identified using the eCDRweb reporting tool
or separately from EPA's Substance Registry Services (SRS) website
(https://www.epa.gov/srs). Instructions for determining subject
chemicals are provided on the CDR website and in CDR guidance.
     Chemical substances undergoing prioritization or risk
evaluation under TSCA section 6. While the current list

of chemical substances undergoing risk evaluation is comprised of ten
chemicals that are not inorganic metal-containing compounds (Ref. 24),
EPA may initiate risk evaluations for inorganic metal-containing
chemicals in the future, which would exclude those chemical substances
from being able to be reported to CDR under a metal compound category.
    For example, consider reporting within the chromium category. There
is a TSCA section 6 action (40 CFR 749.68) that covers several
hexavalent chromium-based water treatment chemicals. Those covered
substances (e.g., Chromic acid (H2Cr2O7), sodium salt (1:2) (CASRN
10588-01-9), Chromic acid (H2CrO4) (CASRN 7738-94-5), and Chromium
trioxide (CrO3) (CASRN 1333-82-0)) would not be reportable within the
chromium category, even if they were manufactured as byproducts.
However, other chromium substances, containing Chromium not in the
hexavalent oxidation state (e.g., Chromium chloride (CrCl3) (CASRN
10025-73-7), Chromium hydroxide (Cr(OH)3) (CASRN 1308-14-1), and
Chromium oxide (Cr2O3) (CASRN 1308-38-9)), if manufactured as byproduct
substances, would be able to be reported within the Chromium compound
category.
    2. Specific site-limited recycled byproducts. EPA is proposing to
exempt specifically identified byproducts that are recycled on-site
from two industries. Portland cement manufacturers that produce Flue
dust, portland cement (CASRN 68475-76-3) (referred to as cement kiln
dust), and manufacturers using the Kraft pulping process to produce
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, under certain scenarios, be exempted from the need to report
these byproduct substances. These byproducts would be exempted from
reporting only when (1) they 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 as
that byproduct was originally manufactured and (2) when the site is
reporting under CDR the byproduct substance or a different chemical
substance that was manufactured from the byproduct or manufactured in
the same overall manufacturing process.
    Based on information provided by these two industries, these
byproduct substances are directly recycled in physically enclosed
systems in a site-limited manner (see definition of ``Site-limited'' at
40 CFR 711.3). For the purposes of CDR, EPA considers an enclosed
system to be a system of equipment directly connected to the production
process that is designed, constructed, and operated in a manner which
prevents emissions, or the release of any chemical substance into the
facility or environment during the production process. Such emissions,
including fugitive emissions, could lead to exposures to workers, the
public, or the environment. For an enclosed system, exposure and
release could only occur due to loss of integrity or failure of the
manufacturing process equipment or control systems.
    To meet the EPA enclosed system scenario, any equipment that the
byproduct is present in at any point during the process sequence, such
as tanks, reaction vessels, reactors, processing units (e.g., a drum
filter), and/or connecting lines, must: (1) Be of high structural
integrity and contained on all sides, (2) pose no foreseeable potential
for escape of constituents to the facility or environment during normal
use, and (3) be connected directly by pipeline or similarly enclosed
device to a production process. Also, any transfers or holding steps
occurring in this system must be necessary to the recycle process and
must take place within physically enclosed equipment that meet the
aforementioned criteria. For example, hard piping or completely sealed
(i.e., welded) equipment would meet these criteria if connected
directly to other enclosed equipment, preventing potential releases
including fugitive emissions.
    EPA recognizes that there may be some potential for exposures and
releases (e.g., through non-routine cleaning of equipment, or
maintenance operations) associated with such enclosed, site-limited
systems, but believes the potential exposures and releases related to
such systems are less than the potential exposures and releases
associated with recycling systems that are not enclosed. Likewise,
systems that transfer the byproduct to a different site for recycling
or other use are expected to have higher levels of potential exposures
and releases. For example, on-site recycling systems that rely on open
troughs for moving material have an increased opportunity for exposures
due to dusting or splashing as compared to the use of an enclosed pipe
for moving material from one part of the manufacturing process to
another.
    Based on 2016 CDR data, the sites reporting under CDR within these
two industries have reported chemicals that are related to these
byproducts because they are subsequently manufactured from the
byproducts or from other substances via the same overall manufacturing
process. EPA therefore would collect exposure-related information about
the manufacturing site for these two industries.
    This proposed exemption is only for the volumes of the byproduct
substance, listed at 40 CFR 711.10(c)(2)(i) (as proposed), that are
recycled in a site-limited manner in physically enclosed systems of the
same overall manufacturing process. Volumes that are used for a
commercial purpose distinct from their manufacture as a byproduct
remain reportable. Also, volumes that are removed from the enclosed
systems, such as those that are stored in an open tank or pit, or
stored in any non-connected tank or vessel, are excluded from this
exemption and remain reportable.
    Portland cement industry--Cement kiln dust. The Portland Cement
Association (PCA) suggested that EPA should eliminate reporting
requirements for cement kiln dust (CKD) that is temporarily stored
before reintroduction into the Portland cement manufacturing process
(Refs. 25 and 26). PCA suggested that their manufacture and recycling
of cement kiln dust is similar to non-isolated intermediates, which are
currently exempted from the need to report under CDR by 40 CFR
711.10(c)(4)(viii). However, EPA's existing policy with respect to non-
isolated intermediates excludes storage in tanks or other vessels
(e.g., shipping containers) even if the vessels are part of an enclosed
system.
    There are circumstances where the cement kiln dust is stored for a
period of time in a tank that is connected in an enclosed system with
the other operating equipment. Because the cement kiln dust is stored,
it cannot meet the requirements of the non-isolated intermediate
exemption and therefore would need to be considered for reporting under
CDR (Refs. 25 and 26).
    EPA agrees that, based on the information provided by PCA, relevant
portions of CKD processing meet the definition of enclosed as described
for this proposed exemption; however it does not meet the non-isolated
intermediate exemption. In addition, the recycling operation uses the
CKD to manufacture clinker (which consists of Portland cement), which
is reported under CDR by its component substances and therefore would
supply the Agency with exposure information from a similar production
process. Based on

CDR data submitted for the most recent principal reporting year (2015),
EPA estimates that approximately 23 million lbs of CKD might meet the
criteria established in this exemption. This is the amount of CKD that
was reported as recycled and used on-site (out of the approximately 1.1
billion lbs total manufactured domestically in 2015).
    Kraft pulping cycle--black liquor and calcium carbonate. The
American Forest & Paper Association (AF&PA) provided EPA with extensive
information about the Kraft pulping cycle and chemicals manufactured as
part of that cycle. Most recently, AF&PA and other industry
representatives communicated with EPA by petitioning for full exemption
from CDR for four manufactured Kraft pulping cycle chemicals, by
submitting comments in response to Federal Register notices related to
the negotiated rulemaking, and by meeting with EPA to view and discuss
a video providing an in-depth explanation of the Kraft pulping cycle
(Refs. 27, 28, 29, and 30).
    AF&PA identified that the Kraft pulping cycle begins with the
production of black liquor as a byproduct of pulping in the production