[Federal Register Volume 84, Number 80 (Thursday, April 25, 2019)]
[Proposed Rules]
[Pages 17692-17727]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-07716]



[[Page 17691]]

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  

[[Page 17692]]


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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: (202) 564-8789; email address: 
[email protected].
    For general information contact: The TSCA-Hotline, ABVI-Goodwill, 
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 
554-1404; email address: [email protected].

SUPPLEMENTARY INFORMATION: 

I. Executive Summary

A. Does this action apply to me?

    You may be potentially affected by this action if you manufacture 
(defined by statute at 15 U.S.C. 2602(9) to include import) chemical 
substances, including 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

[[Page 17693]]

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

[[Page 17694]]

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

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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)
----------------------------------------------------------------------------------------------------------------
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.



[[Page 17696]]



                               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

[[Page 17697]]

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).

[[Page 17698]]

    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

[[Page 17699]]

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)).

[[Page 17700]]

    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 
4.1.3.2 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,

[[Page 17701]]

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.

[[Page 17702]]

    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.

[[Page 17703]]

    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

[[Page 17704]]

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

[[Page 17705]]

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 4.1.3.2 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

[[Page 17706]]

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

[[Page 17707]]

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

[[Page 17708]]

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

[[Page 17709]]

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 
of paper, and the black liquor is subsequently used to manufacture 
green liquor. Calcium oxide and green liquor are used to manufacture 
white liquor, which results in the production of calcium carbonate as a 
byproduct. The calcium carbonate is recycled to produce calcium oxide. 
From the information provided, EPA believes that both black liquor and 
calcium carbonate are byproducts that are recycled in site-limited, 
enclosed systems. Based on CDR data submitted for the most recent 
principal reporting year (2015), EPA estimates that approximately 382 
billion lbs of black liquor and calcium carbonate together might meet 
the criteria established in this exemption. This is the amount of black 
liquor and calcium carbonate that was reported as recycled and used on-
site (out of the approximately 386 billion lbs total manufactured 
domestically in 2015). The other substances in the cycle are 
intentionally manufactured substances and would therefore continue to 
be reportable under CDR. Because the sites would be reporting these 
other substances, their production of black liquor and calcium 
carbonate would meet the requirements for this proposed exemption.
    Changes to the list of exempted processes and related byproduct 
substances. EPA is proposing a petition process for the public to 
request changes to the list of exempted manufacturing processes and 
related byproduct substances. The initial exempted substances were 
selected based on information provided directly to EPA as part of the 
negotiated rulemaking-related activities and through other 
communications with these industries, as described elsewhere in this 
unit. Because there may be other manufacturing processes and related 
byproduct substances that meet the criteria for this exemption (as 
identified at the beginning of this unit) or EPA's interest in these 
byproduct substances may change, EPA may amend the list of byproduct 
substances and processes that have been proposed as part of this 
exemption. The Agency may do this on its own initiative or in response 
to a request from the public, based on EPA's determination of whether 
the manufacturing process and related byproduct substance described 
meet the criteria explained in this unit.
    Any person would be able to request that EPA amend the 
manufacturing process and related byproduct substance exempted list. 
EPA is proposing to model the procedure to request amendments after the 
one described in 40 CFR 711.6(b)(2)(iii) to amend the list of partially 
exempted chemical substances for which the processing and use 
information is of low current interest. The proposed procedure would 
require a written request that identifies the process and byproduct 
chemical substance in question, including a written rationale for the 
request that provides sufficient specific information, including cites 
and relevant documents, to demonstrate to EPA that the byproduct 
substance(s) and manufacturing process(es) in question either would or 
would not meet the criteria for this exemption.
    EPA is proposing to consider the following factors when evaluating 
a request to amend the list of exempted manufacturing processes and 
related byproduct substances: (1) Whether the byproduct substance is 
recycled or otherwise used to manufacture another chemical substance 
within an enclosed system, within the same overall manufacturing 
process, and on the same site as that byproduct was originally 
manufactured; (2) whether the site is reporting under CDR other 
chemical substances, in particular a chemical substance other than the 
byproduct substance that was manufactured from the byproduct or 
manufactured in the same overall manufacturing process; (3) whether EPA 
has a current interest in the byproduct substance; and (4) whether the 
byproduct substance must have already been reported under CDR or would 
be expected to be reported if not exempted by this exemption.
    Regarding the second consideration, EPA expects to be able to 
ascertain typical exposure scenarios for the process based on 
information for other substances that are reported at the facility in 
the same or similar manufacturing process. If no other substances are 
reported, EPA would not have any exposure-related information about the 
manufacturing site.
    Regarding the third consideration, EPA may have a current interest 
in a byproduct substance that is the subject of a rule proposed or 
promulgated under TSCA sections 4, 5(a)(2), 5(b)(4), or 6, or is the 
subject of an ECA developed under the procedures of 40 CFR part 790, or 
is the subject of an order issued under TSCA sections 4, 5(e) or 5(f), 
or is the subject of relief that has been granted under a civil action 
under TSCA section 5 or 7. As noted earlier, lists of subject chemicals 
can be identified using the eCDRweb reporting tool or separately in 
EPA's Substance Registry Services (SRS). Instructions for determining 
subject chemicals are provided on the CDR website and in CDR guidance. 
EPA may also have a current interest in a byproduct substance that is 
undergoing risk evaluation, is being considered for prioritization, or 
that has particular uses or attributes that are of interest. This list 
is not exhaustive. For example, EPA may have a current interest for 
other reasons, including activities under other statutes, such as the 
Resource Conservation and Recovery Act (RCRA).
    If a request related to a particular byproduct substance and 
process is resubmitted, any subsequent request would need to clearly 
identify new information contained in the request. EPA may request 
other information that it believes necessary to evaluate the request. 
EPA would issue a written response to each request within 120 days of 
receipt of the request. As needed, the Agency would initiate rulemaking 
to revise the list of exempted byproduct substances. To assist EPA in 
reaching a decision regarding a particular request prior to a given 
principal reporting year, requests would be required to be submitted to 
EPA no later than 12 months prior to the start of the next principal 
reporting year. EPA is interested in comments that may improve the 
proposed process for requesting amendments to the manufacturing process 
and related byproduct substance exempted list.
    3. Byproducts generated by specified non-integral processes. EPA is 
also proposing to exempt byproducts manufactured in certain equipment 
via processes that are not integral to the production process. An 
integral process

[[Page 17710]]

is the portion of the manufacturing process that is chemically 
necessary or provides primary operational support for the production of 
the intended product. For the purposes of this exemption, certain 
associated processes that are not chemically required to produce the 
intended product would be considered non-integral. These may be 
required due, for example, to other regulations or the need to generate 
heat or electricity on-site, but not specifically necessary for the 
manufacture of the intended product. In this proposal, byproducts 
manufactured due to the use of pollution control equipment and boilers 
that generate heat or electricity on-site, when such equipment is not 
part of the main production process, would be exempted from reporting 
under CDR.
    The site must continue to report chemical substances that are 
subsequently manufactured from these byproducts. The production of 
byproducts in equipment that is integral to the production processes 
remain subject to reporting as well, unless otherwise exempted. For 
example, utilities that produce electricity as a product may be using 
boilers as part of their production of electricity, and therefore those 
boilers are considered equipment integral to the production process. 
Thus, byproducts produced by these electric utility boilers would 
continue to be subject to reporting. Another example, reverberatory 
furnaces, which may function similarly to some boilers, can have a 
chemical processing function such as smelting. This and similar 
equipment, when used in such scenarios, would be considered integral to 
the main production process and any resultant manufactured byproduct 
substances would continue to be subject to reporting.
    Examples of non-integral pollution control equipment include flue 
gas desulfurization and selective catalytic reduction systems. Under 
this proposed exemption, if a byproduct substance produced from this 
equipment is recycled for a non-exempted commercial purpose, the 
byproduct would be exempted from reporting under CDR. However, any 
chemical substance manufactured from the otherwise exempted byproduct 
would be subject to reporting unless otherwise exempted or the 
manufactured volumes are below the reporting threshold. EPA is 
interested in receiving comments on other examples of non-integral 
pollution control equipment, including descriptions of potential 
byproducts that could be produced in such equipment.
    In reviewing how the CDR information is used, EPA believes the 
information about byproducts produced from the identified non-integral 
equipment is generally less critical to be obtained via CDR than 
information about byproducts produced from integral equipment for risk 
evaluations conducted under TSCA. Release from pollution control 
equipment can often be obtained through national inventories such as 
TRI. Among other tools, EPA uses generic scenarios, including OECD-
approved Emission Scenario Documents, to develop environmental release 
assessments. The generic scenarios can be used in combination with 
information from CDR to develop estimates of facility releases. These 
Emission Scenario Documents do not include emissions from non-integral 
equipment; thus, CDR data from such equipment are generally not needed 
to support these environmental release assessments. EPA is interested 
in comments that may improve the approach proposed for this exemption.

E. General Regulatory Text Updates

    EPA is also proposing to make other general updates to the 
regulatory text in 40 CFR part 711 that have been identified subsequent 
to the CDR rule's original promulgation in 2011. The general updates to 
the regulatory text include removing outdated text, consolidating 
byproduct-related exemption text, and simplifying and clarifying 
language throughout the regulatory text.
    1. Removing outdated regulatory text. EPA is proposing to remove 
regulatory text specific to the 2012 CDR submission period. This text 
is no longer relevant because the submission period was completed more 
than five years ago and all phased-in reporting requirements from the 
change from the IUR to CDR have been fully in effect since the 2016 
reporting cycle.
    2. Consolidating byproduct exemption regulatory text. EPA is 
proposing to consolidate regulations regarding byproduct exemptions 
that affect reporting under the CDR rule into 40 CFR 711.10, such that 
all the CDR reporting exemptions regarding manufacturer activities are 
in one place. EPA expects such consolidation would make it easier for 
manufacturers to determine whether all or only some of their 
manufacturing activities are required to be reported under CDR, or 
whether all or some of their manufacturing activities are exempted from 
the need to be reported. Specifically, EPA is proposing that new 
exemptions proposed in this notice and language from 40 CFR 720.30(g) 
and (h) that is currently incorporated by reference would be replicated 
in 40 CFR 711.10(c). EPA intends to continue to interpret the 
replicated language in the same way as it has been interpreted under 
CDR, which for the most part aligns with how it has been interpreted 
under the TSCA section 5 Pre-Manufacture Notice (PMN) program. However, 
there are differences between the two programs that may result in 
different applications of the exemptions covered by this replicated 
regulatory text, and listing all exemptions in the CDR regulations 
instead of cross-referencing to the PMN regulations would allow for 
flexibility in the future as EPA continues to further analyze the CDR 
reporting exemptions.
    3. Simplifying and clarifying regulatory text. EPA is proposing to 
change or add regulatory text to simplify or clarify regulatory 
requirements throughout 40 CFR part 711. These proposed changes are in 
addition to changes necessary for proposals discussed elsewhere in this 
notice, and include revisions to:
     40 CFR 711.1(a) to remove the discussion about compiling 
and keeping current the TSCA Inventory, including the discussion about 
adding new chemicals to the Inventory. This discussion is unnecessary 
for an understanding of the scope of the CDR rule.
     40 CFR 711.1(c) to include a statement about TSCA section 
11 subpoena authority, as a reminder that EPA has this authority for 
compliance purposes.
     40 CFR 711.3 definitions for e-CDRweb, Manufacture, and 
Site for clarification purposes.
     40 CFR 711.6(a)(4) to reverse the order of ``certain forms 
of natural gas'' and ``water'' for clarification purposes.
     40 CFR 711.10 to remove duplicative wording and add 
clarity to the requirements.
     40 CFR 711.15(a) to add clarity to the reporting 
requirements.
     40 CFR 711.35(c)(1) to update references.

IV. Detailed Discussion of the Proposed Modifications to Small 
Manufacturer Definition and Size Standards

    EPA is proposing modifications to the TSCA section 8(a) small 
manufacturer size standards, as required, following EPA's determination 
on November 30, 2017 that revision to the current size standards is 
warranted (82 FR 56824). The proposed standards would apply to small 
manufacturers for TSCA section 8(a) rules, including CDR, unless a 
different standard is identified in the regulatory text of a particular 
rule. EPA

[[Page 17711]]

is also proposing a TSCA section 8(a) definition for small government 
entities.
    Initially, when TSCA was implemented in the 1970's, EPA took a 
case-by-case approach to the definition of small manufacturers and 
processors and established individual size standards for each TSCA 
section 8(a) rule. EPA then developed a general 8(a) small manufacturer 
definition and size standards. These standards, finalized in the 
Federal Register of November 16, 1984 (49 FR 45425), have not been 
changed, although variations have been used for selected chemical-
specific rules. See Unit II.C. of this action for additional 
information, including a description of the current standard.

A. Scope and Content of the Proposed Small Manufacturer Definition 
Update

    For the TSCA section 8(a) small manufacturer definition update, EPA 
is proposing to update the current definition based on inflation. EPA 
is interested in public consideration of this approach and is 
soliciting comments regarding the extent to which this approach would 
reduce the reporting burden for those small manufacturers with fewer 
available resources, while ensuring Agency information needs are still 
met.
    The proposed modification to the TSCA section 8(a) small 
manufacturer size standards are based on a number of factors, 
including: (1) Information gathered during meetings with the Small 
Business Administration, including the Office of Advocacy, regarding 
its definition of small business (Ref. 31); (2) preliminary comments 
and suggestions from representatives of the chemical industry, 
nongovernmental organizations, and state, local, and tribal governments 
submitted when EPA published its final determination that a revision to 
the standards is warranted (82 FR 56824, November 30, 2017); (3) review 
of various alternative exemption criteria; and (4) comments received on 
EPA's User Fees for the Administration of the Toxic Substances Control 
Act proposed rule (TSCA Fees Rule) (83 FR 8212, February 26, 2018). 
Documentation of these meetings, comments, and the analysis can be 
found in the dockets for the determination (EPA-HQ-OPPT-2016-0675), the 
proposed TSCA Fees Rule (EPA-HQ-OPPT-2016-0401), and this proposal 
(EPA-HQ-OPPT-2018-0321).
    The proposed definition would be applicable to chemical 
manufacturers (including importers), but not to chemical processors. 
Because the scope of EPA's analysis of the proposed definition is 
focused on impacts to the CDR, in which reporting is required by 
manufacturers and not processors, EPA believes it is best to continue 
the past practice to develop definitions, as applicable, for small 
processors on a rule-by-rule basis. In addition, EPA has reviewed the 
existing TSCA section 8(a) rules that contain definitions for small 
processors. Because EPA has not received any reports under those rules 
for at least ten years, EPA believes that applying this proposed 
definition to processors would have no impact (Ref. 32). EPA welcomes 
comment on whether the proposed definition should be expanded to 
include processors.
    All data in this preamble represent impacts to the manufacturing 
portion of the chemical industry, as evaluated for the CDR. The 
proposed definition is as follows:
    Proposed small manufacturer definition: EPA is proposing to base 
the update of the current two-standard definition at 40 CFR 704.3 on 
inflation by adjusting the sales standard level for the first part from 
$40 million to $110 million and for the second part from $4 million to 
$11 million. Under this proposal, EPA would use the same definition for 
all manufacturers, except for small governments as discussed in this 
unit. The impacts of this option are provided in Unit I.E.2. The 
definition under this proposal would read:
    (1) First standard. A manufacturer (including importer) of a 
substance is small if its total annual sales, when combined with those 
of its parent company (if any), are less than $110 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 (including importer) will not qualify as small for 
purposes of reporting on the production or importation of that 
substance at that site, unless the manufacturer (including importer) 
qualifies as small under standard (2) of this definition.
    (2) Second standard. A manufacturer (including importer) of a 
substance is small if its total annual sales, when combined with those 
of its parent company (if any), are less than $11 million, regardless 
of the quantity of substances produced or imported by that manufacturer 
(including importer).
    Under CDR, sites that meet the small manufacturer requirements are 
exempted from the need to report either for the full site (based on the 
second standard) or for particular chemical substances (based on the 
first standard), unless the chemical substance the site is 
manufacturing (including importing) is the subject of one of certain 
TSCA actions: A rule proposed or promulgated under TSCA sections 4, 
5(b)(4), or 6, or is the subject of an order in effect under TSCA 
section 5(e), or is the subject of relief that has been granted under a 
civil action under TSCA sections 5 or 7. As part of this proposal, EPA 
is proposing to add TSCA section 4 orders to the list of certain TSCA 
actions. The authority to issue section 4 orders was added to TSCA when 
the statute was amended in 2016.
    The current small manufacturer definition at 40 CFR 704.3 includes 
an inflation index to provide direction for determining the need to 
update the two standards comprising the definition (see Unit II.C.). 
For future inflation adjustments, EPA is proposing to use the Gross 
Domestic Product (GDP) deflator, or implicit price deflator, instead of 
the Produce Price Index (PPI) for Chemical and Allied Products when 
determining the need to adjust the total annual sales values. EPA is 
making this proposal because the types of small manufacturers subject 
to TSCA section 8(a) reporting requirements are broader than those 
defined by the PPI for Chemicals and Allied Products, which covers only 
Chemicals and Allied Products. The GDP deflator is less volatile and is 
broader than the PPI for Chemicals and Allied Products, and therefore 
EPA believes it is a better measure for considering an update to the 
revenue size standards in the proposed definition.
    EPA estimates that the proposed definition would eliminate 
reporting entirely for 93 industry sites and would reduce reporting by 
eliminating the need to report at least one chemical for an additional 
129 industry sites (Ref. 5). Overall, 888 chemical reports from 
industry sites would no longer be submitted to CDR. In sum, the use of 
the inflation adjustment definition results in a reduction of 2 percent 
of sites, an overall reduction of 2 percent of chemical reports, and a 
reduction of 0.07 percent of total volume reported (Ref. 5).
    Proposed small governments definition. In addition to the proposed 
update to the definition for small manufacturers, EPA is proposing a 
definition for small governments. Currently, there is no small 
government definition in TSCA section 8(a). During the 2016 CDR 
reporting period, EPA became aware that the governments were reporting 
under CDR. Examples of governments considered to be manufacturers 
include a publicly owned water treatment facility that manufactures 
ozone onsite for water treatment, or a municipal landfill that

[[Page 17712]]

captures methane gas to be sold. EPA is proposing a small government 
definition to reduce the reporting burden for governments that may lack 
necessary resources. EPA proposes to use the same definition for small 
governments as the Regulatory Flexibility Act (5 U.S.C. 601(5)): A 
small governmental jurisdiction is the government of a city, county, 
town, township, village, school district, or special district with a 
population of less than 50,000. States and tribal governments are not 
considered small governments. EPA is interested in comment on whether 
this definition should be changed for TSCA section 8(a) purposes to 
also include Tribal governments.
    EPA estimates 33 government sites report under CDR in a four-year 
cycle. Under the proposed definition of small governments, reporting 
would be eliminated entirely for four government sites with an 
associated six chemical reports.
    Application of standards. The size standards in this proposed rule 
would apply to all manufacturers of chemical substances subject to TSCA 
section 8(a) reporting and recordkeeping rules, unless the Agency 
specifically provides otherwise in a particular TSCA section 8(a) rule. 
Rules with different definitions than the current small manufacturer 
definition at 40 CFR 704.3 are: the nanoscale rule at 40 CFR 704.20; 
certain chemical-specific rules at 40 CFR 704.43 (Chlorinated 
Naphthalenes) and 40 CFR 704.102 (Hexachloronorbornadiene); and the 
Preliminary Assessment Information Rule (PAIR) at 40 CFR 712. Because 
of an inadvertent error there is currently no applicable definition of 
``small manufacturer'' in 40 CFR 704.104 (Hexafluoropropylene oxide); 
EPA is proposing a correction, as discussed later in this unit.
    Nanoscale materials. On January 12, 2017, EPA finalized the TSCA 
section 8(a) reporting and recordkeeping rule for nanoscale materials, 
which specified a separate small manufacturer definition (82 FR 3641). 
The nanoscale materials rule at 40 CFR 704.20 specifies the following 
definition: Small manufacturer or processor means any manufacturer or 
processor whose total annual sales, when combined with those of its 
parent company (if any), are less than $11 million. In November 2017, 
when EPA determined that the general TSCA section 8(a) small 
manufacturer definition at 40 CFR 704.3 warranted revision, EPA did not 
make a determination as to whether the definition in the nanoscale 
materials rule warranted revision. After further evaluation and 
consideration, EPA has determined that the size standard in the 
nanoscale materials rule definition does not warrant revision.
    In the process of making this determination, EPA evaluated the 
effect of adjusting the small manufacturer size standard for nanoscale 
materials for inflation and found that it would cause no measurable 
impact on the number of reports received. Furthermore, since the first 
reports for nanoscale materials, which would make up a large portion of 
reported information, are due within one year after the final effective 
date of the rule and before any newly proposed small manufacturer 
definition would take effect, EPA does not want to complicate the 
process or potentially confuse regulated entities who are in the 
process of compiling the required information.
    Certain chemical-specific TSCA section 8(a) rules. In addition to 
the nanoscale rule, there are eight chemical-specific rules listed in 
40 CFR 704 subpart B. Five of those rules refer to the current TSCA 
section 8(a) small manufacturer definition listed in 40 CFR 704.3 and 
therefore would be impacted by the proposed approach for updating the 
standards. These impacted five rules are: Sec. Sec.  704.25 (11-
Aminoundecanoic acid); 704.33 (P-tert-butylbenzoic acid (P-TBBA), p-
tert-butyltoluene (P-TBT) and p-tert-butylbenzaldehyde (P-TBB)); 704.45 
(Chlorinated terphenyl); 704.95 (Phosphonic acid, [1,2-ethanediyl-
bis[nitrilobis-(methylene)]]tetrakis- (EDTMPA) and its salts); and 
704.175 (4,4'-methylenebis(2-chloroaniline) (MBOCA)). One of the 
chemical-specific rules in 40 CFR 704 subpart B, 40 CFR 704.104 
(Hexafluoropropylene oxide), only includes a rule-specific small 
processor definition and not a small manufacturer definition. Upon 
review, EPA finds this to be an inadvertent error. As originally 
promulgated, 40 CFR 704.104 included the small manufacturer standard 
via the cross reference in 40 CFR 704.104(c)(2) to the exemption 
provisions in 40 CFR 704.5 which was lost when the exemptions at 40 CFR 
704.5 were amended and the necessary corresponding change was not made 
at 40 CFR 704.104(c)(2) (52 FR 41297, October 27, 1987 and 53 FR 51717, 
Dec. 22, 1988). As such, EPA is including in this proposal a technical 
correction to address this error.
    Two of the chemical-specific rules, namely 40 CFR 704.43 
(Chlorinated Napthalenes) and 40 CFR 704.102 (Hexachloronorbornadiene) 
have their own rule-specific small manufacturer definitions. EPA is not 
proposing to change the definitions for these two rules because it has 
been over ten years since EPA has received any reports under these 
rules. EPA therefore believes a change to the small manufacturer 
definitions for these rules would have no impact. However, EPA is 
interested in comment on whether the small manufacturer definitions for 
these two rules should be changed.
    PAIR rule. EPA is proposing to update the current small 
manufacturer definition in the PAIR rule at 40 CFR 712.25. EPA 
promulgated the TSCA section 8(a) PAIR rule in June 1982, to collect 
information to identify, assess and manage human health and 
environmental risks from chemical substances, mixtures, and categories 
listed on the rule. The 1982 PAIR small manufacturer definition 
predates the current 40 CFR 704.3 small manufacturer definition and has 
not been updated. It states: A manufacturer is qualified as small if 
both of the following criteria are met: (1) Total annual sales taken 
together of all sites owned or controlled by the foreign or domestic 
parent company were below $30 million for the reporting period; [and] 
(2) Total production of the listed substance for the reporting period 
was below 45,400 kilograms (100,000 pounds) at the plant site. EPA is 
proposing to use the small manufacturer definition in 704.3 for the 
PAIR rule.

B. Agency Objectives

    Industry compliance with TSCA reporting and recordkeeping 
requirements involves the expenditure of time, money, and personnel 
resources. These costs have particular impact on companies that have 
limited financial and personnel resources, such as smaller firms. Such 
manufacturers tend to have fewer administrative personnel and less 
capability for data compilation and recordkeeping than larger firms.
    However, while recognizing the burdens on smaller firms, EPA is 
required to make risk management decisions based on reasonably 
available information, such as that collected through CDR. The 
information collection authority of TSCA section 8(a) reflects 
congressional recognition of EPA's need for sufficient data from the 
chemical industry. EPA has concluded that if a firm produces a subject 
chemical in substantial quantities, it is inappropriate to exempt that 
company from TSCA section 8(a) reporting requirements. Production data 
is valuable to EPA as an indicator of chemical exposure and high volume 
chemical production reflects a greater potential for environmental 
release. For this reason, EPA is maintaining the annual production or 
importation

[[Page 17713]]

volume modifier of 100,000 pounds for the first part of the proposed 
updated small manufacturer definition.
    EPA also has the authority to develop new size standards separate 
from the general 8(a) small manufacturer definition in this proposed 
rule. Such development would be done in appropriate cases when the 
Agency finds that the general TSCA section 8(a) small manufacturer 
definition is not suitable for a new specific TSCA section 8(a) rule. 
However, when changing the definition for a specific rule, EPA must 
follow full notice and comment rulemaking procedures with regard to the 
amended definition and size standards.
    EPA has an additional objective for the general TSCA section 8(a) 
small manufacturer definition and size standards. The standards should 
not prevent TSCA section 8(a) rules from providing information that is 
representative of firms of different sizes. Large and small firms have 
varying amounts of capital available, and therefore may utilize 
different production processes, techniques, and equipment. Different 
methods of production may cause the potential for chemical exposure to 
vary among large and small firms. It is important for the Agency to be 
able to monitor these differences. To ensure that EPA would receive 
information from a representative portion of manufacturers regulated 
under TSCA section 8(a), the structure of the definitions and levels of 
the size standards have been designed to allow the Agency to obtain 
production, use, and exposure data from a variety of firms.
    A final objective for the standards is that they be easily analyzed 
and applied by both industry and the Agency. EPA is proposing exemption 
criteria that represent readily available data. These data enable 
identification of companies which would be likely to qualify for a 
small manufacturer exemption. The standards could also be easily 
enforced because the selected criteria would enable EPA to monitor 
compliance with the exemption.

C. Agency Approach and Methodology

    In developing the size standards proposed in this rule, EPA 
examined the utility of several possible criteria for ``small'' as 
possible measures of chemical exposure potential and the resources 
available to manufacturers.
    EPA looked at criteria for ``small'' used by other agencies, 
reviewed other ``small'' manufacturer definitions used by EPA, and 
reexamined criteria used for past rules under TSCA section 8(a), with 
specific focus on the recently finalized TSCA section 8(a) nanoscale 
materials rule (82 FR 3641, January 12, 2017). EPA considered the 
possible utility of parameters that have not been used previously, such 
as market share and net profit. EPA also relied on the input of 
industry representatives documented in the docket for the final 
determination that a revision to the standards is warranted and from 
SBA in meetings with EPA staff (82 FR 56824/EPA-HQ-OPPT-2016-0675-0022 
and Ref. 31).
    No parameter or set of parameters can meet EPA objectives and 
requirements perfectly. The various types of parameters considered, and 
their possible levels, are only approximations of company resources or 
EPA's information needs. EPA reviewed industry comments from the 
determination, as well as considerations factored into the development 
and evaluation of the original definitions, in selecting standards 
which best meet the Agency's requirements. EPA also took into 
consideration the comments on the TSCA Fees Rule (83 FR 8212, February 
26, 2018), regarding the definition of small manufacturer. The 
following unit describes EPA's evaluation of possible alternative 
definitions.

D. Evaluation of Alternative Criteria for Small Manufacturer 
Definitions and Analysis of Selected Options

    In the definitions used in the past by other Federal agencies, as 
well as at EPA under TSCA, there is no single definition of a ``small'' 
business. The definitions and size standards differ according to 
context and purpose. Identified broad categories include (1) benefits 
distribution, (2) data analysis and reporting, and (3) regulation and 
information collection (where flexibility is sought in balance with 
program objectives) (Ref. 5).
    When establishing its size standards, SBA examines various industry 
characteristics such as average firm size, degree of competition within 
an industry, start-up costs and entry barriers, and distribution of 
firms by size. SBA also evaluates federal market factors including a 
small business's share in total industry's receipts. For more details, 
please see the ``SBA's Standards Methodology'' white paper, available 
at www.sba.gov/size. The SBA size standards are industry-specific 
mostly based on either average annual revenue or number of employees, 
for reference please see the SBA size standards at 13 CFR 121.202. In 
order for an entity to be classified as a small business for federal 
contracting and other small business programs, its enterprise level 
revenue or number of employees (including all affiliates) shall not 
exceed the size standard for the applicable industry. These size 
thresholds are determined at the 6-digit North American Industry 
Classification System (NAICS) levels. SBA's employee-based size 
thresholds range from 100 to 1,500 employees to account for differences 
among NAICS codes.
    The size standards are intended to reflect the degree of 
competition within individual industries. SBA size standards vary by 
industry type to reflect the unique competitive characteristics of 
different industries. In some cases, SBA uses a revenue standard, or 
defines a business size in terms of assets. In other cases, the size 
standard is based on the number of employees. Within the chemical 
industry, the values assigned to the employment standards vary 
considerably among different industry groupings, which are represented 
using NAICS codes (Ref. 5).
    For purposes of data analysis and reporting, Bureau of the Census 
(Census) uses a size standard of employee number at 500 to separate 
small businesses into their own subgroup for data reporting. Similarly, 
the U.S. Department of Agriculture's (USDA) Economic Research Service 
(ERS) identifies small farms at less than $350,000 farm income for 
reporting and research purposes. The purpose of these small business 
definitions is to identify companies whose paperwork burden can be 
lessened without substantial impact on the agencies' information bases 
(Ref. 5). Similarly, but to a much greater extent, small business 
definitions developed in regulatory contexts involve detailed program-
specific balancing considerations. For example, the Occupational Safety 
and Health Administration (OSHA) defines a small business as having 10 
employees or fewer for their Fire Protection in Shipyards regulations 
(Ref. 5).
    Not unlike other federal agencies with similar purposes, EPA has 
separate definitions for ``small'' manufacturers, producers, 
processors, waste generators, and facilities under different statutes 
or regulations, including the National Primary Drinking Water 
Regulations, National Pollutant Discharge Elimination System Permit 
Regulations, RCRA laws, and the TRI. Each definition was created to 
meet individual programmatic needs or statutory requirements; it is 
therefore difficult to draw comparisons across the different 
definitions. For more information on the different ``small'' entity 
definitions used by other federal agencies and EPA, see Tables B-2 and 
B-3 in the Economic Analysis (Ref. 5).

[[Page 17714]]

    When EPA first established the general TSCA section 8(a) small 
manufacturer definition at 40 CFR 704.3 (49 FR 45425, November 16, 
1984), EPA considered a number of possible parameters for the size 
standards, including: (1) Total annual company profit, (2) total 
company assets, (3) total annual company sales, (4) annual chemical 
sales, (5) number of company employees, (6) annual production volume 
per chemical, and (7) market share. When EPA reevaluated the size 
standards (82 FR 56824, November 30, 2017), the Agency considered the 
initial parameters again and additionally considered (8) barriers to 
entry, (9) start-up or expansion costs, (10) average firm size as a 
factor of employment and sales, (11) industry competition and 
concentration, (12) growth trends, and (13) technological changes, 
which were suggested by SBA's Office of Advocacy during the comment 
period and SBA consultation as part of EPA's determination process for 
reviewing whether revision to the current size standards for small 
manufacturers and processors was warranted (82 FR 56824, November 30, 
2017).
    To consider these parameters for this proposed rule, EPA explored 
SBA's approach to defining small businesses: A manufacturer (including 
importer) is defined as small in accordance with the size standards 
identified by NAICS codes at 13 CFR 121.201. EPA considered adopting an 
SBA-based size-standard in combination with various production volume 
modifiers such as 25,000; 50,000; and 100,000 pounds. For example, if 
the annual production or importation volume of a particular substance 
at any individual site owned or controlled by the manufacturer 
(including importer) is greater than 50,000 pounds, the manufacturer 
(including importer) would not qualify as small for purposes of 
reporting on the production or importation of that substance at that 
site.
    EPA examined the impact of the various SBA-related definitions and 
the inflation adjusted definition on the number of reports, including 
by subcategories of particular interest to EPA such as TSCA Work Plan 
chemicals and by overall production volume. Details are in Table 2-1 of 
the Economic Analysis (Ref. 5). Any of the revised small manufacturing 
definitions considered resulted in fewer retained reports. Some of the 
definitions resulted in the addition of reports that are currently 
exempted. Details are in Tables 5-15 and 5-16 of the Economic Analysis 
(Ref. 5).
    Comparing the options by the amount of overall production volume 
reported provides another insight into the impacts. Under the SBA-based 
size standards with production volume modifiers of 50,000 and 100,000 
pounds, 38 million and 96 million pounds would be exempted, 
respectively. In comparison, under the inflation adjusted option, 13.7 
billion pounds would be exempted. When compared to the baseline 
production volume, these would result in the retention of reporting on 
99.93 percent (inflation adjusted), 99.9998 percent (SBA-based size-
standard with a production-volume modifier of 50,000 pounds) and 
99.9995 percent (SBA- based size-standard with a production-volume 
modifier of 100,000 pounds). In addition, under the inflation adjusted 
option the average report exempted 15.5 million pounds, whereas under 
the SBA-based size standards with production volume modifiers of 50,000 
and 100,000 pounds, the average report exempted 23,000 pounds and 
37,000 pounds, respectively. More details are in Tables 5-15 and 5-16 
of the Economic Analysis (Ref. 5).
    After analyses, the agency determined that adopting SBA's 
definition with the various production volume modifiers would likely 
result in loss of information for TSCA implementation, such as 
information on TSCA Work Plan chemicals. Given the impacts on losses to 
the CDR information necessary for the TSCA program coupled with the 
inherently higher complexity of an SBA-based definition (system 
involving a mix of revenue and employment bases with levels of size 
standards varying according to NAICS), EPA chose to propose the 
inflation adjustment option. EPA is, however, interested in comments on 
adopting the SBA standard (or an SBA-like standard) for small 
manufacturers, with an alternative production volume modifier, instead 
of the proposed definition. Details of SBA's standard can be found at 
13 CFR 121.201 and on their website (Ref. 33). Details of EPA's 
analysis, options considered, and conclusions are summarized in detail 
in the Economic Analysis (Ref. 5).
    Proposed definition: EPA adjusted the current size standards at 40 
CFR 704.3 to account for inflation, resulting in an increase of the 
total annual sales from $40 million to $110 million for the first 
standard while maintaining the requirement that annual production or 
importation volume not exceed 100,000 pounds, and resulting in an 
increase of the total annual sales from $4 million to $11 million for 
the second standard. This proposed definition would reduce the amount 
of information reported under CDR, resulting in a decrease of 2 percent 
of chemical reports submitted, 2 percent of sites reporting, and 1.4 
percent of total chemicals reported from the baseline conditions of the 
current definition. The baseline conditions are described in the 
Economic Analysis (Ref. 5). In future cycles, this proposed definition 
would reduce overall reporting burden by an estimated -64,295 hours and 
result in a $4,988,270 cost savings over a four-year CDR reporting 
cycle (Ref. 5). See also Unit I.E.2.
    EPA's full analysis of the costs, cost savings, and benefits of 
this proposed definition is presented in detail in the Economic 
Analysis (Ref. 5). EPA welcomes comments on this proposal and on the 
other options and size standards EPA considered for evaluating the 
revised definition. In particular, EPA is seeking comments on an 
alternative definition for a small manufacturer (e.g., an employment-
based size standard varied by industry or a combination of employment-
based and revenue-based varied by industry, such as the SBA standard 
with a 50,000 pound production volume modifier described previously in 
this unit of the preamble) which meets EPA's goal to minimize loss of 
chemicals and site reporting while maximizing reporting burden 
reductions for small businesses. A description on the SBA definition 
and a listing of other Federal government definitions for small 
business, including the employment-based definition used for the final 
TSCA Fees Rule (83 FR 52694, October 17, 2018), is provided in Appendix 
B of the Economic Analysis (Ref. 5).

V. Request for Comment

    EPA requests comment on all changes and other topics described in 
this proposed rule, and the Economic Analyses prepared in support of 
this proposed rule (Refs. 4 and 5). EPA encourages all interested 
persons to submit comments on the issues identified in this Notice and 
to identify any other relevant issues as well. This input will assist 
the Agency in developing final rules that successfully addresses 
information needs while minimizing potential reporting burdens 
associated with the rule. EPA requests that commenters making specific 
recommendations include supporting documentation where appropriate.
    EPA is also interested in receiving comment on whether reporting 
production volumes in ranges instead of to two significant figures 
would reduce burden for submitters while continuing to provide the 
information needed by EPA for implementation of TSCA. The current 
requirement to report to two

[[Page 17715]]

significant figures is, in essence, the reporting of a midpoint of a 
range. For example, if reporting 120,000 pounds, the actual production 
volume would be between 115,000 and 124,999 pounds. If reporting in 
ranges would reduce burden, should the ranges apply to a subset of 
reporters (such as inorganic chemicals or byproduct chemical 
substances), for lower production volumes only, as is done in TRI, 
(such as under 25,000 pounds), or to all? EPA is also interested in how 
a reporter would determine the percentage production volume required 
for physical form and processing and use information when reporting the 
underlying production volume in ranges.

VI. References

    The following is a listing of the documents that are specifically 
referenced in this document. The docket includes these documents and 
other information considered by EPA, including documents that are 
referenced within the documents that are included in the docket, even 
if the referenced document is not physically located in the docket. For 
assistance in locating these other documents, please consult the 
technical person listed under FOR FURTHER INFORMATION CONTACT.

1. EPA (2017). Public Webinar to Obtain Feedback on Improving CDR; 
Outreach meeting. Attended by the public, reporters to CDR, and EPA. 
Washington, DC. May 1, 2017.
2. EPA (2017). CDR Outreach meeting with Earthjustice and Other 
NGOs. Attended by Earthjustice, Safer Chemicals Healthy Families, 
Environmental Health Strategy Center, and EPA. Washington, DC. July 
17, 2017.
3. EPA (2017). CDR Outreach meeting with Environmental Defense Fund 
(EDF). Attended by EDF and EPA. Washington, DC. July 19, 2017.
4. EPA (2018). Economic Analysis for the Proposed Rule on TSCA 
Chemical Data Reporting (CDR) Revisions--(RIN 2070-AK33). Office of 
Pollution, Prevention, and Toxics. Washington, DC. August 2018.
5. EPA (2018). Economic Analysis for the Proposed Rule on TSCA 
Section 8(a) Small Manufacturer Definition Update (RIN 2070-AK33). 
Office of Pollution, Prevention, and Toxics. Washington, DC. August 
2018.
6. EPA (2017). Chemical Data Reporting (CDR): Importance of Data and 
Need for Data on Inorganic Byproducts. August 3, 2017, EPA-HQ-OPPT-
2016-0597-0057.
7. EPA (2018). Problem Formulation of the Risk Evaluation for 
Perchloroethylene (Ethene, 1,1,2,2-Tertrachloro). EPA-740-R1-7017. 
Office of Pollution, Prevention, and Toxics. Washington, DC. May 
2018.
8. Organisation for Economic Co-operation and Development. 
``Internationally Harmonised Functional, Product and Article Use 
Categories.'' 2017. http://www.oecd.org/officialdocuments/publicdisplaydocumentpdf/?cote=env/jm/mono(2017)14&doclanguage=en. 
Accessed May 18, 2018.
9. American Chemistry Council. Letter from Christina Franz to Cathy 
Fehrenbacher, U.S. EPA, September 30, 2015.
10. EPA (2018). OPPT. Email from Nhan Nguyen, Risk Assessment 
Division to Susan Sharkey, Existing Chemicals Branch (ECB), Chemical 
Control Division (CCD), Subject: CDR Function data element for 
consumer/commercial uses. Internal communication. Washington, DC. 
August 1, 2018.
11. EPA (2019). OPPT. Technical Support Document: Harmonizing CDR 
Functional and Product codes with OECD Functional, Product, and 
Article Codes. March 2019.
12. EPA (2019). Instructions for Reporting--2020 TSCA Chemical Data 
Reporting--Draft for Public Comment. Washington, DC. March 14, 2019.
13. EPA (2017). Examples: Reporting under CDR, TRI, and RCRA--
Chemical Data Reporting (CDR) Inorganic Byproducts Negotiated 
Rulemaking; Presentation. EPA-HQ-OPPT-2016-0597-0030.
14. EPA (2017). Meeting Summary of Public Organizational Planning 
Meeting for the Chemical Data Reporting (CDR) Inorganic Byproducts 
Negotiated Rulemaking. EPA-HQ-OPPT-2016-0597-0036.
15. EPA (2016). TSCA Chemical Data Reporting Fact Sheet: Byproducts 
Reporting for the Printed Circuit Board Industry. https://www.epa.gov/sites/production/files/2016-02/documents/final_cdr_fact_sheet_printed_circuit_board_2_22_16.pdf. Retrieved 
August 2, 2016.
16. EPA (2016). TSCA Chemical Data Reporting Fact Sheet: Reporting 
Manufactured Chemical Substances from Metal Mining and Related 
Activities. https://www.epa.gov/sites/production/files/2016-05/documents/cdr_fact_sheet_metal_mining_5may2016.pdf. Retrieved August 
2, 2016.
17. EPA (2016). TSCA Chemical Data Reporting Fact Sheet: Reporting 
for Electricity Generating Sites. https://www.epa.gov/sites/production/files/2016-04/documents/cdr_fact_sheet_electric_generating_27apr2016.pdf. Retrieved August 
2, 2016.
18. EPA (2018). CDR--Co-Manufacturing and Other Reporting Mechanics; 
Internal meeting. Attended by representatives of American Chemistry 
Council (ACC) and EPA. Washington, DC. February 12, 2018.
19. EPA (2014). TSCA Work Plan Chemical Risk Assessment--Antimony 
Trioxide--CASRN: 1309-64-4. https://www.epa.gov/sites/production/files/2015-09/documents/ato_ra_8-28-14_final.pdf. Retrieved May 31, 
2018.
20. EPA (2014). TSCA Work Plan Chemicals. http://www.epa.gov/sites/production/files/2014-02/documents/work_plan_chemicals_web_final.pdf. Retrieved January 30, 2018.
21. EPA (2018). TRI-Listed Chemicals. https://www.epa.gov/sites/production/files/2018-04/ry_2017_tri_chemical_list_4_24_2018.xlsx. 
Retrieved July 5, 2018.
22. EPA (2019). CDR Metal Compound Category Reporting Description; 
Supporting document. Office of Pollution, Prevention, and Toxics. 
Washington, DC. March 2019.
23. EPA (2018). Toxic Chemical Release Inventory Reporting Forms and 
Instructions. https://ofmpub.epa.gov/apex/guideme_ext/guideme_ext/guideme/file/ry_2017_rfi.pdf. Retrieved October 3, 2018.
24. EPA (2018). OPPT. First Ten Chemicals for Risk Evaluation, 
https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/risk-evaluations-existing-chemicals-under-tsca#ten. Accessed August 
3, 2018.
25. EPA (2017). Chemical Data Reporting; Requirements for Inorganic 
Byproduct Chemical Substances; Notice of Intent to Negotiate; 
Comment from PCA. EPA-HQ-OPPT-2016-0597-0019.
26. EPA (2017). Chemical Data Reporting; Requirements for Inorganic 
Byproduct Chemical Substances; Notice of Public Meeting; 
Cancellation and Public Input Opportunity; Comment from PCA. EPA-HQ-
OPPT-2016-0597-0085.
27. EPA (2006). Response Letter from Jim Willis (Director, Chemical 
Control Division) to Dr. John L. Festa (Senior Scientist, AF&PA), 
U.S. EPA, October 2006.
28. EPA (2017). Chemical Data Reporting; Requirements for Inorganic 
Byproduct Chemical Substances; Notice of Intent to Negotiate; 
Comment from AF&PA. EPA-HQ-OPPT-2016-0597-0018.
29. EPA (2017). CDR Outreach Meeting--Overview of CDR Reporting for 
Pulping Chemicals; Internal meeting. Attended by representatives of 
AF&PA and EPA. Washington, DC. March 30, 2017.
30. EPA (2017). CDR Outreach Meeting--Kraft Chemical Looping Process 
Educational Video Presentation; Internal meeting. Attended by 
representatives of AF&PA and EPA. Washington, DC. July 13, 2017.
31. EPA (2018). Four Meetings with SBA--updating the Small 
Manufacturer Definition; Internal meetings. Attended by 
representatives of SBA and EPA. Washington, DC. April 19, May 15, 
and September 11, 2018.
32. EPA (2018). Email from Loraine Passe, Chief, Chemical 
Information and Testing Branch, CCD to Tyler Lloyd, ECB, CCD, 
Subject: Small Manufacturer Update and Small Processor Definition; 
Internal communication. Washington, DC. July 16, 2018.
33. SBA. Table of Size Standards. https://www.sba.gov/document/support--table-size-standards. Retrieved March 12, 2019.
34. EPA (2019). Information Collection Request Proposed Addendum to 
Chemical Data Reporting under the Toxic Substances Control Act (TSCA 
section 8(a)) EPA ICR No. 1884.11; OMB Control Number 2070-0162. 
March 2019.

[[Page 17716]]

VII. Statutory and Executive Order Reviews

    Additional information about these statutes and Executive Orders 
can be found at https://www.epa.gov/laws-regulations-and-executive-orders.

A. Executive Order 12866: Regulatory Planning and Review and Executive 
Order 13563: Improving Regulations and Regulatory Review

    This action is a significant regulatory action that was submitted 
to the Office of Management and Budget for review under Executive Order 
12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 
2011). Any changes made in response to OMB recommendations have been 
documented in the docket for this action as required by section 
6(a)(3)(E) of Executive Order 12866.
    The EPA prepared two economic analyses of the potential costs, cost 
savings, and benefits associated with this action. A copy of these 
economic analyses, entitled Economic Analysis for the TSCA Chemical 
Data Reporting Revisions Rule (Ref. 4) and Economic Analysis for 
Proposed Rule on the TSCA Section 8(a) Small Manufacturer Definition 
Update (Ref. 5), are available in the docket and is briefly summarized 
in Unit I.E.

B. Executive Order 13771: Reducing Regulation and Controlling 
Regulatory Costs

    The CDR revisions and TSCA section 8(a) small manufacturer 
definition update are part of an action that is expected overall to be 
a deregulatory action under Executive Order 13771 (82 FR 9339, February 
3, 2017).

C. Paperwork Reduction Act (PRA)

    For CDR, the information collection requirements in 40 CFR part 711 
related to the submission of Form U's are already approved by OMB under 
the PRA, 44 U.S.C. 3501 et seq. That information collection request 
(ICR) has been assigned EPA ICR No. 1884.11 and OMB Control No. 2070-
0162. Because this proposed rule involves new or revised information 
collection activities that require additional OMB approval, EPA has 
prepared an addendum to the currently approved ICR (Ref. 34 and 83 FR 
36928, July 31, 2018 (EPA-HQ-OPPT-2017-0648). You can find a copy of 
the ICR addendum in the docket for this proposed rule (EPA-HQ-OPPT-
2018-0321), and it is briefly summarized here.
    The ICR addendum quantifies the burdens associated with the 
proposed CDR revisions and TSCA section 8(a) small manufacturer 
definition update (RIN 2070-AK33). EPA is proposing revisions to the 
CDR rule for three primary reasons: Align with amended TSCA, increase 
the usefulness of the CDR data collected, and reduce burden for CDR 
reporters pursuant to TSCA section 8(a)(5). The CDR data collection 
provides chemical manufacture, processing, and use information that 
helps EPA identify what chemicals the public may be exposed to as 
consumers or in commercial and industrial settings. The data also help 
EPA assess routes of potential exposure to those chemicals.
    The PRA mandates that federal agencies estimate the recordkeeping 
and reporting burden of a rule. In this context, the term ``burden'' is 
interpreted as the total time, effort, or financial resources expended 
by individuals to generate, maintain, retain, disclose, or provide 
information to or for a federal agency. It includes the time regulated 
entities need to review instructions and to develop, acquire, install, 
and use technology and systems to collect, validate, verify, and 
disclose information. It also includes time taken to adjust existing 
ways to comply with any previously applicable instructions and 
requirements and to train personnel to respond to the information 
collection task.
    For CDR, users submit data to EPA using a Form U on a four-year 
reporting cycle for the ``principal year'' and for the years since the 
previous principal reporting year (currently three years). Completion 
of the Form U involves reporting on a per-site basis for each of the 
reportable chemicals at that site. Therefore, each site subject to CDR 
requirements is considered a respondent that will submit one Form U 
(response) on one or more chemicals. Sites are subject to CDR reporting 
requirements when annual chemical production volume is at or above 
reporting thresholds (typically 25,000 lbs, but 2,500 lb for certain 
reporters) in any calendar year in the principal reporting year and the 
previous three years. There is one response per respondent, as one Form 
U per site accommodates multiple chemical reports in the same 
submission. Activities for preparing and submitting a CDR reporting 
form include rule familiarization, compliance determination, form 
completion, and recordkeeping.
    The changes covered by the proposed CDR revisions fall in to the 
following categories:
     Co-manufacturer reporting;
     Modifications and additions to reportable data elements;
     Changes to claiming confidentiality; and
     Byproduct provisions.
    The changes proposed for the TSCA section 8(a) small manufacturer 
definition update are as follows:
     First standard. A manufacturer (including importer) of a 
substance is small if its total annual sales, when combined with those 
of its parent company (if any) are less than $110 million. However, if 
the annual production or importation volume of a particular substance 
at any individual site owned or controlled by the manufacturer 
(including importer) is greater than 100,000 pounds, the manufacturer 
(including importer) will not qualify as small for purposes of 
reporting on the production or importation of that substance at that 
site, unless the manufacturer (including importer) qualifies as small 
under the second standard of this definition.
     Second Standard. A manufacturer (including importer) of a 
substance is small if its total annual sales, when combined with those 
of its parent company (if any), are less than $11 million, regardless 
of the quantity of substances produced or imported by that manufacturer 
(including importer).
    These changes are described in further detail in the CDR ICR 
Addendum (Ref. 34). Table 2 summarizes the changes to reporting under 
this proposed definition.

        Table 2--CDR ICR Addendum Summary--Annual Burden and Cost
------------------------------------------------------------------------
 
------------------------------------------------------------------------
Respondents/affected entities:....  Entities potentially affected by
                                     this ICR include companies
                                     manufacturing (including importing)
                                     chemical substances listed on the
                                     TSCA Inventory and regulated under
                                     TSCA section 8.
Respondent's obligation to          Respondents are obligated to report
 respond:.                           to EPA.
Estimated number of respondents:..  5,660.
Frequency of response:............  The collection occurs every four
                                     years. The next CDR collection will
                                     occur in 2020.
Estimated annual incremental        25,201 hours.
 burden:
Estimated annual cost:............  $1,955,042.
------------------------------------------------------------------------


[[Page 17717]]

    For TSCA section 8(a) reporting outside of CDR, including the TSCA 
section 8(a) Preliminary Assessment Information Rule (PAIR) or any of 
the chemical specific TSCA section 8(a) rules, EPA does not estimate 
incremental burden and cost either because EPA has not received any 
chemical reports under the rule for an extended period of time, or 
because the rule uses a different definition that is not being changed 
by this proposal.
    An agency may not conduct or sponsor, and a person is not required 
to respond to, a collection of information unless it displays a 
currently valid OMB control number. The OMB control numbers for the 
EPA's regulations in 40 CFR are listed in 40 CFR part 9.
    Submit your comments on the Agency's need for this information, the 
accuracy of the provided burden estimates and any suggested methods for 
minimizing respondent burden to the EPA using the docket identified at 
the beginning of this rule. You may also send your ICR-related comments 
to OMB's Office of Information and Regulatory Affairs via email to 
[email protected], Attention: Desk Officer for EPA. Since OMB 
is required to make a decision concerning the ICR between 30 and 60 
days after receipt, OMB must receive comments no later than May 28, 
2019. EPA will respond to any ICR-related comments in the final rule.

D. Regulatory Flexibility Act (RFA)

    Pursuant to section 605(b) of the RFA, 5 U.S.C. 601 et seq., I 
certify that this action will not have a significant adverse economic 
impact on a substantial number of small entities. The Agency's basis is 
briefly summarized here and is detailed in two Economic Analyses (Refs. 
4 and 5).
    Under RFA, small entities include small businesses, small 
organizations, and small governmental jurisdictions. For purposes of 
assessing the impacts of this proposed rule on small entities, small 
entity is defined as:
    1. A small business, as defined by the SBA's regulations at 13 CFR 
121.201;
    2. A small governmental jurisdiction that is a government of a 
city, county, town, school district, or special district with a 
population of less than 50,000; and
    3. A small organization that is any not-for-profit enterprise which 
is independently owned and operated and not dominant in its field.
    The regulated community does not include small not-for-profit 
organizations. Additionally, no small governments are expected to be 
adversely affected by the proposed rule; in fact, the proposal creates 
an exemption for small governments. Therefore, the focus of the RFA 
analysis is on small businesses.
    The existing CDR rule, at 40 CFR 711.9, generally exempts from 
reporting small businesses, defined at 40 CFR 704.3 as entities with 
annual sales of less than $40 million and less than 100,000-pound 
production of any given chemical substance at a site; or annual sales 
of less than $4 million. Note that under the proposed rule, as under 
current regulations, a small business would be ineligible for the 
exemption if it produces any chemical substance that is the subject of 
a regulation proposed or promulgated under TSCA sections 4, 5(b)(4), or 
6; that is the subject of an order in effect under TSCA sections 4 or 
5(e); that is subject to a consent agreement under TSCA section 4; or 
that is the subject of relief that has been granted pursuant to a civil 
action under TSCA sections 5 or 7. A small business may also report 
voluntarily.
    For purposes of the economic analysis covering the CDR revisions 
portion of the proposed rule (Ref. 4), this small manufacturer 
exemption is assumed to be unchanged. Conversely, for the TSCA section 
8(a) small manufacturer definition update portion of the rule (Ref. 5), 
reporting requirements on the Form U are assumed to be unchanged with 
changes to the exemption as the focus of the Economic Analysis (Ref. 
5). Further discussions in this unit summarize results from each 
economic analysis, and then provide the synthesized overall conclusion.
    1. CDR revisions. EPA analyzed potential small business impacts 
from this proposed rule for purposes of the small entity analysis using 
the SBA size standards which are either revenue or employment based, 
depending on the industry sector. EPA estimates that 732 small parent 
entities would potentially be affected by the CDR revisions portion of 
the proposed rule. Based on estimated maximum compliance costs 
annualized over a 10-year period and average revenue data for parent 
entities, EPA estimates that the cost-to-sales ratio of the proposed 
rule would be less than one percent for 728 (99.45 percent) of small 
parent entities subject to the rule. An additional two small parent 
entities are expected to incur cost impacts between one and three 
percent, and two small parent entities are expected to incur cost 
impacts above three percent (Ref. 4). Per EPA guidance, even if impacts 
are greater than one percent, as long as the number of entities is 
fewer than 100 and less than 20 percent of total small entities, the 
proposed rule is determined to not result in a significant impact on a 
substantial number of small entities. Therefore, EPA concludes that 
compliance costs associated with CDR revisions portion of the proposed 
rule are not expected to have a significant economic impact on a 
substantial number of small entities (no SISNOSE).
    2. TSCA section 8(a) small manufacturers definition update. The 
TSCA section 8(a) small manufacturer definition update proposed 
definition is as follows:
     First standard, A manufacturer (including importer) of a 
substance is small if its total annual sales, when combined with those 
of its parent company (if any) are less than $110 million. However, if 
the annual production or importation volume of a particular substance 
at any individual site owned or controlled by the manufacturer 
(including importer) is greater than 100,000 pounds, the manufacturer 
or importer will not qualify as small for purposes of reporting on the 
production or importation of that substance at that site, unless the 
manufacturer (including importer) qualifies as small under the second 
standard of this definition.
     Second Standard. A manufacturer (including importer) of a 
substance is small if its total annual sales, when combined with those 
of its parent company (if any), are less than $11 million, regardless 
of the quantity of substances produced or imported by that manufacturer 
(including importer).
    Under the proposed definition, the only change from the current 
TSCA section 8(a) small manufacturer definition is to increase levels 
for revenue size standards. As a result, EPA expects that no currently 
exempt small manufacturers would become newly subject to any current 
TSCA section 8(a) rules under this proposed definition, because all 
manufacturers that are currently exempt would remain exempt under this 
proposal. Moreover, the proposed rule would allow exemptions for 
certain current reporters, thereby eliminating their reporting burden. 
However, a small amount of incremental burden is incurred for rule 
familiarization.
    As done for the CDR revisions portion of the proposed rule, EPA 
analyzed potential small business impacts for purposes of the small 
entity analysis using the SBA size standards which are either revenue 
or employment based, depending on the industry sector. For the small 
manufacturer definition update, EPA estimates that 732 small parent 
entities would potentially be affected by the proposed rule. Based on 
estimated compliance costs annualized over a 10-year period and average

[[Page 17718]]

revenue data for parent entities, EPA estimates that the cost-to-sales 
ratio of the small manufacturer definition update portion of the 
proposed rule would be less than 1% for all of these small parent 
entities (100 percent) (Ref. 5). Per EPA guidance, if impacts are less 
than 1%, a certification that the rule will not result in a significant 
(economic) impact on a substantial number of small entities can be made 
no matter the number of small entities affected. Therefore, the Agency 
concludes that the small manufacturer definition update portion of the 
proposed rule would not affect a significant number of small entities 
(no SISNOSE). Also note that there are no adverse small entity impacts 
to small government entities because under the post-change conditions 
all entities defined as small for purposes of small government 
assessment are the same entities that are newly eligible to take the 
small government exemption and eliminate their CDR reporting burden 
entirely.
    3. CDR rule overall. Note that the two EAs' analyses cover 
overlapping groups, from which results from each analysis can be 
synthesized to reach an overall conclusion that the overall compliance 
costs associated with the proposed rule would not have a significant 
impact on a substantial number of small entities (overall no SISNOSE).
    EPA continues to be interested in the potential impacts of this 
proposed rule on small entities and welcomes comments on issues related 
to such impacts.

E. Unfunded Mandates Reform Act (UMRA)

    This action does not contain an unfunded mandate of $100 million or 
more as described in UMRA, 2 U.S.C. 1531-1538, and would not 
significantly or uniquely affect small governments. According to the 
information derived using the 2016 CDR, there are government entities 
that report to CDR, including: seven municipalities, one county-level 
public utility district, and one tribal entity. However, under the 
proposed changes, four of the municipalities would be exempt, with the 
remaining entities incurring a minimal average incremental burden and 
cost per site at about 3 hours and $262 per year, respectively. 
Consequently, impacts would not exceed $100 million for all 
governments. Additionally, under the proposed small government 
definition, four government entities would be exempt from TSCA section 
8(a) reporting requirements (Ref. 5).
    In sum, the proposed rule is not expected to result in expenditures 
by State, local, and Tribal governments, in the aggregate, or by the 
private sector, of $100 million or more (when adjusted annually for 
inflation) in any one year. Accordingly, this proposed rule is not 
subject to the requirements of sections 202, 203, or 205 of UMRA.

F. Executive Order 13132: Federalism

    This action would not have federalism implications. It would not 
have substantial direct effects on the states, on the relationship 
between the national government and the states, or on the distribution 
of power and responsibilities among the various levels of government as 
specified in Executive Order 13132 (64 FR 43255, August 10, 1999).

G. Executive Order 13175: Consultation and Coordination With Indian 
Tribal Governments

    This action would not have tribal implications because it is not 
expected to have substantial direct effects on tribal governments, on 
the relationship between the Federal Government and the Indian tribes, 
or on the distribution of power and responsibilities between the 
Federal Government and Indian tribes as specified in Executive Order 
13175 (65 FR 67249, November 9, 2000). According to the information 
presented in the economic analysis for the TSCA section 8(a) small 
manufacturer definition update (Ref. 5), there is one tribal entity 
that reported during the 2016 CDR collection. Under the proposed rule, 
this entity is estimated to incur a minimal average incremental burden 
and cost per site at about 1 hour and $103 per year, respectively. 
Consequently, EPA has concluded that the impacts of the proposed rule 
would not significantly nor uniquely affect the communities of tribal 
governments. Thus, Executive Order 13175 does not apply to this 
proposed rule.

H. Executive Order 13045: Protection of Children From Environmental 
Health and Safety Risks

    Executive Order 13045 (62 FR 19885, April 23, 1997), requires that 
federal agencies examine the impacts of each regulatory action on 
children for any economically significant regulation (as defined by 
Executive Order 12866) that the Agency has reason to believe may 
disproportionately affect children. EPA interprets Executive Order 
13045 as applying only to those regulatory actions that concern 
environmental health or safety risks, such that the analysis required 
under section 5-501 of Executive Order 13045 has the potential to 
influence the regulation. This action is not subject to Executive Order 
13045 because it would not establish an environmental standard intended 
to mitigate health or safety risks. Nevertheless, the information 
obtained by the reporting required by this proposed rule would be used 
to inform the Agency's decision-making process regarding chemical 
substances to which children may be disproportionately exposed. This 
information would also assist the Agency and others in determining 
whether the chemical substances covered in this proposed rule present 
potential risks, allowing the Agency and others to take appropriate 
action to investigate and mitigate those risks.

I. Executive Order 13211: Actions Concerning Regulations That 
Significantly Affect Energy Supply, Distribution, or Use

    This action is not a ``significant energy action'' as defined in 
Executive Order 13211 (66 FR 28355, May 22, 2001) because it is not 
likely to have a significant adverse effect on the supply, 
distribution, or use of energy.

J. National Technology Transfer and Advancement Act (NTTAA)

    Because this action does not involve any technical standards, NTTAA 
section 12(d), 15 U.S.C. 272 note, does not apply to this action.

K. Executive Order 12898: Federal Actions To Address Environmental 
Justice in Minority Populations and Low-Income Populations

    This action will not have high and adverse human health or 
environmental effects on minority populations, low-income populations, 
and/or indigenous peoples as specified in Executive Order 12898 (59 FR 
7629, February 16, 1994). The Agency believes that the rule would 
improve the information collected under CDR and better assist EPA and 
others in determining the potential hazards and risks associated with 
the chemical substances covered by the CDR. Because the CDR is an 
information collection requirement, the information that would be 
improved through the proposed rule would enable the Agency to target 
educational, regulatory, or enforcement activities towards industries 
or chemical substances that pose the greatest risks and/or to target 
programs for geographic areas that are at the highest risk. Thus, the 
information to be gathered under the proposed rule would help EPA make 
decisions that would benefit potentially at-risk communities, some of 
which may be disadvantaged.

[[Page 17719]]

    The proposed rule is directed at manufacturers (including 
importers) of chemical substances. All consumers of these chemical 
products and all workers who come into contact with these chemical 
substances could benefit if data regarding the chemical substances' 
health and environmental effects were developed. Therefore, it would 
not appear that the costs and the benefits of the proposed rule would 
be disproportionately distributed across different geographic regions 
or among different categories of individuals.

List of Subjects

40 CFR Part 704

    Environmental protection, Toxic substances control act, Reporting 
and recordkeeping requirements.

40 CFR Part 711

    Environmental protection, Toxic substances control act, TSCA 
chemical data reporting and recordkeeping requirements.

40 CFR Part 712

    Environmental protection, Toxic substances control act, Chemical 
information rules.

    Dated: April 12, 2019.
Alexandra Dapolito Dunn,
Assistant Administrator, Office of Chemical Safety and Pollution 
Prevention.

    Therefore, EPA proposes to amend 40 CFR parts 704, 711 and 712 as 
follows:

PART 704--[AMENDED]

0
 1. The authority citation for part 704 to read as follows:

    Authority: 15 U.S.C. 2607(a).

0
2. Section 704.3 is amended by:
0
a. Revising the definition of ``small manufacturer or importer''.
0
b. Adding in alphabetical order the definition for ``small 
government''.
    The additions and revisions read as follows:


Sec.  704.3  Definitions.

* * * * *
    Small government means the government of a city, county, town, 
township, village, school district, or special district with a 
population of less than 50,000.
* * * * *
    Small manufacturer means a manufacturer (including importer) that 
meets either of the following standards:
    (1) First standard. A manufacturer (including importer) of a 
substance is small if its total annual sales, when combined with those 
of its parent company (if any), are less than $110 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 lbs), the 
manufacturer (including importer) will not qualify as small for 
purposes of reporting on the production or importation of that 
substance at that site, unless the manufacturer (including importer) 
qualifies as small under standard (2) of this definition.
    (2) Second standard. A manufacturer (including importer) of a 
substance is small if its total annual sales, when combined with those 
of its parent company (if any), are less than $11million, regardless of 
the quantity of substances produced or imported by that manufacturer 
(including importer).
    (3) Inflation index. EPA will make use of the Gross Domestic 
Product deflators, 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 Gross Domestic Product 
deflator has changed more than 20 percent since either the most recent 
previous change in sales values or the date of promulgation of this 
rule, whichever is later. EPA will provide notification in the Federal 
Register when changing the total annual sales values.
* * * * *
0
3. Section 704.104 is amended by revising paragraph (c)(2) to read as 
follows:


Sec.  704.104  Hexafluoropropylene oxide.

* * * * *
    (c) * * *
    (2) Persons described in Sec.  704.5 (a) through (f).
* * * * *

PART 711--[AMENDED]

0
 4. The authority citation for part 711 continues to read as follows:

     Authority: 15 U.S.C. 2607(a).

0
 5. Section 711.1 is amended by revising paragraph (a) and (c) to read 
as follows:


Sec.  711.1  Scope and compliance.

    (a) This part specifies reporting and recordkeeping procedures 
under section 8(a) of the Toxic Substances Control Act (TSCA) (15 
U.S.C. 2607(a)) for certain manufacturers (including importers) of 
chemical substances. TSCA section 8(a) authorizes the EPA Administrator 
to require reporting of information necessary for the administration of 
TSCA.
* * * * *
    (c) TSCA section 15(3) makes it unlawful for any person to fail or 
refuse to submit information required under this part. In addition, 
TSCA section 15(3) makes it unlawful for any person to fail to keep, 
and permit access to, records required by this part. Section 16 of TSCA 
provides that any person who violates a provision of TSCA section 15 is 
liable to the United States for a civil penalty and may be criminally 
prosecuted. Pursuant to TSCA section 17, the Federal Government may 
seek judicial relief to compel submission of TSCA section 8(a) 
information and to otherwise restrain any violation of TSCA section 15. 
(EPA does not intend to concentrate its enforcement efforts on 
insignificant clerical errors in reporting.) TSCA section 11 allows for 
inspections to assure compliance and the Administrator may by subpoena 
require the attendance and testimony of witnesses and the production of 
reports, papers, documents, answers to questions, and other information 
that the Administrator deems necessary.
* * * * *
0
6. In section 711.3:
0
a. Revise the definition for e-CDRweb;
0
b. Revise the definition for Manufacture;
0
c. Revise paragraph (1) of the definition for Site;
0
d. Remove the definition for U.S. parent company.
0
e. Add alphabetically the definitions for Inorganic chemical substance 
and Parent company.
    The additions and revisions read as follows:


Sec.  711.3  Definitions.

* * * * *
    e-CDRweb means the electronic, web-based tool provided by EPA for 
the completion of Form U and submission of the CDR data.
* * * * *
    Inorganic chemical substance means any chemical substance which 
does not contain carbon or contains 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.
* * * * *
    Manufacture means to manufacture, produce, or import, for 
commercial purposes. Manufacture includes the extraction, for 
commercial purposes, of a component chemical substance from a 
previously existing chemical substance or complex combination of 
chemical substances. A chemical substance is co-

[[Page 17720]]

manufactured by the person who physically does the manufacturing and 
the person contracting for such production when that chemical 
substance, manufactured other than by import, is:
    (1) Produced exclusively for another person who contracts for such 
production, and
    (2) That other person dictates the specific chemical identity of 
the chemical substance and controls the total amount produced and the 
basic technology for the manufacturing process.
* * * * *
    Parent company means the highest-level company(s) of the site's 
ownership hierarchy as of the start of the submission period during 
which data are being reported according to the following instructions. 
The U.S. parent company is located within the United States while the 
foreign parent company is located outside the United States:
    (1) If the site is entirely owned by a single U.S. company that is 
not owned by another company, that single company is the U.S. parent 
company.
    (2) If the site is entirely owned by a single U.S. company that is, 
itself, owned by another U.S.-based company (e.g., it is a division or 
subsidiary of a higher-level company), the highest-level company in the 
ownership hierarchy is the United States parent company. If there is a 
higher-level parent company that is outside of the United States, the 
highest-level foreign company in the ownership hierarchy is the foreign 
parent company.
    (3) If the site is owned by more than one company (e.g., company A 
owns 40 percent, company B owns 35 percent, and company C owns 25 
percent), the highest-level U.S. company with the largest ownership 
interest in the site is the U.S. parent company. If there is a higher-
level foreign company in the ownership hierarchy, that company is the 
foreign parent company.
    (4) If the site is owned by a 50:50 joint venture or a cooperative, 
the joint venture or cooperative is its own parent company. If the site 
is owned by a U.S. joint venture or cooperative, the highest level of 
the joint venture or cooperative is the U.S. parent company. If the 
site is owned by a joint venture or cooperative outside the United 
States, the highest level of the joint venture or cooperative outside 
the United States is the foreign parent company.
    (5) If the site is entirely owned by a foreign company (i.e., 
without a U.S.-based subsidiary within the site's ownership hierarchy), 
the highest-level foreign parent company is the facility's foreign 
parent company.
    (6) If the site is federally owned, the highest-level federal 
agency or department is the U.S. parent company.
    (7) If the site is owned by a non-federal public entity, that 
entity (such as a municipality, State, or tribe) is the U.S. parent 
company.
* * * * *
    Sites * * *
    (1) For chemical substances manufactured under contract, i.e., by a 
co-manufacturer, the site is the location where the chemical substance 
is physically manufactured.
* * * * *
0
7. Section 711.6 is amended by revising the section heading, the 
introduction paragraph and the first sentence in paragraph (a)(4) to 
read as follows.


Sec.  711.6  Chemical substances for which information is not required.

    The following groups or categories of chemical substances are 
exempted from some or all of the reporting requirements of this part, 
with the following exception: A chemical substance described in 
paragraph (a)(1), (a)(2), or (a)(4), or (b) of this section is not 
exempted from any of the reporting requirements of this part if that 
chemical substance is the subject of a rule proposed or promulgated 
under TSCA sections 4, 5(a)(2), 5(b)(4), or 6, or is the subject of an 
enforceable consent agreement (ECA) developed under the procedures of 
40 CFR part 790, or is the subject of an order issued under TSCA 
sections 4, 5(e), or 5(f), or is the subject of relief that has been 
granted under a civil action under TSCA sections 5 or 7.
* * * * *
    (a) * * *
    (4). Water and certain forms of natural gas.
* * * * *
0
8. Section 711.8 is amended by revising paragraph (a) and (b) to read 
as follows:


Sec.  711.8  Persons who must report.

* * * * *
    (a) Persons subject to recurring reporting--Any person who 
manufactured (including imported) for commercial purposes 25,000 lb 
(11,340 kg) or more of a chemical substance described in Sec.  711.5 at 
any single site owned or controlled by that person during any calendar 
year since the last principal reporting year.
* * * * *
    (b) Exceptions. Any person who manufactured (including imported) 
for commercial purposes any chemical substance that is the subject of a 
rule proposed or promulgated under TSCA sections 5(a)(2), 5(b)(4), or 
6, or is the subject of an order in effect under TSCA sections 4, 5(e) 
or 5(f), or is the subject of relief that has been granted under a 
civil action under TSCA sections 5 or 7 is subject to reporting as 
described in Sec.  711.8(a), except that the applicable production 
volume threshold is 2,500 lb (1,134 kg).
0
9. Section 711.9 is revised to read as follows:


Sec.  711.9  Persons not subject to this part.

    A person described in Sec.  711.8 is not subject to the 
requirements of this part if that person qualifies as a small 
manufacturer or small government as those terms are defined in 40 CFR 
704.3. Notwithstanding this exclusion, a person who qualifies as a 
small manufacturer or small government is subject to this part with 
respect to any chemical substance that is the subject of a rule 
proposed or promulgated under TSCA sections 4, 5(b)(4), or 6, or is the 
subject of an order in effect under TSCA sections 4 or 5(e), or is the 
subject of relief that has been granted under a civil action under TSCA 
sections 5 or 7.
0
10. Section 711.10 is revised to read as follows:


Sec.  711.10  Activities for which reporting is not required.

    A person described in Sec.  711.8 is not subject to the 
requirements of this part with respect to any chemical substance 
described in Sec.  711.5, when:
    (a) The person manufactured or imported the chemical substance 
solely in small quantities for research and development.
    (b) The person imported the chemical substance as part of an 
article.
    (c) The person manufactured the chemical substance in any of the 
following manners:
    (1) Any byproduct if its only commercial purpose is for use by 
public or private organizations that (i) burn it as a fuel, (ii) 
dispose of it as a waste, including in a landfill or for enriching 
soil, or (iii) extract component chemical substances from it for 
commercial purposes. (This exclusion only applies to the byproduct; it 
does not apply to the component substances extracted from the 
byproduct.)
    (2) Byproduct substances listed in subparagraph (i) for the 
following manufacturing processes, when recycled or otherwise used 
within a site-limited, physically enclosed system that is part of the 
same overall manufacturing process from which the byproduct substance 
was generated, and when the site is reporting the byproduct or a 
different chemical substance that was manufactured from the recycled

[[Page 17721]]

byproduct or manufactured in the same overall manufacturing process:
    (i) List of processes and related byproduct substances.
    (A) Portland Cement Manufacturing (i.e., CASRN 68475-76-3, Flue 
dust, portland cement).
    (B) Kraft Pulping Process (i.e., CASRN 66071-92-9, Sulfite liquors 
and Cooking liquors, spent; and CASRN 471-34-1, Carbonic acid calcium 
salt (1:1)).
    (ii) Amendments. EPA may amend the exemptions list in paragraph 
(c)(2)(i) of this section on its own initiative or in response to a 
request from the public based on EPA's determination of whether the 
byproduct substance and process described meet the criteria explained 
in paragraph (c)(2) of this section, based on the considerations listed 
in paragraph (c)(2)(ii)(B) of this section.
    (A) Any person may request that EPA amend the chemical substance 
list in paragraph (c)(2)(i) of this section. Your request must be in 
writing and must be submitted to the address provided in 40 CFR 
700.17(a). Please label your request as follows: Attention: TSCA 
Chemical Data Reporting--Byproduct Exemption Request. Requests must 
identify the manufacturing process and byproduct chemical substance in 
question, as well as its CASRN or other chemical identification number 
as identified in Sec.  711.15(b)(3)(i), and must contain a written 
rationale for the request that provides sufficient specific 
information, addressing the considerations listed in (c)(2)(ii)(B) of 
this section, including cites and relevant documents, to demonstrate to 
EPA that the byproduct substance and process in question either does or 
does not meet the criteria explained in paragraph (c)(2) of this 
section. If a request related to a particular byproduct substance and 
process is resubmitted, any subsequent request must clearly identify 
new information contained in the request. EPA may request other 
information that it believes necessary to evaluate the request. EPA 
will issue a written response to each request within 120 days of 
receipt of the request and will maintain copies of these responses in a 
docket that will be established for each reporting cycle.
    (B) Considerations. In making its determination of whether this 
exemption should apply to a particular manufacturing process and 
related byproduct substance, EPA will consider the totality of 
information available for the process and related byproduct substance 
in question, including but not limited to, one or more of the following 
considerations:
    (1) Whether the byproduct substance is recycled or otherwise used 
to manufacture another chemical substance within an enclosed system, 
within the same overall manufacturing process, and on the same site as 
that byproduct was originally manufactured.
    (2) Whether the site is reporting under CDR other chemical 
substances, in particular a chemical substance other than the byproduct 
substance that was manufactured from the byproduct or manufactured in 
the same overall manufacturing process.
    (3) Whether EPA has a current interest in the byproduct substance.
    (4) That the byproduct substance must have already been reported 
under CDR or would be expected to be reported if not exempted by this 
exemption.
    (C) As needed, the Agency will initiate rulemaking to make 
revisions to the list of substances in paragraph (c)(2)(i) of this 
section.
    (D) To assist EPA in reaching a decision regarding a particular 
request prior to a given principal reporting year, requests must be 
submitted to EPA no later than 12 months prior to the start of the next 
principal reporting year.
    (3) A quantity of the byproduct that is manufactured solely in the 
following equipment when it is not integral to the chemical 
manufacturing processes of the site:
    (i) Pollution control equipment.
    (ii) Boilers used to generate heat or electricity for that site.
    (4) The chemical substances described in this section: (Although 
they are manufactured for commercial purposes under TSCA, they are not 
manufactured for distribution in commerce as chemical substances per se 
and have no commercial purpose separate from the substance, mixture, or 
article of which they are a part.)
    (i) Any impurity.
    (ii) Any byproduct which is not used for commercial purposes.
    (iii) Any chemical substance which results from a chemical reaction 
that occurs incidental to exposure of another chemical substance, 
mixture, or article to environmental factors such as air, moisture, 
microbial organisms, or sunlight.
    (iv) Any chemical substance which results from a chemical reaction 
that occurs incidental to storage or disposal of another chemical 
substance, mixture, or article.
    (v) Any chemical substance which results from a chemical reaction 
that occurs upon end use of another chemical substance, mixture, or 
article such as an adhesive, paint, miscellaneous cleanser or other 
housekeeping product, fuel additive, water softening and treatment 
agent, photographic film, battery, match, or safety flare, and which is 
not itself manufactured or imported for distribution in commerce or for 
use as an intermediate.
    (vi) Any chemical substance which results from a chemical reaction 
that occurs upon use of curable plastic or rubber molding compounds, 
inks, drying oils, metal finishing compounds, adhesives, or paints, or 
any other chemical substance formed during the manufacture of an 
article destined for the marketplace without further chemical change of 
the chemical substance except for those chemical changes that occur as 
described elsewhere in this paragraph.
    (vii) Any chemical substance which results from a chemical reaction 
that occurs when (A) a stabilizer, colorant, odorant, antioxidant, 
filler, solvent, carrier, surfactant, plasticizer, corrosion inhibitor, 
antifoamer or defoamer, dispersant, precipitation inhibitor, binder, 
emulsifier, deemulsifier, dewatering agent, agglomerating agent, 
adhesion promoter, flow modifier, pH neutralizer, sequesterant, 
coagulant, flocculant, fire retardant, lubricant, chelating agent, or 
quality control reagent functions as intended, or (B) a chemical 
substance, which is intended solely to impart a specific physiochemical 
characteristic, functions as intended.
    (viii) Any nonisolated intermediate.
0
11. Section 711.15 is revised to read as follows.


Sec.  711.15  Reporting information to EPA.

    Any person who must report under this part, as described in Sec.  
711.8, must submit the information described in this section for each 
chemical substance described in Sec.  711.5 that the person 
manufactured (including imported) for commercial purposes in an amount 
of 25,000 lb (11,340 kg) or more (or in an amount of 2,500 lb (1,134 
kg) or more for chemical substances subject to the rules, orders, or 
actions described in Sec.  711.8(b)) at any one site during any 
calendar year since the last principal reporting year (e.g., for the 
2020 submission period, consider calendar years 2016, 2017, 2018, and 
2019, because 2015 was the last principal reporting year). The 
principal reporting year for each submission period is the previous 
calendar year (e.g., the principal reporting year for the 2020 
submission period is calendar year 2019). For all submission periods, a 
separate report must be submitted for each chemical substance at each 
site for which the submitter is required to report. A submitter of 
information under

[[Page 17722]]

this part must report information as described in this section to the 
extent that such information is known to or reasonably ascertainable by 
that person.
    (a) Reporting information to EPA. Any person who reports 
information to EPA must complete a Form U using the e-CDRweb reporting 
tool provided by EPA at the address set forth in Sec.  711.35. The 
submission must include all information described in paragraph (b) of 
this section. Persons must submit the chemical reports on a separate 
single Form U for each site for which the person is required to report. 
The e-CDRweb reporting tool is described in the instructions available 
from EPA at the website set forth in Sec.  711.35.
    (b) Information to be reported. The information described in 
paragraphs (b)(1), (b)(2), (b)(3), and (b)(4) of this section must be 
reported for each chemical substance manufactured (including imported) 
in an amount of 25,000 lb (11,340 kg) or more (or in an amount of 2,500 
lb (1,134 kg) or more for chemical substances subject to the rules, 
orders, or actions described in Sec.  711.8(b)) at any one site during 
any calendar year since the last principal reporting year. The 
requirement to report information described in paragraph (b)(4) of this 
section is subject to exemption as described in Sec.  711.6. Persons 
that elect to report eligible chemical substances in categories must 
report as described in Sec.  711.15(b)(3)(i).
    (1) A certification statement signed and dated by an authorized 
official of the submitter company. The authorized official must certify 
that the submitted information has been completed in compliance with 
the requirements of this part and that the confidentiality claims made 
on the Form U are true and correct. The certification must be signed 
and dated by the authorized official for the submitter company, and 
provide that person's name, official title, and email address.
    (2) Company and site information. The following currently correct 
company and site information must be reported for each site at which a 
reportable chemical substance is manufactured (including imported) 
above the applicable production volume threshold, as described in this 
section (see Sec.  711.3 for the ``site'' for importers and special 
situations).
    (i) The legal name, address, and Dun and Bradstreet D-U-N-S[supreg] 
(D&B) number for the highest-level parent company located in the United 
States and, if one exists, the highest-level foreign-based parent 
company. A submitter under this part must obtain a D&B number for the 
parent company if none exists and must report using the standardized 
conventions for the naming of a parent company as provided in the CDR 
Instructions for Reporting identified in Sec.  711.35.
    (ii) The name of a person who will serve as technical contact for 
the submitter company who will be able to answer questions about the 
information submitted by the company to EPA, and that technical contact 
person's full mailing address, telephone number, and email address.
    (iii) The legal name and full street address of each site. A 
submitter under this part must include the appropriate D&B number for 
each site reported, and the county or parish (or other jurisdictional 
indicator) in which the site is located. A submitter under this part 
must obtain a D&B number for the site reported if none exists. For a 
co-manufacturing situation, the contracting company must report both 
the site controlling the contract and the producing company's site 
information.
    (iv) The six-digit NAICS code for the site. A submitter under this 
part must include the appropriate six-digit NAICS code for each site 
reported.
    (3) Chemical-specific information. The following chemical-specific 
information must be reported for each reportable chemical substance 
manufactured (including imported) above the applicable production 
volume threshold, as described in paragraph (b) of this section:
    (i) The specific, currently correct CA Index name as used to list 
the chemical substance on the TSCA Inventory and the correct 
corresponding CASRN for each reportable chemical substance at each 
site. Submitters who wish to report chemical substances listed on the 
confidential portion of the TSCA Inventory will need to report the 
chemical substance using the corresponding TSCA Accession Number that 
is listed on the public portion of the Inventory. In addition to 
reporting the chemical identifying number itself, submitters must 
specify the type of number they are reporting by selecting from among 
the codes in Table 3 of this paragraph.
    (A) Alternative reporting for some inorganic byproduct chemical 
substances. Alternately, a submitter under this part may report an 
inorganic byproduct chemical substance using a designated metal 
compound category, unless the chemical substance is excluded from 
reporting in categories. Metal compound categories are listed in Table 
4 of this paragraph. For purposes of determining whether any of the 
thresholds specified in Sec.  711.8 are met for a metal compound 
category, a submitter must make the threshold determination based on 
the total amount of all members of the metal compound category 
manufactured at the site.
    Excluded substances. Substances excluded from reporting in 
categories include barium carbonate (CASRN 513-77-9); chemical 
substances subject to the rules, orders, or other TSCA actions 
described in Sec.  711.6; and chemicals undergoing risk evaluation 
under TSCA section 6, as described on EPA's CDR website at https://www.epa.gov/cdr.

      Table 3--Codes To Specify Type of Chemical Identifying Number
------------------------------------------------------------------------
              Code                              Number type
------------------------------------------------------------------------
A...............................  TSCA Accession Number.
C...............................  Chemical Abstracts Service Registry
                                   Number (CASRN).
M...............................  TSCA Metal Compound Category Code.
------------------------------------------------------------------------


   Table 4--Metal Compound Categories for Inorganic Byproduct Chemical
                             Substances Only
------------------------------------------------------------------------
              Code                             Category name
------------------------------------------------------------------------
M01.............................  Antimony and Antimony Compounds:
                                   Includes any unique chemical
                                   substance that contains antimony as
                                   part of that chemical's structure.
M02.............................  Arsenic and Arsenic Compounds:
                                   Includes any unique chemical
                                   substance that contains arsenic as
                                   part of that chemical's structure.
M03.............................  Barium and Barium Compounds: Includes
                                   any unique chemical substance that
                                   contains barium as part of that
                                   chemical's structure.
M04.............................  Beryllium and Beryllium Compounds:
                                   Includes any unique chemical
                                   substance that contains beryllium as
                                   part of that chemical's structure.
M05.............................  Cadmium and Cadmium Compounds:
                                   Includes any unique chemical
                                   substance that contains cadmium as
                                   part of that chemical's structure.
M06.............................  Chromium and Chromium Compounds:
                                   Includes any unique chemical
                                   substance that contains chromium as
                                   part of that chemical's structure.
M07.............................  Cobalt and Cobalt Compounds: Includes
                                   any unique chemical substance that
                                   contains cobalt as part of that
                                   chemical's structure.
M08.............................  Copper and Copper Compounds: Includes
                                   any unique chemical substance that
                                   contains copper as part of that
                                   chemical's structure.
M09.............................  Lead and Lead Compounds: Includes any
                                   unique chemical substance that
                                   contains lead as part of that
                                   chemical's structure.
M10.............................  Manganese and Manganese Compounds:
                                   Includes any unique chemical
                                   substance that contains manganese as
                                   part of that chemical's structure.
M11.............................  Mercury and Mercury Compounds:
                                   Includes any unique chemical
                                   substance that contains mercury as
                                   part of that chemical's structure.
M12.............................  Molybdenum and Molybdenum compounds:
                                   Includes any unique chemical
                                   substance that contains molybdenum as
                                   part of that chemical's structure.
M13.............................  Nickel and Nickel Compounds: Includes
                                   any unique chemical substance that
                                   contains nickel as part of that
                                   chemical's structure.

[[Page 17723]]

 
M14.............................  Selenium and Selenium Compounds:
                                   Includes any unique chemical
                                   substance that contains selenium as
                                   part of that chemical's structure.
M15.............................  Silver and Silver Compounds: Includes
                                   any unique chemical substance that
                                   contains silver as part of that
                                   chemical's structure.
M16.............................  Thallium and Thallium Compounds:
                                   Includes any unique chemical
                                   substance that contains thallium as
                                   part of that chemical's structure.
M17.............................  Vanadium and Vanadium compounds:
                                   Includes any unique chemical
                                   substance that contains vanadium as
                                   part of that chemical's structure.
M18.............................  Zinc and Zinc Compounds: Includes any
                                   unique chemical substance that
                                   contains zinc as part of that
                                   chemical's structure.
------------------------------------------------------------------------

    (B) Joint submissions. (1) If an importer submitting a report 
cannot provide the information specified in Sec.  711.15(b)(3)(i) 
because it is unknown to the importer and claimed as confidential by 
the supplier of the chemical substance or mixture, the importer must 
use e-CDRweb to ask the supplier to provide the correct chemical 
identity and, in the case of a mixture, chemical function information 
directly to EPA in a joint submission. Such request must include 
instructions for submitting chemical identity information 
electronically, using e-CDRweb and CDX (see Sec.  711.35), and for 
clearly referencing the importer's submission. Contact information for 
the supplier, a trade name or other designation for the chemical 
substance or mixture, and a copy of the request to the supplier must be 
included with the importer's submission.
    (2) If a manufacturer submitting a report cannot provide the 
information specified in Sec.  711.15(b)(3)(i) because the reportable 
chemical substance is manufactured using a reactant having a specific 
chemical identity that is unknown to the manufacturer and claimed as 
confidential by its supplier, the manufacturer must use e-CDRweb to ask 
the supplier of the confidential reactant to provide the correct 
chemical identity of the confidential reactant directly to EPA in a 
joint submission. Such request must include instructions for submitting 
chemical identity information electronically using e-CDRweb and CDX 
(see Sec.  711.35), and for clearly referencing the manufacturer's 
submission. Contact information for the supplier, a trade name or other 
designation for the chemical substance, and a copy of the request to 
the supplier must be included with the importer's submission.
    (3) EPA will only accept joint submissions that are submitted 
electronically using e-CDRweb and CDX (see Sec.  711.35) and that 
clearly reference the primary submission to which they refer.
    (ii) For the principal reporting year only, a statement indicating, 
for each reportable chemical substance at each site, whether the 
chemical substance is manufactured in the United States, imported into 
the United States, or both manufactured in the United States and 
imported into the United States.
    (iii) For the principal reporting year, the total annual volume (in 
pounds) of each reportable chemical substance domestically manufactured 
or imported at each site. The total annual domestically manufactured 
volume (not including imported volume) and the total annual imported 
volume must be separately reported. These amounts must be reported to 
two significant figures of accuracy. In addition, the total annual 
volume (domestically manufactured plus imported volumes in pounds) of 
each reportable chemical substance at each site for each complete 
calendar year since the last principal reporting year.
    (iv) For the principal reporting year only, the volume used on site 
and the volume directly exported of each reportable chemical substance 
domestically manufactured or imported at each site. These amounts must 
be reported to two significant figures of accuracy.
    (v) For the principal reporting year only, a designation 
indicating, for each imported reportable chemical substance at each 
site, whether the imported chemical substance is physically present at 
the reporting site.
    (vi) For the principal reporting year only, the percentage, rounded 
off to the closest 10 percent, of total production volume of the 
reportable chemical substance, for each reportable chemical substance 
at each site, that is manufactured as a byproduct at the site. Where 
this percentage accounts for less than 5 percent of the total 
production volume of the reportable chemical substance, submitters 
instead must report the percentage, rounded off to the closest 1 
percent.
    (vii) For the principal reporting year only, a designation 
indicating, for each reportable chemical substance at each site, 
whether the chemical substance is being recycled or otherwise used for 
a commercial purpose instead of being disposed of as a waste or 
included in a waste stream.
    (viii) For the principal reporting year only, the total number of 
workers reasonably likely to be exposed to each reportable chemical 
substance at each site. For each reportable chemical substance at each 
site, the submitter must select from among the ranges of workers listed 
in Table 5 of this paragraph and report the corresponding code (i.e., 
W1 through W8):

 Table 5--Codes for Reporting Number of Workers Reasonably Likely To Be
                                 Exposed
------------------------------------------------------------------------
              Code                                 Range
------------------------------------------------------------------------
W1..............................  Fewer than 10 workers.
W2..............................  At least 10 but fewer than 25 workers.
W3..............................  At least 25 but fewer than 50 workers.
W4..............................  At least 50 but fewer than 100
                                   workers.
W5..............................  At least 100 but fewer than 500
                                   workers.
W6..............................  At least 500 but fewer than 1,000
                                   workers.
W7..............................  At least 1,000 but fewer than 10,000
                                   workers.
W8..............................  At least 10,000 workers.
------------------------------------------------------------------------

    (ix) For the principal reporting year only, the maximum 
concentration, measured by percentage of weight, of each reportable 
chemical substance at the time it is sent off-site from each site. If 
the chemical substance is site-limited, you must report the maximum 
concentration, measured by percentage of weight of the reportable 
chemical substance at the time it is reacted on-site to produce a 
different chemical substance. This information must be reported 
regardless of the physical form(s) in which the chemical substance is 
sent off-site/reacted on-site. For each chemical substance at each 
site, select the maximum concentration of the chemical substance from 
among the ranges listed in Table 6 of this paragraph and report the 
corresponding code (i.e., M1 through M5):

Table 6--Codes for Reporting Maximum Concentration of Chemical Substance
------------------------------------------------------------------------
              Code                 Concentration range (percent weight)
------------------------------------------------------------------------
M1..............................  Less than 1 percent by weight.
M2..............................  At least 1 but less than 30 percent by
                                   weight.
M3..............................  At least 30 but less than 60 percent
                                   by weight.
M4..............................  At least 60 but less than 90 percent
                                   by weight.
M5..............................  At least 90 percent by weight.
------------------------------------------------------------------------

    (x) For the principal reporting year only, the physical form(s) of 
the reportable chemical substance as it is sent off-site from each 
site. If the chemical substance is site-limited, you must report the 
physical form(s) of the reportable chemical substance at the time it is 
reacted on-site to produce a

[[Page 17724]]

different chemical substance. For each chemical substance at each site, 
the submitter must report as many physical forms as applicable from 
among the physical forms listed in this unit:
    (A) Dry powder.
    (B) Pellets or large crystals.
    (C) Water- or solvent-wet solid.
    (D) Other solid.
    (E) Gas or vapor.
    (F) Liquid.
    (xi) For the principal reporting year only, submitters must report 
the percentage, rounded off to the closest 10 percent, of total 
production volume of the reportable chemical substance, reported in 
response to paragraph (b)(3)(iv) of this section, that is associated 
with each physical form reported under paragraph (b)(3)(x) of this 
section.
    (4) Chemical-specific information related to processing and use. 
The following chemical-specific information must be reported for each 
reportable chemical substance manufactured (including imported) above 
the applicable production volume threshold, as described in this 
section. Persons subject to paragraph (b)(4) of this section must 
report the information described in paragraphs (b)(4)(i) and (b)(4)(ii) 
of this section for each reportable chemical substance at sites under 
their control and at sites that receive a reportable chemical substance 
from the submitter directly or indirectly (including through a broker/
distributor, from a customer of the submitter, etc.). Information 
reported in response to this paragraph must be reported for the 
principal reporting year only and only to the extent that it is known 
to or reasonably ascertainable by the submitter. Information required 
to be reported under this paragraph is limited to domestic (i.e., 
within the customs territory of the United States) processing and use 
activities. If information responsive to a given data requirement under 
this paragraph, including information in the form of an estimate, is 
not known or reasonably ascertainable, the submitter is not required to 
respond to the requirement.
    (i) Industrial processing and use information--(A) A designation 
indicating the type of industrial processing or use operation(s) at 
each site that receives a reportable chemical substance from the 
submitter site directly or indirectly (whether the recipient site(s) 
are controlled by the submitter site or not). For each chemical 
substance, report the letters which correspond to the appropriate 
processing or use operation(s) listed in Table 7 of this paragraph. A 
particular designation may need to be reported more than once, to the 
extent that a submitter reports more than one sector (under paragraph 
(b)(4)(i)(B) of this section) that applies to a given designation under 
this paragraph.

    Table 7--Codes for Reporting Type of Industrial Processing or Use
                                Operation
------------------------------------------------------------------------
           Designation                           Operation
------------------------------------------------------------------------
PC...............................  Processing as a reactant.
PF...............................  Processing--incorporation into
                                    formulation, mixture, or reaction
                                    product.
PA...............................  Processing--incorporation into
                                    article.
PK...............................  Processing--repackaging.
U................................  Use--non-incorporative activities.
------------------------------------------------------------------------

    (B) A code indicating the sector(s) that best describe the 
industrial activities associated with each industrial processing or use 
operation reported under paragraph (b)(4)(i)(A) of this section. For 
each chemical substance, report the code that corresponds to the 
appropriate sector(s) listed in Table 8 of this paragraph. A particular 
sector code may need to be reported more than once, to the extent that 
a submitter reports more than one function code (under paragraph 
(b)(4)(i)(C) of this section) that applies to a given sector code under 
this paragraph.

             Table 8--Codes for Reporting Industrial Sectors
------------------------------------------------------------------------
              Code                          Sector description
------------------------------------------------------------------------
IS1.............................  Agriculture, forestry, fishing, and
                                   hunting.
IS2.............................  Oil and gas drilling, extraction, and
                                   support activities.
IS3.............................  Mining (except oil and gas) and
                                   support activities.
IS4.............................  Utilities.
IS5.............................  Construction.
IS6.............................  Food, beverage, and tobacco product
                                   manufacturing.
IS7.............................  Textiles, apparel, and leather
                                   manufacturing.
IS8.............................  Wood product manufacturing.
IS9.............................  Paper manufacturing.
IS10............................  Printing and related support
                                   activities.
IS11............................  Petroleum refineries.
IS12............................  Asphalt paving, roofing, and coating
                                   materials manufacturing.
IS13............................  Petroleum lubricating oil and grease
                                   manufacturing.
IS14............................  All other petroleum and coal products
                                   manufacturing.
IS15............................  Petrochemical manufacturing.
IS16............................  Industrial gas manufacturing.
IS17............................  Synthetic dye and pigment
                                   manufacturing.
IS18............................  Carbon black manufacturing.
IS19............................  All other basic inorganic chemical
                                   manufacturing.
IS20............................  Cyclic crude and intermediate
                                   manufacturing.
IS21............................  All other basic organic chemical
                                   manufacturing.
IS22............................  Plastics material and resin
                                   manufacturing.
IS23............................  Synthetic rubber manufacturing.
IS24............................  Organic fiber manufacturing.
IS25............................  Pesticide, fertilizer, and other
                                   agricultural chemical manufacturing.
IS26............................  Pharmaceutical and medicine
                                   manufacturing.
IS27............................  Paint and coating manufacturing.
IS28............................  Adhesive manufacturing.
IS29............................  Soap, cleaning compound, and toilet
                                   preparation manufacturing.
IS30............................  Printing ink manufacturing.
IS31............................  Explosives manufacturing.
IS32............................  Custom compounding of purchased
                                   resins.
IS33............................  Photographic film, paper, plate, and
                                   chemical manufacturing.
IS34............................  All other chemical product and
                                   preparation manufacturing.
IS35............................  Plastics product manufacturing.
IS36............................  Rubber product manufacturing.
IS37............................  Non-metallic mineral product
                                   manufacturing (includes cement, clay,
                                   concrete, glass, gypsum, lime, and
                                   other non-metallic mineral product
                                   manufacturing).
IS38............................  Primary metal manufacturing.
IS39............................  Fabricated metal product
                                   manufacturing.
IS40............................  Machinery manufacturing.
IS41............................  Computer and electronic product
                                   manufacturing.
IS42............................  Electrical equipment, appliance, and
                                   component manufacturing.
IS43............................  Transportation equipment
                                   manufacturing.
IS44............................  Furniture and related product
                                   manufacturing.
IS45............................  Miscellaneous manufacturing.
IS46............................  Wholesale and retail trade.
IS47............................  Services.
IS48............................  Other (requires additional
                                   information).
------------------------------------------------------------------------

    (C) For each sector reported under paragraph (b)(4)(i)(B) of this 
section, function category code(s) as provided in the CDR Instructions 
for Reporting identified in Sec.  711.35 must be selected to designate 
the function category(ies) that best represents the specific manner in 
which the chemical substance is used. A particular function category 
may need to be reported more than once, to the extent that a submitter 
reports more than one industrial processing or use operation/sector 
combination (under paragraphs (b)(4)(i)(A) and (b)(4)(i)(B) of this 
section) that applies to a given function category under this 
paragraph. If more than 10 unique combinations of industrial processing 
or use operations/sector/function categories apply to a chemical 
substance, submitters need only report the 10 unique combinations for 
the chemical substance that cumulatively represent the largest 
percentage of the submitter's production volume for that chemical 
substance, measured by weight. If none of the listed function 
categories accurately describes a use of a chemical substance, the 
category ``Other'' may be used, and must include a description of the 
use.
    (D) The estimated percentage, rounded off to the closest 10 
percent, of total production volume of the reportable chemical 
substance associated with each combination of industrial processing or 
use operation, sector, and function category. Where a

[[Page 17725]]

particular combination of industrial processing or use operation, 
sector, and function category accounts for less than 5 percent of the 
submitter's site's total production volume of a reportable chemical 
substance, the percentage must not be rounded off to 0 percent if the 
production volume attributable to that industrial processing or use 
operation, sector, and function category combination is 25,000 lb 
(11,340 kg) or more during the reporting year. Instead, in such a case, 
submitters must report the percentage, rounded off to the closest 1 
percent, of the submitter's site's total production volume of the 
reportable chemical substance associated with the particular 
combination of industrial processing or use operation, sector, and 
function category.
    (E) For each combination of industrial processing or use operation, 
sector, and function category, the submitter must estimate the number 
of sites at which each reportable chemical substance is processed or 
used. For each combination associated with each chemical substance, the 
submitter must select from among the ranges of sites listed in Table 9 
of this paragraph and report the corresponding code (i.e., S1 through 
S7):

              Table 9--Codes for Reporting Numbers of Sites
------------------------------------------------------------------------
              Code                                 Range
------------------------------------------------------------------------
S1..............................  Fewer than 10 sites.
S2..............................  At least 10 but fewer than 25 sites.
S3..............................  At least 25 but fewer than 100 sites.
S4..............................  At least 100 but fewer than 250 sites.
S5..............................  At least 250 but fewer than 1,000
                                   sites.
S6..............................  At least 1,000 but fewer than 10,000
                                   sites.
S7..............................  At least 10,000 sites.
------------------------------------------------------------------------

    (F) For each combination of industrial processing or use operation, 
sector, and function category, the submitter must estimate the number 
of workers reasonably likely to be exposed to each reportable chemical 
substance. For each combination associated with each chemical 
substance, the submitter must select from among the worker ranges 
listed in paragraph (b)(3)(viii) of this section and report the 
corresponding code (i.e., W1 though W8).
    (ii) Consumer and commercial use information--(A) Using the codes 
as provided in the CDR Instructions for Reporting identified in Sec.  
711.35, submitters must designate the consumer and commercial product 
category or categories that best describe the consumer and commercial 
products in which each reportable chemical substance is used (whether 
the recipient site(s) are controlled by the submitter site or not). If 
more than 10 codes apply to a chemical substance, submitters need only 
report the 10 codes for the chemical substance that cumulatively 
represent the largest percentage of the submitter's production volume 
for that chemical, measured by weight. If none of the listed consumer 
and commercial product categories accurately describes the consumer and 
commercial products in which each reportable chemical substance is 
used, the category ``Other'' may be used, and must include a 
description of the use.
    (B) for each consumer and commercial product category reported 
under paragraph (b)(4)(ii)(A) of this section, code(s) described in 
paragraph (b)(4)(i)(C) of this section must be selected to designate 
the function category(ies) that best represents the specific manner in 
which the chemical substance is used. A particular function category 
may need to be reported more than once, to the extent that a submitter 
reports more than one consumer or commercial product category (under 
paragraphs (b)(4)(ii)(A) of this section) that applies to a given 
function category under this paragraph. If none of the listed function 
categories accurately describes a use of a chemical substance, the 
category ``Other'' may be used, and must include a description of the 
use.
    (C) An indication, within each consumer and commercial product 
category reported under paragraph (b)(4)(ii)(A) of this section, 
whether the use is a consumer or a commercial use.
    (D) Submitters must determine, within each consumer and commercial 
product category reported under paragraph (b)(4)(ii)(A) of this 
section, whether any amount of each reportable chemical substance 
manufactured (including imported) by the submitter is present in (for 
example, a plasticizer chemical substance used to make pacifiers) or on 
(for example, as a component in the paint on a toy) any consumer 
products intended for use by children age 14 or younger, regardless of 
the concentration of the chemical substance remaining in or on the 
product. Submitters must select from the following options: The 
chemical substance is used in or on any consumer products intended for 
use by children, the chemical substance is not used in or on any 
consumer products intended for use by children, or information as to 
whether the chemical substance is used in or on any consumer products 
intended for use by children is not known to or reasonably 
ascertainable by the submitter.
    (E) The estimated percentage, rounded off to the closest 10 
percent, of the submitter's site's total production volume of the 
reportable chemical substance associated with each consumer and 
commercial product category. Where a particular consumer and commercial 
product category accounts for less than 5 percent of the total 
production volume of a reportable chemical substance, the percentage 
must not be rounded off to 0 percent if the production volume 
attributable to that commercial and consumer product category is 25,000 
lb (11,340 kg) or more during the reporting year. Instead, in such a 
case, submitters must report the percentage, rounded off to the closest 
1 percent, of the submitter's site's total production volume of the 
reportable chemical substance associated with the particular consumer 
and commercial product category.
    (F) Where the reportable chemical substance is used in consumer or 
commercial products, the estimated typical maximum concentration, 
measured by weight, of the chemical substance in each consumer and 
commercial product category reported under paragraph (b)(4)(ii)(A) of 
this section. For each chemical substance in each commercial and 
consumer product category reported under paragraph (b)(4)(ii)(A) of 
this section, submitters must select from among the ranges of 
concentrations listed in Table 6 in paragraph (b)(3)(ix) of this 
section and report the corresponding code (i.e., M1 through M5).
    (G) Where the reportable chemical substance is used in a commercial 
product, the submitter must estimate the number of commercial workers 
reasonably likely to be exposed to each reportable chemical substance. 
For each combination associated with each substance, the submitter must 
select from among the worker ranges listed in Table 5 in paragraph 
(b)(3)(viii) of this section and report the corresponding code (i.e., 
W1 though W8).
0
12. Section 711.20 is revised to read as follows:


Sec.  711.20  When to report.

    All information reported to EPA in response to the requirements of 
this part must be submitted during an applicable submission period, 
which runs from June 1 to September 30 at 4-year intervals, beginning 
in 2020. In each submission period, any person described in Sec.  711.8 
must report as described in this part.
0
13. Section 711.22 is amended by revising paragraph (c) to read as 
follows:

[[Page 17726]]

Sec.  711.22  Duplicative reporting.

* * * * *
    (c) Co-manufactured chemicals. This part requires that only one 
report per site be submitted on each chemical substance described in 
Sec.  711.5. When a company contracts with a producing company to 
manufacture a chemical substance, and each party meets the definition 
of ``manufacturer'' as set forth in Sec.  711.3, the contracting 
company must initiate the required report for that site as the primary 
submitter. The contracting company must indicate on the report that 
this is a co-manufacturing situation, notify the producing company, and 
record the production volume domestically co-manufactured as set forth 
in Sec.  711.15(b)(3) and processing and use information set forth in 
Sec.  711.15(b)(4). Upon notification by the contracting company, the 
producing company must also record the production volume domestically 
co-manufactured and complete the rest of the report as prompted by e-
CDRweb.
* * * * *
0
14. Section 711.30 is revised to read as follows.


Sec.  711.30  Confidentiality claims.

    (a) Generally. (1) Any person submitting information under this 
part may assert a confidentiality claim for that information at the 
time it is submitted, except for information described in paragraph 
(2).
    Any such confidentiality claims must be asserted at the time the 
information is submitted. These claims will apply only to the 
information submitted with the claim. Instructions for asserting 
confidentiality claims are provided in the document identified in Sec.  
711.35. Information claimed as confidential in accordance with this 
section will be treated and disclosed in accordance with the procedures 
in 40 CFR part 2.
    (2) Exceptions. Confidentiality claims cannot be made:
    (i) For public contact information if voluntarily provided;
    (ii) For chemical identities listed on the public portion of the 
TSCA Inventory or for chemical category identification when reporting 
pursuant to Sec.  711.15(b)(3)(i);
    (iii) For processing and use data elements required by Sec.  
711.15(b)(4)(i)(A), (B), and (C) and Sec.  711.15(b)(4)(ii)(A), (B), 
and (C), or
    (iv) When a response is left blank or designated as not known or 
reasonably ascertainable.
    (3) All confidentiality claims must be substantiated at time of 
submission, in accordance with the requirements in subsections (b) 
through (f) of this section. Confidentiality claims for the following 
data elements are exempt from this substantiation requirement:
    (i) Production volume information required pursuant to Sec.  
711.15(b)(3)(iii).
    (ii) Joint submission information from the primary submitter 
including trade name and supplier identification required pursuant to 
Sec.  711.15(b)(3)(i)(A), (B), and (C).
    (iii) Joint submission information from the secondary submitter 
including the percentage of formulation required pursuant to Sec.  
711.15(b)(3)(i)(A), (B), and (C).
    (4) All confidentiality claims require certification in accordance 
with subsection (g) of this section. All asserted confidentiality 
claims, whether subject to substantiation and review or not, may only 
be asserted consistent with the representations set forth in the 
certification described in subsection (h) of this section.
    (b) All confidentiality claims requiring substantiation at time of 
submission. For each data element claimed as confidential, you must 
submit with your report detailed written answers to the following 
questions signed and dated by an authorized official.
    (1) Will disclosure of the information claimed as confidential 
likely cause substantial harm to your business's competitive position? 
If you answered yes, explain the substantial harm.
    (2) To the extent your business has disclosed the information to 
others (both internally and externally), has your business taken 
precautions to protect the disclosed information? If yes, please 
explain and identify the specific measures or internal controls your 
business has taken to protect the information claimed as confidential.
    (3) Does any of the information claimed as confidential appear in 
any public documents, including (but not limited to) safety data 
sheets, advertising or promotional material, professional or trade 
publications, or any other media or publications available to the 
general public? If you answered yes, explain why the information should 
be treated as confidential.
    (4) Does any of the information you are claiming as confidential 
constitute a trade secret?
    (5) Is the claim of confidentiality intended to last less than 10 
years (see TSCA section 14(e)(1)(B))? If so, indicate the number of 
years (between 1-10 years) or the specific date after which the claim 
is withdrawn.
    (6) Has EPA, another federal agency, or court made any 
confidentiality determination regarding information associated with 
this chemical substance? If yes, provide the circumstances associated 
with the prior determination, whether the information was found to be 
entitled to confidential treatment, the entity that made the decision, 
and the date of the determination.
    (c) Additional requirements for specific chemical identity. The 
specific chemical identity includes the CA Index name and corresponding 
CASRN as described in Sec.  711.15(b)(3) of this part, and does not 
include generic chemical identities or TSCA Accession Number. Generic 
chemical identities and accession numbers may not be claimed as 
confidential. A person may assert a claim of confidentiality for the 
specific chemical identity of a chemical substance only if the identity 
of that chemical substance is treated as confidential in the Master 
Inventory File as of the time the report is submitted for that chemical 
substance. To assert a claim of confidentiality for the identity of a 
reportable chemical substance, you must submit with the report detailed 
written answers to the questions from paragraph (b) of this section and 
to the following questions signed and dated by an authorized official.
    (1) Is this chemical substance publicly known to be in U.S. 
commerce by a specific chemical identity or name that is consistent 
with its listing on the confidential portion of the TSCA Inventory? If 
yes, explain why the chemical identity should still be afforded 
confidential status (i.e., the chemical is publicly known only as being 
distributed in commerce for research and development purposes). If no, 
complete the certification statement:

    I certify that on the date referenced, I searched the internet 
for the chemical substance identity (i.e., by both chemical 
substance name and CASRN). I did not find a reference to this 
chemical substance which would indicate the chemical is being 
manufactured or imported for a commercial purpose and is available 
in the United States by anyone. [provide date].

    (2) Does this particular chemical substance leave the site of 
manufacture (including import) in any form, e.g., as product, effluent, 
emission? If so, what measures have been taken to guard against the 
discovery of its identity?
    (3) If the chemical substance leaves the site in a product that is 
available to the public or your competitors, can the chemical substance 
be identified by analysis of the product?
    (4) Would disclosure of the specific chemical name release 
confidential process information? If yes, please explain?
    (d) Company, site, and technical contact identity information. A

[[Page 17727]]

submitter may assert a claim of confidentiality for a site, company, or 
technical contact identity only if the linkage of that information to a 
reportable chemical substance is confidential and not publicly 
available. To assert a claim of confidentiality to protect the link 
between the company, site, or technical contact identity and the 
chemical substance information, you must submit with the report 
detailed written answers to the questions from paragraph (b) of this 
section and to the following questions, as applicable, signed and dated 
by an authorized official.
    (1) Has company, site, or technical contact identity information 
been linked with a reportable chemical substance in any public document 
or in any other Federal, State, or local reporting scheme? For example, 
is the chemical identity linked to a facility in a filing under the 
Emergency Planning and Community Right-to-Know Act (EPCRA) section 311, 
namely through a Safety Data Sheet (SDS)? If yes, explain why the 
information should be treated as confidential.
    (e) Additional requirements for processing and use information. A 
submitter may assert a claim of confidentiality for each data element 
required by Sec.  711.15(b)(4)(i)(D), (E) and (F) and Sec.  
711.15(b)(4)(ii)(D), (E) and (F) only if the linkage of the information 
with a reportable chemical substance is confidential and not publicly 
available. To assert a claim of confidentiality for each data element 
required by Sec.  711.15(b)(4) which is potentially eligible for 
protection from disclosure, you must submit with the report detailed 
written answers to the questions from paragraph (b) of this section and 
to the following questions signed and dated by an authorized official:
    (1) Is the information claimed as confidential publicly known? For 
example, is the information available in advertisements or other 
marketing materials, professional journals or other similar materials, 
or in non-confidential mandatory or voluntary government filings or 
publications? Has your company ever publicly released this information? 
If yes, explain why the information should be treated as confidential.
    (2) Has your company ever provided this information on the chemical 
substance to any person and not asked that it be treated as 
confidential? If yes, explain why the information should be treated as 
confidential.
    (f) Joint Submissions. If a primary submitter asks a secondary 
submitter to provide information directly to EPA in a joint submission 
under Sec.  711.15(b)(3)(i)(A) and (B), only the primary submitter may 
assert a confidentiality claim for the data elements it directly 
submits to EPA. The primary submitter must substantiate those claims 
not exempt under subparagraph (a)(3)(ii) of this section. The secondary 
submitter is responsible for asserting all confidentiality claims for 
the data elements it submits directly to EPA and substantiating those 
claims not exempt under subparagraph (a)(3)(iii) of this section.
    (g) Marking substantiations. If any of the information contained in 
the answers to the questions listed in subsections (b) though (e) of 
this section is asserted to contain information that itself is 
considered to be confidential, you must clearly identify the 
information that is claimed confidential by marking the specific 
information on each page with a label such as ``confidential business 
information,'' ``proprietary,'' or ``trade secret.''
    (h) Certification statement for claims. An authorized official of a 
person asserting a claim of confidentiality must certify that the 
submission complies with the requirements of this part by signing and 
dating the following certification statement:

    I certify that all claims for confidentiality asserted with this 
submission are true and correct, and all information submitted 
herein to substantiate such claims is true and correct. Any knowing 
and willful misrepresentation is subject to criminal penalty 
pursuant to 18 U.S.C. 1001. I further certify that: (1) I have taken 
reasonable measures to protect the confidentiality of the 
information; (2) I have determined that the information is not 
required to be disclosed or otherwise made available to the public 
under any other Federal law; (3) I have a reasonable basis to 
conclude that disclosure of the information is likely to cause 
substantial harm to the competitive position of my company; and (4) 
I have a reasonable basis to believe that the information is not 
readily discoverable through reverse engineering.

    (i) No claim of confidentiality. Information not asserted as 
confidential in accordance with the requirements of this section may be 
made public without further notice to the submitter.
0
15. Section 711.35 is amended by revising paragraph (c)(1) to read as 
follows:


Sec.  711.35  Electronic filing.

* * * * *
    (c) * * *
    (1) By website. Go to the EPA Chemical Data Reporting internet 
homepage at http://www.epa.gov/cdr and follow the appropriate links.
* * * * *

PART 712--[AMENDED]

0
 16. The authority citation for part 712 continues to read as follows:

    Authority: 15 U.S.C. 2607(a).

0
17. Section 712.25 is amended by revising paragraph (c) to read as 
follows:


Sec.  712.25  . Exempt manufacturers and importers.

* * * * *
    (c) Persons who qualify as small manufacturers (including 
importers) in respect to a specific chemical substance listed in Sec.  
712.30 are exempt. However, this exemption does not apply with respect 
to any chemical in Sec.  712.30 designated by an asterisk. A 
manufacturer is qualified as small and is exempt from submitting a 
report under this subpart for a chemical substance manufactured at a 
particular plant site if it meets the definition for small manufacturer 
in Sec.  704.3.
* * * * *
[FR Doc. 2019-07716 Filed 4-24-19; 8:45 am]
 BILLING CODE 6560-50-P


