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

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

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

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

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).

    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

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.

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.
------------------------------------------------------------------------

    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

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.

    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-

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

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

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.

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

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

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